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NCT05203965
|
Functional Neuroimaging of Alcoholism Vulnerability: Probing Glutamate and Reward, Using the mGluR5 Inhibitor Mavoglurant
|
The purpose of this study is to evaluate the role of Mavoglurant in clarifying the neurobiology of alcoholism risk. This is a one-site, randomized, within subjects, counterbalanced double-blind study of a single dose (200mg) of Mavoglurant and placebo.
|
This project explores the effects of 1 dose of Mavoglurant, an experimental non-competitive antagonist to metabotropic glutamate receptor-5 (mGlur5) developed by Novartis, in a double-blind, randomized, counterbalanced manner on alcoholism risk-relevant tasks. Drug/placebo will be administered on 2 separate visits separated by 1 week. More specifically, this project examines 4 functional MRI tasks related to different aspects of reward and/or impulsivity-related behavior in different contexts, compares the underlying neural circuitry across tasks, and uses a pharmacologic probe of the glutamatergic system to examine N-methyl-D-Aspartate and Dopamine (NMDA/DA) interactions. The combined measures provide the opportunity to advance our understanding of specific aspects of brain function related to familial alcoholism vulnerability in an already well characterized population as some members evolve into alcohol abuse. In addition, as well as conventional within-task analyses, functional network connectivity and allied approaches will be used to examine brain networks across the tasks.
|
Functional Neuroimaging of Alcoholism Vulnerability: Probing Glutamate and Reward, Using the mGluR5 Inhibitor Mavoglurant
|
Familial Alcoholism Vulnerability
|
* Drug: Mavoglurant (AFQ056)
* Drug: Placebo
|
Inclusion Criteria:~Ages 18-45 years~Estimated full-scale IQ>70~Individual can cooperate with all study procedures~No history of neurological disorder (e.g., epilepsy)~No major medical condition (e.g., cancer)~No history of significant head trauma~Stable medication treatment 6 weeks prior to study enrollment~Negative urine drug and breathe alcohol test at time of MRI scan~Negative urine pregnancy test at time of MRI scan~No MR contra-indications (e.g., in-body metal implant, severe claustrophobia)~No contra-indications to study drug~Exclusion Criteria:~A diagnosis of any psychotic disorder, or current mood or anxiety disorders under DSM-V, using the SCID-V-RV psychiatric interview~A current diagnosis of: a) Alcohol use disorder, if severe (AUD, mild or moderate OK if no craving, tolerance, and withdrawal 3 months prior to interview) b) Substance use disorder~Report of psychotic disorder in a 1º relative~Auditory or visual impairment that interferes with test-taking~Prenatal exposure to alcohol plus currently meeting criteria for features of fetal alcohol syndrome~Not speaking English fluently or being a non-native English speaker, or being educated in a primary language other than English > grade 1~Intellectual Disability (Full Scale IQ<70)~Traumatic brain injury with loss of consciousness > 30 minutes or concussion in last 30 days~Presence or history of neurosurgery or any neurologic illness that may affect brain physiology (e.g., epilepsy, Multiple Sclerosis), including focal brain lesion seen on structural MRI (all structural scans are read by a board certified radiologist)~A current major medical condition (e.g. cancer, heart failure)~Current pregnancy (all females will be tested with urine screens on the day of MRI)~Women not on an effective form of birth control/contraception or abstinent during time of study visits to prevent exposure of the investigational drug to suspected fetus~Current substance use with the exception of marijuana (THC), provided last use of THC was 24+ hours before visit (All participants will receive a urine screen for the presence of marijuana, cocaine, opiates and a breath screen to detect the presence of alcohol)~Inability to comprehend the consent form appropriately~Inability to cooperate with study procedures~Other specific fMRI exclusions include metal devices, clips or fragments in body (orbital xray performed if needed)
|
18 Years
|
45 Years
|
All
|
Accepts Healthy Volunteers
|
Primary Purpose: Prevention
Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: Double
|
| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change in Nucleus accumbens (Nacc)/Ventral striatum (VS) BOLD activation during A1 phase in FHP on study medication vs. placebo | Changes in NAcc/VS BOLD (Blood-oxygen-level-dependent) activation during the A1 loss anticipation prospect phase of the MRI Monetary Incentive Delay task in FHP while on mavoglurant compared to placebo | Mavoglurant and Placebo administration are 1 week apart |
| BOLD activation to alcohol vs. non-alcohol stimuli during ACR task alcohol versus non-alcohol stimuli | Changes in BOLD response in FHP to alcohol versus non-alcohol stimuli in several brain clusters containing MFC, caudate, parahippocampal gyrus, temporal cortex and cerebellum, when administered mavoglurant compared to placebo | Mavoglurant and Placebo administration are 1 week apart |
|
| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Dynamic Causal Modeling (DCM)-determined relationships between nucleus accumbens (NAcc) and -medial PFC BOLD signal during MSDM task | Dynamic Causal Modeling (DCM)-determined relationships between nucleus accumbens (NAcc) and -medial PFC BOLD signal during MSDM fMRI task in FHP while on mavoglurant compared to placebo | Mavoglurant and Placebo administration are 1 week apart |
| Regional differences in BOLD signal | Impairment of top down inhibitory control and related cortical activation of the executive control network in FHP while on mavoglurant compared to placebo measured by regional differences in BOLD signaling | Mavoglurant and Placebo administration are 1 week apart |
|
Alcoholism, Alcohol-Related Disorders, Substance-Related Disorders, Chemically-Induced Disorders, Mental Disorders
|
| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: FHP; Mavoglurant-Placebo<br>Family History Positive (FHP) for alcoholism will be given a single dose of AFQ056 (200 mg) then placebo in two separate experimental study visits separated by 1 week. Drug and Placebo administered 2 hours prior to the MRI and other measures. | Drug: Mavoglurant (AFQ056)<br>* Two 100mg tablets of Mavoglurant will be administered on the morning of one of the two experimental days by a RN or the physician investigator.<br>Drug: Placebo<br>* Two matching tablets of placebo will be administered on the morning of one of the two experimental days by an RN or the physician investigator.<br>|
| Experimental: FHP; Placebo-Mavoglurant<br>Family History Positive (FHP) or alcoholism will be given a single dose of placebo then AFQ056 (200 mg) in two separate experimental study visits separated by 1 week. Drug and Placebo administered 2 hours prior to the MRI and other measures. | Drug: Mavoglurant (AFQ056)<br>* Two 100mg tablets of Mavoglurant will be administered on the morning of one of the two experimental days by a RN or the physician investigator.<br>Drug: Placebo<br>* Two matching tablets of placebo will be administered on the morning of one of the two experimental days by an RN or the physician investigator.<br>|
| Experimental: FHN; Mavoglurant-Placebo<br>Family History Negative (FHN) for alcoholism will be given a single dose of AFQ056 (200 mg) then placebo in two separate experimental study visits separated by 1 week. Drug and Placebo administered 2 hours prior to the MRI and other measures. | Drug: Mavoglurant (AFQ056)<br>* Two 100mg tablets of Mavoglurant will be administered on the morning of one of the two experimental days by a RN or the physician investigator.<br>Drug: Placebo<br>* Two matching tablets of placebo will be administered on the morning of one of the two experimental days by an RN or the physician investigator.<br>|
| Experimental: FHN; Placebo-Mavoglurant<br>Family History Negative (FHN) for alcoholism will be given a single dose of placebo then AFQ056 (200 mg) in two separate experimental study visits separated by 1 week. Drug and Placebo administered 2 hours prior to the MRI and other measures. | Drug: Mavoglurant (AFQ056)<br>* Two 100mg tablets of Mavoglurant will be administered on the morning of one of the two experimental days by a RN or the physician investigator.<br>Drug: Placebo<br>* Two matching tablets of placebo will be administered on the morning of one of the two experimental days by an RN or the physician investigator.<br>|
|
Functional Neuroimaging of Alcoholism Vulnerability: Probing Glutamate and Reward, Using the mGluR5 Inhibitor Mavoglurant
Study Overview
=================
Brief Summary
-----------------
The purpose of this study is to evaluate the role of Mavoglurant in clarifying the neurobiology of alcoholism risk. This is a one-site, randomized, within subjects, counterbalanced double-blind study of a single dose (200mg) of Mavoglurant and placebo.
Detailed Description
-----------------
This project explores the effects of 1 dose of Mavoglurant, an experimental non-competitive antagonist to metabotropic glutamate receptor-5 (mGlur5) developed by Novartis, in a double-blind, randomized, counterbalanced manner on alcoholism risk-relevant tasks. Drug/placebo will be administered on 2 separate visits separated by 1 week. More specifically, this project examines 4 functional MRI tasks related to different aspects of reward and/or impulsivity-related behavior in different contexts, compares the underlying neural circuitry across tasks, and uses a pharmacologic probe of the glutamatergic system to examine N-methyl-D-Aspartate and Dopamine (NMDA/DA) interactions. The combined measures provide the opportunity to advance our understanding of specific aspects of brain function related to familial alcoholism vulnerability in an already well characterized population as some members evolve into alcohol abuse. In addition, as well as conventional within-task analyses, functional network connectivity and allied approaches will be used to examine brain networks across the tasks.
Official Title
-----------------
Functional Neuroimaging of Alcoholism Vulnerability: Probing Glutamate and Reward, Using the mGluR5 Inhibitor Mavoglurant
Conditions
-----------------
Familial Alcoholism Vulnerability
Intervention / Treatment
-----------------
* Drug: Mavoglurant (AFQ056)
* Drug: Placebo
Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Ages 18-45 years Estimated full-scale IQ>70 Individual can cooperate with all study procedures No history of neurological disorder (e.g., epilepsy) No major medical condition (e.g., cancer) No history of significant head trauma Stable medication treatment 6 weeks prior to study enrollment Negative urine drug and breathe alcohol test at time of MRI scan Negative urine pregnancy test at time of MRI scan No MR contra-indications (e.g., in-body metal implant, severe claustrophobia) No contra-indications to study drug Exclusion Criteria: A diagnosis of any psychotic disorder, or current mood or anxiety disorders under DSM-V, using the SCID-V-RV psychiatric interview A current diagnosis of: a) Alcohol use disorder, if severe (AUD, mild or moderate OK if no craving, tolerance, and withdrawal 3 months prior to interview) b) Substance use disorder Report of psychotic disorder in a 1º relative Auditory or visual impairment that interferes with test-taking Prenatal exposure to alcohol plus currently meeting criteria for features of fetal alcohol syndrome Not speaking English fluently or being a non-native English speaker, or being educated in a primary language other than English > grade 1 Intellectual Disability (Full Scale IQ<70) Traumatic brain injury with loss of consciousness > 30 minutes or concussion in last 30 days Presence or history of neurosurgery or any neurologic illness that may affect brain physiology (e.g., epilepsy, Multiple Sclerosis), including focal brain lesion seen on structural MRI (all structural scans are read by a board certified radiologist) A current major medical condition (e.g. cancer, heart failure) Current pregnancy (all females will be tested with urine screens on the day of MRI) Women not on an effective form of birth control/contraception or abstinent during time of study visits to prevent exposure of the investigational drug to suspected fetus Current substance use with the exception of marijuana (THC), provided last use of THC was 24+ hours before visit (All participants will receive a urine screen for the presence of marijuana, cocaine, opiates and a breath screen to detect the presence of alcohol) Inability to comprehend the consent form appropriately Inability to cooperate with study procedures Other specific fMRI exclusions include metal devices, clips or fragments in body (orbital xray performed if needed)
Ages Eligible for Study
-----------------
Minimum Age: 18 Years
Maximum Age: 45 Years
Sexes Eligible for Study
-----------------
All
Accepts Healthy Volunteers
-----------------
Accepts Healthy Volunteers
Study Plan
=================
How is the study designed?
-----------------
Design Details
Primary Purpose: Prevention
Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: Double
Arms and Interventions
| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: FHP; Mavoglurant-Placebo<br>Family History Positive (FHP) for alcoholism will be given a single dose of AFQ056 (200 mg) then placebo in two separate experimental study visits separated by 1 week. Drug and Placebo administered 2 hours prior to the MRI and other measures. | Drug: Mavoglurant (AFQ056)<br>* Two 100mg tablets of Mavoglurant will be administered on the morning of one of the two experimental days by a RN or the physician investigator.<br>Drug: Placebo<br>* Two matching tablets of placebo will be administered on the morning of one of the two experimental days by an RN or the physician investigator.<br>|
| Experimental: FHP; Placebo-Mavoglurant<br>Family History Positive (FHP) or alcoholism will be given a single dose of placebo then AFQ056 (200 mg) in two separate experimental study visits separated by 1 week. Drug and Placebo administered 2 hours prior to the MRI and other measures. | Drug: Mavoglurant (AFQ056)<br>* Two 100mg tablets of Mavoglurant will be administered on the morning of one of the two experimental days by a RN or the physician investigator.<br>Drug: Placebo<br>* Two matching tablets of placebo will be administered on the morning of one of the two experimental days by an RN or the physician investigator.<br>|
| Experimental: FHN; Mavoglurant-Placebo<br>Family History Negative (FHN) for alcoholism will be given a single dose of AFQ056 (200 mg) then placebo in two separate experimental study visits separated by 1 week. Drug and Placebo administered 2 hours prior to the MRI and other measures. | Drug: Mavoglurant (AFQ056)<br>* Two 100mg tablets of Mavoglurant will be administered on the morning of one of the two experimental days by a RN or the physician investigator.<br>Drug: Placebo<br>* Two matching tablets of placebo will be administered on the morning of one of the two experimental days by an RN or the physician investigator.<br>|
| Experimental: FHN; Placebo-Mavoglurant<br>Family History Negative (FHN) for alcoholism will be given a single dose of placebo then AFQ056 (200 mg) in two separate experimental study visits separated by 1 week. Drug and Placebo administered 2 hours prior to the MRI and other measures. | Drug: Mavoglurant (AFQ056)<br>* Two 100mg tablets of Mavoglurant will be administered on the morning of one of the two experimental days by a RN or the physician investigator.<br>Drug: Placebo<br>* Two matching tablets of placebo will be administered on the morning of one of the two experimental days by an RN or the physician investigator.<br>|
What is the study measuring?
-----------------
Primary Outcome Measures
| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change in Nucleus accumbens (Nacc)/Ventral striatum (VS) BOLD activation during A1 phase in FHP on study medication vs. placebo | Changes in NAcc/VS BOLD (Blood-oxygen-level-dependent) activation during the A1 loss anticipation prospect phase of the MRI Monetary Incentive Delay task in FHP while on mavoglurant compared to placebo | Mavoglurant and Placebo administration are 1 week apart |
| BOLD activation to alcohol vs. non-alcohol stimuli during ACR task alcohol versus non-alcohol stimuli | Changes in BOLD response in FHP to alcohol versus non-alcohol stimuli in several brain clusters containing MFC, caudate, parahippocampal gyrus, temporal cortex and cerebellum, when administered mavoglurant compared to placebo | Mavoglurant and Placebo administration are 1 week apart |
Secondary Outcome Measures
| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Dynamic Causal Modeling (DCM)-determined relationships between nucleus accumbens (NAcc) and -medial PFC BOLD signal during MSDM task | Dynamic Causal Modeling (DCM)-determined relationships between nucleus accumbens (NAcc) and -medial PFC BOLD signal during MSDM fMRI task in FHP while on mavoglurant compared to placebo | Mavoglurant and Placebo administration are 1 week apart |
| Regional differences in BOLD signal | Impairment of top down inhibitory control and related cortical activation of the executive control network in FHP while on mavoglurant compared to placebo measured by regional differences in BOLD signaling | Mavoglurant and Placebo administration are 1 week apart |
|
|
NCT00535925
|
Nephropathy In Type 2 Diabetes and Cardio-renal Events
|
The NID-2 study, a multicentric study (21 centres enrolled), was planned in two phases:~Phase 1(observational study, completed in September 2005): after the identification of a type-2 diabetic population with typical Diabetic Nephropathy (DN), to study of the rate of renal and cardiovascular events during a middle term follow-up.~Phase 2(interventional study, started in October 2005): after randomization in two groups, a group (intervention group) is treated with an intensive multifactorial intervention whose aim is to reduce morbidity and mortality due to diabetic complications. The other group (control group) continues the conventional therapy . To avoid bias in the treatment in each center, the randomization was performed for centre.
|
The same patients that completed the first phase of the NID-2 study (observation) were enrolled for the phase 2 of the study (intervention).
|
Nephropathy in Type 2 Diabetes: Effects of an Intensive Multifactorial Intervention Trial on Cardio-renal Events.
|
Diabetic Nephropathy
|
* Drug: SoC therapy
* Drug: irbesartan
* Drug: ramipril
* Drug: hydrochlorothiazide
* Drug: furosemide
* Drug: amlodipine
* Drug: atenolol
* Drug: doxazosin
* Drug: clonidine
* Drug: insulin
* Drug: simvastatin
* Drug: fibrate
* Drug: erythropoietin
* Drug: aspirin
|
Inclusion Criteria:~type 2 diabetic patients~albumin extraction rate (AER= >30 mg/die (micro- or macro-albuminuric ranges) in at least two determinations in the last six months~diabetic retinopathy~patients followed in the outpatients clinic for at least 12 months~Exclusion Criteria:~type 1 diabetic patients~<40 years old
|
40 Years
|
70 Years
|
All
|
No
|
Primary Purpose: Prevention
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
|
| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Number of Participants With Overall Fatal and Non-fatal, Major Adverse Cardiovascular Events (MACEs) | number of MACEs in the two groups are reported. In addition, The primary endpoint was analyzed with event curves for the time-to-first event based on Kaplan-Meier analysis. Cox regression model was used to calculate hazard ratio (HR) and 95% Confidence Interval (CI). Due to the cluster randomized study design, a Cox shared-frailty model was fitted. multivariable model was adjusted for selected potential confounders: age, sex, systolic blood pressure (SBP), hemoglobin, estimated glomerular filtration rate (eGFR), albuminuria, HbA1c, total cholesterol and triglycerides (log-scaled) to reduce risk of bias. | 4 years (in the case the number of events needed by sample size is not reached at the expected 4-year time frame, primary end point will be assessed after the follow-up phase) |
|
| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Number of Participants Who Achieved of BP, HbA1c and Total, HDL and LDL Cholesterol Goals at the End of Intervention Phase | Achievement of targets at end of intervention was performed applying generalized estimating equation (GEE) models, further adjusting for baseline values as covariate. | 13 years |
|
type 2 diabetes, nephropathy, cardiovascular (CV) events
|
Simvastatin, Antimetabolites, Clonidine, Aspirin, Atenolol, Amlodipine, Hydrochlorothiazide, Ramipril, Irbesartan, Doxazosin, Furosemide, Epoetin Alfa, Physiological Effects of Drugs, Anti-Inflammatory Agents, Non-Steroidal, Analgesics, Non-Narcotic, Analgesics, Sensory System Agents, Peripheral Nervous System Agents, Anti-Inflammatory Agents, Antirheumatic Agents, Fibrinolytic Agents, Fibrin Modulating Agents, Molecular Mechanisms of Pharmacological Action, Platelet Aggregation Inhibitors, Cyclooxygenase Inhibitors, Enzyme Inhibitors, Antipyretics, Antihypertensive Agents, Calcium Channel Blockers, Membrane Transport Modulators, Calcium-Regulating Hormones and Agents, Vasodilator Agents, Anticholesteremic Agents, Hypolipidemic Agents, Lipid Regulating Agents, Hydroxymethylglutaryl-CoA Reductase Inhibitors, Diuretics, Natriuretic Agents, Sodium Chloride Symporter Inhibitors, Sodium Potassium Chloride Symporter Inhibitors, Sympatholytics, Autonomic Agents, Adrenergic alpha-2 Receptor Agonists, Adrenergic alpha-Agonists, Adrenergic Agonists, Adrenergic Agents, Neurotransmitter Agents, Hematinics, Angiotensin-Converting Enzyme Inhibitors, Protease Inhibitors, Angiotensin II Type 1 Receptor Blockers, Angiotensin Receptor Antagonists, Anti-Arrhythmia Agents, Adrenergic beta-1 Receptor Antagonists, Adrenergic beta-Antagonists, Adrenergic Antagonists, Adrenergic alpha-1 Receptor Antagonists, Adrenergic alpha-Antagonists
|
| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: Standard of Care (SoC) therapy<br>Control group patients will continue their SoC therapy. During the study such patients could receive all the therapeutic modifications according to the good medical practice of the specialist. | Drug: SoC therapy<br>* the patients have to be treated according the standard good medical practice by any center<br>|
| Experimental: Multifactorial Intensified therapy<br>An intensive multifactorial intervention according Scientific Guidelines is performed to achieve the goals for the following risk factors: hypertension, hyperglycaemia, lipids, anaemia.~In particular, new antihypertensive drugs will be added one by one until the achievement of blood pressure target (<130/80 mmHg). | Drug: irbesartan<br>* Therapy for hypertension:~- Step 1: irbesartan 300 mg/die and ramipril 10 mg/die<br>Drug: ramipril<br>* Therapy for hypertension:~- Step 1: irbesartan 300 mg/die and ramipril 10 mg/die<br>Drug: hydrochlorothiazide<br>* Therapy for hypertension~- Step 2: Diuretic (hydrochlorothiazide 12.5-25 mg/die if serum creatinine <2 mg/dl, furosemide 25-75 mg/die if serum creatinin ≥2 mg/dl)<br>Drug: furosemide<br>* Therapy for hypertension~- Step 2: Diuretic (hydrochlorothiazide 12.5-25 mg/die if serum creatinine <2 mg/dl, furosemide 25-75 mg/die if serum creatinin ≥2 mg/dl)<br>Drug: amlodipine<br>* Therapy for hypertension~- Step 3: amlodipine up to 10 mg/die<br>Drug: atenolol<br>* Therapy for hypertension~- Step 4: atenolol up to 100 mg/die<br>Drug: doxazosin<br>* Therapy for hypertension~- Step 5: doxazosin up to 4 mg/die<br>Drug: clonidine<br>* Therapy for hypertension~- Step 6: clonidine<br>Drug: insulin<br>* Therapy for Hyperglycaemia (to achieve HbA1c <7):~- insulin<br>Drug: simvastatin<br>* Therapy for hypercholesterolemia:~- for reducing LDL cholesterol < 100 mg/dl: simvastatin up to 80 mg/die<br>Drug: fibrate<br>* Therapy for hypertriglyceridemia~- for reducing triglycerides < 150 mg/dl and/or increasing HDL cholesterol > 40-50 mg/dl: a fibrate<br>Drug: erythropoietin<br>* Treatment of anaemia:~- erythropoietin<br>Drug: aspirin<br>* Antiplatelet therapy (in all patients without contraindications):~- aspirin up to 160 mg/die<br>|
|
Nephropathy In Type 2 Diabetes and Cardio-renal Events
Study Overview
=================
Brief Summary
-----------------
The NID-2 study, a multicentric study (21 centres enrolled), was planned in two phases: Phase 1(observational study, completed in September 2005): after the identification of a type-2 diabetic population with typical Diabetic Nephropathy (DN), to study of the rate of renal and cardiovascular events during a middle term follow-up. Phase 2(interventional study, started in October 2005): after randomization in two groups, a group (intervention group) is treated with an intensive multifactorial intervention whose aim is to reduce morbidity and mortality due to diabetic complications. The other group (control group) continues the conventional therapy . To avoid bias in the treatment in each center, the randomization was performed for centre.
Detailed Description
-----------------
The same patients that completed the first phase of the NID-2 study (observation) were enrolled for the phase 2 of the study (intervention).
Official Title
-----------------
Nephropathy in Type 2 Diabetes: Effects of an Intensive Multifactorial Intervention Trial on Cardio-renal Events.
Conditions
-----------------
Diabetic Nephropathy
Intervention / Treatment
-----------------
* Drug: SoC therapy
* Drug: irbesartan
* Drug: ramipril
* Drug: hydrochlorothiazide
* Drug: furosemide
* Drug: amlodipine
* Drug: atenolol
* Drug: doxazosin
* Drug: clonidine
* Drug: insulin
* Drug: simvastatin
* Drug: fibrate
* Drug: erythropoietin
* Drug: aspirin
Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: type 2 diabetic patients albumin extraction rate (AER= >30 mg/die (micro- or macro-albuminuric ranges) in at least two determinations in the last six months diabetic retinopathy patients followed in the outpatients clinic for at least 12 months Exclusion Criteria: type 1 diabetic patients <40 years old
Ages Eligible for Study
-----------------
Minimum Age: 40 Years
Maximum Age: 70 Years
Sexes Eligible for Study
-----------------
All
Accepts Healthy Volunteers
-----------------
No
Study Plan
=================
How is the study designed?
-----------------
Design Details
Primary Purpose: Prevention
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Arms and Interventions
| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: Standard of Care (SoC) therapy<br>Control group patients will continue their SoC therapy. During the study such patients could receive all the therapeutic modifications according to the good medical practice of the specialist. | Drug: SoC therapy<br>* the patients have to be treated according the standard good medical practice by any center<br>|
| Experimental: Multifactorial Intensified therapy<br>An intensive multifactorial intervention according Scientific Guidelines is performed to achieve the goals for the following risk factors: hypertension, hyperglycaemia, lipids, anaemia. In particular, new antihypertensive drugs will be added one by one until the achievement of blood pressure target (<130/80 mmHg). | Drug: irbesartan<br>* Therapy for hypertension: - Step 1: irbesartan 300 mg/die and ramipril 10 mg/die<br>Drug: ramipril<br>* Therapy for hypertension: - Step 1: irbesartan 300 mg/die and ramipril 10 mg/die<br>Drug: hydrochlorothiazide<br>* Therapy for hypertension - Step 2: Diuretic (hydrochlorothiazide 12.5-25 mg/die if serum creatinine <2 mg/dl, furosemide 25-75 mg/die if serum creatinin ≥2 mg/dl)<br>Drug: furosemide<br>* Therapy for hypertension - Step 2: Diuretic (hydrochlorothiazide 12.5-25 mg/die if serum creatinine <2 mg/dl, furosemide 25-75 mg/die if serum creatinin ≥2 mg/dl)<br>Drug: amlodipine<br>* Therapy for hypertension - Step 3: amlodipine up to 10 mg/die<br>Drug: atenolol<br>* Therapy for hypertension - Step 4: atenolol up to 100 mg/die<br>Drug: doxazosin<br>* Therapy for hypertension - Step 5: doxazosin up to 4 mg/die<br>Drug: clonidine<br>* Therapy for hypertension - Step 6: clonidine<br>Drug: insulin<br>* Therapy for Hyperglycaemia (to achieve HbA1c <7): - insulin<br>Drug: simvastatin<br>* Therapy for hypercholesterolemia: - for reducing LDL cholesterol < 100 mg/dl: simvastatin up to 80 mg/die<br>Drug: fibrate<br>* Therapy for hypertriglyceridemia - for reducing triglycerides < 150 mg/dl and/or increasing HDL cholesterol > 40-50 mg/dl: a fibrate<br>Drug: erythropoietin<br>* Treatment of anaemia: - erythropoietin<br>Drug: aspirin<br>* Antiplatelet therapy (in all patients without contraindications): - aspirin up to 160 mg/die<br>|
What is the study measuring?
-----------------
Primary Outcome Measures
| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Number of Participants With Overall Fatal and Non-fatal, Major Adverse Cardiovascular Events (MACEs) | number of MACEs in the two groups are reported. In addition, The primary endpoint was analyzed with event curves for the time-to-first event based on Kaplan-Meier analysis. Cox regression model was used to calculate hazard ratio (HR) and 95% Confidence Interval (CI). Due to the cluster randomized study design, a Cox shared-frailty model was fitted. multivariable model was adjusted for selected potential confounders: age, sex, systolic blood pressure (SBP), hemoglobin, estimated glomerular filtration rate (eGFR), albuminuria, HbA1c, total cholesterol and triglycerides (log-scaled) to reduce risk of bias. | 4 years (in the case the number of events needed by sample size is not reached at the expected 4-year time frame, primary end point will be assessed after the follow-up phase) |
Secondary Outcome Measures
| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Number of Participants Who Achieved of BP, HbA1c and Total, HDL and LDL Cholesterol Goals at the End of Intervention Phase | Achievement of targets at end of intervention was performed applying generalized estimating equation (GEE) models, further adjusting for baseline values as covariate. | 13 years |
Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
type 2 diabetes, nephropathy, cardiovascular (CV) events
|
NCT03222518
|
NSAIDs Versus Paracetamol Versus Paracetamol + NSAIDs in Traumatic Pain Management
|
The purpose of this study is to:~Compare the effect of paracetamol alone against NSAIDs alone against the association of paracetamol + NSAIDs in the treatment of traumatic pain.
|
Paracetamol, NSAIDs, or a combination of the two molecules are usually prescribed. Patients even use these medications without a prescription. It is not known, however, whether or not NSAIDs have an additional value relative to paracetamol for the treatment of pain.~All patients were assigned in a 1:1:1 ratio. Randomization of subjects was performed centrally according to a computer-generated random code provided by one of investigators who was not involved in any other part of the trial. The patients included were divided into 3 groups: Paracetamol group who received paracetamol 1000 mg orally every 8th hour for 7 days; NSAID group who received piroxicam 20 mg orally twice a day for 7 days, and Paracetamol-NSAID combination who received both treatments at the same doses for 7 days. All protocol treatments were administered in opaque packets with code number according to the randomization list by an independent nurse who was not involved in monitoring or follow-up of the individuals. Data were collected for each patient, including demographics, medical history, and findings of the clinical examination. Injury Severity Score (ISS) whose values range from 0 to 75 was also assessed. Each patient was re-evaluated on the 3rd and 7th day post-trauma (D7) using a telephone contact by a clinical research associates who was blinded to the details of the study to note the following clinical data: pain VNS, ED readmissions for residual pain, need for other analgesics other than those of the protocol, other treatment modalities the patient might have used (adherence to the treatment prescribed), and side effects. In addition patients were asked about their satisfaction with pain control following ED using five point Likert scale: very dissatisfied, not satisfied, neutral, satisfied and very satisfied and about the degree to which they adhered to medication schedule. The principal investigator who was aware of the allocation was not involved in monitoring or recording of the outcomes until the data collection was completed.
|
NSAIDs Versus Paracetamol Versus Paracetamol + NSAIDs in Traumatic Pain Management
|
Acute Pain Due to Trauma
|
* Drug: Paracetamol
* Drug: NSAID
* Drug: paracetamol-NSAID
|
Inclusion Criteria:~age 18 years or older~acute (<24 hours) post traumatic pain of the extremity and requiring analgesic treatment upon discharge for pain with intensity >3 on a visual numeric scale~Exclusion criteria:~open fracture~head, abdominal, thoracic or polytrauma.~Need for hospitalization, regular use of paracetamol and NSAIDs during the two weeks before admission to ED~history of allergy or hypersensitivity to either paracetamol or NSAIDs,~contraindication to paracetamol or NSAIDs,~acute /history of GI hemorrhage and renal insufficiency,~an inability to assess pain intensity according to the VNS.~Pregnancy~heart failure~known hepatic cirrhosis~known severe renal impairment (Creatinine clearance <30 ml/min)~swallowing disorders~Refusal, incapacity or difficulties to consent or to communicate
|
18 Years
| null |
All
|
No
|
Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Interventional Model Description: Subjects are randomized in 3 arms:~paracetamol group~NSAID group~paracetamol + NSAID group
Masking: Double
|
| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| new oral analgesic medications needed rate | oral analgesic medications other than those of the protocol prescribed by the treating physicians or taken by patients' own volition | 3 days and 7 days |
|
| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| the between-group difference in mean change in VNS score measured from ED discharge (VNS D0) to 7 days later | [delta VNS= (VNS D0 - VNS D7 / VNS D0) x 100] | 3 and 7 days |
| The appearance of side effects | The appearance of side effects: such as Drowsiness ,Decreased respiratory rate (<14 c / min), Cutaneous rash, Vomiting,Nausea,pruritus, Dizziness.~• Digestive hemorrhage. | 7 days |
| the rate of ED readmissions for residual pain | ED readmissions for residual pain | 3 and 7 days |
| patient satisfaction assessed by Likert's verbal scale. | patient satisfaction assessed by Likert's verbal scale. | 3 and 7 days |
|
acute pain, trauma, paracetamol, NSAID
|
Acetaminophen, Anti-Inflammatory Agents, Non-Steroidal, Piroxicam, Analgesics, Non-Narcotic, Analgesics, Sensory System Agents, Peripheral Nervous System Agents, Physiological Effects of Drugs, Antipyretics, Anti-Inflammatory Agents, Antirheumatic Agents, Cyclooxygenase Inhibitors, Enzyme Inhibitors, Molecular Mechanisms of Pharmacological Action
|
| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: Parcetamol Group<br>The patient receives an envelope containing Paracetamol 1000 mg at the dose of 3 times / day + follow-up sheet + appointment card. | Drug: NSAID<br>* 14 pills of piroxicam 20 mg are provided with a preconised dose of 1 pill 2times per day over 7 days period<br>* Other names: piroxicam;Drug: paracetamol-NSAID<br>* 21 identical pills of paracetamol ith a preconised dose of 1 pill 3 times per day over 7 days period+14 pills of piroxicam 20 mg are provided with a preconised dose of 1 pill 2times per day over 7 days period<br>* Other names: combination;|
| Active Comparator: NSAID Group<br>The patient receives an envelope containing NSAID 20 mg piroxicam twice daily / day + follow-up sheet + appointment card. | Drug: Paracetamol<br>* 21 pills of Paracetamol 1000mg are provided with a preconised dose of 1 pill 3 times per day over 7 days period<br>Drug: paracetamol-NSAID<br>* 21 identical pills of paracetamol ith a preconised dose of 1 pill 3 times per day over 7 days period+14 pills of piroxicam 20 mg are provided with a preconised dose of 1 pill 2times per day over 7 days period<br>* Other names: combination;|
| Active Comparator: NSAID + Paracetamol Group<br>The patient receives an envelope containing NSAID 20 mg piroxicam at a dose of 2 times/day + Paracetamol 1000 mg at a dose of 3 times / day + follow-up sheet + appointment card. | Drug: Paracetamol<br>* 21 pills of Paracetamol 1000mg are provided with a preconised dose of 1 pill 3 times per day over 7 days period<br>Drug: NSAID<br>* 14 pills of piroxicam 20 mg are provided with a preconised dose of 1 pill 2times per day over 7 days period<br>* Other names: piroxicam;|
|
NSAIDs Versus Paracetamol Versus Paracetamol + NSAIDs in Traumatic Pain Management
Study Overview
=================
Brief Summary
-----------------
The purpose of this study is to: Compare the effect of paracetamol alone against NSAIDs alone against the association of paracetamol + NSAIDs in the treatment of traumatic pain.
Detailed Description
-----------------
Paracetamol, NSAIDs, or a combination of the two molecules are usually prescribed. Patients even use these medications without a prescription. It is not known, however, whether or not NSAIDs have an additional value relative to paracetamol for the treatment of pain. All patients were assigned in a 1:1:1 ratio. Randomization of subjects was performed centrally according to a computer-generated random code provided by one of investigators who was not involved in any other part of the trial. The patients included were divided into 3 groups: Paracetamol group who received paracetamol 1000 mg orally every 8th hour for 7 days; NSAID group who received piroxicam 20 mg orally twice a day for 7 days, and Paracetamol-NSAID combination who received both treatments at the same doses for 7 days. All protocol treatments were administered in opaque packets with code number according to the randomization list by an independent nurse who was not involved in monitoring or follow-up of the individuals. Data were collected for each patient, including demographics, medical history, and findings of the clinical examination. Injury Severity Score (ISS) whose values range from 0 to 75 was also assessed. Each patient was re-evaluated on the 3rd and 7th day post-trauma (D7) using a telephone contact by a clinical research associates who was blinded to the details of the study to note the following clinical data: pain VNS, ED readmissions for residual pain, need for other analgesics other than those of the protocol, other treatment modalities the patient might have used (adherence to the treatment prescribed), and side effects. In addition patients were asked about their satisfaction with pain control following ED using five point Likert scale: very dissatisfied, not satisfied, neutral, satisfied and very satisfied and about the degree to which they adhered to medication schedule. The principal investigator who was aware of the allocation was not involved in monitoring or recording of the outcomes until the data collection was completed.
Official Title
-----------------
NSAIDs Versus Paracetamol Versus Paracetamol + NSAIDs in Traumatic Pain Management
Conditions
-----------------
Acute Pain Due to Trauma
Intervention / Treatment
-----------------
* Drug: Paracetamol
* Drug: NSAID
* Drug: paracetamol-NSAID
Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: age 18 years or older acute (<24 hours) post traumatic pain of the extremity and requiring analgesic treatment upon discharge for pain with intensity >3 on a visual numeric scale Exclusion criteria: open fracture head, abdominal, thoracic or polytrauma. Need for hospitalization, regular use of paracetamol and NSAIDs during the two weeks before admission to ED history of allergy or hypersensitivity to either paracetamol or NSAIDs, contraindication to paracetamol or NSAIDs, acute /history of GI hemorrhage and renal insufficiency, an inability to assess pain intensity according to the VNS. Pregnancy heart failure known hepatic cirrhosis known severe renal impairment (Creatinine clearance <30 ml/min) swallowing disorders Refusal, incapacity or difficulties to consent or to communicate
Ages Eligible for Study
-----------------
Minimum Age: 18 Years
Sexes Eligible for Study
-----------------
All
Accepts Healthy Volunteers
-----------------
No
Study Plan
=================
How is the study designed?
-----------------
Design Details
Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Interventional Model Description: Subjects are randomized in 3 arms: paracetamol group NSAID group paracetamol + NSAID group
Masking: Double
Arms and Interventions
| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: Parcetamol Group<br>The patient receives an envelope containing Paracetamol 1000 mg at the dose of 3 times / day + follow-up sheet + appointment card. | Drug: NSAID<br>* 14 pills of piroxicam 20 mg are provided with a preconised dose of 1 pill 2times per day over 7 days period<br>* Other names: piroxicam;Drug: paracetamol-NSAID<br>* 21 identical pills of paracetamol ith a preconised dose of 1 pill 3 times per day over 7 days period+14 pills of piroxicam 20 mg are provided with a preconised dose of 1 pill 2times per day over 7 days period<br>* Other names: combination;|
| Active Comparator: NSAID Group<br>The patient receives an envelope containing NSAID 20 mg piroxicam twice daily / day + follow-up sheet + appointment card. | Drug: Paracetamol<br>* 21 pills of Paracetamol 1000mg are provided with a preconised dose of 1 pill 3 times per day over 7 days period<br>Drug: paracetamol-NSAID<br>* 21 identical pills of paracetamol ith a preconised dose of 1 pill 3 times per day over 7 days period+14 pills of piroxicam 20 mg are provided with a preconised dose of 1 pill 2times per day over 7 days period<br>* Other names: combination;|
| Active Comparator: NSAID + Paracetamol Group<br>The patient receives an envelope containing NSAID 20 mg piroxicam at a dose of 2 times/day + Paracetamol 1000 mg at a dose of 3 times / day + follow-up sheet + appointment card. | Drug: Paracetamol<br>* 21 pills of Paracetamol 1000mg are provided with a preconised dose of 1 pill 3 times per day over 7 days period<br>Drug: NSAID<br>* 14 pills of piroxicam 20 mg are provided with a preconised dose of 1 pill 2times per day over 7 days period<br>* Other names: piroxicam;|
What is the study measuring?
-----------------
Primary Outcome Measures
| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| new oral analgesic medications needed rate | oral analgesic medications other than those of the protocol prescribed by the treating physicians or taken by patients' own volition | 3 days and 7 days |
Secondary Outcome Measures
| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| the between-group difference in mean change in VNS score measured from ED discharge (VNS D0) to 7 days later | [delta VNS= (VNS D0 - VNS D7 / VNS D0) x 100] | 3 and 7 days |
| The appearance of side effects | The appearance of side effects: such as Drowsiness ,Decreased respiratory rate (<14 c / min), Cutaneous rash, Vomiting,Nausea,pruritus, Dizziness. • Digestive hemorrhage. | 7 days |
| the rate of ED readmissions for residual pain | ED readmissions for residual pain | 3 and 7 days |
| patient satisfaction assessed by Likert's verbal scale. | patient satisfaction assessed by Likert's verbal scale. | 3 and 7 days |
Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
acute pain, trauma, paracetamol, NSAID
|
NCT01564550
|
The Effect of Type 2 Diabetes and Dietary Regulation on VLDL1-and VLDL2-triglyceride Metabolism
|
In this study the investigators wish to compare Very Low-Density Lipoprotein (VLDL) kinetics in type 2 diabetic males and healthy males postabsorptive and during hyperinsulinemia. The kinetics is obtained using an ex-vivo VLDL1- and VLDL2-triglyceride labeling technique. The investigators hypothesis is that the investigators will find an increased VLDL1 production in type 2 diabetic males, which is not lowered by hyperinsulinemia. Also the investigators wish to investigate the influence of diet on VLDL1 and VLDL2 production in healthy males, where the investigators expect less variance in VLDL production when the subject is given an isocaloric diet.
|
Patients with type 2 diabetes are more likely to suffer from dyslipidemia. Earlier research has shown that these patients have an increased VLDL production and this could be a key factor in dyslipidemia development. Especially the production of VLDL1 seems to be increased where an inhibitory response to insulin is lacking. Further investigation in VLDL1 and VLDL2 kinetics is required.~The investigators wish:~To extend the method of ex vivo labeling of VLDL-triglyceride, to include separate labeling of VLDL1- and VLDL2-triglyceride for evaluation of the separate lipoprotein subtype kinetics.~To investigate VLDL1- and VLDL2-triglyceride kinetics in the post absorptive state and under experimental hyperinsulinemia in twelve type 2 diabetic males compared to twelve healthy age, sex, and BMI matched males.~To investigate the effect of a three day isocaloric diet compared to a non-restricted diet on the day-to-day variation in VLDL1 and VLDL2-triglyceride kinetics in healthy men. The investigators here examine six subjects on two different days who ingest a non-restricted diet and compare this group to six subjects examined on two different days, who have prior ingest a three day isocaloric diet.
|
The Effect of Type 2 Diabetes and Dietary Regulation on VLDL1-and VLDL2-triglyceride Metabolism
|
Type 2 Diabetes, Dyslipidemia
|
* Drug: Insulin
* Drug: insulin
* Other: diet
* Other: no diet
|
Inclusion Criteria:~patients with type 2 diabetes during at least six month or healthy subjects~male~BMI 25-36 kg/m2~age 35-65~Exclusion Criteria:~other diseases (hypertension and hypercholesterolemia tolerated)~Insulin treatment~alcohol abuse~smoking~medication affecting lipid metabolism apart from statins and antihypertensive drugs paused 2 weeks prior to the study day.~participation in studies involving radioactive isotopes or larger x-ray investigations within the last six month.~blood donation within three month.
|
35 Years
|
65 Years
|
Male
|
Accepts Healthy Volunteers
|
| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| VLDL1 and VLDL2-triglyceride secretion rate (µmol/min) | VLDL1 and VLDL2 kinetics assessed over a single study day. | 7 hours |
|
Type 2 diabetes, Very-low-density-lipoprotein(VLDL), VLDL1, VLDL2, hyperinsulinemia, diet
|
Insulin, Insulin, Globin Zinc, Hypoglycemic Agents, Physiological Effects of Drugs
|
| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| type 2 diabetes<br> | Drug: Insulin<br>* Insulin is given as a constant infusion( 0,6 mU/kg/min) during the hyperinsulinemia period of the study lasting four and a half hour.<br>* Other names: Actrapid, Novo Nordisk, A10AB01;|
| healthy subjects<br> | Drug: insulin<br>* Insulin is given as a constant infusion( 0,6 mU/kg/min) during the hyperinsulinemia period of the study lasting four and a half hour.<br>* Other names: Actrapid, Novo Nordisk, A10AB01;Other: diet<br>* The subjects ingest a three day isocaloric diet (55 % carbohydrate,30% fat, 15 % protein)prior to the study day.<br>Other: no diet<br>* The subjects will ingest a non-restricted diet prior to the study day.<br>|
|
The Effect of Type 2 Diabetes and Dietary Regulation on VLDL1-and VLDL2-triglyceride Metabolism
Study Overview
=================
Brief Summary
-----------------
In this study the investigators wish to compare Very Low-Density Lipoprotein (VLDL) kinetics in type 2 diabetic males and healthy males postabsorptive and during hyperinsulinemia. The kinetics is obtained using an ex-vivo VLDL1- and VLDL2-triglyceride labeling technique. The investigators hypothesis is that the investigators will find an increased VLDL1 production in type 2 diabetic males, which is not lowered by hyperinsulinemia. Also the investigators wish to investigate the influence of diet on VLDL1 and VLDL2 production in healthy males, where the investigators expect less variance in VLDL production when the subject is given an isocaloric diet.
Detailed Description
-----------------
Patients with type 2 diabetes are more likely to suffer from dyslipidemia. Earlier research has shown that these patients have an increased VLDL production and this could be a key factor in dyslipidemia development. Especially the production of VLDL1 seems to be increased where an inhibitory response to insulin is lacking. Further investigation in VLDL1 and VLDL2 kinetics is required. The investigators wish: To extend the method of ex vivo labeling of VLDL-triglyceride, to include separate labeling of VLDL1- and VLDL2-triglyceride for evaluation of the separate lipoprotein subtype kinetics. To investigate VLDL1- and VLDL2-triglyceride kinetics in the post absorptive state and under experimental hyperinsulinemia in twelve type 2 diabetic males compared to twelve healthy age, sex, and BMI matched males. To investigate the effect of a three day isocaloric diet compared to a non-restricted diet on the day-to-day variation in VLDL1 and VLDL2-triglyceride kinetics in healthy men. The investigators here examine six subjects on two different days who ingest a non-restricted diet and compare this group to six subjects examined on two different days, who have prior ingest a three day isocaloric diet.
Official Title
-----------------
The Effect of Type 2 Diabetes and Dietary Regulation on VLDL1-and VLDL2-triglyceride Metabolism
Conditions
-----------------
Type 2 Diabetes, Dyslipidemia
Intervention / Treatment
-----------------
* Drug: Insulin
* Drug: insulin
* Other: diet
* Other: no diet
Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: patients with type 2 diabetes during at least six month or healthy subjects male BMI 25-36 kg/m2 age 35-65 Exclusion Criteria: other diseases (hypertension and hypercholesterolemia tolerated) Insulin treatment alcohol abuse smoking medication affecting lipid metabolism apart from statins and antihypertensive drugs paused 2 weeks prior to the study day. participation in studies involving radioactive isotopes or larger x-ray investigations within the last six month. blood donation within three month.
Ages Eligible for Study
-----------------
Minimum Age: 35 Years
Maximum Age: 65 Years
Sexes Eligible for Study
-----------------
Male
Accepts Healthy Volunteers
-----------------
Accepts Healthy Volunteers
Study Plan
=================
How is the study designed?
-----------------
Arms and Interventions
| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| type 2 diabetes<br> | Drug: Insulin<br>* Insulin is given as a constant infusion( 0,6 mU/kg/min) during the hyperinsulinemia period of the study lasting four and a half hour.<br>* Other names: Actrapid, Novo Nordisk, A10AB01;|
| healthy subjects<br> | Drug: insulin<br>* Insulin is given as a constant infusion( 0,6 mU/kg/min) during the hyperinsulinemia period of the study lasting four and a half hour.<br>* Other names: Actrapid, Novo Nordisk, A10AB01;Other: diet<br>* The subjects ingest a three day isocaloric diet (55 % carbohydrate,30% fat, 15 % protein)prior to the study day.<br>Other: no diet<br>* The subjects will ingest a non-restricted diet prior to the study day.<br>|
What is the study measuring?
-----------------
Primary Outcome Measures
| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| VLDL1 and VLDL2-triglyceride secretion rate (µmol/min) | VLDL1 and VLDL2 kinetics assessed over a single study day. | 7 hours |
Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Type 2 diabetes, Very-low-density-lipoprotein(VLDL), VLDL1, VLDL2, hyperinsulinemia, diet
|
||
NCT02694419
|
The Effect of Obesity on Endometrium in PCOS
|
The effect of Polycystic Ovary Syndrome (PCOS) with or without obesity has received a few attentions. There is a lack of evidence to whether the BMI affects the endometrial blood flow, which is necessary for implantation.
|
Effect of Body Weight on Endometrial Ultrasonographic Characteristics in Polycystic Ovary Syndrome Patients
|
Body Weight, Polycystic Ovary Syndrome
|
* Device: Doppler evaluation
|
Inclusion Criteria:~Women with PCOS are diagnosed according to Rotterdam criteria, (Rotterdam and ASRM-Sponsored, 2004)by the presence of two out of the following three: oligomenorrhea (absence of menses for 35-182 days) or amenorrhea (absence of menses for >182 days), signs or symptoms of hyperandrogenism (acne, hirsutism), US showing polycystic ovaries.~Fertile women had regular menstruation, with at least one previous spontaneous pregnancy.~Exclusion Criteria:~Women known to have hepatic or renal dysfunction, Diabetes mellitus, hypertension, or cardiovascular disease.~If they have used induction of ovulation drugs for the last three months.~If they have used hormonal contraception in the last three months.
|
18 Years
|
40 Years
|
Female
|
No
|
| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| the mean difference in Doppler indices (VI-FI-VFI) | | 24 hours |
|
endometrium
|
Polycystic Ovary Syndrome, Syndrome, Body Weight, Disease, Pathologic Processes, Ovarian Cysts, Cysts, Neoplasms, Ovarian Diseases, Adnexal Diseases, Genital Diseases, Female, Female Urogenital Diseases, Female Urogenital Diseases and Pregnancy Complications, Urogenital Diseases, Genital Diseases, Gonadal Disorders, Endocrine System Diseases
|
| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| obese/PCO<br>Women with PCOS who are overweight\obese with BMI ≥ 25 kg/m2. | Device: Doppler evaluation<br>* Endometrial volume, endometrial and subendometrial vascularity indices are measured by 3D power Doppler<br>|
| normal weight/PCO<br>Women with PCOS who are normal weight with BMI < 25 kg/m2. | Device: Doppler evaluation<br>* Endometrial volume, endometrial and subendometrial vascularity indices are measured by 3D power Doppler<br>|
| Obese/fertile<br>Fertile regularly menstruating women with at least one previous spontaneous pregnancy who are overweight\obese with BMI ≥ 25 kg/m2. | Device: Doppler evaluation<br>* Endometrial volume, endometrial and subendometrial vascularity indices are measured by 3D power Doppler<br>|
| normal weight/fertile<br>Fertile regularly menstruating women with at least one previous spontaneous pregnancy who are normal weight with BMI < 25 kg/m2. | Device: Doppler evaluation<br>* Endometrial volume, endometrial and subendometrial vascularity indices are measured by 3D power Doppler<br>|
|
The Effect of Obesity on Endometrium in PCOS
Study Overview
=================
Brief Summary
-----------------
The effect of Polycystic Ovary Syndrome (PCOS) with or without obesity has received a few attentions. There is a lack of evidence to whether the BMI affects the endometrial blood flow, which is necessary for implantation.
Official Title
-----------------
Effect of Body Weight on Endometrial Ultrasonographic Characteristics in Polycystic Ovary Syndrome Patients
Conditions
-----------------
Body Weight, Polycystic Ovary Syndrome
Intervention / Treatment
-----------------
* Device: Doppler evaluation
Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Women with PCOS are diagnosed according to Rotterdam criteria, (Rotterdam and ASRM-Sponsored, 2004)by the presence of two out of the following three: oligomenorrhea (absence of menses for 35-182 days) or amenorrhea (absence of menses for >182 days), signs or symptoms of hyperandrogenism (acne, hirsutism), US showing polycystic ovaries. Fertile women had regular menstruation, with at least one previous spontaneous pregnancy. Exclusion Criteria: Women known to have hepatic or renal dysfunction, Diabetes mellitus, hypertension, or cardiovascular disease. If they have used induction of ovulation drugs for the last three months. If they have used hormonal contraception in the last three months.
Ages Eligible for Study
-----------------
Minimum Age: 18 Years
Maximum Age: 40 Years
Sexes Eligible for Study
-----------------
Female
Accepts Healthy Volunteers
-----------------
No
Study Plan
=================
How is the study designed?
-----------------
Arms and Interventions
| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| obese/PCO<br>Women with PCOS who are overweight\obese with BMI ≥ 25 kg/m2. | Device: Doppler evaluation<br>* Endometrial volume, endometrial and subendometrial vascularity indices are measured by 3D power Doppler<br>|
| normal weight/PCO<br>Women with PCOS who are normal weight with BMI < 25 kg/m2. | Device: Doppler evaluation<br>* Endometrial volume, endometrial and subendometrial vascularity indices are measured by 3D power Doppler<br>|
| Obese/fertile<br>Fertile regularly menstruating women with at least one previous spontaneous pregnancy who are overweight\obese with BMI ≥ 25 kg/m2. | Device: Doppler evaluation<br>* Endometrial volume, endometrial and subendometrial vascularity indices are measured by 3D power Doppler<br>|
| normal weight/fertile<br>Fertile regularly menstruating women with at least one previous spontaneous pregnancy who are normal weight with BMI < 25 kg/m2. | Device: Doppler evaluation<br>* Endometrial volume, endometrial and subendometrial vascularity indices are measured by 3D power Doppler<br>|
What is the study measuring?
-----------------
Primary Outcome Measures
| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| the mean difference in Doppler indices (VI-FI-VFI) | | 24 hours |
Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
endometrium
|
|||
NCT05017545
|
Carfilzomib and Belatacept for Desensitization
|
Some kidney transplant candidates have a very low chance of getting a kidney transplant because their immune systems are highly sensitized to most kidney donors. Being highly sensitized means that they will likely have to wait a long time (more than 5 years) before an acceptable donor is found for them or, they never receive a compatible donor, and die while on the kidney transplant waitlist.~The purpose of this study is to find out whether two drugs, carfilzomib (Kyprolis®),and belatacept (Nulojix®), can make these kidney transplant candidates less sensitized, and make it easier and quicker to find a kidney donor for them.
|
This study will enroll 15 eligible participants, 18 to 65 years of age, with end stage renal failure on dialysis who are on the waiting list for a deceased donor transplant with calculated panel reactive antibodies (cPRA) ≥99.9% or >98% (with >5 years of waiting time) or, those with cPRA >98% and an human leukocyte antigen (HLA)-incompatible approved living donor who have not received a transplant after 1 year in a paired kidney exchange program. The study will evaluate whether the study treatment is safe and can lower the participant's immune system's sensitization to kidney donors, making it easier to find a well-matched kidney for them.~Participants in the study will be enrolled in two consecutive Cohorts of 5 and 10 patients respectively. The total duration of participation in the study will be 76 weeks for Cohort 1 and 68 weeks for Cohort 2. Participants who undergo kidney transplantation while enrolled in the study will undergo an additional 52 weeks of follow up post-transplant.~The duration of participation for living donors is one study visit. Their participation in the study ends upon completion of this study visit.
|
Measuring the Impact of Carfilzomib and Belatacept on Allogeneic Desensitization in Prospective Kidney Transplant Recipients (ITN089ST)
|
Highly Sensitized Prospective Kidney Transplant Recipients
|
* Biological: carfilzomib
* Biological: belatacept
* Procedure: Bone marrow aspiration
|
Inclusion Criteria:~Individuals who meet all of the following criteria are eligible for enrollment as study subjects-~Subject must be able to understand and provide informed consent~End stage renal disease (ESRD) on dialysis~United Network for Organ Sharing (UNOS) listed for a kidney transplant with any one of the following:~Current calculated panel reactive antibodies (cPRA) ≥ 99.9 percent awaiting deceased donor transplant~Current cPRA >98 percent (with >5 years of waiting time) awaiting deceased donor transplant~Current cPRA >98 percent with Human Leukocyte Antigen (HLA)-incompatible approved living donor and has not received a transplant after 1 year in a kidney paired exchange program~Evidence of established immunity to Epstein-Barr virus (EBV) as demonstrated by serologic testing~Negative result of most recent tuberculosis (TB) testing or appropriately completed latent tuberculosis infection (LTBI) therapy.~Testing should be conducted using either a purified protein derivative (PPD) or interferon-gamma release assay (i.e. QuantiFERON-TB, T-SPOT.TB).~Negative results from tests performed within 12 months prior to study entry are acceptable in the absence of any intervening exposure to TB.~Subjects with a positive test result must have completed appropriate therapy for LTBI.~Note: LTBI treatment regimens should be among those endorsed by the Centers for Disease Control and Prevention (CDC), url: https://www.cdc.gov/tb/topic/treatment/ltbi.htm~Negative Food and Drug Administration (FDA)-approved test for human immunodeficiency virus (HIV) diagnosis (at screening or as documented in medical record, up to 12 months prior to screening)~Negative Hepatitis C antibody test at screening or as documented in medical record, up to 12 months prior to screening.~--If there is a history of treated hepatitis C or there is a suspected false positive hepatitis C virus (HCV) antibody test, then documentation of two consecutive negative HCV quantitative ribonucleic acid (RNA) polymerase chain reaction (PCR) tests separated by at least 6 months is required~Negative result for 2019-novel Coronavirus (2019-nCoV) by real-time reverse transcriptase- polymerase chain reaction (RT-PCR)~Subjects must have an echocardiogram within the previous 1 year without any of the following findings:~severe left ventricular hypertrophy (LVH)~greater than mild LVH accompanied by diastolic dysfunction~left ventricular ejection fraction <40 percent~pulmonary hypertension defined as right ventricular systolic pressure >35 mm Hg or tricuspid regurgitant velocity >2.8 m/s~Female subjects of reproductive potential must have a negative pregnancy test upon study entry~All subjects of reproductive potential must agree to use contraception for the duration of the study~Subjects must have current vaccinations or documented immunity to:~varicella (chickenpox)~measles~hepatitis B~pneumococcus~influenza, and~varicella zoster (if ≥ 50 years old).~Note: If subjects require administration of either live or killed vaccines to meet eligibility requirements, they must wait at least 2 weeks between vaccination and the baseline visit (i.e., at least 4 weeks before initiation of therapy)~Living Donor Inclusion Criteria:~Living donors must meet all of the following criteria to be eligible-~Able to understand and provide informed consent for research~Meets United Network for Organ Sharing (UNOS) requirements for kidney organ donation~Exclusion Criteria:~Individuals who meet any of these criteria are not eligible for enrollment as study subjects-~Inability or unwillingness of a subject to give written informed consent or comply with study protocol~Known active current or history of invasive fungal infection, non-tuberculous mycobacterial infection~Hepatitis B surface antigen or core antibody positive~Serious uncontrolled concomitant major organ disease, excluding kidney failure~Chronic respiratory failure~Uncontrolled systemic hypertension~Previous non-kidney solid organ transplant or bone marrow transplant~Any infection requiring hospitalization and intravenous (IV) therapy within 4 weeks of screening or oral therapy within 2 weeks of screening~History of positive result for 2019-novel Coronavirus (2019-nCoV) by real-time reverse transcriptase reverse transcriptase-polymerase chain reaction (RT-PCR)~Primary or secondary immunodeficiency~History of thromboembolism (except thrombosis of dialysis vascular access site)~Subjects with myocardial infarction within 12 months of screening or cardiac dysrhythmias uncontrolled by medications~History of plasma cell dyscrasia~Known bleeding diathesis or coagulation abnormality~History of active tuberculosis (TB) (even if treated)~Malignancy within the last 5 years except treated basal and squamous cell cancer of the skin or treated cervical cancer in situ~Women who are currently pregnant or nursing~Alcohol, drug, or chemical abuse within 1 year~Treatment with any investigational agent within 4 weeks (or 5 half-lives of investigational drug, whichever is longer) of screening~Current treatment with other biological drug~Current treatment with any medication which increases the risk of thromboembolic events including oral contraceptives~Currently smoking tobacco~Neutropenia (absolute neutrophil count <1000/microliter) or thrombocytopenia (platelet count <100,000/microliter) within 4 weeks prior to screening~Alanine Aminotransferase (ALT) or aspartate aminotransferase (AST) ≥3 times upper limit of normal (ULN) or total bilirubin ≥ 2 times ULN~Past or current medical problems or findings from physical examination or laboratory testing not listed above, which, in the opinion of the investigator, may:~pose additional risks from participation in the study~interfere with the subject's ability to comply with study requirements, or~impact the quality or interpretation of the data obtained from the study.~Exclusion Criteria for Living Donors:~1. There are no exclusion criteria for living donors.
|
18 Years
|
65 Years
|
All
|
No
|
Primary Purpose: Treatment
Allocation: Non-Randomized
Intervention Model: Sequential Assignment
Masking: None (Open Label)
|
| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Proportion of subjects who do not meet a stopping rule for safety and remain free of all of the safety events listed in the outcome description, through Week 20 post treatment initiation or until receiving a transplant, whichever occurs earlier | Proportion of subjects who have not met a subject stopping rule, and remain free of all of the following through Week 20 post treatment initiation or until receiving a transplant, whichever occurs earlier:~Grade 3 or higher infusion reaction,~Grade 3 or higher infections, and~Any malignancy.~The study site will grade the severity of adverse events experienced by the study subjects according to the criteria set forth in the National Cancer Institute's Common Terminology Criteria for Adverse Events (CTCAE) Version 5.0 (Published November 27, 2017). | Up to 20 weeks post treatment initiation |
| Proportion of subjects who meet any one of the pre-specified events detailed in the outcome description: from Baseline to Week 20 post treatment initiation | Proportion of subjects who meet any one of the following compared to Baseline (Visit 0):~Elimination of one human leukocyte antigen (HLA) antibody at Week 20 (which is Study Week 24) post treatment initiation,~50% or greater reduction in the mean fluorescence intensity (MFI) of at least three HLA antibodies at Week 20 (which is Study Week 24) after starting treatment, and/or~Kidney transplant with a previously incompatible donor within 20 weeks after starting treatment without graft loss due to acute antibody mediated rejection occurring within the first four weeks post-transplant and caused by an anamnestic response. | Baseline (Visit 0) to Week 20 post treatment initiation |
|
| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Proportion of subjects transplanted with a previously incompatible donor within 52 weeks after starting treatment | Clinical outcome measure.~Subjects may receive a kidney transplant while in the study, either from a living or deceased donor to whom they were previously compatible, or from a previously incompatible donor in case there is a significant reduction in HLA antibody. | Within 52 weeks post treatment initiation |
| Proportion of subjects with biopsy-proven acute or chronic antibody mediated rejection (AMR) within 52 weeks post-transplant in subjects who undergo a kidney transplant | Clinical outcome measure.~Antibody mediated rejection (AMR) is an important cause of graft loss after organ transplantation and is caused by anti-donor-specific antibodies, especially anti- human leukocyte antigen (HLA) antibodies. | Within 52 weeks post-transplant |
| Number of biopsy-proven acute or chronic AMR events within 52 weeks post-transplant in subjects who undergo a kidney transplant | Clinical outcome measure.~Antibody mediated rejection (AMR) is an important cause of graft loss after organ transplantation and is caused by anti-donor-specific antibodies, especially anti- human leukocyte antigen (HLA) antibodies. | Within 52 weeks post-transplant |
| Incidence of invasive fungal infections, mycobacterial infections or Pneumocystis jirovecii infection within 20 weeks after starting treatment | A measure of infection-related morbidity. | Within 20 weeks post treatment initiation |
| Incidence of invasive fungal infections, mycobacterial infections or Pneumocystis jirovecii infection within 52 weeks after starting treatment | A measure of infection-related morbidity. | Within 52 weeks post treatment initiation |
| Incidence of cytomegalovirus (CMV) infection within 20 weeks after starting treatment | CMV infection confirmed by the presence of detectable CMV in blood by polymerase chain reaction [PCR] diagnostic testing, regardless of whether signs or symptoms are present. | Within 20 weeks post treatment initiation |
| Incidence of cytomegalovirus (CMV) infection within 52 weeks after starting treatment | CMV infection confirmed by the presence of detectable CMV in blood by polymerase chain reaction [PCR] diagnostic testing, regardless of whether signs or symptoms are present. | Within 52 weeks post treatment initiation |
| Incidence of cytomegalovirus (CMV) disease within 20 weeks after starting treatment | CMV disease defined by the presence of detectable CMV in the blood and the presence of other clinical manifestations attributable to the CMV virus. | Within 20 weeks post treatment initiation |
| Incidence of cytomegalovirus (CMV) disease within 52 weeks after starting treatment | CMV disease defined by the presence of detectable CMV in the blood and the presence of other clinical manifestations attributable to the CMV virus. | Within 52 weeks post treatment initiation |
| Incidence of post-transplant lymphoproliferative disorder (PTLD) | As per diagnosis by local pathologist and treating physician. | Within 52 weeks post-transplant |
| Mean number of Human Leukocyte Antigen (HLA) antibodies eliminated, compared to Baseline | Mechanistic outcome measure focusing on change in donor specific antibodies (DSA). | Baseline (Visit 0), Weeks 16, 20, and 52 post treatment initiation |
| Mean proportion of Human Leukocyte Antigen (HLA) antibodies eliminated, compared to Baseline | Mechanistic outcome measure focusing on change in donor specific antibodies (DSA). | Baseline (Visit 0), Weeks 16, 20, and 52 post treatment initiation |
| Mean percent reduction from Baseline in mean fluorescence intensity (MFI) of the immunodominant Human Leukocyte Antigen (HLA) antibody, Class I and Class II | Mechanistic outcome measure focusing on change in donor specific antibodies (DSA). | Baseline (Visit 0), Weeks 16, 20, and 52 post treatment initiation |
| Mean percent reduction from Baseline in mean fluorescence intensity (MFI) of Human Leukocyte Antigen (HLA) antibodies classified by an MFI >10,000 at treatment initiation | Mechanistic outcome measure focusing on change in donor specific antibodies. An MFI of >10,000 reflects a strong DSA intensity. (Reference: A measure of 0 reflects no donor specific antibodies). | Baseline (Visit 0), Weeks 16, 20, and 52 post treatment initiation |
|
calculated panel reactive antibodies (cPRA), desensitization therapy, human leukocyte antigen (HLA) desensitization
|
Abatacept, Immune Checkpoint Inhibitors, Molecular Mechanisms of Pharmacological Action, Antineoplastic Agents, Immunological, Antineoplastic Agents, Immunosuppressive Agents, Immunologic Factors, Physiological Effects of Drugs, Antirheumatic Agents
|
| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Cohort 1 (N=5 Subjects)<br>The two investigational agents used in this study are carfilzomib and belatacept.~Per protocol, Carfilzomib administered intravenously:~Cycle 1 will consist of 2 doses in week 4 (Day 28 and 29). If tolerated, the dose will be increased and administered twice a week in weeks 5 (Day 35 and 36) and 6 (Day 42 and 43).~Cycle 2 will consist of a total of 6 doses, administered twice weekly in weeks 12 (Day 84 and 85), 13 (Day 91 and 92) and 14 (Day 98 and 99).~Per protocol, Belatacept:~-Belatacept will be administered intravenously on days 29 (week 4), 33 (week 5), and weeks 6, 8, 12, 16, then at a lower dose at week 20, 24, 28, 32, 36, 40, 44, 48, 52, and 56. Dosing is based on the recommended dose in the package insert. | Biological: carfilzomib<br>* Administered: Intravenously (IV). Carfilzomib is administered intravenously, on two consecutive days, each week for three weeks per cycle. In this study, subjects will receive 2 cycles of carfilzomib. Dosing for each cycle is based on the recommended dosing for carfilzomib monotherapy in the package insert.~Carfilzomib is a proteasome inhibitor indicated for the treatment of patients with multiple myeloma. In this study, carfilzomib will be used in highly sensitized subjects without myeloma who are awaiting a kidney transplant.<br>* Other names: Kyprolis®;Biological: belatacept<br>* Administered: Intravenously (IV). Belatacept is indicated for the prophylaxis of organ rejection in adult patients receiving a kidney transplant. In this study, belatacept will be used in highly sensitized subjects who are awaiting a kidney transplant.<br>* Other names: Nulojix®;Procedure: Bone marrow aspiration<br>* Subjects will undergo a bone marrow aspiration prior to starting the study regimen and at 16 weeks after starting the study regimen. In subjects who undergo a kidney transplant during the study, another bone marrow aspiration will be done if it has been >4 weeks since the previous bone marrow aspiration.<br>|
| Experimental: Cohort 2 (N=10 Subjects)<br>The enrollment of ten additional subjects and dosing regimen is dependent on the results in Cohort 1.°~Per protocol, Carfilzomib administered intravenously:~Cycle 1 will consist of 2 doses in week 4 (Day 28 and 29). If tolerated, the dose will be increased and administered twice a week in weeks 5 (Day 35 and 36) and 6 (Day 42 and 43).~Cycle 2 will consist of a total of 6 doses, administered twice weekly in weeks 12 (Day 84 and 85), 13 (Day 91 and 92) and 14 (Day 98 and 99).~Per protocol, Belatacept:~-Belatacept will be administered intravenously on days 29 (week 4), 33 (week 5), and weeks 6, 8, 12, 16, then at a lower dose at week 20, 24, 28, 32, 36, 40, 44, 48, 52, and 56. Dosing is based on the recommended dose in the package insert.~° May be modified based on the safety and efficacy analysis of Cohort 1. | Biological: carfilzomib<br>* Administered: Intravenously (IV). Carfilzomib is administered intravenously, on two consecutive days, each week for three weeks per cycle. In this study, subjects will receive 2 cycles of carfilzomib. Dosing for each cycle is based on the recommended dosing for carfilzomib monotherapy in the package insert.~Carfilzomib is a proteasome inhibitor indicated for the treatment of patients with multiple myeloma. In this study, carfilzomib will be used in highly sensitized subjects without myeloma who are awaiting a kidney transplant.<br>* Other names: Kyprolis®;Biological: belatacept<br>* Administered: Intravenously (IV). Belatacept is indicated for the prophylaxis of organ rejection in adult patients receiving a kidney transplant. In this study, belatacept will be used in highly sensitized subjects who are awaiting a kidney transplant.<br>* Other names: Nulojix®;Procedure: Bone marrow aspiration<br>* Subjects will undergo a bone marrow aspiration prior to starting the study regimen and at 16 weeks after starting the study regimen. In subjects who undergo a kidney transplant during the study, another bone marrow aspiration will be done if it has been >4 weeks since the previous bone marrow aspiration.<br>|
|
Carfilzomib and Belatacept for Desensitization
Study Overview
=================
Brief Summary
-----------------
Some kidney transplant candidates have a very low chance of getting a kidney transplant because their immune systems are highly sensitized to most kidney donors. Being highly sensitized means that they will likely have to wait a long time (more than 5 years) before an acceptable donor is found for them or, they never receive a compatible donor, and die while on the kidney transplant waitlist. The purpose of this study is to find out whether two drugs, carfilzomib (Kyprolis®),and belatacept (Nulojix®), can make these kidney transplant candidates less sensitized, and make it easier and quicker to find a kidney donor for them.
Detailed Description
-----------------
This study will enroll 15 eligible participants, 18 to 65 years of age, with end stage renal failure on dialysis who are on the waiting list for a deceased donor transplant with calculated panel reactive antibodies (cPRA) ≥99.9% or >98% (with >5 years of waiting time) or, those with cPRA >98% and an human leukocyte antigen (HLA)-incompatible approved living donor who have not received a transplant after 1 year in a paired kidney exchange program. The study will evaluate whether the study treatment is safe and can lower the participant's immune system's sensitization to kidney donors, making it easier to find a well-matched kidney for them. Participants in the study will be enrolled in two consecutive Cohorts of 5 and 10 patients respectively. The total duration of participation in the study will be 76 weeks for Cohort 1 and 68 weeks for Cohort 2. Participants who undergo kidney transplantation while enrolled in the study will undergo an additional 52 weeks of follow up post-transplant. The duration of participation for living donors is one study visit. Their participation in the study ends upon completion of this study visit.
Official Title
-----------------
Measuring the Impact of Carfilzomib and Belatacept on Allogeneic Desensitization in Prospective Kidney Transplant Recipients (ITN089ST)
Conditions
-----------------
Highly Sensitized Prospective Kidney Transplant Recipients
Intervention / Treatment
-----------------
* Biological: carfilzomib
* Biological: belatacept
* Procedure: Bone marrow aspiration
Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Individuals who meet all of the following criteria are eligible for enrollment as study subjects- Subject must be able to understand and provide informed consent End stage renal disease (ESRD) on dialysis United Network for Organ Sharing (UNOS) listed for a kidney transplant with any one of the following: Current calculated panel reactive antibodies (cPRA) ≥ 99.9 percent awaiting deceased donor transplant Current cPRA >98 percent (with >5 years of waiting time) awaiting deceased donor transplant Current cPRA >98 percent with Human Leukocyte Antigen (HLA)-incompatible approved living donor and has not received a transplant after 1 year in a kidney paired exchange program Evidence of established immunity to Epstein-Barr virus (EBV) as demonstrated by serologic testing Negative result of most recent tuberculosis (TB) testing or appropriately completed latent tuberculosis infection (LTBI) therapy. Testing should be conducted using either a purified protein derivative (PPD) or interferon-gamma release assay (i.e. QuantiFERON-TB, T-SPOT.TB). Negative results from tests performed within 12 months prior to study entry are acceptable in the absence of any intervening exposure to TB. Subjects with a positive test result must have completed appropriate therapy for LTBI. Note: LTBI treatment regimens should be among those endorsed by the Centers for Disease Control and Prevention (CDC), url: https://www.cdc.gov/tb/topic/treatment/ltbi.htm Negative Food and Drug Administration (FDA)-approved test for human immunodeficiency virus (HIV) diagnosis (at screening or as documented in medical record, up to 12 months prior to screening) Negative Hepatitis C antibody test at screening or as documented in medical record, up to 12 months prior to screening. --If there is a history of treated hepatitis C or there is a suspected false positive hepatitis C virus (HCV) antibody test, then documentation of two consecutive negative HCV quantitative ribonucleic acid (RNA) polymerase chain reaction (PCR) tests separated by at least 6 months is required Negative result for 2019-novel Coronavirus (2019-nCoV) by real-time reverse transcriptase- polymerase chain reaction (RT-PCR) Subjects must have an echocardiogram within the previous 1 year without any of the following findings: severe left ventricular hypertrophy (LVH) greater than mild LVH accompanied by diastolic dysfunction left ventricular ejection fraction <40 percent pulmonary hypertension defined as right ventricular systolic pressure >35 mm Hg or tricuspid regurgitant velocity >2.8 m/s Female subjects of reproductive potential must have a negative pregnancy test upon study entry All subjects of reproductive potential must agree to use contraception for the duration of the study Subjects must have current vaccinations or documented immunity to: varicella (chickenpox) measles hepatitis B pneumococcus influenza, and varicella zoster (if ≥ 50 years old). Note: If subjects require administration of either live or killed vaccines to meet eligibility requirements, they must wait at least 2 weeks between vaccination and the baseline visit (i.e., at least 4 weeks before initiation of therapy) Living Donor Inclusion Criteria: Living donors must meet all of the following criteria to be eligible- Able to understand and provide informed consent for research Meets United Network for Organ Sharing (UNOS) requirements for kidney organ donation Exclusion Criteria: Individuals who meet any of these criteria are not eligible for enrollment as study subjects- Inability or unwillingness of a subject to give written informed consent or comply with study protocol Known active current or history of invasive fungal infection, non-tuberculous mycobacterial infection Hepatitis B surface antigen or core antibody positive Serious uncontrolled concomitant major organ disease, excluding kidney failure Chronic respiratory failure Uncontrolled systemic hypertension Previous non-kidney solid organ transplant or bone marrow transplant Any infection requiring hospitalization and intravenous (IV) therapy within 4 weeks of screening or oral therapy within 2 weeks of screening History of positive result for 2019-novel Coronavirus (2019-nCoV) by real-time reverse transcriptase reverse transcriptase-polymerase chain reaction (RT-PCR) Primary or secondary immunodeficiency History of thromboembolism (except thrombosis of dialysis vascular access site) Subjects with myocardial infarction within 12 months of screening or cardiac dysrhythmias uncontrolled by medications History of plasma cell dyscrasia Known bleeding diathesis or coagulation abnormality History of active tuberculosis (TB) (even if treated) Malignancy within the last 5 years except treated basal and squamous cell cancer of the skin or treated cervical cancer in situ Women who are currently pregnant or nursing Alcohol, drug, or chemical abuse within 1 year Treatment with any investigational agent within 4 weeks (or 5 half-lives of investigational drug, whichever is longer) of screening Current treatment with other biological drug Current treatment with any medication which increases the risk of thromboembolic events including oral contraceptives Currently smoking tobacco Neutropenia (absolute neutrophil count <1000/microliter) or thrombocytopenia (platelet count <100,000/microliter) within 4 weeks prior to screening Alanine Aminotransferase (ALT) or aspartate aminotransferase (AST) ≥3 times upper limit of normal (ULN) or total bilirubin ≥ 2 times ULN Past or current medical problems or findings from physical examination or laboratory testing not listed above, which, in the opinion of the investigator, may: pose additional risks from participation in the study interfere with the subject's ability to comply with study requirements, or impact the quality or interpretation of the data obtained from the study. Exclusion Criteria for Living Donors: 1. There are no exclusion criteria for living donors.
Ages Eligible for Study
-----------------
Minimum Age: 18 Years
Maximum Age: 65 Years
Sexes Eligible for Study
-----------------
All
Accepts Healthy Volunteers
-----------------
No
Study Plan
=================
How is the study designed?
-----------------
Design Details
Primary Purpose: Treatment
Allocation: Non-Randomized
Intervention Model: Sequential Assignment
Masking: None (Open Label)
Arms and Interventions
| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Cohort 1 (N=5 Subjects)<br>The two investigational agents used in this study are carfilzomib and belatacept. Per protocol, Carfilzomib administered intravenously: Cycle 1 will consist of 2 doses in week 4 (Day 28 and 29). If tolerated, the dose will be increased and administered twice a week in weeks 5 (Day 35 and 36) and 6 (Day 42 and 43). Cycle 2 will consist of a total of 6 doses, administered twice weekly in weeks 12 (Day 84 and 85), 13 (Day 91 and 92) and 14 (Day 98 and 99). Per protocol, Belatacept: -Belatacept will be administered intravenously on days 29 (week 4), 33 (week 5), and weeks 6, 8, 12, 16, then at a lower dose at week 20, 24, 28, 32, 36, 40, 44, 48, 52, and 56. Dosing is based on the recommended dose in the package insert. | Biological: carfilzomib<br>* Administered: Intravenously (IV). Carfilzomib is administered intravenously, on two consecutive days, each week for three weeks per cycle. In this study, subjects will receive 2 cycles of carfilzomib. Dosing for each cycle is based on the recommended dosing for carfilzomib monotherapy in the package insert. Carfilzomib is a proteasome inhibitor indicated for the treatment of patients with multiple myeloma. In this study, carfilzomib will be used in highly sensitized subjects without myeloma who are awaiting a kidney transplant.<br>* Other names: Kyprolis®;Biological: belatacept<br>* Administered: Intravenously (IV). Belatacept is indicated for the prophylaxis of organ rejection in adult patients receiving a kidney transplant. In this study, belatacept will be used in highly sensitized subjects who are awaiting a kidney transplant.<br>* Other names: Nulojix®;Procedure: Bone marrow aspiration<br>* Subjects will undergo a bone marrow aspiration prior to starting the study regimen and at 16 weeks after starting the study regimen. In subjects who undergo a kidney transplant during the study, another bone marrow aspiration will be done if it has been >4 weeks since the previous bone marrow aspiration.<br>|
| Experimental: Cohort 2 (N=10 Subjects)<br>The enrollment of ten additional subjects and dosing regimen is dependent on the results in Cohort 1.° Per protocol, Carfilzomib administered intravenously: Cycle 1 will consist of 2 doses in week 4 (Day 28 and 29). If tolerated, the dose will be increased and administered twice a week in weeks 5 (Day 35 and 36) and 6 (Day 42 and 43). Cycle 2 will consist of a total of 6 doses, administered twice weekly in weeks 12 (Day 84 and 85), 13 (Day 91 and 92) and 14 (Day 98 and 99). Per protocol, Belatacept: -Belatacept will be administered intravenously on days 29 (week 4), 33 (week 5), and weeks 6, 8, 12, 16, then at a lower dose at week 20, 24, 28, 32, 36, 40, 44, 48, 52, and 56. Dosing is based on the recommended dose in the package insert. ° May be modified based on the safety and efficacy analysis of Cohort 1. | Biological: carfilzomib<br>* Administered: Intravenously (IV). Carfilzomib is administered intravenously, on two consecutive days, each week for three weeks per cycle. In this study, subjects will receive 2 cycles of carfilzomib. Dosing for each cycle is based on the recommended dosing for carfilzomib monotherapy in the package insert. Carfilzomib is a proteasome inhibitor indicated for the treatment of patients with multiple myeloma. In this study, carfilzomib will be used in highly sensitized subjects without myeloma who are awaiting a kidney transplant.<br>* Other names: Kyprolis®;Biological: belatacept<br>* Administered: Intravenously (IV). Belatacept is indicated for the prophylaxis of organ rejection in adult patients receiving a kidney transplant. In this study, belatacept will be used in highly sensitized subjects who are awaiting a kidney transplant.<br>* Other names: Nulojix®;Procedure: Bone marrow aspiration<br>* Subjects will undergo a bone marrow aspiration prior to starting the study regimen and at 16 weeks after starting the study regimen. In subjects who undergo a kidney transplant during the study, another bone marrow aspiration will be done if it has been >4 weeks since the previous bone marrow aspiration.<br>|
What is the study measuring?
-----------------
Primary Outcome Measures
| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Proportion of subjects who do not meet a stopping rule for safety and remain free of all of the safety events listed in the outcome description, through Week 20 post treatment initiation or until receiving a transplant, whichever occurs earlier | Proportion of subjects who have not met a subject stopping rule, and remain free of all of the following through Week 20 post treatment initiation or until receiving a transplant, whichever occurs earlier: Grade 3 or higher infusion reaction, Grade 3 or higher infections, and Any malignancy. The study site will grade the severity of adverse events experienced by the study subjects according to the criteria set forth in the National Cancer Institute's Common Terminology Criteria for Adverse Events (CTCAE) Version 5.0 (Published November 27, 2017). | Up to 20 weeks post treatment initiation |
| Proportion of subjects who meet any one of the pre-specified events detailed in the outcome description: from Baseline to Week 20 post treatment initiation | Proportion of subjects who meet any one of the following compared to Baseline (Visit 0): Elimination of one human leukocyte antigen (HLA) antibody at Week 20 (which is Study Week 24) post treatment initiation, 50% or greater reduction in the mean fluorescence intensity (MFI) of at least three HLA antibodies at Week 20 (which is Study Week 24) after starting treatment, and/or Kidney transplant with a previously incompatible donor within 20 weeks after starting treatment without graft loss due to acute antibody mediated rejection occurring within the first four weeks post-transplant and caused by an anamnestic response. | Baseline (Visit 0) to Week 20 post treatment initiation |
Secondary Outcome Measures
| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Proportion of subjects transplanted with a previously incompatible donor within 52 weeks after starting treatment | Clinical outcome measure. Subjects may receive a kidney transplant while in the study, either from a living or deceased donor to whom they were previously compatible, or from a previously incompatible donor in case there is a significant reduction in HLA antibody. | Within 52 weeks post treatment initiation |
| Proportion of subjects with biopsy-proven acute or chronic antibody mediated rejection (AMR) within 52 weeks post-transplant in subjects who undergo a kidney transplant | Clinical outcome measure. Antibody mediated rejection (AMR) is an important cause of graft loss after organ transplantation and is caused by anti-donor-specific antibodies, especially anti- human leukocyte antigen (HLA) antibodies. | Within 52 weeks post-transplant |
| Number of biopsy-proven acute or chronic AMR events within 52 weeks post-transplant in subjects who undergo a kidney transplant | Clinical outcome measure. Antibody mediated rejection (AMR) is an important cause of graft loss after organ transplantation and is caused by anti-donor-specific antibodies, especially anti- human leukocyte antigen (HLA) antibodies. | Within 52 weeks post-transplant |
| Incidence of invasive fungal infections, mycobacterial infections or Pneumocystis jirovecii infection within 20 weeks after starting treatment | A measure of infection-related morbidity. | Within 20 weeks post treatment initiation |
| Incidence of invasive fungal infections, mycobacterial infections or Pneumocystis jirovecii infection within 52 weeks after starting treatment | A measure of infection-related morbidity. | Within 52 weeks post treatment initiation |
| Incidence of cytomegalovirus (CMV) infection within 20 weeks after starting treatment | CMV infection confirmed by the presence of detectable CMV in blood by polymerase chain reaction [PCR] diagnostic testing, regardless of whether signs or symptoms are present. | Within 20 weeks post treatment initiation |
| Incidence of cytomegalovirus (CMV) infection within 52 weeks after starting treatment | CMV infection confirmed by the presence of detectable CMV in blood by polymerase chain reaction [PCR] diagnostic testing, regardless of whether signs or symptoms are present. | Within 52 weeks post treatment initiation |
| Incidence of cytomegalovirus (CMV) disease within 20 weeks after starting treatment | CMV disease defined by the presence of detectable CMV in the blood and the presence of other clinical manifestations attributable to the CMV virus. | Within 20 weeks post treatment initiation |
| Incidence of cytomegalovirus (CMV) disease within 52 weeks after starting treatment | CMV disease defined by the presence of detectable CMV in the blood and the presence of other clinical manifestations attributable to the CMV virus. | Within 52 weeks post treatment initiation |
| Incidence of post-transplant lymphoproliferative disorder (PTLD) | As per diagnosis by local pathologist and treating physician. | Within 52 weeks post-transplant |
| Mean number of Human Leukocyte Antigen (HLA) antibodies eliminated, compared to Baseline | Mechanistic outcome measure focusing on change in donor specific antibodies (DSA). | Baseline (Visit 0), Weeks 16, 20, and 52 post treatment initiation |
| Mean proportion of Human Leukocyte Antigen (HLA) antibodies eliminated, compared to Baseline | Mechanistic outcome measure focusing on change in donor specific antibodies (DSA). | Baseline (Visit 0), Weeks 16, 20, and 52 post treatment initiation |
| Mean percent reduction from Baseline in mean fluorescence intensity (MFI) of the immunodominant Human Leukocyte Antigen (HLA) antibody, Class I and Class II | Mechanistic outcome measure focusing on change in donor specific antibodies (DSA). | Baseline (Visit 0), Weeks 16, 20, and 52 post treatment initiation |
| Mean percent reduction from Baseline in mean fluorescence intensity (MFI) of Human Leukocyte Antigen (HLA) antibodies classified by an MFI >10,000 at treatment initiation | Mechanistic outcome measure focusing on change in donor specific antibodies. An MFI of >10,000 reflects a strong DSA intensity. (Reference: A measure of 0 reflects no donor specific antibodies). | Baseline (Visit 0), Weeks 16, 20, and 52 post treatment initiation |
Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
calculated panel reactive antibodies (cPRA), desensitization therapy, human leukocyte antigen (HLA) desensitization
|
NCT05611307
|
Late Subclinical Cardiovascular Disease in Testicular Cancer Survivors
|
Late subclinical cardiovascular disease in testicular cancer survivors exposed to cisplatin-based chemotherapy and bone marrow transplant
|
Testicular cancer (TC) is diagnosed in young adult males between 18-39 years old. There are late (≥10 years after treatment) atherosclerotic cardiovascular disease (ASCVD) events after cisplatin-based chemotherapy (CBCT) treatment in testicular cancer survivors (TCS), along with heightened rates of hypertension, dyslipidemia, diabetes mellitus, and metabolic syndrome. Early detection of ASCVD to direct preventive measures in young TCS is an unmet need as these patients typically fall short of traditional 40-45-year age-cut offs for ASCVD screening. ASCVD risk will be evaluated in TCS ≥ 10 years after treatment in three groups: 1)TCS exposed to CBCT, 2)TCS exposed to CBCT and bone marrow transplant (BMT), and 3)TCS cured with surgical resection/surveillance. The focus will be on detecting subclinical atherosclerosis in TCS using blood lipid biomarkers and advanced cardiac CT imaging.
|
Detection of Late Subclinical Cardiovascular Disease in Testicular Cancer Survivors Exposed to Cisplatin-based Chemotherapy and Bone Marrow Transplant
|
Testicular Cancer, Survivorship, ASCVD, Coronary Artery Disease, Lipid Disorder, Hypogonadism, Male, Cisplatin Adverse Reaction, Bone Marrow Transplant Complications
|
* Diagnostic Test: Lipid profile
* Diagnostic Test: Coronary artery assessment
* Diagnostic Test: Hormone levels for hypogonadism
|
Inclusion Criteria~Patients >18 years of age~Patients will be recruited only if cancer-free at clinical evaluation time.~For the cases a confirmed TC diagnosis who received one or more cycles of CBCT-based chemotherapies (CBCT group, Arm 2)~For the cases with a confirmed TC diagnosis who received one or more cycles of CBCT-based chemotherapies and underwent BMT for relapsed refractory disease (CBCT & BMT group, Arm 3).~For the comparison cohort, biopsy-proven TC patients who had surgery for or surveillance of their testicular cancer and never received CBCTCBCT or BMT (surgical/surveillance, Arm 1)~Exclusion Criteria~Prior known myocardial infarction (MI), atherosclerotic cardiovascular disease (ASCVD)~Significant renal disease (GFR<40)~Allergy to iodinated contrast~Antecedent chemotherapy for another primary cancer.
|
18 Years
|
99 Years
|
Male
|
No
|
| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Lipid profile | HDL, LDL, Tg, Cholesterol, Novel Lipid biomarkers using blood draws | More than 10 years after testicular cancer diagnosis, At recruitment |
| Coronary plaque assessment | Coronary calcium score, coronary artery anatomy and plaque assessment using CT scans | More than 10 years after testicular cancer diagnosis, At recruitment |
|
| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Hormone levels | Measurement of testosterone | More than 10 years after testicular cancer diagnosis, At recruitment |
| Serum platinum | Measurement of residual serum platinum levels | More than 10 years after testicular cancer diagnosis, At recruitment |
|
Hormones, Hormones, Hormone Substitutes, and Hormone Antagonists, Physiological Effects of Drugs
|
| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Surgical/Surveillance<br>TCS cured with surgical resection and surveillance (surgical/surveillance, Arm 1) | Diagnostic Test: Lipid profile<br>* Advanced lipid profile<br>Diagnostic Test: Coronary artery assessment<br>* Coronary artery assessment via CT scans<br>Diagnostic Test: Hormone levels for hypogonadism<br>* Hormone levels for hypogonadism<br>|
| Cisplatin-based chemotherapy (CBCT)<br>TCS treat with one or more lines of cisplatin-based chemotherapy | Diagnostic Test: Lipid profile<br>* Advanced lipid profile<br>Diagnostic Test: Coronary artery assessment<br>* Coronary artery assessment via CT scans<br>Diagnostic Test: Hormone levels for hypogonadism<br>* Hormone levels for hypogonadism<br>|
| Cisplatin-based chemotherapy and Bone Marrow Transplant (CBCT/BMT)<br>TCS treat with one or more lines of cisplatin-based chemotherapy, and who have undergone bone marrow transplant | Diagnostic Test: Lipid profile<br>* Advanced lipid profile<br>Diagnostic Test: Coronary artery assessment<br>* Coronary artery assessment via CT scans<br>Diagnostic Test: Hormone levels for hypogonadism<br>* Hormone levels for hypogonadism<br>|
|
Late Subclinical Cardiovascular Disease in Testicular Cancer Survivors
Study Overview
=================
Brief Summary
-----------------
Late subclinical cardiovascular disease in testicular cancer survivors exposed to cisplatin-based chemotherapy and bone marrow transplant
Detailed Description
-----------------
Testicular cancer (TC) is diagnosed in young adult males between 18-39 years old. There are late (≥10 years after treatment) atherosclerotic cardiovascular disease (ASCVD) events after cisplatin-based chemotherapy (CBCT) treatment in testicular cancer survivors (TCS), along with heightened rates of hypertension, dyslipidemia, diabetes mellitus, and metabolic syndrome. Early detection of ASCVD to direct preventive measures in young TCS is an unmet need as these patients typically fall short of traditional 40-45-year age-cut offs for ASCVD screening. ASCVD risk will be evaluated in TCS ≥ 10 years after treatment in three groups: 1)TCS exposed to CBCT, 2)TCS exposed to CBCT and bone marrow transplant (BMT), and 3)TCS cured with surgical resection/surveillance. The focus will be on detecting subclinical atherosclerosis in TCS using blood lipid biomarkers and advanced cardiac CT imaging.
Official Title
-----------------
Detection of Late Subclinical Cardiovascular Disease in Testicular Cancer Survivors Exposed to Cisplatin-based Chemotherapy and Bone Marrow Transplant
Conditions
-----------------
Testicular Cancer, Survivorship, ASCVD, Coronary Artery Disease, Lipid Disorder, Hypogonadism, Male, Cisplatin Adverse Reaction, Bone Marrow Transplant Complications
Intervention / Treatment
-----------------
* Diagnostic Test: Lipid profile
* Diagnostic Test: Coronary artery assessment
* Diagnostic Test: Hormone levels for hypogonadism
Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria Patients >18 years of age Patients will be recruited only if cancer-free at clinical evaluation time. For the cases a confirmed TC diagnosis who received one or more cycles of CBCT-based chemotherapies (CBCT group, Arm 2) For the cases with a confirmed TC diagnosis who received one or more cycles of CBCT-based chemotherapies and underwent BMT for relapsed refractory disease (CBCT & BMT group, Arm 3). For the comparison cohort, biopsy-proven TC patients who had surgery for or surveillance of their testicular cancer and never received CBCTCBCT or BMT (surgical/surveillance, Arm 1) Exclusion Criteria Prior known myocardial infarction (MI), atherosclerotic cardiovascular disease (ASCVD) Significant renal disease (GFR<40) Allergy to iodinated contrast Antecedent chemotherapy for another primary cancer.
Ages Eligible for Study
-----------------
Minimum Age: 18 Years
Maximum Age: 99 Years
Sexes Eligible for Study
-----------------
Male
Accepts Healthy Volunteers
-----------------
No
Study Plan
=================
How is the study designed?
-----------------
Arms and Interventions
| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Surgical/Surveillance<br>TCS cured with surgical resection and surveillance (surgical/surveillance, Arm 1) | Diagnostic Test: Lipid profile<br>* Advanced lipid profile<br>Diagnostic Test: Coronary artery assessment<br>* Coronary artery assessment via CT scans<br>Diagnostic Test: Hormone levels for hypogonadism<br>* Hormone levels for hypogonadism<br>|
| Cisplatin-based chemotherapy (CBCT)<br>TCS treat with one or more lines of cisplatin-based chemotherapy | Diagnostic Test: Lipid profile<br>* Advanced lipid profile<br>Diagnostic Test: Coronary artery assessment<br>* Coronary artery assessment via CT scans<br>Diagnostic Test: Hormone levels for hypogonadism<br>* Hormone levels for hypogonadism<br>|
| Cisplatin-based chemotherapy and Bone Marrow Transplant (CBCT/BMT)<br>TCS treat with one or more lines of cisplatin-based chemotherapy, and who have undergone bone marrow transplant | Diagnostic Test: Lipid profile<br>* Advanced lipid profile<br>Diagnostic Test: Coronary artery assessment<br>* Coronary artery assessment via CT scans<br>Diagnostic Test: Hormone levels for hypogonadism<br>* Hormone levels for hypogonadism<br>|
What is the study measuring?
-----------------
Primary Outcome Measures
| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Lipid profile | HDL, LDL, Tg, Cholesterol, Novel Lipid biomarkers using blood draws | More than 10 years after testicular cancer diagnosis, At recruitment |
| Coronary plaque assessment | Coronary calcium score, coronary artery anatomy and plaque assessment using CT scans | More than 10 years after testicular cancer diagnosis, At recruitment |
Secondary Outcome Measures
| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Hormone levels | Measurement of testosterone | More than 10 years after testicular cancer diagnosis, At recruitment |
| Serum platinum | Measurement of residual serum platinum levels | More than 10 years after testicular cancer diagnosis, At recruitment |
|
||
NCT02500784
|
Improving Beta-2 Adrenergic Signaling in Alzheimer's Disease
|
The purpose of this study is to test the effects of long-term therapeutic doses of formoterol, on a) cerebrospinal fluid (CSF) tau levels, and Amyloid Beta protein 40/42 levels in the CSF, and b) cognitive function in people with mild to moderate Alzheimer' Disease (AD).
|
The purpose of this study is to test the effects of long-term therapeutic doses of formoterol, on a) cerebrospinal fluid CSF tau levels, and A-beta amyloid protein 40/42 levels, and b) cognitive function: NE-ergic neurons undergo significant degeneration in AD. This system plays a significant role in cognition. Recent studies have indicated that increasing NE levels in the brain would significantly improve microglia migration and clearance of A-beta amyloid protein 40/42 levels in mouse models of AD. The investigators plan to test whether long- term daily treatment with inhaled formoterol solution would improve the structure and function of hippocampal neurons in AD. Study Design: Randomization and initiation of experimental treatment: All participants will be given formoterol daily for 52 weeks. The active regimen will be initiated as (20 micro gram, BID). The dose will be decreased if there is evidence of side effects, including cardiac or respiratory alteration changes, gastro-intestinal disturbances or neurological issues.
|
Improving Beta-2 Adrenergic Signaling in Alzheimer's Disease
|
Alzheimer's Disease, Cognitive Dysfunction
|
* Drug: Formoterol A
* Other: Formoterol B (placebo)
|
Inclusion Criteria:~Males and females between the ages of 50-85,~Mild-to-moderate AD (NINCDS/ADRDA criteria for probable AD will be used to establish AD diagnosis).~MMSE 16-26.~Exclusion Criteria:~Non-AD dementia or significant neurological disease such as Parkinson's disease, stroke, brain tumor,multiple sclerosis, seizure disorder, focal brain lesion, or head injury with loss of consciousness.~Hypothyroidism, congestive heart failure (New York Heart Association Class III or IV), significant extrapyramidal symptoms on neurological examination, serum creatinine>1.3 mg/dl, significant arrhythmias or conduction defect abnormalities on ECG,~Use of another beta2 adrenergic drug within the last 2 months.~Residence in a long-term care facility.~Evidence of any significant clinical disorder or laboratory finding that renders the person unsuitable for receiving an investigational new drug.~Known hypersensitivity or prior exposure to formoterol.~Active asthma or family history of asthma.
|
50 Years
|
85 Years
|
All
|
No
|
Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple
|
| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Cognition Evaluation | Participants will be administered the CANTAB every month for 16 months | 1 Month |
| Brain-derived neurotrophic factor (BDNF) Evaluation | Samples of Plasma and Cerebral Spinal Fluid Biomarkers will be taken at baseline and month 16 | Baseline and month 16 |
|
| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Amyloid accumulation | Molecular Imaging will be taken at baseline and month 16 | Baseline and month 16 |
|
Formoterol Fumarate, Bronchodilator Agents, Autonomic Agents, Peripheral Nervous System Agents, Physiological Effects of Drugs, Anti-Asthmatic Agents, Respiratory System Agents, Adrenergic beta-2 Receptor Agonists, Adrenergic beta-Agonists, Adrenergic Agonists, Adrenergic Agents, Neurotransmitter Agents, Molecular Mechanisms of Pharmacological Action
|
| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: Formoterol A<br>12 months, formoterol, 20microgram/2ml, inhaler, BID | Drug: Formoterol A<br>* 20mg/2mL, BID inhaler for 12 months: until progression or unacceptable toxicity develops.<br>* Other names: Performist;|
| Placebo Comparator: Formoterol B<br>12 months, normal saline, 2ml, inhaler, BID | Other: Formoterol B (placebo)<br>* 2mL, BID inhaler for 12 months<br>|
|
Improving Beta-2 Adrenergic Signaling in Alzheimer's Disease
Study Overview
=================
Brief Summary
-----------------
The purpose of this study is to test the effects of long-term therapeutic doses of formoterol, on a) cerebrospinal fluid (CSF) tau levels, and Amyloid Beta protein 40/42 levels in the CSF, and b) cognitive function in people with mild to moderate Alzheimer' Disease (AD).
Detailed Description
-----------------
The purpose of this study is to test the effects of long-term therapeutic doses of formoterol, on a) cerebrospinal fluid CSF tau levels, and A-beta amyloid protein 40/42 levels, and b) cognitive function: NE-ergic neurons undergo significant degeneration in AD. This system plays a significant role in cognition. Recent studies have indicated that increasing NE levels in the brain would significantly improve microglia migration and clearance of A-beta amyloid protein 40/42 levels in mouse models of AD. The investigators plan to test whether long- term daily treatment with inhaled formoterol solution would improve the structure and function of hippocampal neurons in AD. Study Design: Randomization and initiation of experimental treatment: All participants will be given formoterol daily for 52 weeks. The active regimen will be initiated as (20 micro gram, BID). The dose will be decreased if there is evidence of side effects, including cardiac or respiratory alteration changes, gastro-intestinal disturbances or neurological issues.
Official Title
-----------------
Improving Beta-2 Adrenergic Signaling in Alzheimer's Disease
Conditions
-----------------
Alzheimer's Disease, Cognitive Dysfunction
Intervention / Treatment
-----------------
* Drug: Formoterol A
* Other: Formoterol B (placebo)
Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Males and females between the ages of 50-85, Mild-to-moderate AD (NINCDS/ADRDA criteria for probable AD will be used to establish AD diagnosis). MMSE 16-26. Exclusion Criteria: Non-AD dementia or significant neurological disease such as Parkinson's disease, stroke, brain tumor,multiple sclerosis, seizure disorder, focal brain lesion, or head injury with loss of consciousness. Hypothyroidism, congestive heart failure (New York Heart Association Class III or IV), significant extrapyramidal symptoms on neurological examination, serum creatinine>1.3 mg/dl, significant arrhythmias or conduction defect abnormalities on ECG, Use of another beta2 adrenergic drug within the last 2 months. Residence in a long-term care facility. Evidence of any significant clinical disorder or laboratory finding that renders the person unsuitable for receiving an investigational new drug. Known hypersensitivity or prior exposure to formoterol. Active asthma or family history of asthma.
Ages Eligible for Study
-----------------
Minimum Age: 50 Years
Maximum Age: 85 Years
Sexes Eligible for Study
-----------------
All
Accepts Healthy Volunteers
-----------------
No
Study Plan
=================
How is the study designed?
-----------------
Design Details
Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple
Arms and Interventions
| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: Formoterol A<br>12 months, formoterol, 20microgram/2ml, inhaler, BID | Drug: Formoterol A<br>* 20mg/2mL, BID inhaler for 12 months: until progression or unacceptable toxicity develops.<br>* Other names: Performist;|
| Placebo Comparator: Formoterol B<br>12 months, normal saline, 2ml, inhaler, BID | Other: Formoterol B (placebo)<br>* 2mL, BID inhaler for 12 months<br>|
What is the study measuring?
-----------------
Primary Outcome Measures
| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Cognition Evaluation | Participants will be administered the CANTAB every month for 16 months | 1 Month |
| Brain-derived neurotrophic factor (BDNF) Evaluation | Samples of Plasma and Cerebral Spinal Fluid Biomarkers will be taken at baseline and month 16 | Baseline and month 16 |
Secondary Outcome Measures
| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Amyloid accumulation | Molecular Imaging will be taken at baseline and month 16 | Baseline and month 16 |
|
|
NCT02925845
|
Neuromuscular Electrostimulation in Radiocephalic Fistula
|
Objective: To analyze the effect of neuromuscular electrostimulation in the maturation of radiocephalic arteriovenous fistula (RC-AVF) patients with chronic kidney disease (CKD) stage 5-5D~Design: Clinical Trial with medical devices, 18-month, single-center, within the hospital setting.~Disease or disorder study: vascular Access maturation.~Population: Patients with CKD stage 5-5D at the research center.~Project duration: 78 weeks~Methodology:~Patients with CKD stages 5-5D that has undergone a native AV in service stations to give their informed consent and meeting the inclusion criteria will be included.~At baseline two study groups were established:~Group 1: neuromuscular electrostimulation~Group 2: isometric exercises
|
Objective: To analyze the effect of neuromuscular electrostimulation in the maturation of radiocephalic arteriovenous fistula (RC-AVF) patients with chronic kidney disease (CKD) stage 5-5D~Design: Clinical Trial with medical devices, 18-month, single-center, within the hospital setting.~Disease or disorder study: vascular Access maturation.~Population: Patients with CKD stage 5-5D at the research center.~Project duration: 78 weeks~Methodology:~Patients with CKD stages 5-5D that has undergone a native AV in service stations to give their informed consent and meeting the inclusion criteria will be included.~At baseline two study groups were established:~Group 1: neuromuscular electrostimulation~Group 2: isometric exercises~At baseline, patients included in the study the main demographic variables were collected, anthropometric, biochemical parameters, hemodynamic data, Eco Doppler of AV (ECO mapping) and prescribed medical treatment.~Likewise, they will be made an assessment of their muscle strength by skinfold and upper limb static dynamometry in which was made the native AV.~During the study period the following phases were established:~• Phase 1 (4 weeks):~The control group will receive the usual care on an outpatient AV.~Patients assigned to group, will perform a program of AV electrostimulation in the affected upper extremity (according to program) after 7 days of completion of native AV.~At the end of this phase both groups were conducted an ECO doppler (ECO4s) AV regulated by Vascular Surgery.~• Phase 2 (8 weeks):~The control group will receive the usual care on an outpatient AV.~Patients assigned to group, will perform a program of AV electrostimulation in the affected upper extremity (according to program)~At the end of this phase, both groups were conducted an ECO doppler (ECO8s) is regulated by the AV Vascular Surgery~During all phases of the study, patients on hemodialysis follow their analytical controls programmed by Nephrology and receive medical treatment according to standard clinical practice.~At the end of each phase of the study, all patients were performed an assessment of their muscle strength by centimetría, skinfold thickness and static dynamometry member in which AV has been made.~Calendar: A provisional timetable is presented~Presentation of the CEIC study: September 2014~inclusion Period: 78 weeks~Follow-up period: 2 months~Close database: 1 month~Statistical analysis: 1 month~Source of funding: Not available
|
Neuromuscular Electrostimulation Effect on the Maturation of Native Vascular Access (VA) Patients With Kidney Disease 5- Chronic Stages 5d Estimated by Doppler Ultrasound
|
Arteriovenous Fistula
|
* Device: Neuromuscular electrostimulation
|
Inclusion criteria:~Patients aged less than 18 years old~Patients with tracking CCEE Nephrology than 3 months~Patients with AV native AV upper limb without prior~Patients give their written informed consent~Exclusion criteria:~prior cardiovascular event (acute myocardial infarction, unstable angina, stroke ....) in the last 3 months.~AV prior to HD in same upper extremity~Not have given informed written consent~Carrier cardiac pacemaker
|
18 Years
| null |
All
|
No
|
Primary Purpose: Supportive Care
Allocation: Non-Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
|
| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Radiocephalic fístula flow ( millimeters/minuts) | | 8 weeks ultrasonography parameter of maturation |
|
| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Complications related to radiocephalic fistula: thrombosis, haematoma, stenosis, early failure, reintervention | | 8 weeks |
|
Arteriovenous Fistula, Fistula, Pathological Conditions, Anatomical, Arteriovenous Malformations, Vascular Malformations, Cardiovascular Abnormalities, Cardiovascular Diseases, Vascular Fistula, Vascular Diseases, Congenital Abnormalities
|
| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Neuromuscular electrostimulation<br>Patients assigned to the group NMS, following the visit Day Hospital, in the first two hours of each HD session will perform a program of neuromuscular electrostimulation of the limb with the RC-AVF performed in the reference position of the flexors and extensors forearm at the tip intervened in each HD session on the stage previously established in the protocol (duration according to established program). | Device: Neuromuscular electrostimulation<br>* The device CompexTheta 400i provided with various developmental programs rehabilitation exercise with different phases, types and current is used. an adaptive program (heating, toning, muscular atrophy, strength-endurance) will be established for each patient during the study period. It shall apply at the level of the muscle bellies of the flexor and extensor muscles of the forearm dela upper extremity AV created. Electrodes are positioned at the anatomical reference positions. The intensity of the current will increase until a tolerable muscle contraction and painless by the patient.<br>|
| No Intervention: Isometric exercises<br>They will perform isometric exercises operated limb on an outpatient basis (repeated pressure rubber balls, heavy lifting 1-2 kg). | |
|
Neuromuscular Electrostimulation in Radiocephalic Fistula
Study Overview
=================
Brief Summary
-----------------
Objective: To analyze the effect of neuromuscular electrostimulation in the maturation of radiocephalic arteriovenous fistula (RC-AVF) patients with chronic kidney disease (CKD) stage 5-5D Design: Clinical Trial with medical devices, 18-month, single-center, within the hospital setting. Disease or disorder study: vascular Access maturation. Population: Patients with CKD stage 5-5D at the research center. Project duration: 78 weeks Methodology: Patients with CKD stages 5-5D that has undergone a native AV in service stations to give their informed consent and meeting the inclusion criteria will be included. At baseline two study groups were established: Group 1: neuromuscular electrostimulation Group 2: isometric exercises
Detailed Description
-----------------
Objective: To analyze the effect of neuromuscular electrostimulation in the maturation of radiocephalic arteriovenous fistula (RC-AVF) patients with chronic kidney disease (CKD) stage 5-5D Design: Clinical Trial with medical devices, 18-month, single-center, within the hospital setting. Disease or disorder study: vascular Access maturation. Population: Patients with CKD stage 5-5D at the research center. Project duration: 78 weeks Methodology: Patients with CKD stages 5-5D that has undergone a native AV in service stations to give their informed consent and meeting the inclusion criteria will be included. At baseline two study groups were established: Group 1: neuromuscular electrostimulation Group 2: isometric exercises At baseline, patients included in the study the main demographic variables were collected, anthropometric, biochemical parameters, hemodynamic data, Eco Doppler of AV (ECO mapping) and prescribed medical treatment. Likewise, they will be made an assessment of their muscle strength by skinfold and upper limb static dynamometry in which was made the native AV. During the study period the following phases were established: • Phase 1 (4 weeks): The control group will receive the usual care on an outpatient AV. Patients assigned to group, will perform a program of AV electrostimulation in the affected upper extremity (according to program) after 7 days of completion of native AV. At the end of this phase both groups were conducted an ECO doppler (ECO4s) AV regulated by Vascular Surgery. • Phase 2 (8 weeks): The control group will receive the usual care on an outpatient AV. Patients assigned to group, will perform a program of AV electrostimulation in the affected upper extremity (according to program) At the end of this phase, both groups were conducted an ECO doppler (ECO8s) is regulated by the AV Vascular Surgery During all phases of the study, patients on hemodialysis follow their analytical controls programmed by Nephrology and receive medical treatment according to standard clinical practice. At the end of each phase of the study, all patients were performed an assessment of their muscle strength by centimetría, skinfold thickness and static dynamometry member in which AV has been made. Calendar: A provisional timetable is presented Presentation of the CEIC study: September 2014 inclusion Period: 78 weeks Follow-up period: 2 months Close database: 1 month Statistical analysis: 1 month Source of funding: Not available
Official Title
-----------------
Neuromuscular Electrostimulation Effect on the Maturation of Native Vascular Access (VA) Patients With Kidney Disease 5- Chronic Stages 5d Estimated by Doppler Ultrasound
Conditions
-----------------
Arteriovenous Fistula
Intervention / Treatment
-----------------
* Device: Neuromuscular electrostimulation
Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion criteria: Patients aged less than 18 years old Patients with tracking CCEE Nephrology than 3 months Patients with AV native AV upper limb without prior Patients give their written informed consent Exclusion criteria: prior cardiovascular event (acute myocardial infarction, unstable angina, stroke ....) in the last 3 months. AV prior to HD in same upper extremity Not have given informed written consent Carrier cardiac pacemaker
Ages Eligible for Study
-----------------
Minimum Age: 18 Years
Sexes Eligible for Study
-----------------
All
Accepts Healthy Volunteers
-----------------
No
Study Plan
=================
How is the study designed?
-----------------
Design Details
Primary Purpose: Supportive Care
Allocation: Non-Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Arms and Interventions
| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Neuromuscular electrostimulation<br>Patients assigned to the group NMS, following the visit Day Hospital, in the first two hours of each HD session will perform a program of neuromuscular electrostimulation of the limb with the RC-AVF performed in the reference position of the flexors and extensors forearm at the tip intervened in each HD session on the stage previously established in the protocol (duration according to established program). | Device: Neuromuscular electrostimulation<br>* The device CompexTheta 400i provided with various developmental programs rehabilitation exercise with different phases, types and current is used. an adaptive program (heating, toning, muscular atrophy, strength-endurance) will be established for each patient during the study period. It shall apply at the level of the muscle bellies of the flexor and extensor muscles of the forearm dela upper extremity AV created. Electrodes are positioned at the anatomical reference positions. The intensity of the current will increase until a tolerable muscle contraction and painless by the patient.<br>|
| No Intervention: Isometric exercises<br>They will perform isometric exercises operated limb on an outpatient basis (repeated pressure rubber balls, heavy lifting 1-2 kg). | |
What is the study measuring?
-----------------
Primary Outcome Measures
| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Radiocephalic fístula flow ( millimeters/minuts) | | 8 weeks ultrasonography parameter of maturation |
Secondary Outcome Measures
| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Complications related to radiocephalic fistula: thrombosis, haematoma, stenosis, early failure, reintervention | | 8 weeks |
|
|
NCT01698749
|
Effect of Intravitreal Long Acting Dexamethasone Implant, Ozurdex in Patients With Diabetic Macular Edema
|
This study is undertaken to determine the effect of intravitreal long acting dexamethasone implant,(Ozurdex®)in patients with diabetic macular edema.Diabetic macular edema is important cause of visual impairment in patients with diabetes mellitus. Focal/ grid laser photocoagulation is the standard of care in its management. Several adjuncts including intravitreal corticosteroids, Pegabtanib Sodium ,Ranibizumab, Bevacizumab, non-steroidal anti-inflammatory agents, corticosteroids, laser photocoagulation have been tried. Intravitreal Triamcinolone Acetonide (TA), a water insoluble steroid, has been shown to reduce the retinal thickness and improve the visual acuity. However, recurrence of macular edema in patients who receive intravitreal TA is a major concern as the patients need multiple repeat injections because of its short half life. A more potent steroid, dexamethasone has also been tried as an alternative to TA for macular edema; however, its short half life of only 3 hours prevents its clinical application. In search for the ideal corticosteroid preparation, a Dexamethasone Posterior Segment Drug Delivery System (Dexamethasone DDS - Ozurdex®, Allergan Inc, Irvine, California) was recently developed. Promising results have been shown in certain patients with retinal vein occlusions, uveitis receiving this intravitreal drug delivery system with improvement in visual acuity. The present study introduces a novel concept of using Ozurdex ® implant in patients with diabetic macular edema.
|
This study is undertaken to determine the effect of intravitreal long acting dexamethasone implant,(Ozurdex®)in patients with diabetic macular edema.Diabetic macular edema is important cause of visual impairment in patients with diabetes mellitus. Focal/ grid laser photocoagulation is the standard of care in its management. Several adjuncts including intravitreal corticosteroids, Pegabtanib Sodium ,Ranibizumab, Bevacizumab, non-steroidal anti-inflammatory agents, corticosteroids, laser photocoagulation have been tried. Intravitreal Triamcinolone Acetonide (TA), a water insoluble steroid, has been shown to reduce the retinal thickness and improve the visual acuity. However, recurrence of macular edema in patients who receive intravitreal TA is a major concern as the patients need multiple repeat injections because of its short half life. A more potent steroid, dexamethasone has also been tried as an alternative to TA for macular edema; however, its short half life of only 3 hours prevents its clinical application. In search for the ideal corticosteroid preparation, a Dexamethasone Posterior Segment Drug Delivery System (Dexamethasone DDS - Ozurdex®, Allergan Inc, Irvine, California) was recently developed. Promising results have been shown in certain patients with retinal vein occlusions, uveitis receiving this intravitreal drug delivery system with improvement in visual acuity. The present study introduces a novel concept of using Ozurdex ® implant in patients with diabetic macular edema.
|
Effect of Intravitreal Long Acting Dexamethasone Implant, Ozurdex in Patients With Diabetic Macular Edema
|
Vision Disorders, Diabetic Macular Edema, Macular Edema, Cystoid, Clinically Significant Macular Edema
|
* Drug: long acting intravitreal dexamethasone implant
|
Inclusion Criteria:~The patients of Type 1 or Type 2 Diabetes Mellitus fulfilling the following inclusion criteria shall be enrolled in the study:~Patients of Non Proliferative Diabetic retinopathy (NPDR)with clinicaly significant macular edema(CSME)~Patients with Proliferative Diabetic Retinopathy (PDR) with CSME where proliferative component has been adequately treated with laser photocoagulation~Diabetic patients withcystoid macular edema~Minimum central thickness on OCT not less than 300 microns~Exclusion Criteria:~Patients with history of ocular hypertension or glaucoma~Patients with media haze or pupillary non-dilation that does not allow good fundus photography, FFA and OCT.~Patients with macular ischemia on FFA
|
20 Years
|
72 Years
|
All
|
Accepts Healthy Volunteers
|
Primary Purpose: Treatment
Intervention Model: Single Group Assignment
Masking: None (Open Label)
|
| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| change in central macular thickness | The primary outcome is the change in the central macular thickness, either an increase or decrease, as measured by optical coherence tomography as compared to baseline central macular thickness | Baseline and 6 months |
|
| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change in the visual acuity | Change in the visual acuity as measured by the logMAR visual acuity chart | Baseline and 6 months |
|
Ozurdex, Diabetic macular edema, Central macular thickness
|
Hormones, Dexamethasone, Anti-Inflammatory Agents, Antiemetics, Autonomic Agents, Peripheral Nervous System Agents, Physiological Effects of Drugs, Gastrointestinal Agents, Glucocorticoids, Hormones, Hormone Substitutes, and Hormone Antagonists, Antineoplastic Agents, Hormonal, Antineoplastic Agents
|
| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Ozurdex in diabetic macular edema<br>Intravitreal ozurdex given in patients with diabetic macular edema and patients followed up for change in central macular thickness and visual acuity over period of 6 months | Drug: long acting intravitreal dexamethasone implant<br>* Intravitreal ozurdex was given in diabetic patients with clinically significant macular edema and they were followed up for change in central macular thickness and visual acuity over a period of 6 months<br>* Other names: Ozurdex;|
|
Effect of Intravitreal Long Acting Dexamethasone Implant, Ozurdex in Patients With Diabetic Macular Edema
Study Overview
=================
Brief Summary
-----------------
This study is undertaken to determine the effect of intravitreal long acting dexamethasone implant,(Ozurdex®)in patients with diabetic macular edema.Diabetic macular edema is important cause of visual impairment in patients with diabetes mellitus. Focal/ grid laser photocoagulation is the standard of care in its management. Several adjuncts including intravitreal corticosteroids, Pegabtanib Sodium ,Ranibizumab, Bevacizumab, non-steroidal anti-inflammatory agents, corticosteroids, laser photocoagulation have been tried. Intravitreal Triamcinolone Acetonide (TA), a water insoluble steroid, has been shown to reduce the retinal thickness and improve the visual acuity. However, recurrence of macular edema in patients who receive intravitreal TA is a major concern as the patients need multiple repeat injections because of its short half life. A more potent steroid, dexamethasone has also been tried as an alternative to TA for macular edema; however, its short half life of only 3 hours prevents its clinical application. In search for the ideal corticosteroid preparation, a Dexamethasone Posterior Segment Drug Delivery System (Dexamethasone DDS - Ozurdex®, Allergan Inc, Irvine, California) was recently developed. Promising results have been shown in certain patients with retinal vein occlusions, uveitis receiving this intravitreal drug delivery system with improvement in visual acuity. The present study introduces a novel concept of using Ozurdex ® implant in patients with diabetic macular edema.
Detailed Description
-----------------
This study is undertaken to determine the effect of intravitreal long acting dexamethasone implant,(Ozurdex®)in patients with diabetic macular edema.Diabetic macular edema is important cause of visual impairment in patients with diabetes mellitus. Focal/ grid laser photocoagulation is the standard of care in its management. Several adjuncts including intravitreal corticosteroids, Pegabtanib Sodium ,Ranibizumab, Bevacizumab, non-steroidal anti-inflammatory agents, corticosteroids, laser photocoagulation have been tried. Intravitreal Triamcinolone Acetonide (TA), a water insoluble steroid, has been shown to reduce the retinal thickness and improve the visual acuity. However, recurrence of macular edema in patients who receive intravitreal TA is a major concern as the patients need multiple repeat injections because of its short half life. A more potent steroid, dexamethasone has also been tried as an alternative to TA for macular edema; however, its short half life of only 3 hours prevents its clinical application. In search for the ideal corticosteroid preparation, a Dexamethasone Posterior Segment Drug Delivery System (Dexamethasone DDS - Ozurdex®, Allergan Inc, Irvine, California) was recently developed. Promising results have been shown in certain patients with retinal vein occlusions, uveitis receiving this intravitreal drug delivery system with improvement in visual acuity. The present study introduces a novel concept of using Ozurdex ® implant in patients with diabetic macular edema.
Official Title
-----------------
Effect of Intravitreal Long Acting Dexamethasone Implant, Ozurdex in Patients With Diabetic Macular Edema
Conditions
-----------------
Vision Disorders, Diabetic Macular Edema, Macular Edema, Cystoid, Clinically Significant Macular Edema
Intervention / Treatment
-----------------
* Drug: long acting intravitreal dexamethasone implant
Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: The patients of Type 1 or Type 2 Diabetes Mellitus fulfilling the following inclusion criteria shall be enrolled in the study: Patients of Non Proliferative Diabetic retinopathy (NPDR)with clinicaly significant macular edema(CSME) Patients with Proliferative Diabetic Retinopathy (PDR) with CSME where proliferative component has been adequately treated with laser photocoagulation Diabetic patients withcystoid macular edema Minimum central thickness on OCT not less than 300 microns Exclusion Criteria: Patients with history of ocular hypertension or glaucoma Patients with media haze or pupillary non-dilation that does not allow good fundus photography, FFA and OCT. Patients with macular ischemia on FFA
Ages Eligible for Study
-----------------
Minimum Age: 20 Years
Maximum Age: 72 Years
Sexes Eligible for Study
-----------------
All
Accepts Healthy Volunteers
-----------------
Accepts Healthy Volunteers
Study Plan
=================
How is the study designed?
-----------------
Design Details
Primary Purpose: Treatment
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Arms and Interventions
| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Ozurdex in diabetic macular edema<br>Intravitreal ozurdex given in patients with diabetic macular edema and patients followed up for change in central macular thickness and visual acuity over period of 6 months | Drug: long acting intravitreal dexamethasone implant<br>* Intravitreal ozurdex was given in diabetic patients with clinically significant macular edema and they were followed up for change in central macular thickness and visual acuity over a period of 6 months<br>* Other names: Ozurdex;|
What is the study measuring?
-----------------
Primary Outcome Measures
| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| change in central macular thickness | The primary outcome is the change in the central macular thickness, either an increase or decrease, as measured by optical coherence tomography as compared to baseline central macular thickness | Baseline and 6 months |
Secondary Outcome Measures
| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change in the visual acuity | Change in the visual acuity as measured by the logMAR visual acuity chart | Baseline and 6 months |
Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Ozurdex, Diabetic macular edema, Central macular thickness
|
NCT01143246
|
A Placebo-Controlled, Double-Blind Study to Confirm the Reversal of Hepatorenal Syndrome Type 1 With Terlipressin
|
This study is designed to evaluate the efficacy and safety of intravenous terlipressin versus placebo for the treatment of type 1 hepatorenal syndrome (HRS) in participants receiving standard of care albumin therapy.
|
Hepatorenal syndrome is a rare syndrome of marked renal dysfunction in patients with cirrhosis, decompensated liver disease, and portal hypertension. Hepatorenal syndrome type 1 is characterized by a rapid progressive renal impairment and has a very poor prognosis with > 80% mortality within 3 months. At present, there are no approved drug therapies for HRS type 1 in the US, Australia, or Canada. The only curative treatment for HRS type 1 and the underlying end-stage cirrhosis is liver transplantation. However, many patients will not survive long enough to receive a liver transplant and therapy, which may provide a bridge to transplantation, is badly needed. Increased understanding of the pathophysiology of HRS type 1 has demonstrated that vasoconstrictive drug therapy may reverse HRS type 1. Substantial data available from many published clinical investigations in the literature provide compelling evidence suggesting that administration of terlipressin improves renal function in patients with HRS.
|
A Multi-Center, Randomized, Placebo-controlled, Double-Blind Study to Confirm the Reversal of Hepatorenal Syndrome Type 1 With Lucassin® (Terlipressin) (The REVERSE Study)
|
Hepatorenal Syndrome
|
* Drug: Terlipressin
* Drug: Placebo
|
Inclusion Criteria:~Written informed consent by subject or legally authorized representative~At least 18 years of age~Cirrhosis and ascites~Rapidly progressive reduction in renal function characterized by:~Serum creatinine (SCr) ≥ 2.5 mg/dL~Doubling of SCr within 2 weeks (or for observations of shorter duration, SCr values over time meeting slope-based criteria for proportional increases likely to be representative of at least a doubling within 2 weeks~No sustained improvement in renal function (< 20% decrease in SCr and SCr ≥ 2.25 mg/dL) 48 hours after both diuretic withdrawal and the beginning of plasma volume expansion with albumin:~Note: Albumin doses recommended by the International Ascites Club (IAC) are 1 g/kg on the first day (Maximum 100 g) and 20 - 40 g/day thereafter as clinically indicated. It is recommended (if clinically appropriate) that the albumin dose is kept constant during the study drug administration period.~Note: The qualifying SCr value is the SCr value at least 48 hrs after both diuretic withdrawal (if applicable) and the beginning of albumin fluid challenge. The qualifying SCr value must be ≥ 2.25 mg/dL AND at least 80% of the diagnostic (pre-fluid challenge) SCr value.~Exclusion Criteria:~SCr > 7 mg/dL~Shock Note: Hypotension (Mean Arterial Pressure < 70 mm Hg or a decrease > 40 mm Hg in systolic blood pressure from baseline) with evidence of hypoperfusion abnormalities despite adequate fluid resuscitation.~Sepsis or systemic inflammatory response syndrome (SIRS)~Note: SIRS: Presence of 2 or more of the following findings:~Temperature > 38°C or < 36°C; heart rate > 90/min; respiratory rate of > 20/min or a PaCO2 of < 32 mm Hg; white blood cell count of > 12,000 cells/µL or < 4,000/ µL.~Note: Sepsis: Documented infection and systemic inflammatory response syndrome.~< 2 days anti-infective therapy for documented or suspected infection~Proteinuria > 500 mg/day~Hematuria or microhematuria (> 50 red blood cells per high power field)~Clinically significant casts on urinalysis, including granular casts Note: Urine sediment examination is required to exclude presence of granular casts and other clinically significant casts [e.g., red blood cell (RBC) casts].~Evidence of intrinsic or parenchymal renal disease (including acute tubular necrosis)~Obstructive uropathy or other renal pathology on ultrasound or other medical imaging~Current or recent treatment (within 4 weeks) with nephrotoxic drugs, e.g., aminoglycosides, nonsteroidal anti-inflammatory drugs (NSAID) Note: Up to 3 doses of an NSAID within the prior month (prescription or over the counter) is acceptable Note: Use of short-term (< 2 weeks) oral neomycin for acute encephalopathy is acceptable.~Current or recent (within 4 weeks) renal replacement therapy~Superimposed acute liver failure/injury due to factors other than alcoholic hepatitis, including acute viral hepatitis, drugs, medications (e.g., acetaminophen), or other toxins (e.g., mushroom [Amanita] poisoning)~Current or recent treatment (within 48 hours) with octreotide, midodrine, vasopressin, dopamine or other vasopressors~Severe cardiovascular disease as judged by investigator~Estimated life expectancy of less than 3 days~Confirmed pregnancy~Known allergy or sensitivity to terlipressin or another component of the study treatment~Participation in other clinical research studies involving the evaluation of other investigational drugs or devices within 30 days of randomization
|
18 Years
| null |
All
|
No
|
Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double
|
| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Percentage of Participants With Confirmed Hepatorenal Syndrome (HRS) Reversal | Confirmed HRS Reversal: The percentage of participants with two serum creatinine (SCr) values of ≤ 1.5 mg/dL at least 48 hours apart, on treatment, and without intervening renal replacement therapy or liver transplant. | within 14 days |
|
| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Percentage of Participants With HRS Reversal | HRS reversal is defined as at least one SCr value of ≤ 1.5 mg/dL on treatment (up to 24 hours after the last dose of study medication). | within 14 days |
| Percentage of Participants With Transplant-free Survival | Transplant-Free Survival up to 90 days, defined as the time (in days) that each participant survives without liver transplantation from the day of randomization. | Up to 90 days |
| Percentage of Participants With Overall Survival | Overall Survival up to 90 days, defined as the time (in days) that each participant survives from the day of randomization. | Up to 90 days |
| Percentage of Participants With Serious Adverse Events | Clinically significant changes in vital signs, height, weight, immunogenicity and laboratory assessments which qualified for the definition of serious adverse event are reported. | Up to 30 days post treatment (within 44 days) |
|
Hepatorenal syndrome, Renal failure, Cirrhosis, Alcoholic hepatitis, Ascites
|
Terlipressin, Antihypertensive Agents, Vasoconstrictor Agents
|
| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Terlipressin<br>Participants receive terlipressin intravenously as a bolus injection, followed by a saline flush. Dose, duration, retreatment and/or discontinuation may be modified by the investigator, per protocol. | Drug: Terlipressin<br>* Each 6 mL vial contains 1 mg lyophilized terlipressin acetate and 10 mg mannitol in sterile 0.9% sodium chloride solution.<br>* Other names: Lucassin®;|
| Placebo Comparator: Placebo<br>Participants receive matching placebo intravenously as a bolus injection, followed by a saline flush. Dose, duration, retreatment and/or discontinuation may be modified by the investigator, per protocol. | Drug: Placebo<br>* 11 mg mannitol reconstituted with 5 ml of sterile 0.9% sodium chloride solution.<br>* Other names: Saline;|
|
A Placebo-Controlled, Double-Blind Study to Confirm the Reversal of Hepatorenal Syndrome Type 1 With Terlipressin
Study Overview
=================
Brief Summary
-----------------
This study is designed to evaluate the efficacy and safety of intravenous terlipressin versus placebo for the treatment of type 1 hepatorenal syndrome (HRS) in participants receiving standard of care albumin therapy.
Detailed Description
-----------------
Hepatorenal syndrome is a rare syndrome of marked renal dysfunction in patients with cirrhosis, decompensated liver disease, and portal hypertension. Hepatorenal syndrome type 1 is characterized by a rapid progressive renal impairment and has a very poor prognosis with > 80% mortality within 3 months. At present, there are no approved drug therapies for HRS type 1 in the US, Australia, or Canada. The only curative treatment for HRS type 1 and the underlying end-stage cirrhosis is liver transplantation. However, many patients will not survive long enough to receive a liver transplant and therapy, which may provide a bridge to transplantation, is badly needed. Increased understanding of the pathophysiology of HRS type 1 has demonstrated that vasoconstrictive drug therapy may reverse HRS type 1. Substantial data available from many published clinical investigations in the literature provide compelling evidence suggesting that administration of terlipressin improves renal function in patients with HRS.
Official Title
-----------------
A Multi-Center, Randomized, Placebo-controlled, Double-Blind Study to Confirm the Reversal of Hepatorenal Syndrome Type 1 With Lucassin® (Terlipressin) (The REVERSE Study)
Conditions
-----------------
Hepatorenal Syndrome
Intervention / Treatment
-----------------
* Drug: Terlipressin
* Drug: Placebo
Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Written informed consent by subject or legally authorized representative At least 18 years of age Cirrhosis and ascites Rapidly progressive reduction in renal function characterized by: Serum creatinine (SCr) ≥ 2.5 mg/dL Doubling of SCr within 2 weeks (or for observations of shorter duration, SCr values over time meeting slope-based criteria for proportional increases likely to be representative of at least a doubling within 2 weeks No sustained improvement in renal function (< 20% decrease in SCr and SCr ≥ 2.25 mg/dL) 48 hours after both diuretic withdrawal and the beginning of plasma volume expansion with albumin: Note: Albumin doses recommended by the International Ascites Club (IAC) are 1 g/kg on the first day (Maximum 100 g) and 20 - 40 g/day thereafter as clinically indicated. It is recommended (if clinically appropriate) that the albumin dose is kept constant during the study drug administration period. Note: The qualifying SCr value is the SCr value at least 48 hrs after both diuretic withdrawal (if applicable) and the beginning of albumin fluid challenge. The qualifying SCr value must be ≥ 2.25 mg/dL AND at least 80% of the diagnostic (pre-fluid challenge) SCr value. Exclusion Criteria: SCr > 7 mg/dL Shock Note: Hypotension (Mean Arterial Pressure < 70 mm Hg or a decrease > 40 mm Hg in systolic blood pressure from baseline) with evidence of hypoperfusion abnormalities despite adequate fluid resuscitation. Sepsis or systemic inflammatory response syndrome (SIRS) Note: SIRS: Presence of 2 or more of the following findings: Temperature > 38°C or < 36°C; heart rate > 90/min; respiratory rate of > 20/min or a PaCO2 of < 32 mm Hg; white blood cell count of > 12,000 cells/µL or < 4,000/ µL. Note: Sepsis: Documented infection and systemic inflammatory response syndrome. < 2 days anti-infective therapy for documented or suspected infection Proteinuria > 500 mg/day Hematuria or microhematuria (> 50 red blood cells per high power field) Clinically significant casts on urinalysis, including granular casts Note: Urine sediment examination is required to exclude presence of granular casts and other clinically significant casts [e.g., red blood cell (RBC) casts]. Evidence of intrinsic or parenchymal renal disease (including acute tubular necrosis) Obstructive uropathy or other renal pathology on ultrasound or other medical imaging Current or recent treatment (within 4 weeks) with nephrotoxic drugs, e.g., aminoglycosides, nonsteroidal anti-inflammatory drugs (NSAID) Note: Up to 3 doses of an NSAID within the prior month (prescription or over the counter) is acceptable Note: Use of short-term (< 2 weeks) oral neomycin for acute encephalopathy is acceptable. Current or recent (within 4 weeks) renal replacement therapy Superimposed acute liver failure/injury due to factors other than alcoholic hepatitis, including acute viral hepatitis, drugs, medications (e.g., acetaminophen), or other toxins (e.g., mushroom [Amanita] poisoning) Current or recent treatment (within 48 hours) with octreotide, midodrine, vasopressin, dopamine or other vasopressors Severe cardiovascular disease as judged by investigator Estimated life expectancy of less than 3 days Confirmed pregnancy Known allergy or sensitivity to terlipressin or another component of the study treatment Participation in other clinical research studies involving the evaluation of other investigational drugs or devices within 30 days of randomization
Ages Eligible for Study
-----------------
Minimum Age: 18 Years
Sexes Eligible for Study
-----------------
All
Accepts Healthy Volunteers
-----------------
No
Study Plan
=================
How is the study designed?
-----------------
Design Details
Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double
Arms and Interventions
| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Terlipressin<br>Participants receive terlipressin intravenously as a bolus injection, followed by a saline flush. Dose, duration, retreatment and/or discontinuation may be modified by the investigator, per protocol. | Drug: Terlipressin<br>* Each 6 mL vial contains 1 mg lyophilized terlipressin acetate and 10 mg mannitol in sterile 0.9% sodium chloride solution.<br>* Other names: Lucassin®;|
| Placebo Comparator: Placebo<br>Participants receive matching placebo intravenously as a bolus injection, followed by a saline flush. Dose, duration, retreatment and/or discontinuation may be modified by the investigator, per protocol. | Drug: Placebo<br>* 11 mg mannitol reconstituted with 5 ml of sterile 0.9% sodium chloride solution.<br>* Other names: Saline;|
What is the study measuring?
-----------------
Primary Outcome Measures
| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Percentage of Participants With Confirmed Hepatorenal Syndrome (HRS) Reversal | Confirmed HRS Reversal: The percentage of participants with two serum creatinine (SCr) values of ≤ 1.5 mg/dL at least 48 hours apart, on treatment, and without intervening renal replacement therapy or liver transplant. | within 14 days |
Secondary Outcome Measures
| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Percentage of Participants With HRS Reversal | HRS reversal is defined as at least one SCr value of ≤ 1.5 mg/dL on treatment (up to 24 hours after the last dose of study medication). | within 14 days |
| Percentage of Participants With Transplant-free Survival | Transplant-Free Survival up to 90 days, defined as the time (in days) that each participant survives without liver transplantation from the day of randomization. | Up to 90 days |
| Percentage of Participants With Overall Survival | Overall Survival up to 90 days, defined as the time (in days) that each participant survives from the day of randomization. | Up to 90 days |
| Percentage of Participants With Serious Adverse Events | Clinically significant changes in vital signs, height, weight, immunogenicity and laboratory assessments which qualified for the definition of serious adverse event are reported. | Up to 30 days post treatment (within 44 days) |
Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Hepatorenal syndrome, Renal failure, Cirrhosis, Alcoholic hepatitis, Ascites
|
NCT00023426
|
TBTC Study 25: Study of the Tolerability of Higher Doses of Rifapentine in the Treatment of Tuberculosis
|
Randomized, double-blind study of the tolerability of three different doses of rifapentine
|
Prospective, randomized, double-blinded, comparative study. Patients are randomized at the completion of induction phase therapy. Sample-size is 50 HIV-seronegative patients with culture-positive, drug susceptible TB in each treatment arm. The first 75 patients will be randomized 2:1 to 900 mg:600 mg rifapentine. The second 75 patients will be randomized 2:1 to 1200 mg:600 mg rifapentine. The DSMB will review tolerability and safety data on the first 21 patients enrolled (at the 900 mg and 600 mg doses) and approve proceeding to enrollment at the 1200 mg dose.
|
TBTC Study 25:A Prospective, Randomized, Double-Blind Study of the Tolerability of Higher Doses of Rifapentine
|
Tuberculosis
|
* Drug: rifapentine
|
Inclusions:~Drug susceptible culture-positive tuberculosis~Adequate induction therapy~Age >18~Normal screening labs~Karnofsky >=60~Informed consent~Birth control if of child bearing potential~Exclusions:~SilicoTB~Skeletal or CNS TB~Pregnant or breastfeeding~Intolerance to INH or rifamycins~Over 70 days TB treatment just prior to enrollment
|
18 Years
| null |
All
|
No
|
Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double
|
| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Proportion of patients who fail to complete therapy in each of the dosing groups | | |
|
| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 1. Rate of serious adverse events in each of the dosing groups | | |
| 2. Rate of total adverse events in each of the groups | | |
| 3. Rate of relapse in patients with positive sputum culture at 2 months, in each of the groups | | |
|
tuberculosis, tb, rifapentine, safety, dose
|
Rifapentine, Antibiotics, Antitubercular, Antitubercular Agents, Anti-Bacterial Agents, Anti-Infective Agents, Leprostatic Agents
|
| Intervention/Treatment |
| --- |
|Drug: rifapentine|nan|
|
TBTC Study 25: Study of the Tolerability of Higher Doses of Rifapentine in the Treatment of Tuberculosis
Study Overview
=================
Brief Summary
-----------------
Randomized, double-blind study of the tolerability of three different doses of rifapentine
Detailed Description
-----------------
Prospective, randomized, double-blinded, comparative study. Patients are randomized at the completion of induction phase therapy. Sample-size is 50 HIV-seronegative patients with culture-positive, drug susceptible TB in each treatment arm. The first 75 patients will be randomized 2:1 to 900 mg:600 mg rifapentine. The second 75 patients will be randomized 2:1 to 1200 mg:600 mg rifapentine. The DSMB will review tolerability and safety data on the first 21 patients enrolled (at the 900 mg and 600 mg doses) and approve proceeding to enrollment at the 1200 mg dose.
Official Title
-----------------
TBTC Study 25:A Prospective, Randomized, Double-Blind Study of the Tolerability of Higher Doses of Rifapentine
Conditions
-----------------
Tuberculosis
Intervention / Treatment
-----------------
* Drug: rifapentine
Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusions: Drug susceptible culture-positive tuberculosis Adequate induction therapy Age >18 Normal screening labs Karnofsky >=60 Informed consent Birth control if of child bearing potential Exclusions: SilicoTB Skeletal or CNS TB Pregnant or breastfeeding Intolerance to INH or rifamycins Over 70 days TB treatment just prior to enrollment
Ages Eligible for Study
-----------------
Minimum Age: 18 Years
Sexes Eligible for Study
-----------------
All
Accepts Healthy Volunteers
-----------------
No
Study Plan
=================
How is the study designed?
-----------------
Design Details
Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double
Arms and Interventions
| Intervention/Treatment |
| --- |
|Drug: rifapentine|nan|
What is the study measuring?
-----------------
Primary Outcome Measures
| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Proportion of patients who fail to complete therapy in each of the dosing groups | | |
Secondary Outcome Measures
| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 1. Rate of serious adverse events in each of the dosing groups | | |
| 2. Rate of total adverse events in each of the groups | | |
| 3. Rate of relapse in patients with positive sputum culture at 2 months, in each of the groups | | |
Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
tuberculosis, tb, rifapentine, safety, dose
|
NCT05663788
|
Web-based Learning Module on Optical Diagnosis of Early Colorectal Cancer
|
International guidelines recommend deciding the treatment of colorectal lesions based on the estimated histology by endoscopic optical diagnosis. However, the theoretical and practical knowledge on optical diagnosis is not widely expanded~The mail goal of this randomised controlled trial is to compare the pooled sensitivity of optical diagnosis for predicting deep submucosal invasion in large non-pedunculated polyps > 20 mm assessed in routine colonoscopies of gastroenterologists attending a e-learning module (intervention group) vs gastroenterologists who do not (control group)~The main questions the study aims to answer are:~Is the pooled sensitivity of optical diagnosis for predicting deep submucosal invasion in large non-pedunculated polyps assessed in routine colonoscopies increased in those gastroenterologists participating in the e-learning module?~Is the pooled diagnostic accuracy of optical diagnosis for predicting deep sm invasion in large non-pedunculated polyps ≥ 20 mm assessed in routine colonoscopies increased in those gastroenterologists participating in the e-learning module?~In lesions with submucosal invasion, is the en bloc and complete resection rate (R0) increased in those gastroenterologists participating in the e-learning module?~In lesions referred to surgery, is the pooled benign polyps rate decreased in those gastroenterologists participating in the e-learning module?~In lesions treated with advanced en bloc procedures (ESD, TAMIS, fullthickness resection), is the pooled rate of histology with high-grade dysplasia, intramucosal cancer or submucosal invasion increased in those gastroenterologists participating in the e-learning module?~In lesions treated with piecemeal endoscopic resection, is the pooled rate of histology with high-grade dysplasia, intramucosal cancer or submucosal invasion decreased in those gastroenterologists participating in the e-learning module?~Is the diagnostic accuracy for predicting deep submucosal invasion in a test with pictures increased after participating in the e-learning module?~The participants (or subjects of study) are gastroenterologists. They will be randomised to do the e-learning course (intervention group) or not (control group).~Researchers will compare clinical outcomes of gastroenterologists participating in the e-learning module vs gastroenterologists not participating in the e-learning module to see if:~the pooled sensitivity of optical diagnosis for predicting deep submucosal invasion in large non-pedunculated polyps > 20 mm assessed in routine colonoscopies is increased.~the pooled diagnostic accuracy of optical diagnosis for predicting deep sm invasion in large non-pedunculated polyps > 20 mm is increased.~the en bloc and complete resection rate (R0) is increased in lesions with submucosal invasion.~the pooled benign polyps rate decreased in lesions referred to surgery.~the pooled rate of histology with high-grade dysplasia, intramucosal cancer or submucosal invasion increased in lesions treated with advanced en bloc procedures (ESD, TAMIS, fullthickness resection).~the pooled rate of histology with high-grade dysplasia, intramucosal cancer or submucosal invasion decreased in lesions treated with piecemeal endoscopic resection.~the diagnostic accuracy for predicting deep submucosal invasion in a test with pictures after participating is increased.
|
Non-pharmacological multi-centre randomised controlled trial. Gastroenterologists who have performed > 300 colonoscopies without supervision and who have finished/will finish the residency in Gastroenterology between 2014 and 2023 will be invited to participate. Gastroenterologists participating in the study will register the optical diagnosis, endoscopic lesions' characteristics, histology and clinical outcomes of consecutive non-pedunculated lesions ≥ 20 mm found in routine colonoscopies during a whole year. Participants allocated in the intervention group will receive a learning module after six months. Those assigned in the control group will not receive any learning module (they will be offered to do it at the end of the study). Pooled sensitivity and diagnostic accuracy of optical diagnosis for predicting deep submucosal invasion, and clinical outcomes in routine colonoscopies will be compared in both groups. Diagnostic accuracy for predicting deep submucosal invasion in a test with pictures before and after participating will also be compared.
|
Web-based Learning Module to Increase the Accuracy of Optical Diagnosis for Detecting the Invasive Pattern of Colorectal Polyps (LODIP Study). Randomised Controlled Trial
|
Colorectal Cancer, Colorectal Cancer Stage I
|
* Other: E-learning module
|
Inclusion Criteria:~Gastroenterologists who have performed > 300 colonoscopies without supervision and are in the last training year or had finished the Gastroenterology residency after 2014.~Exclusion Criteria:~Endoscopists who have learned the invasive pattern in a centre where endoscopists have published a high diagnostic accuracy for predicting deep submucosal invasion (Japanese centres).
|
28 Years
| null |
All
|
Accepts Healthy Volunteers
|
Primary Purpose: Diagnostic
Allocation: Randomized
Intervention Model: Parallel Assignment
Interventional Model Description: Non-pharmacological multi-centre, stratified (by the centre and experience, with balance randomisation [1:1]), randomised, controlled, parallel trial conducted in Spain.
Masking: None (Open Label)
|
| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Pooled sensitivity of endoscopic optical diagnosis for predicting deep submucosal invasion in routine colonoscopies | Pooled sensitivity of endoscopic optical diagnosis (test assessed by Gastroenterologists according to the ESGE guidelines) for predicting deep submucosal invasion (gold standard measured by the Pathologists according to the WHO criteria) in routine colonoscopies. | immediately after the colonoscopy |
|
| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Pooled Sensitivity of endoscopic optical diagnosis for predicting deep submucosal invasion | Pooled Sensitivity of endoscopic optical diagnosis (test assessed by Gastroenterologists according to the ESGE guidelines) for predicting deep submucosal invasion (gold standard measured by the Pathologists according to the WHO criteria) in routine colonoscopies. | immediately after the colonoscopy |
| Pooled Specificity of endoscopic optical diagnosis for predicting deep submucosal invasion | Pooled Specificity of endoscopic optical diagnosis (test assessed by Gastroenterologists according to the ESGE guidelines) for predicting deep submucosal invasion (gold standard measured by the Pathologists according to the WHO criteria) in routine colonoscopies. | immediately after the colonoscopy |
| Pooled ROC area of endoscopic optical diagnosis for predicting deep submucosal invasion | Pooled ROC area of endoscopic optical diagnosis (test assessed by Gastroenterologists according to the ESGE guidelines) for predicting deep submucosal invasion (gold standard measured by the Pathologists according to the WHO criteria) in routine colonoscopies. | immediately after the colonoscopy |
| Pooled PPV of endoscopic optical diagnosis for predicting deep submucosal invasion | Pooled PPV of endoscopic optical diagnosis (test assessed by Gastroenterologists according to the ESGE guidelines) for predicting deep submucosal invasion (gold standard measured by the Pathologists according to the WHO criteria) in routine colonoscopies. | immediately after the colonoscopy |
| Pooled NPV of endoscopic optical diagnosis for predicting deep submucosal invasion | Pooled NPV of endoscopic optical diagnosis (test assessed by Gastroenterologists according to the ESGE guidelines) for predicting deep submucosal invasion (gold standard measured by the Pathologists according to the WHO criteria) in routine colonoscopies. | immediately after the colonoscopy |
| Pooled LR+ of endoscopic optical diagnosis for predicting deep submucosal invasion | Pooled LR+ of endoscopic optical diagnosis (test assessed by Gastroenterologists according to the ESGE guidelines) for predicting deep submucosal invasion (gold standard measured by the Pathologists according to the WHO criteria) in routine colonoscopies. | immediately after the colonoscopy |
| Pooled LR- of endoscopic optical diagnosis for predicting deep submucosal invasion | Pooled LR- of endoscopic optical diagnosis (test assessed by Gastroenterologists according to the ESGE guidelines) for predicting deep submucosal invasion (gold standard measured by the Pathologists according to the WHO criteria) in routine colonoscopies. | immediately after the colonoscopy |
| Pooled en bloc resection rate in polyps containing submucosal invasion | Pooled en bloc resection rate in polyps containing submucosal invasion found in routine colonoscopies | immediately after the colonoscopy |
| Pooled complete resection rate (R0) in polyps containing submucosal invasion | Pooled complete resection rate (R0) according to the pathologist criteria in polyps containing submucosal invasion | immediately after the colonoscopy |
| Pooled benign polyps rate in lesions refered to surgery | Pooled benign polyps rate in lesions refered to surgery | immediately after the colonoscopy |
| Pooled rate of histology with high-grade dysplasia, intramucosal cancer or submucosal invasion in lesions treated with advanced en bloc procedures (ESD, TAMIS, fullthickness resection) | Pooled rate of histology with high-grade dysplasia, intramucosal cancer or submucosal invasion in lesions treated with advanced en bloc procedures (ESD, TAMIS, fullthickness resection) | immediately after the colonoscopy |
| Pooled rate of histology with high-grade dysplasia, intramucosal cancer or submucosal invasion in lesions treated with piecemeal endoscopic resection | Pooled rate of histology with high-grade dysplasia, intramucosal cancer or submucosal invasion in lesions treated with piecemeal endoscopic resection | immediately after the colonoscopy |
| Pooled Sensitivity of endoscopic optical diagnosis for predicting deep submucosal invasion in a 20-image test before and after the learning module in the intervention group | Pooled Sensitivity of endoscopic optical diagnosis for predicting deep submucosal invasion in a 20-image test before and after the learning module in the intervention group | immediately after the colonoscopy |
| Pooled Specificity of endoscopic optical diagnosis for predicting deep submucosal invasion in a 20-image test before and after the learning module in the intervention group | Pooled Specificity of endoscopic optical diagnosis for predicting deep submucosal invasion in a 20-image test before and after the learning module in the intervention group | immediately after the colonoscopy |
| Pooled ROC area of endoscopic optical diagnosis for predicting deep submucosal invasion in a 20-image test before and after the learning module in the intervention group | Pooled ROC area of endoscopic optical diagnosis for predicting deep submucosal invasion in a 20-image test before and after the learning module in the intervention group | immediately after the colonoscopy |
| Pooled PPV of endoscopic optical diagnosis for predicting deep submucosal invasion in a 20-image test before and after the learning module in the intervention group | Pooled PPV of endoscopic optical diagnosis for predicting deep submucosal invasion in a 20-image test before and after the learning module in the intervention group | immediately after the colonoscopy |
| Pooled NPV of endoscopic optical diagnosis for predicting deep submucosal invasion in a 20-image test before and after the learning module in the intervention group | Pooled NPV of endoscopic optical diagnosis for predicting deep submucosal invasion in a 20-image test before and after the learning module in the intervention group | immediately after the colonoscopy |
| Pooled LR+ of endoscopic optical diagnosis for predicting deep submucosal invasion in a 20-image test before and after the learning module in the intervention group | Pooled LR+ of endoscopic optical diagnosis for predicting deep submucosal invasion in a 20-image test before and after the learning module in the intervention group | immediately after the colonoscopy |
| Pooled LR- of endoscopic optical diagnosis for predicting deep submucosal invasion in a 20-image test before and after the learning module in the intervention group | Pooled LR- of endoscopic optical diagnosis for predicting deep submucosal invasion in a 20-image test before and after the learning module in the intervention group | immediately after the colonoscopy |
|
advance endoscopy, collaborative research, colonoscopy, early colorectal cancer, colorectal polyps, optical diagnosis, training, invasive pattern, magnifying endoscopy, chromoendoscopy, deep submucosal invasion
|
Colorectal Neoplasms, Intestinal Neoplasms, Gastrointestinal Neoplasms, Digestive System Neoplasms, Neoplasms by Site, Neoplasms, Digestive System Diseases, Gastrointestinal Diseases, Colonic Diseases, Intestinal Diseases, Rectal Diseases
|
| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: E-learning module gastroenterologists<br>Gastroenterologists participating in the e-learning module | Other: E-learning module<br>* The intervention is a structured e-learning module on a web-based platform (www.trainingopticaldiagnosis.com) that consists of:~10 modules, including theoretical knowledge and multiple exercises.~2 seminars with a tutor (after Module 5 and Module 10)~feedback from the tutor on three cases recorded by the participant.~20-images test before and after the content described above (10 Modules, 2 seminars with tutors and feedback on three cases)~All the Gastroenterologists participating in the study will predict deep submucosal invasion in their routine colonoscopies and will register clinical outcomes during 12 months. The randomisation and intervention will be conducted 6 months after starting to predict deep submucosal invasion and registering clinical outcomes.<br>|
| No Intervention: Control group<br>Gastroenterologists not participating in the e-learning module | |
|
Web-based Learning Module on Optical Diagnosis of Early Colorectal Cancer
Study Overview
=================
Brief Summary
-----------------
International guidelines recommend deciding the treatment of colorectal lesions based on the estimated histology by endoscopic optical diagnosis. However, the theoretical and practical knowledge on optical diagnosis is not widely expanded The mail goal of this randomised controlled trial is to compare the pooled sensitivity of optical diagnosis for predicting deep submucosal invasion in large non-pedunculated polyps > 20 mm assessed in routine colonoscopies of gastroenterologists attending a e-learning module (intervention group) vs gastroenterologists who do not (control group) The main questions the study aims to answer are: Is the pooled sensitivity of optical diagnosis for predicting deep submucosal invasion in large non-pedunculated polyps assessed in routine colonoscopies increased in those gastroenterologists participating in the e-learning module? Is the pooled diagnostic accuracy of optical diagnosis for predicting deep sm invasion in large non-pedunculated polyps ≥ 20 mm assessed in routine colonoscopies increased in those gastroenterologists participating in the e-learning module? In lesions with submucosal invasion, is the en bloc and complete resection rate (R0) increased in those gastroenterologists participating in the e-learning module? In lesions referred to surgery, is the pooled benign polyps rate decreased in those gastroenterologists participating in the e-learning module? In lesions treated with advanced en bloc procedures (ESD, TAMIS, fullthickness resection), is the pooled rate of histology with high-grade dysplasia, intramucosal cancer or submucosal invasion increased in those gastroenterologists participating in the e-learning module? In lesions treated with piecemeal endoscopic resection, is the pooled rate of histology with high-grade dysplasia, intramucosal cancer or submucosal invasion decreased in those gastroenterologists participating in the e-learning module? Is the diagnostic accuracy for predicting deep submucosal invasion in a test with pictures increased after participating in the e-learning module? The participants (or subjects of study) are gastroenterologists. They will be randomised to do the e-learning course (intervention group) or not (control group). Researchers will compare clinical outcomes of gastroenterologists participating in the e-learning module vs gastroenterologists not participating in the e-learning module to see if: the pooled sensitivity of optical diagnosis for predicting deep submucosal invasion in large non-pedunculated polyps > 20 mm assessed in routine colonoscopies is increased. the pooled diagnostic accuracy of optical diagnosis for predicting deep sm invasion in large non-pedunculated polyps > 20 mm is increased. the en bloc and complete resection rate (R0) is increased in lesions with submucosal invasion. the pooled benign polyps rate decreased in lesions referred to surgery. the pooled rate of histology with high-grade dysplasia, intramucosal cancer or submucosal invasion increased in lesions treated with advanced en bloc procedures (ESD, TAMIS, fullthickness resection). the pooled rate of histology with high-grade dysplasia, intramucosal cancer or submucosal invasion decreased in lesions treated with piecemeal endoscopic resection. the diagnostic accuracy for predicting deep submucosal invasion in a test with pictures after participating is increased.
Detailed Description
-----------------
Non-pharmacological multi-centre randomised controlled trial. Gastroenterologists who have performed > 300 colonoscopies without supervision and who have finished/will finish the residency in Gastroenterology between 2014 and 2023 will be invited to participate. Gastroenterologists participating in the study will register the optical diagnosis, endoscopic lesions' characteristics, histology and clinical outcomes of consecutive non-pedunculated lesions ≥ 20 mm found in routine colonoscopies during a whole year. Participants allocated in the intervention group will receive a learning module after six months. Those assigned in the control group will not receive any learning module (they will be offered to do it at the end of the study). Pooled sensitivity and diagnostic accuracy of optical diagnosis for predicting deep submucosal invasion, and clinical outcomes in routine colonoscopies will be compared in both groups. Diagnostic accuracy for predicting deep submucosal invasion in a test with pictures before and after participating will also be compared.
Official Title
-----------------
Web-based Learning Module to Increase the Accuracy of Optical Diagnosis for Detecting the Invasive Pattern of Colorectal Polyps (LODIP Study). Randomised Controlled Trial
Conditions
-----------------
Colorectal Cancer, Colorectal Cancer Stage I
Intervention / Treatment
-----------------
* Other: E-learning module
Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Gastroenterologists who have performed > 300 colonoscopies without supervision and are in the last training year or had finished the Gastroenterology residency after 2014. Exclusion Criteria: Endoscopists who have learned the invasive pattern in a centre where endoscopists have published a high diagnostic accuracy for predicting deep submucosal invasion (Japanese centres).
Ages Eligible for Study
-----------------
Minimum Age: 28 Years
Sexes Eligible for Study
-----------------
All
Accepts Healthy Volunteers
-----------------
Accepts Healthy Volunteers
Study Plan
=================
How is the study designed?
-----------------
Design Details
Primary Purpose: Diagnostic
Allocation: Randomized
Intervention Model: Parallel Assignment
Interventional Model Description: Non-pharmacological multi-centre, stratified (by the centre and experience, with balance randomisation [1:1]), randomised, controlled, parallel trial conducted in Spain.
Masking: None (Open Label)
Arms and Interventions
| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: E-learning module gastroenterologists<br>Gastroenterologists participating in the e-learning module | Other: E-learning module<br>* The intervention is a structured e-learning module on a web-based platform (www.trainingopticaldiagnosis.com) that consists of: 10 modules, including theoretical knowledge and multiple exercises. 2 seminars with a tutor (after Module 5 and Module 10) feedback from the tutor on three cases recorded by the participant. 20-images test before and after the content described above (10 Modules, 2 seminars with tutors and feedback on three cases) All the Gastroenterologists participating in the study will predict deep submucosal invasion in their routine colonoscopies and will register clinical outcomes during 12 months. The randomisation and intervention will be conducted 6 months after starting to predict deep submucosal invasion and registering clinical outcomes.<br>|
| No Intervention: Control group<br>Gastroenterologists not participating in the e-learning module | |
What is the study measuring?
-----------------
Primary Outcome Measures
| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Pooled sensitivity of endoscopic optical diagnosis for predicting deep submucosal invasion in routine colonoscopies | Pooled sensitivity of endoscopic optical diagnosis (test assessed by Gastroenterologists according to the ESGE guidelines) for predicting deep submucosal invasion (gold standard measured by the Pathologists according to the WHO criteria) in routine colonoscopies. | immediately after the colonoscopy |
Secondary Outcome Measures
| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Pooled Sensitivity of endoscopic optical diagnosis for predicting deep submucosal invasion | Pooled Sensitivity of endoscopic optical diagnosis (test assessed by Gastroenterologists according to the ESGE guidelines) for predicting deep submucosal invasion (gold standard measured by the Pathologists according to the WHO criteria) in routine colonoscopies. | immediately after the colonoscopy |
| Pooled Specificity of endoscopic optical diagnosis for predicting deep submucosal invasion | Pooled Specificity of endoscopic optical diagnosis (test assessed by Gastroenterologists according to the ESGE guidelines) for predicting deep submucosal invasion (gold standard measured by the Pathologists according to the WHO criteria) in routine colonoscopies. | immediately after the colonoscopy |
| Pooled ROC area of endoscopic optical diagnosis for predicting deep submucosal invasion | Pooled ROC area of endoscopic optical diagnosis (test assessed by Gastroenterologists according to the ESGE guidelines) for predicting deep submucosal invasion (gold standard measured by the Pathologists according to the WHO criteria) in routine colonoscopies. | immediately after the colonoscopy |
| Pooled PPV of endoscopic optical diagnosis for predicting deep submucosal invasion | Pooled PPV of endoscopic optical diagnosis (test assessed by Gastroenterologists according to the ESGE guidelines) for predicting deep submucosal invasion (gold standard measured by the Pathologists according to the WHO criteria) in routine colonoscopies. | immediately after the colonoscopy |
| Pooled NPV of endoscopic optical diagnosis for predicting deep submucosal invasion | Pooled NPV of endoscopic optical diagnosis (test assessed by Gastroenterologists according to the ESGE guidelines) for predicting deep submucosal invasion (gold standard measured by the Pathologists according to the WHO criteria) in routine colonoscopies. | immediately after the colonoscopy |
| Pooled LR+ of endoscopic optical diagnosis for predicting deep submucosal invasion | Pooled LR+ of endoscopic optical diagnosis (test assessed by Gastroenterologists according to the ESGE guidelines) for predicting deep submucosal invasion (gold standard measured by the Pathologists according to the WHO criteria) in routine colonoscopies. | immediately after the colonoscopy |
| Pooled LR- of endoscopic optical diagnosis for predicting deep submucosal invasion | Pooled LR- of endoscopic optical diagnosis (test assessed by Gastroenterologists according to the ESGE guidelines) for predicting deep submucosal invasion (gold standard measured by the Pathologists according to the WHO criteria) in routine colonoscopies. | immediately after the colonoscopy |
| Pooled en bloc resection rate in polyps containing submucosal invasion | Pooled en bloc resection rate in polyps containing submucosal invasion found in routine colonoscopies | immediately after the colonoscopy |
| Pooled complete resection rate (R0) in polyps containing submucosal invasion | Pooled complete resection rate (R0) according to the pathologist criteria in polyps containing submucosal invasion | immediately after the colonoscopy |
| Pooled benign polyps rate in lesions refered to surgery | Pooled benign polyps rate in lesions refered to surgery | immediately after the colonoscopy |
| Pooled rate of histology with high-grade dysplasia, intramucosal cancer or submucosal invasion in lesions treated with advanced en bloc procedures (ESD, TAMIS, fullthickness resection) | Pooled rate of histology with high-grade dysplasia, intramucosal cancer or submucosal invasion in lesions treated with advanced en bloc procedures (ESD, TAMIS, fullthickness resection) | immediately after the colonoscopy |
| Pooled rate of histology with high-grade dysplasia, intramucosal cancer or submucosal invasion in lesions treated with piecemeal endoscopic resection | Pooled rate of histology with high-grade dysplasia, intramucosal cancer or submucosal invasion in lesions treated with piecemeal endoscopic resection | immediately after the colonoscopy |
| Pooled Sensitivity of endoscopic optical diagnosis for predicting deep submucosal invasion in a 20-image test before and after the learning module in the intervention group | Pooled Sensitivity of endoscopic optical diagnosis for predicting deep submucosal invasion in a 20-image test before and after the learning module in the intervention group | immediately after the colonoscopy |
| Pooled Specificity of endoscopic optical diagnosis for predicting deep submucosal invasion in a 20-image test before and after the learning module in the intervention group | Pooled Specificity of endoscopic optical diagnosis for predicting deep submucosal invasion in a 20-image test before and after the learning module in the intervention group | immediately after the colonoscopy |
| Pooled ROC area of endoscopic optical diagnosis for predicting deep submucosal invasion in a 20-image test before and after the learning module in the intervention group | Pooled ROC area of endoscopic optical diagnosis for predicting deep submucosal invasion in a 20-image test before and after the learning module in the intervention group | immediately after the colonoscopy |
| Pooled PPV of endoscopic optical diagnosis for predicting deep submucosal invasion in a 20-image test before and after the learning module in the intervention group | Pooled PPV of endoscopic optical diagnosis for predicting deep submucosal invasion in a 20-image test before and after the learning module in the intervention group | immediately after the colonoscopy |
| Pooled NPV of endoscopic optical diagnosis for predicting deep submucosal invasion in a 20-image test before and after the learning module in the intervention group | Pooled NPV of endoscopic optical diagnosis for predicting deep submucosal invasion in a 20-image test before and after the learning module in the intervention group | immediately after the colonoscopy |
| Pooled LR+ of endoscopic optical diagnosis for predicting deep submucosal invasion in a 20-image test before and after the learning module in the intervention group | Pooled LR+ of endoscopic optical diagnosis for predicting deep submucosal invasion in a 20-image test before and after the learning module in the intervention group | immediately after the colonoscopy |
| Pooled LR- of endoscopic optical diagnosis for predicting deep submucosal invasion in a 20-image test before and after the learning module in the intervention group | Pooled LR- of endoscopic optical diagnosis for predicting deep submucosal invasion in a 20-image test before and after the learning module in the intervention group | immediately after the colonoscopy |
Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
advance endoscopy, collaborative research, colonoscopy, early colorectal cancer, colorectal polyps, optical diagnosis, training, invasive pattern, magnifying endoscopy, chromoendoscopy, deep submucosal invasion
|
NCT05642312
|
A Study to Investigate Vamikibart in Participants With Uveitic Macular Edema
|
This study will assess the efficacy and safety of vamikibart in participants with uveitic macular edema.
|
A Phase III, Multicenter, Randomized, Double-Masked, Sham-Controlled Study to Investigate the Efficacy, Safety, Pharmacokinetics and Pharmacodynamics of Vamikibart Administered Intravitreally in Patients With Uveitic Macular Edema
|
Uveitic Macular Edema
|
* Drug: Vamikibart
* Other: Sham
|
Inclusion Criteria:~Female participants: Agreement to remain abstinent (refrain from heterosexual intercourse) or use contraception as defined by the protocol~Diagnosis of macular edema associated with non-infectious uveitis (NIU)~Diagnosis of active or inactive, acute, or chronic NIU of any etiology and of any anatomical type (anterior, intermediate, posterior, panuveitis)~BCVA letter score of 73 to 19 letters (inclusive) on Early Treatment Diabetic Retinopathy Study (EDTRS)-like charts~Exclusion Criteria:~Evidence of active or latent syphilis infection~Evidence of active or latent tuberculosis infection and/or positive tuberculosis assay, or previous or current HIV diagnosis~Serious acute or chronic medical or psychiatric illness~History of major ocular and non-ocular surgical procedures~Uncontrolled IOP or glaucoma or chronic hypotony~Any anatomical changes or media opacity in the study eye preventing evaluation of retina, vitreous, and capture of study images~Prior use of IVT biologics including anti-VEGFs less than 2-4 months prior to Day 1; received IVT Methotrexate within 4 months prior to Day 1~Prior macular laser therapy, cataract surgery within 6 months and laser capsulotomy within 3 months of Day 1~Topical corticosteroids and/or topical NSAID > 3 drops per day in the 14 days prior to Day 1 (D1); intraocular or periocular corticosteroid injections in the 2 months prior to D1; subconjunctival corticosteroid injection within 1 month prior to Day 1; an OZURDEX implant in the 4 months prior to D1; YUTIQ, RETISERT or ILUVIEN implant in the 3 years prior to D1~Diagnosis of macular edema due to any cause other than NIU~Any major ocular conditions that may require medical or surgical intervention during the study period to prevent vision loss
|
18 Years
| null |
All
|
No
|
Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double
|
| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Proportion of participants with ≥ 15 letter improvement from baseline in best-corrected visual acuity (BCVA) at Week 16 | | Week 16 |
|
| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Proportion of participants with ≥ 15 letter improvement from baseline in BCVA at Week 20 | | Week 20 |
| Change from baseline in BCVA at Week 16 | | Week 16 |
| Change from baseline in central subfield thickness (CST) at Week 16 | | Week 16 |
| Change from Baseline in BCVA at Weeks 20 and 52 | | Weeks 20 and 52 |
| Change from baseline in CST at Weeks 20 and 52 | | Weeks 20 and 52 |
| Proportion of participants with uveitic macular edema secondary to non-infectious uveitis (UME) resolution defined by standardized (by machine) CST threshold <325um on optical coherence tomography (OCT) from baseline at Weeks 16 and 52 | | Weeks 16 and 52 |
| Time to rescue treatment | | Up to Week 52 |
| Number of rescue treatments received | | Up to Week 52 |
| Type of rescue treatments received | | Up to Week 52 |
| Proportion of participants with ≥15 letter improvement from baseline in BCVA at Week 16 and 52 | | Weeks 16 and 52 |
| Proportion of participants without ≥15 letter loss from baseline in BCVA at Week 16 and 52 | | Weeks 16 and 52 |
| Number of PRN injections received | | Up to Week 52 |
| Time to first PRN injection | | Up to Week 52 |
| Change from baseline in the National Eye Institute Visual Function Questionnaire-25 (NEI VFQ-25) at Weeks 16 and 52 | | Weeks 16 and 52 |
| Percentage of participants with ocular adverse events (AEs) | | Up to Week 52 |
| Percentage of participants with non-ocular AEs | | Up to Week 52 |
| Percent change from baseline in corneal endothelial cell density at Week 24 | | Week 24 |
| Percentage of participants with adverse events of special interest (AESIs) | | Up to Week 52 |
| Percent change from baseline in corneal endothelial cell density at Week 52 | | Week 52 |
| Aqueous humor (AH) concentration of vamikibart | | Up to Week 52 |
| Serum concentration of vamikibart | | Up to Week 52 |
| Anti-drug antibody titer to vamikibart | | Baseline to Week 52 |
|
Macular Edema, Edema, Macular Degeneration, Retinal Degeneration, Retinal Diseases, Eye Diseases
|
| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Arm A<br>Participants will receive 4 low-dose vamikibart intravitreal (IVT) injections every 4 weeks (Q4W) to Week 12, followed by as-needed (PRN) dosing from Week 20 to Week 48. | Drug: Vamikibart<br>* Participants will receive vamikibart IVT injection<br>* Other names: RO7200220;|
| Experimental: Arm B<br>Participants will receive 4 high-dose vamikibart IVT injections Q4W to Week 12, followed by PRN dosing from Week 20 to Week 48. | Drug: Vamikibart<br>* Participants will receive vamikibart IVT injection<br>* Other names: RO7200220;|
| Sham Comparator: Arm C<br>Participants will receive 4 sham injections Q4W to Week 12, followed by PRN sham dosing from Week 20 to Week 48. | Other: Sham<br>* Participants will receive a sham procedure that mimics an IVT injection.<br>|
|
A Study to Investigate Vamikibart in Participants With Uveitic Macular Edema
Study Overview
=================
Brief Summary
-----------------
This study will assess the efficacy and safety of vamikibart in participants with uveitic macular edema.
Official Title
-----------------
A Phase III, Multicenter, Randomized, Double-Masked, Sham-Controlled Study to Investigate the Efficacy, Safety, Pharmacokinetics and Pharmacodynamics of Vamikibart Administered Intravitreally in Patients With Uveitic Macular Edema
Conditions
-----------------
Uveitic Macular Edema
Intervention / Treatment
-----------------
* Drug: Vamikibart
* Other: Sham
Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Female participants: Agreement to remain abstinent (refrain from heterosexual intercourse) or use contraception as defined by the protocol Diagnosis of macular edema associated with non-infectious uveitis (NIU) Diagnosis of active or inactive, acute, or chronic NIU of any etiology and of any anatomical type (anterior, intermediate, posterior, panuveitis) BCVA letter score of 73 to 19 letters (inclusive) on Early Treatment Diabetic Retinopathy Study (EDTRS)-like charts Exclusion Criteria: Evidence of active or latent syphilis infection Evidence of active or latent tuberculosis infection and/or positive tuberculosis assay, or previous or current HIV diagnosis Serious acute or chronic medical or psychiatric illness History of major ocular and non-ocular surgical procedures Uncontrolled IOP or glaucoma or chronic hypotony Any anatomical changes or media opacity in the study eye preventing evaluation of retina, vitreous, and capture of study images Prior use of IVT biologics including anti-VEGFs less than 2-4 months prior to Day 1; received IVT Methotrexate within 4 months prior to Day 1 Prior macular laser therapy, cataract surgery within 6 months and laser capsulotomy within 3 months of Day 1 Topical corticosteroids and/or topical NSAID > 3 drops per day in the 14 days prior to Day 1 (D1); intraocular or periocular corticosteroid injections in the 2 months prior to D1; subconjunctival corticosteroid injection within 1 month prior to Day 1; an OZURDEX implant in the 4 months prior to D1; YUTIQ, RETISERT or ILUVIEN implant in the 3 years prior to D1 Diagnosis of macular edema due to any cause other than NIU Any major ocular conditions that may require medical or surgical intervention during the study period to prevent vision loss
Ages Eligible for Study
-----------------
Minimum Age: 18 Years
Sexes Eligible for Study
-----------------
All
Accepts Healthy Volunteers
-----------------
No
Study Plan
=================
How is the study designed?
-----------------
Design Details
Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double
Arms and Interventions
| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Arm A<br>Participants will receive 4 low-dose vamikibart intravitreal (IVT) injections every 4 weeks (Q4W) to Week 12, followed by as-needed (PRN) dosing from Week 20 to Week 48. | Drug: Vamikibart<br>* Participants will receive vamikibart IVT injection<br>* Other names: RO7200220;|
| Experimental: Arm B<br>Participants will receive 4 high-dose vamikibart IVT injections Q4W to Week 12, followed by PRN dosing from Week 20 to Week 48. | Drug: Vamikibart<br>* Participants will receive vamikibart IVT injection<br>* Other names: RO7200220;|
| Sham Comparator: Arm C<br>Participants will receive 4 sham injections Q4W to Week 12, followed by PRN sham dosing from Week 20 to Week 48. | Other: Sham<br>* Participants will receive a sham procedure that mimics an IVT injection.<br>|
What is the study measuring?
-----------------
Primary Outcome Measures
| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Proportion of participants with ≥ 15 letter improvement from baseline in best-corrected visual acuity (BCVA) at Week 16 | | Week 16 |
Secondary Outcome Measures
| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Proportion of participants with ≥ 15 letter improvement from baseline in BCVA at Week 20 | | Week 20 |
| Change from baseline in BCVA at Week 16 | | Week 16 |
| Change from baseline in central subfield thickness (CST) at Week 16 | | Week 16 |
| Change from Baseline in BCVA at Weeks 20 and 52 | | Weeks 20 and 52 |
| Change from baseline in CST at Weeks 20 and 52 | | Weeks 20 and 52 |
| Proportion of participants with uveitic macular edema secondary to non-infectious uveitis (UME) resolution defined by standardized (by machine) CST threshold <325um on optical coherence tomography (OCT) from baseline at Weeks 16 and 52 | | Weeks 16 and 52 |
| Time to rescue treatment | | Up to Week 52 |
| Number of rescue treatments received | | Up to Week 52 |
| Type of rescue treatments received | | Up to Week 52 |
| Proportion of participants with ≥15 letter improvement from baseline in BCVA at Week 16 and 52 | | Weeks 16 and 52 |
| Proportion of participants without ≥15 letter loss from baseline in BCVA at Week 16 and 52 | | Weeks 16 and 52 |
| Number of PRN injections received | | Up to Week 52 |
| Time to first PRN injection | | Up to Week 52 |
| Change from baseline in the National Eye Institute Visual Function Questionnaire-25 (NEI VFQ-25) at Weeks 16 and 52 | | Weeks 16 and 52 |
| Percentage of participants with ocular adverse events (AEs) | | Up to Week 52 |
| Percentage of participants with non-ocular AEs | | Up to Week 52 |
| Percent change from baseline in corneal endothelial cell density at Week 24 | | Week 24 |
| Percentage of participants with adverse events of special interest (AESIs) | | Up to Week 52 |
| Percent change from baseline in corneal endothelial cell density at Week 52 | | Week 52 |
| Aqueous humor (AH) concentration of vamikibart | | Up to Week 52 |
| Serum concentration of vamikibart | | Up to Week 52 |
| Anti-drug antibody titer to vamikibart | | Baseline to Week 52 |
|
||
NCT00889278
|
Higher Infused Lymphocyte Counts Improve Antibody Response to Immunization After Autologous Stem Cell Transplantation
|
The purpose of this study is to determine if higher absolute lymphocyte count in the infused stem cell autograft (A-ALC) will lead to an improved antibody response to post-transplant immunization with Pneumococcal Conjugate Vaccine and permit effective immunization at 6 months post-transplant in lymphoma patients receiving Autologous Peripheral Blood Stem Cell Transplantation.
|
Infectious diseases remain a leading cause of morbidity and mortality in patients who receive high-dose chemotherapy followed by Autologous Peripheral Blood Stem Cell Transplantation (APBSCT). Infectious disease complications of transplantation might be reduced by effective post-transplant immunization but reconstitution of the immune system may take months to years after transplantation and responses to immunization are often attenuated in this setting. Correlates of improved immune reconstitution and response to immunization after transplantation would be important to identify. It has been recently shown that higher absolute lymphocyte count in the infused stem cell autograft (A-ALC) and higher ALC at day +15 after stem cell infusion (ALC-15) are independently associated with improved overall survival after APBSCT. The mechanism of this association is unclear, but this finding suggests that improved immune responses to immunization might also be achieved with this approach making it possible to immunize at 6 months instead of at one year. This hypothesis has never been evaluated.~Survival following APBSCT is improved with a higher A-ALC and ALC-15. It is postulated that the higher lymphocyte numbers correlate with improved immune surveillance and destruction of minimal residual disease. Thus, one must consider the probability higher A-ALC will confer improved response to T-cell dependent immunization early after transplant.
|
Higher Infused Lymphocyte Counts Improve Antibody Response to Immunization After Autologous Stem Cell Transplantation
|
Lymphoma
|
Inclusion Criteria:~18 years of age or older~Lymphoma or lymphoproliferative disease diagnosis~Scheduled APBSCT~Able to give informed consent and comply with the procedures of the study~Enrollment in other interventional trials are allowed at the discretion of the investigators~Exclusion Criteria:~Contraindication to Prevnar®~Has received immune globulin within 5 months prior to being enrolled on the study or plans to receive immune globulin prior to the day +270 (+/-30) visit~Currently participating in, or scheduled to participate in any clinical trial using investigational immune modulators (e.g. IL-2) at any time prior to the completion of follow-up in this study.~Any other underlying medical condition that, in the opinion of the investigator, may interfere with the evaluation of study objectives~Day +180(+/- 30days) Eligibility:~Has received immune globulin within the past 5 months prior to the receipt of the vaccine or plans to receive immune globulin prior to the day +270(+/- 30) visit~Is pregnant (as determined by urine or serum B-HCG test)~Participant has a contraindication to Prevnar®~A recent (<72 hours) febrile illness (axillary temperature >99.5°F [>37.5°C], oral temperature >100.3oF [>37.9oC], or rectal temperature >101.3°F[>38.5°C]) prior to the study vaccination
|
18 Years
| null |
All
|
No
|
| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Antibody response to vaccination | To assess the antibody response to Prevnar® and its correlation to autograft absolute lymphocyte count (A-ALC). | 2 Years |
|
Lymphoma, Autologous Peripheral Blood Stem Cell Transplant, APBSCT, Pneumococcal Conjugate Vaccine
|
Lymphoma, Neoplasms by Histologic Type, Neoplasms, Lymphoproliferative Disorders, Lymphatic Diseases, Immunoproliferative Disorders, Immune System Diseases
|
Higher Infused Lymphocyte Counts Improve Antibody Response to Immunization After Autologous Stem Cell Transplantation
Study Overview
=================
Brief Summary
-----------------
The purpose of this study is to determine if higher absolute lymphocyte count in the infused stem cell autograft (A-ALC) will lead to an improved antibody response to post-transplant immunization with Pneumococcal Conjugate Vaccine and permit effective immunization at 6 months post-transplant in lymphoma patients receiving Autologous Peripheral Blood Stem Cell Transplantation.
Detailed Description
-----------------
Infectious diseases remain a leading cause of morbidity and mortality in patients who receive high-dose chemotherapy followed by Autologous Peripheral Blood Stem Cell Transplantation (APBSCT). Infectious disease complications of transplantation might be reduced by effective post-transplant immunization but reconstitution of the immune system may take months to years after transplantation and responses to immunization are often attenuated in this setting. Correlates of improved immune reconstitution and response to immunization after transplantation would be important to identify. It has been recently shown that higher absolute lymphocyte count in the infused stem cell autograft (A-ALC) and higher ALC at day +15 after stem cell infusion (ALC-15) are independently associated with improved overall survival after APBSCT. The mechanism of this association is unclear, but this finding suggests that improved immune responses to immunization might also be achieved with this approach making it possible to immunize at 6 months instead of at one year. This hypothesis has never been evaluated. Survival following APBSCT is improved with a higher A-ALC and ALC-15. It is postulated that the higher lymphocyte numbers correlate with improved immune surveillance and destruction of minimal residual disease. Thus, one must consider the probability higher A-ALC will confer improved response to T-cell dependent immunization early after transplant.
Official Title
-----------------
Higher Infused Lymphocyte Counts Improve Antibody Response to Immunization After Autologous Stem Cell Transplantation
Conditions
-----------------
Lymphoma
Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: 18 years of age or older Lymphoma or lymphoproliferative disease diagnosis Scheduled APBSCT Able to give informed consent and comply with the procedures of the study Enrollment in other interventional trials are allowed at the discretion of the investigators Exclusion Criteria: Contraindication to Prevnar® Has received immune globulin within 5 months prior to being enrolled on the study or plans to receive immune globulin prior to the day +270 (+/-30) visit Currently participating in, or scheduled to participate in any clinical trial using investigational immune modulators (e.g. IL-2) at any time prior to the completion of follow-up in this study. Any other underlying medical condition that, in the opinion of the investigator, may interfere with the evaluation of study objectives Day +180(+/- 30days) Eligibility: Has received immune globulin within the past 5 months prior to the receipt of the vaccine or plans to receive immune globulin prior to the day +270(+/- 30) visit Is pregnant (as determined by urine or serum B-HCG test) Participant has a contraindication to Prevnar® A recent (<72 hours) febrile illness (axillary temperature >99.5°F [>37.5°C], oral temperature >100.3oF [>37.9oC], or rectal temperature >101.3°F[>38.5°C]) prior to the study vaccination
Ages Eligible for Study
-----------------
Minimum Age: 18 Years
Sexes Eligible for Study
-----------------
All
Accepts Healthy Volunteers
-----------------
No
Study Plan
=================
How is the study designed?
-----------------
What is the study measuring?
-----------------
Primary Outcome Measures
| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Antibody response to vaccination | To assess the antibody response to Prevnar® and its correlation to autograft absolute lymphocyte count (A-ALC). | 2 Years |
Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Lymphoma, Autologous Peripheral Blood Stem Cell Transplant, APBSCT, Pneumococcal Conjugate Vaccine
|
||||
NCT00502255
|
Telemonitoring in Patients With Heart Failure
|
The purpose of this study is to investigate if telemonitoring results in a decrease in hospital admissions, with equal quality of care defined as mortality, quality of life and unplanned visits with caregivers. Telemonitoring is expected to be more cost-effective than usual care in patients with heart failure.
|
Telemonitoring in Patients With Heart Failure
|
Heart Failure, Congestive
|
* Device: Health Buddy system
* Device: Telemonitoring in patients with heart failure
|
Inclusion Criteria:~Patients > 18 years~Patients with heart failure NYHA classification II-III-IV~Patient experienced a period of fluid retention~Patient is treated by a cardiologist~Patient is followed-up by a heart failure nurse~Adequate knowledge of the Dutch language~Patient has an active telephone connection, preferably analogue~Patient is mental competent~Patient has the disposal of a balance~Exclusion Criteria:~Patients suffering from COPD, Gold classification 3 or 4~Patient is a dialysis patient~Patient has a visual restriction to read the dialogues on the Health Buddy~Patient is hard of hearing or deaf~Patient suffers from a lethal sickness with a prognosis < 1 year~Patient participates in another trial~Patient needs a hospital admission on short time, i.e., < 3 months~Patient used the Health Buddy in an earlier stage~Patient is an illiterate person.
|
18 Years
| null |
All
|
No
|
Primary Purpose: Health Services Research
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
|
| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| To what extent does the use of Health Buddy result in a decrease in hospital admissions? | | one year |
| To what extent is Health Buddy® more cost-effective than usual care? | | one year |
| To what extent will the amount of planned contacts decrease without an increase of unplanned contacts? | | one year |
|
| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| What is the effect of Health Buddy® in patients with heart failure in regard to drug consumption and therapy compliance and level of knowledge, and quality of life? | | one year |
| To what extent is it - based on patients' characteristics - possible to identify patient with benefits? | | one year |
|
Telemonitoring, Cost-effectiveness, Heart failure, Case management
|
Heart Failure, Heart Diseases, Cardiovascular Diseases
|
| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: telemonitoring<br>Health Buddy in patients home situation | Device: Health Buddy system<br>* Patients are followed on distance by the Health Buddy system.<br>* Other names: Cost effectiveness;|
| Experimental: usual care<br>patients receive care as usual | Device: Telemonitoring in patients with heart failure<br>* Health Buddy in patients home situation.<br>* Other names: TEHAf study;|
|
Telemonitoring in Patients With Heart Failure
Study Overview
=================
Brief Summary
-----------------
The purpose of this study is to investigate if telemonitoring results in a decrease in hospital admissions, with equal quality of care defined as mortality, quality of life and unplanned visits with caregivers. Telemonitoring is expected to be more cost-effective than usual care in patients with heart failure.
Official Title
-----------------
Telemonitoring in Patients With Heart Failure
Conditions
-----------------
Heart Failure, Congestive
Intervention / Treatment
-----------------
* Device: Health Buddy system
* Device: Telemonitoring in patients with heart failure
Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Patients > 18 years Patients with heart failure NYHA classification II-III-IV Patient experienced a period of fluid retention Patient is treated by a cardiologist Patient is followed-up by a heart failure nurse Adequate knowledge of the Dutch language Patient has an active telephone connection, preferably analogue Patient is mental competent Patient has the disposal of a balance Exclusion Criteria: Patients suffering from COPD, Gold classification 3 or 4 Patient is a dialysis patient Patient has a visual restriction to read the dialogues on the Health Buddy Patient is hard of hearing or deaf Patient suffers from a lethal sickness with a prognosis < 1 year Patient participates in another trial Patient needs a hospital admission on short time, i.e., < 3 months Patient used the Health Buddy in an earlier stage Patient is an illiterate person.
Ages Eligible for Study
-----------------
Minimum Age: 18 Years
Sexes Eligible for Study
-----------------
All
Accepts Healthy Volunteers
-----------------
No
Study Plan
=================
How is the study designed?
-----------------
Design Details
Primary Purpose: Health Services Research
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Arms and Interventions
| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: telemonitoring<br>Health Buddy in patients home situation | Device: Health Buddy system<br>* Patients are followed on distance by the Health Buddy system.<br>* Other names: Cost effectiveness;|
| Experimental: usual care<br>patients receive care as usual | Device: Telemonitoring in patients with heart failure<br>* Health Buddy in patients home situation.<br>* Other names: TEHAf study;|
What is the study measuring?
-----------------
Primary Outcome Measures
| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| To what extent does the use of Health Buddy result in a decrease in hospital admissions? | | one year |
| To what extent is Health Buddy® more cost-effective than usual care? | | one year |
| To what extent will the amount of planned contacts decrease without an increase of unplanned contacts? | | one year |
Secondary Outcome Measures
| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| What is the effect of Health Buddy® in patients with heart failure in regard to drug consumption and therapy compliance and level of knowledge, and quality of life? | | one year |
| To what extent is it - based on patients' characteristics - possible to identify patient with benefits? | | one year |
Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Telemonitoring, Cost-effectiveness, Heart failure, Case management
|
|
NCT00356525
|
Chemotherapy Treatment in Re-occurring Non Small Cell Lung Cancer (NSCLC) After Previous Chemotherapy and Surgical Removal of the NSCLC Tumor
|
The purpose of this study is to help answer:~Whether pemetrexed, gemcitabine and/or carboplatin can shrink tumor(s) or make tumor(s) disappear in patients with relapsed lung cancer (lung cancer that has come back after surgical removal and chemotherapy), and to determine how long this will last~Whether pemetrexed, gemcitabine and/or carboplatin can help patients with relapsed lung cancer live longer
|
Phase II, Randomized, Open-Label Trial of Biweekly Pemetrexed Plus Gemcitabine vs. Pemetrexed or Pemetrexed Plus Carboplatin in Relapsed Non Small Cell Lung Cancer After Neoadjuvant or Adjuvant Chemotherapy
|
Lung Neoplasms
|
* Drug: pemetrexed
* Drug: gemcitabine
* Drug: carboplatin
* Drug: Pemetrexed
|
Inclusion Criteria:~You have non-small cell lung cancer that has come back (relapsed) after initial treatment with surgery and chemotherapy.~You have good kidney, liver, and bone marrow organ function.~You are fully active or able to carry out light work such as housework or office work.~Exclusion Criteria:~You have received pemetrexed or gemcitabine in the past for lung cancer~You are currently receiving another treatment for your relapsed lung cancer, or have had chemotherapy or certain other therapies for relapsed lung cancer in the past~You are unable to take corticosteroid drugs like dexamethasone~You are unable or unwilling to take the folic acid pills or Vitamin B12 injections that are required for the study~You are unable to stop taking aspirin or other drugs that control inflammation for certain periods of time during the study~You have had a heart attack in the last 6 months, or have other heart problems that are not controlled with medication
|
18 Years
| null |
All
|
No
|
Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
|
| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Objective Tumor Response | Best response recorded from the start of treatment until disease progression/recurrence using Response Evaluation Criteria In Solid Tumors (RECIST) criteria. Complete Response=disappearance of all target lesions; Partial Response=30% decrease in sum of longest diameter of target lesions; Progressive Disease=20% increase in sum of longest diameter of target lesions; Stable Disease=small changes that do not meet above criteria. | baseline to time of response (up to 17.5 months) |
|
| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Overall Survival | Overall survival is the number of participants who were alive when the trial was terminated. | baseline to trial termination (17.5 months) |
| Time to Progressive Disease | | baseline to measured progressive disease (up to 17.5 months) |
| Duration of Response | | time of response to progressive disease (up to 17.5 months) |
| Time to Treatment Failure | | baseline to stopping treatment (up to 17.5 months) |
|
Carboplatin, Gemcitabine, Pemetrexed, Antineoplastic Agents, Antimetabolites, Antineoplastic, Antimetabolites, Molecular Mechanisms of Pharmacological Action, Enzyme Inhibitors, Folic Acid Antagonists, Nucleic Acid Synthesis Inhibitors
|
| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Less Than One Year: Pemetrexed<br>Disease relapse at less than one year after neoadjuvant/adjuvant chemotherapy | Drug: pemetrexed<br>* 500 mg/m2, intravenous (IV), every 14 days x 6 cycles or until disease progression<br>* Other names: Alimta;Drug: gemcitabine<br>* 1500 mg/m2, intravenous (IV), every 14 days x 6 cycles or until disease progression<br>* Other names: Gemzar;|
| Experimental: Less Than One Year: Pemetrexed + Gemcitabine<br>Disease relapse at less than one year after neoadjuvant/adjuvant chemotherapy | Drug: Pemetrexed<br>* 500 mg/m2, intravenous (IV), every 21 days x 6 cycles or until disease progression<br>* Other names: Alimta;|
| Experimental: One Year or Greater: Pemetrexed + Carboplatin<br>Disease relapse at one year or greater after neoadjuvant/adjuvant chemotherapy | Drug: carboplatin<br>* area under the curve (AUC) 5, intravenous (IV), every 21 days x 6 cycles or until disease progression<br>Drug: Pemetrexed<br>* 500 mg/m2, intravenous (IV), every 21 days x 6 cycles or until disease progression<br>* Other names: Alimta;|
| Experimental: One Year or Greater: Pemetrexed + Gemcitabine<br>Disease relapse at one year or greater after neoadjuvant/adjuvant chemotherapy | Drug: pemetrexed<br>* 500 mg/m2, intravenous (IV), every 14 days x 6 cycles or until disease progression<br>* Other names: Alimta;Drug: gemcitabine<br>* 1500 mg/m2, intravenous (IV), every 14 days x 6 cycles or until disease progression<br>* Other names: Gemzar;|
|
Chemotherapy Treatment in Re-occurring Non Small Cell Lung Cancer (NSCLC) After Previous Chemotherapy and Surgical Removal of the NSCLC Tumor
Study Overview
=================
Brief Summary
-----------------
The purpose of this study is to help answer: Whether pemetrexed, gemcitabine and/or carboplatin can shrink tumor(s) or make tumor(s) disappear in patients with relapsed lung cancer (lung cancer that has come back after surgical removal and chemotherapy), and to determine how long this will last Whether pemetrexed, gemcitabine and/or carboplatin can help patients with relapsed lung cancer live longer
Official Title
-----------------
Phase II, Randomized, Open-Label Trial of Biweekly Pemetrexed Plus Gemcitabine vs. Pemetrexed or Pemetrexed Plus Carboplatin in Relapsed Non Small Cell Lung Cancer After Neoadjuvant or Adjuvant Chemotherapy
Conditions
-----------------
Lung Neoplasms
Intervention / Treatment
-----------------
* Drug: pemetrexed
* Drug: gemcitabine
* Drug: carboplatin
* Drug: Pemetrexed
Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: You have non-small cell lung cancer that has come back (relapsed) after initial treatment with surgery and chemotherapy. You have good kidney, liver, and bone marrow organ function. You are fully active or able to carry out light work such as housework or office work. Exclusion Criteria: You have received pemetrexed or gemcitabine in the past for lung cancer You are currently receiving another treatment for your relapsed lung cancer, or have had chemotherapy or certain other therapies for relapsed lung cancer in the past You are unable to take corticosteroid drugs like dexamethasone You are unable or unwilling to take the folic acid pills or Vitamin B12 injections that are required for the study You are unable to stop taking aspirin or other drugs that control inflammation for certain periods of time during the study You have had a heart attack in the last 6 months, or have other heart problems that are not controlled with medication
Ages Eligible for Study
-----------------
Minimum Age: 18 Years
Sexes Eligible for Study
-----------------
All
Accepts Healthy Volunteers
-----------------
No
Study Plan
=================
How is the study designed?
-----------------
Design Details
Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Arms and Interventions
| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Less Than One Year: Pemetrexed<br>Disease relapse at less than one year after neoadjuvant/adjuvant chemotherapy | Drug: pemetrexed<br>* 500 mg/m2, intravenous (IV), every 14 days x 6 cycles or until disease progression<br>* Other names: Alimta;Drug: gemcitabine<br>* 1500 mg/m2, intravenous (IV), every 14 days x 6 cycles or until disease progression<br>* Other names: Gemzar;|
| Experimental: Less Than One Year: Pemetrexed + Gemcitabine<br>Disease relapse at less than one year after neoadjuvant/adjuvant chemotherapy | Drug: Pemetrexed<br>* 500 mg/m2, intravenous (IV), every 21 days x 6 cycles or until disease progression<br>* Other names: Alimta;|
| Experimental: One Year or Greater: Pemetrexed + Carboplatin<br>Disease relapse at one year or greater after neoadjuvant/adjuvant chemotherapy | Drug: carboplatin<br>* area under the curve (AUC) 5, intravenous (IV), every 21 days x 6 cycles or until disease progression<br>Drug: Pemetrexed<br>* 500 mg/m2, intravenous (IV), every 21 days x 6 cycles or until disease progression<br>* Other names: Alimta;|
| Experimental: One Year or Greater: Pemetrexed + Gemcitabine<br>Disease relapse at one year or greater after neoadjuvant/adjuvant chemotherapy | Drug: pemetrexed<br>* 500 mg/m2, intravenous (IV), every 14 days x 6 cycles or until disease progression<br>* Other names: Alimta;Drug: gemcitabine<br>* 1500 mg/m2, intravenous (IV), every 14 days x 6 cycles or until disease progression<br>* Other names: Gemzar;|
What is the study measuring?
-----------------
Primary Outcome Measures
| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Objective Tumor Response | Best response recorded from the start of treatment until disease progression/recurrence using Response Evaluation Criteria In Solid Tumors (RECIST) criteria. Complete Response=disappearance of all target lesions; Partial Response=30% decrease in sum of longest diameter of target lesions; Progressive Disease=20% increase in sum of longest diameter of target lesions; Stable Disease=small changes that do not meet above criteria. | baseline to time of response (up to 17.5 months) |
Secondary Outcome Measures
| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Overall Survival | Overall survival is the number of participants who were alive when the trial was terminated. | baseline to trial termination (17.5 months) |
| Time to Progressive Disease | | baseline to measured progressive disease (up to 17.5 months) |
| Duration of Response | | time of response to progressive disease (up to 17.5 months) |
| Time to Treatment Failure | | baseline to stopping treatment (up to 17.5 months) |
|
||
NCT03502343
|
Efficacy and Safety of Modified Nab-Paclitaxel Plus Gemcitabine Chemotherapy for Metastatic Pancreatic Cancer
|
Recently, a retrospective study reported the efficacy and safety of modified gemcitabine plus nab-paclitaxel (GnP), which were administered biweekly (on days 1 and 15). With 79 patients of metastatic pancreatic cancer, this study reported similar efficacy and improved toxicity profile compared with standard dose GnP (OS 10 months, PFS 5.4 months, Grade ≥3 Neutropenia 19%, Grade ≥3 sensory neuropathy 1.6%). Also, several studies reported that dose reduction of nab-paclitaxel in breast or pancreatic cancer treatment was not related of decreased survival, or related with prolonged survival and increased treatment exposure. However, this finding need to be evaluated in prospective clinical trial.~This phase II trial will evaluate the efficacy and safety of modified GnP, which omit the day 8 administration of nab-paclitaxel, in metastatic pancreatic cancer.
|
Gemcitabine-based combination therapy have been used to prolong survival for patient with pancreatic cancer. In early 2010s, gemcitabine plus nab-paclitaxel (GnP) combination regimen have been introduced based on the results of randomized phase III clinical trial that showed survival benefit than gemcitabine monotherapy. Nab-paclitaxel is a nanoparticle albumin-bound paclitaxel that showed anti-tumor activity as well as synergistic effect in combination with gemcitabine.~In the Metastatic Pancreatic Adenocarcinoma Clinical Trial (MPACT), the maximal tolerated nab-paclitaxel dose (125 mg/m2) was administrated with 1000 mg/m2 of gemcitabine, on days 1, 8 and 15 for 4 weeks cycle. This combination therapy showed favorable treatment response, but notable severe adverse events were also reported. Grade 3 or higher neuropathy and neutropenia occurred in 17% and 38% of patients, respectively. Also, dose reduction was required in approximately half of the patients.~Recently, a retrospective study reported the efficacy and safety of modified GnP, which were administered biweekly (on days 1 and 15). With 79 patients of metastatic pancreatic cancer, this study reported similar efficacy and improved toxicity profile compared with standard dose GnP (OS 10 months, PFS 5.4 months, Grade ≥3 Neutropenia 19%, Grade ≥3 sensory neuropathy 1.6%). Also, several studies reported that dose reduction of nab-paclitaxel in breast or pancreatic cancer treatment was not related of decreased survival, or related with prolonged survival and increased treatment exposure. However, this finding need to be evaluated in prospective clinical trial.~This phase II trial will evaluate the efficacy and safety of modified GnP, which omit the day 8 administration of nab-paclitaxel, in metastatic pancreatic cancer.
|
Efficacy and Safety of Modified Nab-Paclitaxel Plus Gemcitabine Chemotherapy for Metastatic Pancreatic Cancer: A Single-arm Phase II Clinical Trial
|
Metastatic Pancreatic Cancer
|
* Drug: Modified Gemcitabine plus nab-Paclitaxel Combination Chemotherapy
|
Inclusion Criteria:~Pathologically or cytologically confirmed pancreatic adenocarcinoma~Coexisting extrapancreatic distant metastasis~Older than 19 years old~Measurable primary tumor in pancreas on imaging study at the time of diagnosis, according to the RECIST criteria~Exclusion Criteria:~Previous history of palliative systemic chemotherapy due to pancreatic cancer~Existence of active malignancy of other organ which diagnosed in last five years (except the squamous cell carcinoma or basal cell tumor of skin)~Existence of life-threatening co-morbidity~Poor performance state (ECOG ≥2)~Suspected severe bone marrow suppression (Neutrophil count< 1,500/mm3, Hemoglobin< 9 g/dL, Platelet count< 75,000/mm3)~Suspected severe liver dysfunction (Total bilirubin or Prothrombin Time > 1.5 times of upper normal range) or renal dysfunction (estimated GFR < 50/ml/min/1.73 m²)~Pre-existence of ≥grade 2 peripheral sensory neuropathy~Existence of brain metastasis or meningeal carcinomatosis~Patient with pregnancy or ongoing breast feeding~Do not agree with the informed consent
|
19 Years
| null |
All
|
No
|
Primary Purpose: Treatment
Intervention Model: Single Group Assignment
Masking: None (Open Label)
|
| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Objective response rate | To evaluate treatment efficacy, computed tomography scan, magnetic resonance imaging, or 18F-fluorodeoxyglucose-positron emission tomography (18F-FDGPET) scan will be performed every 8 weeks. Treatment responses according to the RECIST criteria will be reported by designated radiologists and final disease assessment will be independently made by the attending physician. The proportion of patients with the best response of complete response (CR), partial response (PR) is defined as objective response rate. | Every 8 weeks until dropout up to 104 weeks |
| Disease control rate | To evaluate treatment efficacy, computed tomography scan, magnetic resonance imaging, or 18F-fluorodeoxyglucose-positron emission tomography (18F-FDGPET) scan will be performed every 8 weeks. Disease control rate is defined as the proportion of patients with the best response of CR, PR and stable disease. | Every 8 weeks until dropout up to 104 weeks |
|
| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Overall survival | The overall survival is defined as from the date of enrollment to the date of the last follow-up or death of all causes. In case of loss of follow-up, the censoring date will be the day on which the survival is confirmed before follow-up loss. | Every 8 weeks from date of drug administration until the date of patient's death, loss of follow-up, or end of the trial up to 104 weeks |
| Progression-free survival | The progression free survival is defined as from the date of treatment initiation to the date of the event. The event is defined as the date of disease progression or patient's death, which occured first.~In case of loss of follow-up, the censoring date will be the day on which the survival is confirmed before follow-up loss. | Every 8 weeks from date of drug administration until the date of patient's death, loss of follow-up, or end of the trial up to 104 weeks |
| Adverse event | Adverse events will be assessed according to the National Cancer Institute Common Terminology Criteria for Adverse Events (version 4.03) before each cycle until study dropout. | Until dropout from the trial up to 104 weeks |
|
Pancreatic cancer, Metastatic, Modified, Gemcitabine, nab-Paclitaxel
|
Paclitaxel, Gemcitabine, Antineoplastic Agents, Phytogenic, Antineoplastic Agents, Tubulin Modulators, Antimitotic Agents, Mitosis Modulators, Molecular Mechanisms of Pharmacological Action, Antimetabolites, Antineoplastic, Antimetabolites
|
| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Modified Gemcitabine plus nab-Paclitaxel<br>The intervention group | Drug: Modified Gemcitabine plus nab-Paclitaxel Combination Chemotherapy<br>* All patients will receive slow (over 30-40 minutes) intravenous administration of nab-paclitaxel (125 mg/m2) on days 1 and 15, and gemcitabine (1000 mg/m2) on days 1, 8, and 15 of a 28- day cycle (every 4 weeks). Treatment will discontinue if disease progression or intolerable toxicity is observed, if the patient withdraws from the study, or at the physician's discretion.~Dose reduction of the chemotherapeutic agent and/or delay of administration is allowed if serious treatment-related AEs occur, according to specified guideline in study protocol (Level 1: 100% -> 80%; Level 2: 80% -> 60%). If dose reduction is needed more than Level 2, the patient will be dropped from the trial.<br>|
|
Efficacy and Safety of Modified Nab-Paclitaxel Plus Gemcitabine Chemotherapy for Metastatic Pancreatic Cancer
Study Overview
=================
Brief Summary
-----------------
Recently, a retrospective study reported the efficacy and safety of modified gemcitabine plus nab-paclitaxel (GnP), which were administered biweekly (on days 1 and 15). With 79 patients of metastatic pancreatic cancer, this study reported similar efficacy and improved toxicity profile compared with standard dose GnP (OS 10 months, PFS 5.4 months, Grade ≥3 Neutropenia 19%, Grade ≥3 sensory neuropathy 1.6%). Also, several studies reported that dose reduction of nab-paclitaxel in breast or pancreatic cancer treatment was not related of decreased survival, or related with prolonged survival and increased treatment exposure. However, this finding need to be evaluated in prospective clinical trial. This phase II trial will evaluate the efficacy and safety of modified GnP, which omit the day 8 administration of nab-paclitaxel, in metastatic pancreatic cancer.
Detailed Description
-----------------
Gemcitabine-based combination therapy have been used to prolong survival for patient with pancreatic cancer. In early 2010s, gemcitabine plus nab-paclitaxel (GnP) combination regimen have been introduced based on the results of randomized phase III clinical trial that showed survival benefit than gemcitabine monotherapy. Nab-paclitaxel is a nanoparticle albumin-bound paclitaxel that showed anti-tumor activity as well as synergistic effect in combination with gemcitabine. In the Metastatic Pancreatic Adenocarcinoma Clinical Trial (MPACT), the maximal tolerated nab-paclitaxel dose (125 mg/m2) was administrated with 1000 mg/m2 of gemcitabine, on days 1, 8 and 15 for 4 weeks cycle. This combination therapy showed favorable treatment response, but notable severe adverse events were also reported. Grade 3 or higher neuropathy and neutropenia occurred in 17% and 38% of patients, respectively. Also, dose reduction was required in approximately half of the patients. Recently, a retrospective study reported the efficacy and safety of modified GnP, which were administered biweekly (on days 1 and 15). With 79 patients of metastatic pancreatic cancer, this study reported similar efficacy and improved toxicity profile compared with standard dose GnP (OS 10 months, PFS 5.4 months, Grade ≥3 Neutropenia 19%, Grade ≥3 sensory neuropathy 1.6%). Also, several studies reported that dose reduction of nab-paclitaxel in breast or pancreatic cancer treatment was not related of decreased survival, or related with prolonged survival and increased treatment exposure. However, this finding need to be evaluated in prospective clinical trial. This phase II trial will evaluate the efficacy and safety of modified GnP, which omit the day 8 administration of nab-paclitaxel, in metastatic pancreatic cancer.
Official Title
-----------------
Efficacy and Safety of Modified Nab-Paclitaxel Plus Gemcitabine Chemotherapy for Metastatic Pancreatic Cancer: A Single-arm Phase II Clinical Trial
Conditions
-----------------
Metastatic Pancreatic Cancer
Intervention / Treatment
-----------------
* Drug: Modified Gemcitabine plus nab-Paclitaxel Combination Chemotherapy
Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Pathologically or cytologically confirmed pancreatic adenocarcinoma Coexisting extrapancreatic distant metastasis Older than 19 years old Measurable primary tumor in pancreas on imaging study at the time of diagnosis, according to the RECIST criteria Exclusion Criteria: Previous history of palliative systemic chemotherapy due to pancreatic cancer Existence of active malignancy of other organ which diagnosed in last five years (except the squamous cell carcinoma or basal cell tumor of skin) Existence of life-threatening co-morbidity Poor performance state (ECOG ≥2) Suspected severe bone marrow suppression (Neutrophil count< 1,500/mm3, Hemoglobin< 9 g/dL, Platelet count< 75,000/mm3) Suspected severe liver dysfunction (Total bilirubin or Prothrombin Time > 1.5 times of upper normal range) or renal dysfunction (estimated GFR < 50/ml/min/1.73 m²) Pre-existence of ≥grade 2 peripheral sensory neuropathy Existence of brain metastasis or meningeal carcinomatosis Patient with pregnancy or ongoing breast feeding Do not agree with the informed consent
Ages Eligible for Study
-----------------
Minimum Age: 19 Years
Sexes Eligible for Study
-----------------
All
Accepts Healthy Volunteers
-----------------
No
Study Plan
=================
How is the study designed?
-----------------
Design Details
Primary Purpose: Treatment
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Arms and Interventions
| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Modified Gemcitabine plus nab-Paclitaxel<br>The intervention group | Drug: Modified Gemcitabine plus nab-Paclitaxel Combination Chemotherapy<br>* All patients will receive slow (over 30-40 minutes) intravenous administration of nab-paclitaxel (125 mg/m2) on days 1 and 15, and gemcitabine (1000 mg/m2) on days 1, 8, and 15 of a 28- day cycle (every 4 weeks). Treatment will discontinue if disease progression or intolerable toxicity is observed, if the patient withdraws from the study, or at the physician's discretion. Dose reduction of the chemotherapeutic agent and/or delay of administration is allowed if serious treatment-related AEs occur, according to specified guideline in study protocol (Level 1: 100% -> 80%; Level 2: 80% -> 60%). If dose reduction is needed more than Level 2, the patient will be dropped from the trial.<br>|
What is the study measuring?
-----------------
Primary Outcome Measures
| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Objective response rate | To evaluate treatment efficacy, computed tomography scan, magnetic resonance imaging, or 18F-fluorodeoxyglucose-positron emission tomography (18F-FDGPET) scan will be performed every 8 weeks. Treatment responses according to the RECIST criteria will be reported by designated radiologists and final disease assessment will be independently made by the attending physician. The proportion of patients with the best response of complete response (CR), partial response (PR) is defined as objective response rate. | Every 8 weeks until dropout up to 104 weeks |
| Disease control rate | To evaluate treatment efficacy, computed tomography scan, magnetic resonance imaging, or 18F-fluorodeoxyglucose-positron emission tomography (18F-FDGPET) scan will be performed every 8 weeks. Disease control rate is defined as the proportion of patients with the best response of CR, PR and stable disease. | Every 8 weeks until dropout up to 104 weeks |
Secondary Outcome Measures
| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Overall survival | The overall survival is defined as from the date of enrollment to the date of the last follow-up or death of all causes. In case of loss of follow-up, the censoring date will be the day on which the survival is confirmed before follow-up loss. | Every 8 weeks from date of drug administration until the date of patient's death, loss of follow-up, or end of the trial up to 104 weeks |
| Progression-free survival | The progression free survival is defined as from the date of treatment initiation to the date of the event. The event is defined as the date of disease progression or patient's death, which occured first. In case of loss of follow-up, the censoring date will be the day on which the survival is confirmed before follow-up loss. | Every 8 weeks from date of drug administration until the date of patient's death, loss of follow-up, or end of the trial up to 104 weeks |
| Adverse event | Adverse events will be assessed according to the National Cancer Institute Common Terminology Criteria for Adverse Events (version 4.03) before each cycle until study dropout. | Until dropout from the trial up to 104 weeks |
Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Pancreatic cancer, Metastatic, Modified, Gemcitabine, nab-Paclitaxel
|
NCT04563988
|
Factors for Predicting Severe Asthma Exacerbators in Adult Asthmatics: A Real Word- Effectiveness Study
|
This study is a single-center, retrospective, cross-sectional study. It plan to investigate the predictors for asthma exacerbation in long term follow up real world management with analyzing big data of electronic medical records (EMR).
|
The long-term goals of asthma treatment are to achieve well control of symptoms and to minimize the future risk of asthma exacerbations (AEs). Asthma is a heterogeneous disease with various responses to treatment and clinical outcomes. AEs are a prominent feature of severe asthmatics; however, frequent AEs have also been reported in mild asthmatics.~This is a prospectively designed observational study to identify predictors for patients with frequent AEs among adult asthmatics by analyzing medical big data of electronic medical records (EMR), which will provide an insight in the long-term management of adult asthmatics in real-world practice.
|
Factors for Predicting Severe Asthma Exacerbators in Adult Asthmatics: A Real Word- Effectiveness Study
|
Asthma
|
Inclusion Criteria:~Aged ≥17 years~Patients having bronchial asthma with J45-J46 code of International classification of Diseases (10th edition on EMR)~Asthmatics who had been treated by allergy or respiratory specialists~Exclusion Criteria:~Patients who has less than one year for asthma treatment
|
17 Years
| null |
All
|
No
|
| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Identifying prognostic factors for risk of severe asthma exacerbation | Identifying prognostic factors for risk of severe asthma exacerbation | During the initial 2 years |
|
| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Evaluating total IgE (KU/L) to predict severe asthma exacerbation | Evaluating total IgE (KU/L) to predict severe asthma exacerbation | During 10 years of treatment |
| Evaluating peripheral eosiniphil, neutrophil, basophil and lymphocyte counts to predict severe asthma exacerbation | Unit of peripheral eosiniphil, neutrophil, basophil and lymphocyte counts: ×10³/uL | During 10 years of treatment |
| Evaluating ECP (ug/L) to predict severe asthma exacerbation | Evaluating ECP (ug/L) to predict severe asthma exacerbation | During 10 years of treatment |
| Evaluating sputum eosinophils (%) to predict severe asthma exacerbation | Evaluating sputum eosinophils (%) to predict severe asthma exacerbation | During 10 years of treatment |
| Evaluating FEV1 (%) and FEV1/FVC (%) to predict severe asthma exacerbation | Evaluating FEV1 (%) and FEV1/FVC (%) to predict severe asthma exacerbation | During 10 years of treatment |
| Comparing clinical characteristics according to the frequency of severe asthma exacerbation | Comparing clinical characteristics according to the frequency of severe asthma exacerbation | During the initial 2 years |
| Sensitivity and specificity of predictors | Sensitivity and specificity of predictors | during the initial 2 years and the following 3-10 years of treatment |
|
Asthma, Bronchial Diseases, Respiratory Tract Diseases, Lung Diseases, Obstructive, Lung Diseases, Respiratory Hypersensitivity, Hypersensitivity, Immediate, Hypersensitivity, Immune System Diseases
|
Factors for Predicting Severe Asthma Exacerbators in Adult Asthmatics: A Real Word- Effectiveness Study
Study Overview
=================
Brief Summary
-----------------
This study is a single-center, retrospective, cross-sectional study. It plan to investigate the predictors for asthma exacerbation in long term follow up real world management with analyzing big data of electronic medical records (EMR).
Detailed Description
-----------------
The long-term goals of asthma treatment are to achieve well control of symptoms and to minimize the future risk of asthma exacerbations (AEs). Asthma is a heterogeneous disease with various responses to treatment and clinical outcomes. AEs are a prominent feature of severe asthmatics; however, frequent AEs have also been reported in mild asthmatics. This is a prospectively designed observational study to identify predictors for patients with frequent AEs among adult asthmatics by analyzing medical big data of electronic medical records (EMR), which will provide an insight in the long-term management of adult asthmatics in real-world practice.
Official Title
-----------------
Factors for Predicting Severe Asthma Exacerbators in Adult Asthmatics: A Real Word- Effectiveness Study
Conditions
-----------------
Asthma
Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Aged ≥17 years Patients having bronchial asthma with J45-J46 code of International classification of Diseases (10th edition on EMR) Asthmatics who had been treated by allergy or respiratory specialists Exclusion Criteria: Patients who has less than one year for asthma treatment
Ages Eligible for Study
-----------------
Minimum Age: 17 Years
Sexes Eligible for Study
-----------------
All
Accepts Healthy Volunteers
-----------------
No
Study Plan
=================
How is the study designed?
-----------------
What is the study measuring?
-----------------
Primary Outcome Measures
| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Identifying prognostic factors for risk of severe asthma exacerbation | Identifying prognostic factors for risk of severe asthma exacerbation | During the initial 2 years |
Secondary Outcome Measures
| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Evaluating total IgE (KU/L) to predict severe asthma exacerbation | Evaluating total IgE (KU/L) to predict severe asthma exacerbation | During 10 years of treatment |
| Evaluating peripheral eosiniphil, neutrophil, basophil and lymphocyte counts to predict severe asthma exacerbation | Unit of peripheral eosiniphil, neutrophil, basophil and lymphocyte counts: ×10³/uL | During 10 years of treatment |
| Evaluating ECP (ug/L) to predict severe asthma exacerbation | Evaluating ECP (ug/L) to predict severe asthma exacerbation | During 10 years of treatment |
| Evaluating sputum eosinophils (%) to predict severe asthma exacerbation | Evaluating sputum eosinophils (%) to predict severe asthma exacerbation | During 10 years of treatment |
| Evaluating FEV1 (%) and FEV1/FVC (%) to predict severe asthma exacerbation | Evaluating FEV1 (%) and FEV1/FVC (%) to predict severe asthma exacerbation | During 10 years of treatment |
| Comparing clinical characteristics according to the frequency of severe asthma exacerbation | Comparing clinical characteristics according to the frequency of severe asthma exacerbation | During the initial 2 years |
| Sensitivity and specificity of predictors | Sensitivity and specificity of predictors | during the initial 2 years and the following 3-10 years of treatment |
|
||||
NCT05009693
|
Effect of White Light on Fatigue Levels in Patients With Gynecological Cancer
|
White light therapy is one of the non-pharmacological methods in the management of fatigue. Cancer-related fatigue (CRF) is a persistent, subjective sense of physical, emotional, and/or cognitive tiredness or burnout. It is associated with cancer or cancer treatment from the first diagnosis until the end of life that is not proportional to recent physical activity.~It was founded that 10,000 Lux bright white light administered in the morning hours reduced fatigue by 17% in patients with cancer and that the mean fatigue scores of patients decreased from 30.37 to 9.48 compared to before the light administration. According to NCCN (2020), white light of 10,000 Lux can be applied for 30-90 minutes in the morning hours to regulate sleep and manage fatigue in the post treatment period as well as in cancer patients receiving active treatment. However, studies on this subject consist of small sample groups, and more studies are needed to identify the risks and benefits of the application and to determine the optimal application time and duration. The present study was aimed to evaluate the effect of white light on the fatigue levels of patients with gynecological cancer who were treated with chemotherapy. The patients with high levels of fatigue in every dimension were selected so as to have a homogeneous group. The research hypotheses were determined as follows:~H0: White light has no effect on fatigue levels in patients with gynecological cancer.~H1: White light reduces fatigue levels in patients with gynecological cancer.
|
The Effect of White Light on Fatigue Levels in Patients With Gynecological Cancer: A Double Blind Randomized Trial
|
Cancer-related Fatigue, Light; Therapy, Complications
|
* Other: White Light Application
|
Inclusion Criteria:~had a normal state of consciousness,~had no communication disorders, did not work in the night shift,~had a general fatigue level score of ≥1 according to the Brief Fatigue Inventory~Exclusion Criteria:~had natural/artificial lenses,~used medication that causes photosensitivity (tetracycline, doxycycline, nalidixic acid, voriconazole, amiodarone, hydrochlorothiazide, naproxen, piroxicam, chlorpromazine)~had a change in their treatment plan in the last 6 weeks were not included in the study
|
18 Years
| null |
Female
|
Accepts Healthy Volunteers
|
Primary Purpose: Supportive Care
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single
|
| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| White light changes general fatigue scores | White light changes general fatigue levels in patients with gynecological cancer | general fatigue levels of patients on 0., 9. and 21. days |
|
| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| White light changes activity fatigue scores | White light changes activity fatigue levels in patients with gynecological cancer | activity fatigue levels of patients on 0., 9. and 21. days |
|
Cancer-related fatigue, White light therapy, Chemotherapy, Clinical trial
|
Fatigue
|
| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: white light intervention group<br>Between the second and the eighth days of the application phase, the patients in the intervention group were administered a standard white light at 10,000 Lux intensity by an independent nurse (RA1) in their home environment using a Litebook Elite light source (The Litebook Company Ltd., Medicine Hat, AB). The distance between the light source and the patient's face was set at 50 cm, and the intensity of the light for each patient was checked using a Lux Meter. The intervention was applied between 07:00 and 10:00 in the morning for 30 minutes without interruption, and it was continued for seven successive days. The light application procedure was followed based on the previous studies on oncology patients. The second and third evaluations of the fatigue status of patients were completed on the 9th and 21st days. | Other: White Light Application<br>* White Light Therapy<br>|
| No Intervention: Control group<br> | |
|
Effect of White Light on Fatigue Levels in Patients With Gynecological Cancer
Study Overview
=================
Brief Summary
-----------------
White light therapy is one of the non-pharmacological methods in the management of fatigue. Cancer-related fatigue (CRF) is a persistent, subjective sense of physical, emotional, and/or cognitive tiredness or burnout. It is associated with cancer or cancer treatment from the first diagnosis until the end of life that is not proportional to recent physical activity. It was founded that 10,000 Lux bright white light administered in the morning hours reduced fatigue by 17% in patients with cancer and that the mean fatigue scores of patients decreased from 30.37 to 9.48 compared to before the light administration. According to NCCN (2020), white light of 10,000 Lux can be applied for 30-90 minutes in the morning hours to regulate sleep and manage fatigue in the post treatment period as well as in cancer patients receiving active treatment. However, studies on this subject consist of small sample groups, and more studies are needed to identify the risks and benefits of the application and to determine the optimal application time and duration. The present study was aimed to evaluate the effect of white light on the fatigue levels of patients with gynecological cancer who were treated with chemotherapy. The patients with high levels of fatigue in every dimension were selected so as to have a homogeneous group. The research hypotheses were determined as follows: H0: White light has no effect on fatigue levels in patients with gynecological cancer. H1: White light reduces fatigue levels in patients with gynecological cancer.
Official Title
-----------------
The Effect of White Light on Fatigue Levels in Patients With Gynecological Cancer: A Double Blind Randomized Trial
Conditions
-----------------
Cancer-related Fatigue, Light; Therapy, Complications
Intervention / Treatment
-----------------
* Other: White Light Application
Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: had a normal state of consciousness, had no communication disorders, did not work in the night shift, had a general fatigue level score of ≥1 according to the Brief Fatigue Inventory Exclusion Criteria: had natural/artificial lenses, used medication that causes photosensitivity (tetracycline, doxycycline, nalidixic acid, voriconazole, amiodarone, hydrochlorothiazide, naproxen, piroxicam, chlorpromazine) had a change in their treatment plan in the last 6 weeks were not included in the study
Ages Eligible for Study
-----------------
Minimum Age: 18 Years
Sexes Eligible for Study
-----------------
Female
Accepts Healthy Volunteers
-----------------
Accepts Healthy Volunteers
Study Plan
=================
How is the study designed?
-----------------
Design Details
Primary Purpose: Supportive Care
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single
Arms and Interventions
| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: white light intervention group<br>Between the second and the eighth days of the application phase, the patients in the intervention group were administered a standard white light at 10,000 Lux intensity by an independent nurse (RA1) in their home environment using a Litebook Elite light source (The Litebook Company Ltd., Medicine Hat, AB). The distance between the light source and the patient's face was set at 50 cm, and the intensity of the light for each patient was checked using a Lux Meter. The intervention was applied between 07:00 and 10:00 in the morning for 30 minutes without interruption, and it was continued for seven successive days. The light application procedure was followed based on the previous studies on oncology patients. The second and third evaluations of the fatigue status of patients were completed on the 9th and 21st days. | Other: White Light Application<br>* White Light Therapy<br>|
| No Intervention: Control group<br> | |
What is the study measuring?
-----------------
Primary Outcome Measures
| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| White light changes general fatigue scores | White light changes general fatigue levels in patients with gynecological cancer | general fatigue levels of patients on 0., 9. and 21. days |
Secondary Outcome Measures
| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| White light changes activity fatigue scores | White light changes activity fatigue levels in patients with gynecological cancer | activity fatigue levels of patients on 0., 9. and 21. days |
Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Cancer-related fatigue, White light therapy, Chemotherapy, Clinical trial
|
|
NCT01574729
|
Surgery Combined With rAd-p53 Gene in Treatment Advanced Non-small-cell Carcinoma
|
The primary objectives of this study are to investigate the efficacy and safety of surgery combined with rAd-p53 gene therapy in treatment of advanced Non-small-cell lung carcinoma (NSCLC). The study efficacy endpoints include overall survival, progress-free survival, quality of life, and local recurrent rate. The safety endpoint is complications and adverse effects.~The study hypothesis: rAd-p53 gene therapy can prolong the overall survival and reduce the local recurrent rate.
|
Phase II Study of Surgery Combined With Recombinant Adenoviral Human p53 Gene Therapy in Treatment Advanced Non-small-cell Carcinoma
|
Non-small Cell Lung Cancer
|
* Drug: Surgery combined with rAd-p53 gene therapy
* Procedure: Surgery
|
Inclusion Criteria:~historically diagnosed advanced non-small lung cancer~has surgery indication~age 18 years old or greater~life expectancy greater than 12 weeks~ECOG: 0-2~no prior chemotherapy, radiotherapy in 2 weeks~Neutrophils≥1.5×10^9/L,platelet≥80×10^9/L, Hb≥≥80g/L,bilirubin≤1.5×2mg/dl, ALT and AST≤2×institutional upper limit of normal,Cr≤1.5×institutional upper limit of normal,coagulation tests(INR and PTT)within normal range~subject provides signed informed consent~Exclusion Criteria:~hypersensitive to study drug~with a coagulational test unnormal or a bleeding disorder~infections~with serious condition which can't stand a surgery~pregnant or lactating~principle investigator consider not suitable
|
18 Years
| null |
All
|
No
|
Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
|
| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| overall survival | determine the 3-years overall survival | 3 year after the treatment |
| adverse effects | | from starting treatment to 30 days after treatment |
|
| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| local recurrent rate | | 3 years |
| quality of life | | 3 years |
|
p53 gene therapy, non-small cell lung cancer, post-surgery, chemotherapy
|
Carcinoma, Non-Small-Cell Lung, Neoplasms, Lung Neoplasms, Respiratory Tract Neoplasms, Thoracic Neoplasms, Neoplasms by Site, Lung Diseases, Respiratory Tract Diseases, Carcinoma, Bronchogenic, Bronchial Neoplasms
|
| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: Surgery plus post-surgery chemotherapy<br>Surgery plus post-surgery chemotherapy | Procedure: Surgery<br>* Surgery plus post-surgery chemotherapy<br>|
| Experimental: Surgery combined with rAd-p53 gene therapy<br>Surgery combined with the surgery wound surface injection of rAd-p53 plus post-surgery chemotherapy | Drug: Surgery combined with rAd-p53 gene therapy<br>* Surgery combined with rAd-p53 gene therapy during surgery plus post-surgery chemotherapy<br>|
|
Surgery Combined With rAd-p53 Gene in Treatment Advanced Non-small-cell Carcinoma
Study Overview
=================
Brief Summary
-----------------
The primary objectives of this study are to investigate the efficacy and safety of surgery combined with rAd-p53 gene therapy in treatment of advanced Non-small-cell lung carcinoma (NSCLC). The study efficacy endpoints include overall survival, progress-free survival, quality of life, and local recurrent rate. The safety endpoint is complications and adverse effects. The study hypothesis: rAd-p53 gene therapy can prolong the overall survival and reduce the local recurrent rate.
Official Title
-----------------
Phase II Study of Surgery Combined With Recombinant Adenoviral Human p53 Gene Therapy in Treatment Advanced Non-small-cell Carcinoma
Conditions
-----------------
Non-small Cell Lung Cancer
Intervention / Treatment
-----------------
* Drug: Surgery combined with rAd-p53 gene therapy
* Procedure: Surgery
Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: historically diagnosed advanced non-small lung cancer has surgery indication age 18 years old or greater life expectancy greater than 12 weeks ECOG: 0-2 no prior chemotherapy, radiotherapy in 2 weeks Neutrophils≥1.5×10^9/L,platelet≥80×10^9/L, Hb≥≥80g/L,bilirubin≤1.5×2mg/dl, ALT and AST≤2×institutional upper limit of normal,Cr≤1.5×institutional upper limit of normal,coagulation tests(INR and PTT)within normal range subject provides signed informed consent Exclusion Criteria: hypersensitive to study drug with a coagulational test unnormal or a bleeding disorder infections with serious condition which can't stand a surgery pregnant or lactating principle investigator consider not suitable
Ages Eligible for Study
-----------------
Minimum Age: 18 Years
Sexes Eligible for Study
-----------------
All
Accepts Healthy Volunteers
-----------------
No
Study Plan
=================
How is the study designed?
-----------------
Design Details
Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Arms and Interventions
| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: Surgery plus post-surgery chemotherapy<br>Surgery plus post-surgery chemotherapy | Procedure: Surgery<br>* Surgery plus post-surgery chemotherapy<br>|
| Experimental: Surgery combined with rAd-p53 gene therapy<br>Surgery combined with the surgery wound surface injection of rAd-p53 plus post-surgery chemotherapy | Drug: Surgery combined with rAd-p53 gene therapy<br>* Surgery combined with rAd-p53 gene therapy during surgery plus post-surgery chemotherapy<br>|
What is the study measuring?
-----------------
Primary Outcome Measures
| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| overall survival | determine the 3-years overall survival | 3 year after the treatment |
| adverse effects | | from starting treatment to 30 days after treatment |
Secondary Outcome Measures
| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| local recurrent rate | | 3 years |
| quality of life | | 3 years |
Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
p53 gene therapy, non-small cell lung cancer, post-surgery, chemotherapy
|
|
NCT02912546
|
Cerebral Perfusion Associated With Postural Changes: an ASL MR Perfusion Study
|
Postural changes are commonly used as therapeutic maneuver to enhance or reduce cerebral perfusion. For instance, in acute stroke, the patient can be positioned in head down tilt position so as to increase perfusion of cerebral tissues perfusion. In During stroke and in hypertensive patients and during stroke, varying degrees a various loss of cerebral autoregulation is loss are usually observed. The aim of this study is to assess cerebral perfusion with ASL perfusion in human subjects in different conditions: healthy, hypertensive and stroke.
|
Material and methods:~Eighteen stroke patients, eighteen hypertensive patients and eighteen healthy subjects (men and women) will be enrolled. The investigator will use a 1.5 Tesla MRI device with a large magnet bore (70 cm) allowing positions change. Two measures will be performed, one in supine position and the other in head down position (-20°). A 3D FSE ASL sequence will be acquired and Cerebral Blood Flow (CBF) maps will be reconstructed. Volume of interest (VOI) will be placed on cortical grey matter (frontal and posterior gyrus), on subcortical deep grey matter (caudate nuclei, thalami) and subcortical white matter (semi oval centers). Differences in CBF values (in mL/100g/min) will be analyzed using SAS 9.3 software for Windows (SAS Institute, Cary North Carolina, USA).~Expected results and hypothesis:~CBF is expected to significantly vary between the supine and head down positions. It is expected to at least increase in the head down position, for stroke patients. For healthy subjects and hypertensive patients, cerebral autoregulation may limit CBF increase although an increasing trend for CBF is expected.
|
Évaluation en IRM (séquence ASL) de la Variation de Perfusion cérébrale liée à la Position Corporelle.
|
Brain Ischemia
|
* Procedure: MRI
|
Inclusion Criteria:~Group of stroke patients:~Patients between 40 and 70 years old, male or female~With supratentorial ischemia in subacute phase (> H24)~Patients with a recent ischemic stroke with an intracranial hemodynamic unstable and kept lying with head down of about 30~Patient given free and informed consent to participate in research or a family representative~Patient insured under the French social security system~Control Group:~1- Group of patients with Hypertension.~Patients between 40 and 70 years old, matched for age and sex to stroke patients.~With a hypertension diagnosed since 10 years old.~Hypertension defined as three recommendations (OMS 1999, ANAES 1997 JNC VI): blood pressure 140 and / or 90 mmHg found at several consultations.~2- Group with healthy people.~Healthy person between 30 and 70 years old, women and men. Healthy character will be defined on the basis of a physical examination (measurement of heart rate and blood pressure ) and an examination to determine the absence of endocrine pathology ... ) and the absence of drug outlet continuous.~Person insured under the French social security system.~Person who given free and informed his consent to participate in research or a family representative.~Person who are not participating in another clinical study.~Exclusion Criteria:~Patients aged under 40 years and 71 years and older for patients in groups of stroke patients and patients with hypertension~Person under 30 years and 71 years and older for healthy people~Person who refuses or family the participation in the study~Person with heart antecedent or spinal disease~Contraindications to the realization of a MRI (pacemaker, claustrophobia, metallic body may be mobilized).~Person not insured under the French social security system,~Pregnant women~Persons under guardianship or curatorship~Persons deprived of liberty by a judicial or administrative decision~Persons who are participating in another clinical study
|
30 Years
|
70 Years
|
All
|
Accepts Healthy Volunteers
|
Primary Purpose: Other
Allocation: Non-Randomized
Intervention Model: Factorial Assignment
Masking: None (Open Label)
|
| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| The change in the value of the cerebral blood flow | The endpoint is the change in the value of the cerebral blood flow ( ml / 100g / min) depending on the switching position ( 0 ° and -20 °). This development will be assessed in different brain regions . In particular, it will be searched in excess of a threshold of significance .~This will be accomplished independently by two experienced readers (knowing that the variation between and within road has been assessed) . If a significant difference between the two players, it will be made a consensual common measure. | up to 1 year |
|
Stroke, Acute
|
Brain Ischemia, Ischemia, Pathologic Processes, Cerebrovascular Disorders, Brain Diseases, Central Nervous System Diseases, Nervous System Diseases, Vascular Diseases, Cardiovascular Diseases
|
| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: Control group<br>Eighteen healthy subjects and eighteen hypertensive patients (men and women) will be enrolled. A 1.5 Tesla MRI device with a large magnet bore (70 cm) will be used, allowing positions change. Two measures will be performed, one in supine position and the other in head down position (-20°). A 3D FSE ASL sequence will be acquired and Cerebral Blood Flow (CBF) maps will be reconstructed. Volume of interest (VOI) will be placed on cortical grey matter (frontal and posterior gyrus), on subcortical deep grey matter (caudate nuclei, thalami) and subcortical white matter (semi oval centers). Differences in CBF values (in mL/100g/min) will be analyzed using SAS 9.3 software for Windows (SAS Institute, Cary North Carolina, USA). | Procedure: MRI<br>* A 1.5 Tesla MRI device with a large magnet bore (70 cm) allowing positions change will be used. Two measures will be performed, one in supine position and the other in head down position (-20°). A 3D FSE ASL sequence will be acquired and CBF maps reconstructed. Volume of interest (VOI) will be placed on cortical grey matter (frontal and posterior gyrus), on subcortical deep grey matter (caudate nuclei, thalami) and subcortical white matter (semi oval centers<br>|
| Active Comparator: Stroke patients<br>Eighteen stroke patients (men and women) will be enrolled. A 1.5 Tesla MRI device with a large magnet bore (70 cm) will be used, allowing positions change. Two measures will be performed, one in supine position and the other in head down position (-20°). A 3D FSE ASL sequence will be acquired and Cerebral Blood Flow (CBF) maps will be reconstructed. Volume of interest (VOI) will be placed on cortical grey matter (frontal and posterior gyrus), on subcortical deep grey matter (caudate nuclei, thalami) and subcortical white matter (semi oval centers). Differences in CBF values (in mL/100g/min) will be analyzed using SAS 9.3 software for Windows (SAS Institute, Cary North Carolina, USA). | Procedure: MRI<br>* A 1.5 Tesla MRI device with a large magnet bore (70 cm) allowing positions change will be used. Two measures will be performed, one in supine position and the other in head down position (-20°). A 3D FSE ASL sequence will be acquired and CBF maps reconstructed. Volume of interest (VOI) will be placed on cortical grey matter (frontal and posterior gyrus), on subcortical deep grey matter (caudate nuclei, thalami) and subcortical white matter (semi oval centers<br>|
|
Cerebral Perfusion Associated With Postural Changes: an ASL MR Perfusion Study
Study Overview
=================
Brief Summary
-----------------
Postural changes are commonly used as therapeutic maneuver to enhance or reduce cerebral perfusion. For instance, in acute stroke, the patient can be positioned in head down tilt position so as to increase perfusion of cerebral tissues perfusion. In During stroke and in hypertensive patients and during stroke, varying degrees a various loss of cerebral autoregulation is loss are usually observed. The aim of this study is to assess cerebral perfusion with ASL perfusion in human subjects in different conditions: healthy, hypertensive and stroke.
Detailed Description
-----------------
Material and methods: Eighteen stroke patients, eighteen hypertensive patients and eighteen healthy subjects (men and women) will be enrolled. The investigator will use a 1.5 Tesla MRI device with a large magnet bore (70 cm) allowing positions change. Two measures will be performed, one in supine position and the other in head down position (-20°). A 3D FSE ASL sequence will be acquired and Cerebral Blood Flow (CBF) maps will be reconstructed. Volume of interest (VOI) will be placed on cortical grey matter (frontal and posterior gyrus), on subcortical deep grey matter (caudate nuclei, thalami) and subcortical white matter (semi oval centers). Differences in CBF values (in mL/100g/min) will be analyzed using SAS 9.3 software for Windows (SAS Institute, Cary North Carolina, USA). Expected results and hypothesis: CBF is expected to significantly vary between the supine and head down positions. It is expected to at least increase in the head down position, for stroke patients. For healthy subjects and hypertensive patients, cerebral autoregulation may limit CBF increase although an increasing trend for CBF is expected.
Official Title
-----------------
Évaluation en IRM (séquence ASL) de la Variation de Perfusion cérébrale liée à la Position Corporelle.
Conditions
-----------------
Brain Ischemia
Intervention / Treatment
-----------------
* Procedure: MRI
Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Group of stroke patients: Patients between 40 and 70 years old, male or female With supratentorial ischemia in subacute phase (> H24) Patients with a recent ischemic stroke with an intracranial hemodynamic unstable and kept lying with head down of about 30 Patient given free and informed consent to participate in research or a family representative Patient insured under the French social security system Control Group: 1- Group of patients with Hypertension. Patients between 40 and 70 years old, matched for age and sex to stroke patients. With a hypertension diagnosed since 10 years old. Hypertension defined as three recommendations (OMS 1999, ANAES 1997 JNC VI): blood pressure 140 and / or 90 mmHg found at several consultations. 2- Group with healthy people. Healthy person between 30 and 70 years old, women and men. Healthy character will be defined on the basis of a physical examination (measurement of heart rate and blood pressure ) and an examination to determine the absence of endocrine pathology ... ) and the absence of drug outlet continuous. Person insured under the French social security system. Person who given free and informed his consent to participate in research or a family representative. Person who are not participating in another clinical study. Exclusion Criteria: Patients aged under 40 years and 71 years and older for patients in groups of stroke patients and patients with hypertension Person under 30 years and 71 years and older for healthy people Person who refuses or family the participation in the study Person with heart antecedent or spinal disease Contraindications to the realization of a MRI (pacemaker, claustrophobia, metallic body may be mobilized). Person not insured under the French social security system, Pregnant women Persons under guardianship or curatorship Persons deprived of liberty by a judicial or administrative decision Persons who are participating in another clinical study
Ages Eligible for Study
-----------------
Minimum Age: 30 Years
Maximum Age: 70 Years
Sexes Eligible for Study
-----------------
All
Accepts Healthy Volunteers
-----------------
Accepts Healthy Volunteers
Study Plan
=================
How is the study designed?
-----------------
Design Details
Primary Purpose: Other
Allocation: Non-Randomized
Intervention Model: Factorial Assignment
Masking: None (Open Label)
Arms and Interventions
| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: Control group<br>Eighteen healthy subjects and eighteen hypertensive patients (men and women) will be enrolled. A 1.5 Tesla MRI device with a large magnet bore (70 cm) will be used, allowing positions change. Two measures will be performed, one in supine position and the other in head down position (-20°). A 3D FSE ASL sequence will be acquired and Cerebral Blood Flow (CBF) maps will be reconstructed. Volume of interest (VOI) will be placed on cortical grey matter (frontal and posterior gyrus), on subcortical deep grey matter (caudate nuclei, thalami) and subcortical white matter (semi oval centers). Differences in CBF values (in mL/100g/min) will be analyzed using SAS 9.3 software for Windows (SAS Institute, Cary North Carolina, USA). | Procedure: MRI<br>* A 1.5 Tesla MRI device with a large magnet bore (70 cm) allowing positions change will be used. Two measures will be performed, one in supine position and the other in head down position (-20°). A 3D FSE ASL sequence will be acquired and CBF maps reconstructed. Volume of interest (VOI) will be placed on cortical grey matter (frontal and posterior gyrus), on subcortical deep grey matter (caudate nuclei, thalami) and subcortical white matter (semi oval centers<br>|
| Active Comparator: Stroke patients<br>Eighteen stroke patients (men and women) will be enrolled. A 1.5 Tesla MRI device with a large magnet bore (70 cm) will be used, allowing positions change. Two measures will be performed, one in supine position and the other in head down position (-20°). A 3D FSE ASL sequence will be acquired and Cerebral Blood Flow (CBF) maps will be reconstructed. Volume of interest (VOI) will be placed on cortical grey matter (frontal and posterior gyrus), on subcortical deep grey matter (caudate nuclei, thalami) and subcortical white matter (semi oval centers). Differences in CBF values (in mL/100g/min) will be analyzed using SAS 9.3 software for Windows (SAS Institute, Cary North Carolina, USA). | Procedure: MRI<br>* A 1.5 Tesla MRI device with a large magnet bore (70 cm) allowing positions change will be used. Two measures will be performed, one in supine position and the other in head down position (-20°). A 3D FSE ASL sequence will be acquired and CBF maps reconstructed. Volume of interest (VOI) will be placed on cortical grey matter (frontal and posterior gyrus), on subcortical deep grey matter (caudate nuclei, thalami) and subcortical white matter (semi oval centers<br>|
What is the study measuring?
-----------------
Primary Outcome Measures
| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| The change in the value of the cerebral blood flow | The endpoint is the change in the value of the cerebral blood flow ( ml / 100g / min) depending on the switching position ( 0 ° and -20 °). This development will be assessed in different brain regions . In particular, it will be searched in excess of a threshold of significance . This will be accomplished independently by two experienced readers (knowing that the variation between and within road has been assessed) . If a significant difference between the two players, it will be made a consensual common measure. | up to 1 year |
Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Stroke, Acute
|
|
NCT05407545
|
Evaluation of a Motorised Prosthetic Knee
|
The study will investigate the effect over time of the Power Knee (Össur) on performance during daily activities in people with a unilateral transfemoral amputation, will determine subjective feelings and gait kinematics over time during daily activities and will investigate the association between subjective feelings and objective outcomes of performing daily activities.
|
Participants will visit the lab 6 times over a period of 5 weeks. The study includes a familiarisation phase (3 measuring moments) followed by the experimental phase (3 measuring moments). During the measuring sessions, participants will perform four tasks with their current prosthesis and with the Power Knee (Össur). The order in which the devices will be tested, will be reversed on each measuring moment to control for possible order effects and fatigue.~The experimental protocol will entail an L-test and slope walking test that will each be performed 3 times, followed by a 6 minutes of hallway walking (6MWT), 10 min rest and a dual-task 6MWT.~The slope walking test assesses the participants' ability to ascend and descend a 6 m long ramp of 10% inclination as fast as possible. For safety reasons bilateral handrails are warranted. Participants start the test in an upright position in front of the ramp and are asked to ascend the ramp, turn around on the platform, descend the ramp and return to the starting position.~The L-test, requires higher physical activity of the user. During the L-test, participants are asked to rise from a chair, walk 7 meters, turn 90 degrees, walk 3 meters, turn 180 degrees and then return in the same way to the seated position. A total distance of 20 meter is covered.~The 6MWT will be performed on a hallway at a self-selected walking speed, which closely relates to the most efficient walking speed.~The dual-task 6MWT will be compiled out of conducting a 6MWT while performing a cognitive task, i.e. serial subtractions. Serial subtraction is mental arithmetic task that tests attention and working memory. Participants will be asked to continually subtract sevens from a random selected 3-digit number as long as the duration of the test.
|
Evaluation of a Motorised Prosthetic Knee
|
Lower Limb Amputation Above Knee (Injury)
|
* Device: Current prosthesis
* Device: Active Prosthesis (PowerKnee)
|
Inclusion Criteria:~Unilateral transfemoral (above knee) amputation~Healthy subject~Medicare Functional Classification Level: K3-4~Exclusion Criteria:~Any neurological disease~Upper limb or bilateral amputation~Stump pain or bad fit of the socket
|
18 Years
|
75 Years
|
All
|
Accepts Healthy Volunteers
|
Primary Purpose: Basic Science
Intervention Model: Single Group Assignment
Masking: None (Open Label)
|
| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Performance | Time needed to perform the L-test and slope walking test | 70 minutes |
| Performance | Accuracy of the serial subtractions during the dual-6MWT in % | 72 minutes |
| Performance | Distance covered during the 6MWT and dual-6MWT | 144 minutes |
|
| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Physiological | Heart rate during all tasks in beats per minute | 286 minutes |
| Psychological | Visual analogue scale for comfort (score: 0= not comfortable, 100 = comfortable) and fatigue (score: 0= not fatiguing, 100 = fatiguing) during all tasks | 100 minutes |
| Psychological | Borg rating of perceived exertion (score: 6 = No exertion at all , 20 = Maximal exertion) | 96 minutes |
| Psychological | Perceived workload: Nasa-Task Load Index (score: 0 = minimal workload, 100 = Maximal perceived workload ) | 200 minutes |
|
| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Prosthesis<br>A unilateral transfemoral amputee will conduct experiments with the active prosthesis and with the current prosthesis. | Device: Current prosthesis<br>* A unilateral transfemoral amputee will conduct experiments with the current prosthesis<br>Device: Active Prosthesis (PowerKnee)<br>* A unilateral transfemoral amputee will conduct experiments with the Power Knee. The PowerKnee is an active prosthesis developed by Össur.<br>|
|
Evaluation of a Motorised Prosthetic Knee
Study Overview
=================
Brief Summary
-----------------
The study will investigate the effect over time of the Power Knee (Össur) on performance during daily activities in people with a unilateral transfemoral amputation, will determine subjective feelings and gait kinematics over time during daily activities and will investigate the association between subjective feelings and objective outcomes of performing daily activities.
Detailed Description
-----------------
Participants will visit the lab 6 times over a period of 5 weeks. The study includes a familiarisation phase (3 measuring moments) followed by the experimental phase (3 measuring moments). During the measuring sessions, participants will perform four tasks with their current prosthesis and with the Power Knee (Össur). The order in which the devices will be tested, will be reversed on each measuring moment to control for possible order effects and fatigue. The experimental protocol will entail an L-test and slope walking test that will each be performed 3 times, followed by a 6 minutes of hallway walking (6MWT), 10 min rest and a dual-task 6MWT. The slope walking test assesses the participants' ability to ascend and descend a 6 m long ramp of 10% inclination as fast as possible. For safety reasons bilateral handrails are warranted. Participants start the test in an upright position in front of the ramp and are asked to ascend the ramp, turn around on the platform, descend the ramp and return to the starting position. The L-test, requires higher physical activity of the user. During the L-test, participants are asked to rise from a chair, walk 7 meters, turn 90 degrees, walk 3 meters, turn 180 degrees and then return in the same way to the seated position. A total distance of 20 meter is covered. The 6MWT will be performed on a hallway at a self-selected walking speed, which closely relates to the most efficient walking speed. The dual-task 6MWT will be compiled out of conducting a 6MWT while performing a cognitive task, i.e. serial subtractions. Serial subtraction is mental arithmetic task that tests attention and working memory. Participants will be asked to continually subtract sevens from a random selected 3-digit number as long as the duration of the test.
Official Title
-----------------
Evaluation of a Motorised Prosthetic Knee
Conditions
-----------------
Lower Limb Amputation Above Knee (Injury)
Intervention / Treatment
-----------------
* Device: Current prosthesis
* Device: Active Prosthesis (PowerKnee)
Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Unilateral transfemoral (above knee) amputation Healthy subject Medicare Functional Classification Level: K3-4 Exclusion Criteria: Any neurological disease Upper limb or bilateral amputation Stump pain or bad fit of the socket
Ages Eligible for Study
-----------------
Minimum Age: 18 Years
Maximum Age: 75 Years
Sexes Eligible for Study
-----------------
All
Accepts Healthy Volunteers
-----------------
Accepts Healthy Volunteers
Study Plan
=================
How is the study designed?
-----------------
Design Details
Primary Purpose: Basic Science
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Arms and Interventions
| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Prosthesis<br>A unilateral transfemoral amputee will conduct experiments with the active prosthesis and with the current prosthesis. | Device: Current prosthesis<br>* A unilateral transfemoral amputee will conduct experiments with the current prosthesis<br>Device: Active Prosthesis (PowerKnee)<br>* A unilateral transfemoral amputee will conduct experiments with the Power Knee. The PowerKnee is an active prosthesis developed by Össur.<br>|
What is the study measuring?
-----------------
Primary Outcome Measures
| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Performance | Time needed to perform the L-test and slope walking test | 70 minutes |
| Performance | Accuracy of the serial subtractions during the dual-6MWT in % | 72 minutes |
| Performance | Distance covered during the 6MWT and dual-6MWT | 144 minutes |
Secondary Outcome Measures
| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Physiological | Heart rate during all tasks in beats per minute | 286 minutes |
| Psychological | Visual analogue scale for comfort (score: 0= not comfortable, 100 = comfortable) and fatigue (score: 0= not fatiguing, 100 = fatiguing) during all tasks | 100 minutes |
| Psychological | Borg rating of perceived exertion (score: 6 = No exertion at all , 20 = Maximal exertion) | 96 minutes |
| Psychological | Perceived workload: Nasa-Task Load Index (score: 0 = minimal workload, 100 = Maximal perceived workload ) | 200 minutes |
|
||
NCT03576001
|
Multimodality Intervention for Function and Metabolism in SCI
|
The proposed phase 2 trial a randomized, placebo-controlled, parallel group trial in persons with cervical or thoracic SCI, AIS grade A, B, C, or D, 6 months or later after injury. The trial will test the hypothesis that a Home-Based Multimodality Functional Recovery and Metabolic Health Enhancement Program that addresses multiple pathophysiologic factors in SCI and includes functional electrical stimulation during leg cycling (FES-LC) plus arm ergometry and an androgen will be more efficacious than functional electrical stimulation during leg cycling (FES-LC) plus arm ergometry plus placebo in improving aerobic capacity, function, metabolism, bone health, and wellbeing.
|
Study Description: The proposed phase 2 trial a randomized, placebo-controlled, parallel group trial in persons with cervical or thoracic SCI, AIS grade A, B, C, or D, 6 months or later after injury. The trial will test the hypothesis that a Home-Based Multimodality Functional Recovery and Metabolic Health Enhancement Program that addresses multiple pathophysiologic factors in SCI and includes functional electrical stimulation during leg cycling (FES-LC) plus arm ergometry and an androgen will be more efficacious than functional electrical stimulation during leg cycling (FES-LC) plus arm ergometry plus placebo in improving aerobic capacity, function, metabolism, bone health, and wellbeing.~Objectives:~Primary Objective:~• To determine whether the multimodality intervention is more efficacious in improving peak aerobic capacity, and muscle mass and strength than placebo plus functional electrical stimulation during leg cycling (FES-LC) plus arm ergometry alone.~Secondary Objectives:~To determine whether the multimodality intervention is more efficacious than placebo plus functional electrical stimulation during leg cycling (FES-LC) plus arm ergometry in improving metabolic health, as reflected in fasting glucose, hemoglobin A1C, insulin sensitivity, fat mass and distribution, plasma lipids, and inflammation markers.~To determine whether the multimodality intervention is more efficacious than placebo plus functional electrical stimulation during leg cycling (FES-LC) plus arm ergometry in improving volumetric and areal bone density, bone microarchitecture, and bone strength.~To determine the efficacy of the multimodality intervention in improving self-reported physical function (using SCI-FI AT and wellbeing (mood, anxiety, pain, loneliness and life satisfaction)~• To assess safety by structured monitoring of adverse events, and determining the proportion of participants experiencing injury, erythrocytosis, or other androgen-related or exercise-related adverse events.~Endpoints: Primary Endpoint:~Our primary outcome is peak aerobic capacity because it is an excellent marker of overall health, physical function, and mortality. Aerobic capacity is closely related to metabolic health, insulin sensitivity and cardiovascular outcomes. It can be measured accurately in SCI patients and would be expected to improve with the proposed interventions.~Secondary endpoints. Whole body skeletal muscle and fat mass and intraabdominal fat will be assessed by magnetic resonance imaging (MRI), using the Dixon method for separation of water/ fat signals. Body composition will also be measured by DEXA.~Maximal voluntary strength and muscle fatigability in the upper extremity will be assessed using the 1-repetition maximum in chest press.~Total, trabecular and cortical volumetric bone density; trabecular and cortical microarchitecture, both measured using high resolution peripheral quantitative computed tomography (HR-pQCT) at the ultradistal tibia, proximal tibia, and ultradistal radius.~Estimated bone strength of the ultradistal tibia and radius, assessed using microfinite element analysis of the HR-pQCT data.~Areal bone mineral density of the hip and lumbar spine using dual-energy X-ray absorptiometry (DEXA). (aBMD will be measured because DEXA is a clinically used and accepted measure of bone density, and aBMD is predictive of fracture risk.) Serum bone turnover markers, including markers of bone formation (osteocalcin, bone specific alkaline phosphatase (BSAP), (PINP) and bone resorption (CTX).~Spinal Cord Injury - Functional Index (SCI-FI) will be used to assess self-reported function and mobility. SCI-FI is specific for persons with SCI that assesses functional capacity in basic mobility, ambulation, self-care, and fine motor function, and wheelchair ambulation.~Measures of Metabolism: Fasting glucose, A1C; insulin sensitivity using HOMA-IR; IL-6 and hsCRP as inflammation markers; and plasma lipids, apolipoproteins B, C and A, and lipoprotein particles as markers of atherogenicity - all measured in the Brigham Research Assay Laboratory. Visceral fat will be assessed using Dixon MRI technique.~Wellbeing: We will assess mood, anxiety, pain, and life satisfaction as measures of wellbeing. Mood will be assessed using Patient Health Questionnaire (PHQ-9), a 9-item scale that assesses mood and depressive symptoms. We will assess anxiety using GAD-7. Modified Brief Pain Inventory (BPI), a validated measure of pain in SCI, assesses pain intensity (sensory dimension) and interference with function (reactive dimension). Satisfaction with Life Scale is a 5-item scale that assesses happiness with life. Loneliness will be assessed using the Three-Item Loneliness Scale.~Study Population: This proof-of-concept trial will enroll 88 community dwelling men and women with SCI, 19 to 70 years of age, motor C7-T12 cervical and thoracic, AIS A, B, C, or D, 6 months or later after a SCI.~The trial plans to randomize 88 eligible subjects at a single trial site.~Phase: Phase 2~Description of Sites/Facilities Enrolling Participants: This is a single site study that will take place at the Brigham and Women's Hospital in Boston, MA.~Description of Study Intervention: The Home-Based Multimodality Functional Recovery and Metabolic Health Enhancement Program includes training at home consisting of FES-LC plus arm ergometry plus testosterone undecanoate. Testosterone injections will be administered by study staff in the research clinic or by a visiting nurse in the participant's home. The control group will receive FES-LC plus arm ergometry plus placebo injections.~Study Duration: Approximately 54 months~Participant Duration: Approximately 33 weeks (14 weeks for screening, baseline studies, and Day 1, 16 weeks of intervention, and up to 3 weeks of end of study assessments)
|
Effect of a Multimodality Intervention to Improve Function and Metabolism in Spinal Cord Injury
|
Spinal Cord Injuries
|
* Drug: Testosterone Undecanoate
* Behavioral: hybrid exercise
|
INCLUSION CRITERIA~Men and women, 19 to 70 years~Confirmed cervical and thoracic, AIS A-D who are at least 6 months post-injury and who use a wheelchair as their primary mobility mode~Medically stable, able to follow directions~Able to provide informed consent.~For females of reproductive potential who are sexually active: use of highly effective contraception for at least 1 month prior to Day 1 and agreement to use such a method during study participation and for an additional 12 weeks after the end of intervention.~EXCLUSION CRITERIA~Upper extremity musculoskeletal conditions (such as advanced rotator cuff pathology or carpal tunnel syndrome) or neurological disorder that in the assessment of the study investigator would prevent the participant from performing the prescribed arm ergometry.~Current fractures in the upper and lower extremity~In accordance with the Endocrine Society and ISSAM Guidelines25,52, we will exclude individuals with a contraindication for androgen use:~History of prostate or breast cancer~Prostate nodule or induration on digital rectal examination (DRE)~Prostate specific antigen (PSA) > 4 ng/ml or > 3 ng/ml in individuals at high risk of prostate cancer such as African Americans or those with family history of prostate cancer in first degree relatives, unless there has been a negative prostate biopsy within 3 months~Hematocrit > 48%~Conditions that would render exercise and FES unsafe or unfeasible such as severe autonomic dysreflexia, severe pressure sores, severe spasticity and severe pain.~Body mass index (BMI) > 45 kg/m2~Renal dysfunction as indicated by GFR of <50 ml/min, estimated by using the Modification of Diet in Kidney Disease (MDRD) Study equation, in accordance with K/DOQI guidelines~Use of testosterone or other anabolic therapies, including DHEA and androstenedione, or rhGH in the preceding 6 months~Active cancer requiring therapy and which may limit life expectancy to less than 5 years~Psychosis, bipolar disorder, or major untreated depression~Dementia (Mini-Mental Status Exam [MMSE] <24)~Myocardial infarction (MI) or stroke within 3 months of entry~Pacemaker~ALT and AST > 3 x upper limit of normal~Poorly controlled diabetes as indicated by hemoglobin (Hb)-A1c greater than 9.0% or diabetes requiring insulin therapy~Blood thinners such as Coumadin, heparin, rivaroxaban (Xarelto), dabigatran (Pradaxa), lovenox (subcutaneous heparin), apixaban (Eliquis) (aspirin, plavix and other anti-platelet agents are allowed)~Systolic blood pressure (BP) > 170 or diastolic BP > 100 mm Hg~Current grade 2 or greater pressure ulcers at relevant contact sites~Pressure sores or open wounds on the areas that restricts their participation~Because the safety of testosterone has not been established in pregnancy and lactation, we will exclude pregnant or lactating women and women of childbearing potential who are sexually active but are unwilling or unable to use a reliable form of contraception. We will perform a blood test to exclude pregnancy at the time of enrollment.~Participation in a structured exercise program currently or in the past 2 months and unwilling to stop the structured exercise program if ongoing at time of screening. Specifically, participation in a structured exercise program, currently or in the past 2 months, that involves progressive resistance exercise training of moderate to high intensity or regular endurance exercise of moderate to high intensity, and unwillingness to stop the structured exercise program if ongoing at time of screening.~Inability or unwillingness to participate in the exercise training or the assessments of muscle performance and physical performance
|
19 Years
|
70 Years
|
All
|
Accepts Healthy Volunteers
|
Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple
|
| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| peak aerobic capacity | | 16 weeks |
|
| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| whole body skeletal muscle and fat mass | magnetic resonance imaging (MRI) using the Dixon method | 16 weeks |
| maximal voluntary strength and muscle fatigability in upper extremity | 1 repetition maximum in the seated chest press exercise | 16 weeks |
| metabolism measures | fasting glucose A1C; insulin sensitivity; lipoprotein particles | 16 weeks |
| Spinal Cord Injury Function Index Computer Adaptive Test (SCI-FI CAT) | self-report function and mobility computer adaptive test | 16 weeks |
| Mood | Patient Health Questionnaire (PHQ-9) | 16 weeks |
| Anxiety | GAD-7 | 16 weeks |
| Satisfaction with Life | Satisfaction with Life Scale (5 item scale) | 16 weeks |
| Safety Assessment | Adverse and Serious Adverse Event recording classified using MEDRA and SOC coding | throughout 16 weeks of subjects participation |
| Loneliness | Three-Item Loneliness Scale | 16 weeks |
|
Methyltestosterone, Testosterone, Testosterone undecanoate, Testosterone enanthate, Testosterone 17 beta-cypionate, Androgens, Hormones, Hormones, Hormone Substitutes, and Hormone Antagonists, Physiological Effects of Drugs, Antineoplastic Agents, Hormonal, Antineoplastic Agents, Anabolic Agents
|
| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Multi-modality intervention group<br>Hybrid exercise (functional electrical stimulation - leg cycling, FES LC plus arm ergometry) plus Testosterone undecanoate | Drug: Testosterone Undecanoate<br>* administered through injections by study staff<br>Behavioral: hybrid exercise<br>* hybrid exercise: functional electrical stimulation of lower extremity with leg cycling (FES-LC) and arm ergometry, supervised for two weeks and then home-based<br>|
| Placebo Comparator: Placebo group<br>Hybrid exercise plus placebo medication | Behavioral: hybrid exercise<br>* hybrid exercise: functional electrical stimulation of lower extremity with leg cycling (FES-LC) and arm ergometry, supervised for two weeks and then home-based<br>|
|
Multimodality Intervention for Function and Metabolism in SCI
Study Overview
=================
Brief Summary
-----------------
The proposed phase 2 trial a randomized, placebo-controlled, parallel group trial in persons with cervical or thoracic SCI, AIS grade A, B, C, or D, 6 months or later after injury. The trial will test the hypothesis that a Home-Based Multimodality Functional Recovery and Metabolic Health Enhancement Program that addresses multiple pathophysiologic factors in SCI and includes functional electrical stimulation during leg cycling (FES-LC) plus arm ergometry and an androgen will be more efficacious than functional electrical stimulation during leg cycling (FES-LC) plus arm ergometry plus placebo in improving aerobic capacity, function, metabolism, bone health, and wellbeing.
Detailed Description
-----------------
Study Description: The proposed phase 2 trial a randomized, placebo-controlled, parallel group trial in persons with cervical or thoracic SCI, AIS grade A, B, C, or D, 6 months or later after injury. The trial will test the hypothesis that a Home-Based Multimodality Functional Recovery and Metabolic Health Enhancement Program that addresses multiple pathophysiologic factors in SCI and includes functional electrical stimulation during leg cycling (FES-LC) plus arm ergometry and an androgen will be more efficacious than functional electrical stimulation during leg cycling (FES-LC) plus arm ergometry plus placebo in improving aerobic capacity, function, metabolism, bone health, and wellbeing. Objectives: Primary Objective: • To determine whether the multimodality intervention is more efficacious in improving peak aerobic capacity, and muscle mass and strength than placebo plus functional electrical stimulation during leg cycling (FES-LC) plus arm ergometry alone. Secondary Objectives: To determine whether the multimodality intervention is more efficacious than placebo plus functional electrical stimulation during leg cycling (FES-LC) plus arm ergometry in improving metabolic health, as reflected in fasting glucose, hemoglobin A1C, insulin sensitivity, fat mass and distribution, plasma lipids, and inflammation markers. To determine whether the multimodality intervention is more efficacious than placebo plus functional electrical stimulation during leg cycling (FES-LC) plus arm ergometry in improving volumetric and areal bone density, bone microarchitecture, and bone strength. To determine the efficacy of the multimodality intervention in improving self-reported physical function (using SCI-FI AT and wellbeing (mood, anxiety, pain, loneliness and life satisfaction) • To assess safety by structured monitoring of adverse events, and determining the proportion of participants experiencing injury, erythrocytosis, or other androgen-related or exercise-related adverse events. Endpoints: Primary Endpoint: Our primary outcome is peak aerobic capacity because it is an excellent marker of overall health, physical function, and mortality. Aerobic capacity is closely related to metabolic health, insulin sensitivity and cardiovascular outcomes. It can be measured accurately in SCI patients and would be expected to improve with the proposed interventions. Secondary endpoints. Whole body skeletal muscle and fat mass and intraabdominal fat will be assessed by magnetic resonance imaging (MRI), using the Dixon method for separation of water/ fat signals. Body composition will also be measured by DEXA. Maximal voluntary strength and muscle fatigability in the upper extremity will be assessed using the 1-repetition maximum in chest press. Total, trabecular and cortical volumetric bone density; trabecular and cortical microarchitecture, both measured using high resolution peripheral quantitative computed tomography (HR-pQCT) at the ultradistal tibia, proximal tibia, and ultradistal radius. Estimated bone strength of the ultradistal tibia and radius, assessed using microfinite element analysis of the HR-pQCT data. Areal bone mineral density of the hip and lumbar spine using dual-energy X-ray absorptiometry (DEXA). (aBMD will be measured because DEXA is a clinically used and accepted measure of bone density, and aBMD is predictive of fracture risk.) Serum bone turnover markers, including markers of bone formation (osteocalcin, bone specific alkaline phosphatase (BSAP), (PINP) and bone resorption (CTX). Spinal Cord Injury - Functional Index (SCI-FI) will be used to assess self-reported function and mobility. SCI-FI is specific for persons with SCI that assesses functional capacity in basic mobility, ambulation, self-care, and fine motor function, and wheelchair ambulation. Measures of Metabolism: Fasting glucose, A1C; insulin sensitivity using HOMA-IR; IL-6 and hsCRP as inflammation markers; and plasma lipids, apolipoproteins B, C and A, and lipoprotein particles as markers of atherogenicity - all measured in the Brigham Research Assay Laboratory. Visceral fat will be assessed using Dixon MRI technique. Wellbeing: We will assess mood, anxiety, pain, and life satisfaction as measures of wellbeing. Mood will be assessed using Patient Health Questionnaire (PHQ-9), a 9-item scale that assesses mood and depressive symptoms. We will assess anxiety using GAD-7. Modified Brief Pain Inventory (BPI), a validated measure of pain in SCI, assesses pain intensity (sensory dimension) and interference with function (reactive dimension). Satisfaction with Life Scale is a 5-item scale that assesses happiness with life. Loneliness will be assessed using the Three-Item Loneliness Scale. Study Population: This proof-of-concept trial will enroll 88 community dwelling men and women with SCI, 19 to 70 years of age, motor C7-T12 cervical and thoracic, AIS A, B, C, or D, 6 months or later after a SCI. The trial plans to randomize 88 eligible subjects at a single trial site. Phase: Phase 2 Description of Sites/Facilities Enrolling Participants: This is a single site study that will take place at the Brigham and Women's Hospital in Boston, MA. Description of Study Intervention: The Home-Based Multimodality Functional Recovery and Metabolic Health Enhancement Program includes training at home consisting of FES-LC plus arm ergometry plus testosterone undecanoate. Testosterone injections will be administered by study staff in the research clinic or by a visiting nurse in the participant's home. The control group will receive FES-LC plus arm ergometry plus placebo injections. Study Duration: Approximately 54 months Participant Duration: Approximately 33 weeks (14 weeks for screening, baseline studies, and Day 1, 16 weeks of intervention, and up to 3 weeks of end of study assessments)
Official Title
-----------------
Effect of a Multimodality Intervention to Improve Function and Metabolism in Spinal Cord Injury
Conditions
-----------------
Spinal Cord Injuries
Intervention / Treatment
-----------------
* Drug: Testosterone Undecanoate
* Behavioral: hybrid exercise
Participation Criteria
=================
Eligibility Criteria
-----------------
INCLUSION CRITERIA Men and women, 19 to 70 years Confirmed cervical and thoracic, AIS A-D who are at least 6 months post-injury and who use a wheelchair as their primary mobility mode Medically stable, able to follow directions Able to provide informed consent. For females of reproductive potential who are sexually active: use of highly effective contraception for at least 1 month prior to Day 1 and agreement to use such a method during study participation and for an additional 12 weeks after the end of intervention. EXCLUSION CRITERIA Upper extremity musculoskeletal conditions (such as advanced rotator cuff pathology or carpal tunnel syndrome) or neurological disorder that in the assessment of the study investigator would prevent the participant from performing the prescribed arm ergometry. Current fractures in the upper and lower extremity In accordance with the Endocrine Society and ISSAM Guidelines25,52, we will exclude individuals with a contraindication for androgen use: History of prostate or breast cancer Prostate nodule or induration on digital rectal examination (DRE) Prostate specific antigen (PSA) > 4 ng/ml or > 3 ng/ml in individuals at high risk of prostate cancer such as African Americans or those with family history of prostate cancer in first degree relatives, unless there has been a negative prostate biopsy within 3 months Hematocrit > 48% Conditions that would render exercise and FES unsafe or unfeasible such as severe autonomic dysreflexia, severe pressure sores, severe spasticity and severe pain. Body mass index (BMI) > 45 kg/m2 Renal dysfunction as indicated by GFR of <50 ml/min, estimated by using the Modification of Diet in Kidney Disease (MDRD) Study equation, in accordance with K/DOQI guidelines Use of testosterone or other anabolic therapies, including DHEA and androstenedione, or rhGH in the preceding 6 months Active cancer requiring therapy and which may limit life expectancy to less than 5 years Psychosis, bipolar disorder, or major untreated depression Dementia (Mini-Mental Status Exam [MMSE] <24) Myocardial infarction (MI) or stroke within 3 months of entry Pacemaker ALT and AST > 3 x upper limit of normal Poorly controlled diabetes as indicated by hemoglobin (Hb)-A1c greater than 9.0% or diabetes requiring insulin therapy Blood thinners such as Coumadin, heparin, rivaroxaban (Xarelto), dabigatran (Pradaxa), lovenox (subcutaneous heparin), apixaban (Eliquis) (aspirin, plavix and other anti-platelet agents are allowed) Systolic blood pressure (BP) > 170 or diastolic BP > 100 mm Hg Current grade 2 or greater pressure ulcers at relevant contact sites Pressure sores or open wounds on the areas that restricts their participation Because the safety of testosterone has not been established in pregnancy and lactation, we will exclude pregnant or lactating women and women of childbearing potential who are sexually active but are unwilling or unable to use a reliable form of contraception. We will perform a blood test to exclude pregnancy at the time of enrollment. Participation in a structured exercise program currently or in the past 2 months and unwilling to stop the structured exercise program if ongoing at time of screening. Specifically, participation in a structured exercise program, currently or in the past 2 months, that involves progressive resistance exercise training of moderate to high intensity or regular endurance exercise of moderate to high intensity, and unwillingness to stop the structured exercise program if ongoing at time of screening. Inability or unwillingness to participate in the exercise training or the assessments of muscle performance and physical performance
Ages Eligible for Study
-----------------
Minimum Age: 19 Years
Maximum Age: 70 Years
Sexes Eligible for Study
-----------------
All
Accepts Healthy Volunteers
-----------------
Accepts Healthy Volunteers
Study Plan
=================
How is the study designed?
-----------------
Design Details
Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple
Arms and Interventions
| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Multi-modality intervention group<br>Hybrid exercise (functional electrical stimulation - leg cycling, FES LC plus arm ergometry) plus Testosterone undecanoate | Drug: Testosterone Undecanoate<br>* administered through injections by study staff<br>Behavioral: hybrid exercise<br>* hybrid exercise: functional electrical stimulation of lower extremity with leg cycling (FES-LC) and arm ergometry, supervised for two weeks and then home-based<br>|
| Placebo Comparator: Placebo group<br>Hybrid exercise plus placebo medication | Behavioral: hybrid exercise<br>* hybrid exercise: functional electrical stimulation of lower extremity with leg cycling (FES-LC) and arm ergometry, supervised for two weeks and then home-based<br>|
What is the study measuring?
-----------------
Primary Outcome Measures
| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| peak aerobic capacity | | 16 weeks |
Secondary Outcome Measures
| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| whole body skeletal muscle and fat mass | magnetic resonance imaging (MRI) using the Dixon method | 16 weeks |
| maximal voluntary strength and muscle fatigability in upper extremity | 1 repetition maximum in the seated chest press exercise | 16 weeks |
| metabolism measures | fasting glucose A1C; insulin sensitivity; lipoprotein particles | 16 weeks |
| Spinal Cord Injury Function Index Computer Adaptive Test (SCI-FI CAT) | self-report function and mobility computer adaptive test | 16 weeks |
| Mood | Patient Health Questionnaire (PHQ-9) | 16 weeks |
| Anxiety | GAD-7 | 16 weeks |
| Satisfaction with Life | Satisfaction with Life Scale (5 item scale) | 16 weeks |
| Safety Assessment | Adverse and Serious Adverse Event recording classified using MEDRA and SOC coding | throughout 16 weeks of subjects participation |
| Loneliness | Three-Item Loneliness Scale | 16 weeks |
|
|
NCT03523936
|
Gut Microbiota and Antibiotics - Prevention of Side Effects by New Prebiotics
|
Antibiotics disturb the balance of gut microbiota causing dysbiosis. The purpose of this double-blind placebo controlled intervention study is to investigate whether a new prebiotic product could prevent the side effects of antibiotics.
|
Thirty children (2-6 years of age), who require antibiotic treatment assessed by a doctor, will be enrolled in the study. The children will be randomized to receive either the prebiotic product or placebo during the course of antibiotic treatment.~The children will give a faecal sample in the beginning and at the end of the study. The samples will be used for the analysis of microbiota and differences in the microbiota between the groups.
|
Gut Microbiota and Antibiotics - Prevention of Side Effects by New Prebiotics
|
Changes in the Gut Microbiota During an Antibiotic Treatment
|
* Dietary Supplement: Prebiotic product
* Dietary Supplement: Placebo
|
Inclusion Criteria:~An infection requiring antibiotic treatment assessed by a doctor~Exclusion Criteria:~Coaeliac disease or allergy to cereals, use of other prebiotic/probiotic product during the study
|
2 Years
|
6 Years
|
All
|
No
|
Primary Purpose: Prevention
Allocation: Randomized
Intervention Model: Parallel Assignment
Interventional Model Description: Double blind placebo controlled trial
Masking: Single
|
| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Changes of gut microbiota during antibiotic treatment | Gut microbiota and antibiotics - Prevention of side effects by new prebiotics | One week |
|
antibiotics, prebiotics, dysbiosis
|
| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: Prebiotic<br> | Dietary Supplement: Prebiotic product<br>* Prebiotic product used during the course of antibiotic treatment<br>|
| Placebo Comparator: Placebo<br> | Dietary Supplement: Placebo<br>* Placebo<br>|
|
Gut Microbiota and Antibiotics - Prevention of Side Effects by New Prebiotics
Study Overview
=================
Brief Summary
-----------------
Antibiotics disturb the balance of gut microbiota causing dysbiosis. The purpose of this double-blind placebo controlled intervention study is to investigate whether a new prebiotic product could prevent the side effects of antibiotics.
Detailed Description
-----------------
Thirty children (2-6 years of age), who require antibiotic treatment assessed by a doctor, will be enrolled in the study. The children will be randomized to receive either the prebiotic product or placebo during the course of antibiotic treatment. The children will give a faecal sample in the beginning and at the end of the study. The samples will be used for the analysis of microbiota and differences in the microbiota between the groups.
Official Title
-----------------
Gut Microbiota and Antibiotics - Prevention of Side Effects by New Prebiotics
Conditions
-----------------
Changes in the Gut Microbiota During an Antibiotic Treatment
Intervention / Treatment
-----------------
* Dietary Supplement: Prebiotic product
* Dietary Supplement: Placebo
Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: An infection requiring antibiotic treatment assessed by a doctor Exclusion Criteria: Coaeliac disease or allergy to cereals, use of other prebiotic/probiotic product during the study
Ages Eligible for Study
-----------------
Minimum Age: 2 Years
Maximum Age: 6 Years
Sexes Eligible for Study
-----------------
All
Accepts Healthy Volunteers
-----------------
No
Study Plan
=================
How is the study designed?
-----------------
Design Details
Primary Purpose: Prevention
Allocation: Randomized
Intervention Model: Parallel Assignment
Interventional Model Description: Double blind placebo controlled trial
Masking: Single
Arms and Interventions
| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: Prebiotic<br> | Dietary Supplement: Prebiotic product<br>* Prebiotic product used during the course of antibiotic treatment<br>|
| Placebo Comparator: Placebo<br> | Dietary Supplement: Placebo<br>* Placebo<br>|
What is the study measuring?
-----------------
Primary Outcome Measures
| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Changes of gut microbiota during antibiotic treatment | Gut microbiota and antibiotics - Prevention of side effects by new prebiotics | One week |
Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
antibiotics, prebiotics, dysbiosis
|
||
NCT01287923
|
Assessment of Blood Biomarkers by DNA Microarrays in Patients With Aggressive Lymphoma BMS_LyTrans
|
Diffuse Large B-cell Lymphoma (DLBCL) is the most frequent high grade lymphoma in adults. Although immunotherapy has improved its prognosis, DLBCL is a heterogeneous disease with patients exhibiting a wide range of outcomes with a 5-year overall survival ranging between 55 to 94% depending of the International Prognostic Index factor. Diagnostic and prognostic biomarkers are mandatory to optimize treatment. Transcriptomics has been used to detect such new biomarkers using microarrays analyses applied to RNA collected from total tumor tissues or cell extracts. Molecular prognostic factors have been thoroughly studied in DLBCL tumor tissues. However, it is a big challenge to obtain transcriptomic-qualified tumor samples in a multicentric and prospective clinical trial. Coordinating nvestigator hypothesized that blood may be a deep source of native and secreted analytes and therefore carries transcriptomic signatures related to DLBCL and its prognosis. This project is organized in the extension of the GOELAMS-075 clinical trial which concerns aggressive DLBCL.
|
Two complementary approaches will be followed, one at the transcriptomic level for confirmation of diagnostic biomarkers and to assess for predictive biomarkers. The other one concern biologic studies to validate our biomarkers at the tissue level. Our project will be organized around 4 workpackages (WP), each of them includes tasks with a specific schedule & predefined deliverables. The first one concerns the general management, data warehouse, collections and different administrative and preanalytic issues. The 3 other WPs are scientific. We are first going to validate a 30-gene list, candidate diagnostic biomarkers, by qRT-PCR on: *) an independent set of DLBCLs compared to matched healthy blood donors (sensitivity assessment) and, **) on a series of low tumor burden DLBCLs, mantle cell lymphomas and non-malignant inflammatory disease constituted by patients with a septic shock (specificity assessment). All this latter collections are already available and ready to use. Secondly, we will complete our series of 89 hybridized patients on AFFY WholeExon microarrays by 60 supplementary and available samples in order to assess for molecular predictor of patient outcome. This question will be address based on the 3-year and 5-year as well, EFS (Event Free Survivor). All the clinical data are available through the GOELAMS eCRF. Since we dispose of a 31 probesets, 30 single genes, signature for the DLBCL diagnosis that involves 9 genes related to the myeloid compartment including 6 genes involved directly or not to the Myeloid-Derived Cell Suppression (MDSC) process, 20 genes described in the context of the cancer and, 11 genes connected to endothelial cells, we decided to explore by flow cytometry blood circulating cells. We will look for myeloid populations & subpopulations, endothelial cells and microparticles. The goal is the identification of specific MDSC perturbations, angiogenic abnormalities and functional impacts on the immune response in the context of the cancer.~We expect by our work to drive both basic science and clinical implications. On the scientific level, blood carries molecular and cellular components involved in tumor-host interactions. Our project should bring a deeper understanding in the immunological response that takes place in the blood compartment. This immunological response will be characterized on a molecular, cellular and functional level. On a clinical point of view, it may bring a new prognostic model in DLBCL. As blood is easily accessible, we expect it to be easily implemented in clinical practice and to allow the design of new clinical trials stratified on tumor biology features. It may also become a new way to monitor DLBCL's response to treatment. Furthermore, this project will provide a large amount of molecular data that can be easily connected with other ongoing GOELAMS studies. Valorisation of our findings will also be serious issue since our project is highly original and valuable.
|
Assessment of Biomarkers Initially Identified in Whole Blood by DNA Microarrays in Patients With Aggressive Lymphoma BMS_LyTrans
|
DLBCL
|
Inclusion Criteria:~DLBCL or Healthy blood donors or septic patient or GOELAMS 075 patients in completed remission~Written informed consent~Exclusion Criteria:~Age < 18 or > 70~Not written informed consent~Not affiliated with social security
|
18 Years
|
70 Years
|
All
|
Accepts Healthy Volunteers
|
| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Research for cancer-related biomarkers | In this project we propose two complementary approaches with a first one orientated to the continuum of our current findings based on genes differentially expressed in blood between DLBCL patients and healthy people and a second one which takes in account the power and originality of our 075 GOELAMS cohort and will be focused on the research of predictive signatures of the DLBCL. We will go beyond the sole transcriptomic approach and also look for relevant cell biology clues. | 3 years |
|
| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Sensitivity & specificity of the identified molecular signature in the DLBCL diagnosis context | Sensitivity & specificity of the identified molecular signature in the DLBCL | 3 years |
| Identify a prognostic whole blood RNA signature related to aggressive DLBCL | Identify a prognostic whole blood RNA signature related to aggressive DLBCL | 3 years |
| Proportion and phenotypic characteristics of circulating cells expressing the previously identified biomarkers at the time of diagnosis of DLBCL | Proportion and phenotypic characteristics of circulating cells expressing the previously identified biomarkers at the time of diagnosis of DLBCL | 3 years |
| Immune functions of these circulating cells expressing the previously identified biomarkers at the time of diagnosis of DLBCL | Immune functions of these circulating cells expressing the previously identified biomarkers at the time of diagnosis of DLBCL | 3 years |
|
Hematology, Secondary lymphoid organs
|
Lymphoma, Aggression, Neoplasms by Histologic Type, Neoplasms, Lymphoproliferative Disorders, Lymphatic Diseases, Immunoproliferative Disorders, Immune System Diseases, Behavioral Symptoms
|
| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| DLBCL<br>DLBCL patients included 075-GOELAMS trial or 075-like patient. | |
| Healthy controls<br>Blood donors from the EFS (French Blood Bank) of Rennes. | |
| Septic patients<br>septic patients included at the Rennes University Hospital. | |
| DLBCL in completed remission<br>DLBCL patients from the 075 GOELAMS study in completed remission. | |
|
Assessment of Blood Biomarkers by DNA Microarrays in Patients With Aggressive Lymphoma BMS_LyTrans
Study Overview
=================
Brief Summary
-----------------
Diffuse Large B-cell Lymphoma (DLBCL) is the most frequent high grade lymphoma in adults. Although immunotherapy has improved its prognosis, DLBCL is a heterogeneous disease with patients exhibiting a wide range of outcomes with a 5-year overall survival ranging between 55 to 94% depending of the International Prognostic Index factor. Diagnostic and prognostic biomarkers are mandatory to optimize treatment. Transcriptomics has been used to detect such new biomarkers using microarrays analyses applied to RNA collected from total tumor tissues or cell extracts. Molecular prognostic factors have been thoroughly studied in DLBCL tumor tissues. However, it is a big challenge to obtain transcriptomic-qualified tumor samples in a multicentric and prospective clinical trial. Coordinating nvestigator hypothesized that blood may be a deep source of native and secreted analytes and therefore carries transcriptomic signatures related to DLBCL and its prognosis. This project is organized in the extension of the GOELAMS-075 clinical trial which concerns aggressive DLBCL.
Detailed Description
-----------------
Two complementary approaches will be followed, one at the transcriptomic level for confirmation of diagnostic biomarkers and to assess for predictive biomarkers. The other one concern biologic studies to validate our biomarkers at the tissue level. Our project will be organized around 4 workpackages (WP), each of them includes tasks with a specific schedule & predefined deliverables. The first one concerns the general management, data warehouse, collections and different administrative and preanalytic issues. The 3 other WPs are scientific. We are first going to validate a 30-gene list, candidate diagnostic biomarkers, by qRT-PCR on: *) an independent set of DLBCLs compared to matched healthy blood donors (sensitivity assessment) and, **) on a series of low tumor burden DLBCLs, mantle cell lymphomas and non-malignant inflammatory disease constituted by patients with a septic shock (specificity assessment). All this latter collections are already available and ready to use. Secondly, we will complete our series of 89 hybridized patients on AFFY WholeExon microarrays by 60 supplementary and available samples in order to assess for molecular predictor of patient outcome. This question will be address based on the 3-year and 5-year as well, EFS (Event Free Survivor). All the clinical data are available through the GOELAMS eCRF. Since we dispose of a 31 probesets, 30 single genes, signature for the DLBCL diagnosis that involves 9 genes related to the myeloid compartment including 6 genes involved directly or not to the Myeloid-Derived Cell Suppression (MDSC) process, 20 genes described in the context of the cancer and, 11 genes connected to endothelial cells, we decided to explore by flow cytometry blood circulating cells. We will look for myeloid populations & subpopulations, endothelial cells and microparticles. The goal is the identification of specific MDSC perturbations, angiogenic abnormalities and functional impacts on the immune response in the context of the cancer. We expect by our work to drive both basic science and clinical implications. On the scientific level, blood carries molecular and cellular components involved in tumor-host interactions. Our project should bring a deeper understanding in the immunological response that takes place in the blood compartment. This immunological response will be characterized on a molecular, cellular and functional level. On a clinical point of view, it may bring a new prognostic model in DLBCL. As blood is easily accessible, we expect it to be easily implemented in clinical practice and to allow the design of new clinical trials stratified on tumor biology features. It may also become a new way to monitor DLBCL's response to treatment. Furthermore, this project will provide a large amount of molecular data that can be easily connected with other ongoing GOELAMS studies. Valorisation of our findings will also be serious issue since our project is highly original and valuable.
Official Title
-----------------
Assessment of Biomarkers Initially Identified in Whole Blood by DNA Microarrays in Patients With Aggressive Lymphoma BMS_LyTrans
Conditions
-----------------
DLBCL
Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: DLBCL or Healthy blood donors or septic patient or GOELAMS 075 patients in completed remission Written informed consent Exclusion Criteria: Age < 18 or > 70 Not written informed consent Not affiliated with social security
Ages Eligible for Study
-----------------
Minimum Age: 18 Years
Maximum Age: 70 Years
Sexes Eligible for Study
-----------------
All
Accepts Healthy Volunteers
-----------------
Accepts Healthy Volunteers
Study Plan
=================
How is the study designed?
-----------------
Arms and Interventions
| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| DLBCL<br>DLBCL patients included 075-GOELAMS trial or 075-like patient. | |
| Healthy controls<br>Blood donors from the EFS (French Blood Bank) of Rennes. | |
| Septic patients<br>septic patients included at the Rennes University Hospital. | |
| DLBCL in completed remission<br>DLBCL patients from the 075 GOELAMS study in completed remission. | |
What is the study measuring?
-----------------
Primary Outcome Measures
| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Research for cancer-related biomarkers | In this project we propose two complementary approaches with a first one orientated to the continuum of our current findings based on genes differentially expressed in blood between DLBCL patients and healthy people and a second one which takes in account the power and originality of our 075 GOELAMS cohort and will be focused on the research of predictive signatures of the DLBCL. We will go beyond the sole transcriptomic approach and also look for relevant cell biology clues. | 3 years |
Secondary Outcome Measures
| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Sensitivity & specificity of the identified molecular signature in the DLBCL diagnosis context | Sensitivity & specificity of the identified molecular signature in the DLBCL | 3 years |
| Identify a prognostic whole blood RNA signature related to aggressive DLBCL | Identify a prognostic whole blood RNA signature related to aggressive DLBCL | 3 years |
| Proportion and phenotypic characteristics of circulating cells expressing the previously identified biomarkers at the time of diagnosis of DLBCL | Proportion and phenotypic characteristics of circulating cells expressing the previously identified biomarkers at the time of diagnosis of DLBCL | 3 years |
| Immune functions of these circulating cells expressing the previously identified biomarkers at the time of diagnosis of DLBCL | Immune functions of these circulating cells expressing the previously identified biomarkers at the time of diagnosis of DLBCL | 3 years |
Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Hematology, Secondary lymphoid organs
|
||
NCT04134143
|
Multiple Applications of ExpressGraft-C9T1 Skin Tissue as a Treatment for Diabetic Foot Ulcers
|
Some people with diabetes get foot ulcers that do not heal. These ulcers can get infected and cause other medical problems.~Five patients with these foot ulcers volunteered to participate in the first part of this study (C9T12015, NCT02657876). They are called Cohort 1 in this registration. Cohort 1 received one application (piece) of an experimental skin tissue to make sure it was safe.~This study will extend the safety test of the experimental skin tissue. It will find out if it is safe to use more than once to cover non-healing ulcers.~This extension will include two more groups, Cohort 2 and Cohort 3. Cohort 2 may get up to 5 applications. Cohort 3 may get up to 10 applications. The number of applications will depend on how well the wound is healing.~Participants will be in the study up to one year.
|
An Open-Label, Prospective, Safety, and Tolerability Study of ExpressGraft- C9T1 Skin Tissue in the Treatment of Diabetic Foot Ulcers
|
Diabetes, Diabetic Foot Ulcer, Non-healing Wound
|
* Biological: ExpressGraft-C9T1 Skin Tissue
|
Volunteers will be consented. Then there will be a run-in period for the doctor to run some tests. If the tests show the study would be good for the patient, the doctor will enroll them as participants in the trial.~Inclusion Criteria:~To be considered for inclusion, a participant:~Agrees to practice birth control for the duration of the study~Has documented Type 1 or Type 2 diabetes and an HbA1C score of 10 or below~Has protocol-defined sufficient blood pressure and flow to the foot~Has stable medications for 2 weeks before treatment (other than diabetes medications or antibiotics)~Is able and willing to attend scheduled visits and comply with study procedures~If a smoker, agrees to try quitting and will accept counseling for it (Cohorts 2 and 3 only)~Has documented informed consent for study enrollment~Has had an uninfected, appropriately-sized diabetic ulcer on the foot for at least 4 weeks but not more than 1 year~Exclusion Criteria:~The doctor may not consider for inclusion a participant who:~Is pregnant, nursing, or a prisoner~Has had osteomyelitis in the foot with the ulcer in the last 30 days~Has a history of poor compliance~Has received drugs or therapies not allowed per protocol~Has used an investigational product within the last 60 days~Has ever received therapy for the study ulcer with any cell and/or tissue product (CTP)~Has a study ulcer in a condition not appropriate for the study~Has a medical condition or history that, per protocol or in the opinion of the study doctor, might put the safety of the participant in danger
|
18 Years
|
80 Years
|
All
|
No
|
Primary Purpose: Treatment
Allocation: Non-Randomized
Intervention Model: Sequential Assignment
Interventional Model Description: Cohort 2 will begin when the study starts, and after the safety monitoring board approves progression to the next cohort, Cohort 3 will begin.
Masking: None (Open Label)
|
| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Number of participants with adverse events at Week 12 | Clinically significant vital signs, infection, blood chemistry, hematology and immunological evaluations are recorded as adverse events | at Week 12 |
| Number of participants with adverse events through study completion | Clinically significant vital signs, infection, blood chemistry, hematology and immunological evaluations are recorded as adverse events | at approximately 12 months |
|
Diabetic Foot, Foot Ulcer, Ulcer, Pathologic Processes, Diabetic Angiopathies, Vascular Diseases, Cardiovascular Diseases, Leg Ulcer, Skin Ulcer, Skin Diseases, Diabetes Complications, Diabetes Mellitus, Endocrine System Diseases, Diabetic Neuropathies, Foot Diseases
|
| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Cohort 1: One Application<br>Participants enrolled in Cohort 1 received one application of experimental skin tissue during the first part of this trial (NCT02657876) | Biological: ExpressGraft-C9T1 Skin Tissue<br>* A round patch of experimental skin tissue that the doctor applies over the ulcer<br>* Other names: Experimental skin tissue;|
| Experimental: Cohort 2: Up to Five Applications<br>Participants enrolled in Cohort 2 may receive up to 5 applications of experimental skin tissue as required for wound healing | Biological: ExpressGraft-C9T1 Skin Tissue<br>* A round patch of experimental skin tissue that the doctor applies over the ulcer<br>* Other names: Experimental skin tissue;|
| Experimental: Cohort 3: Up to Ten Applications<br>Participants enrolled in Cohort 3 may receive up to 10 applications of experimental skin tissue as required for wound healing | Biological: ExpressGraft-C9T1 Skin Tissue<br>* A round patch of experimental skin tissue that the doctor applies over the ulcer<br>* Other names: Experimental skin tissue;|
|
Multiple Applications of ExpressGraft-C9T1 Skin Tissue as a Treatment for Diabetic Foot Ulcers
Study Overview
=================
Brief Summary
-----------------
Some people with diabetes get foot ulcers that do not heal. These ulcers can get infected and cause other medical problems. Five patients with these foot ulcers volunteered to participate in the first part of this study (C9T12015, NCT02657876). They are called Cohort 1 in this registration. Cohort 1 received one application (piece) of an experimental skin tissue to make sure it was safe. This study will extend the safety test of the experimental skin tissue. It will find out if it is safe to use more than once to cover non-healing ulcers. This extension will include two more groups, Cohort 2 and Cohort 3. Cohort 2 may get up to 5 applications. Cohort 3 may get up to 10 applications. The number of applications will depend on how well the wound is healing. Participants will be in the study up to one year.
Official Title
-----------------
An Open-Label, Prospective, Safety, and Tolerability Study of ExpressGraft- C9T1 Skin Tissue in the Treatment of Diabetic Foot Ulcers
Conditions
-----------------
Diabetes, Diabetic Foot Ulcer, Non-healing Wound
Intervention / Treatment
-----------------
* Biological: ExpressGraft-C9T1 Skin Tissue
Participation Criteria
=================
Eligibility Criteria
-----------------
Volunteers will be consented. Then there will be a run-in period for the doctor to run some tests. If the tests show the study would be good for the patient, the doctor will enroll them as participants in the trial. Inclusion Criteria: To be considered for inclusion, a participant: Agrees to practice birth control for the duration of the study Has documented Type 1 or Type 2 diabetes and an HbA1C score of 10 or below Has protocol-defined sufficient blood pressure and flow to the foot Has stable medications for 2 weeks before treatment (other than diabetes medications or antibiotics) Is able and willing to attend scheduled visits and comply with study procedures If a smoker, agrees to try quitting and will accept counseling for it (Cohorts 2 and 3 only) Has documented informed consent for study enrollment Has had an uninfected, appropriately-sized diabetic ulcer on the foot for at least 4 weeks but not more than 1 year Exclusion Criteria: The doctor may not consider for inclusion a participant who: Is pregnant, nursing, or a prisoner Has had osteomyelitis in the foot with the ulcer in the last 30 days Has a history of poor compliance Has received drugs or therapies not allowed per protocol Has used an investigational product within the last 60 days Has ever received therapy for the study ulcer with any cell and/or tissue product (CTP) Has a study ulcer in a condition not appropriate for the study Has a medical condition or history that, per protocol or in the opinion of the study doctor, might put the safety of the participant in danger
Ages Eligible for Study
-----------------
Minimum Age: 18 Years
Maximum Age: 80 Years
Sexes Eligible for Study
-----------------
All
Accepts Healthy Volunteers
-----------------
No
Study Plan
=================
How is the study designed?
-----------------
Design Details
Primary Purpose: Treatment
Allocation: Non-Randomized
Intervention Model: Sequential Assignment
Interventional Model Description: Cohort 2 will begin when the study starts, and after the safety monitoring board approves progression to the next cohort, Cohort 3 will begin.
Masking: None (Open Label)
Arms and Interventions
| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Cohort 1: One Application<br>Participants enrolled in Cohort 1 received one application of experimental skin tissue during the first part of this trial (NCT02657876) | Biological: ExpressGraft-C9T1 Skin Tissue<br>* A round patch of experimental skin tissue that the doctor applies over the ulcer<br>* Other names: Experimental skin tissue;|
| Experimental: Cohort 2: Up to Five Applications<br>Participants enrolled in Cohort 2 may receive up to 5 applications of experimental skin tissue as required for wound healing | Biological: ExpressGraft-C9T1 Skin Tissue<br>* A round patch of experimental skin tissue that the doctor applies over the ulcer<br>* Other names: Experimental skin tissue;|
| Experimental: Cohort 3: Up to Ten Applications<br>Participants enrolled in Cohort 3 may receive up to 10 applications of experimental skin tissue as required for wound healing | Biological: ExpressGraft-C9T1 Skin Tissue<br>* A round patch of experimental skin tissue that the doctor applies over the ulcer<br>* Other names: Experimental skin tissue;|
What is the study measuring?
-----------------
Primary Outcome Measures
| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Number of participants with adverse events at Week 12 | Clinically significant vital signs, infection, blood chemistry, hematology and immunological evaluations are recorded as adverse events | at Week 12 |
| Number of participants with adverse events through study completion | Clinically significant vital signs, infection, blood chemistry, hematology and immunological evaluations are recorded as adverse events | at approximately 12 months |
|
|||
NCT05510479
|
Post-market Evaluation of OdySight App to Monitor Near Visual Acuity at Home (TIL002)
|
OdySight is a mobile application allowing self-testing of visual parameters including near visual acuity and communication of the data to an online dashboard to patient's doctors. TIL-002 post-market clinical trial objective is to evaluate the near visual acuity at home, measured with OdySight application in comparison to the standardized methods. The clinical trial is intended to prove that OdySight can provide relevant data and participate in the remote monitoring of subject vision.
|
Post-market Study for At-home Evaluation of Near Visual Acuity With OdySight, a Smartphone Based Medical Application in Comparison to a Standardized Method (TIL002)
|
Visual Impairment
|
* Other: Software as medical device
|
Inclusion Criteria:~General inclusion criteria:~Age ≥ 18 years, all genders~Affiliated to or beneficiary of the French health care system~Signed/written informed consent~Already user of Odysight on a compatible smartphone/tablet~Patients willing and able to comply with all study and follow-up procedure~Ophthalmic inclusion criterion:~Baseline binocular visual acuity with habitual correction ≥ 20/63 (3/10) AND with at least an eye ≥ 20/200 (1/10).~Exclusion Criteria:~General exclusion criteria:~Any pathology that is considered by the investigator as capable of affecting the quality of the main evaluation criteria.~Any planned surgery likely to modify patient refraction during the study (cataract surgery for example)~Subject not considered by the investigator or designee to correctly use ODYSIGHT modules~Subject unable to recognize alphabet letters or unable to correctly distinguish body laterality~Not French speaking patient~Epileptic users
|
18 Years
| null |
All
|
Accepts Healthy Volunteers
|
| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Equivalence between OdySight and standardized methods - Near Visual Acuity | To assess the equivalence between a smartphone based evaluation of near visual acuity with ODYSIGHT at home and standardized methods (Sloan ETDRS near vision letter chart and Landolt C near vision chart) performed in clinic. | 2 months |
|
| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Equivalence between OdySight and standardized methods - 4-meter distance Visual Acuity | ETDRS visual acuity at a 4-meter distance at clinic and near visual acuity evaluated with ODYSIGHT at home. | 2 months |
|
Visual acuity, Digital therapeutics, Medical software, ETDRS, Macular Edema, Age-related Macular Degeneration
|
Vision Disorders, Vision, Low, Sensation Disorders, Neurologic Manifestations, Nervous System Diseases, Eye Diseases
|
| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| OdySight vs Standardized methods<br>All patients perform Visual Acuity testing through OdySight and according to standard practice | Other: Software as medical device<br>* At home measurements of visual acuity through a mobile app<br>|
|
Post-market Evaluation of OdySight App to Monitor Near Visual Acuity at Home (TIL002)
Study Overview
=================
Brief Summary
-----------------
OdySight is a mobile application allowing self-testing of visual parameters including near visual acuity and communication of the data to an online dashboard to patient's doctors. TIL-002 post-market clinical trial objective is to evaluate the near visual acuity at home, measured with OdySight application in comparison to the standardized methods. The clinical trial is intended to prove that OdySight can provide relevant data and participate in the remote monitoring of subject vision.
Official Title
-----------------
Post-market Study for At-home Evaluation of Near Visual Acuity With OdySight, a Smartphone Based Medical Application in Comparison to a Standardized Method (TIL002)
Conditions
-----------------
Visual Impairment
Intervention / Treatment
-----------------
* Other: Software as medical device
Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: General inclusion criteria: Age ≥ 18 years, all genders Affiliated to or beneficiary of the French health care system Signed/written informed consent Already user of Odysight on a compatible smartphone/tablet Patients willing and able to comply with all study and follow-up procedure Ophthalmic inclusion criterion: Baseline binocular visual acuity with habitual correction ≥ 20/63 (3/10) AND with at least an eye ≥ 20/200 (1/10). Exclusion Criteria: General exclusion criteria: Any pathology that is considered by the investigator as capable of affecting the quality of the main evaluation criteria. Any planned surgery likely to modify patient refraction during the study (cataract surgery for example) Subject not considered by the investigator or designee to correctly use ODYSIGHT modules Subject unable to recognize alphabet letters or unable to correctly distinguish body laterality Not French speaking patient Epileptic users
Ages Eligible for Study
-----------------
Minimum Age: 18 Years
Sexes Eligible for Study
-----------------
All
Accepts Healthy Volunteers
-----------------
Accepts Healthy Volunteers
Study Plan
=================
How is the study designed?
-----------------
Arms and Interventions
| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| OdySight vs Standardized methods<br>All patients perform Visual Acuity testing through OdySight and according to standard practice | Other: Software as medical device<br>* At home measurements of visual acuity through a mobile app<br>|
What is the study measuring?
-----------------
Primary Outcome Measures
| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Equivalence between OdySight and standardized methods - Near Visual Acuity | To assess the equivalence between a smartphone based evaluation of near visual acuity with ODYSIGHT at home and standardized methods (Sloan ETDRS near vision letter chart and Landolt C near vision chart) performed in clinic. | 2 months |
Secondary Outcome Measures
| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Equivalence between OdySight and standardized methods - 4-meter distance Visual Acuity | ETDRS visual acuity at a 4-meter distance at clinic and near visual acuity evaluated with ODYSIGHT at home. | 2 months |
Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Visual acuity, Digital therapeutics, Medical software, ETDRS, Macular Edema, Age-related Macular Degeneration
|
||
NCT00529243
|
Evaluating the Effect of CHanging EnfuvirtidE to Raltegravir in HIV Infected Subjects
|
The primary objective of this study is:~To assess the virologic effect of changing enfuvirtide to MK-0518(raltegravir) in human immunodeficiency virus type 1(HIV-1) infected patients who have an undetectable level of serum human immunodeficiency virus(HIV) (< 75 copies/ml by branch deoxyribonucleic acid (bDNA) assay, < 50 copies/ml by Ultrasensitive Polymerase Chain Reaction(PCR) assay) on their current HIV medication regimen.~Hypothesis:~HIV-1 infected individuals well controlled on an enfuvirtide containing regimen with HIV RNA levels below limits of quantification can safely have the investigational integrase inhibitor, MK-0518 substituted for enfuvirtide without loss of virologic suppression.
|
Human immunodeficiency virus type 1(HIV-1) infected patients who have had an undetectable viral load on an enfuvirtide containing regimen at the Kaiser Permanente Hayward, Los Angeles, San Francisco, and Santa Clara Medical Centers will be enrolled. Patients will receive open label MK-0518 (raltegravir) 400mg orally twice a day as substitution for enfuvirtide for 24 weeks.
|
Virologic Outcomes of Changing Enfuvirtide to Raltegravir in HIV-1 Patients Well Controlled on an Enfuvirtide Based Regimen
|
HIV Infections
|
* Drug: raltegravir
|
Inclusion Criteria:~Patients must meet all of the following inclusion criteria to be eligible for participation in this study.~Subject is ≥ 18 years of age and able to understand and willing to sign a written informed consent form, which must be obtained prior to initiation of the study.~Documented laboratory diagnosis of HIV-1 infection (positive Enzyme-linked immunosorbent assay (ELISA) HIV-1 antibody test confirmed by western blot, p24 assay, HIV-1 RNA, or culture).~Have documented plasma HIV-1 RNA level(s) of < 75 copies/ml by branched deoxyribonucleic acid(bDNA) assay, or < 50 copies/ml by Ultrasensitive Polymerase Chain Reaction(PCR) for at least 6 months prior to screening visit.~Currently receiving a stable antiretroviral regimen consisting of enfuvirtide plus at least 2 other antiretrovirals for at least 6 months.~Negative serum pregnancy test (females of childbearing potential only) and are willing to use an adequate method of contraception throughout the duration of the study.~Exclusion Criteria:~Patients who meet any of the following exclusion criteria are not to be enrolled in this study.~Any prior therapy with MK-0518 or any other HIV-1 integrase inhibitor.~Any HIV-1 viral load > 75 copies/ml by bDNA assay, or > 50 copies/ml by Ultrasensitive PCR assay in the 6 months prior to screening visit (A single blip of HIV-1 viral load >75 copies but <400 copies by bDNA assay, or >50 copies but <400 copies by Ultrasensitive PCR assay in the six months prior to screening visit with at least one subsequent HIV-1 viral load below the limit of detection will be accepted.)~Any previous known hypersensitivity to components of the study drug formulation.~Weight < 40 kilograms.~Patient requires or is anticipated to require any of the prohibited medications noted in the protocol.~Acute therapy for serious illness (in the opinion of the investigator) within 14 days prior to study entry unless the subject has completed ≥ 7 days of therapy and is considered clinically stable by the investigator.~Any condition which, in the opinion of the investigator, would compromise the subject's ability to participate in the study.~Any active opportunistic infections or Centers for Disease Control and Prevention (CDC) Category C conditions (with the exception of stable cutaneous Kaposi's Sarcoma and wasting syndrome due to HIV infection).~Any malignancy requiring chemotherapy.~Subject has any of the following laboratory results at screening:~Hemoglobin < 8.0 gr/dl Absolute neutrophil count < 750 cells/ml Platelet count < 40,000 Creatinine > 2.0 or calculated creatinine clearance < 40 ml/min~Female patient who is pregnant or breast-feeding, or expecting to conceive or donate eggs during the study. Male patient who is planning to impregnate or provide sperm donation during the study.
|
18 Years
| null |
All
|
No
|
Primary Purpose: Treatment
Intervention Model: Single Group Assignment
Masking: None (Open Label)
|
| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Number of Patients With Undetectable Human Immunodeficiency Virus (HIV) Viral Load at Week 24. | To assess the virologic effect of changing enfuvirtide to MK-0518 (raltegravir) in human immunodeficiency virus type 1 (HIV-1) infected patients who have an undetectable level of serum HIV (undetectable level of serum HIV defined as < 75 copies/ml by bDNA assay or < 50 copies/ml by Ultrasensitive PCR assay) on their current HIV medication regimen. | 24 Weeks |
|
| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Average Change in Cluster of Differentiation 4(CD4) Cell Count From Baseline at Week 24 | To study the immunologic effect of changing enfuvirtide to MK-0518 (raltegravir) in HIV-1 infected patients who have an undetectable level of serum HIV (undetectable serum HIV defined as < 75 copies/ml by bDNA assay or < 50 copies/ml by Ultrasensitive PCR assay)on their current HIV medication regimen. | 24 Weeks |
|
Treatment Experience, On enfuvirtide
|
Raltegravir Potassium, Anti-HIV Agents, Anti-Retroviral Agents, Antiviral Agents, Anti-Infective Agents, HIV Integrase Inhibitors, Integrase Inhibitors, Enzyme Inhibitors, Molecular Mechanisms of Pharmacological Action
|
| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: MK-0518 (raltegravir)<br>Open label, single arm. All patients to receive MK-0518 400mg orally twice a day for 24 weeks, as substitution for enfuvirtide. | Drug: raltegravir<br>* This is a single-arm, open-label, non-randomized pilot study in human immunodeficiency virus type 1 (HIV-1) positive patients who have an undetectable viral load on their current enfuvirtide containing medication regimen. The treatment regimen will consist of replacing enfuvirtide with MK-0518 400 mg twice a day given as part of the patient's HIV medication regimen. The study regimen will be administered for 24 weeks, with patients given the option of continuing on the study medication past that time if they wish to. Patients serve as their own control as they have viral control (HIV ribonucleic acid (RNA) below limits of quantification) for at least 6 months with enfuvirtide prior to switch to raltegravir.<br>* Other names: MK-0518, Isentress;|
|
Evaluating the Effect of CHanging EnfuvirtidE to Raltegravir in HIV Infected Subjects
Study Overview
=================
Brief Summary
-----------------
The primary objective of this study is: To assess the virologic effect of changing enfuvirtide to MK-0518(raltegravir) in human immunodeficiency virus type 1(HIV-1) infected patients who have an undetectable level of serum human immunodeficiency virus(HIV) (< 75 copies/ml by branch deoxyribonucleic acid (bDNA) assay, < 50 copies/ml by Ultrasensitive Polymerase Chain Reaction(PCR) assay) on their current HIV medication regimen. Hypothesis: HIV-1 infected individuals well controlled on an enfuvirtide containing regimen with HIV RNA levels below limits of quantification can safely have the investigational integrase inhibitor, MK-0518 substituted for enfuvirtide without loss of virologic suppression.
Detailed Description
-----------------
Human immunodeficiency virus type 1(HIV-1) infected patients who have had an undetectable viral load on an enfuvirtide containing regimen at the Kaiser Permanente Hayward, Los Angeles, San Francisco, and Santa Clara Medical Centers will be enrolled. Patients will receive open label MK-0518 (raltegravir) 400mg orally twice a day as substitution for enfuvirtide for 24 weeks.
Official Title
-----------------
Virologic Outcomes of Changing Enfuvirtide to Raltegravir in HIV-1 Patients Well Controlled on an Enfuvirtide Based Regimen
Conditions
-----------------
HIV Infections
Intervention / Treatment
-----------------
* Drug: raltegravir
Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Patients must meet all of the following inclusion criteria to be eligible for participation in this study. Subject is ≥ 18 years of age and able to understand and willing to sign a written informed consent form, which must be obtained prior to initiation of the study. Documented laboratory diagnosis of HIV-1 infection (positive Enzyme-linked immunosorbent assay (ELISA) HIV-1 antibody test confirmed by western blot, p24 assay, HIV-1 RNA, or culture). Have documented plasma HIV-1 RNA level(s) of < 75 copies/ml by branched deoxyribonucleic acid(bDNA) assay, or < 50 copies/ml by Ultrasensitive Polymerase Chain Reaction(PCR) for at least 6 months prior to screening visit. Currently receiving a stable antiretroviral regimen consisting of enfuvirtide plus at least 2 other antiretrovirals for at least 6 months. Negative serum pregnancy test (females of childbearing potential only) and are willing to use an adequate method of contraception throughout the duration of the study. Exclusion Criteria: Patients who meet any of the following exclusion criteria are not to be enrolled in this study. Any prior therapy with MK-0518 or any other HIV-1 integrase inhibitor. Any HIV-1 viral load > 75 copies/ml by bDNA assay, or > 50 copies/ml by Ultrasensitive PCR assay in the 6 months prior to screening visit (A single blip of HIV-1 viral load >75 copies but <400 copies by bDNA assay, or >50 copies but <400 copies by Ultrasensitive PCR assay in the six months prior to screening visit with at least one subsequent HIV-1 viral load below the limit of detection will be accepted.) Any previous known hypersensitivity to components of the study drug formulation. Weight < 40 kilograms. Patient requires or is anticipated to require any of the prohibited medications noted in the protocol. Acute therapy for serious illness (in the opinion of the investigator) within 14 days prior to study entry unless the subject has completed ≥ 7 days of therapy and is considered clinically stable by the investigator. Any condition which, in the opinion of the investigator, would compromise the subject's ability to participate in the study. Any active opportunistic infections or Centers for Disease Control and Prevention (CDC) Category C conditions (with the exception of stable cutaneous Kaposi's Sarcoma and wasting syndrome due to HIV infection). Any malignancy requiring chemotherapy. Subject has any of the following laboratory results at screening: Hemoglobin < 8.0 gr/dl Absolute neutrophil count < 750 cells/ml Platelet count < 40,000 Creatinine > 2.0 or calculated creatinine clearance < 40 ml/min Female patient who is pregnant or breast-feeding, or expecting to conceive or donate eggs during the study. Male patient who is planning to impregnate or provide sperm donation during the study.
Ages Eligible for Study
-----------------
Minimum Age: 18 Years
Sexes Eligible for Study
-----------------
All
Accepts Healthy Volunteers
-----------------
No
Study Plan
=================
How is the study designed?
-----------------
Design Details
Primary Purpose: Treatment
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Arms and Interventions
| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: MK-0518 (raltegravir)<br>Open label, single arm. All patients to receive MK-0518 400mg orally twice a day for 24 weeks, as substitution for enfuvirtide. | Drug: raltegravir<br>* This is a single-arm, open-label, non-randomized pilot study in human immunodeficiency virus type 1 (HIV-1) positive patients who have an undetectable viral load on their current enfuvirtide containing medication regimen. The treatment regimen will consist of replacing enfuvirtide with MK-0518 400 mg twice a day given as part of the patient's HIV medication regimen. The study regimen will be administered for 24 weeks, with patients given the option of continuing on the study medication past that time if they wish to. Patients serve as their own control as they have viral control (HIV ribonucleic acid (RNA) below limits of quantification) for at least 6 months with enfuvirtide prior to switch to raltegravir.<br>* Other names: MK-0518, Isentress;|
What is the study measuring?
-----------------
Primary Outcome Measures
| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Number of Patients With Undetectable Human Immunodeficiency Virus (HIV) Viral Load at Week 24. | To assess the virologic effect of changing enfuvirtide to MK-0518 (raltegravir) in human immunodeficiency virus type 1 (HIV-1) infected patients who have an undetectable level of serum HIV (undetectable level of serum HIV defined as < 75 copies/ml by bDNA assay or < 50 copies/ml by Ultrasensitive PCR assay) on their current HIV medication regimen. | 24 Weeks |
Secondary Outcome Measures
| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Average Change in Cluster of Differentiation 4(CD4) Cell Count From Baseline at Week 24 | To study the immunologic effect of changing enfuvirtide to MK-0518 (raltegravir) in HIV-1 infected patients who have an undetectable level of serum HIV (undetectable serum HIV defined as < 75 copies/ml by bDNA assay or < 50 copies/ml by Ultrasensitive PCR assay)on their current HIV medication regimen. | 24 Weeks |
Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Treatment Experience, On enfuvirtide
|
NCT05244694
|
Impact of Insulin on Sympathetic Nervous System-mediated Peripheral Vasoconstriction
|
The purpose of this project is to determine if hyperinsulinemia attenuates sympathetic nervous system-mediated vasoconstriction in the human leg.
|
Impact of Insulin on Sympathetic Nervous System-mediated Peripheral Vasoconstriction
|
Vasoconstriction, Healthy, Insulin Resistance
|
* Drug: Insulin
|
Inclusion Criteria:~healthy adult men and women;~18-45 years of age;~BMI 18-30 kg/m2;~non-pregnant/non-breastfeeding;~non-nicotine users;~Exclusion Criteria:~taking any medications known to affect metabolic, respiratory, cardiovascular, and/or autonomic functions~Self-reported history of:~hepatic, renal, pulmonary, cardiovascular, or neurological disease;~stroke or neurovascular disease;~bleeding/clotting disorders;~sleep apnea or other sleep disorders;~diabetes;~smoking;~history of alcoholism or substance abuse, excessive alcohol consumption;~hypertension;~active cancer;~autoimmune disease;~immunosuppressant therapy
|
18 Years
|
45 Years
|
All
|
Accepts Healthy Volunteers
|
Primary Purpose: Basic Science
Intervention Model: Single Group Assignment
Masking: None (Open Label)
|
| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Amount of leg blood flow | Measured with Doppler ultrasound (mL/min) | Change from baseline at minute 60 |
|
| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Amount of muscle sympathetic nerve activity (MSNA) | MSNA burst incidence (bursts/100 heart beats) | Change from baseline at minute 60 |
| Amount of cerebral blood flow | Measured with trans-cranial Doppler ultrasound (cm/s) | Change from baseline at minute 60 |
|
Insulin, Hypoglycemic Agents, Physiological Effects of Drugs
|
| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Insulin<br>Participants will complete a 60 minute hyperinsulinemic-euglycemic infusion. | Drug: Insulin<br>* Priming dose then a constant infusion at 40 mU•m-2•min-1<br>|
|
Impact of Insulin on Sympathetic Nervous System-mediated Peripheral Vasoconstriction
Study Overview
=================
Brief Summary
-----------------
The purpose of this project is to determine if hyperinsulinemia attenuates sympathetic nervous system-mediated vasoconstriction in the human leg.
Official Title
-----------------
Impact of Insulin on Sympathetic Nervous System-mediated Peripheral Vasoconstriction
Conditions
-----------------
Vasoconstriction, Healthy, Insulin Resistance
Intervention / Treatment
-----------------
* Drug: Insulin
Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: healthy adult men and women; 18-45 years of age; BMI 18-30 kg/m2; non-pregnant/non-breastfeeding; non-nicotine users; Exclusion Criteria: taking any medications known to affect metabolic, respiratory, cardiovascular, and/or autonomic functions Self-reported history of: hepatic, renal, pulmonary, cardiovascular, or neurological disease; stroke or neurovascular disease; bleeding/clotting disorders; sleep apnea or other sleep disorders; diabetes; smoking; history of alcoholism or substance abuse, excessive alcohol consumption; hypertension; active cancer; autoimmune disease; immunosuppressant therapy
Ages Eligible for Study
-----------------
Minimum Age: 18 Years
Maximum Age: 45 Years
Sexes Eligible for Study
-----------------
All
Accepts Healthy Volunteers
-----------------
Accepts Healthy Volunteers
Study Plan
=================
How is the study designed?
-----------------
Design Details
Primary Purpose: Basic Science
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Arms and Interventions
| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Insulin<br>Participants will complete a 60 minute hyperinsulinemic-euglycemic infusion. | Drug: Insulin<br>* Priming dose then a constant infusion at 40 mU•m-2•min-1<br>|
What is the study measuring?
-----------------
Primary Outcome Measures
| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Amount of leg blood flow | Measured with Doppler ultrasound (mL/min) | Change from baseline at minute 60 |
Secondary Outcome Measures
| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Amount of muscle sympathetic nerve activity (MSNA) | MSNA burst incidence (bursts/100 heart beats) | Change from baseline at minute 60 |
| Amount of cerebral blood flow | Measured with trans-cranial Doppler ultrasound (cm/s) | Change from baseline at minute 60 |
|
||
NCT05017376
|
Evaluating the Effect of Optical Zones on Correction for SMILE: Vector Analysis
|
Evaluate the effect of the size of optical zones (OZ) on myopia and astigmatism correction in small incision lenticular extraction.
|
To retrospectively study whether different surgical optical zone sizes affect the correction of diopter and astigmatism in myopia patients. Divided into 2 groups according to the diameter of the optical zone. The vector analysis method was used to analyze the changes and errors of astigmatism in TR and SIR after operation. Generalized Estimation Equation (GEE) model is used for multiple regression analysis to evaluate the potential factors related to the error value.
|
Evaluating the Effect of Optical Zones on Myopia and Astigmatism Correction in SMILE: Vector Analysis
|
Myopia
|
* Procedure: small incision lenticular extraction
|
Inclusion Criteria:~no ocular conditions~normal topography~central corneal thickness, >500µm~residual stromal thickness, >280 µm~pupil diameter, 2.78-4.9 mm (average, 3.76±0.43 mm);~Exclusion Criteria:~history of intraocular surgery~pupil diameter, >4.9 mm or <2.78mm~keratoconus or corneal ectasia
|
18 Years
|
45 Years
|
All
|
No
|
| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| astigmatic changes | Observe the effect on changes in astigmatism by target induced astigmatism (TIA) versus surgically induced astigmatism (SIA) | 2021.03 |
| error value | Target refraction (TR) and surgically induced refraction (SIR) under different optical zones | 2021.04 |
|
small incision lenticule extraction, vector analysis
|
Myopia, Refractive Errors, Eye Diseases
|
| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| group A<br>small optical zone | Procedure: small incision lenticular extraction<br>* In patients with the same degree of myopia, different optical zones were designed for operation<br>|
| group B<br>large optical zone | Procedure: small incision lenticular extraction<br>* In patients with the same degree of myopia, different optical zones were designed for operation<br>|
|
Evaluating the Effect of Optical Zones on Correction for SMILE: Vector Analysis
Study Overview
=================
Brief Summary
-----------------
Evaluate the effect of the size of optical zones (OZ) on myopia and astigmatism correction in small incision lenticular extraction.
Detailed Description
-----------------
To retrospectively study whether different surgical optical zone sizes affect the correction of diopter and astigmatism in myopia patients. Divided into 2 groups according to the diameter of the optical zone. The vector analysis method was used to analyze the changes and errors of astigmatism in TR and SIR after operation. Generalized Estimation Equation (GEE) model is used for multiple regression analysis to evaluate the potential factors related to the error value.
Official Title
-----------------
Evaluating the Effect of Optical Zones on Myopia and Astigmatism Correction in SMILE: Vector Analysis
Conditions
-----------------
Myopia
Intervention / Treatment
-----------------
* Procedure: small incision lenticular extraction
Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: no ocular conditions normal topography central corneal thickness, >500µm residual stromal thickness, >280 µm pupil diameter, 2.78-4.9 mm (average, 3.76±0.43 mm); Exclusion Criteria: history of intraocular surgery pupil diameter, >4.9 mm or <2.78mm keratoconus or corneal ectasia
Ages Eligible for Study
-----------------
Minimum Age: 18 Years
Maximum Age: 45 Years
Sexes Eligible for Study
-----------------
All
Accepts Healthy Volunteers
-----------------
No
Study Plan
=================
How is the study designed?
-----------------
Arms and Interventions
| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| group A<br>small optical zone | Procedure: small incision lenticular extraction<br>* In patients with the same degree of myopia, different optical zones were designed for operation<br>|
| group B<br>large optical zone | Procedure: small incision lenticular extraction<br>* In patients with the same degree of myopia, different optical zones were designed for operation<br>|
What is the study measuring?
-----------------
Primary Outcome Measures
| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| astigmatic changes | Observe the effect on changes in astigmatism by target induced astigmatism (TIA) versus surgically induced astigmatism (SIA) | 2021.03 |
| error value | Target refraction (TR) and surgically induced refraction (SIR) under different optical zones | 2021.04 |
Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
small incision lenticule extraction, vector analysis
|
||
NCT02360995
|
The Clinical Investigation of Toothpaste as Compared to Toothpaste and Mouthwash in Reducing Plaque and Gingivitis: A Six-week Clinical Study in the US
|
The objective of this clinical research study is to evaluate clinical efficacy of Colgate Total Toothpaste as compared to Crest Pro-Health Toothpaste and Crest Pro-Health Mouthwash, and Crest Cavity Protection Toothpaste and Crest Fluoride Mouthwash in reducing gingivitis and dental plaque in adults in a six-week clinical study.
|
The Clinical Investigation of Colgate Total Toothpaste as Compared to Crest Pro-Health Toothpaste and Crest Pro-Health Mouthwash, and Crest Cavity Protection Toothpaste and Crest Fluoride Mouthwash in Reducing Plaque and Gingivitis: A Six-week Clinical Study in the US
|
Dental Plaque, Gingivitis
|
* Drug: Triclosan/fluoride toothpaste
* Drug: stannous fluoride toothpaste
* Drug: fluoride toothpaste
* Drug: Fluoride Mouthwash
* Drug: cetylpyridinium chloride Mouthwash
|
Inclusion Criteria:~Subjects, ages 18-70, inclusive.~Availability for the six-week duration of the clinical research study.~Good general health.~Minimum of 20 uncrowned permanent natural teeth (excluding third molars).~Initial gingivitis index of at least 1.0 as determined by the use of the Loe and Silness Gingival Index.~Initial plaque index of at least 1.5 as determined by the use of the Quigley and Hein Plaque Index (Turesky Modification).~Signed Informed Consent Form~Exclusion Criteria:~Presence of orthodontic bands.~Presence of partial removable dentures.~Tumor(s) of the soft or hard tissues of the oral cavity.~Advanced periodontal disease (purulent exudate, tooth mobility, and/or extensive loss of periodontal attachment or alveolar bone).~Five or more carious lesions requiring immediate restorative treatment.~Antibiotic use any time during the one month prior to entry into the study.~Participation in any other clinical study or test panel within the one month prior to entry into the study.~Dental prophylaxis during the past two weeks prior to baseline examinations.~History of allergies to oral care/personal care consumer products or their ingredients.~On any prescription medicines that might interfere with the study outcome.~An existing medical condition which prohibits eating or drinking for periods up to 4 hours.~History of alcohol or drug abuse.~Pregnant or lactating subjects.
|
18 Years
|
70 Years
|
All
|
Accepts Healthy Volunteers
|
Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Triple
|
| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Dental Plaque Scores | Dental Plaque (Quigley-Hein, Turesky Modification Index) Units on a scale 0 to 5 (0 = no plaque, 1 = separate flecks of plaque on the tooth, 2 = a thin continuous band of plaque, 3 = a band of plaque up to one-third of the tooth, 4 = plaque covering up to two thirds of the of the tooth, 5 = plaque covering two-thirds or more of the crown of the tooth) | Baseline |
| Dental Plaque Scores | Dental Plaque (Quigley-Hein, Turesky Modification Index) Units on a scale 0 to 5 (0 = no plaque, 1 = separate flecks of plaque on the tooth, 2 = a thin continuous band of plaque, 3 = a band of plaque up to one-third of the tooth, 4 = plaque covering up to two thirds of the of the tooth, 5 = plaque covering two-thirds or more of the crown of the tooth) | 4 weeks |
| Dental Plaque Scores | Dental Plaque (Quigley-Hein, Turesky Modification Index) Units on a scale 0 to 5 (0 = no plaque, 1 = separate flecks of plaque on the tooth, 2 = a thin continuous band of plaque, 3 = a band of plaque up to one-third of the tooth, 4 = plaque covering up to two thirds of the of the tooth, 5 = plaque covering two-thirds or more of the crown of the tooth) | 6 weeks |
| Gingivitis Scores | Gingivitis scale (Loe & Silness Gingival Index) Units on a scale 0 to 3 (0 = no inflammation, 1 = Mild inflammation-slight change in color and little change in texture 2 = Moderate inflammation-moderate glazing, redness, edema and hypertrophy. Tendency to bleed upon probing. 3 = Severe inflammation-marked redness and hypertrophy. Tendency to spontaneous bleeding) | Baseline |
| Gingivitis Scores | Gingivitis scale (Loe & Silness Gingival Index) Units on a scale 0 to 3 (0 = no inflammation, 1 = Mild inflammation-slight change in color and little change in texture 2 = Moderate inflammation-moderate glazing, redness, edema and hypertrophy. Tendency to bleed upon probing. 3 = Severe inflammation-marked redness and hypertrophy. Tendency to spontaneous bleeding) | 4 weeks |
| Gingivitis Scores | Gingivitis scale (Loe & Silness Gingival Index) Units on a scale 0 to 3 (0 = no inflammation, 1 = Mild inflammation-slight change in color and little change in texture 2 = Moderate inflammation-moderate glazing, redness, edema and hypertrophy. Tendency to bleed upon probing. 3 = Severe inflammation-marked redness and hypertrophy. Tendency to spontaneous bleeding) | 6 weeks |
|
Fatty Acid Synthesis Inhibitors, Hypolipidemic Agents, Antimetabolites, Lipid Regulating Agents, Triclosan, Cetylpyridinium, Fluorides, Tin Fluorides, Cariostatic Agents, Protective Agents, Physiological Effects of Drugs, Anti-Infective Agents, Local, Anti-Infective Agents, Molecular Mechanisms of Pharmacological Action
|
| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: Total Toothpaste<br>Triclosan/fluoride toothpaste | Drug: Triclosan/fluoride toothpaste<br>* Brush whole mouth with Total toothpaste (sold in the US), using a Total 360 toothbrush, 2 times/day for 6 weeks (study duration).<br>* Other names: Total toothpaste;|
| Active Comparator: Toothpaste + Mouthwash<br>Stannous fluoride toothpaste & cetylpyridinium chloride Mouthwash | Drug: stannous fluoride toothpaste<br>* Brush whole mouth with Crest Pro-Health toothpaste using an Oral B Pro-Health toothbrush for 1 minute, 2 times/day for 6 weeks (study duration).<br>* Other names: Crest Pro-Health toothpaste;Drug: cetylpyridinium chloride Mouthwash<br>* Immediately after each toothbrushing rinse whole mouth with 20 ml of Crest Pro-Health Mouthrinse for 30 seconds each time.<br>* Other names: Crest Pro-Health Multi-Protection mouthwash;|
| Placebo Comparator: Control group<br>fluoride toothpaste +fluoride mouthwash | Drug: fluoride toothpaste<br>* Brush whole mouth with Crest Cavity Protection toothpaste using an Oral B Indicator toothbrush for 1 minute, 2 times/day for 6 weeks (study duration).<br>* Other names: Crest Cavity Protection toothpaste;Drug: Fluoride Mouthwash<br>* Immediately after each toothbrushing rinse whole mouth with 20 ml of Crest fluoride Mouthrinse for 30 seconds each time.<br>* Other names: Crest Pro-Health For Me Breezy Mint mouthwash;|
|
The Clinical Investigation of Toothpaste as Compared to Toothpaste and Mouthwash in Reducing Plaque and Gingivitis: A Six-week Clinical Study in the US
Study Overview
=================
Brief Summary
-----------------
The objective of this clinical research study is to evaluate clinical efficacy of Colgate Total Toothpaste as compared to Crest Pro-Health Toothpaste and Crest Pro-Health Mouthwash, and Crest Cavity Protection Toothpaste and Crest Fluoride Mouthwash in reducing gingivitis and dental plaque in adults in a six-week clinical study.
Official Title
-----------------
The Clinical Investigation of Colgate Total Toothpaste as Compared to Crest Pro-Health Toothpaste and Crest Pro-Health Mouthwash, and Crest Cavity Protection Toothpaste and Crest Fluoride Mouthwash in Reducing Plaque and Gingivitis: A Six-week Clinical Study in the US
Conditions
-----------------
Dental Plaque, Gingivitis
Intervention / Treatment
-----------------
* Drug: Triclosan/fluoride toothpaste
* Drug: stannous fluoride toothpaste
* Drug: fluoride toothpaste
* Drug: Fluoride Mouthwash
* Drug: cetylpyridinium chloride Mouthwash
Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Subjects, ages 18-70, inclusive. Availability for the six-week duration of the clinical research study. Good general health. Minimum of 20 uncrowned permanent natural teeth (excluding third molars). Initial gingivitis index of at least 1.0 as determined by the use of the Loe and Silness Gingival Index. Initial plaque index of at least 1.5 as determined by the use of the Quigley and Hein Plaque Index (Turesky Modification). Signed Informed Consent Form Exclusion Criteria: Presence of orthodontic bands. Presence of partial removable dentures. Tumor(s) of the soft or hard tissues of the oral cavity. Advanced periodontal disease (purulent exudate, tooth mobility, and/or extensive loss of periodontal attachment or alveolar bone). Five or more carious lesions requiring immediate restorative treatment. Antibiotic use any time during the one month prior to entry into the study. Participation in any other clinical study or test panel within the one month prior to entry into the study. Dental prophylaxis during the past two weeks prior to baseline examinations. History of allergies to oral care/personal care consumer products or their ingredients. On any prescription medicines that might interfere with the study outcome. An existing medical condition which prohibits eating or drinking for periods up to 4 hours. History of alcohol or drug abuse. Pregnant or lactating subjects.
Ages Eligible for Study
-----------------
Minimum Age: 18 Years
Maximum Age: 70 Years
Sexes Eligible for Study
-----------------
All
Accepts Healthy Volunteers
-----------------
Accepts Healthy Volunteers
Study Plan
=================
How is the study designed?
-----------------
Design Details
Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Triple
Arms and Interventions
| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: Total Toothpaste<br>Triclosan/fluoride toothpaste | Drug: Triclosan/fluoride toothpaste<br>* Brush whole mouth with Total toothpaste (sold in the US), using a Total 360 toothbrush, 2 times/day for 6 weeks (study duration).<br>* Other names: Total toothpaste;|
| Active Comparator: Toothpaste + Mouthwash<br>Stannous fluoride toothpaste & cetylpyridinium chloride Mouthwash | Drug: stannous fluoride toothpaste<br>* Brush whole mouth with Crest Pro-Health toothpaste using an Oral B Pro-Health toothbrush for 1 minute, 2 times/day for 6 weeks (study duration).<br>* Other names: Crest Pro-Health toothpaste;Drug: cetylpyridinium chloride Mouthwash<br>* Immediately after each toothbrushing rinse whole mouth with 20 ml of Crest Pro-Health Mouthrinse for 30 seconds each time.<br>* Other names: Crest Pro-Health Multi-Protection mouthwash;|
| Placebo Comparator: Control group<br>fluoride toothpaste +fluoride mouthwash | Drug: fluoride toothpaste<br>* Brush whole mouth with Crest Cavity Protection toothpaste using an Oral B Indicator toothbrush for 1 minute, 2 times/day for 6 weeks (study duration).<br>* Other names: Crest Cavity Protection toothpaste;Drug: Fluoride Mouthwash<br>* Immediately after each toothbrushing rinse whole mouth with 20 ml of Crest fluoride Mouthrinse for 30 seconds each time.<br>* Other names: Crest Pro-Health For Me Breezy Mint mouthwash;|
What is the study measuring?
-----------------
Primary Outcome Measures
| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Dental Plaque Scores | Dental Plaque (Quigley-Hein, Turesky Modification Index) Units on a scale 0 to 5 (0 = no plaque, 1 = separate flecks of plaque on the tooth, 2 = a thin continuous band of plaque, 3 = a band of plaque up to one-third of the tooth, 4 = plaque covering up to two thirds of the of the tooth, 5 = plaque covering two-thirds or more of the crown of the tooth) | Baseline |
| Dental Plaque Scores | Dental Plaque (Quigley-Hein, Turesky Modification Index) Units on a scale 0 to 5 (0 = no plaque, 1 = separate flecks of plaque on the tooth, 2 = a thin continuous band of plaque, 3 = a band of plaque up to one-third of the tooth, 4 = plaque covering up to two thirds of the of the tooth, 5 = plaque covering two-thirds or more of the crown of the tooth) | 4 weeks |
| Dental Plaque Scores | Dental Plaque (Quigley-Hein, Turesky Modification Index) Units on a scale 0 to 5 (0 = no plaque, 1 = separate flecks of plaque on the tooth, 2 = a thin continuous band of plaque, 3 = a band of plaque up to one-third of the tooth, 4 = plaque covering up to two thirds of the of the tooth, 5 = plaque covering two-thirds or more of the crown of the tooth) | 6 weeks |
| Gingivitis Scores | Gingivitis scale (Loe & Silness Gingival Index) Units on a scale 0 to 3 (0 = no inflammation, 1 = Mild inflammation-slight change in color and little change in texture 2 = Moderate inflammation-moderate glazing, redness, edema and hypertrophy. Tendency to bleed upon probing. 3 = Severe inflammation-marked redness and hypertrophy. Tendency to spontaneous bleeding) | Baseline |
| Gingivitis Scores | Gingivitis scale (Loe & Silness Gingival Index) Units on a scale 0 to 3 (0 = no inflammation, 1 = Mild inflammation-slight change in color and little change in texture 2 = Moderate inflammation-moderate glazing, redness, edema and hypertrophy. Tendency to bleed upon probing. 3 = Severe inflammation-marked redness and hypertrophy. Tendency to spontaneous bleeding) | 4 weeks |
| Gingivitis Scores | Gingivitis scale (Loe & Silness Gingival Index) Units on a scale 0 to 3 (0 = no inflammation, 1 = Mild inflammation-slight change in color and little change in texture 2 = Moderate inflammation-moderate glazing, redness, edema and hypertrophy. Tendency to bleed upon probing. 3 = Severe inflammation-marked redness and hypertrophy. Tendency to spontaneous bleeding) | 6 weeks |
|
|||
NCT03938831
|
Dexmedetomidine and Delirium in Elderly Patients
|
Investigators investigates the effect of perioperative dexmedetomidine 0.5 ug/kg/hr followed by a postoperative continuous infusion fentanyl-based PCA(Patient-Controlled Analgesia) drug mixed with dexmedetomidine 0.2ug/kg/hr for two days on reducing postoperative delirium and postoperative rescue analgesics in elderly patients who undergo hip surgery. The other half of patients received fentanyl-based PCA only.
|
Elderly patients are susceptible to postoperative delirium. Delirium occurs in 10~60% and is associated with longer hospital stays, increased costs, and morbidity. Postoperative delirium usually occurs 2~3 days after surgery. Intraoperative infusion of dexmedetomidine lacks preventing postoperative delirium in elderly noncardiac major surgery.~We hypothesized postoperative dexmedetomidine for two days as a mixture drug of fentanyl-based PCA could reduce the incidence of postoperative delirium. We compared this effect with other control group who received fentanyl-based PCA only.~We also investigate EEG patterns of patients during emergence and compared the EEG patterns who developed delirium postoperatively in PACU(Postanesthesia care unit) or general ward. Dexmedetomidine has analgesic effect. We expected postoperative dexmedetomidine has benefits of opioid sparing effects.
|
Effect of Dexmedetomidine in Postoperative Delirium in Hip Surgery
|
Delirium, Dexmedetomidine, Postoperative PCA
|
* Drug: Dexmedetomidine
* Drug: Fentanyl-based PCA infusion
|
Inclusion Criteria: over 65 yrs old elderly patient who undergo elective hip surgery and ASA(The American Society of Anesthesiologists) physical status I-III~Exclusion Criteria:~history of dementia, drug abuser, hypersensitivity to dexmedetomidine, fentanyl, propofol, disable to speech, reject the clinical study, hemodynamic instability during surgery, an illiterate, pregnancy
|
65 Years
| null |
All
|
No
|
Primary Purpose: Prevention
Allocation: Randomized
Intervention Model: Parallel Assignment
Interventional Model Description: randomized control
Masking: Single
|
| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| delirium | reduction of incidence of delirium | 2 days |
|
Dexmedetomidine, Fentanyl, Hypnotics and Sedatives, Central Nervous System Depressants, Physiological Effects of Drugs, Analgesics, Non-Narcotic, Analgesics, Sensory System Agents, Peripheral Nervous System Agents, Adrenergic alpha-2 Receptor Agonists, Adrenergic alpha-Agonists, Adrenergic Agonists, Adrenergic Agents, Neurotransmitter Agents, Molecular Mechanisms of Pharmacological Action, Analgesics, Opioid, Narcotics, Adjuvants, Anesthesia, Anesthetics, Intravenous, Anesthetics, General, Anesthetics
|
| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: dexmedetomidine group<br>dexmedetomidine mixture with fentanyl-based PCA infusion for 2 days | Drug: Dexmedetomidine<br>* dexmedetomidine 0.5 micg/kg/hr infusion during operation and followed by 0.2 mic/kg/hr with fentanyl-based PCA mixture for 2 days<br>Drug: Fentanyl-based PCA infusion<br>* Fentanyl-based PCA infusion<br>|
| Placebo Comparator: control group<br>Fentanyl-based PCA infusion for 2 days | Drug: Fentanyl-based PCA infusion<br>* Fentanyl-based PCA infusion<br>|
|
Dexmedetomidine and Delirium in Elderly Patients
Study Overview
=================
Brief Summary
-----------------
Investigators investigates the effect of perioperative dexmedetomidine 0.5 ug/kg/hr followed by a postoperative continuous infusion fentanyl-based PCA(Patient-Controlled Analgesia) drug mixed with dexmedetomidine 0.2ug/kg/hr for two days on reducing postoperative delirium and postoperative rescue analgesics in elderly patients who undergo hip surgery. The other half of patients received fentanyl-based PCA only.
Detailed Description
-----------------
Elderly patients are susceptible to postoperative delirium. Delirium occurs in 10 60% and is associated with longer hospital stays, increased costs, and morbidity. Postoperative delirium usually occurs 2 3 days after surgery. Intraoperative infusion of dexmedetomidine lacks preventing postoperative delirium in elderly noncardiac major surgery. We hypothesized postoperative dexmedetomidine for two days as a mixture drug of fentanyl-based PCA could reduce the incidence of postoperative delirium. We compared this effect with other control group who received fentanyl-based PCA only. We also investigate EEG patterns of patients during emergence and compared the EEG patterns who developed delirium postoperatively in PACU(Postanesthesia care unit) or general ward. Dexmedetomidine has analgesic effect. We expected postoperative dexmedetomidine has benefits of opioid sparing effects.
Official Title
-----------------
Effect of Dexmedetomidine in Postoperative Delirium in Hip Surgery
Conditions
-----------------
Delirium, Dexmedetomidine, Postoperative PCA
Intervention / Treatment
-----------------
* Drug: Dexmedetomidine
* Drug: Fentanyl-based PCA infusion
Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: over 65 yrs old elderly patient who undergo elective hip surgery and ASA(The American Society of Anesthesiologists) physical status I-III Exclusion Criteria: history of dementia, drug abuser, hypersensitivity to dexmedetomidine, fentanyl, propofol, disable to speech, reject the clinical study, hemodynamic instability during surgery, an illiterate, pregnancy
Ages Eligible for Study
-----------------
Minimum Age: 65 Years
Sexes Eligible for Study
-----------------
All
Accepts Healthy Volunteers
-----------------
No
Study Plan
=================
How is the study designed?
-----------------
Design Details
Primary Purpose: Prevention
Allocation: Randomized
Intervention Model: Parallel Assignment
Interventional Model Description: randomized control
Masking: Single
Arms and Interventions
| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: dexmedetomidine group<br>dexmedetomidine mixture with fentanyl-based PCA infusion for 2 days | Drug: Dexmedetomidine<br>* dexmedetomidine 0.5 micg/kg/hr infusion during operation and followed by 0.2 mic/kg/hr with fentanyl-based PCA mixture for 2 days<br>Drug: Fentanyl-based PCA infusion<br>* Fentanyl-based PCA infusion<br>|
| Placebo Comparator: control group<br>Fentanyl-based PCA infusion for 2 days | Drug: Fentanyl-based PCA infusion<br>* Fentanyl-based PCA infusion<br>|
What is the study measuring?
-----------------
Primary Outcome Measures
| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| delirium | reduction of incidence of delirium | 2 days |
|
||
NCT03146923
|
Decreasing Intakes & Absorption of Phosphorus in Haemodialysis Patients Through Food Choices
|
Based on new evidence renal dietitians in Ireland are revising the diet sheet that is used to teach patients about reducing blood phosphate. Changes that renal dietitians plan to make to the dietary phosphorus prescription~Inclusion of some nuts and pulses~More detailed education re phosphate additives~More accurate protein prescription~Inclusion of more whole grains~Encouraging the use of foods with a low phosphorus to protein ratio~The investigators want to test the two diet prescription to find out, which one is better at reducing blood phosphate and which one is more acceptable to patients. The investigators also want to make sure it is safe.
|
Background:~Chronic Kidney Disease (CKD) afflicts one in twenty Irish citizens who are over age 45 and is a significant risk factor for cardiovascular disease, premature death and significantly impacts healthcare utilisation. As kidney function deteriorates, phosphorus, upregulates counter regulatory hormones (immunoreactive Parathyroid Hormone (iPTH) and Fibroblast Growth Factor 23 (FGF23), the elevated levels of which are maladaptive. Collectively these abnormalities and their complications are referred to as Chronic Kidney Disease, Mineral & Bone Disorder (CKD MBD). Hyperphosphataemia or high blood phosphate levels is associated with increased mortality, in dialysis patients, in the earlier stages of CKD and even in patients with normal renal function. The use of phosphorus restricted diets in combination with oral phosphate binders has become well established in the management of patients with CKD stages 3-5 (including CKD stage 5D).~Experts have called for research into the dietary management of phosphate in the CKD population. The current evidence base is weak and in a recent Cochrane systematic review the authors concluded that there was limited low quality evidence to indicate that dietary interventions may positively affect CKD-MBD.~In recent years there has been increased focus on dietary phosphorus restriction in the management of CKD-MBD and a number of experts have suggested changes in how we manage dietary phosphorus. Several potential strategies have been suggested and in response the Renal Interest Group (RIG) of the Irish Nutrition & Dietetic Institute (INDI) held a 1 day meeting in Dublin in January 2015 which brought together numerous experts in the field to summarise our current understanding and the recent advances in the field.~Following on from this, RIG set up a working group to translate the new knowledge from the advanced study day and from further literature reviews into a modified low phosphate diet sheet.~Almost all people who have end stage kidney disease (ESKD) and require dialysis to survive, follow a dietary phosphorus restriction, to control high blood phosphate, with the aim of reducing the risk of cardiovascular disease, fractures and death.~Research Hypothesis: The modified low phosphate diet sheet is superior to current treatment in haemodialysis patients~Study Objectives~Primary Objective: To determine if the modified low phosphorus dietary prescription is superior to current management in reducing serum phosphate levels in HD patients~Secondary Objectives To determine if the modified low phosphorus diet is tolerable To determine if the modified low phosphorus diet is safe To determine if the modified low phosphorus diet brings the renal diet closer to healthy eating advice e.g. increased fibre intake.
|
Decreasing Intakes & Absorption of Phosphorus in Haemodialysis Patients Through Food Choices
|
Renal Dialysis, Hyperphosphatemia, Dietary Modification
|
* Other: Current Low Phosphorus Diet Prescription
* Other: Modified Low Phosphorus Diet Prescription
|
Inclusion Criteria:~>18 years~Self reported urine output less than 2 cups (400mls) / day~On maintenance haemodialysis for > 3 months~Phosphate >1.6mmole/L on average of last 3 available routine monthly blood tests~Exclusion Criteria:~Hyperkalemia, defined as a predialysis serum K on routine monthly blood test of >6mmoles/l in the month preceding the trial.~Parathyroidectomy~Corrected serum calcium <2.2 or > 2.6mmol/L or local normal units where ranges varied significantly from 2.2-2.6mmoles/l.~Acute concurrent illness, requiring hospitalisation in the 2 weeks prior to recruitment.
|
18 Years
| null |
All
|
No
|
Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Interventional Model Description: Multicentre Parallel Arm Randomised Controlled Trial
Masking: Single
|
| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Serum Phosphate | Difference in serum phosphate value at 1 month v baseline, in those randomised to the modified diet compared to the difference in serum phosphate value at 1 month v baseline in those randomised to standard care. | 1 month |
|
| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Dietary Intake | Between arm difference in dietary phosphate intake (separating phosphate into high & low bioavailability).~Between arm difference in dietary fibre intake. | 1 month |
| Serum iPTH | Difference in serum iPTH value at 1 month v baseline, in those randomised to the modified diet compared to the difference in serum iPTH value at 1 month v baseline in those randomised to standard care. | 1 month |
| Palatability and Subject Acceptance (Tolerability) | Palatability and subject acceptance of modified diet as assessed by 5 point Likert Scale | 1 month |
| FGF23 (Exploratory Endpoint) | Within subject change in geometric mean FGF-23 measurement at baseline as compared to the end of the 1 month intervention. Because of evidence that subjects with diabetes handle phosphorus differently we will analyse result for FGF 23 separately in patients with and without diabetes (Muras et al., 2013, Yoda et al., 2012). | 1 month |
| Serum Potassium (Safety Endpoints): | Check serum potassium in week 2. Difference in serum potassium value at 1 month v baseline, in those randomised to the modified diet compared to the difference in serum potassium value at 1 month v baseline in those randomised to standard care. | 1 month |
|
Hyperphosphatemia, Phosphorus Metabolism Disorders, Metabolic Diseases
|
| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: Standard Care Arm<br>Patients randomised to the standard care arm will be re educated using the current low phosphorus diet prescription. | Other: Current Low Phosphorus Diet Prescription<br>* Routine / Standard Care: Routine dietary intervention is currently provided by one-to-one counselling to the subject and his/her relevant family members or carers, by a state registered dietitian regarding a diet which provides <15mg Phosphorus /g Protein (over the day). This is equivalent to approximately 1000mg P / day. This is based on the 'Eating Well with Kidney Disease' dietsheet produced by the Renal Interest Group (RIG) of the Irish Nutrition & Dietetic Institute (INDI) in 2010 and includes following main components:~Restricting protein intake to requirements (1-1.2g/kg Ideal Body Weight)~Restricting dairy intake (1-1.5 portions per day)~Avoiding foods high in phosphate~Avoiding foods with phosphate additives<br>|
| Experimental: Modified Intervention Arm<br>Patients randomised to the intervention arm will be educated using a modified low phosphorus diet prescription. | Other: Modified Low Phosphorus Diet Prescription<br>* Modified Low Phosphorus Diet Prescription: The new prescription recommends five changes to current management~Introduction of some plant protein in the form of pulses and nuts where the phosphorus is largely bound by phytate~Increased focus on avoiding additives~Introduction of more whole grains e.g. wholemeal sliced pan/ pasta/rice .~Avoiding over-prescription of protein which carries an obligatory phosphorus load.~Focus on high protein foods with a low phosphorus to protein ratio<br>|
|
Decreasing Intakes & Absorption of Phosphorus in Haemodialysis Patients Through Food Choices
Study Overview
=================
Brief Summary
-----------------
Based on new evidence renal dietitians in Ireland are revising the diet sheet that is used to teach patients about reducing blood phosphate. Changes that renal dietitians plan to make to the dietary phosphorus prescription Inclusion of some nuts and pulses More detailed education re phosphate additives More accurate protein prescription Inclusion of more whole grains Encouraging the use of foods with a low phosphorus to protein ratio The investigators want to test the two diet prescription to find out, which one is better at reducing blood phosphate and which one is more acceptable to patients. The investigators also want to make sure it is safe.
Detailed Description
-----------------
Background: Chronic Kidney Disease (CKD) afflicts one in twenty Irish citizens who are over age 45 and is a significant risk factor for cardiovascular disease, premature death and significantly impacts healthcare utilisation. As kidney function deteriorates, phosphorus, upregulates counter regulatory hormones (immunoreactive Parathyroid Hormone (iPTH) and Fibroblast Growth Factor 23 (FGF23), the elevated levels of which are maladaptive. Collectively these abnormalities and their complications are referred to as Chronic Kidney Disease, Mineral & Bone Disorder (CKD MBD). Hyperphosphataemia or high blood phosphate levels is associated with increased mortality, in dialysis patients, in the earlier stages of CKD and even in patients with normal renal function. The use of phosphorus restricted diets in combination with oral phosphate binders has become well established in the management of patients with CKD stages 3-5 (including CKD stage 5D). Experts have called for research into the dietary management of phosphate in the CKD population. The current evidence base is weak and in a recent Cochrane systematic review the authors concluded that there was limited low quality evidence to indicate that dietary interventions may positively affect CKD-MBD. In recent years there has been increased focus on dietary phosphorus restriction in the management of CKD-MBD and a number of experts have suggested changes in how we manage dietary phosphorus. Several potential strategies have been suggested and in response the Renal Interest Group (RIG) of the Irish Nutrition & Dietetic Institute (INDI) held a 1 day meeting in Dublin in January 2015 which brought together numerous experts in the field to summarise our current understanding and the recent advances in the field. Following on from this, RIG set up a working group to translate the new knowledge from the advanced study day and from further literature reviews into a modified low phosphate diet sheet. Almost all people who have end stage kidney disease (ESKD) and require dialysis to survive, follow a dietary phosphorus restriction, to control high blood phosphate, with the aim of reducing the risk of cardiovascular disease, fractures and death. Research Hypothesis: The modified low phosphate diet sheet is superior to current treatment in haemodialysis patients Study Objectives Primary Objective: To determine if the modified low phosphorus dietary prescription is superior to current management in reducing serum phosphate levels in HD patients Secondary Objectives To determine if the modified low phosphorus diet is tolerable To determine if the modified low phosphorus diet is safe To determine if the modified low phosphorus diet brings the renal diet closer to healthy eating advice e.g. increased fibre intake.
Official Title
-----------------
Decreasing Intakes & Absorption of Phosphorus in Haemodialysis Patients Through Food Choices
Conditions
-----------------
Renal Dialysis, Hyperphosphatemia, Dietary Modification
Intervention / Treatment
-----------------
* Other: Current Low Phosphorus Diet Prescription
* Other: Modified Low Phosphorus Diet Prescription
Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: >18 years Self reported urine output less than 2 cups (400mls) / day On maintenance haemodialysis for > 3 months Phosphate >1.6mmole/L on average of last 3 available routine monthly blood tests Exclusion Criteria: Hyperkalemia, defined as a predialysis serum K on routine monthly blood test of >6mmoles/l in the month preceding the trial. Parathyroidectomy Corrected serum calcium <2.2 or > 2.6mmol/L or local normal units where ranges varied significantly from 2.2-2.6mmoles/l. Acute concurrent illness, requiring hospitalisation in the 2 weeks prior to recruitment.
Ages Eligible for Study
-----------------
Minimum Age: 18 Years
Sexes Eligible for Study
-----------------
All
Accepts Healthy Volunteers
-----------------
No
Study Plan
=================
How is the study designed?
-----------------
Design Details
Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Interventional Model Description: Multicentre Parallel Arm Randomised Controlled Trial
Masking: Single
Arms and Interventions
| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: Standard Care Arm<br>Patients randomised to the standard care arm will be re educated using the current low phosphorus diet prescription. | Other: Current Low Phosphorus Diet Prescription<br>* Routine / Standard Care: Routine dietary intervention is currently provided by one-to-one counselling to the subject and his/her relevant family members or carers, by a state registered dietitian regarding a diet which provides <15mg Phosphorus /g Protein (over the day). This is equivalent to approximately 1000mg P / day. This is based on the 'Eating Well with Kidney Disease' dietsheet produced by the Renal Interest Group (RIG) of the Irish Nutrition & Dietetic Institute (INDI) in 2010 and includes following main components: Restricting protein intake to requirements (1-1.2g/kg Ideal Body Weight) Restricting dairy intake (1-1.5 portions per day) Avoiding foods high in phosphate Avoiding foods with phosphate additives<br>|
| Experimental: Modified Intervention Arm<br>Patients randomised to the intervention arm will be educated using a modified low phosphorus diet prescription. | Other: Modified Low Phosphorus Diet Prescription<br>* Modified Low Phosphorus Diet Prescription: The new prescription recommends five changes to current management Introduction of some plant protein in the form of pulses and nuts where the phosphorus is largely bound by phytate Increased focus on avoiding additives Introduction of more whole grains e.g. wholemeal sliced pan/ pasta/rice . Avoiding over-prescription of protein which carries an obligatory phosphorus load. Focus on high protein foods with a low phosphorus to protein ratio<br>|
What is the study measuring?
-----------------
Primary Outcome Measures
| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Serum Phosphate | Difference in serum phosphate value at 1 month v baseline, in those randomised to the modified diet compared to the difference in serum phosphate value at 1 month v baseline in those randomised to standard care. | 1 month |
Secondary Outcome Measures
| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Dietary Intake | Between arm difference in dietary phosphate intake (separating phosphate into high & low bioavailability). Between arm difference in dietary fibre intake. | 1 month |
| Serum iPTH | Difference in serum iPTH value at 1 month v baseline, in those randomised to the modified diet compared to the difference in serum iPTH value at 1 month v baseline in those randomised to standard care. | 1 month |
| Palatability and Subject Acceptance (Tolerability) | Palatability and subject acceptance of modified diet as assessed by 5 point Likert Scale | 1 month |
| FGF23 (Exploratory Endpoint) | Within subject change in geometric mean FGF-23 measurement at baseline as compared to the end of the 1 month intervention. Because of evidence that subjects with diabetes handle phosphorus differently we will analyse result for FGF 23 separately in patients with and without diabetes (Muras et al., 2013, Yoda et al., 2012). | 1 month |
| Serum Potassium (Safety Endpoints): | Check serum potassium in week 2. Difference in serum potassium value at 1 month v baseline, in those randomised to the modified diet compared to the difference in serum potassium value at 1 month v baseline in those randomised to standard care. | 1 month |
|
|
NCT02718170
|
Buried Intramedullary K-wire Fixation Compared With Plate and Screw Fixation for Metacarpal Fractures in Unstable Extra-Articular Metacarpal Fractures
|
Randomized controlled trial comparing a technique for buried intramedullary k-wire fixation to plate and screw fixation for unstable extra-articular metacarpal fractures.
|
Metacarpal fractures are a common injury to the hand. Most fractures occur due to direct force from either a axial load to the dorsum of the metacarpophalangeal joint or low energy fall onto an outstretched hand. Many of these fractures can be treated closed with a closed reduction and splinting however, some displaced or angulated fractures require open reduction and internal fixation. Many fixation techniques have been used, however to the investigators knowledge, no one has prospectively randomized patients to compare plate and screw fixation with buried intramedullary k-wire fixation.~The purpose of this study is to compare Plate and screw and buried intramedullary fixation, using the Disabilities of the Arm, Shoulder, and Hand (DASH) questionnaire as the primary outcome measured. Secondary outcomes will include total active motion, complications, cost, reoperation rate.
|
Buried Intramedullary K-wire Fixation Compared With Plate and Screw Fixation in Unstable Extra-Articular Metacarpal Fractures: A Randomized, Controlled Study
|
Metacarpal Fracture
|
* Procedure: Buried Intramedullary K-wire Fixation
* Procedure: Plate and Screw Fixation
|
Inclusion Criteria:~The patient has an unstable extra-articular metacarpal fracture that meets operative indications~Informed consent is obtained from the patient or proxy~Male or female who are 16 years of age or older~Exclusion Criteria:~If the patients range of motion was decreased prior to injury (previous upper extremity injury, osteoarthritis, etc.)~Pathological Fracture~Greater than 21 days from fracture to definitive open reduction and internal fixation~If contamination or wounds from open fractures do not permit standardized buried intramedullary fixation or plate and screw fixation~Highly comminuted diaphyseal fractures~Articular fractures~Multiple fractures involving bones other than another metacarpal in the same upper extremity~The patient had a previous upper extremity injury that has limited hand function or finger range of motion
|
14 Years
| null |
All
|
No
|
Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
|
| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Disability as measured by Disability of Arm, Shoulder and Hand Score | | 3 months |
|
| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Total Active Motion in degrees | Measured by goniometer | 3 months |
| Grip Strength | | 3 months |
| Disability as measured by Disability of Arm, Shoulder and Hand Score | | 1 year |
|
Fractures, Bone, Wounds and Injuries
|
| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Buried Intramedullary K-wire Fixation<br>Patients randomized to buried intramedullary k-wire fixation will undergo a standardized antegrade open reduction and fixation procedure with an intramedullary k-wire. | Procedure: Buried Intramedullary K-wire Fixation<br> <br> |
| Active Comparator: Plate and Screw Fixation<br>Patients randomized to Plate and Screw Fixation will undergo a standardized open reduction and internal fixation with plate and screws. Brand of plate will be left to the operating surgeon's discretion. | Procedure: Plate and Screw Fixation<br> <br> |
|
Buried Intramedullary K-wire Fixation Compared With Plate and Screw Fixation for Metacarpal Fractures in Unstable Extra-Articular Metacarpal Fractures
Study Overview
=================
Brief Summary
-----------------
Randomized controlled trial comparing a technique for buried intramedullary k-wire fixation to plate and screw fixation for unstable extra-articular metacarpal fractures.
Detailed Description
-----------------
Metacarpal fractures are a common injury to the hand. Most fractures occur due to direct force from either a axial load to the dorsum of the metacarpophalangeal joint or low energy fall onto an outstretched hand. Many of these fractures can be treated closed with a closed reduction and splinting however, some displaced or angulated fractures require open reduction and internal fixation. Many fixation techniques have been used, however to the investigators knowledge, no one has prospectively randomized patients to compare plate and screw fixation with buried intramedullary k-wire fixation. The purpose of this study is to compare Plate and screw and buried intramedullary fixation, using the Disabilities of the Arm, Shoulder, and Hand (DASH) questionnaire as the primary outcome measured. Secondary outcomes will include total active motion, complications, cost, reoperation rate.
Official Title
-----------------
Buried Intramedullary K-wire Fixation Compared With Plate and Screw Fixation in Unstable Extra-Articular Metacarpal Fractures: A Randomized, Controlled Study
Conditions
-----------------
Metacarpal Fracture
Intervention / Treatment
-----------------
* Procedure: Buried Intramedullary K-wire Fixation
* Procedure: Plate and Screw Fixation
Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: The patient has an unstable extra-articular metacarpal fracture that meets operative indications Informed consent is obtained from the patient or proxy Male or female who are 16 years of age or older Exclusion Criteria: If the patients range of motion was decreased prior to injury (previous upper extremity injury, osteoarthritis, etc.) Pathological Fracture Greater than 21 days from fracture to definitive open reduction and internal fixation If contamination or wounds from open fractures do not permit standardized buried intramedullary fixation or plate and screw fixation Highly comminuted diaphyseal fractures Articular fractures Multiple fractures involving bones other than another metacarpal in the same upper extremity The patient had a previous upper extremity injury that has limited hand function or finger range of motion
Ages Eligible for Study
-----------------
Minimum Age: 14 Years
Sexes Eligible for Study
-----------------
All
Accepts Healthy Volunteers
-----------------
No
Study Plan
=================
How is the study designed?
-----------------
Design Details
Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Arms and Interventions
| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Buried Intramedullary K-wire Fixation<br>Patients randomized to buried intramedullary k-wire fixation will undergo a standardized antegrade open reduction and fixation procedure with an intramedullary k-wire. | Procedure: Buried Intramedullary K-wire Fixation<br> <br> |
| Active Comparator: Plate and Screw Fixation<br>Patients randomized to Plate and Screw Fixation will undergo a standardized open reduction and internal fixation with plate and screws. Brand of plate will be left to the operating surgeon's discretion. | Procedure: Plate and Screw Fixation<br> <br> |
What is the study measuring?
-----------------
Primary Outcome Measures
| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Disability as measured by Disability of Arm, Shoulder and Hand Score | | 3 months |
Secondary Outcome Measures
| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Total Active Motion in degrees | Measured by goniometer | 3 months |
| Grip Strength | | 3 months |
| Disability as measured by Disability of Arm, Shoulder and Hand Score | | 1 year |
|
|
NCT04112030
|
Role of DIA in Diagnosing Nature of Indeterminate Biliary Duct Stricture
|
The study aimed to assess role of DIA in diagnosing nature of indeterminate bile ducts stricture
|
Biliary strictures (BSs) are common in clinical practice, but differentiating nature of the stricture either benign or malignant remains a challenge. Although there is a great advance in imaging and laboratory investigations, nature of BS is still unclear in some patients. Therefore, preoperative evaluation of such strictures is mandatory to put suitable plan with appropriate management.~BS is considered indeterminate biliary duct stricture (IBDS) if it has the following conditions; 1) no obvious mass on abdominal ultrasound (US), or magnetic resonance cholangiopancreatography (MRCP); 2) no distant metastasis on abdominal US, or MRI; and 3) no recent history of hepatobiliary surgery in the last 3 months.~IBDS has a particularly complex challenge, because patients and their physicians must weigh the malignant potential against benign etiologies in the face of morbidity of surgical intervention. About 15-24% of the patients had surgical intervention for suspected IBDS have a benign aetiology. Therefore, preoperative evaluation of such strictures is mandatory to put suitable plan with appropriate management.~Conventional cytological evaluation (CCE) has become the standard modality of practice for the investigation of such stricture. CCE had low diagnostic yield with an overall sensitivity of 41.6% and a negative predictive value of 58%. This low diagnostic yield is mainly attributed to desmoplastic reaction in BS.~Radiological elevation of BS with different modalities as MRCP enables us to detect the stricture and its extent and exclude other causes of obstruction. These modalities fail to determine nature of BS in many cases. In addition to, inability to take tissue sampling or perform therapeutic intervention.~Recently, there is a great advance in endoscopic assessment of BS as cholangioscopy, intraductal ultrasonography (IDUS), and confocal laser endomicroscopy. These techniques have high diagnostic yield in diagnosing nature of BS but secondary to high cost, complexity, and unavailability of these procedures, making them of limited use in evaluation the nature of IBDS.~Advanced cytological techniques have been emerged to identify nature of IBDS i.e., digital image analysis (DIA), and fluorescence in-situ hybridization (FISH) where both techniques detect the chromosomal alterations in malignant cells.~FISH is significantly more sensitive than CCE for assessment the nature of IBDS. However, the specificity of FISH was poor compared to the excellent specificity of CCE. The compromised specificity of FISH may limit its utility in the detection of nature of IBDS.~DIA has been widely used in many malignant diseases, especially in cervical cancer where it had 70% to 91.7%, sensitivity and 54.1% to 100% specificity for the diagnosis of different malignant diseases in published studies.~Role of DIA in pancreatobiliary malignancies is still controversial. Also, there are limited studies that have addressed the use of DIA in diagnosing the nature of IBDS. In addition to unavailability, the high cost and the complexity of advanced endoscopes, we designed this work to evaluate the diagnostic performance of DIA in identification nature of IBDS in comparison to CCE. Also, we perform a cost analysis of DIA vs. CCE in diagnosing nature of IBDS.
|
Role of Digital Image Analysis in Diagnosing Nature of Indeterminate Biliary Duct Stricture
|
Bile Duct Stricture
|
* Diagnostic Test: Digital image analysis
|
Inclusion Criteria:~Any patient presented with biliary stricture with no obvious cause in abdominal imaging~Exclusion Criteria:~biliary obstruction due to other causes as stones, or tumor,~biliary surgery within the last six months~Coagulopathy~lost follow up
|
18 Years
| null |
All
|
No
|
| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Diagnostic performance of DIA compared to routine cytology in case of IBDS | all samples were subjected to DIA and routine cytology and the result was compared with final diagnosis | Baseline |
|
Constriction, Pathologic, Pathological Conditions, Anatomical
|
| Intervention/Treatment |
| --- |
|Diagnostic Test: Digital image analysis|nan|
|
Role of DIA in Diagnosing Nature of Indeterminate Biliary Duct Stricture
Study Overview
=================
Brief Summary
-----------------
The study aimed to assess role of DIA in diagnosing nature of indeterminate bile ducts stricture
Detailed Description
-----------------
Biliary strictures (BSs) are common in clinical practice, but differentiating nature of the stricture either benign or malignant remains a challenge. Although there is a great advance in imaging and laboratory investigations, nature of BS is still unclear in some patients. Therefore, preoperative evaluation of such strictures is mandatory to put suitable plan with appropriate management. BS is considered indeterminate biliary duct stricture (IBDS) if it has the following conditions; 1) no obvious mass on abdominal ultrasound (US), or magnetic resonance cholangiopancreatography (MRCP); 2) no distant metastasis on abdominal US, or MRI; and 3) no recent history of hepatobiliary surgery in the last 3 months. IBDS has a particularly complex challenge, because patients and their physicians must weigh the malignant potential against benign etiologies in the face of morbidity of surgical intervention. About 15-24% of the patients had surgical intervention for suspected IBDS have a benign aetiology. Therefore, preoperative evaluation of such strictures is mandatory to put suitable plan with appropriate management. Conventional cytological evaluation (CCE) has become the standard modality of practice for the investigation of such stricture. CCE had low diagnostic yield with an overall sensitivity of 41.6% and a negative predictive value of 58%. This low diagnostic yield is mainly attributed to desmoplastic reaction in BS. Radiological elevation of BS with different modalities as MRCP enables us to detect the stricture and its extent and exclude other causes of obstruction. These modalities fail to determine nature of BS in many cases. In addition to, inability to take tissue sampling or perform therapeutic intervention. Recently, there is a great advance in endoscopic assessment of BS as cholangioscopy, intraductal ultrasonography (IDUS), and confocal laser endomicroscopy. These techniques have high diagnostic yield in diagnosing nature of BS but secondary to high cost, complexity, and unavailability of these procedures, making them of limited use in evaluation the nature of IBDS. Advanced cytological techniques have been emerged to identify nature of IBDS i.e., digital image analysis (DIA), and fluorescence in-situ hybridization (FISH) where both techniques detect the chromosomal alterations in malignant cells. FISH is significantly more sensitive than CCE for assessment the nature of IBDS. However, the specificity of FISH was poor compared to the excellent specificity of CCE. The compromised specificity of FISH may limit its utility in the detection of nature of IBDS. DIA has been widely used in many malignant diseases, especially in cervical cancer where it had 70% to 91.7%, sensitivity and 54.1% to 100% specificity for the diagnosis of different malignant diseases in published studies. Role of DIA in pancreatobiliary malignancies is still controversial. Also, there are limited studies that have addressed the use of DIA in diagnosing the nature of IBDS. In addition to unavailability, the high cost and the complexity of advanced endoscopes, we designed this work to evaluate the diagnostic performance of DIA in identification nature of IBDS in comparison to CCE. Also, we perform a cost analysis of DIA vs. CCE in diagnosing nature of IBDS.
Official Title
-----------------
Role of Digital Image Analysis in Diagnosing Nature of Indeterminate Biliary Duct Stricture
Conditions
-----------------
Bile Duct Stricture
Intervention / Treatment
-----------------
* Diagnostic Test: Digital image analysis
Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Any patient presented with biliary stricture with no obvious cause in abdominal imaging Exclusion Criteria: biliary obstruction due to other causes as stones, or tumor, biliary surgery within the last six months Coagulopathy lost follow up
Ages Eligible for Study
-----------------
Minimum Age: 18 Years
Sexes Eligible for Study
-----------------
All
Accepts Healthy Volunteers
-----------------
No
Study Plan
=================
How is the study designed?
-----------------
Arms and Interventions
| Intervention/Treatment |
| --- |
|Diagnostic Test: Digital image analysis|nan|
What is the study measuring?
-----------------
Primary Outcome Measures
| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Diagnostic performance of DIA compared to routine cytology in case of IBDS | all samples were subjected to DIA and routine cytology and the result was compared with final diagnosis | Baseline |
|
|||
NCT00702598
|
The WORKER Study: Escitalopram and Telephone-based Cognitive Behaviour Therapy (CBT) for Depressed Working People
|
This study will investigate the additional benefits of telephone-based cognitive behavioral therapy (Tel-CBT) as added treatment to an antidepressant (escitalopram) in working people with major depressive disorder (MDD) versus treatment with escitalopram alone. Outcomes will include depression symptom rating scales and measures of work absence and productivity. The hypothesis is that Tel-CBT and escitalopram will result in better outcomes than escitalopram alone in working patients with MDD.
|
Rationale CBT is recognized as an effective psychological treatment for MDD. However, there are still considerable barriers to access CBT. Newer methods of delivering CBT, such as over the telephone (Tel-CBT), allow for greater access and convenience, at potentially lower cost. This is especially relevant for working people because the service can be delivered during evenings and weekends, so they do not need to leave work to attend clinic appointments. Ease of access is also important for rural settings where distance to health facilities can be a barrier to care. The ease of delivery of Tel-CBT, both in setup and maintenance costs, may also make it an important component of enhanced support for primary care. Preliminary studies have shown that addition of Tel-CBT leads to better outcomes than usual care alone (Simon et al, 2004; Wang et al, 2007).~This study will investigate the added value of Tel-CBT as adjunctive treatment to an antidepressant (escitalopram) in working people with MDD versus treatment with escitalopram alone, focusing on work-related outcomes. Escitalopram offers advantages as a first-choice treatment for depressed working people, given its superior efficacy compared to other antidepressants, excellent tolerability and simplicity of use for family physicians. Observational studies have shown significant reductions in sick leave when depressed patients are treated with escitalopram (Winkler et al, 2007). Outcome will be rigorously evaluated by assessing absenteeism and work productivity, response and remission rates, and quality of life, after acute (3 month) treatment and longer-term (6 month) follow-up.~Research Method This is a 6-month, multi-centre, single-blind (rater), randomized, parallel-design study to assess the efficacy of escitalopram and Tel-CBT in the treatment of working subjects with MDD, compared to treatment with escitalopram alone. A total of 150 depressed patients meeting entry criteria will be enrolled over a 1 year period.~Eligible patients will be treated with escitalopram 10-20 mg/d for the entire treatment period (6 months). Patients will be randomized to addition of telephone-based CBT with 8 sessions conducted over a 3 month period, or to a (placebo) control condition of reminder telephone calls. Outcomes (HAM-D, MADRS) will be primarily assessed over the telephone by raters blind to treatment assignment. Other outcome measures will be assessed by patient-rated questionnaires administered over the internet using a secure web site, and by ratings from the treating physician (CGI and adverse events).~Statistical Analysis All randomized subjects who have at least one follow-up visit will be included in the analysis based on intent-to-treat. Ineligible subjects who are inappropriately randomized will be excluded from the analysis. Missing data will be imputed using last observation carried forward (LOCF). For the analyses the treatment variables will remain coded and the analysts and investigators will remain blinded to variable identity during analysis and interpretation.~The pre-specified primary efficacy endpoint is the adjusted mean change from baseline to endpoint (12 weeks) in the HAM-D score using LOCF. All comparisons will be analyzed using ANCOVA adjusting for baseline value and centre. The secondary outcomes will also be analyzed using a similar analysis, when appropriate. Post hoc analyses will also examine observed case data. Categorical data (such as proportions of the sample with adverse events) will be analyzed using chi-square tests or Fisher's test where cell sizes warrant.
|
The WORKER Study: A Randomized Controlled Trial of Escitalopram and Telephone-based Cognitive Behaviour Therapy in Working Patients With Major Depressive Disorder
|
Major Depressive Disorder (MDD)
|
* Behavioral: Telephone-based Cognitive Behaviour Therapy (CBT)
* Behavioral: Telephone reminder calls
|
Inclusion Criteria:~Male and female outpatients aged 18-65 years.~Patients will meet DSM-IV criteria for major depressive disorder as determined by the mood disorders section of the Mini International Neuropsychiatric Interview (MINI, Sheehan et al, 1998).~Currently employed (or off work for 2 weeks or less, and expecting to return to work at the start of study).~A score of 18 or greater on the self-rated version of the MADRS, indicating at least moderately severe depression.~Competency to give informed consent.~Exclusion Criteria:~Patients on short-term (except for circumstances under Inclusion Criteria) or long-term disability.~Pregnant women, lactating women and sexually active women of childbearing potential who are not using medically accepted means of contraception.~Serious suicidal risks as judged by the study doctor.~The following DSM-IV diagnoses (to ensure a homogenous diagnostic group): Organic mental disorders; Substance abuse/dependence, including alcohol, active within the last year; Schizophrenia, Paranoid or Delusional Disorders; Other Psychotic disorders; Panic disorder; Generalized Anxiety Disorder; Obsessive-Compulsive Disorder, or Post Traumatic Stress Disorder, if a primary diagnosis; Bipolar Disorder;Bulimia Nervosa; Anorexia Nervosa.~Serious illness including cardiac, hepatic, renal, respiratory, endocrinologic, neurologic and hematologic disease that is not stabilized.~Regular or current use of other psychotropic drugs.~Use of monoamine oxidase inhibitors within 14 days of Visit 1, fluoxetine within 5 weeks of Visit 1, and other antidepressants within 7 days of Visit 1 (to ensure adequate drug washouts prior to starting escitalopram).~Previous use of escitalopram.~Treatment resistance in the current episode, as defined by failure (lack of clinically significant response) of two or more antidepressants given at therapeutic doses for at least 6 weeks.~Patients who start formal psychotherapy (e.g. cognitive-behavioural or interpersonal psychotherapy) within 3 months of Visit 1, or who plan to initiate such psychotherapy during this study.~Patients involved in any other form of treatment for depression.
|
19 Years
|
65 Years
|
All
|
No
|
Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single
|
| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change in adjusted HAM-D and MADRS scores at 3 month followup | | 6 months |
|
| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| At 3 and 6 month followup: clinical response and remission rates, absenteeism and work productivity, adverse events, quality of life, and cost-effectiveness. | | 6 months |
|
Depression, occupational function, rating scales, RCT, cognitive behaviour therapy, CBT, escitalopram, antidepressants
|
Depressive Disorder, Depression, Depressive Disorder, Major, Mood Disorders, Mental Disorders, Behavioral Symptoms
|
| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: 1<br>Telephone-based Cognitive Behaviour Therapy | Behavioral: Telephone-based Cognitive Behaviour Therapy (CBT)<br>* Telephone-based CBT: Eight sessions of telephone-based CBT (Tel-CBT) will be delivered over 8-10 weeks, based on a published manual (Simon et al, 2004). Tel-CBT has been modified to be briefer than traditional CBT (30-40 minutes instead of 60 minutes per session) and will be offered at convenient times (including evening sessions). The initial Tel-CBT session will occur within 2 weeks of randomization, with subsequent sessions occurring every 1-2 weeks depending on scheduling and patient preference. The initial session focuses on motivation enhancement exercises, subsequent sessions emphasize identifying, challenging and distancing from negative thoughts, and the final session focuses on a personal care plan and self-management skills.<br>|
| Placebo Comparator: 2<br>Telephone reminder calls | Behavioral: Telephone reminder calls<br>* Telephone reminder calls: Weekly telephone calls for 8 weeks to inquire on progress and remind patients to take their medications properly<br>|
|
The WORKER Study: Escitalopram and Telephone-based Cognitive Behaviour Therapy (CBT) for Depressed Working People
Study Overview
=================
Brief Summary
-----------------
This study will investigate the additional benefits of telephone-based cognitive behavioral therapy (Tel-CBT) as added treatment to an antidepressant (escitalopram) in working people with major depressive disorder (MDD) versus treatment with escitalopram alone. Outcomes will include depression symptom rating scales and measures of work absence and productivity. The hypothesis is that Tel-CBT and escitalopram will result in better outcomes than escitalopram alone in working patients with MDD.
Detailed Description
-----------------
Rationale CBT is recognized as an effective psychological treatment for MDD. However, there are still considerable barriers to access CBT. Newer methods of delivering CBT, such as over the telephone (Tel-CBT), allow for greater access and convenience, at potentially lower cost. This is especially relevant for working people because the service can be delivered during evenings and weekends, so they do not need to leave work to attend clinic appointments. Ease of access is also important for rural settings where distance to health facilities can be a barrier to care. The ease of delivery of Tel-CBT, both in setup and maintenance costs, may also make it an important component of enhanced support for primary care. Preliminary studies have shown that addition of Tel-CBT leads to better outcomes than usual care alone (Simon et al, 2004; Wang et al, 2007). This study will investigate the added value of Tel-CBT as adjunctive treatment to an antidepressant (escitalopram) in working people with MDD versus treatment with escitalopram alone, focusing on work-related outcomes. Escitalopram offers advantages as a first-choice treatment for depressed working people, given its superior efficacy compared to other antidepressants, excellent tolerability and simplicity of use for family physicians. Observational studies have shown significant reductions in sick leave when depressed patients are treated with escitalopram (Winkler et al, 2007). Outcome will be rigorously evaluated by assessing absenteeism and work productivity, response and remission rates, and quality of life, after acute (3 month) treatment and longer-term (6 month) follow-up. Research Method This is a 6-month, multi-centre, single-blind (rater), randomized, parallel-design study to assess the efficacy of escitalopram and Tel-CBT in the treatment of working subjects with MDD, compared to treatment with escitalopram alone. A total of 150 depressed patients meeting entry criteria will be enrolled over a 1 year period. Eligible patients will be treated with escitalopram 10-20 mg/d for the entire treatment period (6 months). Patients will be randomized to addition of telephone-based CBT with 8 sessions conducted over a 3 month period, or to a (placebo) control condition of reminder telephone calls. Outcomes (HAM-D, MADRS) will be primarily assessed over the telephone by raters blind to treatment assignment. Other outcome measures will be assessed by patient-rated questionnaires administered over the internet using a secure web site, and by ratings from the treating physician (CGI and adverse events). Statistical Analysis All randomized subjects who have at least one follow-up visit will be included in the analysis based on intent-to-treat. Ineligible subjects who are inappropriately randomized will be excluded from the analysis. Missing data will be imputed using last observation carried forward (LOCF). For the analyses the treatment variables will remain coded and the analysts and investigators will remain blinded to variable identity during analysis and interpretation. The pre-specified primary efficacy endpoint is the adjusted mean change from baseline to endpoint (12 weeks) in the HAM-D score using LOCF. All comparisons will be analyzed using ANCOVA adjusting for baseline value and centre. The secondary outcomes will also be analyzed using a similar analysis, when appropriate. Post hoc analyses will also examine observed case data. Categorical data (such as proportions of the sample with adverse events) will be analyzed using chi-square tests or Fisher's test where cell sizes warrant.
Official Title
-----------------
The WORKER Study: A Randomized Controlled Trial of Escitalopram and Telephone-based Cognitive Behaviour Therapy in Working Patients With Major Depressive Disorder
Conditions
-----------------
Major Depressive Disorder (MDD)
Intervention / Treatment
-----------------
* Behavioral: Telephone-based Cognitive Behaviour Therapy (CBT)
* Behavioral: Telephone reminder calls
Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Male and female outpatients aged 18-65 years. Patients will meet DSM-IV criteria for major depressive disorder as determined by the mood disorders section of the Mini International Neuropsychiatric Interview (MINI, Sheehan et al, 1998). Currently employed (or off work for 2 weeks or less, and expecting to return to work at the start of study). A score of 18 or greater on the self-rated version of the MADRS, indicating at least moderately severe depression. Competency to give informed consent. Exclusion Criteria: Patients on short-term (except for circumstances under Inclusion Criteria) or long-term disability. Pregnant women, lactating women and sexually active women of childbearing potential who are not using medically accepted means of contraception. Serious suicidal risks as judged by the study doctor. The following DSM-IV diagnoses (to ensure a homogenous diagnostic group): Organic mental disorders; Substance abuse/dependence, including alcohol, active within the last year; Schizophrenia, Paranoid or Delusional Disorders; Other Psychotic disorders; Panic disorder; Generalized Anxiety Disorder; Obsessive-Compulsive Disorder, or Post Traumatic Stress Disorder, if a primary diagnosis; Bipolar Disorder;Bulimia Nervosa; Anorexia Nervosa. Serious illness including cardiac, hepatic, renal, respiratory, endocrinologic, neurologic and hematologic disease that is not stabilized. Regular or current use of other psychotropic drugs. Use of monoamine oxidase inhibitors within 14 days of Visit 1, fluoxetine within 5 weeks of Visit 1, and other antidepressants within 7 days of Visit 1 (to ensure adequate drug washouts prior to starting escitalopram). Previous use of escitalopram. Treatment resistance in the current episode, as defined by failure (lack of clinically significant response) of two or more antidepressants given at therapeutic doses for at least 6 weeks. Patients who start formal psychotherapy (e.g. cognitive-behavioural or interpersonal psychotherapy) within 3 months of Visit 1, or who plan to initiate such psychotherapy during this study. Patients involved in any other form of treatment for depression.
Ages Eligible for Study
-----------------
Minimum Age: 19 Years
Maximum Age: 65 Years
Sexes Eligible for Study
-----------------
All
Accepts Healthy Volunteers
-----------------
No
Study Plan
=================
How is the study designed?
-----------------
Design Details
Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single
Arms and Interventions
| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: 1<br>Telephone-based Cognitive Behaviour Therapy | Behavioral: Telephone-based Cognitive Behaviour Therapy (CBT)<br>* Telephone-based CBT: Eight sessions of telephone-based CBT (Tel-CBT) will be delivered over 8-10 weeks, based on a published manual (Simon et al, 2004). Tel-CBT has been modified to be briefer than traditional CBT (30-40 minutes instead of 60 minutes per session) and will be offered at convenient times (including evening sessions). The initial Tel-CBT session will occur within 2 weeks of randomization, with subsequent sessions occurring every 1-2 weeks depending on scheduling and patient preference. The initial session focuses on motivation enhancement exercises, subsequent sessions emphasize identifying, challenging and distancing from negative thoughts, and the final session focuses on a personal care plan and self-management skills.<br>|
| Placebo Comparator: 2<br>Telephone reminder calls | Behavioral: Telephone reminder calls<br>* Telephone reminder calls: Weekly telephone calls for 8 weeks to inquire on progress and remind patients to take their medications properly<br>|
What is the study measuring?
-----------------
Primary Outcome Measures
| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change in adjusted HAM-D and MADRS scores at 3 month followup | | 6 months |
Secondary Outcome Measures
| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| At 3 and 6 month followup: clinical response and remission rates, absenteeism and work productivity, adverse events, quality of life, and cost-effectiveness. | | 6 months |
Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Depression, occupational function, rating scales, RCT, cognitive behaviour therapy, CBT, escitalopram, antidepressants
|
NCT00665288
|
Survey of Attitudes and Factors Associated With CPR in an Older Population
|
The goal of this study is to conduct a survey to better understand the factors associated with undertaking cardiopulmonary resuscitation (CPR) training and performing CPR in an emergency situation.
|
Background: Overall survival rate for out-of-hospital cardiac arrest rarely exceeds 5%. While bystander cardiopulmonary resuscitation (CPR) can increase survival for cardiac arrest victims up to four times, bystander CPR rates remain low in Canada (15%). Survivors have a quality of life similar to the general population. Most cardiac arrest victims are men in their sixties; they usually collapse in their own home (85%), where bystander CPR rates are even lower. The event is witnessed by a family member or bystander 50% of the time. These statistics appear to support a strategy of targeted CPR training for an older population that is most likely to witness a cardiac arrest event. Interest in CPR training appears to decrease with advancing age. Behaviour surrounding CPR training and performance has never been studied using the theoretical constructs of a well validated behavioural theory (the Theory of Planned Behaviour).~Objectives: The overall goal of this study is to conduct a survey to better understand the behavioural factors associated with successful CPR knowledge transfer in an independent-living older population (aged 55 or more). Specific objectives are: 1) To conduct semi-structured qualitative interviews to identify factors influencing CPR training and performance behaviours; 2) To then develop a survey instrument about factors influencing CPR training and performance behaviours based on a systematic review of the literature, the results of the semi-structured interviews, and theoretical constructs; and 3) To conduct a telephone survey among an independent-living population aged 55 or more using the survey instrument, and to identify factors and strategies that might be targeted by KT interventions.~Methods: Objective 1: We will tape-record semi-structured qualitative interviews conducted among 20 randomly selected participants aged 55 or older, and perform inductive analyses to identify categories and themes. Objective 2: The survey instrument will be developed based on a completed systematic review of the literature, and results from objective 1. The two behaviours under study will be �seeking CPR training and providing CPR to a cardiac arrest victim�. Objective 3: We will develop and conduct a nation-wide telephone survey using random digit dialling. The telephone survey will be centrally administered and stratified by province and large or small communities in order to obtain a representative random sample of the Canadian population. The study population will include all men and women aged 55 or older, living independently in the community, with the ability to communicate in English or French. We will seek to obtain a participation rate of 60% or greater. We estimate requiring approximately 500 respondents to identify factors and strategies for improving CPR KT in our target population. Analyses will include measures of sampling bias, reliability of the measures, construct validity, as well as multiple regression analyses to identify constructs and beliefs most salient to seniors� decisions about whether to attend CPR classes or perform CPR.
|
A Survey of Attitudes and Factors Associated With Successful Cardiopulmonary Resuscitation (CPR) Knowledge Transfer in an Older Population Most Likely to Witness Cardiac Arrest
|
Cardiac Arrest
|
Inclusion Criteria:~Canadian; stratified by province~Independent-living individuals aged 55 years or older~Ability to communicate in French or English~Exclusion Criteria:~persons living in the Northwest Territories, Yukon Territory, or Nunavut
|
55 Years
| null |
All
|
Accepts Healthy Volunteers
|
| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Measure the intent to engage in CPR training or intent to perform CPR | Descriptive statistics will be used to determine the most commonly cited barriers and facilitators to the target behaviour (intent to do CPR or obtain training in CPR). For each behaviour, the strength of the relation with the predictive constructs will be tested. | January-May 2010 |
|
cardiac arrest, heart arrest, CPR, resuscitation, bystander CPR
|
Heart Arrest, Heart Diseases, Cardiovascular Diseases
|
Survey of Attitudes and Factors Associated With CPR in an Older Population
Study Overview
=================
Brief Summary
-----------------
The goal of this study is to conduct a survey to better understand the factors associated with undertaking cardiopulmonary resuscitation (CPR) training and performing CPR in an emergency situation.
Detailed Description
-----------------
Background: Overall survival rate for out-of-hospital cardiac arrest rarely exceeds 5%. While bystander cardiopulmonary resuscitation (CPR) can increase survival for cardiac arrest victims up to four times, bystander CPR rates remain low in Canada (15%). Survivors have a quality of life similar to the general population. Most cardiac arrest victims are men in their sixties; they usually collapse in their own home (85%), where bystander CPR rates are even lower. The event is witnessed by a family member or bystander 50% of the time. These statistics appear to support a strategy of targeted CPR training for an older population that is most likely to witness a cardiac arrest event. Interest in CPR training appears to decrease with advancing age. Behaviour surrounding CPR training and performance has never been studied using the theoretical constructs of a well validated behavioural theory (the Theory of Planned Behaviour). Objectives: The overall goal of this study is to conduct a survey to better understand the behavioural factors associated with successful CPR knowledge transfer in an independent-living older population (aged 55 or more). Specific objectives are: 1) To conduct semi-structured qualitative interviews to identify factors influencing CPR training and performance behaviours; 2) To then develop a survey instrument about factors influencing CPR training and performance behaviours based on a systematic review of the literature, the results of the semi-structured interviews, and theoretical constructs; and 3) To conduct a telephone survey among an independent-living population aged 55 or more using the survey instrument, and to identify factors and strategies that might be targeted by KT interventions. Methods: Objective 1: We will tape-record semi-structured qualitative interviews conducted among 20 randomly selected participants aged 55 or older, and perform inductive analyses to identify categories and themes. Objective 2: The survey instrument will be developed based on a completed systematic review of the literature, and results from objective 1. The two behaviours under study will be �seeking CPR training and providing CPR to a cardiac arrest victim�. Objective 3: We will develop and conduct a nation-wide telephone survey using random digit dialling. The telephone survey will be centrally administered and stratified by province and large or small communities in order to obtain a representative random sample of the Canadian population. The study population will include all men and women aged 55 or older, living independently in the community, with the ability to communicate in English or French. We will seek to obtain a participation rate of 60% or greater. We estimate requiring approximately 500 respondents to identify factors and strategies for improving CPR KT in our target population. Analyses will include measures of sampling bias, reliability of the measures, construct validity, as well as multiple regression analyses to identify constructs and beliefs most salient to seniors� decisions about whether to attend CPR classes or perform CPR.
Official Title
-----------------
A Survey of Attitudes and Factors Associated With Successful Cardiopulmonary Resuscitation (CPR) Knowledge Transfer in an Older Population Most Likely to Witness Cardiac Arrest
Conditions
-----------------
Cardiac Arrest
Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Canadian; stratified by province Independent-living individuals aged 55 years or older Ability to communicate in French or English Exclusion Criteria: persons living in the Northwest Territories, Yukon Territory, or Nunavut
Ages Eligible for Study
-----------------
Minimum Age: 55 Years
Sexes Eligible for Study
-----------------
All
Accepts Healthy Volunteers
-----------------
Accepts Healthy Volunteers
Study Plan
=================
How is the study designed?
-----------------
What is the study measuring?
-----------------
Primary Outcome Measures
| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Measure the intent to engage in CPR training or intent to perform CPR | Descriptive statistics will be used to determine the most commonly cited barriers and facilitators to the target behaviour (intent to do CPR or obtain training in CPR). For each behaviour, the strength of the relation with the predictive constructs will be tested. | January-May 2010 |
Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
cardiac arrest, heart arrest, CPR, resuscitation, bystander CPR
|
||||
NCT05363332
|
Impact and Sequelae of High Ventilatory Drive in Critically Ill COVID-19 Patients
|
Critically ill COVID-19 patients with acute respiratory failure, in the intensive care unit (ICU), often feature high respiratory drive, determining large inspiratory efforts resulting in high pressures and global and regional over-distention, leading to lung injury. SARS-CoV-2 neurotropic-penetration in control centers in medulla oblongata might contribute to dysregulation and to excessively high respiratory drive observed in these patients. These pathophysiological conditions may often lead to the development of patient-ventilator asynchronies in aptients under mechanical ventilation, again leading to high tidal volumes and increased lung injury. These phenomena can contribute to prolonged duration of mechanical ventilation and ICU length of stay, but also can result in long term adverse outcomes like emotional/psychological and cognitive sequelae. All them compromising the quality of life of critically ill survivors after ICU discharge.~The investigators will conduct a multicenter study in adult critically ill COVID-19 patients with hypoxemic respiratory failure, aiming to: 1) characterize incidence and clustering of high respiratory drive by developing algorithms, 2) apply artificial intelligence in respiratory signals to identify potentially harmful patient-ventilator interactions, 3) characterize cognitive and emotional sequelae in critically ill COVID-19 survivors after ICU discharge and 4) identify sets of genes and transcriptomic signatures whose quantified expression predisposed to asynchronies and cognitive impairment in critically ill COVID-19 patients.
|
Impact and Sequelae of High Ventilatory Drive in Critically Ill COVID-19 Patients With Acute Respiratory Failure Requiring High Flow Oxygen or Mechanical Ventilation: Mechanistic and Genomic Characterization Using Artificial Intelligence
|
COVID-19, Critical Illness, Hypoxemic Respiratory Failure, Neurocognitive Dysfunction, Mechanical Ventilation Complication
|
Inclusion Criteria:~Adults patients with hypoxemic respiratory failure.~Admitted to ICU.~Mechanical ventilation or high flow nasal cannula~Exclusion Criteria:~Neurologic patients with brainsteam affection.
|
18 Years
| null |
All
|
No
|
| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Respiratory drive | To characterize the high respiratory drive phenomena in critically ill COVID-19 patients undergoing mechanical ventilation. | From day 1 at ICU until the day were the criteria of PaFi > 300 is met, up to 30 days |
|
| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Cluster of high respiratory drive | To describe the incidence and clustering of high respiratory drive throughout mechanical ventilation period by the development of specific algorithms. | From day 1 of mechanical ventilation until the day of mechanical ventilation discontinuation, up to 30 days |
| Artificial intelligence algorithms | To apply artificial intelligence (machine learning, deep learning, pattern/image recognition and entropy) in physiologic respiratory signals to identify potentially harmful patient-ventilator interactions. | From day 1 of mechanical ventilation until the day of mechanical ventilation discontinuation, up to 30 days |
| Neurocognitive disorders | To characterize cognitive and emotional sequelae in critically ill COVID-19 survivors at 1 month and 1 year after ICU discharge. | 1 month after ICU discharge and 1 year after ICU discharge |
| Gene expression | Application of massive sequencing of gene expression and circulating micro-RNA in blood samples to identify sets of genes and c-miRNA whose quantified expression is related to ventilatory asynchronies and cognitive and emotional impairment in critically ill COVID-19 patients. | day 1 of ICU admission |
|
COVID-19, Respiratory Insufficiency, Critical Illness, Cognitive Dysfunction, Pneumonia, Viral, Pneumonia, Respiratory Tract Infections, Infections, Virus Diseases, Coronavirus Infections, Coronaviridae Infections, Nidovirales Infections, RNA Virus Infections, Lung Diseases, Respiratory Tract Diseases, Disease Attributes, Pathologic Processes, Respiration Disorders, Cognition Disorders, Neurocognitive Disorders, Mental Disorders
|
| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| COVID-19 Cohort<br>Patients with a diagnosis of moderate or severe pneumonia or ARDS secondary to COVID-19. | |
| Non COVID-19 Cohort<br>Patients with a diagnosis of moderate or severe pneumonia or ARDS not secondary to COVID-19. | |
|
Impact and Sequelae of High Ventilatory Drive in Critically Ill COVID-19 Patients
Study Overview
=================
Brief Summary
-----------------
Critically ill COVID-19 patients with acute respiratory failure, in the intensive care unit (ICU), often feature high respiratory drive, determining large inspiratory efforts resulting in high pressures and global and regional over-distention, leading to lung injury. SARS-CoV-2 neurotropic-penetration in control centers in medulla oblongata might contribute to dysregulation and to excessively high respiratory drive observed in these patients. These pathophysiological conditions may often lead to the development of patient-ventilator asynchronies in aptients under mechanical ventilation, again leading to high tidal volumes and increased lung injury. These phenomena can contribute to prolonged duration of mechanical ventilation and ICU length of stay, but also can result in long term adverse outcomes like emotional/psychological and cognitive sequelae. All them compromising the quality of life of critically ill survivors after ICU discharge. The investigators will conduct a multicenter study in adult critically ill COVID-19 patients with hypoxemic respiratory failure, aiming to: 1) characterize incidence and clustering of high respiratory drive by developing algorithms, 2) apply artificial intelligence in respiratory signals to identify potentially harmful patient-ventilator interactions, 3) characterize cognitive and emotional sequelae in critically ill COVID-19 survivors after ICU discharge and 4) identify sets of genes and transcriptomic signatures whose quantified expression predisposed to asynchronies and cognitive impairment in critically ill COVID-19 patients.
Official Title
-----------------
Impact and Sequelae of High Ventilatory Drive in Critically Ill COVID-19 Patients With Acute Respiratory Failure Requiring High Flow Oxygen or Mechanical Ventilation: Mechanistic and Genomic Characterization Using Artificial Intelligence
Conditions
-----------------
COVID-19, Critical Illness, Hypoxemic Respiratory Failure, Neurocognitive Dysfunction, Mechanical Ventilation Complication
Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Adults patients with hypoxemic respiratory failure. Admitted to ICU. Mechanical ventilation or high flow nasal cannula Exclusion Criteria: Neurologic patients with brainsteam affection.
Ages Eligible for Study
-----------------
Minimum Age: 18 Years
Sexes Eligible for Study
-----------------
All
Accepts Healthy Volunteers
-----------------
No
Study Plan
=================
How is the study designed?
-----------------
Arms and Interventions
| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| COVID-19 Cohort<br>Patients with a diagnosis of moderate or severe pneumonia or ARDS secondary to COVID-19. | |
| Non COVID-19 Cohort<br>Patients with a diagnosis of moderate or severe pneumonia or ARDS not secondary to COVID-19. | |
What is the study measuring?
-----------------
Primary Outcome Measures
| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Respiratory drive | To characterize the high respiratory drive phenomena in critically ill COVID-19 patients undergoing mechanical ventilation. | From day 1 at ICU until the day were the criteria of PaFi > 300 is met, up to 30 days |
Secondary Outcome Measures
| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Cluster of high respiratory drive | To describe the incidence and clustering of high respiratory drive throughout mechanical ventilation period by the development of specific algorithms. | From day 1 of mechanical ventilation until the day of mechanical ventilation discontinuation, up to 30 days |
| Artificial intelligence algorithms | To apply artificial intelligence (machine learning, deep learning, pattern/image recognition and entropy) in physiologic respiratory signals to identify potentially harmful patient-ventilator interactions. | From day 1 of mechanical ventilation until the day of mechanical ventilation discontinuation, up to 30 days |
| Neurocognitive disorders | To characterize cognitive and emotional sequelae in critically ill COVID-19 survivors at 1 month and 1 year after ICU discharge. | 1 month after ICU discharge and 1 year after ICU discharge |
| Gene expression | Application of massive sequencing of gene expression and circulating micro-RNA in blood samples to identify sets of genes and c-miRNA whose quantified expression is related to ventilatory asynchronies and cognitive and emotional impairment in critically ill COVID-19 patients. | day 1 of ICU admission |
|
||||
NCT02411695
|
Study to Assess the Safety, Tolerability and Pharmacokinetics of Oral Brexpiprazole (OPC- 34712) in Adolescents With Schizophrenia
|
The purpose of this study is to assess the safety, tolerability and pharmacokinetics (PK) of oral brexpipirazole in adolescent subjects with schizophrenia or Other Related Psychiatric Disorders.
|
Schizophrenia is a severely delibitating mental illness that affects approximately 1% of the world population. The onset of schizophrenia symptoms typically peaks in late adolescence and early adulthood. In a minority of cases, the initial episode may occur during childhood or early adolescence. Patients who experience this early-onset schizophrenia exhibit symptoms that are more severe and follow a more chronic course; adolescents with schizophrenia may never achieve full remission of the initial episode. The prognosis for early-onset schizophrenia tends to be poor, and cognitive impairment is greater compared with individuals whose onset of schizophrenia occurs later in life. Several antipsychotics have been investigated for the treatment of adolescent schizophrenia, however, there is a particular challenge because developing bodies are more sensitive to side effects of antipsychotics, particularly with respect to weight gain. In order to enroll a population that includes the younger ages, adolescents with other related psychiatric disorders are also included in this study.
|
A Phase 1, Multicenter, Open-label, Dose-Escalation Trial to Assess the Safety, Tolerability and Pharmacokinetics of Oral Brexpiprazole (OPC- 34712) in Adolescents With Schizophrenia
|
Schizophrenia
|
* Drug: Brexpiprazole (OPC-34712)
|
Inclusion Criteria:~Male and female subjects 13 to 17 years of age, inclusive, at the time of informed consent.~Subjects with a current diagnosis of primary schizophrenia spectrum or bipolar spectrum disorder, as defined by DSM-IV-TR criteria, and confirmed by K-SADS-PL.~No psychiatric hospitalizations within the past 12 weeks.~Subjects require treatment with antipsychotic medications.~Subjects who have received previous outpatient antipsychotic treatment at an adequate dose for an adequate duration (at least 6 weeks) and who showed a previous good response to such antipsychotic treatment (other than clozapine) in the last 12 months.~Subjects with a body weight at Screening greater than or equal to 30 kg.~Exclusion Criteria:~Sexually active females of childbearing potential and male subjects who are not practicing two different methods of birth control with their partner (or abstinence) during the trial and for 30 days after the last dose of trial medication~Females who are breast-feeding and/or who have a positive pregnancy test result prior to receiving trial drug.~Subjects who have received continuous medication therapy to treat schizophrenia and schizophrenia spectrum diagnosis for less than six months prior to first dose of study medication AND subjects who have received continuous medication therapy to treat bipolar and bipolar spectrum disorder for less than two months in the past three years; or subjects who require more than one antipsychotic..~Subjects with a current DSM-IV-TR diagnosis other than schizophrenia spectrum , bipolar spectrum, including any Axis I or Axis II (DSM-IV-TR) disorder.~Subjects with a clinical presentation and/or history of any neurodevelopmental disorder~Subjects who have met DSM-IV-TR criteria for substance abuse or dependence within the past 180 days.~Subjects who currently have clinically significant neurological, hepatic, renal, metabolic, hematological, immunological, cardiovascular, pulmonary, or gastrointestinal disorders such as any history of myocardial infarction, congestive heart failure, HIV seropositive status/acquired immunodeficiency syndrome, or chronic hepatitis B or C.~Subjects with IDDM (ie, any subjects using insulin) are excluded. Subjects with non-IDDM may be eligible for the trial if their condition is stable.~Subjects with epilepsy or a history of seizures.~Any major surgery or blood transfusion within 30 days prior to first dose of trial medication.~Subjects with a positive drug screen for cocaine or other illicit drugs, or alcohol are excluded and may not be retested or re-screened.~Prohibited concomitant medications used within the exclusionary period prior to Day 1 of the Dose Escalation Phase or anticipated need for such medications during the trial.~Subjects who participated in a clinical trial and were exposed to IMP within the last 30 days or who participated in more than two interventional clinical trials within the past year.~Subjects with a history of true allergic response (ie, not intolerance) to more than one class of medications.~Inability to tolerate oral medication or swallow tablets.
|
13 Years
|
17 Years
|
All
|
No
|
Primary Purpose: Treatment
Allocation: Non-Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
|
| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Reported Adverse Events (AEs) at 30 day Follow-Up | | 30 day Follow-Up |
| Change from Baseline to Day 17 in Vital Signs | | Baseline to Day 17 |
| Change from Baseline to Day 17 ECGs | | Baseline to Day 17 |
| Change from Baseline to Day 17 Hematology | | Baseline to Day 17 |
| Change from Baseline to Day 14 Physical examination | | Baseline to Day 14 |
| Change from Baseline to Day 17 Body weight | | Baseline to Day 17 |
| Change from Baseline to Day 17 Serum chemistry | Including Prolactin concentrations | Baseline to Day 17 |
| Change from Baseline to Day 17 Urinalysis | | Baseline to Day 17 |
| Maximal peak steady-state plasma concentration | | At Day 14 |
| Minimum trough steady-state plasma concentration | | At Day 14 |
| Time to maximum peak steady-state plasma concentration | | At Day 14 |
| Area under the concentration-time curve during the dosing interval at steady-state | | At Day 14 |
| Terminal elimination half-life | | At Day 14 |
| For Brex only, apparent cleanse and apparent volume of distribution | | At Day 14 |
|
| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Mean change in CGI-S score | | Day -1 of Dose Titration Phase to Day 7 and Day 14 of Fixed Dose Phase |
| Mean change in CGI-I score | | Day 7 and Day 14 |
| Glycosylated haemoglobin [HbA1c] | | Baseline to Day 17 |
| Change from Baseline to Day 17 Adrenocorticotropic hormone [ACTH] | | Baseline to Day 17 |
| Change from Baseline to Day 17 Cortisol | | Baseline to Day 17 |
| Change from Baseline to Day 17 Thyroid stimulating hormone [TSH] | | Baseline to Day 17 |
| Change from Baseline to Day 17 Prothrombin time [PT] | | Baseline to Day 17 |
| Change from Baseline to Day 17 Activated partial thromboplastin time [aPTT] | | Baseline to Day 17 |
| Change from Baseline to Day 17 International normalized ratio [INR] | | Baseline to Day 17 |
| For subjects with a current primary schizophrenia spectrum diagnosis, mean change in Positive and Negative Syndrom Scale (PANSS) | | Day-1 to Day 15 |
| For subjects with a current diagnosis of bipolar spectrum disorder, mean change in Young Mania Rating Scale (YMRS) | | Day -1 to Day 15 |
|
Adolescent, Otsuka,, Brexpiprazole
|
Brexpiprazole, Serotonin Agents, Neurotransmitter Agents, Molecular Mechanisms of Pharmacological Action, Physiological Effects of Drugs, Dopamine Agonists, Dopamine Agents
|
| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Cohort 1<br>0.5 mg, Brexpipraxzole (OPC-34712) | Drug: Brexpiprazole (OPC-34712)<br>* Subjects who are deemed eligible for the trial will be assigned to a dosing cohort and will enter a Dose Titration Phase during which they will receive a starting dose of brexpiprazole for 2 to 10 days based on their assigned titration schedule. The Dose Titration Phase may be extended up to a maximum of 14 days, based on the observed safety and tolerability profile of the previous cohort's Dose Titration Phase. Following the Dose Titration Phase, subjects will enter the Fixed Dose Phase and will be administered the assigned dose for that cohort for 14 days.<br>|
| Experimental: Cohort 2<br>1mg, Brexpipraxzole (OPC-34712) | Drug: Brexpiprazole (OPC-34712)<br>* Subjects who are deemed eligible for the trial will be assigned to a dosing cohort and will enter a Dose Titration Phase during which they will receive a starting dose of brexpiprazole for 2 to 10 days based on their assigned titration schedule. The Dose Titration Phase may be extended up to a maximum of 14 days, based on the observed safety and tolerability profile of the previous cohort's Dose Titration Phase. Following the Dose Titration Phase, subjects will enter the Fixed Dose Phase and will be administered the assigned dose for that cohort for 14 days.<br>|
| Experimental: Cohort 3<br>2mg, Brexpipraxzole (OPC-34712) | Drug: Brexpiprazole (OPC-34712)<br>* Subjects who are deemed eligible for the trial will be assigned to a dosing cohort and will enter a Dose Titration Phase during which they will receive a starting dose of brexpiprazole for 2 to 10 days based on their assigned titration schedule. The Dose Titration Phase may be extended up to a maximum of 14 days, based on the observed safety and tolerability profile of the previous cohort's Dose Titration Phase. Following the Dose Titration Phase, subjects will enter the Fixed Dose Phase and will be administered the assigned dose for that cohort for 14 days.<br>|
| Experimental: Cohort 4<br>3 mg, Brexpipraxzole (OPC-34712) | Drug: Brexpiprazole (OPC-34712)<br>* Subjects who are deemed eligible for the trial will be assigned to a dosing cohort and will enter a Dose Titration Phase during which they will receive a starting dose of brexpiprazole for 2 to 10 days based on their assigned titration schedule. The Dose Titration Phase may be extended up to a maximum of 14 days, based on the observed safety and tolerability profile of the previous cohort's Dose Titration Phase. Following the Dose Titration Phase, subjects will enter the Fixed Dose Phase and will be administered the assigned dose for that cohort for 14 days.<br>|
| Experimental: Cohort 5<br>4mg, Brexpipraxzole (OPC-34712) | Drug: Brexpiprazole (OPC-34712)<br>* Subjects who are deemed eligible for the trial will be assigned to a dosing cohort and will enter a Dose Titration Phase during which they will receive a starting dose of brexpiprazole for 2 to 10 days based on their assigned titration schedule. The Dose Titration Phase may be extended up to a maximum of 14 days, based on the observed safety and tolerability profile of the previous cohort's Dose Titration Phase. Following the Dose Titration Phase, subjects will enter the Fixed Dose Phase and will be administered the assigned dose for that cohort for 14 days.<br>|
|
Study to Assess the Safety, Tolerability and Pharmacokinetics of Oral Brexpiprazole (OPC- 34712) in Adolescents With Schizophrenia
Study Overview
=================
Brief Summary
-----------------
The purpose of this study is to assess the safety, tolerability and pharmacokinetics (PK) of oral brexpipirazole in adolescent subjects with schizophrenia or Other Related Psychiatric Disorders.
Detailed Description
-----------------
Schizophrenia is a severely delibitating mental illness that affects approximately 1% of the world population. The onset of schizophrenia symptoms typically peaks in late adolescence and early adulthood. In a minority of cases, the initial episode may occur during childhood or early adolescence. Patients who experience this early-onset schizophrenia exhibit symptoms that are more severe and follow a more chronic course; adolescents with schizophrenia may never achieve full remission of the initial episode. The prognosis for early-onset schizophrenia tends to be poor, and cognitive impairment is greater compared with individuals whose onset of schizophrenia occurs later in life. Several antipsychotics have been investigated for the treatment of adolescent schizophrenia, however, there is a particular challenge because developing bodies are more sensitive to side effects of antipsychotics, particularly with respect to weight gain. In order to enroll a population that includes the younger ages, adolescents with other related psychiatric disorders are also included in this study.
Official Title
-----------------
A Phase 1, Multicenter, Open-label, Dose-Escalation Trial to Assess the Safety, Tolerability and Pharmacokinetics of Oral Brexpiprazole (OPC- 34712) in Adolescents With Schizophrenia
Conditions
-----------------
Schizophrenia
Intervention / Treatment
-----------------
* Drug: Brexpiprazole (OPC-34712)
Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Male and female subjects 13 to 17 years of age, inclusive, at the time of informed consent. Subjects with a current diagnosis of primary schizophrenia spectrum or bipolar spectrum disorder, as defined by DSM-IV-TR criteria, and confirmed by K-SADS-PL. No psychiatric hospitalizations within the past 12 weeks. Subjects require treatment with antipsychotic medications. Subjects who have received previous outpatient antipsychotic treatment at an adequate dose for an adequate duration (at least 6 weeks) and who showed a previous good response to such antipsychotic treatment (other than clozapine) in the last 12 months. Subjects with a body weight at Screening greater than or equal to 30 kg. Exclusion Criteria: Sexually active females of childbearing potential and male subjects who are not practicing two different methods of birth control with their partner (or abstinence) during the trial and for 30 days after the last dose of trial medication Females who are breast-feeding and/or who have a positive pregnancy test result prior to receiving trial drug. Subjects who have received continuous medication therapy to treat schizophrenia and schizophrenia spectrum diagnosis for less than six months prior to first dose of study medication AND subjects who have received continuous medication therapy to treat bipolar and bipolar spectrum disorder for less than two months in the past three years; or subjects who require more than one antipsychotic.. Subjects with a current DSM-IV-TR diagnosis other than schizophrenia spectrum , bipolar spectrum, including any Axis I or Axis II (DSM-IV-TR) disorder. Subjects with a clinical presentation and/or history of any neurodevelopmental disorder Subjects who have met DSM-IV-TR criteria for substance abuse or dependence within the past 180 days. Subjects who currently have clinically significant neurological, hepatic, renal, metabolic, hematological, immunological, cardiovascular, pulmonary, or gastrointestinal disorders such as any history of myocardial infarction, congestive heart failure, HIV seropositive status/acquired immunodeficiency syndrome, or chronic hepatitis B or C. Subjects with IDDM (ie, any subjects using insulin) are excluded. Subjects with non-IDDM may be eligible for the trial if their condition is stable. Subjects with epilepsy or a history of seizures. Any major surgery or blood transfusion within 30 days prior to first dose of trial medication. Subjects with a positive drug screen for cocaine or other illicit drugs, or alcohol are excluded and may not be retested or re-screened. Prohibited concomitant medications used within the exclusionary period prior to Day 1 of the Dose Escalation Phase or anticipated need for such medications during the trial. Subjects who participated in a clinical trial and were exposed to IMP within the last 30 days or who participated in more than two interventional clinical trials within the past year. Subjects with a history of true allergic response (ie, not intolerance) to more than one class of medications. Inability to tolerate oral medication or swallow tablets.
Ages Eligible for Study
-----------------
Minimum Age: 13 Years
Maximum Age: 17 Years
Sexes Eligible for Study
-----------------
All
Accepts Healthy Volunteers
-----------------
No
Study Plan
=================
How is the study designed?
-----------------
Design Details
Primary Purpose: Treatment
Allocation: Non-Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Arms and Interventions
| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Cohort 1<br>0.5 mg, Brexpipraxzole (OPC-34712) | Drug: Brexpiprazole (OPC-34712)<br>* Subjects who are deemed eligible for the trial will be assigned to a dosing cohort and will enter a Dose Titration Phase during which they will receive a starting dose of brexpiprazole for 2 to 10 days based on their assigned titration schedule. The Dose Titration Phase may be extended up to a maximum of 14 days, based on the observed safety and tolerability profile of the previous cohort's Dose Titration Phase. Following the Dose Titration Phase, subjects will enter the Fixed Dose Phase and will be administered the assigned dose for that cohort for 14 days.<br>|
| Experimental: Cohort 2<br>1mg, Brexpipraxzole (OPC-34712) | Drug: Brexpiprazole (OPC-34712)<br>* Subjects who are deemed eligible for the trial will be assigned to a dosing cohort and will enter a Dose Titration Phase during which they will receive a starting dose of brexpiprazole for 2 to 10 days based on their assigned titration schedule. The Dose Titration Phase may be extended up to a maximum of 14 days, based on the observed safety and tolerability profile of the previous cohort's Dose Titration Phase. Following the Dose Titration Phase, subjects will enter the Fixed Dose Phase and will be administered the assigned dose for that cohort for 14 days.<br>|
| Experimental: Cohort 3<br>2mg, Brexpipraxzole (OPC-34712) | Drug: Brexpiprazole (OPC-34712)<br>* Subjects who are deemed eligible for the trial will be assigned to a dosing cohort and will enter a Dose Titration Phase during which they will receive a starting dose of brexpiprazole for 2 to 10 days based on their assigned titration schedule. The Dose Titration Phase may be extended up to a maximum of 14 days, based on the observed safety and tolerability profile of the previous cohort's Dose Titration Phase. Following the Dose Titration Phase, subjects will enter the Fixed Dose Phase and will be administered the assigned dose for that cohort for 14 days.<br>|
| Experimental: Cohort 4<br>3 mg, Brexpipraxzole (OPC-34712) | Drug: Brexpiprazole (OPC-34712)<br>* Subjects who are deemed eligible for the trial will be assigned to a dosing cohort and will enter a Dose Titration Phase during which they will receive a starting dose of brexpiprazole for 2 to 10 days based on their assigned titration schedule. The Dose Titration Phase may be extended up to a maximum of 14 days, based on the observed safety and tolerability profile of the previous cohort's Dose Titration Phase. Following the Dose Titration Phase, subjects will enter the Fixed Dose Phase and will be administered the assigned dose for that cohort for 14 days.<br>|
| Experimental: Cohort 5<br>4mg, Brexpipraxzole (OPC-34712) | Drug: Brexpiprazole (OPC-34712)<br>* Subjects who are deemed eligible for the trial will be assigned to a dosing cohort and will enter a Dose Titration Phase during which they will receive a starting dose of brexpiprazole for 2 to 10 days based on their assigned titration schedule. The Dose Titration Phase may be extended up to a maximum of 14 days, based on the observed safety and tolerability profile of the previous cohort's Dose Titration Phase. Following the Dose Titration Phase, subjects will enter the Fixed Dose Phase and will be administered the assigned dose for that cohort for 14 days.<br>|
What is the study measuring?
-----------------
Primary Outcome Measures
| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Reported Adverse Events (AEs) at 30 day Follow-Up | | 30 day Follow-Up |
| Change from Baseline to Day 17 in Vital Signs | | Baseline to Day 17 |
| Change from Baseline to Day 17 ECGs | | Baseline to Day 17 |
| Change from Baseline to Day 17 Hematology | | Baseline to Day 17 |
| Change from Baseline to Day 14 Physical examination | | Baseline to Day 14 |
| Change from Baseline to Day 17 Body weight | | Baseline to Day 17 |
| Change from Baseline to Day 17 Serum chemistry | Including Prolactin concentrations | Baseline to Day 17 |
| Change from Baseline to Day 17 Urinalysis | | Baseline to Day 17 |
| Maximal peak steady-state plasma concentration | | At Day 14 |
| Minimum trough steady-state plasma concentration | | At Day 14 |
| Time to maximum peak steady-state plasma concentration | | At Day 14 |
| Area under the concentration-time curve during the dosing interval at steady-state | | At Day 14 |
| Terminal elimination half-life | | At Day 14 |
| For Brex only, apparent cleanse and apparent volume of distribution | | At Day 14 |
Secondary Outcome Measures
| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Mean change in CGI-S score | | Day -1 of Dose Titration Phase to Day 7 and Day 14 of Fixed Dose Phase |
| Mean change in CGI-I score | | Day 7 and Day 14 |
| Glycosylated haemoglobin [HbA1c] | | Baseline to Day 17 |
| Change from Baseline to Day 17 Adrenocorticotropic hormone [ACTH] | | Baseline to Day 17 |
| Change from Baseline to Day 17 Cortisol | | Baseline to Day 17 |
| Change from Baseline to Day 17 Thyroid stimulating hormone [TSH] | | Baseline to Day 17 |
| Change from Baseline to Day 17 Prothrombin time [PT] | | Baseline to Day 17 |
| Change from Baseline to Day 17 Activated partial thromboplastin time [aPTT] | | Baseline to Day 17 |
| Change from Baseline to Day 17 International normalized ratio [INR] | | Baseline to Day 17 |
| For subjects with a current primary schizophrenia spectrum diagnosis, mean change in Positive and Negative Syndrom Scale (PANSS) | | Day-1 to Day 15 |
| For subjects with a current diagnosis of bipolar spectrum disorder, mean change in Young Mania Rating Scale (YMRS) | | Day -1 to Day 15 |
Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Adolescent, Otsuka,, Brexpiprazole
|
NCT02255357
|
Investigation of Intranasal Oxytocin on Relapse Risk in Cocaine-dependent Patients.
|
This proposal describes a combined laboratory and clinical trial preliminary investigation to advance medication development for cocaine dependence. The main objective is to test whether intranasal Oxytocin could reduce relapse risk by reducing stress sensitivity. To measure the stress sensitivity, this study will evaluate a new stress challenge: a) Intranasal desmopressin, a vasopressin analog, will be used an endocrine stressor; its effects will be evaluated by serial measurements of serum Adrenocorticotropin hormone (ACTH), and self reports; b) if pretreatment with intranasal oxytocin dampens the ACTH and subjective response to intranasal desmopressin. These measures will be tested during a 7-day inpatient abstinence induction hospitalization. For those patients with family and work obligations, an outpatient abstinence induction procedure is available. The response to the desmopressin challenge will be compared to a cohort of matched control subjects. After abstinence induction, cocaine dependent patients enter a 6-week, double blind, randomized, placebo-controlled trial of 24 IU of intranasal oxytocin vs. placebo, to monitor if this reduces the relapse risk.
|
This study is based on the findings that chronic stress, caused in these patients by cocaine dependence, increases the sensitivity of the Hypothalamo-Pituitary-Adrenal (HPA) axis and CNS stress pathways to vasopressin. For their part, oxytocin systems, in chronic stress, acquire an increasing moderating effect on CNS stress system and the HPA axis. Cocaine dependence generates increased responsivity of stress system to oxytocin in the face of depleted oxytocin stores; thus creating an environment where exogenous oxytocin could exert a strong regulatory effect. Intranasal administration provides a convenient method to deliver these small peptides to the brain. Studying the feasibility of this approach, and its applicability to the treatment of cocaine-dependent patients, will be a goal of the study. The main outcome of this study will be the number of consecutive days of abstinence from cocaine after abstinence induction. A secondary outcome will be: Is the acute effect of intranasal oxytocin on desmopressin-induced ACTH secretion associated with the number of days of continued abstinence.
|
Investigation of the Effect of Intranasal Oxytocin on Relapse Risk in Cocaine-dependent Patients
|
Cocaine Dependence
|
* Drug: Placebo
* Drug: Intranasal Oxytocin
|
Study Inclusion Criteria (cocaine-dependent participants):~Age 18 to 60.~Meet DSM-IV criteria for current cocaine dependence and is seeking treatment.~Displays at least one cocaine-positive urine toxicology during screening.~Use of cocaine at least 4 days in the past month, with at least weekly use, or reports episodic binges of large amounts of cocaine (at least $200) at least 2x/month.~Able to give informed consent and comply with study procedures.~Can pass the blindfolded scent test recognizing the scent of cinnamon or coffee.~Study Exclusion Criteria (cocaine-dependent participants):~Meets DSM-IV criteria for bipolar disorder, schizophrenia or any psychotic disorder other than transient psychosis due to drug abuse. Severe depression is an exclusion criteria (Hamilton Depression Scale ≥ 15).~History of allergy or adverse event related to Oxytocin or Desmopressin. Patient using Oxytocin or Vasopressin-based products cannot participate.~Chronic organic mental disorder, insufficient proficiency in English, or any condition or status (illiteracy) that would render an individual incapable of giving informed consent.~Significant current suicidal risk, suicide attempt within the past year.~Unstable physical disorders, which might make participation hazardous.~Coronary Vascular disease as indicated by history, or suspected by abnormal ECG.~Currently meets DSM-IV criteria for another substance dependence or abuse disorder other than nicotine, or alcohol. If alcohol dependent, must not be in need of detoxification.~Participants who cannot comply with study procedures during the inpatient or outpatient abstinence induction (phase 1) will not proceed to Phase 2.~Pregnancy, positive urine pregnancy test, or breastfeeding. Women who wish to participate must agree to use a method of contraception during the study and sign a written commitment to that effect, and submit to a urine pregnancy test every two weeks of Phase 2.~History of transphenoidal surgery or sinus surgery in the past month. Simple nasal congestion is not exclusionary.~Study Inclusion Criteria (healthy volunteers):~Age 18 to 60.~Able to give informed consent and comply with study procedures.~Can pass the blindfolded scent test recognizing the scent of cinnamon or coffee.~Study Exclusion Criteria (healthy volunteers):~DSM-IV Axis 1 psychiatric diagnosis. Severe Major Depression (Hamilton Depression Scale > 15) is an exclusion criteria.~Unstable physical disorders, which might make participation hazardous.~Diagnosis of Substance Abuse or Dependence disorder, with exception of nicotine dependence. Patients in remission may participate if its duration is greater than 2 years preceding participation.~History of allergy or adverse event related to oxytocin or desmopressin. Patient using oxytocin or vasopressin-based products cannot participate.~Chronic organic mental disorder, insufficient proficiency in English or illiteracy that would render an individual incapable of giving informed consent.~History of transphenoidal surgery or sinus surgery in the past month. Simple nasal congestion is not exclusionary.
|
18 Years
|
60 Years
|
All
|
Accepts Healthy Volunteers
|
Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double
|
| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Weeks of Abstinence From Cocaine | this is outcome for the phase 2, clinicial trial portion of this combined laboratory and clinical trial laboratory human study~For the human laboratory study, Phase 1, the primary outcome is differences in ACTH levels following a) Intranasal Desmopressin, and, on a consecutive day, b) Intranasal Desmopressin preceded by a treatment with Intranasal Oxytocin (Syntocinon). this takes place on 2 consecutive days | Phase 1: 7 days; Phase 2: 6 weeks |
|
Oxytocin, Vasopressin, Cocaine
|
Oxytocin, Oxytocics, Reproductive Control Agents, Physiological Effects of Drugs
|
| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Placebo Comparator: Placebo<br>Solution containing only the excipients of the original solution without Oxytocin. | Drug: Placebo<br>* Solution containing only the excipients of the original solution without Oxytocin.<br>|
| Active Comparator: Intranasal Syntocinon<br>Intranasal Oxytocin 24 IU per day. | Drug: Intranasal Oxytocin<br>* solution containing Oxytocin 6 IU/0.1cc or per puff is used in this arm<br>* Other names: Syntocinon;|
|
Investigation of Intranasal Oxytocin on Relapse Risk in Cocaine-dependent Patients.
Study Overview
=================
Brief Summary
-----------------
This proposal describes a combined laboratory and clinical trial preliminary investigation to advance medication development for cocaine dependence. The main objective is to test whether intranasal Oxytocin could reduce relapse risk by reducing stress sensitivity. To measure the stress sensitivity, this study will evaluate a new stress challenge: a) Intranasal desmopressin, a vasopressin analog, will be used an endocrine stressor; its effects will be evaluated by serial measurements of serum Adrenocorticotropin hormone (ACTH), and self reports; b) if pretreatment with intranasal oxytocin dampens the ACTH and subjective response to intranasal desmopressin. These measures will be tested during a 7-day inpatient abstinence induction hospitalization. For those patients with family and work obligations, an outpatient abstinence induction procedure is available. The response to the desmopressin challenge will be compared to a cohort of matched control subjects. After abstinence induction, cocaine dependent patients enter a 6-week, double blind, randomized, placebo-controlled trial of 24 IU of intranasal oxytocin vs. placebo, to monitor if this reduces the relapse risk.
Detailed Description
-----------------
This study is based on the findings that chronic stress, caused in these patients by cocaine dependence, increases the sensitivity of the Hypothalamo-Pituitary-Adrenal (HPA) axis and CNS stress pathways to vasopressin. For their part, oxytocin systems, in chronic stress, acquire an increasing moderating effect on CNS stress system and the HPA axis. Cocaine dependence generates increased responsivity of stress system to oxytocin in the face of depleted oxytocin stores; thus creating an environment where exogenous oxytocin could exert a strong regulatory effect. Intranasal administration provides a convenient method to deliver these small peptides to the brain. Studying the feasibility of this approach, and its applicability to the treatment of cocaine-dependent patients, will be a goal of the study. The main outcome of this study will be the number of consecutive days of abstinence from cocaine after abstinence induction. A secondary outcome will be: Is the acute effect of intranasal oxytocin on desmopressin-induced ACTH secretion associated with the number of days of continued abstinence.
Official Title
-----------------
Investigation of the Effect of Intranasal Oxytocin on Relapse Risk in Cocaine-dependent Patients
Conditions
-----------------
Cocaine Dependence
Intervention / Treatment
-----------------
* Drug: Placebo
* Drug: Intranasal Oxytocin
Participation Criteria
=================
Eligibility Criteria
-----------------
Study Inclusion Criteria (cocaine-dependent participants): Age 18 to 60. Meet DSM-IV criteria for current cocaine dependence and is seeking treatment. Displays at least one cocaine-positive urine toxicology during screening. Use of cocaine at least 4 days in the past month, with at least weekly use, or reports episodic binges of large amounts of cocaine (at least $200) at least 2x/month. Able to give informed consent and comply with study procedures. Can pass the blindfolded scent test recognizing the scent of cinnamon or coffee. Study Exclusion Criteria (cocaine-dependent participants): Meets DSM-IV criteria for bipolar disorder, schizophrenia or any psychotic disorder other than transient psychosis due to drug abuse. Severe depression is an exclusion criteria (Hamilton Depression Scale ≥ 15). History of allergy or adverse event related to Oxytocin or Desmopressin. Patient using Oxytocin or Vasopressin-based products cannot participate. Chronic organic mental disorder, insufficient proficiency in English, or any condition or status (illiteracy) that would render an individual incapable of giving informed consent. Significant current suicidal risk, suicide attempt within the past year. Unstable physical disorders, which might make participation hazardous. Coronary Vascular disease as indicated by history, or suspected by abnormal ECG. Currently meets DSM-IV criteria for another substance dependence or abuse disorder other than nicotine, or alcohol. If alcohol dependent, must not be in need of detoxification. Participants who cannot comply with study procedures during the inpatient or outpatient abstinence induction (phase 1) will not proceed to Phase 2. Pregnancy, positive urine pregnancy test, or breastfeeding. Women who wish to participate must agree to use a method of contraception during the study and sign a written commitment to that effect, and submit to a urine pregnancy test every two weeks of Phase 2. History of transphenoidal surgery or sinus surgery in the past month. Simple nasal congestion is not exclusionary. Study Inclusion Criteria (healthy volunteers): Age 18 to 60. Able to give informed consent and comply with study procedures. Can pass the blindfolded scent test recognizing the scent of cinnamon or coffee. Study Exclusion Criteria (healthy volunteers): DSM-IV Axis 1 psychiatric diagnosis. Severe Major Depression (Hamilton Depression Scale > 15) is an exclusion criteria. Unstable physical disorders, which might make participation hazardous. Diagnosis of Substance Abuse or Dependence disorder, with exception of nicotine dependence. Patients in remission may participate if its duration is greater than 2 years preceding participation. History of allergy or adverse event related to oxytocin or desmopressin. Patient using oxytocin or vasopressin-based products cannot participate. Chronic organic mental disorder, insufficient proficiency in English or illiteracy that would render an individual incapable of giving informed consent. History of transphenoidal surgery or sinus surgery in the past month. Simple nasal congestion is not exclusionary.
Ages Eligible for Study
-----------------
Minimum Age: 18 Years
Maximum Age: 60 Years
Sexes Eligible for Study
-----------------
All
Accepts Healthy Volunteers
-----------------
Accepts Healthy Volunteers
Study Plan
=================
How is the study designed?
-----------------
Design Details
Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double
Arms and Interventions
| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Placebo Comparator: Placebo<br>Solution containing only the excipients of the original solution without Oxytocin. | Drug: Placebo<br>* Solution containing only the excipients of the original solution without Oxytocin.<br>|
| Active Comparator: Intranasal Syntocinon<br>Intranasal Oxytocin 24 IU per day. | Drug: Intranasal Oxytocin<br>* solution containing Oxytocin 6 IU/0.1cc or per puff is used in this arm<br>* Other names: Syntocinon;|
What is the study measuring?
-----------------
Primary Outcome Measures
| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Weeks of Abstinence From Cocaine | this is outcome for the phase 2, clinicial trial portion of this combined laboratory and clinical trial laboratory human study For the human laboratory study, Phase 1, the primary outcome is differences in ACTH levels following a) Intranasal Desmopressin, and, on a consecutive day, b) Intranasal Desmopressin preceded by a treatment with Intranasal Oxytocin (Syntocinon). this takes place on 2 consecutive days | Phase 1: 7 days; Phase 2: 6 weeks |
Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Oxytocin, Vasopressin, Cocaine
|
|
NCT00493285
|
Safety and Tolerability Study to Evaluate MEDI-534 in Children 6 to < 24 Months of Age
|
The overall objective of the MEDI-534 clinical development program is to evaluate the safety, efficacy and tolerability of MEDI-534 for the prevention of serious RSV and PIV3 disease in young infants.
|
The primary objective of this study is to describe the safety and tolerability of multiple doses of MEDI-534 at 10^4, 10^5, or 10^6 TCID50 when administered to RSV and PIV3 seronegative children 6 to <24 months of age.
|
A Phase 1, Randomized, Double-Blind, Placebo-Controlled, Dose-Escalation Study to Evaluate the Safety, Tolerability,Immunogenicity, and Viral Shedding of MEDI-534, a Live, Attenuated Intranasal Vaccine Against Respiratory Syncytial Virus (RSV) and Parainfluenza Virus Type 3 (PIV), in Healthy Children 6 to <24 Months of Age
|
Respiratory Viral Infections, Respiratory Syncytial Virus Infections, Parainfluenza Virus 3, Human
|
* Biological: MEDI-534
* Biological: MEDI-534
* Biological: MEDI-534
|
Inclusion Criteria:~Male or female whose age on the day of randomization is 6 to <24 months (reached 6th month birthday and not yet reached 2nd year birthday)~Subject is seronegative to both RSV and PIV3 at screening~Subject was the product of normal full term pregnancy (defined as >36 weeks gestation)~Subject is in general good health~Subject's legal representative is available by telephone~Written informed consent and HIPAA authorization (if applicable) obtained from the subject's legal representative~Subject's legal representative is able to understand and comply with the requirements of the protocol as judged by the investigator~Subject is available to complete the follow-up period, which will be through the end of RSV season (provisionally defined as 01/Apr for the United States) or 180 days after the final dose of study vaccine, whichever is later~Subject's legal representative must be willing and able to bring the subject to the study site for evaluation of respiratory illness in accordance with the protocol~Exclusion Criteria:~Any fever (equal to or greater than 100.4°F [equal to or greater than 38.0°C], regardless of route) or lower respiratory illness (Section 4.1.2) within 7 days prior to randomization~Moderate or severe nasal congestion that in the investigator's opinion could prevent intranasal delivery of vaccine~Any drug therapy (chronic or other) within 7 days prior to randomization or expected receipt through the protocol-specified blood collection 28 days after each study vaccine dosing, except that infrequent use of over-the-counter medications such as pain relievers are permitted according to the judgment of the investigator~Any current or expected receipt of immunosuppressive agents including steroids (2 mg/kg per day of prednisone or its equivalent, or equal to or greater than 20 mg/day if the subject weighs >10 kg, given daily or on alternate days for equal to or greater than 14 days); children in this category should not receive study vaccine until immunosuppressive agents including corticosteroid therapy have been discontinued for equal to or greater than 30 days; the use of topical steroids is permitted according to the judgment of the investigator~History of receipt of blood transfusion or expected receipt through 30 days following final study vaccine dosing~History of receipt of immunoglobulin products or expected receipt through 30 days after study vaccine dosing~Receipt of any investigational drug within 60 days prior to randomization or expected receipt through 30 days after final study vaccine dosing~Receipt of any live virus vaccine (excluding rotavirus vaccine) within 28 days prior to randomization or expected receipt within a 28-day window around any study vaccine dose~Receipt of any inactivated (i.e., non-live) vaccine or rotavirus vaccine within 14 days prior to randomization or expected receipt within a 14-day window around any study vaccine dose~Known or suspected immunodeficiency, including HIV~Living in the same home or enrolled in the same classroom at day care with infants <24 months of age (only one child per household may be enrolled into the study)~Contact with pregnant caregiver~A household contact who is immunocompromised; the subject should also avoid close contact with immunocompromised individuals for at least 30 days after any study vaccine dose~A household contact who is a health care provider in contact with immunocompromised patients or who is a day care provider for infants under the age of 6 months~History of allergic reaction to any component of the study vaccine~Previous medical history, or evidence, of an intercurrent or chronic illness that, in the opinion of the investigator, may compromise the safety of the subject~Known or suspected active or chronic hepatitis infection~History of medical diagnosis of asthma, reactive airway disease, wheezing requiring medication, cystic fibrosis, bronchopulmonary dysplasia, chronic pulmonary disease, medically confirmed apnea, hospitalization for respiratory illness or mechanical ventilation~Family member or household contact who is an employee of the research center or otherwise involved with the conduct of the study~Any condition that, in the opinion of the investigator, might interfere with study vaccine evaluation
|
6 Months
|
23 Months
|
All
|
Accepts Healthy Volunteers
|
Primary Purpose: Prevention
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple
|
| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Number of Participants With Solicited Adverse Events (SEs) After Dose 1 | The SEs for this study included fever ≥ 100.4°F, runny/stuffy nose, cough, drowsiness, loss of appetite/decreased urine output, irritability/fussiness, laryngitis, and epistaxis. | Days 0-28 after Dose 1 (Dose 1 was on Day 0) |
| Number of Participants With SEs After Dose 2 | The SEs for this study included fever ≥ 100.4°F, runny/stuffy nose, cough, drowsiness, loss of appetite/decreased urine output, irritability/fussiness, laryngitis, and epistaxis. | Days 0-28 after Dose 2 (Dose 2 was on Day 48-64) |
| Number of Participants With SEs After Dose 3 | The SEs for this study included fever ≥ 100.4°F, runny/stuffy nose, cough, drowsiness, loss of appetite/decreased urine output, irritability/fussiness, laryngitis, and epistaxis. | Days 0-28 after Dose 3 (Dose 3 was 48-64 days after Dose 2) |
| Number of Participants With Adverse Events (AEs) After Dose 1 | Unsolicited AEs reported by 1 or more participants in either treatment group through 28 days post Dose 1. | Days 0-28 after Dose 1 (Dose 1 was on Day 0) |
| Number of Participants With AEs After Dose 2 | Unsolicited AEs reported by 1 or more participants in either treatment group through 28 days post Dose 2. | Days 0-28 after Dose 2 (Dose 2 was on Day 48-64) |
| Number of Participants With AEs After Dose 3 | Unsolicited AEs reported by 1 or more participants in either treatment group through 28 days post Dose 3. | Days 0-28 after Dose 3 (Dose 3 was 48-64 days after Dose 2) |
| Number of Subjects With Medically-attended Lower Respiratory Illnesses (MA-LRIs) | An MA-LRI was a healthcare provider-confirmed diagnosis of 1 or more of the following: wheezing, pneumonia, croup, rhonchi (not cleared with cough or suctioning), rales, bronchitis, bronchiolitis, apnea. | Days 0 to 180 days after final dose or the end of the RSV season, whichever was later |
| Number of Participants With Serious Adverse Events (SAEs) | Events resulting in death; were life-threatening; resulted in inpatient hospitalization/prolongation of hospitalization; resulted in persistent or significant disability or incapacity; were a congenital anomaly/birth defect in the offspring of a participant; or were an important medical event that may not have resulted in death, threatened life, or required hospitalization and may have jeopardized the participant and required medical/surgical intervention to prevent one of the above outcomes. | Days 0-28 after any dose |
| Number of Participants With Significant New Medical Conditions (SNMCs) | A SNMC is a newly diagnosed medical condition that is of a chronic, ongoing nature and is assessed by the investigator as medically significant. | Day 0 through 180 days after the final dose or through the end of the RSV season, whichever was later |
|
| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Number of Participants Shedding Vaccine-like Virus at Any Time During Study Participation | Number of participants with nasal wash specimens that were positive for RSV or PIV3 by culture and identified as vaccine-type virus by RT-PCR. | Days 7, 12, and 28 after each dose and during visits for pre-specified illness symptoms occurring Day 0 through 28-34 days post each dose. |
| Number of Participants Shedding Vaccine-like Virus at 7 Days After Dose 1 | Number of participants with nasal wash specimens that were positive for RSV or PIV3 by culture and identified as vaccine-type virus by RT-PCR. | Days 7-10 after Dose 1 (Dose 1 was on Day 0) |
| Number of Participants Shedding Vaccine-like Virus at 12 Days After Dose 1 | Number of participants with nasal wash specimens that were positive for RSV or PIV3 by culture and identified as vaccine-type virus by RT-PCR. | Days 12-18 after Dose 1 (Dose 1 was on Day 0) |
| Number of Participants Shedding Vaccine-like Virus at 28 Days After Dose 1 | Number of participants with nasal wash specimens that were positive for RSV or PIV3 by culture and identified as vaccine-type virus by RT-PCR. | Days 28-34 after Dose 1 (Dose 1 was on Day 0) |
| Number of Participants With Shedding of Vaccine-like Virus on Any Day During Days 0-28 After Dose 1 | Number of participants with nasal wash specimens that were positive for RSV or PIV3 by culture and identified as vaccine-type virus by RT-PCR. | Days 0-34 after Dose 1 (Dose 1 was on Day 0) |
| Number of Participants Shedding Vaccine-like Virus at 7 Days After Dose 2 | Number of participants with nasal wash specimens that were positive for RSV or PIV3 by culture and identified as vaccine-type virus by RT-PCR. | Days 7-10 after Dose 2 (Dose 2 was on Day 48-64) |
| Number of Participants Shedding Vaccine-like Virus at 12 Days After Dose 2 | Number of participants with nasal wash specimens that were positive for RSV or PIV3 by culture and identified as vaccine-type virus by RT-PCR. | Days 12-18 after Dose 2 (Dose 2 was on Day 48-64) |
| Number of Participants Shedding Vaccine-like Virus at 28 Days After Dose 2 | Number of participants with nasal wash specimens that were positive for RSV or PIV3 by culture and identified as vaccine-type virus by RT-PCR. | Days 28-34 after Dose 2 (Dose 2 was on Day 48-64) |
| Number of Participants With Shedding of Vaccine-like Virus on Any Day During Days 0-28 After Dose 2 | Number of participants with nasal wash specimens that were positive for RSV or PIV3 by culture and identified as vaccine-type virus by RT-PCR. | Days 0-34 after Dose 2 (Dose 2 was on Day 48-64) |
| Number of Participants Shedding Vaccine-like Virus at 7 Days After Dose 3 | Number of participants with nasal wash specimens that were positive for RSV or PIV3 by culture and identified as vaccine-type virus by RT-PCR. | Days 7-10 after Dose 3 (Dose 3 was 48-64 days after Dose 2) |
| Number of Participants Shedding Vaccine-like Virus at 12 Days After Dose 3 | Number of participants with nasal wash specimens that were positive for RSV or PIV3 by culture and identified as vaccine-type virus by RT-PCR. | Days 12-18 after Dose 3 (Dose 3 was 48-64 days after Dose 2) |
| Number of Participants Shedding Vaccine-like Virus at 28 Days After Dose 3 | Number of participants with nasal wash specimens that were positive for RSV or PIV3 by culture and identified as vaccine-type virus by RT-PCR. | Days 28-34 after Dose 3 (Dose 3 was 48-64 days after Dose 2) |
| Number of Participants With Shedding of Vaccine-like Virus on Any Day During Days 0-28 After Dose 3 | Number of participants with nasal wash specimens that were positive for RSV or PIV3 by culture and identified as vaccine-type virus by RT-PCR. | Days 0-34 after Dose 3 (Dose 3 was 48-64 days after Dose 2) |
| Geometric Mean Titers (GMTs) of Serum Antibodies to RSV at Baseline | Pre-dose GMT of serum antibody response to RSV as measured by microneutralization assay. Limit of quantification is 5. For results reported as < 5, a value of 2.5 was imputed. | Baseline (Day 0 prior to Dose 1) |
| Geometric Mean Titers (GMTs) of Serum Antibodies to RSV at Day 28 Post Dose 1 | Post dose GMT of serum antibody response to RSV as measured by microneutralization assay. Limit of quantification is 5. For results reported as < 5, a value of 2.5 was imputed. | Day 28-34 after Dose 1 (Dose 1 was on Day 0) |
| Geometric Mean Titers (GMTs) of Serum Antibodies to RSV at Day 28 Post Dose 2 | Post dose GMT of serum antibody response to RSV as measured by microneutralization assay. Limit of quantification is 5. For results reported as < 5, a value of 2.5 was imputed. | Day 28-34 after Dose 2 (Dose 2 was on Day 48-64) |
| Geometric Mean Titers (GMTs) of Serum Antibodies to RSV at Day 28 Post Dose 3 | Post dose GMT of serum antibody response to RSV as measured by microneutralization assay. Limit of quantification is 5. For results reported as < 5, a value of 2.5 was imputed. | Day 28-34 after Dose 3 (Dose 3 was 48-64 days after Dose 2) |
| Geometric Mean Titers (GMTs) of Serum Hemagglutination Inhibition (HAI) Antibodies to PIV3 at Baseline | Post dose GMT of serum antibody response to PIV3 as measured by HAI assay. Limit of quantification is 4. For results reported as < 4, a value of 2 was imputed. | Baseline (Day 0 prior to Dose 1) |
| Geometric Mean Titers (GMTs) of Serum HAI Antibodies to PIV3 Day 28 Post Dose 1 | Post dose GMT of serum antibody response to PIV3 as measured by HAI assay. Limit of quantification is 4. For results reported as < 4, a value of 2 was imputed. | Day 28-34 after Dose 1 (Dose 1 was on Day 0) |
| Geometric Mean Titers (GMTs) of Serum HAI Antibodies to PIV3 Day 28 Post Dose 2 | Post dose GMT of serum antibody response to PIV3 as measured by HAI assay. Limit of quantification is 4. For results reported as < 4, a value of 2 was imputed. | Day 28-34 after Dose 2 (Dose 2 was on Day 48-64) |
| Geometric Mean Titers (GMTs) of Serum HAI Antibodies to PIV3 Day 28 Post Dose 3 | Post dose GMT of serum antibody response to PIV3 as measured by HAI assay. Limit of quantification is 4. For results reported as < 4, a value of 2 was imputed. | Day 28-34 after Dose 3 (Dose 3 was 48-64 days after Dose 2) |
| Number of Participants With Seroresponse to RSV 28 Days After Dose 1 | Seroresponse is equal to or greater than a 4-fold rise in RSV antibody from baseline as measured by microneutralization assay. | Days 28-34 after Dose 1 (Dose 1 was on Day 0) |
| Number of Participants With Seroresponse to RSV 28 Days After Dose 2 | Seroresponse is equal to or greater than a 4-fold rise in RSV antibody from baseline as measured by microneutralization assay. | Days 28-34 after Dose 2 (Dose 2 was on Day 48-64) |
| Number of Participants With Seroresponse to RSV 28 Days After Dose 3 | Seroresponse is equal to or greater than a 4-fold rise in RSV antibody from baseline as measured by microneutralization assay. | Days 28-34 after Dose 3 (Dose 3 was 48-64 days after Dose 2) |
| Number of Participants With Seroresponse to PIV3 28 Days After Dose 1 | Seroresponse is equal to or greater than a 4-fold rise in PIV3 antibody from baseline as measured by HAI assay. | Days 28-34 after Dose 1 (Dose 1 was on Day 0) |
| Number of Participants With Seroresponse to PIV3 28 Days After Dose 2 | Seroresponse is equal to or greater than a 4-fold rise in PIV3 antibody from baseline as measured by HAI assay. | Days 28-34 after Dose 2 (Dose 2 was on Day 48-64) |
| Number of Participants With Seroresponse to PIV3 28 Days After Dose 3 | Seroresponse is equal to or greater than a 4-fold rise in PIV3 antibody from baseline as measured by HAI assay. | Days 28-34 after Dose 3 (Dose 3 was 48-64 days after Dose 2) |
|
Lower Respiratory Tract Illness, RSV and PIV3 infection
|
Infections, Communicable Diseases, Virus Diseases, Respiratory Syncytial Virus Infections, Paramyxoviridae Infections, Disease Attributes, Pathologic Processes, Pneumovirus Infections, Mononegavirales Infections, RNA Virus Infections
|
| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: 1<br>MEDI-534 at 10^4 TCID50 at 0, 2, and 4 months (Nasal spray) | Biological: MEDI-534<br>* Multiple doses of MEDI-534 or Placebo at 10^4 TCID50<br>|
| Active Comparator: 2<br>MEDI-534 at 10^5 TCID50 at 0, 2, and 4 months (Nasal Spray) | Biological: MEDI-534<br>* Multiple doses of MEDI-534 or Placebo at 10 ^5 TCID50.<br>|
| Active Comparator: 3<br>MEDI-534 at 10^6 TCID50 at 0, 2, and 4 months (Nasal Spray) | Biological: MEDI-534<br>* Multiple doses of MEDI-534 or Placebo at 10^6 TCID50.<br>|
|
Safety and Tolerability Study to Evaluate MEDI-534 in Children 6 to < 24 Months of Age
Study Overview
=================
Brief Summary
-----------------
The overall objective of the MEDI-534 clinical development program is to evaluate the safety, efficacy and tolerability of MEDI-534 for the prevention of serious RSV and PIV3 disease in young infants.
Detailed Description
-----------------
The primary objective of this study is to describe the safety and tolerability of multiple doses of MEDI-534 at 10^4, 10^5, or 10^6 TCID50 when administered to RSV and PIV3 seronegative children 6 to <24 months of age.
Official Title
-----------------
A Phase 1, Randomized, Double-Blind, Placebo-Controlled, Dose-Escalation Study to Evaluate the Safety, Tolerability,Immunogenicity, and Viral Shedding of MEDI-534, a Live, Attenuated Intranasal Vaccine Against Respiratory Syncytial Virus (RSV) and Parainfluenza Virus Type 3 (PIV), in Healthy Children 6 to <24 Months of Age
Conditions
-----------------
Respiratory Viral Infections, Respiratory Syncytial Virus Infections, Parainfluenza Virus 3, Human
Intervention / Treatment
-----------------
* Biological: MEDI-534
* Biological: MEDI-534
* Biological: MEDI-534
Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Male or female whose age on the day of randomization is 6 to <24 months (reached 6th month birthday and not yet reached 2nd year birthday) Subject is seronegative to both RSV and PIV3 at screening Subject was the product of normal full term pregnancy (defined as >36 weeks gestation) Subject is in general good health Subject's legal representative is available by telephone Written informed consent and HIPAA authorization (if applicable) obtained from the subject's legal representative Subject's legal representative is able to understand and comply with the requirements of the protocol as judged by the investigator Subject is available to complete the follow-up period, which will be through the end of RSV season (provisionally defined as 01/Apr for the United States) or 180 days after the final dose of study vaccine, whichever is later Subject's legal representative must be willing and able to bring the subject to the study site for evaluation of respiratory illness in accordance with the protocol Exclusion Criteria: Any fever (equal to or greater than 100.4°F [equal to or greater than 38.0°C], regardless of route) or lower respiratory illness (Section 4.1.2) within 7 days prior to randomization Moderate or severe nasal congestion that in the investigator's opinion could prevent intranasal delivery of vaccine Any drug therapy (chronic or other) within 7 days prior to randomization or expected receipt through the protocol-specified blood collection 28 days after each study vaccine dosing, except that infrequent use of over-the-counter medications such as pain relievers are permitted according to the judgment of the investigator Any current or expected receipt of immunosuppressive agents including steroids (2 mg/kg per day of prednisone or its equivalent, or equal to or greater than 20 mg/day if the subject weighs >10 kg, given daily or on alternate days for equal to or greater than 14 days); children in this category should not receive study vaccine until immunosuppressive agents including corticosteroid therapy have been discontinued for equal to or greater than 30 days; the use of topical steroids is permitted according to the judgment of the investigator History of receipt of blood transfusion or expected receipt through 30 days following final study vaccine dosing History of receipt of immunoglobulin products or expected receipt through 30 days after study vaccine dosing Receipt of any investigational drug within 60 days prior to randomization or expected receipt through 30 days after final study vaccine dosing Receipt of any live virus vaccine (excluding rotavirus vaccine) within 28 days prior to randomization or expected receipt within a 28-day window around any study vaccine dose Receipt of any inactivated (i.e., non-live) vaccine or rotavirus vaccine within 14 days prior to randomization or expected receipt within a 14-day window around any study vaccine dose Known or suspected immunodeficiency, including HIV Living in the same home or enrolled in the same classroom at day care with infants <24 months of age (only one child per household may be enrolled into the study) Contact with pregnant caregiver A household contact who is immunocompromised; the subject should also avoid close contact with immunocompromised individuals for at least 30 days after any study vaccine dose A household contact who is a health care provider in contact with immunocompromised patients or who is a day care provider for infants under the age of 6 months History of allergic reaction to any component of the study vaccine Previous medical history, or evidence, of an intercurrent or chronic illness that, in the opinion of the investigator, may compromise the safety of the subject Known or suspected active or chronic hepatitis infection History of medical diagnosis of asthma, reactive airway disease, wheezing requiring medication, cystic fibrosis, bronchopulmonary dysplasia, chronic pulmonary disease, medically confirmed apnea, hospitalization for respiratory illness or mechanical ventilation Family member or household contact who is an employee of the research center or otherwise involved with the conduct of the study Any condition that, in the opinion of the investigator, might interfere with study vaccine evaluation
Ages Eligible for Study
-----------------
Minimum Age: 6 Months
Maximum Age: 23 Months
Sexes Eligible for Study
-----------------
All
Accepts Healthy Volunteers
-----------------
Accepts Healthy Volunteers
Study Plan
=================
How is the study designed?
-----------------
Design Details
Primary Purpose: Prevention
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple
Arms and Interventions
| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: 1<br>MEDI-534 at 10^4 TCID50 at 0, 2, and 4 months (Nasal spray) | Biological: MEDI-534<br>* Multiple doses of MEDI-534 or Placebo at 10^4 TCID50<br>|
| Active Comparator: 2<br>MEDI-534 at 10^5 TCID50 at 0, 2, and 4 months (Nasal Spray) | Biological: MEDI-534<br>* Multiple doses of MEDI-534 or Placebo at 10 ^5 TCID50.<br>|
| Active Comparator: 3<br>MEDI-534 at 10^6 TCID50 at 0, 2, and 4 months (Nasal Spray) | Biological: MEDI-534<br>* Multiple doses of MEDI-534 or Placebo at 10^6 TCID50.<br>|
What is the study measuring?
-----------------
Primary Outcome Measures
| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Number of Participants With Solicited Adverse Events (SEs) After Dose 1 | The SEs for this study included fever ≥ 100.4°F, runny/stuffy nose, cough, drowsiness, loss of appetite/decreased urine output, irritability/fussiness, laryngitis, and epistaxis. | Days 0-28 after Dose 1 (Dose 1 was on Day 0) |
| Number of Participants With SEs After Dose 2 | The SEs for this study included fever ≥ 100.4°F, runny/stuffy nose, cough, drowsiness, loss of appetite/decreased urine output, irritability/fussiness, laryngitis, and epistaxis. | Days 0-28 after Dose 2 (Dose 2 was on Day 48-64) |
| Number of Participants With SEs After Dose 3 | The SEs for this study included fever ≥ 100.4°F, runny/stuffy nose, cough, drowsiness, loss of appetite/decreased urine output, irritability/fussiness, laryngitis, and epistaxis. | Days 0-28 after Dose 3 (Dose 3 was 48-64 days after Dose 2) |
| Number of Participants With Adverse Events (AEs) After Dose 1 | Unsolicited AEs reported by 1 or more participants in either treatment group through 28 days post Dose 1. | Days 0-28 after Dose 1 (Dose 1 was on Day 0) |
| Number of Participants With AEs After Dose 2 | Unsolicited AEs reported by 1 or more participants in either treatment group through 28 days post Dose 2. | Days 0-28 after Dose 2 (Dose 2 was on Day 48-64) |
| Number of Participants With AEs After Dose 3 | Unsolicited AEs reported by 1 or more participants in either treatment group through 28 days post Dose 3. | Days 0-28 after Dose 3 (Dose 3 was 48-64 days after Dose 2) |
| Number of Subjects With Medically-attended Lower Respiratory Illnesses (MA-LRIs) | An MA-LRI was a healthcare provider-confirmed diagnosis of 1 or more of the following: wheezing, pneumonia, croup, rhonchi (not cleared with cough or suctioning), rales, bronchitis, bronchiolitis, apnea. | Days 0 to 180 days after final dose or the end of the RSV season, whichever was later |
| Number of Participants With Serious Adverse Events (SAEs) | Events resulting in death; were life-threatening; resulted in inpatient hospitalization/prolongation of hospitalization; resulted in persistent or significant disability or incapacity; were a congenital anomaly/birth defect in the offspring of a participant; or were an important medical event that may not have resulted in death, threatened life, or required hospitalization and may have jeopardized the participant and required medical/surgical intervention to prevent one of the above outcomes. | Days 0-28 after any dose |
| Number of Participants With Significant New Medical Conditions (SNMCs) | A SNMC is a newly diagnosed medical condition that is of a chronic, ongoing nature and is assessed by the investigator as medically significant. | Day 0 through 180 days after the final dose or through the end of the RSV season, whichever was later |
Secondary Outcome Measures
| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Number of Participants Shedding Vaccine-like Virus at Any Time During Study Participation | Number of participants with nasal wash specimens that were positive for RSV or PIV3 by culture and identified as vaccine-type virus by RT-PCR. | Days 7, 12, and 28 after each dose and during visits for pre-specified illness symptoms occurring Day 0 through 28-34 days post each dose. |
| Number of Participants Shedding Vaccine-like Virus at 7 Days After Dose 1 | Number of participants with nasal wash specimens that were positive for RSV or PIV3 by culture and identified as vaccine-type virus by RT-PCR. | Days 7-10 after Dose 1 (Dose 1 was on Day 0) |
| Number of Participants Shedding Vaccine-like Virus at 12 Days After Dose 1 | Number of participants with nasal wash specimens that were positive for RSV or PIV3 by culture and identified as vaccine-type virus by RT-PCR. | Days 12-18 after Dose 1 (Dose 1 was on Day 0) |
| Number of Participants Shedding Vaccine-like Virus at 28 Days After Dose 1 | Number of participants with nasal wash specimens that were positive for RSV or PIV3 by culture and identified as vaccine-type virus by RT-PCR. | Days 28-34 after Dose 1 (Dose 1 was on Day 0) |
| Number of Participants With Shedding of Vaccine-like Virus on Any Day During Days 0-28 After Dose 1 | Number of participants with nasal wash specimens that were positive for RSV or PIV3 by culture and identified as vaccine-type virus by RT-PCR. | Days 0-34 after Dose 1 (Dose 1 was on Day 0) |
| Number of Participants Shedding Vaccine-like Virus at 7 Days After Dose 2 | Number of participants with nasal wash specimens that were positive for RSV or PIV3 by culture and identified as vaccine-type virus by RT-PCR. | Days 7-10 after Dose 2 (Dose 2 was on Day 48-64) |
| Number of Participants Shedding Vaccine-like Virus at 12 Days After Dose 2 | Number of participants with nasal wash specimens that were positive for RSV or PIV3 by culture and identified as vaccine-type virus by RT-PCR. | Days 12-18 after Dose 2 (Dose 2 was on Day 48-64) |
| Number of Participants Shedding Vaccine-like Virus at 28 Days After Dose 2 | Number of participants with nasal wash specimens that were positive for RSV or PIV3 by culture and identified as vaccine-type virus by RT-PCR. | Days 28-34 after Dose 2 (Dose 2 was on Day 48-64) |
| Number of Participants With Shedding of Vaccine-like Virus on Any Day During Days 0-28 After Dose 2 | Number of participants with nasal wash specimens that were positive for RSV or PIV3 by culture and identified as vaccine-type virus by RT-PCR. | Days 0-34 after Dose 2 (Dose 2 was on Day 48-64) |
| Number of Participants Shedding Vaccine-like Virus at 7 Days After Dose 3 | Number of participants with nasal wash specimens that were positive for RSV or PIV3 by culture and identified as vaccine-type virus by RT-PCR. | Days 7-10 after Dose 3 (Dose 3 was 48-64 days after Dose 2) |
| Number of Participants Shedding Vaccine-like Virus at 12 Days After Dose 3 | Number of participants with nasal wash specimens that were positive for RSV or PIV3 by culture and identified as vaccine-type virus by RT-PCR. | Days 12-18 after Dose 3 (Dose 3 was 48-64 days after Dose 2) |
| Number of Participants Shedding Vaccine-like Virus at 28 Days After Dose 3 | Number of participants with nasal wash specimens that were positive for RSV or PIV3 by culture and identified as vaccine-type virus by RT-PCR. | Days 28-34 after Dose 3 (Dose 3 was 48-64 days after Dose 2) |
| Number of Participants With Shedding of Vaccine-like Virus on Any Day During Days 0-28 After Dose 3 | Number of participants with nasal wash specimens that were positive for RSV or PIV3 by culture and identified as vaccine-type virus by RT-PCR. | Days 0-34 after Dose 3 (Dose 3 was 48-64 days after Dose 2) |
| Geometric Mean Titers (GMTs) of Serum Antibodies to RSV at Baseline | Pre-dose GMT of serum antibody response to RSV as measured by microneutralization assay. Limit of quantification is 5. For results reported as < 5, a value of 2.5 was imputed. | Baseline (Day 0 prior to Dose 1) |
| Geometric Mean Titers (GMTs) of Serum Antibodies to RSV at Day 28 Post Dose 1 | Post dose GMT of serum antibody response to RSV as measured by microneutralization assay. Limit of quantification is 5. For results reported as < 5, a value of 2.5 was imputed. | Day 28-34 after Dose 1 (Dose 1 was on Day 0) |
| Geometric Mean Titers (GMTs) of Serum Antibodies to RSV at Day 28 Post Dose 2 | Post dose GMT of serum antibody response to RSV as measured by microneutralization assay. Limit of quantification is 5. For results reported as < 5, a value of 2.5 was imputed. | Day 28-34 after Dose 2 (Dose 2 was on Day 48-64) |
| Geometric Mean Titers (GMTs) of Serum Antibodies to RSV at Day 28 Post Dose 3 | Post dose GMT of serum antibody response to RSV as measured by microneutralization assay. Limit of quantification is 5. For results reported as < 5, a value of 2.5 was imputed. | Day 28-34 after Dose 3 (Dose 3 was 48-64 days after Dose 2) |
| Geometric Mean Titers (GMTs) of Serum Hemagglutination Inhibition (HAI) Antibodies to PIV3 at Baseline | Post dose GMT of serum antibody response to PIV3 as measured by HAI assay. Limit of quantification is 4. For results reported as < 4, a value of 2 was imputed. | Baseline (Day 0 prior to Dose 1) |
| Geometric Mean Titers (GMTs) of Serum HAI Antibodies to PIV3 Day 28 Post Dose 1 | Post dose GMT of serum antibody response to PIV3 as measured by HAI assay. Limit of quantification is 4. For results reported as < 4, a value of 2 was imputed. | Day 28-34 after Dose 1 (Dose 1 was on Day 0) |
| Geometric Mean Titers (GMTs) of Serum HAI Antibodies to PIV3 Day 28 Post Dose 2 | Post dose GMT of serum antibody response to PIV3 as measured by HAI assay. Limit of quantification is 4. For results reported as < 4, a value of 2 was imputed. | Day 28-34 after Dose 2 (Dose 2 was on Day 48-64) |
| Geometric Mean Titers (GMTs) of Serum HAI Antibodies to PIV3 Day 28 Post Dose 3 | Post dose GMT of serum antibody response to PIV3 as measured by HAI assay. Limit of quantification is 4. For results reported as < 4, a value of 2 was imputed. | Day 28-34 after Dose 3 (Dose 3 was 48-64 days after Dose 2) |
| Number of Participants With Seroresponse to RSV 28 Days After Dose 1 | Seroresponse is equal to or greater than a 4-fold rise in RSV antibody from baseline as measured by microneutralization assay. | Days 28-34 after Dose 1 (Dose 1 was on Day 0) |
| Number of Participants With Seroresponse to RSV 28 Days After Dose 2 | Seroresponse is equal to or greater than a 4-fold rise in RSV antibody from baseline as measured by microneutralization assay. | Days 28-34 after Dose 2 (Dose 2 was on Day 48-64) |
| Number of Participants With Seroresponse to RSV 28 Days After Dose 3 | Seroresponse is equal to or greater than a 4-fold rise in RSV antibody from baseline as measured by microneutralization assay. | Days 28-34 after Dose 3 (Dose 3 was 48-64 days after Dose 2) |
| Number of Participants With Seroresponse to PIV3 28 Days After Dose 1 | Seroresponse is equal to or greater than a 4-fold rise in PIV3 antibody from baseline as measured by HAI assay. | Days 28-34 after Dose 1 (Dose 1 was on Day 0) |
| Number of Participants With Seroresponse to PIV3 28 Days After Dose 2 | Seroresponse is equal to or greater than a 4-fold rise in PIV3 antibody from baseline as measured by HAI assay. | Days 28-34 after Dose 2 (Dose 2 was on Day 48-64) |
| Number of Participants With Seroresponse to PIV3 28 Days After Dose 3 | Seroresponse is equal to or greater than a 4-fold rise in PIV3 antibody from baseline as measured by HAI assay. | Days 28-34 after Dose 3 (Dose 3 was 48-64 days after Dose 2) |
Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Lower Respiratory Tract Illness, RSV and PIV3 infection
|
NCT05099380
|
Validation of Senofilcon A With New UV / HEV Filter
|
This is a bilateral, dispensing, randomized, controlled, subject-masked, 2-arm parallel study to evaluate safety and efficacy
|
Validation of Senofilcon A With New UV / HEV Filter
|
Visual Acuity
|
* Device: senofilcon A C3
* Device: senofilcon A
|
Inclusion Criteria:~Potential subjects must satisfy all of the following criteria to be enrolled in the study:~Read, understand, and sign the STATEMENT OF INFORMED CONSENT and receive a fully executed copy of the form.~Appear able and willing to adhere to the instructions set forth in this clinical protocol.~Be between 18 and 39 (inclusive) years of age at the time of screening.~By self-report, habitually wear spherical silicone hydrogel soft contact lenses in both eyes in a daily reusable or daily disposable wear modality (i.e. not extended wear modality). Habitual wear is defined as a minimum of 6 hours of wear per day, for a minimum of 5 days per week during the past 30 days.~Have a habitual contact lens prescription that is current within the prior 6 months, and they must have worn that prescription for at least 2 weeks prior to entering the study.~The subject's vertex corrected spherical equivalent distance refraction must be in the range of -1.00 through -6.00 D in both eyes.~The subject's refractive cylinder must be 1.00 D or less.~The subject must have best corrected visual acuity of 20/25 or better in each eye.~Exclusion Criteria:~Potential subjects who meet any of the following criteria will be excluded from participating in the study:~Be currently pregnant or lactating.~Have any ocular or systemic allergies or diseases that may interfere with contact lens wear.~Have any autoimmune disease or use of medication, which may interfere with contact lens wear. Habitual medications used by successful soft contact lens wearers are considered acceptable.~Have any previous, or planned, ocular or interocular surgery (e.g., radial keratotomy, PRK, LASIK, etc.).~Be currently wearing lenses in a monovision, multifocal, toric, or extended wear modality.~Have participated in a contact lens or lens care product clinical trial within 14 days prior to study enrollment~Be an employee (e.g., Investigator, Coordinator, Technician) or immediate family member of an employee (including partner, child, parent, grandparent, grandchild or sibling of the employee or their spouse) of the clinical site.~Have a history of binocular vision abnormality or strabismus.~Have any infectious disease (e.g., hepatitis, tuberculosis) or contagious immunosuppressive diseases (e.g., HIV) by self-report. 10. Have any Grade 3 or greater slit lamp findings (e.g., edema, corneal neovascularization, corneal staining, tarsal abnormalities, conjunctival injection) on the FDA classification scale, any previous history or signs of a contact lens-related corneal inflammatory event (e.g., past peripheral ulcer or round peripheral scar), or any other ocular abnormality that may contraindicate contact lens wear.~11. Have any ocular infection. 12. Have any corneal distortion resulting from previous hard or rigid gas permeable contact lens wear.~13. Have entropion, ectropion, extrusions, chalazia, recurrent styes, glaucoma, history of recurrent corneal erosions, or aphakia.
|
18 Years
|
39 Years
|
All
|
Accepts Healthy Volunteers
|
Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single
|
| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Overall Quality of Vision Score | Overall quality of vision score was assessed using the Contact Lens User Experience™ (CLUE) questionnaire. CLUE is a validated patient-reported outcomes (PRO) questionnaire to assess patient-experience attributes of soft contact lenses (comfort, vision, handling, and packaging) in a contact-lens wearing population in the US, ages 18-65. Derived CLUE scores using Item Response Theory (IRT) follow a normal distribution with a population average score of 60 (SD 20), where higher scores indicate a more favorable/positive response with a range of 0-120. The average CLUE vision score for each lens type was reported. | 2-Week Follow-up |
| Distance Monocular logMAR Visual Acuity | Monocular visual acuity was measured on a logMAR (Logarithm of Minimal Angle of Resolution) scale and was evaluated at distance (4 meter) under high luminance high contrast lighting condition using ETDRS (Early Treatment Diabetic Retinopathy Study) charts. Letter-by-letter results calculated the visual performance score for each chart read. LogMAR scores closer to zero, or below zero, indicate a better visual acuity. A logMAR visual performance score of 0.0 is equivalent to Snellen visual acuity of 20/20. | 2-Week Follow-up |
| Proportion of Eyes With Grade 3 or Higher Slit Lamp Findings | Slit Lamp Findings (SLF) were assessed using a biomicroscope and was graded using the FDA grading scale (Grade: 0, 1,2, 3 and 4) with grade 0 represents the absence of findings and 1 to 4 representing successively worse findings (i.e. Grade 1 = trace, Grade 2 = Mild, Grade 3 = moderate and Grade 4 = severe). This was performed on each subject eye at every study visit (baseline, unscheduled visits, 2-week follow-up and final evaluation). The data was then dichotomized into two groups. Those with Grade 3 or higher SLF and those with Grade 2 or lower. The proportion of eyes with Grade 3 or higher SLF was reported. | up to 2-week follow-up |
| Proportion of Eyes With Unacceptable Lens Fitting | Contact lens fitting acceptance was assessed for each subject eye using a biomicroscope post lens insertion and the 2-week follow-up. Lens fit was a binary variable where acceptable lens fit=1 and unacceptable lens fit=0. The proportion of eyes with unacceptable lens fit was reported. Summaries presented in the Participant flow are summarized by planned arm, where as summaries for this measure are summarized by actual arm. One subject was dispensed the incorrect study lens, there for, the number of subjects that were randomized to the Control were 149 but 150 subjects were actually dispensed the control. | Up to 2-Week Follow-up |
|
| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Overall Comfort Scores | Overall comfort scores were assessed using the Contact Lens User Experience™ (CLUE) questionnaire. CLUE is a validated patient-reported outcomes (PRO) questionnaire to assess patient-experience attributes of soft contact lenses (comfort, vision, handling, and packaging) in a contact-lens wearing population in the US, ages 18-65. Derived CLUE scores using Item Response Theory (IRT) follow a normal distribution with a population average score of 60 (SD 20), where higher scores indicate a more favorable/positive response with a range of 0-120. The average CLUE comfort score for each lens type was reported. | 2-Week Follow-up |
| Overall Handling Scores | Overall handling scores were assessed using the Contact Lens User Experience™ (CLUE) questionnaire. CLUE is a validated patient-reported outcomes (PRO) questionnaire to assess patient-experience attributes of soft contact lenses (comfort, vision, handling, and packaging) in a contact-lens wearing population in the US, ages 18-65. Derived CLUE scores using Item Response Theory (IRT) follow a normal distribution with a population average score of 60 (SD 20), where higher scores indicate a more favorable/positive response with a range of 0-120. The average CLUE handling score for each lens type was reported. | 2-Week Follow-up |
| Situational Visual Performance - Indoors | Indoor performance was assessed using the individual questionnaire item Clarity of Vision indoors in bright light with a 5-point Likert scale (1: Excellent, 2: Very Good, 3: Good, 4: Fair and 5: Poor) and a Not Applicable response option. Subject responses were reported by lens using frequencies. | 2-Week Follow-up |
| Situational Visual Performance - Digital Devices | Situational visual performance related to digital device use was assessed using the individual preference item Overall preference while using computer screens & digital devices. The response set include: Strongly prefer my habitual lenses, Slightly prefer my habitual lenses, No Preference, Slightly prefer the study lenses and Strongly prefer the study lenses. Responses were collapsed into three categories for analysis purpose: Prefer Study Lens, No Preference, Prefer Habitual Lens. Subject responses were reported by lens using frequencies. | 2-Week Follow-up |
|
| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: TEST lens<br>Eligible subjects that are habitual wearers of silicone hydrogel spherical contact lenses will be randomized to the TEST Lens for the duration of the study. | Device: senofilcon A C3<br>* TEST Lens<br>|
| Active Comparator: CONTROL lens<br>Eligible subjects that are habitual wearers of silicone hydrogel spherical contact lenses will be randomized to the CONTROL Lens for the duration of the study. | Device: senofilcon A<br>* CONTROL Lens<br>|
|
Validation of Senofilcon A With New UV / HEV Filter
Study Overview
=================
Brief Summary
-----------------
This is a bilateral, dispensing, randomized, controlled, subject-masked, 2-arm parallel study to evaluate safety and efficacy
Official Title
-----------------
Validation of Senofilcon A With New UV / HEV Filter
Conditions
-----------------
Visual Acuity
Intervention / Treatment
-----------------
* Device: senofilcon A C3
* Device: senofilcon A
Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Potential subjects must satisfy all of the following criteria to be enrolled in the study: Read, understand, and sign the STATEMENT OF INFORMED CONSENT and receive a fully executed copy of the form. Appear able and willing to adhere to the instructions set forth in this clinical protocol. Be between 18 and 39 (inclusive) years of age at the time of screening. By self-report, habitually wear spherical silicone hydrogel soft contact lenses in both eyes in a daily reusable or daily disposable wear modality (i.e. not extended wear modality). Habitual wear is defined as a minimum of 6 hours of wear per day, for a minimum of 5 days per week during the past 30 days. Have a habitual contact lens prescription that is current within the prior 6 months, and they must have worn that prescription for at least 2 weeks prior to entering the study. The subject's vertex corrected spherical equivalent distance refraction must be in the range of -1.00 through -6.00 D in both eyes. The subject's refractive cylinder must be 1.00 D or less. The subject must have best corrected visual acuity of 20/25 or better in each eye. Exclusion Criteria: Potential subjects who meet any of the following criteria will be excluded from participating in the study: Be currently pregnant or lactating. Have any ocular or systemic allergies or diseases that may interfere with contact lens wear. Have any autoimmune disease or use of medication, which may interfere with contact lens wear. Habitual medications used by successful soft contact lens wearers are considered acceptable. Have any previous, or planned, ocular or interocular surgery (e.g., radial keratotomy, PRK, LASIK, etc.). Be currently wearing lenses in a monovision, multifocal, toric, or extended wear modality. Have participated in a contact lens or lens care product clinical trial within 14 days prior to study enrollment Be an employee (e.g., Investigator, Coordinator, Technician) or immediate family member of an employee (including partner, child, parent, grandparent, grandchild or sibling of the employee or their spouse) of the clinical site. Have a history of binocular vision abnormality or strabismus. Have any infectious disease (e.g., hepatitis, tuberculosis) or contagious immunosuppressive diseases (e.g., HIV) by self-report. 10. Have any Grade 3 or greater slit lamp findings (e.g., edema, corneal neovascularization, corneal staining, tarsal abnormalities, conjunctival injection) on the FDA classification scale, any previous history or signs of a contact lens-related corneal inflammatory event (e.g., past peripheral ulcer or round peripheral scar), or any other ocular abnormality that may contraindicate contact lens wear. 11. Have any ocular infection. 12. Have any corneal distortion resulting from previous hard or rigid gas permeable contact lens wear. 13. Have entropion, ectropion, extrusions, chalazia, recurrent styes, glaucoma, history of recurrent corneal erosions, or aphakia.
Ages Eligible for Study
-----------------
Minimum Age: 18 Years
Maximum Age: 39 Years
Sexes Eligible for Study
-----------------
All
Accepts Healthy Volunteers
-----------------
Accepts Healthy Volunteers
Study Plan
=================
How is the study designed?
-----------------
Design Details
Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single
Arms and Interventions
| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: TEST lens<br>Eligible subjects that are habitual wearers of silicone hydrogel spherical contact lenses will be randomized to the TEST Lens for the duration of the study. | Device: senofilcon A C3<br>* TEST Lens<br>|
| Active Comparator: CONTROL lens<br>Eligible subjects that are habitual wearers of silicone hydrogel spherical contact lenses will be randomized to the CONTROL Lens for the duration of the study. | Device: senofilcon A<br>* CONTROL Lens<br>|
What is the study measuring?
-----------------
Primary Outcome Measures
| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Overall Quality of Vision Score | Overall quality of vision score was assessed using the Contact Lens User Experience™ (CLUE) questionnaire. CLUE is a validated patient-reported outcomes (PRO) questionnaire to assess patient-experience attributes of soft contact lenses (comfort, vision, handling, and packaging) in a contact-lens wearing population in the US, ages 18-65. Derived CLUE scores using Item Response Theory (IRT) follow a normal distribution with a population average score of 60 (SD 20), where higher scores indicate a more favorable/positive response with a range of 0-120. The average CLUE vision score for each lens type was reported. | 2-Week Follow-up |
| Distance Monocular logMAR Visual Acuity | Monocular visual acuity was measured on a logMAR (Logarithm of Minimal Angle of Resolution) scale and was evaluated at distance (4 meter) under high luminance high contrast lighting condition using ETDRS (Early Treatment Diabetic Retinopathy Study) charts. Letter-by-letter results calculated the visual performance score for each chart read. LogMAR scores closer to zero, or below zero, indicate a better visual acuity. A logMAR visual performance score of 0.0 is equivalent to Snellen visual acuity of 20/20. | 2-Week Follow-up |
| Proportion of Eyes With Grade 3 or Higher Slit Lamp Findings | Slit Lamp Findings (SLF) were assessed using a biomicroscope and was graded using the FDA grading scale (Grade: 0, 1,2, 3 and 4) with grade 0 represents the absence of findings and 1 to 4 representing successively worse findings (i.e. Grade 1 = trace, Grade 2 = Mild, Grade 3 = moderate and Grade 4 = severe). This was performed on each subject eye at every study visit (baseline, unscheduled visits, 2-week follow-up and final evaluation). The data was then dichotomized into two groups. Those with Grade 3 or higher SLF and those with Grade 2 or lower. The proportion of eyes with Grade 3 or higher SLF was reported. | up to 2-week follow-up |
| Proportion of Eyes With Unacceptable Lens Fitting | Contact lens fitting acceptance was assessed for each subject eye using a biomicroscope post lens insertion and the 2-week follow-up. Lens fit was a binary variable where acceptable lens fit=1 and unacceptable lens fit=0. The proportion of eyes with unacceptable lens fit was reported. Summaries presented in the Participant flow are summarized by planned arm, where as summaries for this measure are summarized by actual arm. One subject was dispensed the incorrect study lens, there for, the number of subjects that were randomized to the Control were 149 but 150 subjects were actually dispensed the control. | Up to 2-Week Follow-up |
Secondary Outcome Measures
| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Overall Comfort Scores | Overall comfort scores were assessed using the Contact Lens User Experience™ (CLUE) questionnaire. CLUE is a validated patient-reported outcomes (PRO) questionnaire to assess patient-experience attributes of soft contact lenses (comfort, vision, handling, and packaging) in a contact-lens wearing population in the US, ages 18-65. Derived CLUE scores using Item Response Theory (IRT) follow a normal distribution with a population average score of 60 (SD 20), where higher scores indicate a more favorable/positive response with a range of 0-120. The average CLUE comfort score for each lens type was reported. | 2-Week Follow-up |
| Overall Handling Scores | Overall handling scores were assessed using the Contact Lens User Experience™ (CLUE) questionnaire. CLUE is a validated patient-reported outcomes (PRO) questionnaire to assess patient-experience attributes of soft contact lenses (comfort, vision, handling, and packaging) in a contact-lens wearing population in the US, ages 18-65. Derived CLUE scores using Item Response Theory (IRT) follow a normal distribution with a population average score of 60 (SD 20), where higher scores indicate a more favorable/positive response with a range of 0-120. The average CLUE handling score for each lens type was reported. | 2-Week Follow-up |
| Situational Visual Performance - Indoors | Indoor performance was assessed using the individual questionnaire item Clarity of Vision indoors in bright light with a 5-point Likert scale (1: Excellent, 2: Very Good, 3: Good, 4: Fair and 5: Poor) and a Not Applicable response option. Subject responses were reported by lens using frequencies. | 2-Week Follow-up |
| Situational Visual Performance - Digital Devices | Situational visual performance related to digital device use was assessed using the individual preference item Overall preference while using computer screens & digital devices. The response set include: Strongly prefer my habitual lenses, Slightly prefer my habitual lenses, No Preference, Slightly prefer the study lenses and Strongly prefer the study lenses. Responses were collapsed into three categories for analysis purpose: Prefer Study Lens, No Preference, Prefer Habitual Lens. Subject responses were reported by lens using frequencies. | 2-Week Follow-up |
|
|||
NCT02264756
|
Improving Antibiotic Use in Hospitalized Patients With Pneumonia
|
The purpose of the study is to determine whether an antimicrobial stewardship program can decrease the length of hospital stay for patients with pneumonia. The antimicrobial stewardship program is run by a pharmacist and doctor with extensive training in managing infectious diseases. These two health care professionals are responsible for reviewing the records of patients admitted to hospital with pneumonia, and then making specific recommendations to the patient's attending physician about how to manage antibiotic treatment. These recommendations might include discontinuing the antibiotic, or changing the way antibiotics are delivered from intravenous form to pill form, among many other potential options. The attending physician considers whether these recommendations should be followed or rejected. The study has a control group of patients who are not reviewed by the antimicrobial stewardship team, and their length of hospital stay will be compared to the reviewed group of patients. Any differences between these two groups will be assumed to be due to the impact of the antimicrobial stewardship program. So far, no previous study has been able to demonstrate that an antimicrobial stewardship program can reduce the length of stay of patients admitted to hospital with pneumonia. This study has some important differences from previous studies that may make its conclusions more accurately reflect the true impact of antimicrobial stewardship programs. The most important difference is how the timing of the review is modelled in the analysis of the study results. Because the timing of the review varies between patients, with some patients being reviewed at earlier and some at later times, this subtle difference, if not accounted for in the analysis, can mask a true positive effect of the program on length of stay. The investigators study will account for this variation.
|
In immune-competent adult patients admitted to a hospital ward with a diagnosis of community-acquired pneumonia, does a multi-faceted ASP utilizing prospective chart audit and feedback compared with usual care reduce the LOS without increasing the risk of death or readmission at 30 days post-discharge from hospital? In Ontario, pneumonia is the leading cause of death from bacterial infections and accounts for over 18,000 years of life lost annually due to premature mortality. Pneumonia accounts for the majority of antibiotic utilization in both hospital and outpatient settings. Evidence-based guidelines for the diagnosis and management of pneumonia are available to physicians. Adherence to these evidence-based guidelines is associated with both reduced mortality and antibiotic utilization.~Antimicrobial stewardship is defined as any intervention that minimizes unwarranted variation in antimicrobial utilization from evidence-based best practice with the intent of improving patient safety and quality of care. Unwarranted refers to the absence of patient- or disease-specific reasons to justify practice variation from evidence-based practice standards. Antimicrobial stewardship can be operationalized in many different ways, but prospective audit and feedback (persuasive approach) and restricted antimicrobial prescribing policies (restrictive approach) appear to be the most efficacious interventions to achieve the goals of antimicrobial stewardship. Antimicrobial stewardship programs have demonstrated efficacy in improving antimicrobial prescribing and reducing rates of hospital-acquired infections. Antimicrobial stewardship programs directed to CAP patients have demonstrated reductions in mortality, but have failed to demonstrate reductions in length of stay.~All participants will be admitted patients to the Royal Victoria Regional Health Centre (RVRHC), a 319 bed community-based, university-affiliated, acute care hospital located in Barrie, Ontario, Canada.~All patients enrolled in the study will be admitted to one of four medical wards. All study patients will be admitted to a hospitalist service. Admission to any medical ward is controlled by bed allocation, a non-medical administrative service within the hospital responsible for patient flow and assigning patient care. Hospitalists are not assigned to any one specific medical ward, but provide care across all medical wards.~All eligible CAP who meet the ASP review criteria will be exposed to the ASP intervention. The ASP intervention (ASP-i) consists of a prospective chart audit and physician feedback (persuasive) approach . The ASP members who conduct all the audits and make recommendations consist of an infectious diseases-trained pharmacist (LM) and an infectious diseases trained physician (GD). All patients are reviewed by both members. The ASP intervention (ASP-i) recommendations are guided by the Infectious Diseases Society of America CAP guidelines and the Canadian Thoracic Society guidelines for the management of chronic obstructive pulmonary disease. The possible ASP-i recommendations are based on those recommended by the National Health Service in the United Kingdom and include the following:~i) No change to current care ii) Discontinue antibiotic(s) iii) Intravenous to oral conversion iv) Duration of therapy v) Dosing change vi) Narrow or broaden spectrum of therapy The ASP-i recommendations are not mutually exclusive. All recommendations are documented in the patient's electronic medical record and communicated directly to the attending physician by the ASP members.~This is a pragmatic controlled clinical study intended to measure the effectiveness of a 'real world' program. The ASP-i will be implemented in a modified stepped wedge design; baseline patient data will be collected for all enrolled patients on each of the medical wards for the first three months of the study, and then the ASP-i will be introduced to each medical ward in a non-randomized sequential fashion in two month intervals until all medical wards are exposed to the intervention.~The unit of analysis will be individual patients adjusted for potential clustering effects within hospital wards.~The primary outcome is length of hospital stay (LOS) measured in minutes from the documented time of admission to the documented time of discharge (or censoring). All patients will be administratively censored at 14 days after hospital admission if they have not been discharged home.~Enrollment of patients started on April 1, 2013. The study is expected to enroll patients until March 31, 2015. All consecutive patients that meet the inclusion criteria and have no exclusion criteria will be eligible for the intervention. The ASP-i intervention may be implemented anytime after 48 hours post-admission in those patients who meet the criteria for ASP review. All patients who have not experienced an outcome at 14 days after admission will be censored from the study. Patients who die or are transferred from the ward (to the intensive care unit or other hospital) will also be censored. Patients who are discharged from hospital and are not censored will be contacted at 30 days post-discharge to determine their adherence with antibiotic prescription (if relevant), survival status and readmission status.~The sample size expected for the current study is 'fixed' and has been previously estimated to be between 400 to 500 CAP patients per calendar year. The accrual period will be 24 months. Assuming 70% of patients in the control arm will achieve the primary outcome of being discharged alive from hospital, and setting power = 0.8 and statistical significance (2-sided) α = 0.05, the detectable ASP-i effect size is estimated to be up to an approximately 20% reduction in length of stay.~An extended Cox regression analysis will be used to compare the primary and secondary outcomes between the control and intervention groups. Violations of the proportional hazards assumption for each covariate will be identified by using the method of Schoenfeld residuals. Results will be reported as hazard ratios with 95% confidence intervals. Time to ASP-i will be modeled as a time-variant covariate in the final model to account for any time-dependent bias.~Other variables known to be associated with the primary and secondary outcomes will also be included in the final model, and include; age, sex, charlson comorbidity index, CURB-65 score, time (days) to clinical resolution, and complications from pneumonia such as empyema. Fixed effects of wards on the outcomes will accounted for by including them as indicator variables in the final model. Maturation of ASP-i effect on outcomes over time will be adjusted by including a categorical time variable in the final model (time variable will be defined as 'quarter' from start of study). A dichotomous variable for acceptance or rejection of the ASP-i will be part of an interaction term with the control/intervention group variable to permit a per protocol analysis.
|
Evaluating the Effectiveness of an Antimicrobial Stewardship Program on Reducing the Length of Stay of Immune-competent Adult Patients Admitted to a Hospital Ward With a Diagnosis of Community-acquired Pneumonia
|
Pneumonia
|
* Other: ASP review
|
Inclusion Criteria:~have a positive Febrile Respiratory Illness (FRI) screen on admission to hospital (http://www.health.gov.on.ca/fr/public/programs/emu/sars/reports/dir_122303_acute_care_nonoutbreak.pdf)~diagnosed with pneumonia by the admitting physician (Acute exacerbations of chronic obstructive lung disease are considered within the definition of pneumonia for the purposes of this study as they are commonly treated with the same antimicrobial regimens as patients with pneumonia)~admitted to a medical ward~Exclusion Criteria:~hospitalized for ≥ 48 consecutive hours in the preceding 3 months~receiving immunosuppressants [defined as ≥ 40 mg prednisone daily (or steroid equivalent) for ≥ 2 weeks preceding hospitalization OR any other immunosuppressant used for systemic illness OR to prevent transplant rejection]~neutropenic [defined as a polymorphonuclear count ≤ 0.5 x 109 cells/L] from any cause~immunocompromised [defined as having leukemia, lymphoma, HIV with CD4 cell count ≤ 200, splenectomy or on cytotoxic chemotherapy]~admitted to high acuity units such as intensive care units~require mechanical ventilation, either non-invasive or invasive~have a life expectancy of ≤ 3 months (palliative)
|
18 Years
| null |
All
|
No
|
| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Hospital length of stay | Time to discharge or censoring event | Patients will be followed for 14 days from date of admission and if not discharged will be administratively censored |
|
| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 30-day post-discharge mortality rate | all cause mortality at 30 days post-discharge from hospital | 30 calendar days after hospital discharge |
| 30-day post-discharge readmission rate | all cause readmission rate at 30 days post-discharge from hospital | 30 calendar days after hospital discharge |
| Days of antimicrobial therapy | Total days of antimicrobial therapy used per patient upto a maximum of 30-days post-discharge from hospital | Total days of antimicrobial therapy for each antibiotic calculated from date of first administration on admission to hospital to date of discontinuation (or to date of censoring, whichever comes first) upto a maximum of 30 days post-discharge follow-up |
| Duration of antimicrobial therapy | Total duration of antimicrobial therapy per patient upto a maximum of 30-days post discharge from hospital | Total duration of all antibiotics administered starting from date of administration of first antibiotic to date of discontinuation of last antibiotic (or to date of censoring, whichever comes first) upto a maximum of 30 days post-discharge from hospital |
|
Community-acquired pneumonia, Pragmatic clinical trial, Antimicrobial stewardship, length of stay, stepped-wedge design, time-dependent bias
|
Pneumonia, Respiratory Tract Diseases, Respiratory Tract Infections, Infections, Lung Diseases
|
| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Ward CAP<br>Adult immune-competent patients admitted to ward with clinical diagnosis of community-acquired pneumonia will be potentially exposed to ASP review | Other: ASP review<br>* patients admitted to hospital with a diagnosis of community-acquired pneumonia will be reviewed by team members of antimicrobial stewardship program and subsequently feedback to attending physicians will be offered in the form of recommendations for antibiotic management<br>* Other names: prospective chart audit and attending physician feedback;|
|
Improving Antibiotic Use in Hospitalized Patients With Pneumonia
Study Overview
=================
Brief Summary
-----------------
The purpose of the study is to determine whether an antimicrobial stewardship program can decrease the length of hospital stay for patients with pneumonia. The antimicrobial stewardship program is run by a pharmacist and doctor with extensive training in managing infectious diseases. These two health care professionals are responsible for reviewing the records of patients admitted to hospital with pneumonia, and then making specific recommendations to the patient's attending physician about how to manage antibiotic treatment. These recommendations might include discontinuing the antibiotic, or changing the way antibiotics are delivered from intravenous form to pill form, among many other potential options. The attending physician considers whether these recommendations should be followed or rejected. The study has a control group of patients who are not reviewed by the antimicrobial stewardship team, and their length of hospital stay will be compared to the reviewed group of patients. Any differences between these two groups will be assumed to be due to the impact of the antimicrobial stewardship program. So far, no previous study has been able to demonstrate that an antimicrobial stewardship program can reduce the length of stay of patients admitted to hospital with pneumonia. This study has some important differences from previous studies that may make its conclusions more accurately reflect the true impact of antimicrobial stewardship programs. The most important difference is how the timing of the review is modelled in the analysis of the study results. Because the timing of the review varies between patients, with some patients being reviewed at earlier and some at later times, this subtle difference, if not accounted for in the analysis, can mask a true positive effect of the program on length of stay. The investigators study will account for this variation.
Detailed Description
-----------------
In immune-competent adult patients admitted to a hospital ward with a diagnosis of community-acquired pneumonia, does a multi-faceted ASP utilizing prospective chart audit and feedback compared with usual care reduce the LOS without increasing the risk of death or readmission at 30 days post-discharge from hospital? In Ontario, pneumonia is the leading cause of death from bacterial infections and accounts for over 18,000 years of life lost annually due to premature mortality. Pneumonia accounts for the majority of antibiotic utilization in both hospital and outpatient settings. Evidence-based guidelines for the diagnosis and management of pneumonia are available to physicians. Adherence to these evidence-based guidelines is associated with both reduced mortality and antibiotic utilization. Antimicrobial stewardship is defined as any intervention that minimizes unwarranted variation in antimicrobial utilization from evidence-based best practice with the intent of improving patient safety and quality of care. Unwarranted refers to the absence of patient- or disease-specific reasons to justify practice variation from evidence-based practice standards. Antimicrobial stewardship can be operationalized in many different ways, but prospective audit and feedback (persuasive approach) and restricted antimicrobial prescribing policies (restrictive approach) appear to be the most efficacious interventions to achieve the goals of antimicrobial stewardship. Antimicrobial stewardship programs have demonstrated efficacy in improving antimicrobial prescribing and reducing rates of hospital-acquired infections. Antimicrobial stewardship programs directed to CAP patients have demonstrated reductions in mortality, but have failed to demonstrate reductions in length of stay. All participants will be admitted patients to the Royal Victoria Regional Health Centre (RVRHC), a 319 bed community-based, university-affiliated, acute care hospital located in Barrie, Ontario, Canada. All patients enrolled in the study will be admitted to one of four medical wards. All study patients will be admitted to a hospitalist service. Admission to any medical ward is controlled by bed allocation, a non-medical administrative service within the hospital responsible for patient flow and assigning patient care. Hospitalists are not assigned to any one specific medical ward, but provide care across all medical wards. All eligible CAP who meet the ASP review criteria will be exposed to the ASP intervention. The ASP intervention (ASP-i) consists of a prospective chart audit and physician feedback (persuasive) approach . The ASP members who conduct all the audits and make recommendations consist of an infectious diseases-trained pharmacist (LM) and an infectious diseases trained physician (GD). All patients are reviewed by both members. The ASP intervention (ASP-i) recommendations are guided by the Infectious Diseases Society of America CAP guidelines and the Canadian Thoracic Society guidelines for the management of chronic obstructive pulmonary disease. The possible ASP-i recommendations are based on those recommended by the National Health Service in the United Kingdom and include the following: i) No change to current care ii) Discontinue antibiotic(s) iii) Intravenous to oral conversion iv) Duration of therapy v) Dosing change vi) Narrow or broaden spectrum of therapy The ASP-i recommendations are not mutually exclusive. All recommendations are documented in the patient's electronic medical record and communicated directly to the attending physician by the ASP members. This is a pragmatic controlled clinical study intended to measure the effectiveness of a 'real world' program. The ASP-i will be implemented in a modified stepped wedge design; baseline patient data will be collected for all enrolled patients on each of the medical wards for the first three months of the study, and then the ASP-i will be introduced to each medical ward in a non-randomized sequential fashion in two month intervals until all medical wards are exposed to the intervention. The unit of analysis will be individual patients adjusted for potential clustering effects within hospital wards. The primary outcome is length of hospital stay (LOS) measured in minutes from the documented time of admission to the documented time of discharge (or censoring). All patients will be administratively censored at 14 days after hospital admission if they have not been discharged home. Enrollment of patients started on April 1, 2013. The study is expected to enroll patients until March 31, 2015. All consecutive patients that meet the inclusion criteria and have no exclusion criteria will be eligible for the intervention. The ASP-i intervention may be implemented anytime after 48 hours post-admission in those patients who meet the criteria for ASP review. All patients who have not experienced an outcome at 14 days after admission will be censored from the study. Patients who die or are transferred from the ward (to the intensive care unit or other hospital) will also be censored. Patients who are discharged from hospital and are not censored will be contacted at 30 days post-discharge to determine their adherence with antibiotic prescription (if relevant), survival status and readmission status. The sample size expected for the current study is 'fixed' and has been previously estimated to be between 400 to 500 CAP patients per calendar year. The accrual period will be 24 months. Assuming 70% of patients in the control arm will achieve the primary outcome of being discharged alive from hospital, and setting power = 0.8 and statistical significance (2-sided) α = 0.05, the detectable ASP-i effect size is estimated to be up to an approximately 20% reduction in length of stay. An extended Cox regression analysis will be used to compare the primary and secondary outcomes between the control and intervention groups. Violations of the proportional hazards assumption for each covariate will be identified by using the method of Schoenfeld residuals. Results will be reported as hazard ratios with 95% confidence intervals. Time to ASP-i will be modeled as a time-variant covariate in the final model to account for any time-dependent bias. Other variables known to be associated with the primary and secondary outcomes will also be included in the final model, and include; age, sex, charlson comorbidity index, CURB-65 score, time (days) to clinical resolution, and complications from pneumonia such as empyema. Fixed effects of wards on the outcomes will accounted for by including them as indicator variables in the final model. Maturation of ASP-i effect on outcomes over time will be adjusted by including a categorical time variable in the final model (time variable will be defined as 'quarter' from start of study). A dichotomous variable for acceptance or rejection of the ASP-i will be part of an interaction term with the control/intervention group variable to permit a per protocol analysis.
Official Title
-----------------
Evaluating the Effectiveness of an Antimicrobial Stewardship Program on Reducing the Length of Stay of Immune-competent Adult Patients Admitted to a Hospital Ward With a Diagnosis of Community-acquired Pneumonia
Conditions
-----------------
Pneumonia
Intervention / Treatment
-----------------
* Other: ASP review
Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: have a positive Febrile Respiratory Illness (FRI) screen on admission to hospital (http://www.health.gov.on.ca/fr/public/programs/emu/sars/reports/dir_122303_acute_care_nonoutbreak.pdf) diagnosed with pneumonia by the admitting physician (Acute exacerbations of chronic obstructive lung disease are considered within the definition of pneumonia for the purposes of this study as they are commonly treated with the same antimicrobial regimens as patients with pneumonia) admitted to a medical ward Exclusion Criteria: hospitalized for ≥ 48 consecutive hours in the preceding 3 months receiving immunosuppressants [defined as ≥ 40 mg prednisone daily (or steroid equivalent) for ≥ 2 weeks preceding hospitalization OR any other immunosuppressant used for systemic illness OR to prevent transplant rejection] neutropenic [defined as a polymorphonuclear count ≤ 0.5 x 109 cells/L] from any cause immunocompromised [defined as having leukemia, lymphoma, HIV with CD4 cell count ≤ 200, splenectomy or on cytotoxic chemotherapy] admitted to high acuity units such as intensive care units require mechanical ventilation, either non-invasive or invasive have a life expectancy of ≤ 3 months (palliative)
Ages Eligible for Study
-----------------
Minimum Age: 18 Years
Sexes Eligible for Study
-----------------
All
Accepts Healthy Volunteers
-----------------
No
Study Plan
=================
How is the study designed?
-----------------
Arms and Interventions
| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Ward CAP<br>Adult immune-competent patients admitted to ward with clinical diagnosis of community-acquired pneumonia will be potentially exposed to ASP review | Other: ASP review<br>* patients admitted to hospital with a diagnosis of community-acquired pneumonia will be reviewed by team members of antimicrobial stewardship program and subsequently feedback to attending physicians will be offered in the form of recommendations for antibiotic management<br>* Other names: prospective chart audit and attending physician feedback;|
What is the study measuring?
-----------------
Primary Outcome Measures
| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Hospital length of stay | Time to discharge or censoring event | Patients will be followed for 14 days from date of admission and if not discharged will be administratively censored |
Secondary Outcome Measures
| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 30-day post-discharge mortality rate | all cause mortality at 30 days post-discharge from hospital | 30 calendar days after hospital discharge |
| 30-day post-discharge readmission rate | all cause readmission rate at 30 days post-discharge from hospital | 30 calendar days after hospital discharge |
| Days of antimicrobial therapy | Total days of antimicrobial therapy used per patient upto a maximum of 30-days post-discharge from hospital | Total days of antimicrobial therapy for each antibiotic calculated from date of first administration on admission to hospital to date of discontinuation (or to date of censoring, whichever comes first) upto a maximum of 30 days post-discharge follow-up |
| Duration of antimicrobial therapy | Total duration of antimicrobial therapy per patient upto a maximum of 30-days post discharge from hospital | Total duration of all antibiotics administered starting from date of administration of first antibiotic to date of discontinuation of last antibiotic (or to date of censoring, whichever comes first) upto a maximum of 30 days post-discharge from hospital |
Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Community-acquired pneumonia, Pragmatic clinical trial, Antimicrobial stewardship, length of stay, stepped-wedge design, time-dependent bias
|
|
NCT01071005
|
Pharmacodynamics of Lorelin Depot (Leuprorelin Acetate - Bergamo) Compared to Lupron Depot ® (Leuprorelin Acetate - Abbot)
|
The primary objective of this study is to examine, in healthy subjects, the comparative pharmacodynamics of Lorelin Depot (leuprorelin), manufactured by the Chemical Pharmaceutical Laboratory Bergamo Ltda with the product Lupron Depot ® (leuprorelin), manufactured by Abbott Laboratories Ltd, through the strength of biological markers follicle stimulating hormone (FSH), luteinizing hormone (LH) and total testosterone, associated with the activity of the substance.~Secondarily be observed safety (tolerability) of subjects in clinical research through the comparison of clinical and laboratory parameters pre-and post-study, and incidence of adverse events.
|
Randomized Clinical Trial of the Pharmacodynamics of Lorelin Depot 3.75Mg (Leuprorelin Acetate) Produced by Laboratório Químico Farmacêutico Bergamo LTDA. Compared to Lupron Depot ® 3.75 Mg Produced by Abbott in Healthy Subjects
|
Healthy
|
* Drug: Lorelin Depot Bergamo
* Drug: Lupron Depot - Abbott
|
Inclusion Criteria:~Accept the Informed Consent.~Subjects of research males aged 40 to 45 years;~Subject of research with body mass index greater than or equal to 19 and less than or equal to 30;~Be considered healthy, from the analysis of the clinical history and medical examination;~Laboratory tests with results outside the values considered normal, but not considered clinically relevant.~Exclusion Criteria:~Have donated or lost 450 mL or more of blood in the three months preceding the study;~Have participated in any experimental study or have taken any experimental drug in the last three months prior to the start of the study;~Have made regular use of medication in the last 4 weeks prior to the start of the study or have made use of any medication a week before the study began;~Have been hospitalized for any reason, up to 8 weeks before the study;~Provide history of alcohol abuse, drugs or medications, or have ingested alcohol within 48 hours prior to the period of hospitalization;~Have a history of liver disease, renal, pulmonary, gastrointestinal, hematological or psychiatric;~Amendments pressure of any etiology requiring pharmacological treatment;~Present history of myocardial infarction, angina and / or heart failure.
|
40 Years
|
45 Years
|
Male
|
Accepts Healthy Volunteers
|
Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
|
| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Decrease of serum levels of luteinizing hormone, Testosterone and FSH | | 56 days |
|
| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Evaluation of safety through the adverse affects investigation | | 56 days |
|
Decrease serum levels of luteinizing hormone, FSH and Testosterone
|
Leuprolide, Fertility Agents, Female, Fertility Agents, Reproductive Control Agents, Physiological Effects of Drugs, Antineoplastic Agents, Hormonal, Antineoplastic Agents
|
| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Test<br>Lorelin Depot - Bergamo | Drug: Lorelin Depot Bergamo<br>* Lorelin Depot Bergamo, 3,75 mg, single dose.<br>|
| Active Comparator: comparator<br>Lupron Depot® - Abbott | Drug: Lupron Depot - Abbott<br>* Lupron Depot 3,75 mg, single dose.<br>|
|
Pharmacodynamics of Lorelin Depot (Leuprorelin Acetate - Bergamo) Compared to Lupron Depot ® (Leuprorelin Acetate - Abbot)
Study Overview
=================
Brief Summary
-----------------
The primary objective of this study is to examine, in healthy subjects, the comparative pharmacodynamics of Lorelin Depot (leuprorelin), manufactured by the Chemical Pharmaceutical Laboratory Bergamo Ltda with the product Lupron Depot ® (leuprorelin), manufactured by Abbott Laboratories Ltd, through the strength of biological markers follicle stimulating hormone (FSH), luteinizing hormone (LH) and total testosterone, associated with the activity of the substance. Secondarily be observed safety (tolerability) of subjects in clinical research through the comparison of clinical and laboratory parameters pre-and post-study, and incidence of adverse events.
Official Title
-----------------
Randomized Clinical Trial of the Pharmacodynamics of Lorelin Depot 3.75Mg (Leuprorelin Acetate) Produced by Laboratório Químico Farmacêutico Bergamo LTDA. Compared to Lupron Depot ® 3.75 Mg Produced by Abbott in Healthy Subjects
Conditions
-----------------
Healthy
Intervention / Treatment
-----------------
* Drug: Lorelin Depot Bergamo
* Drug: Lupron Depot - Abbott
Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Accept the Informed Consent. Subjects of research males aged 40 to 45 years; Subject of research with body mass index greater than or equal to 19 and less than or equal to 30; Be considered healthy, from the analysis of the clinical history and medical examination; Laboratory tests with results outside the values considered normal, but not considered clinically relevant. Exclusion Criteria: Have donated or lost 450 mL or more of blood in the three months preceding the study; Have participated in any experimental study or have taken any experimental drug in the last three months prior to the start of the study; Have made regular use of medication in the last 4 weeks prior to the start of the study or have made use of any medication a week before the study began; Have been hospitalized for any reason, up to 8 weeks before the study; Provide history of alcohol abuse, drugs or medications, or have ingested alcohol within 48 hours prior to the period of hospitalization; Have a history of liver disease, renal, pulmonary, gastrointestinal, hematological or psychiatric; Amendments pressure of any etiology requiring pharmacological treatment; Present history of myocardial infarction, angina and / or heart failure.
Ages Eligible for Study
-----------------
Minimum Age: 40 Years
Maximum Age: 45 Years
Sexes Eligible for Study
-----------------
Male
Accepts Healthy Volunteers
-----------------
Accepts Healthy Volunteers
Study Plan
=================
How is the study designed?
-----------------
Design Details
Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Arms and Interventions
| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Test<br>Lorelin Depot - Bergamo | Drug: Lorelin Depot Bergamo<br>* Lorelin Depot Bergamo, 3,75 mg, single dose.<br>|
| Active Comparator: comparator<br>Lupron Depot® - Abbott | Drug: Lupron Depot - Abbott<br>* Lupron Depot 3,75 mg, single dose.<br>|
What is the study measuring?
-----------------
Primary Outcome Measures
| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Decrease of serum levels of luteinizing hormone, Testosterone and FSH | | 56 days |
Secondary Outcome Measures
| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Evaluation of safety through the adverse affects investigation | | 56 days |
Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Decrease serum levels of luteinizing hormone, FSH and Testosterone
|
|
NCT00943098
|
Evaluation of the Efficacy and Safety of Diclofenac HPBCD 75mg/ml in Treatment of Pain Following Dental Surgery
|
The present study is aimed at demonstrating the therapeutic equivalence of diclofenac HPBCD 75mg/1ml s.c. with the marketed reference product, Voltarol® 75mg/3ml i.m. in the treatment of acute moderate-to-severe pain after dental impaction surgery.
|
Efficacy and Safety of a Single s.c. Diclofenac HPBCD 75mg/1ml Injection as Compared to a Single i.m. Voltarol® 75mg/3ml, in the Treatment of Acute Moderate-to-severe Post-surgical Pain Following Dental Surgery (Impacted 3rd Molar Removal).
|
Dental Pain
|
* Drug: Diclofenac HPBCD s.c. 75mg/ml
* Drug: Voltarol 75mg/3ml i.m.
|
Inclusion Criteria:~Patients undergoing surgical extraction of a single fully or partially impacted mandibular 3rd molar requiring bone removal.~Patients experiencing moderate to severe post-operative pain within 6 hours from end of surgery.~Pre-operative laboratory tests in the reference ranges or without clinically significant abnormalities as judged by the Investigator.~Exclusion Criteria:~Surgery performed under general anaesthesia, or sedation.~Complications occurring during the surgical procedure or in the period before randomisation as judged by the investigator.~Acute local or systemic infection at the time of surgery that could confound the post-surgical evaluation.~Patients with clinical signs of gastritis, gastro-duodenal ulcer, GI bleeding. Other GI disturbances or disease that in the opinion of the investigator could be negatively affected by the administration of NSAIDs.~Clinical signs or history of coagulation disorders that could be negatively affected by NSAIDs administration.~Hepatic or renal impairment.~Patients with significant cardiac impairment, history of cerebrovascular disease, history or peripheral arterial disease, uncontrolled hypertension.~Hypersensitivity to diclofenac or other NSAIDs or to one of the study medication components.~Patients under chronic treatment with topical or systemic analgesics/NSAIDs.~Patients under treatment with any medication that may affect the treatment efficacy evaluation.~Patients under treatment with any medication whose concomitant use may be susceptible to interactions with diclofenac or may affect safety.
|
18 Years
|
65 Years
|
All
|
No
|
Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double
|
| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Pain Intensity Difference (PID) | Pain intensity difference (PID) was derived by subtracting each pain intensity score (PI) from the baseline PI score (t0), where PI was assessed by the patient on a 0-100 mm VAS (from 0 = no pain to 100 = worst pain imaginable). | 1.5 hours |
|
| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| PIDs | | at 15 minutes post-dose. |
| PIDs | | at 30 minutes post-dose. |
| PIDs | | at 45 minutes post-dose. |
| PIDs | | at 60 minutes post-dose. |
| PIDs | | at 90 minutes post-dose. |
| PIDs | | at 2 hours post-dose. |
| PIDs | | at 3 hours post-dose. |
| PIDs | | at 4 hours post-dose. |
| PIDs | | at 5 hours post-dose. |
| PIDs | | at 6 hours post-dose. |
| PIDs | | at 7 hours post-dose. |
| PIDs | | at 8 hours post-dose. |
|
Diclofenac, Anti-Inflammatory Agents, Non-Steroidal, Analgesics, Non-Narcotic, Analgesics, Sensory System Agents, Peripheral Nervous System Agents, Physiological Effects of Drugs, Anti-Inflammatory Agents, Antirheumatic Agents, Cyclooxygenase Inhibitors, Enzyme Inhibitors, Molecular Mechanisms of Pharmacological Action
|
| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Diclofenac HPBCD s.c. 75mg/ml<br> | Drug: Diclofenac HPBCD s.c. 75mg/ml<br>* 1 single injection at day of dental surgical extraction<br>|
| Active Comparator: Voltarol 75mg/3ml i.m.<br> | Drug: Voltarol 75mg/3ml i.m.<br>* 1 single injection at day of dental surgical extraction<br>|
|
Evaluation of the Efficacy and Safety of Diclofenac HPBCD 75mg/ml in Treatment of Pain Following Dental Surgery
Study Overview
=================
Brief Summary
-----------------
The present study is aimed at demonstrating the therapeutic equivalence of diclofenac HPBCD 75mg/1ml s.c. with the marketed reference product, Voltarol® 75mg/3ml i.m. in the treatment of acute moderate-to-severe pain after dental impaction surgery.
Official Title
-----------------
Efficacy and Safety of a Single s.c. Diclofenac HPBCD 75mg/1ml Injection as Compared to a Single i.m. Voltarol® 75mg/3ml, in the Treatment of Acute Moderate-to-severe Post-surgical Pain Following Dental Surgery (Impacted 3rd Molar Removal).
Conditions
-----------------
Dental Pain
Intervention / Treatment
-----------------
* Drug: Diclofenac HPBCD s.c. 75mg/ml
* Drug: Voltarol 75mg/3ml i.m.
Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Patients undergoing surgical extraction of a single fully or partially impacted mandibular 3rd molar requiring bone removal. Patients experiencing moderate to severe post-operative pain within 6 hours from end of surgery. Pre-operative laboratory tests in the reference ranges or without clinically significant abnormalities as judged by the Investigator. Exclusion Criteria: Surgery performed under general anaesthesia, or sedation. Complications occurring during the surgical procedure or in the period before randomisation as judged by the investigator. Acute local or systemic infection at the time of surgery that could confound the post-surgical evaluation. Patients with clinical signs of gastritis, gastro-duodenal ulcer, GI bleeding. Other GI disturbances or disease that in the opinion of the investigator could be negatively affected by the administration of NSAIDs. Clinical signs or history of coagulation disorders that could be negatively affected by NSAIDs administration. Hepatic or renal impairment. Patients with significant cardiac impairment, history of cerebrovascular disease, history or peripheral arterial disease, uncontrolled hypertension. Hypersensitivity to diclofenac or other NSAIDs or to one of the study medication components. Patients under chronic treatment with topical or systemic analgesics/NSAIDs. Patients under treatment with any medication that may affect the treatment efficacy evaluation. Patients under treatment with any medication whose concomitant use may be susceptible to interactions with diclofenac or may affect safety.
Ages Eligible for Study
-----------------
Minimum Age: 18 Years
Maximum Age: 65 Years
Sexes Eligible for Study
-----------------
All
Accepts Healthy Volunteers
-----------------
No
Study Plan
=================
How is the study designed?
-----------------
Design Details
Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double
Arms and Interventions
| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Diclofenac HPBCD s.c. 75mg/ml<br> | Drug: Diclofenac HPBCD s.c. 75mg/ml<br>* 1 single injection at day of dental surgical extraction<br>|
| Active Comparator: Voltarol 75mg/3ml i.m.<br> | Drug: Voltarol 75mg/3ml i.m.<br>* 1 single injection at day of dental surgical extraction<br>|
What is the study measuring?
-----------------
Primary Outcome Measures
| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Pain Intensity Difference (PID) | Pain intensity difference (PID) was derived by subtracting each pain intensity score (PI) from the baseline PI score (t0), where PI was assessed by the patient on a 0-100 mm VAS (from 0 = no pain to 100 = worst pain imaginable). | 1.5 hours |
Secondary Outcome Measures
| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| PIDs | | at 15 minutes post-dose. |
| PIDs | | at 30 minutes post-dose. |
| PIDs | | at 45 minutes post-dose. |
| PIDs | | at 60 minutes post-dose. |
| PIDs | | at 90 minutes post-dose. |
| PIDs | | at 2 hours post-dose. |
| PIDs | | at 3 hours post-dose. |
| PIDs | | at 4 hours post-dose. |
| PIDs | | at 5 hours post-dose. |
| PIDs | | at 6 hours post-dose. |
| PIDs | | at 7 hours post-dose. |
| PIDs | | at 8 hours post-dose. |
|
||
NCT01075581
|
Intranasal Injection Versus Topical Administration of Epinephrin During Endoscopic Sinus Surgery
|
Intranasal injection of epinephrine is used routinely during endoscopic sinus surgery (ESS) to reduce bleeding in the nasal mucosa and thereby improve visualization of the surgical field. However, systemic absorption of epinephrine via the nasal mucosa is often accompanied by cardiovascular side effects during the early postinjection period, putting in risk patients with cardiovascular morbidity. Evidence indicate that topical administration of epinephrine achieves similar hemostatic effects compared with injection of epinephrine, while avoiding systemic adverse effects. We wish to conduct a prospective controlled trial assessing the hemostatic and hemodynamic effects of intranasal injection compared to topical application of epinephrin during ESS, in order to evaluate whether the previous could be avoided due to its untoward effects.~We hypothesize that topical administration of epinephrine provides a hemostatic effect not inferior to that of intranasal injection while minimizing hemodynamic instability during ESS.
|
Introduction:~Intranasal injection of epinephrine is used routinely during endoscopic sinus surgery (ESS) to reduce bleeding in the nasal mucosa and hence improve visualization of the surgical field [1, 2].~Systemic absorption of epinephrine via the nasal mucosa, due to its vasoconstriction ability and cardiac effect, is often accompanied by cardiovascular side effects (e.g., hypertension, hypotension, tachycardia, cardiac arrhythmias, etc) during the early postinjection period [1, 3-5]. In patients with minimal cardiac reserve, these acute hyperdynamic effects may result in myocardial ischemia or infarction [6, 7]. The nasal mucosa has an excellent absorbing capability which may be utilized for local administration of vasoconstrictive substances instead of intranasal injection [8, 9], thus avoiding their systemic adverse effects .~Evidence indicate that topical use of epinephrine may achieve similar hemostatic effects compared with injection of epinephrine [10]. Another pilot study has demonstrated that epinephrine injection better facilitates visualization of the surgical field, yet topical application does not involve hemodynamic side effects [11]. However, a prospective, randomized larger trial has shown that, when local anesthetic containing epinephrine was used compared with normal saline (NS) injection for ESS, there was no significant reduction in intraoperative blood loss or duration of surgery. More importantly, a significantly higher mean arterial blood pressure (MABP) was associated with injection of epinephrine [2].~The objective of the current study is to compare the hemostatic and hemodynamic effects of intranasal injection versus topical application of epinephrin during ESS, in order to evaluate whether the previous could be avoided due to its untoward effects.~Study design:~After obtaining informed consent, patients will be assigned to one of two groups - intranasal injection group (IG) or topical application (TG) of epinephrine, by computer-generated assignment of random numbers.~Intra-operative surgical management:~Routine ESS will be performed on each subject. Resection and removal of different structures in the sinonasal complex will be executed appropriately as indicated according to underlying pathology.~Intra-operative vasoconstrictor administration Vials containing either epinephrine 1:100,000 or saline will be prepared in the operating room (OR) by the surgeon, with the assistance of the OR nurse. The content of the vials will not be disclosed to the surgeon (or anesthetist), who will thus not be aware of the type of solution being diluted. While patients allocated to the IG group will be injected with epinephrine, saline injection (total of 8 mL) will be used in the TG group.~Topical epinephrine will be applied in exactly the same manner and quantity for the saline-injected group as for the IG group:~Following initiation of general anesthesia and intubation, cotton pledgets soaked in 1 mL epinephrine 1:1,000 will be positioned in the nasal cavity for approximately 10 minutes. Following this, all patients will receive intranasal injection according to their assigned group. In the IG group a total of 8 mL of epinephrine 1:100,000 will be injected in the lateral nasal wall in two locations: the area superior to the insertion of the middle turbinate and area anterior to the posterior insertion of the middle turbinate, at the spheno-palatine artery region. The injection will be applied to both sides (total of 8 mL). Following the injection, Epinephrine-soaked cotton pledgets (1 mL of 1:1,000) will be placed at the middle meatus and anterior to the sphenoethmoidal recess. During the procedure the pledgets will be used at various locations as required for primary decongestion.~In the TG group, saline will be injected instead of epinephrine.~Patient assessment:~Patients' parameters will be collected during the procedure by an anesthesiologist via iMDsoft software. A printout delineating the following data will be obtained: heart rate, ECG for arrhythmias, systolic (SP) and mean arterial pressure (MAP) measured from a blood pressure cuff once per 2 minutes, and total intraoperative blood loss. These parameters will be monitored by the anesthetist throughout the procedure.~Study patients will be monitored throughout the procedure for any hemodynamic events potentially related to the vasoconstrictor applied to them. We will continue follow-up until they discharge in order to detect any post-operative complications that may occur due to systemic absorption of epinephrine.~Previous studies have demonstrated a significant increase in the plasma catecholamine level after nasal injection of epinephrine, which was associated with hemodynamic fluctuations [1, 11]. We therefore wish to analyze the systemic absorption of injected epinephrine during ESS.~Intraoperative catecholamine blood levels (epinephrine and norepinephrine) will be obtained by taking blood samples (7ml in each sample) from each patient: immediately after intubation (baseline), before pladget placement, 5min after pladget placement, before injection (approximately 10 minutes after applying epinephrine gauze strips), 2min post injection and placement of cotton pledgets (to both sides), 5min, 10min and 15 minutes post injection.~Other records will include: patient demographics, the duration of surgery, extent of nasosinusal polyposis/number of structures to be operated, the presence of polyps will be recorded, and need for intraoperative pharmacological intervention (vasopressors, vasodilators, inotropes, etc.).~The primary endpoint of the study will be changes in intraoperative hemodynamic parameters, and incidence of hemodynamic events during surgery, and specifically in the immediate post injection/topical application period (5min). These will include:~Lowest and highest HR, SP and MAP values.~Mean HR, SP and MAP during surgery.~Incidence of hypotensive and hypertensive events (>20% relative to baseline).~Incidence of tachycardic (HR>115) and bradycardic (HR<55) events. Analysis for correlation of these parameters with catecholamine blood levels will be performed.~The secondary endpoints will include:~Extent of nasal bleeding (estimated by assessment of the suction bottles, sponges, and the surgical drapes and gowns).~The total number of epinephrin pledgets used during surgery.~Incidence of arrhythmias and ST changes on ECG.~Subjective surgeons' evaluation of the feasibility of performing the procedure, effectiveness of hemostasis, and visualization of the operative field.~Pharmacokinetics of epinephrine administered to the nasal mucosa via injection and topical administration.~Post-operative complications due to systemic absorption of epinephrine in patients with risk factors (i.e., arteriosclerosis, hypertension, ischemic heart disease and other cardiac problems, anemia, preexistent liver or renal damage, and endocrinologic dysfunction such as hyperthyroidism, phaeochromocytoma, and diabetes mellitus) will be monitored until the patients discharge.~References~Anderhuber W, Walch C, Nemeth E, Semmelrock HJ, Berghold A, Ranftl G, Stammberger H. Plasma adrenaline concentrations during functional endoscopic sinus surgery. Laryngoscope 1999;109: 204-7.~Javer AR, Gheriani H, Mechor B, Flamer D, Genoway K, Yunker WK. Effect of intraoperative injection of 0.25% bupivacaine with 1:200,000 epinephrine on intraoperative blood loss in FESS. Am J Rhinol Allergy 2009;23: 437-41.~van Hasselt CA, Low JM, Waldron J, Gibb AG, Oh TE. Plasma catecholamine levels following topical application versus infiltration of adrenaline for nasal surgery. Anaesth Intensive Care 1992;20: 332-6.~Yang JJ, Wang QP, Wang TY, Sun J, Wang ZY, Zuo D, Xu JG. Marked hypotension induced by adrenaline contained in local anesthetic. Laryngoscope 2005;115: 348-52.~Moshaver A, Lin D, Pinto R, Witterick IJ. The hemostatic and hemodynamic effects of epinephrine during endoscopic sinus surgery: a randomized clinical trial. Arch Otolaryngol Head Neck Surg 2009;135: 1005-9.~Campagni MA, Howie MB, White PF, McSweeney TD. Comparative effects of oral clonidine and intravenous esmolol in attenuating the hemodynamic response to epinephrine injection. J Clin Anesth 1999;11: 208-15.~Kaufman E, Garfunkel A, Findler M, Elad S, Zusman SP, Malamed SF, Galili D. [Emergencies evolving from local anesthesia]. Refuat Hapeh Vehashinayim 2002;19: 13-8, 98.~Lang S, Rothen-Rutishauser B, Perriard JC, Schmidt MC, Merkle HP. Permeation and pathways of human calcitonin (hCT) across excised bovine nasal mucosa. Peptides 1998;19: 599-607.~Roth Y, Chapnik JS, Cole P. Feasibility of aerosol vaccination in humans. Ann Otol Rhinol Laryngol 2003;112: 264-70.~Lee TJ, Huang CC, Chang PH, Chang CJ, Chen YW. Hemostasis during functional endoscopic sinus surgery: the effect of local infiltration with adrenaline. Otolaryngol Head Neck Surg 2009;140: 209-14.~Cohen-Kerem R, Brown S, Villasenor LV, Witterick I. Epinephrine/Lidocaine injection vs. saline during endoscopic sinus surgery. Laryngoscope 2008;118: 1275-81.~Dershwitz M, Hoke JF, Rosow CE, Michalowski P, Connors PM, Muir KT, Dienstag JL. Pharmacokinetics and pharmacodynamics of remifentanil in volunteer subjects with severe liver disease. Anesthesiology 1996;84: 812-20.~Wormald PJ, van Renen G, Perks J, Jones JA, Langton-Hewer CD. The effect of the total intravenous anesthesia compared with inhalational anesthesia on the surgical field during endoscopic sinus surgery. Am J Rhinol 2005;19: 514-20.
|
Hemostatic and Hemodynamic Effects of Intranasal Injection Compared to Topical Administration of Epinephrin in Endoscopic Sinus Surgery
|
Hypertension, Hypotension, Tachycardia, Bradycardia, Arrhythmia
|
* Drug: Epinephrin (Intranasal injection)
* Drug: Epinephrin (Topical administration)
|
Inclusion Criteria:~Patients with ASA I-III,~Patients undergoing elective FESS at Sourasky Medical Center for Chronic rhinosinusitis with or without polyposis, including FESS combined with septoplasty and/or conchotomy.~Exclusion Criteria:~Patients scheduled for endoscopic resection of a tumor or closure of a cerebrospinal fluid leak, and~Patients for whom epinephrine was contraindicated.
|
18 Years
|
80 Years
|
All
|
No
|
Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple
|
| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Intraoperative hemodynamic alterations (instability) | Changes in intraoperative hemodynamic parameters will be monitored continuously,and any event will be documented, including: lowest and highest HR, SP and MAP values; mean HR, SP and MAP during surgery; incidence of hypotensive and hypertensive events (>20% relative to baseline); incidence of tachycardic (HR>115) and bradycardic (HR<55) events. | duration of surgery |
|
| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Hemostasis | Hemostatic effects will be evaluated by the following parameters:~By the surgeon, via a subjective surgical grade scoring system.~By the extent of nasal bleeding (estimated by assessment of the suction bottles, sponges, and the surgical drapes and gowns).~By the total number of epinephrin pledgets used during surgery. | duration of surgery |
|
Hemodynamic instability, Hemostasis
|
Epinephrine, Racepinephrine, Epinephryl borate, Adrenergic alpha-Agonists, Adrenergic Agonists, Adrenergic Agents, Neurotransmitter Agents, Molecular Mechanisms of Pharmacological Action, Physiological Effects of Drugs, Adrenergic beta-Agonists, Bronchodilator Agents, Autonomic Agents, Peripheral Nervous System Agents, Anti-Asthmatic Agents, Respiratory System Agents, Mydriatics, Sympathomimetics, Vasoconstrictor Agents
|
| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: Topical administration<br>An an intranasal injection of saline will be used as control, and thereafter cotton pledgets soaked in 1 mL epinephrine 1:1,000 will be placed in the nasal cavity during surgery when necessary. | Drug: Epinephrin (Topical administration)<br>* An intranasal injection of saline solution, followed by placement of cotton pledgets (soaked in 1 mL epinephrine 1:1,000) in the nasal cavity when required.<br>* Other names: Adrenaline;|
| Experimental: Intranasal injection<br>An intranasal injection of 8 mL epinephrine 1:100,000 will be performed as traditionally practiced in ESS. Thereafter, cotton pledgets soaked in 1 mL epinephrine 1:1,000 will be placed in the nasal cavity during surgery when necessary. | Drug: Epinephrin (Intranasal injection)<br>* A total of 8 mL of epinephrine 1:100,000 will be injected in the lateral nasal wall, followed by placement of cotton pledgets (soaked in 1 mL epinephrine 1:1,000) in the nasal cavity when required.<br>* Other names: Adrenaline;|
|
Intranasal Injection Versus Topical Administration of Epinephrin During Endoscopic Sinus Surgery
Study Overview
=================
Brief Summary
-----------------
Intranasal injection of epinephrine is used routinely during endoscopic sinus surgery (ESS) to reduce bleeding in the nasal mucosa and thereby improve visualization of the surgical field. However, systemic absorption of epinephrine via the nasal mucosa is often accompanied by cardiovascular side effects during the early postinjection period, putting in risk patients with cardiovascular morbidity. Evidence indicate that topical administration of epinephrine achieves similar hemostatic effects compared with injection of epinephrine, while avoiding systemic adverse effects. We wish to conduct a prospective controlled trial assessing the hemostatic and hemodynamic effects of intranasal injection compared to topical application of epinephrin during ESS, in order to evaluate whether the previous could be avoided due to its untoward effects. We hypothesize that topical administration of epinephrine provides a hemostatic effect not inferior to that of intranasal injection while minimizing hemodynamic instability during ESS.
Detailed Description
-----------------
Introduction: Intranasal injection of epinephrine is used routinely during endoscopic sinus surgery (ESS) to reduce bleeding in the nasal mucosa and hence improve visualization of the surgical field [1, 2]. Systemic absorption of epinephrine via the nasal mucosa, due to its vasoconstriction ability and cardiac effect, is often accompanied by cardiovascular side effects (e.g., hypertension, hypotension, tachycardia, cardiac arrhythmias, etc) during the early postinjection period [1, 3-5]. In patients with minimal cardiac reserve, these acute hyperdynamic effects may result in myocardial ischemia or infarction [6, 7]. The nasal mucosa has an excellent absorbing capability which may be utilized for local administration of vasoconstrictive substances instead of intranasal injection [8, 9], thus avoiding their systemic adverse effects . Evidence indicate that topical use of epinephrine may achieve similar hemostatic effects compared with injection of epinephrine [10]. Another pilot study has demonstrated that epinephrine injection better facilitates visualization of the surgical field, yet topical application does not involve hemodynamic side effects [11]. However, a prospective, randomized larger trial has shown that, when local anesthetic containing epinephrine was used compared with normal saline (NS) injection for ESS, there was no significant reduction in intraoperative blood loss or duration of surgery. More importantly, a significantly higher mean arterial blood pressure (MABP) was associated with injection of epinephrine [2]. The objective of the current study is to compare the hemostatic and hemodynamic effects of intranasal injection versus topical application of epinephrin during ESS, in order to evaluate whether the previous could be avoided due to its untoward effects. Study design: After obtaining informed consent, patients will be assigned to one of two groups - intranasal injection group (IG) or topical application (TG) of epinephrine, by computer-generated assignment of random numbers. Intra-operative surgical management: Routine ESS will be performed on each subject. Resection and removal of different structures in the sinonasal complex will be executed appropriately as indicated according to underlying pathology. Intra-operative vasoconstrictor administration Vials containing either epinephrine 1:100,000 or saline will be prepared in the operating room (OR) by the surgeon, with the assistance of the OR nurse. The content of the vials will not be disclosed to the surgeon (or anesthetist), who will thus not be aware of the type of solution being diluted. While patients allocated to the IG group will be injected with epinephrine, saline injection (total of 8 mL) will be used in the TG group. Topical epinephrine will be applied in exactly the same manner and quantity for the saline-injected group as for the IG group: Following initiation of general anesthesia and intubation, cotton pledgets soaked in 1 mL epinephrine 1:1,000 will be positioned in the nasal cavity for approximately 10 minutes. Following this, all patients will receive intranasal injection according to their assigned group. In the IG group a total of 8 mL of epinephrine 1:100,000 will be injected in the lateral nasal wall in two locations: the area superior to the insertion of the middle turbinate and area anterior to the posterior insertion of the middle turbinate, at the spheno-palatine artery region. The injection will be applied to both sides (total of 8 mL). Following the injection, Epinephrine-soaked cotton pledgets (1 mL of 1:1,000) will be placed at the middle meatus and anterior to the sphenoethmoidal recess. During the procedure the pledgets will be used at various locations as required for primary decongestion. In the TG group, saline will be injected instead of epinephrine. Patient assessment: Patients' parameters will be collected during the procedure by an anesthesiologist via iMDsoft software. A printout delineating the following data will be obtained: heart rate, ECG for arrhythmias, systolic (SP) and mean arterial pressure (MAP) measured from a blood pressure cuff once per 2 minutes, and total intraoperative blood loss. These parameters will be monitored by the anesthetist throughout the procedure. Study patients will be monitored throughout the procedure for any hemodynamic events potentially related to the vasoconstrictor applied to them. We will continue follow-up until they discharge in order to detect any post-operative complications that may occur due to systemic absorption of epinephrine. Previous studies have demonstrated a significant increase in the plasma catecholamine level after nasal injection of epinephrine, which was associated with hemodynamic fluctuations [1, 11]. We therefore wish to analyze the systemic absorption of injected epinephrine during ESS. Intraoperative catecholamine blood levels (epinephrine and norepinephrine) will be obtained by taking blood samples (7ml in each sample) from each patient: immediately after intubation (baseline), before pladget placement, 5min after pladget placement, before injection (approximately 10 minutes after applying epinephrine gauze strips), 2min post injection and placement of cotton pledgets (to both sides), 5min, 10min and 15 minutes post injection. Other records will include: patient demographics, the duration of surgery, extent of nasosinusal polyposis/number of structures to be operated, the presence of polyps will be recorded, and need for intraoperative pharmacological intervention (vasopressors, vasodilators, inotropes, etc.). The primary endpoint of the study will be changes in intraoperative hemodynamic parameters, and incidence of hemodynamic events during surgery, and specifically in the immediate post injection/topical application period (5min). These will include: Lowest and highest HR, SP and MAP values. Mean HR, SP and MAP during surgery. Incidence of hypotensive and hypertensive events (>20% relative to baseline). Incidence of tachycardic (HR>115) and bradycardic (HR<55) events. Analysis for correlation of these parameters with catecholamine blood levels will be performed. The secondary endpoints will include: Extent of nasal bleeding (estimated by assessment of the suction bottles, sponges, and the surgical drapes and gowns). The total number of epinephrin pledgets used during surgery. Incidence of arrhythmias and ST changes on ECG. Subjective surgeons' evaluation of the feasibility of performing the procedure, effectiveness of hemostasis, and visualization of the operative field. Pharmacokinetics of epinephrine administered to the nasal mucosa via injection and topical administration. Post-operative complications due to systemic absorption of epinephrine in patients with risk factors (i.e., arteriosclerosis, hypertension, ischemic heart disease and other cardiac problems, anemia, preexistent liver or renal damage, and endocrinologic dysfunction such as hyperthyroidism, phaeochromocytoma, and diabetes mellitus) will be monitored until the patients discharge. References Anderhuber W, Walch C, Nemeth E, Semmelrock HJ, Berghold A, Ranftl G, Stammberger H. Plasma adrenaline concentrations during functional endoscopic sinus surgery. Laryngoscope 1999;109: 204-7. Javer AR, Gheriani H, Mechor B, Flamer D, Genoway K, Yunker WK. Effect of intraoperative injection of 0.25% bupivacaine with 1:200,000 epinephrine on intraoperative blood loss in FESS. Am J Rhinol Allergy 2009;23: 437-41. van Hasselt CA, Low JM, Waldron J, Gibb AG, Oh TE. Plasma catecholamine levels following topical application versus infiltration of adrenaline for nasal surgery. Anaesth Intensive Care 1992;20: 332-6. Yang JJ, Wang QP, Wang TY, Sun J, Wang ZY, Zuo D, Xu JG. Marked hypotension induced by adrenaline contained in local anesthetic. Laryngoscope 2005;115: 348-52. Moshaver A, Lin D, Pinto R, Witterick IJ. The hemostatic and hemodynamic effects of epinephrine during endoscopic sinus surgery: a randomized clinical trial. Arch Otolaryngol Head Neck Surg 2009;135: 1005-9. Campagni MA, Howie MB, White PF, McSweeney TD. Comparative effects of oral clonidine and intravenous esmolol in attenuating the hemodynamic response to epinephrine injection. J Clin Anesth 1999;11: 208-15. Kaufman E, Garfunkel A, Findler M, Elad S, Zusman SP, Malamed SF, Galili D. [Emergencies evolving from local anesthesia]. Refuat Hapeh Vehashinayim 2002;19: 13-8, 98. Lang S, Rothen-Rutishauser B, Perriard JC, Schmidt MC, Merkle HP. Permeation and pathways of human calcitonin (hCT) across excised bovine nasal mucosa. Peptides 1998;19: 599-607. Roth Y, Chapnik JS, Cole P. Feasibility of aerosol vaccination in humans. Ann Otol Rhinol Laryngol 2003;112: 264-70. Lee TJ, Huang CC, Chang PH, Chang CJ, Chen YW. Hemostasis during functional endoscopic sinus surgery: the effect of local infiltration with adrenaline. Otolaryngol Head Neck Surg 2009;140: 209-14. Cohen-Kerem R, Brown S, Villasenor LV, Witterick I. Epinephrine/Lidocaine injection vs. saline during endoscopic sinus surgery. Laryngoscope 2008;118: 1275-81. Dershwitz M, Hoke JF, Rosow CE, Michalowski P, Connors PM, Muir KT, Dienstag JL. Pharmacokinetics and pharmacodynamics of remifentanil in volunteer subjects with severe liver disease. Anesthesiology 1996;84: 812-20. Wormald PJ, van Renen G, Perks J, Jones JA, Langton-Hewer CD. The effect of the total intravenous anesthesia compared with inhalational anesthesia on the surgical field during endoscopic sinus surgery. Am J Rhinol 2005;19: 514-20.
Official Title
-----------------
Hemostatic and Hemodynamic Effects of Intranasal Injection Compared to Topical Administration of Epinephrin in Endoscopic Sinus Surgery
Conditions
-----------------
Hypertension, Hypotension, Tachycardia, Bradycardia, Arrhythmia
Intervention / Treatment
-----------------
* Drug: Epinephrin (Intranasal injection)
* Drug: Epinephrin (Topical administration)
Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Patients with ASA I-III, Patients undergoing elective FESS at Sourasky Medical Center for Chronic rhinosinusitis with or without polyposis, including FESS combined with septoplasty and/or conchotomy. Exclusion Criteria: Patients scheduled for endoscopic resection of a tumor or closure of a cerebrospinal fluid leak, and Patients for whom epinephrine was contraindicated.
Ages Eligible for Study
-----------------
Minimum Age: 18 Years
Maximum Age: 80 Years
Sexes Eligible for Study
-----------------
All
Accepts Healthy Volunteers
-----------------
No
Study Plan
=================
How is the study designed?
-----------------
Design Details
Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple
Arms and Interventions
| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: Topical administration<br>An an intranasal injection of saline will be used as control, and thereafter cotton pledgets soaked in 1 mL epinephrine 1:1,000 will be placed in the nasal cavity during surgery when necessary. | Drug: Epinephrin (Topical administration)<br>* An intranasal injection of saline solution, followed by placement of cotton pledgets (soaked in 1 mL epinephrine 1:1,000) in the nasal cavity when required.<br>* Other names: Adrenaline;|
| Experimental: Intranasal injection<br>An intranasal injection of 8 mL epinephrine 1:100,000 will be performed as traditionally practiced in ESS. Thereafter, cotton pledgets soaked in 1 mL epinephrine 1:1,000 will be placed in the nasal cavity during surgery when necessary. | Drug: Epinephrin (Intranasal injection)<br>* A total of 8 mL of epinephrine 1:100,000 will be injected in the lateral nasal wall, followed by placement of cotton pledgets (soaked in 1 mL epinephrine 1:1,000) in the nasal cavity when required.<br>* Other names: Adrenaline;|
What is the study measuring?
-----------------
Primary Outcome Measures
| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Intraoperative hemodynamic alterations (instability) | Changes in intraoperative hemodynamic parameters will be monitored continuously,and any event will be documented, including: lowest and highest HR, SP and MAP values; mean HR, SP and MAP during surgery; incidence of hypotensive and hypertensive events (>20% relative to baseline); incidence of tachycardic (HR>115) and bradycardic (HR<55) events. | duration of surgery |
Secondary Outcome Measures
| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Hemostasis | Hemostatic effects will be evaluated by the following parameters: By the surgeon, via a subjective surgical grade scoring system. By the extent of nasal bleeding (estimated by assessment of the suction bottles, sponges, and the surgical drapes and gowns). By the total number of epinephrin pledgets used during surgery. | duration of surgery |
Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Hemodynamic instability, Hemostasis
|
NCT04035512
|
The Expressive Writing in Bariatric Surgery
|
The aim of the present study is to test the efficacy of a psychological intervention focused on the expressive writing on the weight loss and adherence, 3 months after surgery in obese population undergoing to bariatric surgery. The sample will be divided into two groups: the expressive writing group that will perform the psychological intervention focused on expressive writing, and the control group that will not perform the psychological intervention. The assignment to the two groups will be randomized. The randomization will be carried out leaving each participant free to blindly choose one of the two sealed envelopes containing the writing instruction sheet and an empty sheet, respectively.~All participants will complete psychometric questionnaires 3 days before surgery (T0) and 3 months (T1) after surgery in order to test the predicted variation on the chosen outcome in a very early stage after surgery. In order to assess the adherence level with a non self - report measure, the serum levels of 25(OH)D, B12, sideraemia and iron at T1 will be collected. Moreover, the adherence to follow up visits (surgical, nutritional and psychological) at 1 and 3 months will be assessed.~The main hypothesis is that those patients undergoing expressive writing would have a greater early Excess Weight Loss % (EWL%), lower level of psychological impairment and higher level of adherence to treatment 3 months after surgery, compare to those patients who are not undergoing expressive writing.
|
Obesity is a multifactorial disease characterized by genetic, social, cultural and psychological factors. Its complex nature requires a multidisciplinary intervention in order to guarantee an optimal outcome. Currently, laparoscopic bariatric surgery represents the gold standard intervention to treat morbid obesity and related comorbidities, as well as to improve quality of life. The expected Excess Weight Loss (%EWL) after the most popular bariatric procedures ranges between 60% and 70%, respectively at 1 and 2 years after surgery. However, literature shows that more than 30% of bariatric patients do not reach the expected weight loss and up to one third regain substantial weight in the long term period. Several studies showed correlation between post-surgery weight loss or %EWL and personality disorders, eating disorders, mood disorders and anxiety disorder. Also childhood traumatic experiences, that could be associated to the development of obesity, had a role in weight loss after surgery and in affecting emotional regulation. Recent studies also showed the role of emotional regulation and in particular as the difficulty in identifying and describing emotions, known as alexithymia, was associated respectively to lower %Total Weight Loss at 3 and 6 months after gastric bypass and at 12 months after laparoscopic sleeve gastrectomy.~Considering the influence of alexithymia on people living with obesity seeking a weight loss program, it is conceivable that an intervention focused on emotional state could improve outcome after surgery in term of weight loss.~The expressive writing is a form of writing therapy developed primarily by James W. Pennebaker in the late 1980s consisting of writing about stressful and difficult experience for 15-20 min for 3-5 consecutive days, including one's thoughts and feelings. The expressive writing allows people to express and process emotions, feelings, and thoughts related to the life events and consequent changes and this may favor a mental reorganization of the negative events, a greater expression and regulation of the emotions related to them. This intervention could provoke social, emotional, and consequently, psychophysical changes as is showed in patients with chronic diseases and cancer. It is conceivable that the externalization and the processing of the traumatic events linked to the disease, can favor an improvement of the ability of express emotions and the reduction of the negative thoughts associated.~Recruitment: all patients, considered eligible after a multidisciplinary assessment, will be contacted to request participation in the study. Those who accepted the participation, will be randomized in two groups: the expressive writing group that will perform the psychological intervention focused on expressive writing, and the control group that will not perform the psychological intervention. The randomization will be carried out leaving each participant free to blindly choose one of the two sealed envelopes containing the writing instruction sheet and an empty sheet, respectively. Then all the participants of both groups will complete the informed consent and the questionnaires 3 days before surgery (T0).~According to the randomized recruitment all patients of the expressive writing group will be scheduled for 3 consecutive days (20 minutes each day) on which they will complete the writing task. The procedure for the writing group will be as follow:~on day 1 the researcher will call the participant at designed time and will provide a brief introduction to the writing task. Participant will be asked to go a quiet place in their house where they would have no interruptions but can still be close to the phone. Next, participants were given standardized instructions. Then participants will ask to start writing immediately after hanging up the phone and to write for 20 minutes. The researcher will call the participants after 20 minutes. The procedure for the second and third writing days will be identical.~The above method was previously tested by Zakowski et al., 2004. The control group (no expressive writing) will just complete the above mentioned questionnaires.~Both groups will fill the same questionnaires also at 3 months follow up (T1). In order to assess the adherence level with a non self - report measure, the serum levels of 25(OH)D, B12, sideraemia and iron at T1 will be collected according to the blood analysis provided for the hospital protocol of bariatric surgery.~Moreover, the adherence to follow up visits (surgical and nutritional) at 1 and 3 months will be assessed.~The weight measures at T0, and T1 will be collected in order to test the EWL% reached in both groups.~The present study has been approved by the Ethics Committee of the Department of Dynamic and Clinical Psychology Sapienza University of Rome on April 3rd, 2019.
|
The Expressive Writing as Psychological Intervention in Bariatric Population. Prospective Longitudinal Multi Centric Study
|
Bariatric Surgery Candidate
|
* Other: Expressive writing
|
Inclusion Criteria:~The inclusion criteria will follow the European Guidelines on Metabolic and Bariatric Surgery (Fried et al., 2014):~With BMI ≥ 40 kg/m2, with BMI 35-40 kg/m2 with co-morbidities in which surgically induced weight loss is expected to improve the disorder~declared eligible for pre-operative psychological assessment.~Exclusion Criteria:~presence of a psychiatric disorder or drug/ alcohol abuse~cognitive impairment~level of education less than primary school~revisional surgery.
|
18 Years
|
60 Years
|
All
|
No
|
Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Sequential Assignment
Interventional Model Description: The sample will be divided into two group, in a randomized way. The expressive writing group that will perform the writing task and the control group that will not perform the writing task. The study includes two measurements, pre-operatively (T0) and 3 months after surgery (T1)
Masking: None (Open Label)
|
| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Excess Weight Loss (%EWL) | Those patients undergoing expressive writing would have a greater early Excess Weight Loss % (EWL%) | 3 month |
| Emotional Regulation (Toronto Alexithymia Scale) | The TAS-20 is a self-administered questionnaire, consisting of 20 items. The scale ranges between 20 to 100 and it allows to identify alexithymic (> 60), not alexithymic (< 51) and probably alexithymic patients (51-60).We expect that those patients undergoing expressive writing would have a lower score (<51) compared to control group patients. | 3 month |
| Adherence (Visual Analogue Scale) | The VAS asks individuals to mark a line at the point along a continuum showing how much of each drug they have taken in the past 6 months from 0% to 100% where 0% means you have taken no drug/s in the past 6 months, 50% means you have taken half of your drug/s in the past 6 months and 100% means you have taken all of your drug/s in the past 6 months. After surgery it will be used also to assess the adherence to nutritional supplements provided by the bariatric protocol. We expect that those patients undergoing expressive writing would have a higher level of adherence to treatment on VAS score (>90). | 3 month |
|
Bariatric surgery, Expressive writing, Obesity, Alexithymia, Adherence
|
| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Expressive writing<br>The expressive writing group will perform the writing task, for 3 consecutive days, 20 minutes each day | Other: Expressive writing<br>* The procedure for the writing group will be as follow:~on day 1 the researcher will call the participant at designed time and will provide a brief introduction to the writing task. Participant will be asked to go in a quiet place in their house where they would have no interruptions but can still be close to the phone. Next, participants were given standardized instructions. Then participants will ask to start writing immediately after hanging up the phone and to write for 20 minutes. The researcher will call the participants after 20 minutes. The procedure for the second and third writing days will be identical.~The above method was previously tested by Zakowski et al., 2004.<br>|
| No Intervention: Control group<br>Any intervention | |
|
The Expressive Writing in Bariatric Surgery
Study Overview
=================
Brief Summary
-----------------
The aim of the present study is to test the efficacy of a psychological intervention focused on the expressive writing on the weight loss and adherence, 3 months after surgery in obese population undergoing to bariatric surgery. The sample will be divided into two groups: the expressive writing group that will perform the psychological intervention focused on expressive writing, and the control group that will not perform the psychological intervention. The assignment to the two groups will be randomized. The randomization will be carried out leaving each participant free to blindly choose one of the two sealed envelopes containing the writing instruction sheet and an empty sheet, respectively. All participants will complete psychometric questionnaires 3 days before surgery (T0) and 3 months (T1) after surgery in order to test the predicted variation on the chosen outcome in a very early stage after surgery. In order to assess the adherence level with a non self - report measure, the serum levels of 25(OH)D, B12, sideraemia and iron at T1 will be collected. Moreover, the adherence to follow up visits (surgical, nutritional and psychological) at 1 and 3 months will be assessed. The main hypothesis is that those patients undergoing expressive writing would have a greater early Excess Weight Loss % (EWL%), lower level of psychological impairment and higher level of adherence to treatment 3 months after surgery, compare to those patients who are not undergoing expressive writing.
Detailed Description
-----------------
Obesity is a multifactorial disease characterized by genetic, social, cultural and psychological factors. Its complex nature requires a multidisciplinary intervention in order to guarantee an optimal outcome. Currently, laparoscopic bariatric surgery represents the gold standard intervention to treat morbid obesity and related comorbidities, as well as to improve quality of life. The expected Excess Weight Loss (%EWL) after the most popular bariatric procedures ranges between 60% and 70%, respectively at 1 and 2 years after surgery. However, literature shows that more than 30% of bariatric patients do not reach the expected weight loss and up to one third regain substantial weight in the long term period. Several studies showed correlation between post-surgery weight loss or %EWL and personality disorders, eating disorders, mood disorders and anxiety disorder. Also childhood traumatic experiences, that could be associated to the development of obesity, had a role in weight loss after surgery and in affecting emotional regulation. Recent studies also showed the role of emotional regulation and in particular as the difficulty in identifying and describing emotions, known as alexithymia, was associated respectively to lower %Total Weight Loss at 3 and 6 months after gastric bypass and at 12 months after laparoscopic sleeve gastrectomy. Considering the influence of alexithymia on people living with obesity seeking a weight loss program, it is conceivable that an intervention focused on emotional state could improve outcome after surgery in term of weight loss. The expressive writing is a form of writing therapy developed primarily by James W. Pennebaker in the late 1980s consisting of writing about stressful and difficult experience for 15-20 min for 3-5 consecutive days, including one's thoughts and feelings. The expressive writing allows people to express and process emotions, feelings, and thoughts related to the life events and consequent changes and this may favor a mental reorganization of the negative events, a greater expression and regulation of the emotions related to them. This intervention could provoke social, emotional, and consequently, psychophysical changes as is showed in patients with chronic diseases and cancer. It is conceivable that the externalization and the processing of the traumatic events linked to the disease, can favor an improvement of the ability of express emotions and the reduction of the negative thoughts associated. Recruitment: all patients, considered eligible after a multidisciplinary assessment, will be contacted to request participation in the study. Those who accepted the participation, will be randomized in two groups: the expressive writing group that will perform the psychological intervention focused on expressive writing, and the control group that will not perform the psychological intervention. The randomization will be carried out leaving each participant free to blindly choose one of the two sealed envelopes containing the writing instruction sheet and an empty sheet, respectively. Then all the participants of both groups will complete the informed consent and the questionnaires 3 days before surgery (T0). According to the randomized recruitment all patients of the expressive writing group will be scheduled for 3 consecutive days (20 minutes each day) on which they will complete the writing task. The procedure for the writing group will be as follow: on day 1 the researcher will call the participant at designed time and will provide a brief introduction to the writing task. Participant will be asked to go a quiet place in their house where they would have no interruptions but can still be close to the phone. Next, participants were given standardized instructions. Then participants will ask to start writing immediately after hanging up the phone and to write for 20 minutes. The researcher will call the participants after 20 minutes. The procedure for the second and third writing days will be identical. The above method was previously tested by Zakowski et al., 2004. The control group (no expressive writing) will just complete the above mentioned questionnaires. Both groups will fill the same questionnaires also at 3 months follow up (T1). In order to assess the adherence level with a non self - report measure, the serum levels of 25(OH)D, B12, sideraemia and iron at T1 will be collected according to the blood analysis provided for the hospital protocol of bariatric surgery. Moreover, the adherence to follow up visits (surgical and nutritional) at 1 and 3 months will be assessed. The weight measures at T0, and T1 will be collected in order to test the EWL% reached in both groups. The present study has been approved by the Ethics Committee of the Department of Dynamic and Clinical Psychology Sapienza University of Rome on April 3rd, 2019.
Official Title
-----------------
The Expressive Writing as Psychological Intervention in Bariatric Population. Prospective Longitudinal Multi Centric Study
Conditions
-----------------
Bariatric Surgery Candidate
Intervention / Treatment
-----------------
* Other: Expressive writing
Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: The inclusion criteria will follow the European Guidelines on Metabolic and Bariatric Surgery (Fried et al., 2014): With BMI ≥ 40 kg/m2, with BMI 35-40 kg/m2 with co-morbidities in which surgically induced weight loss is expected to improve the disorder declared eligible for pre-operative psychological assessment. Exclusion Criteria: presence of a psychiatric disorder or drug/ alcohol abuse cognitive impairment level of education less than primary school revisional surgery.
Ages Eligible for Study
-----------------
Minimum Age: 18 Years
Maximum Age: 60 Years
Sexes Eligible for Study
-----------------
All
Accepts Healthy Volunteers
-----------------
No
Study Plan
=================
How is the study designed?
-----------------
Design Details
Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Sequential Assignment
Interventional Model Description: The sample will be divided into two group, in a randomized way. The expressive writing group that will perform the writing task and the control group that will not perform the writing task. The study includes two measurements, pre-operatively (T0) and 3 months after surgery (T1)
Masking: None (Open Label)
Arms and Interventions
| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Expressive writing<br>The expressive writing group will perform the writing task, for 3 consecutive days, 20 minutes each day | Other: Expressive writing<br>* The procedure for the writing group will be as follow: on day 1 the researcher will call the participant at designed time and will provide a brief introduction to the writing task. Participant will be asked to go in a quiet place in their house where they would have no interruptions but can still be close to the phone. Next, participants were given standardized instructions. Then participants will ask to start writing immediately after hanging up the phone and to write for 20 minutes. The researcher will call the participants after 20 minutes. The procedure for the second and third writing days will be identical. The above method was previously tested by Zakowski et al., 2004.<br>|
| No Intervention: Control group<br>Any intervention | |
What is the study measuring?
-----------------
Primary Outcome Measures
| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Excess Weight Loss (%EWL) | Those patients undergoing expressive writing would have a greater early Excess Weight Loss % (EWL%) | 3 month |
| Emotional Regulation (Toronto Alexithymia Scale) | The TAS-20 is a self-administered questionnaire, consisting of 20 items. The scale ranges between 20 to 100 and it allows to identify alexithymic (> 60), not alexithymic (< 51) and probably alexithymic patients (51-60).We expect that those patients undergoing expressive writing would have a lower score (<51) compared to control group patients. | 3 month |
| Adherence (Visual Analogue Scale) | The VAS asks individuals to mark a line at the point along a continuum showing how much of each drug they have taken in the past 6 months from 0% to 100% where 0% means you have taken no drug/s in the past 6 months, 50% means you have taken half of your drug/s in the past 6 months and 100% means you have taken all of your drug/s in the past 6 months. After surgery it will be used also to assess the adherence to nutritional supplements provided by the bariatric protocol. We expect that those patients undergoing expressive writing would have a higher level of adherence to treatment on VAS score (>90). | 3 month |
Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Bariatric surgery, Expressive writing, Obesity, Alexithymia, Adherence
|
||
NCT00556712
|
A Study of Tarceva (Erlotinib) Following Platinum-Based Chemotherapy in Patients With Advanced, Recurrent, or Metastatic Non-Small Cell Lung Cancer (NSCLC)
|
This 2 arm study will evaluate the efficacy, safety, and pharmacokinetics of Tarceva, compared with placebo, following platinum-based chemotherapy in patients with advanced, recurrent, or metastatic NSCLC who have not had disease progression or unacceptable toxicity during chemotherapy. Following 4 cycles of platinum-based chemotherapy, eligible patients will be randomized to receive either Tarceva 150mg po daily, or placebo daily. The anticipated time on study treatment is until disease progression; the target sample size is 500+ individuals.
|
A Randomized, Double-blind Study to Evaluate the Effect of Tarceva or Placebo Following Platinum-based CT on Overall Survival and Disease Progression in Patients With Advanced, Recurrent or Metastatic NSCLS Who Have Not Experienced Disease Progression or Unacceptable Toxicity During Chemotherapy
|
Non-Small Cell Lung Cancer
|
* Drug: erlotinib [Tarceva]
* Drug: Placebo
|
Inclusion Criteria:~adult patients >=18 years of age;~histologically documented, locally advanced , recurrent or metastatic NSCLC;~measurable disease;~no disease progression after 4 cycles of platinum-based chemotherapy.~Exclusion Criteria:~unstable systemic disease;~any other malignancies in the last 5 years.
|
18 Years
| null |
All
|
No
|
Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double
|
| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Percentage of Participants With PD According to Response Evaluation Criteria in Solid Tumors (RECIST) or Death (Data Cutoff 17 May 2008) | Progression-free survival (PFS) was defined as the time from randomization to PD or death, whichever occurred first. For target lesions (TLs), PD was defined at least a 20 percent (%) increase in the sum of the largest diameter (SLD), taking as reference the smallest SLD recorded from baseline (BL) more the appearance of one or more new lesions. For non-target lesions (NTLs), PD was defined as the appearance of 1 or more new lesions and/or unequivocal progression of existing NTLs. Participants without PD or death were censored at the date of last tumor assessment where non-progression was documented. | Screening, BL [≤21 days after randomization], every 6 weeks thereafter until Week 48, every 12 weeks thereafter until PD, discontinuation of study treatment, or end of survival follow-up, up to data cutoff of 17 May 2008 (up to 27 months) |
| PFS in All Participants (Data Cutoff 17 May 2008) | The median time, in weeks, from randomization to PFS event. Participants without PD or death were censored at the date of last tumor assessment where non-progression was documented. The 95% confidence interval (CI) was estimated using Kaplan-Meier methodology. | Screening, BL (≤21 days after randomization), every 6 weeks thereafter until Week 48, every 12 weeks thereafter until PD, discontinuation of study treatment, or end of survival follow-up, up to data cutoff of 17 May 2008 (up to 27 months) |
| Probable Percentage of Participants Remaining Alive and Free of Disease Progression at 6 Months (Data Cutoff 17 May 2008) | PFS was defined as the time from randomization to PD or death, whichever occurred first. For TLs, PD was defined at least a 20% increase in the SLD, taking as reference the smallest SLD recorded from BL more the appearance of one or more new lesions. For NTLs, PD was defined as the appearance of 1 or more new lesions and/or unequivocal progression of existing NTLs. Participants without PD or death were censored at the date of last tumor assessment where non-progression was documented. The 95% CI was estimated using Kaplan-Meier methodology. | 6 months |
| Percentage of Epidermal Growth Factor Receptor (EGFR) Immunohistochemistry (IHC) Positive Participants With PD or Death (Data Cutoff 17 May 2008) | PFS was defined as the time from randomization to PD or death, whichever occurred first. For TLs, PD was defined at least a 20% increase in the SLD, taking as reference the smallest SLD recorded since treatment started or the appearance of one or more new lesions. For NTLs, PD was defined as the appearance of 1 or more new lesions and/or unequivocal progression of existing NTLs. Participants without PD or death were censored at the date of last tumor assessment where non-progression was documented. | Screening, BL (≤21 days after randomization), every 6 weeks thereafter until Week 48, every 12 weeks thereafter until PD, discontinuation of study treatment, or end of survival follow-up, up to data cutoff of 17 May 2008 (up to 27 months) |
| PFS in EGFR IHC Positive Population (Data Cutoff 17 May 2008) | The median time, in weeks, from randomization to PFS event. Participants without PD or death were censored at the date of last tumor assessment where non-progression was documented. The 95% CI was estimated using Kaplan-Meier methodology. | Screening, BL (≤ 21 days after randomization), every 6 weeks thereafter until Week 48, every 12 weeks thereafter until PD, discontinuation of study treatment, or end of survival follow-up, up to data cutoff of 17 May 2008 (up to 27 months) |
| Probable Percentage of Participants in the EGFR IHC Positive Population Remaining Alive and Progression Free at 6 Months (Data Cutoff 17 May 2008) | PFS was defined as the time from randomization to PD or death, whichever occurred first. For TLs, PD was defined at least a 20% increase in the SLD, taking as reference the smallest SLD recorded since treatment started or the appearance of one or more new lesions. For NTLs, PD was defined as the appearance of 1 or more new lesions and/or unequivocal progression of existing NTLs. Participants without PD or death were censored at the date of last tumor assessment where non-progression was documented. The 95% CI was estimated using Kaplan-Meier methodology. | 6 months |
|
| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Percentage of All Participants Who Died (Data Cutoff 12 January 2012) | | Screening, BL (≤21 days after randomization), every 6 weeks thereafter until Week 48, every 12 weeks thereafter until PD, discontinuation of study treatment, or end of survival follow-up, up to data cutoff of 12 January 2012 (up to 71 months). |
| Overall Survival (OS) in All Participants (Data Cutoff 12 January 2012) | OS was defined as the median time, in months, from the date of randomization to the date of death, due to any cause. Patients who have not died at the time of the final analysis will be censored at the date the patient was last known to be alive. The 95% CI was estimated using Kaplan-Meier methodology. | Screening, BL (≤ 21 days after randomization), every 6 weeks thereafter until Week 48, every 12 weeks thereafter until PD, discontinuation of study treatment, or end of survival follow-up, up to data cutoff of 12 January 2012 (up to 71 months) |
| Probable Percentage of Participants Remaining Alive at 1 Year (Data Cutoff 12 January 2012) | OS was defined as the median time, in months, from the date of randomization to the date of death, due to any cause. Patients who have not died at the time of the final analysis will be censored at the date the patient was last known to be alive. The 95% CI was estimated using Kaplan-Meier methodology. | 1 year |
| Percentage of EGFR IHC Positive Participants Who Died (Data Cutoff 12 January 2012) | | Screening, BL (≤21 days after randomization), every 6 weeks thereafter until Week 48, every 12 weeks thereafter until PD, discontinuation of study treatment, or end of survival follow-up, up to data cutoff of 12 January 2012 (up to 71 months) |
| OS in EGFR IHC Positive Population (Data Cutoff 12 January 2012) | OS was defined as the median time, in months, from the date of randomization to the date of death, due to any cause. Patients who have not died at the time of the final analysis will be censored at the date the patient was last known to be alive. The 95% CI was estimated using Kaplan-Meier methodology. | Screening, BL (≤21 days after randomization), every 6 weeks thereafter until Week 48, every 12 weeks thereafter until PD, discontinuation of study treatment, or end of survival follow-up, up to data cutoff of 12 January 2012 (up to 71 months) |
| Probable Percentage of Participants in the EGFR IHC Positive Population Remaining Alive at 1 Year (Data Cutoff 12 January 2012) | OS was defined as the median time, in months, from the date of randomization to the date of death, due to any cause. Patients who have not died at the time of the final analysis will be censored at the date the patient was last known to be alive. The 95% CI was estimated using Kaplan-Meier methodology. | 1 year |
| Percentage of EGFR IHC Negative Participants With PD or Death (Data Cutoff 17 May 2008) | PFS was defined as the time from randomization to PD or death, whichever occurred first. For TLs, PD was defined at least a 20% increase in the SLD, taking as reference the smallest SLD recorded since treatment started or the appearance of one or more new lesions. For NTLs, PD was defined as the appearance of 1 or more new lesions and/or unequivocal progression of existing NTLs. Participants without PD or death were censored at the date of last tumor assessment where non-progression was documented. | Screening, BL (≤21 days after randomization), every 6 weeks thereafter until Week 48, every 12 weeks thereafter until PD, discontinuation of study treatment, or end of survival follow-up, up to data cutoff of 17 May 2008 (up to 71 months) |
| PFS in EGFR IHC Negative Participants (Data Cutoff 17 May 2008) | The median time, in weeks, from randomization to PFS event. Participants without PD or death were censored at the date of last tumor assessment where non-progression was documented. The 95% CI was estimated using Kaplan-Meier methodology. | Screening, BL (≤21 days after randomization), every 6 weeks thereafter until Week 48, every 12 weeks thereafter until PD, discontinuation of study treatment, or end of survival follow-up, up to data cutoff of 17 May 2008 (up to 27 months) |
| Probable Percentage of Participants in the EGFR IHC Negative Population Remaining Alive and Free of Disease Progression at 6 Months (Data Cutoff 17 May 2008) | PFS was defined as the time from randomization to PD or death, whichever occurred first. For TLs, PD was defined at least a 20% increase in the SLD, taking as reference the smallest SLD recorded since treatment started or the appearance of one or more new lesions. For NTLs, PD was defined as the appearance of 1 or more new lesions and/or unequivocal progression of existing NTLs. Participants without PD or death were censored at the date of last tumor assessment where non-progression was documented. The 95% CI was estimated using Kaplan-Meier methodology. | 6 months |
| Percentage of EGFR IHC Negative Participants Who Died (Data Cutoff 17 May 2008) | | Screening, BL (≤21 days after randomization), every 6 weeks thereafter until Week 48, every 12 weeks thereafter until PD, discontinuation of study treatment, or end of survival follow-up, up to data cutoff of 17 May 2008 (up to 27 months) |
| OS in EGFR IHC Negative Participants (Data Cutoff 17 May 2008) | OS was defined as the median time, in months, from the date of randomization to the date of death, due to any cause. Patients who have not died at the time of the final analysis will be censored at the date the patient was last known to be alive. The 95% CI was estimated using Kaplan-Meier methodology. | Screening, BL (≤21 days after randomization), every 6 weeks thereafter until Week 48, every 12 weeks thereafter until PD, discontinuation of study treatment, or end of survival follow-up, up to data cutoff of 17 May 2008 (up to 27 months) |
| Probable Percentage of Participants in the EGFR IHC Negative Population Remaining Alive at 1 Year (Data Cutoff 17 May 2008) | OS was defined as the median time, in months, from the date of randomization to the date of death, due to any cause. Patients who have not died at the time of the final analysis will be censored at the date the patient was last known to be alive. The 95% CI was estimated using Kaplan-Meier methodology. | 1 year |
| Time to Progression (Data Cutoff 17 May 2008) | The median time, in weeks, between randomization and TTP event. Participants without PD were censored at the date of last tumor assessment where non-progression was documented. If a participant received a second anti-cancer therapy without prior documentation of PD, the participant was censored at the date of last tumor assessment before starting new chemotherapy. | Screening, BL (≤21 days after randomization), every 6 weeks thereafter until Week 48, every 12 weeks thereafter until PD, discontinuation of study treatment, or end of survival follow-up, up to data cutoff of 17 May 2008 (up to 27 months) |
| Probable Percentage of Participants Remaining Progression-Free in the TTP Analysis at 6 Months (Data Cutoff 17 May 2008) | TTP was defined as the time from the date of randomization to the first date PD was recorded. For TLs, PD was defined at least a 20% increase in the SLD, taking as reference the smallest SLD recorded since treatment started or the appearance of one or more new lesions. For NTLs, PD was defined as the appearance of 1 or more new lesions and/or unequivocal progression of existing NTLs. Participants without PD were censored at the date of last tumor assessment where non-progression was documented. If a participant received a second anti-cancer therapy without prior documentation of PD, the participant was censored at the date of last tumor assessment before starting new chemotherapy. The 95% CI was estimated using Kaplan-Meier methodology. | 6 months |
| Percentage of Participants With a Best Overall Response (BOR) of Confirmed Complete Response (CR) or Partial Response (PR) According to RECIST (Data Cutoff 17 May 2008) | BOR was defined as CR or PR confirmed by repeat assessments performed no less than 4 weeks after the criteria for response was first met. For TLs, CR was defined as the disappearance of all TLs, and PR was defined as at least a 30% decrease in the SLD of the TLs, taking as a reference the baseline (BL) SLD. For NTLs, CR was defined as the disappearance of all NTLs and normalization of tumor marker levels. The 95% CI for one sample binomial was determined using the Pearson-Clopper method. | Screening, BL (≤21 days after randomization), every 6 weeks thereafter until Week 48, every 12 weeks thereafter until PD, discontinuation of study treatment, or end of survival follow-up, up to data cutoff of 17 May 2008 (up to 27 months) |
| Percentage of Participants With a CR, PR, Stable Disease (SD), or PD According to RECIST (Data Cutoff 17 May 2008) | For TLs, CR was defined as the disappearance of all TLs; PR was defined as at least a 30% decrease in the SLD of the TLs, taking as a reference the BL SLD; SD was defined as neither sufficient decrease in SLD to qualify for PR nor sufficient increase in SLD to qualify for PD; and PD was defined as at least a 20% increase in the SLD of TLs, taking as reference the smallest SLD recorded since the treatment started. For NTLs, CR was defined as the disappearance of all NTLs and normalization of tumor marker levels; SD/incomplete response was defined as the persistence of 1 or more NTLs and/or maintenance of tumor marker levels above normal limits; and PD was defined as the appearance of 1 or more new lesions and/or unequivocal progression of existing NTLs. The 95% CI for one sample binomial was determined using the Pearson-Clopper method. | Screening, BL (≤21 days after randomization), every 6 weeks thereafter until Week 48, every 12 weeks thereafter until PD, discontinuation of study treatment, or end of survival follow-up, up to data cutoff of 17 May 2008 (up to 27 months) |
| Percentage of Participants With a Response Upgrade From BL According to RECIST (Data Cutoff 17 May 2008) | Response upgrade was defined by a change of PR to CR or of SD to PR or CR from BL to the end of treatment. For TLs, CR was defined as the disappearance of all TLs; PR was defined as at least a 30% decrease in the SLD of the TLs, taking as a reference the BL SLD; SD was defined as neither sufficient decrease in SLD to qualify for PR nor sufficient increase in SLD to qualify for PD; and PD was defined as at least a 20% increase in the SLD of TLs, taking as reference the smallest SLD recorded since the treatment started. For NTLs, CR was defined as the disappearance of all NTLs and normalization of tumor marker levels; SD/incomplete response was defined as the persistence of 1 or more NTLs and/or maintenance of tumor marker levels above normal limits; and PD was defined as the appearance of 1 or more new lesions and/or unequivocal progression of existing NTLs. The 95% CI for one sample binomial was determined using the Pearson-Clopper method. | Screening, BL (≤21 days after randomization), every 6 weeks thereafter until Week 48, every 12 weeks thereafter until PD, discontinuation of study treatment, or end of survival follow-up, up to data cutoff of 17 May 2008 (up to 27 months) |
| Percentage of Participants With a Change of PR to CR or SD to PR or CR From BL to End of Treatment According to RECIST (Data Cutoff 17 May 2008) | For TLs, CR was defined as the disappearance of all TLs; PR was defined as at least a 30% decrease in the SLD of the TLs, taking as a reference the BL SLD; SD was defined as neither sufficient decrease in SLD to qualify for PR nor sufficient increase in SLD to qualify for PD; and PD was defined as at least a 20% increase in the SLD of TLs, taking as reference the smallest SLD recorded since the treatment started. For NTLs, CR was defined as the disappearance of all NTLs and normalization of tumor marker levels; SD/incomplete response was defined as the persistence of 1 or more NTLs and/or maintenance of tumor marker levels above normal limits; and PD was defined as the appearance of 1 or more new lesions and/or unequivocal progression of existing NTLs. The 95% CI for one sample binomial was determined using the Pearson-Clopper method. | Screening, BL (≤21 days after randomization), every 6 weeks thereafter until Week 48, every 12 weeks thereafter until PD, discontinuation of study treatment, or end of survival follow-up, up to data cutoff of 17 May 2008 (up to 27 months) |
| Percentage of Participants With CR, PR, or SD or With SD [Maintained For Greater Than (>) 12 Weeks] or CR or PR (Data Cutoff 17 May 2008) | Disease control was defined as a best response of CR or PR or SD or a best response of SD for more than 12 weeks, or CR or PR. For TLs, CR was defined as the disappearance of all TLs; PR was defined as at least a 30% decrease in the SLD of the TLs, taking as a reference the BL SLD; SD was defined as neither sufficient decrease in SLD to qualify for PR nor sufficient increase in SLD to qualify for PD. For NTLs, CR was defined as the disappearance of all NTLs and normalization of tumor marker levels; SD/incomplete response was defined as the persistence of 1 or more NTLs and/or maintenance of tumor marker levels above normal limits. The 95% CI for one sample binomial was determined using the Pearson-Clopper method. | Screening, BL (≤21 days after randomization), every 6 weeks thereafter until Week 48, every 12 weeks thereafter until PD, discontinuation of study treatment, or end of survival follow-up, up to data cutoff of 17 May 2008 (up to 27 months) |
| Percentage of Participants With Symptom Progression Assessed Using the Lung Cancer Subscale (LCS) (Data Cutoff 17 May 2008) | LCS scores were obtained from a 7-item questionnaire from the Functional Assessment of Cancer Therapy - Lung (FACT-L) version (V) 4. Participants responded to questions assessing symptoms commonly reported by lung cancer patients; such as shortness of breath, loss of weight, and tightness in chest; on a scale from 0-4, where 0 equaled (=) not at all and 4 = very much. The participants' responses were summed to result in an overall score, where a higher score indicated more severe symptoms. A change of 2 to 3 points in score was determined to be a clinically meaningful decline. | Screening, BL (≤21 days after randomization), every 6 weeks thereafter until Week 48, every 12 weeks thereafter until PD, discontinuation of study treatment, or end of survival follow-up, up to data cutoff of 17 May 2008 (up to 27 months) |
| Time to Symptom Progression (Data Cutoff 17 May 2008) | The median time, in weeks, from the date of randomization to the date of documented clinically meaningful decline in LCS from BL or death, whichever occurred first. LCS scores were obtained from a 7-item questionnaire from the FACT-L V 4. Participants responded to questions assessing symptoms commonly reported by lung cancer patients; such as shortness of breath, loss of weight, and tightness in chest; on a scale from 0-4, where 0 = not at all and 4 = very much. The participants' responses were summed to result in an overall score, where a higher score indicated more severe symptoms. A change of 2 to 3 points in score was determined to be a clinically meaningful decline. The 95% CI was determined using Kaplan-Meier methodology. | Screening, BL (≤21 days after randomization), every 6 weeks thereafter until Week 48, every 12 weeks thereafter until PD, discontinuation of study treatment, or end of survival follow-up, up to data cutoff of 17 May 2008 (up to 27 months) |
| Probable Percentage of Participants Remaining Without Symptom Progression at 6 Months (Data Cutoff 17 May 2008) | LCS scores were obtained from a 7-item questionnaire from the FACT-L V 4. Participants responded to questions assessing symptoms commonly reported by lung cancer patients; such as shortness of breath, loss of weight, and tightness in chest; on a scale from 0-4, where 0 = not at all and 4 = very much. The participants' responses were summed to result in an overall score, where a higher score indicated more severe symptoms. A change of 2 to 3 points in score was determined to be a clinically meaningful decline. The 95% CI was estimated using Kaplan-Meier methodology. | 6 months |
| Percentage of Participants With Deterioration Assessed Using the Trial Outcome Index (Data Cutoff 17 May 2008) | The Trial Outcome Index (TOI) was defined as the sum of the scores of the Physical Well-Being (PWB), Functional Well-Being (FWB), and LCS. PWB, FWB, and LCS scores were obtained from 7-item questionnaires from the FACT-L V 4. Participants responded to questions assessing symptoms on a scale from 0-4, where 0 = not at all and 4 = very much. Higher score indicated more severe symptoms. A clinically meaningful decline in TOI score was defined as at least a 6 point decline from BL. Participants without a clinically meaningful decline in TOI at the time of analysis were censored at the time of the last FACT-L assessment. | Screening, BL (≤21 days after randomization), every 6 weeks thereafter until Week 48, every 12 weeks thereafter until PD, discontinuation of study treatment, or end of survival follow-up, up to data cutoff of 17 May 2008 (up to 27 months) |
| Time to Deterioration in TOI (Data Cutoff 17 May 2008) | The median time, in weeks, from the date of randomization until a clinically meaningful decline from BL in TOI or death, whichever occurred first. TOI was defined as the sum of PWB, FWB, and LCS scores, which were obtained from 7-item questionnaires from the FACT-L V 4. Participants responded to questions assessing symptoms on a scale from 0-4, where 0 = not at all and 4 = very much. Higher score indicated more severe symptoms. A clinically meaningful decline in TOI score was defined as at least a 6 point decline from BL Participants without a clinically meaningful decline in TOI at the time of analysis were censored at the time of the last FACT-L assessment. The 95% CI was determined using Kaplan-Meier methodology. | Screening, BL (≤21 days after randomization), every 6 weeks thereafter until Week 48, every 12 weeks thereafter until PD, discontinuation of study treatment, or end of survival follow-up, up to data cutoff of 17 May 2008 (up to 27 months) |
| Probable Percentage of Participants Remaining Without Deterioration in TOI at 6 Months (Data Cutoff 17 May 2008) | TOI was defined as the sum of the scores of the PWB, FWB, and LCS. PWB, FWB, and LCS scores were obtained from 7-item questionnaires from the FACT-L V 4. Participants responded to questions assessing symptoms on a scale from 0-4, where 0 = not at all and 4 = very much. Higher score indicated more severe symptoms. A clinically meaningful decline in TOI score was defined as at least a 6 point decline from BL. Participants without a clinically meaningful decline in TOI at the time of analysis were censored at the time of the last FACT-L assessment. The 95% CI was estimated using Kaplan-Meier methodology. | 6 months |
| Percentage of Participants With Deterioration in Quality of Life Assessed Using TOI, SWB, and EWB (Data Cutoff 17 May 2008) | Deterioration in quality of life (QoL) was defined as a clinically meaningful decline in the total FACT-L score, the sum of the TOI, Social/Family Well-Being (SWB) and Emotional Well-Being (EWB) of the FACT-L questionnaires. TOI (PWB + FWB + LCS), SWB and EWB scores were obtained from 7-item (6-item in the case of EWB) questionnaires from the FACT-L V 4. Participants responded to questions assessing symptoms on a scale from 0-4, where 0 = not at all and 4 = very much. Higher score indicated more severe symptoms. A clinically meaningful decline in FACT-L score was defined as at least a 6 point decline from BL. Participants without a clinically meaningful decline in TOI at the time of analysis were censored at the time of the last FACT-L. | Screening, BL (≤21 days after randomization), every 6 weeks thereafter until Week 48, every 12 weeks thereafter until PD, discontinuation of study treatment, or end of survival follow-up, up to data cutoff of 17 May 2008 (up to 27 months) |
| Time to Deterioration in QoL (Data Cutoff 17 May 2008) | The median time, in weeks, from the date of randomization until a clinically meaningful decline from BL in total FACT-L or death, whichever occurred first. Total FACT-L score was defined as the sum of the TOI, SWB and EWB of the FACT-L questionnaires. TOI (PWB + FWB + LCS), SWB and EWB scores were obtained from 7-item (6-item in the case of EWB) questionnaires from the FACT-L V 4. Participants responded to questions assessing symptoms on a scale from 0-4, where 0 = not at all and 4 = very much. Higher score indicated more severe symptoms. A clinically meaningful decline in FACT-L score was defined as at least a 6 point decline from BL. Participants without a clinically meaningful decline in TOI at the time of analysis were censored at the time of the last FACT-L assessment. The 95% CI was determined using Kaplan-Meier methodology. | Screening, BL (≤21 days after randomization), every 6 weeks thereafter until Week 48, every 12 weeks thereafter until PD, discontinuation of study treatment, or end of survival follow-up, up to data cutoff of 17 May 2008 (up to 27 months) |
| Probable Percentage of Participants Remaining Without Deterioration in QoL at 6 Months (Data Cutoff 17 May 2008) | Deterioration in QoL was defined as a clinically meaningful decline in the total FACT-L score, the sum of the TOI, SWB and EWB of the FACT-L questionnaires. TOI (PWB + FWB + LCS), SWB and EWB scores were obtained from 7-item (6-item in the case of EWB) questionnaires from the FACT-L V 4. Participants responded to questions assessing symptoms on a scale from 0-4, where 0 = not at all and 4 = very much. Higher score indicated more severe symptoms. A clinically meaningful decline in FACT-L score was defined as at least a 6 point decline from BL. Participants without a clinically meaningful decline in TOI at the time of analysis were censored at the time of the last FACT-L. The 95% CI was estimated using Kaplan-Meier methodology. | 6 months |
| Functional Assessment of Chronic Illness Therapy - Lung (FACT-L) Scores (Data Cutoff 17 May 2008) | Total FACT-L score=sum of TOI, SWB, and EWB of FACT-L questionnaires. TOI (PWB+FWB+LCS), SWB, and EWB scores obtained from 7-item (6-item for EWB) questionnaires from FACT-L V4. Participants responded to questions assessing symptoms (scale 0-4; 0=not at all and 4=very much). Higher score=more severe symptoms. The 7-item LCS assessed symptoms such as shortness of breath, loss of weight, tightness in chest. Participants responded to questions assessing symptoms (scale: 0-4; 0=not at all and 4=very much). Scores from 0-35; higher score=more severe symptoms. The 27 items of FACT-G were scored in the following domains: PWB (7 items, total score 0-28), SWB (7 items; total score 0-28), EWB (6 items, total score 0-24), and FWB (7 items; total score 0-28), higher scores=better QoL. Participants responded to items on 5-point Likert scale (0=Not at all to 4=Very much; total score: 0-108). Higher score=better QOL. TOI score=PWB+FWB+LCS; Total TOI score: 0-92; higher scores=better QOL. | Screening, BL (≤21 days after randomization), every 6 weeks thereafter until Week 48, every 12 weeks thereafter until PD, discontinuation of study treatment, or end of survival follow-up, up to data cutoff of 17 May 2008 (up to 27 months) |
| Change From BL in FACT-L Scores (Data Cutoff 17 May 2008) | Total FACT-L score=sum of TOI, SWB, and EWB of FACT-L questionnaires. TOI (PWB+FWB+LCS), SWB, and EWB scores obtained from 7-item (6-item for EWB) questionnaires from FACT-L V4. Participants responded to questions assessing symptoms (scale 0-4; 0=not at all and 4=very much). Higher score=more severe symptoms. The 7-item LCS assessed symptoms such as shortness of breath, loss of weight, tightness in chest. Participants responded to questions assessing symptoms (scale: 0-4; 0=not at all and 4=very much). Scores from 0-35; higher score=more severe symptoms. The 27 items of FACT-G were scored in the following domains: PWB (7 items, total score 0-28), SWB (7 items; total score 0-28), EWB (6 items, total score 0-24), and FWB (7 items; total score 0-28), higher scores=better QoL. Participants responded to items on 5-point Likert scale (0=Not at all to 4=Very much; total score: 0-108). Higher score=better QOL. TOI score=PWB+FWB+LCS; Total TOI score: 0-92; higher scores=better QOL. | Screening, BL (≤21 days after randomization), every 6 weeks thereafter until Week 48, every 12 weeks thereafter until PD, discontinuation of study treatment, or end of survival follow-up, up to data cutoff of 17 May 2008 (up to 27 months) |
|
Erlotinib Hydrochloride, Antineoplastic Agents, Protein Kinase Inhibitors, Enzyme Inhibitors, Molecular Mechanisms of Pharmacological Action
|
| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Erlotinib<br>Participants received erlotinib, 150 milligrams (mg), orally (PO), daily from randomization until progressive disease (PD), death, or unacceptable toxicity. | Drug: erlotinib [Tarceva]<br>* 150mg po daily<br>|
| Placebo Comparator: Placebo<br>Participants received a placebo, PO, daily, from randomization until PD, death, or unacceptable toxicity. | Drug: Placebo<br>* po daily<br>|
|
A Study of Tarceva (Erlotinib) Following Platinum-Based Chemotherapy in Patients With Advanced, Recurrent, or Metastatic Non-Small Cell Lung Cancer (NSCLC)
Study Overview
=================
Brief Summary
-----------------
This 2 arm study will evaluate the efficacy, safety, and pharmacokinetics of Tarceva, compared with placebo, following platinum-based chemotherapy in patients with advanced, recurrent, or metastatic NSCLC who have not had disease progression or unacceptable toxicity during chemotherapy. Following 4 cycles of platinum-based chemotherapy, eligible patients will be randomized to receive either Tarceva 150mg po daily, or placebo daily. The anticipated time on study treatment is until disease progression; the target sample size is 500+ individuals.
Official Title
-----------------
A Randomized, Double-blind Study to Evaluate the Effect of Tarceva or Placebo Following Platinum-based CT on Overall Survival and Disease Progression in Patients With Advanced, Recurrent or Metastatic NSCLS Who Have Not Experienced Disease Progression or Unacceptable Toxicity During Chemotherapy
Conditions
-----------------
Non-Small Cell Lung Cancer
Intervention / Treatment
-----------------
* Drug: erlotinib [Tarceva]
* Drug: Placebo
Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: adult patients >=18 years of age; histologically documented, locally advanced , recurrent or metastatic NSCLC; measurable disease; no disease progression after 4 cycles of platinum-based chemotherapy. Exclusion Criteria: unstable systemic disease; any other malignancies in the last 5 years.
Ages Eligible for Study
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Minimum Age: 18 Years
Sexes Eligible for Study
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All
Accepts Healthy Volunteers
-----------------
No
Study Plan
=================
How is the study designed?
-----------------
Design Details
Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double
Arms and Interventions
| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Erlotinib<br>Participants received erlotinib, 150 milligrams (mg), orally (PO), daily from randomization until progressive disease (PD), death, or unacceptable toxicity. | Drug: erlotinib [Tarceva]<br>* 150mg po daily<br>|
| Placebo Comparator: Placebo<br>Participants received a placebo, PO, daily, from randomization until PD, death, or unacceptable toxicity. | Drug: Placebo<br>* po daily<br>|
What is the study measuring?
-----------------
Primary Outcome Measures
| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Percentage of Participants With PD According to Response Evaluation Criteria in Solid Tumors (RECIST) or Death (Data Cutoff 17 May 2008) | Progression-free survival (PFS) was defined as the time from randomization to PD or death, whichever occurred first. For target lesions (TLs), PD was defined at least a 20 percent (%) increase in the sum of the largest diameter (SLD), taking as reference the smallest SLD recorded from baseline (BL) more the appearance of one or more new lesions. For non-target lesions (NTLs), PD was defined as the appearance of 1 or more new lesions and/or unequivocal progression of existing NTLs. Participants without PD or death were censored at the date of last tumor assessment where non-progression was documented. | Screening, BL [≤21 days after randomization], every 6 weeks thereafter until Week 48, every 12 weeks thereafter until PD, discontinuation of study treatment, or end of survival follow-up, up to data cutoff of 17 May 2008 (up to 27 months) |
| PFS in All Participants (Data Cutoff 17 May 2008) | The median time, in weeks, from randomization to PFS event. Participants without PD or death were censored at the date of last tumor assessment where non-progression was documented. The 95% confidence interval (CI) was estimated using Kaplan-Meier methodology. | Screening, BL (≤21 days after randomization), every 6 weeks thereafter until Week 48, every 12 weeks thereafter until PD, discontinuation of study treatment, or end of survival follow-up, up to data cutoff of 17 May 2008 (up to 27 months) |
| Probable Percentage of Participants Remaining Alive and Free of Disease Progression at 6 Months (Data Cutoff 17 May 2008) | PFS was defined as the time from randomization to PD or death, whichever occurred first. For TLs, PD was defined at least a 20% increase in the SLD, taking as reference the smallest SLD recorded from BL more the appearance of one or more new lesions. For NTLs, PD was defined as the appearance of 1 or more new lesions and/or unequivocal progression of existing NTLs. Participants without PD or death were censored at the date of last tumor assessment where non-progression was documented. The 95% CI was estimated using Kaplan-Meier methodology. | 6 months |
| Percentage of Epidermal Growth Factor Receptor (EGFR) Immunohistochemistry (IHC) Positive Participants With PD or Death (Data Cutoff 17 May 2008) | PFS was defined as the time from randomization to PD or death, whichever occurred first. For TLs, PD was defined at least a 20% increase in the SLD, taking as reference the smallest SLD recorded since treatment started or the appearance of one or more new lesions. For NTLs, PD was defined as the appearance of 1 or more new lesions and/or unequivocal progression of existing NTLs. Participants without PD or death were censored at the date of last tumor assessment where non-progression was documented. | Screening, BL (≤21 days after randomization), every 6 weeks thereafter until Week 48, every 12 weeks thereafter until PD, discontinuation of study treatment, or end of survival follow-up, up to data cutoff of 17 May 2008 (up to 27 months) |
| PFS in EGFR IHC Positive Population (Data Cutoff 17 May 2008) | The median time, in weeks, from randomization to PFS event. Participants without PD or death were censored at the date of last tumor assessment where non-progression was documented. The 95% CI was estimated using Kaplan-Meier methodology. | Screening, BL (≤ 21 days after randomization), every 6 weeks thereafter until Week 48, every 12 weeks thereafter until PD, discontinuation of study treatment, or end of survival follow-up, up to data cutoff of 17 May 2008 (up to 27 months) |
| Probable Percentage of Participants in the EGFR IHC Positive Population Remaining Alive and Progression Free at 6 Months (Data Cutoff 17 May 2008) | PFS was defined as the time from randomization to PD or death, whichever occurred first. For TLs, PD was defined at least a 20% increase in the SLD, taking as reference the smallest SLD recorded since treatment started or the appearance of one or more new lesions. For NTLs, PD was defined as the appearance of 1 or more new lesions and/or unequivocal progression of existing NTLs. Participants without PD or death were censored at the date of last tumor assessment where non-progression was documented. The 95% CI was estimated using Kaplan-Meier methodology. | 6 months |
Secondary Outcome Measures
| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Percentage of All Participants Who Died (Data Cutoff 12 January 2012) | | Screening, BL (≤21 days after randomization), every 6 weeks thereafter until Week 48, every 12 weeks thereafter until PD, discontinuation of study treatment, or end of survival follow-up, up to data cutoff of 12 January 2012 (up to 71 months). |
| Overall Survival (OS) in All Participants (Data Cutoff 12 January 2012) | OS was defined as the median time, in months, from the date of randomization to the date of death, due to any cause. Patients who have not died at the time of the final analysis will be censored at the date the patient was last known to be alive. The 95% CI was estimated using Kaplan-Meier methodology. | Screening, BL (≤ 21 days after randomization), every 6 weeks thereafter until Week 48, every 12 weeks thereafter until PD, discontinuation of study treatment, or end of survival follow-up, up to data cutoff of 12 January 2012 (up to 71 months) |
| Probable Percentage of Participants Remaining Alive at 1 Year (Data Cutoff 12 January 2012) | OS was defined as the median time, in months, from the date of randomization to the date of death, due to any cause. Patients who have not died at the time of the final analysis will be censored at the date the patient was last known to be alive. The 95% CI was estimated using Kaplan-Meier methodology. | 1 year |
| Percentage of EGFR IHC Positive Participants Who Died (Data Cutoff 12 January 2012) | | Screening, BL (≤21 days after randomization), every 6 weeks thereafter until Week 48, every 12 weeks thereafter until PD, discontinuation of study treatment, or end of survival follow-up, up to data cutoff of 12 January 2012 (up to 71 months) |
| OS in EGFR IHC Positive Population (Data Cutoff 12 January 2012) | OS was defined as the median time, in months, from the date of randomization to the date of death, due to any cause. Patients who have not died at the time of the final analysis will be censored at the date the patient was last known to be alive. The 95% CI was estimated using Kaplan-Meier methodology. | Screening, BL (≤21 days after randomization), every 6 weeks thereafter until Week 48, every 12 weeks thereafter until PD, discontinuation of study treatment, or end of survival follow-up, up to data cutoff of 12 January 2012 (up to 71 months) |
| Probable Percentage of Participants in the EGFR IHC Positive Population Remaining Alive at 1 Year (Data Cutoff 12 January 2012) | OS was defined as the median time, in months, from the date of randomization to the date of death, due to any cause. Patients who have not died at the time of the final analysis will be censored at the date the patient was last known to be alive. The 95% CI was estimated using Kaplan-Meier methodology. | 1 year |
| Percentage of EGFR IHC Negative Participants With PD or Death (Data Cutoff 17 May 2008) | PFS was defined as the time from randomization to PD or death, whichever occurred first. For TLs, PD was defined at least a 20% increase in the SLD, taking as reference the smallest SLD recorded since treatment started or the appearance of one or more new lesions. For NTLs, PD was defined as the appearance of 1 or more new lesions and/or unequivocal progression of existing NTLs. Participants without PD or death were censored at the date of last tumor assessment where non-progression was documented. | Screening, BL (≤21 days after randomization), every 6 weeks thereafter until Week 48, every 12 weeks thereafter until PD, discontinuation of study treatment, or end of survival follow-up, up to data cutoff of 17 May 2008 (up to 71 months) |
| PFS in EGFR IHC Negative Participants (Data Cutoff 17 May 2008) | The median time, in weeks, from randomization to PFS event. Participants without PD or death were censored at the date of last tumor assessment where non-progression was documented. The 95% CI was estimated using Kaplan-Meier methodology. | Screening, BL (≤21 days after randomization), every 6 weeks thereafter until Week 48, every 12 weeks thereafter until PD, discontinuation of study treatment, or end of survival follow-up, up to data cutoff of 17 May 2008 (up to 27 months) |
| Probable Percentage of Participants in the EGFR IHC Negative Population Remaining Alive and Free of Disease Progression at 6 Months (Data Cutoff 17 May 2008) | PFS was defined as the time from randomization to PD or death, whichever occurred first. For TLs, PD was defined at least a 20% increase in the SLD, taking as reference the smallest SLD recorded since treatment started or the appearance of one or more new lesions. For NTLs, PD was defined as the appearance of 1 or more new lesions and/or unequivocal progression of existing NTLs. Participants without PD or death were censored at the date of last tumor assessment where non-progression was documented. The 95% CI was estimated using Kaplan-Meier methodology. | 6 months |
| Percentage of EGFR IHC Negative Participants Who Died (Data Cutoff 17 May 2008) | | Screening, BL (≤21 days after randomization), every 6 weeks thereafter until Week 48, every 12 weeks thereafter until PD, discontinuation of study treatment, or end of survival follow-up, up to data cutoff of 17 May 2008 (up to 27 months) |
| OS in EGFR IHC Negative Participants (Data Cutoff 17 May 2008) | OS was defined as the median time, in months, from the date of randomization to the date of death, due to any cause. Patients who have not died at the time of the final analysis will be censored at the date the patient was last known to be alive. The 95% CI was estimated using Kaplan-Meier methodology. | Screening, BL (≤21 days after randomization), every 6 weeks thereafter until Week 48, every 12 weeks thereafter until PD, discontinuation of study treatment, or end of survival follow-up, up to data cutoff of 17 May 2008 (up to 27 months) |
| Probable Percentage of Participants in the EGFR IHC Negative Population Remaining Alive at 1 Year (Data Cutoff 17 May 2008) | OS was defined as the median time, in months, from the date of randomization to the date of death, due to any cause. Patients who have not died at the time of the final analysis will be censored at the date the patient was last known to be alive. The 95% CI was estimated using Kaplan-Meier methodology. | 1 year |
| Time to Progression (Data Cutoff 17 May 2008) | The median time, in weeks, between randomization and TTP event. Participants without PD were censored at the date of last tumor assessment where non-progression was documented. If a participant received a second anti-cancer therapy without prior documentation of PD, the participant was censored at the date of last tumor assessment before starting new chemotherapy. | Screening, BL (≤21 days after randomization), every 6 weeks thereafter until Week 48, every 12 weeks thereafter until PD, discontinuation of study treatment, or end of survival follow-up, up to data cutoff of 17 May 2008 (up to 27 months) |
| Probable Percentage of Participants Remaining Progression-Free in the TTP Analysis at 6 Months (Data Cutoff 17 May 2008) | TTP was defined as the time from the date of randomization to the first date PD was recorded. For TLs, PD was defined at least a 20% increase in the SLD, taking as reference the smallest SLD recorded since treatment started or the appearance of one or more new lesions. For NTLs, PD was defined as the appearance of 1 or more new lesions and/or unequivocal progression of existing NTLs. Participants without PD were censored at the date of last tumor assessment where non-progression was documented. If a participant received a second anti-cancer therapy without prior documentation of PD, the participant was censored at the date of last tumor assessment before starting new chemotherapy. The 95% CI was estimated using Kaplan-Meier methodology. | 6 months |
| Percentage of Participants With a Best Overall Response (BOR) of Confirmed Complete Response (CR) or Partial Response (PR) According to RECIST (Data Cutoff 17 May 2008) | BOR was defined as CR or PR confirmed by repeat assessments performed no less than 4 weeks after the criteria for response was first met. For TLs, CR was defined as the disappearance of all TLs, and PR was defined as at least a 30% decrease in the SLD of the TLs, taking as a reference the baseline (BL) SLD. For NTLs, CR was defined as the disappearance of all NTLs and normalization of tumor marker levels. The 95% CI for one sample binomial was determined using the Pearson-Clopper method. | Screening, BL (≤21 days after randomization), every 6 weeks thereafter until Week 48, every 12 weeks thereafter until PD, discontinuation of study treatment, or end of survival follow-up, up to data cutoff of 17 May 2008 (up to 27 months) |
| Percentage of Participants With a CR, PR, Stable Disease (SD), or PD According to RECIST (Data Cutoff 17 May 2008) | For TLs, CR was defined as the disappearance of all TLs; PR was defined as at least a 30% decrease in the SLD of the TLs, taking as a reference the BL SLD; SD was defined as neither sufficient decrease in SLD to qualify for PR nor sufficient increase in SLD to qualify for PD; and PD was defined as at least a 20% increase in the SLD of TLs, taking as reference the smallest SLD recorded since the treatment started. For NTLs, CR was defined as the disappearance of all NTLs and normalization of tumor marker levels; SD/incomplete response was defined as the persistence of 1 or more NTLs and/or maintenance of tumor marker levels above normal limits; and PD was defined as the appearance of 1 or more new lesions and/or unequivocal progression of existing NTLs. The 95% CI for one sample binomial was determined using the Pearson-Clopper method. | Screening, BL (≤21 days after randomization), every 6 weeks thereafter until Week 48, every 12 weeks thereafter until PD, discontinuation of study treatment, or end of survival follow-up, up to data cutoff of 17 May 2008 (up to 27 months) |
| Percentage of Participants With a Response Upgrade From BL According to RECIST (Data Cutoff 17 May 2008) | Response upgrade was defined by a change of PR to CR or of SD to PR or CR from BL to the end of treatment. For TLs, CR was defined as the disappearance of all TLs; PR was defined as at least a 30% decrease in the SLD of the TLs, taking as a reference the BL SLD; SD was defined as neither sufficient decrease in SLD to qualify for PR nor sufficient increase in SLD to qualify for PD; and PD was defined as at least a 20% increase in the SLD of TLs, taking as reference the smallest SLD recorded since the treatment started. For NTLs, CR was defined as the disappearance of all NTLs and normalization of tumor marker levels; SD/incomplete response was defined as the persistence of 1 or more NTLs and/or maintenance of tumor marker levels above normal limits; and PD was defined as the appearance of 1 or more new lesions and/or unequivocal progression of existing NTLs. The 95% CI for one sample binomial was determined using the Pearson-Clopper method. | Screening, BL (≤21 days after randomization), every 6 weeks thereafter until Week 48, every 12 weeks thereafter until PD, discontinuation of study treatment, or end of survival follow-up, up to data cutoff of 17 May 2008 (up to 27 months) |
| Percentage of Participants With a Change of PR to CR or SD to PR or CR From BL to End of Treatment According to RECIST (Data Cutoff 17 May 2008) | For TLs, CR was defined as the disappearance of all TLs; PR was defined as at least a 30% decrease in the SLD of the TLs, taking as a reference the BL SLD; SD was defined as neither sufficient decrease in SLD to qualify for PR nor sufficient increase in SLD to qualify for PD; and PD was defined as at least a 20% increase in the SLD of TLs, taking as reference the smallest SLD recorded since the treatment started. For NTLs, CR was defined as the disappearance of all NTLs and normalization of tumor marker levels; SD/incomplete response was defined as the persistence of 1 or more NTLs and/or maintenance of tumor marker levels above normal limits; and PD was defined as the appearance of 1 or more new lesions and/or unequivocal progression of existing NTLs. The 95% CI for one sample binomial was determined using the Pearson-Clopper method. | Screening, BL (≤21 days after randomization), every 6 weeks thereafter until Week 48, every 12 weeks thereafter until PD, discontinuation of study treatment, or end of survival follow-up, up to data cutoff of 17 May 2008 (up to 27 months) |
| Percentage of Participants With CR, PR, or SD or With SD [Maintained For Greater Than (>) 12 Weeks] or CR or PR (Data Cutoff 17 May 2008) | Disease control was defined as a best response of CR or PR or SD or a best response of SD for more than 12 weeks, or CR or PR. For TLs, CR was defined as the disappearance of all TLs; PR was defined as at least a 30% decrease in the SLD of the TLs, taking as a reference the BL SLD; SD was defined as neither sufficient decrease in SLD to qualify for PR nor sufficient increase in SLD to qualify for PD. For NTLs, CR was defined as the disappearance of all NTLs and normalization of tumor marker levels; SD/incomplete response was defined as the persistence of 1 or more NTLs and/or maintenance of tumor marker levels above normal limits. The 95% CI for one sample binomial was determined using the Pearson-Clopper method. | Screening, BL (≤21 days after randomization), every 6 weeks thereafter until Week 48, every 12 weeks thereafter until PD, discontinuation of study treatment, or end of survival follow-up, up to data cutoff of 17 May 2008 (up to 27 months) |
| Percentage of Participants With Symptom Progression Assessed Using the Lung Cancer Subscale (LCS) (Data Cutoff 17 May 2008) | LCS scores were obtained from a 7-item questionnaire from the Functional Assessment of Cancer Therapy - Lung (FACT-L) version (V) 4. Participants responded to questions assessing symptoms commonly reported by lung cancer patients; such as shortness of breath, loss of weight, and tightness in chest; on a scale from 0-4, where 0 equaled (=) not at all and 4 = very much. The participants' responses were summed to result in an overall score, where a higher score indicated more severe symptoms. A change of 2 to 3 points in score was determined to be a clinically meaningful decline. | Screening, BL (≤21 days after randomization), every 6 weeks thereafter until Week 48, every 12 weeks thereafter until PD, discontinuation of study treatment, or end of survival follow-up, up to data cutoff of 17 May 2008 (up to 27 months) |
| Time to Symptom Progression (Data Cutoff 17 May 2008) | The median time, in weeks, from the date of randomization to the date of documented clinically meaningful decline in LCS from BL or death, whichever occurred first. LCS scores were obtained from a 7-item questionnaire from the FACT-L V 4. Participants responded to questions assessing symptoms commonly reported by lung cancer patients; such as shortness of breath, loss of weight, and tightness in chest; on a scale from 0-4, where 0 = not at all and 4 = very much. The participants' responses were summed to result in an overall score, where a higher score indicated more severe symptoms. A change of 2 to 3 points in score was determined to be a clinically meaningful decline. The 95% CI was determined using Kaplan-Meier methodology. | Screening, BL (≤21 days after randomization), every 6 weeks thereafter until Week 48, every 12 weeks thereafter until PD, discontinuation of study treatment, or end of survival follow-up, up to data cutoff of 17 May 2008 (up to 27 months) |
| Probable Percentage of Participants Remaining Without Symptom Progression at 6 Months (Data Cutoff 17 May 2008) | LCS scores were obtained from a 7-item questionnaire from the FACT-L V 4. Participants responded to questions assessing symptoms commonly reported by lung cancer patients; such as shortness of breath, loss of weight, and tightness in chest; on a scale from 0-4, where 0 = not at all and 4 = very much. The participants' responses were summed to result in an overall score, where a higher score indicated more severe symptoms. A change of 2 to 3 points in score was determined to be a clinically meaningful decline. The 95% CI was estimated using Kaplan-Meier methodology. | 6 months |
| Percentage of Participants With Deterioration Assessed Using the Trial Outcome Index (Data Cutoff 17 May 2008) | The Trial Outcome Index (TOI) was defined as the sum of the scores of the Physical Well-Being (PWB), Functional Well-Being (FWB), and LCS. PWB, FWB, and LCS scores were obtained from 7-item questionnaires from the FACT-L V 4. Participants responded to questions assessing symptoms on a scale from 0-4, where 0 = not at all and 4 = very much. Higher score indicated more severe symptoms. A clinically meaningful decline in TOI score was defined as at least a 6 point decline from BL. Participants without a clinically meaningful decline in TOI at the time of analysis were censored at the time of the last FACT-L assessment. | Screening, BL (≤21 days after randomization), every 6 weeks thereafter until Week 48, every 12 weeks thereafter until PD, discontinuation of study treatment, or end of survival follow-up, up to data cutoff of 17 May 2008 (up to 27 months) |
| Time to Deterioration in TOI (Data Cutoff 17 May 2008) | The median time, in weeks, from the date of randomization until a clinically meaningful decline from BL in TOI or death, whichever occurred first. TOI was defined as the sum of PWB, FWB, and LCS scores, which were obtained from 7-item questionnaires from the FACT-L V 4. Participants responded to questions assessing symptoms on a scale from 0-4, where 0 = not at all and 4 = very much. Higher score indicated more severe symptoms. A clinically meaningful decline in TOI score was defined as at least a 6 point decline from BL Participants without a clinically meaningful decline in TOI at the time of analysis were censored at the time of the last FACT-L assessment. The 95% CI was determined using Kaplan-Meier methodology. | Screening, BL (≤21 days after randomization), every 6 weeks thereafter until Week 48, every 12 weeks thereafter until PD, discontinuation of study treatment, or end of survival follow-up, up to data cutoff of 17 May 2008 (up to 27 months) |
| Probable Percentage of Participants Remaining Without Deterioration in TOI at 6 Months (Data Cutoff 17 May 2008) | TOI was defined as the sum of the scores of the PWB, FWB, and LCS. PWB, FWB, and LCS scores were obtained from 7-item questionnaires from the FACT-L V 4. Participants responded to questions assessing symptoms on a scale from 0-4, where 0 = not at all and 4 = very much. Higher score indicated more severe symptoms. A clinically meaningful decline in TOI score was defined as at least a 6 point decline from BL. Participants without a clinically meaningful decline in TOI at the time of analysis were censored at the time of the last FACT-L assessment. The 95% CI was estimated using Kaplan-Meier methodology. | 6 months |
| Percentage of Participants With Deterioration in Quality of Life Assessed Using TOI, SWB, and EWB (Data Cutoff 17 May 2008) | Deterioration in quality of life (QoL) was defined as a clinically meaningful decline in the total FACT-L score, the sum of the TOI, Social/Family Well-Being (SWB) and Emotional Well-Being (EWB) of the FACT-L questionnaires. TOI (PWB + FWB + LCS), SWB and EWB scores were obtained from 7-item (6-item in the case of EWB) questionnaires from the FACT-L V 4. Participants responded to questions assessing symptoms on a scale from 0-4, where 0 = not at all and 4 = very much. Higher score indicated more severe symptoms. A clinically meaningful decline in FACT-L score was defined as at least a 6 point decline from BL. Participants without a clinically meaningful decline in TOI at the time of analysis were censored at the time of the last FACT-L. | Screening, BL (≤21 days after randomization), every 6 weeks thereafter until Week 48, every 12 weeks thereafter until PD, discontinuation of study treatment, or end of survival follow-up, up to data cutoff of 17 May 2008 (up to 27 months) |
| Time to Deterioration in QoL (Data Cutoff 17 May 2008) | The median time, in weeks, from the date of randomization until a clinically meaningful decline from BL in total FACT-L or death, whichever occurred first. Total FACT-L score was defined as the sum of the TOI, SWB and EWB of the FACT-L questionnaires. TOI (PWB + FWB + LCS), SWB and EWB scores were obtained from 7-item (6-item in the case of EWB) questionnaires from the FACT-L V 4. Participants responded to questions assessing symptoms on a scale from 0-4, where 0 = not at all and 4 = very much. Higher score indicated more severe symptoms. A clinically meaningful decline in FACT-L score was defined as at least a 6 point decline from BL. Participants without a clinically meaningful decline in TOI at the time of analysis were censored at the time of the last FACT-L assessment. The 95% CI was determined using Kaplan-Meier methodology. | Screening, BL (≤21 days after randomization), every 6 weeks thereafter until Week 48, every 12 weeks thereafter until PD, discontinuation of study treatment, or end of survival follow-up, up to data cutoff of 17 May 2008 (up to 27 months) |
| Probable Percentage of Participants Remaining Without Deterioration in QoL at 6 Months (Data Cutoff 17 May 2008) | Deterioration in QoL was defined as a clinically meaningful decline in the total FACT-L score, the sum of the TOI, SWB and EWB of the FACT-L questionnaires. TOI (PWB + FWB + LCS), SWB and EWB scores were obtained from 7-item (6-item in the case of EWB) questionnaires from the FACT-L V 4. Participants responded to questions assessing symptoms on a scale from 0-4, where 0 = not at all and 4 = very much. Higher score indicated more severe symptoms. A clinically meaningful decline in FACT-L score was defined as at least a 6 point decline from BL. Participants without a clinically meaningful decline in TOI at the time of analysis were censored at the time of the last FACT-L. The 95% CI was estimated using Kaplan-Meier methodology. | 6 months |
| Functional Assessment of Chronic Illness Therapy - Lung (FACT-L) Scores (Data Cutoff 17 May 2008) | Total FACT-L score=sum of TOI, SWB, and EWB of FACT-L questionnaires. TOI (PWB+FWB+LCS), SWB, and EWB scores obtained from 7-item (6-item for EWB) questionnaires from FACT-L V4. Participants responded to questions assessing symptoms (scale 0-4; 0=not at all and 4=very much). Higher score=more severe symptoms. The 7-item LCS assessed symptoms such as shortness of breath, loss of weight, tightness in chest. Participants responded to questions assessing symptoms (scale: 0-4; 0=not at all and 4=very much). Scores from 0-35; higher score=more severe symptoms. The 27 items of FACT-G were scored in the following domains: PWB (7 items, total score 0-28), SWB (7 items; total score 0-28), EWB (6 items, total score 0-24), and FWB (7 items; total score 0-28), higher scores=better QoL. Participants responded to items on 5-point Likert scale (0=Not at all to 4=Very much; total score: 0-108). Higher score=better QOL. TOI score=PWB+FWB+LCS; Total TOI score: 0-92; higher scores=better QOL. | Screening, BL (≤21 days after randomization), every 6 weeks thereafter until Week 48, every 12 weeks thereafter until PD, discontinuation of study treatment, or end of survival follow-up, up to data cutoff of 17 May 2008 (up to 27 months) |
| Change From BL in FACT-L Scores (Data Cutoff 17 May 2008) | Total FACT-L score=sum of TOI, SWB, and EWB of FACT-L questionnaires. TOI (PWB+FWB+LCS), SWB, and EWB scores obtained from 7-item (6-item for EWB) questionnaires from FACT-L V4. Participants responded to questions assessing symptoms (scale 0-4; 0=not at all and 4=very much). Higher score=more severe symptoms. The 7-item LCS assessed symptoms such as shortness of breath, loss of weight, tightness in chest. Participants responded to questions assessing symptoms (scale: 0-4; 0=not at all and 4=very much). Scores from 0-35; higher score=more severe symptoms. The 27 items of FACT-G were scored in the following domains: PWB (7 items, total score 0-28), SWB (7 items; total score 0-28), EWB (6 items, total score 0-24), and FWB (7 items; total score 0-28), higher scores=better QoL. Participants responded to items on 5-point Likert scale (0=Not at all to 4=Very much; total score: 0-108). Higher score=better QOL. TOI score=PWB+FWB+LCS; Total TOI score: 0-92; higher scores=better QOL. | Screening, BL (≤21 days after randomization), every 6 weeks thereafter until Week 48, every 12 weeks thereafter until PD, discontinuation of study treatment, or end of survival follow-up, up to data cutoff of 17 May 2008 (up to 27 months) |
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NCT03994744
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Assessing Safety and Efficacy of Sintilimab and Metformin Combination Therapy in SCLC
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In this Single arm study, histologically or cytologically confirmed ED-stage small cell lung cancer (SCLC) patients resistant to or relapsed after standard chemotherapy will be enrolled to investigate the Efficacy and Safety of a Combination of Sintilimab and Metformin.~Primary outcome:~Objective response rate (ORR), Safety of the combination therapy~Secondary outcome:~Overall survival (OS), Progression-free survival (PFS), Duration of response(DOR),
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Exploratory Endpoints:~The association between the efficacy of the combination treatment and changes in CTC counts after administration of the treatment.~Evaluating the correlation between programmed death ligand 1 (PD-L1) expression derived from circulating tumor cells (CTC) and tumor tissue cells, and the predictive role of CTC PD-L1 expression in ED-SCLC.~The compositional changes in the gut microbiota after administration of the treatment and its association with the efficacy of the combination treatment.
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A Phase II Open-label, Single-arm Study Assessing the Efficacy and Safety of Combination Therapy of Sintilimab and Metformin With Relapsed PD-L1 Positive Small Cell Lung Cancer
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Small-cell Lung Cancer, Small Cell Lung Carcinoma, Small Cell Lung Cancer Recurrent, Small Cell Lung Cancer Extensive Stage
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* Drug: PD-1 inhibitor
* Drug: Metformin
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Inclusion Criteria:~Male or female patient, age≥18 and≤65;~Eastern Cooperative Oncology Group (ECOG) performance status ≤2;~The life expectancy of greater than 12 weeks;~Participants must have histologically or cytologically confirmed metastatic or extended disease of SCLC (ED-SCLC).~According to RECIST1.1, participants must have been confirmed Disease progression (within 6 months, confirmed by imaging test)after platinum-based doublet chemotherapy OR after (PFS>6 months, ) platinum-based doublet chemotherapy and refused to continue chemotherapy, OR after second-line or more lines of systemic chemotherapy limited disease SCLC (LD-SCLC) patients with disease progression after Synchronous chemoradiotherapy, must receive firstline systematic platinum-based doublet chemotherapy and refused to receive chemotherapy again.~Evaluable or measurable lesion is required, defined as at least one lesion (not brain metastasis) that can be accurately measured based on RECIST 1.1;~Participant need to provided tumor tissue (from an archival tumor sample obtained within 1 year or from a new biopsy sample) for PD-L1 immunohistochemical (IHC) assay, and PD-L1expression in more than 1% cells is required;~Participant is able to the ability to swallow oral medications~Participants have to meet the following criteria to ensure function of vital organs:~Absolute neutrophil count (ANC) ≥1.5×109/L or White blood cell count >3.5×109/L;Platelets >80×109/L; Hemoglobin (HGB)≥90 g/L;Serum total bilirubin ≤ 1.5 x upper limit of normal (ULN); AST(SGOT)/ALT(SGPT) ≤2.5 ×ULN; ALB≥2.8g/dL;Serum creatinine ≤ 1.5 x institutional ULN OR creatinine clearance ≥40 mL/min using the Cockcroft-Gault equation~Participants must agree to use adequate contraception (hormonal or barrier method of birth control; abstinence) through the treatment, and for at least 180 days after the last dose of study treatment; Participants must have the ability to understand and be willing to sign a written informed consent document.~Exclusion Criteria:~Participants who were diagnosed as mixed pathological type of small cell lung cancer~Participants who had long-term use of metformin (>2 weeks) 6 months prior to study entry, or diagnosed with type-2 diabetes,~Participants received treatment with anti-PD1, -PDL1, -CTLA4, -CD137 inhibitors before, or any therapy specifically targeting T-cell co-stimulation or checkpoint pathways.~Participants received cellular immunotherapy before~Participants with Uncontrolled intercurrent illness including, but not limited to:~Ongoing or active infection; Known history of Human Immunodeficiency Virus (HIV) infection Acute or chronic active hepatitis B (HBV DNA >1*10^3 copies/ml or >200 IU/mL) or, acute or chronic active hepatitis C (with a positive Hepatitis C antibody test result) Active tuberculosis Congestive heart failure (Class III-IV, according to New York Heart Association classification), or and clinically significant Cardiac arrhythmia if poorly controlled; Uncontrolled arterial hypertension (systolic blood pressure ≥160mmHg or diastolic blood pressure ≥100mmHg) Any arterial thrombosis, embolism, ischemia, myocardial infarction, unstable angina, or cerebrovascular accident within 6 months prior to enrollment,~Participants with symptomatic Central nervous metastasis or meningeal carcinomatosis are excluded; Participants with asymptomatic brain metastases or with brain metastases that have been treated and stable in a subsequent scan are allowed to include if there is measurable lesion outside the Central nervous system and no history of intracranial hemorrhage, and not midbrain, pons, cerebellum, medulla or spinal cord metastasis, and do not need glucocorticoid therapy.~Participants receiving glucocorticoid (>30 mg prednisone equivalent a day) or any Immunosuppressive drug within 14 days prior to study recruitment; Participants receiving inhaled or Topical corticosteroids, adrenal corticosteroid replacement therapy (>10 mg prednisone equivalent a day) are allowed if they have no active autoimmune disease~Participants with a known additional malignancy (Except for Non-melanoma skin cancer and the following in situ carcinoma: in situ bladder carcinoma, in situ gastric carcinoma, in situ colonic carcinoma, in situ endometrial carcinoma, in situ cervical carcinoma /dysplasia, in situ melanoma carcinoma and in situ breast Carcinoma) unless they Maintained Complete Remission for at least 5 years and do not need corresponding treatment during the study~Participants who have not recovered (i.e., ≤ Grade 1 according to NCI CTCAE V4or at baseline) from adverse effects due to a previously administered agent.~Participants who have uncontrollable effusion, such as pleural and ascites that cannot be controlled by drainage or other treatment~Patients who have active autoimmune diseases; excluding patients whose active autoimmune disease is caused by Vitiligo or asthma that is completely relieved in childhood and Patients with hypothyroidism requiring only hormone replacement therapy~Patients with known Allogeneic organ transplantation (except corneal transplantation) or allogeneic hematopoietic stem cell transplantation~Patients who are pregnant or breastfeeding,~Patients who are allergic to monoclonal antibody drugs~Patients who have contraindications to metformin including severe allergic reactions and intolerance~Patients who are not eligible for this study, as Assessed by Investigator
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18 Years
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65 Years
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All
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No
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Primary Purpose: Treatment
Intervention Model: Single Group Assignment
Interventional Model Description: Patients fulfilling Eligibility Criteria will be included in our study. Participants will be given intravenous administration of Sintilimab (1200mg/3w).~Metformin treatment will be given (day20) 1 week before the second administration of Sintilimab at a dose of 2000 mg daily (1000mg BID).~Treatments will be administrated for one year or until disease progression, death, or unacceptable toxicity.~Regular follow-up and safety assessment: Patients were assessed for drug safety and treatment efficacy every 2 cycles (6 weeks) in the first 3 months after enrollment, and then evaluated every 4 cycles (12 weeks). Assessment of tumor response, adverse events. Follow-up until disease progression and patient death.
Masking: None (Open Label)
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| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Objective response rate of Sintilimab and Metformin(ORR) | Assessing the response of treatment of each patient using RECIST 1.1 criteria, the investigators calculate the percentage of patients meet partial response (30% decrease in diameter) and complete response in the arm. | 1 year |
| Safety of the combination therapy of Sintilimab and Metformin: CTCAE4.03 grading | Incidence and severity of (serious) adverse events in each individual according to the CTCAE4.03 grading. | 2 year |
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| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Median overall survival (OS) time of Sintilimab and Metformin | Use K-M to estimate the median OS of single arm. | 2 years |
| Median progression free survival(PFS) of Sintilimab and Metformin | Use K-M to estimate the median PFS of single arm. | 1 year |
| Median duration of response (DoR) of Sintilimab and Metformin | Use K-M to estimate the median DoR of single arm. | 1 year |
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immunotherapy, metformin, PD-L1, PD-1 checkpoint inhibitor
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Metformin, Immune Checkpoint Inhibitors, Hypoglycemic Agents, Physiological Effects of Drugs, Molecular Mechanisms of Pharmacological Action, Antineoplastic Agents, Immunological, Antineoplastic Agents
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| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Sintilimab and Metformin<br>Participants will be given intravenous administration of Sintilimab (1200mg/3w) Metformin treatment will be given (day20) 1 week before the second administration of Sintilimab a a dose of 2000 mg daily (1000mg BID).~The duration of treatment will be up to one year, or till the disease progression, death, or unacceptable toxicity show up. | Drug: PD-1 inhibitor<br>* Intravenous administration of Sintilimab (1200mg/3weeks)<br>* Other names: IBI380;Drug: Metformin<br>* Metformin treatment will be given (day20) 1 week before the second administration of Sintilimab at a dose of 2000 mg daily (1000mg BID).~To reduce GI toxicity, participants start Metformin at 1000 mg daily (500mg am, 500 mg pm) for 1 week.<br>|
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Assessing Safety and Efficacy of Sintilimab and Metformin Combination Therapy in SCLC
Study Overview
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Brief Summary
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In this Single arm study, histologically or cytologically confirmed ED-stage small cell lung cancer (SCLC) patients resistant to or relapsed after standard chemotherapy will be enrolled to investigate the Efficacy and Safety of a Combination of Sintilimab and Metformin. Primary outcome: Objective response rate (ORR), Safety of the combination therapy Secondary outcome: Overall survival (OS), Progression-free survival (PFS), Duration of response(DOR),
Detailed Description
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Exploratory Endpoints: The association between the efficacy of the combination treatment and changes in CTC counts after administration of the treatment. Evaluating the correlation between programmed death ligand 1 (PD-L1) expression derived from circulating tumor cells (CTC) and tumor tissue cells, and the predictive role of CTC PD-L1 expression in ED-SCLC. The compositional changes in the gut microbiota after administration of the treatment and its association with the efficacy of the combination treatment.
Official Title
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A Phase II Open-label, Single-arm Study Assessing the Efficacy and Safety of Combination Therapy of Sintilimab and Metformin With Relapsed PD-L1 Positive Small Cell Lung Cancer
Conditions
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Small-cell Lung Cancer, Small Cell Lung Carcinoma, Small Cell Lung Cancer Recurrent, Small Cell Lung Cancer Extensive Stage
Intervention / Treatment
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* Drug: PD-1 inhibitor
* Drug: Metformin
Participation Criteria
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Eligibility Criteria
-----------------
Inclusion Criteria: Male or female patient, age≥18 and≤65; Eastern Cooperative Oncology Group (ECOG) performance status ≤2; The life expectancy of greater than 12 weeks; Participants must have histologically or cytologically confirmed metastatic or extended disease of SCLC (ED-SCLC). According to RECIST1.1, participants must have been confirmed Disease progression (within 6 months, confirmed by imaging test)after platinum-based doublet chemotherapy OR after (PFS>6 months, ) platinum-based doublet chemotherapy and refused to continue chemotherapy, OR after second-line or more lines of systemic chemotherapy limited disease SCLC (LD-SCLC) patients with disease progression after Synchronous chemoradiotherapy, must receive firstline systematic platinum-based doublet chemotherapy and refused to receive chemotherapy again. Evaluable or measurable lesion is required, defined as at least one lesion (not brain metastasis) that can be accurately measured based on RECIST 1.1; Participant need to provided tumor tissue (from an archival tumor sample obtained within 1 year or from a new biopsy sample) for PD-L1 immunohistochemical (IHC) assay, and PD-L1expression in more than 1% cells is required; Participant is able to the ability to swallow oral medications Participants have to meet the following criteria to ensure function of vital organs: Absolute neutrophil count (ANC) ≥1.5×109/L or White blood cell count >3.5×109/L;Platelets >80×109/L; Hemoglobin (HGB)≥90 g/L;Serum total bilirubin ≤ 1.5 x upper limit of normal (ULN); AST(SGOT)/ALT(SGPT) ≤2.5 ×ULN; ALB≥2.8g/dL;Serum creatinine ≤ 1.5 x institutional ULN OR creatinine clearance ≥40 mL/min using the Cockcroft-Gault equation Participants must agree to use adequate contraception (hormonal or barrier method of birth control; abstinence) through the treatment, and for at least 180 days after the last dose of study treatment; Participants must have the ability to understand and be willing to sign a written informed consent document. Exclusion Criteria: Participants who were diagnosed as mixed pathological type of small cell lung cancer Participants who had long-term use of metformin (>2 weeks) 6 months prior to study entry, or diagnosed with type-2 diabetes, Participants received treatment with anti-PD1, -PDL1, -CTLA4, -CD137 inhibitors before, or any therapy specifically targeting T-cell co-stimulation or checkpoint pathways. Participants received cellular immunotherapy before Participants with Uncontrolled intercurrent illness including, but not limited to: Ongoing or active infection; Known history of Human Immunodeficiency Virus (HIV) infection Acute or chronic active hepatitis B (HBV DNA >1*10^3 copies/ml or >200 IU/mL) or, acute or chronic active hepatitis C (with a positive Hepatitis C antibody test result) Active tuberculosis Congestive heart failure (Class III-IV, according to New York Heart Association classification), or and clinically significant Cardiac arrhythmia if poorly controlled; Uncontrolled arterial hypertension (systolic blood pressure ≥160mmHg or diastolic blood pressure ≥100mmHg) Any arterial thrombosis, embolism, ischemia, myocardial infarction, unstable angina, or cerebrovascular accident within 6 months prior to enrollment, Participants with symptomatic Central nervous metastasis or meningeal carcinomatosis are excluded; Participants with asymptomatic brain metastases or with brain metastases that have been treated and stable in a subsequent scan are allowed to include if there is measurable lesion outside the Central nervous system and no history of intracranial hemorrhage, and not midbrain, pons, cerebellum, medulla or spinal cord metastasis, and do not need glucocorticoid therapy. Participants receiving glucocorticoid (>30 mg prednisone equivalent a day) or any Immunosuppressive drug within 14 days prior to study recruitment; Participants receiving inhaled or Topical corticosteroids, adrenal corticosteroid replacement therapy (>10 mg prednisone equivalent a day) are allowed if they have no active autoimmune disease Participants with a known additional malignancy (Except for Non-melanoma skin cancer and the following in situ carcinoma: in situ bladder carcinoma, in situ gastric carcinoma, in situ colonic carcinoma, in situ endometrial carcinoma, in situ cervical carcinoma /dysplasia, in situ melanoma carcinoma and in situ breast Carcinoma) unless they Maintained Complete Remission for at least 5 years and do not need corresponding treatment during the study Participants who have not recovered (i.e., ≤ Grade 1 according to NCI CTCAE V4or at baseline) from adverse effects due to a previously administered agent. Participants who have uncontrollable effusion, such as pleural and ascites that cannot be controlled by drainage or other treatment Patients who have active autoimmune diseases; excluding patients whose active autoimmune disease is caused by Vitiligo or asthma that is completely relieved in childhood and Patients with hypothyroidism requiring only hormone replacement therapy Patients with known Allogeneic organ transplantation (except corneal transplantation) or allogeneic hematopoietic stem cell transplantation Patients who are pregnant or breastfeeding, Patients who are allergic to monoclonal antibody drugs Patients who have contraindications to metformin including severe allergic reactions and intolerance Patients who are not eligible for this study, as Assessed by Investigator
Ages Eligible for Study
-----------------
Minimum Age: 18 Years
Maximum Age: 65 Years
Sexes Eligible for Study
-----------------
All
Accepts Healthy Volunteers
-----------------
No
Study Plan
=================
How is the study designed?
-----------------
Design Details
Primary Purpose: Treatment
Intervention Model: Single Group Assignment
Interventional Model Description: Patients fulfilling Eligibility Criteria will be included in our study. Participants will be given intravenous administration of Sintilimab (1200mg/3w). Metformin treatment will be given (day20) 1 week before the second administration of Sintilimab at a dose of 2000 mg daily (1000mg BID). Treatments will be administrated for one year or until disease progression, death, or unacceptable toxicity. Regular follow-up and safety assessment: Patients were assessed for drug safety and treatment efficacy every 2 cycles (6 weeks) in the first 3 months after enrollment, and then evaluated every 4 cycles (12 weeks). Assessment of tumor response, adverse events. Follow-up until disease progression and patient death.
Masking: None (Open Label)
Arms and Interventions
| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Sintilimab and Metformin<br>Participants will be given intravenous administration of Sintilimab (1200mg/3w) Metformin treatment will be given (day20) 1 week before the second administration of Sintilimab a a dose of 2000 mg daily (1000mg BID). The duration of treatment will be up to one year, or till the disease progression, death, or unacceptable toxicity show up. | Drug: PD-1 inhibitor<br>* Intravenous administration of Sintilimab (1200mg/3weeks)<br>* Other names: IBI380;Drug: Metformin<br>* Metformin treatment will be given (day20) 1 week before the second administration of Sintilimab at a dose of 2000 mg daily (1000mg BID). To reduce GI toxicity, participants start Metformin at 1000 mg daily (500mg am, 500 mg pm) for 1 week.<br>|
What is the study measuring?
-----------------
Primary Outcome Measures
| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Objective response rate of Sintilimab and Metformin(ORR) | Assessing the response of treatment of each patient using RECIST 1.1 criteria, the investigators calculate the percentage of patients meet partial response (30% decrease in diameter) and complete response in the arm. | 1 year |
| Safety of the combination therapy of Sintilimab and Metformin: CTCAE4.03 grading | Incidence and severity of (serious) adverse events in each individual according to the CTCAE4.03 grading. | 2 year |
Secondary Outcome Measures
| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Median overall survival (OS) time of Sintilimab and Metformin | Use K-M to estimate the median OS of single arm. | 2 years |
| Median progression free survival(PFS) of Sintilimab and Metformin | Use K-M to estimate the median PFS of single arm. | 1 year |
| Median duration of response (DoR) of Sintilimab and Metformin | Use K-M to estimate the median DoR of single arm. | 1 year |
Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
immunotherapy, metformin, PD-L1, PD-1 checkpoint inhibitor
|
NCT05595928
|
Investigating Maternal Effects of Positions Applied in Patients Preparing for Caesarean Section Under Spinal Anesthesia
|
After the approval of the Ethics Committee, 120 patients were planned to be included in the study between 15.06.2022 and 15.01.2023. Women who underwent elective cesarean delivery under spinal anesthesia were randomized to the supine position, 15° left-lateral tilt position, or 30° left-lateral tilt position. The position will be changed to supine before the incision. It was planned to recruit 40 patients from each group, with a total of 120 patients. Anesthetic management was standardized and fluid administration with 10 mL/kg isotonic was planned. Hypotension (systolic blood pressure [SBP] reduction > 20% baseline or SBP <90 mm Hg) will be treated with intravenous bolus ephedrine based on maternal heart rate. The primary outcome is planned to include maternal SBP in 15 minutes of anesthesia induction, the amount of vasoactive drug administered before the end of surgery, and the incidence of hypotension during cesarean delivery.
|
Pregnant women in the supine position may compress the Inferior Vena Cava (IVC) by compression of the enlarged uterus in the third trimester. In this way, it is considered that it may reduce the amount of returning blood and cause hypotension. The incidence of this condition, called Supine Hypotension Syndrome, was reported to be 8%-10% (1-3). Spinal anesthesia, decreased sympathetic tonus, decreased systemic vascular resistance, and vasodilation may also cause hypotension in the patient (4).~It was considered that if the uterus is tilted, the pressure on the IVC would be removed, increasing the return, blood volume and cardiac output, improving the fetus, blood supply and oxygen supply (5). However, studies that were conducted so far have not proven significant differences and there is no routine standard practice (6-8). Here, the purpose was to investigate the maternal effects between supine, tilt to the left of 15-degree, and tilt to the left of 30-degree., References~Howard BK, Goodson JH, Mengert WF. Supine hypotensive syndrome in late pregnancy. Obstet Gynecol. 1953;1:371-377.~Kinsella SM, Lohmann G. Supine hypotensive syndrome. Obstet Gynecol. 1994;83:774-788.~Rees GA, Willis BA. Resuscitation in late pregnancy. Anaesthesia. 1988;43:347-349.~Dyer RA, Reed AR, van Dyk D, et al. Hemodynamic effects of ephedrine, phenylephrine, and the coadministration of phenylephrine with oxytocin during spinal anesthesia for elective cesarean delivery. Anesthesiology. 2009;111:753-765.~Kinsella SM. Lateral tilt for pregnant women: why 15-degree? Anaesthesia. 2003;58:835-836.~Ellington C, Katz VL, Watson WJ, Spielman FJ. The effect of lateral tilt on maternal and fetal hemodynamic variables. Obstet Gynecol. 1991;77:201-203.~Bamber JH, Dresner M. Aortocaval compression in pregnancy: the effect of changing the degree and direction of lateral tilt on maternal cardiac output. Anesth Analg.~2003;97:256-258.~Calvache JA, Mu.oz MF, Baron FJ. Hemodynamic effects of a right lumbar-pelvic wedge during spinal anesthesia for cesarean section. Int J Obstet Anesth. 2011;20:307-311.
|
Investigating Maternal Effects of Positions Applied in Patients Preparing for Caesarean Section Under Spinal Anesthesia
|
Hypotension
|
* Other: position
|
Inclusion Criteria:~Elective cesarean delivery with term pregnancy~Patient's height 150-180 cm~American Society of Anesthesiologists (ASA) Physical Condition II~Body Mass Index (BMI) <35 kg/m2.~Exclusion Criteria:~Fetal macrosomia~Uterine abnormalities (e.g. large fibroids, bicornuate uterus)~Polyhydramnios~Torn membranes, oligohydramnios~Intrauterine growth restriction~Gestational or non-gestational hypertension, diabetes, or eclampsia~Contraindications for spinal anesthesia
|
18 Years
|
35 Years
|
Female
|
No
|
| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| position | the purpose was to investigate the maternal effects between supine, tilt to the left of 15-degree, and tilt to the left of 30-degree. | through study completion, an average of 6 months |
|
Hypotension, Vascular Diseases, Cardiovascular Diseases
|
| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Supine<br>supine | Other: position<br>* To compare whether there is a difference between maternal and fetal effects of Supine, 15-degree left tilt, and 30-degrees left tilt.<br>|
| 15° left-lateral tilt position<br>15° left-lateral tilt position. | Other: position<br>* To compare whether there is a difference between maternal and fetal effects of Supine, 15-degree left tilt, and 30-degrees left tilt.<br>|
| 30° left-lateral tilt position.<br>30° left-lateral tilt position. | Other: position<br>* To compare whether there is a difference between maternal and fetal effects of Supine, 15-degree left tilt, and 30-degrees left tilt.<br>|
|
Investigating Maternal Effects of Positions Applied in Patients Preparing for Caesarean Section Under Spinal Anesthesia
Study Overview
=================
Brief Summary
-----------------
After the approval of the Ethics Committee, 120 patients were planned to be included in the study between 15.06.2022 and 15.01.2023. Women who underwent elective cesarean delivery under spinal anesthesia were randomized to the supine position, 15° left-lateral tilt position, or 30° left-lateral tilt position. The position will be changed to supine before the incision. It was planned to recruit 40 patients from each group, with a total of 120 patients. Anesthetic management was standardized and fluid administration with 10 mL/kg isotonic was planned. Hypotension (systolic blood pressure [SBP] reduction > 20% baseline or SBP <90 mm Hg) will be treated with intravenous bolus ephedrine based on maternal heart rate. The primary outcome is planned to include maternal SBP in 15 minutes of anesthesia induction, the amount of vasoactive drug administered before the end of surgery, and the incidence of hypotension during cesarean delivery.
Detailed Description
-----------------
Pregnant women in the supine position may compress the Inferior Vena Cava (IVC) by compression of the enlarged uterus in the third trimester. In this way, it is considered that it may reduce the amount of returning blood and cause hypotension. The incidence of this condition, called Supine Hypotension Syndrome, was reported to be 8%-10% (1-3). Spinal anesthesia, decreased sympathetic tonus, decreased systemic vascular resistance, and vasodilation may also cause hypotension in the patient (4). It was considered that if the uterus is tilted, the pressure on the IVC would be removed, increasing the return, blood volume and cardiac output, improving the fetus, blood supply and oxygen supply (5). However, studies that were conducted so far have not proven significant differences and there is no routine standard practice (6-8). Here, the purpose was to investigate the maternal effects between supine, tilt to the left of 15-degree, and tilt to the left of 30-degree., References Howard BK, Goodson JH, Mengert WF. Supine hypotensive syndrome in late pregnancy. Obstet Gynecol. 1953;1:371-377. Kinsella SM, Lohmann G. Supine hypotensive syndrome. Obstet Gynecol. 1994;83:774-788. Rees GA, Willis BA. Resuscitation in late pregnancy. Anaesthesia. 1988;43:347-349. Dyer RA, Reed AR, van Dyk D, et al. Hemodynamic effects of ephedrine, phenylephrine, and the coadministration of phenylephrine with oxytocin during spinal anesthesia for elective cesarean delivery. Anesthesiology. 2009;111:753-765. Kinsella SM. Lateral tilt for pregnant women: why 15-degree? Anaesthesia. 2003;58:835-836. Ellington C, Katz VL, Watson WJ, Spielman FJ. The effect of lateral tilt on maternal and fetal hemodynamic variables. Obstet Gynecol. 1991;77:201-203. Bamber JH, Dresner M. Aortocaval compression in pregnancy: the effect of changing the degree and direction of lateral tilt on maternal cardiac output. Anesth Analg. 2003;97:256-258. Calvache JA, Mu.oz MF, Baron FJ. Hemodynamic effects of a right lumbar-pelvic wedge during spinal anesthesia for cesarean section. Int J Obstet Anesth. 2011;20:307-311.
Official Title
-----------------
Investigating Maternal Effects of Positions Applied in Patients Preparing for Caesarean Section Under Spinal Anesthesia
Conditions
-----------------
Hypotension
Intervention / Treatment
-----------------
* Other: position
Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Elective cesarean delivery with term pregnancy Patient's height 150-180 cm American Society of Anesthesiologists (ASA) Physical Condition II Body Mass Index (BMI) <35 kg/m2. Exclusion Criteria: Fetal macrosomia Uterine abnormalities (e.g. large fibroids, bicornuate uterus) Polyhydramnios Torn membranes, oligohydramnios Intrauterine growth restriction Gestational or non-gestational hypertension, diabetes, or eclampsia Contraindications for spinal anesthesia
Ages Eligible for Study
-----------------
Minimum Age: 18 Years
Maximum Age: 35 Years
Sexes Eligible for Study
-----------------
Female
Accepts Healthy Volunteers
-----------------
No
Study Plan
=================
How is the study designed?
-----------------
Arms and Interventions
| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Supine<br>supine | Other: position<br>* To compare whether there is a difference between maternal and fetal effects of Supine, 15-degree left tilt, and 30-degrees left tilt.<br>|
| 15° left-lateral tilt position<br>15° left-lateral tilt position. | Other: position<br>* To compare whether there is a difference between maternal and fetal effects of Supine, 15-degree left tilt, and 30-degrees left tilt.<br>|
| 30° left-lateral tilt position.<br>30° left-lateral tilt position. | Other: position<br>* To compare whether there is a difference between maternal and fetal effects of Supine, 15-degree left tilt, and 30-degrees left tilt.<br>|
What is the study measuring?
-----------------
Primary Outcome Measures
| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| position | the purpose was to investigate the maternal effects between supine, tilt to the left of 15-degree, and tilt to the left of 30-degree. | through study completion, an average of 6 months |
|
|||
NCT00413829
|
Immediate Effects of Lucentis® in Conjunction With Photodynamic Therapy With Visudyne® in Exudative AMD(IECOMB)
|
This study is an evaluation of the short term effects on CNV perfusion of a same-day administration of photodynamic therapy (PDT) with Visudyne® and an intravitreal injection of Lucentis® (ranibizumab, 0.3 mg). An evaluation of the short term effects on CNV perfusion of this combined treatment is needed for better understanding of treatment effects.
|
The primary objective is to quantify the short term effects on CNV perfusion of the same-day administration of photodynamic therapy with Visudyne® and an intravitreal injection of ranibizumab. These short term effects will be assessed with visual acuity measurements and ophthalmic examinations including indocyanine green (ICG) and fluorescein angiography (FA) as well as Optical Coherence Tomography (OCT) measurements. The primary variable for this assessment is the incidence of CNV closure one week after combined therapy as assessed with high speed ICG angiography. Fluorescein and ICG angiography will be performed using a scanning laser ophthalmoscope (HRA). All angiographic studies and OCT examinations will be evaluated by the Bern Photographic Reading Center in a masked fashion. Visual acuity assessments will be performed with Early Treatment Diabetic Retinopathy Study (ETDRS)-like visual acuity testing charts.~A secondary objective is to explore the effect of the same-day administration of photodynamic therapy with Visudyne® and an intravitreal injection of ranibizumab:~on retinal thickness as measured by OCT over time~in change of total lesion area, area of CNV assessed by FA~in mean change of VA from baseline over time
|
Open-label, Phase II Study Assessing Immediate Effects of Lucentis®(Ranibizumab) Administered in Conjunction With Photodynamic Therapy With Visudyne® in Patients With Choroidal Neovascularization Secondary to AMD
|
Age Related Macular Degeneration
|
* Drug: Intravitreal ranibizumab with photodynamic therapy
|
Inclusion Criteria:~Patients 50 years of age or greater~Patients with subfoveal choroidal neovascularization lesions secondary to AMD, either predominantly classic, occult, or minimally classic.~CNV lesion in the study eye is ≤5400 microns in greatest linear dimension~Patients who have a best corrected visual acuity (BCVA) score between 73 and 24 letters, inclusively, in the study eye using ETDRS-like grading charts (approximately 20/40 to 20/320) measured at 4 meters~Willing to return for follow up scheduled visits for a 6 months period~Only one eye will be assessed in the study. If both eyes are eligible, the one with the worse visual acuity will be selected for treatment and study unless, based on medical reasons, the investigator deems the other eye the more appropriate candidate for treatment and study~Exclusion Criteria:~Patients who have a BCVA of < 33 letters (approximately 20/200) in both eyes~Prior treatment in the study eye with verteporfin, external-beam radiation therapy, vitrectomy, submacular surgery, other surgical intervention for AMD, or transpupillary thermotherapy~Previous or current intravitreal drug delivery (e.g., intravitreal corticosteroid injection or device implantation) in the study eye~Focal laser photocoagulation (juxta-, extra- or subfoveal ) in the study eye~Concomitant use of chronic NSAIDs or steroids (by any route) for the duration of study participation (chronic use is defined as multiple doses taken daily for three or more consecutive days at any time during the study). Note that ASA (aspirin) taken as low dose up to 100 mg daily (qd) for prophylaxis of myocardial infarction (MI) and/or stroke is permitted during study~Current use or likely need for systemic medications known to be toxic to the lens, retina or optic nerve, including Deferoxamine, Chloroquine/ hydroxychloroquine (Plaquenil), Tamoxifen, Phenothiazines and Ethambutol is excluded~History of glaucoma filtration surgery, corneal transplant surgery or extracapsular extraction of cataract with phacoemulsification within six months preceding Day One, or a history of post-operative complications within the last 12 months preceding Day One in the study eye (uveitis, cyclitis etc.)~History of uncontrolled glaucoma in the study eye (defined as intraocular pressure ≥ 25 mmHg despite treatment with topical anti-glaucomatous medication).~Aphakia or absence of the posterior capsule in the study eye~Previous violation of the posterior capsule in the study eye is also excluded unless it occurred as a result of YAG posterior capsulotomy in association with prior, posterior chamber intraocular lens implantation~Spherical equivalent of the refractive error in the study eye demonstrating more than -8 diopters of myopia~Presence of a retinal pigment epithelial tear involving the macula in the study eye~Angioid streaks or precursors of CNV in either eye due to other causes, such as ocular histoplasmosis, trauma, or pathologic myopia~Active intraocular inflammation (grade trace or above) in the study eye~Any active infection involving an eyeball adnexa~Vitreous hemorrhage or history of rhegmatogenous retinal detachment or macular hole (Stage 3 or 4) in the study eye
|
50 Years
| null |
All
|
No
|
Primary Purpose: Treatment
Allocation: Non-Randomized
Intervention Model: Single Group Assignment
Masking: None (Open Label)
|
| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| incidence of CNV closure one week after combined therapy as assessed with high speed ICG angiography | | 24 months |
|
| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| retinal thickness as measured by OCT over time | | 24 months |
| change of total lesion area, area of CNV and area of leakage over time as assessed by FA | | 24 months |
| mean change of VA from baseline over time | | 24 months |
|
age related macular degeneration, anti-VEGF therapy
|
Ranibizumab, Angiogenesis Inhibitors, Angiogenesis Modulating Agents, Growth Substances, Physiological Effects of Drugs, Growth Inhibitors, Antineoplastic Agents
|
| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Other: 1<br> | Drug: Intravitreal ranibizumab with photodynamic therapy<br>* Intravitreal injection, photodynamic therapy<br>|
|
Immediate Effects of Lucentis® in Conjunction With Photodynamic Therapy With Visudyne® in Exudative AMD(IECOMB)
Study Overview
=================
Brief Summary
-----------------
This study is an evaluation of the short term effects on CNV perfusion of a same-day administration of photodynamic therapy (PDT) with Visudyne® and an intravitreal injection of Lucentis® (ranibizumab, 0.3 mg). An evaluation of the short term effects on CNV perfusion of this combined treatment is needed for better understanding of treatment effects.
Detailed Description
-----------------
The primary objective is to quantify the short term effects on CNV perfusion of the same-day administration of photodynamic therapy with Visudyne® and an intravitreal injection of ranibizumab. These short term effects will be assessed with visual acuity measurements and ophthalmic examinations including indocyanine green (ICG) and fluorescein angiography (FA) as well as Optical Coherence Tomography (OCT) measurements. The primary variable for this assessment is the incidence of CNV closure one week after combined therapy as assessed with high speed ICG angiography. Fluorescein and ICG angiography will be performed using a scanning laser ophthalmoscope (HRA). All angiographic studies and OCT examinations will be evaluated by the Bern Photographic Reading Center in a masked fashion. Visual acuity assessments will be performed with Early Treatment Diabetic Retinopathy Study (ETDRS)-like visual acuity testing charts. A secondary objective is to explore the effect of the same-day administration of photodynamic therapy with Visudyne® and an intravitreal injection of ranibizumab: on retinal thickness as measured by OCT over time in change of total lesion area, area of CNV assessed by FA in mean change of VA from baseline over time
Official Title
-----------------
Open-label, Phase II Study Assessing Immediate Effects of Lucentis®(Ranibizumab) Administered in Conjunction With Photodynamic Therapy With Visudyne® in Patients With Choroidal Neovascularization Secondary to AMD
Conditions
-----------------
Age Related Macular Degeneration
Intervention / Treatment
-----------------
* Drug: Intravitreal ranibizumab with photodynamic therapy
Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Patients 50 years of age or greater Patients with subfoveal choroidal neovascularization lesions secondary to AMD, either predominantly classic, occult, or minimally classic. CNV lesion in the study eye is ≤5400 microns in greatest linear dimension Patients who have a best corrected visual acuity (BCVA) score between 73 and 24 letters, inclusively, in the study eye using ETDRS-like grading charts (approximately 20/40 to 20/320) measured at 4 meters Willing to return for follow up scheduled visits for a 6 months period Only one eye will be assessed in the study. If both eyes are eligible, the one with the worse visual acuity will be selected for treatment and study unless, based on medical reasons, the investigator deems the other eye the more appropriate candidate for treatment and study Exclusion Criteria: Patients who have a BCVA of < 33 letters (approximately 20/200) in both eyes Prior treatment in the study eye with verteporfin, external-beam radiation therapy, vitrectomy, submacular surgery, other surgical intervention for AMD, or transpupillary thermotherapy Previous or current intravitreal drug delivery (e.g., intravitreal corticosteroid injection or device implantation) in the study eye Focal laser photocoagulation (juxta-, extra- or subfoveal ) in the study eye Concomitant use of chronic NSAIDs or steroids (by any route) for the duration of study participation (chronic use is defined as multiple doses taken daily for three or more consecutive days at any time during the study). Note that ASA (aspirin) taken as low dose up to 100 mg daily (qd) for prophylaxis of myocardial infarction (MI) and/or stroke is permitted during study Current use or likely need for systemic medications known to be toxic to the lens, retina or optic nerve, including Deferoxamine, Chloroquine/ hydroxychloroquine (Plaquenil), Tamoxifen, Phenothiazines and Ethambutol is excluded History of glaucoma filtration surgery, corneal transplant surgery or extracapsular extraction of cataract with phacoemulsification within six months preceding Day One, or a history of post-operative complications within the last 12 months preceding Day One in the study eye (uveitis, cyclitis etc.) History of uncontrolled glaucoma in the study eye (defined as intraocular pressure ≥ 25 mmHg despite treatment with topical anti-glaucomatous medication). Aphakia or absence of the posterior capsule in the study eye Previous violation of the posterior capsule in the study eye is also excluded unless it occurred as a result of YAG posterior capsulotomy in association with prior, posterior chamber intraocular lens implantation Spherical equivalent of the refractive error in the study eye demonstrating more than -8 diopters of myopia Presence of a retinal pigment epithelial tear involving the macula in the study eye Angioid streaks or precursors of CNV in either eye due to other causes, such as ocular histoplasmosis, trauma, or pathologic myopia Active intraocular inflammation (grade trace or above) in the study eye Any active infection involving an eyeball adnexa Vitreous hemorrhage or history of rhegmatogenous retinal detachment or macular hole (Stage 3 or 4) in the study eye
Ages Eligible for Study
-----------------
Minimum Age: 50 Years
Sexes Eligible for Study
-----------------
All
Accepts Healthy Volunteers
-----------------
No
Study Plan
=================
How is the study designed?
-----------------
Design Details
Primary Purpose: Treatment
Allocation: Non-Randomized
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Arms and Interventions
| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Other: 1<br> | Drug: Intravitreal ranibizumab with photodynamic therapy<br>* Intravitreal injection, photodynamic therapy<br>|
What is the study measuring?
-----------------
Primary Outcome Measures
| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| incidence of CNV closure one week after combined therapy as assessed with high speed ICG angiography | | 24 months |
Secondary Outcome Measures
| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| retinal thickness as measured by OCT over time | | 24 months |
| change of total lesion area, area of CNV and area of leakage over time as assessed by FA | | 24 months |
| mean change of VA from baseline over time | | 24 months |
Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
age related macular degeneration, anti-VEGF therapy
|
NCT00145782
|
The Ebeltoft Health Promotion Project
|
The objective of The Ebeltoft Health Promotion Project is investigate the effect of multiphasic preventive health screenings and discussions with general practitioners of a random population of patients in primary care.~Outcome parameters are the cardiovascular risk profile, number of health care contacts, life years gained, direct costs, i.e. health care costs, and total cost, i.e. including productivity costs.
|
The Ebeltoft project was designed as a randomized controlled trial in the district of Ebeltoft, Aarhus County, Denmark. All nine general practitioners (GPs) from the four primary care units in the district participated. All patients listed in the primary care units between 30 and 49 years of age by January 1, 1991 (N=3,464) were identified in the Danish Civil Registration system, each Danish resident has a ten digit number, through which personal data can be extracted from the health and social registries. A random selection of 2,030 of the 3,464 persons was sampled for invitation to participate in the study. Those who agreed to participate were randomly divided into one control group and two intervention groups (A and B). Randomization of subjects into control and intervention groups was stratified by primary care unit, sex, age, body mass index (BMI), and cohabitation status as stated by the subjects in the invitation questionnaire. Invited subjects received an invitation questionnaire in September 1991. All subjects who agreed to participate also received questionnaires about their health, health beliefs, and social and demographic status at baseline and after one and five years. Subjects in the two intervention groups were offered a broad (multiphasic) health screening at baseline and after one and five years. After five years all subjects received a questionnaire and an invitation to a health screening and consultation. From December 1, 1991 to October 1, 1997 specially trained laboratory technicians carried out health screenings that included evaluations of cardiovascular, pulmonary, liver and kidney function, endocrine dysfunction, BMI, physical endurance, hearing and sight. Evaluation of cardiovascular function included a calculation of cardiovascular risk score (CRS), giving an estimate of the risk of premature cardiovascular disease for each individual. CRS was based on sex, familial inheritance (number of family members with ischemic heart disease before age 55), tobacco consumption, blood pressure, total serum cholesterol, and BMI.1 Within three weeks of the screenings, all participants received a written letter from their GP explaining the tests. Targeted life style counsels were included in the letter if the test results were outside a predefined range. All subjects who had been informed that they had an elevated or high CRS were encouraged to see their GP, regardless of their intervention status. After the health screenings, the subjects in group B were invited to attend a 45-minute patient centred health consultation with their GP. The health consultations were aimed primarily at discussing lifestyle-related health problems and giving the subject an opportunity to define up to three goals relating to lifestyle changes.~We investigate the impact of the intervention on the cardiovascular risk profile, number of health care contacts, the direct and total costs, and the health effects by comparing mean costs and expected life years gained of the intervention groups with those of the control group.
|
The Ebeltoft Health Promotion Project - A Randomized Controlled Trial With Multiphasic Preventive Health Screenings and Discussions in General Practice.
|
Primary Prevention
|
* Behavioral: Life style
|
Inclusion Criteria:~Aged 30 to 49 1. january 1991~Registered with a local general practitioner in the district of Ebeltoft~Exclusion Criteria:~Unable to understand and respond to a mailed invitation questionnaire
|
30 Years
|
50 Years
|
All
|
Accepts Healthy Volunteers
|
Primary Purpose: Prevention
Allocation: Randomized
Intervention Model: Factorial Assignment
Masking: None (Open Label)
|
| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Cardiovascular risk profile after 5 and 15 years | | |
| Life years gained and cost effectiveness after 6 years | | |
| All cause mortality after 15 years | | |
|
multiphasic screening, primary health care, randomized controlled trial, Risk factors
|
| Intervention/Treatment |
| --- |
|Behavioral: Life style|nan|
|
The Ebeltoft Health Promotion Project
Study Overview
=================
Brief Summary
-----------------
The objective of The Ebeltoft Health Promotion Project is investigate the effect of multiphasic preventive health screenings and discussions with general practitioners of a random population of patients in primary care. Outcome parameters are the cardiovascular risk profile, number of health care contacts, life years gained, direct costs, i.e. health care costs, and total cost, i.e. including productivity costs.
Detailed Description
-----------------
The Ebeltoft project was designed as a randomized controlled trial in the district of Ebeltoft, Aarhus County, Denmark. All nine general practitioners (GPs) from the four primary care units in the district participated. All patients listed in the primary care units between 30 and 49 years of age by January 1, 1991 (N=3,464) were identified in the Danish Civil Registration system, each Danish resident has a ten digit number, through which personal data can be extracted from the health and social registries. A random selection of 2,030 of the 3,464 persons was sampled for invitation to participate in the study. Those who agreed to participate were randomly divided into one control group and two intervention groups (A and B). Randomization of subjects into control and intervention groups was stratified by primary care unit, sex, age, body mass index (BMI), and cohabitation status as stated by the subjects in the invitation questionnaire. Invited subjects received an invitation questionnaire in September 1991. All subjects who agreed to participate also received questionnaires about their health, health beliefs, and social and demographic status at baseline and after one and five years. Subjects in the two intervention groups were offered a broad (multiphasic) health screening at baseline and after one and five years. After five years all subjects received a questionnaire and an invitation to a health screening and consultation. From December 1, 1991 to October 1, 1997 specially trained laboratory technicians carried out health screenings that included evaluations of cardiovascular, pulmonary, liver and kidney function, endocrine dysfunction, BMI, physical endurance, hearing and sight. Evaluation of cardiovascular function included a calculation of cardiovascular risk score (CRS), giving an estimate of the risk of premature cardiovascular disease for each individual. CRS was based on sex, familial inheritance (number of family members with ischemic heart disease before age 55), tobacco consumption, blood pressure, total serum cholesterol, and BMI.1 Within three weeks of the screenings, all participants received a written letter from their GP explaining the tests. Targeted life style counsels were included in the letter if the test results were outside a predefined range. All subjects who had been informed that they had an elevated or high CRS were encouraged to see their GP, regardless of their intervention status. After the health screenings, the subjects in group B were invited to attend a 45-minute patient centred health consultation with their GP. The health consultations were aimed primarily at discussing lifestyle-related health problems and giving the subject an opportunity to define up to three goals relating to lifestyle changes. We investigate the impact of the intervention on the cardiovascular risk profile, number of health care contacts, the direct and total costs, and the health effects by comparing mean costs and expected life years gained of the intervention groups with those of the control group.
Official Title
-----------------
The Ebeltoft Health Promotion Project - A Randomized Controlled Trial With Multiphasic Preventive Health Screenings and Discussions in General Practice.
Conditions
-----------------
Primary Prevention
Intervention / Treatment
-----------------
* Behavioral: Life style
Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Aged 30 to 49 1. january 1991 Registered with a local general practitioner in the district of Ebeltoft Exclusion Criteria: Unable to understand and respond to a mailed invitation questionnaire
Ages Eligible for Study
-----------------
Minimum Age: 30 Years
Maximum Age: 50 Years
Sexes Eligible for Study
-----------------
All
Accepts Healthy Volunteers
-----------------
Accepts Healthy Volunteers
Study Plan
=================
How is the study designed?
-----------------
Design Details
Primary Purpose: Prevention
Allocation: Randomized
Intervention Model: Factorial Assignment
Masking: None (Open Label)
Arms and Interventions
| Intervention/Treatment |
| --- |
|Behavioral: Life style|nan|
What is the study measuring?
-----------------
Primary Outcome Measures
| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Cardiovascular risk profile after 5 and 15 years | | |
| Life years gained and cost effectiveness after 6 years | | |
| All cause mortality after 15 years | | |
Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
multiphasic screening, primary health care, randomized controlled trial, Risk factors
|
||
NCT04623060
|
Low-Volume Interval Training and Resistance Exercise in Individual With Stroke
|
To examine the feasibility of Low-Volume Interval Training (LV-ITT) and Resistance Exercise (RE) on walking performance (walking endurance, gait speed, functional balance), lower limb muscle strength and quality of life among individuals with post-stroke.
|
Prescribing aerobic and resistance training in concurrence is proposed as an optimum strategy to target cardiovascular as well as musculoskeletal functions in individuals with post-stroke. Lower limb's resistance training alone in chronic stroke produces a large effect on muscle strength. However, it has shown uncertainty results on walking performance. Therefore, it is suggested that to prescribe mix training (treadmill training and strength training) in order to improve muscle strength, gait performance and quality of life in stroke survivors. Previous studies have shown the effect of mixed training on walking performance and endurance in other populations such as multiple sclerosis and coronary artery disease. However, there is a lack of study that conducted mixed training among chronic post-stroke. Therefore, the feasibility study on the effectiveness of combining LV-ITT and RE in post-stroke should be conducted.
|
Feasibility of Low-Volume Interval Training and Resistance Exercise on Walking Performance, Aerobic Fitness, Muscle Strength and Quality Of Life in Individual With Stroke
|
Stroke
|
* Other: Combination of Low-volume interval treadmill training and Resistance Training
|
Inclusion Criteria:~Age range between 45-65 years' old~At least 3-months post-stroke~Gait speed ≤1.0 m·s -¹ measured by the 10 m walk test.~Able to walk 10 m overground with assistive devices as needed and no physical assistance.~Able to walk for 3 min on the treadmill at ≥0.17 m·s -¹ (0.4 mph) with no aerobic exercise contraindications.~Modified Rankin Score (mRS) of <4 at the screening~American Heart Association class B (2), allowing for aerobic capacity <6 metabolic equivalent (MET)~Exclusion Criteria:~Significant resting ECG abnormalities~Hospitalization for cardiac or pulmonary disease within 3 months~Using Pacemaker~Aphasia~Significant musculotendinous or bony restrictions of the affected limb, or any serious chronic disease independently causing disability or profound atrophy of the affected limb that will comprise further indications to participation significant.
|
45 Years
|
65 Years
|
All
|
No
|
Primary Purpose: Treatment
Intervention Model: Single Group Assignment
Masking: None (Open Label)
|
| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change in Six Minute Walk Test | This test measures the distance that an individual can quickly walk in a period of 6 minutes on a flat surface. Participants will complete one trial with the gait aide prescribed to them. The distance will be recorded. Participants can stop and rest or discontinue to the test at any time. | 0, 6 weeks |
|
| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change in 10-meter walk test | This assessment will include four 10-meter walking tasks at maximal comfortable speed. | 0, 6 weeks |
| Change in Lower Limb Muscle Strength | Handheld dynamometer for knee extensor | 0, 6 weeks |
| Change in Timed Up and Go test | Functional Balance | 0, 6 weeks |
| Stroke Impact Scale (SIS) | Quality of Life | 0,week 6 |
| Adherence | Attendance and completion of home-based sessions measured via exercise diary | 0 to 6 weeks |
| Adverse Events | Any adverse event or near miss is required to be reported as standard of care at Selayang Hospital | 0 to 6 weeks |
| Patient satisfaction | Questionnaire | 6 weeks |
|
Low-Volume Interval Training, Resistance Training
|
Nervous System Diseases, Vascular Diseases, Cardiovascular Diseases, Stroke, Cerebrovascular Disorders, Brain Diseases, Central Nervous System Diseases
|
| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Intervention<br>3 sessions/week for 6 weeks | Other: Combination of Low-volume interval treadmill training and Resistance Training<br>* Low-volume interval training (LV-ITT) protocols included a 5 min warm-up (30%-50%VO2peak) up to 20min of LV-ITT and a 5 min cooling down (30%-50% VO2peak). The LV-ITT will repeat 60s bursts of fast treadmill walking at maximum tolerate speed (0% incline), alternate with pre-specified recovery periods about 4 minutes according to protocol. Each time the participants completed a burst successfully, treadmill speed will be increased by 0.1 mph for the next burst. The recovery periods will be 4 minutes. The intervention will be conducted for about 30 minutes.~Resistance training will be conducted by using a horizontal leg press machine. They are encouraged to focus on an explosive concentric movement and a controlled eccentric movement such that the time on each phase was in the ratio 1:2.<br>|
|
Low-Volume Interval Training and Resistance Exercise in Individual With Stroke
Study Overview
=================
Brief Summary
-----------------
To examine the feasibility of Low-Volume Interval Training (LV-ITT) and Resistance Exercise (RE) on walking performance (walking endurance, gait speed, functional balance), lower limb muscle strength and quality of life among individuals with post-stroke.
Detailed Description
-----------------
Prescribing aerobic and resistance training in concurrence is proposed as an optimum strategy to target cardiovascular as well as musculoskeletal functions in individuals with post-stroke. Lower limb's resistance training alone in chronic stroke produces a large effect on muscle strength. However, it has shown uncertainty results on walking performance. Therefore, it is suggested that to prescribe mix training (treadmill training and strength training) in order to improve muscle strength, gait performance and quality of life in stroke survivors. Previous studies have shown the effect of mixed training on walking performance and endurance in other populations such as multiple sclerosis and coronary artery disease. However, there is a lack of study that conducted mixed training among chronic post-stroke. Therefore, the feasibility study on the effectiveness of combining LV-ITT and RE in post-stroke should be conducted.
Official Title
-----------------
Feasibility of Low-Volume Interval Training and Resistance Exercise on Walking Performance, Aerobic Fitness, Muscle Strength and Quality Of Life in Individual With Stroke
Conditions
-----------------
Stroke
Intervention / Treatment
-----------------
* Other: Combination of Low-volume interval treadmill training and Resistance Training
Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Age range between 45-65 years' old At least 3-months post-stroke Gait speed ≤1.0 m·s -¹ measured by the 10 m walk test. Able to walk 10 m overground with assistive devices as needed and no physical assistance. Able to walk for 3 min on the treadmill at ≥0.17 m·s -¹ (0.4 mph) with no aerobic exercise contraindications. Modified Rankin Score (mRS) of <4 at the screening American Heart Association class B (2), allowing for aerobic capacity <6 metabolic equivalent (MET) Exclusion Criteria: Significant resting ECG abnormalities Hospitalization for cardiac or pulmonary disease within 3 months Using Pacemaker Aphasia Significant musculotendinous or bony restrictions of the affected limb, or any serious chronic disease independently causing disability or profound atrophy of the affected limb that will comprise further indications to participation significant.
Ages Eligible for Study
-----------------
Minimum Age: 45 Years
Maximum Age: 65 Years
Sexes Eligible for Study
-----------------
All
Accepts Healthy Volunteers
-----------------
No
Study Plan
=================
How is the study designed?
-----------------
Design Details
Primary Purpose: Treatment
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Arms and Interventions
| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Intervention<br>3 sessions/week for 6 weeks | Other: Combination of Low-volume interval treadmill training and Resistance Training<br>* Low-volume interval training (LV-ITT) protocols included a 5 min warm-up (30%-50%VO2peak) up to 20min of LV-ITT and a 5 min cooling down (30%-50% VO2peak). The LV-ITT will repeat 60s bursts of fast treadmill walking at maximum tolerate speed (0% incline), alternate with pre-specified recovery periods about 4 minutes according to protocol. Each time the participants completed a burst successfully, treadmill speed will be increased by 0.1 mph for the next burst. The recovery periods will be 4 minutes. The intervention will be conducted for about 30 minutes. Resistance training will be conducted by using a horizontal leg press machine. They are encouraged to focus on an explosive concentric movement and a controlled eccentric movement such that the time on each phase was in the ratio 1:2.<br>|
What is the study measuring?
-----------------
Primary Outcome Measures
| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change in Six Minute Walk Test | This test measures the distance that an individual can quickly walk in a period of 6 minutes on a flat surface. Participants will complete one trial with the gait aide prescribed to them. The distance will be recorded. Participants can stop and rest or discontinue to the test at any time. | 0, 6 weeks |
Secondary Outcome Measures
| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change in 10-meter walk test | This assessment will include four 10-meter walking tasks at maximal comfortable speed. | 0, 6 weeks |
| Change in Lower Limb Muscle Strength | Handheld dynamometer for knee extensor | 0, 6 weeks |
| Change in Timed Up and Go test | Functional Balance | 0, 6 weeks |
| Stroke Impact Scale (SIS) | Quality of Life | 0,week 6 |
| Adherence | Attendance and completion of home-based sessions measured via exercise diary | 0 to 6 weeks |
| Adverse Events | Any adverse event or near miss is required to be reported as standard of care at Selayang Hospital | 0 to 6 weeks |
| Patient satisfaction | Questionnaire | 6 weeks |
Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Low-Volume Interval Training, Resistance Training
|
NCT01544244
|
The Global Shoulder Concept (GSC) Method Versus Classic Physical Therapy for Shoulder Tendinitis
|
The primary objective of this study is to demonstrate the superiority of the CGE physical therapy protocol versus a standard physical therapy protocol of the shoulder by measuring the following after 1 month of physical therapy: the FI2S score including validated measures of pain, glenohumeral joint range of motion in the three planes, the ability to perform certain everyday activities and the strength of forward elevation measured with a dynamometer.
|
Secondary objectives:~To study the evolution of passive glenohumeral range of motion~To study the evolution of the global range of passive and active motion for each method used~To evaluate functional recovery (DASH)~To evaluate the impact on quality of life (SF36)~To study the difference in visual analog scale scores for pain during physical therapy sessions~Compare the two methods/groups after three months.
|
Comparison of the Global Shoulder Concept (GSC) Method Versus Classic Physical Therapy for Shoulder Tendinitis: a Prospective, Randomized Study
|
Shoulder, Tendinopathy
|
* Procedure: GSC physical therapy
* Procedure: Standard physical therapy
|
Inclusion Criteria:~The patient must have given his/her informed and signed consent~The patient must be insured or beneficiary of a health insurance plan~painful, chronic tendinopathy (more than 3 months) of the rotator cuff, confirmed by MRI~Exclusion Criteria:~The patient is pregnant or breastfeeding~Any emergency situation~Non-mechanical tendinopathies (metabolic, neurological, capsulitis, reflex sympathetic dystrophy) and tendon surgery (tendon surgery and acromioplasty)
|
18 Years
|
70 Years
|
All
|
No
|
Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
|
| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| change in FI2S score | | 90 days |
|
| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change in visual analog scale for pain | | Day 1 versus baseline |
| Change in visual analog scale for pain | | Day 5 versus baseline |
| Change in visual analog scale for pain | | Day 12 versus baseline |
| Change in visual analog scale for pain | | Day 19 versus baseline |
| Change in visual analog scale for pain | | Day 26 versus baseline |
| Change in visual analog scale for pain | | Day 90 versus baseline |
| Scapulohumeral amplitude gain in 3 main directions | Passive and active mobility are evaluated by manual goniometry. | Day 1 |
| Scapulohumeral amplitude gain in 3 main directions | Passive and active mobility are evaluated by manual goniometry. | Day 26 |
| Scapulohumeral amplitude gain in 3 main directions | Passive and active mobility are evaluated by manual goniometry. | Day 90 |
| Functional gain as measured by the DASH self questionnaire | | Day 1 |
| Functional gain as measured by the DASH self questionnaire | | Day 5 |
| Functional gain as measured by the DASH self questionnaire | | Day 12 |
| Functional gain as measured by the DASH self questionnaire | | Day 19 |
| Functional gain as measured by the DASH self questionnaire | | Day 26 |
| Functional gain as measured by the DASH self questionnaire | | Day 90 |
| FI2S score | | Day 1 |
| FI2S score | | Day 5 |
| FI2S score | | Day 12 |
| FI2S score | | Day 19 |
| FI2S score | | Day 26 |
| SF36 self questionnaire | | Day 1 |
| SF36 self questionnaire | | Day 26 |
| SF36 self questionnaire | | Day 90 |
|
comparison of physical therapy strategies
|
Tendinopathy, Muscular Diseases, Musculoskeletal Diseases, Tendon Injuries, Wounds and Injuries
|
| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: GSC physcial therapy<br>Patients included in this arm of the study will follow the Global Shoulder Concept physical therapy sequence. | Procedure: GSC physical therapy<br>* Global Shoulder Concept physical therapy sequence for shoulder tendonitis. The procedures used in this protocol refer to physical therapy sequences, not to devices or drugs.<br>|
| Active Comparator: Standard<br>Patients in this arm of the study will follow the standard physical therapy sequence. | Procedure: Standard physical therapy<br>* Standard physical therapy sequence for shoulder tendonitis. The procedures used in this protocol refer to physical therapy sequences, not to devices or drugs.<br>|
|
The Global Shoulder Concept (GSC) Method Versus Classic Physical Therapy for Shoulder Tendinitis
Study Overview
=================
Brief Summary
-----------------
The primary objective of this study is to demonstrate the superiority of the CGE physical therapy protocol versus a standard physical therapy protocol of the shoulder by measuring the following after 1 month of physical therapy: the FI2S score including validated measures of pain, glenohumeral joint range of motion in the three planes, the ability to perform certain everyday activities and the strength of forward elevation measured with a dynamometer.
Detailed Description
-----------------
Secondary objectives: To study the evolution of passive glenohumeral range of motion To study the evolution of the global range of passive and active motion for each method used To evaluate functional recovery (DASH) To evaluate the impact on quality of life (SF36) To study the difference in visual analog scale scores for pain during physical therapy sessions Compare the two methods/groups after three months.
Official Title
-----------------
Comparison of the Global Shoulder Concept (GSC) Method Versus Classic Physical Therapy for Shoulder Tendinitis: a Prospective, Randomized Study
Conditions
-----------------
Shoulder, Tendinopathy
Intervention / Treatment
-----------------
* Procedure: GSC physical therapy
* Procedure: Standard physical therapy
Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: The patient must have given his/her informed and signed consent The patient must be insured or beneficiary of a health insurance plan painful, chronic tendinopathy (more than 3 months) of the rotator cuff, confirmed by MRI Exclusion Criteria: The patient is pregnant or breastfeeding Any emergency situation Non-mechanical tendinopathies (metabolic, neurological, capsulitis, reflex sympathetic dystrophy) and tendon surgery (tendon surgery and acromioplasty)
Ages Eligible for Study
-----------------
Minimum Age: 18 Years
Maximum Age: 70 Years
Sexes Eligible for Study
-----------------
All
Accepts Healthy Volunteers
-----------------
No
Study Plan
=================
How is the study designed?
-----------------
Design Details
Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Arms and Interventions
| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: GSC physcial therapy<br>Patients included in this arm of the study will follow the Global Shoulder Concept physical therapy sequence. | Procedure: GSC physical therapy<br>* Global Shoulder Concept physical therapy sequence for shoulder tendonitis. The procedures used in this protocol refer to physical therapy sequences, not to devices or drugs.<br>|
| Active Comparator: Standard<br>Patients in this arm of the study will follow the standard physical therapy sequence. | Procedure: Standard physical therapy<br>* Standard physical therapy sequence for shoulder tendonitis. The procedures used in this protocol refer to physical therapy sequences, not to devices or drugs.<br>|
What is the study measuring?
-----------------
Primary Outcome Measures
| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| change in FI2S score | | 90 days |
Secondary Outcome Measures
| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change in visual analog scale for pain | | Day 1 versus baseline |
| Change in visual analog scale for pain | | Day 5 versus baseline |
| Change in visual analog scale for pain | | Day 12 versus baseline |
| Change in visual analog scale for pain | | Day 19 versus baseline |
| Change in visual analog scale for pain | | Day 26 versus baseline |
| Change in visual analog scale for pain | | Day 90 versus baseline |
| Scapulohumeral amplitude gain in 3 main directions | Passive and active mobility are evaluated by manual goniometry. | Day 1 |
| Scapulohumeral amplitude gain in 3 main directions | Passive and active mobility are evaluated by manual goniometry. | Day 26 |
| Scapulohumeral amplitude gain in 3 main directions | Passive and active mobility are evaluated by manual goniometry. | Day 90 |
| Functional gain as measured by the DASH self questionnaire | | Day 1 |
| Functional gain as measured by the DASH self questionnaire | | Day 5 |
| Functional gain as measured by the DASH self questionnaire | | Day 12 |
| Functional gain as measured by the DASH self questionnaire | | Day 19 |
| Functional gain as measured by the DASH self questionnaire | | Day 26 |
| Functional gain as measured by the DASH self questionnaire | | Day 90 |
| FI2S score | | Day 1 |
| FI2S score | | Day 5 |
| FI2S score | | Day 12 |
| FI2S score | | Day 19 |
| FI2S score | | Day 26 |
| SF36 self questionnaire | | Day 1 |
| SF36 self questionnaire | | Day 26 |
| SF36 self questionnaire | | Day 90 |
Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
comparison of physical therapy strategies
|
NCT05485064
|
Moderate Sedation Combined With Acupuncture Anesthesia in Gastroscopy and Colonoscopy on Screening Research
|
The purpose of this study is mainly about the feasibility and rationality of moderate sedation combined with acupuncture anesthesia in the application of gastroscopy and colonoscopy ,Then we evaluate the effectiveness and advantages of the combination of acupuncture anesthesia and drug anesthesia.
|
With the increase of the proportion of the patients who crave for performing painless gastroscopy and colonoscopy in recent years, it is crucial to seek a more secure and effective method of anesthesia or sedation. At present, the universal anesthetic method on gastroscopy and colonoscopy in China is the general anesthesia without intubation which usually uses propofol and opioid analgesics,Although the satisfaction of patients is high, the incidence of anesthesia-related complications and drug-related adverse reactions is high .The incidence of adverse events during the gastroscopy and colonoscopy is high, and the medical expense of anesthesia is high. At present, more than 2/3 of the patients undergo painless gastroscopy or colonoscopy are middle-aged and elderly patients, so the overdose which prolongs the recovery time、discharge time of patients and reduces the recovery quality of patients is common. The moderate sedation, which fundmentally does not affect hemodynamics、autonomous respiration and protective reflexes, is incomparable to general anesthesia . And acupuncture anesthesia also acts as a safe anesthetic method can provide safer analgesic effect.Theoretically，the combination of both of them is a relatively perfect and safe painless method.
|
Moderate Sedation Combined With Acupuncture Anesthesia in Gastroscopy and Colonoscopy on Screening Research
|
Gastrointestinal Endoscopy
|
* Drug: fentanyl
* Procedure: eletroacupuncture(transcutaneous electrical acupuncture point stimulation )
* Drug: placebo needle
* Drug: remimazolam
|
Inclusion Criteria:~Outpatients~Patients with ASA grade I-III~A sufficient level of education to understand study procedures and can communicate with investigators.~Exclusion Criteria:~Patients with serious systemic diseases such as severe cardiopulmonary disease or hepatic diseases or renal diseases.~Patients under the age of 18.~Patients who did not sign the informed consent form.~Patients who have a history of alcohol abuse or drug abuse.~People who are allergic to anesthetic related ingredients, such as soybeans, eggs and so on.~Patients with extreme fear or anxiety about acupuncture.~Patients with relative contraindications of gastrointestinal endoscopy.~-
|
18 Years
|
100 Years
|
All
|
Accepts Healthy Volunteers
|
Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double
|
| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| patient satisfaction with sedation instrument，PSSI | The investigator 2 needs to use VAS scores to evaluate satisfaction about sedation feeling when they accepted gastroscopy and colonoscopy .The score ranges from 0 to10 and need patients evaluate it by themself when the gastroscopy or colonoscopy were finished.The score from 0 （extremely dissatisfied）to 10（extremely satisfied）. | During gastroscopy and colonoscopy |
| clinical satisfaction with sedation instrument，CSSI | The investigator 2 needs to use VAS scores to evaluate satisfaction about doctors when they carry out the operation.The score from 0 （extremely dissatisfied）to 10（extremely satisfied）. | During gastroscopy and colonoscopy |
| patient's pain score | The investigator 2 needs to use VAS scores to evaluate patients' pain score .The score from 0 （extremely dissatisfied）to 10（extremely satisfied）. | During gastroscopy and colonoscopy |
|
| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| the extent of cardia exposure | The investigator 2 needs to record the extent of cardia exposure to evaluate these interventions'effect on gastroscopy ，the investigator 2 use the table of the extent of preventriculus exposure（score from 1 to 4，1=the extent of exposure lower than 25%；2=the extent of exposure between 25% and 50%；3=the extent of exposure between 50%and 75%；4=the extent of exposure between 75%and 100%） | During gastroscopy and colonoscopy |
| adverse reactions | The investigator 2 needs to record the adverse reactions such as nausea、emesis, salivation, restlessness, and breath holding to analyze efficacy of relate treatment. | During gastroscopy and colonoscopy |
| patient's recovery time | The investigator 2 needs to record to evaluate patient's recovery quality about patients | The end of gastroscopy and colonoscopy |
| patient's departure time | The investigator 2 needs to record patient's departure time to evaluate recovery quality about patients | The end of gastroscopy and colonoscopy |
| time to resume normal operation | The investigator 2 needs to record the time to resume normal operation about patient | The end of gastroscopy and colonoscopy |
| operation time about gastrointestinal endoscopy | The investigator 2 needs to record operation time about gastrointestinal endoscopy. | During gastroscopy and colonoscopy |
| heart rate | The investigator 2 needs to record heart rate（for example 60 times/min）before gastrointestinal endoscopy 、during gastrointestinal endoscopy and the end of gastrointestinal endoscopy respectively.（tachycardia：heart rate is more than 100 times/min；bradycardia：heart rate is less than 60 times/min） | before gastrointestinal endoscopy、during gastrointestinal endoscopy and the end of gastrointestinal endoscopy |
| pulse oximetry | The investigator 2 needs to record pulse oximetry (for example 97% )before gastrointestinal endoscopy 、during gastrointestinal endoscopy and the end of gastrointestinal endoscopy respectively.（hypoxemia：pulse oximetry is lower than 90%） | before gastrointestinal endoscopy、during gastrointestinal endoscopy and the end of gastrointestinal endoscopy |
| systolic pressure 、diastolic pressure | The investigator 2 needs to record systolic pressure 、diastolic pressure(for example 120/75mmHg ) before gastrointestinal endoscopy 、during gastrointestinal endoscopy and the end of gastrointestinal endoscopy respectively.（hypertension：systolic pressure ≥140mmHg or diastolic pressure ≥90mmHg；hypotension：systolic pressure ≤90mmHg or diastolic pressure ≤60mmHg） | before gastrointestinal endoscopy、during gastrointestinal endoscopy and the end of gastrointestinal endoscopy |
| respiratory rate | The investigator 2 needs to record respiratory rate(for example 15 times/min)before gastrointestinal endoscopy 、during gastrointestinal endoscopy and the end of gastrointestinal endoscopy respectively.（tachypnea：respiratory rate is more than 20 times/min；bradypnea：respiratory rate is less than 12 times/min） | before gastrointestinal endoscopy、during gastrointestinal endoscopy and the end of gastrointestinal endoscopy |
|
eletroacupuncture, moderate sedation, remimazolam, transcutaneous electrical acupuncture point stimulation
|
Anesthetics, General, Fentanyl, Analgesics, Opioid, Narcotics, Central Nervous System Depressants, Physiological Effects of Drugs, Analgesics, Sensory System Agents, Peripheral Nervous System Agents, Adjuvants, Anesthesia, Anesthetics, Intravenous, Anesthetics
|
| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: electroacupuncture(transcutaneous electrical acupuncture point stimulation )and remimazolam<br>The investigator 1 combine electroacupuncture(transcutaneous acupoint electrical stimulation ) with remimazolam to sedate patients moderately to finish gastroscopy and colonoscopy. | Procedure: eletroacupuncture(transcutaneous electrical acupuncture point stimulation )<br>* The investigator 1 use electroacupunture(transcutaneous electrical acupuncture point stimulation )to coordinate with remimazolam<br>Drug: remimazolam<br>* The investigator 1 use remimazolam to sedate patients coordinate with eletroacupuncture(transcutaneous electrical acupuncture point stimulation )or placebo needle<br>|
| Experimental: placebo needle and remimazolam<br>The investigator 1 combine placebo needle with remimazolam to sedate patients moderately to finish gastroscopy and colonoscopy. | Drug: placebo needle<br>* The investigator 1 use placebo needle to sedate patients coordinate with remimazolam<br>Drug: remimazolam<br>* The investigator 1 use remimazolam to sedate patients coordinate with eletroacupuncture(transcutaneous electrical acupuncture point stimulation )or placebo needle<br>|
| Experimental: fentanyl and remimazolam<br>The investigator 1 combine fentanyl with remimazolam to sedate patients moderately to finish gastroscopy and colonoscopy. | Drug: fentanyl<br>* The investigator 1 use fentanyl to sedate patients coordinate with remimazolam<br>Drug: remimazolam<br>* The investigator 1 use remimazolam to sedate patients coordinate with eletroacupuncture(transcutaneous electrical acupuncture point stimulation )or placebo needle<br>|
|
Moderate Sedation Combined With Acupuncture Anesthesia in Gastroscopy and Colonoscopy on Screening Research
Study Overview
=================
Brief Summary
-----------------
The purpose of this study is mainly about the feasibility and rationality of moderate sedation combined with acupuncture anesthesia in the application of gastroscopy and colonoscopy ,Then we evaluate the effectiveness and advantages of the combination of acupuncture anesthesia and drug anesthesia.
Detailed Description
-----------------
With the increase of the proportion of the patients who crave for performing painless gastroscopy and colonoscopy in recent years, it is crucial to seek a more secure and effective method of anesthesia or sedation. At present, the universal anesthetic method on gastroscopy and colonoscopy in China is the general anesthesia without intubation which usually uses propofol and opioid analgesics,Although the satisfaction of patients is high, the incidence of anesthesia-related complications and drug-related adverse reactions is high .The incidence of adverse events during the gastroscopy and colonoscopy is high, and the medical expense of anesthesia is high. At present, more than 2/3 of the patients undergo painless gastroscopy or colonoscopy are middle-aged and elderly patients, so the overdose which prolongs the recovery time、discharge time of patients and reduces the recovery quality of patients is common. The moderate sedation, which fundmentally does not affect hemodynamics、autonomous respiration and protective reflexes, is incomparable to general anesthesia . And acupuncture anesthesia also acts as a safe anesthetic method can provide safer analgesic effect.Theoretically，the combination of both of them is a relatively perfect and safe painless method.
Official Title
-----------------
Moderate Sedation Combined With Acupuncture Anesthesia in Gastroscopy and Colonoscopy on Screening Research
Conditions
-----------------
Gastrointestinal Endoscopy
Intervention / Treatment
-----------------
* Drug: fentanyl
* Procedure: eletroacupuncture(transcutaneous electrical acupuncture point stimulation )
* Drug: placebo needle
* Drug: remimazolam
Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Outpatients Patients with ASA grade I-III A sufficient level of education to understand study procedures and can communicate with investigators. Exclusion Criteria: Patients with serious systemic diseases such as severe cardiopulmonary disease or hepatic diseases or renal diseases. Patients under the age of 18. Patients who did not sign the informed consent form. Patients who have a history of alcohol abuse or drug abuse. People who are allergic to anesthetic related ingredients, such as soybeans, eggs and so on. Patients with extreme fear or anxiety about acupuncture. Patients with relative contraindications of gastrointestinal endoscopy. -
Ages Eligible for Study
-----------------
Minimum Age: 18 Years
Maximum Age: 100 Years
Sexes Eligible for Study
-----------------
All
Accepts Healthy Volunteers
-----------------
Accepts Healthy Volunteers
Study Plan
=================
How is the study designed?
-----------------
Design Details
Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double
Arms and Interventions
| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: electroacupuncture(transcutaneous electrical acupuncture point stimulation )and remimazolam<br>The investigator 1 combine electroacupuncture(transcutaneous acupoint electrical stimulation ) with remimazolam to sedate patients moderately to finish gastroscopy and colonoscopy. | Procedure: eletroacupuncture(transcutaneous electrical acupuncture point stimulation )<br>* The investigator 1 use electroacupunture(transcutaneous electrical acupuncture point stimulation )to coordinate with remimazolam<br>Drug: remimazolam<br>* The investigator 1 use remimazolam to sedate patients coordinate with eletroacupuncture(transcutaneous electrical acupuncture point stimulation )or placebo needle<br>|
| Experimental: placebo needle and remimazolam<br>The investigator 1 combine placebo needle with remimazolam to sedate patients moderately to finish gastroscopy and colonoscopy. | Drug: placebo needle<br>* The investigator 1 use placebo needle to sedate patients coordinate with remimazolam<br>Drug: remimazolam<br>* The investigator 1 use remimazolam to sedate patients coordinate with eletroacupuncture(transcutaneous electrical acupuncture point stimulation )or placebo needle<br>|
| Experimental: fentanyl and remimazolam<br>The investigator 1 combine fentanyl with remimazolam to sedate patients moderately to finish gastroscopy and colonoscopy. | Drug: fentanyl<br>* The investigator 1 use fentanyl to sedate patients coordinate with remimazolam<br>Drug: remimazolam<br>* The investigator 1 use remimazolam to sedate patients coordinate with eletroacupuncture(transcutaneous electrical acupuncture point stimulation )or placebo needle<br>|
What is the study measuring?
-----------------
Primary Outcome Measures
| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| patient satisfaction with sedation instrument，PSSI | The investigator 2 needs to use VAS scores to evaluate satisfaction about sedation feeling when they accepted gastroscopy and colonoscopy .The score ranges from 0 to10 and need patients evaluate it by themself when the gastroscopy or colonoscopy were finished.The score from 0 （extremely dissatisfied）to 10（extremely satisfied）. | During gastroscopy and colonoscopy |
| clinical satisfaction with sedation instrument，CSSI | The investigator 2 needs to use VAS scores to evaluate satisfaction about doctors when they carry out the operation.The score from 0 （extremely dissatisfied）to 10（extremely satisfied）. | During gastroscopy and colonoscopy |
| patient's pain score | The investigator 2 needs to use VAS scores to evaluate patients' pain score .The score from 0 （extremely dissatisfied）to 10（extremely satisfied）. | During gastroscopy and colonoscopy |
Secondary Outcome Measures
| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| the extent of cardia exposure | The investigator 2 needs to record the extent of cardia exposure to evaluate these interventions'effect on gastroscopy ，the investigator 2 use the table of the extent of preventriculus exposure（score from 1 to 4，1=the extent of exposure lower than 25%；2=the extent of exposure between 25% and 50%；3=the extent of exposure between 50%and 75%；4=the extent of exposure between 75%and 100%） | During gastroscopy and colonoscopy |
| adverse reactions | The investigator 2 needs to record the adverse reactions such as nausea、emesis, salivation, restlessness, and breath holding to analyze efficacy of relate treatment. | During gastroscopy and colonoscopy |
| patient's recovery time | The investigator 2 needs to record to evaluate patient's recovery quality about patients | The end of gastroscopy and colonoscopy |
| patient's departure time | The investigator 2 needs to record patient's departure time to evaluate recovery quality about patients | The end of gastroscopy and colonoscopy |
| time to resume normal operation | The investigator 2 needs to record the time to resume normal operation about patient | The end of gastroscopy and colonoscopy |
| operation time about gastrointestinal endoscopy | The investigator 2 needs to record operation time about gastrointestinal endoscopy. | During gastroscopy and colonoscopy |
| heart rate | The investigator 2 needs to record heart rate（for example 60 times/min）before gastrointestinal endoscopy 、during gastrointestinal endoscopy and the end of gastrointestinal endoscopy respectively.（tachycardia：heart rate is more than 100 times/min；bradycardia：heart rate is less than 60 times/min） | before gastrointestinal endoscopy、during gastrointestinal endoscopy and the end of gastrointestinal endoscopy |
| pulse oximetry | The investigator 2 needs to record pulse oximetry (for example 97% )before gastrointestinal endoscopy 、during gastrointestinal endoscopy and the end of gastrointestinal endoscopy respectively.（hypoxemia：pulse oximetry is lower than 90%） | before gastrointestinal endoscopy、during gastrointestinal endoscopy and the end of gastrointestinal endoscopy |
| systolic pressure 、diastolic pressure | The investigator 2 needs to record systolic pressure 、diastolic pressure(for example 120/75mmHg ) before gastrointestinal endoscopy 、during gastrointestinal endoscopy and the end of gastrointestinal endoscopy respectively.（hypertension：systolic pressure ≥140mmHg or diastolic pressure ≥90mmHg；hypotension：systolic pressure ≤90mmHg or diastolic pressure ≤60mmHg） | before gastrointestinal endoscopy、during gastrointestinal endoscopy and the end of gastrointestinal endoscopy |
| respiratory rate | The investigator 2 needs to record respiratory rate(for example 15 times/min)before gastrointestinal endoscopy 、during gastrointestinal endoscopy and the end of gastrointestinal endoscopy respectively.（tachypnea：respiratory rate is more than 20 times/min；bradypnea：respiratory rate is less than 12 times/min） | before gastrointestinal endoscopy、during gastrointestinal endoscopy and the end of gastrointestinal endoscopy |
Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
eletroacupuncture, moderate sedation, remimazolam, transcutaneous electrical acupuncture point stimulation
|
NCT05179044
|
Utilization of a Knee Brace With Extension Swing
|
The purpose of this research is to help determine if use of the Guardian brace during prehab and post-op rehab after TKA can help improve functional outcomes and reduce the incidence of post-operative flexion contractures which reduce knee range of motion after surgery.
|
This will be a prospective study with consecutive TKA patients with pre-operative flexion contractures of 5 degrees or greater. Patients will be randomized to one of two groups: 1) use of the Guardian knee brace peri-operatively, and 2) no Guardian brace use.~Pre-operative range of motion (ROM) and leg strength will be tested (4 to 6 weeks pre-operatively and the week before surgery) as well as during the recovery period at 6 weeks and 3 months post-operatively. The study will attempt to quantify quadriceps and hamstring strength using a Medical Engineering TKR2000, which can digitally measure quadriceps and hamstring strength with accuracy equivalent to a Biodex Dynanometer. The TKR2000 also accurately measures terminal flexion and extension of the lower extremity. Pre- and post-operative patient reported outcome measures (KOOS JR. score) will also be collected.
|
Utilization of a Knee Brace With Extension Swing Assist Peri-operatively to Prevent Flexion Contractures and Improves Quadriceps Strength After Total Knee Arthroplasty (TKA)
|
Osteo Arthritis Knee
|
* Device: Guardian Sport Rehabilitator knee brace
|
Inclusion Criteria:~Patients ≥18 years of age~Surgical candidates undergoing primary TKA~Surgical candidates with pre-operative flexion contracture of 10 degrees or greater~Patient is willing to cooperate and follow study protocol and visit schedule~Exclusion Criteria:~Patient is pregnant~Patient is unable to provide written consent~Patient has psychiatric disorder that precludes safe study participation~Patients with a prior history of surgery in the affected knee~Vulnerable patient populations
|
18 Years
|
90 Years
|
All
|
No
|
Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
|
| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change in extensor leg strength | Measured by the TKR2000 which is a patient controlled mechanical over-pressure stretching and strengthening device designed and developed to diminish issues with muscle guarding. The device uses a lever arm with a comfortable foam roller padding placed against the patients' ankle and is moved by an electric actuator. At each scheduled visit, subjects will be examined to determine extensor leg strength on the affected leg. | Visit 1( 1 week pre surgery), Visit 2 (2 weeks post surgery) , Visit 3 (6 weeks post surgery), Visit 4 ( 12 weeks post surgery) |
| Change in flexor leg strength | Measured by the TKR2000 which is a patient controlled mechanical over-pressure stretching and strengthening device designed and developed to diminish issues with muscle guarding. The device uses a lever arm with a comfortable foam roller padding placed against the patients' ankle and is moved by an electric actuator. At each scheduled visit, subjects will be examined to determine flexor leg strength on the affected leg. | Visit 1( 1 week pre surgery), Visit 2 (2 weeks post surgery) , Visit 3 (6 weeks post surgery), Visit 4 ( 12 weeks post surgery) |
| Change in range of motion following knee replacement surgery | At each scheduled visit, subjects will be examined to determine their range of motion (ROM) in the affected leg to see the range of motion change from pre-op to post- op. | Visit 1( 1 week pre surgery), Visit 2 (2 weeks post surgery) , Visit 3 (6 weeks post surgery), Visit 4 ( 12 weeks post surgery) |
|
Osteoarthritis, Osteoarthritis, Knee, Arthritis, Joint Diseases, Musculoskeletal Diseases, Rheumatic Diseases
|
| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Guardian knee brace group<br>Patients undergoing elective Total knee arthroplasty (TKA) by surgeons from NYU Langone with the presence of a pre-operative knee flexion contracture greater than 5 degrees and willingness to participate in our institution's outpatient rehabilitation and physical therapy. Those randomized to this group will be fitted with a Guardian Rehabilitator Brace. | Device: Guardian Sport Rehabilitator knee brace<br>* The Guardian Sport Rehabilitator knee brace has pneumatic condyles that can be used to support and control the knee joint as well as an extension swing assist design which automatically assists in extending the knee when the patient themselves may guard against it. The Guardian Rehabilitator Knee Brace is considered by the FDA as a Class I external medical device. It is used on label and therefore exempt from IDE requirements.The Guardian Brace FDA registration to manufacturer external limb devices is attached for reference.<br>|
| No Intervention: No Guardian brace used group<br>Patients undergoing elective Total knee arthroplasty (TKA) by surgeons from NYU Langone with the presence of a pre-operative knee flexion contracture greater than 5 degrees and willingness to participate in our institution's outpatient rehabilitation and physical therapy as part of standard of care. | |
|
Utilization of a Knee Brace With Extension Swing
Study Overview
=================
Brief Summary
-----------------
The purpose of this research is to help determine if use of the Guardian brace during prehab and post-op rehab after TKA can help improve functional outcomes and reduce the incidence of post-operative flexion contractures which reduce knee range of motion after surgery.
Detailed Description
-----------------
This will be a prospective study with consecutive TKA patients with pre-operative flexion contractures of 5 degrees or greater. Patients will be randomized to one of two groups: 1) use of the Guardian knee brace peri-operatively, and 2) no Guardian brace use. Pre-operative range of motion (ROM) and leg strength will be tested (4 to 6 weeks pre-operatively and the week before surgery) as well as during the recovery period at 6 weeks and 3 months post-operatively. The study will attempt to quantify quadriceps and hamstring strength using a Medical Engineering TKR2000, which can digitally measure quadriceps and hamstring strength with accuracy equivalent to a Biodex Dynanometer. The TKR2000 also accurately measures terminal flexion and extension of the lower extremity. Pre- and post-operative patient reported outcome measures (KOOS JR. score) will also be collected.
Official Title
-----------------
Utilization of a Knee Brace With Extension Swing Assist Peri-operatively to Prevent Flexion Contractures and Improves Quadriceps Strength After Total Knee Arthroplasty (TKA)
Conditions
-----------------
Osteo Arthritis Knee
Intervention / Treatment
-----------------
* Device: Guardian Sport Rehabilitator knee brace
Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Patients ≥18 years of age Surgical candidates undergoing primary TKA Surgical candidates with pre-operative flexion contracture of 10 degrees or greater Patient is willing to cooperate and follow study protocol and visit schedule Exclusion Criteria: Patient is pregnant Patient is unable to provide written consent Patient has psychiatric disorder that precludes safe study participation Patients with a prior history of surgery in the affected knee Vulnerable patient populations
Ages Eligible for Study
-----------------
Minimum Age: 18 Years
Maximum Age: 90 Years
Sexes Eligible for Study
-----------------
All
Accepts Healthy Volunteers
-----------------
No
Study Plan
=================
How is the study designed?
-----------------
Design Details
Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Arms and Interventions
| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Guardian knee brace group<br>Patients undergoing elective Total knee arthroplasty (TKA) by surgeons from NYU Langone with the presence of a pre-operative knee flexion contracture greater than 5 degrees and willingness to participate in our institution's outpatient rehabilitation and physical therapy. Those randomized to this group will be fitted with a Guardian Rehabilitator Brace. | Device: Guardian Sport Rehabilitator knee brace<br>* The Guardian Sport Rehabilitator knee brace has pneumatic condyles that can be used to support and control the knee joint as well as an extension swing assist design which automatically assists in extending the knee when the patient themselves may guard against it. The Guardian Rehabilitator Knee Brace is considered by the FDA as a Class I external medical device. It is used on label and therefore exempt from IDE requirements.The Guardian Brace FDA registration to manufacturer external limb devices is attached for reference.<br>|
| No Intervention: No Guardian brace used group<br>Patients undergoing elective Total knee arthroplasty (TKA) by surgeons from NYU Langone with the presence of a pre-operative knee flexion contracture greater than 5 degrees and willingness to participate in our institution's outpatient rehabilitation and physical therapy as part of standard of care. | |
What is the study measuring?
-----------------
Primary Outcome Measures
| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change in extensor leg strength | Measured by the TKR2000 which is a patient controlled mechanical over-pressure stretching and strengthening device designed and developed to diminish issues with muscle guarding. The device uses a lever arm with a comfortable foam roller padding placed against the patients' ankle and is moved by an electric actuator. At each scheduled visit, subjects will be examined to determine extensor leg strength on the affected leg. | Visit 1( 1 week pre surgery), Visit 2 (2 weeks post surgery) , Visit 3 (6 weeks post surgery), Visit 4 ( 12 weeks post surgery) |
| Change in flexor leg strength | Measured by the TKR2000 which is a patient controlled mechanical over-pressure stretching and strengthening device designed and developed to diminish issues with muscle guarding. The device uses a lever arm with a comfortable foam roller padding placed against the patients' ankle and is moved by an electric actuator. At each scheduled visit, subjects will be examined to determine flexor leg strength on the affected leg. | Visit 1( 1 week pre surgery), Visit 2 (2 weeks post surgery) , Visit 3 (6 weeks post surgery), Visit 4 ( 12 weeks post surgery) |
| Change in range of motion following knee replacement surgery | At each scheduled visit, subjects will be examined to determine their range of motion (ROM) in the affected leg to see the range of motion change from pre-op to post- op. | Visit 1( 1 week pre surgery), Visit 2 (2 weeks post surgery) , Visit 3 (6 weeks post surgery), Visit 4 ( 12 weeks post surgery) |
|
||
NCT02640469
|
Alcohol Versus Chlorhexidine With and Without Water
|
Currently at NYU institutions, providine-iodine and chlorhexidine medicated soaps are available as hand disinfection options. The purpose of this study is to determine the relative efficacy of traditional hand scrubs with chlorhexidine with or without rinsing with water after scrubbing is complete versus dry hand rubs with alcohol.
|
No current recommendations exist advocating the use of Providine-iodine or Chlorhexidine. Providine-iodine is safe and effective at reducing skin colonization with gram positive and negative bacteria, mycobacterium tuberculosis, fungi and viruses. Chlorhexidine similarly disrupts cellular membranes. It is bacteriocidal and bacteriostatic and has immediate and more lasting effect than iodine because it can bind to the stratum corneum of the skin and is effective against gram positive and negative organisms, lipophilic viruses and yeasts.~All subjects who are employees of the NYU Hospital for Joint Diseases and have experience with surgical hand disinfection will be asked to enroll. Subjects will be randomized into one of three study arms using an online randomizer: (1) the standard chlorhexidine with water rinse, (2) chlorhexidine without water rinse(experimental), and (3) standard chlorhexidine followed by sterillium hand rub. After hand disinfection protocol has been completed, each subject will have each hand cultured three times using a cotton swab culture stick and sent to the microbiology lab for processing
|
Efficacy of the Use of Alcohol-bases Solutions Versus Chlorhexidine With or Without Water for Hand Sanitation Prior to Surgical Procedure
|
Infection
|
* Other: Chlorhexidine with water rinse
* Other: Chlorhexidine without water rinse
* Other: Chlorhexidine + sterillium hand rub
|
Inclusion Criteria:~Orthopedic resident or surgical employee of NY U~Over 21 years of age~Procedural knowledge of correct aseptic scrub technique~Exclusion Criteria:~No surgical experience~Under 21 years of age~Refusal to consent
|
18 Years
| null |
All
|
Accepts Healthy Volunteers
|
Primary Purpose: Prevention
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double
|
| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Number of positive cultures in each group | Evaluated using a Students T-test and analysis of variance (ANOVA). | 1 day |
|
chlorhexidine, sterility, sterile hands
|
Chlorhexidine, Chlorhexidine gluconate, Anti-Infective Agents, Local, Anti-Infective Agents, Disinfectants, Dermatologic Agents
|
| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: Chlorhexidine with water rinse<br>This is a traditional method of disinfection used at NYU Hospital for Joint Disease. Following disinfection protocol, each subject will have hand cultured three times using a cotton swab culture and sent to microbiology for processing. | Other: Chlorhexidine with water rinse<br>* This procedure will be followed for both the right and left hands and arms:~scrub each side of finger, in between fingers and back and front of hands for 2 minutes, followed by scrubbing of arms, keeping hands higher than arms at all times, wash each side of the arms from wrist to elbow for 1 minute<br>|
| Experimental: Chlorhexidine without water rinse<br>This is an experimental method of disinfection. Following disinfection protocol, each subject will have hand cultured three times using a cotton swab culture and sent to microbiology for processing. | Other: Chlorhexidine without water rinse<br>* Scrub each side of finger, in between fingers and back and front of hands for 2 minutes, proceed to scrub the arms, keeping the hand higher than the arm at all times, wash each side of the arms from wrist to elbow for 1 minute, and repeat the process on the other arm.<br>|
| Active Comparator: Chlorhexidine + sterillium hand rub<br>This is a standard method of disinfection used at NYU Hospital for Joint Disease. Following disinfection protocol, each subject will have hand cultured three times using a cotton swab culture and sent to microbiology for processing. | Other: Chlorhexidine + sterillium hand rub<br>* Scrub each side of finger, in between fingers and back and front of hands for 2 minutes, Scrub each side of finger, in between fingers and back and front of hands for 2 minutes, proceed to scrub the arms, keeping the hand higher than the arm at all times, wash each side of the arms from wrist to elbow for 1 minute, and repeat the process on the other arm. Rinse hands and arms by passing through water in one direction, dry hands, and rub 5 mL of alcohol into the palm of the hands, forearms and elbows. Ensure that the whole skin area on both arms is covered.<br>|
|
Alcohol Versus Chlorhexidine With and Without Water
Study Overview
=================
Brief Summary
-----------------
Currently at NYU institutions, providine-iodine and chlorhexidine medicated soaps are available as hand disinfection options. The purpose of this study is to determine the relative efficacy of traditional hand scrubs with chlorhexidine with or without rinsing with water after scrubbing is complete versus dry hand rubs with alcohol.
Detailed Description
-----------------
No current recommendations exist advocating the use of Providine-iodine or Chlorhexidine. Providine-iodine is safe and effective at reducing skin colonization with gram positive and negative bacteria, mycobacterium tuberculosis, fungi and viruses. Chlorhexidine similarly disrupts cellular membranes. It is bacteriocidal and bacteriostatic and has immediate and more lasting effect than iodine because it can bind to the stratum corneum of the skin and is effective against gram positive and negative organisms, lipophilic viruses and yeasts. All subjects who are employees of the NYU Hospital for Joint Diseases and have experience with surgical hand disinfection will be asked to enroll. Subjects will be randomized into one of three study arms using an online randomizer: (1) the standard chlorhexidine with water rinse, (2) chlorhexidine without water rinse(experimental), and (3) standard chlorhexidine followed by sterillium hand rub. After hand disinfection protocol has been completed, each subject will have each hand cultured three times using a cotton swab culture stick and sent to the microbiology lab for processing
Official Title
-----------------
Efficacy of the Use of Alcohol-bases Solutions Versus Chlorhexidine With or Without Water for Hand Sanitation Prior to Surgical Procedure
Conditions
-----------------
Infection
Intervention / Treatment
-----------------
* Other: Chlorhexidine with water rinse
* Other: Chlorhexidine without water rinse
* Other: Chlorhexidine + sterillium hand rub
Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Orthopedic resident or surgical employee of NY U Over 21 years of age Procedural knowledge of correct aseptic scrub technique Exclusion Criteria: No surgical experience Under 21 years of age Refusal to consent
Ages Eligible for Study
-----------------
Minimum Age: 18 Years
Sexes Eligible for Study
-----------------
All
Accepts Healthy Volunteers
-----------------
Accepts Healthy Volunteers
Study Plan
=================
How is the study designed?
-----------------
Design Details
Primary Purpose: Prevention
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double
Arms and Interventions
| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: Chlorhexidine with water rinse<br>This is a traditional method of disinfection used at NYU Hospital for Joint Disease. Following disinfection protocol, each subject will have hand cultured three times using a cotton swab culture and sent to microbiology for processing. | Other: Chlorhexidine with water rinse<br>* This procedure will be followed for both the right and left hands and arms: scrub each side of finger, in between fingers and back and front of hands for 2 minutes, followed by scrubbing of arms, keeping hands higher than arms at all times, wash each side of the arms from wrist to elbow for 1 minute<br>|
| Experimental: Chlorhexidine without water rinse<br>This is an experimental method of disinfection. Following disinfection protocol, each subject will have hand cultured three times using a cotton swab culture and sent to microbiology for processing. | Other: Chlorhexidine without water rinse<br>* Scrub each side of finger, in between fingers and back and front of hands for 2 minutes, proceed to scrub the arms, keeping the hand higher than the arm at all times, wash each side of the arms from wrist to elbow for 1 minute, and repeat the process on the other arm.<br>|
| Active Comparator: Chlorhexidine + sterillium hand rub<br>This is a standard method of disinfection used at NYU Hospital for Joint Disease. Following disinfection protocol, each subject will have hand cultured three times using a cotton swab culture and sent to microbiology for processing. | Other: Chlorhexidine + sterillium hand rub<br>* Scrub each side of finger, in between fingers and back and front of hands for 2 minutes, Scrub each side of finger, in between fingers and back and front of hands for 2 minutes, proceed to scrub the arms, keeping the hand higher than the arm at all times, wash each side of the arms from wrist to elbow for 1 minute, and repeat the process on the other arm. Rinse hands and arms by passing through water in one direction, dry hands, and rub 5 mL of alcohol into the palm of the hands, forearms and elbows. Ensure that the whole skin area on both arms is covered.<br>|
What is the study measuring?
-----------------
Primary Outcome Measures
| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Number of positive cultures in each group | Evaluated using a Students T-test and analysis of variance (ANOVA). | 1 day |
Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
chlorhexidine, sterility, sterile hands
|
|
NCT04236583
|
Improving the Hospital-to-Home Transition Through Post-Discharge Virtual Visits in Primary Care
|
The purpose of this study is to test a new process for having a virtual visit with a primary care doctor after discharge from the hospital, instead of an in-person visit.
|
The goal of this project is to fully develop the protocol for identifying patients who would benefit from a virtual visit and develop the protocol for implementing the virtual visit. The value of this project is that the results will provide ample preliminary data for a future randomized controlled trial to determine the effectiveness of the intervention. This project will have an intervention group only. The hypothesis is that the intervention can be implemented in a way that is feasible and acceptable to providers and patients.
|
Improving the Hospital-to-Home Transition Through Post-Discharge Virtual Visits in Primary Care
|
Telehealth
|
* Other: Telehealth
|
Inclusion Criteria:~Medical inpatients, age >=18, with an existing WCIMA attending as his or her PCP~Patients with disposition to home~Medically appropriate for a video visit (as determined by inpatient attending)~Patients or caregivers must be able to enroll in MyChart before discharge, must be capable of using the Weill Cornell Connect app to do a video visit at home using broadband access or the equivalent (must own a device compatible with the app, e.g.~smartphone or tablet)~English speaking~Cognitively able to participate or Caregiver must be able to participate
|
18 Years
| null |
All
|
No
|
Primary Purpose: Other
Intervention Model: Single Group Assignment
Masking: None (Open Label)
|
| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Proportion of patients meeting inclusion criteria over the study period out of all patients being discharged over the same time period | | 6 months post-intervention |
| Proportion of patients who consent to participate out of all those found to be eligible | | 6 months post-intervention |
| Proportion of patients who successfully schedule video visits out of all of those who consent | | 6 months post-intervention |
| Proportion of patients who successfully complete video visit out of all of those who scheduled | | 6 months post-intervention |
|
| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Patient satisfaction with the video visit | Based on a previously validated instrument (Parmanto et. al, Int J Telerehab 2016 Spring; 8(1): 3-10). Measured through 5-point likert scale,free response, multiple choice, and yes/no questions. | Within one month post-intervention |
| Physician satisfaction with the video visit | Measured through multiple choice, yes/no, and free-response (only asked if specific responses are received) questions. | Within one month post-intervention |
| Number of in-person visits instead of or in addition to video visit | | 6 months post-intervention |
|
Video Visits, Virtual Visits, Telehealth
|
| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Telehealth<br>Eligible patients will be given the option to consent to having one virtual visit with their primary care physician within four weeks after discharge from the hospital. Usual follow-up care will occur during this visit. | Other: Telehealth<br>* Post-discharge virtual visit<br>* Other names: Video Visits;|
|
Improving the Hospital-to-Home Transition Through Post-Discharge Virtual Visits in Primary Care
Study Overview
=================
Brief Summary
-----------------
The purpose of this study is to test a new process for having a virtual visit with a primary care doctor after discharge from the hospital, instead of an in-person visit.
Detailed Description
-----------------
The goal of this project is to fully develop the protocol for identifying patients who would benefit from a virtual visit and develop the protocol for implementing the virtual visit. The value of this project is that the results will provide ample preliminary data for a future randomized controlled trial to determine the effectiveness of the intervention. This project will have an intervention group only. The hypothesis is that the intervention can be implemented in a way that is feasible and acceptable to providers and patients.
Official Title
-----------------
Improving the Hospital-to-Home Transition Through Post-Discharge Virtual Visits in Primary Care
Conditions
-----------------
Telehealth
Intervention / Treatment
-----------------
* Other: Telehealth
Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Medical inpatients, age >=18, with an existing WCIMA attending as his or her PCP Patients with disposition to home Medically appropriate for a video visit (as determined by inpatient attending) Patients or caregivers must be able to enroll in MyChart before discharge, must be capable of using the Weill Cornell Connect app to do a video visit at home using broadband access or the equivalent (must own a device compatible with the app, e.g. smartphone or tablet) English speaking Cognitively able to participate or Caregiver must be able to participate
Ages Eligible for Study
-----------------
Minimum Age: 18 Years
Sexes Eligible for Study
-----------------
All
Accepts Healthy Volunteers
-----------------
No
Study Plan
=================
How is the study designed?
-----------------
Design Details
Primary Purpose: Other
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Arms and Interventions
| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Telehealth<br>Eligible patients will be given the option to consent to having one virtual visit with their primary care physician within four weeks after discharge from the hospital. Usual follow-up care will occur during this visit. | Other: Telehealth<br>* Post-discharge virtual visit<br>* Other names: Video Visits;|
What is the study measuring?
-----------------
Primary Outcome Measures
| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Proportion of patients meeting inclusion criteria over the study period out of all patients being discharged over the same time period | | 6 months post-intervention |
| Proportion of patients who consent to participate out of all those found to be eligible | | 6 months post-intervention |
| Proportion of patients who successfully schedule video visits out of all of those who consent | | 6 months post-intervention |
| Proportion of patients who successfully complete video visit out of all of those who scheduled | | 6 months post-intervention |
Secondary Outcome Measures
| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Patient satisfaction with the video visit | Based on a previously validated instrument (Parmanto et. al, Int J Telerehab 2016 Spring; 8(1): 3-10). Measured through 5-point likert scale,free response, multiple choice, and yes/no questions. | Within one month post-intervention |
| Physician satisfaction with the video visit | Measured through multiple choice, yes/no, and free-response (only asked if specific responses are received) questions. | Within one month post-intervention |
| Number of in-person visits instead of or in addition to video visit | | 6 months post-intervention |
Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Video Visits, Virtual Visits, Telehealth
|
|
NCT04315792
|
Evaluate Efficacy and Safety of Endoxifen in Bipolar I Disorder Patients
|
The present study aims to evaluate the efficacy and safety of 8 mg endoxifen in the study population. As endoxifen represents a totally new class of drugs in the treatment of the bipolar disorder, it is essential to compare the drug against placebo to rule out the psychological influence upon study results. More so given the risks to patients and their communities from a medication whose efficacy has not been thoroughly evaluated against a placebo control. Thus, Endoxifen will be compared to placebo to demonstrate that the test product is active and to establish that the study is sufficiently sensitive to detect differences between the investigational products.
|
Protein Kinase C (PKC) plays a major role in the regulation of both pre and postsynaptic neurotransmission. Excessive activation of PKC results in symptoms related to bipolar disorder. PKC exists as a family of closely related subspecies, has a heterogeneous distribution in the brain (with particularly high levels in presynaptic nerve terminals), and plays a crucial role in the regulation of neuronal excitability, neurotransmitter release, regulation of synaptic plasticity and various forms of learning and memory. Research findings show that the PKC pathway can be used as a target for developing treatment strategies for bipolar disorder. Endoxifen exhibited activity in inhibiting the PKC activity.~In patients with acute bipolar mania, rapid reduction of symptoms is a key treatment goal; however, there is also a need for effective maintenance of effect treatment beyond the period of acute stabilization. The current study will evaluate the efficacy and safety of Endoxifen in Bipolar I Disorder patients against a control placebo arm.
|
A Double-blind, Oral, Multiple-dose, Parallel, Randomized Study to Evaluate Efficacy and Safety of Endoxifen in Bipolar I Disorder Patients
|
Bipolar I Disorder
|
* Drug: Endoxifen
* Drug: Placebo oral tablet
|
Inclusion Criteria:~Male and female patients, 18 to 65 (both inclusive) years of age willing to give written informed consent along with at least one first degree relative (the legally acceptable representative [LAR]) to participate in the study before initiating any study related procedures.~Patients must have a diagnosis of bipolar I disorder and currently display an acute manic episodes with or without mixed features according to DSM-5 criteria as judged by the Investigator.~Young Mania Rating Scale (YMRS) total score of > 20 and ≥4 on two of four core items (irritability, speech, content, disruptive/aggressive behavior) at screening and at randomization (baseline).~Score of >4 in Severity of illness criteria of Clinical Global Impressions- bipolar disorder (CGI-BP) Scale for overall illness at screening and at randomization (baseline).~Ready for voluntary hospitalization (along with the accompanying LAR if required and as advised by the Investigator) for the current manic episode 2 days prior to randomization up to 21 days of in-patient treatment period.~Last intake of the medication(s) for BPD should be 2-7 days prior to randomization depending upon the individual drug's plasma half-life.~Patient and / or LAR understand and agree to comply with all the study requirements.~Male patients of child begetting potential must be practicing adequate contraception.~Females of reproductive potential (which include girls who have entered puberty and all women who have a uterus and ovaries and have not completed menopause), must use anacceptable and effective method of avoiding pregnancy, starting at least four weeks before the first dose of study drug and continuing until at least one month after the last dose of study drug.~Subjects judged clinically not to be at serious suicide risk.~Exclusion Criteria:~Newly diagnosed patients and not having any suitable treatment exposure in the past for their bipolar mood disorder.~> 20% improvement in YMRS total scores between screening and randomization visits.~Patients who meet DSM-5 criteria for any psychiatric disorder other than Bipolar I Disorder with Acute Mania Episode with or without mixed features.~Patients with seizure disorder.~Obsessive compulsive disorder or any other co-morbid Axis I anxiety disorder~Patients with borderline or anti-social personality disorder of sufficient current severity to interfere with conduct of the study~Patients with classical premenopausal symptoms found at risk of developing intolerable hot flushes, irregular vaginal bleeding.~Use of the following medications:~Antihypertensive agents if stable dose has not been administered for at least 1 month before randomization~Antidepressants in the week (or a period of 5 half-lives of the drug) prior to randomization~Continuous daily or standing orders use of benzodiazepines during the month preceding screening (approximately 5 weeks prior to screening)~Potent cytochrome P450 (CYP) inducers and CYP2D6/CYP3A4 inhibitors 14 days prior to randomization~Depot antipsychotic medications within 1 dosing interval prior to randomization~Use of systemic estrogens 6 weeks prior to randomization~Patients currently on carbapenem agents~Any of the following laboratory abnormalities~Serum bilirubin ≥ 1.5 times ULN~Serum AST/ALT ≥ 2.5 times ULN~Serum TSH >10% above the ULN, regardless of treatment for hypothyroidism or hyperthyroidism~Serum triglyceride level > 2.5 times ULN~Patients with the following cardiac conditions are excluded:~Recent myocardial infarction (<12 months)~QTc prolongation (screening electrocardiogram with QTc >450 msec for men, QTc> 470 msec for women)~History of QTc prolongation or using concomitant medications (as judged by the Investigator) which prolong QTc interval~Sustained cardiac arrhythmia or history of sustained cardiac arrhythmia~De compensatory congestive heart failure~Complete left bundle branch block~First-degree heart block with PR interval > 0.22 seconds~Presence of a coagulation disorder; active or past history of venous thromboembolism including deep venous thrombosis or pulmonary embolism.~Current prolonged immobilization.~History or current presence of retinal pathology including retinal vein thrombosis~Increased risk of stroke as per the Investigator's discretion.~History of hypersensitivity or intolerance to tamoxifen or any other ingredients of the preparation.~Serious, unstable illnesses including hepatic, renal, gastroenterologic, respiratory, cardiovascular (including ischemic heart disease), endocrinologic, neurologic, immunologic, or hematologic disease as per history and medical examination.~Drug screen positive for any drug of abuse at screening (with the exception of benzodiazepines used in therapeutic dose for management of acute mania), active substance abuse in the past 2 months or history of substance dependence (excluding nicotine and caffeine) within 3 months of screening.~History of breast or uterine cancer, or abnormal uterine bleeding.~Current leukopenia or thrombocytopenia as judged by the Investigator in the best health interest of the subject.~Clinically significant suicidal or homicidal ideation.~Participation in a clinical trial of another investigational drug within 30 days prior to screening.
|
18 Years
|
65 Years
|
All
|
No
|
Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double
|
| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Evaluate the efficacy and establish superiority of endoxifen 8 mg against placebo in Bipolar I Disorder patients (Mean change in total YMRS score) | Mean change in total YMRS score at Day 21 against baseline (in-patient setup) | 3 weeks |
|
| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Evaluate the safety and tolerability of all the treatments among Bipolar I Disorder patients (treatment related adverse events) | All treatment related adverse events including abnormal laboratory parameters | 3 weeks |
|
Endoxifen, Bipolar I Disorder
|
| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Endoxifen Arm<br>Endoxifen enteric-coated tablet (8 mg). Patients will continue treatment with their initial randomized medication for 3 weeks | Drug: Endoxifen<br>* Administration of Endoxifen for 3 weeks<br>|
| Placebo Comparator: Placebo Arm<br>Placebo tablets of endoxifen. Patients will continue administration with their initial randomized medication for 3 weeks | Drug: Placebo oral tablet<br>* Administration of Placebo for 3 weeks<br>|
|
Evaluate Efficacy and Safety of Endoxifen in Bipolar I Disorder Patients
Study Overview
=================
Brief Summary
-----------------
The present study aims to evaluate the efficacy and safety of 8 mg endoxifen in the study population. As endoxifen represents a totally new class of drugs in the treatment of the bipolar disorder, it is essential to compare the drug against placebo to rule out the psychological influence upon study results. More so given the risks to patients and their communities from a medication whose efficacy has not been thoroughly evaluated against a placebo control. Thus, Endoxifen will be compared to placebo to demonstrate that the test product is active and to establish that the study is sufficiently sensitive to detect differences between the investigational products.
Detailed Description
-----------------
Protein Kinase C (PKC) plays a major role in the regulation of both pre and postsynaptic neurotransmission. Excessive activation of PKC results in symptoms related to bipolar disorder. PKC exists as a family of closely related subspecies, has a heterogeneous distribution in the brain (with particularly high levels in presynaptic nerve terminals), and plays a crucial role in the regulation of neuronal excitability, neurotransmitter release, regulation of synaptic plasticity and various forms of learning and memory. Research findings show that the PKC pathway can be used as a target for developing treatment strategies for bipolar disorder. Endoxifen exhibited activity in inhibiting the PKC activity. In patients with acute bipolar mania, rapid reduction of symptoms is a key treatment goal; however, there is also a need for effective maintenance of effect treatment beyond the period of acute stabilization. The current study will evaluate the efficacy and safety of Endoxifen in Bipolar I Disorder patients against a control placebo arm.
Official Title
-----------------
A Double-blind, Oral, Multiple-dose, Parallel, Randomized Study to Evaluate Efficacy and Safety of Endoxifen in Bipolar I Disorder Patients
Conditions
-----------------
Bipolar I Disorder
Intervention / Treatment
-----------------
* Drug: Endoxifen
* Drug: Placebo oral tablet
Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Male and female patients, 18 to 65 (both inclusive) years of age willing to give written informed consent along with at least one first degree relative (the legally acceptable representative [LAR]) to participate in the study before initiating any study related procedures. Patients must have a diagnosis of bipolar I disorder and currently display an acute manic episodes with or without mixed features according to DSM-5 criteria as judged by the Investigator. Young Mania Rating Scale (YMRS) total score of > 20 and ≥4 on two of four core items (irritability, speech, content, disruptive/aggressive behavior) at screening and at randomization (baseline). Score of >4 in Severity of illness criteria of Clinical Global Impressions- bipolar disorder (CGI-BP) Scale for overall illness at screening and at randomization (baseline). Ready for voluntary hospitalization (along with the accompanying LAR if required and as advised by the Investigator) for the current manic episode 2 days prior to randomization up to 21 days of in-patient treatment period. Last intake of the medication(s) for BPD should be 2-7 days prior to randomization depending upon the individual drug's plasma half-life. Patient and / or LAR understand and agree to comply with all the study requirements. Male patients of child begetting potential must be practicing adequate contraception. Females of reproductive potential (which include girls who have entered puberty and all women who have a uterus and ovaries and have not completed menopause), must use anacceptable and effective method of avoiding pregnancy, starting at least four weeks before the first dose of study drug and continuing until at least one month after the last dose of study drug. Subjects judged clinically not to be at serious suicide risk. Exclusion Criteria: Newly diagnosed patients and not having any suitable treatment exposure in the past for their bipolar mood disorder. > 20% improvement in YMRS total scores between screening and randomization visits. Patients who meet DSM-5 criteria for any psychiatric disorder other than Bipolar I Disorder with Acute Mania Episode with or without mixed features. Patients with seizure disorder. Obsessive compulsive disorder or any other co-morbid Axis I anxiety disorder Patients with borderline or anti-social personality disorder of sufficient current severity to interfere with conduct of the study Patients with classical premenopausal symptoms found at risk of developing intolerable hot flushes, irregular vaginal bleeding. Use of the following medications: Antihypertensive agents if stable dose has not been administered for at least 1 month before randomization Antidepressants in the week (or a period of 5 half-lives of the drug) prior to randomization Continuous daily or standing orders use of benzodiazepines during the month preceding screening (approximately 5 weeks prior to screening) Potent cytochrome P450 (CYP) inducers and CYP2D6/CYP3A4 inhibitors 14 days prior to randomization Depot antipsychotic medications within 1 dosing interval prior to randomization Use of systemic estrogens 6 weeks prior to randomization Patients currently on carbapenem agents Any of the following laboratory abnormalities Serum bilirubin ≥ 1.5 times ULN Serum AST/ALT ≥ 2.5 times ULN Serum TSH >10% above the ULN, regardless of treatment for hypothyroidism or hyperthyroidism Serum triglyceride level > 2.5 times ULN Patients with the following cardiac conditions are excluded: Recent myocardial infarction (<12 months) QTc prolongation (screening electrocardiogram with QTc >450 msec for men, QTc> 470 msec for women) History of QTc prolongation or using concomitant medications (as judged by the Investigator) which prolong QTc interval Sustained cardiac arrhythmia or history of sustained cardiac arrhythmia De compensatory congestive heart failure Complete left bundle branch block First-degree heart block with PR interval > 0.22 seconds Presence of a coagulation disorder; active or past history of venous thromboembolism including deep venous thrombosis or pulmonary embolism. Current prolonged immobilization. History or current presence of retinal pathology including retinal vein thrombosis Increased risk of stroke as per the Investigator's discretion. History of hypersensitivity or intolerance to tamoxifen or any other ingredients of the preparation. Serious, unstable illnesses including hepatic, renal, gastroenterologic, respiratory, cardiovascular (including ischemic heart disease), endocrinologic, neurologic, immunologic, or hematologic disease as per history and medical examination. Drug screen positive for any drug of abuse at screening (with the exception of benzodiazepines used in therapeutic dose for management of acute mania), active substance abuse in the past 2 months or history of substance dependence (excluding nicotine and caffeine) within 3 months of screening. History of breast or uterine cancer, or abnormal uterine bleeding. Current leukopenia or thrombocytopenia as judged by the Investigator in the best health interest of the subject. Clinically significant suicidal or homicidal ideation. Participation in a clinical trial of another investigational drug within 30 days prior to screening.
Ages Eligible for Study
-----------------
Minimum Age: 18 Years
Maximum Age: 65 Years
Sexes Eligible for Study
-----------------
All
Accepts Healthy Volunteers
-----------------
No
Study Plan
=================
How is the study designed?
-----------------
Design Details
Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double
Arms and Interventions
| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Endoxifen Arm<br>Endoxifen enteric-coated tablet (8 mg). Patients will continue treatment with their initial randomized medication for 3 weeks | Drug: Endoxifen<br>* Administration of Endoxifen for 3 weeks<br>|
| Placebo Comparator: Placebo Arm<br>Placebo tablets of endoxifen. Patients will continue administration with their initial randomized medication for 3 weeks | Drug: Placebo oral tablet<br>* Administration of Placebo for 3 weeks<br>|
What is the study measuring?
-----------------
Primary Outcome Measures
| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Evaluate the efficacy and establish superiority of endoxifen 8 mg against placebo in Bipolar I Disorder patients (Mean change in total YMRS score) | Mean change in total YMRS score at Day 21 against baseline (in-patient setup) | 3 weeks |
Secondary Outcome Measures
| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Evaluate the safety and tolerability of all the treatments among Bipolar I Disorder patients (treatment related adverse events) | All treatment related adverse events including abnormal laboratory parameters | 3 weeks |
Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Endoxifen, Bipolar I Disorder
|
|
NCT05198258
|
Implementation and Evaluation of Neck-specific Exercises
|
Persistent pain and disability in whiplash-associated disorders (WAD) grade II and III are common. Randomized controlled studies (RCTs) have shown promising result for neck-specific exercise (NSE) programmes in chronic WAD with clinically and statistically significant improvement in pain and disability. Neck-specific exercise with internet support (NSEIT) and four visits to a physiotherapist was non-inferior to NSE at a physiotherapist clinic 2 times a week in 12 weeks (24 visits). The aims of the proposed study are to evaluate an implementation strategy for NSE and NSEIT in primary health care and to evaluate the effectiveness of NSE and NSEIT in clinical practice.
|
The study is a prospective cluster-randomized study with hybrid II trial design.~In total will 20 physiotherapy clinics in primary health care be recruited. Reg. physiotherapists working in the twenty physiotherapy clinics will be included. The clinics will be randomised to two groups with different implementation strategy: (A, intervention) three theoretical on-line lectures and the three hours' practical training with additional support; (B, control) the same education and practical training as A but with no additional support. Twenty-five patients with neck pain will be consecutively recruited from each clinic, a total of 500 patients. Outcome measurements will be conducted at baseline, 3- and 12-months.~This trial will evaluate the implementation strategy in terms of adoption of and adherence to NSEIT and NSE in clinical primary health care, also measuring diffusion of the method to other neck pain patients. In parallel, effectiveness of the exercises are evaluated.~All analyses will be conducted in collaboration with a statistician using parametric or non-parametric statistics depending on the type of data.~The implementation strategy will be analyzed using parametric t-test and a linear mixed model Analysis of Variance (ANOVA) or non-parametric Mann-Whitney U test and Kruskal-Wallis to evaluate differences between group A and B and change in variables over time.~To further evaluate the implementation strategy will two focus group studies be conducted, with a purposeful sample of physiotherapists included in the cluster-randomized mixed-design study. The overall aim of these qualitative studies is to deepen the knowledge on the uptake of the new method, i.e., the NSEIT/NSE programme (adoption), the implementation in clinical practice (implementation), and how it continues to be used (maintenance).~The effectiveness of NSEIT and NSE will be analysed with a linear mixed model Analysis of Variance (ANOVA) or Kruskal-Wallis depending on the data.~The effect of neck-specific exercises in the present study will also be evaluated and compared to the results in our former RCT-studies.~Sample size and power regarding group differences were calculated by a statistician. Sample size calculation was based on the assumption that 15% more patients will receive neck-specific exercises in the intervention group (40% in the intervention group and 25% in the control group). The required sample size under individual randomization will be 150 patients in each arm. With ten physiotherapy clinics (clusters) in each arm (a total of 20 clusters), intra-cluster correlation of 0.02 and a cluster size of 21 patients, a total of 420 patients are recruited for 80% power and a significance level of 0.05. To ensure that enough people are in each group after dropouts, a total of 500 patients will be included, 25 patients from each cluster. The patients will be consecutively recruited.~Patients who are included in both the intervention and control groups and received neck-specific exercises will be treated as one group in terms of the effect of the intervention. The sample size calculation to evaluate effectiveness was based on a clinically relevant improvement of 7% on the Neck Disability Index (NDI), effect size 0.2 (Cohen's f) or 0.4 (Cohen's d), and correlation among repeated measures of 0.3, resulting in a total of 56 participants for 80% power and a significance level of 0.05. With an expected dropout rate of 20%, a total of 70 participating patients are needed.~The patients will be analysed as one group and the total number of patients may be more than 70 because patients will be included at each clinic. All analyses will be conducted in collaboration with a statistician using parametric or non-parametric statistics depending on the type of data. Data will be analysed according to intention to treat and supplemented with per protocol analysis.
|
Evaluation of Implementation and Effectiveness of Neck-specific Exercise for Persistent Disability and Pain After Whiplash Injury; a Randomized Controlled Study Using a Hybrid II Design
|
Neck Pain, Whiplash Injuries, Neck Disorder
|
* Other: Implementation strategy - experimental group
* Other: Implementation - control group
|
Inclusion criteria implementation~- Reg. physiotherapists working in twenty physiotherapy clinics in primary health care.~Exclusion criteria implementation~- No exclusion criterta~Inclusion criteria to evaluate the effectiveness of neck-specific exercise~The physiotherapists will include patients ≥ 18 years with neck pain.~Patients are required to have internet access by phone, tablet, or computer~Be able to read and understand Swedish~Exclusion criteria:~Physiotherapists should exclude patients with red flagsi.e., symptoms that suggest a serious illness or spinal abnormality.~Serious trauma to the neck and no X-ray~Preceding neck surgery~Osteoporosis~Myelopathy~History of cancer~Unexplained weight loss~Present fever, history of infections~Constant and progressive non-mechanical pain~Insidious progression of pain~Signs of spinal cord compression (neurological examination to exclude spinal cord or cervical myelopathy such as clumsy hands, altered gait, or disturbances of sexual, bladder or sphincter function).
|
18 Years
| null |
All
|
No
|
Primary Purpose: Other
Allocation: Randomized
Intervention Model: Parallel Assignment
Interventional Model Description: The study is a prospective cluster-randomized mixed-design study with hybrid II trial design.~Twenty physiotherapy clinics in primary health care will be included.
Masking: Single
|
| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Implementation - Adoption of neck-specific exercise programmes | Proportion of patients with neck pain receiving neck-specific exercise | Baseline to 3 and 12 months (proportions of 500 patients with neck pain from 20 physiotherapy clinics) |
| Patient Effectiveness - Neck Disability Index | Self-reported neck-specific function | Change from baseline to 3 months (after treatment) and 12 months follow-up |
|
| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Implementation - The Evidence-Based Practice Attitude Scale (EBPAS) | Physiotherapists attitudes to implementation of evidence-based practice | Baseline |
| Implementation - Practitioner Confidence Scale (PCS) | Self-efficacy and confidence to diagnose and treat patients with neck pain | Change from baseline to 3 months (after treatment) and 12 months follow-up |
| Patient - Pain intensity (current, average last week, worst pain last week) in neck, head, and arm, and dizziness (current, average last week, worst dizziness last week) | Numeric Rating Scale (NRS); 0=no pain or dizziness, 10=worst imaginable pain or dizziness). | Change from baseline to 3 months (after treatment) and 12 months follow-up |
| Patient - rating of self-perceived health | How is your current health in general? Numeric Rating Scale 0-10, 0=the worst health; 10= the best health you can imagine | Change from baseline to 3 months (after treatment) and 12 months follow-up |
| Patient - Workability | Self-reported workability measured with the Work Ability Score (WAS). The worker's self-assessment of his/her current ability to work compared to the lifetime best.WAS; (0 = currently can not work at all, 10=work ability at it's best | Change from baseline to 3 months (after treatment) and 12 months follow-up |
| Patient - The patient's assessment of perceived anxiety and depression | During the last week, have you felt anxious or depressed? Numeric Rating Scale (0-10), 0=no, not at all; 10= yes, very much | Change from baseline to 3 months (after treatment) and 12 months follow-up |
| Patient - Improvement or deterioration over time | Global Rating scale (GRS) (-5=vastly worse, 0=unchanged, 5=completely recovered) | Measured at 3 months and 15 months follow up |
|
Whiplash-associated disorders, Implementation Science, Neck pain, Rehabilitation, Exercise, Internet, Randomized Controlled Trial
|
Neck Pain, Whiplash Injuries, Pain, Neurologic Manifestations, Neck Injuries, Wounds and Injuries
|
| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Implementation study - experimental group<br>Physiotherapists in the experimental group (group A) will receive on-line theoretical education including three hours of practical training by the project leaders. The standardized theoretical education includes three 45 minutes on-line lectures. The theoretical education will be followed by three hours practical training including clinical examination in patients with neck disability and instructions how to perform the neck-specific exercises.To facilitate the implementation process, group A will receive additional support; the physiotherapists can contact the project leader via e-mail, phone, online meetings and/or outreach visits | Other: Implementation strategy - experimental group<br>* On-line theoretical education and three hours of practical training by the project leaders. Contact with the project team via e-mail, phone and on-line repetition of the education for remaining of the clinical examination, neck-specific program and the progression of exercises.<br>|
| Active Comparator: Implementation study - control group<br>Physiotherapists in the control group (group B) will receive the same theoretical and practical training as group A but without additional support from the research group or education after the first three theoretical on-line lectures and the three hours practical education. | Other: Implementation - control group<br>* Physiotherapists in the control group will receive the same theoretical and practical training as the experimental group but without repetition of the education or support from the research team.<br>|
|
Implementation and Evaluation of Neck-specific Exercises
Study Overview
=================
Brief Summary
-----------------
Persistent pain and disability in whiplash-associated disorders (WAD) grade II and III are common. Randomized controlled studies (RCTs) have shown promising result for neck-specific exercise (NSE) programmes in chronic WAD with clinically and statistically significant improvement in pain and disability. Neck-specific exercise with internet support (NSEIT) and four visits to a physiotherapist was non-inferior to NSE at a physiotherapist clinic 2 times a week in 12 weeks (24 visits). The aims of the proposed study are to evaluate an implementation strategy for NSE and NSEIT in primary health care and to evaluate the effectiveness of NSE and NSEIT in clinical practice.
Detailed Description
-----------------
The study is a prospective cluster-randomized study with hybrid II trial design. In total will 20 physiotherapy clinics in primary health care be recruited. Reg. physiotherapists working in the twenty physiotherapy clinics will be included. The clinics will be randomised to two groups with different implementation strategy: (A, intervention) three theoretical on-line lectures and the three hours' practical training with additional support; (B, control) the same education and practical training as A but with no additional support. Twenty-five patients with neck pain will be consecutively recruited from each clinic, a total of 500 patients. Outcome measurements will be conducted at baseline, 3- and 12-months. This trial will evaluate the implementation strategy in terms of adoption of and adherence to NSEIT and NSE in clinical primary health care, also measuring diffusion of the method to other neck pain patients. In parallel, effectiveness of the exercises are evaluated. All analyses will be conducted in collaboration with a statistician using parametric or non-parametric statistics depending on the type of data. The implementation strategy will be analyzed using parametric t-test and a linear mixed model Analysis of Variance (ANOVA) or non-parametric Mann-Whitney U test and Kruskal-Wallis to evaluate differences between group A and B and change in variables over time. To further evaluate the implementation strategy will two focus group studies be conducted, with a purposeful sample of physiotherapists included in the cluster-randomized mixed-design study. The overall aim of these qualitative studies is to deepen the knowledge on the uptake of the new method, i.e., the NSEIT/NSE programme (adoption), the implementation in clinical practice (implementation), and how it continues to be used (maintenance). The effectiveness of NSEIT and NSE will be analysed with a linear mixed model Analysis of Variance (ANOVA) or Kruskal-Wallis depending on the data. The effect of neck-specific exercises in the present study will also be evaluated and compared to the results in our former RCT-studies. Sample size and power regarding group differences were calculated by a statistician. Sample size calculation was based on the assumption that 15% more patients will receive neck-specific exercises in the intervention group (40% in the intervention group and 25% in the control group). The required sample size under individual randomization will be 150 patients in each arm. With ten physiotherapy clinics (clusters) in each arm (a total of 20 clusters), intra-cluster correlation of 0.02 and a cluster size of 21 patients, a total of 420 patients are recruited for 80% power and a significance level of 0.05. To ensure that enough people are in each group after dropouts, a total of 500 patients will be included, 25 patients from each cluster. The patients will be consecutively recruited. Patients who are included in both the intervention and control groups and received neck-specific exercises will be treated as one group in terms of the effect of the intervention. The sample size calculation to evaluate effectiveness was based on a clinically relevant improvement of 7% on the Neck Disability Index (NDI), effect size 0.2 (Cohen's f) or 0.4 (Cohen's d), and correlation among repeated measures of 0.3, resulting in a total of 56 participants for 80% power and a significance level of 0.05. With an expected dropout rate of 20%, a total of 70 participating patients are needed. The patients will be analysed as one group and the total number of patients may be more than 70 because patients will be included at each clinic. All analyses will be conducted in collaboration with a statistician using parametric or non-parametric statistics depending on the type of data. Data will be analysed according to intention to treat and supplemented with per protocol analysis.
Official Title
-----------------
Evaluation of Implementation and Effectiveness of Neck-specific Exercise for Persistent Disability and Pain After Whiplash Injury; a Randomized Controlled Study Using a Hybrid II Design
Conditions
-----------------
Neck Pain, Whiplash Injuries, Neck Disorder
Intervention / Treatment
-----------------
* Other: Implementation strategy - experimental group
* Other: Implementation - control group
Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion criteria implementation - Reg. physiotherapists working in twenty physiotherapy clinics in primary health care. Exclusion criteria implementation - No exclusion criterta Inclusion criteria to evaluate the effectiveness of neck-specific exercise The physiotherapists will include patients ≥ 18 years with neck pain. Patients are required to have internet access by phone, tablet, or computer Be able to read and understand Swedish Exclusion criteria: Physiotherapists should exclude patients with red flagsi.e., symptoms that suggest a serious illness or spinal abnormality. Serious trauma to the neck and no X-ray Preceding neck surgery Osteoporosis Myelopathy History of cancer Unexplained weight loss Present fever, history of infections Constant and progressive non-mechanical pain Insidious progression of pain Signs of spinal cord compression (neurological examination to exclude spinal cord or cervical myelopathy such as clumsy hands, altered gait, or disturbances of sexual, bladder or sphincter function).
Ages Eligible for Study
-----------------
Minimum Age: 18 Years
Sexes Eligible for Study
-----------------
All
Accepts Healthy Volunteers
-----------------
No
Study Plan
=================
How is the study designed?
-----------------
Design Details
Primary Purpose: Other
Allocation: Randomized
Intervention Model: Parallel Assignment
Interventional Model Description: The study is a prospective cluster-randomized mixed-design study with hybrid II trial design. Twenty physiotherapy clinics in primary health care will be included.
Masking: Single
Arms and Interventions
| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Implementation study - experimental group<br>Physiotherapists in the experimental group (group A) will receive on-line theoretical education including three hours of practical training by the project leaders. The standardized theoretical education includes three 45 minutes on-line lectures. The theoretical education will be followed by three hours practical training including clinical examination in patients with neck disability and instructions how to perform the neck-specific exercises.To facilitate the implementation process, group A will receive additional support; the physiotherapists can contact the project leader via e-mail, phone, online meetings and/or outreach visits | Other: Implementation strategy - experimental group<br>* On-line theoretical education and three hours of practical training by the project leaders. Contact with the project team via e-mail, phone and on-line repetition of the education for remaining of the clinical examination, neck-specific program and the progression of exercises.<br>|
| Active Comparator: Implementation study - control group<br>Physiotherapists in the control group (group B) will receive the same theoretical and practical training as group A but without additional support from the research group or education after the first three theoretical on-line lectures and the three hours practical education. | Other: Implementation - control group<br>* Physiotherapists in the control group will receive the same theoretical and practical training as the experimental group but without repetition of the education or support from the research team.<br>|
What is the study measuring?
-----------------
Primary Outcome Measures
| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Implementation - Adoption of neck-specific exercise programmes | Proportion of patients with neck pain receiving neck-specific exercise | Baseline to 3 and 12 months (proportions of 500 patients with neck pain from 20 physiotherapy clinics) |
| Patient Effectiveness - Neck Disability Index | Self-reported neck-specific function | Change from baseline to 3 months (after treatment) and 12 months follow-up |
Secondary Outcome Measures
| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Implementation - The Evidence-Based Practice Attitude Scale (EBPAS) | Physiotherapists attitudes to implementation of evidence-based practice | Baseline |
| Implementation - Practitioner Confidence Scale (PCS) | Self-efficacy and confidence to diagnose and treat patients with neck pain | Change from baseline to 3 months (after treatment) and 12 months follow-up |
| Patient - Pain intensity (current, average last week, worst pain last week) in neck, head, and arm, and dizziness (current, average last week, worst dizziness last week) | Numeric Rating Scale (NRS); 0=no pain or dizziness, 10=worst imaginable pain or dizziness). | Change from baseline to 3 months (after treatment) and 12 months follow-up |
| Patient - rating of self-perceived health | How is your current health in general? Numeric Rating Scale 0-10, 0=the worst health; 10= the best health you can imagine | Change from baseline to 3 months (after treatment) and 12 months follow-up |
| Patient - Workability | Self-reported workability measured with the Work Ability Score (WAS). The worker's self-assessment of his/her current ability to work compared to the lifetime best.WAS; (0 = currently can not work at all, 10=work ability at it's best | Change from baseline to 3 months (after treatment) and 12 months follow-up |
| Patient - The patient's assessment of perceived anxiety and depression | During the last week, have you felt anxious or depressed? Numeric Rating Scale (0-10), 0=no, not at all; 10= yes, very much | Change from baseline to 3 months (after treatment) and 12 months follow-up |
| Patient - Improvement or deterioration over time | Global Rating scale (GRS) (-5=vastly worse, 0=unchanged, 5=completely recovered) | Measured at 3 months and 15 months follow up |
Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Whiplash-associated disorders, Implementation Science, Neck pain, Rehabilitation, Exercise, Internet, Randomized Controlled Trial
|
NCT04157387
|
Cyriax Inferior Capsule Stretching in Idiopathic Adhesive Capsulitis
|
The objective of study is to find out the effectiveness of cyriax capsular stretching in idiopathic adhesive capsulitis and to find out the combined effect of capsular stretching's, mobilization and conservative treatment on pain and Range of Motion (ROM) in idiopathic adhesive capsulitis.
|
This Randomized study was carried out at Pakistan Railway Hospital Rawalpindi. A total of 28 patients were screened out as per inclusion criteria and randomly placed into two groups A and B through lottery method. The Visual Analogue scale, Shoulder Pain and Disability Index, and Range of Motion of shoulder joint were used as outcome measures. All the patients were assessed at baseline before intervention and at the completion of 3weeks of treatment.
|
Effect of Cyriax Inferior Capsule Stretching in Idiopathic Adhesive Capsulitis
|
Adhesive Capsulitis
|
* Other: Cyriax inferior capsular stretching + Manual Therapy
* Other: Manual therapy
|
Inclusion Criteria:~Idiopathic Adhesive capsulitis phase 1 and phase 2~Follow capsular pattern ( ER > Abduction> IR)~Exclusion Criteria:~Adhesive capsulitis phase 3~Any intrinsic etiology i.e. rheumatoid arthritis,~infection,~gout,~haemarthrosis or~tumor or Arthritis in stage III or in stage II with a spastic end-feel
|
30 Years
|
70 Years
|
All
|
No
|
Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single
|
| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Goniometer | Changes from the baseline, Measure the available range of motion or the position of the shoulder joint - typically this is a measure of passive motion like External Rotation, External Rotation and Internal Rotation. | 3rd week |
| Visual Analogue Scale (VAS) | Changes from the baseline, Normative values are not presented so by using a ruler , the score is calculated by measure the distance on 10cm line between the no pain point and the patient's mark, provide a range of score from 0-100. A higher score indicates greater pain intensity. | 3rd Week |
| Shoulder pain and disability index (SPADI) | Changes from the Baseline, SPADI is a self-administered questionnaire that aims to measure pain and disability associated with shoulder disease. It consists of two dimensions, one for pain and second for functional activities.~The pain element consists of five questions regarding severity of pain and to measure the degree of severity that an individual faced during various activities of daily life that involve upper extremity use. There are eight questions.~Each subscale is summed up and a total SPADI score is expressed as a percentage.Total pain score : --/50 ×100 = %, Total disability score: --/80 × 100 = %, Total SPADI score: --/130 × 100 = %.~A score of 0 indicates best 100 indicates worst. A higher score shows more disability. | 3rd week |
|
Adhesive Capsulitis, Cyriax Manual Therapy, Stretching
|
Bursitis, Joint Diseases, Musculoskeletal Diseases
|
| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Cyriax inferior capsular stretching + Manual Therapy<br>Cyriax inferior capsular stretching~+ Electrotherapy Manual therapy : Kaltenborn grade 1 and 2 Mobilization~Active ROM exercises :~Home plan include :, wall walking exercises, pendulum exercises ,towel stretch exercises, Cross Body Adduction | Other: Cyriax inferior capsular stretching + Manual Therapy<br>* Electro-therapy 10mins Manual therapy : Kalternbon grade 1 and 2 Mobilization : Inferior glide (10x3), posterior glide, (10 reps x 3 sets), anterior glide (10 reps x 3 sets), Active ROM exercises : 10 reps x 3 sets Home plan include :, wall walking exercises, pendulum exercises ,towel stretch exercises, Cross Body Adduction (10reps x 2 sets ,each) Cyriax inferior capsular stretching<br>|
| Active Comparator: Manual Therapy<br>Analgesic short-wave diathermy Manual Therapy: Kalternbon grade 1 and 2 Mobilization :, Home plan include :, wall walking exercises, pendulum exercises ,towel stretch exercises, Cross Body Adduction. | Other: Manual therapy<br>* Before starting capsule stretching technique, Analgesic short-wave diathermy may be given for 10 minutes.~Kalternbon grade 1 and 2 Mobilization : Inferior glide (10x3), posterior glide, (10 reps x 3 sets), anterior glide (10 reps x 3 sets), Home plan include :, wall walking exercises, pendulum exercises ,towel stretch exercises, Cross Body Adduction (10reps x 2 sets ,each)<br>|
|
Cyriax Inferior Capsule Stretching in Idiopathic Adhesive Capsulitis
Study Overview
=================
Brief Summary
-----------------
The objective of study is to find out the effectiveness of cyriax capsular stretching in idiopathic adhesive capsulitis and to find out the combined effect of capsular stretching's, mobilization and conservative treatment on pain and Range of Motion (ROM) in idiopathic adhesive capsulitis.
Detailed Description
-----------------
This Randomized study was carried out at Pakistan Railway Hospital Rawalpindi. A total of 28 patients were screened out as per inclusion criteria and randomly placed into two groups A and B through lottery method. The Visual Analogue scale, Shoulder Pain and Disability Index, and Range of Motion of shoulder joint were used as outcome measures. All the patients were assessed at baseline before intervention and at the completion of 3weeks of treatment.
Official Title
-----------------
Effect of Cyriax Inferior Capsule Stretching in Idiopathic Adhesive Capsulitis
Conditions
-----------------
Adhesive Capsulitis
Intervention / Treatment
-----------------
* Other: Cyriax inferior capsular stretching + Manual Therapy
* Other: Manual therapy
Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Idiopathic Adhesive capsulitis phase 1 and phase 2 Follow capsular pattern ( ER > Abduction> IR) Exclusion Criteria: Adhesive capsulitis phase 3 Any intrinsic etiology i.e. rheumatoid arthritis, infection, gout, haemarthrosis or tumor or Arthritis in stage III or in stage II with a spastic end-feel
Ages Eligible for Study
-----------------
Minimum Age: 30 Years
Maximum Age: 70 Years
Sexes Eligible for Study
-----------------
All
Accepts Healthy Volunteers
-----------------
No
Study Plan
=================
How is the study designed?
-----------------
Design Details
Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single
Arms and Interventions
| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Cyriax inferior capsular stretching + Manual Therapy<br>Cyriax inferior capsular stretching + Electrotherapy Manual therapy : Kaltenborn grade 1 and 2 Mobilization Active ROM exercises : Home plan include :, wall walking exercises, pendulum exercises ,towel stretch exercises, Cross Body Adduction | Other: Cyriax inferior capsular stretching + Manual Therapy<br>* Electro-therapy 10mins Manual therapy : Kalternbon grade 1 and 2 Mobilization : Inferior glide (10x3), posterior glide, (10 reps x 3 sets), anterior glide (10 reps x 3 sets), Active ROM exercises : 10 reps x 3 sets Home plan include :, wall walking exercises, pendulum exercises ,towel stretch exercises, Cross Body Adduction (10reps x 2 sets ,each) Cyriax inferior capsular stretching<br>|
| Active Comparator: Manual Therapy<br>Analgesic short-wave diathermy Manual Therapy: Kalternbon grade 1 and 2 Mobilization :, Home plan include :, wall walking exercises, pendulum exercises ,towel stretch exercises, Cross Body Adduction. | Other: Manual therapy<br>* Before starting capsule stretching technique, Analgesic short-wave diathermy may be given for 10 minutes. Kalternbon grade 1 and 2 Mobilization : Inferior glide (10x3), posterior glide, (10 reps x 3 sets), anterior glide (10 reps x 3 sets), Home plan include :, wall walking exercises, pendulum exercises ,towel stretch exercises, Cross Body Adduction (10reps x 2 sets ,each)<br>|
What is the study measuring?
-----------------
Primary Outcome Measures
| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Goniometer | Changes from the baseline, Measure the available range of motion or the position of the shoulder joint - typically this is a measure of passive motion like External Rotation, External Rotation and Internal Rotation. | 3rd week |
| Visual Analogue Scale (VAS) | Changes from the baseline, Normative values are not presented so by using a ruler , the score is calculated by measure the distance on 10cm line between the no pain point and the patient's mark, provide a range of score from 0-100. A higher score indicates greater pain intensity. | 3rd Week |
| Shoulder pain and disability index (SPADI) | Changes from the Baseline, SPADI is a self-administered questionnaire that aims to measure pain and disability associated with shoulder disease. It consists of two dimensions, one for pain and second for functional activities. The pain element consists of five questions regarding severity of pain and to measure the degree of severity that an individual faced during various activities of daily life that involve upper extremity use. There are eight questions. Each subscale is summed up and a total SPADI score is expressed as a percentage.Total pain score : --/50 ×100 = %, Total disability score: --/80 × 100 = %, Total SPADI score: --/130 × 100 = %. A score of 0 indicates best 100 indicates worst. A higher score shows more disability. | 3rd week |
Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Adhesive Capsulitis, Cyriax Manual Therapy, Stretching
|
|
NCT04830787
|
Correlation Between Myocardial Deformation and Coronary Artery Tortuosity in Patients With Hypertrophic Cardiomyopathy
|
Correlation between Myocardial Deformation and Coronary Tortuosity and Analysis of Genetic Factors Among Hypertrophic Cardiomyopathy Patients
|
Excessive tortuosity of the coronary arteries (TCA) is a somewhat common finding in patients referred for coronary angiography, reported in 14-40% of patients referred for angiography. The presence of TCA has been associated with chest pain and myocardial perfusion abnormalities during stress in the absence of obstructive coronary artery disease. Fluid dynamic modeling suggests that stress-induced ischemia may be attributable to a reduction in distal coronary artery perfusion pressure from viscous and turbulence energy losses. The physiologic reasons for TCA are unclear. The roles of TCA on prognosis of HCM are also needed to explore. Pre-clinical studies where elastases and collagenases were used to alter arterial morphology together with genetic and pathologic analysis of rare clinical disorders such as arterial tortuosity syndrome have indicated that arterial tortuosity arises from abnormalities in arterial elastin fibers and extracellular matrix. Apart from inherited disorders, some but not all studies have linked TCA with hypertension and female sex, and with increased left ventricular (LV) mass from pressure but not volume overload and smaller heart size.~Hypertrophic cardiomyopathy (HCM) is associated with an increased left ventricular (LV) wall thickness. HCM is the most common genetic heart disease, characterized by marked clinical and morphologic heterogeneity. Diagnosis is usually based on the echocardiographic finding of unexplained left ventricular (LV) hypertrophy, defined by increased wall thickness in 1 or more LV segments. LV mass is generally assumed to be increased in patients with phenotypically expressed HCM, based largely on early pathological studies. TCA among HCM patients have not been studied. So, firstly, we choose HCM and non-HCM patients to investigate the relationship between TCA and HCM, and further explore the potential roles of TCA for prognosis in HCM.~In HCM patients, disruption of the ordered arrangement of myofibers alters normal cardiac mechanical function, resulting in temporal and spatial heterogeneity in regional myocardial contractility. Although global LV function is generally unaltered, asynchrony and asynergy in regional function lead to delayed diastolic relaxation and impaired diastolic filling. Whilst LV ejection fraction is frequently normal in both, LV strain assessment could differentiate, compared to normal person. Cardiovascular magnetic resonance (CMR), by virtue of its high-resolution volumetric reconstruction of the LV chamber, currently affords a highly accurate and reproducible quantitative assessment of mass . So secondly, we sought to establish if cardiovascular magnetic resonance myocardial feature tracking (CMR-FT), an emerging method allowing accurate assessment of myocardial deformation, differentiates between HCM with or without TCA. Additionally, we want to explore the potential genetic factor on TCA in HCM.~This is a single-center, retrospective, case control study that will evaluate the difference of TCA between HCM and non-HCM, and explore the prognostic roles of TCA in the first part. In the second part, we will use CMR-FT to compare the myocardial strain between HCM with or without TCA and analyze the relationship of strain and TCA. In the third part, we choose HCM patients and non-HCM to investigate potential genetic factors for TCA in HCM.
|
Correlation Between Myocardial Deformation and Coronary Artery Morphology in Patients With Hypertrophic Cardiomyopathy and Analysis of Genetic Factors：A Prospective, Single-center, Case-control Study
|
Myocardial Deformation, Coronary Artery Anomaly, Hypertrophic Cardiomyopathy, Genetic Mutation, Prognosis
|
* Other: no intervention
|
Inclusion Criteria:~Subjects must meet all the following inclusion criteria to be eligible for participation in this study~18<age≤85；~Patients with hypertrophic cardiomyopathy and without hypertrophic cardiomyopathy undergoing coronary angiography and echocardiography;~Willing to sign informed consent.~Exclusion Criteria:~Subjects who meet any of the following exclusion criteria are not to be enrolled in this study~All coronary arteries can not be shown clearly in coronary angiography~Prior coronary artery bypass surgery, valve prosthesis~Connective tissue disease~Cardiac dilatation(left ventricular end diastolic diameter, ≥55mm male，≥50mm female )~Congenital heart failure, LVEF<35%~Coronary total occlusion, changes in coronary morphology, such as long stents implantation（≥12mm）
|
18 Years
|
85 Years
|
All
|
Accepts Healthy Volunteers
|
| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| coronary artery tortuosity and tortuosity score in hypertrophic cardiomyopathy patients | Severe tortuosity was defined as ≥2 consecutive curvatures of ≥180° in a major epicardial coronary artery ≥2 mm in diameter . Mild tortuosity was defined as either ≥3 consecutive curvatures of 45° to 90° in a major epicardial coronary artery, or ≥3 consecutive curvatures of 90° to 180° in an artery <2 mm in diameter. The tortuosity score was calculated as a sum of scores for each major epicardial coronary artery (left anterior descending, left circumflex, right coronary artery) with 0=no tortuosity, 1=mild tortuosity,2=tortuosity, 3=severe tortuosity. We will evaluate if the patients have coronary artery tortuosity and assess the number of tortuosity score for every coronary artery and add the score up for every patients. | six months |
| prognostic roles of coronary artery tortuosity in hypertrophic cardiomyopathy | retrospectively included HCM patients with echocardiography and coronary angiography (CAG), in Fuwai Central China Cardiovascular Hospital from 1st Dec 2017 to 10th Jun 2021. All patients were followed up until the censoring day of 1st July 2022. The primary outcomes were composite of all-cause death, maglinant arrhythmia, ischemic stroke. Death was documented according to medical records, death certificates, or follow-up questionnaires by family members. Arrhythmia included ventricular fibrillation, sustained ventricular tachycardia, second-degree type II and third-degree atrioventricular block. | 2017/12/01-2022/07/01 |
| prognostic roles of coronary artery tortuosity in hypertrophic cardiomyopathy | etrospectively included HCM patients with echocardiography and coronary angiography (CAG), in Fuwai Central China Cardiovascular Hospital from 1st Dec 2017 to 10th Jun 2021. All patients were followed up until the censoring day of 1st July 2022. The secondary outcomes were composite of primary outcomes and rehospitalization. | 2017/12/01-2022/07/01 |
|
| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| myocardial strain and strain rate in hypertrophic cardiomyopathy patients with coronary artery tortuosity | observe the difference of myocardial strain between hypertrophic cardiomyopathy with and without coronary artery tortuosity, Global longitudinal strain (GLS), global longitudinal strain rate (GLSR), global circumferential strain (GCS), global circumferential strain rate (GCSR), global radial strain (GRS), and global radial strain rate (GRSR) of the LV and RV will be calculated and segmental strain and strain rate will also be assessed respectively | six months |
| genetic factors(such as genetic mutation site for HCM(MYBPC3,MYH7,ACTC1,TNNI3)) for hypertrophic cardiomyopathy patients with coronary artery tortuosity | do genetic testing, observe the difference for genetic factors such as gene mutation for hypertrophic cardiomyopathy with and without coronary artery tortuosity, all the 40 genes which has been found to be implicated in HCM will be tested, such as MYBPC3, MYH7, TPM1,TNNT2 and TNNI3. | two months |
|
hypertrophic cardiomyopathy, tortuosity of coronary arteries, myocardial strain, prognosis, genetic mutation
|
Cardiomyopathies, Cardiomyopathy, Hypertrophic, Hypertrophy, Heart Diseases, Cardiovascular Diseases, Pathological Conditions, Anatomical, Aortic Stenosis, Subvalvular, Aortic Valve Stenosis, Aortic Valve Disease, Heart Valve Diseases
|
| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| hypertrophic cardiomyopathy<br>patients with hypertrophic cardiomyopathy | Other: no intervention<br>* there is no intervention, we just chose patients diagnosed with hypertrophic cardiomyopathy and underwent CAG, and patients without hypertrophic cardiomyopathy as control ,the two groups are matched with age, gender and hypertension.<br>|
| control without hypertrophic cardiomyopathy<br>controls without hypertrophic cardiomyopathy | |
|
Correlation Between Myocardial Deformation and Coronary Artery Tortuosity in Patients With Hypertrophic Cardiomyopathy
Study Overview
=================
Brief Summary
-----------------
Correlation between Myocardial Deformation and Coronary Tortuosity and Analysis of Genetic Factors Among Hypertrophic Cardiomyopathy Patients
Detailed Description
-----------------
Excessive tortuosity of the coronary arteries (TCA) is a somewhat common finding in patients referred for coronary angiography, reported in 14-40% of patients referred for angiography. The presence of TCA has been associated with chest pain and myocardial perfusion abnormalities during stress in the absence of obstructive coronary artery disease. Fluid dynamic modeling suggests that stress-induced ischemia may be attributable to a reduction in distal coronary artery perfusion pressure from viscous and turbulence energy losses. The physiologic reasons for TCA are unclear. The roles of TCA on prognosis of HCM are also needed to explore. Pre-clinical studies where elastases and collagenases were used to alter arterial morphology together with genetic and pathologic analysis of rare clinical disorders such as arterial tortuosity syndrome have indicated that arterial tortuosity arises from abnormalities in arterial elastin fibers and extracellular matrix. Apart from inherited disorders, some but not all studies have linked TCA with hypertension and female sex, and with increased left ventricular (LV) mass from pressure but not volume overload and smaller heart size. Hypertrophic cardiomyopathy (HCM) is associated with an increased left ventricular (LV) wall thickness. HCM is the most common genetic heart disease, characterized by marked clinical and morphologic heterogeneity. Diagnosis is usually based on the echocardiographic finding of unexplained left ventricular (LV) hypertrophy, defined by increased wall thickness in 1 or more LV segments. LV mass is generally assumed to be increased in patients with phenotypically expressed HCM, based largely on early pathological studies. TCA among HCM patients have not been studied. So, firstly, we choose HCM and non-HCM patients to investigate the relationship between TCA and HCM, and further explore the potential roles of TCA for prognosis in HCM. In HCM patients, disruption of the ordered arrangement of myofibers alters normal cardiac mechanical function, resulting in temporal and spatial heterogeneity in regional myocardial contractility. Although global LV function is generally unaltered, asynchrony and asynergy in regional function lead to delayed diastolic relaxation and impaired diastolic filling. Whilst LV ejection fraction is frequently normal in both, LV strain assessment could differentiate, compared to normal person. Cardiovascular magnetic resonance (CMR), by virtue of its high-resolution volumetric reconstruction of the LV chamber, currently affords a highly accurate and reproducible quantitative assessment of mass . So secondly, we sought to establish if cardiovascular magnetic resonance myocardial feature tracking (CMR-FT), an emerging method allowing accurate assessment of myocardial deformation, differentiates between HCM with or without TCA. Additionally, we want to explore the potential genetic factor on TCA in HCM. This is a single-center, retrospective, case control study that will evaluate the difference of TCA between HCM and non-HCM, and explore the prognostic roles of TCA in the first part. In the second part, we will use CMR-FT to compare the myocardial strain between HCM with or without TCA and analyze the relationship of strain and TCA. In the third part, we choose HCM patients and non-HCM to investigate potential genetic factors for TCA in HCM.
Official Title
-----------------
Correlation Between Myocardial Deformation and Coronary Artery Morphology in Patients With Hypertrophic Cardiomyopathy and Analysis of Genetic Factors：A Prospective, Single-center, Case-control Study
Conditions
-----------------
Myocardial Deformation, Coronary Artery Anomaly, Hypertrophic Cardiomyopathy, Genetic Mutation, Prognosis
Intervention / Treatment
-----------------
* Other: no intervention
Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Subjects must meet all the following inclusion criteria to be eligible for participation in this study 18<age≤85； Patients with hypertrophic cardiomyopathy and without hypertrophic cardiomyopathy undergoing coronary angiography and echocardiography; Willing to sign informed consent. Exclusion Criteria: Subjects who meet any of the following exclusion criteria are not to be enrolled in this study All coronary arteries can not be shown clearly in coronary angiography Prior coronary artery bypass surgery, valve prosthesis Connective tissue disease Cardiac dilatation(left ventricular end diastolic diameter, ≥55mm male，≥50mm female ) Congenital heart failure, LVEF<35% Coronary total occlusion, changes in coronary morphology, such as long stents implantation（≥12mm）
Ages Eligible for Study
-----------------
Minimum Age: 18 Years
Maximum Age: 85 Years
Sexes Eligible for Study
-----------------
All
Accepts Healthy Volunteers
-----------------
Accepts Healthy Volunteers
Study Plan
=================
How is the study designed?
-----------------
Arms and Interventions
| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| hypertrophic cardiomyopathy<br>patients with hypertrophic cardiomyopathy | Other: no intervention<br>* there is no intervention, we just chose patients diagnosed with hypertrophic cardiomyopathy and underwent CAG, and patients without hypertrophic cardiomyopathy as control ,the two groups are matched with age, gender and hypertension.<br>|
| control without hypertrophic cardiomyopathy<br>controls without hypertrophic cardiomyopathy | |
What is the study measuring?
-----------------
Primary Outcome Measures
| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| coronary artery tortuosity and tortuosity score in hypertrophic cardiomyopathy patients | Severe tortuosity was defined as ≥2 consecutive curvatures of ≥180° in a major epicardial coronary artery ≥2 mm in diameter . Mild tortuosity was defined as either ≥3 consecutive curvatures of 45° to 90° in a major epicardial coronary artery, or ≥3 consecutive curvatures of 90° to 180° in an artery <2 mm in diameter. The tortuosity score was calculated as a sum of scores for each major epicardial coronary artery (left anterior descending, left circumflex, right coronary artery) with 0=no tortuosity, 1=mild tortuosity,2=tortuosity, 3=severe tortuosity. We will evaluate if the patients have coronary artery tortuosity and assess the number of tortuosity score for every coronary artery and add the score up for every patients. | six months |
| prognostic roles of coronary artery tortuosity in hypertrophic cardiomyopathy | retrospectively included HCM patients with echocardiography and coronary angiography (CAG), in Fuwai Central China Cardiovascular Hospital from 1st Dec 2017 to 10th Jun 2021. All patients were followed up until the censoring day of 1st July 2022. The primary outcomes were composite of all-cause death, maglinant arrhythmia, ischemic stroke. Death was documented according to medical records, death certificates, or follow-up questionnaires by family members. Arrhythmia included ventricular fibrillation, sustained ventricular tachycardia, second-degree type II and third-degree atrioventricular block. | 2017/12/01-2022/07/01 |
| prognostic roles of coronary artery tortuosity in hypertrophic cardiomyopathy | etrospectively included HCM patients with echocardiography and coronary angiography (CAG), in Fuwai Central China Cardiovascular Hospital from 1st Dec 2017 to 10th Jun 2021. All patients were followed up until the censoring day of 1st July 2022. The secondary outcomes were composite of primary outcomes and rehospitalization. | 2017/12/01-2022/07/01 |
Secondary Outcome Measures
| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| myocardial strain and strain rate in hypertrophic cardiomyopathy patients with coronary artery tortuosity | observe the difference of myocardial strain between hypertrophic cardiomyopathy with and without coronary artery tortuosity, Global longitudinal strain (GLS), global longitudinal strain rate (GLSR), global circumferential strain (GCS), global circumferential strain rate (GCSR), global radial strain (GRS), and global radial strain rate (GRSR) of the LV and RV will be calculated and segmental strain and strain rate will also be assessed respectively | six months |
| genetic factors(such as genetic mutation site for HCM(MYBPC3,MYH7,ACTC1,TNNI3)) for hypertrophic cardiomyopathy patients with coronary artery tortuosity | do genetic testing, observe the difference for genetic factors such as gene mutation for hypertrophic cardiomyopathy with and without coronary artery tortuosity, all the 40 genes which has been found to be implicated in HCM will be tested, such as MYBPC3, MYH7, TPM1,TNNT2 and TNNI3. | two months |
Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
hypertrophic cardiomyopathy, tortuosity of coronary arteries, myocardial strain, prognosis, genetic mutation
|
|
NCT01617694
|
Comparison Between Remifentanil Target-controlled Infusion and Dexmedetomidine Bolus Administration for Smooth Emergence From General Sevoflurane Anesthesia
|
Remifentanil target-controlled infusion and dexmedetomidine single-dose administration are known to reduce airway response and haemodynamic stimulation during anaesthetic recovery. The investigators will compare the effects of two drugs on prevention of cough during emergence from general sevoflurane anaesthesia.
| null |
Thyroid Neoplasm
|
* Drug: dexmedetomidine
* Drug: Normal Saline
|
Inclusion Criteria:~female patient,~aged 20-60 yr,~ASA physical status 1-2,~patients undergoing elective thyroidectomy under general anesthesia~Exclusion Criteria:~sighs of difficult airway,~history of respiratory disease or chronic cough,~cardiovascular disease,~pregnant or breast-feeding woman.
|
20 Years
|
60 Years
|
Female
|
No
|
Primary Purpose: Prevention
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double
|
| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| coughing response | Emergence cough was defined as the cough occurrence during peri-extubation period, from sevoflurane discontinuation to 5 min after extubation. The severity of cough was assessed and recorded by the following cough grading system: Grade 0, no cough; Grade 1, single cough with mild severity; Grade 2, cough persistence less than 5 s with moderate severity; Grade 3, severe, persistent cough for more than 5 s (bucking). | from discontinuation of anesthetic agent (sevoflurane) to 5 min after extubation. |
|
dexmedetomidine, remifentanil, target-controlled infusion
|
Analgesics, Dexmedetomidine, Hypnotics and Sedatives, Central Nervous System Depressants, Physiological Effects of Drugs, Analgesics, Non-Narcotic, Sensory System Agents, Peripheral Nervous System Agents, Adrenergic alpha-2 Receptor Agonists, Adrenergic alpha-Agonists, Adrenergic Agonists, Adrenergic Agents, Neurotransmitter Agents, Molecular Mechanisms of Pharmacological Action
|
| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: group R<br>continuation of remifentanil target controlled infusion (TCI) at effect-site concentration of 2 ng/ml during anesthetic recovery until extubation. | Drug: dexmedetomidine<br>* Fifteen minutes before the end of surgery, the first practitioner replace the syringe of remifentanil as new one; new syringe contains remifentanil in remifentanil group (Group R), and normal saline in dexmedetomidine group (Group D), respectively. There are no drug labeling in the new syringe, so the second practitioner can't know which drug was contained in the new syringe. Simultaneously, the second practitioner remifentanil concentration on monitor of TCI pump will be adjusted to 2.0 ng•ml-1. Ten minutes before the end of surgery, 10 ml of dexmedetomidine 0.5 mcg•kg-1 mixed with normal saline will be given for 5 min in Group D; in Group R, 10 ml of normal saline will be given by the first practitioner.<br>Drug: Normal Saline<br> <br> |
| Active Comparator: group D<br>remifentanil TCI discontinuation and dexmedetomidine 0.5 mg/kg intravenous injection before 10 min of the end of surgery | Drug: dexmedetomidine<br>* Fifteen minutes before the end of surgery, the first practitioner replace the syringe of remifentanil as new one; new syringe contains remifentanil in remifentanil group (Group R), and normal saline in dexmedetomidine group (Group D), respectively. There are no drug labeling in the new syringe, so the second practitioner can't know which drug was contained in the new syringe. Simultaneously, the second practitioner remifentanil concentration on monitor of TCI pump will be adjusted to 2.0 ng•ml-1. Ten minutes before the end of surgery, 10 ml of dexmedetomidine 0.5 mcg•kg-1 mixed with normal saline will be given for 5 min in Group D; in Group R, 10 ml of normal saline will be given by the first practitioner.<br>Drug: Normal Saline<br> <br> |
|
Comparison Between Remifentanil Target-controlled Infusion and Dexmedetomidine Bolus Administration for Smooth Emergence From General Sevoflurane Anesthesia
Study Overview
=================
Brief Summary
-----------------
Remifentanil target-controlled infusion and dexmedetomidine single-dose administration are known to reduce airway response and haemodynamic stimulation during anaesthetic recovery. The investigators will compare the effects of two drugs on prevention of cough during emergence from general sevoflurane anaesthesia.
Conditions
-----------------
Thyroid Neoplasm
Intervention / Treatment
-----------------
* Drug: dexmedetomidine
* Drug: Normal Saline
Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: female patient, aged 20-60 yr, ASA physical status 1-2, patients undergoing elective thyroidectomy under general anesthesia Exclusion Criteria: sighs of difficult airway, history of respiratory disease or chronic cough, cardiovascular disease, pregnant or breast-feeding woman.
Ages Eligible for Study
-----------------
Minimum Age: 20 Years
Maximum Age: 60 Years
Sexes Eligible for Study
-----------------
Female
Accepts Healthy Volunteers
-----------------
No
Study Plan
=================
How is the study designed?
-----------------
Design Details
Primary Purpose: Prevention
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double
Arms and Interventions
| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: group R<br>continuation of remifentanil target controlled infusion (TCI) at effect-site concentration of 2 ng/ml during anesthetic recovery until extubation. | Drug: dexmedetomidine<br>* Fifteen minutes before the end of surgery, the first practitioner replace the syringe of remifentanil as new one; new syringe contains remifentanil in remifentanil group (Group R), and normal saline in dexmedetomidine group (Group D), respectively. There are no drug labeling in the new syringe, so the second practitioner can't know which drug was contained in the new syringe. Simultaneously, the second practitioner remifentanil concentration on monitor of TCI pump will be adjusted to 2.0 ng•ml-1. Ten minutes before the end of surgery, 10 ml of dexmedetomidine 0.5 mcg•kg-1 mixed with normal saline will be given for 5 min in Group D; in Group R, 10 ml of normal saline will be given by the first practitioner.<br>Drug: Normal Saline<br> <br> |
| Active Comparator: group D<br>remifentanil TCI discontinuation and dexmedetomidine 0.5 mg/kg intravenous injection before 10 min of the end of surgery | Drug: dexmedetomidine<br>* Fifteen minutes before the end of surgery, the first practitioner replace the syringe of remifentanil as new one; new syringe contains remifentanil in remifentanil group (Group R), and normal saline in dexmedetomidine group (Group D), respectively. There are no drug labeling in the new syringe, so the second practitioner can't know which drug was contained in the new syringe. Simultaneously, the second practitioner remifentanil concentration on monitor of TCI pump will be adjusted to 2.0 ng•ml-1. Ten minutes before the end of surgery, 10 ml of dexmedetomidine 0.5 mcg•kg-1 mixed with normal saline will be given for 5 min in Group D; in Group R, 10 ml of normal saline will be given by the first practitioner.<br>Drug: Normal Saline<br> <br> |
What is the study measuring?
-----------------
Primary Outcome Measures
| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| coughing response | Emergence cough was defined as the cough occurrence during peri-extubation period, from sevoflurane discontinuation to 5 min after extubation. The severity of cough was assessed and recorded by the following cough grading system: Grade 0, no cough; Grade 1, single cough with mild severity; Grade 2, cough persistence less than 5 s with moderate severity; Grade 3, severe, persistent cough for more than 5 s (bucking). | from discontinuation of anesthetic agent (sevoflurane) to 5 min after extubation. |
Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
dexmedetomidine, remifentanil, target-controlled infusion
|
||
NCT01315223
|
Outpatient Lung Impedance-Guided Preventive Therapy in Patients With Chronic Heart Failure (CHF)
|
Patients suffering from Chronic Heart Failure (CHF) are hospitalized for acute heart failure (AHF) several times a year. Currently, we have no method for prediction of future developments of AHF. In our center we have investigated the monitoring of lung impedence as a predictor for future deterioration. It was found that a decrease in lung impedence of more than 15% from normal value predicts AHF development with sensitivity of 98%. In this study we try to prove the hypothesis that preventive treatment according to lung impedence value may prevent future hospitalizations for AHF and improve clinical outcome.~Patients recruited by year:~2011 - 50; 2012 - 25; 2013 - 35; 2014 - 30; 2015 - 50; 2016 - 5
| null |
Chronic Congestive Heart Failure
|
* Other: Lung impedence-guided treatment
|
Inclusion Criteria:~Patients suffering from CHF, NYHA II-IV class~LV lower than 35% to LV lower than 45%~Exclusion Criteria:~Patients with additional disease with life-expectancy of less than 2 years
|
18 Years
| null |
All
|
No
|
Primary Purpose: Prevention
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
|
| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Reduction of hospitalization for acute heart failure | | Five years |
|
| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Improved clinical outcome for CHF patients | | Five years |
|
Heart Failure, Heart Diseases, Cardiovascular Diseases
|
| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| No Intervention: Conventional treatment CHF patients<br>One hundred and fifty patients with CHF will be treated according to current guidelines (conventional treatment). | |
| Experimental: Lung impedence-guided treatment<br> | Other: Lung impedence-guided treatment<br>* One hundred fifty patients with CHF will be treated according to common practice and values of lung impedance<br>|
|
Outpatient Lung Impedance-Guided Preventive Therapy in Patients With Chronic Heart Failure (CHF)
Study Overview
=================
Brief Summary
-----------------
Patients suffering from Chronic Heart Failure (CHF) are hospitalized for acute heart failure (AHF) several times a year. Currently, we have no method for prediction of future developments of AHF. In our center we have investigated the monitoring of lung impedence as a predictor for future deterioration. It was found that a decrease in lung impedence of more than 15% from normal value predicts AHF development with sensitivity of 98%. In this study we try to prove the hypothesis that preventive treatment according to lung impedence value may prevent future hospitalizations for AHF and improve clinical outcome. Patients recruited by year: 2011 - 50; 2012 - 25; 2013 - 35; 2014 - 30; 2015 - 50; 2016 - 5
Conditions
-----------------
Chronic Congestive Heart Failure
Intervention / Treatment
-----------------
* Other: Lung impedence-guided treatment
Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Patients suffering from CHF, NYHA II-IV class LV lower than 35% to LV lower than 45% Exclusion Criteria: Patients with additional disease with life-expectancy of less than 2 years
Ages Eligible for Study
-----------------
Minimum Age: 18 Years
Sexes Eligible for Study
-----------------
All
Accepts Healthy Volunteers
-----------------
No
Study Plan
=================
How is the study designed?
-----------------
Design Details
Primary Purpose: Prevention
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Arms and Interventions
| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| No Intervention: Conventional treatment CHF patients<br>One hundred and fifty patients with CHF will be treated according to current guidelines (conventional treatment). | |
| Experimental: Lung impedence-guided treatment<br> | Other: Lung impedence-guided treatment<br>* One hundred fifty patients with CHF will be treated according to common practice and values of lung impedance<br>|
What is the study measuring?
-----------------
Primary Outcome Measures
| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Reduction of hospitalization for acute heart failure | | Five years |
Secondary Outcome Measures
| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Improved clinical outcome for CHF patients | | Five years |
|
||
NCT00231972
|
Enhancing HIV Prevention by Using Behavioral Intervention Among HIV-Infected Men
|
This study will evaluate the effectiveness of a behavioral intervention program versus standard prevention case management in promoting safer sex practices in HIV-infected men.
|
In recent years, the spread of HIV and other STDs has increased, especially among men who have sex with men. This increase signifies continued sexual risk taking within this population. In order to curb the increase of HIV infections, prevention programs are needed. A standard prevention case management program has been developed; however, new programs that further improve outcomes are needed. This study will evaluate the effectiveness of a behavioral intervention program versus standard prevention case management (PCM) in promoting safer sex practices in HIV-infected men.~Participants in this 1-year open-label study will be randomly assigned to receive either PCM alone or a behavioral intervention called Project Enhance, in addition to PCM. The behavioral intervention will be administered by a trained medical social worker on an individual basis. It will include an education component, as well as motivational and behavioral skills enhancement. PCM will entail standard case management, as well as referrals to specific services that each individual may need. Treatment will occur for only the first 3 months, after which follow-up sessions will be held every 3 months for the remainder of the year.
|
Enhancing HIV Prevention Among HIV Infected Men
|
HIV Infections
|
* Behavioral: Project Enhance
* Behavioral: Standard prevention case management (PCM)
|
Inclusion Criteria:~HIV infected~Receives primary health care at Fenway Community Health~Identifies as a man who has sex with men~Has engaged in unprotected anal or vaginal intercourse within 3 months of study enrollment~Exclusion Criteria:~All episodes of unprotected anal intercourse occurred with only a single primary partner who is also HIV infected~Plans to relocate over the upcoming year
|
18 Years
| null |
Male
|
No
|
Primary Purpose: Prevention
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
|
| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Reduction in rates of unprotected anal intercourse from baseline to 12-month follow-up | | Measured at Months 3, 6, 9, and 12 |
|
| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Incidence of sexually transmitted diseases | | Measured at Months 3, 6, 9, and 12 |
| Higher risk-reduction self-efficacy | | Measured at Months 3, 6, 9, and 12 |
| Increased behavioral intentions to engage in safer behaviors | | Measured at Months 3, 6, 9, and 12 |
| Increased risk-reduction strategies (other than condom use) | | Measured at Months 3, 6, 9, and 12 |
|
HIV, MSM
|
HIV Infections, Blood-Borne Infections, Communicable Diseases, Infections, Sexually Transmitted Diseases, Viral, Sexually Transmitted Diseases, Lentivirus Infections, Retroviridae Infections, RNA Virus Infections, Virus Diseases, Genital Diseases, Urogenital Diseases, Immunologic Deficiency Syndromes, Immune System Diseases
|
| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Project Enhance<br>Participants will receive the risk reduction program, Project Enhance | Behavioral: Project Enhance<br>* The behavioral intervention will be administered by a trained medical social worker on an individual basis. It will include an education component, as well as motivational and behavioral skills enhancement. Treatment will occur for only the first 3 months, after which follow-up sessions will be held every 3 months for the remainder of the year.<br>* Other names: Project Enhance Behavioral Intervention;|
| Active Comparator: Active Comparison Condition<br>Participants will receive standard prevention case management | Behavioral: Standard prevention case management (PCM)<br>* Participants will receive standard PCM for HIV prevention.<br>* Other names: Project Enhance Prevention Case Management;|
|
Enhancing HIV Prevention by Using Behavioral Intervention Among HIV-Infected Men
Study Overview
=================
Brief Summary
-----------------
This study will evaluate the effectiveness of a behavioral intervention program versus standard prevention case management in promoting safer sex practices in HIV-infected men.
Detailed Description
-----------------
In recent years, the spread of HIV and other STDs has increased, especially among men who have sex with men. This increase signifies continued sexual risk taking within this population. In order to curb the increase of HIV infections, prevention programs are needed. A standard prevention case management program has been developed; however, new programs that further improve outcomes are needed. This study will evaluate the effectiveness of a behavioral intervention program versus standard prevention case management (PCM) in promoting safer sex practices in HIV-infected men. Participants in this 1-year open-label study will be randomly assigned to receive either PCM alone or a behavioral intervention called Project Enhance, in addition to PCM. The behavioral intervention will be administered by a trained medical social worker on an individual basis. It will include an education component, as well as motivational and behavioral skills enhancement. PCM will entail standard case management, as well as referrals to specific services that each individual may need. Treatment will occur for only the first 3 months, after which follow-up sessions will be held every 3 months for the remainder of the year.
Official Title
-----------------
Enhancing HIV Prevention Among HIV Infected Men
Conditions
-----------------
HIV Infections
Intervention / Treatment
-----------------
* Behavioral: Project Enhance
* Behavioral: Standard prevention case management (PCM)
Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: HIV infected Receives primary health care at Fenway Community Health Identifies as a man who has sex with men Has engaged in unprotected anal or vaginal intercourse within 3 months of study enrollment Exclusion Criteria: All episodes of unprotected anal intercourse occurred with only a single primary partner who is also HIV infected Plans to relocate over the upcoming year
Ages Eligible for Study
-----------------
Minimum Age: 18 Years
Sexes Eligible for Study
-----------------
Male
Accepts Healthy Volunteers
-----------------
No
Study Plan
=================
How is the study designed?
-----------------
Design Details
Primary Purpose: Prevention
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Arms and Interventions
| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Project Enhance<br>Participants will receive the risk reduction program, Project Enhance | Behavioral: Project Enhance<br>* The behavioral intervention will be administered by a trained medical social worker on an individual basis. It will include an education component, as well as motivational and behavioral skills enhancement. Treatment will occur for only the first 3 months, after which follow-up sessions will be held every 3 months for the remainder of the year.<br>* Other names: Project Enhance Behavioral Intervention;|
| Active Comparator: Active Comparison Condition<br>Participants will receive standard prevention case management | Behavioral: Standard prevention case management (PCM)<br>* Participants will receive standard PCM for HIV prevention.<br>* Other names: Project Enhance Prevention Case Management;|
What is the study measuring?
-----------------
Primary Outcome Measures
| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Reduction in rates of unprotected anal intercourse from baseline to 12-month follow-up | | Measured at Months 3, 6, 9, and 12 |
Secondary Outcome Measures
| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Incidence of sexually transmitted diseases | | Measured at Months 3, 6, 9, and 12 |
| Higher risk-reduction self-efficacy | | Measured at Months 3, 6, 9, and 12 |
| Increased behavioral intentions to engage in safer behaviors | | Measured at Months 3, 6, 9, and 12 |
| Increased risk-reduction strategies (other than condom use) | | Measured at Months 3, 6, 9, and 12 |
Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
HIV, MSM
|
NCT03824119
|
Postpartum NSAIDS and Maternal Hypertension
|
Previous studies have suggested that NSAID use causes an increase in blood pressure. Further, blood pressure elevation has been noted in women with pregnancy related hypertensive disease during the postpartum period. NSAIDs remain part of standard postpartum care in women with hypertensive disease. The objective of this study is to determine whether postpartum standard care withholding NSAID use is associated with a clinically significant reduction in postpartum hypertension in women with pregnancy induced hypertension. The investigators hypothesize that women with pregnancy induced hypertensive disease will be half as likely to have blood pressure elevation of 150/100 mmHg in the first 24 hours postpartum.~This study is an open label randomized trial of women with antepartum hypertension. Women will be randomized to receive standard postpartum care or standard postpartum care without NSAIDs. Blood pressure measurements and patient outcomes will be recorded. The study period will begin at the time of delivery and will end at the time of hospital discharge.
|
The objective of this study is to determine whether the withholding of NSAID use is associated with a clinically significant decrease in postpartum hypertension in women with antepartum hypertension. The investigators are interested in whether the use of NSAIDs elevates blood pressure to greater than or equal to 150/100 mmHg (by either systolic or diastolic parameters) more frequently in hypertensive women. The investigators hypothesize that among participants with hypertensive disease associated with pregnancy, those who have NSAIDs withheld from standard postpartum care (experimental arm) will be half as likely to have an increase of blood pressure of 150/100 mmHg in the first 24 hours postpartum compared to participants receiving standard care that includes NSAIDs (control arm).~This trial is a randomized, open label study investigating the effect of NSAID use on blood pressure during the immediate postpartum period in women with chronic hypertension (cHTN) or pregnancy induced hypertension (PIH). The experimental group in this study will be women randomized to withholding NSAIDs during the study period, as women with hypertension routinely receive NSAIDs postpartum. Women with a diagnosis of pregnancy induced hypertension [gestational hypertension (gHTN), preeclampsia, superimposed preeclampsia, ] or cHTN will be enrolled antepartum and will be separated into two groups by the route of delivery: vaginal vs. cesarean delivery. Participants in the control arm will be assigned to receive standard care, which includes NSAIDs (ketorolac, ibuprofen) and participants in the experimental arm will be assigned to receive standard care with NSAIDs withheld in the postpartum period for the duration of hospitalization. The intervention period will last approximately 2-4 days and will conclude at the time of hospital discharge.~Blood pressure measurements will be obtained and recorded routinely in the postpartum period until hospital discharge. More frequent measurements may be performed in the event of severe blood pressure elevations at the discretion of the provider and treating clinical team. Complete Blood Count (CBC) on postpartum Day 1 will be performed as part of standard care. Additional laboratory evaluations will be performed at the discretion of the provider. In addition to blood pressure measurement, pain scale scores will be recorded daily using a Numeric Pain Scale Score. Initiation of anti-hypertensive medication, severe hypertension (BP 160/110 mmHg), treatment with magnesium sulfate and adverse maternal outcomes (cerebrovascular accident, congestive heart failure, pulmonary edema, eclamptic seizure, death) will be documented and abstracted from the medical record.~A power calculation to estimate the appropriate number of subjects needed to detect a difference of 30% in the primary outcome, with an alpha level of 0.05 and 80% power demonstrates that approximately 100 subjects per group (50 in the experimental group and 50 in the control group) will be needed for each delivery route tested (vaginal and cesarean).
|
Effect of Non-steroidal Anti-inflammatory Use on Blood Pressure in Women With Hypertensive Disorders of Pregnancy: A Randomized Open Label Trial
|
Preeclampsia, Gestational Hypertension, Superimposed Preeclampsia, Chronic Hypertension in Obstetric Context
|
* Drug: Ibuprofen 600 mg
* Other: Standard Postpartum Care without NSAIDs
|
Inclusion Criteria:~Women 18 years or older delivering at LAC/USC Hospital~Delivery occurring at or after 20 weeks gestation~Diagnosis of antenatal hypertensive disorder: gestational hypertension, preeclampsia without severe features, preeclampsia with severe features, superimposed preeclampsia, eclampsia, chronic hypertension~Exclusion Criteria:~HELLP Syndrome~Renal dysfunction (Serum Creatinine >1.1 in current pregnancy)~Known liver disease~Low platelet count (<50,000 during hospital admission)~Known sensitivity or allergy to ibuprofen or acetaminophen~Use of therapeutic doses of anticoagulation~Postpartum hemorrhage requiring blood transfusion~Neonate with platelet disorder or thrombocytopenia in breastfeeding mother
|
18 Years
| null |
Female
|
Accepts Healthy Volunteers
|
Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
|
| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Proportion of participants with blood pressure elevation | Incidence of Systolic Blood Pressure of 150 mmHg or Diastolic Blood Pressure of 100 mmHg or above | 24 hours postpartum |
|
| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Proportion of participants with blood pressure elevation | Incidence of Systolic Blood Pressure of 150 mmHg or Diastolic Blood Pressure of 100 mmHg or above | 48, 72 and 96 hours postpartum |
| Number of participants with eclamptic Seizure | Documented occurrence of new onset generalized tonic-clonic seizure(s) or coma in a woman with preeclampsia | Through study completion, up to 6 weeks postpartum |
| Number of participants with stroke | New onset neurologic deficit associated with neuroimaging (CT scan or MRI) evidence of brain infarction or bleeding | Through study completion, up to 6 weeks postpartum |
| Initiation of anti-hypertensive medication | Provider documentation of initiation of anti-hypertensive medication (e.g. nifedipine, labetalol) | Randomization through hospital discharge, an average of 3-7 days |
| Pain numerical rating scale (NRS) score | Numerical pain scale score 0-10; 0= no pain and 10=worst possible pain; total score reported | Randomization through hospital discharge, measured daily, an average of 3-7 days |
| Number of participants with renal failure | Creatinine >1.1 or doubled | Through study completion, up to 6 weeks postpartum |
| Number of participants with pulmonary edema | Evidence of lung infiltrates on chest radiograph or CT scan | Through study completion, up to 6 weeks postpartum |
| Number of participants who die | | From the date of randomization through date of death from any cause, assessed up to 6 weeks postpartum |
| Length of hospital stay | Number of days from delivery to hospital discharge | Through hospital discharge, an average of 3-7 days |
|
Ibuprofen, Anti-Inflammatory Agents, Non-Steroidal, Analgesics, Non-Narcotic, Analgesics, Sensory System Agents, Peripheral Nervous System Agents, Physiological Effects of Drugs, Anti-Inflammatory Agents, Antirheumatic Agents, Cyclooxygenase Inhibitors, Enzyme Inhibitors, Molecular Mechanisms of Pharmacological Action
|
| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: Standard Postpartum Care<br>Subjects will receive NSAIDs (e.g. ibuprofen, ketorolac) for routine postpartum pain management. | Drug: Ibuprofen 600 mg<br>* Standard postpartum care (including administration of NSAIDs)<br>* Other names: Standard Postpartum Care;|
| Active Comparator: Standard Postpartum Care without NSAIDs<br>Subjects will receive standard postpartum care without NSAID administration for pain management. Acetaminophen or narcotics will be substituted for ibuprofen as indicated by provider. | Other: Standard Postpartum Care without NSAIDs<br>* NSAID administration will be withheld from this group.<br>|
|
Postpartum NSAIDS and Maternal Hypertension
Study Overview
=================
Brief Summary
-----------------
Previous studies have suggested that NSAID use causes an increase in blood pressure. Further, blood pressure elevation has been noted in women with pregnancy related hypertensive disease during the postpartum period. NSAIDs remain part of standard postpartum care in women with hypertensive disease. The objective of this study is to determine whether postpartum standard care withholding NSAID use is associated with a clinically significant reduction in postpartum hypertension in women with pregnancy induced hypertension. The investigators hypothesize that women with pregnancy induced hypertensive disease will be half as likely to have blood pressure elevation of 150/100 mmHg in the first 24 hours postpartum. This study is an open label randomized trial of women with antepartum hypertension. Women will be randomized to receive standard postpartum care or standard postpartum care without NSAIDs. Blood pressure measurements and patient outcomes will be recorded. The study period will begin at the time of delivery and will end at the time of hospital discharge.
Detailed Description
-----------------
The objective of this study is to determine whether the withholding of NSAID use is associated with a clinically significant decrease in postpartum hypertension in women with antepartum hypertension. The investigators are interested in whether the use of NSAIDs elevates blood pressure to greater than or equal to 150/100 mmHg (by either systolic or diastolic parameters) more frequently in hypertensive women. The investigators hypothesize that among participants with hypertensive disease associated with pregnancy, those who have NSAIDs withheld from standard postpartum care (experimental arm) will be half as likely to have an increase of blood pressure of 150/100 mmHg in the first 24 hours postpartum compared to participants receiving standard care that includes NSAIDs (control arm). This trial is a randomized, open label study investigating the effect of NSAID use on blood pressure during the immediate postpartum period in women with chronic hypertension (cHTN) or pregnancy induced hypertension (PIH). The experimental group in this study will be women randomized to withholding NSAIDs during the study period, as women with hypertension routinely receive NSAIDs postpartum. Women with a diagnosis of pregnancy induced hypertension [gestational hypertension (gHTN), preeclampsia, superimposed preeclampsia, ] or cHTN will be enrolled antepartum and will be separated into two groups by the route of delivery: vaginal vs. cesarean delivery. Participants in the control arm will be assigned to receive standard care, which includes NSAIDs (ketorolac, ibuprofen) and participants in the experimental arm will be assigned to receive standard care with NSAIDs withheld in the postpartum period for the duration of hospitalization. The intervention period will last approximately 2-4 days and will conclude at the time of hospital discharge. Blood pressure measurements will be obtained and recorded routinely in the postpartum period until hospital discharge. More frequent measurements may be performed in the event of severe blood pressure elevations at the discretion of the provider and treating clinical team. Complete Blood Count (CBC) on postpartum Day 1 will be performed as part of standard care. Additional laboratory evaluations will be performed at the discretion of the provider. In addition to blood pressure measurement, pain scale scores will be recorded daily using a Numeric Pain Scale Score. Initiation of anti-hypertensive medication, severe hypertension (BP 160/110 mmHg), treatment with magnesium sulfate and adverse maternal outcomes (cerebrovascular accident, congestive heart failure, pulmonary edema, eclamptic seizure, death) will be documented and abstracted from the medical record. A power calculation to estimate the appropriate number of subjects needed to detect a difference of 30% in the primary outcome, with an alpha level of 0.05 and 80% power demonstrates that approximately 100 subjects per group (50 in the experimental group and 50 in the control group) will be needed for each delivery route tested (vaginal and cesarean).
Official Title
-----------------
Effect of Non-steroidal Anti-inflammatory Use on Blood Pressure in Women With Hypertensive Disorders of Pregnancy: A Randomized Open Label Trial
Conditions
-----------------
Preeclampsia, Gestational Hypertension, Superimposed Preeclampsia, Chronic Hypertension in Obstetric Context
Intervention / Treatment
-----------------
* Drug: Ibuprofen 600 mg
* Other: Standard Postpartum Care without NSAIDs
Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Women 18 years or older delivering at LAC/USC Hospital Delivery occurring at or after 20 weeks gestation Diagnosis of antenatal hypertensive disorder: gestational hypertension, preeclampsia without severe features, preeclampsia with severe features, superimposed preeclampsia, eclampsia, chronic hypertension Exclusion Criteria: HELLP Syndrome Renal dysfunction (Serum Creatinine >1.1 in current pregnancy) Known liver disease Low platelet count (<50,000 during hospital admission) Known sensitivity or allergy to ibuprofen or acetaminophen Use of therapeutic doses of anticoagulation Postpartum hemorrhage requiring blood transfusion Neonate with platelet disorder or thrombocytopenia in breastfeeding mother
Ages Eligible for Study
-----------------
Minimum Age: 18 Years
Sexes Eligible for Study
-----------------
Female
Accepts Healthy Volunteers
-----------------
Accepts Healthy Volunteers
Study Plan
=================
How is the study designed?
-----------------
Design Details
Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Arms and Interventions
| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: Standard Postpartum Care<br>Subjects will receive NSAIDs (e.g. ibuprofen, ketorolac) for routine postpartum pain management. | Drug: Ibuprofen 600 mg<br>* Standard postpartum care (including administration of NSAIDs)<br>* Other names: Standard Postpartum Care;|
| Active Comparator: Standard Postpartum Care without NSAIDs<br>Subjects will receive standard postpartum care without NSAID administration for pain management. Acetaminophen or narcotics will be substituted for ibuprofen as indicated by provider. | Other: Standard Postpartum Care without NSAIDs<br>* NSAID administration will be withheld from this group.<br>|
What is the study measuring?
-----------------
Primary Outcome Measures
| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Proportion of participants with blood pressure elevation | Incidence of Systolic Blood Pressure of 150 mmHg or Diastolic Blood Pressure of 100 mmHg or above | 24 hours postpartum |
Secondary Outcome Measures
| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Proportion of participants with blood pressure elevation | Incidence of Systolic Blood Pressure of 150 mmHg or Diastolic Blood Pressure of 100 mmHg or above | 48, 72 and 96 hours postpartum |
| Number of participants with eclamptic Seizure | Documented occurrence of new onset generalized tonic-clonic seizure(s) or coma in a woman with preeclampsia | Through study completion, up to 6 weeks postpartum |
| Number of participants with stroke | New onset neurologic deficit associated with neuroimaging (CT scan or MRI) evidence of brain infarction or bleeding | Through study completion, up to 6 weeks postpartum |
| Initiation of anti-hypertensive medication | Provider documentation of initiation of anti-hypertensive medication (e.g. nifedipine, labetalol) | Randomization through hospital discharge, an average of 3-7 days |
| Pain numerical rating scale (NRS) score | Numerical pain scale score 0-10; 0= no pain and 10=worst possible pain; total score reported | Randomization through hospital discharge, measured daily, an average of 3-7 days |
| Number of participants with renal failure | Creatinine >1.1 or doubled | Through study completion, up to 6 weeks postpartum |
| Number of participants with pulmonary edema | Evidence of lung infiltrates on chest radiograph or CT scan | Through study completion, up to 6 weeks postpartum |
| Number of participants who die | | From the date of randomization through date of death from any cause, assessed up to 6 weeks postpartum |
| Length of hospital stay | Number of days from delivery to hospital discharge | Through hospital discharge, an average of 3-7 days |
|
|
NCT02045641
|
Pleural and Pericardial Effusion Following Open Heart Surgery
|
One of the most common postoperative complications after open cardiac surgery is fluid accumulation between the pleural membranes or in the pericardial sac. This study investigates the consequence of such fluid accumulations on physical performance, recovery-time, cardiac and respiratory complications, and quality of life. Half of the participants will be followed closely and offered fluid drainage at a low threshold, and half of the participants will follow the current postoperative regimen.
|
Introduction:~Knowledge concerning the impact of pleural and pericardial effusions on physical performance, recovery-time, cardiac and respiratory complications, and quality of life after open cardiac surgery is scarce. A more aggressive approach towards effusions has been suggested, but further studies are needed.~Objectives:~to determine the size of pleural and pericardial effusion that results in at least 30% reduction of physical performance in the 6-minute walk test.~to compare the improvement in physical performance between the intervention group and the control group, measured from baseline to day 30 after surgery.~Materials and methods:~A randomised controlled intervention trial. Patients admitted for open cardiac surgery (aortic valve surgery, coronary artery bypass graft surgery and combinations) will be randomised into either an intervention group or a control group. The intervention group will be followed with physical tests and ultrasonic examination the month following surgery. Pleural or pericardial effusion of a predefined size will be drained. The control group will follow the current postoperative regimen.
|
The Clinical Impact of an Aggressive Approach Towards Pleural and Pericardial Effusions Following Open Heart Surgery: a Step Towards Standard Guidelines
|
Heart Disease, Pleural Effusion, Pericardial Effusion
|
* Procedure: pleuracentesis
|
Inclusion Criteria:~Age >18 years.~Admitted for elective aortic valve surgery, coronary artery bypass graft surgery or combinations.~Be able to understand the written and oral patient information and to give informed consent.~Exclusion Criteria:~Surgical combinations involving the mitral valve since they are already examined with full echocardiography prior to discharge, which may influence protocol driven decisions.~Simultaneous participation in any other clinical intervention trial
|
18 Years
| null |
All
|
No
|
Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
|
| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| change in walking distance before and after intervention | The primary outcome measure is the change in walking distance before and after pleuracentesis, subsequently the size of pleural effusion (both cm measured on ultrasound and drained volume) that results in a reduction of distance in the 6 minute walk test of at least 30%. | day 4, day 15, day 30 |
|
| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| change in walking distance from baseline to day 30 after surgery | The difference in walking distance from before surgery (day 0) to after surgery (day 30) will be compared between the intervention arm (+ pleuracentesis) and the control arm (standard postoperative regimen) | day 0 and day 30 |
|
cardiac surgery, postoperative treatment, pleural effusion, physical performance
|
Pleural Effusion, Heart Diseases, Pericardial Effusion, Cardiovascular Diseases, Pleural Diseases, Respiratory Tract Diseases
|
| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| No Intervention: current postoperative regimen<br>The group will follow the current postoperative regimen at the surgical ward; screening for pleural effusions with x-ray and further diagnostic procedures in case of symptoms. Treatment will be entirely in the hands of the clinical personnel. | |
| Experimental: pleuracentesis<br>The group will follow the current postoperative regimen. In addition they will be followed with ultrasound examination, clinical examination, spirometry examination and 6 minute walk test. In case of either a) pleural effusion > 400ml OR b) pleural effusion< 400ml with symptoms in rest or during the walk test, the effusion will be drained and examinations will be repeated. In case of pericardial effusion of predefined size and location, either the surgeon on call or a cardiologist will be consulted. | Procedure: pleuracentesis<br>* Direct needle drainage of pleural effusions with dynamic ultrasound technique<br>|
|
Pleural and Pericardial Effusion Following Open Heart Surgery
Study Overview
=================
Brief Summary
-----------------
One of the most common postoperative complications after open cardiac surgery is fluid accumulation between the pleural membranes or in the pericardial sac. This study investigates the consequence of such fluid accumulations on physical performance, recovery-time, cardiac and respiratory complications, and quality of life. Half of the participants will be followed closely and offered fluid drainage at a low threshold, and half of the participants will follow the current postoperative regimen.
Detailed Description
-----------------
Introduction: Knowledge concerning the impact of pleural and pericardial effusions on physical performance, recovery-time, cardiac and respiratory complications, and quality of life after open cardiac surgery is scarce. A more aggressive approach towards effusions has been suggested, but further studies are needed. Objectives: to determine the size of pleural and pericardial effusion that results in at least 30% reduction of physical performance in the 6-minute walk test. to compare the improvement in physical performance between the intervention group and the control group, measured from baseline to day 30 after surgery. Materials and methods: A randomised controlled intervention trial. Patients admitted for open cardiac surgery (aortic valve surgery, coronary artery bypass graft surgery and combinations) will be randomised into either an intervention group or a control group. The intervention group will be followed with physical tests and ultrasonic examination the month following surgery. Pleural or pericardial effusion of a predefined size will be drained. The control group will follow the current postoperative regimen.
Official Title
-----------------
The Clinical Impact of an Aggressive Approach Towards Pleural and Pericardial Effusions Following Open Heart Surgery: a Step Towards Standard Guidelines
Conditions
-----------------
Heart Disease, Pleural Effusion, Pericardial Effusion
Intervention / Treatment
-----------------
* Procedure: pleuracentesis
Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Age >18 years. Admitted for elective aortic valve surgery, coronary artery bypass graft surgery or combinations. Be able to understand the written and oral patient information and to give informed consent. Exclusion Criteria: Surgical combinations involving the mitral valve since they are already examined with full echocardiography prior to discharge, which may influence protocol driven decisions. Simultaneous participation in any other clinical intervention trial
Ages Eligible for Study
-----------------
Minimum Age: 18 Years
Sexes Eligible for Study
-----------------
All
Accepts Healthy Volunteers
-----------------
No
Study Plan
=================
How is the study designed?
-----------------
Design Details
Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Arms and Interventions
| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| No Intervention: current postoperative regimen<br>The group will follow the current postoperative regimen at the surgical ward; screening for pleural effusions with x-ray and further diagnostic procedures in case of symptoms. Treatment will be entirely in the hands of the clinical personnel. | |
| Experimental: pleuracentesis<br>The group will follow the current postoperative regimen. In addition they will be followed with ultrasound examination, clinical examination, spirometry examination and 6 minute walk test. In case of either a) pleural effusion > 400ml OR b) pleural effusion< 400ml with symptoms in rest or during the walk test, the effusion will be drained and examinations will be repeated. In case of pericardial effusion of predefined size and location, either the surgeon on call or a cardiologist will be consulted. | Procedure: pleuracentesis<br>* Direct needle drainage of pleural effusions with dynamic ultrasound technique<br>|
What is the study measuring?
-----------------
Primary Outcome Measures
| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| change in walking distance before and after intervention | The primary outcome measure is the change in walking distance before and after pleuracentesis, subsequently the size of pleural effusion (both cm measured on ultrasound and drained volume) that results in a reduction of distance in the 6 minute walk test of at least 30%. | day 4, day 15, day 30 |
Secondary Outcome Measures
| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| change in walking distance from baseline to day 30 after surgery | The difference in walking distance from before surgery (day 0) to after surgery (day 30) will be compared between the intervention arm (+ pleuracentesis) and the control arm (standard postoperative regimen) | day 0 and day 30 |
Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
cardiac surgery, postoperative treatment, pleural effusion, physical performance
|
NCT01489735
|
The Use of International GerdQ Questionnaire
|
There are three main directions for use GerdQ in practice. First of all, GerdQ can be used to diagnose GERD with an accuracy comparable to the accuracy of diagnosis of GERD by the specialist (gastroenterologist). Using GerdQ can evaluate the impact of disease on the patient's life and help in choosing treatment of GERD, as well as direct assessment of treatment efficacy.~In connection with mentioned above, this study is devoted to the estimation of possibility to use GerdQ in routine practice of Russian physicians.
|
Observational non-interventional study on the use of international GerdQ questionnaire for the diagnosis of gastroesophageal reflux disease in the Russian practice
|
Observational Non-interventional Study on the Use of International GerdQ Questionnaire for the Diagnosis of Gastroesophageal Reflux Disease in the Russian Practice
|
Gastroesophageal Reflux Disease
|
Inclusion Criteria:~Signing of informed consent to participate in the study~patients of both sexes, 18 years and older~planned esophagogastroduodenoscopy~Exclusion Criteria:~Surgical intervention for upper digestive tract (surgery for gastroesophageal reflux disease, peptic ulcer disease, etc.) In the past~the presence of contraindications for esophagogastroduodenoscopy or pH-metry~refusal to sign informed consent~acceptance of antisecretory drugs (proton pump inhibitors, h2-receptor blockers), antacids and prokinetics for 7 days before enrollment~Pregnancy~Confirmed or suspected malignancy~Impairment of the mental sphere~Acceptance of nsaids (including acetylsalicylic acid at a dose of 150 mg / day), cytostatics, antibiotics (tetracyclines, lincosamides) at enrollment and during the preceding 30 days
|
18 Years
| null |
All
|
No
|
| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Sensitivity of GerdQ questionnaire = rate of GERD by GerdQ questionnaire (total score ≥8) / number of patients whose GERD was confirmed by instrumental examinations. | | Up to 6 months |
| Specificity of GerdQ questionnaire = rate of GERD by GerdQ questionnaire (total score <8) / number of patients whose GERD diagnosis was excluded on the basis of instrumental examination | | Up to 6 months |
|
| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Sensitivity of GERD diagnosis made by gastroenterologist = result of completion of GerdQ questionnaire / the results of clinical assessment by gastroenterologist. | | Up to 6 months |
| Frequency of GERD diagnosis based on instrumental examination (endoscopy, pH-metry) in studied patients. | | Up to 6 months |
| Prevalence of GERD with the completed GerdQ questionnaire, which corresponds to the proportion (%) of patients with a total score of ≥ 8 in the questionnaire, among study patients. | | Up to 6 months |
|
GERD, GERD Q QUESTIONNAIRE
|
Gastroesophageal Reflux, Esophageal Motility Disorders, Deglutition Disorders, Esophageal Diseases, Gastrointestinal Diseases, Digestive System Diseases
|
| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| 1<br> | |
|
The Use of International GerdQ Questionnaire
Study Overview
=================
Brief Summary
-----------------
There are three main directions for use GerdQ in practice. First of all, GerdQ can be used to diagnose GERD with an accuracy comparable to the accuracy of diagnosis of GERD by the specialist (gastroenterologist). Using GerdQ can evaluate the impact of disease on the patient's life and help in choosing treatment of GERD, as well as direct assessment of treatment efficacy. In connection with mentioned above, this study is devoted to the estimation of possibility to use GerdQ in routine practice of Russian physicians.
Detailed Description
-----------------
Observational non-interventional study on the use of international GerdQ questionnaire for the diagnosis of gastroesophageal reflux disease in the Russian practice
Official Title
-----------------
Observational Non-interventional Study on the Use of International GerdQ Questionnaire for the Diagnosis of Gastroesophageal Reflux Disease in the Russian Practice
Conditions
-----------------
Gastroesophageal Reflux Disease
Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Signing of informed consent to participate in the study patients of both sexes, 18 years and older planned esophagogastroduodenoscopy Exclusion Criteria: Surgical intervention for upper digestive tract (surgery for gastroesophageal reflux disease, peptic ulcer disease, etc.) In the past the presence of contraindications for esophagogastroduodenoscopy or pH-metry refusal to sign informed consent acceptance of antisecretory drugs (proton pump inhibitors, h2-receptor blockers), antacids and prokinetics for 7 days before enrollment Pregnancy Confirmed or suspected malignancy Impairment of the mental sphere Acceptance of nsaids (including acetylsalicylic acid at a dose of 150 mg / day), cytostatics, antibiotics (tetracyclines, lincosamides) at enrollment and during the preceding 30 days
Ages Eligible for Study
-----------------
Minimum Age: 18 Years
Sexes Eligible for Study
-----------------
All
Accepts Healthy Volunteers
-----------------
No
Study Plan
=================
How is the study designed?
-----------------
Arms and Interventions
| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| 1<br> | |
What is the study measuring?
-----------------
Primary Outcome Measures
| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Sensitivity of GerdQ questionnaire = rate of GERD by GerdQ questionnaire (total score ≥8) / number of patients whose GERD was confirmed by instrumental examinations. | | Up to 6 months |
| Specificity of GerdQ questionnaire = rate of GERD by GerdQ questionnaire (total score <8) / number of patients whose GERD diagnosis was excluded on the basis of instrumental examination | | Up to 6 months |
Secondary Outcome Measures
| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Sensitivity of GERD diagnosis made by gastroenterologist = result of completion of GerdQ questionnaire / the results of clinical assessment by gastroenterologist. | | Up to 6 months |
| Frequency of GERD diagnosis based on instrumental examination (endoscopy, pH-metry) in studied patients. | | Up to 6 months |
| Prevalence of GERD with the completed GerdQ questionnaire, which corresponds to the proportion (%) of patients with a total score of ≥ 8 in the questionnaire, among study patients. | | Up to 6 months |
Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
GERD, GERD Q QUESTIONNAIRE
|
||
NCT02630719
|
Timolol Eye Drops in the Treatment of Acute Migraine Headache
|
The goal of this study is to determine whether timolol eye drops are effective in alleviating acute migraine headaches. Subjects will be randomized to receive either timolol eye drops or placebo (tears) to use as a migraine abortive medication.
|
Timolol Eye Drops in the Treatment of Acute Migraine Headache
|
Migraine
|
* Drug: Timolol eye drops
* Drug: Artificial tears
|
Inclusion Criteria:~Diagnosis of migraine headache~Exclusion Criteria~Non-migraine headache~Use of systemic beta-blocker~Medical history of hypotension, bradycardia, syncope or other significant cardiovascular disease~Medical history of difficulty breathing, asthma or chronic obstructive pulmonary disease or other pulmonary disease~Medical history of glaucoma, ocular hypertension or hypotony, punctual stenosis, current use of other ophthalmic medications~Previous adverse reaction to timolol or other beta-blockers~Inability to self-administer eye drop due to physical or cognitive disorders~Currently pregnant or breastfeeding~Pregnant in the past year~Non-english speaker
|
18 Years
| null |
All
|
No
|
Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: Single
|
| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Timolol Eye Drops in the Treatment of Acute Migraine Headache | Percent of migraine attacks at 0 or 1 on the 4-point Rating Scale recommended by the International Headache Society:~0: no headache~mild headache~moderate headaches~severe headache | 4 months |
|
headache
|
Timolol, Ophthalmic Solutions, Lubricant Eye Drops, Pharmaceutical Solutions, Adrenergic beta-Antagonists, Adrenergic Antagonists, Adrenergic Agents, Neurotransmitter Agents, Molecular Mechanisms of Pharmacological Action, Physiological Effects of Drugs, Anti-Arrhythmia Agents, Antihypertensive Agents
|
| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: Timolol eye drops<br>All subjects received timolol eye drops or placebo (artificial tears) for two months then crossed over to the opposite medication for the final two months of the study. | Drug: Timolol eye drops<br>* eye drops<br>|
| Placebo Comparator: Artificial tears<br>All subjects received timolol eye drops or placebo (artificial tears) for two months then crossed over to the opposite medication for the final two months of the study. | Drug: Artificial tears<br>* Placebo drop<br>|
|
Timolol Eye Drops in the Treatment of Acute Migraine Headache
Study Overview
=================
Brief Summary
-----------------
The goal of this study is to determine whether timolol eye drops are effective in alleviating acute migraine headaches. Subjects will be randomized to receive either timolol eye drops or placebo (tears) to use as a migraine abortive medication.
Official Title
-----------------
Timolol Eye Drops in the Treatment of Acute Migraine Headache
Conditions
-----------------
Migraine
Intervention / Treatment
-----------------
* Drug: Timolol eye drops
* Drug: Artificial tears
Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Diagnosis of migraine headache Exclusion Criteria Non-migraine headache Use of systemic beta-blocker Medical history of hypotension, bradycardia, syncope or other significant cardiovascular disease Medical history of difficulty breathing, asthma or chronic obstructive pulmonary disease or other pulmonary disease Medical history of glaucoma, ocular hypertension or hypotony, punctual stenosis, current use of other ophthalmic medications Previous adverse reaction to timolol or other beta-blockers Inability to self-administer eye drop due to physical or cognitive disorders Currently pregnant or breastfeeding Pregnant in the past year Non-english speaker
Ages Eligible for Study
-----------------
Minimum Age: 18 Years
Sexes Eligible for Study
-----------------
All
Accepts Healthy Volunteers
-----------------
No
Study Plan
=================
How is the study designed?
-----------------
Design Details
Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: Single
Arms and Interventions
| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: Timolol eye drops<br>All subjects received timolol eye drops or placebo (artificial tears) for two months then crossed over to the opposite medication for the final two months of the study. | Drug: Timolol eye drops<br>* eye drops<br>|
| Placebo Comparator: Artificial tears<br>All subjects received timolol eye drops or placebo (artificial tears) for two months then crossed over to the opposite medication for the final two months of the study. | Drug: Artificial tears<br>* Placebo drop<br>|
What is the study measuring?
-----------------
Primary Outcome Measures
| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Timolol Eye Drops in the Treatment of Acute Migraine Headache | Percent of migraine attacks at 0 or 1 on the 4-point Rating Scale recommended by the International Headache Society: 0: no headache mild headache moderate headaches severe headache | 4 months |
Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
headache
|
||
NCT04421625
|
Patients and Health Staff of Cancer Centres During the Covid-19 Pandemic
|
The Covid-19 has, in a few weeks, made the world tremble: the number of deaths (mainly elderly and / or co-morbid) continues to increase, the confinement causes the collapsing of the economy and the decline of relationships inter-human. The data are too fragmented and the disease too recent to know its repercussions on the 3 million French people who have or have had cancer. The investigators would like, in 3 populations: * patients in treatment, * or in follow-up and * health personnel, to constitute a large prospective and longitudinal database of data: i / serological: humoral response, test performance, monitoring of serum immunoglobulin levels , reinfection threshold,…; ii / clinical: incidence, severity, mortality and their favorable factors impact of cancer treatment on Covid-19 infection and modification of the quality of oncological care in the context. In parallel, on a more limited sample of establishments, it will be : * appreciate the economic and functional repercussions, * will try to find out about the infection modalities in patients and health personnel and * will appreciate the levels of anxiety and depression to which health staff are subject.
|
The participation of the study will be offered to each patient when they will come to the centre (by oncologist, radiotherapist, surgeon, ...). For the health staff, the information can be delivered through different channels (posting, mail, mail, intranet...). This will make the informed consent available to all staff. Participation will be voluntary: staff who have read the information note and wish to participate in the study will have to register on the PAPESCO-01 screening schedule, during which they will sign their consent with the occupational physician (or anyone delegated by occupational medicine), then have their first sample and complete the various questionnaires.~The screening of the patients and of the health staff will be done by 2 or 3 techniques depending of the results. The first technic is a blood test done at M0 (inclusion), M3, M6, M9 and M12 and on demand in case of Covid-19 symptoms (rapid serology (immediate analysis), ELISA serology (differed analysis on frozen sample), genotyping of FCGR2A and FCGR3A gens (only at M0)). The second technic nasal swab test (RT-PCR) is done only in case of symptoms (whatever the result of the minute test is) for the hospitalized patients. The results of the tests realised in town will be get back through the questionnaires. The third technic is the questionnaires to the patients and the health staff.
|
Patients and Health Staff of Cancer Centres During the Covid-19 Pandemic: Constitution of a Biological Collection Linked to a Prospective, Multicenter Cohort Study
|
COVID-19
|
* Diagnostic Test: Diagnostic test for SARS-Cov2 for patients and health staff
|
Inclusion Criteria:~Age >= 18 years~Population in Cancer centres responding to one of these 3 definitions: patients having a treatment in process, patients under surveillance ( having completed their treatment for more than a year), health staff.~Subjects who may or may not have had an infection compatible or proven with a Covid-19 infection.~Information to the participants and signature of the informed consent.~Subject affiliated with a social insurance~Exclusion Criteria:~Refusal of consent~Patients who are unable to consent or have a psychiatric history~Inability to submit to the medical follow-up of the study for geographical, social or psychological reasons~Person under guardianship or protection of vulnerable adults~Person deprived of liberty by a judicial or administrative decision
|
18 Years
| null |
All
|
Accepts Healthy Volunteers
|
Primary Purpose: Screening
Intervention Model: Single Group Assignment
Masking: None (Open Label)
|
| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Establishment of a clinical basis for to describe the number and severity of Covid-19 infections in Cancer centres staff and patients. | The clinical basis will done through a Covid 19 clinical signs follow-up questionnaire. | 12 months |
| Establishment of a biological basis for to describe the number and severity of Covid-19 infections in Cancer centres staff and patients. | The biological basis will be done through the serologic status (rapid immunochromatography test) and IgM and IgG titles (immuno-enzymatic assay like ELISA) performed at M0.~The result of the SARS-CoV-2 coronavirus genome detection tests (molecular test by RT-PCR) conducted in town will be collected by questionnaire. | 15 days |
| Establishment of a biological basis for to describe the number and severity of Covid-19 infections in Cancer centres staff and patients. | The biological basis will be done through the serologic status (rapid immunochromatography test) and IgM and IgG titles (immuno-enzymatic assay like ELISA) performed at M3.~The result of the SARS-CoV-2 coronavirus genome detection tests (molecular test by RT-PCR) conducted in town will be collected by questionnaire. | 3 months |
| Establishment of a biological basis for to describe the number and severity of Covid-19 infections in Cancer centres staff and patients. | The biological basis will be done through the serologic status (rapid immunochromatography test) and IgM and IgG titles (immuno-enzymatic assay like ELISA) performed at M6.~The result of the SARS-CoV-2 coronavirus genome detection tests (molecular test by RT-PCR) conducted in town will be collected by questionnaire. | 6 months |
| Establishment of a biological basis for to describe the number and severity of Covid-19 infections in Cancer centres staff and patients. | The biological basis will be done through the serologic status (rapid immunochromatography test) and IgM and IgG titles (immuno-enzymatic assay like ELISA) performed at M9.~The result of the SARS-CoV-2 coronavirus genome detection tests (molecular test by RT-PCR) conducted in town will be collected by questionnaire. | 9 months |
| Establishment of a biological basis for to describe the number and severity of Covid-19 infections in Cancer centres staff and patients. | The biological basis will be done through the serologic status (rapid immunochromatography test) and IgM and IgG titles (immuno-enzymatic assay like ELISA) performed at M12.~The result of the SARS-CoV-2 coronavirus genome detection tests (molecular test by RT-PCR) conducted in town will be collected by questionnaire. | 12 months |
|
| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Dosage of IgM and IgG anti SARS-CoV2 | The evaluation will be done through the dosage of IgM and IgG anti-SARS-CoV2 at different time of measurement M0, M3, M6, M9 and M12 using a qualitive immunochomatographic test and quantitative ELISA test. | screening period, 3 months, 6 monthes, 9 months and 12 months |
| Evaluate the diagnostic performance of the minute test for IgM | The result obtained by the qualitative minute test for IgM will be compared to the quantitative ELISA test to know the specificity, sensitivity, positive predictive value, negative predictive value | 12 months |
| Evaluate the quantification of IgG in long term (M12) in the Cancer Centres populations | The quantification of IgG level at M12 will be obtained by using the quantitative ELISA test for patients in cancer centres and health staff. | 12 months |
| Evaluate the frequency of reinfections among the persons who have developed IgG | The evaluation will be done on subjects who had previously developed IgG and have clinical signs of Covid-19. The signs will be confirmed by RT-PCR which detect the RNA of SARS-CoV2 using a nasal swab test. | 12 months |
| Evaluate the threshold of protective IgG among the subjects who have developed IgG | The evaluation is based on whether or not a reinfection occurs during follow-up and it will be done by the concentration of IgG anti-SARS-CoV2 using the quantitative ELISA test. | 12 months |
| Evaluate the influence of polymorphisms of receptor of IgG Fc-gamma low-affinity (FcδIIA, FcδIIIa) on the humoral immune response | The evaluation will be done by analysing the anti-SARS-CoV2 antibodies according to the FCGR2A and FCGR3A genotypes using RT-PCR | 12 months |
| Evaluate the severity of Covid-19 infection (invisible, visible, prolonged, severe and fatal) by age group | The evaluation will be done by knowing the number of Covid-19-realated death, severe infections (oxygen therapy needed), moderate infections, prolonged symptomatic infections and asymptomatic infections reported to all subjects with a positive serology and/or a positive RT-PCR test. | 12 months |
| Evaluate the frequency of reinfection by Covid-19 (recurrence of evocative clinical symptoms and positive viral PCR or positive IgM serology) during follow-up | The evaluation will be done by knowing the number of subjects who have a recurrence of clinical symptoms and/or positive SARS-CoV2 RT-PCR and/or a positive IgM serology (by the quantitative ELISA test or the qualitative minute test) | 12 months |
| Evaluate the risk factors (clinical and therapeutic) to develop severe forms of Covid-19 infection in patients | The evaluation will be done on subjects who have a seropositivity and/or a positive SARS-CoV2 RT-PCR and/or a positive IgM serology (by the ELISA test or the minute test). The factors that are significantly associated to severe forms or mortality are : current or recent cancer treatment (Immunotherapy, chemotherapy based on the frequency of grade 3/4 neutropenia and/or lymphopenia), radiation therapy, surgery), concomitant treatment, comorbidities, type of cancer and stage, cancer-related medical history, biological markers | 12 months |
| Evaluate the changes in health care practice | The evaluation will be done by using the PMSI (Program of medicalisation of information systems). This program allows describing the medical activity in health establishment. It is divided in 4 domains: MCO (Medicine, Surgery, Obstetric and Odontology), Follow-up care and rehabilitation, psychiatry, and home care | 12 months |
| Evaluate the resources associated with organizational changes | The evaluation will be done by identifying the monetary value of resources mobilized more or less according to the observed changes at the level of modifications in patient treatment scheme (e.g. chemotherapy, radiotherapy and surgery), teleconsultations, and diagnostic of new cancers | 12 months |
| Evaluate the allocated resources | The evaluation will be done by knowing the number of health staff sick leave. The information will be obtained with the human resources data and work medicine. | 12 months |
| Evaluate the incidence of Covid-19 infections | The incidence will be obtained by counting the number of subjects infected by SARS-CoV2 (patients and health staff) every four months | 12 months |
| Evaluate the distribution of risk factors for contamination in patients and in the general population | The evaluation will be done by doing percentages (qualitative factors) / Average or median (quantitative variables) using the Constances cohort for the general population | 12 months |
| Evaluate the anxiety state over time | The evaluation will be done before the screening, 3, 6, 9 and 12 months after the screening through the STAI state (State-Trait Anxiety Inventory) questionnaire with 20 items. It evaluates the felling of apprehension, tension, nervousness, anxiety. It is composed of 20 questions. Each answer is noted form 1 to 4. A high score (more than 48 for men and 55 for women) represents a high level of anxiety. | screening period, 3 months, 6 monthes, 9 months and 12 months |
| Evaluate the depression over time | The Depression is evaluated before the screening, 3, 6, 9 and 12 months after the screening through the HADS (Hospital Anxiety and Depression Scale) questionnaire with 14 items. Each answer is coded from 0 to 3.The global score variates from 0 to 42. A high score (from 15 to 42) represents the existence of an anxio-depressive syndrome. | screening period, 3 months, 6 monthes, 9 months and 12 months |
| Evaluate the post-traumatic developments | The post-traumatic development is evaluated with the PTGI (post-Traumatic Growth Inventory) with 21 items. Each answer is noted from 0 to 5. A high score represents a change to a very great degree. It evaluates the positive changes perceives such as relating to others, news possibilities, personal strength, spiritual change and appreciation life | 12 months |
| Evaluate the change in health care change frequency | The evaluation will be done by analysing the number of time the health care of the patient has been changed using the medical file of the patient. | 12 months |
| Evaluate the number of patients concerned by health care changes | The evaluation will be done by analysing the medical file of the patient and calculate the number of patients for which the health care has been changed. | 12 months |
| Evaluate the rate of morbidity | The rate of morbidity will be obtained by calculating the number of new cases of disease occurring during the study with the help of the medical file of each patient. | 12 months |
| Evaluate the rate of mortality | The rate of mortality will be obtained by calculating the ratio of actual deaths to expected deaths. | 12 months |
|
COVID-19, Cancer patients, Health staff
|
COVID-19, Pneumonia, Viral, Pneumonia, Respiratory Tract Infections, Infections, Virus Diseases, Coronavirus Infections, Coronaviridae Infections, Nidovirales Infections, RNA Virus Infections, Lung Diseases, Respiratory Tract Diseases
|
| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Diagnostic test for SARS-Cov2 for patients and health staff<br>Blood test (rapid serology (immediate analysis), ELISA serology (differed analysis on frozen sample), genotyping of FCGR2A and FCGR3A gens)~Nasal swab test (only if the patient has symptoms)~Questionnaires | Diagnostic Test: Diagnostic test for SARS-Cov2 for patients and health staff<br>* Diagnostic test for SARS-CoV2 :~Blood test to analyse the IgG and IgM with an immediate qualitative analysis (serological test) and a differed quantitative analysis (ELISA test)~Results of nasal swab that will allow extracting the RNA and realizing a RT-PCR (only if the participants present symptoms). It will be obtained by standard local laboratories.~Questionnaires (based on serology, clinic, economy (socio-demographic and lifestyle questionnaire) and epidemiology)<br>|
|
Patients and Health Staff of Cancer Centres During the Covid-19 Pandemic
Study Overview
=================
Brief Summary
-----------------
The Covid-19 has, in a few weeks, made the world tremble: the number of deaths (mainly elderly and / or co-morbid) continues to increase, the confinement causes the collapsing of the economy and the decline of relationships inter-human. The data are too fragmented and the disease too recent to know its repercussions on the 3 million French people who have or have had cancer. The investigators would like, in 3 populations: * patients in treatment, * or in follow-up and * health personnel, to constitute a large prospective and longitudinal database of data: i / serological: humoral response, test performance, monitoring of serum immunoglobulin levels , reinfection threshold,…; ii / clinical: incidence, severity, mortality and their favorable factors impact of cancer treatment on Covid-19 infection and modification of the quality of oncological care in the context. In parallel, on a more limited sample of establishments, it will be : * appreciate the economic and functional repercussions, * will try to find out about the infection modalities in patients and health personnel and * will appreciate the levels of anxiety and depression to which health staff are subject.
Detailed Description
-----------------
The participation of the study will be offered to each patient when they will come to the centre (by oncologist, radiotherapist, surgeon, ...). For the health staff, the information can be delivered through different channels (posting, mail, mail, intranet...). This will make the informed consent available to all staff. Participation will be voluntary: staff who have read the information note and wish to participate in the study will have to register on the PAPESCO-01 screening schedule, during which they will sign their consent with the occupational physician (or anyone delegated by occupational medicine), then have their first sample and complete the various questionnaires. The screening of the patients and of the health staff will be done by 2 or 3 techniques depending of the results. The first technic is a blood test done at M0 (inclusion), M3, M6, M9 and M12 and on demand in case of Covid-19 symptoms (rapid serology (immediate analysis), ELISA serology (differed analysis on frozen sample), genotyping of FCGR2A and FCGR3A gens (only at M0)). The second technic nasal swab test (RT-PCR) is done only in case of symptoms (whatever the result of the minute test is) for the hospitalized patients. The results of the tests realised in town will be get back through the questionnaires. The third technic is the questionnaires to the patients and the health staff.
Official Title
-----------------
Patients and Health Staff of Cancer Centres During the Covid-19 Pandemic: Constitution of a Biological Collection Linked to a Prospective, Multicenter Cohort Study
Conditions
-----------------
COVID-19
Intervention / Treatment
-----------------
* Diagnostic Test: Diagnostic test for SARS-Cov2 for patients and health staff
Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Age >= 18 years Population in Cancer centres responding to one of these 3 definitions: patients having a treatment in process, patients under surveillance ( having completed their treatment for more than a year), health staff. Subjects who may or may not have had an infection compatible or proven with a Covid-19 infection. Information to the participants and signature of the informed consent. Subject affiliated with a social insurance Exclusion Criteria: Refusal of consent Patients who are unable to consent or have a psychiatric history Inability to submit to the medical follow-up of the study for geographical, social or psychological reasons Person under guardianship or protection of vulnerable adults Person deprived of liberty by a judicial or administrative decision
Ages Eligible for Study
-----------------
Minimum Age: 18 Years
Sexes Eligible for Study
-----------------
All
Accepts Healthy Volunteers
-----------------
Accepts Healthy Volunteers
Study Plan
=================
How is the study designed?
-----------------
Design Details
Primary Purpose: Screening
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Arms and Interventions
| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Diagnostic test for SARS-Cov2 for patients and health staff<br>Blood test (rapid serology (immediate analysis), ELISA serology (differed analysis on frozen sample), genotyping of FCGR2A and FCGR3A gens) Nasal swab test (only if the patient has symptoms) Questionnaires | Diagnostic Test: Diagnostic test for SARS-Cov2 for patients and health staff<br>* Diagnostic test for SARS-CoV2 : Blood test to analyse the IgG and IgM with an immediate qualitative analysis (serological test) and a differed quantitative analysis (ELISA test) Results of nasal swab that will allow extracting the RNA and realizing a RT-PCR (only if the participants present symptoms). It will be obtained by standard local laboratories. Questionnaires (based on serology, clinic, economy (socio-demographic and lifestyle questionnaire) and epidemiology)<br>|
What is the study measuring?
-----------------
Primary Outcome Measures
| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Establishment of a clinical basis for to describe the number and severity of Covid-19 infections in Cancer centres staff and patients. | The clinical basis will done through a Covid 19 clinical signs follow-up questionnaire. | 12 months |
| Establishment of a biological basis for to describe the number and severity of Covid-19 infections in Cancer centres staff and patients. | The biological basis will be done through the serologic status (rapid immunochromatography test) and IgM and IgG titles (immuno-enzymatic assay like ELISA) performed at M0. The result of the SARS-CoV-2 coronavirus genome detection tests (molecular test by RT-PCR) conducted in town will be collected by questionnaire. | 15 days |
| Establishment of a biological basis for to describe the number and severity of Covid-19 infections in Cancer centres staff and patients. | The biological basis will be done through the serologic status (rapid immunochromatography test) and IgM and IgG titles (immuno-enzymatic assay like ELISA) performed at M3. The result of the SARS-CoV-2 coronavirus genome detection tests (molecular test by RT-PCR) conducted in town will be collected by questionnaire. | 3 months |
| Establishment of a biological basis for to describe the number and severity of Covid-19 infections in Cancer centres staff and patients. | The biological basis will be done through the serologic status (rapid immunochromatography test) and IgM and IgG titles (immuno-enzymatic assay like ELISA) performed at M6. The result of the SARS-CoV-2 coronavirus genome detection tests (molecular test by RT-PCR) conducted in town will be collected by questionnaire. | 6 months |
| Establishment of a biological basis for to describe the number and severity of Covid-19 infections in Cancer centres staff and patients. | The biological basis will be done through the serologic status (rapid immunochromatography test) and IgM and IgG titles (immuno-enzymatic assay like ELISA) performed at M9. The result of the SARS-CoV-2 coronavirus genome detection tests (molecular test by RT-PCR) conducted in town will be collected by questionnaire. | 9 months |
| Establishment of a biological basis for to describe the number and severity of Covid-19 infections in Cancer centres staff and patients. | The biological basis will be done through the serologic status (rapid immunochromatography test) and IgM and IgG titles (immuno-enzymatic assay like ELISA) performed at M12. The result of the SARS-CoV-2 coronavirus genome detection tests (molecular test by RT-PCR) conducted in town will be collected by questionnaire. | 12 months |
Secondary Outcome Measures
| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Dosage of IgM and IgG anti SARS-CoV2 | The evaluation will be done through the dosage of IgM and IgG anti-SARS-CoV2 at different time of measurement M0, M3, M6, M9 and M12 using a qualitive immunochomatographic test and quantitative ELISA test. | screening period, 3 months, 6 monthes, 9 months and 12 months |
| Evaluate the diagnostic performance of the minute test for IgM | The result obtained by the qualitative minute test for IgM will be compared to the quantitative ELISA test to know the specificity, sensitivity, positive predictive value, negative predictive value | 12 months |
| Evaluate the quantification of IgG in long term (M12) in the Cancer Centres populations | The quantification of IgG level at M12 will be obtained by using the quantitative ELISA test for patients in cancer centres and health staff. | 12 months |
| Evaluate the frequency of reinfections among the persons who have developed IgG | The evaluation will be done on subjects who had previously developed IgG and have clinical signs of Covid-19. The signs will be confirmed by RT-PCR which detect the RNA of SARS-CoV2 using a nasal swab test. | 12 months |
| Evaluate the threshold of protective IgG among the subjects who have developed IgG | The evaluation is based on whether or not a reinfection occurs during follow-up and it will be done by the concentration of IgG anti-SARS-CoV2 using the quantitative ELISA test. | 12 months |
| Evaluate the influence of polymorphisms of receptor of IgG Fc-gamma low-affinity (FcδIIA, FcδIIIa) on the humoral immune response | The evaluation will be done by analysing the anti-SARS-CoV2 antibodies according to the FCGR2A and FCGR3A genotypes using RT-PCR | 12 months |
| Evaluate the severity of Covid-19 infection (invisible, visible, prolonged, severe and fatal) by age group | The evaluation will be done by knowing the number of Covid-19-realated death, severe infections (oxygen therapy needed), moderate infections, prolonged symptomatic infections and asymptomatic infections reported to all subjects with a positive serology and/or a positive RT-PCR test. | 12 months |
| Evaluate the frequency of reinfection by Covid-19 (recurrence of evocative clinical symptoms and positive viral PCR or positive IgM serology) during follow-up | The evaluation will be done by knowing the number of subjects who have a recurrence of clinical symptoms and/or positive SARS-CoV2 RT-PCR and/or a positive IgM serology (by the quantitative ELISA test or the qualitative minute test) | 12 months |
| Evaluate the risk factors (clinical and therapeutic) to develop severe forms of Covid-19 infection in patients | The evaluation will be done on subjects who have a seropositivity and/or a positive SARS-CoV2 RT-PCR and/or a positive IgM serology (by the ELISA test or the minute test). The factors that are significantly associated to severe forms or mortality are : current or recent cancer treatment (Immunotherapy, chemotherapy based on the frequency of grade 3/4 neutropenia and/or lymphopenia), radiation therapy, surgery), concomitant treatment, comorbidities, type of cancer and stage, cancer-related medical history, biological markers | 12 months |
| Evaluate the changes in health care practice | The evaluation will be done by using the PMSI (Program of medicalisation of information systems). This program allows describing the medical activity in health establishment. It is divided in 4 domains: MCO (Medicine, Surgery, Obstetric and Odontology), Follow-up care and rehabilitation, psychiatry, and home care | 12 months |
| Evaluate the resources associated with organizational changes | The evaluation will be done by identifying the monetary value of resources mobilized more or less according to the observed changes at the level of modifications in patient treatment scheme (e.g. chemotherapy, radiotherapy and surgery), teleconsultations, and diagnostic of new cancers | 12 months |
| Evaluate the allocated resources | The evaluation will be done by knowing the number of health staff sick leave. The information will be obtained with the human resources data and work medicine. | 12 months |
| Evaluate the incidence of Covid-19 infections | The incidence will be obtained by counting the number of subjects infected by SARS-CoV2 (patients and health staff) every four months | 12 months |
| Evaluate the distribution of risk factors for contamination in patients and in the general population | The evaluation will be done by doing percentages (qualitative factors) / Average or median (quantitative variables) using the Constances cohort for the general population | 12 months |
| Evaluate the anxiety state over time | The evaluation will be done before the screening, 3, 6, 9 and 12 months after the screening through the STAI state (State-Trait Anxiety Inventory) questionnaire with 20 items. It evaluates the felling of apprehension, tension, nervousness, anxiety. It is composed of 20 questions. Each answer is noted form 1 to 4. A high score (more than 48 for men and 55 for women) represents a high level of anxiety. | screening period, 3 months, 6 monthes, 9 months and 12 months |
| Evaluate the depression over time | The Depression is evaluated before the screening, 3, 6, 9 and 12 months after the screening through the HADS (Hospital Anxiety and Depression Scale) questionnaire with 14 items. Each answer is coded from 0 to 3.The global score variates from 0 to 42. A high score (from 15 to 42) represents the existence of an anxio-depressive syndrome. | screening period, 3 months, 6 monthes, 9 months and 12 months |
| Evaluate the post-traumatic developments | The post-traumatic development is evaluated with the PTGI (post-Traumatic Growth Inventory) with 21 items. Each answer is noted from 0 to 5. A high score represents a change to a very great degree. It evaluates the positive changes perceives such as relating to others, news possibilities, personal strength, spiritual change and appreciation life | 12 months |
| Evaluate the change in health care change frequency | The evaluation will be done by analysing the number of time the health care of the patient has been changed using the medical file of the patient. | 12 months |
| Evaluate the number of patients concerned by health care changes | The evaluation will be done by analysing the medical file of the patient and calculate the number of patients for which the health care has been changed. | 12 months |
| Evaluate the rate of morbidity | The rate of morbidity will be obtained by calculating the number of new cases of disease occurring during the study with the help of the medical file of each patient. | 12 months |
| Evaluate the rate of mortality | The rate of mortality will be obtained by calculating the ratio of actual deaths to expected deaths. | 12 months |
Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
COVID-19, Cancer patients, Health staff
|
NCT05112328
|
The Effects of Pancreatic Enzyme Supplementation in Critically Ill Patients on Enteral Feeding
|
Determine the effect of high-dose pancreatic enzyme supplementation on nutritional indicators and clinical course in critically ill patients undergoing enteral nutrition.
|
The Effects of Pancreatic Enzyme Supplementation in Critically Ill Patients on Enteral Feeding: Prospective Randomized Controlled Trial
|
Critically Ill, Enteral Feeding, Exocrine Pancreatic Insufficiency
|
* Drug: Exocrine Pancreatic Enzyme
* Drug: Placebo
|
Inclusion Criteria:~Adults 19 years and older~Hospitalized in the surgical/medical intensive care unit of the Seoul National University Hospital~Enteral nutrition~Patients who consented to this study~Patients with risk factors for pancreatic exocrine dysfunction~Shock (Norepinephrine)~Sepsis (3 rd definition of sepsis)~Diabetes~Cardiac arrest~hyperlactatemia serum lactate > 2 mmol/L)~Mechanical ventilation~Continuous renal replacement therapy~Exclusion Criteria:~chronic pancreatitis~unresectable pancreatic cancer~History of pancreatectomy~Underlying diseases in which the effect of Exocrine pancreatic enzyme administration is difficult to show~Inflammatory bowel disease~Short bowel syndrome
|
18 Years
| null |
All
|
No
|
Primary Purpose: Supportive Care
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple
|
| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change of Phase angle (°) | Change from Baseline Phase angle (°) at 2 weeks or discharge | Baseline, 7 days after starting enteral nutrition, 14 days after starting enteral nutrition |
|
| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Skeletal Muscle Mass (SMM) (kg) | Skeletal Muscle Mass (SMM) (kg) | Baseline, 7 days after starting enteral nutrition, 14 days after starting enteral nutrition |
|
Exocrine Pancreatic Insufficiency, Critical Illness, Disease Attributes, Pathologic Processes, Pancreatic Diseases, Digestive System Diseases
|
| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Intervention<br>Exocrine Pacancreatic enzyme(Norzyme Capsule 40000 capsules) after meals 3 times a day | Drug: Exocrine Pancreatic Enzyme<br>* Pancreatic enzyme supplementation for critically ill patients on enteral nutrition<br>* Other names: Norzyme;|
| Placebo Comparator: Control<br>Placebo after meals 3 times a day | Drug: Placebo<br>* Placebo of Pancreatic enzyme for critically ill patients on enteral nutrition<br>|
|
The Effects of Pancreatic Enzyme Supplementation in Critically Ill Patients on Enteral Feeding
Study Overview
=================
Brief Summary
-----------------
Determine the effect of high-dose pancreatic enzyme supplementation on nutritional indicators and clinical course in critically ill patients undergoing enteral nutrition.
Official Title
-----------------
The Effects of Pancreatic Enzyme Supplementation in Critically Ill Patients on Enteral Feeding: Prospective Randomized Controlled Trial
Conditions
-----------------
Critically Ill, Enteral Feeding, Exocrine Pancreatic Insufficiency
Intervention / Treatment
-----------------
* Drug: Exocrine Pancreatic Enzyme
* Drug: Placebo
Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Adults 19 years and older Hospitalized in the surgical/medical intensive care unit of the Seoul National University Hospital Enteral nutrition Patients who consented to this study Patients with risk factors for pancreatic exocrine dysfunction Shock (Norepinephrine) Sepsis (3 rd definition of sepsis) Diabetes Cardiac arrest hyperlactatemia serum lactate > 2 mmol/L) Mechanical ventilation Continuous renal replacement therapy Exclusion Criteria: chronic pancreatitis unresectable pancreatic cancer History of pancreatectomy Underlying diseases in which the effect of Exocrine pancreatic enzyme administration is difficult to show Inflammatory bowel disease Short bowel syndrome
Ages Eligible for Study
-----------------
Minimum Age: 18 Years
Sexes Eligible for Study
-----------------
All
Accepts Healthy Volunteers
-----------------
No
Study Plan
=================
How is the study designed?
-----------------
Design Details
Primary Purpose: Supportive Care
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple
Arms and Interventions
| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Intervention<br>Exocrine Pacancreatic enzyme(Norzyme Capsule 40000 capsules) after meals 3 times a day | Drug: Exocrine Pancreatic Enzyme<br>* Pancreatic enzyme supplementation for critically ill patients on enteral nutrition<br>* Other names: Norzyme;|
| Placebo Comparator: Control<br>Placebo after meals 3 times a day | Drug: Placebo<br>* Placebo of Pancreatic enzyme for critically ill patients on enteral nutrition<br>|
What is the study measuring?
-----------------
Primary Outcome Measures
| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change of Phase angle (°) | Change from Baseline Phase angle (°) at 2 weeks or discharge | Baseline, 7 days after starting enteral nutrition, 14 days after starting enteral nutrition |
Secondary Outcome Measures
| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Skeletal Muscle Mass (SMM) (kg) | Skeletal Muscle Mass (SMM) (kg) | Baseline, 7 days after starting enteral nutrition, 14 days after starting enteral nutrition |
|
||
NCT04523298
|
Use of Non-ablative Vaginal Erbium YAG Laser for the Treatment of Prolapse
|
This is a single center, investigator initiated study, sponsored by the UZ Leuven, Leuven, Belgium; comparing laser treatment to pelvic floor exercises (PFE).~Women with symptomatic prolapse (grade II-IV) who seek for a conservative treatment, with no history of previous POP-surgery will be randomised to either the laser-arm or the PFE-arm.~There are 3 visits where vaginal application of laser will be performed, with a 4-weeks interval. Each application lasts around 15 minutes. The vaginal laser procedure will be performed in an outpatient setting, not requiring any specific preparation, analgesia or anesthesia, by one of two experienced operators.~The primary objective is to evaluate the effects of VEL treatment for reduction of prolapse symptoms and as a secondary outcome objective measurements. These endpoints are in line with the recommendations by Durnea et al., as being the most relevant and patient centered outcomes.~The second goals are to register adverse events and to determine for how long the effects of laser are sustained, with a maximum of two years. To do so, the investigators will measure long term satisfaction with, and the longevity of the effect (measured by the need for repeat or alternative therapy) of laser therapy.~Duration of follow-up per patient: max 27 months
|
Use of Non-ablative Vaginal Erbium YAG Laser for the Treatment of Prolapse: a Randomized Controlled Clinical Trial
|
Prolapse
|
* Procedure: Non-ablative vaginal Erbium YAG laser treatment
* Other: Pelvic floor exercises (PFE)
|
Inclusion Criteria:~The presence of POP symptoms~Diagnosis of cystocele or rectocele of grade II to IV according to the POP-Q system, leading the prolapse (i.e. C ≤ Ba/Bp)~Voluntary informed consent~Exclusion Criteria:~Symptoms or anatomical evidence for intussusception / rectal prolapse~Leading descent of the middle compartment (C > Ba/Bp)~Grade IV prolapse~Previous POP surgery~Pregnancy or <12 months postpartum~Vaginal bleeding, injuries or infection in the treated area
|
18 Years
| null |
Female
|
Accepts Healthy Volunteers
|
Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
|
| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Primary outcome is the subjective improvement of POP symptoms, assessed by the Pelvic Organ Prolapse Distress Inventory-6 (POPDI-6). | Participants have to answer 6 questions concerning POP symptoms with a response scale from 0 to 4 (not present (=0), not at all (=1), somewhat (=2), moderately (=3), quite a bit (=4)). The score (range 0 to 100) is then obtained by multiplying the mean value of all of the answered items by 25. Missing items are dealt with by using the mean from answered items only. Higher scores indicate more distress. This questionnaire is available and validated in English, Dutch and French. Success is defined as a reduction in scores of at least 25% compared with baseline. | 6 months after last treatment |
|
| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Assessment of the anatomical success rate by means of the POP-Q system | Anatomical success is defined as POP-Q = grade 0 (no prolapse) or grade I (leading edge < -1cm) | At every visit (ie. week 4, 8 and 12, optional: 16, 20 and 24 weeks), 6, 12 and 24 months after end of treatment |
| Assessment of the rate of patient satisfaction by means of the Patient Global Impression of Improvement (PGI) | a 5-point Likert scale (1=much worse, 2=worse, 3=same, 4=better, 5=much better) | At every visit (ie. week 4, 8 and 12, optional: 16, 20 and 24 weeks), 6, 12 and 24 months after end of treatment |
| Assessment of the degree of discomfort of the treatment procedure by the patient | VAS-score (Visual Analogue Scale: 0-10cm, continuous scale); the higher the score, the higher the discomfort | At every visit (ie. week 4, 8 and 12, optional: 16, 20 and 24 weeks), 6, 12 and 24 months after end of treatment |
| Assessment of the longevity of the effect of laser therapy | Measured by the need for repeating the same, or initiating an alternative therapy | At every visit (ie. week 4, 8 and 12), end of treatment (ie. 4 months after randomisation), 6, 12 and 24 months after end of treatment |
| Assessment of sexual function, by means of the Pelvic Organ prolapse/Urinary Incontinence Sexual Questionnaire IUGA revised (PISQ-IR) | The PISQ-IR is a questionnaire with twenty questions. Q1 is a question to divide the patients based on sexual activity. Not sexually active (NSA) women are referred to Q2-Q6. Sexually active (SA) women are asked to fill out Q7-Q20. The questionnaire for NSA women consists of five questions or 12 items. A higher score refers to a higher impact of PFD on sexual functioning. The questionnaire for SA women consists of 14 questions wherein women with a partner have to fill out all 14, being 22 items. Women without partner can skip questions 13 and 14, filling out 19 items. A lower score refers to a lower impact of PFD on sexual functioning. This questionnaire is available and validated in English, Dutch and French. | At every visit (ie. week 4, 8 and 12, optional: 16, 20 and 24 weeks), 6, 12 and 24 months after end of treatment |
| Assessment of urinary symptoms by means of the Urogenital Distress Inventory (UDI-6) | The final UDI-6 score is calculated by adding all scores as explained in the above, and dividing the result to 6 to obtain a mean value which is in turn multiplied by 25 to obtain the scale score. The score varies from 0 to 100. The basic interpretation of the score is that the higher the score, the higher the disability. This questionnaire is available and validated in English, Dutch and French. | At every visit (ie. week 4, 8 and 12, optional: 16, 20 and 24 weeks), 6, 12 and 24 months after end of treatment |
|
laser, pelvic floor treatment
|
Prolapse, Pathological Conditions, Anatomical
|
| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Laser<br> | Procedure: Non-ablative vaginal Erbium YAG laser treatment<br>* There are 3 visits where vaginal application of laser will be performed, with a 4-weeks interval. If needed, 3 extra laser applications can be added to the treatment (ie. with a maximum of 6 applications). Each application lasts around 15 minutes. The vaginal laser procedure will be performed in an outpatient setting, not requiring any specific preparation, analgesia or anesthesia, by one of two experienced operators.~Laser therapy is performed using a 2940 nm VEL (SP Spectro, Fotona, Slovenia(24)) with SMOOTH mode setting, which enables non-ablative, thermal-only operation(25). The parameters are selected based on extensive preclinical and clinical studies(26,27,28).~Each laser treatment session consists of a full vaginal canal irradiation (using a 360° circular adapter), followed by additional irradiation of the prolapsed anterior wall (using a 90° angular adaptor) and concluded with irradiation of the vestibule area.<br>|
| Active Comparator: PFE<br> | Other: Pelvic floor exercises (PFE)<br>* Standard PFE in Belgium are 9 sessions with a pelvic floor physiotherapist of choice, which can be extended by another 9 sessions, if clinically indicated. There are different strategies, though that will be on discretion of the physiotherapist. We will register the type of physiotherapy (standard (PFMT) versus assisted pelvic floor muscles training (APFMT)), number of completed sessions and duration of therapy. What is exactly done by the patient is registered as a variable.<br>|
|
Use of Non-ablative Vaginal Erbium YAG Laser for the Treatment of Prolapse
Study Overview
=================
Brief Summary
-----------------
This is a single center, investigator initiated study, sponsored by the UZ Leuven, Leuven, Belgium; comparing laser treatment to pelvic floor exercises (PFE). Women with symptomatic prolapse (grade II-IV) who seek for a conservative treatment, with no history of previous POP-surgery will be randomised to either the laser-arm or the PFE-arm. There are 3 visits where vaginal application of laser will be performed, with a 4-weeks interval. Each application lasts around 15 minutes. The vaginal laser procedure will be performed in an outpatient setting, not requiring any specific preparation, analgesia or anesthesia, by one of two experienced operators. The primary objective is to evaluate the effects of VEL treatment for reduction of prolapse symptoms and as a secondary outcome objective measurements. These endpoints are in line with the recommendations by Durnea et al., as being the most relevant and patient centered outcomes. The second goals are to register adverse events and to determine for how long the effects of laser are sustained, with a maximum of two years. To do so, the investigators will measure long term satisfaction with, and the longevity of the effect (measured by the need for repeat or alternative therapy) of laser therapy. Duration of follow-up per patient: max 27 months
Official Title
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Use of Non-ablative Vaginal Erbium YAG Laser for the Treatment of Prolapse: a Randomized Controlled Clinical Trial
Conditions
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Prolapse
Intervention / Treatment
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* Procedure: Non-ablative vaginal Erbium YAG laser treatment
* Other: Pelvic floor exercises (PFE)
Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: The presence of POP symptoms Diagnosis of cystocele or rectocele of grade II to IV according to the POP-Q system, leading the prolapse (i.e. C ≤ Ba/Bp) Voluntary informed consent Exclusion Criteria: Symptoms or anatomical evidence for intussusception / rectal prolapse Leading descent of the middle compartment (C > Ba/Bp) Grade IV prolapse Previous POP surgery Pregnancy or <12 months postpartum Vaginal bleeding, injuries or infection in the treated area
Ages Eligible for Study
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Minimum Age: 18 Years
Sexes Eligible for Study
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Female
Accepts Healthy Volunteers
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Accepts Healthy Volunteers
Study Plan
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How is the study designed?
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Design Details
Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Arms and Interventions
| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Laser<br> | Procedure: Non-ablative vaginal Erbium YAG laser treatment<br>* There are 3 visits where vaginal application of laser will be performed, with a 4-weeks interval. If needed, 3 extra laser applications can be added to the treatment (ie. with a maximum of 6 applications). Each application lasts around 15 minutes. The vaginal laser procedure will be performed in an outpatient setting, not requiring any specific preparation, analgesia or anesthesia, by one of two experienced operators. Laser therapy is performed using a 2940 nm VEL (SP Spectro, Fotona, Slovenia(24)) with SMOOTH mode setting, which enables non-ablative, thermal-only operation(25). The parameters are selected based on extensive preclinical and clinical studies(26,27,28). Each laser treatment session consists of a full vaginal canal irradiation (using a 360° circular adapter), followed by additional irradiation of the prolapsed anterior wall (using a 90° angular adaptor) and concluded with irradiation of the vestibule area.<br>|
| Active Comparator: PFE<br> | Other: Pelvic floor exercises (PFE)<br>* Standard PFE in Belgium are 9 sessions with a pelvic floor physiotherapist of choice, which can be extended by another 9 sessions, if clinically indicated. There are different strategies, though that will be on discretion of the physiotherapist. We will register the type of physiotherapy (standard (PFMT) versus assisted pelvic floor muscles training (APFMT)), number of completed sessions and duration of therapy. What is exactly done by the patient is registered as a variable.<br>|
What is the study measuring?
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Primary Outcome Measures
| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Primary outcome is the subjective improvement of POP symptoms, assessed by the Pelvic Organ Prolapse Distress Inventory-6 (POPDI-6). | Participants have to answer 6 questions concerning POP symptoms with a response scale from 0 to 4 (not present (=0), not at all (=1), somewhat (=2), moderately (=3), quite a bit (=4)). The score (range 0 to 100) is then obtained by multiplying the mean value of all of the answered items by 25. Missing items are dealt with by using the mean from answered items only. Higher scores indicate more distress. This questionnaire is available and validated in English, Dutch and French. Success is defined as a reduction in scores of at least 25% compared with baseline. | 6 months after last treatment |
Secondary Outcome Measures
| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Assessment of the anatomical success rate by means of the POP-Q system | Anatomical success is defined as POP-Q = grade 0 (no prolapse) or grade I (leading edge < -1cm) | At every visit (ie. week 4, 8 and 12, optional: 16, 20 and 24 weeks), 6, 12 and 24 months after end of treatment |
| Assessment of the rate of patient satisfaction by means of the Patient Global Impression of Improvement (PGI) | a 5-point Likert scale (1=much worse, 2=worse, 3=same, 4=better, 5=much better) | At every visit (ie. week 4, 8 and 12, optional: 16, 20 and 24 weeks), 6, 12 and 24 months after end of treatment |
| Assessment of the degree of discomfort of the treatment procedure by the patient | VAS-score (Visual Analogue Scale: 0-10cm, continuous scale); the higher the score, the higher the discomfort | At every visit (ie. week 4, 8 and 12, optional: 16, 20 and 24 weeks), 6, 12 and 24 months after end of treatment |
| Assessment of the longevity of the effect of laser therapy | Measured by the need for repeating the same, or initiating an alternative therapy | At every visit (ie. week 4, 8 and 12), end of treatment (ie. 4 months after randomisation), 6, 12 and 24 months after end of treatment |
| Assessment of sexual function, by means of the Pelvic Organ prolapse/Urinary Incontinence Sexual Questionnaire IUGA revised (PISQ-IR) | The PISQ-IR is a questionnaire with twenty questions. Q1 is a question to divide the patients based on sexual activity. Not sexually active (NSA) women are referred to Q2-Q6. Sexually active (SA) women are asked to fill out Q7-Q20. The questionnaire for NSA women consists of five questions or 12 items. A higher score refers to a higher impact of PFD on sexual functioning. The questionnaire for SA women consists of 14 questions wherein women with a partner have to fill out all 14, being 22 items. Women without partner can skip questions 13 and 14, filling out 19 items. A lower score refers to a lower impact of PFD on sexual functioning. This questionnaire is available and validated in English, Dutch and French. | At every visit (ie. week 4, 8 and 12, optional: 16, 20 and 24 weeks), 6, 12 and 24 months after end of treatment |
| Assessment of urinary symptoms by means of the Urogenital Distress Inventory (UDI-6) | The final UDI-6 score is calculated by adding all scores as explained in the above, and dividing the result to 6 to obtain a mean value which is in turn multiplied by 25 to obtain the scale score. The score varies from 0 to 100. The basic interpretation of the score is that the higher the score, the higher the disability. This questionnaire is available and validated in English, Dutch and French. | At every visit (ie. week 4, 8 and 12, optional: 16, 20 and 24 weeks), 6, 12 and 24 months after end of treatment |
Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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laser, pelvic floor treatment
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NCT02989857
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Study of AG-120 in Previously Treated Advanced Cholangiocarcinoma With IDH1 Mutations (ClarIDHy)
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Study AG120-C-005 is a Phase 3, multicenter, randomized, double-blind, placebo-controlled study of orally administered AG-120. Participants, all personnel involved in the evaluation of participants' response to treatment (e.g., Investigators, study coordinators, study pharmacists), and designated Sponsor team members will be blinded to study treatment. Participants are required to have a histologically-confirmed diagnosis of isocitrate dehydrogenase-1 (IDH1) gene-mutated cholangiocarcinoma that is not eligible for curative resection, transplantation, or ablative therapies prior to enrollment. IDH1 mutation testing will be performed at participating investigative sites. Participants must have progression of disease and have received at least 1 but not more than 2 prior treatment regimens for advanced disease (nonresectable or metastatic). All participants must have received either a gemcitabine or a 5 fluorouracil (5-FU) based chemotherapy regimen.
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A Phase 3, Multicenter, Randomized, Double-Blind, Placebo-controlled Study of AG-120 in Previously-treated Subjects With Nonresectable or Metastatic Cholangiocarcinoma With an IDH1 Mutation
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Advanced Cholangiocarcinoma, Metastatic Cholangiocarcinoma
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* Drug: AG-120
* Drug: Placebo
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Inclusion Criteria:~Be ≥18 years of age.~Have a histopathological diagnosis (fresh or banked tumor biopsy sample, preferably collected within the last 3 years) of nonresectable or metastatic cholangiocarcinoma and are not eligible for curative resection, transplantation, or ablative therapies.~Have documented IDH1 gene-mutated disease (from a fresh tumor biopsy or the most recent banked tumor tissue available) based on central laboratory testing (R132C/L/G/H/S mutation variants tested).~Have an Eastern Cooperative Oncology Group performance status (ECOG PS) score of 0 or 1~Have an expected survival of ≥3 months.~Have at least one evaluable and measurable lesion as defined by Response Evaluation Criteria in Solid Tumors (RECIST) v1.1. Participants who have received prior local therapy (including but not limited to embolization, chemoembolization, radiofrequency ablation, or radiation therapy) are eligible provided measurable disease falls outside of the treatment field or within the field and has shown ≥20% growth in size since post-treatment assessment.~Have documented disease progression following at least 1 and no more than 2 prior systemic regimens for advanced disease (nonresectable or metastatic). Participants must have received at least 1 gemcitabine- or 5-FU-containing regimen for advanced cholangiocarcinoma. Participants who have received systemic adjuvant chemotherapy will be permitted provided there is documented disease progression during or within 6 months of completing the therapy.~Exclusion criteria:~Received a prior IDH inhibitor.~Received systemic anticancer therapy or an investigational agent <2 weeks prior to Day 1 (washout from prior immune based anticancer therapy is 4 weeks). In addition, the first dose of study treatment should not occur before a period ≥5 half-lives of the investigational agent has elapsed.~Received radiotherapy to metastatic sites of disease <2 weeks prior to Day 1.~Underwent hepatic radiation, chemoembolization, and radiofrequency ablation <4 weeks prior to Day 1.~Have known symptomatic brain metastases requiring steroids. Participants with previously diagnosed brain metastases are eligible if they have completed their treatment and have recovered from the acute effects of radiation therapy or surgery prior to study entry, have discontinued corticosteroid treatment for these metastases for at least 4 weeks and have radiographically stable disease for at least 3 months prior to study entry. Note: up to 10 mg per day of prednisone equivalent will be allowed.
|
18 Years
| null |
All
|
No
|
Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Interventional Model Description: Patients randomized in a 2:1 allocation (AG-120 vs Placebo)
Masking: Double
|
| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Progression Free Survival (PFS) as Determined by the Independent Radiology Committee (IRC) | PFS is defined as the time from date of randomization to the date of first documented disease progression as assessed by the IRC using Response Evaluation Criteria in Solid Tumors [RECIST] v1.1, or date of death due to any cause, whichever occurred first. Disease progression was defined as greater than or equal to (≥)20 percent (%) increase in sum of the diameter of target lesions, taking as reference the smallest sum diameter recorded since the treatment started. In addition to the relative increase of 20%, the sum must also demonstrate an absolute increase of at least 5 millimeters (mm) or the appearance of 1 or more new lesions. | From the date of randomization to the date of first documentation of disease progression or death due to any cause (Up to approximately 2 years) |
|
| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Percentage of Participants With Adverse Events (AEs) and Serious Adverse Events (SAEs) | An AE is any untoward medical occurrence associated with the use of a drug in participants, whether or not considered drug related. An AE or suspected adverse reaction is considered serious (an SAE) if it is fatal, life-threatening, causes in-patient hospitalization or prolongation of existing hospitalization, persistent or significant incapacity or substantial disruption of the ability to conduct normal life functions, congenital anomaly/birth defect in a neonate/infant born to a mother or father exposed to study treatment or is an important medical event. Treatment-emergent adverse events are reported. | From first dose of study drug up to 28 days after last dose for each intervention (Up to approximately 4 Years) |
| Percentage of Participants Who Experienced Laboratory Abnormalities Reported as Grade 3 or Higher Adverse Events | The laboratory parameters evaluated by the investigator included hematology and chemistry. Laboratory abnormalities reported in this endpoint are Grade 3 or higher adverse events. Grading categories were determined by the National Cancer Institute Common Terminology Criteria for Adverse Events (NCI CTCAE), version 4.03. | From first dose of the study drug up to end of treatment visit for each intervention (Up to approximately 4 Years) |
| Percentage of Participants With Clinically Significant Grade 3 or Higher Vital Signs AEs | Clinically significant vital signs were recorded as adverse events; there were some vital signs reported as Grade 3 or higher adverse events. Grading categories were determined by NCI CTCAE, version 4.03. | From first dose of the study drug up to end of treatment visit for each intervention (Up to approximately 4 Years) |
| Percentage of Participants With Eastern Cooperative Oncology Group (ECOG) Performance Status | The Eastern Cooperative Oncology Group Performance Status (ECOG PS) score classified participants according to their functional impairment, with scores ranging from 0 to 4. ECOG PS: 0 = fully active, able to carry on all pre-disease performance without restriction; 1 = restricted in physically strenuous activity but ambulatory and able to carry out work of a light or sedentary nature, e.g., light housework, office work; 2 = ambulatory and capable of all self-care but unable to carry out any work activities, up and about more than 50% of waking hours; 3 = capable of only limited self-care, confined to bed or chair more than 50% of waking hours; 4 = completely disabled, cannot carry on any self-care, totally confined to bed or chair. A higher score means a worse functional status. | Baseline |
| Percentage of Participants Who Required At Least One Concomitant Medications During the Treatment | Concomitant medications were medications that were ongoing or initiated after the first dose of the study drug but before the last dose plus 28 days. Percentage of participants who required at least one concomitant medications during the study along with their prescribed study drug (AG-120 or placebo) were reported. | From first dose of study drug up to 28 days after last dose (Up to approximately 4 Years) |
| Percentage of Participants With Abnormal Electrocardiogram (ECG) Changes Reported as Adverse Events | | Pre-dose C1D1, C2D1; Post-dose C1D1, C1D15, C2D1 and Day 1 of C3D1 and all cycles thereafter up to last dose plus 28 days (Up to approximately 4 years) |
| Overall Survival (OS) | Overall survival was defined as the time in months from date of randomization to the date of death due to any cause. Participants without documentation of death at the time of the final collection were censored at the date the participant was last known to be alive, or the final collection date, whichever is earlier. | From date of randomization until the date of death due to any cause (Up to approximately 2 years) |
| Objective Response Rate (ORR) as Assessed by the Investigator RECIST Version 1.1 | ORR as assessed by the investigator was defined as the percentage of participants with a best overall response (BOR) defined as complete response (CR) or partial response (PR) per RECIST v1.1. CR: disappearance of all target and non-target lesions (TLs) and all pathological lymph nodes (LNs) (target and non target), with short axis <10mm. PR: ≥30% decrease in sum of diameters (SOD) from Baseline. | From the date of randomization up to confirmed CR or PR (Up to approximately 2 years) |
| ORR as Assessed by the IRC Per RECIST v1.1 | ORR as assessed by the IRC was defined as the percentage of participants with a best overall response (BOR) defined as complete response (CR) or partial response (PR) per RECIST v1.1. CR: disappearance of all target and non-target lesions (TLs) and all pathological lymph nodes (LNs) (target and non target), with short axis <10mm. PR: ≥30% decrease in sum of diameters (SOD) from Baseline. | From the date of randomization up to confirmed CR or PR (Up to approximately 2 years) |
| Duration of Response (DOR) as Assessed by the Investigator | DOR was defined as the time in months from date of first documented CR or PR to date of first documented disease progression or death due to any cause, whichever is earlier, as assessed by the Investigator per RECIST v1.1. CR: disappearance of all target and non-target lesions (TLs) and all pathological lymph nodes (LNs) (target and non target), with short axis <10mm. PR: ≥30% decrease in sum of diameters (SOD) from Baseline. Participants with response and without progression were censored at the last observation. | From the date of first confirmed CR or PR to disease progression or death regardless of cause (Up to approximately 2 years) |
| DOR as Assessed by the IRC Per RECIST v1.1 | DOR was defined as the time in months from date of first documented CR or PR to date of first documented disease progression or death due to any cause, whichever is earlier, as assessed by the IRC per RECIST v1.1. CR: disappearance of all target and non-target lesions (TLs) and all pathological lymph nodes (LNs) (target and non target), with short axis <10mm. PR: ≥30% decrease in sum of diameters (SOD) from Baseline. Participants with response and without progression were censored at the last observation. | From the date of first confirmed CR or PR to disease progression or death regardless of cause (Up to approximately 2 years) |
| Time to Response (TTR) as Assessed by the Investigator | TTR was defined as the time from date of randomization to date of first documented CR or PR for responders, as assessed by the Investigator per RECIST v1.1. CR: disappearance of all target and non-target lesions (TLs) and all pathological lymph nodes (LNs) (target and non target), with short axis <10mm. PR: ≥30% decrease in sum of diameters (SOD) from Baseline. Only responders were analyzed for this outcome measure. | From the date of randomization up to the date of first documented CR or PR (Up to approximately 2 years) |
| TTR as Assessed by the IRC Per RECIST v1.1 | TTR was defined as the time from date of randomization to date of first documented CR or PR for responders, as assessed by the IRC per RECIST v1.1. CR: disappearance of all target and non-target lesions (TLs) and all pathological lymph nodes (LNs) (target and non target), with short axis <10mm. PR: ≥30% decrease in sum of diameters (SOD) from Baseline. Only responders were analyzed for this outcome measure. | From the date of randomization up to the date of first documented CR or PR (Up to approximately 2 years) |
| PFS as Determined by Investigator | PFS was defined as the time from date of randomization to the date of first documented disease progression as assessed by the investigator using RECIST v1.1, or date of death due to any cause, whichever occurred first. Disease progression was defined as ≥20% increase in sum of the diameter of target lesions, taking as reference the smallest sum diameter recorded since the treatment started. In addition to the relative increase of 20%, the sum must also demonstrate an absolute increase of at least 5 mm or the appearance of 1 or more new lesions. No progression or death by data cutoff date was censored at the last adequate assessment date. | From the date of randomization to the date of first documentation of disease progression or death due to any cause (Up to approximately 2 years) |
| Change From Baseline in Health-Related Quality of Life (HRQOL) Based on European Organization for Research and Treatment of Cancer (EORTC) Quality of Life Questionnaire- Core 30 Subscales Scores | EORTC-QLQ-C30 is the European Organization for Research and Treatment of Cancer - Quality of Life Questionnaire - Core Questionnaire. For EORTC QLQ-C30, subscales of physical functioning, pain, and appetite loss were assessed. These had 4 response levels (not at all, a little, quite a bit, and very much). For functional scales, higher scores=better QOL (positive change from Baseline=improvement). For symptom scales, lower scores=better QOL (negative change from Baseline=improvement). Using linear transformation, raw scores were standardized, so that scores ranged from 0 to 100. | Cycle 2 Day 1 and Cycle 3 Day 1 |
| Change From Baseline in HRQOL Based on: Quality of Life Questionnaire - Cholangiocarcinoma and Gallbladder Cancer Module (QLQ-BIL21) | For HRQOL based on QLQ-BIL21, subscales of eating symptoms and pain symptoms were assessed. Each item is a 4-point Likert scale. There are 4 response levels (not at all, a little, quite a bit, and very much). Raw scores are converted into scale scores ranging from 0 to 100. For symptom scales, lower scores=better QOL (negative change from Baseline=improvement). | Cycle 2 Day 1 and Cycle 3 Day 1 |
| Percentage of Participants With Change Based on HRQOL: Patient Global Impression of Change (PGI-C) | The PGI-C is a self-rated evaluative instrument for assessment across 3 domains (physical function, appetite loss, and pain). The PGI-C is measured using a 7-point Likert scale, with 6= very much better, 5= moderately better, 4= a little better, 3= no change, 2= a little worse, 1= moderately worse, and 0= very much worse. A lower score indicates a worse outcome. Percentages are rounded off to whole number at the nearest decimal. | Cycle 2 Day 1 and Cycle 3 Day 1 |
| Percentage of Participants With Severity Based on HRQOL: Patient Global Impression of Severity (PGI-S) | The anchor-based questionnaire PGI-S contains the following 3 items (the severity of the physical functioning decline over the past week, the severity of the appetite decrease over the past week, and the severity of the pain over the past week). The PGI-S was measured using the possible outcomes none, mild, moderate, severe, and very severe. Percentages are rounded off to whole number at the nearest decimal. | Cycle 2 Day 1 and Cycle 3 Day 1 |
| Percentage of Participants With Each EuroQol 5 Dimensions 5 Levels (EQ-5D-5L) Dimension Response | The EQ-5D-5L assesses general health-related quality of life. Health is defined in 5 dimensions: mobility, self-care, usual activities, pain/discomfort, and anxiety/depression. Each dimension has 5 levels: no problems, slight problems, moderate problems, severe problems, and extreme problems. Percentages are rounded off to whole number at the nearest decimal. | Cycle 3 Day 1 |
| Change From Baseline in EQ-5D-5L Visual Analogue Scale (EQ-5D-5L VAS) Score | The EQ visual analogue scale records the patient's self-rated health on a vertical visual analogue scale, where the endpoints are labelled The best health you can imagine and The worst health you can imagine. Responses are marked on a 0-100 scale with higher scores indicating higher health-related quality of life (i.e., better outcome). | Cycle 3 Day 1 |
| Maximum Observed Plasma Concentration (Cmax) of AG-120 | Crossover C1D1 and crossover C2D1 visits were combined with C1D1 and C2D1 visits, respectively for the analysis of this endpoint. | Post-dose Cycle 1 Day 1 and Cycle 2 Day 1 (each cycle = 28 days) |
| Time to Reach Maximal Plasma Concentration (Tmax) of AG-120 | Crossover C1D1 and crossover C2D1 visits were combined with C1D1 and C2D1 visits, respectively for the analysis of this endpoint. | Post-dose Cycle 1 Day 1 and Cycle 2 Day 1 (each cycle = 28 days) |
| Area Under the Plasma Concentration-time Curve From Time Zero to 24 Hours (AUC0-24) | Crossover C2D1 visit was combined with C2D1 visit for the analysis of this endpoint. | Post-dose of Cycle 2 Day 1 (each cycle = 28 days) |
| Area Under the Plasma Concentration-time Curve From Time Zero to 4 Hours (AUC0-4) | Crossover C1D1 and crossover C2D1 visits were combined with C1D1 and C2D1 visits, respectively for the analysis of this endpoint. | Post-dose of Cycle 1 Day 1 and Cycle 2 Day 1 (each cycle = 28 days) |
| Accumulation Ratio Based on AUC0-4 (Racc AUC0-4) | Crossover C2D1 visit was combined with C2D1 visit for the analysis of this endpoint. | Post-dose Cycle 2 Day 1 (each cycle = 28 days) |
| Accumulation Ratio Based on Cmax (Racc Cmax) | Crossover C2D1 visit was combined with C2D1 visit for the analysis of this endpoint. | Post-dose Cycle 2 Day 1 (each cycle = 28 days) |
| Plasma 2-hydroxyglutarate (2-HG) Levels of AG-120: B (Baseline Effect Value) | B is the Baseline Effect Value. Crossover C1D1 and crossover C2D1 visits were combined with C1D1 and C2D1 visits, respectively for the analysis of this endpoint. | Post-dose Cycle 1 Day 1 and Cycle 2 Day 1 (each cycle = 28 days) |
| Plasma 2-hydroxyglutarate (2-HG) Levels of AG-120: AUEC0-4 | AUEC0-4 is the area of the response curve from time point zero (predose) up to 4 hr postdose. Crossover C1D1 and crossover C2D1 visits were combined with C1D1 and C2D1 visits, respectively for the analysis of this endpoint. | Post-dose Cycle 1 Day 1 and Cycle 2 Day 1 (each cycle = 28 days) |
| Plasma 2-hydroxyglutarate (2-HG) Levels of AG-120: %BAUEC0-4 | %BAUEC0-4 is the percent inhibition for AUEC0-4. Crossover C1D1 and crossover C2D1 visits were combined with C1D1 and C2D1 visits, respectively for the analysis of this endpoint. | Post-dose Cycle 1 Day 1 and Cycle 2 Day 1 (each cycle = 28 days) |
| Plasma 2-hydroxyglutarate (2-HG) Levels of AG-120: Rtrough | Rtrough is the observed response value at the end of a dosing interval. Crossover C2D1 visit was combined with C2D1 visit for the analysis of this endpoint. | Post-dose Cycle 2 Day 1 (each cycle = 28 days) |
| Plasma 2-hydroxyglutarate (2-HG) Levels of AG-120: %BRtrough | %BRtrough is the percent inhibition for Rtrough. Crossover C2D1 visit was combined with C2D1 visit for the analysis of this endpoint. | Post-dose Cycle 2 Day 1 (each cycle = 28 days) |
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IDH1
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Ivosidenib, Antineoplastic Agents, Enzyme Inhibitors, Molecular Mechanisms of Pharmacological Action
|
| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: AG-120<br>Participants received AG-120 500 mg, tablet, orally, once a day (QD) in each 28-day treatment cycle, until occurrence of disease progression, unacceptable toxicity, confirmed pregnancy, death, subject withdrawal, lost to follow-up, or the sponsor ended the study for up to approximately 45 months. | Drug: AG-120<br>* Tablet administered orally<br>* Other names: Ivosidenib;|
| Placebo Comparator: Placebo<br>Participants received AG-120 matched placebo, orally, QD in each 28-day treatment cycle, until occurrence of disease progression, unacceptable toxicity, confirmed pregnancy, death, subject withdrawal, lost to follow-up or the sponsor ended the study for up to approximately 7 months. Participants who experienced disease progression and received placebo were allowed to cross over and receive AG-120. | Drug: Placebo<br>* Tablet administered orally<br>|
| Experimental: After Cross over to AG-120<br>Participants who experienced disease progression and received placebo were allowed to cross over to receive AG-120 500 mg, tablet, orally, QD in each 28-day treatment cycle for up to approximately 32 months. | Drug: AG-120<br>* Tablet administered orally<br>* Other names: Ivosidenib;|
|
Study of AG-120 in Previously Treated Advanced Cholangiocarcinoma With IDH1 Mutations (ClarIDHy)
Study Overview
=================
Brief Summary
-----------------
Study AG120-C-005 is a Phase 3, multicenter, randomized, double-blind, placebo-controlled study of orally administered AG-120. Participants, all personnel involved in the evaluation of participants' response to treatment (e.g., Investigators, study coordinators, study pharmacists), and designated Sponsor team members will be blinded to study treatment. Participants are required to have a histologically-confirmed diagnosis of isocitrate dehydrogenase-1 (IDH1) gene-mutated cholangiocarcinoma that is not eligible for curative resection, transplantation, or ablative therapies prior to enrollment. IDH1 mutation testing will be performed at participating investigative sites. Participants must have progression of disease and have received at least 1 but not more than 2 prior treatment regimens for advanced disease (nonresectable or metastatic). All participants must have received either a gemcitabine or a 5 fluorouracil (5-FU) based chemotherapy regimen.
Official Title
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A Phase 3, Multicenter, Randomized, Double-Blind, Placebo-controlled Study of AG-120 in Previously-treated Subjects With Nonresectable or Metastatic Cholangiocarcinoma With an IDH1 Mutation
Conditions
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Advanced Cholangiocarcinoma, Metastatic Cholangiocarcinoma
Intervention / Treatment
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* Drug: AG-120
* Drug: Placebo
Participation Criteria
=================
Eligibility Criteria
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Inclusion Criteria: Be ≥18 years of age. Have a histopathological diagnosis (fresh or banked tumor biopsy sample, preferably collected within the last 3 years) of nonresectable or metastatic cholangiocarcinoma and are not eligible for curative resection, transplantation, or ablative therapies. Have documented IDH1 gene-mutated disease (from a fresh tumor biopsy or the most recent banked tumor tissue available) based on central laboratory testing (R132C/L/G/H/S mutation variants tested). Have an Eastern Cooperative Oncology Group performance status (ECOG PS) score of 0 or 1 Have an expected survival of ≥3 months. Have at least one evaluable and measurable lesion as defined by Response Evaluation Criteria in Solid Tumors (RECIST) v1.1. Participants who have received prior local therapy (including but not limited to embolization, chemoembolization, radiofrequency ablation, or radiation therapy) are eligible provided measurable disease falls outside of the treatment field or within the field and has shown ≥20% growth in size since post-treatment assessment. Have documented disease progression following at least 1 and no more than 2 prior systemic regimens for advanced disease (nonresectable or metastatic). Participants must have received at least 1 gemcitabine- or 5-FU-containing regimen for advanced cholangiocarcinoma. Participants who have received systemic adjuvant chemotherapy will be permitted provided there is documented disease progression during or within 6 months of completing the therapy. Exclusion criteria: Received a prior IDH inhibitor. Received systemic anticancer therapy or an investigational agent <2 weeks prior to Day 1 (washout from prior immune based anticancer therapy is 4 weeks). In addition, the first dose of study treatment should not occur before a period ≥5 half-lives of the investigational agent has elapsed. Received radiotherapy to metastatic sites of disease <2 weeks prior to Day 1. Underwent hepatic radiation, chemoembolization, and radiofrequency ablation <4 weeks prior to Day 1. Have known symptomatic brain metastases requiring steroids. Participants with previously diagnosed brain metastases are eligible if they have completed their treatment and have recovered from the acute effects of radiation therapy or surgery prior to study entry, have discontinued corticosteroid treatment for these metastases for at least 4 weeks and have radiographically stable disease for at least 3 months prior to study entry. Note: up to 10 mg per day of prednisone equivalent will be allowed.
Ages Eligible for Study
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Minimum Age: 18 Years
Sexes Eligible for Study
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All
Accepts Healthy Volunteers
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No
Study Plan
=================
How is the study designed?
-----------------
Design Details
Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Interventional Model Description: Patients randomized in a 2:1 allocation (AG-120 vs Placebo)
Masking: Double
Arms and Interventions
| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: AG-120<br>Participants received AG-120 500 mg, tablet, orally, once a day (QD) in each 28-day treatment cycle, until occurrence of disease progression, unacceptable toxicity, confirmed pregnancy, death, subject withdrawal, lost to follow-up, or the sponsor ended the study for up to approximately 45 months. | Drug: AG-120<br>* Tablet administered orally<br>* Other names: Ivosidenib;|
| Placebo Comparator: Placebo<br>Participants received AG-120 matched placebo, orally, QD in each 28-day treatment cycle, until occurrence of disease progression, unacceptable toxicity, confirmed pregnancy, death, subject withdrawal, lost to follow-up or the sponsor ended the study for up to approximately 7 months. Participants who experienced disease progression and received placebo were allowed to cross over and receive AG-120. | Drug: Placebo<br>* Tablet administered orally<br>|
| Experimental: After Cross over to AG-120<br>Participants who experienced disease progression and received placebo were allowed to cross over to receive AG-120 500 mg, tablet, orally, QD in each 28-day treatment cycle for up to approximately 32 months. | Drug: AG-120<br>* Tablet administered orally<br>* Other names: Ivosidenib;|
What is the study measuring?
-----------------
Primary Outcome Measures
| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Progression Free Survival (PFS) as Determined by the Independent Radiology Committee (IRC) | PFS is defined as the time from date of randomization to the date of first documented disease progression as assessed by the IRC using Response Evaluation Criteria in Solid Tumors [RECIST] v1.1, or date of death due to any cause, whichever occurred first. Disease progression was defined as greater than or equal to (≥)20 percent (%) increase in sum of the diameter of target lesions, taking as reference the smallest sum diameter recorded since the treatment started. In addition to the relative increase of 20%, the sum must also demonstrate an absolute increase of at least 5 millimeters (mm) or the appearance of 1 or more new lesions. | From the date of randomization to the date of first documentation of disease progression or death due to any cause (Up to approximately 2 years) |
Secondary Outcome Measures
| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Percentage of Participants With Adverse Events (AEs) and Serious Adverse Events (SAEs) | An AE is any untoward medical occurrence associated with the use of a drug in participants, whether or not considered drug related. An AE or suspected adverse reaction is considered serious (an SAE) if it is fatal, life-threatening, causes in-patient hospitalization or prolongation of existing hospitalization, persistent or significant incapacity or substantial disruption of the ability to conduct normal life functions, congenital anomaly/birth defect in a neonate/infant born to a mother or father exposed to study treatment or is an important medical event. Treatment-emergent adverse events are reported. | From first dose of study drug up to 28 days after last dose for each intervention (Up to approximately 4 Years) |
| Percentage of Participants Who Experienced Laboratory Abnormalities Reported as Grade 3 or Higher Adverse Events | The laboratory parameters evaluated by the investigator included hematology and chemistry. Laboratory abnormalities reported in this endpoint are Grade 3 or higher adverse events. Grading categories were determined by the National Cancer Institute Common Terminology Criteria for Adverse Events (NCI CTCAE), version 4.03. | From first dose of the study drug up to end of treatment visit for each intervention (Up to approximately 4 Years) |
| Percentage of Participants With Clinically Significant Grade 3 or Higher Vital Signs AEs | Clinically significant vital signs were recorded as adverse events; there were some vital signs reported as Grade 3 or higher adverse events. Grading categories were determined by NCI CTCAE, version 4.03. | From first dose of the study drug up to end of treatment visit for each intervention (Up to approximately 4 Years) |
| Percentage of Participants With Eastern Cooperative Oncology Group (ECOG) Performance Status | The Eastern Cooperative Oncology Group Performance Status (ECOG PS) score classified participants according to their functional impairment, with scores ranging from 0 to 4. ECOG PS: 0 = fully active, able to carry on all pre-disease performance without restriction; 1 = restricted in physically strenuous activity but ambulatory and able to carry out work of a light or sedentary nature, e.g., light housework, office work; 2 = ambulatory and capable of all self-care but unable to carry out any work activities, up and about more than 50% of waking hours; 3 = capable of only limited self-care, confined to bed or chair more than 50% of waking hours; 4 = completely disabled, cannot carry on any self-care, totally confined to bed or chair. A higher score means a worse functional status. | Baseline |
| Percentage of Participants Who Required At Least One Concomitant Medications During the Treatment | Concomitant medications were medications that were ongoing or initiated after the first dose of the study drug but before the last dose plus 28 days. Percentage of participants who required at least one concomitant medications during the study along with their prescribed study drug (AG-120 or placebo) were reported. | From first dose of study drug up to 28 days after last dose (Up to approximately 4 Years) |
| Percentage of Participants With Abnormal Electrocardiogram (ECG) Changes Reported as Adverse Events | | Pre-dose C1D1, C2D1; Post-dose C1D1, C1D15, C2D1 and Day 1 of C3D1 and all cycles thereafter up to last dose plus 28 days (Up to approximately 4 years) |
| Overall Survival (OS) | Overall survival was defined as the time in months from date of randomization to the date of death due to any cause. Participants without documentation of death at the time of the final collection were censored at the date the participant was last known to be alive, or the final collection date, whichever is earlier. | From date of randomization until the date of death due to any cause (Up to approximately 2 years) |
| Objective Response Rate (ORR) as Assessed by the Investigator RECIST Version 1.1 | ORR as assessed by the investigator was defined as the percentage of participants with a best overall response (BOR) defined as complete response (CR) or partial response (PR) per RECIST v1.1. CR: disappearance of all target and non-target lesions (TLs) and all pathological lymph nodes (LNs) (target and non target), with short axis <10mm. PR: ≥30% decrease in sum of diameters (SOD) from Baseline. | From the date of randomization up to confirmed CR or PR (Up to approximately 2 years) |
| ORR as Assessed by the IRC Per RECIST v1.1 | ORR as assessed by the IRC was defined as the percentage of participants with a best overall response (BOR) defined as complete response (CR) or partial response (PR) per RECIST v1.1. CR: disappearance of all target and non-target lesions (TLs) and all pathological lymph nodes (LNs) (target and non target), with short axis <10mm. PR: ≥30% decrease in sum of diameters (SOD) from Baseline. | From the date of randomization up to confirmed CR or PR (Up to approximately 2 years) |
| Duration of Response (DOR) as Assessed by the Investigator | DOR was defined as the time in months from date of first documented CR or PR to date of first documented disease progression or death due to any cause, whichever is earlier, as assessed by the Investigator per RECIST v1.1. CR: disappearance of all target and non-target lesions (TLs) and all pathological lymph nodes (LNs) (target and non target), with short axis <10mm. PR: ≥30% decrease in sum of diameters (SOD) from Baseline. Participants with response and without progression were censored at the last observation. | From the date of first confirmed CR or PR to disease progression or death regardless of cause (Up to approximately 2 years) |
| DOR as Assessed by the IRC Per RECIST v1.1 | DOR was defined as the time in months from date of first documented CR or PR to date of first documented disease progression or death due to any cause, whichever is earlier, as assessed by the IRC per RECIST v1.1. CR: disappearance of all target and non-target lesions (TLs) and all pathological lymph nodes (LNs) (target and non target), with short axis <10mm. PR: ≥30% decrease in sum of diameters (SOD) from Baseline. Participants with response and without progression were censored at the last observation. | From the date of first confirmed CR or PR to disease progression or death regardless of cause (Up to approximately 2 years) |
| Time to Response (TTR) as Assessed by the Investigator | TTR was defined as the time from date of randomization to date of first documented CR or PR for responders, as assessed by the Investigator per RECIST v1.1. CR: disappearance of all target and non-target lesions (TLs) and all pathological lymph nodes (LNs) (target and non target), with short axis <10mm. PR: ≥30% decrease in sum of diameters (SOD) from Baseline. Only responders were analyzed for this outcome measure. | From the date of randomization up to the date of first documented CR or PR (Up to approximately 2 years) |
| TTR as Assessed by the IRC Per RECIST v1.1 | TTR was defined as the time from date of randomization to date of first documented CR or PR for responders, as assessed by the IRC per RECIST v1.1. CR: disappearance of all target and non-target lesions (TLs) and all pathological lymph nodes (LNs) (target and non target), with short axis <10mm. PR: ≥30% decrease in sum of diameters (SOD) from Baseline. Only responders were analyzed for this outcome measure. | From the date of randomization up to the date of first documented CR or PR (Up to approximately 2 years) |
| PFS as Determined by Investigator | PFS was defined as the time from date of randomization to the date of first documented disease progression as assessed by the investigator using RECIST v1.1, or date of death due to any cause, whichever occurred first. Disease progression was defined as ≥20% increase in sum of the diameter of target lesions, taking as reference the smallest sum diameter recorded since the treatment started. In addition to the relative increase of 20%, the sum must also demonstrate an absolute increase of at least 5 mm or the appearance of 1 or more new lesions. No progression or death by data cutoff date was censored at the last adequate assessment date. | From the date of randomization to the date of first documentation of disease progression or death due to any cause (Up to approximately 2 years) |
| Change From Baseline in Health-Related Quality of Life (HRQOL) Based on European Organization for Research and Treatment of Cancer (EORTC) Quality of Life Questionnaire- Core 30 Subscales Scores | EORTC-QLQ-C30 is the European Organization for Research and Treatment of Cancer - Quality of Life Questionnaire - Core Questionnaire. For EORTC QLQ-C30, subscales of physical functioning, pain, and appetite loss were assessed. These had 4 response levels (not at all, a little, quite a bit, and very much). For functional scales, higher scores=better QOL (positive change from Baseline=improvement). For symptom scales, lower scores=better QOL (negative change from Baseline=improvement). Using linear transformation, raw scores were standardized, so that scores ranged from 0 to 100. | Cycle 2 Day 1 and Cycle 3 Day 1 |
| Change From Baseline in HRQOL Based on: Quality of Life Questionnaire - Cholangiocarcinoma and Gallbladder Cancer Module (QLQ-BIL21) | For HRQOL based on QLQ-BIL21, subscales of eating symptoms and pain symptoms were assessed. Each item is a 4-point Likert scale. There are 4 response levels (not at all, a little, quite a bit, and very much). Raw scores are converted into scale scores ranging from 0 to 100. For symptom scales, lower scores=better QOL (negative change from Baseline=improvement). | Cycle 2 Day 1 and Cycle 3 Day 1 |
| Percentage of Participants With Change Based on HRQOL: Patient Global Impression of Change (PGI-C) | The PGI-C is a self-rated evaluative instrument for assessment across 3 domains (physical function, appetite loss, and pain). The PGI-C is measured using a 7-point Likert scale, with 6= very much better, 5= moderately better, 4= a little better, 3= no change, 2= a little worse, 1= moderately worse, and 0= very much worse. A lower score indicates a worse outcome. Percentages are rounded off to whole number at the nearest decimal. | Cycle 2 Day 1 and Cycle 3 Day 1 |
| Percentage of Participants With Severity Based on HRQOL: Patient Global Impression of Severity (PGI-S) | The anchor-based questionnaire PGI-S contains the following 3 items (the severity of the physical functioning decline over the past week, the severity of the appetite decrease over the past week, and the severity of the pain over the past week). The PGI-S was measured using the possible outcomes none, mild, moderate, severe, and very severe. Percentages are rounded off to whole number at the nearest decimal. | Cycle 2 Day 1 and Cycle 3 Day 1 |
| Percentage of Participants With Each EuroQol 5 Dimensions 5 Levels (EQ-5D-5L) Dimension Response | The EQ-5D-5L assesses general health-related quality of life. Health is defined in 5 dimensions: mobility, self-care, usual activities, pain/discomfort, and anxiety/depression. Each dimension has 5 levels: no problems, slight problems, moderate problems, severe problems, and extreme problems. Percentages are rounded off to whole number at the nearest decimal. | Cycle 3 Day 1 |
| Change From Baseline in EQ-5D-5L Visual Analogue Scale (EQ-5D-5L VAS) Score | The EQ visual analogue scale records the patient's self-rated health on a vertical visual analogue scale, where the endpoints are labelled The best health you can imagine and The worst health you can imagine. Responses are marked on a 0-100 scale with higher scores indicating higher health-related quality of life (i.e., better outcome). | Cycle 3 Day 1 |
| Maximum Observed Plasma Concentration (Cmax) of AG-120 | Crossover C1D1 and crossover C2D1 visits were combined with C1D1 and C2D1 visits, respectively for the analysis of this endpoint. | Post-dose Cycle 1 Day 1 and Cycle 2 Day 1 (each cycle = 28 days) |
| Time to Reach Maximal Plasma Concentration (Tmax) of AG-120 | Crossover C1D1 and crossover C2D1 visits were combined with C1D1 and C2D1 visits, respectively for the analysis of this endpoint. | Post-dose Cycle 1 Day 1 and Cycle 2 Day 1 (each cycle = 28 days) |
| Area Under the Plasma Concentration-time Curve From Time Zero to 24 Hours (AUC0-24) | Crossover C2D1 visit was combined with C2D1 visit for the analysis of this endpoint. | Post-dose of Cycle 2 Day 1 (each cycle = 28 days) |
| Area Under the Plasma Concentration-time Curve From Time Zero to 4 Hours (AUC0-4) | Crossover C1D1 and crossover C2D1 visits were combined with C1D1 and C2D1 visits, respectively for the analysis of this endpoint. | Post-dose of Cycle 1 Day 1 and Cycle 2 Day 1 (each cycle = 28 days) |
| Accumulation Ratio Based on AUC0-4 (Racc AUC0-4) | Crossover C2D1 visit was combined with C2D1 visit for the analysis of this endpoint. | Post-dose Cycle 2 Day 1 (each cycle = 28 days) |
| Accumulation Ratio Based on Cmax (Racc Cmax) | Crossover C2D1 visit was combined with C2D1 visit for the analysis of this endpoint. | Post-dose Cycle 2 Day 1 (each cycle = 28 days) |
| Plasma 2-hydroxyglutarate (2-HG) Levels of AG-120: B (Baseline Effect Value) | B is the Baseline Effect Value. Crossover C1D1 and crossover C2D1 visits were combined with C1D1 and C2D1 visits, respectively for the analysis of this endpoint. | Post-dose Cycle 1 Day 1 and Cycle 2 Day 1 (each cycle = 28 days) |
| Plasma 2-hydroxyglutarate (2-HG) Levels of AG-120: AUEC0-4 | AUEC0-4 is the area of the response curve from time point zero (predose) up to 4 hr postdose. Crossover C1D1 and crossover C2D1 visits were combined with C1D1 and C2D1 visits, respectively for the analysis of this endpoint. | Post-dose Cycle 1 Day 1 and Cycle 2 Day 1 (each cycle = 28 days) |
| Plasma 2-hydroxyglutarate (2-HG) Levels of AG-120: %BAUEC0-4 | %BAUEC0-4 is the percent inhibition for AUEC0-4. Crossover C1D1 and crossover C2D1 visits were combined with C1D1 and C2D1 visits, respectively for the analysis of this endpoint. | Post-dose Cycle 1 Day 1 and Cycle 2 Day 1 (each cycle = 28 days) |
| Plasma 2-hydroxyglutarate (2-HG) Levels of AG-120: Rtrough | Rtrough is the observed response value at the end of a dosing interval. Crossover C2D1 visit was combined with C2D1 visit for the analysis of this endpoint. | Post-dose Cycle 2 Day 1 (each cycle = 28 days) |
| Plasma 2-hydroxyglutarate (2-HG) Levels of AG-120: %BRtrough | %BRtrough is the percent inhibition for Rtrough. Crossover C2D1 visit was combined with C2D1 visit for the analysis of this endpoint. | Post-dose Cycle 2 Day 1 (each cycle = 28 days) |
Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
IDH1
|
|
NCT01804374
|
Phase II Open Label, Non-randomized Study of Sorafenib and Everolimus in Relapsed and Non-resectable Osteosarcoma
|
This is a trial for patients affected by metastatic or relapsed osteosarcoma which progressed after first or further line treatments. In this trial, all patients will be treated until progression or unacceptable toxicity with sorafenib and everolimus. The treatment with sorafenib and everolimus aimed to obtain a 50% rate of patients free from further progression of the disease after 6 months from study entry.
|
Patients affected by metastatic or relapsed osteosarcoma which progressed after first or further line treatments still have a poor outcome. Standard chemotherapy has limited activity in these patients.~In a previous study in patient affected by relapsed unresectable osteosarcoma, sorafenib alone demonstrated promising activity. In the preclinical setting, everolimus was able to improve the activity of sorafenib. Sorafenib and everolimus, by hitting crucial pathways which are essential for osteosarcoma cell proliferation and survival, with an entirely different approach aimed to overcome the resistance to standard chemotherapy showed by relapsed osteosarcoma. In this trial, all patients will be treated with sorafenib and everolimus at the dosage of 800 mg and 5 mg per day, respectively. Both drugs have to be taken orally. The treatment will be continued until progression or unacceptable toxicities. The objective of the present trial is to obtain a 50% rate of patients alive and free from progression of their disease 6 months after trial enrolment. The disease will be evaluated every 2 months with a CT scan.
|
A Phase II, Open Label, Non-randomized Study of Second or Third Line Treatment With the Combination of Sorafenib and Everolimus in Patients Affected by Relapsed and Non-resectable High-grade Osteosarcoma
|
Metastatic Osteosarcoma, Relapsed Osteosarcoma
|
* Drug: Sorafenib
* Drug: Everolimus
|
Inclusion Criteria:~Patients with histologically documented and not surgically resectable or metastatic high-grade osteosarcoma which progressed after first or second line treatments for relapsing disease~Measurable disease as defined by RECIST criteria vs. 1.1 (bone lesions are allowed). Baseline evaluations must be completed within 28 days prior to enrollment~Eastern Cooperative Oncology Group(ECOG) Performance Status of 0 or 1. ECOG PS 2 patients are eligible if the PS 2 depends solely on orthopedic problems~Estimated life expectancy of at least 3months~Age≥18 years~Adequate bone marrow, liver and renal function: Hemoglobin>9.0g/dl, Absolute neutrophil count>1,500/mm3, Platelet>100,000/μl Total bilirubin<1.5 times the upper limit of normal (ULN), ALT and AST<2.5xULN (<5xULN for patients with liver involvement of their cancer), PT-INR/PTT<1.5xULN, Serum creatinine<2xULN~Written informed consent~Exclusion Criteria:~Dementia or significantly altered mental status that would prohibit the understanding or rendering of informed consent and compliance with the requirements of this protocol~Patients with any severe and/or uncontrolled medical conditions such as unstable angina pectoris, symptomatic congestive heart failure, myocardial infarction ≤6months, serious uncontrolled cardiac arrhythmia, uncontrolled hyperlipidemia, active or uncontrolled severe infection, cirrhosis, chronic or persistent active hepatitis or severely impaired lung function.~History of HIV infection and active clinically serious infections (>grade 2 according to NCI-CTCAE vs. 4.0)~Symptomatic metastatic brain or meningeal tumors (unless the patient is >6months from definitive therapy, has a negative imaging study within 4weeks of study entry and is clinically stable with respect to the tumor at the time of study entry)~Patients with seizure disorders requiring medication~Pregnant or breast-feeding patients. Women of childbearing potential must have a negative pregnancy test performed within 7days of the start of treatment. Both men and women must use adequate barrier birth control measures during the course of the trial and 8weeks after last dose of study drug~Patients with evidence or history of bleeding diathesis~Patients undergoing renal dialysis~Patients unable to swallow oral medications~Uncontrolled diabetes (fasting glucose>2xULN)~Patients receiving chronic, systemic treatment with corticosteroids or another immunosuppressive agent (except corticosteroids with a daily dosage equivalent to prednisone ≤20mg for adrenal insufficiency). Patients receiving corticosteroids must be on a stable dose for ≥4weeks prior to the first dose of Everolimus. Topical or inhaled corticosteroids are permitted~Patients with a history of another malignancy within 5years prior to study entry, except curatively treated non-melanotic skin cancer or in-situ cervical cancer skin or other solid tumors curatively treated with no evidence of disease for ≥3years. Patients with severe and/or uncontrolled concurrent medical disease that in the opinion of the investigator could cause unacceptable safety risks or compromise compliance with the protocol~Anticancer chemotherapy or immunotherapy during the study or within 4weeks of study entry~Radiotherapy during study or within 3weeks of start of study drug. (Palliative radiotherapy will be allowed)~Major surgery within 4weeks of start of study~Investigational drug therapy outside of this trial during or within 4weeks of study entry~Prior exposure to the study drugs or their analogues~Patients with known hypersensitivity to sorafenib, everolimus or other rapamycin analogs, or to its excipients~Substance abuse, medical, psychological or social conditions that may interfere with the patient's participation in the study or evaluation of the study results~A history of noncompliance to medical regimens or inability or unwillingness to return for scheduled visits
|
18 Years
| null |
All
|
No
|
Primary Purpose: Treatment
Intervention Model: Single Group Assignment
Masking: None (Open Label)
|
| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Progression Free Survival rate at 6 months | Progression Free Survival rate at 6 months refers to the rate of patients alive and free from progression of the disease at 6 months from registration into the study. Disease will be assessed every 8 weeks up to 2 years until progression or death whichever came first. | 6 months from registration into the study |
|
| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| progression free survival | Progression Free Survival (PFS) refers to the time from registration into the study to the date of progressive disease or death whichever came first assessed every 8 weeks up to 2 years. In the absence of progression, time will be censored at the date of last tumor assessment or follow-up | From randomization until progression or death whichever came first up to 2 years |
| overall survival | Overall survival (OS) is the time interval between date of registration into study and the date of death. For alive patients, time will be censored at the date of last follow-up. | From randomization until death followed up to 5 years |
| Overall response rate | Overall response rate refers to the rate of patients with complete, partial or minimal responses (defined as shrinkage of target lesions between 10 and 30%) according to RECIST 1.1. Disease will be assessed every 8 weeks up to 2 years. | From randomization until progression or death whichever came first up to 2 years |
| Duration of response | Duration of response refers to the time from the date of the first assessement of non-progression to the date of progressive disease or death. Disease will be assessed every 8 weeks up to 2 years until progression or death whichever came first. In the absence of progression time will be censored at the date of last tumor assessment or follow-up. | calculated from date of first assessement of non-progression until progression or death whichever came first up to 2 years |
| Non-dimensional pattern of response | Non-dimensional pattern of response refers to the evaluation of any consistent variation in radio metabolic diagnostic test (i.e. PET or Bone scan) and/or changes in signal intensity, contrast uptake/enhancement and tumor density at CT/MRI according to Modified Response Criteria (MRC). From this point of view, patients will be considered in response if there has been an objective response or at least ONE of the following criteria are met:~An unequivocal reduction in tumor density at CT scan;~An unequivocal reduction in signal intensity and/or contrast enhancement at MRI;~An unequivocal reduction in SUV at PET scan;~An unequivocal reduction in bone scan uptake.~Disease will be assessed every 8 weeks up to 2 years until progression or death whichever came first. | calculated from randomization until progression or death whichever came first up to 2 years |
| clinical benefit | Clinical Benefit will be prospectively evaluated by means of Pain and Analgesic Scale recording of analgesic consume and as lack of progression of disease at six months. | evaluated at each visit from randomizzation until progression or death whichever came first up to 2 years |
| Safety | Safety will be captured by recording: physical examinations, vital signs, performance status/body weight; blood tests and chemistry tests; intensity and severity of adverse events, use of analgesic medication at each visit until 28 days after last dose of study treatment assumption up to 2 years. Adverse events will be evaluated according to Common Terminology Criteria for Adverse Events (CTCAE) Version 4.0 | assessed at each visit from randomizzation until 28 days after the last dose of study treatment assumption up to 2 years |
|
osteosarcoma, sorafenib, everolimus, sarcoma
|
Everolimus, Sorafenib, MTOR Inhibitors, Protein Kinase Inhibitors, Enzyme Inhibitors, Molecular Mechanisms of Pharmacological Action, Immunosuppressive Agents, Immunologic Factors, Physiological Effects of Drugs, Antineoplastic Agents
|
| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: sorafenib and everolimus<br>This is an open label study: all patients will be treated with sorafenib 400 mg twice a day in combination with everolimus 5mg per day | Drug: Sorafenib<br>* Sorafenib tablet 200 milligrams packed in bottle containing 140 tablets. Sorafenib will be administered orally twice daily at the same time every day. Two 200 mg tablets will be taken either one hour before or two hours after a meal followed by a glass of water in the morning and in the evening. In general, patient should have a low to moderate fat meal. Patients will receive Sorafenib until progression, toxicity, withdrawal of informed consent or clinical investigator decision<br>* Other names: Nexavar;Drug: Everolimus<br>* Everolimus is formulated in tablets of 2.5 or 5 mg strength, blister-packed under aluminum foil in units of 10 tablets. Everolimus will be administered orally once daily at the same time every day immediately after a meal, as a single dose of 5 mg. Patients should have a low-fat breakfast. After this light meal, study medication of Everolimus is to be taken. The tablets of Everolimus should not be chewed or crushed. Patients will receive Everolimus until progression, toxicity, withdrawal of informed consent or clinical investigator decision<br>* Other names: Certican;|
|
Phase II Open Label, Non-randomized Study of Sorafenib and Everolimus in Relapsed and Non-resectable Osteosarcoma
Study Overview
=================
Brief Summary
-----------------
This is a trial for patients affected by metastatic or relapsed osteosarcoma which progressed after first or further line treatments. In this trial, all patients will be treated until progression or unacceptable toxicity with sorafenib and everolimus. The treatment with sorafenib and everolimus aimed to obtain a 50% rate of patients free from further progression of the disease after 6 months from study entry.
Detailed Description
-----------------
Patients affected by metastatic or relapsed osteosarcoma which progressed after first or further line treatments still have a poor outcome. Standard chemotherapy has limited activity in these patients. In a previous study in patient affected by relapsed unresectable osteosarcoma, sorafenib alone demonstrated promising activity. In the preclinical setting, everolimus was able to improve the activity of sorafenib. Sorafenib and everolimus, by hitting crucial pathways which are essential for osteosarcoma cell proliferation and survival, with an entirely different approach aimed to overcome the resistance to standard chemotherapy showed by relapsed osteosarcoma. In this trial, all patients will be treated with sorafenib and everolimus at the dosage of 800 mg and 5 mg per day, respectively. Both drugs have to be taken orally. The treatment will be continued until progression or unacceptable toxicities. The objective of the present trial is to obtain a 50% rate of patients alive and free from progression of their disease 6 months after trial enrolment. The disease will be evaluated every 2 months with a CT scan.
Official Title
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A Phase II, Open Label, Non-randomized Study of Second or Third Line Treatment With the Combination of Sorafenib and Everolimus in Patients Affected by Relapsed and Non-resectable High-grade Osteosarcoma
Conditions
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Metastatic Osteosarcoma, Relapsed Osteosarcoma
Intervention / Treatment
-----------------
* Drug: Sorafenib
* Drug: Everolimus
Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Patients with histologically documented and not surgically resectable or metastatic high-grade osteosarcoma which progressed after first or second line treatments for relapsing disease Measurable disease as defined by RECIST criteria vs. 1.1 (bone lesions are allowed). Baseline evaluations must be completed within 28 days prior to enrollment Eastern Cooperative Oncology Group(ECOG) Performance Status of 0 or 1. ECOG PS 2 patients are eligible if the PS 2 depends solely on orthopedic problems Estimated life expectancy of at least 3months Age≥18 years Adequate bone marrow, liver and renal function: Hemoglobin>9.0g/dl, Absolute neutrophil count>1,500/mm3, Platelet>100,000/μl Total bilirubin<1.5 times the upper limit of normal (ULN), ALT and AST<2.5xULN (<5xULN for patients with liver involvement of their cancer), PT-INR/PTT<1.5xULN, Serum creatinine<2xULN Written informed consent Exclusion Criteria: Dementia or significantly altered mental status that would prohibit the understanding or rendering of informed consent and compliance with the requirements of this protocol Patients with any severe and/or uncontrolled medical conditions such as unstable angina pectoris, symptomatic congestive heart failure, myocardial infarction ≤6months, serious uncontrolled cardiac arrhythmia, uncontrolled hyperlipidemia, active or uncontrolled severe infection, cirrhosis, chronic or persistent active hepatitis or severely impaired lung function. History of HIV infection and active clinically serious infections (>grade 2 according to NCI-CTCAE vs. 4.0) Symptomatic metastatic brain or meningeal tumors (unless the patient is >6months from definitive therapy, has a negative imaging study within 4weeks of study entry and is clinically stable with respect to the tumor at the time of study entry) Patients with seizure disorders requiring medication Pregnant or breast-feeding patients. Women of childbearing potential must have a negative pregnancy test performed within 7days of the start of treatment. Both men and women must use adequate barrier birth control measures during the course of the trial and 8weeks after last dose of study drug Patients with evidence or history of bleeding diathesis Patients undergoing renal dialysis Patients unable to swallow oral medications Uncontrolled diabetes (fasting glucose>2xULN) Patients receiving chronic, systemic treatment with corticosteroids or another immunosuppressive agent (except corticosteroids with a daily dosage equivalent to prednisone ≤20mg for adrenal insufficiency). Patients receiving corticosteroids must be on a stable dose for ≥4weeks prior to the first dose of Everolimus. Topical or inhaled corticosteroids are permitted Patients with a history of another malignancy within 5years prior to study entry, except curatively treated non-melanotic skin cancer or in-situ cervical cancer skin or other solid tumors curatively treated with no evidence of disease for ≥3years. Patients with severe and/or uncontrolled concurrent medical disease that in the opinion of the investigator could cause unacceptable safety risks or compromise compliance with the protocol Anticancer chemotherapy or immunotherapy during the study or within 4weeks of study entry Radiotherapy during study or within 3weeks of start of study drug. (Palliative radiotherapy will be allowed) Major surgery within 4weeks of start of study Investigational drug therapy outside of this trial during or within 4weeks of study entry Prior exposure to the study drugs or their analogues Patients with known hypersensitivity to sorafenib, everolimus or other rapamycin analogs, or to its excipients Substance abuse, medical, psychological or social conditions that may interfere with the patient's participation in the study or evaluation of the study results A history of noncompliance to medical regimens or inability or unwillingness to return for scheduled visits
Ages Eligible for Study
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Minimum Age: 18 Years
Sexes Eligible for Study
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All
Accepts Healthy Volunteers
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No
Study Plan
=================
How is the study designed?
-----------------
Design Details
Primary Purpose: Treatment
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Arms and Interventions
| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: sorafenib and everolimus<br>This is an open label study: all patients will be treated with sorafenib 400 mg twice a day in combination with everolimus 5mg per day | Drug: Sorafenib<br>* Sorafenib tablet 200 milligrams packed in bottle containing 140 tablets. Sorafenib will be administered orally twice daily at the same time every day. Two 200 mg tablets will be taken either one hour before or two hours after a meal followed by a glass of water in the morning and in the evening. In general, patient should have a low to moderate fat meal. Patients will receive Sorafenib until progression, toxicity, withdrawal of informed consent or clinical investigator decision<br>* Other names: Nexavar;Drug: Everolimus<br>* Everolimus is formulated in tablets of 2.5 or 5 mg strength, blister-packed under aluminum foil in units of 10 tablets. Everolimus will be administered orally once daily at the same time every day immediately after a meal, as a single dose of 5 mg. Patients should have a low-fat breakfast. After this light meal, study medication of Everolimus is to be taken. The tablets of Everolimus should not be chewed or crushed. Patients will receive Everolimus until progression, toxicity, withdrawal of informed consent or clinical investigator decision<br>* Other names: Certican;|
What is the study measuring?
-----------------
Primary Outcome Measures
| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Progression Free Survival rate at 6 months | Progression Free Survival rate at 6 months refers to the rate of patients alive and free from progression of the disease at 6 months from registration into the study. Disease will be assessed every 8 weeks up to 2 years until progression or death whichever came first. | 6 months from registration into the study |
Secondary Outcome Measures
| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| progression free survival | Progression Free Survival (PFS) refers to the time from registration into the study to the date of progressive disease or death whichever came first assessed every 8 weeks up to 2 years. In the absence of progression, time will be censored at the date of last tumor assessment or follow-up | From randomization until progression or death whichever came first up to 2 years |
| overall survival | Overall survival (OS) is the time interval between date of registration into study and the date of death. For alive patients, time will be censored at the date of last follow-up. | From randomization until death followed up to 5 years |
| Overall response rate | Overall response rate refers to the rate of patients with complete, partial or minimal responses (defined as shrinkage of target lesions between 10 and 30%) according to RECIST 1.1. Disease will be assessed every 8 weeks up to 2 years. | From randomization until progression or death whichever came first up to 2 years |
| Duration of response | Duration of response refers to the time from the date of the first assessement of non-progression to the date of progressive disease or death. Disease will be assessed every 8 weeks up to 2 years until progression or death whichever came first. In the absence of progression time will be censored at the date of last tumor assessment or follow-up. | calculated from date of first assessement of non-progression until progression or death whichever came first up to 2 years |
| Non-dimensional pattern of response | Non-dimensional pattern of response refers to the evaluation of any consistent variation in radio metabolic diagnostic test (i.e. PET or Bone scan) and/or changes in signal intensity, contrast uptake/enhancement and tumor density at CT/MRI according to Modified Response Criteria (MRC). From this point of view, patients will be considered in response if there has been an objective response or at least ONE of the following criteria are met: An unequivocal reduction in tumor density at CT scan; An unequivocal reduction in signal intensity and/or contrast enhancement at MRI; An unequivocal reduction in SUV at PET scan; An unequivocal reduction in bone scan uptake. Disease will be assessed every 8 weeks up to 2 years until progression or death whichever came first. | calculated from randomization until progression or death whichever came first up to 2 years |
| clinical benefit | Clinical Benefit will be prospectively evaluated by means of Pain and Analgesic Scale recording of analgesic consume and as lack of progression of disease at six months. | evaluated at each visit from randomizzation until progression or death whichever came first up to 2 years |
| Safety | Safety will be captured by recording: physical examinations, vital signs, performance status/body weight; blood tests and chemistry tests; intensity and severity of adverse events, use of analgesic medication at each visit until 28 days after last dose of study treatment assumption up to 2 years. Adverse events will be evaluated according to Common Terminology Criteria for Adverse Events (CTCAE) Version 4.0 | assessed at each visit from randomizzation until 28 days after the last dose of study treatment assumption up to 2 years |
Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
osteosarcoma, sorafenib, everolimus, sarcoma
|
NCT01591408
|
EEG Biofeedback Therapy as an Adjunct Treatment for PTSD
|
The proposed study, Placebo-controlled study of EEG biofeedback therapy as an adjunct treatment for PTSD, evaluating symptoms and EEG dynamics, will investigate the brain dynamics associated with PTSD symptom reduction associated with EEG biofeedback therapy or sham EEG biofeedback in addition to treatment as usual at the Naval Medical Center, San Diego (NMCSD) OASIS program.~EEG biofeedback treatment protocols for PTSD and other disorders have been developed and honed by private practice clinicians over the past 25 years, during which EEG biofeedback has become an increasingly popular adjunct therapy.~The reported success of EEG biofeedback as a non-drug intervention with lasting efficacy warrants a clinical study investigating not only symptom reduction, but also the underlying neurobiological mechanism. To this end, we propose a study using high density EEG recordings before and after treatment for PTSD symptoms to determine which brain activities correlate with reported symptom changes.~The proposed study could expand treatment alternatives for servicemen with PTSD. If EEG biofeedback is shown to improve symptom reduction over the placebo controlled condition, it would offer a non-pharmacological intervention that would avoid undesirable side effects, and accelerate recovery compared with the current standard of care.
|
EEG biofeedback is an emerging alternative approach to treating PTSD, for which there is still insufficient evidence to assume unequivocal clinical utility. However, a 1991 report showed PTSD symptom reduction in 14 subjects receiving EEG biofeedback, as compared to 13 subjects receiving traditional treatment (Peniston, 1991), and a recent case study of 2 PTSD patients receiving EEG biofeedback therapy also showed reduce symptom severity using a newer protocol and device (Othmer, 2009). Another recent study focused on the anxiety symptoms of PTSD and showed that EEG biofeedback significantly reduced anxiety compared to subjects not receiving treatment (Walker, 2009).~EEG biofeedback has also been explored as a treatment for non-PTSD related anxiety disorders, with results showing significant changes in reported anxiety correlated with increased or decreased alpha-frequency (~8-12 Hz) power (Hardt, 1978). Similarly, alpha-frequency EEG biofeedback has been shown to reduce anxiety and to reduce heart rate reactivity to a stressor after 8 sessions of EEG biofeedback training (Rice, 1993). While EEG biofeedback has been shown to significantly change EEG power dynamics (Egner, 2004), it is still unclear if and how EEG biofeedback can effect long-term and complex changes in cognitive and/or emotional functioning.~Some attention has been given to other types of biofeedback for the treatment for PTSD, such as heart rate variability (HRV) biofeedback, which may be relevant in understanding the background of biofeedback with respect to PTSD treatment. While one study reported no difference in symptom reduction between treatment as usual and treatment as usual plus HRV biofeedback (Lande, 2010), a handful of other studies have reported significant associations between HRV changes and PTSD symptoms. Specifically, increased HRV was significantly correlated with PTSD symptom reduction, which was more effective with respiratory sinus arrhythmia (RSA) (which affects HRV) biofeedback than with progressive muscle relaxation (Zucker, 2009). Furthermore, combat-related PTSD subjects showed lower resting HRV than controls, but training with HRV biofeedback increased PTSD subjects' HRV and simultaneously decreased their PTSD symptoms (Tan, 2011). Finally, a quantitative EEG study showed that an acute session of RSA biofeedback was associated with an increase in alpha-band power and reduced higher frequency beta-band power, suggesting a neural impact of RSA training and HRV regulation (Sherlin, 2010).~Summary The proposed study of EEG biofeedback at the OASIS program will not only address the clinical efficacy, but also the brain activations associated with specific symptoms of PTSD through collection of high-density EEG data before and after EEG biofeedback treatment. These data will help elucidate the neural correlates of PTSD symptom expression as well as address the potential efficacy of EEG biofeedback therapy as an adjunct treatment for PTSD-like symptoms.
|
Placebo-controlled Study of EEG Biofeedback Therapy as an Adjunct Treatment for PTSD, Evaluating Symptoms and EEG Dynamics
|
PTSD, Anxiety, Trauma, Sleep Disorders
|
* Device: EEG biofeedback
|
Inclusion Criteria:~Male,~active military,~participating in PTSD program at NMCSD~Exclusion Criteria:~Seizure disorder.
|
18 Years
|
40 Years
|
Male
|
No
|
Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single
|
| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Improved Symptom Ratings | Will test whether subjects receiving real EEG biofeedback report decreased anxiety and irritability relative to subjects receiving sham biofeedback. The scale for each rating was a 0-10, with 0 meaning not at all and 10 being extremely anxious/irritable. | 4 weeks |
|
EEG biofeedback, neurofeedback, therapy, adjunct
|
Sleep Wake Disorders, Nervous System Diseases, Neurologic Manifestations, Mental Disorders
|
| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: EEG biofeedback<br>Subjects will receive EEG biofeedback according to their own brain rhythms | Device: EEG biofeedback<br>* EEG data is collected from the scalp. Data is decomposed in real time and a portion of the signal is fed back to the subject via a vibrating stuffed animal and visual cues.<br>* Other names: EEG info device;|
| Sham Comparator: sham EEG biofeedback<br>Subjects will receive feedback according to someone else's brain rhythms collected during a different session. | Device: EEG biofeedback<br>* EEG data is collected from the scalp. Data is decomposed in real time and a portion of the signal is fed back to the subject via a vibrating stuffed animal and visual cues.<br>* Other names: EEG info device;|
|
EEG Biofeedback Therapy as an Adjunct Treatment for PTSD
Study Overview
=================
Brief Summary
-----------------
The proposed study, Placebo-controlled study of EEG biofeedback therapy as an adjunct treatment for PTSD, evaluating symptoms and EEG dynamics, will investigate the brain dynamics associated with PTSD symptom reduction associated with EEG biofeedback therapy or sham EEG biofeedback in addition to treatment as usual at the Naval Medical Center, San Diego (NMCSD) OASIS program. EEG biofeedback treatment protocols for PTSD and other disorders have been developed and honed by private practice clinicians over the past 25 years, during which EEG biofeedback has become an increasingly popular adjunct therapy. The reported success of EEG biofeedback as a non-drug intervention with lasting efficacy warrants a clinical study investigating not only symptom reduction, but also the underlying neurobiological mechanism. To this end, we propose a study using high density EEG recordings before and after treatment for PTSD symptoms to determine which brain activities correlate with reported symptom changes. The proposed study could expand treatment alternatives for servicemen with PTSD. If EEG biofeedback is shown to improve symptom reduction over the placebo controlled condition, it would offer a non-pharmacological intervention that would avoid undesirable side effects, and accelerate recovery compared with the current standard of care.
Detailed Description
-----------------
EEG biofeedback is an emerging alternative approach to treating PTSD, for which there is still insufficient evidence to assume unequivocal clinical utility. However, a 1991 report showed PTSD symptom reduction in 14 subjects receiving EEG biofeedback, as compared to 13 subjects receiving traditional treatment (Peniston, 1991), and a recent case study of 2 PTSD patients receiving EEG biofeedback therapy also showed reduce symptom severity using a newer protocol and device (Othmer, 2009). Another recent study focused on the anxiety symptoms of PTSD and showed that EEG biofeedback significantly reduced anxiety compared to subjects not receiving treatment (Walker, 2009). EEG biofeedback has also been explored as a treatment for non-PTSD related anxiety disorders, with results showing significant changes in reported anxiety correlated with increased or decreased alpha-frequency ( 8-12 Hz) power (Hardt, 1978). Similarly, alpha-frequency EEG biofeedback has been shown to reduce anxiety and to reduce heart rate reactivity to a stressor after 8 sessions of EEG biofeedback training (Rice, 1993). While EEG biofeedback has been shown to significantly change EEG power dynamics (Egner, 2004), it is still unclear if and how EEG biofeedback can effect long-term and complex changes in cognitive and/or emotional functioning. Some attention has been given to other types of biofeedback for the treatment for PTSD, such as heart rate variability (HRV) biofeedback, which may be relevant in understanding the background of biofeedback with respect to PTSD treatment. While one study reported no difference in symptom reduction between treatment as usual and treatment as usual plus HRV biofeedback (Lande, 2010), a handful of other studies have reported significant associations between HRV changes and PTSD symptoms. Specifically, increased HRV was significantly correlated with PTSD symptom reduction, which was more effective with respiratory sinus arrhythmia (RSA) (which affects HRV) biofeedback than with progressive muscle relaxation (Zucker, 2009). Furthermore, combat-related PTSD subjects showed lower resting HRV than controls, but training with HRV biofeedback increased PTSD subjects' HRV and simultaneously decreased their PTSD symptoms (Tan, 2011). Finally, a quantitative EEG study showed that an acute session of RSA biofeedback was associated with an increase in alpha-band power and reduced higher frequency beta-band power, suggesting a neural impact of RSA training and HRV regulation (Sherlin, 2010). Summary The proposed study of EEG biofeedback at the OASIS program will not only address the clinical efficacy, but also the brain activations associated with specific symptoms of PTSD through collection of high-density EEG data before and after EEG biofeedback treatment. These data will help elucidate the neural correlates of PTSD symptom expression as well as address the potential efficacy of EEG biofeedback therapy as an adjunct treatment for PTSD-like symptoms.
Official Title
-----------------
Placebo-controlled Study of EEG Biofeedback Therapy as an Adjunct Treatment for PTSD, Evaluating Symptoms and EEG Dynamics
Conditions
-----------------
PTSD, Anxiety, Trauma, Sleep Disorders
Intervention / Treatment
-----------------
* Device: EEG biofeedback
Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Male, active military, participating in PTSD program at NMCSD Exclusion Criteria: Seizure disorder.
Ages Eligible for Study
-----------------
Minimum Age: 18 Years
Maximum Age: 40 Years
Sexes Eligible for Study
-----------------
Male
Accepts Healthy Volunteers
-----------------
No
Study Plan
=================
How is the study designed?
-----------------
Design Details
Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single
Arms and Interventions
| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: EEG biofeedback<br>Subjects will receive EEG biofeedback according to their own brain rhythms | Device: EEG biofeedback<br>* EEG data is collected from the scalp. Data is decomposed in real time and a portion of the signal is fed back to the subject via a vibrating stuffed animal and visual cues.<br>* Other names: EEG info device;|
| Sham Comparator: sham EEG biofeedback<br>Subjects will receive feedback according to someone else's brain rhythms collected during a different session. | Device: EEG biofeedback<br>* EEG data is collected from the scalp. Data is decomposed in real time and a portion of the signal is fed back to the subject via a vibrating stuffed animal and visual cues.<br>* Other names: EEG info device;|
What is the study measuring?
-----------------
Primary Outcome Measures
| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Improved Symptom Ratings | Will test whether subjects receiving real EEG biofeedback report decreased anxiety and irritability relative to subjects receiving sham biofeedback. The scale for each rating was a 0-10, with 0 meaning not at all and 10 being extremely anxious/irritable. | 4 weeks |
Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
EEG biofeedback, neurofeedback, therapy, adjunct
|
|
NCT02545153
|
Fibrin Sealant for Cholangiotomy Closure Study
|
Bile leak reduction from the common bile duct, as a result of glue appliance after cholangiotomy.
|
Laparoscopic common bile duct exploration is a way of dealing with common bile duct stones that has gained increasing acceptance. Following a cholangiotomy there is, however, the risk of bile leakage from the incision.~A way of avoiding leakage following cholangiotomy may be to apply fibrin sealant on the cholangiotomy.~The present study is based on patients undergoing laparoscopic cholecystectomy at the department of surgery, Enköping hospital, Sweden. The patients are informed about the study prior to the procedure. Cholangiography is performed routinely. In case common bile duct stones are encountered on the cholangiography, an incision is made in the common bile duct and the stones are extracted. After the stone extraction, a t tube is introduced into the cholangiotomy and the incision is closed with running Vicryl sutures.~When the cholangiotomy has been closed, the randomisation is performed with a sealed envelope system. If the patient is randomised to fibrin sealant, this is applied on the cholangiotomy. A passive drain is introduced before the abdomen is closed.~Postoperatively, the amount of bile in the passive drain is measured by an observer randomised to the allocation.~If the amount of bile in the drain does not exceed 100 ml three days postoperatively, a secondary cholangiography is performed through the t tube. If the contrast passes to the duodenum and no contrast leakage is seen, the t tube is withdrawn.~All postoperative complications are registered according to the Clavien-Dindo system.
|
Randomised Controlled Trial of Fibrin Sealant to Prevent Bile Leakage After Cholangiotomy
|
Common Bile Duct Gall Stones, Infection, Bile Leak
|
* Drug: Tisseel, Baxter (Aprotinin and Fibrinogen)
* Drug: Control
|
Inclusion Criteria:~Gallbladder disease~Exclusion Criteria:~Cancer/Tumor
|
18 Years
|
85 Years
|
All
|
No
|
Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single
|
| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Postoperative biliary leakage | The amount of bile in the drain is measured daily until it is withdrawn | From the the day of surgery until discharge and/or removal of abdominal drain, up to two weeks |
|
Fibrin Tissue Adhesive, Aprotinin, Hemostatics, Coagulants, Trypsin Inhibitors, Serine Proteinase Inhibitors, Protease Inhibitors, Enzyme Inhibitors, Molecular Mechanisms of Pharmacological Action
|
| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: Fibrin sealant<br>Tisseel, Baxter (Aprotinin and Fibrinogen) | Drug: Tisseel, Baxter (Aprotinin and Fibrinogen)<br>* After introducton of t tube and closure of the incision with running sutures, fibrin sealant is applied on the incision.<br>* Other names: Closing the incision with fibrin sealant;|
| Placebo Comparator: Control<br>Suturing the incision without fibrin glue | Drug: Control<br>* No fibrin sealant applied<br>* Other names: Closing the incision without fibrin sealant;|
|
Fibrin Sealant for Cholangiotomy Closure Study
Study Overview
=================
Brief Summary
-----------------
Bile leak reduction from the common bile duct, as a result of glue appliance after cholangiotomy.
Detailed Description
-----------------
Laparoscopic common bile duct exploration is a way of dealing with common bile duct stones that has gained increasing acceptance. Following a cholangiotomy there is, however, the risk of bile leakage from the incision. A way of avoiding leakage following cholangiotomy may be to apply fibrin sealant on the cholangiotomy. The present study is based on patients undergoing laparoscopic cholecystectomy at the department of surgery, Enköping hospital, Sweden. The patients are informed about the study prior to the procedure. Cholangiography is performed routinely. In case common bile duct stones are encountered on the cholangiography, an incision is made in the common bile duct and the stones are extracted. After the stone extraction, a t tube is introduced into the cholangiotomy and the incision is closed with running Vicryl sutures. When the cholangiotomy has been closed, the randomisation is performed with a sealed envelope system. If the patient is randomised to fibrin sealant, this is applied on the cholangiotomy. A passive drain is introduced before the abdomen is closed. Postoperatively, the amount of bile in the passive drain is measured by an observer randomised to the allocation. If the amount of bile in the drain does not exceed 100 ml three days postoperatively, a secondary cholangiography is performed through the t tube. If the contrast passes to the duodenum and no contrast leakage is seen, the t tube is withdrawn. All postoperative complications are registered according to the Clavien-Dindo system.
Official Title
-----------------
Randomised Controlled Trial of Fibrin Sealant to Prevent Bile Leakage After Cholangiotomy
Conditions
-----------------
Common Bile Duct Gall Stones, Infection, Bile Leak
Intervention / Treatment
-----------------
* Drug: Tisseel, Baxter (Aprotinin and Fibrinogen)
* Drug: Control
Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Gallbladder disease Exclusion Criteria: Cancer/Tumor
Ages Eligible for Study
-----------------
Minimum Age: 18 Years
Maximum Age: 85 Years
Sexes Eligible for Study
-----------------
All
Accepts Healthy Volunteers
-----------------
No
Study Plan
=================
How is the study designed?
-----------------
Design Details
Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single
Arms and Interventions
| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: Fibrin sealant<br>Tisseel, Baxter (Aprotinin and Fibrinogen) | Drug: Tisseel, Baxter (Aprotinin and Fibrinogen)<br>* After introducton of t tube and closure of the incision with running sutures, fibrin sealant is applied on the incision.<br>* Other names: Closing the incision with fibrin sealant;|
| Placebo Comparator: Control<br>Suturing the incision without fibrin glue | Drug: Control<br>* No fibrin sealant applied<br>* Other names: Closing the incision without fibrin sealant;|
What is the study measuring?
-----------------
Primary Outcome Measures
| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Postoperative biliary leakage | The amount of bile in the drain is measured daily until it is withdrawn | From the the day of surgery until discharge and/or removal of abdominal drain, up to two weeks |
|
||
NCT02420015
|
Mobile Health Technology to Enhance Abstinence in Smokers With Schizophrenia
|
This study is designed to evaluate if a treatment the investigators call iCOMMIT is effective at helping smokers with schizophrenia stop smoking. iCOMMIT is a smoking cessation treatment that combines mobile technology with behavioral strategies, counseling, and medications.
|
The purpose of this 2-arm randomized controlled trial (RCT) is to evaluate the efficacy of Multi-Component Mobile-enhanced Treatment for Smoking Cessation (iCOMMIT) in helping individuals with schizophrenia or other psychotic disorders stop smoking. Eligible participants will be randomized to receive iCOMMIT, which includes smoking cessation counseling, pharmacotherapy, and mobile technology components, or a control intervention that includes smoking cessation counseling and pharmacotherapy, but no mobile technology components. The control condition represents an intensive standard of care and helps control for monitoring, counselor, time, and attention effects.~The primary outcome for the study will be self-reported and bio-verified prolonged smoking abstinence at the 6-month follow-up. Self-reported prolonged abstinence will be verified by saliva cotinine assay. Secondary outcomes will include 7- and 30-day point prevalence abstinence at each assessment, where abstinence is defined as no tobacco use in the prior 7 or 30 days.
|
Mobile Health Technology to Enhance Abstinence in Smokers With Schizophrenia
|
Schizophrenia, Cigarette Smoking
|
* Drug: Nicotine replacement therapy
* Drug: Bupropion
* Behavioral: cognitive-behavioral smoking cessation counseling
* Behavioral: Mobile Contingency Management
* Behavioral: Stay Quit Coach
* Behavioral: SMS text messaging
|
Inclusion Criteria:~Currently smoke at least ten cigarettes a day~Have been smoking for at least one year~Meet criteria for schizophrenia, schizoaffective disorder, or another psychotic disorder based on structured clinical interview~Can speak and write fluent conversational English~Are between 18 and 70 years of age~Are willing to make a smoking cessation attempt~Score 26 or higher on the Montreal Cognitive Assessment~Exclusion Criteria:~Have a history of myocardial infarction in the past 6 months~Have a contraindication to NRT with no medical clearance from the primary care provider or study physician~Use and unwillingness to stop use of other forms of nicotine such as cigars, pipes, or chewing tobacco~Are pregnant~Meet criteria for a current manic episode based on structured clinical interview~Are currently enrolled in another smoking cessation trial~Are currently imprisoned or in psychiatric hospitalization
|
18 Years
|
70 Years
|
All
|
No
|
Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
|
| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Number of Participants Who Self-report Prolonged Abstinence | Prolonged abstinence will exclude tobacco use in the first two weeks following the quit date, as is consistent with other smoking cessation trials. | 6 month follow-up |
| Number of Participants Whose Prolonged Abstinence is Bio-verified | Self-reported prolonged abstinence (primary outcome) will be verified by cotinine assay. Saliva samples will be collected from participants who self-report prolonged abstinence at each follow-up. | 6 month follow-up |
|
| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Number of Participants Who Report 7 Day Point Prevalence Abstinence | Secondary smoking outcomes will include 7-day point prevalence abstinence at each assessment, where abstinence is defined as no tobacco use in the prior 7 days. | 3 months post-quit attempt (Session 5) |
| Number of Participants Who Report 30 Day Point Prevalence Abstinence | Secondary smoking outcomes will include 30-day point prevalence abstinence at each assessment, where abstinence is defined as no tobacco use in the prior 30 days. | 3 months post-quit attempt (Session 5) |
| Number of Participants Who Report 7 Day Point Prevalence Abstinence | Secondary smoking outcomes will include 7-day point prevalence abstinence at each assessment, where abstinence is defined as no tobacco use in the prior 7 days. | 6 months post-quit attempt (Session 6) |
| Number of Participants Who Report 30 Day Point Prevalence Abstinence | Secondary smoking outcomes will include 30-day point prevalence abstinence at each assessment, where abstinence is defined as no tobacco use in the prior 30 days. | 6 months post-quit attempt (Session 6) |
|
Cholinergic Agonists, Bupropion, Nicotine, Ganglionic Stimulants, Autonomic Agents, Peripheral Nervous System Agents, Physiological Effects of Drugs, Nicotinic Agonists, Cholinergic Agents, Neurotransmitter Agents, Molecular Mechanisms of Pharmacological Action, Antidepressive Agents, Second-Generation, Antidepressive Agents, Psychotropic Drugs, Dopamine Uptake Inhibitors, Neurotransmitter Uptake Inhibitors, Membrane Transport Modulators, Dopamine Agents, Cytochrome P-450 CYP2D6 Inhibitors, Cytochrome P-450 Enzyme Inhibitors, Enzyme Inhibitors
|
| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: iCOMMIT<br>The components of the intervention include 1) behavioral therapy in the form of mobile contingency management (mCM) designed to increase early abstinent rates; 2) pharmacotherapy for smoking cessation [including nicotine replacement therapy (NRT) and bupropion]; 3) four sessions of guideline based cognitive-behavioral smoking cessation counseling designed to increased coping skills specific to smoking cessation; 4) a smart-phone based relapse prevention application (the Stay Quit Coach) that is populated during the counseling sessions; and 5) SMS text messaging reminders to increase medication adherence. | Drug: Nicotine replacement therapy<br>* Participants will be prescribed NRT patch and one nicotine rescue method (e.g., nicotine gum, lozenge, inhaler) for use during the post-quit phase of the study. Participants will be given the choice between nicotine gum, nicotine inhaler, or nicotine nasal spray, and will be instructed to use the rescue method as needed to reduce cigarette cravings<br>* Other names: nicotine gum, patch, inhaler, and/or lozenge;Drug: Bupropion<br>* All participants who are medically eligible will be prescribed bupropion, which they will start two weeks prior to their quit day. Dosage will be 150 mg/daily for days 1-7 and 300 mg/daily (administered in two daily doses) until the 3-month follow-up<br>* Other names: Zyban;Behavioral: cognitive-behavioral smoking cessation counseling<br>* Participants will receive four 20-minute smoking cessation counseling sessions and a participant manual. The four sessions are based on standard cognitive-behavioral therapy techniques shown to be efficacious for smoking cessation.<br>Behavioral: Mobile Contingency Management<br>* Participants will be asked to provide video recordings of themselves taking carbon monoxide readings in order to confirm smoking abstinence. Participants are asked to upload these videos to the study's secured server, and are provided monetary reward for videos that suggest smoking abstinence.<br>* Other names: mCM;Behavioral: Stay Quit Coach<br>* Stay Quit Coach is a smart phone application that serves as a source of readily available support and information for adults who are already in treatment to quit smoking and to help them stay quit after treatment. The app guides user in creating tailored plans that include their personal reasons for quitting, interactive tools to help users cope with urges to smoke, motivational messages, support contacts to help users stay smoke free and how to address lapses. Participants assigned to this condition will be asked to use Stay Quit Coach from Session 2 through the 6-month follow-up.<br>Behavioral: SMS text messaging<br>* Patients assigned to this condition will receive text messages relevant to their current status in their smoking quit attempt, including messages reminding participants to take their smoking cessation medication.<br>* Other names: texting;|
| Active Comparator: Control Group<br>The components of the intervention include 1) pharmacotherapy for smoking cessation [including nicotine replacement therapy (NRT) and bupropion]; and 2) four sessions of guideline based cognitive-behavioral smoking cessation counseling designed to increased coping skills specific to smoking cessation. | Drug: Nicotine replacement therapy<br>* Participants will be prescribed NRT patch and one nicotine rescue method (e.g., nicotine gum, lozenge, inhaler) for use during the post-quit phase of the study. Participants will be given the choice between nicotine gum, nicotine inhaler, or nicotine nasal spray, and will be instructed to use the rescue method as needed to reduce cigarette cravings<br>* Other names: nicotine gum, patch, inhaler, and/or lozenge;Drug: Bupropion<br>* All participants who are medically eligible will be prescribed bupropion, which they will start two weeks prior to their quit day. Dosage will be 150 mg/daily for days 1-7 and 300 mg/daily (administered in two daily doses) until the 3-month follow-up<br>* Other names: Zyban;Behavioral: cognitive-behavioral smoking cessation counseling<br>* Participants will receive four 20-minute smoking cessation counseling sessions and a participant manual. The four sessions are based on standard cognitive-behavioral therapy techniques shown to be efficacious for smoking cessation.<br>|
|
Mobile Health Technology to Enhance Abstinence in Smokers With Schizophrenia
Study Overview
=================
Brief Summary
-----------------
This study is designed to evaluate if a treatment the investigators call iCOMMIT is effective at helping smokers with schizophrenia stop smoking. iCOMMIT is a smoking cessation treatment that combines mobile technology with behavioral strategies, counseling, and medications.
Detailed Description
-----------------
The purpose of this 2-arm randomized controlled trial (RCT) is to evaluate the efficacy of Multi-Component Mobile-enhanced Treatment for Smoking Cessation (iCOMMIT) in helping individuals with schizophrenia or other psychotic disorders stop smoking. Eligible participants will be randomized to receive iCOMMIT, which includes smoking cessation counseling, pharmacotherapy, and mobile technology components, or a control intervention that includes smoking cessation counseling and pharmacotherapy, but no mobile technology components. The control condition represents an intensive standard of care and helps control for monitoring, counselor, time, and attention effects. The primary outcome for the study will be self-reported and bio-verified prolonged smoking abstinence at the 6-month follow-up. Self-reported prolonged abstinence will be verified by saliva cotinine assay. Secondary outcomes will include 7- and 30-day point prevalence abstinence at each assessment, where abstinence is defined as no tobacco use in the prior 7 or 30 days.
Official Title
-----------------
Mobile Health Technology to Enhance Abstinence in Smokers With Schizophrenia
Conditions
-----------------
Schizophrenia, Cigarette Smoking
Intervention / Treatment
-----------------
* Drug: Nicotine replacement therapy
* Drug: Bupropion
* Behavioral: cognitive-behavioral smoking cessation counseling
* Behavioral: Mobile Contingency Management
* Behavioral: Stay Quit Coach
* Behavioral: SMS text messaging
Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Currently smoke at least ten cigarettes a day Have been smoking for at least one year Meet criteria for schizophrenia, schizoaffective disorder, or another psychotic disorder based on structured clinical interview Can speak and write fluent conversational English Are between 18 and 70 years of age Are willing to make a smoking cessation attempt Score 26 or higher on the Montreal Cognitive Assessment Exclusion Criteria: Have a history of myocardial infarction in the past 6 months Have a contraindication to NRT with no medical clearance from the primary care provider or study physician Use and unwillingness to stop use of other forms of nicotine such as cigars, pipes, or chewing tobacco Are pregnant Meet criteria for a current manic episode based on structured clinical interview Are currently enrolled in another smoking cessation trial Are currently imprisoned or in psychiatric hospitalization
Ages Eligible for Study
-----------------
Minimum Age: 18 Years
Maximum Age: 70 Years
Sexes Eligible for Study
-----------------
All
Accepts Healthy Volunteers
-----------------
No
Study Plan
=================
How is the study designed?
-----------------
Design Details
Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Arms and Interventions
| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: iCOMMIT<br>The components of the intervention include 1) behavioral therapy in the form of mobile contingency management (mCM) designed to increase early abstinent rates; 2) pharmacotherapy for smoking cessation [including nicotine replacement therapy (NRT) and bupropion]; 3) four sessions of guideline based cognitive-behavioral smoking cessation counseling designed to increased coping skills specific to smoking cessation; 4) a smart-phone based relapse prevention application (the Stay Quit Coach) that is populated during the counseling sessions; and 5) SMS text messaging reminders to increase medication adherence. | Drug: Nicotine replacement therapy<br>* Participants will be prescribed NRT patch and one nicotine rescue method (e.g., nicotine gum, lozenge, inhaler) for use during the post-quit phase of the study. Participants will be given the choice between nicotine gum, nicotine inhaler, or nicotine nasal spray, and will be instructed to use the rescue method as needed to reduce cigarette cravings<br>* Other names: nicotine gum, patch, inhaler, and/or lozenge;Drug: Bupropion<br>* All participants who are medically eligible will be prescribed bupropion, which they will start two weeks prior to their quit day. Dosage will be 150 mg/daily for days 1-7 and 300 mg/daily (administered in two daily doses) until the 3-month follow-up<br>* Other names: Zyban;Behavioral: cognitive-behavioral smoking cessation counseling<br>* Participants will receive four 20-minute smoking cessation counseling sessions and a participant manual. The four sessions are based on standard cognitive-behavioral therapy techniques shown to be efficacious for smoking cessation.<br>Behavioral: Mobile Contingency Management<br>* Participants will be asked to provide video recordings of themselves taking carbon monoxide readings in order to confirm smoking abstinence. Participants are asked to upload these videos to the study's secured server, and are provided monetary reward for videos that suggest smoking abstinence.<br>* Other names: mCM;Behavioral: Stay Quit Coach<br>* Stay Quit Coach is a smart phone application that serves as a source of readily available support and information for adults who are already in treatment to quit smoking and to help them stay quit after treatment. The app guides user in creating tailored plans that include their personal reasons for quitting, interactive tools to help users cope with urges to smoke, motivational messages, support contacts to help users stay smoke free and how to address lapses. Participants assigned to this condition will be asked to use Stay Quit Coach from Session 2 through the 6-month follow-up.<br>Behavioral: SMS text messaging<br>* Patients assigned to this condition will receive text messages relevant to their current status in their smoking quit attempt, including messages reminding participants to take their smoking cessation medication.<br>* Other names: texting;|
| Active Comparator: Control Group<br>The components of the intervention include 1) pharmacotherapy for smoking cessation [including nicotine replacement therapy (NRT) and bupropion]; and 2) four sessions of guideline based cognitive-behavioral smoking cessation counseling designed to increased coping skills specific to smoking cessation. | Drug: Nicotine replacement therapy<br>* Participants will be prescribed NRT patch and one nicotine rescue method (e.g., nicotine gum, lozenge, inhaler) for use during the post-quit phase of the study. Participants will be given the choice between nicotine gum, nicotine inhaler, or nicotine nasal spray, and will be instructed to use the rescue method as needed to reduce cigarette cravings<br>* Other names: nicotine gum, patch, inhaler, and/or lozenge;Drug: Bupropion<br>* All participants who are medically eligible will be prescribed bupropion, which they will start two weeks prior to their quit day. Dosage will be 150 mg/daily for days 1-7 and 300 mg/daily (administered in two daily doses) until the 3-month follow-up<br>* Other names: Zyban;Behavioral: cognitive-behavioral smoking cessation counseling<br>* Participants will receive four 20-minute smoking cessation counseling sessions and a participant manual. The four sessions are based on standard cognitive-behavioral therapy techniques shown to be efficacious for smoking cessation.<br>|
What is the study measuring?
-----------------
Primary Outcome Measures
| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Number of Participants Who Self-report Prolonged Abstinence | Prolonged abstinence will exclude tobacco use in the first two weeks following the quit date, as is consistent with other smoking cessation trials. | 6 month follow-up |
| Number of Participants Whose Prolonged Abstinence is Bio-verified | Self-reported prolonged abstinence (primary outcome) will be verified by cotinine assay. Saliva samples will be collected from participants who self-report prolonged abstinence at each follow-up. | 6 month follow-up |
Secondary Outcome Measures
| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Number of Participants Who Report 7 Day Point Prevalence Abstinence | Secondary smoking outcomes will include 7-day point prevalence abstinence at each assessment, where abstinence is defined as no tobacco use in the prior 7 days. | 3 months post-quit attempt (Session 5) |
| Number of Participants Who Report 30 Day Point Prevalence Abstinence | Secondary smoking outcomes will include 30-day point prevalence abstinence at each assessment, where abstinence is defined as no tobacco use in the prior 30 days. | 3 months post-quit attempt (Session 5) |
| Number of Participants Who Report 7 Day Point Prevalence Abstinence | Secondary smoking outcomes will include 7-day point prevalence abstinence at each assessment, where abstinence is defined as no tobacco use in the prior 7 days. | 6 months post-quit attempt (Session 6) |
| Number of Participants Who Report 30 Day Point Prevalence Abstinence | Secondary smoking outcomes will include 30-day point prevalence abstinence at each assessment, where abstinence is defined as no tobacco use in the prior 30 days. | 6 months post-quit attempt (Session 6) |
|
|
NCT01492660
|
Echogenic Versus Stimulating Needle and Catheter for Sciatic Blocks
|
Patients scheduled for total knee replacements and suitable for sciatic nerve block will be randomized to one of 2 groups.~Group 1 will have the nerve block performed using a standard Pajunk block needle under ultrasound guidance and with electrical nerve stimulation (ENS), and have catheter placement also guided by electrical nerve stimulation. Group 2 will have the block performed using a Sonoplex echogenic block needle and have an echogenic catheter sited, all under ultrasound (US) guidance. Group 2 will have needle location aided by ENS, but ENS will not be used for catheter location.~An observer blinded to the needle type will assess the quality of needle visualisation on a recording of the US image taken during the procedure, along with adequacy of spread of local anesthetic. The primary outcome will be needle visibility, and secondary outcomes will be block success rate, block performance time, complication rate, number of needle passes per block, and adequacy of spread of local anesthetic.
|
A total of 70 patients with ASA physical status 1 to 4, scheduled for elective total knee arthroplasty and deemed suitable to receive a sciatic nerve block will be included in the study. They will be randomised to one of two groups prior to the block procedure using a closed envelope system.~Recruitment will take place in the preoperative clinic. All blocks will be performed in the block room using standard monitoring, sterile precautions and titrated intravenous sedation.~Prior to the sciatic nerve block a continuous femoral nerve block will be performed according to standard procedure. Once this is complete the patient will be positioned for the sciatic nerve block.~A preprocedural scan will be done as per standard practice and skin will be infiltrated with 1% lidocaine.~The anaesthetist performing the block will be aware of the study group allocation due to the requirement for physically handling the block needles, and will proceed to position the needle into the required location site to facilitate catheter insertion, with the aid of electrical nerve stimulation via the needle. This will be recorded using the ultrasound machines cineloop facility.~If after 6 passes the operator is unable either to contact the nerve according to the ultrasound image or elicit a twitch response, the procedure will be abandoned and this will be considered a failed block. In this case analgesia will be covered with periarticular infiltration and opioids.~During needle positioning, the observer will record the number of needle redirections required to optimally locate the needle, each redirection being defined as every movement which follows a withdrawal of more than 2cm. The observer will also record the number of skin punctures required and any arterial or venous punctures.~Group E will have the block performed using the echogenic needle, and the echogenic catheter will be placed using ultrasound guidance.~The catheter will be inserted through the needle by a second anesthetist. This process will be continuously recording using the cineloop feature of the ultrasound machine. Once the catheter is deemed to be in an appropriate position, local anaesthetic will be injected by the second anaesthetist while observing the disposition of the local anaesthetic perineurally in short axis. This will be confirmed with a long axis view of the nerve (also recorded).~Group S will have the block performed with a standard needle and catheter, guided by electrical nerve stimulation.~Acceptable muscle twitch response will be plantar- or dorsiflexion, inversion or eversion with an initial nerve current strength of 0.5mA at a frequency of 2Hz. If a satisfactory motor response cannot be elicited, current will be increased in stages to 1.5mA. If a response still cannot be elicited this will be recorded but the catheter will still be used if its position is deemed satisfactory using colour Doppler - a medley of colour adjacent to the nerve with the injection of agitated dextrose 5%. Once the catheter is deemed to be in an appropriate position, local anaesthetic will be injected by the second anaesthetist while observing the disposition of the local anaesthetic perineurally in short axis. This will be confirmed with a long axis view of the nerve (also recorded).~Once the catheter has been sited using the above techniques, a bolus of agitated 5% dextrose will be injected through the catheter and Doppler ultrasound will be used to locate where in the tissues the injected fluid is being deposited. This will also be recorded and subsequently assessed.~An assistant present during the block will time two aspects of the procedure:~Time from first skin contact with needle to first muscle response to nerve stimulation. This will be done only on the day of surgery during the block procedure until the desired muscle twitch is elicited.~Time from first skin contact to completion of catheter insertion (Block time).This is done during the block procedure only on the day of surgery as noted above~Once catheter position has been assessed a total of 20 millilitres of 2% mepivacaine will be injected via the catheter in both groups. Over the subsequent 30 minutes a second blinded observer will take observations every 5 minutes to assess the degree of motor and sensory block.~The video recording of the block procedure will be sent along with the data collection form to two of the co-investigators, who will independently assess the following:~At the time of nerve contact by the needle, assign a rating for visibility of the needle shaft and tip according to the following scale:~not visualised or poorly visualised - needle tip/shaft being isoechoic or only slightly more echogenic than background parenchyma.~tip or shaft visualised with some difficulty - tip/shaft readily identified as being more echogenic than the background parenchyma but not seen in their entirety~excellent visibility shaft and tip strongly echogenic relative to tissue and visualised in their entirety.~Assign the same rating after completion of injection~Judge whether circumferential and longitudinal spread of local anaesthetic is either adequate or inadequate.~Following the operation a standard infusion of 0.1% ropivacaine at 4cc/hr will be commenced via the sciatic catheter. Post operative care will be as per the standard practice at this institution.~One week post operatively the patient will be telephoned at home to check for persisting neurological symptoms.
|
Comparison of Visibility of Echogenic and Standard Non-echogenic Block Needles During Ultrasound Guided Sciatic Blocks. A Randomized Prospective Study
|
Osteoarthritis Knee, Postoperative Pain
|
* Device: echogenic needle and catheter
* Device: Neurostimulation to position needle and catheter
|
Inclusion Criteria:~Patients age 18-80 years listed for total knee arthroplasty.~ASA I-IV.~Able to give informed consent~Able to cooperate with study protocol.~Exclusion Criteria:~Standard contraindication to regional anaesthesia/analgesia: local infection, coagulopathy, local anaesthetic allergy, patient refusal, diabetes mellitus, peripheral neuropathy, pre-existing nerve injury)~Inability to consent~Patient refusal~Pregnant patients
|
18 Years
|
80 Years
|
All
|
No
|
Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double
|
| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Visibility of needle tip and catheter tip | Needle tip visibility graded by blinded observers Catheter tip visibility graded by blinded observers | Day 1 |
|
| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| number of needle passes | The number of times the needle is withdrawn more than 2 cm and resited | Day 1 |
| success rate of block | Motor and sensory block will be evaluated on standard grading system every 5 minutes for 30 minutes post injection | Day 1 |
| Block procedure time | Time from needle insertion to the end of catheter insertion | Day 1 |
| Immediate complications | Vascular punctures, venous or arterial | Day 1 |
| delayed complications | telephone interview to elicit delayed neurologic symptoms | One week after surgery/block |
|
Ultrasonography, nerve block, catheters, needle, anesthesia
|
Osteoarthritis, Knee, Osteoarthritis, Arthritis, Joint Diseases, Musculoskeletal Diseases, Rheumatic Diseases
|
| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Echogenic needle and catheter<br>The echogenic needle will be positioned using ultrasonography and neurostimulation with an end point of plantar or dorsiflexion with 0.6mA of current strength. The catheter will be inserted using ultrasonography alone. 20 Ml of 2% mepivacaine will be inserted using the catheter. The distribution of drug will be evaluated using short axis and long axis views. Sensory motor block evaluation every 5 minutes for 30 minutes. Duration of block procedure, number of passes and success will be evaluated | Device: echogenic needle and catheter<br>* Visibility of needle shaft and tip with engraved markers. Ultrasonographic Visibility of catheter tip<br>* Other names: Pajunk sonolong sonoset;|
| Active Comparator: Neurostimulation<br>The non echogenic needle will be positioned using ultrasonography and neurostimulation with plantar or dorsiflexion as the end point with 0.6mA current.The catheter will be positioned using neurostimulation with plantar or dorsiflexion with 0.6-1.5mA current. | Device: Neurostimulation to position needle and catheter<br>* The non echogenic needle will be positioned using ultrasonography and neurostimulation and the catheter will be positioned using neurostimulation with plantar or dorsiflexion with 0.6-1.5mA current. 20mL of 2% mepivacaine will be injected via the catheter. Sensory motor block will be evaluated every 5 minutes for 30 mins<br>* Other names: Pajunk Stimulaong Plexus catheter set;|
|
Echogenic Versus Stimulating Needle and Catheter for Sciatic Blocks
Study Overview
=================
Brief Summary
-----------------
Patients scheduled for total knee replacements and suitable for sciatic nerve block will be randomized to one of 2 groups. Group 1 will have the nerve block performed using a standard Pajunk block needle under ultrasound guidance and with electrical nerve stimulation (ENS), and have catheter placement also guided by electrical nerve stimulation. Group 2 will have the block performed using a Sonoplex echogenic block needle and have an echogenic catheter sited, all under ultrasound (US) guidance. Group 2 will have needle location aided by ENS, but ENS will not be used for catheter location. An observer blinded to the needle type will assess the quality of needle visualisation on a recording of the US image taken during the procedure, along with adequacy of spread of local anesthetic. The primary outcome will be needle visibility, and secondary outcomes will be block success rate, block performance time, complication rate, number of needle passes per block, and adequacy of spread of local anesthetic.
Detailed Description
-----------------
A total of 70 patients with ASA physical status 1 to 4, scheduled for elective total knee arthroplasty and deemed suitable to receive a sciatic nerve block will be included in the study. They will be randomised to one of two groups prior to the block procedure using a closed envelope system. Recruitment will take place in the preoperative clinic. All blocks will be performed in the block room using standard monitoring, sterile precautions and titrated intravenous sedation. Prior to the sciatic nerve block a continuous femoral nerve block will be performed according to standard procedure. Once this is complete the patient will be positioned for the sciatic nerve block. A preprocedural scan will be done as per standard practice and skin will be infiltrated with 1% lidocaine. The anaesthetist performing the block will be aware of the study group allocation due to the requirement for physically handling the block needles, and will proceed to position the needle into the required location site to facilitate catheter insertion, with the aid of electrical nerve stimulation via the needle. This will be recorded using the ultrasound machines cineloop facility. If after 6 passes the operator is unable either to contact the nerve according to the ultrasound image or elicit a twitch response, the procedure will be abandoned and this will be considered a failed block. In this case analgesia will be covered with periarticular infiltration and opioids. During needle positioning, the observer will record the number of needle redirections required to optimally locate the needle, each redirection being defined as every movement which follows a withdrawal of more than 2cm. The observer will also record the number of skin punctures required and any arterial or venous punctures. Group E will have the block performed using the echogenic needle, and the echogenic catheter will be placed using ultrasound guidance. The catheter will be inserted through the needle by a second anesthetist. This process will be continuously recording using the cineloop feature of the ultrasound machine. Once the catheter is deemed to be in an appropriate position, local anaesthetic will be injected by the second anaesthetist while observing the disposition of the local anaesthetic perineurally in short axis. This will be confirmed with a long axis view of the nerve (also recorded). Group S will have the block performed with a standard needle and catheter, guided by electrical nerve stimulation. Acceptable muscle twitch response will be plantar- or dorsiflexion, inversion or eversion with an initial nerve current strength of 0.5mA at a frequency of 2Hz. If a satisfactory motor response cannot be elicited, current will be increased in stages to 1.5mA. If a response still cannot be elicited this will be recorded but the catheter will still be used if its position is deemed satisfactory using colour Doppler - a medley of colour adjacent to the nerve with the injection of agitated dextrose 5%. Once the catheter is deemed to be in an appropriate position, local anaesthetic will be injected by the second anaesthetist while observing the disposition of the local anaesthetic perineurally in short axis. This will be confirmed with a long axis view of the nerve (also recorded). Once the catheter has been sited using the above techniques, a bolus of agitated 5% dextrose will be injected through the catheter and Doppler ultrasound will be used to locate where in the tissues the injected fluid is being deposited. This will also be recorded and subsequently assessed. An assistant present during the block will time two aspects of the procedure: Time from first skin contact with needle to first muscle response to nerve stimulation. This will be done only on the day of surgery during the block procedure until the desired muscle twitch is elicited. Time from first skin contact to completion of catheter insertion (Block time).This is done during the block procedure only on the day of surgery as noted above Once catheter position has been assessed a total of 20 millilitres of 2% mepivacaine will be injected via the catheter in both groups. Over the subsequent 30 minutes a second blinded observer will take observations every 5 minutes to assess the degree of motor and sensory block. The video recording of the block procedure will be sent along with the data collection form to two of the co-investigators, who will independently assess the following: At the time of nerve contact by the needle, assign a rating for visibility of the needle shaft and tip according to the following scale: not visualised or poorly visualised - needle tip/shaft being isoechoic or only slightly more echogenic than background parenchyma. tip or shaft visualised with some difficulty - tip/shaft readily identified as being more echogenic than the background parenchyma but not seen in their entirety excellent visibility shaft and tip strongly echogenic relative to tissue and visualised in their entirety. Assign the same rating after completion of injection Judge whether circumferential and longitudinal spread of local anaesthetic is either adequate or inadequate. Following the operation a standard infusion of 0.1% ropivacaine at 4cc/hr will be commenced via the sciatic catheter. Post operative care will be as per the standard practice at this institution. One week post operatively the patient will be telephoned at home to check for persisting neurological symptoms.
Official Title
-----------------
Comparison of Visibility of Echogenic and Standard Non-echogenic Block Needles During Ultrasound Guided Sciatic Blocks. A Randomized Prospective Study
Conditions
-----------------
Osteoarthritis Knee, Postoperative Pain
Intervention / Treatment
-----------------
* Device: echogenic needle and catheter
* Device: Neurostimulation to position needle and catheter
Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Patients age 18-80 years listed for total knee arthroplasty. ASA I-IV. Able to give informed consent Able to cooperate with study protocol. Exclusion Criteria: Standard contraindication to regional anaesthesia/analgesia: local infection, coagulopathy, local anaesthetic allergy, patient refusal, diabetes mellitus, peripheral neuropathy, pre-existing nerve injury) Inability to consent Patient refusal Pregnant patients
Ages Eligible for Study
-----------------
Minimum Age: 18 Years
Maximum Age: 80 Years
Sexes Eligible for Study
-----------------
All
Accepts Healthy Volunteers
-----------------
No
Study Plan
=================
How is the study designed?
-----------------
Design Details
Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double
Arms and Interventions
| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Echogenic needle and catheter<br>The echogenic needle will be positioned using ultrasonography and neurostimulation with an end point of plantar or dorsiflexion with 0.6mA of current strength. The catheter will be inserted using ultrasonography alone. 20 Ml of 2% mepivacaine will be inserted using the catheter. The distribution of drug will be evaluated using short axis and long axis views. Sensory motor block evaluation every 5 minutes for 30 minutes. Duration of block procedure, number of passes and success will be evaluated | Device: echogenic needle and catheter<br>* Visibility of needle shaft and tip with engraved markers. Ultrasonographic Visibility of catheter tip<br>* Other names: Pajunk sonolong sonoset;|
| Active Comparator: Neurostimulation<br>The non echogenic needle will be positioned using ultrasonography and neurostimulation with plantar or dorsiflexion as the end point with 0.6mA current.The catheter will be positioned using neurostimulation with plantar or dorsiflexion with 0.6-1.5mA current. | Device: Neurostimulation to position needle and catheter<br>* The non echogenic needle will be positioned using ultrasonography and neurostimulation and the catheter will be positioned using neurostimulation with plantar or dorsiflexion with 0.6-1.5mA current. 20mL of 2% mepivacaine will be injected via the catheter. Sensory motor block will be evaluated every 5 minutes for 30 mins<br>* Other names: Pajunk Stimulaong Plexus catheter set;|
What is the study measuring?
-----------------
Primary Outcome Measures
| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Visibility of needle tip and catheter tip | Needle tip visibility graded by blinded observers Catheter tip visibility graded by blinded observers | Day 1 |
Secondary Outcome Measures
| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| number of needle passes | The number of times the needle is withdrawn more than 2 cm and resited | Day 1 |
| success rate of block | Motor and sensory block will be evaluated on standard grading system every 5 minutes for 30 minutes post injection | Day 1 |
| Block procedure time | Time from needle insertion to the end of catheter insertion | Day 1 |
| Immediate complications | Vascular punctures, venous or arterial | Day 1 |
| delayed complications | telephone interview to elicit delayed neurologic symptoms | One week after surgery/block |
Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Ultrasonography, nerve block, catheters, needle, anesthesia
|
NCT04676724
|
Study of Sequential GSK3228836 and Peginterferon Treatment in Participants With Chronic Hepatitis B (CHB)
|
This study is intended to evaluate if 12 or 24 weeks of treatment with GSK3228836 followed by up to 24 weeks of pegylated interferon (PegIFN) can increase the rate of hepatitis B virus surface antigen (HBsAg) loss in participants on stable nucleos(t)ide analogue (NA) therapy, and whether virologic response can be sustained once PegIFN treatment is discontinued. Participants will be randomized to receive GSK3228836 for 12 or 24 weeks followed by up to 24 weeks of PegIFN.
|
A Phase IIb Multi-Center, Randomised, Open Label Study to Assess the Efficacy and Safety of Sequential Treatment With GSK3228836 Followed by Pegylated Interferon Alpha 2a in Participants With Chronic Hepatitis B Virus (B-Together)
|
Hepatitis B
|
* Drug: GSK3228836
* Drug: PegIFN
* Drug: NA therapy
|
Inclusion Criteria:~18 to 75 years of age at the time of signing the informed consent.~Participants who are eligible to be treated with PegIFN.~Documented chronic HBV infection >=6 months prior to screening and currently receiving stable NA therapy except telbivudine, defined as no changes to their NA regimen from at least 6 months prior to screening and with no planned changes to the stable regimen over the duration of the study.~Plasma or serum HBsAg concentration >100 International Units per milliliter (IU/mL).~Plasma or serum HBV DNA concentration <90 IU/mL.~ALT <=2 times ULN.~A male participant is eligible to participate if they agree to the following during the intervention period and for at least 90 days after the last dose of study treatment: a) Refrain from donating sperm; b) Be abstinent from heterosexual intercourse as their preferred and usual lifestyle (abstinent on a long term and persistent basis) and agree to remain abstinent or agree to use contraception/barrier: Agree to use a male condom (and should also be advised of the benefit for a female partner to use a highly effective method of contraception as a condom may break or leak) when having sexual intercourse with a woman of childbearing potential who is not currently pregnant.~A female participant is eligible to participate: a) If she is not pregnant or breastfeeding; b) at least one of the following conditions applies: Is not a woman of childbearing potential (WOCBP) or is a WOCBP and using a contraceptive method that is highly effective (with a failure rate of <1 percent per year), preferably with low user dependency during the intervention period and for at least 90 days after the last dose of study treatment.~A WOCBP must have both a negative highly sensitive pregnancy test within 24 hours before the first dose of study intervention. If a urine test cannot be confirmed as negative, a serum pregnancy test is required. In such cases, the participant must be excluded from participation if the serum pregnancy result is positive.~Capable of giving signed informed consent.~Exclusion Criteria:~Clinically significant abnormalities, aside from chronic HBV infection in medical history or physical examination.~Co-infection with: Current or past history of Hepatitis C virus (HCV); Human immunodeficiency virus (HIV); Hepatitis D virus (HDV).~History of or suspected liver cirrhosis and/or evidence of cirrhosis as determined by both: Aspartate aminotransferase (AST)-Platelet Index (APRI) >2 and FibroSure/FibroTest result >0.7. If only one parameter (APRI or FibroSure/FibroTest) result is positive, a discussion with the Medical Monitor is required before inclusion in study is permitted. Regardless of APRI of Fibrosure/FibroTest score, if the participant meets one of the following criteria, they will be excluded from the study: a) Liver biopsy (i.e., Metavir Score F4); b) Liver stiffness >12 kilopascals (kPa).~Diagnosed or suspected hepatocellular carcinoma as evidenced by the following: Alpha- fetoprotein concentration >=200 nanogram per milliliter (ng/mL); If the screening alpha fetoprotein concentration is >=50 ng/mL and <200 ng/mL, the absence of liver mass must be documented by imaging within 6 months before randomization.~History of malignancy within the past 5 years with the exception of specific cancers that are cured by surgical resection (e.g., skin cancer). Participants under evaluation for possible malignancy are not eligible.~History of vasculitis or presence of symptoms and signs of potential vasculitis (e.g., vasculitic rash, skin ulceration, repeated blood detected in urine without identified cause) or history/presence of other diseases that may be associated with vasculitis condition (e.g., systemic lupus erythematosus, rheumatoid arthritis, relapsing polychondritis, mononeuritis multiplex).~History of extrahepatic disorders possibly related to HBV immune conditions (e.g., nephrotic syndrome, any type of glomerulonephritis, polyarteritis nodosa, cryoglobulinemia, uncontrolled hypertension).~Poorly controlled thyroid dysfunction or abnormal thyroid stimulating hormone (TSH) levels~Positive (or borderline positive) anti-neutrophil cytoplasmic antibody (ANCA) at screening. Participants that meet these criteria may be considered for inclusion in the study following: a) Analysis of myeloperoxidase (MPO)-ANCA [perinuclear ANCA (pANCA)] and PR3-ANCA [classical ANCA (cANCA)]; b) A discussion with the Medical Monitor to review participant's complete medical history to ensure no past history or current manifestations of a vasculitic/inflammatory/auto-immune condition.~Low complement 3 (C3) at screening and evidence of past history or current manifestations of vasculitic/inflammatory/auto-immune conditions. All participants with low C3 at screening should have their medical history discussed with the Medical Monitor prior to enrolment.~History of alcohol or drug abuse/dependence. Current alcohol use as judged by investigator to potentially interfere with participant compliance; History of or current drug abuse/dependence as judged by the investigator to potentially interfere with participant compliance. Refers to illicit drugs and substances with abuse potential. Medications that are used by the participant as directed, whether over-the-counter or through prescription, are acceptable and would not meet the exclusion criteria.~Pre-existing severe psychiatric condition or a history of severe psychiatric disorders, including severe depression, suicidal ideation and attempted suicide.~Currently taking, or took within 3 months of screening, any immunosuppressing drugs (e.g., prednisone), other than a short course of therapy (<=2 weeks) or topical/inhaled steroid use.~Participants for whom immunosuppressive treatment is not advised, including therapeutic doses of steroids, will be excluded.~Participants with prior treatment with PegINF or interferon will be excluded~Participants requiring anti-coagulation therapies (for example warfarin, Factor Xa inhibitors or anti-platelet agents like clopidogrel).~Participants currently taking, or took within 6 months of screening, telbivudine.~The participant has participated in a clinical trial and has received an investigational product within the following time period prior to the first dosing day in the current study: 5 half-lives (if known) or twice the duration (if known) of the biological effect of the study treatment (whichever is longer) or 90 days (if half-life or duration is unknown).~Prior treatment with any oligonucleotide or small interfering ribonucleic acid (siRNA) within 12 months prior to the first dosing day.~Fridericia's QT correction formula (QTcF) >=450 milliseconds (msec) (if single electrocardiogram [ECG] at screening shows QTcF>=450 msec, a mean of triplicate measurements should be used to confirm that participant meets exclusion criterion).~Laboratory results as follows: Serum albumin <3.5 grams per deciliter (g/dL); Glomerular filtration rate (GFR) <60 milliliter per minute per 1.73 square meter (mL/min /1.73 m^2) as calculated by the Chronic Kidney Disease Epidemiologic Collaboration (CKD-EPI) formula (for Japan, Japanese Society of Nephrology Chronic Kidney Disease Initiative [JSN-CKDI equation]); International normalized ratio (INR) >1.25; Platelet count <140x10^9 cells/L; Baseline hemoglobin <10 g/dL; Total bilirubin >1.25 times ULN (For participants with benign unconjugated hyperbilirubinemia with total bilirubin >1.25 times ULN, discussion for inclusion to the study is required with the Medical Monitor); Urine albumin to creatinine ratio (ACR) >=0.03 milligram (mg)/mg (or >=30 mg/g). In the event of an ACR above this threshold, eligibility may be confirmed by a second measurement. In cases where participants have low urine albumin and low urine creatinine levels resulting in a urine ACR calculation >=0.03 mg/mg (or >=30 mg/g), the investigator should confirm that the participant does not have a history of diabetes, hypertension or other risk factors that may affect renal function and discuss with the Medical Monitor, or designee.~History of/sensitivity to GSK3228836 or components thereof or a history of drug or other allergy that, in the opinion of the investigator or Medical Monitor, contraindicates their participation.
|
18 Years
|
75 Years
|
All
|
No
|
Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Interventional Model Description: Participants will be randomised in a ratio of 1:1 to one of two treatment arms: 24 weeks GSK3228836 followed by up to 24 weeks PegIFN, or 12 weeks GSK3228836 followed by up to 24 weeks PegIFN.
Masking: None (Open Label)
|
| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Percentage of participants who achieve sustained virologic response (SVR) for 24 weeks after end of treatment | Sustained virologic response is defined as undetectable levels of HBsAg and Hepatitis-B virus deoxy-ribonucleic acid (HBV DNA) on treatment. | From off-treatment Week 1 to off-treatment Week 24 |
|
| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Percentage of participants achieving HBsAg and HBV DNA < lower limit of quantitation (LLOQ) | Percentage of participants achieving HBsAg and HBV DNA <LLOQ. | From off-treatment Week 1 to off-treatment Week 24 |
| Percentage of participants with alanine aminotransferase (ALT) normalization over time in absence of rescue medication | Limited to participants having Baseline ALT> upper limit of normal (ULN). | Up to 72 weeks |
| Absolute values of HBsAg levels | Blood samples will be collected to assess HBsAg levels. | Up to 72 weeks |
| Change from Baseline in HBsAg levels | Blood samples will be collected to assess HBsAg levels. | Baseline and up to 72 weeks |
| Absolute values of HBV DNA levels | Blood samples will be collected to assess HBV DNA levels. | Up to 72 weeks |
| Change from Baseline in HBV DNA levels | Blood samples will be collected to assess HBV DNA levels. | Baseline and up to 72 weeks |
| Absolute values of Hepatitis B virus e-antigen (HBeAg) levels | Blood samples will be collected to assess HBeAg levels. | Up to 72 weeks |
| Change from Baseline in HBeAg levels | Blood samples will be collected to assess HBeAg levels. | Baseline and up to 72 weeks |
| Absolute values of HBs antibody levels | Blood samples will be collected to assess HBs antibody levels. | Up to 72 weeks |
| Change from Baseline in HBs antibody levels | Blood samples will be collected to assess HBs antibody levels. | Baseline and up to 72 weeks |
| Absolute values of HBe antibody levels | Blood samples will be collected to assess HBe antibody levels. | Up to 72 weeks |
| Change from Baseline in HBe antibody levels | Blood samples will be collected to assess HBe antibody levels. | Baseline and up to 72 weeks |
| Absolute values of ALT | Blood samples will be collected to assess ALT levels. | Up to 72 weeks |
| Change from Baseline in ALT | Blood samples will be collected to assess ALT levels. | Baseline and up to 72 weeks |
| Time to ALT normalization in absence of rescue medication | Time to ALT normalization in absence of rescue medication will be measured in participants having Baseline ALT>ULN. | Baseline and up to 72 weeks |
|
Chronic Hepatitis B, GSK3228836, Pegylated interferon, Nucleos(t)ide analogue, Sustained virologic response
|
Hepatitis A, Hepatitis B, Hepatitis B, Chronic, Hepatitis, Hepatitis, Chronic, Liver Diseases, Digestive System Diseases, Hepatitis, Viral, Human, Virus Diseases, Infections, Enterovirus Infections, Picornaviridae Infections, RNA Virus Infections, Blood-Borne Infections, Communicable Diseases, Hepadnaviridae Infections, DNA Virus Infections, Chronic Disease, Disease Attributes, Pathologic Processes
|
| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: GSK3228836 for 24 weeks + PegIFN for up to 24 weeks<br>Eligible participants on stable NA therapy will receive GSK3228836 for 24 weeks, followed by up to 24 weeks of PegIFN. | Drug: GSK3228836<br>* Participants will be administered GSK3228836.<br>Drug: PegIFN<br>* Participants will be administered PegIFN.<br>Drug: NA therapy<br>* Participants will continue to receive their NA therapy for the duration of the study.<br>|
| Experimental: GSK3228836 for 12 weeks + PegIFN for up to 24 weeks<br>Eligible participants on stable NA therapy will receive GSK3228836 for 12 weeks, followed by up to 24 weeks of PegIFN. | Drug: GSK3228836<br>* Participants will be administered GSK3228836.<br>Drug: PegIFN<br>* Participants will be administered PegIFN.<br>Drug: NA therapy<br>* Participants will continue to receive their NA therapy for the duration of the study.<br>|
|
Study of Sequential GSK3228836 and Peginterferon Treatment in Participants With Chronic Hepatitis B (CHB)
Study Overview
=================
Brief Summary
-----------------
This study is intended to evaluate if 12 or 24 weeks of treatment with GSK3228836 followed by up to 24 weeks of pegylated interferon (PegIFN) can increase the rate of hepatitis B virus surface antigen (HBsAg) loss in participants on stable nucleos(t)ide analogue (NA) therapy, and whether virologic response can be sustained once PegIFN treatment is discontinued. Participants will be randomized to receive GSK3228836 for 12 or 24 weeks followed by up to 24 weeks of PegIFN.
Official Title
-----------------
A Phase IIb Multi-Center, Randomised, Open Label Study to Assess the Efficacy and Safety of Sequential Treatment With GSK3228836 Followed by Pegylated Interferon Alpha 2a in Participants With Chronic Hepatitis B Virus (B-Together)
Conditions
-----------------
Hepatitis B
Intervention / Treatment
-----------------
* Drug: GSK3228836
* Drug: PegIFN
* Drug: NA therapy
Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: 18 to 75 years of age at the time of signing the informed consent. Participants who are eligible to be treated with PegIFN. Documented chronic HBV infection >=6 months prior to screening and currently receiving stable NA therapy except telbivudine, defined as no changes to their NA regimen from at least 6 months prior to screening and with no planned changes to the stable regimen over the duration of the study. Plasma or serum HBsAg concentration >100 International Units per milliliter (IU/mL). Plasma or serum HBV DNA concentration <90 IU/mL. ALT <=2 times ULN. A male participant is eligible to participate if they agree to the following during the intervention period and for at least 90 days after the last dose of study treatment: a) Refrain from donating sperm; b) Be abstinent from heterosexual intercourse as their preferred and usual lifestyle (abstinent on a long term and persistent basis) and agree to remain abstinent or agree to use contraception/barrier: Agree to use a male condom (and should also be advised of the benefit for a female partner to use a highly effective method of contraception as a condom may break or leak) when having sexual intercourse with a woman of childbearing potential who is not currently pregnant. A female participant is eligible to participate: a) If she is not pregnant or breastfeeding; b) at least one of the following conditions applies: Is not a woman of childbearing potential (WOCBP) or is a WOCBP and using a contraceptive method that is highly effective (with a failure rate of <1 percent per year), preferably with low user dependency during the intervention period and for at least 90 days after the last dose of study treatment. A WOCBP must have both a negative highly sensitive pregnancy test within 24 hours before the first dose of study intervention. If a urine test cannot be confirmed as negative, a serum pregnancy test is required. In such cases, the participant must be excluded from participation if the serum pregnancy result is positive. Capable of giving signed informed consent. Exclusion Criteria: Clinically significant abnormalities, aside from chronic HBV infection in medical history or physical examination. Co-infection with: Current or past history of Hepatitis C virus (HCV); Human immunodeficiency virus (HIV); Hepatitis D virus (HDV). History of or suspected liver cirrhosis and/or evidence of cirrhosis as determined by both: Aspartate aminotransferase (AST)-Platelet Index (APRI) >2 and FibroSure/FibroTest result >0.7. If only one parameter (APRI or FibroSure/FibroTest) result is positive, a discussion with the Medical Monitor is required before inclusion in study is permitted. Regardless of APRI of Fibrosure/FibroTest score, if the participant meets one of the following criteria, they will be excluded from the study: a) Liver biopsy (i.e., Metavir Score F4); b) Liver stiffness >12 kilopascals (kPa). Diagnosed or suspected hepatocellular carcinoma as evidenced by the following: Alpha- fetoprotein concentration >=200 nanogram per milliliter (ng/mL); If the screening alpha fetoprotein concentration is >=50 ng/mL and <200 ng/mL, the absence of liver mass must be documented by imaging within 6 months before randomization. History of malignancy within the past 5 years with the exception of specific cancers that are cured by surgical resection (e.g., skin cancer). Participants under evaluation for possible malignancy are not eligible. History of vasculitis or presence of symptoms and signs of potential vasculitis (e.g., vasculitic rash, skin ulceration, repeated blood detected in urine without identified cause) or history/presence of other diseases that may be associated with vasculitis condition (e.g., systemic lupus erythematosus, rheumatoid arthritis, relapsing polychondritis, mononeuritis multiplex). History of extrahepatic disorders possibly related to HBV immune conditions (e.g., nephrotic syndrome, any type of glomerulonephritis, polyarteritis nodosa, cryoglobulinemia, uncontrolled hypertension). Poorly controlled thyroid dysfunction or abnormal thyroid stimulating hormone (TSH) levels Positive (or borderline positive) anti-neutrophil cytoplasmic antibody (ANCA) at screening. Participants that meet these criteria may be considered for inclusion in the study following: a) Analysis of myeloperoxidase (MPO)-ANCA [perinuclear ANCA (pANCA)] and PR3-ANCA [classical ANCA (cANCA)]; b) A discussion with the Medical Monitor to review participant's complete medical history to ensure no past history or current manifestations of a vasculitic/inflammatory/auto-immune condition. Low complement 3 (C3) at screening and evidence of past history or current manifestations of vasculitic/inflammatory/auto-immune conditions. All participants with low C3 at screening should have their medical history discussed with the Medical Monitor prior to enrolment. History of alcohol or drug abuse/dependence. Current alcohol use as judged by investigator to potentially interfere with participant compliance; History of or current drug abuse/dependence as judged by the investigator to potentially interfere with participant compliance. Refers to illicit drugs and substances with abuse potential. Medications that are used by the participant as directed, whether over-the-counter or through prescription, are acceptable and would not meet the exclusion criteria. Pre-existing severe psychiatric condition or a history of severe psychiatric disorders, including severe depression, suicidal ideation and attempted suicide. Currently taking, or took within 3 months of screening, any immunosuppressing drugs (e.g., prednisone), other than a short course of therapy (<=2 weeks) or topical/inhaled steroid use. Participants for whom immunosuppressive treatment is not advised, including therapeutic doses of steroids, will be excluded. Participants with prior treatment with PegINF or interferon will be excluded Participants requiring anti-coagulation therapies (for example warfarin, Factor Xa inhibitors or anti-platelet agents like clopidogrel). Participants currently taking, or took within 6 months of screening, telbivudine. The participant has participated in a clinical trial and has received an investigational product within the following time period prior to the first dosing day in the current study: 5 half-lives (if known) or twice the duration (if known) of the biological effect of the study treatment (whichever is longer) or 90 days (if half-life or duration is unknown). Prior treatment with any oligonucleotide or small interfering ribonucleic acid (siRNA) within 12 months prior to the first dosing day. Fridericia's QT correction formula (QTcF) >=450 milliseconds (msec) (if single electrocardiogram [ECG] at screening shows QTcF>=450 msec, a mean of triplicate measurements should be used to confirm that participant meets exclusion criterion). Laboratory results as follows: Serum albumin <3.5 grams per deciliter (g/dL); Glomerular filtration rate (GFR) <60 milliliter per minute per 1.73 square meter (mL/min /1.73 m^2) as calculated by the Chronic Kidney Disease Epidemiologic Collaboration (CKD-EPI) formula (for Japan, Japanese Society of Nephrology Chronic Kidney Disease Initiative [JSN-CKDI equation]); International normalized ratio (INR) >1.25; Platelet count <140x10^9 cells/L; Baseline hemoglobin <10 g/dL; Total bilirubin >1.25 times ULN (For participants with benign unconjugated hyperbilirubinemia with total bilirubin >1.25 times ULN, discussion for inclusion to the study is required with the Medical Monitor); Urine albumin to creatinine ratio (ACR) >=0.03 milligram (mg)/mg (or >=30 mg/g). In the event of an ACR above this threshold, eligibility may be confirmed by a second measurement. In cases where participants have low urine albumin and low urine creatinine levels resulting in a urine ACR calculation >=0.03 mg/mg (or >=30 mg/g), the investigator should confirm that the participant does not have a history of diabetes, hypertension or other risk factors that may affect renal function and discuss with the Medical Monitor, or designee. History of/sensitivity to GSK3228836 or components thereof or a history of drug or other allergy that, in the opinion of the investigator or Medical Monitor, contraindicates their participation.
Ages Eligible for Study
-----------------
Minimum Age: 18 Years
Maximum Age: 75 Years
Sexes Eligible for Study
-----------------
All
Accepts Healthy Volunteers
-----------------
No
Study Plan
=================
How is the study designed?
-----------------
Design Details
Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Interventional Model Description: Participants will be randomised in a ratio of 1:1 to one of two treatment arms: 24 weeks GSK3228836 followed by up to 24 weeks PegIFN, or 12 weeks GSK3228836 followed by up to 24 weeks PegIFN.
Masking: None (Open Label)
Arms and Interventions
| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: GSK3228836 for 24 weeks + PegIFN for up to 24 weeks<br>Eligible participants on stable NA therapy will receive GSK3228836 for 24 weeks, followed by up to 24 weeks of PegIFN. | Drug: GSK3228836<br>* Participants will be administered GSK3228836.<br>Drug: PegIFN<br>* Participants will be administered PegIFN.<br>Drug: NA therapy<br>* Participants will continue to receive their NA therapy for the duration of the study.<br>|
| Experimental: GSK3228836 for 12 weeks + PegIFN for up to 24 weeks<br>Eligible participants on stable NA therapy will receive GSK3228836 for 12 weeks, followed by up to 24 weeks of PegIFN. | Drug: GSK3228836<br>* Participants will be administered GSK3228836.<br>Drug: PegIFN<br>* Participants will be administered PegIFN.<br>Drug: NA therapy<br>* Participants will continue to receive their NA therapy for the duration of the study.<br>|
What is the study measuring?
-----------------
Primary Outcome Measures
| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Percentage of participants who achieve sustained virologic response (SVR) for 24 weeks after end of treatment | Sustained virologic response is defined as undetectable levels of HBsAg and Hepatitis-B virus deoxy-ribonucleic acid (HBV DNA) on treatment. | From off-treatment Week 1 to off-treatment Week 24 |
Secondary Outcome Measures
| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Percentage of participants achieving HBsAg and HBV DNA < lower limit of quantitation (LLOQ) | Percentage of participants achieving HBsAg and HBV DNA <LLOQ. | From off-treatment Week 1 to off-treatment Week 24 |
| Percentage of participants with alanine aminotransferase (ALT) normalization over time in absence of rescue medication | Limited to participants having Baseline ALT> upper limit of normal (ULN). | Up to 72 weeks |
| Absolute values of HBsAg levels | Blood samples will be collected to assess HBsAg levels. | Up to 72 weeks |
| Change from Baseline in HBsAg levels | Blood samples will be collected to assess HBsAg levels. | Baseline and up to 72 weeks |
| Absolute values of HBV DNA levels | Blood samples will be collected to assess HBV DNA levels. | Up to 72 weeks |
| Change from Baseline in HBV DNA levels | Blood samples will be collected to assess HBV DNA levels. | Baseline and up to 72 weeks |
| Absolute values of Hepatitis B virus e-antigen (HBeAg) levels | Blood samples will be collected to assess HBeAg levels. | Up to 72 weeks |
| Change from Baseline in HBeAg levels | Blood samples will be collected to assess HBeAg levels. | Baseline and up to 72 weeks |
| Absolute values of HBs antibody levels | Blood samples will be collected to assess HBs antibody levels. | Up to 72 weeks |
| Change from Baseline in HBs antibody levels | Blood samples will be collected to assess HBs antibody levels. | Baseline and up to 72 weeks |
| Absolute values of HBe antibody levels | Blood samples will be collected to assess HBe antibody levels. | Up to 72 weeks |
| Change from Baseline in HBe antibody levels | Blood samples will be collected to assess HBe antibody levels. | Baseline and up to 72 weeks |
| Absolute values of ALT | Blood samples will be collected to assess ALT levels. | Up to 72 weeks |
| Change from Baseline in ALT | Blood samples will be collected to assess ALT levels. | Baseline and up to 72 weeks |
| Time to ALT normalization in absence of rescue medication | Time to ALT normalization in absence of rescue medication will be measured in participants having Baseline ALT>ULN. | Baseline and up to 72 weeks |
Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Chronic Hepatitis B, GSK3228836, Pegylated interferon, Nucleos(t)ide analogue, Sustained virologic response
|
|
NCT02010541
|
The Influence of Technology, Education and Psychological Support on Metabolic Control in Children With T1D
|
The first purpose of this study is to is to compare metabolic control of type 1 diabetes among children under the age of 7 years who use an insulin pump and a real-time (RT) glucose sensor, and children who use only insulin pump; the investigators will also determine dietary habits, their knowledge of type 1 diabetes management and emotional aspects of experiencing illness in the family, in both groups of children.
|
The Influence of Diabetes Related Technology, Education and Psychological Support on Metabolic Control in Young Children With Type 1 Diabetes
|
Type 1 Diabetes
|
Inclusion Criteria:~age up to 7 years~insulin pump for at least 6 months~more than 6 months of duration of type 1 diabetes~complete remission~normal blood pressure for age, only therapy insulin.~Exclusion Criteria:~age over 8 years~type 1 diabetes less than 6 months~insulin pump less than 6 months~still in remission~associated diseases on drug therapy, high blood pressure
| null |
7 Years
|
All
|
No
|
| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Glycaemic control | We will determine HbA1c, average blood glucose, number of blood glucose readings/use of sensors, average AUC for sensor users, readings above and under target for both groups at the beginning and afer 3 months. | 3 months |
|
| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| knowledge on diet and diabetes management | Questionnaire on diet, questionnaire on diabetes management; we will assess the knowledge on diet in T1D and diabetes management in both groups at the beginning, we will give support wherever needed and check after 3 months if it had an influence on metabolic control. | 3 months |
|
type 1 diabetes among young children, sensor, insulin pump, education, psychological support
|
Diabetes Mellitus, Type 1, Diabetes Mellitus, Glucose Metabolism Disorders, Metabolic Diseases, Endocrine System Diseases, Autoimmune Diseases, Immune System Diseases
|
| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| insulin pump group<br>20 children below the age of 7 years who use an insulin pump for at least 6 months, more than 6 months of duration of type 1 diabetes, complete remission, no associated disease (normal blood pressure for age, only therapy insulin). | |
| RT (real time) -CGMS group<br>20 children below the age of 7 years who use an insulin pump and RT-CGMS on regular basis for at least 6 months, more than 6 months of duration of type 1 diabetes, complete remission, no associated disease (normal blood pressure for age, only therapy insulin). pump for at least 6 months, and children below the age of 7 years who use RT-CGMS on regular | |
|
The Influence of Technology, Education and Psychological Support on Metabolic Control in Children With T1D
Study Overview
=================
Brief Summary
-----------------
The first purpose of this study is to is to compare metabolic control of type 1 diabetes among children under the age of 7 years who use an insulin pump and a real-time (RT) glucose sensor, and children who use only insulin pump; the investigators will also determine dietary habits, their knowledge of type 1 diabetes management and emotional aspects of experiencing illness in the family, in both groups of children.
Official Title
-----------------
The Influence of Diabetes Related Technology, Education and Psychological Support on Metabolic Control in Young Children With Type 1 Diabetes
Conditions
-----------------
Type 1 Diabetes
Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: age up to 7 years insulin pump for at least 6 months more than 6 months of duration of type 1 diabetes complete remission normal blood pressure for age, only therapy insulin. Exclusion Criteria: age over 8 years type 1 diabetes less than 6 months insulin pump less than 6 months still in remission associated diseases on drug therapy, high blood pressure
Ages Eligible for Study
-----------------
Maximum Age: 7 Years
Sexes Eligible for Study
-----------------
All
Accepts Healthy Volunteers
-----------------
No
Study Plan
=================
How is the study designed?
-----------------
Arms and Interventions
| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| insulin pump group<br>20 children below the age of 7 years who use an insulin pump for at least 6 months, more than 6 months of duration of type 1 diabetes, complete remission, no associated disease (normal blood pressure for age, only therapy insulin). | |
| RT (real time) -CGMS group<br>20 children below the age of 7 years who use an insulin pump and RT-CGMS on regular basis for at least 6 months, more than 6 months of duration of type 1 diabetes, complete remission, no associated disease (normal blood pressure for age, only therapy insulin). pump for at least 6 months, and children below the age of 7 years who use RT-CGMS on regular | |
What is the study measuring?
-----------------
Primary Outcome Measures
| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Glycaemic control | We will determine HbA1c, average blood glucose, number of blood glucose readings/use of sensors, average AUC for sensor users, readings above and under target for both groups at the beginning and afer 3 months. | 3 months |
Secondary Outcome Measures
| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| knowledge on diet and diabetes management | Questionnaire on diet, questionnaire on diabetes management; we will assess the knowledge on diet in T1D and diabetes management in both groups at the beginning, we will give support wherever needed and check after 3 months if it had an influence on metabolic control. | 3 months |
Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
type 1 diabetes among young children, sensor, insulin pump, education, psychological support
|
|||
NCT00011622
|
Maternal Glucose Measurement in Pregnancy Using a Continuous Ambulatory Subcutaneous Monitor
|
This proposal is a pilot study to describe the variations of blood sugar in pregnant women with various degrees of glucose intolerance, and how they relate to standardized meals. Blood sugar control during pregnancy is important to prevent complications for the newborn. The variation and timing of the blood sugar measurements in gestational diabetics and how this relates to the baby's outcome is controversial. We will use an FDA approved device called Minimed Glucose Continuous Monitor, which is used in clinical practice for certain diabetics. It is very small, similar to a beeper, and is connected to the patient through a small plastic catheter subcutaneously. This measures blood sugar every five minutes for a total of 288 readings a day with minimum discomfort. The hypothesis of this study is that use of the Minimed glucose monitor will provide information about variations of blood sugar in gestational diabetics that is missed by capillary glucose monitors.~Our conclusions will allow us to compare blood glucose trends among the groups. After the data is analyzed in this pilot study, we plan to design a bigger study involving more subjects to study the impact of the blood sugar variations in the outcome of the newborn, and to obtain generalizable results for the population in general.
|
We will coordinate the study through the CRC. The women will have to come in only twice, to have the monitor placed and then taken off three days later. A blood sample will be collected at each visit. Meals and snacks will be provided for each day of the study, specially packaged, to supply an equivalent amount of calories for each subject. These will meet the nutritional requirements for both the mother and the fetus. Women will do separate fingerstick blood sugar measurements using a capillary glucometer four times a day, to ensure the accuracy of the sensor's readings.
|
Maternal Glucose Measurement in Pregnancy Using a Continuous Ambulatory Subcutaneous Monitor
|
Pregnancy
|
* Device: Continuous ambulatory subcutaneous glucose monitor
|
1. Inclusion Criteria~Pregnant women, between 28 and 36 weeks of gestation. Gestational age will be determined by a combination of the date of the last menstrual period and ultrasound, done during the first or second trimester of pregnancy.~Previous glucose challenge test and if abnormal, an oral glucose tolerance test.~Body mass index (BMI) between 25 and 30 Kg/m2.~Gestational diabetes in a previous pregnancy, if glucose between pregnancies was normal.
|
18 Years
|
45 Years
|
Female
|
Accepts Healthy Volunteers
|
| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
|
| Intervention/Treatment |
| --- |
|Device: Continuous ambulatory subcutaneous glucose monitor|nan|
|
Maternal Glucose Measurement in Pregnancy Using a Continuous Ambulatory Subcutaneous Monitor
Study Overview
=================
Brief Summary
-----------------
This proposal is a pilot study to describe the variations of blood sugar in pregnant women with various degrees of glucose intolerance, and how they relate to standardized meals. Blood sugar control during pregnancy is important to prevent complications for the newborn. The variation and timing of the blood sugar measurements in gestational diabetics and how this relates to the baby's outcome is controversial. We will use an FDA approved device called Minimed Glucose Continuous Monitor, which is used in clinical practice for certain diabetics. It is very small, similar to a beeper, and is connected to the patient through a small plastic catheter subcutaneously. This measures blood sugar every five minutes for a total of 288 readings a day with minimum discomfort. The hypothesis of this study is that use of the Minimed glucose monitor will provide information about variations of blood sugar in gestational diabetics that is missed by capillary glucose monitors. Our conclusions will allow us to compare blood glucose trends among the groups. After the data is analyzed in this pilot study, we plan to design a bigger study involving more subjects to study the impact of the blood sugar variations in the outcome of the newborn, and to obtain generalizable results for the population in general.
Detailed Description
-----------------
We will coordinate the study through the CRC. The women will have to come in only twice, to have the monitor placed and then taken off three days later. A blood sample will be collected at each visit. Meals and snacks will be provided for each day of the study, specially packaged, to supply an equivalent amount of calories for each subject. These will meet the nutritional requirements for both the mother and the fetus. Women will do separate fingerstick blood sugar measurements using a capillary glucometer four times a day, to ensure the accuracy of the sensor's readings.
Official Title
-----------------
Maternal Glucose Measurement in Pregnancy Using a Continuous Ambulatory Subcutaneous Monitor
Conditions
-----------------
Pregnancy
Intervention / Treatment
-----------------
* Device: Continuous ambulatory subcutaneous glucose monitor
Participation Criteria
=================
Eligibility Criteria
-----------------
1. Inclusion Criteria Pregnant women, between 28 and 36 weeks of gestation. Gestational age will be determined by a combination of the date of the last menstrual period and ultrasound, done during the first or second trimester of pregnancy. Previous glucose challenge test and if abnormal, an oral glucose tolerance test. Body mass index (BMI) between 25 and 30 Kg/m2. Gestational diabetes in a previous pregnancy, if glucose between pregnancies was normal.
Ages Eligible for Study
-----------------
Minimum Age: 18 Years
Maximum Age: 45 Years
Sexes Eligible for Study
-----------------
Female
Accepts Healthy Volunteers
-----------------
Accepts Healthy Volunteers
Study Plan
=================
How is the study designed?
-----------------
Arms and Interventions
| Intervention/Treatment |
| --- |
|Device: Continuous ambulatory subcutaneous glucose monitor|nan|
What is the study measuring?
-----------------
Primary Outcome Measures
| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
|
||||
NCT00396006
|
Efficacy and Safety Study of Augmentation Therapy With ARALAST Fraction IV-1 (Human Alpha 1 - Proteinase Inhibitor)
|
The purpose of this study is to evaluate the effects of weekly augmentation therapy with ARALAST Fraction IV-1 (Fr IV-1) on epithelial lining fluid (ELF) alpha 1-proteinase inhibitor levels and other ELF analytes and to assess the safety of the treatment. Eligible subjects with a diagnosis of severe congenital alpha 1-antitrypsin deficiency will receive 8 consecutive weekly treatments with 60 mg/kg/week of functional ARALAST Fr IV-1 administered intravenously. The efficacy and safety assessments will include two bronchoscopies with bronchoalveolar lavage on study initiation and on study termination and multiple imaging and laboratory safety assessments. Each subject will participate for a minimum of 12 weeks.
|
The Effect of Augmentation Therapy With ARALAST Fraction IV-1 (ARALAST) Alpha1-Proteinase Inhibitor (α1-PI) on the Level of α1-PI and Other Analytes in the Bronchoalveolar (BAL) Epithelial Lining Fluid (ELF)
|
Alpha 1-Antitrypsin Deficiency
|
* Biological: Alpha1-Proteinase Inhibitor
|
Inclusion Criteria:~Signed and dated informed consent.~Male or female 18 years of age or older.~Documented, endogenous serum α1-PI level < 40 mg/dL measured at screening (unless otherwise approved by the Sponsor) after a minimum of 28-day washout of any prior replacement therapy (if applicable).~Phenotype Pi Z (which includes Pi*Z/Z, Pi*Z/Null, or Pi*Malton/Z), or Pi*Null/Null.~Pulmonary functions at screening meeting the following criteria:~Forced expiratory volume at 1 second (FEV1) >= 50% of predicted value; or~FEV1 > 35% of predicted value and diffusing capacity for carbon monoxide > 45% of predicated value, with no supplemental oxygen therapy and < 3 pulmonary exacerbations or bronchitis requiring antibiotics/corticosteroids within the past 12 months).~For any female of childbearing potential, a negative urine test for pregnancy within 7 days prior to the first bronchoalveolar lavage (BAL) visit and agreement to employ adequate birth control measures for the duration of the study.~No clinically significant abnormalities detected on a 12-lead electrocardiogram (ECG) performed at the screening visit (ECG previously obtained within the past 12 months may be used, if available).~Laboratory results obtained at the screening visit, meeting the following criteria:~Serum alanine aminotransferase (ALT) <= 2 times upper limit of normal (ULN)~Serum aspartate aminotransferase (AST) <= 2 times ULN~Serum total bilirubin <= 2 times ULN~Proteinuria < +2 on dipstick analysis~Serum creatinine <= 1.5 times ULN~Absolute neutrophil count (ANC) >= 1500 cells/mm3~Hemoglobin (Hgb) >= 10.0 g/dL~Platelet count >= 105/mm3~If the subject is treated with respiratory medications, such as inhaled bronchodilators or inhaled corticosteroids, or other chronic medications for the treatment of the subjects´s other medical condition(s), the subject's medication doses were unchanged for at least 14 days prior to the baseline BAL visit.~Exclusion Criteria:~Clinically significant pulmonary impairment, other than chronic pulmonary disease (COPD).~The subject has received any alpha 1 proteinase inhibitor (α1-PI) augmentation therapy (e.g., Prolastin, Zemaira, Aralast, or an investigational α1-PI, by any route including intravenous and inhaled) within 28 days prior to screening.~The subject has received an investigational drug or device within 1 month prior to screening, or the subject is currently receiving an investigational drug or device. If the subject receives another investigational drug or device after enrollment, the subjects is to be withdrawn from the trial.~Presence of clinical symptoms of any lower respiratory tract infection or acute pulmonary exacerbation within 14 days prior to screening.~The subject has a known selective Immunoglobulin A (IgA) deficiency (IgA level less than 15 mg/dL) and/or antibody against IgA.~The subject is pregnant or lactating, or intends to become pregnant during the course of the study.~The subject is not a suitable candidate for a BAL procedure.~Moderate or severe bronchiectasis (total daily sputum production > 10 mL).~Clinically significant medical, psychiatric, or cognitive illness, or recreational drug/alcohol use that, in the opinion of the investigator, would affect subject safety or compliance.~Prior history of adverse reaction to local anaesthetics, sedatives, pain control drugs, and other medication employed at the study center for perioperative care associated with the BAL procedure.~Long-term use of oral or parenteral glucocorticosteroid within 28 days prior to screening.
|
18 Years
| null |
All
|
No
|
Primary Purpose: Treatment
Allocation: Non-Randomized
Intervention Model: Single Group Assignment
Masking: None (Open Label)
|
| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change in Bronchoalveolar Lavage (BAL) Epithelial Lining Fluid (ELF) Alpha1-Proteinase Inhibitor (α1-PI) Level | Median change BAL ELF antigenic α1-PI level the from baseline to post-treatment | BAL procedures were performed at baseline and after 8 consecutive weeks of treatment (minimum of 12 weeks) |
| The Number of Adverse Events (AEs) Related to the Infusion of ARALAST Fr. IV 1 Administered at a Rate of 0.2 mL/kg/Min | | During 8 consecutive weeks of treatment |
| Number of Changes in the Rate of Infusion | Number of decreases in the rate or discontinuations of infusion at 0.2 mL/kg/min | During 8 consecutive weeks of treatment |
|
| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Ratio of Post- to Pre-treatment BAL ELF Antineutrophil Elastase Capacity (ANEC) Levels | Median ratio of post- to pre-treatment BAL ELF ANEC levels | BAL procedures were performed at baseline and after 8 consecutive weeks of treatment (minimum of 12 weeks) |
| Change in in the Ratio of BAL ELF α1-PI to Human Neutrophil Elastase (HNE) Complex Concentration | Median change in the ratio of BAL ELF α1-PI to HNE complex concentration from baseline to post-treatment | BAL procedures were performed at baseline and after 8 consecutive weeks of treatment (minimum of 12 weeks) |
| Change in the α1-PI Plasma Level | Mean change in the plasma level of α1-PI from baseline to post-treatment | Blood samples were collected at baseline and after 8 consecutive weeks of treatment |
| Change in the Plasma Antineutrophil Elastase Capacity (ANEC) Level | Mean change in the plasma ANEC level from baseline to post-treatment | Blood samples were collected at baseline and after 8 consecutive weeks of treatment |
| Clinically Significant Changes in Vital Signs From Pre- to Post-Infusion | Clinically significant changes in vital signs from pre- to post-infusion are: • Heart rate: 25% increase above pre-infusion value • Blood pressure: ≥ 30 mm Hg change from pre-infusion blood pressure (systolic or diastolic) • Temperature: an increase in body temperature to >38°C (>100.4°F). If the pre-infusion body temperature was already >38°C (>100.4°F), then any further increase in body temperature by 1.1°C (1.98°F) or more was considered clinically significant. • Respiratory rate: 25% increase above pre-infusion value | During 8 consecutive weeks of infusion |
|
Protease Inhibitors, Alpha 1-Antitrypsin, Enzyme Inhibitors, Molecular Mechanisms of Pharmacological Action, Trypsin Inhibitors, Serine Proteinase Inhibitors
|
| Intervention/Treatment |
| --- |
|Biological: Alpha1-Proteinase Inhibitor|60 mg/kg, weekly, intravenous infusion|
|
Efficacy and Safety Study of Augmentation Therapy With ARALAST Fraction IV-1 (Human Alpha 1 - Proteinase Inhibitor)
Study Overview
=================
Brief Summary
-----------------
The purpose of this study is to evaluate the effects of weekly augmentation therapy with ARALAST Fraction IV-1 (Fr IV-1) on epithelial lining fluid (ELF) alpha 1-proteinase inhibitor levels and other ELF analytes and to assess the safety of the treatment. Eligible subjects with a diagnosis of severe congenital alpha 1-antitrypsin deficiency will receive 8 consecutive weekly treatments with 60 mg/kg/week of functional ARALAST Fr IV-1 administered intravenously. The efficacy and safety assessments will include two bronchoscopies with bronchoalveolar lavage on study initiation and on study termination and multiple imaging and laboratory safety assessments. Each subject will participate for a minimum of 12 weeks.
Official Title
-----------------
The Effect of Augmentation Therapy With ARALAST Fraction IV-1 (ARALAST) Alpha1-Proteinase Inhibitor (α1-PI) on the Level of α1-PI and Other Analytes in the Bronchoalveolar (BAL) Epithelial Lining Fluid (ELF)
Conditions
-----------------
Alpha 1-Antitrypsin Deficiency
Intervention / Treatment
-----------------
* Biological: Alpha1-Proteinase Inhibitor
Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Signed and dated informed consent. Male or female 18 years of age or older. Documented, endogenous serum α1-PI level < 40 mg/dL measured at screening (unless otherwise approved by the Sponsor) after a minimum of 28-day washout of any prior replacement therapy (if applicable). Phenotype Pi Z (which includes Pi*Z/Z, Pi*Z/Null, or Pi*Malton/Z), or Pi*Null/Null. Pulmonary functions at screening meeting the following criteria: Forced expiratory volume at 1 second (FEV1) >= 50% of predicted value; or FEV1 > 35% of predicted value and diffusing capacity for carbon monoxide > 45% of predicated value, with no supplemental oxygen therapy and < 3 pulmonary exacerbations or bronchitis requiring antibiotics/corticosteroids within the past 12 months). For any female of childbearing potential, a negative urine test for pregnancy within 7 days prior to the first bronchoalveolar lavage (BAL) visit and agreement to employ adequate birth control measures for the duration of the study. No clinically significant abnormalities detected on a 12-lead electrocardiogram (ECG) performed at the screening visit (ECG previously obtained within the past 12 months may be used, if available). Laboratory results obtained at the screening visit, meeting the following criteria: Serum alanine aminotransferase (ALT) <= 2 times upper limit of normal (ULN) Serum aspartate aminotransferase (AST) <= 2 times ULN Serum total bilirubin <= 2 times ULN Proteinuria < +2 on dipstick analysis Serum creatinine <= 1.5 times ULN Absolute neutrophil count (ANC) >= 1500 cells/mm3 Hemoglobin (Hgb) >= 10.0 g/dL Platelet count >= 105/mm3 If the subject is treated with respiratory medications, such as inhaled bronchodilators or inhaled corticosteroids, or other chronic medications for the treatment of the subjects´s other medical condition(s), the subject's medication doses were unchanged for at least 14 days prior to the baseline BAL visit. Exclusion Criteria: Clinically significant pulmonary impairment, other than chronic pulmonary disease (COPD). The subject has received any alpha 1 proteinase inhibitor (α1-PI) augmentation therapy (e.g., Prolastin, Zemaira, Aralast, or an investigational α1-PI, by any route including intravenous and inhaled) within 28 days prior to screening. The subject has received an investigational drug or device within 1 month prior to screening, or the subject is currently receiving an investigational drug or device. If the subject receives another investigational drug or device after enrollment, the subjects is to be withdrawn from the trial. Presence of clinical symptoms of any lower respiratory tract infection or acute pulmonary exacerbation within 14 days prior to screening. The subject has a known selective Immunoglobulin A (IgA) deficiency (IgA level less than 15 mg/dL) and/or antibody against IgA. The subject is pregnant or lactating, or intends to become pregnant during the course of the study. The subject is not a suitable candidate for a BAL procedure. Moderate or severe bronchiectasis (total daily sputum production > 10 mL). Clinically significant medical, psychiatric, or cognitive illness, or recreational drug/alcohol use that, in the opinion of the investigator, would affect subject safety or compliance. Prior history of adverse reaction to local anaesthetics, sedatives, pain control drugs, and other medication employed at the study center for perioperative care associated with the BAL procedure. Long-term use of oral or parenteral glucocorticosteroid within 28 days prior to screening.
Ages Eligible for Study
-----------------
Minimum Age: 18 Years
Sexes Eligible for Study
-----------------
All
Accepts Healthy Volunteers
-----------------
No
Study Plan
=================
How is the study designed?
-----------------
Design Details
Primary Purpose: Treatment
Allocation: Non-Randomized
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Arms and Interventions
| Intervention/Treatment |
| --- |
|Biological: Alpha1-Proteinase Inhibitor|60 mg/kg, weekly, intravenous infusion|
What is the study measuring?
-----------------
Primary Outcome Measures
| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change in Bronchoalveolar Lavage (BAL) Epithelial Lining Fluid (ELF) Alpha1-Proteinase Inhibitor (α1-PI) Level | Median change BAL ELF antigenic α1-PI level the from baseline to post-treatment | BAL procedures were performed at baseline and after 8 consecutive weeks of treatment (minimum of 12 weeks) |
| The Number of Adverse Events (AEs) Related to the Infusion of ARALAST Fr. IV 1 Administered at a Rate of 0.2 mL/kg/Min | | During 8 consecutive weeks of treatment |
| Number of Changes in the Rate of Infusion | Number of decreases in the rate or discontinuations of infusion at 0.2 mL/kg/min | During 8 consecutive weeks of treatment |
Secondary Outcome Measures
| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Ratio of Post- to Pre-treatment BAL ELF Antineutrophil Elastase Capacity (ANEC) Levels | Median ratio of post- to pre-treatment BAL ELF ANEC levels | BAL procedures were performed at baseline and after 8 consecutive weeks of treatment (minimum of 12 weeks) |
| Change in in the Ratio of BAL ELF α1-PI to Human Neutrophil Elastase (HNE) Complex Concentration | Median change in the ratio of BAL ELF α1-PI to HNE complex concentration from baseline to post-treatment | BAL procedures were performed at baseline and after 8 consecutive weeks of treatment (minimum of 12 weeks) |
| Change in the α1-PI Plasma Level | Mean change in the plasma level of α1-PI from baseline to post-treatment | Blood samples were collected at baseline and after 8 consecutive weeks of treatment |
| Change in the Plasma Antineutrophil Elastase Capacity (ANEC) Level | Mean change in the plasma ANEC level from baseline to post-treatment | Blood samples were collected at baseline and after 8 consecutive weeks of treatment |
| Clinically Significant Changes in Vital Signs From Pre- to Post-Infusion | Clinically significant changes in vital signs from pre- to post-infusion are: • Heart rate: 25% increase above pre-infusion value • Blood pressure: ≥ 30 mm Hg change from pre-infusion blood pressure (systolic or diastolic) • Temperature: an increase in body temperature to >38°C (>100.4°F). If the pre-infusion body temperature was already >38°C (>100.4°F), then any further increase in body temperature by 1.1°C (1.98°F) or more was considered clinically significant. • Respiratory rate: 25% increase above pre-infusion value | During 8 consecutive weeks of infusion |
|
||
NCT03058861
|
Mitigating ACEs in Pediatric Primary Care
|
The project is designed to assess Adverse Childhood Experiences (ACEs) and test a parenting intervention in pediatric primary care.
|
The goal of the project is to affect policy and practice related to Adverse Childhood Experiences (ACEs) screening and intervention in pediatric primary care. First, the investigators will develop and test a new ACEs screening tool that is brief, has a pediatric perspective, builds on parents' strengths, and measures parenting-related ACEs that can be treated. The new ACEs screening tool will measure parenting-related ACEs (e.g. corporal punishment, threatening, humiliation) and family stressors (e.g. divorce, incarceration, mental illness). A research assistant will invite approximately 1000 parents to complete the survey in the Vanderbilt Pediatric Primary Care Clinic. Measures will include child behavior problems that the investigators hypothesize will be associated with elevated parenting scores. The second part of the project will be to recruit English and Spanish-speaking parents for a randomized controlled trial (RCT) to determine if educational interventions can help educate parents about ACEs and decrease parenting-related ACE scores two months post-intervention. In the RCT, the investigators will recruit 300 to 400 parents to participate in the study. Parents in the intervention group will receive 1) a copy of the Play Nicely Healthy Discipline Handbook, 2) information about how to view the Play Nicely multimedia program online and 3) the TN ACEs Handout. Parents in the Control Group will receive routine primary care. Follow up data will be obtained 2 months after enrollment.
|
Mitigating ACEs in Pediatric Primary Care
|
Violence, Parenting
|
* Behavioral: Play Nicely Program
|
Inclusion Criteria:~Parents of 2-10 year old children presenting for a well visit.~Exclusion Criteria:~Parents do not speak English, Spanish, or Arabic.
|
18 Years
|
70 Years
|
All
|
Accepts Healthy Volunteers
|
Primary Purpose: Prevention
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
|
| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change from baseline Parenting Survey at 2 months | Parenting Survey: 12 item scale that assesses parenting behaviors. | Baseline and 2 months |
|
| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change from baseline Attitudes Toward Spanking scale at 2 months | Attitudes Toward Spanking scale | Baseline and 2 months |
|
| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Discipline education - Play Nicely program<br>Parents in the intervention group will receive 1) a copy of the Play Nicely Healthy Discipline Handbook (see www.playnicely.org), 2) information about how to view the Play Nicely multimedia program online and 3) the TN ACEs Handout. | Behavioral: Play Nicely Program<br>* Play Nicely multimedia program and handbook that provides education about healthy discipline strategies.<br>|
| No Intervention: Control Group<br>Routine primary care will be provided. | |
|
Mitigating ACEs in Pediatric Primary Care
Study Overview
=================
Brief Summary
-----------------
The project is designed to assess Adverse Childhood Experiences (ACEs) and test a parenting intervention in pediatric primary care.
Detailed Description
-----------------
The goal of the project is to affect policy and practice related to Adverse Childhood Experiences (ACEs) screening and intervention in pediatric primary care. First, the investigators will develop and test a new ACEs screening tool that is brief, has a pediatric perspective, builds on parents' strengths, and measures parenting-related ACEs that can be treated. The new ACEs screening tool will measure parenting-related ACEs (e.g. corporal punishment, threatening, humiliation) and family stressors (e.g. divorce, incarceration, mental illness). A research assistant will invite approximately 1000 parents to complete the survey in the Vanderbilt Pediatric Primary Care Clinic. Measures will include child behavior problems that the investigators hypothesize will be associated with elevated parenting scores. The second part of the project will be to recruit English and Spanish-speaking parents for a randomized controlled trial (RCT) to determine if educational interventions can help educate parents about ACEs and decrease parenting-related ACE scores two months post-intervention. In the RCT, the investigators will recruit 300 to 400 parents to participate in the study. Parents in the intervention group will receive 1) a copy of the Play Nicely Healthy Discipline Handbook, 2) information about how to view the Play Nicely multimedia program online and 3) the TN ACEs Handout. Parents in the Control Group will receive routine primary care. Follow up data will be obtained 2 months after enrollment.
Official Title
-----------------
Mitigating ACEs in Pediatric Primary Care
Conditions
-----------------
Violence, Parenting
Intervention / Treatment
-----------------
* Behavioral: Play Nicely Program
Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Parents of 2-10 year old children presenting for a well visit. Exclusion Criteria: Parents do not speak English, Spanish, or Arabic.
Ages Eligible for Study
-----------------
Minimum Age: 18 Years
Maximum Age: 70 Years
Sexes Eligible for Study
-----------------
All
Accepts Healthy Volunteers
-----------------
Accepts Healthy Volunteers
Study Plan
=================
How is the study designed?
-----------------
Design Details
Primary Purpose: Prevention
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Arms and Interventions
| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Discipline education - Play Nicely program<br>Parents in the intervention group will receive 1) a copy of the Play Nicely Healthy Discipline Handbook (see www.playnicely.org), 2) information about how to view the Play Nicely multimedia program online and 3) the TN ACEs Handout. | Behavioral: Play Nicely Program<br>* Play Nicely multimedia program and handbook that provides education about healthy discipline strategies.<br>|
| No Intervention: Control Group<br>Routine primary care will be provided. | |
What is the study measuring?
-----------------
Primary Outcome Measures
| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change from baseline Parenting Survey at 2 months | Parenting Survey: 12 item scale that assesses parenting behaviors. | Baseline and 2 months |
Secondary Outcome Measures
| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change from baseline Attitudes Toward Spanking scale at 2 months | Attitudes Toward Spanking scale | Baseline and 2 months |
|
||
NCT01118286
|
Treatment of Hypertension With Adalat® in Combination With Other Drugs
|
To investigate the therapeutic effectiveness of long acting nifedipine containing combination therapy in the treatment of hypertensive patients.
|
AdADOSE - Antihypertensive Treatment With Adalat® in Different Doses and Combination Therapy
|
Hypertension
|
* Drug: Nifedipine (Adalat, BAYA1040)
|
Inclusion Criteria:~Previously untreated hypertensive patients starting with combination therapy containing nifedipine or~Insufficiently controlled hypertensive pts. receiving nifedipine as an add-on to existing non-CCB (calcium-channel-blocker) containing antihypertensive therapy~Exclusion Criteria:~None. Exclusion criteria are defined by contraindications and precautions as stated in the local product information.
|
18 Years
| null |
All
|
No
|
| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Evaluation of treatment success (lowering of blood pressure in mmHg) in adult hypertensive patients | | After three months |
|
Hypertension, Drug therapy, combination
|
Nifedipine, Calcium Channel Blockers, Membrane Transport Modulators, Molecular Mechanisms of Pharmacological Action, Calcium-Regulating Hormones and Agents, Physiological Effects of Drugs, Tocolytic Agents, Reproductive Control Agents, Vasodilator Agents
|
| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Group 1<br> | Drug: Nifedipine (Adalat, BAYA1040)<br>* Previously untreated hypertensive adult patients starting with combination therapy containing nifedipine or insufficiently controlled hypertensive patients receiving nifedipine as an add-on to existing non-CCB containing antihypertensive therapy. The decision of including the patient as well as decision on dosage and duration is taken by the investigator.<br>|
|
Treatment of Hypertension With Adalat® in Combination With Other Drugs
Study Overview
=================
Brief Summary
-----------------
To investigate the therapeutic effectiveness of long acting nifedipine containing combination therapy in the treatment of hypertensive patients.
Official Title
-----------------
AdADOSE - Antihypertensive Treatment With Adalat® in Different Doses and Combination Therapy
Conditions
-----------------
Hypertension
Intervention / Treatment
-----------------
* Drug: Nifedipine (Adalat, BAYA1040)
Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Previously untreated hypertensive patients starting with combination therapy containing nifedipine or Insufficiently controlled hypertensive pts. receiving nifedipine as an add-on to existing non-CCB (calcium-channel-blocker) containing antihypertensive therapy Exclusion Criteria: None. Exclusion criteria are defined by contraindications and precautions as stated in the local product information.
Ages Eligible for Study
-----------------
Minimum Age: 18 Years
Sexes Eligible for Study
-----------------
All
Accepts Healthy Volunteers
-----------------
No
Study Plan
=================
How is the study designed?
-----------------
Arms and Interventions
| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Group 1<br> | Drug: Nifedipine (Adalat, BAYA1040)<br>* Previously untreated hypertensive adult patients starting with combination therapy containing nifedipine or insufficiently controlled hypertensive patients receiving nifedipine as an add-on to existing non-CCB containing antihypertensive therapy. The decision of including the patient as well as decision on dosage and duration is taken by the investigator.<br>|
What is the study measuring?
-----------------
Primary Outcome Measures
| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Evaluation of treatment success (lowering of blood pressure in mmHg) in adult hypertensive patients | | After three months |
Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Hypertension, Drug therapy, combination
|
|||
NCT02312700
|
An Interactive Empowerment Tool for Breast Cancer Patients
|
The study is aimed to verify the effect of an online interactive tool on patient empowerment. The tool is based on a validated psychological questionnaire administrated to breast cancer patients before their first encounter with physician.
|
The study is intended to develop an IEm (Interactive Empowerment) tool aimed at enhancing physician-patient experience by providing physicians a personalized patient's profile, accompanied by a list of recommendations to suggest him how to interact with that specific patient on the basis of his/her personal profile. Developed in the framework of the FP7 project P-Medicine, the IEm tool uses the ALGA-BC questionnaire, a recent validated instrument specifically developed to perform a brief evaluation of the breast cancer patients' psychological status, to provide the physician a patient's profile based on 8 factors. As soon as the questionnaire has been completed, the patient's answers are automatically elaborated and sent to the physician's computer. Provided to the physicians at the very beginning of the visit, such information is supposed to be crucial for them to find a tailored way to communicate with the patient. Moreover, in order to help physicians to correctly interpret the patient's score, any time the scores are out of a certain range (normal values) they will receive a recommendation that helps them to find the best way to interact with the patient. Supposing that the patient empowerment can be reached through the improved patient's participation in the clinical process, we argue that a more effective and personalized interaction between patient and physician may have a key role in promoting it.
|
Development of an Interactive Empowerment Tool in Support of Patient Empowerment.
|
Breast Cancer, Empowerment
|
* Behavioral: Interactive empowerment tool
|
Inclusion Criteria:~The patient is aged 18 to 74 years at randomisation.~The patient has been diagnosed as having a primary breast cancer requiring a radical surgery~The patient is able to understand the Informed Consent Form, and understand study procedures.~The patient has signed the Informed Consent Form.~Exclusion Criteria:~The patient has a recurrent breast cancer diagnosis~The patient has an overt psychiatric illness that would interfere with the measurement of the psychological variables included in the questionnaire~Inability to freely consent to take part in the study~Inability to understand the study materials.~Current participation in another clinical trial relating to the breast cancer treatment~Any condition that, in the researcher's opinion, compromises the subject's ability to meet protocol requirements or to complete the study.
|
18 Years
|
74 Years
|
Female
|
No
|
Primary Purpose: Supportive Care
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single
|
| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Improvements in the Patient Empowerment Score | Patient empowerment score will be measured in the experimental versus the control group by mean of patients' comprehension level relatively to the information doctors provided to them. | Up to 30 min after the visit |
|
empowerment, communication, shared decision making
|
Breast Neoplasms, Neoplasms by Site, Neoplasms, Breast Diseases, Skin Diseases
|
| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Interactive empowerment (IEm) group<br>Intervention: Patients fill in the questionnaire online and their profile (obtained from their answers) is immediately sent to the physician | Behavioral: Interactive empowerment tool<br> <br> |
| Sham Comparator: Control<br>Intervention: Patients fill in the questionnaire online, but their profile (obtained from their answers) is not sent to the physician | Behavioral: Interactive empowerment tool<br> <br> |
|
An Interactive Empowerment Tool for Breast Cancer Patients
Study Overview
=================
Brief Summary
-----------------
The study is aimed to verify the effect of an online interactive tool on patient empowerment. The tool is based on a validated psychological questionnaire administrated to breast cancer patients before their first encounter with physician.
Detailed Description
-----------------
The study is intended to develop an IEm (Interactive Empowerment) tool aimed at enhancing physician-patient experience by providing physicians a personalized patient's profile, accompanied by a list of recommendations to suggest him how to interact with that specific patient on the basis of his/her personal profile. Developed in the framework of the FP7 project P-Medicine, the IEm tool uses the ALGA-BC questionnaire, a recent validated instrument specifically developed to perform a brief evaluation of the breast cancer patients' psychological status, to provide the physician a patient's profile based on 8 factors. As soon as the questionnaire has been completed, the patient's answers are automatically elaborated and sent to the physician's computer. Provided to the physicians at the very beginning of the visit, such information is supposed to be crucial for them to find a tailored way to communicate with the patient. Moreover, in order to help physicians to correctly interpret the patient's score, any time the scores are out of a certain range (normal values) they will receive a recommendation that helps them to find the best way to interact with the patient. Supposing that the patient empowerment can be reached through the improved patient's participation in the clinical process, we argue that a more effective and personalized interaction between patient and physician may have a key role in promoting it.
Official Title
-----------------
Development of an Interactive Empowerment Tool in Support of Patient Empowerment.
Conditions
-----------------
Breast Cancer, Empowerment
Intervention / Treatment
-----------------
* Behavioral: Interactive empowerment tool
Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: The patient is aged 18 to 74 years at randomisation. The patient has been diagnosed as having a primary breast cancer requiring a radical surgery The patient is able to understand the Informed Consent Form, and understand study procedures. The patient has signed the Informed Consent Form. Exclusion Criteria: The patient has a recurrent breast cancer diagnosis The patient has an overt psychiatric illness that would interfere with the measurement of the psychological variables included in the questionnaire Inability to freely consent to take part in the study Inability to understand the study materials. Current participation in another clinical trial relating to the breast cancer treatment Any condition that, in the researcher's opinion, compromises the subject's ability to meet protocol requirements or to complete the study.
Ages Eligible for Study
-----------------
Minimum Age: 18 Years
Maximum Age: 74 Years
Sexes Eligible for Study
-----------------
Female
Accepts Healthy Volunteers
-----------------
No
Study Plan
=================
How is the study designed?
-----------------
Design Details
Primary Purpose: Supportive Care
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single
Arms and Interventions
| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Interactive empowerment (IEm) group<br>Intervention: Patients fill in the questionnaire online and their profile (obtained from their answers) is immediately sent to the physician | Behavioral: Interactive empowerment tool<br> <br> |
| Sham Comparator: Control<br>Intervention: Patients fill in the questionnaire online, but their profile (obtained from their answers) is not sent to the physician | Behavioral: Interactive empowerment tool<br> <br> |
What is the study measuring?
-----------------
Primary Outcome Measures
| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Improvements in the Patient Empowerment Score | Patient empowerment score will be measured in the experimental versus the control group by mean of patients' comprehension level relatively to the information doctors provided to them. | Up to 30 min after the visit |
Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
empowerment, communication, shared decision making
|
|
NCT05148078
|
Pediatric Radiation Oncology With Movie Induced Sedation Effect (PROMISE)
|
PROMISE (Pediatric Radiation Oncology with Movie Induced Sedation Effect) is an interactive incentive-based movie system that integrates with a video surveillance gating module (VisionRT) as an alternative sedation solution for pediatric patients undergoing radiation treatment (RT). This single-arm, open label, single-center phase II clinical trial is to implement PROMISE for all children ages 3-11 who are planned to undergo RT at the institution. The primary goal is to decrease the total number of pediatric patients who require general anesthesia through the use of PROMISE, with secondary goals being to assess the impact that PROMISE has on patient/family anxiety and quality of life, treatment time and clinical efficiency, and overall cost. The investigators hypothesize that PROMISE will lead to a reduction in the percentage of patients ages 3-7 who require general anesthesia use from 70% (historical control) to 30%.
|
Radiation therapy (RT) requires precise immobilization in order to accurately deliver a conformal dose to the target(s) while avoiding nearby organs at risk. In children, RT frequently requires daily anesthesia use during the entire course of treatment, often up to 4-6 weeks total. While the data varies, ~40-50% of children, and the majority of those under the age of 7, require daily general anesthesia. Anesthesia can have significant short- and long-term detrimental effects on patient health, including increased risk of hypoxia, allergic reactions, hyperthermia, vascular access device complications (20-25%), and neurocognitive impairment. Furthermore, daily anesthesia provides significant logistical and financial burden, with the average 6-week course of daily anesthesia for RT being approximately $50,000 in payer charges.~Pediatric Radiation Oncology with Movie Induced Sedation Effect (PROMISE) is an interactive, incentive-based movie system that integrates with a video surveillance gating module (VisionRT) to help keep a children's attention and prevent children from moving during radiation treatment. While audiovisual distraction techniques have previously been described, PROMISE is the first system that allows for real time monitoring of patient motion and automatic shutting off of the beam and video if the patient moves outside of defined parameters. This not only provides a built-in safety mechanism, but also allows for real time behavior training that incentives patients to not move.~The investigators propose implementing PROMISE for all children between ages 3-11 undergoing radiation treatment through a phase II clinical trial with the following workflow: 1) During the CT simulation scan, a training session will be conducted, where the child will learn to lie still with positive and negative feedbacks provided by the system for behavioral training. This session will also be used as a screening test to choose children suitable for PROMISE. Only children meeting the movement-requirements during the training session will be selected as candidates for the following non-sedated radiation treatment. 2) During the treatment, a child will watch an age-appropriate movie or video of participant/s choice. A 3D surface imaging system will be used to monitor the motion of the child. If the motion exceeds any pre-defined positioning thresholds (e.g., conventional radiotherapy (CRT): 0.5 cm in translation movements and 2° in three rotational angles; stereotactic radiotherapy (SBRT): 0.15 cm and 0.5 degree), the treatment beam will be shut off and the movie will be paused. 3) Beyond threshold movements the child will be instructed with the effectiveness of movement control strategy. 4) If the child reverts to treatment position within a pre-defined temporal threshold (e.g. 1 minute), the treatment will be resumed with a continuing movie. 5) If the child cannot revert to the treatment position within a pre-defined time threshold/or the movement is beyond any pre-defined re-alignment threshold value (e.g., 1 cm / 5° in three rotational angles), the radiation beam and the movie will be turned off, the patient will be readjusted and the treatment will resume. 6) In any treatment fraction, PROMISE treatment will be ceased if therapists have to re-position the child multiple times. If the child is consecutively noncompliant with PROMISE treatments for two fractions, participant will receive radiotherapy treatment with general anesthesia for all subsequent fractions, unless instructed by physician to re-attempt PROMISE.~The primary objective is to decrease the total number of pediatric patients who require general anesthesia through the use of PROMISE. The secondary objectives are to assess the impact that PROMISE has on patient/family anxiety and quality of life, treatment time and clinical efficiency, and overall cost, and to determine the average patient movement and beam stoppages with PROMISE. Patient/family-reported health quality of life will be assessed using PedsQL 3.0 Cancer Module and patient anxiety will be measured by the modified Yale Preoperative Anxiety Survey Short Form (mYPAS-SF).~The hypothesis is that PROMISE will lead to a reduction in the percentage of patients ages 3-7 who require general anesthesia use from 70% (historical control) to 30%. Using a two-sided exact binomial test with a significance level of 0.05 and power=80%, a sample size of 13 patients (ages 3-7) will be needed to detect this difference. In the investigator's past experience, ~42% of children ages 3-11 (eligibility criteria) are between 3-7 years old, so 30 children total will be needed to enroll 13 who are between 3-7 years old.
|
Pediatric Radiation Oncology With Movie Induced Sedation Effect (PROMISE): A Phase II Clinical Trial to Safely Reduce Anesthesia Use
|
Pediatric Cancer
|
* Other: PROMISE (Pediatric Radiation Oncology with Movie Induced Sedation Effect)
|
Inclusion Criteria:~Planned to undergo radiation treatment~Age 3-11 years~Eastern Cooperative Oncology Group (ECOG) performance status ≤ 2 at screening~Parents or guardians with the ability to understand and the willingness to sign a written informed consent.~Exclusion Criteria:~Subjects with documented medical behavior conditions or other conditions necessitating anesthesia use~Uncontrolled intercurrent illness including, but not limited to, ongoing or active infection, symptomatic congestive heart failure, unstable angina pectoris, cardiac arrhythmia, or psychiatric illness/social situations that, in the opinion of the investigator, would limit compliance with study requirements.~Subjects whose parents opt to not include them (the subject) in the clinical trial.
|
3 Years
|
11 Years
|
All
|
No
|
Primary Purpose: Supportive Care
Intervention Model: Single Group Assignment
Masking: None (Open Label)
|
| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Percentage of pediatric patients age 3-7 who require daily general anesthesia for all treatments | To change the total number of pediatric patients who require general anesthesia through the use of PROMISE. | 30 days |
|
| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Patient-reported health quality of life (QOL) | Patient-reported health quality of life is assessed using Pediatric Quality of Life Inventory (PedsQL) 3.0 Cancer Module. It is a 5-point Likert scale from 0 (never) to 4(almost always) and the scores are transformed to a 0 to 100 scale, with higher scores indicating a better health-related quality of life. | 30 days (+/- 14 days) after treatment termination |
| Family-reported health quality of life | Family-reported health quality of life is assessed using Pediatric Quality of Life Inventory (PedsQL) 3.0 Cancer Module. It is a 5-point Likert scale from 0 (never) to 4(almost always) and the scores are transformed to a 0 to 100 scale, with higher scores indicating a better health-related quality of life. | 30 days (+/- 14 days) after treatment termination |
| Patient reported anxiety | Patient reported anxiety is measured by the modified Yale Preoperative Anxiety Survey Short Form (mYPAS-SF).The mYPAS consists of 5 items (activity, vocalizations, emotional expressivity, state of apparent arousal). Behavior is rated from 1 to 4 or 1 to 6 (depending on the item), with higher numbers indicating the highest severity within that item (i.e, high levels of anxiety). | 30 days (+/- 14 days) after treatment termination |
| Family reported anxiety | Family reported anxiety is measured by the modified Yale Preoperative Anxiety Survey Short Form (mYPAS-SF).The mYPAS consists of 5 items (activity, vocalizations, emotional expressivity, state of apparent arousal). Behavior is rated from 1 to 4 or 1 to 6 (depending on the item), with higher numbers indicating the highest severity within that item (i.e, high levels of anxiety) | 30 days (+/- 14 days) after treatment termination |
| Patient Movement | To determine the average patient movement and beam stoppages with PROMISE | 30 days (+/- 14 days) after treatment termination |
|
radiotherapy
|
| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: General Anesthesia Decrease use : PROMISE<br>To decrease the total number of pediatric patients who require general anesthesia through the use of PROMISE | Other: PROMISE (Pediatric Radiation Oncology with Movie Induced Sedation Effect)<br>* Pediatric Radiation Oncology with Movie Induced Sedation Effect (PROMISE) is an interactive, incentive-based movie system that integrates with a video surveillance gating module (VisionRT) to help keep a child's attention and prevent him or her from moving during radiation treatment. This technology is being studied as an alternative sedation solution for pediatric patients needing radiation treatment. As part of the trial, patients will be attempted to have CT simulation scan and first radiation treatment(s) using PROMISE, with general anesthesia on standby should PROMISE be unsuccessful. If PROMISE is unsuccessful for a given patient, then standard of care general anesthesia will be used for that patient's radiation treatment and PROMISE will be reattempted at physician discretion with anesthesia on standby.<br>|
|
Pediatric Radiation Oncology With Movie Induced Sedation Effect (PROMISE)
Study Overview
=================
Brief Summary
-----------------
PROMISE (Pediatric Radiation Oncology with Movie Induced Sedation Effect) is an interactive incentive-based movie system that integrates with a video surveillance gating module (VisionRT) as an alternative sedation solution for pediatric patients undergoing radiation treatment (RT). This single-arm, open label, single-center phase II clinical trial is to implement PROMISE for all children ages 3-11 who are planned to undergo RT at the institution. The primary goal is to decrease the total number of pediatric patients who require general anesthesia through the use of PROMISE, with secondary goals being to assess the impact that PROMISE has on patient/family anxiety and quality of life, treatment time and clinical efficiency, and overall cost. The investigators hypothesize that PROMISE will lead to a reduction in the percentage of patients ages 3-7 who require general anesthesia use from 70% (historical control) to 30%.
Detailed Description
-----------------
Radiation therapy (RT) requires precise immobilization in order to accurately deliver a conformal dose to the target(s) while avoiding nearby organs at risk. In children, RT frequently requires daily anesthesia use during the entire course of treatment, often up to 4-6 weeks total. While the data varies, 40-50% of children, and the majority of those under the age of 7, require daily general anesthesia. Anesthesia can have significant short- and long-term detrimental effects on patient health, including increased risk of hypoxia, allergic reactions, hyperthermia, vascular access device complications (20-25%), and neurocognitive impairment. Furthermore, daily anesthesia provides significant logistical and financial burden, with the average 6-week course of daily anesthesia for RT being approximately $50,000 in payer charges. Pediatric Radiation Oncology with Movie Induced Sedation Effect (PROMISE) is an interactive, incentive-based movie system that integrates with a video surveillance gating module (VisionRT) to help keep a children's attention and prevent children from moving during radiation treatment. While audiovisual distraction techniques have previously been described, PROMISE is the first system that allows for real time monitoring of patient motion and automatic shutting off of the beam and video if the patient moves outside of defined parameters. This not only provides a built-in safety mechanism, but also allows for real time behavior training that incentives patients to not move. The investigators propose implementing PROMISE for all children between ages 3-11 undergoing radiation treatment through a phase II clinical trial with the following workflow: 1) During the CT simulation scan, a training session will be conducted, where the child will learn to lie still with positive and negative feedbacks provided by the system for behavioral training. This session will also be used as a screening test to choose children suitable for PROMISE. Only children meeting the movement-requirements during the training session will be selected as candidates for the following non-sedated radiation treatment. 2) During the treatment, a child will watch an age-appropriate movie or video of participant/s choice. A 3D surface imaging system will be used to monitor the motion of the child. If the motion exceeds any pre-defined positioning thresholds (e.g., conventional radiotherapy (CRT): 0.5 cm in translation movements and 2° in three rotational angles; stereotactic radiotherapy (SBRT): 0.15 cm and 0.5 degree), the treatment beam will be shut off and the movie will be paused. 3) Beyond threshold movements the child will be instructed with the effectiveness of movement control strategy. 4) If the child reverts to treatment position within a pre-defined temporal threshold (e.g. 1 minute), the treatment will be resumed with a continuing movie. 5) If the child cannot revert to the treatment position within a pre-defined time threshold/or the movement is beyond any pre-defined re-alignment threshold value (e.g., 1 cm / 5° in three rotational angles), the radiation beam and the movie will be turned off, the patient will be readjusted and the treatment will resume. 6) In any treatment fraction, PROMISE treatment will be ceased if therapists have to re-position the child multiple times. If the child is consecutively noncompliant with PROMISE treatments for two fractions, participant will receive radiotherapy treatment with general anesthesia for all subsequent fractions, unless instructed by physician to re-attempt PROMISE. The primary objective is to decrease the total number of pediatric patients who require general anesthesia through the use of PROMISE. The secondary objectives are to assess the impact that PROMISE has on patient/family anxiety and quality of life, treatment time and clinical efficiency, and overall cost, and to determine the average patient movement and beam stoppages with PROMISE. Patient/family-reported health quality of life will be assessed using PedsQL 3.0 Cancer Module and patient anxiety will be measured by the modified Yale Preoperative Anxiety Survey Short Form (mYPAS-SF). The hypothesis is that PROMISE will lead to a reduction in the percentage of patients ages 3-7 who require general anesthesia use from 70% (historical control) to 30%. Using a two-sided exact binomial test with a significance level of 0.05 and power=80%, a sample size of 13 patients (ages 3-7) will be needed to detect this difference. In the investigator's past experience, 42% of children ages 3-11 (eligibility criteria) are between 3-7 years old, so 30 children total will be needed to enroll 13 who are between 3-7 years old.
Official Title
-----------------
Pediatric Radiation Oncology With Movie Induced Sedation Effect (PROMISE): A Phase II Clinical Trial to Safely Reduce Anesthesia Use
Conditions
-----------------
Pediatric Cancer
Intervention / Treatment
-----------------
* Other: PROMISE (Pediatric Radiation Oncology with Movie Induced Sedation Effect)
Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Planned to undergo radiation treatment Age 3-11 years Eastern Cooperative Oncology Group (ECOG) performance status ≤ 2 at screening Parents or guardians with the ability to understand and the willingness to sign a written informed consent. Exclusion Criteria: Subjects with documented medical behavior conditions or other conditions necessitating anesthesia use Uncontrolled intercurrent illness including, but not limited to, ongoing or active infection, symptomatic congestive heart failure, unstable angina pectoris, cardiac arrhythmia, or psychiatric illness/social situations that, in the opinion of the investigator, would limit compliance with study requirements. Subjects whose parents opt to not include them (the subject) in the clinical trial.
Ages Eligible for Study
-----------------
Minimum Age: 3 Years
Maximum Age: 11 Years
Sexes Eligible for Study
-----------------
All
Accepts Healthy Volunteers
-----------------
No
Study Plan
=================
How is the study designed?
-----------------
Design Details
Primary Purpose: Supportive Care
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Arms and Interventions
| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: General Anesthesia Decrease use : PROMISE<br>To decrease the total number of pediatric patients who require general anesthesia through the use of PROMISE | Other: PROMISE (Pediatric Radiation Oncology with Movie Induced Sedation Effect)<br>* Pediatric Radiation Oncology with Movie Induced Sedation Effect (PROMISE) is an interactive, incentive-based movie system that integrates with a video surveillance gating module (VisionRT) to help keep a child's attention and prevent him or her from moving during radiation treatment. This technology is being studied as an alternative sedation solution for pediatric patients needing radiation treatment. As part of the trial, patients will be attempted to have CT simulation scan and first radiation treatment(s) using PROMISE, with general anesthesia on standby should PROMISE be unsuccessful. If PROMISE is unsuccessful for a given patient, then standard of care general anesthesia will be used for that patient's radiation treatment and PROMISE will be reattempted at physician discretion with anesthesia on standby.<br>|
What is the study measuring?
-----------------
Primary Outcome Measures
| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Percentage of pediatric patients age 3-7 who require daily general anesthesia for all treatments | To change the total number of pediatric patients who require general anesthesia through the use of PROMISE. | 30 days |
Secondary Outcome Measures
| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Patient-reported health quality of life (QOL) | Patient-reported health quality of life is assessed using Pediatric Quality of Life Inventory (PedsQL) 3.0 Cancer Module. It is a 5-point Likert scale from 0 (never) to 4(almost always) and the scores are transformed to a 0 to 100 scale, with higher scores indicating a better health-related quality of life. | 30 days (+/- 14 days) after treatment termination |
| Family-reported health quality of life | Family-reported health quality of life is assessed using Pediatric Quality of Life Inventory (PedsQL) 3.0 Cancer Module. It is a 5-point Likert scale from 0 (never) to 4(almost always) and the scores are transformed to a 0 to 100 scale, with higher scores indicating a better health-related quality of life. | 30 days (+/- 14 days) after treatment termination |
| Patient reported anxiety | Patient reported anxiety is measured by the modified Yale Preoperative Anxiety Survey Short Form (mYPAS-SF).The mYPAS consists of 5 items (activity, vocalizations, emotional expressivity, state of apparent arousal). Behavior is rated from 1 to 4 or 1 to 6 (depending on the item), with higher numbers indicating the highest severity within that item (i.e, high levels of anxiety). | 30 days (+/- 14 days) after treatment termination |
| Family reported anxiety | Family reported anxiety is measured by the modified Yale Preoperative Anxiety Survey Short Form (mYPAS-SF).The mYPAS consists of 5 items (activity, vocalizations, emotional expressivity, state of apparent arousal). Behavior is rated from 1 to 4 or 1 to 6 (depending on the item), with higher numbers indicating the highest severity within that item (i.e, high levels of anxiety) | 30 days (+/- 14 days) after treatment termination |
| Patient Movement | To determine the average patient movement and beam stoppages with PROMISE | 30 days (+/- 14 days) after treatment termination |
Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
radiotherapy
|
|
NCT03280199
|
The Impact of Different Simulator Characteristics on Transfer of Learning
|
This study aims to explore the impact of different simulator characteristics on transfer of learning.
|
During an ISUOG basic training course, participants will be randomly assigned to 30 minutes of simulator training during which time they will practice the 2nd trimester US scan. A total of four different simulators are being used for training. After completing the practical basic training session, they shift the type of simulator that they trained on to one of the remaining three simulators. On this simulator, they are required to perform selected planes for the 2nd-trimester scan. The planes produced are recorded and evaluated by fetal medicine specialists using the ISUOG 20 planes checklist. The performances of participants coming from each of the four simulators are examined and the role of 1) type of simulator interaction (physical mannequin vs. virtual abdomen vs. fixed-point scan) and 2) the type of image acquisition (real US images vs. computer-generated images) are examined.
|
The Impact of Different Simulator Characteristics on Transfer of Learning
|
Simulation-based Medical Education, Ultrasound Simulation, Education, Professional
|
* Other: simulation types
|
Inclusion Criteria:~ISUOG course participants~Exclusion Criteria:~More than 50 independent 2nd trimester US scan before attending the course.
|
18 Years
|
90 Years
|
All
|
Accepts Healthy Volunteers
|
Primary Purpose: Other
Allocation: Randomized
Intervention Model: Factorial Assignment
Masking: Single
|
| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Correct planes | Number of correct planes produced | 30 minutes |
|
| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Other: Type of simulator - 1<br>VR simulator with physical mannequin and probe.~PLEASE NOTE THAT THE INTERVENTIONS BEING COMPARED ARE DIFFERENT TYPES OF SIMULATORS - NOT A DRUG! | Other: simulation types<br>* Different types of simulation interfaces and image acquisitions<br>|
| Other: Type of simulator - 2<br>VR simulator with virtual mannequin / abdomen~PLEASE NOTE THAT THE INTERVENTIONS BEING COMPARED ARE DIFFERENT TYPES OF SIMULATORS - NOT A DRUG! | Other: simulation types<br>* Different types of simulation interfaces and image acquisitions<br>|
| Other: Type of image acquisition - 3<br>US images are acquired through real US volumes from patients~PLEASE NOTE THAT THE INTERVENTIONS BEING COMPARED ARE DIFFERENT TYPES OF SIMULATORS - NOT A DRUG! | Other: simulation types<br>* Different types of simulation interfaces and image acquisitions<br>|
| Other: Type of image acquisition - 4<br>US images are acquired through computer-generated images.~PLEASE NOTE THAT THE INTERVENTIONS BEING COMPARED ARE DIFFERENT TYPES OF SIMULATORS - NOT A DRUG! | Other: simulation types<br>* Different types of simulation interfaces and image acquisitions<br>|
|
The Impact of Different Simulator Characteristics on Transfer of Learning
Study Overview
=================
Brief Summary
-----------------
This study aims to explore the impact of different simulator characteristics on transfer of learning.
Detailed Description
-----------------
During an ISUOG basic training course, participants will be randomly assigned to 30 minutes of simulator training during which time they will practice the 2nd trimester US scan. A total of four different simulators are being used for training. After completing the practical basic training session, they shift the type of simulator that they trained on to one of the remaining three simulators. On this simulator, they are required to perform selected planes for the 2nd-trimester scan. The planes produced are recorded and evaluated by fetal medicine specialists using the ISUOG 20 planes checklist. The performances of participants coming from each of the four simulators are examined and the role of 1) type of simulator interaction (physical mannequin vs. virtual abdomen vs. fixed-point scan) and 2) the type of image acquisition (real US images vs. computer-generated images) are examined.
Official Title
-----------------
The Impact of Different Simulator Characteristics on Transfer of Learning
Conditions
-----------------
Simulation-based Medical Education, Ultrasound Simulation, Education, Professional
Intervention / Treatment
-----------------
* Other: simulation types
Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: ISUOG course participants Exclusion Criteria: More than 50 independent 2nd trimester US scan before attending the course.
Ages Eligible for Study
-----------------
Minimum Age: 18 Years
Maximum Age: 90 Years
Sexes Eligible for Study
-----------------
All
Accepts Healthy Volunteers
-----------------
Accepts Healthy Volunteers
Study Plan
=================
How is the study designed?
-----------------
Design Details
Primary Purpose: Other
Allocation: Randomized
Intervention Model: Factorial Assignment
Masking: Single
Arms and Interventions
| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Other: Type of simulator - 1<br>VR simulator with physical mannequin and probe. PLEASE NOTE THAT THE INTERVENTIONS BEING COMPARED ARE DIFFERENT TYPES OF SIMULATORS - NOT A DRUG! | Other: simulation types<br>* Different types of simulation interfaces and image acquisitions<br>|
| Other: Type of simulator - 2<br>VR simulator with virtual mannequin / abdomen PLEASE NOTE THAT THE INTERVENTIONS BEING COMPARED ARE DIFFERENT TYPES OF SIMULATORS - NOT A DRUG! | Other: simulation types<br>* Different types of simulation interfaces and image acquisitions<br>|
| Other: Type of image acquisition - 3<br>US images are acquired through real US volumes from patients PLEASE NOTE THAT THE INTERVENTIONS BEING COMPARED ARE DIFFERENT TYPES OF SIMULATORS - NOT A DRUG! | Other: simulation types<br>* Different types of simulation interfaces and image acquisitions<br>|
| Other: Type of image acquisition - 4<br>US images are acquired through computer-generated images. PLEASE NOTE THAT THE INTERVENTIONS BEING COMPARED ARE DIFFERENT TYPES OF SIMULATORS - NOT A DRUG! | Other: simulation types<br>* Different types of simulation interfaces and image acquisitions<br>|
What is the study measuring?
-----------------
Primary Outcome Measures
| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Correct planes | Number of correct planes produced | 30 minutes |
|
|||
NCT05598060
|
Preoperative Stereotactic Body Radiotherapy (SBRT) Followed by Hepatectomy for Centrally Located Hepatocellular Carcinoma: a Prospective, Single-center, Phase I Study
|
Hepatocellular carcinoma (HCC) is the sixth prevalent malignancy worldwide. Although surgical excision is considered the standard treatment for resectable HCC, a high rate of postoperative recurrence was observed after partial hepatectomy, with a marginal recurrence rate up to 30%. Narrow margin resection may be the most appropriate procedure for centrally located HCC because the premise for survival is the conservation of more normal liver parenchyma. Unfortunately, narrow margin resection has been reported to contribute to poor survival outcomes. However, no (neo)adjuvant therapy before (or after) hepatectomy is generally considered to be effective in reducing post-operative recurrence.~Radiotherapy (RT) has been well used in many solid malignant tumors as an (neo)adjuvant to surgical treatment, including HCC. SBRT has shown encouraging rates of local control for HCC. Compared with standard fractionation radiation, SBRT can achieve more precise delivery of high-dose radiation beams to the lesion, obtaining a much smaller target volume. Meanwhile, it could be finished in a short period which can bring more convenience to patients. Recently, several study and randomized controlled trials revealed the survival benefit of adjuvant RT (IMRT and SBRT) in patients with HCC. However, there are still lack of exploration for the efficacy of neoadjuvant SBRT. This study is to analyze the safety of preoperative SBRT followed by hepatectomy for centrally located hepatocellular carcinoma.
|
Preoperative Stereotactic Body Radiotherapy (SBRT) Followed by Hepatectomy for Centrally Located Hepatocellular Carcinoma: a Prospective, Single-center, Phase I Study
|
Hepatectomy, Centrally Located Hepatocellular Carcinoma, Stereotactic Body Radiotherapy
|
* Radiation: Neoadjuvant stereotactic body radiation therapy (Multiple ascending dose) followed by hepatectomy for centrally located hepatocellular carcinoma.
|
Inclusion Criteria:~Aged ≥18 years;~Confirmed diagnosis of HCC. The diagnosis can be established radiographically by the criteria of the American Association for the Study of the Liver (AASLD), or by histologic diagnosis from the core biopsy;~Centrally located hepatocellular carcinoma and medically fit to undergo surgery as determined by the Multiple Disciplinary Team (MDT);~BCLC stage A~No imaging evidence of direct invasion of stomach, duodenum, small intestine, large intestine or diaphragm of the intrahepatic lesions to be treated with radiotherapy;~Child-Pugh class A and B7;~ECOG (Eastern Cooperative Oncology Group) performance status 0 or 1;~Willing to provide tissue from an excisional biopsy of a tumor lesion;~For patients with active HBV: HBV DNA < 2000 IU/mL during screening, and have initiated anti-HBV treatment at least 7 days prior to SBRT and willingness to continue anti-HBV treatment during the study;~Adequate organ and marrow function as defined below:~1)Marrow: absolute neutrophil count ≥1.5×109/L; platelets ≥50×109/L; hemoglobin ≥90g/L; 2)Liver: total bilirubin ≤3× institutional upper limit of normal (ULN); AST(aspartate aminotransferase) or ALT(alanine aminotransferase) ≤ 5× institutional ULN; albumin ≥29g/L; 3)Kidney: creatinine ≤ 1.5× institutional ULN or estimated glomerular filtration rate (GFR) ≥50 mL/min/1.73 m2 (according to the Cockcroft-Gault formula); 11. Women of childbearing potential must be willing to use a highly effective method of contraception for the course of the study through 30 days after radiotherapy. Female patient of childbearing potential should have a negative serum pregnancy test before 72h of her first treatment. Sexually active males must agree to use an adequate method of contraception starting with the treatment through 4 months after radiotherapy.~Exclusion Criteria:~Have received local or systemic treatments in the past, including but not limited to TACE, immunotherapy, targeted therapy, radiotherapy, radiofrequency therapy, etc.;~Severe bleeding tendency or coagulation dysfunction within the previous 6 months;~Extrahepatic metastasis;~Prior abdominal irradiation;~Any major surgery within 1 months prior to enrolment;~Known history of active Bacillus Tuberculosis (TB)~Known additional malignancy that is progressing or requires active treatment. Exceptions include basal cell carcinoma of the skin or squamous cell carcinoma of the skin that has undergone potentially curative therapy, or in situ cervical cancer.~Active infection requiring systemic therapy;~Diagnosis of immunodeficiency or is receiving systemic steroid therapy or any other form of immunosuppressive therapy;~Known psychiatric or substance abuse disorders ;~Pregnant or breastfeeding;~Known history of human immunodeficiency virus (HIV: HIV 1/2 antibodies);~Received a live vaccine within 30 days before radiotherapy.
|
18 Years
|
75 Years
|
All
|
No
|
Primary Purpose: Treatment
Intervention Model: Single Group Assignment
Masking: None (Open Label)
|
| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Safety and tolerability of radiotherapy followed by hepatectomy : Incidence of Treatment-Emergent Adverse events (CTCAE v5.0) | Safety and tolerability of radiotherapy followed by hepatectomy | 3 months after resection |
|
| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Local recurrence free survival | Local recurrence free survival | from date of enrollment to date of first documented local recurrence. Assessed up to 12 months |
| Progression free survival | Progression free survival | from date of enrollment to the date of first documented progression. Assessed up to 12 months |
| Overall survival | Overall survival | from date of enrollment to the date of death from any cause. Assessed up to 12 months |
| Time to Progress | Time to Progress | from date of enrollment to the date of progress. Assessed up to 12 months |
| Quality of life by EORTC QLQ-C30 | Quality of life by EORTC QLQ-C30 | through study completion, an average of 1 year |
|
Liver Diseases, Carcinoma, Carcinoma, Hepatocellular, Neoplasms, Glandular and Epithelial, Neoplasms by Histologic Type, Neoplasms, Adenocarcinoma, Liver Neoplasms, Digestive System Neoplasms, Neoplasms by Site, Digestive System Diseases
|
| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: neoadjuvant stereotactic body radiation therapy followed by hepatectomy<br>Experimental: Phase1(Cohort 1): neoadjuvant stereotactic body radiation therapy (24Gy/3Fr) followed by hepatectomy Experimental: Phase1(Cohort 2): neoadjuvant stereotactic body radiation therapy (30Gy/3Fr) followed by hepatectomy Experimental: Phase1(Cohort 3): neoadjuvant stereotactic body radiation therapy (36Gy/3Fr) followed by hepatectomy | Radiation: Neoadjuvant stereotactic body radiation therapy (Multiple ascending dose) followed by hepatectomy for centrally located hepatocellular carcinoma.<br>* Neoadjuvant stereotactic body radiation therapy (Multiple ascending dose) followed by hepatectomy for centrally located hepatocellular carcinoma.<br>|
|
Preoperative Stereotactic Body Radiotherapy (SBRT) Followed by Hepatectomy for Centrally Located Hepatocellular Carcinoma: a Prospective, Single-center, Phase I Study
Study Overview
=================
Brief Summary
-----------------
Hepatocellular carcinoma (HCC) is the sixth prevalent malignancy worldwide. Although surgical excision is considered the standard treatment for resectable HCC, a high rate of postoperative recurrence was observed after partial hepatectomy, with a marginal recurrence rate up to 30%. Narrow margin resection may be the most appropriate procedure for centrally located HCC because the premise for survival is the conservation of more normal liver parenchyma. Unfortunately, narrow margin resection has been reported to contribute to poor survival outcomes. However, no (neo)adjuvant therapy before (or after) hepatectomy is generally considered to be effective in reducing post-operative recurrence. Radiotherapy (RT) has been well used in many solid malignant tumors as an (neo)adjuvant to surgical treatment, including HCC. SBRT has shown encouraging rates of local control for HCC. Compared with standard fractionation radiation, SBRT can achieve more precise delivery of high-dose radiation beams to the lesion, obtaining a much smaller target volume. Meanwhile, it could be finished in a short period which can bring more convenience to patients. Recently, several study and randomized controlled trials revealed the survival benefit of adjuvant RT (IMRT and SBRT) in patients with HCC. However, there are still lack of exploration for the efficacy of neoadjuvant SBRT. This study is to analyze the safety of preoperative SBRT followed by hepatectomy for centrally located hepatocellular carcinoma.
Official Title
-----------------
Preoperative Stereotactic Body Radiotherapy (SBRT) Followed by Hepatectomy for Centrally Located Hepatocellular Carcinoma: a Prospective, Single-center, Phase I Study
Conditions
-----------------
Hepatectomy, Centrally Located Hepatocellular Carcinoma, Stereotactic Body Radiotherapy
Intervention / Treatment
-----------------
* Radiation: Neoadjuvant stereotactic body radiation therapy (Multiple ascending dose) followed by hepatectomy for centrally located hepatocellular carcinoma.
Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Aged ≥18 years; Confirmed diagnosis of HCC. The diagnosis can be established radiographically by the criteria of the American Association for the Study of the Liver (AASLD), or by histologic diagnosis from the core biopsy; Centrally located hepatocellular carcinoma and medically fit to undergo surgery as determined by the Multiple Disciplinary Team (MDT); BCLC stage A No imaging evidence of direct invasion of stomach, duodenum, small intestine, large intestine or diaphragm of the intrahepatic lesions to be treated with radiotherapy; Child-Pugh class A and B7; ECOG (Eastern Cooperative Oncology Group) performance status 0 or 1; Willing to provide tissue from an excisional biopsy of a tumor lesion; For patients with active HBV: HBV DNA < 2000 IU/mL during screening, and have initiated anti-HBV treatment at least 7 days prior to SBRT and willingness to continue anti-HBV treatment during the study; Adequate organ and marrow function as defined below: 1)Marrow: absolute neutrophil count ≥1.5×109/L; platelets ≥50×109/L; hemoglobin ≥90g/L; 2)Liver: total bilirubin ≤3× institutional upper limit of normal (ULN); AST(aspartate aminotransferase) or ALT(alanine aminotransferase) ≤ 5× institutional ULN; albumin ≥29g/L; 3)Kidney: creatinine ≤ 1.5× institutional ULN or estimated glomerular filtration rate (GFR) ≥50 mL/min/1.73 m2 (according to the Cockcroft-Gault formula); 11. Women of childbearing potential must be willing to use a highly effective method of contraception for the course of the study through 30 days after radiotherapy. Female patient of childbearing potential should have a negative serum pregnancy test before 72h of her first treatment. Sexually active males must agree to use an adequate method of contraception starting with the treatment through 4 months after radiotherapy. Exclusion Criteria: Have received local or systemic treatments in the past, including but not limited to TACE, immunotherapy, targeted therapy, radiotherapy, radiofrequency therapy, etc.; Severe bleeding tendency or coagulation dysfunction within the previous 6 months; Extrahepatic metastasis; Prior abdominal irradiation; Any major surgery within 1 months prior to enrolment; Known history of active Bacillus Tuberculosis (TB) Known additional malignancy that is progressing or requires active treatment. Exceptions include basal cell carcinoma of the skin or squamous cell carcinoma of the skin that has undergone potentially curative therapy, or in situ cervical cancer. Active infection requiring systemic therapy; Diagnosis of immunodeficiency or is receiving systemic steroid therapy or any other form of immunosuppressive therapy; Known psychiatric or substance abuse disorders ; Pregnant or breastfeeding; Known history of human immunodeficiency virus (HIV: HIV 1/2 antibodies); Received a live vaccine within 30 days before radiotherapy.
Ages Eligible for Study
-----------------
Minimum Age: 18 Years
Maximum Age: 75 Years
Sexes Eligible for Study
-----------------
All
Accepts Healthy Volunteers
-----------------
No
Study Plan
=================
How is the study designed?
-----------------
Design Details
Primary Purpose: Treatment
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Arms and Interventions
| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: neoadjuvant stereotactic body radiation therapy followed by hepatectomy<br>Experimental: Phase1(Cohort 1): neoadjuvant stereotactic body radiation therapy (24Gy/3Fr) followed by hepatectomy Experimental: Phase1(Cohort 2): neoadjuvant stereotactic body radiation therapy (30Gy/3Fr) followed by hepatectomy Experimental: Phase1(Cohort 3): neoadjuvant stereotactic body radiation therapy (36Gy/3Fr) followed by hepatectomy | Radiation: Neoadjuvant stereotactic body radiation therapy (Multiple ascending dose) followed by hepatectomy for centrally located hepatocellular carcinoma.<br>* Neoadjuvant stereotactic body radiation therapy (Multiple ascending dose) followed by hepatectomy for centrally located hepatocellular carcinoma.<br>|
What is the study measuring?
-----------------
Primary Outcome Measures
| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Safety and tolerability of radiotherapy followed by hepatectomy : Incidence of Treatment-Emergent Adverse events (CTCAE v5.0) | Safety and tolerability of radiotherapy followed by hepatectomy | 3 months after resection |
Secondary Outcome Measures
| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Local recurrence free survival | Local recurrence free survival | from date of enrollment to date of first documented local recurrence. Assessed up to 12 months |
| Progression free survival | Progression free survival | from date of enrollment to the date of first documented progression. Assessed up to 12 months |
| Overall survival | Overall survival | from date of enrollment to the date of death from any cause. Assessed up to 12 months |
| Time to Progress | Time to Progress | from date of enrollment to the date of progress. Assessed up to 12 months |
| Quality of life by EORTC QLQ-C30 | Quality of life by EORTC QLQ-C30 | through study completion, an average of 1 year |
|
||
NCT02541318
|
Study of Effects of Dao-In Exercise on the Perimenopausal Women With Sleep Disturbance
|
Among health problems of peri-menopausal women, sleep disturbances is very common complaint. The aim of this study is to realize the body constitution of the peri-menopausal women with sleep disturbance; and to evaluate the effects of Duo-in practice on this population to see if this intervention can decrease the dosage of hormone replacement therapy.~Quasi-experimental design and convenient sampling are both adopted. Participants will be recruited from China Medical University, Tri-Service General Hospital, Taiwan Society of Health Promotion, and Dr. Chen's Obstetrics and Gynecology Clinic. One hundred of participants who are willing to try Duo-in exercise to improve their sleep quality will be randomly assigned into experiment group and control group. The experiment group will practice Duo-in exercise 20 minutes every day for 2 months; while there is no intervention in the control group. Then, after 2 weeks, the participants of experiment and control group will crossover. The experiment group has no intervention, but the control group will practice Duo-in exercise for 2 months. Chinese version of the Pittsburgh Sleep Quality Index (CPSQI), Body Constitution Questionnaire (BCQ), peri-menopausal disturbance scale, and peri-menopausal fatigue scale will be used in the assessment at each time point. According to previous experience, a total of 70 participants will completed the whole observation course. Generalized estimating equations (GEE) is applied to analyzed the repeated measurement of different time and groups.~This study will provide the evidence for Duo-in exercise as complementary treatment for hormone replacement therapy for peri-menopausal women, and also for integration of Dao-in exercise into mainstream treatment for other patients with sleep disturbance.
|
Study of Effects of Dao-In Exercise on the Perimenopausal Women With Sleep Disturbance
|
Peri-menopausal Women, Sleep Disturbances, Dao-in Exercise, Body Constitution
|
* Behavioral: Duo-in exercise
|
Inclusion Criteria:~peri-menopausal women who have sleep disturbances.~peri-menopausal women who can walk freely and without any disable.~Exclusion Criteria:~peri-menopausal women who have cancer and other life-threatening diseases.~peri-menopausal women who have psychological diseases.
|
45 Years
|
60 Years
|
Female
|
No
|
Primary Purpose: Supportive Care
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
|
| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Chinese version of the Pittsburgh Sleep Quality Index (CPSQI) | | 2 months after practicing Duo-In |
| Body Constitution Questionnaire (BCQ) | | 2 months after practicing Duo-In |
|
| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Peri-menopausal disturbance scale | | 2 months after practicing Duo-In |
| Peri-menopausal fatigue scale | | 2 months after practicing Duo-In |
|
peri-menopausal women, sleep disturbances, Dao-in exercise, body constitution
|
Dyssomnias, Parasomnias, Sleep Wake Disorders, Nervous System Diseases, Mental Disorders
|
| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Practice-from Beginning Group<br>The Practice-from Beginning Group will practice Duo-in exercise 20 minutes every day for 2 months; while there is no intervention in the Practice-2 month Later Group. Then, after 2 weeks, the participants of Practice-from Beginning Group and Practice-2 month Later Group will crossover. The Practice-from Beginning Group has no intervention, but the Practice-2 month Later Group will practice Duo-in exercise for 2 months. | Behavioral: Duo-in exercise<br>* Duo-in exercise was originated from China and with a 5000-years history. Ancient people adopted Duo-in to treat and prevent diseases.<br>|
| Other: Practice-2 month Later Group<br>The Practice-from Beginning Group will practice Duo-in exercise 20 minutes every day for 2 months; while there is no intervention in the Practice-2 month Later Group. Then, after 2 weeks, the participants of Practice-from Beginning Group and Practice-2 month Later Group will crossover. The Practice-from Beginning Group has no intervention, but the Practice-2 month Later Group will practice Duo-in exercise for 2 months. | Behavioral: Duo-in exercise<br>* Duo-in exercise was originated from China and with a 5000-years history. Ancient people adopted Duo-in to treat and prevent diseases.<br>|
|
Study of Effects of Dao-In Exercise on the Perimenopausal Women With Sleep Disturbance
Study Overview
=================
Brief Summary
-----------------
Among health problems of peri-menopausal women, sleep disturbances is very common complaint. The aim of this study is to realize the body constitution of the peri-menopausal women with sleep disturbance; and to evaluate the effects of Duo-in practice on this population to see if this intervention can decrease the dosage of hormone replacement therapy. Quasi-experimental design and convenient sampling are both adopted. Participants will be recruited from China Medical University, Tri-Service General Hospital, Taiwan Society of Health Promotion, and Dr. Chen's Obstetrics and Gynecology Clinic. One hundred of participants who are willing to try Duo-in exercise to improve their sleep quality will be randomly assigned into experiment group and control group. The experiment group will practice Duo-in exercise 20 minutes every day for 2 months; while there is no intervention in the control group. Then, after 2 weeks, the participants of experiment and control group will crossover. The experiment group has no intervention, but the control group will practice Duo-in exercise for 2 months. Chinese version of the Pittsburgh Sleep Quality Index (CPSQI), Body Constitution Questionnaire (BCQ), peri-menopausal disturbance scale, and peri-menopausal fatigue scale will be used in the assessment at each time point. According to previous experience, a total of 70 participants will completed the whole observation course. Generalized estimating equations (GEE) is applied to analyzed the repeated measurement of different time and groups. This study will provide the evidence for Duo-in exercise as complementary treatment for hormone replacement therapy for peri-menopausal women, and also for integration of Dao-in exercise into mainstream treatment for other patients with sleep disturbance.
Official Title
-----------------
Study of Effects of Dao-In Exercise on the Perimenopausal Women With Sleep Disturbance
Conditions
-----------------
Peri-menopausal Women, Sleep Disturbances, Dao-in Exercise, Body Constitution
Intervention / Treatment
-----------------
* Behavioral: Duo-in exercise
Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: peri-menopausal women who have sleep disturbances. peri-menopausal women who can walk freely and without any disable. Exclusion Criteria: peri-menopausal women who have cancer and other life-threatening diseases. peri-menopausal women who have psychological diseases.
Ages Eligible for Study
-----------------
Minimum Age: 45 Years
Maximum Age: 60 Years
Sexes Eligible for Study
-----------------
Female
Accepts Healthy Volunteers
-----------------
No
Study Plan
=================
How is the study designed?
-----------------
Design Details
Primary Purpose: Supportive Care
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Arms and Interventions
| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Practice-from Beginning Group<br>The Practice-from Beginning Group will practice Duo-in exercise 20 minutes every day for 2 months; while there is no intervention in the Practice-2 month Later Group. Then, after 2 weeks, the participants of Practice-from Beginning Group and Practice-2 month Later Group will crossover. The Practice-from Beginning Group has no intervention, but the Practice-2 month Later Group will practice Duo-in exercise for 2 months. | Behavioral: Duo-in exercise<br>* Duo-in exercise was originated from China and with a 5000-years history. Ancient people adopted Duo-in to treat and prevent diseases.<br>|
| Other: Practice-2 month Later Group<br>The Practice-from Beginning Group will practice Duo-in exercise 20 minutes every day for 2 months; while there is no intervention in the Practice-2 month Later Group. Then, after 2 weeks, the participants of Practice-from Beginning Group and Practice-2 month Later Group will crossover. The Practice-from Beginning Group has no intervention, but the Practice-2 month Later Group will practice Duo-in exercise for 2 months. | Behavioral: Duo-in exercise<br>* Duo-in exercise was originated from China and with a 5000-years history. Ancient people adopted Duo-in to treat and prevent diseases.<br>|
What is the study measuring?
-----------------
Primary Outcome Measures
| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Chinese version of the Pittsburgh Sleep Quality Index (CPSQI) | | 2 months after practicing Duo-In |
| Body Constitution Questionnaire (BCQ) | | 2 months after practicing Duo-In |
Secondary Outcome Measures
| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Peri-menopausal disturbance scale | | 2 months after practicing Duo-In |
| Peri-menopausal fatigue scale | | 2 months after practicing Duo-In |
Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
peri-menopausal women, sleep disturbances, Dao-in exercise, body constitution
|
|
NCT04650334
|
Collaborative Care for Perinatal Depression Care in Vietnam
|
Depression is the most common medical disorder of pregnancy, and suicide, most frequently found in women with depression, is a major source of maternal mortality. Perinatal depression affects approximately 15% of women in pregnancy and the year postpartum and affects both women and their children, both medically and as a result of impairment in the ability to care for self and others. In low- and middle-income countries (LMICs) where food insecurity can be severe, growth stunting is seen among the infants of women with untreated depression. Fortunately, effective treatment of perinatal depression with antidepressant medications and evidence-based psychosocial interventions (such as collaborative care) mitigates these risks. Yet there are a range of obstacles within LMICs to the delivery of services for perinatal depression and maternal suicide prevention, including a lack of awareness of this disorder and related evidence-based treatments, stigma among patients and providers, scarcity of specialty mental health care providers, and the lack of health information technology supports for the longitudinal care of chronic illness.
|
The investigators plan to use a participatory approach to systematically identify and adapt key elements of evidence-based models of perinatal depression care delivery to the cultural and health services context of Can Tho, Vietnam. Over the two-year study period the investigators will first develop a model, adapted from evidence-based approaches, for screening and treatment for women receiving perinatal care in community health centers as well as obstetric hospitals. Simultaneous exploration of potential implementation strategies to support and sustain this model in context will be identified along with the creation of a training and implementation toolkit for this setting. Using these strategies and tools the investigators will then carry out a pilot perinatal collaborative care study in a public health center and the prenatal care practice of the Can Tho Obstetric and Gynecologic Hospital. The results of this pilot will be used to revise and enhance the treatment model and related implementation tools. These will be used in subsequent trials of effectiveness and/or implementation broadly in the health care system of Can Tho. The investigators propose a mixed methods and participatory action research (PAR) developmental approach to tailor the standard collaborative care approach for the Can Tho city region of southern Vietnam. A linked capacity development program will work to develop the research skills of the Can Tho University of Medicine and Pharmacy (CTUMP) team through structured activities and interactions with investigators from the University of Washington.~Specific Aims: The specific aims of this proposed work, to be carried out over 2 years in health centers delivering perinatal care, are:~Aim 1 (Phase 1, months 1-12) Develop a tailored form of the collaborative care model of perinatal depression for the Can Tho health system context and an associated implementation plan and toolkit:~Carry out a participatory development effort to inform a collaborative care model for depression care and suicide prevention tailored to the existing health system infrastructure;~Identify potential strategies to support large scale implementation of this adapted model;~Develop an implementation toolkit to support this implementation.~Aim 2 (Phase 2 and Phase 3, months 13-24) Carry out a prospective pilot implementation study of the tailored collaborative care model and implementation approach:~Implement this model in perinatal care settings to assess the acceptability, feasibility, and costs of the model implementation toolkit via process and clinical outcome measures;~Revise and re-assess the model and implementation toolkit.~Aim 3 (Phase 1-3, months 1-24) Develop capacity in the Can Tho investigator team related to implementation science strategies to improve mental health care delivery:~Provide ongoing remote training of junior faculty at the CTUMP through ongoing feedback and involvement in the research efforts, completion of remote implementation research training, a monthly publication development meeting, and a journal club;~Conduct an annual in-person/virtual training addressing behavioral health integration and implementation science in Can Tho, Vietnam.
|
Developing a Tailored Implementation Plan for Collaborative Care of Perinatal Depression in Vietnam
|
Perinatal Depression
|
* Behavioral: Collaborative Care
|
Inclusion Criteria:~eligible to be screened for depression during pregnancy and 1 year post partum~Exclusion Criteria:~Severe mental illness
|
16 Years
|
45 Years
|
Female
|
No
|
Primary Purpose: Health Services Research
Intervention Model: Single Group Assignment
Masking: None (Open Label)
|
| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Screening rates for perinatal depression | The rates of screening for perinatal depression by the clinical team will be determined. The rates of reported scores on the validated Vietnamese translation of the Patient Health Questionnaire - 9 item (PHQ-9) measure will be recorded for women receiving care at the study clinics. The scale ranges from 0-27 and a higher score is worse than lower however the completion of the survey is all that is required for this measure and not the total score. Women eligible for screening are those in pregnancy and 12 months postpartum. A total of 4 screenings are expected in this period - one in the first two trimesters of pregnancy and one in the third trimester and one in each of the six month periods following delivery. The rate will be reported for all eligible women (those in each of the above periods) who received a screening. | 4 months |
| Rates of weekly use of a patient registry for systematic case review. Adherence to weekly use of patient registry for systematic case review | The use of the Care Manager Tracking System patient registry for weekly systematic case reviews will be assessed. Updated cases within the registry, preparation for case review, and documentation of treatment changes of patients will be assessed. The use of this tool for each week of the pilot study will be assessed. | 4 months |
| Patient participation in Thinking Healthy treatment | The number of women who screen positive for risk of perinatal depression (PHQ-9 greater than or equal to 10) who agree to participate in the Thinking Healthy treatment program. | 4 months |
| Persistence in Thinking Healthy treatment | The rate of women who agree to participate in the Thinking Healthy treatment who complete all treatment sessions. | 4 months |
|
| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Rate of clinical improvement in depression symptom scores | Depression symptom scores among patients will be collected using the Patient Health Questionnaire - 9 item (PHQ-9) measure. This scale allows scores from 0-27 and a higher score is worse (greater symptomatology). The rate of patients with 50% reduction in symptoms will be determined as a measure of clinically significant improvement. | 4 months |
|
Asphyxia Neonatorum, Depression, Depressive Disorder, Behavioral Symptoms, Mood Disorders, Mental Disorders, Infant, Newborn, Diseases
|
| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Other: Perinatal Collaborative Care<br>Experimental: Perinatal Collaborative Care in Can Tho, Vietnam This is an active treatment arm consisting of 3 health centers receiving training in collaborative care and enrollment of a total of 100 perinatal patients into collaborative care. | Behavioral: Collaborative Care<br>* Health services intervention to implement a team based model of care for perinatal depression.<br>* Other names: Thinking Healthy;|
|
Collaborative Care for Perinatal Depression Care in Vietnam
Study Overview
=================
Brief Summary
-----------------
Depression is the most common medical disorder of pregnancy, and suicide, most frequently found in women with depression, is a major source of maternal mortality. Perinatal depression affects approximately 15% of women in pregnancy and the year postpartum and affects both women and their children, both medically and as a result of impairment in the ability to care for self and others. In low- and middle-income countries (LMICs) where food insecurity can be severe, growth stunting is seen among the infants of women with untreated depression. Fortunately, effective treatment of perinatal depression with antidepressant medications and evidence-based psychosocial interventions (such as collaborative care) mitigates these risks. Yet there are a range of obstacles within LMICs to the delivery of services for perinatal depression and maternal suicide prevention, including a lack of awareness of this disorder and related evidence-based treatments, stigma among patients and providers, scarcity of specialty mental health care providers, and the lack of health information technology supports for the longitudinal care of chronic illness.
Detailed Description
-----------------
The investigators plan to use a participatory approach to systematically identify and adapt key elements of evidence-based models of perinatal depression care delivery to the cultural and health services context of Can Tho, Vietnam. Over the two-year study period the investigators will first develop a model, adapted from evidence-based approaches, for screening and treatment for women receiving perinatal care in community health centers as well as obstetric hospitals. Simultaneous exploration of potential implementation strategies to support and sustain this model in context will be identified along with the creation of a training and implementation toolkit for this setting. Using these strategies and tools the investigators will then carry out a pilot perinatal collaborative care study in a public health center and the prenatal care practice of the Can Tho Obstetric and Gynecologic Hospital. The results of this pilot will be used to revise and enhance the treatment model and related implementation tools. These will be used in subsequent trials of effectiveness and/or implementation broadly in the health care system of Can Tho. The investigators propose a mixed methods and participatory action research (PAR) developmental approach to tailor the standard collaborative care approach for the Can Tho city region of southern Vietnam. A linked capacity development program will work to develop the research skills of the Can Tho University of Medicine and Pharmacy (CTUMP) team through structured activities and interactions with investigators from the University of Washington. Specific Aims: The specific aims of this proposed work, to be carried out over 2 years in health centers delivering perinatal care, are: Aim 1 (Phase 1, months 1-12) Develop a tailored form of the collaborative care model of perinatal depression for the Can Tho health system context and an associated implementation plan and toolkit: Carry out a participatory development effort to inform a collaborative care model for depression care and suicide prevention tailored to the existing health system infrastructure; Identify potential strategies to support large scale implementation of this adapted model; Develop an implementation toolkit to support this implementation. Aim 2 (Phase 2 and Phase 3, months 13-24) Carry out a prospective pilot implementation study of the tailored collaborative care model and implementation approach: Implement this model in perinatal care settings to assess the acceptability, feasibility, and costs of the model implementation toolkit via process and clinical outcome measures; Revise and re-assess the model and implementation toolkit. Aim 3 (Phase 1-3, months 1-24) Develop capacity in the Can Tho investigator team related to implementation science strategies to improve mental health care delivery: Provide ongoing remote training of junior faculty at the CTUMP through ongoing feedback and involvement in the research efforts, completion of remote implementation research training, a monthly publication development meeting, and a journal club; Conduct an annual in-person/virtual training addressing behavioral health integration and implementation science in Can Tho, Vietnam.
Official Title
-----------------
Developing a Tailored Implementation Plan for Collaborative Care of Perinatal Depression in Vietnam
Conditions
-----------------
Perinatal Depression
Intervention / Treatment
-----------------
* Behavioral: Collaborative Care
Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: eligible to be screened for depression during pregnancy and 1 year post partum Exclusion Criteria: Severe mental illness
Ages Eligible for Study
-----------------
Minimum Age: 16 Years
Maximum Age: 45 Years
Sexes Eligible for Study
-----------------
Female
Accepts Healthy Volunteers
-----------------
No
Study Plan
=================
How is the study designed?
-----------------
Design Details
Primary Purpose: Health Services Research
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Arms and Interventions
| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Other: Perinatal Collaborative Care<br>Experimental: Perinatal Collaborative Care in Can Tho, Vietnam This is an active treatment arm consisting of 3 health centers receiving training in collaborative care and enrollment of a total of 100 perinatal patients into collaborative care. | Behavioral: Collaborative Care<br>* Health services intervention to implement a team based model of care for perinatal depression.<br>* Other names: Thinking Healthy;|
What is the study measuring?
-----------------
Primary Outcome Measures
| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Screening rates for perinatal depression | The rates of screening for perinatal depression by the clinical team will be determined. The rates of reported scores on the validated Vietnamese translation of the Patient Health Questionnaire - 9 item (PHQ-9) measure will be recorded for women receiving care at the study clinics. The scale ranges from 0-27 and a higher score is worse than lower however the completion of the survey is all that is required for this measure and not the total score. Women eligible for screening are those in pregnancy and 12 months postpartum. A total of 4 screenings are expected in this period - one in the first two trimesters of pregnancy and one in the third trimester and one in each of the six month periods following delivery. The rate will be reported for all eligible women (those in each of the above periods) who received a screening. | 4 months |
| Rates of weekly use of a patient registry for systematic case review. Adherence to weekly use of patient registry for systematic case review | The use of the Care Manager Tracking System patient registry for weekly systematic case reviews will be assessed. Updated cases within the registry, preparation for case review, and documentation of treatment changes of patients will be assessed. The use of this tool for each week of the pilot study will be assessed. | 4 months |
| Patient participation in Thinking Healthy treatment | The number of women who screen positive for risk of perinatal depression (PHQ-9 greater than or equal to 10) who agree to participate in the Thinking Healthy treatment program. | 4 months |
| Persistence in Thinking Healthy treatment | The rate of women who agree to participate in the Thinking Healthy treatment who complete all treatment sessions. | 4 months |
Secondary Outcome Measures
| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Rate of clinical improvement in depression symptom scores | Depression symptom scores among patients will be collected using the Patient Health Questionnaire - 9 item (PHQ-9) measure. This scale allows scores from 0-27 and a higher score is worse (greater symptomatology). The rate of patients with 50% reduction in symptoms will be determined as a measure of clinically significant improvement. | 4 months |
|
|
NCT04896554
|
Comparison of the Health Literacy of Our Patients Who Quit Smoking and Who Cannot Quit Smoking
|
The aim of the study was determined to examine the relationship between the health literacy scales of the patients who came to the smoking cessation clinic and their smoking cessation success.~The patient follow-up files registered in the archive of the smoking cessation clinic will be scanned for the last 2 years and the demographic data and follow-up information of the patients will be reached. Patients who have completed the 1-year follow-up period will be contacted by phone, questioning whether they smoke or not, and will be invited to answer the health literacy scale. Accepting patients will be divided into two groups as those who quit smoking and those who cannot, and health literacy scales will be compared.
|
Comparison of the Health Literacy of Our Patients Who Quit Smoking and Who Cannot Quit Smoking
|
Smoking Cessation, Health Literacy
|
* Behavioral: Health literacy scale
|
Inclusion Criteria:~Patients who applied to the smoking cessation clinic for smoking cessation~over the age of 18~Those who agree to answer the health literacy scale form~Exclusion Criteria:~Patients under the age of 18~Those who do not agree to answer the health literacy scale form
|
18 Years
| null |
All
|
No
|
Primary Purpose: Health Services Research
Allocation: Non-Randomized
Intervention Model: Crossover Assignment
Masking: None (Open Label)
|
| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Health literacy | The Turkish version of The European Health Literacy Survey (HLS-EU) Health Literacy Questionnaire scale (ASOY-TR) was used to measure health literacy. This scale consists of 47 questions. Each item has 4 degrees such that 1 = Very difficult, 2 = Difficult, 3 = Easy, 4 = Very easy. Code 5 is used for the expression I don't know. The total score that can be obtained from the scale is between 47-188. For the sake of ease of calculation, the total score is standardized with the following formula to take a value between 0-50.~Formula = Index = (arithmetic mean-1) x [50/3] High score means better health literacy. | After 1 year of follow-up in the smoking cessation clinic |
|
health literacy, smoking cessation
|
| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: quit smoking<br>patients who have quit smoking | Behavioral: Health literacy scale<br>* The Turkish version of The European Health Literacy Survey (HLS-EU) Health Literacy Questionnaire scale (ASOY-TR) was used to measure health literacy. This scale consists of 47 questions. Each item has 4 degrees such that 1 = Very difficult, 2 = Difficult, 3 = Easy, 4 = Very easy. Code 5 is used for the expression I don't know. The total score that can be obtained from the scale is between 47-188. For the sake of ease of calculation, the total score is standardized with the following formula to take a value between 0-50.~Formula = Index = (arithmetic mean-1) x [50/3] High score means better health literacy.<br>|
| Active Comparator: not quit smoking<br>patients who have not quit smoking | Behavioral: Health literacy scale<br>* The Turkish version of The European Health Literacy Survey (HLS-EU) Health Literacy Questionnaire scale (ASOY-TR) was used to measure health literacy. This scale consists of 47 questions. Each item has 4 degrees such that 1 = Very difficult, 2 = Difficult, 3 = Easy, 4 = Very easy. Code 5 is used for the expression I don't know. The total score that can be obtained from the scale is between 47-188. For the sake of ease of calculation, the total score is standardized with the following formula to take a value between 0-50.~Formula = Index = (arithmetic mean-1) x [50/3] High score means better health literacy.<br>|
|
Comparison of the Health Literacy of Our Patients Who Quit Smoking and Who Cannot Quit Smoking
Study Overview
=================
Brief Summary
-----------------
The aim of the study was determined to examine the relationship between the health literacy scales of the patients who came to the smoking cessation clinic and their smoking cessation success. The patient follow-up files registered in the archive of the smoking cessation clinic will be scanned for the last 2 years and the demographic data and follow-up information of the patients will be reached. Patients who have completed the 1-year follow-up period will be contacted by phone, questioning whether they smoke or not, and will be invited to answer the health literacy scale. Accepting patients will be divided into two groups as those who quit smoking and those who cannot, and health literacy scales will be compared.
Official Title
-----------------
Comparison of the Health Literacy of Our Patients Who Quit Smoking and Who Cannot Quit Smoking
Conditions
-----------------
Smoking Cessation, Health Literacy
Intervention / Treatment
-----------------
* Behavioral: Health literacy scale
Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Patients who applied to the smoking cessation clinic for smoking cessation over the age of 18 Those who agree to answer the health literacy scale form Exclusion Criteria: Patients under the age of 18 Those who do not agree to answer the health literacy scale form
Ages Eligible for Study
-----------------
Minimum Age: 18 Years
Sexes Eligible for Study
-----------------
All
Accepts Healthy Volunteers
-----------------
No
Study Plan
=================
How is the study designed?
-----------------
Design Details
Primary Purpose: Health Services Research
Allocation: Non-Randomized
Intervention Model: Crossover Assignment
Masking: None (Open Label)
Arms and Interventions
| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: quit smoking<br>patients who have quit smoking | Behavioral: Health literacy scale<br>* The Turkish version of The European Health Literacy Survey (HLS-EU) Health Literacy Questionnaire scale (ASOY-TR) was used to measure health literacy. This scale consists of 47 questions. Each item has 4 degrees such that 1 = Very difficult, 2 = Difficult, 3 = Easy, 4 = Very easy. Code 5 is used for the expression I don't know. The total score that can be obtained from the scale is between 47-188. For the sake of ease of calculation, the total score is standardized with the following formula to take a value between 0-50. Formula = Index = (arithmetic mean-1) x [50/3] High score means better health literacy.<br>|
| Active Comparator: not quit smoking<br>patients who have not quit smoking | Behavioral: Health literacy scale<br>* The Turkish version of The European Health Literacy Survey (HLS-EU) Health Literacy Questionnaire scale (ASOY-TR) was used to measure health literacy. This scale consists of 47 questions. Each item has 4 degrees such that 1 = Very difficult, 2 = Difficult, 3 = Easy, 4 = Very easy. Code 5 is used for the expression I don't know. The total score that can be obtained from the scale is between 47-188. For the sake of ease of calculation, the total score is standardized with the following formula to take a value between 0-50. Formula = Index = (arithmetic mean-1) x [50/3] High score means better health literacy.<br>|
What is the study measuring?
-----------------
Primary Outcome Measures
| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Health literacy | The Turkish version of The European Health Literacy Survey (HLS-EU) Health Literacy Questionnaire scale (ASOY-TR) was used to measure health literacy. This scale consists of 47 questions. Each item has 4 degrees such that 1 = Very difficult, 2 = Difficult, 3 = Easy, 4 = Very easy. Code 5 is used for the expression I don't know. The total score that can be obtained from the scale is between 47-188. For the sake of ease of calculation, the total score is standardized with the following formula to take a value between 0-50. Formula = Index = (arithmetic mean-1) x [50/3] High score means better health literacy. | After 1 year of follow-up in the smoking cessation clinic |
Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
health literacy, smoking cessation
|
|||
NCT05462067
|
Combined EDOF / Trifocal
|
The purpose of this study is to obtain postoperative visual performance data of patients with bilateral implantation of the AT LARA IOL or the AT LARA implanted in the dominant eye and AT LISA tri implanted in the other eye. Dependence on spectacles, the occurrence of photic phenomena and patient and surgeon satisfaction with the patient's visual performance will be documented. Furthermore, the refraction data will be used to optimize the IOL constants for IOL power calculations.
|
An extended depth of field can enable patients to do most everyday tasks without glasses. Compared to MIOLs, side effects such as glare and halo perception are expected to be less frequent and with lower intensity. This study is designed to assess visual performance and satisfaction in patients who underwent bilateral AT LARA IOL implantation or a mixed implantation of AT LARA in the dominant eye and AT LISA tri in the non-dominant eye. All patients will be offered enrolment after successful implantation in both eyes. Therefore, the preoperative and surgical data are recorded retrospectively, the follow-up examinations will be documented prospectively. This approach is justified and does not cause bias, as the purpose of this study is to investigate the performance of the IOL after successful implantation and uncomplicated surgery.~In this retrospective/prospective, non-randomized study, subjects will receive either binocular implantation of AT LARA/AT LARA toric or AT LARA/AT LARA toric in the distance dominant eye and AT LISA tri/AT LISA tri toric in the non-dominant eye. The main outcome parameter is best corrected visual acuity (CDVA). Secondary outcome parameters are: preferred near and intermediate distance, UDVA, DCIVA (Salzburg Reading desk in preferred distance), DCNVA (Salzburg Reading Desk in preferred near distance), distance corrected intermediate and near visual acuity with different contrast settings (Salzburg Reading Desk), manifest refraction, monocular and binocular defocus curve analysis, dysphotopsia simulation (Halo & Glare Simulator), subjective patient satisfaction (MacAlinden) questionnaire.~Patients have different demands for intermediate and near vision as well as distances needed for daily routine. Comparing both groups indicates there is individual lens fitting for patients depending on their own needs. Subjects are to be evaluated 2-4 months and 5-8 months after implantation of either configuration.
|
Visual Performance of Patients With Either Bilateral Implantation of the ZEISS AT LARA or the ZEISS AT LARA in One Eye and ZEISS AT LISA Tri in the Other (Presbyopia IOL Concept Evaluation).
|
Cataract
|
* Device: AT LARA IOL
* Device: AT LISA Tri IOL
|
Inclusion Criteria:~Patients bilaterally implanted with the AT LARA IOL or the AT LARA and AT LISA tri IOLs or their toric versions~Age 18 and older~Uncomplicated implantation of study IOLs~No visual acuity limiting pathologies~Clear intraocular media~Availability, willingness and sufficient cognitive awareness to comply with examination procedures~Written informed consent for participation in the study and data protection~Exclusion Criteria:~Visual potential of less than 0.63 (decimal) in each eye due to ocular pathologies, e.g. retinal disorders~Postoperative CDVA >0.2 log MAR~Visual field loss which has impact on visual acuity~Use of systemic or ocular medication that might affect vision~Acute or chronic disease, illness, ocular trauma or surgery that would confound results (e.g. macular degeneration, cystoid macular edema, proliferative diabetic retinopathy, etc.)~Patients with amblyopia, strabismus, forme fruste keratoconus or keratoconus~Capsular or zonular abnormalities that have affected postoperative centration or tilt of the lens (e.g. pseudoexfoliation syndrome)~Pupil abnormalities (non-reactive, tonic pupils, abnormally shaped pupils, or pupils that do not dilate at least 3.5 mm under mesopic/scotopic conditions)~Patient participates in other clinical trial (former participation is no exclusion criterion)
|
18 Years
| null |
All
|
No
|
Primary Purpose: Treatment
Allocation: Non-Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
|
| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change in preoperative and postoperative binocular Corrected Distance Visual Acuity (CDVA) | The uncorrected and best corrected distance visual acuity is determined with standard reading charts at a distance of 4 or 5 m; logMar visual acuity is recorded.~Near visual acuity (40 cm) and intermediate visual acuity (67 cm) are documented using suitable visual acuity charts for the respective distance or converted using conversion tables. The logMar visual acuity is recorded.~Uncorrected visual acuity will be scored for distance, intermediate and near vision:~logMAR 0.0 or better = 5~logMar 0.1 = 4~logMar 0.2 = 3~logMar 0.3 = 2~logMAR worse than 0.3 = 1 Scores for the individual distances will be added to a total score. | Pre-op, 2-4 Months, & 5-8 Months |
|
| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Postoperative uncorrected monocular and binocular distance visual acuity | The uncorrected and best corrected distance visual acuity is determined with standard reading charts at a distance of 4 or 5 m; logMar visual acuity is recorded.~Near visual acuity (40 cm) and intermediate visual acuity (67 cm) are documented using suitable visual acuity charts for the respective distance or converted using conversion tables. The logMar visual acuity is recorded.~Uncorrected visual acuity will be scored for distance, intermediate and near vision:~logMAR 0.0 or better = 5~logMar 0.1 = 4~logMar 0.2 = 3~logMar 0.3 = 2~logMAR worse than 0.3 = 1 Scores for the individual distances will be added to a total score. | 2-4 Months, & 5-8 Months |
| Postoperative uncorrected and distance-corrected binocular near visual acuity | The uncorrected and best corrected distance visual acuity is determined with standard reading charts at a distance of 4 or 5 m; logMar visual acuity is recorded.~Near visual acuity (40 cm) and intermediate visual acuity (67 cm) are documented using suitable visual acuity charts for the respective distance or converted using conversion tables. The logMar visual acuity is recorded.~Uncorrected visual acuity will be scored for distance, intermediate and near vision:~logMAR 0.0 or better = 5~logMar 0.1 = 4~logMar 0.2 = 3~logMar 0.3 = 2~logMAR worse than 0.3 = 1 Scores for the individual distances will be added to a total score. | 2-4 Months, & 5-8 Months |
| Postoperative uncorrected and distance-corrected binocular intermediate visual acuity | The uncorrected and best corrected distance visual acuity is determined with standard reading charts at a distance of 4 or 5 m; logMar visual acuity is recorded.~Near visual acuity (40 cm) and intermediate visual acuity (67 cm) are documented using suitable visual acuity charts for the respective distance or converted using conversion tables. The logMar visual acuity is recorded.~Uncorrected visual acuity will be scored for distance, intermediate and near vision:~logMAR 0.0 or better = 5~logMar 0.1 = 4~logMar 0.2 = 3~logMar 0.3 = 2~logMAR worse than 0.3 = 1 Scores for the individual distances will be added to a total score. | 2-4 Months, & 5-8 Months |
| Reading speed and acuity, and preferred reading distance (Salzburg reading desk) | Sites at which the Salzburg Reading Desk is available will examine reading speed and acuity at 40 cm and 66 cm at the two postoperative visits. The following parameters will be documented: words per minute (WPM), characters per minute (CPM), words missed (reading speed recalculated when missed words are selected), LogMAR reading acuity, average reading distance, average reading time. | 2-4 Months, & 5-8 Months |
| Postoperative use of spectacles (near, intermediate, distance) | The surgeon asks: How often do you need glasses for near/intermediate/distance vision?. The answers are classified into 0%, 25%, 50%, 75% and 100% of the total time. | 2-4 Months, & 5-8 Months |
| Photic phenomena | The McAlinden Quality of Vision (QoV) questionnaire will be used to assess the size and intensity of halo and glare | 2-4 Months, & 5-8 Months |
| Defocus curve | Best-corrected distance defocus curve testing from +1.0 D to -4.0 D shall be performed. The image shall be defocused in -0.5 D increments with spherical minus lenses and a visual acuity measurement is obtained at each defocus increment. | 2-4 Months, & 5-8 Months |
| Patient satisfaction | The McAlinden Quality of Vision (QoV) questionnaire will be used to assess patient satisfaction. Patients are asked two closed answered questions, with Yes or No being the answer. 'Would you decide to have multifocal IOLs again?' and ' Would you recommend the same lens to your relatives and friends?' | 2-4 Months, & 5-8 Months |
| Surgeon's assessment | The surgeon completes a short questionnaire on the handling and performance of the lens. The ease of implantation, achievement of the target refraction, satisfaction with the patient's vision and general satisfaction are recorded. | 2-4 Months, & 5-8 Months |
| Optimization of IOL-constants | For this purpose, the corneal radii, the axial length, the measured anterior chamber depth and the implanted IOL power are recorded during biometry to determine the correct IOL power. Postoperatively, the subjective refraction achieved is documented as spherical equivalent and forwarded to Prof. Dr. Achim Langenbucher, Medical Faculty of Saarland University, Experimental Ophthalmology, for evaluation with the IOL-Con software | 2-4 Months, & 5-8 Months |
|
Cataract, Lens Diseases, Eye Diseases
|
| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: Binocular EDOF IOL<br>Binocular EDOF IOL for treatment of cataract | Device: AT LARA IOL<br>* EDOF IOL for treatment of cataract<br>|
| Experimental: Combined Edof and Trifocal IOL<br>Combined EDOF and Trifocal IOL - EDOF in the distance dominant eye / Trifocal in the non-dominant eye | Device: AT LARA IOL<br>* EDOF IOL for treatment of cataract<br>Device: AT LISA Tri IOL<br>* Trifocal IOL for treatment of cataract<br>|
|
Combined EDOF / Trifocal
Study Overview
=================
Brief Summary
-----------------
The purpose of this study is to obtain postoperative visual performance data of patients with bilateral implantation of the AT LARA IOL or the AT LARA implanted in the dominant eye and AT LISA tri implanted in the other eye. Dependence on spectacles, the occurrence of photic phenomena and patient and surgeon satisfaction with the patient's visual performance will be documented. Furthermore, the refraction data will be used to optimize the IOL constants for IOL power calculations.
Detailed Description
-----------------
An extended depth of field can enable patients to do most everyday tasks without glasses. Compared to MIOLs, side effects such as glare and halo perception are expected to be less frequent and with lower intensity. This study is designed to assess visual performance and satisfaction in patients who underwent bilateral AT LARA IOL implantation or a mixed implantation of AT LARA in the dominant eye and AT LISA tri in the non-dominant eye. All patients will be offered enrolment after successful implantation in both eyes. Therefore, the preoperative and surgical data are recorded retrospectively, the follow-up examinations will be documented prospectively. This approach is justified and does not cause bias, as the purpose of this study is to investigate the performance of the IOL after successful implantation and uncomplicated surgery. In this retrospective/prospective, non-randomized study, subjects will receive either binocular implantation of AT LARA/AT LARA toric or AT LARA/AT LARA toric in the distance dominant eye and AT LISA tri/AT LISA tri toric in the non-dominant eye. The main outcome parameter is best corrected visual acuity (CDVA). Secondary outcome parameters are: preferred near and intermediate distance, UDVA, DCIVA (Salzburg Reading desk in preferred distance), DCNVA (Salzburg Reading Desk in preferred near distance), distance corrected intermediate and near visual acuity with different contrast settings (Salzburg Reading Desk), manifest refraction, monocular and binocular defocus curve analysis, dysphotopsia simulation (Halo & Glare Simulator), subjective patient satisfaction (MacAlinden) questionnaire. Patients have different demands for intermediate and near vision as well as distances needed for daily routine. Comparing both groups indicates there is individual lens fitting for patients depending on their own needs. Subjects are to be evaluated 2-4 months and 5-8 months after implantation of either configuration.
Official Title
-----------------
Visual Performance of Patients With Either Bilateral Implantation of the ZEISS AT LARA or the ZEISS AT LARA in One Eye and ZEISS AT LISA Tri in the Other (Presbyopia IOL Concept Evaluation).
Conditions
-----------------
Cataract
Intervention / Treatment
-----------------
* Device: AT LARA IOL
* Device: AT LISA Tri IOL
Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Patients bilaterally implanted with the AT LARA IOL or the AT LARA and AT LISA tri IOLs or their toric versions Age 18 and older Uncomplicated implantation of study IOLs No visual acuity limiting pathologies Clear intraocular media Availability, willingness and sufficient cognitive awareness to comply with examination procedures Written informed consent for participation in the study and data protection Exclusion Criteria: Visual potential of less than 0.63 (decimal) in each eye due to ocular pathologies, e.g. retinal disorders Postoperative CDVA >0.2 log MAR Visual field loss which has impact on visual acuity Use of systemic or ocular medication that might affect vision Acute or chronic disease, illness, ocular trauma or surgery that would confound results (e.g. macular degeneration, cystoid macular edema, proliferative diabetic retinopathy, etc.) Patients with amblyopia, strabismus, forme fruste keratoconus or keratoconus Capsular or zonular abnormalities that have affected postoperative centration or tilt of the lens (e.g. pseudoexfoliation syndrome) Pupil abnormalities (non-reactive, tonic pupils, abnormally shaped pupils, or pupils that do not dilate at least 3.5 mm under mesopic/scotopic conditions) Patient participates in other clinical trial (former participation is no exclusion criterion)
Ages Eligible for Study
-----------------
Minimum Age: 18 Years
Sexes Eligible for Study
-----------------
All
Accepts Healthy Volunteers
-----------------
No
Study Plan
=================
How is the study designed?
-----------------
Design Details
Primary Purpose: Treatment
Allocation: Non-Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Arms and Interventions
| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: Binocular EDOF IOL<br>Binocular EDOF IOL for treatment of cataract | Device: AT LARA IOL<br>* EDOF IOL for treatment of cataract<br>|
| Experimental: Combined Edof and Trifocal IOL<br>Combined EDOF and Trifocal IOL - EDOF in the distance dominant eye / Trifocal in the non-dominant eye | Device: AT LARA IOL<br>* EDOF IOL for treatment of cataract<br>Device: AT LISA Tri IOL<br>* Trifocal IOL for treatment of cataract<br>|
What is the study measuring?
-----------------
Primary Outcome Measures
| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change in preoperative and postoperative binocular Corrected Distance Visual Acuity (CDVA) | The uncorrected and best corrected distance visual acuity is determined with standard reading charts at a distance of 4 or 5 m; logMar visual acuity is recorded. Near visual acuity (40 cm) and intermediate visual acuity (67 cm) are documented using suitable visual acuity charts for the respective distance or converted using conversion tables. The logMar visual acuity is recorded. Uncorrected visual acuity will be scored for distance, intermediate and near vision: logMAR 0.0 or better = 5 logMar 0.1 = 4 logMar 0.2 = 3 logMar 0.3 = 2 logMAR worse than 0.3 = 1 Scores for the individual distances will be added to a total score. | Pre-op, 2-4 Months, & 5-8 Months |
Secondary Outcome Measures
| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Postoperative uncorrected monocular and binocular distance visual acuity | The uncorrected and best corrected distance visual acuity is determined with standard reading charts at a distance of 4 or 5 m; logMar visual acuity is recorded. Near visual acuity (40 cm) and intermediate visual acuity (67 cm) are documented using suitable visual acuity charts for the respective distance or converted using conversion tables. The logMar visual acuity is recorded. Uncorrected visual acuity will be scored for distance, intermediate and near vision: logMAR 0.0 or better = 5 logMar 0.1 = 4 logMar 0.2 = 3 logMar 0.3 = 2 logMAR worse than 0.3 = 1 Scores for the individual distances will be added to a total score. | 2-4 Months, & 5-8 Months |
| Postoperative uncorrected and distance-corrected binocular near visual acuity | The uncorrected and best corrected distance visual acuity is determined with standard reading charts at a distance of 4 or 5 m; logMar visual acuity is recorded. Near visual acuity (40 cm) and intermediate visual acuity (67 cm) are documented using suitable visual acuity charts for the respective distance or converted using conversion tables. The logMar visual acuity is recorded. Uncorrected visual acuity will be scored for distance, intermediate and near vision: logMAR 0.0 or better = 5 logMar 0.1 = 4 logMar 0.2 = 3 logMar 0.3 = 2 logMAR worse than 0.3 = 1 Scores for the individual distances will be added to a total score. | 2-4 Months, & 5-8 Months |
| Postoperative uncorrected and distance-corrected binocular intermediate visual acuity | The uncorrected and best corrected distance visual acuity is determined with standard reading charts at a distance of 4 or 5 m; logMar visual acuity is recorded. Near visual acuity (40 cm) and intermediate visual acuity (67 cm) are documented using suitable visual acuity charts for the respective distance or converted using conversion tables. The logMar visual acuity is recorded. Uncorrected visual acuity will be scored for distance, intermediate and near vision: logMAR 0.0 or better = 5 logMar 0.1 = 4 logMar 0.2 = 3 logMar 0.3 = 2 logMAR worse than 0.3 = 1 Scores for the individual distances will be added to a total score. | 2-4 Months, & 5-8 Months |
| Reading speed and acuity, and preferred reading distance (Salzburg reading desk) | Sites at which the Salzburg Reading Desk is available will examine reading speed and acuity at 40 cm and 66 cm at the two postoperative visits. The following parameters will be documented: words per minute (WPM), characters per minute (CPM), words missed (reading speed recalculated when missed words are selected), LogMAR reading acuity, average reading distance, average reading time. | 2-4 Months, & 5-8 Months |
| Postoperative use of spectacles (near, intermediate, distance) | The surgeon asks: How often do you need glasses for near/intermediate/distance vision?. The answers are classified into 0%, 25%, 50%, 75% and 100% of the total time. | 2-4 Months, & 5-8 Months |
| Photic phenomena | The McAlinden Quality of Vision (QoV) questionnaire will be used to assess the size and intensity of halo and glare | 2-4 Months, & 5-8 Months |
| Defocus curve | Best-corrected distance defocus curve testing from +1.0 D to -4.0 D shall be performed. The image shall be defocused in -0.5 D increments with spherical minus lenses and a visual acuity measurement is obtained at each defocus increment. | 2-4 Months, & 5-8 Months |
| Patient satisfaction | The McAlinden Quality of Vision (QoV) questionnaire will be used to assess patient satisfaction. Patients are asked two closed answered questions, with Yes or No being the answer. 'Would you decide to have multifocal IOLs again?' and ' Would you recommend the same lens to your relatives and friends?' | 2-4 Months, & 5-8 Months |
| Surgeon's assessment | The surgeon completes a short questionnaire on the handling and performance of the lens. The ease of implantation, achievement of the target refraction, satisfaction with the patient's vision and general satisfaction are recorded. | 2-4 Months, & 5-8 Months |
| Optimization of IOL-constants | For this purpose, the corneal radii, the axial length, the measured anterior chamber depth and the implanted IOL power are recorded during biometry to determine the correct IOL power. Postoperatively, the subjective refraction achieved is documented as spherical equivalent and forwarded to Prof. Dr. Achim Langenbucher, Medical Faculty of Saarland University, Experimental Ophthalmology, for evaluation with the IOL-Con software | 2-4 Months, & 5-8 Months |
|
|
NCT04838535
|
Follicular Fluid Raman Shifts and IVF Outcomes
|
This study intends to collect about 150 cases of follicular fluid samples from PCOS and non-PCOS infertility patients undergoing in vitro fertilization (IVF) or intracytoplasmic sperm injection (ICSI) cycles (in clinical routines).We tend to detect Raman metabolic profile of the follicular fluid of the PCOS and non-PCOS groups, and find the correlation between the metabolic profile of the follicular fluid of PCOS patients and the oocyte quality, IVF outcome and subsequent embryo development are also under investigation. Metabolomics analysis was applied to look for markers of follicular fluid in PCOS patients, and further exploring data and strategies to improve the embryonic development potential and IVF outcome of PCOS patients.
|
The Correlation Between Follicular Fluid Raman Spectrum and Embryo Development in Infertile Patients With Polycystic Ovary Syndrome
|
IVF, Polycystic Ovary Syndrome
|
* Diagnostic Test: Raman spectrum
|
Inclusion Criteria:~Patients fit the Rotterdam criteria for PCOS~Patients under IVF cycles~Exclusion Criteria:~Patients with male factors infertility~Patients with fallopian tube factors infertility
| null | null |
Female
|
Accepts Healthy Volunteers
|
Primary Purpose: Screening
Intervention Model: Single Group Assignment
Masking: None (Open Label)
|
| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Difference between polycystic ovary syndrome and normal follicular fluids | Raman spectrum was applied and the Raman spectrum characteristic absorption peak can be revealed. PCA analysis was used to measure the degree of differential shifts. | 24 months |
|
Polycystic Ovary Syndrome, Syndrome, Disease, Pathologic Processes, Ovarian Cysts, Cysts, Neoplasms, Ovarian Diseases, Adnexal Diseases, Genital Diseases, Female, Female Urogenital Diseases, Female Urogenital Diseases and Pregnancy Complications, Urogenital Diseases, Genital Diseases, Gonadal Disorders, Endocrine System Diseases
|
| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Other: PCOS follicular fluid<br> | Diagnostic Test: Raman spectrum<br>* The wavelength of the follicular fluids were scaned by Raman spectrum<br>|
|
Follicular Fluid Raman Shifts and IVF Outcomes
Study Overview
=================
Brief Summary
-----------------
This study intends to collect about 150 cases of follicular fluid samples from PCOS and non-PCOS infertility patients undergoing in vitro fertilization (IVF) or intracytoplasmic sperm injection (ICSI) cycles (in clinical routines).We tend to detect Raman metabolic profile of the follicular fluid of the PCOS and non-PCOS groups, and find the correlation between the metabolic profile of the follicular fluid of PCOS patients and the oocyte quality, IVF outcome and subsequent embryo development are also under investigation. Metabolomics analysis was applied to look for markers of follicular fluid in PCOS patients, and further exploring data and strategies to improve the embryonic development potential and IVF outcome of PCOS patients.
Official Title
-----------------
The Correlation Between Follicular Fluid Raman Spectrum and Embryo Development in Infertile Patients With Polycystic Ovary Syndrome
Conditions
-----------------
IVF, Polycystic Ovary Syndrome
Intervention / Treatment
-----------------
* Diagnostic Test: Raman spectrum
Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Patients fit the Rotterdam criteria for PCOS Patients under IVF cycles Exclusion Criteria: Patients with male factors infertility Patients with fallopian tube factors infertility
Sexes Eligible for Study
-----------------
Female
Accepts Healthy Volunteers
-----------------
Accepts Healthy Volunteers
Study Plan
=================
How is the study designed?
-----------------
Design Details
Primary Purpose: Screening
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Arms and Interventions
| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Other: PCOS follicular fluid<br> | Diagnostic Test: Raman spectrum<br>* The wavelength of the follicular fluids were scaned by Raman spectrum<br>|
What is the study measuring?
-----------------
Primary Outcome Measures
| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Difference between polycystic ovary syndrome and normal follicular fluids | Raman spectrum was applied and the Raman spectrum characteristic absorption peak can be revealed. PCA analysis was used to measure the degree of differential shifts. | 24 months |
|
|||
NCT03752736
|
Sun Safety Skills for Elementary School Students
|
The overarching goal of this work is to pilot-test a song-based instructional video designed to help elementary school (kindergarten) age children independently apply sunscreen effectively (i.e., covers all needed areas), efficiently (i.e., can be accomplished in 2-3 minutes), consistently (i.e., continues to apply sunscreen routinely before recess both during and after the intervention), without impacting classroom function (i.e., no mess). The video is also designed to encourage use of hats and sunglasses. The outcomes of interest include identification of gaps in skills that are consistent for this age group (i.e., commonly miss application to the back of neck), areas of learning refinement (i.e., generalization of skills with different outfits on), and flexibility in terms of adapting practice (i.e., can they do it without the video). The investigators hope that this pilot project will pave the way for broader clinical / educational implementation of this intervention within schools.
|
The investigators will use an unblinded, open label, A-B design with a randomized follow-up period to evaluate the study objectives. The primary aim is to characterize the proportion of students (per class and total, or across classes) who productively engage in the in-classroom sunscreen application tasks when using the video guided sunscreen intervention (i.e., success is defined as any appropriate participation with video guided tasks, completing tasks and putting sunscreen away, sitting down by end of 2 minute, 42 second video intervention) relative to the proportion who achieve success (i.e., any appropriate effort to apply sunscreen, put away sunscreen and sit down within a two minute window) WITHOUT use of the video.~One hundred eight kindergarten students across four kindergarten classrooms (N = 27 per class) will complete a two-week baseline period in which the participants are provide a 2-minute window and allowed access to their sunscreen without instruction. Classroom teachers, trained to score our primary outcome (child does/does not complete this task within two-minute window), will evaluate outcomes for each child daily for two weeks (baseline period). Percentage of students who are able to complete this task is our primary endpoint. Change trajectories from beginning to end of the baseline period (Time 1/Day 1 - Time 2/Day 10) and from the beginning to end of treatment (Time 2 - Time 3) will be calculated for each class. The average percentage of the second week in the baseline period and the second week in the intervention period will be used to calculate the successful rate for each period with 95% confidence intervals.~To address a subsidiary aim, related to whether or not student competence with sunscreen application (systematic, % of body covered / body parts neglected, and completeness of coverage of face) is impacted by the video intervention, a randomly selected subset of students will be evaluated by a trained member of the study team for competence of application at Time 1,2, 3 and 4. Changes trajectories will be calculated by class for this subset of students.~At the study outset, all four classrooms will be randomized to either an extended intervention (EI) or maintenance (M) condition using a 1:1 randomization scheme. This will offer some descriptive, feasibility data regarding the tolerability of randomization by classroom, and a preliminary look at dose-response trends and short-term maintenance effects. Upon completion of the two-week baseline period and two-week standard intervention period, the two classrooms assigned to the EI condition will receive the video-based intervention for two additional weeks and the two classrooms assigned to the M condition will continue to receive a two- minute window for sunscreen application, but no video-based instruction. Change trajectories from Time 3-Time 4 (two-week follow up) will be compared by follow-up assignment condition and will provide preliminary information about dosing and maintenance effects.~Student, teacher, parent and administrator perceptions of the acceptability, value and utility of the intervention will be assessed at a single time point at the conclusion of the study.~Study Setting and Participants:~General Education Kindergarten students who meet all study eligibility requirements (i.e., including health requirements appropriate to the use of sunscreen) and who assent to participate and who receive parental consent to participate at Sedgwick Elementary School will be included in the present study. Special education students who are mainstreamed may also be considered eligible to participate via consensus from both parent and teacher.~Recruitment and screening: Recruitment efforts will include collaborative (research team + kinder teachers) efforts to provide parents an overview of the study goals and objectives, and to obtain consent/assent. The investigators will plan to have a parent-focused meeting in the weeks prior to the commencement of the study.~Intervention: The song-based video guided sun screen intervention is 2-3 minutes long, with 30 seconds allotted at the beginning for students to prepare their sunscreen materials and get ready, two minutes of instruction that guides their application of sunscreen to all exposed areas of skin starting with their head and working systematically down to their feet, and then 30 seconds of guided instruction for putting the sunscreen materials away and sitting back down at their desks.
|
Sun Safety Skills for Elementary School Students
|
Sunburn, Skin Cancer Prevention
|
* Behavioral: I wear sunscreen everyday song-based video
|
Inclusion Criteria:~General education Kinder students (Sedgwick Elementary School in 2018-2019).~Child assent and parental consent are required to participate.~Exclusion Criteria:~Non-general education status;~significant medical, mental health and/or behavioral problem~child refusal of assent or parental refusal of consent;~known or identified allergy to ingredients in sunscreen;~moving out of the grade or school during the intervention or follow-up period;~participation in a concurrent sunscreen intervention protocol are exclusionary criteria.
|
5 Years
|
7 Years
|
All
|
Accepts Healthy Volunteers
|
Primary Purpose: Prevention
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
|
| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Teacher Ratings of Kinder Students' Successful/Not Successful Self-Application of Sunscreen. | Change in the proportion of kindergarten students who successfully complete independent self-application of sunscreen within the allotted 2.5 minute time window from baseline (Time 1) to posttreatment (Time 2). Successful completion of the sun screen task (i.e., Kinder Students' self-application of sunscreen within the 2.5 minute window allotted by the intervention) will be determined via direct observation by the classroom teacher. Teachers will be formally trained by the study staff to rate student performance (i.e., successful/not successful) with self-application of sunscreen per a manualized study protocol. | Baseline to Posttreatment (Time 1 - Time 2; each Time is up to 15 minutes and separated by 2 weeks) |
|
| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Teacher Identified Barriers to Kinder Student Self-Application of Sunscreen | Teacher identified barriers, or the cognitive, emotional, behavioral, environmental, factors that interfered with a student's successful completion of the self-application of sunscreen task will be recorded by the classroom teacher daily during the sunscreen intervention. This descriptive outcome will be qualitative (i.e., teacher generated list). | Baseline to Posttreatment (Time 1 - Time 2; each Time is up to 15 minutes and separated by 2 weeks) |
| Teacher, parent and administrator perceptions of intervention utility. | Teacher, parents and administrators respond to a single item question, In your opinion, how useful was this intervention in terms of getting students engaged in sun protective behavior? This single item is modeled after utility questions used in health services research and educational research, and will be scored on an 11-point likert type scale, where 0 indicates not at all useful; and 10 indicates very useful. | Posttreatment (Time 2; up to 15 minutes) |
| Teacher, parent and administrator perceptions of intervention value. | Teacher, parents and administrators respond to a single item question In your opinion, how valuable was this intervention to your overall curriculum? This single item is modeled after value questions used in health services and educational research and will be Responses will be scored on an 11-point likert type scale, where a score of 0 indicates not at all valuable and a score of 10 indicates very valuable. | Posttreatment (Time 2; up to 15 minutes) |
| Student perceptions of intervention likability | Kinder students respond to a single item question Did you like the sunscreen video? As Kinder students are not proficient readers, this question will be read aloud to the class, and students will respond individually by casting a secret ballot in a voting booth set up in the classroom- -under the direct supervision of the study staff. Yes votes will be cast using a piece of paper with a happy face on it; no votes will be cast using a piece of paper with a sad face on it. In this way, students can respond individually to this question without having to read, tell their answer to the teacher, and without undue influence of their peers. Results will be tallied by class. | Posttreatment (Time 2; up to 15 minutes) |
|
Sunscreen, Sun protection, Education, skin cancer, school-aged children, prevention
|
Sunscreening Agents, Radiation-Protective Agents, Protective Agents, Physiological Effects of Drugs, Dermatologic Agents
|
| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: Extended intervention<br>Upon completion of the two-week baseline period and two-week standard intervention period, the two classrooms assigned to the Extended intervention condition will receive the I wear sunscreen everyday song-based video intervention daily for two additional weeks. | Behavioral: I wear sunscreen everyday song-based video<br>* All four classes (arms) will be shown (sitting on carpet, not participating) a 2-3 minute song-based video titled I wear sunscreen everyday in which they observe elementary age children applying sunscreen in a systematic fashion. Following the viewing, classes will be administered this video guided, song- based intervention while their teacher documents their independent participation using our classroom map data collection sheet.<br>|
| No Intervention: Maintenance<br>The two classrooms assigned to the Maintenance condition will continue to receive a two- minute window for sunscreen application, but no I wear sunscreen everyday song-based video instruction.~Change trajectories from Time 3-Time 4 (two-week follow up) will be compared by follow-up assignment condition and will provide preliminary information about dosing and maintenance effects. | |
|
Sun Safety Skills for Elementary School Students
Study Overview
=================
Brief Summary
-----------------
The overarching goal of this work is to pilot-test a song-based instructional video designed to help elementary school (kindergarten) age children independently apply sunscreen effectively (i.e., covers all needed areas), efficiently (i.e., can be accomplished in 2-3 minutes), consistently (i.e., continues to apply sunscreen routinely before recess both during and after the intervention), without impacting classroom function (i.e., no mess). The video is also designed to encourage use of hats and sunglasses. The outcomes of interest include identification of gaps in skills that are consistent for this age group (i.e., commonly miss application to the back of neck), areas of learning refinement (i.e., generalization of skills with different outfits on), and flexibility in terms of adapting practice (i.e., can they do it without the video). The investigators hope that this pilot project will pave the way for broader clinical / educational implementation of this intervention within schools.
Detailed Description
-----------------
The investigators will use an unblinded, open label, A-B design with a randomized follow-up period to evaluate the study objectives. The primary aim is to characterize the proportion of students (per class and total, or across classes) who productively engage in the in-classroom sunscreen application tasks when using the video guided sunscreen intervention (i.e., success is defined as any appropriate participation with video guided tasks, completing tasks and putting sunscreen away, sitting down by end of 2 minute, 42 second video intervention) relative to the proportion who achieve success (i.e., any appropriate effort to apply sunscreen, put away sunscreen and sit down within a two minute window) WITHOUT use of the video. One hundred eight kindergarten students across four kindergarten classrooms (N = 27 per class) will complete a two-week baseline period in which the participants are provide a 2-minute window and allowed access to their sunscreen without instruction. Classroom teachers, trained to score our primary outcome (child does/does not complete this task within two-minute window), will evaluate outcomes for each child daily for two weeks (baseline period). Percentage of students who are able to complete this task is our primary endpoint. Change trajectories from beginning to end of the baseline period (Time 1/Day 1 - Time 2/Day 10) and from the beginning to end of treatment (Time 2 - Time 3) will be calculated for each class. The average percentage of the second week in the baseline period and the second week in the intervention period will be used to calculate the successful rate for each period with 95% confidence intervals. To address a subsidiary aim, related to whether or not student competence with sunscreen application (systematic, % of body covered / body parts neglected, and completeness of coverage of face) is impacted by the video intervention, a randomly selected subset of students will be evaluated by a trained member of the study team for competence of application at Time 1,2, 3 and 4. Changes trajectories will be calculated by class for this subset of students. At the study outset, all four classrooms will be randomized to either an extended intervention (EI) or maintenance (M) condition using a 1:1 randomization scheme. This will offer some descriptive, feasibility data regarding the tolerability of randomization by classroom, and a preliminary look at dose-response trends and short-term maintenance effects. Upon completion of the two-week baseline period and two-week standard intervention period, the two classrooms assigned to the EI condition will receive the video-based intervention for two additional weeks and the two classrooms assigned to the M condition will continue to receive a two- minute window for sunscreen application, but no video-based instruction. Change trajectories from Time 3-Time 4 (two-week follow up) will be compared by follow-up assignment condition and will provide preliminary information about dosing and maintenance effects. Student, teacher, parent and administrator perceptions of the acceptability, value and utility of the intervention will be assessed at a single time point at the conclusion of the study. Study Setting and Participants: General Education Kindergarten students who meet all study eligibility requirements (i.e., including health requirements appropriate to the use of sunscreen) and who assent to participate and who receive parental consent to participate at Sedgwick Elementary School will be included in the present study. Special education students who are mainstreamed may also be considered eligible to participate via consensus from both parent and teacher. Recruitment and screening: Recruitment efforts will include collaborative (research team + kinder teachers) efforts to provide parents an overview of the study goals and objectives, and to obtain consent/assent. The investigators will plan to have a parent-focused meeting in the weeks prior to the commencement of the study. Intervention: The song-based video guided sun screen intervention is 2-3 minutes long, with 30 seconds allotted at the beginning for students to prepare their sunscreen materials and get ready, two minutes of instruction that guides their application of sunscreen to all exposed areas of skin starting with their head and working systematically down to their feet, and then 30 seconds of guided instruction for putting the sunscreen materials away and sitting back down at their desks.
Official Title
-----------------
Sun Safety Skills for Elementary School Students
Conditions
-----------------
Sunburn, Skin Cancer Prevention
Intervention / Treatment
-----------------
* Behavioral: I wear sunscreen everyday song-based video
Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: General education Kinder students (Sedgwick Elementary School in 2018-2019). Child assent and parental consent are required to participate. Exclusion Criteria: Non-general education status; significant medical, mental health and/or behavioral problem child refusal of assent or parental refusal of consent; known or identified allergy to ingredients in sunscreen; moving out of the grade or school during the intervention or follow-up period; participation in a concurrent sunscreen intervention protocol are exclusionary criteria.
Ages Eligible for Study
-----------------
Minimum Age: 5 Years
Maximum Age: 7 Years
Sexes Eligible for Study
-----------------
All
Accepts Healthy Volunteers
-----------------
Accepts Healthy Volunteers
Study Plan
=================
How is the study designed?
-----------------
Design Details
Primary Purpose: Prevention
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Arms and Interventions
| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: Extended intervention<br>Upon completion of the two-week baseline period and two-week standard intervention period, the two classrooms assigned to the Extended intervention condition will receive the I wear sunscreen everyday song-based video intervention daily for two additional weeks. | Behavioral: I wear sunscreen everyday song-based video<br>* All four classes (arms) will be shown (sitting on carpet, not participating) a 2-3 minute song-based video titled I wear sunscreen everyday in which they observe elementary age children applying sunscreen in a systematic fashion. Following the viewing, classes will be administered this video guided, song- based intervention while their teacher documents their independent participation using our classroom map data collection sheet.<br>|
| No Intervention: Maintenance<br>The two classrooms assigned to the Maintenance condition will continue to receive a two- minute window for sunscreen application, but no I wear sunscreen everyday song-based video instruction. Change trajectories from Time 3-Time 4 (two-week follow up) will be compared by follow-up assignment condition and will provide preliminary information about dosing and maintenance effects. | |
What is the study measuring?
-----------------
Primary Outcome Measures
| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Teacher Ratings of Kinder Students' Successful/Not Successful Self-Application of Sunscreen. | Change in the proportion of kindergarten students who successfully complete independent self-application of sunscreen within the allotted 2.5 minute time window from baseline (Time 1) to posttreatment (Time 2). Successful completion of the sun screen task (i.e., Kinder Students' self-application of sunscreen within the 2.5 minute window allotted by the intervention) will be determined via direct observation by the classroom teacher. Teachers will be formally trained by the study staff to rate student performance (i.e., successful/not successful) with self-application of sunscreen per a manualized study protocol. | Baseline to Posttreatment (Time 1 - Time 2; each Time is up to 15 minutes and separated by 2 weeks) |
Secondary Outcome Measures
| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Teacher Identified Barriers to Kinder Student Self-Application of Sunscreen | Teacher identified barriers, or the cognitive, emotional, behavioral, environmental, factors that interfered with a student's successful completion of the self-application of sunscreen task will be recorded by the classroom teacher daily during the sunscreen intervention. This descriptive outcome will be qualitative (i.e., teacher generated list). | Baseline to Posttreatment (Time 1 - Time 2; each Time is up to 15 minutes and separated by 2 weeks) |
| Teacher, parent and administrator perceptions of intervention utility. | Teacher, parents and administrators respond to a single item question, In your opinion, how useful was this intervention in terms of getting students engaged in sun protective behavior? This single item is modeled after utility questions used in health services research and educational research, and will be scored on an 11-point likert type scale, where 0 indicates not at all useful; and 10 indicates very useful. | Posttreatment (Time 2; up to 15 minutes) |
| Teacher, parent and administrator perceptions of intervention value. | Teacher, parents and administrators respond to a single item question In your opinion, how valuable was this intervention to your overall curriculum? This single item is modeled after value questions used in health services and educational research and will be Responses will be scored on an 11-point likert type scale, where a score of 0 indicates not at all valuable and a score of 10 indicates very valuable. | Posttreatment (Time 2; up to 15 minutes) |
| Student perceptions of intervention likability | Kinder students respond to a single item question Did you like the sunscreen video? As Kinder students are not proficient readers, this question will be read aloud to the class, and students will respond individually by casting a secret ballot in a voting booth set up in the classroom- -under the direct supervision of the study staff. Yes votes will be cast using a piece of paper with a happy face on it; no votes will be cast using a piece of paper with a sad face on it. In this way, students can respond individually to this question without having to read, tell their answer to the teacher, and without undue influence of their peers. Results will be tallied by class. | Posttreatment (Time 2; up to 15 minutes) |
Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Sunscreen, Sun protection, Education, skin cancer, school-aged children, prevention
|
NCT03506490
|
Acute Effects of Aerobic Exercise on Motor Memory Consolidation in Older People
|
Scientific evidence suggests that an aerobic exercise session promotes improvements in the consolidation of motor memory in adults. In this sense, the main purpose of this study was to investigate if an aerobic training session could improve motor memory consolidation in older people.
|
The participants of this study were 33 subjects of both genders (M = 68 years old; SD = 4.2 years old) and were divided in two groups: a control group (N = 15; M = 67, 6 years old; SD = 4.1 years old) and an experimental group (N = 18; M = 67, 4 years old; SD = 4.4 years old). The participants performed a Soda Pop test before the aerobic training session (Baseline). The training session lasted 45 minutes and was composed of running exercises. After the training session, the motor memory consolidation was held in three different stages: Training; 1 hour after training; 24 hours after training.
|
Acute Effects of Aerobic Exercise on Motor Memory Consolidation in Older People
|
Elderly
|
* Other: Aerobic exercises
|
Inclusion Criteria:~-~Exclusion Criteria:~sensory abnormalities;~mental abnormalities;~motor abnormalities;~other atypical health problems.
|
65 Years
| null |
All
|
Accepts Healthy Volunteers
|
Primary Purpose: Prevention
Intervention Model: Single Group Assignment
Masking: None (Open Label)
|
| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| The participants performed a Soda Pop test before the aerobic training session (Baseline). | The participants performed a Soda Pop test before the aerobic training session (Baseline). | The participants performed a Soda Pop test before the aerobic training session (Baseline). |
|
| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Experimental<br>The participants of this study were 33 subjects of both genders (M = 68 years old; SD = 4.2 years old) and were divided in two groups: a control group (N = 15; M = 67, 6 years old; SD = 4.1 years old) and an experimental group (N = 18; M = 67, 4 years old; SD = 4.4 years old). The participants performed a Soda Pop test before the aerobic training session (Baseline). The training session lasted 45 minutes and was composed of running exercises. After the training session, the motor memory consolidation was held in three different stages: Training; 1 hour after training; 24 hours after training. | Other: Aerobic exercises<br>* The training session lasted 45 minutes and was composed of running exercises.<br>|
|
Acute Effects of Aerobic Exercise on Motor Memory Consolidation in Older People
Study Overview
=================
Brief Summary
-----------------
Scientific evidence suggests that an aerobic exercise session promotes improvements in the consolidation of motor memory in adults. In this sense, the main purpose of this study was to investigate if an aerobic training session could improve motor memory consolidation in older people.
Detailed Description
-----------------
The participants of this study were 33 subjects of both genders (M = 68 years old; SD = 4.2 years old) and were divided in two groups: a control group (N = 15; M = 67, 6 years old; SD = 4.1 years old) and an experimental group (N = 18; M = 67, 4 years old; SD = 4.4 years old). The participants performed a Soda Pop test before the aerobic training session (Baseline). The training session lasted 45 minutes and was composed of running exercises. After the training session, the motor memory consolidation was held in three different stages: Training; 1 hour after training; 24 hours after training.
Official Title
-----------------
Acute Effects of Aerobic Exercise on Motor Memory Consolidation in Older People
Conditions
-----------------
Elderly
Intervention / Treatment
-----------------
* Other: Aerobic exercises
Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: - Exclusion Criteria: sensory abnormalities; mental abnormalities; motor abnormalities; other atypical health problems.
Ages Eligible for Study
-----------------
Minimum Age: 65 Years
Sexes Eligible for Study
-----------------
All
Accepts Healthy Volunteers
-----------------
Accepts Healthy Volunteers
Study Plan
=================
How is the study designed?
-----------------
Design Details
Primary Purpose: Prevention
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Arms and Interventions
| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Experimental<br>The participants of this study were 33 subjects of both genders (M = 68 years old; SD = 4.2 years old) and were divided in two groups: a control group (N = 15; M = 67, 6 years old; SD = 4.1 years old) and an experimental group (N = 18; M = 67, 4 years old; SD = 4.4 years old). The participants performed a Soda Pop test before the aerobic training session (Baseline). The training session lasted 45 minutes and was composed of running exercises. After the training session, the motor memory consolidation was held in three different stages: Training; 1 hour after training; 24 hours after training. | Other: Aerobic exercises<br>* The training session lasted 45 minutes and was composed of running exercises.<br>|
What is the study measuring?
-----------------
Primary Outcome Measures
| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| The participants performed a Soda Pop test before the aerobic training session (Baseline). | The participants performed a Soda Pop test before the aerobic training session (Baseline). | The participants performed a Soda Pop test before the aerobic training session (Baseline). |
|
|||
NCT05125055
|
Neoadjuvant Anti-PD-1 and TP Versus TPF on Pathological Response in OSCC
|
To compare the pathological efficacy of neoadjuvant Toripalimab and Albumin paclitaxel /Cisplatin (TTP) with Docetaxel/ Cisplatin/ 5-flurouracil (TPF) for patients with locally advanced resectable oral squamous cell carcinoma (OSCC), and to determine the safety of neoadjuvant TTP. In order to explore a better protocol of neoadjuvant therapy to improve the efficacy in patients with locally advanced OSCC.
|
In the previous Illuminate trial, neoadjuvant anti-programmed death-1 (PD-1) of Toripalimab and Albumin paclitaxel /Cisplatin (TTP) therapy was used in 20 patients with locally advanced and resectable oral squamous cell carcinoma (OSCC), and the neoadjuvant therapy was well-tolerated. The major pathologic response (MPR) rate was 60% (12/20), including 30% (6/20) pathological complete response (pCR). Furthermore, the MPR might transfer to survival benefit in the patients received neoadjuvant therapy. Therefore, in this randomized trial, we aimed to compare the pathological response of neoadjuvant TTP therapy versus TPF chemotherapy in the patients with locally advanced OSCC (Illuminate-2 trial). A total of 80 patients will be enrolled in this trial, and the primary endpoint is MPR rate. The neoadjuvant TTP arm will receive two cycles of intravenous Albumin paclitaxel (260mg/ m^2), Cisplatin (75mg/ m^2) and Toripalimab (anti-PD1 inhibitor, 240 mg) on d1 and d22, followed by the standard treatment of surgery and postoperative adjuvant therapy. The neoadjuvant TPF arm will received two cycles of intravenous Docetaxel (75mg/m^2), Cisplatin (75mg/m^2) on d1 (d22), and 5-Fu(750mg/m^2/day) for 5 days (d1-5 and d22-26), followed by the standard treatment of surgery and postoperative adjuvant therapy.
|
Neoadjuvant Toripalimab and Albumin Paclitaxel /Cisplatin Versus Docetaxel/ Cisplatin/ 5-fluorouracil (TPF) on Pathological Response in Patients With Locally Advanced and Resectable Oral Squamous Cell Carcinoma
|
Oral Squamous Cell Carcinoma, Neoadjvant Therapy, Anti-PD-1, Chemotherapy
|
* Drug: Toripalimab (anti-programmed death-1 inhibitor)
* Drug: Albumin paclitaxel
* Drug: Cisplatin
* Drug: Docetaxel
* Drug: 5-Fluorouracil
|
Inclusion Criteria:~Age: 18-75 years old~Gender: male and female~Eastern Cooperative Oncology Group (ECOG) performance status (PS): 0-2~Histopathological diagnosis of oral squamous cell carcinoma (including tongue, gums, cheek, floor of mouth, hard palate, and posterior molar region)~Primary tumor with a clinical stage of III/IVA (T1-2/N1-2/M0 or T3-4a/cN0-2/M0, AJCC2018)~Patients must have at least one measurable lesion according to the Response Evaluation Criteria in Solid Tumors (RECIST v1.1)~Blood routine: white blood cells (WBCs) >3,000/mm3, hemoglobin >8 g/L, platelets >80,000/mm3~Liver function: alanine amino transferase/aspartate amino transferase (ALAT/ASAT) <2.5 times the upper limit of normal and bilirubin <1.5 times the upper limit of normal~Renal function: Serum creatinine <1.5 times the upper limit of normal~Coagulation function: INR, PT, APTT<1.5 times the upper limit of normal~Signed the informed consent form~Exclusion Criteria:~Unresolved grade 2 [(Common Terminology Criteria for Adverse Events (CTCAE 5.0)] or higher toxic reactions caused by previous anticancer treatments~Known allergic reaction to any ingredients or excipients of the therapy~Known history of malignancy, unless been cured and no recurrence for 5 years~Known history of radiation to head and neck~Active severe clinical infection (> National Cancer Institute (NCI)-CTCAE version 5.0 grade 2 infection)~Obvious cardiovascular abnormalities [such as myocardial infarction, superior vena cava syndrome, grade 2 or higher heart disease diagnosed according to the New York Heart Association (NYHA) classification 3 months before enrollment]~Patients receiving immunology-based treatment for any reason~Patients with a history of active bleeding, coagulopathy, or receiving coumarin anticoagulation therapy~Pregnant or lactating women~Uncontrollable hypertension (systolic blood pressure >150 mmHg and/or diastolic blood pressure >90 mmHg) or cardiovascular diseases with clinical significance (such as activity), such as cerebrovascular accidents (≤ 6 months before screening), myocardial infarction (≤6 months before screening), unstable angina pectoris, NYHA grade II or above congestive heart failure, or severe arrhythmia that cannot be controlled by drugs or has a potential impact on trial treatment~Complicated with severe, uncontrolled infection or known human immunodeficiency virus (HIV) infection, or diagnosed as acquired immunodeficiency syndrome (AIDS); or uncontrolled autoimmune disease; or history of allogeneic tissue/organ transplantation, stem cell or bone marrow transplantation, or solid organ transplantation~Participation in other clinical trials within 30 days before enrollment~Other situations that the investigator considers unsuitable with respect to participating in the trial
|
18 Years
|
75 Years
|
All
|
No
|
Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
|
| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Major pathologic response | The major pathologic response (MPR): the percentage of tumor cells before and after treatment was compared according to biopsy specimens before neoadjuvant therapy and pathological specimens after surgery; the percentage of residual viable tumor (RVT) cells was evaluated on resected tumor slides. MPR was defined as ≤ 10% RVT%. | 3 months |
|
| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 2-year disease-free survival rate | Disease-free survival was calculated from the date of randomization to tumor recurrence or death from any cause. | 24 months |
| 2-year overall survival rate | Overall survival was calculated from the date of randomization to death from any cause. | 24 months |
|
Tubulin Modulators, Antimitotic Agents, Mitosis Modulators, Molecular Mechanisms of Pharmacological Action, Antimetabolites, Antimetabolites, Antineoplastic, Immunosuppressive Agents, Immunologic Factors, Physiological Effects of Drugs, Antineoplastic Agents, Phytogenic, Antineoplastic Agents, Paclitaxel, Docetaxel, Fluorouracil
|
| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Neoadjuvant TTP<br>The participants will receive two cycles of intravenous Albumin paclitaxel (260mg/ m^2), Cisplatin (75mg/ m^2) and Toripalimab (anti-PD-1 inhibitor, 240 mg) on d1 and d22. | Drug: Toripalimab (anti-programmed death-1 inhibitor)<br>* The participants will receive two cycles of Toripalimab, with 21 days each. 240mg of Toripalimab will be used intravenously on the first day of each cycle.<br>Drug: Albumin paclitaxel<br>* The participants will receive two cycles of Albumin paclitaxel, with 21 days each. 260mg/m^2 of Albumin paclitaxel will be used intravenously on the first day of each cycle.<br>Drug: Cisplatin<br>* The participants will receive two cycles of Cisplatin, with 21 days each. 75mg/m^2 of Cisplatin will be used intravenously on the first day of each cycle.<br>|
| Active Comparator: Neoadjuvant TPF<br>The participants will receive two cycles of intravenous Docetaxel (75 mg/m^2) on d1 and d22, Cisplatin (75 mg/m^2) on d1 and d22, and 5-Fluorouracil (750 mg/m^2/day) for 5 days (d1-5 and d22-26), the interval is 16±1 days. | Drug: Cisplatin<br>* The participants will receive two cycles of Cisplatin, with 21 days each. 75mg/m^2 of Cisplatin will be used intravenously on the first day of each cycle.<br>Drug: Docetaxel<br>* The participants will receive two cycles of Docetaxel, with 21 days each. 75mg/m^2 of Docetaxel will be used intravenously on the first day of each cycle.<br>Drug: 5-Fluorouracil<br>* The participants will receive two cycles of 5-Fluorouracil, with 21 days each. 750mg/m^2/d of 5-Fluorouracil will be used as a 120-hour continuous intravenous infusion on days 1 through 5.<br>|
|
Neoadjuvant Anti-PD-1 and TP Versus TPF on Pathological Response in OSCC
Study Overview
=================
Brief Summary
-----------------
To compare the pathological efficacy of neoadjuvant Toripalimab and Albumin paclitaxel /Cisplatin (TTP) with Docetaxel/ Cisplatin/ 5-flurouracil (TPF) for patients with locally advanced resectable oral squamous cell carcinoma (OSCC), and to determine the safety of neoadjuvant TTP. In order to explore a better protocol of neoadjuvant therapy to improve the efficacy in patients with locally advanced OSCC.
Detailed Description
-----------------
In the previous Illuminate trial, neoadjuvant anti-programmed death-1 (PD-1) of Toripalimab and Albumin paclitaxel /Cisplatin (TTP) therapy was used in 20 patients with locally advanced and resectable oral squamous cell carcinoma (OSCC), and the neoadjuvant therapy was well-tolerated. The major pathologic response (MPR) rate was 60% (12/20), including 30% (6/20) pathological complete response (pCR). Furthermore, the MPR might transfer to survival benefit in the patients received neoadjuvant therapy. Therefore, in this randomized trial, we aimed to compare the pathological response of neoadjuvant TTP therapy versus TPF chemotherapy in the patients with locally advanced OSCC (Illuminate-2 trial). A total of 80 patients will be enrolled in this trial, and the primary endpoint is MPR rate. The neoadjuvant TTP arm will receive two cycles of intravenous Albumin paclitaxel (260mg/ m^2), Cisplatin (75mg/ m^2) and Toripalimab (anti-PD1 inhibitor, 240 mg) on d1 and d22, followed by the standard treatment of surgery and postoperative adjuvant therapy. The neoadjuvant TPF arm will received two cycles of intravenous Docetaxel (75mg/m^2), Cisplatin (75mg/m^2) on d1 (d22), and 5-Fu(750mg/m^2/day) for 5 days (d1-5 and d22-26), followed by the standard treatment of surgery and postoperative adjuvant therapy.
Official Title
-----------------
Neoadjuvant Toripalimab and Albumin Paclitaxel /Cisplatin Versus Docetaxel/ Cisplatin/ 5-fluorouracil (TPF) on Pathological Response in Patients With Locally Advanced and Resectable Oral Squamous Cell Carcinoma
Conditions
-----------------
Oral Squamous Cell Carcinoma, Neoadjvant Therapy, Anti-PD-1, Chemotherapy
Intervention / Treatment
-----------------
* Drug: Toripalimab (anti-programmed death-1 inhibitor)
* Drug: Albumin paclitaxel
* Drug: Cisplatin
* Drug: Docetaxel
* Drug: 5-Fluorouracil
Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Age: 18-75 years old Gender: male and female Eastern Cooperative Oncology Group (ECOG) performance status (PS): 0-2 Histopathological diagnosis of oral squamous cell carcinoma (including tongue, gums, cheek, floor of mouth, hard palate, and posterior molar region) Primary tumor with a clinical stage of III/IVA (T1-2/N1-2/M0 or T3-4a/cN0-2/M0, AJCC2018) Patients must have at least one measurable lesion according to the Response Evaluation Criteria in Solid Tumors (RECIST v1.1) Blood routine: white blood cells (WBCs) >3,000/mm3, hemoglobin >8 g/L, platelets >80,000/mm3 Liver function: alanine amino transferase/aspartate amino transferase (ALAT/ASAT) <2.5 times the upper limit of normal and bilirubin <1.5 times the upper limit of normal Renal function: Serum creatinine <1.5 times the upper limit of normal Coagulation function: INR, PT, APTT<1.5 times the upper limit of normal Signed the informed consent form Exclusion Criteria: Unresolved grade 2 [(Common Terminology Criteria for Adverse Events (CTCAE 5.0)] or higher toxic reactions caused by previous anticancer treatments Known allergic reaction to any ingredients or excipients of the therapy Known history of malignancy, unless been cured and no recurrence for 5 years Known history of radiation to head and neck Active severe clinical infection (> National Cancer Institute (NCI)-CTCAE version 5.0 grade 2 infection) Obvious cardiovascular abnormalities [such as myocardial infarction, superior vena cava syndrome, grade 2 or higher heart disease diagnosed according to the New York Heart Association (NYHA) classification 3 months before enrollment] Patients receiving immunology-based treatment for any reason Patients with a history of active bleeding, coagulopathy, or receiving coumarin anticoagulation therapy Pregnant or lactating women Uncontrollable hypertension (systolic blood pressure >150 mmHg and/or diastolic blood pressure >90 mmHg) or cardiovascular diseases with clinical significance (such as activity), such as cerebrovascular accidents (≤ 6 months before screening), myocardial infarction (≤6 months before screening), unstable angina pectoris, NYHA grade II or above congestive heart failure, or severe arrhythmia that cannot be controlled by drugs or has a potential impact on trial treatment Complicated with severe, uncontrolled infection or known human immunodeficiency virus (HIV) infection, or diagnosed as acquired immunodeficiency syndrome (AIDS); or uncontrolled autoimmune disease; or history of allogeneic tissue/organ transplantation, stem cell or bone marrow transplantation, or solid organ transplantation Participation in other clinical trials within 30 days before enrollment Other situations that the investigator considers unsuitable with respect to participating in the trial
Ages Eligible for Study
-----------------
Minimum Age: 18 Years
Maximum Age: 75 Years
Sexes Eligible for Study
-----------------
All
Accepts Healthy Volunteers
-----------------
No
Study Plan
=================
How is the study designed?
-----------------
Design Details
Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Arms and Interventions
| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Neoadjuvant TTP<br>The participants will receive two cycles of intravenous Albumin paclitaxel (260mg/ m^2), Cisplatin (75mg/ m^2) and Toripalimab (anti-PD-1 inhibitor, 240 mg) on d1 and d22. | Drug: Toripalimab (anti-programmed death-1 inhibitor)<br>* The participants will receive two cycles of Toripalimab, with 21 days each. 240mg of Toripalimab will be used intravenously on the first day of each cycle.<br>Drug: Albumin paclitaxel<br>* The participants will receive two cycles of Albumin paclitaxel, with 21 days each. 260mg/m^2 of Albumin paclitaxel will be used intravenously on the first day of each cycle.<br>Drug: Cisplatin<br>* The participants will receive two cycles of Cisplatin, with 21 days each. 75mg/m^2 of Cisplatin will be used intravenously on the first day of each cycle.<br>|
| Active Comparator: Neoadjuvant TPF<br>The participants will receive two cycles of intravenous Docetaxel (75 mg/m^2) on d1 and d22, Cisplatin (75 mg/m^2) on d1 and d22, and 5-Fluorouracil (750 mg/m^2/day) for 5 days (d1-5 and d22-26), the interval is 16±1 days. | Drug: Cisplatin<br>* The participants will receive two cycles of Cisplatin, with 21 days each. 75mg/m^2 of Cisplatin will be used intravenously on the first day of each cycle.<br>Drug: Docetaxel<br>* The participants will receive two cycles of Docetaxel, with 21 days each. 75mg/m^2 of Docetaxel will be used intravenously on the first day of each cycle.<br>Drug: 5-Fluorouracil<br>* The participants will receive two cycles of 5-Fluorouracil, with 21 days each. 750mg/m^2/d of 5-Fluorouracil will be used as a 120-hour continuous intravenous infusion on days 1 through 5.<br>|
What is the study measuring?
-----------------
Primary Outcome Measures
| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Major pathologic response | The major pathologic response (MPR): the percentage of tumor cells before and after treatment was compared according to biopsy specimens before neoadjuvant therapy and pathological specimens after surgery; the percentage of residual viable tumor (RVT) cells was evaluated on resected tumor slides. MPR was defined as ≤ 10% RVT%. | 3 months |
Secondary Outcome Measures
| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 2-year disease-free survival rate | Disease-free survival was calculated from the date of randomization to tumor recurrence or death from any cause. | 24 months |
| 2-year overall survival rate | Overall survival was calculated from the date of randomization to death from any cause. | 24 months |
|
|
NCT01471002
|
Study to Evaluate the Efficacy of Percutaneous Cryoablation for Renal Tumours < 4cm in Patients Who Are Not Candidates for Partial Nephrectomy
|
The main objective is to evaluate the oncologic efficacy of percutaneous cryoablation of renal tumors smaller than 4 cm in patients with renal cancer that cannot be offered a partial nephrectomy. The oncologic outcome will be assessed by the presence or absence of residue or recurrence during a follow-up by MRI performed the first 12 months (M1, M3, M6, M12).
|
Prospective Study to Evaluate the Efficacy of Percutaneous Cryoablation for Renal Tumours < 4cm in Patients Who Are Not Candidates for Partial Nephrectomy
|
Renal Tumors Less Than 4 cm
|
* Device: Galil Medical patented 17G Cryoablation Needles
|
Inclusion Criteria:~Patients should have the following characteristics:~About 75 years, or~Whatever the age:~A context of family-type tumor (VHL, hereditary carcinoma, tubulo-papillary ...);~or solitary kidney, when the tumor is not easily accessible for nephron-sparing surgery: Malignant centro-hilar or intra-parenchymal;~or in a local recurrence (single or multiple) after partial nephrectomy (within a limit of 3 tumors to be treated);~or in a subject with impaired renal function and therefore at risk of severe renal insufficiency (risk defined by a creatinine clearance below 30 ml / min by MDRD formula);~and who do not present any contra-indication for cryoablation treatment.~The tumor(s) should meet the following criteria:~Presence of one to three solid tumors of the native renal parenchyma with a largest diameter less than (or equal to) 40 mm, which corresponds to a maximum volume of about 32 cc, as measured by MRI.~A preoperative MRI is essential since this technique presents a higher sensitivity. This control will also give more consistency to the evaluation of the radiological semiology at follow-up.~And its/their location(s) will be accessible to a percutaneous approach.~The search of metastases, including a thoracic CT scan, should be negative.~Exclusion Criter ia:~- Partial nephrectomy feasible in good technical and oncologic conditions in patients under 75 years and in the absence of family tumors.~Contraindication to any form of sedation.~Irreversible coagulopathy~Tumor> 4cm~Contraindication to MRI or gadolinium (proven allergy). NB: Patients with a glomerular filtration rate below 30 ml/min/1, 73 m2 will be injected with a single dose of the macrocyclic gadolinium with the highest thermodynamic stability (Dotarem or Prohance), given the united recommendations of AFSSAPS and EMA (European Medicines Agency) [45]. On the contrary, the linear molecules of gadolinium, due to their lower stability, will be contra-indicated because of the risk of systemic nephrogenic fibrosis (FNS).~Recurrence on the same location after a procedure performed out of the thermoablation protocol.~Biopsy proven benign tumor~Predominantly cystic tumor, defined by a necrotic content constituting over one third of tumor volume~Presence of endo-venous extension, of proven secondary extensions, visceral or in the lymph nodes (especially lung). In this regard, a thoracic CT scan will be routinely required before treatment, according to the recommendations of urological societies.~Psychiatric disorders and adults under guardianship~Pregnancy or breastfeeding~Minor patients~Legal safeguard~Participation in another clinical trial
|
18 Years
| null |
All
|
No
|
Primary Purpose: Treatment
Intervention Model: Single Group Assignment
Masking: None (Open Label)
|
| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Suspicious contrast enhancement and progression in size of the cryolesion detected by MRI | The success of cryoablation will be declared if the control at 1 year shows no suspicious contrast enhancement (the suspicious character is defined by significant contrast uptake (>15%) and heterogeneous or nodular or crescent-shape contrast enhancement) and if the cryolesion is not progressing in size compared to early post-ablation control (M1). | 1 year |
|
Kidney Neoplasms, Urologic Neoplasms, Urogenital Neoplasms, Neoplasms by Site, Neoplasms, Female Urogenital Diseases, Female Urogenital Diseases and Pregnancy Complications, Urogenital Diseases, Kidney Diseases, Urologic Diseases, Male Urogenital Diseases
|
| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Renal cancer without nephrectomy<br>patients with renal cancer that cannot be offered a partial nephrectomy | Device: Galil Medical patented 17G Cryoablation Needles<br> <br> |
|
Study to Evaluate the Efficacy of Percutaneous Cryoablation for Renal Tumours < 4cm in Patients Who Are Not Candidates for Partial Nephrectomy
Study Overview
=================
Brief Summary
-----------------
The main objective is to evaluate the oncologic efficacy of percutaneous cryoablation of renal tumors smaller than 4 cm in patients with renal cancer that cannot be offered a partial nephrectomy. The oncologic outcome will be assessed by the presence or absence of residue or recurrence during a follow-up by MRI performed the first 12 months (M1, M3, M6, M12).
Official Title
-----------------
Prospective Study to Evaluate the Efficacy of Percutaneous Cryoablation for Renal Tumours < 4cm in Patients Who Are Not Candidates for Partial Nephrectomy
Conditions
-----------------
Renal Tumors Less Than 4 cm
Intervention / Treatment
-----------------
* Device: Galil Medical patented 17G Cryoablation Needles
Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Patients should have the following characteristics: About 75 years, or Whatever the age: A context of family-type tumor (VHL, hereditary carcinoma, tubulo-papillary ...); or solitary kidney, when the tumor is not easily accessible for nephron-sparing surgery: Malignant centro-hilar or intra-parenchymal; or in a local recurrence (single or multiple) after partial nephrectomy (within a limit of 3 tumors to be treated); or in a subject with impaired renal function and therefore at risk of severe renal insufficiency (risk defined by a creatinine clearance below 30 ml / min by MDRD formula); and who do not present any contra-indication for cryoablation treatment. The tumor(s) should meet the following criteria: Presence of one to three solid tumors of the native renal parenchyma with a largest diameter less than (or equal to) 40 mm, which corresponds to a maximum volume of about 32 cc, as measured by MRI. A preoperative MRI is essential since this technique presents a higher sensitivity. This control will also give more consistency to the evaluation of the radiological semiology at follow-up. And its/their location(s) will be accessible to a percutaneous approach. The search of metastases, including a thoracic CT scan, should be negative. Exclusion Criter ia: - Partial nephrectomy feasible in good technical and oncologic conditions in patients under 75 years and in the absence of family tumors. Contraindication to any form of sedation. Irreversible coagulopathy Tumor> 4cm Contraindication to MRI or gadolinium (proven allergy). NB: Patients with a glomerular filtration rate below 30 ml/min/1, 73 m2 will be injected with a single dose of the macrocyclic gadolinium with the highest thermodynamic stability (Dotarem or Prohance), given the united recommendations of AFSSAPS and EMA (European Medicines Agency) [45]. On the contrary, the linear molecules of gadolinium, due to their lower stability, will be contra-indicated because of the risk of systemic nephrogenic fibrosis (FNS). Recurrence on the same location after a procedure performed out of the thermoablation protocol. Biopsy proven benign tumor Predominantly cystic tumor, defined by a necrotic content constituting over one third of tumor volume Presence of endo-venous extension, of proven secondary extensions, visceral or in the lymph nodes (especially lung). In this regard, a thoracic CT scan will be routinely required before treatment, according to the recommendations of urological societies. Psychiatric disorders and adults under guardianship Pregnancy or breastfeeding Minor patients Legal safeguard Participation in another clinical trial
Ages Eligible for Study
-----------------
Minimum Age: 18 Years
Sexes Eligible for Study
-----------------
All
Accepts Healthy Volunteers
-----------------
No
Study Plan
=================
How is the study designed?
-----------------
Design Details
Primary Purpose: Treatment
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Arms and Interventions
| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Renal cancer without nephrectomy<br>patients with renal cancer that cannot be offered a partial nephrectomy | Device: Galil Medical patented 17G Cryoablation Needles<br> <br> |
What is the study measuring?
-----------------
Primary Outcome Measures
| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Suspicious contrast enhancement and progression in size of the cryolesion detected by MRI | The success of cryoablation will be declared if the control at 1 year shows no suspicious contrast enhancement (the suspicious character is defined by significant contrast uptake (>15%) and heterogeneous or nodular or crescent-shape contrast enhancement) and if the cryolesion is not progressing in size compared to early post-ablation control (M1). | 1 year |
|
|||
NCT05079958
|
Effects of Cognitive-behavioral Education and Exercise Interventions on Smoking Cessation
|
The purpose of the study is to adopt the Trans-theoretical Model to facilitate step-by-step changes in a patient's smoking behavior and explore the effect of Cognitive-Behavioral Education Course and Exercise Program on Smoking cessation, physical health, and mental health of smokers with CAD.
|
Smoking is a major risk factor of coronary artery disease (CAD) and is responsible for the death of one in three patients with cardiovascular diseases. Smoking cessation is one of the most favorable methods for reducing the risk of cardiovascular diseases; even for patients with a heart disease, quitting smoking can reduce the chance of a relapse of said disease. However, the Health Promotion Administration revealed that among male patients with acute myocardial infarction (AMI), 79.5% had smoked and 35.6% continued to smoke after an episode of AMI. Although previous studies confirmed that health education and exercises can increase smoking cessation rates, patients' lack of motivation to quit smoking has resulted in a failure rate of 65.5%. Therefore, identifying methods to strengthen patients' motivation to quit smoking is a key to successfully achieving smoking cessation.~The purpose of the study is to adopt the Trans-theoretical Model to facilitate step-by-step changes in a patient's smoking behavior and explore the effect of Cognitive-Behavioral Education Course and Exercise Program on Smoking cessation, physical health, and mental health of smokers with CAD. This study is composed of three stages in three years period, recruiting patients (who meet the selection criteria) from the cardiology department of a medical center in northern Taiwan. For the first stage, a cross-sectional method will be employed to investigate the relationship between smoking status and various physiological and psychological indicators in patients with CAD. For the second stage, subjects who are at the smoking cessation stage of precontemplation and contemplation will be recruited.~A quasi-experimental design will be used to determine the effects of a four-week cognitive-behavioral education course related to smoking cessation on the participants' smoking cessation behavior, smoking decision-making, and self-efficacy in smoking cessation. For the third stage, subjects from Stages 1 and 2 who are at the preparation and action stage will be recruited and randomly divided into experimental or control group to identify the effect of a 12-week brisk walking on improving the participants' immediate (short-term), three-month, and six month (long-term) health status. The primary indicator used for health status evaluation is smoking cessation success rate; the secondary indicators used are physiological status (i.e., nicotine addiction, lung carbon monoxide concentration, heart rate variability, and smoking withdrawal syndrome) and psychological status (i.e., depression and resilience). SPSS for Window 24.0 software will be used in statistical analysis. The type one error is 0.05. In inferences analysis, chi-square test, Pearson correlation coefficient, independent t test, one-way ANOVA and post hoc comparison (scheffe) test will be used to examine the variance among groups. Finally, ANCOVA and GEE mode will be used to test the effectiveness of intervention at stage 1 and stage 2, respectively.
|
Effects of Cognitive-behavioral Education and Exercise Interventions on Smoking Cessation and Physical and Mental Health in Patients With Coronary Heart Disease: Application of the Transtheoretical Model
|
Coronary Artery Disease, Smoking Cessation
|
* Behavioral: cognitive-behavioral education
* Behavioral: 12-week brisk walking
|
Inclusion Criteria:~Those who meet the diagnosis and can perform aerobic exercise after being referred by a physician.~Those who have a clear consciousness and have no mental disorders as recorded in medical records or verbally.~Those who can walk on their own.~Participated in the first or second phase of the study and the smoking cessation phase is in the preparation and action phases~Exclusion Criteria:~Irregular heart rhythm.~Install a heart regulator.~Those who already have regular exercise (3 times a week, 20-30 minutes of physical activity each time).
|
20 Years
|
80 Years
|
All
|
No
|
Primary Purpose: Supportive Care
Allocation: Randomized
Intervention Model: Parallel Assignment
Interventional Model Description: For the third stage, subjects will be recruited and randomly divided into experimental or control group to identify the effect of a 12-week brisk walking on improving the participants' immediate (short-term), three-month, and six month (long-term) health status.
Masking: None (Open Label)
|
| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Stage3-The change of smoking cessation success rate | smoking cessation success | 12-weeks, three-month, and six month |
| Stage2-The change of smoking cessation behavior | Only one question, Are you currently considering quitting smoking? The smoking cessation behavior change stage is divided into 5 periods according to the cross-theoretical model, and they are respectively 1. Unintentional period: current smoking, and no smoking cessation will be considered in the next six months. 2. Intent period: currently smoking, but considering quitting in the next six months. 3. Preparation period: currently smoking, and plan to quit smoking within the nearest month. 4. Action period: I have quit smoking, but less than six months. 5. Maintenance period: I have quit smoking for more than six months. | Before, 4-weeks. |
|
| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Stage3-The change of Fagerstrom Test for Nicotine Dependence (FTND) | Used the Fagerstrom Test for Nicotine Dependence (FTND) translated by Health Promotion Administration, Ministry of Health and Welfare. The content of the scale includes six questions. The total score of the scale is 0-10 points. The higher the score, the higher the nicotine dependence index; the lower than 4 points means the degree of addiction is not high. If you are determined to quit smoking, you will be successful; 4-6 is divided into addiction High degree, need to work hard to quit smoking; 7-10 points nicotine addiction is very high, and professionals are needed to help quit smoking | 12-weeks, three-month, and six month |
| Stage3-The change of lung carbon monoxide concentration | physiological status | 12-weeks, three-month, and six month |
| Stage3-The change of heart rate variability | physiological status | 12-weeks, three-month, and six month |
| Stage3-The change of smoking withdrawal syndrome | We used French Minnesota Nicotine Withdrawal Scale, MNWS to assess smoking addiction and withdrawal symptoms. This Includes 1 craving for smoking and 8 withdrawal symptoms (depressed mood; irritability, frustration or anger; anxiety; difficulty concentrating; restlessness; increased appetite; difficulty falling asleep; restless sleep and the urge to smoke). The items are the feelings of those who quit smoking in the past day, and are scored on a scale of 0 to 4. Not at all: 0 points; mild: 1 point; moderate: 2 points; quite severe: 3 points; extremely severe: 4 points. The score includes the smoking craving degree and the eight withdrawal symptoms, which are used to evaluate smoking cessation After the impact, the higher the score, the more severe the withdrawal symptoms. | 12-weeks, three-month, and six month |
| Stage3-The change of the Center for Epidemiological Studies -Depression Scales (CESD-10) | We used the Center for Epidemiological Studies -Depression Scales (CESD-10). There are a total of 10 questions, measuring the frequency of depression symptoms in the subject within a week. Each item is given a score of 0 to 3, with a total score of 0 to 30. The higher the score, the more severe the depression. When the scale score ≥ 10 points, it indicates that there is a tendency to depression. | 12-weeks, three-month, and six month |
| Stage3-The change of Taiwanese Version of the Brief Resilience Scale | We used Taiwanese Version of the Brief Resilience Scale (BRS). The scale has 6 items divided into two dimensions: resilience and succumbing. Questions 1, 3, and 5 are positive questions, the measurement aspect is resilience, questions 2, 4, and 6 are negative questions, and the measurement aspect is yield. The scoring method uses Likert's 5-point scoring method, from 1 to 5 points each representing strongly disagree to strongly agree, and the negative questions are scored in reverse. The BRS score calculation method is to calculate the average of the individual scores of the 6 items. The higher the average, the higher the psychological resilience, and vice versa, the lower the psychological resilience. | 12-weeks, three-month, and six month |
| Stage2- smoking decision-making | This scale was developed by Chia et al (2013). There are 6 questions on the scale, including benefits and costs. The score for the benefit part is 3-15 points, the higher score indicates that smoking is important, which means that smoking can gain benefits, and smoking is actually bad [negative reaction]. The score for the costs part is scored 3-15 points. The higher the score indicates that smoking will pay the price, meaning that it is important not to smoke [positive reaction]. | Before, 4-weeks. |
| Stage2- self-efficacy in smoking cessation | The self-efficacy in smoking cessation developed by Ou, Li and Yan (2000).It was used to evaluate the confidence of the subjects to not smoke in various situations. There are a total of 14 questions on the scale. The Likert four-point calculation is used. The scoring method is used to answer that I will never smoke (4 points), I may not smoke (3 points), I may smoke (2 points), and I will definitely smoke (1 point). The score ranges from 14 to 56 points. The higher the score, the better the self-efficacy of refusal to smoke. | Before, 4-weeks. |
|
Coronary artery disease, Trans-theoretical Model, Smoking cessation
|
Coronary Artery Disease, Myocardial Ischemia, Coronary Disease, Heart Diseases, Cardiovascular Diseases, Arteriosclerosis, Arterial Occlusive Diseases, Vascular Diseases
|
| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Stage2 - cognitive-behavioral education<br>A quasi-experimental design will be used to determine the effects of a four-week cognitive-behavioral education course related to smoking cessation on the participants' smoking cessation behavior, smoking decision-making, and self-efficacy in smoking cessation. | Behavioral: cognitive-behavioral education<br>* four-week cognitive-behavioral education course<br>|
| Experimental: Stage 3- 12-week brisk walking<br>Subjects who are at the preparation and action stage will be recruited and randomly divided into experimental or control group to identify the effect of a 12-week brisk walking on improving the participants' immediate (short-term), three-month, and six month (long-term) health status. | Behavioral: 12-week brisk walking<br>* 12-week brisk walking<br>|
|
Effects of Cognitive-behavioral Education and Exercise Interventions on Smoking Cessation
Study Overview
=================
Brief Summary
-----------------
The purpose of the study is to adopt the Trans-theoretical Model to facilitate step-by-step changes in a patient's smoking behavior and explore the effect of Cognitive-Behavioral Education Course and Exercise Program on Smoking cessation, physical health, and mental health of smokers with CAD.
Detailed Description
-----------------
Smoking is a major risk factor of coronary artery disease (CAD) and is responsible for the death of one in three patients with cardiovascular diseases. Smoking cessation is one of the most favorable methods for reducing the risk of cardiovascular diseases; even for patients with a heart disease, quitting smoking can reduce the chance of a relapse of said disease. However, the Health Promotion Administration revealed that among male patients with acute myocardial infarction (AMI), 79.5% had smoked and 35.6% continued to smoke after an episode of AMI. Although previous studies confirmed that health education and exercises can increase smoking cessation rates, patients' lack of motivation to quit smoking has resulted in a failure rate of 65.5%. Therefore, identifying methods to strengthen patients' motivation to quit smoking is a key to successfully achieving smoking cessation. The purpose of the study is to adopt the Trans-theoretical Model to facilitate step-by-step changes in a patient's smoking behavior and explore the effect of Cognitive-Behavioral Education Course and Exercise Program on Smoking cessation, physical health, and mental health of smokers with CAD. This study is composed of three stages in three years period, recruiting patients (who meet the selection criteria) from the cardiology department of a medical center in northern Taiwan. For the first stage, a cross-sectional method will be employed to investigate the relationship between smoking status and various physiological and psychological indicators in patients with CAD. For the second stage, subjects who are at the smoking cessation stage of precontemplation and contemplation will be recruited. A quasi-experimental design will be used to determine the effects of a four-week cognitive-behavioral education course related to smoking cessation on the participants' smoking cessation behavior, smoking decision-making, and self-efficacy in smoking cessation. For the third stage, subjects from Stages 1 and 2 who are at the preparation and action stage will be recruited and randomly divided into experimental or control group to identify the effect of a 12-week brisk walking on improving the participants' immediate (short-term), three-month, and six month (long-term) health status. The primary indicator used for health status evaluation is smoking cessation success rate; the secondary indicators used are physiological status (i.e., nicotine addiction, lung carbon monoxide concentration, heart rate variability, and smoking withdrawal syndrome) and psychological status (i.e., depression and resilience). SPSS for Window 24.0 software will be used in statistical analysis. The type one error is 0.05. In inferences analysis, chi-square test, Pearson correlation coefficient, independent t test, one-way ANOVA and post hoc comparison (scheffe) test will be used to examine the variance among groups. Finally, ANCOVA and GEE mode will be used to test the effectiveness of intervention at stage 1 and stage 2, respectively.
Official Title
-----------------
Effects of Cognitive-behavioral Education and Exercise Interventions on Smoking Cessation and Physical and Mental Health in Patients With Coronary Heart Disease: Application of the Transtheoretical Model
Conditions
-----------------
Coronary Artery Disease, Smoking Cessation
Intervention / Treatment
-----------------
* Behavioral: cognitive-behavioral education
* Behavioral: 12-week brisk walking
Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Those who meet the diagnosis and can perform aerobic exercise after being referred by a physician. Those who have a clear consciousness and have no mental disorders as recorded in medical records or verbally. Those who can walk on their own. Participated in the first or second phase of the study and the smoking cessation phase is in the preparation and action phases Exclusion Criteria: Irregular heart rhythm. Install a heart regulator. Those who already have regular exercise (3 times a week, 20-30 minutes of physical activity each time).
Ages Eligible for Study
-----------------
Minimum Age: 20 Years
Maximum Age: 80 Years
Sexes Eligible for Study
-----------------
All
Accepts Healthy Volunteers
-----------------
No
Study Plan
=================
How is the study designed?
-----------------
Design Details
Primary Purpose: Supportive Care
Allocation: Randomized
Intervention Model: Parallel Assignment
Interventional Model Description: For the third stage, subjects will be recruited and randomly divided into experimental or control group to identify the effect of a 12-week brisk walking on improving the participants' immediate (short-term), three-month, and six month (long-term) health status.
Masking: None (Open Label)
Arms and Interventions
| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Stage2 - cognitive-behavioral education<br>A quasi-experimental design will be used to determine the effects of a four-week cognitive-behavioral education course related to smoking cessation on the participants' smoking cessation behavior, smoking decision-making, and self-efficacy in smoking cessation. | Behavioral: cognitive-behavioral education<br>* four-week cognitive-behavioral education course<br>|
| Experimental: Stage 3- 12-week brisk walking<br>Subjects who are at the preparation and action stage will be recruited and randomly divided into experimental or control group to identify the effect of a 12-week brisk walking on improving the participants' immediate (short-term), three-month, and six month (long-term) health status. | Behavioral: 12-week brisk walking<br>* 12-week brisk walking<br>|
What is the study measuring?
-----------------
Primary Outcome Measures
| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Stage3-The change of smoking cessation success rate | smoking cessation success | 12-weeks, three-month, and six month |
| Stage2-The change of smoking cessation behavior | Only one question, Are you currently considering quitting smoking? The smoking cessation behavior change stage is divided into 5 periods according to the cross-theoretical model, and they are respectively 1. Unintentional period: current smoking, and no smoking cessation will be considered in the next six months. 2. Intent period: currently smoking, but considering quitting in the next six months. 3. Preparation period: currently smoking, and plan to quit smoking within the nearest month. 4. Action period: I have quit smoking, but less than six months. 5. Maintenance period: I have quit smoking for more than six months. | Before, 4-weeks. |
Secondary Outcome Measures
| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Stage3-The change of Fagerstrom Test for Nicotine Dependence (FTND) | Used the Fagerstrom Test for Nicotine Dependence (FTND) translated by Health Promotion Administration, Ministry of Health and Welfare. The content of the scale includes six questions. The total score of the scale is 0-10 points. The higher the score, the higher the nicotine dependence index; the lower than 4 points means the degree of addiction is not high. If you are determined to quit smoking, you will be successful; 4-6 is divided into addiction High degree, need to work hard to quit smoking; 7-10 points nicotine addiction is very high, and professionals are needed to help quit smoking | 12-weeks, three-month, and six month |
| Stage3-The change of lung carbon monoxide concentration | physiological status | 12-weeks, three-month, and six month |
| Stage3-The change of heart rate variability | physiological status | 12-weeks, three-month, and six month |
| Stage3-The change of smoking withdrawal syndrome | We used French Minnesota Nicotine Withdrawal Scale, MNWS to assess smoking addiction and withdrawal symptoms. This Includes 1 craving for smoking and 8 withdrawal symptoms (depressed mood; irritability, frustration or anger; anxiety; difficulty concentrating; restlessness; increased appetite; difficulty falling asleep; restless sleep and the urge to smoke). The items are the feelings of those who quit smoking in the past day, and are scored on a scale of 0 to 4. Not at all: 0 points; mild: 1 point; moderate: 2 points; quite severe: 3 points; extremely severe: 4 points. The score includes the smoking craving degree and the eight withdrawal symptoms, which are used to evaluate smoking cessation After the impact, the higher the score, the more severe the withdrawal symptoms. | 12-weeks, three-month, and six month |
| Stage3-The change of the Center for Epidemiological Studies -Depression Scales (CESD-10) | We used the Center for Epidemiological Studies -Depression Scales (CESD-10). There are a total of 10 questions, measuring the frequency of depression symptoms in the subject within a week. Each item is given a score of 0 to 3, with a total score of 0 to 30. The higher the score, the more severe the depression. When the scale score ≥ 10 points, it indicates that there is a tendency to depression. | 12-weeks, three-month, and six month |
| Stage3-The change of Taiwanese Version of the Brief Resilience Scale | We used Taiwanese Version of the Brief Resilience Scale (BRS). The scale has 6 items divided into two dimensions: resilience and succumbing. Questions 1, 3, and 5 are positive questions, the measurement aspect is resilience, questions 2, 4, and 6 are negative questions, and the measurement aspect is yield. The scoring method uses Likert's 5-point scoring method, from 1 to 5 points each representing strongly disagree to strongly agree, and the negative questions are scored in reverse. The BRS score calculation method is to calculate the average of the individual scores of the 6 items. The higher the average, the higher the psychological resilience, and vice versa, the lower the psychological resilience. | 12-weeks, three-month, and six month |
| Stage2- smoking decision-making | This scale was developed by Chia et al (2013). There are 6 questions on the scale, including benefits and costs. The score for the benefit part is 3-15 points, the higher score indicates that smoking is important, which means that smoking can gain benefits, and smoking is actually bad [negative reaction]. The score for the costs part is scored 3-15 points. The higher the score indicates that smoking will pay the price, meaning that it is important not to smoke [positive reaction]. | Before, 4-weeks. |
| Stage2- self-efficacy in smoking cessation | The self-efficacy in smoking cessation developed by Ou, Li and Yan (2000).It was used to evaluate the confidence of the subjects to not smoke in various situations. There are a total of 14 questions on the scale. The Likert four-point calculation is used. The scoring method is used to answer that I will never smoke (4 points), I may not smoke (3 points), I may smoke (2 points), and I will definitely smoke (1 point). The score ranges from 14 to 56 points. The higher the score, the better the self-efficacy of refusal to smoke. | Before, 4-weeks. |
Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Coronary artery disease, Trans-theoretical Model, Smoking cessation
|
NCT00258713
|
A 36-Week Extension to Protocol ISA04-03
|
The purpose of this study is to determine the safety and efficacy of voclosporin in patients with plaque psoriasis.
|
Psoriasis is a chronic skin condition that can have a significant impact on patient's physical and mental well being. The most common form of psoriasis is plaque psoriasis. Targeted treatments in psoriasis have been reported recently, yet cyclosporine, a calcineurin inhibitor (CNi) remains one of the treatments which has the greatest efficacy. Voclosporin represents the possibility of a calcineurin inhibitor which is not only as efficacious as cyclosporine A, but also has an improved toxicity profile.
|
A 36-Week Extension to Protocol ISA04-03 to Evaluate the Safety and Efficacy of ISA247 in Patients With Plaque Psoriasis
|
Psoriasis
|
* Drug: voclosporin
|
Inclusion Criteria:~Males and females aged 18-66 years inclusive at the time of visit 1.~Diagnosed with plaque psoriasis ≥ 6 months.~Currently participating in study ISA04-03 and completed the study up to and including Visit 9 of study ISA04-03.~Not pregnant or nursing of planning to become pregnant during the course of the study~Sexually-active women of child-bearing potential (including those who are < 1 year postmenopausal) and sexually-active men who are practicing a highly effective method of birth control. A highly effective method of birth control is defined as one that results in a low failure rate (i.e., less than 1% per year) when used consistently and correctly and will include implants, injectables, combined oral contraceptives, double-barrier method, sexual abstinence, or a sterile partner. Sexually-active men and women of child-bearing potential should continue to practice contraception as outlined above during treatment and for ≥ 3 months after the last dose of voclosporin.~Written informed consent prior to any study related procedures.~Able to keep study appointments and cooperate with all study requirements, in the opinion of the investigator.~Exclusion Criteria:~Has generalized erythrodermic, guttate, or pustular psoriasis.~Have other dermatoses that would interfere with the evaluation of psoriasis, at the discretion of the investigator.~A current malignancy or history of malignancy within 5 years or a history of lymphoma at any time. Subjects can be enrolled with a history of squamous or basal cell carcinoma that has been surgically excised or removed with curettage and electrodesiccation.~Has current, uncontrolled bacterial, viral, or fungal infection that requires intravenous antibiotics or antifungals.~Has a current streptococcal infection that required oral antibiotics.~A known history of tuberculosis.~Serologic evidence or known latent human immunodeficiency virus (HIV), hepatitis B (HBV) or hepatitis C (HCV) virus.~Uncontrolled hypertension as defined as 3 readings of systolic blood pressure ≥ 150 mm Hg or diastolic blood pressure ≥ 90 mm Hg.~MDRD GFR ≤ 60 mL/min.~Unstable renal function (variation in GFR ≥ 30%).~Alanine transaminase, aspartate transaminase, or gamma-glutamyl transferase ≥ 3x upper limit of normal(ULN).~White blood cell count ≤ 2.8x10 to the ninth power/L.~Triglycerides ≥ 3x ULN.~Is currently taking or requires the following prohibited medications or treatments during the treatment period: drugs potentiating the nephrotoxicity of voclosporin such as chronic NSAID's or ACE inhibitors, drugs interfering with it's pharmacokinetics; drugs considered to contribute to psoriasis flare; or, systemic and topical psoriasis medication (including psoralen/ultraviolet A light treatment) that may interfere with assessment of study drug efficacy.~Has taken biological agent(s), except flu shots, tetanus shots, or boosters, within 3 months of the start of treatment. Biological agents include any virus, therapeutic serum, toxin, antitoxin, or analogous product applicable to the prevention, treatment, or cure of diseases or injuries of man.~A history of clinically defined allergy to cyclosporine or any of the constituents of the voclosporin formulation (vitamin E, medium chain triglyceride oil, Tween 40, ethanol).~A history of alcoholism or drug addiction within 1 year prior to study entry.~Weighs < 45 kg (99 lbs) or > 140 kg (308 lbs).~A history of disease, including mental/emotional disorder that would interfere with the subject's participation in the study, or that might cause the administration of ISA247 to pose a significant risk to the subject, in the opinion of the investigator.
|
18 Years
|
66 Years
|
All
|
No
|
Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple
|
| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| To investigate long-term safety and tolerability of voclosporin | | Sixty weeks of continuous treatment |
|
| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| To determine the proportion of subjects achieving and/or maintaining a PASI-75 | | Sixty weeks of continuous treatment |
| To determine the proportion of subjects achieving and/or maintaining a reduction of 2 points in the SGA | | Sixty weeks of continuous treatment |
| To evaluate the effect of voclosporin on subject quality of life | | Sixty weeks of continuous treatment |
|
Randomized Controlled Trials, Immunosuppression, Adult, Chronic Disease, Dermatologic Agents, Female, Humans, Male, Middle Aged, Severity of Illness Index, Treatment Outcome, Quality of Life, Double-Blind Method
|
Psoriasis, Skin Diseases, Papulosquamous, Skin Diseases
|
| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: 1<br> | Drug: voclosporin<br>* voclosporin 0.2, 0.3, or 0.4 mg/kg BID<br>|
| Active Comparator: 2<br> | Drug: voclosporin<br>* voclosporin 0.2, 0.3, or 0.4 mg/kg BID<br>|
| Active Comparator: 3<br> | Drug: voclosporin<br>* voclosporin 0.2, 0.3, or 0.4 mg/kg BID<br>|
|
A 36-Week Extension to Protocol ISA04-03
Study Overview
=================
Brief Summary
-----------------
The purpose of this study is to determine the safety and efficacy of voclosporin in patients with plaque psoriasis.
Detailed Description
-----------------
Psoriasis is a chronic skin condition that can have a significant impact on patient's physical and mental well being. The most common form of psoriasis is plaque psoriasis. Targeted treatments in psoriasis have been reported recently, yet cyclosporine, a calcineurin inhibitor (CNi) remains one of the treatments which has the greatest efficacy. Voclosporin represents the possibility of a calcineurin inhibitor which is not only as efficacious as cyclosporine A, but also has an improved toxicity profile.
Official Title
-----------------
A 36-Week Extension to Protocol ISA04-03 to Evaluate the Safety and Efficacy of ISA247 in Patients With Plaque Psoriasis
Conditions
-----------------
Psoriasis
Intervention / Treatment
-----------------
* Drug: voclosporin
Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Males and females aged 18-66 years inclusive at the time of visit 1. Diagnosed with plaque psoriasis ≥ 6 months. Currently participating in study ISA04-03 and completed the study up to and including Visit 9 of study ISA04-03. Not pregnant or nursing of planning to become pregnant during the course of the study Sexually-active women of child-bearing potential (including those who are < 1 year postmenopausal) and sexually-active men who are practicing a highly effective method of birth control. A highly effective method of birth control is defined as one that results in a low failure rate (i.e., less than 1% per year) when used consistently and correctly and will include implants, injectables, combined oral contraceptives, double-barrier method, sexual abstinence, or a sterile partner. Sexually-active men and women of child-bearing potential should continue to practice contraception as outlined above during treatment and for ≥ 3 months after the last dose of voclosporin. Written informed consent prior to any study related procedures. Able to keep study appointments and cooperate with all study requirements, in the opinion of the investigator. Exclusion Criteria: Has generalized erythrodermic, guttate, or pustular psoriasis. Have other dermatoses that would interfere with the evaluation of psoriasis, at the discretion of the investigator. A current malignancy or history of malignancy within 5 years or a history of lymphoma at any time. Subjects can be enrolled with a history of squamous or basal cell carcinoma that has been surgically excised or removed with curettage and electrodesiccation. Has current, uncontrolled bacterial, viral, or fungal infection that requires intravenous antibiotics or antifungals. Has a current streptococcal infection that required oral antibiotics. A known history of tuberculosis. Serologic evidence or known latent human immunodeficiency virus (HIV), hepatitis B (HBV) or hepatitis C (HCV) virus. Uncontrolled hypertension as defined as 3 readings of systolic blood pressure ≥ 150 mm Hg or diastolic blood pressure ≥ 90 mm Hg. MDRD GFR ≤ 60 mL/min. Unstable renal function (variation in GFR ≥ 30%). Alanine transaminase, aspartate transaminase, or gamma-glutamyl transferase ≥ 3x upper limit of normal(ULN). White blood cell count ≤ 2.8x10 to the ninth power/L. Triglycerides ≥ 3x ULN. Is currently taking or requires the following prohibited medications or treatments during the treatment period: drugs potentiating the nephrotoxicity of voclosporin such as chronic NSAID's or ACE inhibitors, drugs interfering with it's pharmacokinetics; drugs considered to contribute to psoriasis flare; or, systemic and topical psoriasis medication (including psoralen/ultraviolet A light treatment) that may interfere with assessment of study drug efficacy. Has taken biological agent(s), except flu shots, tetanus shots, or boosters, within 3 months of the start of treatment. Biological agents include any virus, therapeutic serum, toxin, antitoxin, or analogous product applicable to the prevention, treatment, or cure of diseases or injuries of man. A history of clinically defined allergy to cyclosporine or any of the constituents of the voclosporin formulation (vitamin E, medium chain triglyceride oil, Tween 40, ethanol). A history of alcoholism or drug addiction within 1 year prior to study entry. Weighs < 45 kg (99 lbs) or > 140 kg (308 lbs). A history of disease, including mental/emotional disorder that would interfere with the subject's participation in the study, or that might cause the administration of ISA247 to pose a significant risk to the subject, in the opinion of the investigator.
Ages Eligible for Study
-----------------
Minimum Age: 18 Years
Maximum Age: 66 Years
Sexes Eligible for Study
-----------------
All
Accepts Healthy Volunteers
-----------------
No
Study Plan
=================
How is the study designed?
-----------------
Design Details
Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple
Arms and Interventions
| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: 1<br> | Drug: voclosporin<br>* voclosporin 0.2, 0.3, or 0.4 mg/kg BID<br>|
| Active Comparator: 2<br> | Drug: voclosporin<br>* voclosporin 0.2, 0.3, or 0.4 mg/kg BID<br>|
| Active Comparator: 3<br> | Drug: voclosporin<br>* voclosporin 0.2, 0.3, or 0.4 mg/kg BID<br>|
What is the study measuring?
-----------------
Primary Outcome Measures
| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| To investigate long-term safety and tolerability of voclosporin | | Sixty weeks of continuous treatment |
Secondary Outcome Measures
| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| To determine the proportion of subjects achieving and/or maintaining a PASI-75 | | Sixty weeks of continuous treatment |
| To determine the proportion of subjects achieving and/or maintaining a reduction of 2 points in the SGA | | Sixty weeks of continuous treatment |
| To evaluate the effect of voclosporin on subject quality of life | | Sixty weeks of continuous treatment |
Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Randomized Controlled Trials, Immunosuppression, Adult, Chronic Disease, Dermatologic Agents, Female, Humans, Male, Middle Aged, Severity of Illness Index, Treatment Outcome, Quality of Life, Double-Blind Method
|
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