nct_id
stringlengths 11
11
| brief_title
stringlengths 7
300
| brief_summary
stringlengths 0
4.99k
| detailed_descriptions
stringlengths 0
31.8k
| official_title
stringlengths 16
598
⌀ | conditions
stringlengths 0
11k
| interventions
stringlengths 0
3.18k
| eligibility_criteria
stringlengths 0
19.6k
⌀ | minimum_age
stringclasses 304
values | maximum_age
stringclasses 448
values | gender
stringclasses 4
values | healthy_volunteers
stringclasses 3
values | design_details
stringlengths 0
1.17k
| primary_outcome_measures
stringlengths 75
136k
| secondary_outcome_measures
stringlengths 0
185k
| keywords
stringlengths 0
18.8k
| mesh_terms
stringlengths 0
8.39k
| arms_and_interventions
stringlengths 0
109k
| structured_text
stringlengths 539
193k
|
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
NCT04475562
|
Can the Electronic Nose Smell COVID-19?
|
Infection with SARS-CoV-2 causes Corona Virus Disease (COVID-19). The most standard diagnostic method is reverse transcription-polymerase chain reaction (RT-PCR) on a nasopharyngeal and/or an oropharyngeal swab. The high occurrence of false-negative results due to the non-presence of SARS-CoV-2 in the oropharyngeal environment renders this sampling method not ideal. Therefore, a new sampling device is desirable. This proof-of-principle study investigates the possibility to train machine-learning classifiers with an electronic nose (Aeonose) to differentiate between COVID-19 positive- and negative persons based on volatile organic compounds (VOCs) analysis.~Methods: between April and June 2020, participants were invited for breath analysis when a swab for RT-PCR was collected. If the RT-PCR resulted negative, presence of SARS-CoV-2 specific antibodies was checked to confirm the negative result. All participants breathed through the Aeonose for five minutes. This device contains metal-oxide sensors that change in conductivity upon reaction with VOCs in exhaled breath. These conductivity changes are input data for machine-learning and used for pattern recognition. The result is a value between -1 and +1, indicating the infection probability.
|
Can the Electronic Nose Smell COVID-19? A Proof-of-principle Study
|
SARS-CoV Infection, Covid19
|
* Device: Aeonose
|
Inclusion Criteria:~Participants of whom an oropharyngeal or nasopharyngeal swab was collected to perform RT-PCR on.~Exclusion Criteria:~Participants who were experiencing dyspnea or needed supplemental oxygen.
|
18 Years
| null |
All
|
No
|
Primary Purpose: Diagnostic
Intervention Model: Single Group Assignment
Masking: None (Open Label)
|
| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| COVID 19 positive vs negative | Ability of the eNose to distinguish COVID-19 positive from COVID-19 negative persons based on VOC patterns. | 3 months |
|
Electronic nose, Volatile organic compounds, Diagnosis
|
RNA Virus Infections, COVID-19, Coronavirus Infections, Coronaviridae Infections, Nidovirales Infections, Severe Acute Respiratory Syndrome, Pneumonia, Viral, Pneumonia, Respiratory Tract Infections, Infections, Virus Diseases, Lung Diseases, Respiratory Tract Diseases
|
| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Other: COVID-19 suspected<br>Participants were recruited at the outpatient clinic for MUMC+ employees with COVID-19 symptoms or at the nursing unit where a SARS-CoV-2 patient was admitted. | Device: Aeonose<br>* All participants breathed through the Aeonose for five minutes. This device contains metal-oxide sensors that change in conductivity upon reaction with VOCs in exhaled breath. These conductivity changes are input data for machine-learning and used for pattern recognition. A nose clip was placed on the nose of each participant to avoid entry of non-filtered air in the device. Before measuring, the Aeonose was flushed with room air, guided through a carbon filter as well. During each measurement, a video was displayed to distract the participant and to reduce the chance of hyperventilation. Failed breath tests were excluded from analysis; the reason for failure was documented. Four similar Aeonose devices were used for breath analysis. A full-measurement procedure required sixteen minutes.<br>|
|
Can the Electronic Nose Smell COVID-19?
Study Overview
=================
Brief Summary
-----------------
Infection with SARS-CoV-2 causes Corona Virus Disease (COVID-19). The most standard diagnostic method is reverse transcription-polymerase chain reaction (RT-PCR) on a nasopharyngeal and/or an oropharyngeal swab. The high occurrence of false-negative results due to the non-presence of SARS-CoV-2 in the oropharyngeal environment renders this sampling method not ideal. Therefore, a new sampling device is desirable. This proof-of-principle study investigates the possibility to train machine-learning classifiers with an electronic nose (Aeonose) to differentiate between COVID-19 positive- and negative persons based on volatile organic compounds (VOCs) analysis. Methods: between April and June 2020, participants were invited for breath analysis when a swab for RT-PCR was collected. If the RT-PCR resulted negative, presence of SARS-CoV-2 specific antibodies was checked to confirm the negative result. All participants breathed through the Aeonose for five minutes. This device contains metal-oxide sensors that change in conductivity upon reaction with VOCs in exhaled breath. These conductivity changes are input data for machine-learning and used for pattern recognition. The result is a value between -1 and +1, indicating the infection probability.
Official Title
-----------------
Can the Electronic Nose Smell COVID-19? A Proof-of-principle Study
Conditions
-----------------
SARS-CoV Infection, Covid19
Intervention / Treatment
-----------------
* Device: Aeonose
Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Participants of whom an oropharyngeal or nasopharyngeal swab was collected to perform RT-PCR on. Exclusion Criteria: Participants who were experiencing dyspnea or needed supplemental oxygen.
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: Diagnostic
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Arms and Interventions
| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Other: COVID-19 suspected<br>Participants were recruited at the outpatient clinic for MUMC+ employees with COVID-19 symptoms or at the nursing unit where a SARS-CoV-2 patient was admitted. | Device: Aeonose<br>* All participants breathed through the Aeonose for five minutes. This device contains metal-oxide sensors that change in conductivity upon reaction with VOCs in exhaled breath. These conductivity changes are input data for machine-learning and used for pattern recognition. A nose clip was placed on the nose of each participant to avoid entry of non-filtered air in the device. Before measuring, the Aeonose was flushed with room air, guided through a carbon filter as well. During each measurement, a video was displayed to distract the participant and to reduce the chance of hyperventilation. Failed breath tests were excluded from analysis; the reason for failure was documented. Four similar Aeonose devices were used for breath analysis. A full-measurement procedure required sixteen minutes.<br>|
What is the study measuring?
-----------------
Primary Outcome Measures
| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| COVID 19 positive vs negative | Ability of the eNose to distinguish COVID-19 positive from COVID-19 negative persons based on VOC patterns. | 3 months |
Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Electronic nose, Volatile organic compounds, Diagnosis
|
||
NCT01609140
|
A Phase II Study of the Safety and Efficacy of MPSK3169A in Patients With Coronary Heart Disease or High Risk of Coronary Heart Disease
|
The purpose of this study is to evaluate the safety and cholesterol lowering effects of MPSK3169A when given as subcutaneous (SC) injections over a 24-week period to patients with a high risk of cardiovascular events and LDL-c levels well above goal.
|
A Phase II, Randomized, Placebo-Controlled, Double-Blind Study of the Safety and Efficacy of MPSK3169A in Patients With Coronary Heart Disease or High Risk of Coronary Heart Disease
|
Coronary Heart Disease
|
* Drug: MPSK3169A
* Drug: MPSK3169A
* Drug: MPSK3169A
* Drug: MPSK3169A
* Drug: MPSK3169A
* Drug: Placebo
|
Inclusion Criteria:~Use of a standard-of-care statin at a stable dose, or intolerance of statins, without use of other lipid modifying therapies~Fasting LDL cholesterol 90-250 mg/dL on the statin regimen above~And at least one of the following:~Coronary heart disease (CHD) with a history of myocardial infarction (MI), percutaneous coronary intervention (PCI), coronary artery bypass graft surgery (CABG), or prior coronary angiography demonstrating coronary atherosclerosis~A CHD risk equivalent condition, including diabetes mellitus (type 1 or 2), chronic kidney disease, prior stroke, carotid disease, peripheral arterial disease, or abdominal aortic aneurism~>/=2 CHD risk factors (age >/= 45 years for men or >/= 55 years for women; smoking; hypertension; low HDL cholesterol; family history of premature CHD) and a high risk of a CV event based on risk estimation systems~Exclusion Criteria:~Severe congestive heart failure (NYHA Class III-IV) or left ventricular ejection fraction </= 35%~Recent (within 3 months) MI, unstable angina, stroke, transient ischemic attack, CABG, PCI, hospital admission for heart failure, major surgery, uncontrolled cardiac arrhythmia (other than atrial fibrillation or flutter), or initiation of renal replacement therapy (dialysis)~Fasting serum triglyceride level >/= 400 mg/dL~Homozygous familial hypercholesterolemia~Poorly controlled diabetes mellitus, hypertension or thyroid disease~Liver or muscle disease, including abnormal test results at screening~Pregnant or lactating~The above list is not intended to contain all factors relevant to a patient's eligibility for the study.
|
18 Years
|
80 Years
|
All
|
No
|
Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double
|
| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Absolute change from baseline in LDL-c concentration | | at Day 169 |
|
| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Absolute change from baseline in LDL-c concentration for each arm at the nadir for that arm | | over the 24 week treatment period |
| Average value over time of the change in LDL-c (absolute and percent change) for each arm, up to Day 169, weighted by the number of weeks between consecutive LDL-c measurements | | up to Day 169 |
| Percent change from baseline in LDL-c concentration at Day 169 and at the nadir for each arm | | at Day 169 and over the 24 week treatment period |
| Percent and absolute change from baseline in LDL-c concentration at all other designated timepoints | | at all other designated timepoints |
| Percent and absolute change from baseline in total cholesterol, non-HDL-c, and apolipoprotein B (ApoB) at Day 169 and at the nadir for each arm | | at Day 169 and over the 24 week treatment period |
|
Hyperlipidemia, Dyslipidemia
|
Heart Diseases, Coronary Disease, Coronary Artery Disease, Myocardial Ischemia, Cardiovascular Diseases, Vascular Diseases, Arteriosclerosis, Arterial Occlusive Diseases
|
| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: A<br> | Drug: MPSK3169A<br>* Dose regimen A, repeating subcutaneous injections every 4 weeks<br>|
| Experimental: B<br> | Drug: MPSK3169A<br>* Dose regimen B, repeating subcutaneous injections every 4 weeks<br>|
| Experimental: C<br> | Drug: MPSK3169A<br>* Dose regimen C, repeating subcutaneous injections every 4 weeks<br>|
| Experimental: D<br> | Drug: MPSK3169A<br>* Dose regimen D, repeating subcutaneous injections every 4 weeks<br>|
| Experimental: E<br> | Drug: MPSK3169A<br>* Dose regimen E, repeating subcutaneous injections every 4 weeks<br>|
| Placebo Comparator: F<br> | Drug: Placebo<br>* Repeating subcutaneous injections of placebo every 4 weeks<br>|
|
A Phase II Study of the Safety and Efficacy of MPSK3169A in Patients With Coronary Heart Disease or High Risk of Coronary Heart Disease
Study Overview
=================
Brief Summary
-----------------
The purpose of this study is to evaluate the safety and cholesterol lowering effects of MPSK3169A when given as subcutaneous (SC) injections over a 24-week period to patients with a high risk of cardiovascular events and LDL-c levels well above goal.
Official Title
-----------------
A Phase II, Randomized, Placebo-Controlled, Double-Blind Study of the Safety and Efficacy of MPSK3169A in Patients With Coronary Heart Disease or High Risk of Coronary Heart Disease
Conditions
-----------------
Coronary Heart Disease
Intervention / Treatment
-----------------
* Drug: MPSK3169A
* Drug: MPSK3169A
* Drug: MPSK3169A
* Drug: MPSK3169A
* Drug: MPSK3169A
* Drug: Placebo
Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Use of a standard-of-care statin at a stable dose, or intolerance of statins, without use of other lipid modifying therapies Fasting LDL cholesterol 90-250 mg/dL on the statin regimen above And at least one of the following: Coronary heart disease (CHD) with a history of myocardial infarction (MI), percutaneous coronary intervention (PCI), coronary artery bypass graft surgery (CABG), or prior coronary angiography demonstrating coronary atherosclerosis A CHD risk equivalent condition, including diabetes mellitus (type 1 or 2), chronic kidney disease, prior stroke, carotid disease, peripheral arterial disease, or abdominal aortic aneurism >/=2 CHD risk factors (age >/= 45 years for men or >/= 55 years for women; smoking; hypertension; low HDL cholesterol; family history of premature CHD) and a high risk of a CV event based on risk estimation systems Exclusion Criteria: Severe congestive heart failure (NYHA Class III-IV) or left ventricular ejection fraction </= 35% Recent (within 3 months) MI, unstable angina, stroke, transient ischemic attack, CABG, PCI, hospital admission for heart failure, major surgery, uncontrolled cardiac arrhythmia (other than atrial fibrillation or flutter), or initiation of renal replacement therapy (dialysis) Fasting serum triglyceride level >/= 400 mg/dL Homozygous familial hypercholesterolemia Poorly controlled diabetes mellitus, hypertension or thyroid disease Liver or muscle disease, including abnormal test results at screening Pregnant or lactating The above list is not intended to contain all factors relevant to a patient's eligibility for the study.
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: A<br> | Drug: MPSK3169A<br>* Dose regimen A, repeating subcutaneous injections every 4 weeks<br>|
| Experimental: B<br> | Drug: MPSK3169A<br>* Dose regimen B, repeating subcutaneous injections every 4 weeks<br>|
| Experimental: C<br> | Drug: MPSK3169A<br>* Dose regimen C, repeating subcutaneous injections every 4 weeks<br>|
| Experimental: D<br> | Drug: MPSK3169A<br>* Dose regimen D, repeating subcutaneous injections every 4 weeks<br>|
| Experimental: E<br> | Drug: MPSK3169A<br>* Dose regimen E, repeating subcutaneous injections every 4 weeks<br>|
| Placebo Comparator: F<br> | Drug: Placebo<br>* Repeating subcutaneous injections of placebo every 4 weeks<br>|
What is the study measuring?
-----------------
Primary Outcome Measures
| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Absolute change from baseline in LDL-c concentration | | at Day 169 |
Secondary Outcome Measures
| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Absolute change from baseline in LDL-c concentration for each arm at the nadir for that arm | | over the 24 week treatment period |
| Average value over time of the change in LDL-c (absolute and percent change) for each arm, up to Day 169, weighted by the number of weeks between consecutive LDL-c measurements | | up to Day 169 |
| Percent change from baseline in LDL-c concentration at Day 169 and at the nadir for each arm | | at Day 169 and over the 24 week treatment period |
| Percent and absolute change from baseline in LDL-c concentration at all other designated timepoints | | at all other designated timepoints |
| Percent and absolute change from baseline in total cholesterol, non-HDL-c, and apolipoprotein B (ApoB) at Day 169 and at the nadir for each arm | | at Day 169 and over the 24 week treatment period |
Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Hyperlipidemia, Dyslipidemia
|
|
NCT00570180
|
Combination Bortezomib-containing Regimens in Newly Diagnosed Patients With t (4; 14) Positive Multiple Myeloma
|
Given the disappointing results with routine ASCT in t(4;14) patients, we propose this open label phase II study of bortezomib along with dexamethasone and pegylated liposomal doxorubicin (Doxil/Caelyx), referred to as the DBd regimen, for 4 cycles, followed by post-induction therapy with cyclophosphamide + bortezomib + prednisone (referred to as the CyBorP regimen) for 8 cycles. Since patients with t(4;14) remain at high risk for relapse, maintenance therapy with dexamethasone weekly will be given until disease progression.
|
PROTOCOL SYNOPSIS A. TITLE: An Open-Label Phase II Study of the Efficacy of Combination Bortezomib-containing Regimens in the Treatment of newly diagnosed patients with t (4;14) positive Multiple Myeloma.~B. RATIONALE: Between 15 and 20% of myeloma patients exhibit a t(4;14), which results in translocation of the receptor tyrosine kinase (TK) fibroblast growth factor receptor 3 (FGFR3) from chromosome 4 to the Immunoglobulin H (IgH) locus. The presence of a t(4;14) appears to confer an extremely poor prognosis. Patients with this abnormality do not experience prolonged remissions after a single autologous stem cell transplant (ASCT) using high-dose melphalan, and the optimal therapy of this group has not yet been defined. Specifically, data from Princess Margaret Hospital and the Mayo Clinic both indicate that the median progression-free survival (PFS) is only about 8 months and overall survival 18-22 months after ASCT. Unpublished data from the French Francophone Myeloma Intergroup (IFM) studies suggest that tandem transplants may improve these results modestly, but the outcome is still inferior compared with other cytogenetic subgroups.~Initial unpublished observations suggested that t(4;14) patients with relapsed/refractory disease were uniquely sensitive to the new agent bortezomib. More recent information in larger numbers of patients indicates that responses to single agent bortezomib are seen in up to 50-65% of t(4;14) patients; the duration of response is similar to that seen in other subsets, i.e. in the range of 5-7 months. Combinations of bortezomib with agents such as doxorubicin, pegylated liposomal doxorubicin, thalidomide, cyclophosphamide, melphalan, thalidomide and corticosteroids have been evaluated in a number of clinical studies in recurrent myeloma, and the response rates (RR) appear to be improved compared to single agent bortezomib, and toxicity has been acceptable.~In newly diagnosed myeloma patients, combinations such as vincristine, doxorubicin, dexamethasone (VAD) and thalidomide + dexamethasone are often utilized before ASCT. A study by Hussein et al. substituted pegylated liposomal doxorubicin for the conventional formulation of doxorubicin and noted a similar response rate with less grade 3/4 neutropenia, alopecia and sepsis; in addition, patients do not necessarily require a central venous catheter. More recently, Cavenagh et al. has reported remarkable activity with the so-called PAD regimen of bortezomib, doxorubicin and dexamethasone, with a combined Complete Remission (CR) + Partial Response (PR) rate of 67% following 1 cycle, and 93% after 4 cycles, with no impairment of the ability to collect blood stem cells for ASCT. Preliminary data from an ongoing Canadian phase II study of Doxil/Caelyx + Bortezomib + Dexamethasone (DBd), in which pegylated liposomal doxorubin, bortezomib and dexamethasone are combined, has produced encouraging results to date with minimal toxicity. In that study, DBd therapy was given for 4 cycles before ASCT independently of cytogenetic classification.~Given the disappointing results with routine ASCT in t(4;14) patients, we propose this open label phase II study of bortezomib along with dexamethasone and pegylated liposomal doxorubicin (Doxil/Caelyx), referred to as the DBd regimen, for 4 cycles, followed by post-induction therapy with cyclophosphamide + bortezomib + prednisone (referred to as the CyBorP regimen) for 8 cycles. Since patients with t(4;14) remain at high risk for relapse, maintenance therapy with dexamethasone weekly will be given until disease progression. This approach will test the hypothesis that bortezomib-based therapy can improve the outcome of newly diagnosed t(4;14) multiple myeloma patients.~C. OBJECTIVES OF THE STUDY: To evaluate the efficacy of the DBd regimen given as induction therapy, followed by post-induction therapy with CyBorP and maintenance therapy with dexamethasone in t(4;14) positive multiple myeloma (MM) patients.~Primary Objectives~To determine the time to progression (TTP) with this treatment regimen. Secondary Endpoints~To determine the objective response rate following DBd induction therapy~To determine the duration of response following DBd induction therapy~To determine the objective response rate following CyBorP post-induction therapy~To determine the duration of response following CyBorP post-induction therapy~To determine PFS~To determine overall survival~To determine the safety profile of this regimen~To examine the ability of bortezomib based regimens to repress FGFR3 signaling~D. STUDY DESIGN: This is an open-label, Phase II study of induction therapy with bortezomib, pegylated liposomal doxorubicin (Doxil/Caelyx) and dexamethasone as initial therapy in patients with t(4;14). Each 21 day-cycle consists of bortezomib 1.3 mg/m2 (given as an I.V. bolus on Days 1, 4, 8, and 11) followed by a 10-day rest period (Days 12 to 21). DOXIL/CAELYX 30 mg/m2 will be given after bortezomib as at least a 1-hour I.V. infusion on Day 4 of each 21-day cycle. Dexamethasone 40 mg PO will be given on days 1-4, days 8-11 and days 15-18 during the first cycle. For the subsequent 3 cycles, dexamethasone 40 mg PO will be given on days 1-4 and days 11-14. Patients who do not experience disease progression may undergo elective, as per the attending physician's discretion, stem cell mobilization followed by stem cell collection and cryopreservation. Patients will then receive post-induction therapy with cyclophosphamide + bortezomib + prednisone (1.5 mg/m2 bortezomib on days 1, 8, and 15 I.V. + cyclophosphamide 300 mg/m2 PO weekly + prednisone 100 mg PO on alternate days) for 8 monthly 28 day cycles, followed by maintenance therapy with 40 mg of dexamethasone weekly per month until disease progression occurs.~E. PATIENT CHARACTERISTICS: Untreated multiple myeloma patients who are t(4;14) positive by fluorescence in situ hybridization (FISH) will be considered for the study. Exclusion criteria include inadequate liver function aspartate aminotransferase (AST} and alanine aminotransferase (ALT) > 2.5 times the upper limit of normal), thrombocytopenia (platelets < 50 X 109/L), neutropenia (absolute neutrophil count < 1.0 x 109/L), pregnant or lactating women, and women of childbearing potential (WCBP) who are not using adequate contraception and Left Ventricular Ejection Fraction (LVEF) below the institutional Lower Limit Normal (LLN) or less than 40%; whichever value is higher. A patient may have received up to 4 months of other anti myeloma therapy, as part of the induction therapy, prior enrollment and still be considered eligible to participate in the study, as long as the patient's multiple myeloma has not progressed in the current regimen and the other eligibility criteria are met.~F. STATISTICAL PLAN: The TTP from initiation of chemotherapy in patients treated with ASCT for this subset is approximately 12 months. An increase in TTP from 12 to 21 months would be of clinical significance. Using an 80% power to detect this time difference in a two-sided comparison patient, a sample size of 36 evaluable patients is required. This calculation assumes that each patient will be evaluated at a fixed time of 24 months. Assuming a 20% drop-out rate, a total sample size of 45 patients will be required.~G. STUDY DESIGN: It is assumed that the new regimen will not be of further interest in t(4;14) positive myeloma patients if the TTP from the time of starting induction therapy is less than 21 months. Each patient will be followed every month until disease progression and then after every 6 moths up to 5 years for survival. An interim analysis will also be performed after 12 patients have completed the post-induction therapy with cyclophosphamide + bortezomib + prednisone (CyBorP).~H. PATIENT ACCRUAL AND STUDY DURATION: Patients with t(4;14) represents only 15% of all myeloma patients, as such, accrual will be highly dependant on number of participating centers. It is estimated that approximately 350 newly-diagnosed patients will require cytogenetic screening in order to meet the accrual target. Accrual is expected to be complete within 48 months. Additional time is required, of course, to allow the response data to mature. All patients registered in the study will be accounted for (screen failures + enrolled patients). The number of patients who are not evaluable, who died or withdrew before treatment began will be specified. The distribution of follow-up times will be described and the number of patients lost to follow-up will be monitored.~I. EFFICACY PARAMETERS: Beginning in cycle 1, the response to treatment will be determined during each cycle using the International Myeloma Working Group uniform response criteria for multiple myeloma as outlined in Section 11.0. Responses will be assessed by monoclonal protein, monoclonal paraprotein (M protein) quantification from serum and a 24-hour urine collection (including immunofixation, if needed), bone marrow plasma cells, assessment of lytic lesions, and soft tissue plasmacytomas. For patients with light chain disease or non-secretory myeloma, a serum sample for Free Lite chain testing will be obtained and the results will be compared to the levels reported quantified in the urine.~J. REGISTRATION: Patients will be registered by completing the eligibility and enrollment checklist and forwarding it by fax to the Multiple Myeloma Research Coordinator at Princess Margaret Hospital at 416-946-4419, between the hours of 9 am and 4 pm Eastern Standard Time, up to 5 business days prior commencement of cycle 1 day 1. The research coordinator should also be contacted by phone at 416 946-4627. The checklist will be verified and a patient number will be assigned for eligible patients.~K. SAMPLE PROCESSING: Centralized screening will be employed at Princess Margaret Hospital. Following informed consent site should send two fresh heparinized (green top tube) marrow samples (5cc per tube or best available) by overnight courier (see Appendix VI for shipping and notification instructions) for t4;14 screening test. Tri-color fluorescence in situ hybridization (FISH) for t(4;14) will be performed and reported back to referring site within 5-7 working days.
|
An Open-label Phase II Study of the Efficacy of Combination Bortezomib-containing Regimens in the Treatment of Newly Diagnosed Patients With t (4; 14) Positive Multiple Myeloma
|
Multiple Myeloma
|
* Drug: Bortezomib
|
Inclusion Criteria:~Patients previously diagnosed with MM based on criteria from the International Myeloma Working Group (IMWG)~Patients who have 'measurable' disease~Age 18 years at the time of signing Informed Consent~A patient may have received up to 4 months of other anti myeloma therapy, as part of the induction therapy, prior enrollment and still be considered eligible to participate in the study, as long as the patient's multiple myeloma has not progressed on the current regimen and the other eligibility criteria are met.~Patient is t(4;14) positive on screening assay.~Exclusion Criteria:~Concomitant therapy medications that include corticosteroids (> 10 mg per day of prednisone or equivalent) or other therapy that is or may be active against myeloma prior to day 1 (with the exception of radiation therapy or induction therapy as described under the above inclusion criteria section~Peripheral neuropathy of Grade 2 or greater.~Patients with evidence of mucosal or internal bleeding and/or refractoriness to platelet transfusions (i.e., unable to maintain a platelet count 50 x 109 /L).~Patients with an absolute neutrophil count (ANC) < 1.0 x 109/L. Treatment to raise the ANC, such as granulocyte colony-stimulating factor (G-CSF) or granulocyte-macrophage colony-stimulating factor (GM-CSF) is not allowed within 14 days of study entry.~Patients with hemoglobin < 80 g/L despite transfusion.~Pregnant or lactating women
|
18 Years
| null |
All
|
No
|
Primary Purpose: Treatment
Intervention Model: Single Group Assignment
Masking: None (Open Label)
|
| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| To determine the time to progression (TTP) with this treatment regimen | Measured from the date of enrollment to the date of disease progression. Otherwise, censored at the time of last disease assessment. Responses were assessed using the International Myeloma Working Group criteria, involving a modified version of the European Group for Blood and Marrow Transplantation (EBMT) criteria, where the category of stringent complete response (sCR) was included for patients with normalization of the free light chain ratio.10,11 Bone marrow aspirate and biopsy were obtained routinely after induction therapy to confirm CR or sCR. Serum free light chain assay and serum and/or urine electrophoresis were performed monthly; immunofixation was performed when confirmation of very good partial response (VGPR), CR, or sCR was necessary. | Patients were followed monthly until disease progression and subsequently every six months for up to five years to assess OS. |
|
| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| To determine the objective response rate/duration following DBd induction and Cybor P post induction therapy | Objective response after completing induction therapy and until disease progression. | Patients were followed monthly until disease progression |
| To determine PFS | PFS was measured from the date of enrollment to the date of disease progression or death from any cause, otherwise censored at the time of last disease assessment. | 5 years |
| To determine overall survival | Patients were followed monthly until disease progression and subsequently every six months for up to five years to assess OS. | 5 years |
| To determine the safety profile of this regimen | Safety analyses focused on hematological and non-hematological adverse events of all grades. Toxicity was graded using the National Cancer Institute Common Terminology Criteria for Adverse Events (CTCAE version 3.0) | 5 years |
|
newly diagnosed
|
Bortezomib, Antineoplastic Agents
|
| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Single Arm<br>Please see intervention description for Bortezomib (Velcade) | Drug: Bortezomib<br>* 21 day-cycle Induction therapy:bortezomib 1.3 mg/m2 (I.V. Days 1, 4, 8, and 11), then 10-day rest period. DOXIL 30 mg/m2 given after bortezomib (I.V. infusion Day 4 of each cycle). Dexamethasone 40 mg PO on days 1-4,8-11 and 15-18 during the first cycle. Subsequent 3 cycles, dexamethasone 40 mg PO given on days 1-4 and 11-14. Patients who don't progress may undergo elective stem cell mobilization, stem cell collection and cryopreservation. Patients will then receive post-induction therapy 1.5 mg/m2 bortezomib days 1, 8, and 15 I.V. + cyclophosphamide 300 mg/m2 PO weekly + prednisone 100 mg PO on alternate days for 8 monthly 28 day cycles.Maintenance therapy with weekly 40 mg dexamethasone (days 1, 8, 15 and 22) every month until disease progression occurs.<br>* Other names: Velcade;|
|
Combination Bortezomib-containing Regimens in Newly Diagnosed Patients With t (4; 14) Positive Multiple Myeloma
Study Overview
=================
Brief Summary
-----------------
Given the disappointing results with routine ASCT in t(4;14) patients, we propose this open label phase II study of bortezomib along with dexamethasone and pegylated liposomal doxorubicin (Doxil/Caelyx), referred to as the DBd regimen, for 4 cycles, followed by post-induction therapy with cyclophosphamide + bortezomib + prednisone (referred to as the CyBorP regimen) for 8 cycles. Since patients with t(4;14) remain at high risk for relapse, maintenance therapy with dexamethasone weekly will be given until disease progression.
Detailed Description
-----------------
PROTOCOL SYNOPSIS A. TITLE: An Open-Label Phase II Study of the Efficacy of Combination Bortezomib-containing Regimens in the Treatment of newly diagnosed patients with t (4;14) positive Multiple Myeloma. B. RATIONALE: Between 15 and 20% of myeloma patients exhibit a t(4;14), which results in translocation of the receptor tyrosine kinase (TK) fibroblast growth factor receptor 3 (FGFR3) from chromosome 4 to the Immunoglobulin H (IgH) locus. The presence of a t(4;14) appears to confer an extremely poor prognosis. Patients with this abnormality do not experience prolonged remissions after a single autologous stem cell transplant (ASCT) using high-dose melphalan, and the optimal therapy of this group has not yet been defined. Specifically, data from Princess Margaret Hospital and the Mayo Clinic both indicate that the median progression-free survival (PFS) is only about 8 months and overall survival 18-22 months after ASCT. Unpublished data from the French Francophone Myeloma Intergroup (IFM) studies suggest that tandem transplants may improve these results modestly, but the outcome is still inferior compared with other cytogenetic subgroups. Initial unpublished observations suggested that t(4;14) patients with relapsed/refractory disease were uniquely sensitive to the new agent bortezomib. More recent information in larger numbers of patients indicates that responses to single agent bortezomib are seen in up to 50-65% of t(4;14) patients; the duration of response is similar to that seen in other subsets, i.e. in the range of 5-7 months. Combinations of bortezomib with agents such as doxorubicin, pegylated liposomal doxorubicin, thalidomide, cyclophosphamide, melphalan, thalidomide and corticosteroids have been evaluated in a number of clinical studies in recurrent myeloma, and the response rates (RR) appear to be improved compared to single agent bortezomib, and toxicity has been acceptable. In newly diagnosed myeloma patients, combinations such as vincristine, doxorubicin, dexamethasone (VAD) and thalidomide + dexamethasone are often utilized before ASCT. A study by Hussein et al. substituted pegylated liposomal doxorubicin for the conventional formulation of doxorubicin and noted a similar response rate with less grade 3/4 neutropenia, alopecia and sepsis; in addition, patients do not necessarily require a central venous catheter. More recently, Cavenagh et al. has reported remarkable activity with the so-called PAD regimen of bortezomib, doxorubicin and dexamethasone, with a combined Complete Remission (CR) + Partial Response (PR) rate of 67% following 1 cycle, and 93% after 4 cycles, with no impairment of the ability to collect blood stem cells for ASCT. Preliminary data from an ongoing Canadian phase II study of Doxil/Caelyx + Bortezomib + Dexamethasone (DBd), in which pegylated liposomal doxorubin, bortezomib and dexamethasone are combined, has produced encouraging results to date with minimal toxicity. In that study, DBd therapy was given for 4 cycles before ASCT independently of cytogenetic classification. Given the disappointing results with routine ASCT in t(4;14) patients, we propose this open label phase II study of bortezomib along with dexamethasone and pegylated liposomal doxorubicin (Doxil/Caelyx), referred to as the DBd regimen, for 4 cycles, followed by post-induction therapy with cyclophosphamide + bortezomib + prednisone (referred to as the CyBorP regimen) for 8 cycles. Since patients with t(4;14) remain at high risk for relapse, maintenance therapy with dexamethasone weekly will be given until disease progression. This approach will test the hypothesis that bortezomib-based therapy can improve the outcome of newly diagnosed t(4;14) multiple myeloma patients. C. OBJECTIVES OF THE STUDY: To evaluate the efficacy of the DBd regimen given as induction therapy, followed by post-induction therapy with CyBorP and maintenance therapy with dexamethasone in t(4;14) positive multiple myeloma (MM) patients. Primary Objectives To determine the time to progression (TTP) with this treatment regimen. Secondary Endpoints To determine the objective response rate following DBd induction therapy To determine the duration of response following DBd induction therapy To determine the objective response rate following CyBorP post-induction therapy To determine the duration of response following CyBorP post-induction therapy To determine PFS To determine overall survival To determine the safety profile of this regimen To examine the ability of bortezomib based regimens to repress FGFR3 signaling D. STUDY DESIGN: This is an open-label, Phase II study of induction therapy with bortezomib, pegylated liposomal doxorubicin (Doxil/Caelyx) and dexamethasone as initial therapy in patients with t(4;14). Each 21 day-cycle consists of bortezomib 1.3 mg/m2 (given as an I.V. bolus on Days 1, 4, 8, and 11) followed by a 10-day rest period (Days 12 to 21). DOXIL/CAELYX 30 mg/m2 will be given after bortezomib as at least a 1-hour I.V. infusion on Day 4 of each 21-day cycle. Dexamethasone 40 mg PO will be given on days 1-4, days 8-11 and days 15-18 during the first cycle. For the subsequent 3 cycles, dexamethasone 40 mg PO will be given on days 1-4 and days 11-14. Patients who do not experience disease progression may undergo elective, as per the attending physician's discretion, stem cell mobilization followed by stem cell collection and cryopreservation. Patients will then receive post-induction therapy with cyclophosphamide + bortezomib + prednisone (1.5 mg/m2 bortezomib on days 1, 8, and 15 I.V. + cyclophosphamide 300 mg/m2 PO weekly + prednisone 100 mg PO on alternate days) for 8 monthly 28 day cycles, followed by maintenance therapy with 40 mg of dexamethasone weekly per month until disease progression occurs. E. PATIENT CHARACTERISTICS: Untreated multiple myeloma patients who are t(4;14) positive by fluorescence in situ hybridization (FISH) will be considered for the study. Exclusion criteria include inadequate liver function aspartate aminotransferase (AST} and alanine aminotransferase (ALT) > 2.5 times the upper limit of normal), thrombocytopenia (platelets < 50 X 109/L), neutropenia (absolute neutrophil count < 1.0 x 109/L), pregnant or lactating women, and women of childbearing potential (WCBP) who are not using adequate contraception and Left Ventricular Ejection Fraction (LVEF) below the institutional Lower Limit Normal (LLN) or less than 40%; whichever value is higher. A patient may have received up to 4 months of other anti myeloma therapy, as part of the induction therapy, prior enrollment and still be considered eligible to participate in the study, as long as the patient's multiple myeloma has not progressed in the current regimen and the other eligibility criteria are met. F. STATISTICAL PLAN: The TTP from initiation of chemotherapy in patients treated with ASCT for this subset is approximately 12 months. An increase in TTP from 12 to 21 months would be of clinical significance. Using an 80% power to detect this time difference in a two-sided comparison patient, a sample size of 36 evaluable patients is required. This calculation assumes that each patient will be evaluated at a fixed time of 24 months. Assuming a 20% drop-out rate, a total sample size of 45 patients will be required. G. STUDY DESIGN: It is assumed that the new regimen will not be of further interest in t(4;14) positive myeloma patients if the TTP from the time of starting induction therapy is less than 21 months. Each patient will be followed every month until disease progression and then after every 6 moths up to 5 years for survival. An interim analysis will also be performed after 12 patients have completed the post-induction therapy with cyclophosphamide + bortezomib + prednisone (CyBorP). H. PATIENT ACCRUAL AND STUDY DURATION: Patients with t(4;14) represents only 15% of all myeloma patients, as such, accrual will be highly dependant on number of participating centers. It is estimated that approximately 350 newly-diagnosed patients will require cytogenetic screening in order to meet the accrual target. Accrual is expected to be complete within 48 months. Additional time is required, of course, to allow the response data to mature. All patients registered in the study will be accounted for (screen failures + enrolled patients). The number of patients who are not evaluable, who died or withdrew before treatment began will be specified. The distribution of follow-up times will be described and the number of patients lost to follow-up will be monitored. I. EFFICACY PARAMETERS: Beginning in cycle 1, the response to treatment will be determined during each cycle using the International Myeloma Working Group uniform response criteria for multiple myeloma as outlined in Section 11.0. Responses will be assessed by monoclonal protein, monoclonal paraprotein (M protein) quantification from serum and a 24-hour urine collection (including immunofixation, if needed), bone marrow plasma cells, assessment of lytic lesions, and soft tissue plasmacytomas. For patients with light chain disease or non-secretory myeloma, a serum sample for Free Lite chain testing will be obtained and the results will be compared to the levels reported quantified in the urine. J. REGISTRATION: Patients will be registered by completing the eligibility and enrollment checklist and forwarding it by fax to the Multiple Myeloma Research Coordinator at Princess Margaret Hospital at 416-946-4419, between the hours of 9 am and 4 pm Eastern Standard Time, up to 5 business days prior commencement of cycle 1 day 1. The research coordinator should also be contacted by phone at 416 946-4627. The checklist will be verified and a patient number will be assigned for eligible patients. K. SAMPLE PROCESSING: Centralized screening will be employed at Princess Margaret Hospital. Following informed consent site should send two fresh heparinized (green top tube) marrow samples (5cc per tube or best available) by overnight courier (see Appendix VI for shipping and notification instructions) for t4;14 screening test. Tri-color fluorescence in situ hybridization (FISH) for t(4;14) will be performed and reported back to referring site within 5-7 working days.
Official Title
-----------------
An Open-label Phase II Study of the Efficacy of Combination Bortezomib-containing Regimens in the Treatment of Newly Diagnosed Patients With t (4; 14) Positive Multiple Myeloma
Conditions
-----------------
Multiple Myeloma
Intervention / Treatment
-----------------
* Drug: Bortezomib
Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Patients previously diagnosed with MM based on criteria from the International Myeloma Working Group (IMWG) Patients who have 'measurable' disease Age 18 years at the time of signing Informed Consent A patient may have received up to 4 months of other anti myeloma therapy, as part of the induction therapy, prior enrollment and still be considered eligible to participate in the study, as long as the patient's multiple myeloma has not progressed on the current regimen and the other eligibility criteria are met. Patient is t(4;14) positive on screening assay. Exclusion Criteria: Concomitant therapy medications that include corticosteroids (> 10 mg per day of prednisone or equivalent) or other therapy that is or may be active against myeloma prior to day 1 (with the exception of radiation therapy or induction therapy as described under the above inclusion criteria section Peripheral neuropathy of Grade 2 or greater. Patients with evidence of mucosal or internal bleeding and/or refractoriness to platelet transfusions (i.e., unable to maintain a platelet count 50 x 109 /L). Patients with an absolute neutrophil count (ANC) < 1.0 x 109/L. Treatment to raise the ANC, such as granulocyte colony-stimulating factor (G-CSF) or granulocyte-macrophage colony-stimulating factor (GM-CSF) is not allowed within 14 days of study entry. Patients with hemoglobin < 80 g/L despite transfusion. Pregnant or lactating women
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: Single Arm<br>Please see intervention description for Bortezomib (Velcade) | Drug: Bortezomib<br>* 21 day-cycle Induction therapy:bortezomib 1.3 mg/m2 (I.V. Days 1, 4, 8, and 11), then 10-day rest period. DOXIL 30 mg/m2 given after bortezomib (I.V. infusion Day 4 of each cycle). Dexamethasone 40 mg PO on days 1-4,8-11 and 15-18 during the first cycle. Subsequent 3 cycles, dexamethasone 40 mg PO given on days 1-4 and 11-14. Patients who don't progress may undergo elective stem cell mobilization, stem cell collection and cryopreservation. Patients will then receive post-induction therapy 1.5 mg/m2 bortezomib days 1, 8, and 15 I.V. + cyclophosphamide 300 mg/m2 PO weekly + prednisone 100 mg PO on alternate days for 8 monthly 28 day cycles.Maintenance therapy with weekly 40 mg dexamethasone (days 1, 8, 15 and 22) every month until disease progression occurs.<br>* Other names: Velcade;|
What is the study measuring?
-----------------
Primary Outcome Measures
| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| To determine the time to progression (TTP) with this treatment regimen | Measured from the date of enrollment to the date of disease progression. Otherwise, censored at the time of last disease assessment. Responses were assessed using the International Myeloma Working Group criteria, involving a modified version of the European Group for Blood and Marrow Transplantation (EBMT) criteria, where the category of stringent complete response (sCR) was included for patients with normalization of the free light chain ratio.10,11 Bone marrow aspirate and biopsy were obtained routinely after induction therapy to confirm CR or sCR. Serum free light chain assay and serum and/or urine electrophoresis were performed monthly; immunofixation was performed when confirmation of very good partial response (VGPR), CR, or sCR was necessary. | Patients were followed monthly until disease progression and subsequently every six months for up to five years to assess OS. |
Secondary Outcome Measures
| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| To determine the objective response rate/duration following DBd induction and Cybor P post induction therapy | Objective response after completing induction therapy and until disease progression. | Patients were followed monthly until disease progression |
| To determine PFS | PFS was measured from the date of enrollment to the date of disease progression or death from any cause, otherwise censored at the time of last disease assessment. | 5 years |
| To determine overall survival | Patients were followed monthly until disease progression and subsequently every six months for up to five years to assess OS. | 5 years |
| To determine the safety profile of this regimen | Safety analyses focused on hematological and non-hematological adverse events of all grades. Toxicity was graded using the National Cancer Institute Common Terminology Criteria for Adverse Events (CTCAE version 3.0) | 5 years |
Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
newly diagnosed
|
NCT05610189
|
Multiple-dose Trial to Determine the Clinical Bioequivalence Between Tavapadon Tablets in Participants With Parkinson's Disease
|
The primary purpose of the study is to evaluate the bioequivalence (BE) of tavapadon 15 milligram (mg) tablet to 3x5 mg tablets in participants with Parkinson's disease.
|
A Phase 1, Randomized, Multiple-dose, Crossover Trial in Participants With Parkinson's Disease to Evaluate the Clinical Bioequivalence Between Tavapadon Tablets
|
Parkinson Disease
|
* Drug: Tavapadon
|
Inclusion Criteria:~Body mass index of 17.5 to 38.0 kilograms per square meter (kg/m^2), inclusive, and total body weight >50 kg (110 pounds [lb]) at Screening.~Participants with a diagnosis of Parkinson's disease (PD) that is consistent with the United Kingdom (UK) Parkinson's Disease Society Brain Bank diagnostic criteria.~Must be modified Hoehn & Yahr Stage I-III inclusive.~Must be on a stable dose of L-Dopa of at least 300 mg daily in conjunction with a dopa-decarboxylase inhibitor (e.g., L-Dopa/carbidopa, L Dopa/carbidopa/entacapone or L-Dopa/benserazide) administered at least 3 times per day for at least 2 weeks prior to the Day 1 Visit.~Exclusion Criteria:~Participants with a history or clinical features consistent with essential tremor, atypical or secondary parkinsonian syndrome (including, but not limited to, progressive supranuclear palsy, multiple system atrophy, cortico-basal degeneration, or drug-induced or poststroke parkinsonism).~Participants with a history of psychosis or hallucinations within the previous 12 months.~Participants with epilepsy, or history of epilepsy, or conditions that lower seizure threshold, seizures of any etiology (including substance or drug withdrawal), or who have increased risk of seizures as evidenced by history of electroencephalogram with epileptiform activity are excluded. Participants with a history of febrile seizures only are allowed with medical monitor approval.~History of substance or alcohol-use disorder (excluding nicotine; Diagnostic and Statistical Manual of Mental Disorders, 5th edition criteria) within 2 years prior to signing the informed consent form (ICF).~Participants who answer Yes on the C-SSRS Suicidal Ideation Item 4 (Active Suicidal Ideation with Some Intent to Act, Without Specific Plan) and whose most recent episode meeting criteria for this C-SSRS Item 4 occurred within the last 6 months, OR Participants who answer Yes on the C-SSRS Suicidal Ideation Item 5 (Active Suicidal Ideation with Specific Plan and Intent) and whose most recent episode meeting criteria for this C-SSRS Item 5 occurred within the last 6 months OR Participants who answer Yes on any of the 5 C-SSRS Suicidal Behavior Items (actual attempt, interrupted attempt, aborted attempt, preparatory acts, or behavior) and whose most recent episode meeting criteria for any of these 5 C-SSRS Suicidal Behavior Items occurred within the last 2 years, OR Participants who, in the opinion of the investigator, present a serious risk of suicide.~Participants who have attempted suicide in the past.~Positive result for human immunodeficiency virus (HIV) antibody, hepatitis B surface antigen, hepatitis B core antibody, or hepatitis C antibody with detectable viral ribonucleic acid (RNA) levels at Screening.~Have been diagnosed with symptomatic coronavirus disease (COVID-19) or test positive (i.e., using polymerase chain reaction [PCR] or rapid antigen test) for COVID-19 within 30 days prior to signing the ICF.~Participants taking strong or moderate cytochrome P450 family 3 subfamily A member 4 (CYP3A4) inducers or inhibitors or who would be likely to require concomitant therapy with CYP3A4 inducers or inhibitors during the trial.~NOTE: Other protocol-defined inclusion and exclusion criteria may apply.
|
45 Years
|
80 Years
|
All
|
No
|
Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: None (Open Label)
|
| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Maximum Observed Plasma Concentration (Cmax) of Tavapadon | | Pre-dose and at multiple timepoints post-dose up to Day 28 |
| Area Under the Plasma Concentration-time Curve Over the Dosing Interval (AUCτ) of Tavapadon | | Pre-dose and at multiple timepoints post-dose up to Day 28 |
|
| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Minimum Steady-state Plasma Concentration (Cmin,ss) of Tavapadon | | Pre-dose and at multiple timepoints post-dose up to Day 28 |
| Average Steady-state Plasma Concentration (Cavg,ss) of Tavapadon | | Pre-dose and at multiple timepoints post-dose up to Day 28 |
| Trough Concentration (Ctrough) of Tavapadon | | Pre-dose and at multiple timepoints post-dose up to Day 28 |
| Time of Maximum Observed Concentration (Tmax) of Tavapadon | | Pre-dose and at multiple timepoints post-dose up to Day 28 |
| Degree of Fluctuation [(Cmax - Cmin)/Cavg,ss] of Tavapadon | | Pre-dose and at multiple timepoints post-dose up to Day 28 |
| Peak-to-Trough Ratio (PTR) of Tavapadon | | Pre-dose and at multiple timepoints post-dose up to Day 28 |
| Swing [(Cmax - Cmin)/Cmin,ss] of Tavapadon | | Pre-dose and at multiple timepoints post-dose up to Day 28 |
| Apparent Clearance of Tavapadon From Plasma (CL/F) | | Pre-dose and at multiple timepoints post-dose up to Day 28 |
| Number of Participants With Adverse Events (AEs) and AEs by Severity | | Up to Day 36 |
| Number of Participants with Clinically Significant Changes in Electrocardiogram (ECG) Values | | Up to Day 29 |
| Number of Participants With Clinically Significant Changes in Vital Sign Values | | Up to Day 29 |
| Number of Participants With Clinically Significant Changes in Clinical Laboratory Assessments | | Up to Day 29 |
| Number of Participants With Clinically Significant Changes in Physical and Neurological Examination Results | | Up to Day 29 |
| Changes in Suicidality Assessed Using the Columbia Suicide Severity Rating Scale (C-SSRS) | The C-SSRS includes 'yes' or 'no' responses for assessment of suicidal ideation and behavior as well as numeric ratings for severity of ideation, if present (from 1 to 5, with 5 being the most severe). Greater lethality or potential lethality of suicidal behaviors (endorsed on the behavior subscale) indicates increased risk. | Up to Day 29 |
|
Parkinsonian Disorders, Brain Diseases, Central Nervous System Diseases, Nervous System Diseases, Movement Disorders, Neurodegenerative Diseases, Dopamine Agonist, Dopamine Therapy
|
Parkinson Disease, Parkinsonian Disorders, Basal Ganglia Diseases, Brain Diseases, Central Nervous System Diseases, Nervous System Diseases, Movement Disorders, Synucleinopathies, Neurodegenerative Diseases
|
| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Cohort 1: Tavapadon 1x15 mg Followed by 3x5 mg<br>Participants will receive tavapadon 1x15 mg tablet, orally, once daily (QD) from Day 15 to 21.~Participants will receive tavapadon 3x5 mg tablets, orally, QD from Day 22 to 28. | Drug: Tavapadon<br>* Oral tablets<br>* Other names: PF-06649751;|
| Experimental: Cohort 2: Tavapadon 3x5 mg Followed by 1x15 mg<br>Participants will receive tavapadon 3x5 mg tablets, orally, QD from Day 15 to 21.~Participants will receive tavapadon 1x15 mg tablet, orally, QD from Day 22 to 28. | Drug: Tavapadon<br>* Oral tablets<br>* Other names: PF-06649751;|
|
Multiple-dose Trial to Determine the Clinical Bioequivalence Between Tavapadon Tablets in Participants With Parkinson's Disease
Study Overview
=================
Brief Summary
-----------------
The primary purpose of the study is to evaluate the bioequivalence (BE) of tavapadon 15 milligram (mg) tablet to 3x5 mg tablets in participants with Parkinson's disease.
Official Title
-----------------
A Phase 1, Randomized, Multiple-dose, Crossover Trial in Participants With Parkinson's Disease to Evaluate the Clinical Bioequivalence Between Tavapadon Tablets
Conditions
-----------------
Parkinson Disease
Intervention / Treatment
-----------------
* Drug: Tavapadon
Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Body mass index of 17.5 to 38.0 kilograms per square meter (kg/m^2), inclusive, and total body weight >50 kg (110 pounds [lb]) at Screening. Participants with a diagnosis of Parkinson's disease (PD) that is consistent with the United Kingdom (UK) Parkinson's Disease Society Brain Bank diagnostic criteria. Must be modified Hoehn & Yahr Stage I-III inclusive. Must be on a stable dose of L-Dopa of at least 300 mg daily in conjunction with a dopa-decarboxylase inhibitor (e.g., L-Dopa/carbidopa, L Dopa/carbidopa/entacapone or L-Dopa/benserazide) administered at least 3 times per day for at least 2 weeks prior to the Day 1 Visit. Exclusion Criteria: Participants with a history or clinical features consistent with essential tremor, atypical or secondary parkinsonian syndrome (including, but not limited to, progressive supranuclear palsy, multiple system atrophy, cortico-basal degeneration, or drug-induced or poststroke parkinsonism). Participants with a history of psychosis or hallucinations within the previous 12 months. Participants with epilepsy, or history of epilepsy, or conditions that lower seizure threshold, seizures of any etiology (including substance or drug withdrawal), or who have increased risk of seizures as evidenced by history of electroencephalogram with epileptiform activity are excluded. Participants with a history of febrile seizures only are allowed with medical monitor approval. History of substance or alcohol-use disorder (excluding nicotine; Diagnostic and Statistical Manual of Mental Disorders, 5th edition criteria) within 2 years prior to signing the informed consent form (ICF). Participants who answer Yes on the C-SSRS Suicidal Ideation Item 4 (Active Suicidal Ideation with Some Intent to Act, Without Specific Plan) and whose most recent episode meeting criteria for this C-SSRS Item 4 occurred within the last 6 months, OR Participants who answer Yes on the C-SSRS Suicidal Ideation Item 5 (Active Suicidal Ideation with Specific Plan and Intent) and whose most recent episode meeting criteria for this C-SSRS Item 5 occurred within the last 6 months OR Participants who answer Yes on any of the 5 C-SSRS Suicidal Behavior Items (actual attempt, interrupted attempt, aborted attempt, preparatory acts, or behavior) and whose most recent episode meeting criteria for any of these 5 C-SSRS Suicidal Behavior Items occurred within the last 2 years, OR Participants who, in the opinion of the investigator, present a serious risk of suicide. Participants who have attempted suicide in the past. Positive result for human immunodeficiency virus (HIV) antibody, hepatitis B surface antigen, hepatitis B core antibody, or hepatitis C antibody with detectable viral ribonucleic acid (RNA) levels at Screening. Have been diagnosed with symptomatic coronavirus disease (COVID-19) or test positive (i.e., using polymerase chain reaction [PCR] or rapid antigen test) for COVID-19 within 30 days prior to signing the ICF. Participants taking strong or moderate cytochrome P450 family 3 subfamily A member 4 (CYP3A4) inducers or inhibitors or who would be likely to require concomitant therapy with CYP3A4 inducers or inhibitors during the trial. NOTE: Other protocol-defined inclusion and exclusion criteria may apply.
Ages Eligible for Study
-----------------
Minimum Age: 45 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: Crossover Assignment
Masking: None (Open Label)
Arms and Interventions
| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Cohort 1: Tavapadon 1x15 mg Followed by 3x5 mg<br>Participants will receive tavapadon 1x15 mg tablet, orally, once daily (QD) from Day 15 to 21. Participants will receive tavapadon 3x5 mg tablets, orally, QD from Day 22 to 28. | Drug: Tavapadon<br>* Oral tablets<br>* Other names: PF-06649751;|
| Experimental: Cohort 2: Tavapadon 3x5 mg Followed by 1x15 mg<br>Participants will receive tavapadon 3x5 mg tablets, orally, QD from Day 15 to 21. Participants will receive tavapadon 1x15 mg tablet, orally, QD from Day 22 to 28. | Drug: Tavapadon<br>* Oral tablets<br>* Other names: PF-06649751;|
What is the study measuring?
-----------------
Primary Outcome Measures
| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Maximum Observed Plasma Concentration (Cmax) of Tavapadon | | Pre-dose and at multiple timepoints post-dose up to Day 28 |
| Area Under the Plasma Concentration-time Curve Over the Dosing Interval (AUCτ) of Tavapadon | | Pre-dose and at multiple timepoints post-dose up to Day 28 |
Secondary Outcome Measures
| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Minimum Steady-state Plasma Concentration (Cmin,ss) of Tavapadon | | Pre-dose and at multiple timepoints post-dose up to Day 28 |
| Average Steady-state Plasma Concentration (Cavg,ss) of Tavapadon | | Pre-dose and at multiple timepoints post-dose up to Day 28 |
| Trough Concentration (Ctrough) of Tavapadon | | Pre-dose and at multiple timepoints post-dose up to Day 28 |
| Time of Maximum Observed Concentration (Tmax) of Tavapadon | | Pre-dose and at multiple timepoints post-dose up to Day 28 |
| Degree of Fluctuation [(Cmax - Cmin)/Cavg,ss] of Tavapadon | | Pre-dose and at multiple timepoints post-dose up to Day 28 |
| Peak-to-Trough Ratio (PTR) of Tavapadon | | Pre-dose and at multiple timepoints post-dose up to Day 28 |
| Swing [(Cmax - Cmin)/Cmin,ss] of Tavapadon | | Pre-dose and at multiple timepoints post-dose up to Day 28 |
| Apparent Clearance of Tavapadon From Plasma (CL/F) | | Pre-dose and at multiple timepoints post-dose up to Day 28 |
| Number of Participants With Adverse Events (AEs) and AEs by Severity | | Up to Day 36 |
| Number of Participants with Clinically Significant Changes in Electrocardiogram (ECG) Values | | Up to Day 29 |
| Number of Participants With Clinically Significant Changes in Vital Sign Values | | Up to Day 29 |
| Number of Participants With Clinically Significant Changes in Clinical Laboratory Assessments | | Up to Day 29 |
| Number of Participants With Clinically Significant Changes in Physical and Neurological Examination Results | | Up to Day 29 |
| Changes in Suicidality Assessed Using the Columbia Suicide Severity Rating Scale (C-SSRS) | The C-SSRS includes 'yes' or 'no' responses for assessment of suicidal ideation and behavior as well as numeric ratings for severity of ideation, if present (from 1 to 5, with 5 being the most severe). Greater lethality or potential lethality of suicidal behaviors (endorsed on the behavior subscale) indicates increased risk. | Up to Day 29 |
Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Parkinsonian Disorders, Brain Diseases, Central Nervous System Diseases, Nervous System Diseases, Movement Disorders, Neurodegenerative Diseases, Dopamine Agonist, Dopamine Therapy
|
|
NCT04921150
|
Standardized Management of Complex Twins
|
At present, the incidence of monochorionic twins in all pregnancies is around 3-5‰ worldwide.In 2019, the twin Committee of China Maternal and Child Health Association conducted statistics from 48 medical units all over the country, showing that there were 4,876 cases of monochorionic twins, accounting for 10.2‰ of all pregnancies.In addition to increased incidence of preterm delivery, miscarriage, and maternal complication, the unique placental vascular structure of monochorionic twins is associated with complex fetal complication such as twin-twin transfusion syndrome, selective intraurine growth restriction, twin anaemia-erythrocytosis sequence, twin reversed arterial perfusion sequence, one of twin with dysplasia, twins with single amniotic sac and conjunctions are common. At present, there is no unified standard for the diagnosis and treatment of these complicated twins, and various treatment methods have a great impact on the pregnancy outcome and fetal prognosis.Therefore, the standardized management of complex twins benefits diagnosis and treatment of complex twins and improves fetal prognosis.
|
Standardized Management of Complex Twins
|
Twins
|
* Other: standardization management
|
Inclusion Criteria:~complex twin disease 18-45 years~Exclusion Criteria:~single pregnancy normal twin pregnancy
| null | null |
Female
|
Accepts Healthy Volunteers
|
Primary Purpose: Treatment
Allocation: Non-Randomized
Intervention Model: Sequential Assignment
Masking: None (Open Label)
|
| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Standardized management system of twin pregnancy clinic | S/D score and Apgar score of complex twin pregnancy assessed by clinical doctors | 1 year |
|
| Intervention/Treatment |
| --- |
|Other: standardization management|Apply standardization management to improve the outcomes of pregnancy|
|
Standardized Management of Complex Twins
Study Overview
=================
Brief Summary
-----------------
At present, the incidence of monochorionic twins in all pregnancies is around 3-5‰ worldwide.In 2019, the twin Committee of China Maternal and Child Health Association conducted statistics from 48 medical units all over the country, showing that there were 4,876 cases of monochorionic twins, accounting for 10.2‰ of all pregnancies.In addition to increased incidence of preterm delivery, miscarriage, and maternal complication, the unique placental vascular structure of monochorionic twins is associated with complex fetal complication such as twin-twin transfusion syndrome, selective intraurine growth restriction, twin anaemia-erythrocytosis sequence, twin reversed arterial perfusion sequence, one of twin with dysplasia, twins with single amniotic sac and conjunctions are common. At present, there is no unified standard for the diagnosis and treatment of these complicated twins, and various treatment methods have a great impact on the pregnancy outcome and fetal prognosis.Therefore, the standardized management of complex twins benefits diagnosis and treatment of complex twins and improves fetal prognosis.
Official Title
-----------------
Standardized Management of Complex Twins
Conditions
-----------------
Twins
Intervention / Treatment
-----------------
* Other: standardization management
Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: complex twin disease 18-45 years Exclusion Criteria: single pregnancy normal twin pregnancy
Sexes Eligible for Study
-----------------
Female
Accepts Healthy Volunteers
-----------------
Accepts Healthy Volunteers
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
| Intervention/Treatment |
| --- |
|Other: standardization management|Apply standardization management to improve the outcomes of pregnancy|
What is the study measuring?
-----------------
Primary Outcome Measures
| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Standardized management system of twin pregnancy clinic | S/D score and Apgar score of complex twin pregnancy assessed by clinical doctors | 1 year |
|
||||
NCT01610648
|
Improving the STOP-Bang Screening Questionnaire for Patients With Sleep Apnea
|
The study is being conducted to test the ability of a simple questionnaire to detect mild, moderate or severe obstructive sleep apnea. The investigators are also investigating whether adding the size of the neck and waist can add to the accuracy of the questionnaire.~The study will be conducted at the Center for Sleep Medicine at Tufts Medical Center. The investigators hope to enroll 250 patients in our study at Tufts Medical Center.
|
We will complete a 12 item questionnaire and data sheet with the study subjects based on their responses and 2 measurements specified below, right before application of a study the start of their sleep study called Polysomnography.~If available, we will also use information from the subjects medical record, including information regarding a history of diabetes (blood sugar that is too high), high blood pressure and laboratory data such as blood sugar and blood lipids (fats in the blood). We will record this information for research purposes.~The 2 measurements performed for research purposes consist of the size of the neck and waist using a flexible tape measure. After the sleep study, we will also use results from that study in this research. We expect the subjects study participation to be completed in 30 minutes or less.~There will be no follow up. If a participant cannot complete the sleep study for any reason, the study team may decide to withdraw the subject's participation without further notice.~The study will be open for participation from June 2012 through November of 2012.
|
Improving the Sensitivity and Specificity of the STOP-Bang Screening Questionnaire for Patients With Obstructive Sleep Apnea
|
Sleep Apnea, Metabolic Syndrome
|
Inclusion Criteria:~Referral to the sleep center for a diagnostic study
|
18 Years
| null |
All
|
No
|
| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Cut-off value determination for each of three STOP-Bang versions | Determine the best cutoff value using receiver-operating characteristics curves separately for each of the 3 versions of the STOP-Bang questionnaire (original, re-weighted, Stop-Bang MEtS) for subjects with confirmed mild, moderate and severe sleep apnea according to the Apnea-Hypopnea Index AHI as defined by the society for sleep medicine. The cut-off values will be calculated separately for each category of severity. | The outcome measure will be assessed after aggregate data analysis has been completed. It is expected for January 2013 (up to 2 years) |
|
| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Cut-off value determination for each of three STOP-Bang versions | Determine the best cutoff value using receiver-operating characteristics curves separately for each of the 3 versions of the STOP-Bang questionnaire (original, re-weighted, Stop-Bang MEtS) for subjects with confirmed mild, moderate and severe sleep apnea according to the Oxygen Desaturation Index ODI as defined by the Society for sleep medicine. The cut-off values will be calculated separately for each category of severity. | The outcome measure will be assessed after aggregate data analysis has been completed. It is expected for January 2013 (up to 2 years) |
|
OSA, metabolic syndrome, Apnea-hypopnea index, Oxygen desaturation index
|
Apnea, Sleep Apnea Syndromes, Metabolic Syndrome, Respiration Disorders, Respiratory Tract Diseases, Signs and Symptoms, Respiratory, Sleep Disorders, Intrinsic, Dyssomnias, Sleep Wake Disorders, Nervous System Diseases, Insulin Resistance, Hyperinsulinism, Glucose Metabolism Disorders, Metabolic Diseases
|
| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Patients presenting for a diagnostic sleep study<br>Patients presenting to the TMC sleep center for sleep study | |
|
Improving the STOP-Bang Screening Questionnaire for Patients With Sleep Apnea
Study Overview
=================
Brief Summary
-----------------
The study is being conducted to test the ability of a simple questionnaire to detect mild, moderate or severe obstructive sleep apnea. The investigators are also investigating whether adding the size of the neck and waist can add to the accuracy of the questionnaire. The study will be conducted at the Center for Sleep Medicine at Tufts Medical Center. The investigators hope to enroll 250 patients in our study at Tufts Medical Center.
Detailed Description
-----------------
We will complete a 12 item questionnaire and data sheet with the study subjects based on their responses and 2 measurements specified below, right before application of a study the start of their sleep study called Polysomnography. If available, we will also use information from the subjects medical record, including information regarding a history of diabetes (blood sugar that is too high), high blood pressure and laboratory data such as blood sugar and blood lipids (fats in the blood). We will record this information for research purposes. The 2 measurements performed for research purposes consist of the size of the neck and waist using a flexible tape measure. After the sleep study, we will also use results from that study in this research. We expect the subjects study participation to be completed in 30 minutes or less. There will be no follow up. If a participant cannot complete the sleep study for any reason, the study team may decide to withdraw the subject's participation without further notice. The study will be open for participation from June 2012 through November of 2012.
Official Title
-----------------
Improving the Sensitivity and Specificity of the STOP-Bang Screening Questionnaire for Patients With Obstructive Sleep Apnea
Conditions
-----------------
Sleep Apnea, Metabolic Syndrome
Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Referral to the sleep center for a diagnostic 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?
-----------------
Arms and Interventions
| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Patients presenting for a diagnostic sleep study<br>Patients presenting to the TMC sleep center for sleep study | |
What is the study measuring?
-----------------
Primary Outcome Measures
| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Cut-off value determination for each of three STOP-Bang versions | Determine the best cutoff value using receiver-operating characteristics curves separately for each of the 3 versions of the STOP-Bang questionnaire (original, re-weighted, Stop-Bang MEtS) for subjects with confirmed mild, moderate and severe sleep apnea according to the Apnea-Hypopnea Index AHI as defined by the society for sleep medicine. The cut-off values will be calculated separately for each category of severity. | The outcome measure will be assessed after aggregate data analysis has been completed. It is expected for January 2013 (up to 2 years) |
Secondary Outcome Measures
| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Cut-off value determination for each of three STOP-Bang versions | Determine the best cutoff value using receiver-operating characteristics curves separately for each of the 3 versions of the STOP-Bang questionnaire (original, re-weighted, Stop-Bang MEtS) for subjects with confirmed mild, moderate and severe sleep apnea according to the Oxygen Desaturation Index ODI as defined by the Society for sleep medicine. The cut-off values will be calculated separately for each category of severity. | The outcome measure will be assessed after aggregate data analysis has been completed. It is expected for January 2013 (up to 2 years) |
Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
OSA, metabolic syndrome, Apnea-hypopnea index, Oxygen desaturation index
|
||
NCT02714920
|
DNA Repair Enzyme Signature in Head and Neck Cancer (CHEMRAD)
|
Squamous cell carcinoma (HNSCC) is the most frequent form of head and neck cancer. The therapeutic choice depends on the stage of the disease and the habits of the medical teams. Surgery, radiotherapy and chemotherapy can be used, alone or combined. However, none of the existing strategies has proven its superiority.~Chemotherapy and radiotherapy induce DNA damages in the tumor cells. However, cells have the ability to induce DNA reparation, capable of causing treatment resistance. DNA reparation in non-tumor tissues can also explain the toxicity of cancer treatments.~Investigation of DNA repair pathways involved in chemo- or radiation resistance could offer a good strategy for identifying biomarkers or indicators of treatment response. This study will explore the capacity of a comprehensive functional approach that addresses several pathways, based on the use of three innovative patented technologies, to classify the tumor response of HNSCC patients to treatments according to their DNA Repair Enzyme Signature.~Our hypothesis is that taking into account various clinical parameters (e.g. patient and tumor characteristics), treatment strategy and measuring the DNA Repair Enzyme Signature would create patients' profiles and optimize their management.
|
DNA Repair Enzyme Signature Associated With Response to Chemo- and Radio-therapy in Head and Neck Cancer: ChemRadAssay
|
Head Cancer, Neck Cancer
|
* Other: CHEMRAD assay
|
Inclusion Criteria:~Age over 18 years old;~HNSCC proven on a biopsy, located in the oral cavity or the oropharynx (the tumor must be accessible to a biopsy during an outpatient visit);~Tumor accessible to a biopsy under local anesthesia;~TNM classification: any stage except M1;~Eligible for radiotherapy as a curative treatment;~No surgery planned as exclusive treatment;~Able to comply with the scheduled visits;~Affiliated to or beneficiary of a social security system (or equivalent) ;~Having given written informed consent prior to any procedure related to the study.~Exclusion Criteria:~Recurrence or second cancer in a previously irradiated area;~Nasopharyngeal carcinoma;~Tumor requiring general anesthesia to perform the biopsy;~Radiotherapy planned to be provided outside of the investigation center;~Pregnant or lactating woman;~Adult ward of court (under guardianship or trusteeship).
|
18 Years
| null |
All
|
No
|
Primary Purpose: Screening
Intervention Model: Single Group Assignment
Masking: None (Open Label)
|
| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| DNA Repair Enzyme Signature biomarkers profiles according to intrinsic or treatment-induced radio- or chemo-resistance in different tumor and clinical settings. | Results of DNA Repair Enzyme biomarker profiles of tumor cells will be quantified before and during treatment with:~The excision/synthesis assay, as the incorporated fluorescence intensity;~The ODN (Oligonucleotide) assay, as the percentage of cleavage for the DNA target lesions;~The DSB (Double-strand breaks) Assay, as the incorporated fluorescence intensity.~The radio- or chemo-resistance will be defined as disease-free survival, i.e. absence of local or regional recurrence in irradiated tissue seen on CT-scan.~The different tumor and clinical settings will be determined with:~Patient and tumor characteristics, i.e. age, sex, etiological factors (tobacco, alcohol), localization and stage of the tumor, HPV (Human Papilloma Virus) status, p53 status;~Treatment strategy, i.e. all the treatments that will be administered to the patient and their sequence, including International Nonproprietary Name of the drugs and doses of chemo and/or radiotherapy | 18 months after the end of the treatments (approximately 24 months after the beginning of the study) |
|
| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| DNA Repair Enzyme Signature biomarkers profiles according to instrinsic or treatment-induced radio- or chemo-resistance. | Results of DNA Repair Enzyme biomarker profiles of tumor cells will be quantified before and during treatment with:~The excision/synthesis assay, as the incorporated fluorescence intensity;~The ODN assay, as the percentage of cleavage for the DNA target lesions;~The DSB Assay, as the incorporated fluorescence intensity. The radio- or chemo-resistance will be defined as disease-free survival, i.e. absence of local or regional recurrence in irradiated tissue measured on the CT-scan performed 4 months after the end of the treatment. | 4 months after the end of the treatments (approximately 10 months after the beginning of the study) |
| DNA Repair Enzyme Signature biomarkers profiles according to tumor response to treatment | Results of DNA Repair Enzyme biomarker profiles of tumor cells will be quantified before and during treatment with:~The excision/synthesis assay, as the incorporated fluorescence intensity;~The ODN assay, as the percentage of cleavage for the DNA target lesions;~The DSB Assay, as the incorporated fluorescence intensity. Global response to treatment measured on the CT-scan according to RECIST criteria, at 4 months after the end of the treatment. | 4 months after the end of the treatments (approximately 10 months after the beginning of the study) |
| DNA Repair Enzyme Signature biomarkers profiles according to tumor response to treatment | Results of DNA Repair Enzyme biomarker profiles of tumor cells will be quantified before and during treatment with:~The excision/synthesis assay, as the incorporated fluorescence intensity;~The ODN assay, as the percentage of cleavage for the DNA target lesions;~The DSB Assay, as the incorporated fluorescence intensity. Global response to treatment measured on the CT-scan according to RECIST criteria, at 18 months, after the end of the treatment. | 18 months after the end of the treatments (approximately 24 months after the beginning of the study) |
| DNA Repair Enzyme Signature biomarkers profiles according to immediate treatment-induced toxicity | Results of DNA Repair Enzyme biomarker profiles of tumor cells will be quantified before and during treatment with:~The excision/synthesis assay, as the incorporated fluorescence intensity;~The ODN assay, as the percentage of cleavage for the DNA target lesions;~The DSB Assay, as the incorporated fluorescence intensity. Treatment-induced adverse events occurring during the treatment. | At the end of the treatments (an average of 6 months after the beginning of the study) |
| DNA Repair Enzyme Signature biomarkers profiles of Peripheral Blood Mononuclear Cells (PBMCs). | Results of DNA repair enzyme signature of Peripheral Blood Mononuclear Cells quantified before and during treatment with:~The ODN assay, as the percentage of cleavage for the DNA target lesions;~The DSB Assay, as the incorporated fluorescence intensity. | 4 months after the end of the treatment (approximately 10 months after the beginning of the study) |
| DNA Repair Enzyme Signature biomarkers profiles of Peripheral Blood Mononuclear Cells (PBMCs). | Results of DNA repair enzyme signature of Peripheral Blood Mononuclear Cells quantified before and during treatment with:~The ODN assay, as the percentage of cleavage for the DNA target lesions;~The DSB Assay, as the incorporated fluorescence intensity. | 18 months after the end of the treatment (approximately 24 months after the beginning of the study) |
|
DNA Repair Enzyme Signature, instrinsic radio- or chemo-resistance, treatment-induced radio- or chemo-resistance
|
Head and Neck Neoplasms, Neoplasms by Site, Neoplasms
|
| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Other: DNA Repair enzyme signature<br>Tumor biopsies and blood samples performed specifically to determine DNA Repair enzyme signature biomarkers profiles (CHEMRAD assay) | Other: CHEMRAD assay<br>* CHEMRAD is a new biomarker research strategy based on three assays that enables the functional characterization of DNA repair capacities.<br>|
|
DNA Repair Enzyme Signature in Head and Neck Cancer (CHEMRAD)
Study Overview
=================
Brief Summary
-----------------
Squamous cell carcinoma (HNSCC) is the most frequent form of head and neck cancer. The therapeutic choice depends on the stage of the disease and the habits of the medical teams. Surgery, radiotherapy and chemotherapy can be used, alone or combined. However, none of the existing strategies has proven its superiority. Chemotherapy and radiotherapy induce DNA damages in the tumor cells. However, cells have the ability to induce DNA reparation, capable of causing treatment resistance. DNA reparation in non-tumor tissues can also explain the toxicity of cancer treatments. Investigation of DNA repair pathways involved in chemo- or radiation resistance could offer a good strategy for identifying biomarkers or indicators of treatment response. This study will explore the capacity of a comprehensive functional approach that addresses several pathways, based on the use of three innovative patented technologies, to classify the tumor response of HNSCC patients to treatments according to their DNA Repair Enzyme Signature. Our hypothesis is that taking into account various clinical parameters (e.g. patient and tumor characteristics), treatment strategy and measuring the DNA Repair Enzyme Signature would create patients' profiles and optimize their management.
Official Title
-----------------
DNA Repair Enzyme Signature Associated With Response to Chemo- and Radio-therapy in Head and Neck Cancer: ChemRadAssay
Conditions
-----------------
Head Cancer, Neck Cancer
Intervention / Treatment
-----------------
* Other: CHEMRAD assay
Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Age over 18 years old; HNSCC proven on a biopsy, located in the oral cavity or the oropharynx (the tumor must be accessible to a biopsy during an outpatient visit); Tumor accessible to a biopsy under local anesthesia; TNM classification: any stage except M1; Eligible for radiotherapy as a curative treatment; No surgery planned as exclusive treatment; Able to comply with the scheduled visits; Affiliated to or beneficiary of a social security system (or equivalent) ; Having given written informed consent prior to any procedure related to the study. Exclusion Criteria: Recurrence or second cancer in a previously irradiated area; Nasopharyngeal carcinoma; Tumor requiring general anesthesia to perform the biopsy; Radiotherapy planned to be provided outside of the investigation center; Pregnant or lactating woman; Adult ward of court (under guardianship or trusteeship).
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: Screening
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Arms and Interventions
| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Other: DNA Repair enzyme signature<br>Tumor biopsies and blood samples performed specifically to determine DNA Repair enzyme signature biomarkers profiles (CHEMRAD assay) | Other: CHEMRAD assay<br>* CHEMRAD is a new biomarker research strategy based on three assays that enables the functional characterization of DNA repair capacities.<br>|
What is the study measuring?
-----------------
Primary Outcome Measures
| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| DNA Repair Enzyme Signature biomarkers profiles according to intrinsic or treatment-induced radio- or chemo-resistance in different tumor and clinical settings. | Results of DNA Repair Enzyme biomarker profiles of tumor cells will be quantified before and during treatment with: The excision/synthesis assay, as the incorporated fluorescence intensity; The ODN (Oligonucleotide) assay, as the percentage of cleavage for the DNA target lesions; The DSB (Double-strand breaks) Assay, as the incorporated fluorescence intensity. The radio- or chemo-resistance will be defined as disease-free survival, i.e. absence of local or regional recurrence in irradiated tissue seen on CT-scan. The different tumor and clinical settings will be determined with: Patient and tumor characteristics, i.e. age, sex, etiological factors (tobacco, alcohol), localization and stage of the tumor, HPV (Human Papilloma Virus) status, p53 status; Treatment strategy, i.e. all the treatments that will be administered to the patient and their sequence, including International Nonproprietary Name of the drugs and doses of chemo and/or radiotherapy | 18 months after the end of the treatments (approximately 24 months after the beginning of the study) |
Secondary Outcome Measures
| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| DNA Repair Enzyme Signature biomarkers profiles according to instrinsic or treatment-induced radio- or chemo-resistance. | Results of DNA Repair Enzyme biomarker profiles of tumor cells will be quantified before and during treatment with: The excision/synthesis assay, as the incorporated fluorescence intensity; The ODN assay, as the percentage of cleavage for the DNA target lesions; The DSB Assay, as the incorporated fluorescence intensity. The radio- or chemo-resistance will be defined as disease-free survival, i.e. absence of local or regional recurrence in irradiated tissue measured on the CT-scan performed 4 months after the end of the treatment. | 4 months after the end of the treatments (approximately 10 months after the beginning of the study) |
| DNA Repair Enzyme Signature biomarkers profiles according to tumor response to treatment | Results of DNA Repair Enzyme biomarker profiles of tumor cells will be quantified before and during treatment with: The excision/synthesis assay, as the incorporated fluorescence intensity; The ODN assay, as the percentage of cleavage for the DNA target lesions; The DSB Assay, as the incorporated fluorescence intensity. Global response to treatment measured on the CT-scan according to RECIST criteria, at 4 months after the end of the treatment. | 4 months after the end of the treatments (approximately 10 months after the beginning of the study) |
| DNA Repair Enzyme Signature biomarkers profiles according to tumor response to treatment | Results of DNA Repair Enzyme biomarker profiles of tumor cells will be quantified before and during treatment with: The excision/synthesis assay, as the incorporated fluorescence intensity; The ODN assay, as the percentage of cleavage for the DNA target lesions; The DSB Assay, as the incorporated fluorescence intensity. Global response to treatment measured on the CT-scan according to RECIST criteria, at 18 months, after the end of the treatment. | 18 months after the end of the treatments (approximately 24 months after the beginning of the study) |
| DNA Repair Enzyme Signature biomarkers profiles according to immediate treatment-induced toxicity | Results of DNA Repair Enzyme biomarker profiles of tumor cells will be quantified before and during treatment with: The excision/synthesis assay, as the incorporated fluorescence intensity; The ODN assay, as the percentage of cleavage for the DNA target lesions; The DSB Assay, as the incorporated fluorescence intensity. Treatment-induced adverse events occurring during the treatment. | At the end of the treatments (an average of 6 months after the beginning of the study) |
| DNA Repair Enzyme Signature biomarkers profiles of Peripheral Blood Mononuclear Cells (PBMCs). | Results of DNA repair enzyme signature of Peripheral Blood Mononuclear Cells quantified before and during treatment with: The ODN assay, as the percentage of cleavage for the DNA target lesions; The DSB Assay, as the incorporated fluorescence intensity. | 4 months after the end of the treatment (approximately 10 months after the beginning of the study) |
| DNA Repair Enzyme Signature biomarkers profiles of Peripheral Blood Mononuclear Cells (PBMCs). | Results of DNA repair enzyme signature of Peripheral Blood Mononuclear Cells quantified before and during treatment with: The ODN assay, as the percentage of cleavage for the DNA target lesions; The DSB Assay, as the incorporated fluorescence intensity. | 18 months after the end of the treatment (approximately 24 months after the beginning of the study) |
Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
DNA Repair Enzyme Signature, instrinsic radio- or chemo-resistance, treatment-induced radio- or chemo-resistance
|
|
NCT02169986
|
Atopic Dermatitis Adherence Study
|
Forgetting is usually listed as the most important cause of low adherence among patients. Most studies to date have looked at the adherence of adults or adolescent population. No studies have been done looking specifically at adherence to topical treatment by parents/caregivers of young children. Our project will try to replicate the same results among the parents/caregivers responsible for children ten years and under. The population in this study will be the parents/caregivers of children 10 and under with atopic dermatitis and the intervention will be the effect of electronic reminders in adherence rates for the use of a moisturizer which is recognized as part of the standard of care in the treatment of atopic dermatitis.
|
Non Adherence to treatment is a common concern among physicians because it is associated with negative impact on patients' health. Among the different factors that can explain why treatment adherence is so low, forgetfulness is the most common.~Several interventions have been put into practice. Some of them have been proven to be successful, others not. An effective intervention not only has to be successful but also practical.~Technology is an integral part of our everyday lives. In Canada, most adults have access to smartphones, which opens the door to a world of new innovations. Among these are useful applications designed to improve different aspects of every day life.~Electronic reminders are applications designed to send messages, which could improve the adherence to treatment. So far, there are several studies that have proven this benefit in older children and adult population. At this moment, there are no studies involving younger children. Therefore, in this study, the null hypothesis is that electronic reminders will improve the adherence to twice daily application of moisturizers among parents/caregivers of children 10 and under with atopic dermatitis.~The study population will be parents/caregivers of children age 10 and under with atopic dermatitis recruited from Dr. Bergman's paediatric dermatology clinic.~The parents/caregivers of the patients will be invited to participate in this project by the Medical Office Assistant who will send them a letter with the invitation one week before their scheduled appointment. If they agree to participate, they will be asked to sign a consent form and then they will be asked to select an unmarked envelope from a container. The envelopes contain the information for two different groups, one is the experimental and the other the control group.~The experimental group will have the extra task of downloading and utilizing an application called MediSafe. This application will be set up to send reminders two times per day. The control group will be encouraged to continue with the standard of care with no added intervention. Both groups will received a free unlabeled bottle of CeraVe cream. The moisturizer will be unlabeled so as not to allow parents/caregivers perceptions on a specific brand to affect their utilization. External forces such as advertising the parents/caregivers sees or cost of the product could affect the parents/caregivers perception of value and in turn affect adherence.~The parents/caregivers will also receive a calendar in which they have to mark every time their children have moisturizer applied. The calendar will be provided as label on the bottle of moisturizer.~If during the study period the parents/caregivers run out of moisturizer, they can return to the clinic to pick up extra bottles of moisturizer at no cost.~The atopic dermatitis of patients from both groups will be assessed using the EASI score at the beginning and at the end of the 28 days.~Additionally, the parents/caregivers of both groups will be asked to fill up a brief survey form. They will submit this form, along with the calendar label, in an unmarked envelope to maintain anonymity.~The bottles of moisturizer will be weighed before and after the study and also every time a refill of moisturizer is required, to determine the amount of moisturizer used by each group.~This study will follow the standard of care for treatment of atopic dermatitis; no treatment will be withheld.~The principal outcome of this study is to probe whether or not electronic reminders can improve the adherence of moisturizer use in parents/caregivers of children 10 years and under with atopic dermatitis. The changes in the EASI score of the patients after the study and the differences in the amount of moisturizer used per body surface area will be secondary outcomes.~The number of times the calendar label will be marked will reflect the adherence to the treatment. Other data such as severity of eczema, and amount of moisturizer used will be collected. The height, weight, severity of eczema and use of steroid/calcineurin inhibitors will provide additional information that could be used indirectly to measure adherence.~Regarding the data analysis:~Mean differences between the experimental and control groups on adherence and EASI scores will be analyzed using Student's t-test for independent groups. Possible difference on treatment compliance between baseline and post-implementation within the groups will be explored using Student's dependent t-test for paired samples. This pilot study's sample size will be sufficient for the planned analyses, and to help determine effect size and power needed to conduct a larger study on this topic. Univariate descriptive statistics will be reported for all variables.
|
Family Practice Resident Research Project: Do Electronic Reminders Increase Adherence of Moisturizer Utilization in Paediatric Atopic Dermatitis?
|
Atopic Dermatitis/Eczema
|
* Behavioral: electronic reminders
|
Inclusion Criteria:~Parents/caregivers of children age 10 and under with atopic dermatitis from Dr. Bergman's dermatology clinic.~The parents/caregivers must have a smartphone and not already be using an electronic reminder system.~At least one of the parents/caregivers must have an adequate level of English proficiency in order to follow the instructions required by this project mostly because the electronic reminders are available in English only.~Exclusion Criteria:~All parents/caregivers of children over the age of 10 with atopic dermatitis.~Patients receiving systemic immunosuppressive therapy.~Patients who have a documented sensitivity to CeraVe.~Parents/caregivers unable to follow instructions in English,~Parents/caregivers without smartphones.~Parents/caregivers already using electronic reminders.
| null |
10 Years
|
All
|
No
|
Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single
|
| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Adherence | The results on adherence of the 20 parents/caregivers in the experimental arm(using electronic reminders) will be contrasted with another 20 parents/caregivers in the control arm. | Effects of electronic reminders on the adherence of 20 parents/caregivers at the end of 28 days study |
|
| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| EASI score changes | The differences in the EASI score on both groups can be used as and indirect measurement of the adherence of the parents/caregivers to the treatment. | The EASI score of the patients' eczema will be measured at the beginning and end of the 28 days study |
| Moisturizer | The moisturizer jar will be weighted at the beginning and end of the study. That way the amount of moisturizer will be calculated in grams. Because the body surface of the patients in both groups will be obtained at the beginning of the study, the amount of moisturizer per surface can be estimated. If there are significant differences in the use of moisturizer among both groups per unit of surface, this could be used as an indirect measurement of adherence. | The use of moisturizer among both groups could be used as an indirect measure of adherence to treatment |
|
Eczema, Dermatitis, Atopic, Dermatitis, Skin Diseases, Skin Diseases, Genetic, Genetic Diseases, Inborn, Skin Diseases, Eczematous, Hypersensitivity, Immediate, Hypersensitivity, Immune System Diseases
|
| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| No Intervention: control group<br>Parents/caregivers will receive the standard of care. | |
| Experimental: electronic reminders<br>In this group, the parents/caregivers will receive two daily electronic reminders in addition to the standard of care. | Behavioral: electronic reminders<br> <br> |
|
Atopic Dermatitis Adherence Study
Study Overview
=================
Brief Summary
-----------------
Forgetting is usually listed as the most important cause of low adherence among patients. Most studies to date have looked at the adherence of adults or adolescent population. No studies have been done looking specifically at adherence to topical treatment by parents/caregivers of young children. Our project will try to replicate the same results among the parents/caregivers responsible for children ten years and under. The population in this study will be the parents/caregivers of children 10 and under with atopic dermatitis and the intervention will be the effect of electronic reminders in adherence rates for the use of a moisturizer which is recognized as part of the standard of care in the treatment of atopic dermatitis.
Detailed Description
-----------------
Non Adherence to treatment is a common concern among physicians because it is associated with negative impact on patients' health. Among the different factors that can explain why treatment adherence is so low, forgetfulness is the most common. Several interventions have been put into practice. Some of them have been proven to be successful, others not. An effective intervention not only has to be successful but also practical. Technology is an integral part of our everyday lives. In Canada, most adults have access to smartphones, which opens the door to a world of new innovations. Among these are useful applications designed to improve different aspects of every day life. Electronic reminders are applications designed to send messages, which could improve the adherence to treatment. So far, there are several studies that have proven this benefit in older children and adult population. At this moment, there are no studies involving younger children. Therefore, in this study, the null hypothesis is that electronic reminders will improve the adherence to twice daily application of moisturizers among parents/caregivers of children 10 and under with atopic dermatitis. The study population will be parents/caregivers of children age 10 and under with atopic dermatitis recruited from Dr. Bergman's paediatric dermatology clinic. The parents/caregivers of the patients will be invited to participate in this project by the Medical Office Assistant who will send them a letter with the invitation one week before their scheduled appointment. If they agree to participate, they will be asked to sign a consent form and then they will be asked to select an unmarked envelope from a container. The envelopes contain the information for two different groups, one is the experimental and the other the control group. The experimental group will have the extra task of downloading and utilizing an application called MediSafe. This application will be set up to send reminders two times per day. The control group will be encouraged to continue with the standard of care with no added intervention. Both groups will received a free unlabeled bottle of CeraVe cream. The moisturizer will be unlabeled so as not to allow parents/caregivers perceptions on a specific brand to affect their utilization. External forces such as advertising the parents/caregivers sees or cost of the product could affect the parents/caregivers perception of value and in turn affect adherence. The parents/caregivers will also receive a calendar in which they have to mark every time their children have moisturizer applied. The calendar will be provided as label on the bottle of moisturizer. If during the study period the parents/caregivers run out of moisturizer, they can return to the clinic to pick up extra bottles of moisturizer at no cost. The atopic dermatitis of patients from both groups will be assessed using the EASI score at the beginning and at the end of the 28 days. Additionally, the parents/caregivers of both groups will be asked to fill up a brief survey form. They will submit this form, along with the calendar label, in an unmarked envelope to maintain anonymity. The bottles of moisturizer will be weighed before and after the study and also every time a refill of moisturizer is required, to determine the amount of moisturizer used by each group. This study will follow the standard of care for treatment of atopic dermatitis; no treatment will be withheld. The principal outcome of this study is to probe whether or not electronic reminders can improve the adherence of moisturizer use in parents/caregivers of children 10 years and under with atopic dermatitis. The changes in the EASI score of the patients after the study and the differences in the amount of moisturizer used per body surface area will be secondary outcomes. The number of times the calendar label will be marked will reflect the adherence to the treatment. Other data such as severity of eczema, and amount of moisturizer used will be collected. The height, weight, severity of eczema and use of steroid/calcineurin inhibitors will provide additional information that could be used indirectly to measure adherence. Regarding the data analysis: Mean differences between the experimental and control groups on adherence and EASI scores will be analyzed using Student's t-test for independent groups. Possible difference on treatment compliance between baseline and post-implementation within the groups will be explored using Student's dependent t-test for paired samples. This pilot study's sample size will be sufficient for the planned analyses, and to help determine effect size and power needed to conduct a larger study on this topic. Univariate descriptive statistics will be reported for all variables.
Official Title
-----------------
Family Practice Resident Research Project: Do Electronic Reminders Increase Adherence of Moisturizer Utilization in Paediatric Atopic Dermatitis?
Conditions
-----------------
Atopic Dermatitis/Eczema
Intervention / Treatment
-----------------
* Behavioral: electronic reminders
Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Parents/caregivers of children age 10 and under with atopic dermatitis from Dr. Bergman's dermatology clinic. The parents/caregivers must have a smartphone and not already be using an electronic reminder system. At least one of the parents/caregivers must have an adequate level of English proficiency in order to follow the instructions required by this project mostly because the electronic reminders are available in English only. Exclusion Criteria: All parents/caregivers of children over the age of 10 with atopic dermatitis. Patients receiving systemic immunosuppressive therapy. Patients who have a documented sensitivity to CeraVe. Parents/caregivers unable to follow instructions in English, Parents/caregivers without smartphones. Parents/caregivers already using electronic reminders.
Ages Eligible for Study
-----------------
Maximum Age: 10 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 |
| --- | --- |
| No Intervention: control group<br>Parents/caregivers will receive the standard of care. | |
| Experimental: electronic reminders<br>In this group, the parents/caregivers will receive two daily electronic reminders in addition to the standard of care. | Behavioral: electronic reminders<br> <br> |
What is the study measuring?
-----------------
Primary Outcome Measures
| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Adherence | The results on adherence of the 20 parents/caregivers in the experimental arm(using electronic reminders) will be contrasted with another 20 parents/caregivers in the control arm. | Effects of electronic reminders on the adherence of 20 parents/caregivers at the end of 28 days study |
Secondary Outcome Measures
| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| EASI score changes | The differences in the EASI score on both groups can be used as and indirect measurement of the adherence of the parents/caregivers to the treatment. | The EASI score of the patients' eczema will be measured at the beginning and end of the 28 days study |
| Moisturizer | The moisturizer jar will be weighted at the beginning and end of the study. That way the amount of moisturizer will be calculated in grams. Because the body surface of the patients in both groups will be obtained at the beginning of the study, the amount of moisturizer per surface can be estimated. If there are significant differences in the use of moisturizer among both groups per unit of surface, this could be used as an indirect measurement of adherence. | The use of moisturizer among both groups could be used as an indirect measure of adherence to treatment |
|
|
NCT00163696
|
Multi Breath Nitrogen Washout (MBNW) as a Measure of Small Airway Function in Patients With Respiratory Disease
|
The researchers are investigating a novel technique, the multi breath nitrogen washout technique, to measure airway changes in various respiratory diseases.
|
It is well documented that there are significant ventilatory changes in respiratory diseases such as cystic fibrosis, asthma and the onset of bronchiolitis obliterans syndrome (BOS) following chronic rejection of lung transplantation. At present, we use measures such as spirometry and lung biopsies to determine the changes of airway function and disease severity. Our aim is to develop a novel technique called the multi breath nitrogen washout (MBNW) which we believe is able to measure the inhomogeneity of ventilation in both the larger airways (conductive region, generation 1 - 16) as well as the smaller airways (acinar region 17 - 23). Our belief is that these measurements are much more subtle than current techniques and will be more sensitive in measuring large and small airway changes in disease. The MBNW can also give us an insight as to which particular zones of the lung are affected in differing respiratory disease. For example, it is believed that BOS begins at the distal portion of the lung (acinar region) and proceeds towards the proximal zone (conductive). However, at present no current techniques can differentiate between damage to the acinar zone and the conductive zone or indeed accurately measure small airway (acinar zone) function. We believe the the MBNW has the capacity to do so.
|
Measurements of Inhomogeneity of the Small Airway With Patients With Cystic Fibrosis, Asthma and Bronchiolitis Obliterans Syndrome (Post Transplant) Using the Multi Breath Nitrogen Washout Technique
|
Cystic Fibrosis, Asthma, Bronchiolitis Obliterans, Lung Transplantation
|
Inclusion Criteria:~Doctor diagnosed cystic fibrosis, asthma~Lung transplant recipient~Exclusion Criteria:~Smoke history of less than 10 pack years
|
18 Years
|
65 Years
|
All
|
No
|
| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
|
MBNW, Ventilation, small airways, Lung Transplant recipients (Bronchiolitis Obliterans syndrome)
|
Bronchiolitis, Cystic Fibrosis, Asthma, Bronchiolitis Obliterans, Bronchiolitis Obliterans Syndrome, Fibrosis, Bronchial Diseases, Respiratory Tract Diseases, Lung Diseases, Obstructive, Lung Diseases, Respiratory Hypersensitivity, Hypersensitivity, Immediate, Hypersensitivity, Immune System Diseases, Pathologic Processes, Pancreatic Diseases, Digestive System Diseases, Genetic Diseases, Inborn, Infant, Newborn, Diseases, Bronchitis, Respiratory Tract Infections, Infections, Organizing Pneumonia, Graft vs Host Disease
|
Multi Breath Nitrogen Washout (MBNW) as a Measure of Small Airway Function in Patients With Respiratory Disease
Study Overview
=================
Brief Summary
-----------------
The researchers are investigating a novel technique, the multi breath nitrogen washout technique, to measure airway changes in various respiratory diseases.
Detailed Description
-----------------
It is well documented that there are significant ventilatory changes in respiratory diseases such as cystic fibrosis, asthma and the onset of bronchiolitis obliterans syndrome (BOS) following chronic rejection of lung transplantation. At present, we use measures such as spirometry and lung biopsies to determine the changes of airway function and disease severity. Our aim is to develop a novel technique called the multi breath nitrogen washout (MBNW) which we believe is able to measure the inhomogeneity of ventilation in both the larger airways (conductive region, generation 1 - 16) as well as the smaller airways (acinar region 17 - 23). Our belief is that these measurements are much more subtle than current techniques and will be more sensitive in measuring large and small airway changes in disease. The MBNW can also give us an insight as to which particular zones of the lung are affected in differing respiratory disease. For example, it is believed that BOS begins at the distal portion of the lung (acinar region) and proceeds towards the proximal zone (conductive). However, at present no current techniques can differentiate between damage to the acinar zone and the conductive zone or indeed accurately measure small airway (acinar zone) function. We believe the the MBNW has the capacity to do so.
Official Title
-----------------
Measurements of Inhomogeneity of the Small Airway With Patients With Cystic Fibrosis, Asthma and Bronchiolitis Obliterans Syndrome (Post Transplant) Using the Multi Breath Nitrogen Washout Technique
Conditions
-----------------
Cystic Fibrosis, Asthma, Bronchiolitis Obliterans, Lung Transplantation
Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Doctor diagnosed cystic fibrosis, asthma Lung transplant recipient Exclusion Criteria: Smoke history of less than 10 pack years
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?
-----------------
What is the study measuring?
-----------------
Primary Outcome Measures
| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
MBNW, Ventilation, small airways, Lung Transplant recipients (Bronchiolitis Obliterans syndrome)
|
||||
NCT00101062
|
Letrozole and Celecoxib in Treating Postmenopausal Women With Locally Advanced or Metastatic Breast Cancer
|
RATIONALE: Estrogen can cause the growth of breast cancer cells. Hormone therapy using letrozole may fight breast cancer by lowering the amount of estrogen the body makes. Celecoxib may stop the growth of tumor cells by blocking some of the enzymes needed for cell growth and by blocking blood flow to the tumor. Giving letrozole with celecoxib may kill more tumor cells.~PURPOSE: This phase II trial is studying how well letrozole and celecoxib work in treating postmenopausal women with locally advanced or metastatic breast cancer.
|
OBJECTIVES:~Primary~Determine the response rate in postmenopausal women with hormone receptor-positive locally advanced or metastatic adenocarcinoma of the breast treated with letrozole and celecoxib as first-line therapy.~Secondary~Determine the time to disease progression and overall survival of patients treated with this regimen.~Determine the toxicity of this regimen in these patients.~Compare cyclooxygenase activity in blood and tumor cells from these patients before and after treatment with this regimen.~Determine the effect of this regimen on aromatase activity, tumor proliferation, and angiogenesis in tumor samples from these patients.~OUTLINE: This is a multicenter study.~Patients receive oral letrozole once daily and oral celecoxib twice daily on days 1-28. Courses repeat every 28 days in the absence of disease progression or unacceptable toxicity.~Patients are followed for survival.~PROJECTED ACCRUAL: A total of 45-72 patients will be accrued for this study.
|
Phase II Study of Letrozole (Femara) and Celecoxib (Celebrex) in Postmenopausal Women With Hormone Receptor-Positive Locally Advanced or Metastatic Breast Cancer
|
Breast Cancer
|
* Drug: celecoxib
* Drug: letrozole
|
DISEASE CHARACTERISTICS:~Histologically or cytologically confirmed adenocarcinoma of the breast~Locally advanced or metastatic disease~Measurable disease~No bone disease only~No history of brain metastases unless controlled with radiotherapy or surgical resection for ≥ 6 months before study entry~Hormone receptor status:~Estrogen receptor- OR progesterone receptor-positive~PATIENT CHARACTERISTICS:~Age~18 and over~Sex~Female~Menopausal status~Postmenopausal, as defined by 1 of the following:~Prior bilateral oophorectomy~Prior bilateral ovarian irradiation~No spontaneous menstrual bleeding within the past 12 months~Age 55 and over AND prior hysterectomy without oophorectomy~Age 54 and under AND prior hysterectomy without oophorectomy (or status of ovaries is unknown) AND documented follicle-stimulating hormone level in postmenopausal range~Performance status~ECOG 0-2~Life expectancy~At least 3 months~Hematopoietic~Granulocyte count ≥ 1,000/mm^3~Platelet count ≥ 100,000/mm^3~Hepatic~Bilirubin ≤ 1.5 times upper limit of normal (ULN)~AST and ALT ≤ 2.5 times ULN~Renal~Creatinine ≤ 1.5 times ULN~Other~No prior allergic reaction attributed to compounds of similar chemical or biologic composition to study drugs~No prior allergic reaction to sulfonamides~No active peptic ulcer disease~No active infection~No other medical condition that would preclude study participation~Able to swallow oral medication~PRIOR CONCURRENT THERAPY:~Biologic therapy~Not specified~Chemotherapy~No prior chemotherapy for metastatic or recurrent disease~Endocrine therapy~No prior endocrine therapy for metastatic disease~Prior adjuvant tamoxifen allowed~No prior aromatase inhibitors~No prior hormonal therapy for recurrent disease~No other concurrent hormonal therapy~Radiotherapy~See Disease Characteristics~See Menopausal status~No concurrent radiotherapy~Surgery~See Disease Characteristics~See Menopausal status~Other~No concurrent fluconazole or lithium~No concurrent aspirin, non-steroidal anti-inflammatory drugs, or other cyclooxygenase-2 inhibitors~Concurrent chronic cardioprotective low-dose aspirin allowed~No other concurrent investigational agents
|
18 Years
| null |
Female
|
No
|
Primary Purpose: Treatment
Masking: None (Open Label)
|
| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
|
stage IIIA breast cancer, stage IIIB breast cancer, stage IIIC breast cancer, stage IV breast cancer, recurrent breast cancer
|
Celecoxib, Letrozole, Antineoplastic Agents, Aromatase Inhibitors, Steroid Synthesis Inhibitors, Enzyme Inhibitors, Molecular Mechanisms of Pharmacological Action, Estrogen Antagonists, Hormone Antagonists, Hormones, Hormone Substitutes, and Hormone Antagonists, 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, Cyclooxygenase 2 Inhibitors, Cyclooxygenase Inhibitors
|
| Intervention/Treatment |
| --- |
|Drug: celecoxib|nan|
|Drug: letrozole|nan|
|
Letrozole and Celecoxib in Treating Postmenopausal Women With Locally Advanced or Metastatic Breast Cancer
Study Overview
=================
Brief Summary
-----------------
RATIONALE: Estrogen can cause the growth of breast cancer cells. Hormone therapy using letrozole may fight breast cancer by lowering the amount of estrogen the body makes. Celecoxib may stop the growth of tumor cells by blocking some of the enzymes needed for cell growth and by blocking blood flow to the tumor. Giving letrozole with celecoxib may kill more tumor cells. PURPOSE: This phase II trial is studying how well letrozole and celecoxib work in treating postmenopausal women with locally advanced or metastatic breast cancer.
Detailed Description
-----------------
OBJECTIVES: Primary Determine the response rate in postmenopausal women with hormone receptor-positive locally advanced or metastatic adenocarcinoma of the breast treated with letrozole and celecoxib as first-line therapy. Secondary Determine the time to disease progression and overall survival of patients treated with this regimen. Determine the toxicity of this regimen in these patients. Compare cyclooxygenase activity in blood and tumor cells from these patients before and after treatment with this regimen. Determine the effect of this regimen on aromatase activity, tumor proliferation, and angiogenesis in tumor samples from these patients. OUTLINE: This is a multicenter study. Patients receive oral letrozole once daily and oral celecoxib twice daily on days 1-28. Courses repeat every 28 days in the absence of disease progression or unacceptable toxicity. Patients are followed for survival. PROJECTED ACCRUAL: A total of 45-72 patients will be accrued for this study.
Official Title
-----------------
Phase II Study of Letrozole (Femara) and Celecoxib (Celebrex) in Postmenopausal Women With Hormone Receptor-Positive Locally Advanced or Metastatic Breast Cancer
Conditions
-----------------
Breast Cancer
Intervention / Treatment
-----------------
* Drug: celecoxib
* Drug: letrozole
Participation Criteria
=================
Eligibility Criteria
-----------------
DISEASE CHARACTERISTICS: Histologically or cytologically confirmed adenocarcinoma of the breast Locally advanced or metastatic disease Measurable disease No bone disease only No history of brain metastases unless controlled with radiotherapy or surgical resection for ≥ 6 months before study entry Hormone receptor status: Estrogen receptor- OR progesterone receptor-positive PATIENT CHARACTERISTICS: Age 18 and over Sex Female Menopausal status Postmenopausal, as defined by 1 of the following: Prior bilateral oophorectomy Prior bilateral ovarian irradiation No spontaneous menstrual bleeding within the past 12 months Age 55 and over AND prior hysterectomy without oophorectomy Age 54 and under AND prior hysterectomy without oophorectomy (or status of ovaries is unknown) AND documented follicle-stimulating hormone level in postmenopausal range Performance status ECOG 0-2 Life expectancy At least 3 months Hematopoietic Granulocyte count ≥ 1,000/mm^3 Platelet count ≥ 100,000/mm^3 Hepatic Bilirubin ≤ 1.5 times upper limit of normal (ULN) AST and ALT ≤ 2.5 times ULN Renal Creatinine ≤ 1.5 times ULN Other No prior allergic reaction attributed to compounds of similar chemical or biologic composition to study drugs No prior allergic reaction to sulfonamides No active peptic ulcer disease No active infection No other medical condition that would preclude study participation Able to swallow oral medication PRIOR CONCURRENT THERAPY: Biologic therapy Not specified Chemotherapy No prior chemotherapy for metastatic or recurrent disease Endocrine therapy No prior endocrine therapy for metastatic disease Prior adjuvant tamoxifen allowed No prior aromatase inhibitors No prior hormonal therapy for recurrent disease No other concurrent hormonal therapy Radiotherapy See Disease Characteristics See Menopausal status No concurrent radiotherapy Surgery See Disease Characteristics See Menopausal status Other No concurrent fluconazole or lithium No concurrent aspirin, non-steroidal anti-inflammatory drugs, or other cyclooxygenase-2 inhibitors Concurrent chronic cardioprotective low-dose aspirin allowed No other concurrent investigational agents
Ages Eligible for Study
-----------------
Minimum Age: 18 Years
Sexes Eligible for Study
-----------------
Female
Accepts Healthy Volunteers
-----------------
No
Study Plan
=================
How is the study designed?
-----------------
Design Details
Primary Purpose: Treatment
Masking: None (Open Label)
Arms and Interventions
| Intervention/Treatment |
| --- |
|Drug: celecoxib|nan|
|Drug: letrozole|nan|
What is the study measuring?
-----------------
Primary Outcome Measures
| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
stage IIIA breast cancer, stage IIIB breast cancer, stage IIIC breast cancer, stage IV breast cancer, recurrent breast cancer
|
|
NCT03815253
|
Electro-acupuncture for Central Obesity
|
In this study, a 8-week, single blinded, randomized controlled clinical trial will be conducted to examine the efficacy and safety of body acupuncture in the treatment of central obesity in Hong Kong.
|
This is a pilot single-blind, randomized, sham-controlled trial. 168 central obesity patients will be randomly assigned to acupuncture group or control group. The duration of the treatment will be 8 weeks with 2 session per week and the follow-up period will be 2 weeks.
|
Electro-acupuncture for Central Obesity: a Single Blinded Randomized Sham-controlled Clinical Trial
|
Central Obesity
|
* Other: acupuncture
|
Inclusion Criteria:~Patients who meet all of the following criteria are defined as eligible participants: men and women aged between 18 and 65 years old; BMI ≥ 25 kg/m2; central obesity, defined as WC of ≥ 90 cm in men and ≥ 80 cm in non-pregnant women according to ICD-10 [24]; not receiving any other weight control measures or any medical and/or drug history in last 3months.~Exclusion Criteria:~Patients who meet any of the following criteria should be excluded from the study: endocrine diseases, including thyroid disorder, pituitary disorder, sex gland disorder, etc.; heart diseases, including arrhythmia, heart failure, myocardial infarction, patients with pacemaker; allergy and immunology diseases; bleeding tendency; pregnant or lactating women; impaired hepatic or renal function; stroke or unable to exercise.
|
18 Years
|
65 Years
|
All
|
No
|
Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Interventional Model Description: single-blinded, randomized, sham-controlled clinical trial
Masking: Single
|
| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Changes in waist circumference | Waist circumference will be measured around the abdomen at the level of the umbilicus (belly button). | 0,1,2,3,4,5,6,7,8, 11, 15,18, 21, 24 weeks |
|
| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Changes in hip circumference | hip circumference measured at the level of maximum posterior extension of the buttocks | 0,1,2,3,4,5,6,7,8,9,11,15,18, 21, 24 weeks |
| Adverse events after treatment and follow up | Adverse events of acupuncture treatment will be assessed using the Treatment Emergent Symptom Scale (TESS) and would be evaluated during the whole procedure, as well as laboratory tests (whole blood counts, renal and liver functions) if needed. All clinical adverse events will be recorded in terms of intensity (mild, moderate, or severe), duration, outcome and relationship to the study. | 0,1,2,3,4,5,6,7,8, 15,18, 21, 24 weeks |
| Changes in waist-to-hip circumference ratio | waist-to-hip ratio is the dimensionless ratio of the circumference of the waist to that of the hips. This is calculated as waist measurement divided by hip measurement ( W ÷ H ). | 0,1,2,3,4,5,6,7,8, 15,18, 21, 24 weeks |
| Changes in Body Mass Index | Body Mass Index is a simple calculation using a person's height and weight. The formula is BMI = kg/m2 where kg is a person's weight in kilograms and m2 is their height in metres squared. | 0,1,2,3,4,5,6,7,8, 15,18, 21, 24 weeks |
| Changes in body fat percentage | The body fat percentage (BFP) of a human or other living being is the total mass of fat divided by total body mass, multiplied by 100. Body fat percentage will be measured by Omron Karada Scan HBF-701. | 0,1,2,3,4,5,6,7,8, 15,18, 21, 24 weeks |
| Changes in total cholesterol (TC), triglyceride (TG) and fasting blood glucose (FBG) | Total cholesterol (TC), triglyceride (TG) and fasting blood glucose (FBG) will be measured before and after the 8-week treatment. | 0, 8 weeks |
|
Obesity, Obesity, Abdominal, Overweight, Overnutrition, Nutrition Disorders, Body Weight
|
| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Acupuncture group<br>Body electro-acupuncture will be conducted for 2 sessions per week over 8 consecutive weeks.~Body electro-acupuncture will choose eight acupoints as Tianshu(ST-25), Daheng(SP-15), Daimai(GB-26), Qihai(CV-6), Zhongwan(CV-12), Zusanli (ST-36), Fenlong(ST-40), Sanyinjiao(SP-6).Disposable acupuncture needles (verum acupuncture needles asia-med Special No. 16 with 0.30 x 0.30mm matching the Streitberger sham-needles) will be inserted at a depth of 10-25 mm into the points.~We will also deliver electrical stimulation with dense-disperse waves with 50Hz at 10 volts through electrical acupuncture stimulation instrument (ES-160 6-Channel Programmable Electro-acupuncture) to the abdominal points. The bodily needles will be retained for 30 minutes. | Other: acupuncture<br>* Body electro-acupuncture will choose eight acupoints as Tianshu(ST-25), Daheng(SP-15), Daimai(GB-26), Qihai(CV-6), Zhongwan(CV-12), Zusanli (ST-36), Fenlong(ST-40), Sanyinjiao(SP-6).Disposable acupuncture needles (verum acupuncture needles asia-med Special No. 16 with 0.30 x 0.30mm matching the Streitberger sham-needles) will be inserted at a depth of 10-25 mm into the points.~We will also deliver electrical stimulation with dense-disperse waves with 50Hz at 10 volts through electrical acupuncture stimulation instrument (ES-160 6-Channel Programmable Electro-acupuncture) to the abdominal points. The bodily needles will be retained for 30 minutes.<br>|
| Placebo Comparator: sham-acupuncture group<br>As to the participants allocated to control group, Streitberger's non-invasive acupuncture needles (Gauge 8 x 1.2 / 0.30 x 30 mm) will be applied to act as sham control at the same acupoints with same stimulation modality. However, the needles will be only adhered to the skin instead of insertion. The validity and credibility of this model has been well demonstrated. | Other: acupuncture<br>* Body electro-acupuncture will choose eight acupoints as Tianshu(ST-25), Daheng(SP-15), Daimai(GB-26), Qihai(CV-6), Zhongwan(CV-12), Zusanli (ST-36), Fenlong(ST-40), Sanyinjiao(SP-6).Disposable acupuncture needles (verum acupuncture needles asia-med Special No. 16 with 0.30 x 0.30mm matching the Streitberger sham-needles) will be inserted at a depth of 10-25 mm into the points.~We will also deliver electrical stimulation with dense-disperse waves with 50Hz at 10 volts through electrical acupuncture stimulation instrument (ES-160 6-Channel Programmable Electro-acupuncture) to the abdominal points. The bodily needles will be retained for 30 minutes.<br>|
|
Electro-acupuncture for Central Obesity
Study Overview
=================
Brief Summary
-----------------
In this study, a 8-week, single blinded, randomized controlled clinical trial will be conducted to examine the efficacy and safety of body acupuncture in the treatment of central obesity in Hong Kong.
Detailed Description
-----------------
This is a pilot single-blind, randomized, sham-controlled trial. 168 central obesity patients will be randomly assigned to acupuncture group or control group. The duration of the treatment will be 8 weeks with 2 session per week and the follow-up period will be 2 weeks.
Official Title
-----------------
Electro-acupuncture for Central Obesity: a Single Blinded Randomized Sham-controlled Clinical Trial
Conditions
-----------------
Central Obesity
Intervention / Treatment
-----------------
* Other: acupuncture
Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Patients who meet all of the following criteria are defined as eligible participants: men and women aged between 18 and 65 years old; BMI ≥ 25 kg/m2; central obesity, defined as WC of ≥ 90 cm in men and ≥ 80 cm in non-pregnant women according to ICD-10 [24]; not receiving any other weight control measures or any medical and/or drug history in last 3months. Exclusion Criteria: Patients who meet any of the following criteria should be excluded from the study: endocrine diseases, including thyroid disorder, pituitary disorder, sex gland disorder, etc.; heart diseases, including arrhythmia, heart failure, myocardial infarction, patients with pacemaker; allergy and immunology diseases; bleeding tendency; pregnant or lactating women; impaired hepatic or renal function; stroke or unable to exercise.
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
Interventional Model Description: single-blinded, randomized, sham-controlled clinical trial
Masking: Single
Arms and Interventions
| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Acupuncture group<br>Body electro-acupuncture will be conducted for 2 sessions per week over 8 consecutive weeks. Body electro-acupuncture will choose eight acupoints as Tianshu(ST-25), Daheng(SP-15), Daimai(GB-26), Qihai(CV-6), Zhongwan(CV-12), Zusanli (ST-36), Fenlong(ST-40), Sanyinjiao(SP-6).Disposable acupuncture needles (verum acupuncture needles asia-med Special No. 16 with 0.30 x 0.30mm matching the Streitberger sham-needles) will be inserted at a depth of 10-25 mm into the points. We will also deliver electrical stimulation with dense-disperse waves with 50Hz at 10 volts through electrical acupuncture stimulation instrument (ES-160 6-Channel Programmable Electro-acupuncture) to the abdominal points. The bodily needles will be retained for 30 minutes. | Other: acupuncture<br>* Body electro-acupuncture will choose eight acupoints as Tianshu(ST-25), Daheng(SP-15), Daimai(GB-26), Qihai(CV-6), Zhongwan(CV-12), Zusanli (ST-36), Fenlong(ST-40), Sanyinjiao(SP-6).Disposable acupuncture needles (verum acupuncture needles asia-med Special No. 16 with 0.30 x 0.30mm matching the Streitberger sham-needles) will be inserted at a depth of 10-25 mm into the points. We will also deliver electrical stimulation with dense-disperse waves with 50Hz at 10 volts through electrical acupuncture stimulation instrument (ES-160 6-Channel Programmable Electro-acupuncture) to the abdominal points. The bodily needles will be retained for 30 minutes.<br>|
| Placebo Comparator: sham-acupuncture group<br>As to the participants allocated to control group, Streitberger's non-invasive acupuncture needles (Gauge 8 x 1.2 / 0.30 x 30 mm) will be applied to act as sham control at the same acupoints with same stimulation modality. However, the needles will be only adhered to the skin instead of insertion. The validity and credibility of this model has been well demonstrated. | Other: acupuncture<br>* Body electro-acupuncture will choose eight acupoints as Tianshu(ST-25), Daheng(SP-15), Daimai(GB-26), Qihai(CV-6), Zhongwan(CV-12), Zusanli (ST-36), Fenlong(ST-40), Sanyinjiao(SP-6).Disposable acupuncture needles (verum acupuncture needles asia-med Special No. 16 with 0.30 x 0.30mm matching the Streitberger sham-needles) will be inserted at a depth of 10-25 mm into the points. We will also deliver electrical stimulation with dense-disperse waves with 50Hz at 10 volts through electrical acupuncture stimulation instrument (ES-160 6-Channel Programmable Electro-acupuncture) to the abdominal points. The bodily needles will be retained for 30 minutes.<br>|
What is the study measuring?
-----------------
Primary Outcome Measures
| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Changes in waist circumference | Waist circumference will be measured around the abdomen at the level of the umbilicus (belly button). | 0,1,2,3,4,5,6,7,8, 11, 15,18, 21, 24 weeks |
Secondary Outcome Measures
| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Changes in hip circumference | hip circumference measured at the level of maximum posterior extension of the buttocks | 0,1,2,3,4,5,6,7,8,9,11,15,18, 21, 24 weeks |
| Adverse events after treatment and follow up | Adverse events of acupuncture treatment will be assessed using the Treatment Emergent Symptom Scale (TESS) and would be evaluated during the whole procedure, as well as laboratory tests (whole blood counts, renal and liver functions) if needed. All clinical adverse events will be recorded in terms of intensity (mild, moderate, or severe), duration, outcome and relationship to the study. | 0,1,2,3,4,5,6,7,8, 15,18, 21, 24 weeks |
| Changes in waist-to-hip circumference ratio | waist-to-hip ratio is the dimensionless ratio of the circumference of the waist to that of the hips. This is calculated as waist measurement divided by hip measurement ( W ÷ H ). | 0,1,2,3,4,5,6,7,8, 15,18, 21, 24 weeks |
| Changes in Body Mass Index | Body Mass Index is a simple calculation using a person's height and weight. The formula is BMI = kg/m2 where kg is a person's weight in kilograms and m2 is their height in metres squared. | 0,1,2,3,4,5,6,7,8, 15,18, 21, 24 weeks |
| Changes in body fat percentage | The body fat percentage (BFP) of a human or other living being is the total mass of fat divided by total body mass, multiplied by 100. Body fat percentage will be measured by Omron Karada Scan HBF-701. | 0,1,2,3,4,5,6,7,8, 15,18, 21, 24 weeks |
| Changes in total cholesterol (TC), triglyceride (TG) and fasting blood glucose (FBG) | Total cholesterol (TC), triglyceride (TG) and fasting blood glucose (FBG) will be measured before and after the 8-week treatment. | 0, 8 weeks |
|
|
NCT02332746
|
Exploring Temporal Relationships Between Self-worth and Physical Activity Middle-aged Women
|
The purpose of this study is to explore temporal relationships between self-worth and physical activity (PA) participation in middle-aged women (aged 35-64 years). We are particularly interested in the predictive role of self-worth on women's daily PA participation.~This study will include two phases: a pilot phase to test the procedures and a test phase to assess self-worth and PA. During the test phase, Women will receive text message prompts in the morning, afternoon, and evening for 28 days on their cell phones. Each prompt will include a link to an 11-item mobile Internet-based survey assessing momentary PA, self-worth, and self-efficacy. Women will also concurrently wear an activity monitor (GENEActiv) to objectively measure their activity levels throughout the study.
|
Using ecological momentary assessment, the purpose of this study is to explore temporal relationships between self-worth and physical activity (PA) participation in middle-aged women (aged 35-64 years).~This study will occur in two phases. During an initial pilot phase ten women will be asked to test the instruments and procedures for this study. During the second phase, the test phase, 60-100 women will be asked to complete daily surveys assessing their self-worth, self-efficacy, and PA participation. The results of the pilot phase will be used to modify instruments and procedures before the test phase commences.~During the pilot phase, 10 women will be asked to participate in an initial intake appointment to sign the informed consent form, complete baseline questionnaires, receive an activity monitor, and receive instructions on completing the daily surveys and wearing the activity monitor. Women will also be asked to provide their typical daily wake times and bedtimes during this appointment to guide the sampling schedule. Ecological momentary assessment (EMA) in which women receive two or three daily prompts to complete a short survey will be used in this study. Women will be asked to answer seven questions assessing their momentary activity (1), self-efficacy (1), and self-worth (5) twice per day for one week and three times per day for one week. Five women will be assigned to each condition each week so that half of the sample receives the twice per day condition during the first week and half receives the twice per day condition during the second week of the pilot phase. Women sampled twice per day will be prompted to complete assessments 1) 15 minutes after their typical wake time reported during their intake appointment and 2) 90 minutes prior to their typical bedtime. Women sampled three times per day will be prompted one additional time during the afternoon (random time between 2:00 and 3:00pm). Women will be prompted to complete the survey via text message. A link will be provided in each text message to direct women to a mobile compatible Qualtrics survey containing seven items assessing women's current activity, self-efficacy, general self-worth, knowledge self-worth, emotional self-worth, social self-worth, and physical self-worth. At the end of the two week pilot phase, women will be asked to complete a survey to provide feedback on the sampling scheme and the usability of the mobile survey. Results of the survey will inform modifications to the test phase.~During the test phase, 60-100 women will be asked to participate in an initial intake appointment to sign the informed consent form, complete baseline questionnaires, receive an activity monitor, and receive instructions on completing the daily surveys and wearing the activity monitor. Women will be asked to answer eleven questions assessing their current activity (1), self-efficacy (1), and self-worth (9) three times per day for 28 days, depending upon the results of the pilot phase. The three-times daily sampling scheme will be adopted for the test phase. Therefore, women will receive text message prompts with a link to the mobile compatible Qualtrics survey daily in the morning, afternoon, and evening.~Current activity will be measured using an item modified from a recent EMA study by Dunton and colleagues (2012). Using a list of options, this item assesses the activity in which the participant was engaged immediately prior to receiving the prompt. One item from the Exercise Self-Efficacy Scale (McAuley, 1993) will be used to assess women's confidence in their ability to participate in daily PA on a scale of 0% to 100% - I am able to participate in physical activity at a moderate intensity for 30+ minutes today without quitting. General self-worth will be measured using one item from the general self-worth subscale of the Adult Self-Perception Profile (Messer & Harter, 1986). Women will choose among four statements to indicate how they feel about themselves: Which of the following statements is most true of how you feel RIGHT NOW? It is REALLY TRUE that I am dissatisfied with myself It is SORT OF TRUE that I am dissatisfied with myself It is SORT OF TRUE that I am satisfied with myself It is REALLY TRUE that I am satisfied with myself~The Women's Physical Activity Self-Worth Inventory (WPASWI) (Huberty et al., 2013) will be used to measure knowledge, emotional, and social self-worth. Women will be asked the extent to which they agree (strongly disagree, somewhat disagree, somewhat agree, strongly agree) with statements describing their knowledge, emotional, and social self-worth. One WPASWI item from each of the self-worth domains was chosen for the pilot phase. Based upon results of the pilot phase, the EMA survey was modified for the test phase and two items were chosen to assess each domain, for a total of six items from the WPASWI. Examples include: RIGHT NOW - My knowledge about physical activity affects the way I feel about myself. (knowledge self-worth) RIGHT NOW - I feel it is important to take time to be physically active today. (emotional self-worth) RIGHT NOW - I need to know I have friends or family to support my commitment to exercise in order to feel good about myself. (social self-worth)~Two items from the Physical Self-Perception Profile (Fox & Corbin, 1989) will be used to measure perceived body attractiveness and physical condition, both important subdomains of physical self-worth. Women will be asked the extent to which they agree (strongly disagree, somewhat disagree, somewhat agree, strongly agree) with the following statements:~RIGHT NOW - I feel confident about the appearance of my body. (body attractiveness) RIGHT NOW - I am confident in my level of physical conditioning and fitness. (physical condition)~In summary, the EMA survey used in the test phase of this study will include eleven items assessing momentary activity (1) (Dunton et al., 2012); self-efficacy (1) (McAuley, 1993), general self-worth (1) (Messer & Harter, 1986); knowledge (2), emotional (2), and social (2) self-worth (Huberty et al., 2013); and physical self-worth (2) (Fox & Corbin, 1989).~Women will also be asked to wear a GENEActiv accelerometer for the duration of their participation in the study (14 days for the pilot phase and 28 days for the test phase). All participants will receive their GENEActiv during the initial intake appointment and will return the device during a schedule appointment with a researcher. Women not local to the Phoenix area will receive and return their GENEActiv by mail. As part of wearing the activity monitor, women will also be asked to log their wear time, wake time, and bedtime. All participants will receive comprehensive feedback on their time spent in sedentary, light, moderate, and vigorous activity each day.~During the intake appointment, women will also be asked to complete the full-length questionnaires upon which the EMA survey was developed (i.e., Exercise Self-Efficacy Scale [McAuley, 1993], Adult Self-Perception Profile [Messer & Harter, 1986], WPASWI [Huberty et al., 2013], Physical Self-Perception Profile [Fox & Corbin, 1989]), a demographics questionnaire, and a regular PA questionnaire (Past-Week Modifiable Activity Questionnaire [Gabriel et al., 2010]).
|
Novel Exploration of Temporal Relationships Between Self-worth and Physical Activity in Middle-aged Women
|
Self Esteem, Physical Activity
|
Inclusion Criteria:~35-64 years of age~English speaking~Able to ambulate~Own a mobile phone with access to text messaging and cellular Internet~Able to receive text messages from a short code~Agree that user rates will apply when receiving text messages and completing assessments~Exclusion Criteria:~Males~Not within age range; children~Non-English speaking~Unable to ambulate~Do not own a mobile phone with access to text messaging or cellular Internet~Not able to receive text messages from a short code~Do not agree to accept user rates
|
35 Years
|
64 Years
|
Female
|
Accepts Healthy Volunteers
|
| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Self-Worth | General self-worth: One item from the general self-worth subscale of the Adult Self-Perception Profile (Messer & Harter, 1986) Knowledge, emotional, and social self-worth: Six items (two per self-worth domain) from the Women's Physical Activity Self-Worth Inventory (Huberty et al., 2013) Physical self-worth: Two items from the Physical Self-Perception Profile (Fox & Corbin, 1989) | 28 days |
| Physical Activity - Accelerometer | GENEActiv wrist-worn accelerometer | 28 days |
|
| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Exercise Self-Efficacy | One item from the Exercise Self-Efficacy Scale (McAuley, 1993) | 28 days |
| Current Activity | One item from a recent EMA study by Dunton et al. (2012) | 28 days |
|
| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Middle-aged women<br>Middle-aged women (35-64 years) | |
|
Exploring Temporal Relationships Between Self-worth and Physical Activity Middle-aged Women
Study Overview
=================
Brief Summary
-----------------
The purpose of this study is to explore temporal relationships between self-worth and physical activity (PA) participation in middle-aged women (aged 35-64 years). We are particularly interested in the predictive role of self-worth on women's daily PA participation. This study will include two phases: a pilot phase to test the procedures and a test phase to assess self-worth and PA. During the test phase, Women will receive text message prompts in the morning, afternoon, and evening for 28 days on their cell phones. Each prompt will include a link to an 11-item mobile Internet-based survey assessing momentary PA, self-worth, and self-efficacy. Women will also concurrently wear an activity monitor (GENEActiv) to objectively measure their activity levels throughout the study.
Detailed Description
-----------------
Using ecological momentary assessment, the purpose of this study is to explore temporal relationships between self-worth and physical activity (PA) participation in middle-aged women (aged 35-64 years). This study will occur in two phases. During an initial pilot phase ten women will be asked to test the instruments and procedures for this study. During the second phase, the test phase, 60-100 women will be asked to complete daily surveys assessing their self-worth, self-efficacy, and PA participation. The results of the pilot phase will be used to modify instruments and procedures before the test phase commences. During the pilot phase, 10 women will be asked to participate in an initial intake appointment to sign the informed consent form, complete baseline questionnaires, receive an activity monitor, and receive instructions on completing the daily surveys and wearing the activity monitor. Women will also be asked to provide their typical daily wake times and bedtimes during this appointment to guide the sampling schedule. Ecological momentary assessment (EMA) in which women receive two or three daily prompts to complete a short survey will be used in this study. Women will be asked to answer seven questions assessing their momentary activity (1), self-efficacy (1), and self-worth (5) twice per day for one week and three times per day for one week. Five women will be assigned to each condition each week so that half of the sample receives the twice per day condition during the first week and half receives the twice per day condition during the second week of the pilot phase. Women sampled twice per day will be prompted to complete assessments 1) 15 minutes after their typical wake time reported during their intake appointment and 2) 90 minutes prior to their typical bedtime. Women sampled three times per day will be prompted one additional time during the afternoon (random time between 2:00 and 3:00pm). Women will be prompted to complete the survey via text message. A link will be provided in each text message to direct women to a mobile compatible Qualtrics survey containing seven items assessing women's current activity, self-efficacy, general self-worth, knowledge self-worth, emotional self-worth, social self-worth, and physical self-worth. At the end of the two week pilot phase, women will be asked to complete a survey to provide feedback on the sampling scheme and the usability of the mobile survey. Results of the survey will inform modifications to the test phase. During the test phase, 60-100 women will be asked to participate in an initial intake appointment to sign the informed consent form, complete baseline questionnaires, receive an activity monitor, and receive instructions on completing the daily surveys and wearing the activity monitor. Women will be asked to answer eleven questions assessing their current activity (1), self-efficacy (1), and self-worth (9) three times per day for 28 days, depending upon the results of the pilot phase. The three-times daily sampling scheme will be adopted for the test phase. Therefore, women will receive text message prompts with a link to the mobile compatible Qualtrics survey daily in the morning, afternoon, and evening. Current activity will be measured using an item modified from a recent EMA study by Dunton and colleagues (2012). Using a list of options, this item assesses the activity in which the participant was engaged immediately prior to receiving the prompt. One item from the Exercise Self-Efficacy Scale (McAuley, 1993) will be used to assess women's confidence in their ability to participate in daily PA on a scale of 0% to 100% - I am able to participate in physical activity at a moderate intensity for 30+ minutes today without quitting. General self-worth will be measured using one item from the general self-worth subscale of the Adult Self-Perception Profile (Messer & Harter, 1986). Women will choose among four statements to indicate how they feel about themselves: Which of the following statements is most true of how you feel RIGHT NOW? It is REALLY TRUE that I am dissatisfied with myself It is SORT OF TRUE that I am dissatisfied with myself It is SORT OF TRUE that I am satisfied with myself It is REALLY TRUE that I am satisfied with myself The Women's Physical Activity Self-Worth Inventory (WPASWI) (Huberty et al., 2013) will be used to measure knowledge, emotional, and social self-worth. Women will be asked the extent to which they agree (strongly disagree, somewhat disagree, somewhat agree, strongly agree) with statements describing their knowledge, emotional, and social self-worth. One WPASWI item from each of the self-worth domains was chosen for the pilot phase. Based upon results of the pilot phase, the EMA survey was modified for the test phase and two items were chosen to assess each domain, for a total of six items from the WPASWI. Examples include: RIGHT NOW - My knowledge about physical activity affects the way I feel about myself. (knowledge self-worth) RIGHT NOW - I feel it is important to take time to be physically active today. (emotional self-worth) RIGHT NOW - I need to know I have friends or family to support my commitment to exercise in order to feel good about myself. (social self-worth) Two items from the Physical Self-Perception Profile (Fox & Corbin, 1989) will be used to measure perceived body attractiveness and physical condition, both important subdomains of physical self-worth. Women will be asked the extent to which they agree (strongly disagree, somewhat disagree, somewhat agree, strongly agree) with the following statements: RIGHT NOW - I feel confident about the appearance of my body. (body attractiveness) RIGHT NOW - I am confident in my level of physical conditioning and fitness. (physical condition) In summary, the EMA survey used in the test phase of this study will include eleven items assessing momentary activity (1) (Dunton et al., 2012); self-efficacy (1) (McAuley, 1993), general self-worth (1) (Messer & Harter, 1986); knowledge (2), emotional (2), and social (2) self-worth (Huberty et al., 2013); and physical self-worth (2) (Fox & Corbin, 1989). Women will also be asked to wear a GENEActiv accelerometer for the duration of their participation in the study (14 days for the pilot phase and 28 days for the test phase). All participants will receive their GENEActiv during the initial intake appointment and will return the device during a schedule appointment with a researcher. Women not local to the Phoenix area will receive and return their GENEActiv by mail. As part of wearing the activity monitor, women will also be asked to log their wear time, wake time, and bedtime. All participants will receive comprehensive feedback on their time spent in sedentary, light, moderate, and vigorous activity each day. During the intake appointment, women will also be asked to complete the full-length questionnaires upon which the EMA survey was developed (i.e., Exercise Self-Efficacy Scale [McAuley, 1993], Adult Self-Perception Profile [Messer & Harter, 1986], WPASWI [Huberty et al., 2013], Physical Self-Perception Profile [Fox & Corbin, 1989]), a demographics questionnaire, and a regular PA questionnaire (Past-Week Modifiable Activity Questionnaire [Gabriel et al., 2010]).
Official Title
-----------------
Novel Exploration of Temporal Relationships Between Self-worth and Physical Activity in Middle-aged Women
Conditions
-----------------
Self Esteem, Physical Activity
Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: 35-64 years of age English speaking Able to ambulate Own a mobile phone with access to text messaging and cellular Internet Able to receive text messages from a short code Agree that user rates will apply when receiving text messages and completing assessments Exclusion Criteria: Males Not within age range; children Non-English speaking Unable to ambulate Do not own a mobile phone with access to text messaging or cellular Internet Not able to receive text messages from a short code Do not agree to accept user rates
Ages Eligible for Study
-----------------
Minimum Age: 35 Years
Maximum Age: 64 Years
Sexes Eligible for Study
-----------------
Female
Accepts Healthy Volunteers
-----------------
Accepts Healthy Volunteers
Study Plan
=================
How is the study designed?
-----------------
Arms and Interventions
| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Middle-aged women<br>Middle-aged women (35-64 years) | |
What is the study measuring?
-----------------
Primary Outcome Measures
| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Self-Worth | General self-worth: One item from the general self-worth subscale of the Adult Self-Perception Profile (Messer & Harter, 1986) Knowledge, emotional, and social self-worth: Six items (two per self-worth domain) from the Women's Physical Activity Self-Worth Inventory (Huberty et al., 2013) Physical self-worth: Two items from the Physical Self-Perception Profile (Fox & Corbin, 1989) | 28 days |
| Physical Activity - Accelerometer | GENEActiv wrist-worn accelerometer | 28 days |
Secondary Outcome Measures
| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Exercise Self-Efficacy | One item from the Exercise Self-Efficacy Scale (McAuley, 1993) | 28 days |
| Current Activity | One item from a recent EMA study by Dunton et al. (2012) | 28 days |
|
||||
NCT03866681
|
Sirolimus Combined With Low-dose Warfarin for the Treatment of Refractory PNH
|
Classical paroxysmal nocturnal hemoglobinuria(PNH) is mainly characterized by hemolysis and thrombosis, which reduced patients ' quality of life(QoL) greatly and even lead to death. Glucocorticoids and symptomatic supportive therapy are traditional treatments and the response rate is far from satisfactory. Eculizumab is an effective therapy but it is expensive and not available in China mainland.The investigators aim to explore the efficacy and safety of sirolimus for refractory classic PNH.
|
Classical paroxysmal nocturnal hemoglobinuria(PNH) is mainly characterized by hemolysis and thrombosis, which reduced patients ' quality of life(QoL) greatly and even lead to death. There is no ideal therapy except for eculizumab, expensive and not available in China mainland. Glucocorticoids and symptomatic supportive therapy are traditional treatments. The response rate is 30%, far from satisfactory. In recent years, T lymphocyte-mediated destruction of normal hematopoietic stem cells have been reported to involve the pathogenesis of PNH, making immunomodulatory drugs be potential effective treatments.~Sirolimus (rapamycin), produced by the bacterium Streptomyces hygroscopicus, is a mammalian target of Rapamycin (mTOR) inhibitor. mTOR is a serine/threonine kinase that regulates cell growth, proliferation, metabolism and survival. It has two interacting complex, mTORC1 and mTORC2. Sirolimus primarily inhibits mTORC1, has been demonstrated for its immunomodulatory effects and ability to improve hematopoietic stem cell function. Recently, sirolimus has been reported to be effective and well tolerated in the treatment of immune-mediated cytopenias, even in multi-immunosuppressants resistant patients. In addition, classical PNH patients have a higher risk of thrombosis especially in refractory ones and it is reasonable to use low-dose warfarin in the management of patients with classic refractory PNH.~In this study, it is anticipated to evaluate the effect of sirolimus combined with low-dose warfarin on patients with refractory classic PNH. The adverse effects and QoL on different time points were documented.
|
Sirolimus Combined With Low-dose Warfarin for the Treatment of Refractory Classic Paroxysmal Nocturnal Hemoglobinuria ,a Prospective Study
|
Paroxysmal Nocturnal Hemoglobinuria
|
* Drug: sirolimus
|
Inclusion Criteria:~age 18-70 years~diagnosed with PNH and no thrombosis~ineffective, relapsed or intolerant to conventional treatment (eg glucocorticoids, • • iron, folic acid, androgen, etc.)~not available for hematopoietic stem cell transplantation~ECOG≤2~agreed to sign the consent forms~Exclusion Criteria:~severe heart, liver and kidney dysfunction~combined with thrombotic complications~people who are pregnant and breastfeeding~history of other immunosuppressive agents in recent 3 months~Patients who are not eligible to participate in this trial due to any reason based • • • on the consideration of investigator
|
18 Years
|
70 Years
|
All
|
No
|
Primary Purpose: Treatment
Intervention Model: Single Group Assignment
Masking: None (Open Label)
|
| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Hemoglobin | Hemoglobin in g/L | 2 years |
|
| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Short Form 36 items(SF-36) questionnaire | SF-36 questionnaire in scores | 2 years |
|
Sirolimus, Warfarin, Anti-Bacterial Agents, Anti-Infective Agents, Antibiotics, Antineoplastic, Antineoplastic Agents, Antifungal Agents, Immunosuppressive Agents, Immunologic Factors, Physiological Effects of Drugs, Anticoagulants
|
| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Patients cohort<br>A total of 40 patients with refractory classic PNH will be included and will be intervened by a combined therapy including sirolimus and low-dose warfarin | Drug: sirolimus<br>* The dose of sirolimus is adjusted according to monitored serum concentration, maintain Rapamycin concentration ranging from 4 to 10ng/ml.Warfarin was administered orally at a dose of 1mg per day for a year,then gradually reduced to stop.<br>* Other names: warfarin;|
|
Sirolimus Combined With Low-dose Warfarin for the Treatment of Refractory PNH
Study Overview
=================
Brief Summary
-----------------
Classical paroxysmal nocturnal hemoglobinuria(PNH) is mainly characterized by hemolysis and thrombosis, which reduced patients ' quality of life(QoL) greatly and even lead to death. Glucocorticoids and symptomatic supportive therapy are traditional treatments and the response rate is far from satisfactory. Eculizumab is an effective therapy but it is expensive and not available in China mainland.The investigators aim to explore the efficacy and safety of sirolimus for refractory classic PNH.
Detailed Description
-----------------
Classical paroxysmal nocturnal hemoglobinuria(PNH) is mainly characterized by hemolysis and thrombosis, which reduced patients ' quality of life(QoL) greatly and even lead to death. There is no ideal therapy except for eculizumab, expensive and not available in China mainland. Glucocorticoids and symptomatic supportive therapy are traditional treatments. The response rate is 30%, far from satisfactory. In recent years, T lymphocyte-mediated destruction of normal hematopoietic stem cells have been reported to involve the pathogenesis of PNH, making immunomodulatory drugs be potential effective treatments. Sirolimus (rapamycin), produced by the bacterium Streptomyces hygroscopicus, is a mammalian target of Rapamycin (mTOR) inhibitor. mTOR is a serine/threonine kinase that regulates cell growth, proliferation, metabolism and survival. It has two interacting complex, mTORC1 and mTORC2. Sirolimus primarily inhibits mTORC1, has been demonstrated for its immunomodulatory effects and ability to improve hematopoietic stem cell function. Recently, sirolimus has been reported to be effective and well tolerated in the treatment of immune-mediated cytopenias, even in multi-immunosuppressants resistant patients. In addition, classical PNH patients have a higher risk of thrombosis especially in refractory ones and it is reasonable to use low-dose warfarin in the management of patients with classic refractory PNH. In this study, it is anticipated to evaluate the effect of sirolimus combined with low-dose warfarin on patients with refractory classic PNH. The adverse effects and QoL on different time points were documented.
Official Title
-----------------
Sirolimus Combined With Low-dose Warfarin for the Treatment of Refractory Classic Paroxysmal Nocturnal Hemoglobinuria ,a Prospective Study
Conditions
-----------------
Paroxysmal Nocturnal Hemoglobinuria
Intervention / Treatment
-----------------
* Drug: sirolimus
Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: age 18-70 years diagnosed with PNH and no thrombosis ineffective, relapsed or intolerant to conventional treatment (eg glucocorticoids, • • iron, folic acid, androgen, etc.) not available for hematopoietic stem cell transplantation ECOG≤2 agreed to sign the consent forms Exclusion Criteria: severe heart, liver and kidney dysfunction combined with thrombotic complications people who are pregnant and breastfeeding history of other immunosuppressive agents in recent 3 months Patients who are not eligible to participate in this trial due to any reason based • • • on the consideration of investigator
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
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Arms and Interventions
| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Patients cohort<br>A total of 40 patients with refractory classic PNH will be included and will be intervened by a combined therapy including sirolimus and low-dose warfarin | Drug: sirolimus<br>* The dose of sirolimus is adjusted according to monitored serum concentration, maintain Rapamycin concentration ranging from 4 to 10ng/ml.Warfarin was administered orally at a dose of 1mg per day for a year,then gradually reduced to stop.<br>* Other names: warfarin;|
What is the study measuring?
-----------------
Primary Outcome Measures
| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Hemoglobin | Hemoglobin in g/L | 2 years |
Secondary Outcome Measures
| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Short Form 36 items(SF-36) questionnaire | SF-36 questionnaire in scores | 2 years |
|
|
NCT01511198
|
Efficacy and Safety of Metformin and Liraglutide in Obese Subjects With Type 2 Diabetes Previously Treated With an Oral Hypoglycemic Agent
|
This trial is conducted in the United States of America (USA). The aim of this trial is to determine the dose-response relationship for body weight and five escalating doses of NNC 90-1170 (liraglutide) in subjects with type 2 diabetes previously treated with an oral hypoglycemic agent (OHA).
|
NNC 90-1170 Dose-response, Efficacy and Safety: A 12-week Randomized, Multicenter, Doubleblind, Double-dummy, Parallel-group Study of Metformin and Five Doses of NNC 90-1170 in Previously-treated OHA Monotherapy Obese Subjects With Type 2 Diabetes
|
Diabetes, Diabetes Mellitus, Type 2
|
* Drug: liraglutide
* Drug: metformin
|
Inclusion Criteria:~Type 2 diabetic~Treated with OHA (oral hypoglycaemic agent monotherapy for at least 3 months. Prior use of metformin is allowed~Body Mass Index (BMI) between 27.0-42.0 kg/m^2 (inclusive)~HbA1c maximum 10% based on analysis from central laboratory~Exclusion Criteria:~Cardiac problems~Uncontrolled treated/untreated hypertension~Proliferative retinopathy or known autonomic neuropathy~Recurrent severe hypoglycemia as judged by the investigator~Known or suspected allergy to trial product or related products~Use of any drug (except for OHAs), which in the investigators opinion could interfere with the glucose level or body weight or any contraindication to metformin use or intolerance to metformin 1000 mg (prior to trial entry or during run-in period). Stable doses, for 3 months or greater, of thyroid hormone replacement are allowed~Known or suspected abuse of alcohol or narcotics~Current treatment with thiazolidinediones or chronic daily use of insulin (more than 7 days) within three months in the absence of intercurrent illness~TSH (thyroid stimulating hormone) below 0.2 or above 15 U/mL~Type 1 or other specific causes of diabetes
|
18 Years
|
75 Years
|
All
|
No
|
Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double
|
| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Body weight | | |
|
| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| FPG (fasting plasma glucose) | | |
| HbA1c (glycosylated haemoglobin) | | |
| Fructosamine | | |
| Lipids | | |
| Adverse events | | |
|
Metformin, Liraglutide, Hypoglycemic Agents, Physiological Effects of Drugs, Incretins, Hormones, Hormones, Hormone Substitutes, and Hormone Antagonists
|
| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: 0.045 mg<br> | Drug: liraglutide<br>* Injected subcutaneously once daily<br>* Other names: NNC 90-1170;|
| Experimental: 0.225 mg<br> | Drug: liraglutide<br>* Injected subcutaneously once daily<br>* Other names: NNC 90-1170;|
| Experimental: 0.45 mg<br> | Drug: liraglutide<br>* Injected subcutaneously once daily<br>* Other names: NNC 90-1170;|
| Experimental: 0.60 mg<br> | Drug: liraglutide<br>* Injected subcutaneously once daily<br>* Other names: NNC 90-1170;|
| Experimental: 0.75 mg<br> | Drug: liraglutide<br>* Injected subcutaneously once daily<br>* Other names: NNC 90-1170;|
| Active Comparator: Met<br> | Drug: metformin<br>* 1000 mg twice daily, administered orally<br>|
|
Efficacy and Safety of Metformin and Liraglutide in Obese Subjects With Type 2 Diabetes Previously Treated With an Oral Hypoglycemic Agent
Study Overview
=================
Brief Summary
-----------------
This trial is conducted in the United States of America (USA). The aim of this trial is to determine the dose-response relationship for body weight and five escalating doses of NNC 90-1170 (liraglutide) in subjects with type 2 diabetes previously treated with an oral hypoglycemic agent (OHA).
Official Title
-----------------
NNC 90-1170 Dose-response, Efficacy and Safety: A 12-week Randomized, Multicenter, Doubleblind, Double-dummy, Parallel-group Study of Metformin and Five Doses of NNC 90-1170 in Previously-treated OHA Monotherapy Obese Subjects With Type 2 Diabetes
Conditions
-----------------
Diabetes, Diabetes Mellitus, Type 2
Intervention / Treatment
-----------------
* Drug: liraglutide
* Drug: metformin
Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Type 2 diabetic Treated with OHA (oral hypoglycaemic agent monotherapy for at least 3 months. Prior use of metformin is allowed Body Mass Index (BMI) between 27.0-42.0 kg/m^2 (inclusive) HbA1c maximum 10% based on analysis from central laboratory Exclusion Criteria: Cardiac problems Uncontrolled treated/untreated hypertension Proliferative retinopathy or known autonomic neuropathy Recurrent severe hypoglycemia as judged by the investigator Known or suspected allergy to trial product or related products Use of any drug (except for OHAs), which in the investigators opinion could interfere with the glucose level or body weight or any contraindication to metformin use or intolerance to metformin 1000 mg (prior to trial entry or during run-in period). Stable doses, for 3 months or greater, of thyroid hormone replacement are allowed Known or suspected abuse of alcohol or narcotics Current treatment with thiazolidinediones or chronic daily use of insulin (more than 7 days) within three months in the absence of intercurrent illness TSH (thyroid stimulating hormone) below 0.2 or above 15 U/mL Type 1 or other specific causes of diabetes
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: Double
Arms and Interventions
| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: 0.045 mg<br> | Drug: liraglutide<br>* Injected subcutaneously once daily<br>* Other names: NNC 90-1170;|
| Experimental: 0.225 mg<br> | Drug: liraglutide<br>* Injected subcutaneously once daily<br>* Other names: NNC 90-1170;|
| Experimental: 0.45 mg<br> | Drug: liraglutide<br>* Injected subcutaneously once daily<br>* Other names: NNC 90-1170;|
| Experimental: 0.60 mg<br> | Drug: liraglutide<br>* Injected subcutaneously once daily<br>* Other names: NNC 90-1170;|
| Experimental: 0.75 mg<br> | Drug: liraglutide<br>* Injected subcutaneously once daily<br>* Other names: NNC 90-1170;|
| Active Comparator: Met<br> | Drug: metformin<br>* 1000 mg twice daily, administered orally<br>|
What is the study measuring?
-----------------
Primary Outcome Measures
| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Body weight | | |
Secondary Outcome Measures
| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| FPG (fasting plasma glucose) | | |
| HbA1c (glycosylated haemoglobin) | | |
| Fructosamine | | |
| Lipids | | |
| Adverse events | | |
|
||
NCT00602511
|
Thalidomide Versus Bortezomib in Melphalan Refractory Myeloma
|
The purpose of the study is to compare thalidomide + dexamethasone with bortezomib + dexamethasone in patients with multiple myeloma refractory to melphalan therapy. The main goal is to find out which of these two 2:nd line regimens that offers the patients the best chance for a response with as long duration and as good quality of life as possible.
|
The study is an open randomized multicentre study in which patients with multiple myeloma refractory to melphalan therapy are randomized between bortezomib and thalidomide therapy, in both arms with the addition of dexamethasone. In case of failure to the initially given treatment the patient will be crossed over to the alternative treatment.~The number of patients needed is calculated to 300, based upon the hypothesis of a 50% difference in progression free survival, a significance level of 95% and a power of 80%. With 12 patients being recruited each month during 25 months and a 4 months follow-up after the last included patient, the total study time will be 29 months.~The dose regimens for bortezomib and thalidomide follow general clinical praxis as regards recommendations for optimal dosing in the Nordic countries.~Evaluation of response and toxicity is performed every 3 weeks for at least 12 weeks, thereafter every 6 weeks. Evaluation of efficacy is done according to The International Myeloma Working Group Uniform Response Criteria. Evaluation of toxicity is done by CTCAE grading. Evaluation of quality of life is done by the EORTC QLQ30 questionnaires with the addition of the myeloma specific MY-24 module which are mailed to the patients at predetermined intervals during the study.
|
Thalidomide Versus Bortezomib in Melphalan Refractory Myeloma
|
Multiple Myeloma
|
* Drug: Bortezomib
* Drug: Thalidomide
|
Inclusion Criteria:~Treatment demanding multiple myeloma~Refractoriness to melphalan~Acceptance of rules for prevention of pregnancy~Exclusion Criteria:~Previous treatment with bortezomib, thalidomide, or lenalidomide~Sensory neuropathy grade III or neuropathic pain grade II~Severe concomitant disorder, e.g. other malignancy or severe heart disease~Transformation to plasma cell leukemia or aggressive lymphoma~Frequent visits for bortezomib injections not feasible~Anticipated non-adherence to study protocol~Pregnancy~Anticipated non-adherence to rules for prevention of pregnancy~Severe thrombocytopenia (Thrombocyte count less than 25000/microliter)
|
18 Years
| null |
All
|
No
|
Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: None (Open Label)
|
| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Progression free survival | | |
|
| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Response rate | | |
| Response duration | | |
| Time to start of other treatment | | |
| Toxicity | | |
| Quality of life | | |
| Response rate after cross-over | | |
| Response duration after cross-over | | |
|
Melfalan refractory multiple myeloma, Multiple myeloma, Relapsing, Refractory, Thalidomide, Bortezomib, Randomized clinical trial
|
Thalidomide, Bortezomib, Antineoplastic Agents, Immunosuppressive Agents, Immunologic Factors, Physiological Effects of Drugs, Leprostatic Agents, Anti-Bacterial Agents, Anti-Infective Agents, Angiogenesis Inhibitors, Angiogenesis Modulating Agents, Growth Substances, Growth Inhibitors
|
| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: 1<br>Bortezomib - dexamethasone | Drug: Bortezomib<br>* Bortezomib 1,3 mg/m2 intravenously on days 1, 4, 8 och 11 of every 3 weeks cycle until maximal response, toxicity or maximum 8 cycles~Dexamethasone 20 mg days 1-2, 4-5, 8-9 and 11-12 during the first 2 cycles, thereafter individualized dose depending on response and toxicity<br>|
| Experimental: 2<br>Thalidomide - dexamethasone | Drug: Thalidomide<br>* Thalidomide 50 mg/day with dose escalation every 3 weeks until response or toxicity, maximal dose 200 mg/day~Dexamethasone 40 mg/day day 1-4 every 3 weeks for at least 2 courses, thereafter individualized dose depending on response and toxicity<br>|
|
Thalidomide Versus Bortezomib in Melphalan Refractory Myeloma
Study Overview
=================
Brief Summary
-----------------
The purpose of the study is to compare thalidomide + dexamethasone with bortezomib + dexamethasone in patients with multiple myeloma refractory to melphalan therapy. The main goal is to find out which of these two 2:nd line regimens that offers the patients the best chance for a response with as long duration and as good quality of life as possible.
Detailed Description
-----------------
The study is an open randomized multicentre study in which patients with multiple myeloma refractory to melphalan therapy are randomized between bortezomib and thalidomide therapy, in both arms with the addition of dexamethasone. In case of failure to the initially given treatment the patient will be crossed over to the alternative treatment. The number of patients needed is calculated to 300, based upon the hypothesis of a 50% difference in progression free survival, a significance level of 95% and a power of 80%. With 12 patients being recruited each month during 25 months and a 4 months follow-up after the last included patient, the total study time will be 29 months. The dose regimens for bortezomib and thalidomide follow general clinical praxis as regards recommendations for optimal dosing in the Nordic countries. Evaluation of response and toxicity is performed every 3 weeks for at least 12 weeks, thereafter every 6 weeks. Evaluation of efficacy is done according to The International Myeloma Working Group Uniform Response Criteria. Evaluation of toxicity is done by CTCAE grading. Evaluation of quality of life is done by the EORTC QLQ30 questionnaires with the addition of the myeloma specific MY-24 module which are mailed to the patients at predetermined intervals during the study.
Official Title
-----------------
Thalidomide Versus Bortezomib in Melphalan Refractory Myeloma
Conditions
-----------------
Multiple Myeloma
Intervention / Treatment
-----------------
* Drug: Bortezomib
* Drug: Thalidomide
Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Treatment demanding multiple myeloma Refractoriness to melphalan Acceptance of rules for prevention of pregnancy Exclusion Criteria: Previous treatment with bortezomib, thalidomide, or lenalidomide Sensory neuropathy grade III or neuropathic pain grade II Severe concomitant disorder, e.g. other malignancy or severe heart disease Transformation to plasma cell leukemia or aggressive lymphoma Frequent visits for bortezomib injections not feasible Anticipated non-adherence to study protocol Pregnancy Anticipated non-adherence to rules for prevention of pregnancy Severe thrombocytopenia (Thrombocyte count less than 25000/microliter)
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: None (Open Label)
Arms and Interventions
| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: 1<br>Bortezomib - dexamethasone | Drug: Bortezomib<br>* Bortezomib 1,3 mg/m2 intravenously on days 1, 4, 8 och 11 of every 3 weeks cycle until maximal response, toxicity or maximum 8 cycles Dexamethasone 20 mg days 1-2, 4-5, 8-9 and 11-12 during the first 2 cycles, thereafter individualized dose depending on response and toxicity<br>|
| Experimental: 2<br>Thalidomide - dexamethasone | Drug: Thalidomide<br>* Thalidomide 50 mg/day with dose escalation every 3 weeks until response or toxicity, maximal dose 200 mg/day Dexamethasone 40 mg/day day 1-4 every 3 weeks for at least 2 courses, thereafter individualized dose depending on response and toxicity<br>|
What is the study measuring?
-----------------
Primary Outcome Measures
| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Progression free survival | | |
Secondary Outcome Measures
| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Response rate | | |
| Response duration | | |
| Time to start of other treatment | | |
| Toxicity | | |
| Quality of life | | |
| Response rate after cross-over | | |
| Response duration after cross-over | | |
Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Melfalan refractory multiple myeloma, Multiple myeloma, Relapsing, Refractory, Thalidomide, Bortezomib, Randomized clinical trial
|
NCT04741360
|
Improving New Learning and Memory in School Aged Children
|
The currently proposed study addresses a critical need in the clinical care of school-aged children with TBI through the modification of an existing, proven efficacious treatment protocol for learning and memory deficits in persons with moderate to severe TBI, the modified Story Memory Technique (mSMT), as well as the conduct of a pilot double blind, placebo-controlled, RCT of this new pediatric adaptation of the mSMT. Over a decade of research and development conducted at our center has demonstrated the mSMT to be effective for improving new learning and memory in adults with TBI, across three realms of functioning: objective behavior, brain functioning and everyday life. This convincing data provides Class I evidence supporting the efficacy of the mSMT for improving new learning and memory in adults with TBI. Clinical applications around the world have equally attested to its utility in the clinical care of adults with TBI. This highlights the tremendous potential of the mSMT to vastly improve the everyday lives and educational successes of children and adoles-cents living with TBI and the resultant learning and memory deficits. The currently proposed pilot work will begin to document that efficacy. The results of this study therefore have the potential to change clinical practice, inform policy, and improve the lives of children and adolescents living with TBI.
|
The currently proposed study addresses a critical need in the clinical care of school-aged children with TBI through the modification of an existing, proven efficacious treatment protocol for learning and memory deficits in persons with moderate to severe TBI, the modified Story Memory Technique (mSMT), as well as the conduct of a pilot double blind, placebo-controlled, RCT of this new pediatric adaptation of the mSMT. Over a decade of research and development conducted at our center has demonstrated the mSMT to be effective for improving new learning and memory in adults with TBI, across three realms of functioning: objective behavior, brain functioning and everyday life. This convincing data provides Class I evidence supporting the efficacy of the mSMT for improving new learning and memory in adults with TBI. Clinical applications around the world have equally attested to its utility in the clinical care of adults with TBI. This highlights the tremendous potential of the mSMT to vastly improve the everyday lives and educational successes of children and adoles-cents living with TBI and the resultant learning and memory deficits. The currently proposed pilot work will begin to document that efficacy. The results of this study therefore have the potential to change clinical practice, inform policy, and improve the lives of children and adolescents living with TBI.
|
Improving New Learning and Memory in School Aged Children
|
Traumatic Brain Injury
|
* Other: Modified Story Memory Technique
|
Inclusion Criteria:~Be between the ages of 9 and 17.~Have sustained a TBI at least 1 year ago, that has affected his or her memory.~Be able to speak and read English fluently.~Exclusion Criteria:~Diagnosis of MS, or neurological injury or disease in the past (like brain tumor or epilepsy).~History of significant psychiatric illness (like bipolar disorder, schizophrenia or psychosis).~Uncontrolled seizures or other unstable medical complications.
|
9 Years
|
17 Years
|
All
|
No
|
Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double
|
| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| CVLT-C Learning Slope | Memory | 6 months |
|
Pediatrics
|
Brain Injuries, Brain Injuries, Traumatic, Brain Diseases, Central Nervous System Diseases, Nervous System Diseases, Craniocerebral Trauma, Trauma, Nervous System, Wounds and Injuries
|
| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Modified Story Memory Technique<br> | Other: Modified Story Memory Technique<br>* 10-session computerized program to improve new learning and memory<br>|
| Other: Control<br> | Other: Modified Story Memory Technique<br>* 10-session computerized program to improve new learning and memory<br>|
|
Improving New Learning and Memory in School Aged Children
Study Overview
=================
Brief Summary
-----------------
The currently proposed study addresses a critical need in the clinical care of school-aged children with TBI through the modification of an existing, proven efficacious treatment protocol for learning and memory deficits in persons with moderate to severe TBI, the modified Story Memory Technique (mSMT), as well as the conduct of a pilot double blind, placebo-controlled, RCT of this new pediatric adaptation of the mSMT. Over a decade of research and development conducted at our center has demonstrated the mSMT to be effective for improving new learning and memory in adults with TBI, across three realms of functioning: objective behavior, brain functioning and everyday life. This convincing data provides Class I evidence supporting the efficacy of the mSMT for improving new learning and memory in adults with TBI. Clinical applications around the world have equally attested to its utility in the clinical care of adults with TBI. This highlights the tremendous potential of the mSMT to vastly improve the everyday lives and educational successes of children and adoles-cents living with TBI and the resultant learning and memory deficits. The currently proposed pilot work will begin to document that efficacy. The results of this study therefore have the potential to change clinical practice, inform policy, and improve the lives of children and adolescents living with TBI.
Detailed Description
-----------------
The currently proposed study addresses a critical need in the clinical care of school-aged children with TBI through the modification of an existing, proven efficacious treatment protocol for learning and memory deficits in persons with moderate to severe TBI, the modified Story Memory Technique (mSMT), as well as the conduct of a pilot double blind, placebo-controlled, RCT of this new pediatric adaptation of the mSMT. Over a decade of research and development conducted at our center has demonstrated the mSMT to be effective for improving new learning and memory in adults with TBI, across three realms of functioning: objective behavior, brain functioning and everyday life. This convincing data provides Class I evidence supporting the efficacy of the mSMT for improving new learning and memory in adults with TBI. Clinical applications around the world have equally attested to its utility in the clinical care of adults with TBI. This highlights the tremendous potential of the mSMT to vastly improve the everyday lives and educational successes of children and adoles-cents living with TBI and the resultant learning and memory deficits. The currently proposed pilot work will begin to document that efficacy. The results of this study therefore have the potential to change clinical practice, inform policy, and improve the lives of children and adolescents living with TBI.
Official Title
-----------------
Improving New Learning and Memory in School Aged Children
Conditions
-----------------
Traumatic Brain Injury
Intervention / Treatment
-----------------
* Other: Modified Story Memory Technique
Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Be between the ages of 9 and 17. Have sustained a TBI at least 1 year ago, that has affected his or her memory. Be able to speak and read English fluently. Exclusion Criteria: Diagnosis of MS, or neurological injury or disease in the past (like brain tumor or epilepsy). History of significant psychiatric illness (like bipolar disorder, schizophrenia or psychosis). Uncontrolled seizures or other unstable medical complications.
Ages Eligible for Study
-----------------
Minimum Age: 9 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: Randomized
Intervention Model: Parallel Assignment
Masking: Double
Arms and Interventions
| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Modified Story Memory Technique<br> | Other: Modified Story Memory Technique<br>* 10-session computerized program to improve new learning and memory<br>|
| Other: Control<br> | Other: Modified Story Memory Technique<br>* 10-session computerized program to improve new learning and memory<br>|
What is the study measuring?
-----------------
Primary Outcome Measures
| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| CVLT-C Learning Slope | Memory | 6 months |
Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Pediatrics
|
|
NCT01089543
|
A Study of E3810 for Japanese Subjects With Functional Dyspepsia (SAMURAI Study: Suppression of Acid Milieu With Rabeprazole Improving Functional Dyspepsia ) (Study E3810-J081-204)
|
The purpose of this study is to assess the efficacy and safety of rabeprazole compared to placebo in Japanese subjects with Functional Dyspepsia.
|
A Multi-Center, Randomized, Double-Blind Study of E3810 for Japanese Subjects With Functional Dyspepsia
|
Functional Dyspepsia
|
* Drug: Rabeprazole
* Drug: Rabeprazole
* Drug: Rabeprazole
* Drug: Placebo
|
Inclusion criteria:~-Participants diagnosed as Functional Dyspepsia according to Rome III criteria.~Exclusion criteria:~Participants with neuropsychiatric disorder.~Participants diagnosed with irritable bowel syndrome, inflammatory bowel disease and serious constipation.
|
20 Years
| null |
All
|
No
|
Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double
|
| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Rate of Complete Dyspepsia Symptom Relief | The rate of complete dyspepsia symptom relief according to the Dyspepsia Symptom Questionnaire (DSQ) was defined as a score of 1 for all four major dyspeptic symptoms at week 8 and according to the diary defined as all four dyspepsia symptoms recorded absent during the 7 days prior to week 8. Values presented as percentage of participants. | Up to 8 Weeks (including 7 days prior) |
|
| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Rate of Satisfactory Symptom Relief | The rate of satisfactory symptom relief according to the DSQ defined as scores of <= 2 for all four major dyspepsia symptoms at week 8 and the diary recordings defined as a frequency of <= 1 day for all four major dyspepsia symptoms during the 7 days before week 8. Lastly, treatment success according to the participants' impression questionnaire where participants answered yes or no when asked if given the choice, whether they would want to continue to take the study drug after clinical trial completion. Values presented as percentage of participants. | Up to 8 Weeks (including 7 days prior) |
|
dyspepsia, rabeprazole, Japan
|
Rabeprazole, Anti-Ulcer Agents, Gastrointestinal Agents, Proton Pump Inhibitors, Enzyme Inhibitors, Molecular Mechanisms of Pharmacological Action
|
| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Rabeprazole 10 mg<br> | Drug: Rabeprazole<br>* Rabeprazole 10 mg tablet taken orally once daily after breakfast for 8 weeks.<br>* Other names: E3810;|
| Experimental: Rabeprazole 20 mg<br> | Drug: Rabeprazole<br>* Rabeprazole 20 mg tablet taken orally once daily after breakfast for 8 weeks.<br>* Other names: E3810;|
| Experimental: Rabeprazole 40 mg<br> | Drug: Rabeprazole<br>* Rabeprazole 40 mg tablet taken orally once daily after breakfast for 8 weeks.<br>* Other names: E3810;|
| Placebo Comparator: Placebo<br> | Drug: Placebo<br>* Rabeprazole Placebo tablet taken orally once daily after breakfast for 8 weeks.<br>* Other names: E3810;|
|
A Study of E3810 for Japanese Subjects With Functional Dyspepsia (SAMURAI Study: Suppression of Acid Milieu With Rabeprazole Improving Functional Dyspepsia ) (Study E3810-J081-204)
Study Overview
=================
Brief Summary
-----------------
The purpose of this study is to assess the efficacy and safety of rabeprazole compared to placebo in Japanese subjects with Functional Dyspepsia.
Official Title
-----------------
A Multi-Center, Randomized, Double-Blind Study of E3810 for Japanese Subjects With Functional Dyspepsia
Conditions
-----------------
Functional Dyspepsia
Intervention / Treatment
-----------------
* Drug: Rabeprazole
* Drug: Rabeprazole
* Drug: Rabeprazole
* Drug: Placebo
Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion criteria: -Participants diagnosed as Functional Dyspepsia according to Rome III criteria. Exclusion criteria: Participants with neuropsychiatric disorder. Participants diagnosed with irritable bowel syndrome, inflammatory bowel disease and serious constipation.
Ages Eligible for Study
-----------------
Minimum Age: 20 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: Rabeprazole 10 mg<br> | Drug: Rabeprazole<br>* Rabeprazole 10 mg tablet taken orally once daily after breakfast for 8 weeks.<br>* Other names: E3810;|
| Experimental: Rabeprazole 20 mg<br> | Drug: Rabeprazole<br>* Rabeprazole 20 mg tablet taken orally once daily after breakfast for 8 weeks.<br>* Other names: E3810;|
| Experimental: Rabeprazole 40 mg<br> | Drug: Rabeprazole<br>* Rabeprazole 40 mg tablet taken orally once daily after breakfast for 8 weeks.<br>* Other names: E3810;|
| Placebo Comparator: Placebo<br> | Drug: Placebo<br>* Rabeprazole Placebo tablet taken orally once daily after breakfast for 8 weeks.<br>* Other names: E3810;|
What is the study measuring?
-----------------
Primary Outcome Measures
| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Rate of Complete Dyspepsia Symptom Relief | The rate of complete dyspepsia symptom relief according to the Dyspepsia Symptom Questionnaire (DSQ) was defined as a score of 1 for all four major dyspeptic symptoms at week 8 and according to the diary defined as all four dyspepsia symptoms recorded absent during the 7 days prior to week 8. Values presented as percentage of participants. | Up to 8 Weeks (including 7 days prior) |
Secondary Outcome Measures
| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Rate of Satisfactory Symptom Relief | The rate of satisfactory symptom relief according to the DSQ defined as scores of <= 2 for all four major dyspepsia symptoms at week 8 and the diary recordings defined as a frequency of <= 1 day for all four major dyspepsia symptoms during the 7 days before week 8. Lastly, treatment success according to the participants' impression questionnaire where participants answered yes or no when asked if given the choice, whether they would want to continue to take the study drug after clinical trial completion. Values presented as percentage of participants. | Up to 8 Weeks (including 7 days prior) |
Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
dyspepsia, rabeprazole, Japan
|
|
NCT00610623
|
Azithromycin as a Quorum-Sensing Inhibitor for the Prevention of Pseudomonas Aeruginosa Ventilator-Associated Pneumonia
|
The purpose of this study is to assess the clinical efficacy of azithromycin, used as a quorum-sensing blocker, when compared to placebo for preventing or delaying the occurrence of pneumonia in ventilated patients colonized with Pseudomonas aeruginosa.
|
Proof of Concept Study to Investigate the Impact of Azithromycin Administered iv Versus Placebo on the Prevention of Pneumonia in Ventilated Patients Colonized by Pseudomonas Aeruginosa
|
Pneumonia, Ventilator-Associated, Pseudomonas Infections
|
* Drug: azithromycin
* Drug: placebo
|
Inclusion Criteria:~Male and non pregnant female aged 18 to 75 years~Patients hospitalized in ICU, under mechanically assisted ventilation expected to be mandatory for 3 days or more~Reasonable survival chance within next few days with an Apache score 10-25~Tracheal aspirate found positive for P. aeruginosa~The subject (or a close family member in case of incompetence) understands the procedure, agrees to participate, and is willing to give written informed consent~Informed consent must be obtained for all subjects before enrollment in the study, by patient or by a close family member~Exclusion Criteria:~Poor prognosis as judged by Apache score II score >25~Pregnant female~Grossly under-or overweight (BMI<18or >29)~Ongoing therapy with a macrolide~Known allergy to any macrolide~Proven P. aeruginosa pneumonia~Ongoing anti-pseudomonal therapy with a proven susceptible colonizing strain~Anticipated short duration of mechanical ventilation (<3 days)~Known drug interaction that could either decrease efficacy or raise safety concerns~Severe hepatic failure (type C, score >10 on Child Pugh scale)~Sick sinus syndrome or long QT syndrome~Recent donation of blood or participation in another clinical trial within 3 months~Any situation exposing the patient to higher risk or possibly confounding results
|
18 Years
|
75 Years
|
All
|
No
|
Primary Purpose: Prevention
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple
|
| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Occurrence of and time to Pseudomonas aeruginosa pneumonia | | daily |
|
| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| occurrence of and time to death | | daily |
| time to extubation | | daily |
| overall outcome | | daily |
| duration of hospitalization and ICU stay | | daily |
| occurrence of infections to other bacterial strains | | daily |
| cost assessment | | daily |
| demonstrate using in vitro and in vivo parameters that azithromycin can be used as a quorum-sensing blocker against P. aeruginosa | | daily |
| determine whether prolonged treatment with azithromycin may induce resistance to any of 11 anti-pseudomonal antibiotics | | daily |
| determine whether P. aeruginosa can develop resistance to the quorum-sensing effect of azithromycin | | daily |
|
Pseudomonas aeruginosa, Pneumonia, Ventilator-Associated, Quorum Sensing
|
Azithromycin, Anti-Bacterial Agents, Anti-Infective Agents
|
| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: 1<br>azithromycin iv 300 mg/day | Drug: azithromycin<br>* 300 mg/day, IV from day 1 to 20<br>* Other names: Zithromax;|
| Placebo Comparator: 2<br>Placebo | Drug: placebo<br>* once per day, IV from day 1 to 20<br>|
|
Azithromycin as a Quorum-Sensing Inhibitor for the Prevention of Pseudomonas Aeruginosa Ventilator-Associated Pneumonia
Study Overview
=================
Brief Summary
-----------------
The purpose of this study is to assess the clinical efficacy of azithromycin, used as a quorum-sensing blocker, when compared to placebo for preventing or delaying the occurrence of pneumonia in ventilated patients colonized with Pseudomonas aeruginosa.
Official Title
-----------------
Proof of Concept Study to Investigate the Impact of Azithromycin Administered iv Versus Placebo on the Prevention of Pneumonia in Ventilated Patients Colonized by Pseudomonas Aeruginosa
Conditions
-----------------
Pneumonia, Ventilator-Associated, Pseudomonas Infections
Intervention / Treatment
-----------------
* Drug: azithromycin
* Drug: placebo
Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Male and non pregnant female aged 18 to 75 years Patients hospitalized in ICU, under mechanically assisted ventilation expected to be mandatory for 3 days or more Reasonable survival chance within next few days with an Apache score 10-25 Tracheal aspirate found positive for P. aeruginosa The subject (or a close family member in case of incompetence) understands the procedure, agrees to participate, and is willing to give written informed consent Informed consent must be obtained for all subjects before enrollment in the study, by patient or by a close family member Exclusion Criteria: Poor prognosis as judged by Apache score II score >25 Pregnant female Grossly under-or overweight (BMI<18or >29) Ongoing therapy with a macrolide Known allergy to any macrolide Proven P. aeruginosa pneumonia Ongoing anti-pseudomonal therapy with a proven susceptible colonizing strain Anticipated short duration of mechanical ventilation (<3 days) Known drug interaction that could either decrease efficacy or raise safety concerns Severe hepatic failure (type C, score >10 on Child Pugh scale) Sick sinus syndrome or long QT syndrome Recent donation of blood or participation in another clinical trial within 3 months Any situation exposing the patient to higher risk or possibly confounding results
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: Prevention
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple
Arms and Interventions
| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: 1<br>azithromycin iv 300 mg/day | Drug: azithromycin<br>* 300 mg/day, IV from day 1 to 20<br>* Other names: Zithromax;|
| Placebo Comparator: 2<br>Placebo | Drug: placebo<br>* once per day, IV from day 1 to 20<br>|
What is the study measuring?
-----------------
Primary Outcome Measures
| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Occurrence of and time to Pseudomonas aeruginosa pneumonia | | daily |
Secondary Outcome Measures
| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| occurrence of and time to death | | daily |
| time to extubation | | daily |
| overall outcome | | daily |
| duration of hospitalization and ICU stay | | daily |
| occurrence of infections to other bacterial strains | | daily |
| cost assessment | | daily |
| demonstrate using in vitro and in vivo parameters that azithromycin can be used as a quorum-sensing blocker against P. aeruginosa | | daily |
| determine whether prolonged treatment with azithromycin may induce resistance to any of 11 anti-pseudomonal antibiotics | | daily |
| determine whether P. aeruginosa can develop resistance to the quorum-sensing effect of azithromycin | | daily |
Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Pseudomonas aeruginosa, Pneumonia, Ventilator-Associated, Quorum Sensing
|
|
NCT04021953
|
The People Like Us Evaluation Study
|
The study is a pragmatic, randomized controlled trial design to evaluate an online video series developed by a community-based organization in Singapore for gay, bisexual and queer men.~A total of 300 HIV-negative, gay, bisexual and queer men in Singapore aged 18 to 29 years old will be recruited with the assistance of the partner community-based organization (CBO), Action for AIDS Singapore. Recruitment will utilize both online and offline channels, and with the help of other CBOs in Singapore. Participants should also not have watched the video prior to their participation in this study, which will be ascertained through a questionnaire.~Participants will subsequently be randomized into the intervention arm (n=150) and the control arm (n=150). The treatment group (n=150) will be assigned the intervention along with sexual health information via a pamphlet, while the control group (n=150) will be assigned only the sexual health information via a pamphlet. This will be conducted through block randomization.
|
Evaluation of eHealth Videos for the Singaporean Gay, Bisexual and Queer Male Community
|
Sexually Transmitted Infection, Stigma, Social, HIV/AIDS, Homosexuality, Health Behavior, Health Care Seeking Behavior
|
* Behavioral: People Like Us Online Video Series Intervention
* Behavioral: Sexual Health Pamphlet (Standard of Care)
|
Inclusion Criteria:~Self-reported HIV-negative status, or unsure of HIV status~Self-reported gay, bisexual or queer sexual orientation~Self-reported male gender, regardless of sex assigned at birth~Self-reported age of 18 to 29 years old at point of recruitment~Singapore citizen or permanent resident at the point of recruitment~Self-reported as never having watched an online video drama series by Gayhealth.sg or Action for AIDS in the last year~Exclusion Criteria:~Participants who have watched the People Like Us Series prior to study~Participants who have self-reported being HIV-positive~Participants who are not English-literate~Participants aged below 18 or above 29 at baseline recruitment
|
18 Years
|
29 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 in intention to test for HIV at 3 months | Participants are asked: How likely are you to get tested for HIV in the next three months?; to which they may respond:~Extremely unlikely to get tested~Very unlikely to get tested~Somewhat unlikely to get tested~Somewhat likely to get tested~Very likely to get tested~Extremely likely to get tested | 3 months |
| Change in intention to test for HIV at 6 months | Participants are asked: How likely are you to get tested for HIV in the next three months?; to which they may respond:~Extremely unlikely to get tested~Very unlikely to get tested~Somewhat unlikely to get tested~Somewhat likely to get tested~Very likely to get tested~Extremely likely to get tested | 6 months |
| Change in intention to test for Syphilis at 3 months | Participants are asked: How likely are you to get tested for Syphilis in the next three months?; to which they may respond:~Extremely unlikely to get tested~Very unlikely to get tested~Somewhat unlikely to get tested~Somewhat likely to get tested~Very likely to get tested~Extremely likely to get tested | 3 months |
| Change in intention to test for Syphilis at 6 months | Participants are asked: How likely are you to get tested for Syphilis in the next three months?; to which they may respond:~Extremely unlikely to get tested~Very unlikely to get tested~Somewhat unlikely to get tested~Somewhat likely to get tested~Very likely to get tested~Extremely likely to get tested | 6 months |
| Change in intention to test for Chlamydia and Gonorrhea at 3 months | Participants are asked: How likely are you to get tested for Chlamydia and Gonorrhea in the next three months?; to which they may respond:~Extremely unlikely to get tested~Very unlikely to get tested~Somewhat unlikely to get tested~Somewhat likely to get tested~Very likely to get tested~Extremely likely to get tested | 3 months |
| Change in intention to test for Chlamydia and Gonorrhea at 6 months | Participants are asked: How likely are you to get tested for Chlamydia and Gonorrhea in the next three months?; to which they may respond:~Extremely unlikely to get tested~Very unlikely to get tested~Somewhat unlikely to get tested~Somewhat likely to get tested~Very likely to get tested~Extremely likely to get tested | 6 months |
| HIV testing at 3 months | Participants are asked: When did you go for you last (most recent) voluntary HIV test?; to which they may respond:~Never~In the last 3 months~In the last 6 months~6 to 12 months ago~More than 1 year ago | 3 months |
| HIV testing at 6 months | Participants are asked: When did you go for you last (most recent) voluntary HIV test?; to which they may respond:~Never~In the last 3 months~In the last 6 months~6 to 12 months ago~More than 1 year ago | 6 months |
| Syphilis testing at 3 months | Participants are asked: When did you go for you last (most recent) voluntary Syphilis test?; to which they may respond:~Never~In the last 3 months~In the last 6 months~6 to 12 months ago~More than 1 year ago | 3 months |
| Syphilis testing at 6 months | Participants are asked: When did you go for you last (most recent) voluntary Syphilis test?; to which they may respond:~Never~In the last 3 months~In the last 6 months~6 to 12 months ago~More than 1 year ago | 6 months |
| Chlamydia and Gonorrhea testing at 3 months | Participants are asked: When did you go for you last (most recent) voluntary Chlamydia or Gonorrhea test?; to which they may respond:~Never~In the last 3 months~In the last 6 months~6 to 12 months ago~More than 1 year ago | 3 months |
| Chlamydia and Gonorrhea testing at 6 months | Participants are asked: When did you go for you last (most recent) voluntary Chlamydia or Gonorrhea test?; to which they may respond:~Never~In the last 3 months~In the last 6 months~6 to 12 months ago~More than 1 year ago | 6 months |
| Self-reported regularity of HIV testing at 3 months | Participants are asked: On average, how regularly do you test for HIV?; to which they may respond:~I do not test regularly~Once every few years~Once a year~Once every 6 months~Once every 3 months~Once a month | 3 months |
| Self-reported regularity of HIV testing at 6 months | Participants are asked: On average, how regularly do you test for HIV?; to which they may respond:~I do not test regularly~Once every few years~Once a year~Once every 6 months~Once every 3 months~Once a month | 6 months |
| Self-reported regularity of Syphilis testing at 3 months | Participants are asked: On average, how regularly do you test for Syphilis?; to which they may respond:~I do not test regularly~Once every few years~Once a year~Once every 6 months~Once every 3 months~Once a month | 3 months |
| Self-reported regularity of Syphilis testing at 6 months | Participants are asked: On average, how regularly do you test for Syphilis?; to which they may respond:~I do not test regularly~Once every few years~Once a year~Once every 6 months~Once every 3 months~Once a month | 6 months |
| Self-reported regularity of Chlamydia and Gonorrhea testing at 3 months | Participants are asked: On average, how regularly do you test for Chlamydia and Gonorrhea?; to which they may respond:~I do not test regularly~Once every few years~Once a year~Once every 6 months~Once every 3 months~Once a month | 3 months |
| Self-reported regularity of Chlamydia and Gonorrhea testing at 6 months | Participants are asked: On average, how regularly do you test for Chlamydia and Gonorrhea?; to which they may respond:~I do not test regularly~Once every few years~Once a year~Once every 6 months~Once every 3 months~Once a month | 6 months |
|
| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Risk perception for HIV | Risk perception is measures through a questions (slider scale) that asks participants: How much risk do you think you are at of getting HIV?. Participants will rate this from 0 to 10 (0=no risk at all; 10=very high risk) | 3 months and 6 months |
| Risk perception for other sexually transmitted infections | Risk perception is measures through a questions (slider scale) that asks participants: How much risk do you think you are at of getting other sexually transmitted infections?. Participants will rate this from 0 to 10 (0=no risk at all; 10=very high risk) | 3 months and 6 months |
| Knowledge of HIV Pre-Exposure Prophylaxis | Participants are tested on their knowledge of HIV Pre-Exposure Prophylaxis by providing a response (1=True; 2=False; 3=I do not know) to two questions:~HIV Pre-Exposure Prophylaxis is an effective means of preventing HIV infection. The correct answer is True.~HIV Pre-Exposure Prophylaxis can also reduce the chances of acquiring other STIs. The correct answer is False.~Each correct answer provides a score of 1 point. | 3 months and 6 months |
| Knowledge of risks associated with acquiring other sexually transmitted infections | Participants are tested on their knowledge of other sexually transmitted infections by providing a response (1=True; 2=False; 3=I do not know) to three questions:~Gonorrhea can be transmitted through oral sex. The correct answer is True.~Chemsex, or the use of substances during sex, often increases a person's risk of engaging in risky sexual behavior and acquiring HIV or other STIs The correct answer is True.~There is a/are clinics in Singapore where I can test anonymously for HIV and Syphilis. The correct answer is True.~Each correct answer provides a score of 1 point. | 3 months and 6 months |
| Knowledge of HIV | Participants are tested on their knowledge of HIV by providing a response (1=True; 2=False; 3=I do not know) to two questions:~An HIV-positive individual who has achieved viral suppression or an 'undetectable' viral load has almost zero chances of transmitting the virus to someone else through sexual intercourse. The correct answer is True.~An HIV-positive individual on effective treatment can live a long, healthy, and productive life. The correct answer is True.~Each correct answer provides a score of 1 point. | 3 months and 6 months |
| Connectedness to LGBT Community | This is an 8-item scale adapted from Frost & Meyer (2012) that measures a participant's self-perceived connectedness to the LGBT community on a 4-point Likert Scale. The measure is a sum score of all 8 items. | 3 months and 6 months |
| Modified Self-Concealment Scale | This is a 7-item scale adapted from Scrimshaw (2013) that measures a participant's self-concealment of their sexual orientation on a 5-point Likert Scale. The measure is a sum score of all 7 items. | 3 months and 6 months |
| Consistent condom use for anal sex with casual partners or sex workers | This is assessed by the question, In the last 3 months, how often did you use a condom when having anal sex with a casual partner? or In the last 3 months, how often did you use a condom when having anal sex with a sex worker/money boy? (Options are always, more than half the time, about half the time, less than half the time, never used a condom). Participants who give the answer 'Always' are classified as having consistent condom usage for anal sex with causal partners or sex workers. | 3 months and 6 months |
| Incidence of sexually transmitted infections | This is defined as self-reporting a diagnosis of Syphilis, Chlamydia, Genital Herpes, Genital Warts, Hepatitis C, or Gonorrhea at the 3-month or 6-month follow-up. | 3 months and 6 months |
| Perceived Homophobia | This is a 6-item scale adapted from Smolenski, Ross, Risser, and Rosser (2009) that measures a participant's self-concealment of their sexual orientation. The measure is a sum score of all 6 items. | 3 months and 6 months |
| Internalized Homophobia | This is a 5-item scale adapted from Frost and Meyer (2013) that measures a participant's internalized homophobia on a 4-point Likert Scale. The measure is a sum score of all 5 items. | 3 months and 6 months |
| HIV testing self-efficacy | This is a 10-item scale adapted from Jamil and colleagues (2015) that measures a participant's self-efficacy in HIV testing on a 5-point Likert Scale. The measure is a sum score of all 10 items. | 3 months and 6 months |
| HIV testing social norms | This is a 9-item scale adapted from Pettifor and colleagues (2010) that measures a participant's perceptions on norms around HIV testing on a 4-point Likert Scale. The measure is a sum score of all 9 items. | 3 months and 6 months |
|
Singapore, HIV Testing, STI Testing, Homophobia, eHealth
|
Sexually Transmitted Diseases, Communicable Diseases, Infections, Genital Diseases, Urogenital Diseases, Disease Attributes, Pathologic Processes
|
| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Intervention Group<br>The online intervention comprises a series of six videos, each about 10-minutes in length, entitled the People Like Us series. The intervention was developed by gayhealth.sg and Action for AIDS Singapore in 2018. The series follow the love and sex lives of four ethnically-diverse GBQ men of varying socioeconomic backgrounds, as they negotiate issues of sexual health, mental health, and relationships throughout the six-part miniseries.~The intervention group will also be provided with an e-pamphlet on sexual wellness catered to GBMSM. This e-pamphlet has been developed by the National Skin Centre and Department of Sexually Transmitted Infections Clinic specifically for information on sexual wellness among GBMSM. It comprises segments on HIV/STI symptoms, etiology, information on how to seek help for HIV/STI, behavioral and biomedical methods of HIV prevention. | Behavioral: People Like Us Online Video Series Intervention<br>* People Like Us miniseries incorporates key sexual health messages to:~Increase viewers' knowledge and perceptions of HIV and other STI risk;~Address homophobia and sexual orientation disclosure;~Increase safer-sex negotiation self-efficacy;~Promote positive attitudes towards condom use and other safe sex behaviors;~Build skills and self-efficacy for practicing safer sex;~Provide information on HIV and other STI testing and its benefits;~Provide information on resources for HIV/STI testing and other mental health services;~Model appropriate behaviors around practicing safer sex.~Each video in the six-part series ends with an educational video segment featuring the managers of Action for AIDS and Gayhealth.sg, who provide a brief synopsis of the episode and cover key points relevant to mental and sexual health for GBQ men.<br>Behavioral: Sexual Health Pamphlet (Standard of Care)<br>* The control group will be provided with an e-pamphlet on sexual wellness catered to GBMSM. This e-pamphlet has been developed by the National Skin Centre and Department of Sexually Transmitted Infections Clinic specifically for information on sexual wellness among GBMSM. It comprises segments on HIV/STI symptoms, etiology, information on how to seek help for HIV/STI, behavioral and biomedical methods of HIV prevention.<br>|
| Active Comparator: Control Group<br>The control group will be provided with an e-pamphlet on sexual wellness catered to GBMSM. This e-pamphlet has been developed by the National Skin Centre and Department of Sexually Transmitted Infections Clinic specifically for information on sexual wellness among GBMSM. It comprises segments on HIV/STI symptoms, etiology, information on how to seek help for HIV/STI, behavioral and biomedical methods of HIV prevention. | Behavioral: Sexual Health Pamphlet (Standard of Care)<br>* The control group will be provided with an e-pamphlet on sexual wellness catered to GBMSM. This e-pamphlet has been developed by the National Skin Centre and Department of Sexually Transmitted Infections Clinic specifically for information on sexual wellness among GBMSM. It comprises segments on HIV/STI symptoms, etiology, information on how to seek help for HIV/STI, behavioral and biomedical methods of HIV prevention.<br>|
|
The People Like Us Evaluation Study
Study Overview
=================
Brief Summary
-----------------
The study is a pragmatic, randomized controlled trial design to evaluate an online video series developed by a community-based organization in Singapore for gay, bisexual and queer men. A total of 300 HIV-negative, gay, bisexual and queer men in Singapore aged 18 to 29 years old will be recruited with the assistance of the partner community-based organization (CBO), Action for AIDS Singapore. Recruitment will utilize both online and offline channels, and with the help of other CBOs in Singapore. Participants should also not have watched the video prior to their participation in this study, which will be ascertained through a questionnaire. Participants will subsequently be randomized into the intervention arm (n=150) and the control arm (n=150). The treatment group (n=150) will be assigned the intervention along with sexual health information via a pamphlet, while the control group (n=150) will be assigned only the sexual health information via a pamphlet. This will be conducted through block randomization.
Official Title
-----------------
Evaluation of eHealth Videos for the Singaporean Gay, Bisexual and Queer Male Community
Conditions
-----------------
Sexually Transmitted Infection, Stigma, Social, HIV/AIDS, Homosexuality, Health Behavior, Health Care Seeking Behavior
Intervention / Treatment
-----------------
* Behavioral: People Like Us Online Video Series Intervention
* Behavioral: Sexual Health Pamphlet (Standard of Care)
Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Self-reported HIV-negative status, or unsure of HIV status Self-reported gay, bisexual or queer sexual orientation Self-reported male gender, regardless of sex assigned at birth Self-reported age of 18 to 29 years old at point of recruitment Singapore citizen or permanent resident at the point of recruitment Self-reported as never having watched an online video drama series by Gayhealth.sg or Action for AIDS in the last year Exclusion Criteria: Participants who have watched the People Like Us Series prior to study Participants who have self-reported being HIV-positive Participants who are not English-literate Participants aged below 18 or above 29 at baseline recruitment
Ages Eligible for Study
-----------------
Minimum Age: 18 Years
Maximum Age: 29 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: Intervention Group<br>The online intervention comprises a series of six videos, each about 10-minutes in length, entitled the People Like Us series. The intervention was developed by gayhealth.sg and Action for AIDS Singapore in 2018. The series follow the love and sex lives of four ethnically-diverse GBQ men of varying socioeconomic backgrounds, as they negotiate issues of sexual health, mental health, and relationships throughout the six-part miniseries. The intervention group will also be provided with an e-pamphlet on sexual wellness catered to GBMSM. This e-pamphlet has been developed by the National Skin Centre and Department of Sexually Transmitted Infections Clinic specifically for information on sexual wellness among GBMSM. It comprises segments on HIV/STI symptoms, etiology, information on how to seek help for HIV/STI, behavioral and biomedical methods of HIV prevention. | Behavioral: People Like Us Online Video Series Intervention<br>* People Like Us miniseries incorporates key sexual health messages to: Increase viewers' knowledge and perceptions of HIV and other STI risk; Address homophobia and sexual orientation disclosure; Increase safer-sex negotiation self-efficacy; Promote positive attitudes towards condom use and other safe sex behaviors; Build skills and self-efficacy for practicing safer sex; Provide information on HIV and other STI testing and its benefits; Provide information on resources for HIV/STI testing and other mental health services; Model appropriate behaviors around practicing safer sex. Each video in the six-part series ends with an educational video segment featuring the managers of Action for AIDS and Gayhealth.sg, who provide a brief synopsis of the episode and cover key points relevant to mental and sexual health for GBQ men.<br>Behavioral: Sexual Health Pamphlet (Standard of Care)<br>* The control group will be provided with an e-pamphlet on sexual wellness catered to GBMSM. This e-pamphlet has been developed by the National Skin Centre and Department of Sexually Transmitted Infections Clinic specifically for information on sexual wellness among GBMSM. It comprises segments on HIV/STI symptoms, etiology, information on how to seek help for HIV/STI, behavioral and biomedical methods of HIV prevention.<br>|
| Active Comparator: Control Group<br>The control group will be provided with an e-pamphlet on sexual wellness catered to GBMSM. This e-pamphlet has been developed by the National Skin Centre and Department of Sexually Transmitted Infections Clinic specifically for information on sexual wellness among GBMSM. It comprises segments on HIV/STI symptoms, etiology, information on how to seek help for HIV/STI, behavioral and biomedical methods of HIV prevention. | Behavioral: Sexual Health Pamphlet (Standard of Care)<br>* The control group will be provided with an e-pamphlet on sexual wellness catered to GBMSM. This e-pamphlet has been developed by the National Skin Centre and Department of Sexually Transmitted Infections Clinic specifically for information on sexual wellness among GBMSM. It comprises segments on HIV/STI symptoms, etiology, information on how to seek help for HIV/STI, behavioral and biomedical methods of HIV prevention.<br>|
What is the study measuring?
-----------------
Primary Outcome Measures
| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change in intention to test for HIV at 3 months | Participants are asked: How likely are you to get tested for HIV in the next three months?; to which they may respond: Extremely unlikely to get tested Very unlikely to get tested Somewhat unlikely to get tested Somewhat likely to get tested Very likely to get tested Extremely likely to get tested | 3 months |
| Change in intention to test for HIV at 6 months | Participants are asked: How likely are you to get tested for HIV in the next three months?; to which they may respond: Extremely unlikely to get tested Very unlikely to get tested Somewhat unlikely to get tested Somewhat likely to get tested Very likely to get tested Extremely likely to get tested | 6 months |
| Change in intention to test for Syphilis at 3 months | Participants are asked: How likely are you to get tested for Syphilis in the next three months?; to which they may respond: Extremely unlikely to get tested Very unlikely to get tested Somewhat unlikely to get tested Somewhat likely to get tested Very likely to get tested Extremely likely to get tested | 3 months |
| Change in intention to test for Syphilis at 6 months | Participants are asked: How likely are you to get tested for Syphilis in the next three months?; to which they may respond: Extremely unlikely to get tested Very unlikely to get tested Somewhat unlikely to get tested Somewhat likely to get tested Very likely to get tested Extremely likely to get tested | 6 months |
| Change in intention to test for Chlamydia and Gonorrhea at 3 months | Participants are asked: How likely are you to get tested for Chlamydia and Gonorrhea in the next three months?; to which they may respond: Extremely unlikely to get tested Very unlikely to get tested Somewhat unlikely to get tested Somewhat likely to get tested Very likely to get tested Extremely likely to get tested | 3 months |
| Change in intention to test for Chlamydia and Gonorrhea at 6 months | Participants are asked: How likely are you to get tested for Chlamydia and Gonorrhea in the next three months?; to which they may respond: Extremely unlikely to get tested Very unlikely to get tested Somewhat unlikely to get tested Somewhat likely to get tested Very likely to get tested Extremely likely to get tested | 6 months |
| HIV testing at 3 months | Participants are asked: When did you go for you last (most recent) voluntary HIV test?; to which they may respond: Never In the last 3 months In the last 6 months 6 to 12 months ago More than 1 year ago | 3 months |
| HIV testing at 6 months | Participants are asked: When did you go for you last (most recent) voluntary HIV test?; to which they may respond: Never In the last 3 months In the last 6 months 6 to 12 months ago More than 1 year ago | 6 months |
| Syphilis testing at 3 months | Participants are asked: When did you go for you last (most recent) voluntary Syphilis test?; to which they may respond: Never In the last 3 months In the last 6 months 6 to 12 months ago More than 1 year ago | 3 months |
| Syphilis testing at 6 months | Participants are asked: When did you go for you last (most recent) voluntary Syphilis test?; to which they may respond: Never In the last 3 months In the last 6 months 6 to 12 months ago More than 1 year ago | 6 months |
| Chlamydia and Gonorrhea testing at 3 months | Participants are asked: When did you go for you last (most recent) voluntary Chlamydia or Gonorrhea test?; to which they may respond: Never In the last 3 months In the last 6 months 6 to 12 months ago More than 1 year ago | 3 months |
| Chlamydia and Gonorrhea testing at 6 months | Participants are asked: When did you go for you last (most recent) voluntary Chlamydia or Gonorrhea test?; to which they may respond: Never In the last 3 months In the last 6 months 6 to 12 months ago More than 1 year ago | 6 months |
| Self-reported regularity of HIV testing at 3 months | Participants are asked: On average, how regularly do you test for HIV?; to which they may respond: I do not test regularly Once every few years Once a year Once every 6 months Once every 3 months Once a month | 3 months |
| Self-reported regularity of HIV testing at 6 months | Participants are asked: On average, how regularly do you test for HIV?; to which they may respond: I do not test regularly Once every few years Once a year Once every 6 months Once every 3 months Once a month | 6 months |
| Self-reported regularity of Syphilis testing at 3 months | Participants are asked: On average, how regularly do you test for Syphilis?; to which they may respond: I do not test regularly Once every few years Once a year Once every 6 months Once every 3 months Once a month | 3 months |
| Self-reported regularity of Syphilis testing at 6 months | Participants are asked: On average, how regularly do you test for Syphilis?; to which they may respond: I do not test regularly Once every few years Once a year Once every 6 months Once every 3 months Once a month | 6 months |
| Self-reported regularity of Chlamydia and Gonorrhea testing at 3 months | Participants are asked: On average, how regularly do you test for Chlamydia and Gonorrhea?; to which they may respond: I do not test regularly Once every few years Once a year Once every 6 months Once every 3 months Once a month | 3 months |
| Self-reported regularity of Chlamydia and Gonorrhea testing at 6 months | Participants are asked: On average, how regularly do you test for Chlamydia and Gonorrhea?; to which they may respond: I do not test regularly Once every few years Once a year Once every 6 months Once every 3 months Once a month | 6 months |
Secondary Outcome Measures
| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Risk perception for HIV | Risk perception is measures through a questions (slider scale) that asks participants: How much risk do you think you are at of getting HIV?. Participants will rate this from 0 to 10 (0=no risk at all; 10=very high risk) | 3 months and 6 months |
| Risk perception for other sexually transmitted infections | Risk perception is measures through a questions (slider scale) that asks participants: How much risk do you think you are at of getting other sexually transmitted infections?. Participants will rate this from 0 to 10 (0=no risk at all; 10=very high risk) | 3 months and 6 months |
| Knowledge of HIV Pre-Exposure Prophylaxis | Participants are tested on their knowledge of HIV Pre-Exposure Prophylaxis by providing a response (1=True; 2=False; 3=I do not know) to two questions: HIV Pre-Exposure Prophylaxis is an effective means of preventing HIV infection. The correct answer is True. HIV Pre-Exposure Prophylaxis can also reduce the chances of acquiring other STIs. The correct answer is False. Each correct answer provides a score of 1 point. | 3 months and 6 months |
| Knowledge of risks associated with acquiring other sexually transmitted infections | Participants are tested on their knowledge of other sexually transmitted infections by providing a response (1=True; 2=False; 3=I do not know) to three questions: Gonorrhea can be transmitted through oral sex. The correct answer is True. Chemsex, or the use of substances during sex, often increases a person's risk of engaging in risky sexual behavior and acquiring HIV or other STIs The correct answer is True. There is a/are clinics in Singapore where I can test anonymously for HIV and Syphilis. The correct answer is True. Each correct answer provides a score of 1 point. | 3 months and 6 months |
| Knowledge of HIV | Participants are tested on their knowledge of HIV by providing a response (1=True; 2=False; 3=I do not know) to two questions: An HIV-positive individual who has achieved viral suppression or an 'undetectable' viral load has almost zero chances of transmitting the virus to someone else through sexual intercourse. The correct answer is True. An HIV-positive individual on effective treatment can live a long, healthy, and productive life. The correct answer is True. Each correct answer provides a score of 1 point. | 3 months and 6 months |
| Connectedness to LGBT Community | This is an 8-item scale adapted from Frost & Meyer (2012) that measures a participant's self-perceived connectedness to the LGBT community on a 4-point Likert Scale. The measure is a sum score of all 8 items. | 3 months and 6 months |
| Modified Self-Concealment Scale | This is a 7-item scale adapted from Scrimshaw (2013) that measures a participant's self-concealment of their sexual orientation on a 5-point Likert Scale. The measure is a sum score of all 7 items. | 3 months and 6 months |
| Consistent condom use for anal sex with casual partners or sex workers | This is assessed by the question, In the last 3 months, how often did you use a condom when having anal sex with a casual partner? or In the last 3 months, how often did you use a condom when having anal sex with a sex worker/money boy? (Options are always, more than half the time, about half the time, less than half the time, never used a condom). Participants who give the answer 'Always' are classified as having consistent condom usage for anal sex with causal partners or sex workers. | 3 months and 6 months |
| Incidence of sexually transmitted infections | This is defined as self-reporting a diagnosis of Syphilis, Chlamydia, Genital Herpes, Genital Warts, Hepatitis C, or Gonorrhea at the 3-month or 6-month follow-up. | 3 months and 6 months |
| Perceived Homophobia | This is a 6-item scale adapted from Smolenski, Ross, Risser, and Rosser (2009) that measures a participant's self-concealment of their sexual orientation. The measure is a sum score of all 6 items. | 3 months and 6 months |
| Internalized Homophobia | This is a 5-item scale adapted from Frost and Meyer (2013) that measures a participant's internalized homophobia on a 4-point Likert Scale. The measure is a sum score of all 5 items. | 3 months and 6 months |
| HIV testing self-efficacy | This is a 10-item scale adapted from Jamil and colleagues (2015) that measures a participant's self-efficacy in HIV testing on a 5-point Likert Scale. The measure is a sum score of all 10 items. | 3 months and 6 months |
| HIV testing social norms | This is a 9-item scale adapted from Pettifor and colleagues (2010) that measures a participant's perceptions on norms around HIV testing on a 4-point Likert Scale. The measure is a sum score of all 9 items. | 3 months and 6 months |
Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Singapore, HIV Testing, STI Testing, Homophobia, eHealth
|
|
NCT03881514
|
Mode of Delivery on Newborn Hearing Test
|
Neonatal hearing screening may fail due to some perinatal and neonatal factors. It is well known that false positivity increases cost and maternal anxiety and anxiety in the neonatal hearing screening. The effect of the type of delivery to hearing screening is not yet clear. The first automated mode of delivery of babies born in Turkey auditory brainstem response (SAD's), the authors aimed to evaluate the effects of the test results and false positive rate.~newborns were evaluated with brainstem response test. The AABR test was performed before patients were discharged. Perinatal and neonatal variables and AABR test results were recorded retrospectively.
|
The Effect of Mode of Delivery on Automated Auditory Brainstem Response (AABR) Test
|
Hearing Loss, Neonatal
|
Inclusion Criteria:~records of birth process and~pregnancy test results of newborns.~Exclusion Criteria:~newborn;~She was in a neonatal intensive care,~congenital / chromosomal anomaly,~undergoing congenital cmv infection,~facial / ear deformity,~families with hearing problems,~those with hyperbiliromyemia,~<12 hours after delivery,~maternal infection,~dm,~recurrent abortion,~smoking,~plesanta previa,
|
18 Years
|
40 Years
|
Female
|
No
|
| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| newborn hearing screening results | hearing test results of newborns. The test results will be grouped according to the type of birth. The effect of the type of delivery on hearing test results will be investigated. The relationship between vaginal route and cesarean section and hearing test will be the first results.~hearing test results were evaluated separately for the right and left ear as 'passed the test' and 'left test'. | 1 week after delivery |
|
Newborn Hearing Screening, Automated Auditory Brainstem Response, Mode Of Delivery
|
Hearing Loss, Hearing Disorders, Ear Diseases, Otorhinolaryngologic Diseases, Sensation Disorders, Neurologic Manifestations, Nervous System Diseases
|
Mode of Delivery on Newborn Hearing Test
Study Overview
=================
Brief Summary
-----------------
Neonatal hearing screening may fail due to some perinatal and neonatal factors. It is well known that false positivity increases cost and maternal anxiety and anxiety in the neonatal hearing screening. The effect of the type of delivery to hearing screening is not yet clear. The first automated mode of delivery of babies born in Turkey auditory brainstem response (SAD's), the authors aimed to evaluate the effects of the test results and false positive rate. newborns were evaluated with brainstem response test. The AABR test was performed before patients were discharged. Perinatal and neonatal variables and AABR test results were recorded retrospectively.
Official Title
-----------------
The Effect of Mode of Delivery on Automated Auditory Brainstem Response (AABR) Test
Conditions
-----------------
Hearing Loss, Neonatal
Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: records of birth process and pregnancy test results of newborns. Exclusion Criteria: newborn; She was in a neonatal intensive care, congenital / chromosomal anomaly, undergoing congenital cmv infection, facial / ear deformity, families with hearing problems, those with hyperbiliromyemia, <12 hours after delivery, maternal infection, dm, recurrent abortion, smoking, plesanta previa,
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?
-----------------
What is the study measuring?
-----------------
Primary Outcome Measures
| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| newborn hearing screening results | hearing test results of newborns. The test results will be grouped according to the type of birth. The effect of the type of delivery on hearing test results will be investigated. The relationship between vaginal route and cesarean section and hearing test will be the first results. hearing test results were evaluated separately for the right and left ear as 'passed the test' and 'left test'. | 1 week after delivery |
Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Newborn Hearing Screening, Automated Auditory Brainstem Response, Mode Of Delivery
|
|||||
NCT00616122
|
Sunitinib, Cyclophosphamide, and Methotrexate in Treating Patients With Metastatic Breast Cancer
|
RATIONALE: Sunitinib may stop the growth of tumor cells by blocking some of the enzymes needed for cell growth. Drugs used in chemotherapy, such as cyclophosphamide and methotrexate, work in different ways to stop the growth of tumor cells, either by killing the cells or by stopping them from dividing. Giving sunitinib together with combination chemotherapy may kill more tumor cells.~PURPOSE: This phase I/II trial is studying the side effects and best dose of sunitinib when given together with cyclophosphamide and methotrexate to see how well they work in treating patients with metastatic breast cancer.
|
OBJECTIVES:~Primary~To determine the maximum tolerated dose of the combination of metronomic dose cyclophosphamide and methotrexate with continuous dosing sunitinib malate. (Phase I)~To determine the time to disease progression in patients with metastatic breast cancer treated with metronomic dose chemotherapy with cyclophosphamide and methotrexate combined with continuous dosing of sunitinib malate. (Phase II)~Secondary~To determine the response rate in patients receiving this treatment.~To determine the duration of response in patients receiving this treatment.~To determine the toxicity of this regimen in these patients.~To determine the feasibility by assessment of toxicities of this regimen and number of voluntary withdrawals from the study.~To correlate outcome measures with possible surrogate markers including serial measurements of circulating tumor cells and circulating endothelial cells.~OUTLINE: This is a dose-escalation study of sunitinib malate.~Phase I: Patients receive oral sunitinib malate once daily. Beginning 14 days later, patients also receive oral cyclophosphamide once daily on days 1-21 and oral methotrexate twice daily on days 1, 2, 8, 9, 15, and 16. Treatment with sunitinib malate, cyclophosphamide, and methotrexate repeats every 21 days* in the absence of disease progression or unacceptable toxicity.~Phase II: Patients receive sunitinib malate at the maximum tolerated dose determined in phase I and cyclophosphamide and methotrexate as in phase I.~NOTE: *Course 1 includes 2 weeks of sunitinib malate alone followed by sunitinib malate, cyclophosphamide, and methotrexate for 21 days~Blood samples are collected periodically for measurement of circulating tumor cells, circulating endothelial cells, and vascular endothelial growth factor (VEGF) levels.~After completion of study treatment, patients are followed for 30 days and then every 2 months for 1 year.
|
Phase I/II Study of SU11248 (Sutent) in Combination With Metronomic Dosing of Cyclophosphamide and Methotrexate in Patients With Metastatic Breast Cancer
|
Breast Cancer
|
* Drug: cyclophosphamide
* Drug: methotrexate
* Drug: sunitinib malate
* Other: laboratory biomarker analysis
|
DISEASE CHARACTERISTICS:~Pathologically confirmed diagnosis of breast cancer with documented progressive disease~Metastatic disease~Measurable disease as defined by RECIST criteria or evaluable disease~Must have received at least one prior chemotherapy regimen for metastatic breast cancer~Patients refusing all other chemotherapy for breast cancer may enroll without prior treatment~Patients with HER2-overexpression disease must have been previously treated with trastuzumab (Herceptin®)~Patients with stable brain metastases are eligible~Hormone receptor status not specified~PATIENT CHARACTERISTICS:~Menopausal status not specified~Eastern Cooperative Oncology Group (ECOG) performance status 0-2~Life expectancy ≥ 12 weeks~Absolute Neutrophil Count (ANC) ≥ 1,000/mm³~Platelet count ≥ 100,000/mm³~Creatinine ≤ 1.5 times upper limit of normal (ULN)~aspartate aminotransferase (AST) and alanine aminotransferase (ALT) ≤ 2.5 times ULN (≤ 5 times ULN in the presence of liver metastases)~Total bilirubin ≤ 1.5 times ULN~Able to take oral medications and maintain hydration~Not pregnant or nursing~Negative pregnancy test~Fertile patients must use effective contraception during and for 6 months after treatment~No severe concurrent illness including, but not limited to, any of the following:~Congestive heart failure~Significant cardiac disease~Uncontrolled hypertension~Must be able to read and speak English~PRIOR CONCURRENT THERAPY:~See Disease Characteristics~At least 2 weeks since prior treatment, including chemotherapy, hormonal therapy, trastuzumab (Herceptin®), or other targeted therapies~Prior bevacizumab allowed if discontinued for any reason other than toxicity~No potent inducers or inhibitors of CYP3A4 enzymes that effect the metabolism of sunitinib malate~No prior sunitinib malate~No other concurrent investigational therapy~No concurrent radiotherapy~Concurrent bisphosphonates allowed
|
18 Years
|
120 Years
|
All
|
No
|
Primary Purpose: Treatment
Intervention Model: Single Group Assignment
Masking: None (Open Label)
|
| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Maximum Tolerated Dose of Sunitinib (Phase I) | Patients in each cohort were followed for DLT for at least 8 weeks (2 week lead-in with sunitinib and 6 weeks of treatment with sunitinib and metronomic cyclophosphamide and methotrexate) before opening accrual to the next dose level. Dose limiting toxicity (DLT) defined as: 1) ≥ grade 3 anemia that does not resolve with appropriate growth factors afebrile grade 4 neutropenia that does not resolve with growth factor support after ≥ 7 days 2) grade 4 neutropenia associated with fever (1 reading of oral temperature > 38.5 degrees Celsius or 3 readings of oral temperature > 38.0 degrees Celsius in a 24 hour period) 3) ≥ grade 3 thrombocytopenia 4) ≥ grade 3 non-hematologic toxicities, except those that can be controlled to grade 2 or less with appropriate treatment.~5) Inability to resume treatment with any of the study medications within 14 days of stopping due to treatment related toxicity. | 8 weeks |
| Patients With Progression-free Survival (PFS) Greater Than or Equal to 12 Weeks (Phase II) | Progression defined as: 25% increase or an increase of 10 sq. cm (whichever is smaller) in the sum of products of measurable lesions over smallest sum observed (over baseline if no decrease), or appearance of any lesion which had disappeared, or clear worsening of any evaluable disease, or appearance of any new lesion/site, or failure to return for evaluation due to deteriorating condition (unless deterioration is clearly unrelated to this cancer). | up to 12 weeks after treatment start date |
|
| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Overall Response Rate | Per Response Evaluation Criteria in Solid Tumors (RECIST): Complete Response (CR): Complete disappearance of all measurable and evaluable disease. No new lesions.~Partial Response (PR): greater than or equal to 50% decrease under baseline in the sum of the products of perpendicular diameters of all measurable lesions. No progression of evaluable disease. No new lesions.~Stable: Does not qualify for complete response, partial response or progression. | until disease progression, up to 13 months post treatment |
| Duration of Response | Duration of response refers to duration of single partial response observed per Response Evaluation Criteria in Solid Tumors (RECIST):~Complete Response (CR): Complete disappearance of all measurable and evaluable disease. No new lesions.~Partial Response (PR): greater than or equal to 50% decrease under baseline in the sum of the products of perpendicular diameters of all measurable lesions. No progression of evaluable disease. No new lesions.~Stable: Does not qualify for complete response, partial response or progression.~Progression: 25% increase or an increase of 10 sq. cm (whichever is smaller) in the sum of products of measurable lesions over smallest sum observed (over baseline if no decrease), OR appearance of any lesion which had disappeared, or clear worsening of any evaluable disease, or appearance of any new lesion/site, or failure to return for evaluation due to deteriorating condition (unless deterioration is clearly unrelated to this cancer). | until disease progression up to 13 months post treatment |
|
recurrent breast cancer, stage IV breast cancer, male breast cancer
|
Antimetabolites, Cyclophosphamide, Methotrexate, Sunitinib, Immunosuppressive Agents, Immunologic Factors, Physiological Effects of Drugs, Antirheumatic Agents, Antineoplastic Agents, Alkylating, Alkylating Agents, Molecular Mechanisms of Pharmacological Action, Antineoplastic Agents, Myeloablative Agonists, Abortifacient Agents, Nonsteroidal, Abortifacient Agents, Reproductive Control Agents, Antimetabolites, Antineoplastic, Dermatologic Agents, Enzyme Inhibitors, Folic Acid Antagonists, Nucleic Acid Synthesis Inhibitors, Angiogenesis Inhibitors, Angiogenesis Modulating Agents, Growth Substances, Growth Inhibitors, Protein Kinase Inhibitors
|
| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Sunitinib, Cyclophosphamide, and Methotrexate<br> | Drug: cyclophosphamide<br> <br> Drug: methotrexate<br> <br> Drug: sunitinib malate<br> <br> Other: laboratory biomarker analysis<br> <br> |
|
Sunitinib, Cyclophosphamide, and Methotrexate in Treating Patients With Metastatic Breast Cancer
Study Overview
=================
Brief Summary
-----------------
RATIONALE: Sunitinib may stop the growth of tumor cells by blocking some of the enzymes needed for cell growth. Drugs used in chemotherapy, such as cyclophosphamide and methotrexate, work in different ways to stop the growth of tumor cells, either by killing the cells or by stopping them from dividing. Giving sunitinib together with combination chemotherapy may kill more tumor cells. PURPOSE: This phase I/II trial is studying the side effects and best dose of sunitinib when given together with cyclophosphamide and methotrexate to see how well they work in treating patients with metastatic breast cancer.
Detailed Description
-----------------
OBJECTIVES: Primary To determine the maximum tolerated dose of the combination of metronomic dose cyclophosphamide and methotrexate with continuous dosing sunitinib malate. (Phase I) To determine the time to disease progression in patients with metastatic breast cancer treated with metronomic dose chemotherapy with cyclophosphamide and methotrexate combined with continuous dosing of sunitinib malate. (Phase II) Secondary To determine the response rate in patients receiving this treatment. To determine the duration of response in patients receiving this treatment. To determine the toxicity of this regimen in these patients. To determine the feasibility by assessment of toxicities of this regimen and number of voluntary withdrawals from the study. To correlate outcome measures with possible surrogate markers including serial measurements of circulating tumor cells and circulating endothelial cells. OUTLINE: This is a dose-escalation study of sunitinib malate. Phase I: Patients receive oral sunitinib malate once daily. Beginning 14 days later, patients also receive oral cyclophosphamide once daily on days 1-21 and oral methotrexate twice daily on days 1, 2, 8, 9, 15, and 16. Treatment with sunitinib malate, cyclophosphamide, and methotrexate repeats every 21 days* in the absence of disease progression or unacceptable toxicity. Phase II: Patients receive sunitinib malate at the maximum tolerated dose determined in phase I and cyclophosphamide and methotrexate as in phase I. NOTE: *Course 1 includes 2 weeks of sunitinib malate alone followed by sunitinib malate, cyclophosphamide, and methotrexate for 21 days Blood samples are collected periodically for measurement of circulating tumor cells, circulating endothelial cells, and vascular endothelial growth factor (VEGF) levels. After completion of study treatment, patients are followed for 30 days and then every 2 months for 1 year.
Official Title
-----------------
Phase I/II Study of SU11248 (Sutent) in Combination With Metronomic Dosing of Cyclophosphamide and Methotrexate in Patients With Metastatic Breast Cancer
Conditions
-----------------
Breast Cancer
Intervention / Treatment
-----------------
* Drug: cyclophosphamide
* Drug: methotrexate
* Drug: sunitinib malate
* Other: laboratory biomarker analysis
Participation Criteria
=================
Eligibility Criteria
-----------------
DISEASE CHARACTERISTICS: Pathologically confirmed diagnosis of breast cancer with documented progressive disease Metastatic disease Measurable disease as defined by RECIST criteria or evaluable disease Must have received at least one prior chemotherapy regimen for metastatic breast cancer Patients refusing all other chemotherapy for breast cancer may enroll without prior treatment Patients with HER2-overexpression disease must have been previously treated with trastuzumab (Herceptin®) Patients with stable brain metastases are eligible Hormone receptor status not specified PATIENT CHARACTERISTICS: Menopausal status not specified Eastern Cooperative Oncology Group (ECOG) performance status 0-2 Life expectancy ≥ 12 weeks Absolute Neutrophil Count (ANC) ≥ 1,000/mm³ Platelet count ≥ 100,000/mm³ Creatinine ≤ 1.5 times upper limit of normal (ULN) aspartate aminotransferase (AST) and alanine aminotransferase (ALT) ≤ 2.5 times ULN (≤ 5 times ULN in the presence of liver metastases) Total bilirubin ≤ 1.5 times ULN Able to take oral medications and maintain hydration Not pregnant or nursing Negative pregnancy test Fertile patients must use effective contraception during and for 6 months after treatment No severe concurrent illness including, but not limited to, any of the following: Congestive heart failure Significant cardiac disease Uncontrolled hypertension Must be able to read and speak English PRIOR CONCURRENT THERAPY: See Disease Characteristics At least 2 weeks since prior treatment, including chemotherapy, hormonal therapy, trastuzumab (Herceptin®), or other targeted therapies Prior bevacizumab allowed if discontinued for any reason other than toxicity No potent inducers or inhibitors of CYP3A4 enzymes that effect the metabolism of sunitinib malate No prior sunitinib malate No other concurrent investigational therapy No concurrent radiotherapy Concurrent bisphosphonates allowed
Ages Eligible for Study
-----------------
Minimum Age: 18 Years
Maximum Age: 120 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: Sunitinib, Cyclophosphamide, and Methotrexate<br> | Drug: cyclophosphamide<br> <br> Drug: methotrexate<br> <br> Drug: sunitinib malate<br> <br> Other: laboratory biomarker analysis<br> <br> |
What is the study measuring?
-----------------
Primary Outcome Measures
| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Maximum Tolerated Dose of Sunitinib (Phase I) | Patients in each cohort were followed for DLT for at least 8 weeks (2 week lead-in with sunitinib and 6 weeks of treatment with sunitinib and metronomic cyclophosphamide and methotrexate) before opening accrual to the next dose level. Dose limiting toxicity (DLT) defined as: 1) ≥ grade 3 anemia that does not resolve with appropriate growth factors afebrile grade 4 neutropenia that does not resolve with growth factor support after ≥ 7 days 2) grade 4 neutropenia associated with fever (1 reading of oral temperature > 38.5 degrees Celsius or 3 readings of oral temperature > 38.0 degrees Celsius in a 24 hour period) 3) ≥ grade 3 thrombocytopenia 4) ≥ grade 3 non-hematologic toxicities, except those that can be controlled to grade 2 or less with appropriate treatment. 5) Inability to resume treatment with any of the study medications within 14 days of stopping due to treatment related toxicity. | 8 weeks |
| Patients With Progression-free Survival (PFS) Greater Than or Equal to 12 Weeks (Phase II) | Progression defined as: 25% increase or an increase of 10 sq. cm (whichever is smaller) in the sum of products of measurable lesions over smallest sum observed (over baseline if no decrease), or appearance of any lesion which had disappeared, or clear worsening of any evaluable disease, or appearance of any new lesion/site, or failure to return for evaluation due to deteriorating condition (unless deterioration is clearly unrelated to this cancer). | up to 12 weeks after treatment start date |
Secondary Outcome Measures
| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Overall Response Rate | Per Response Evaluation Criteria in Solid Tumors (RECIST): Complete Response (CR): Complete disappearance of all measurable and evaluable disease. No new lesions. Partial Response (PR): greater than or equal to 50% decrease under baseline in the sum of the products of perpendicular diameters of all measurable lesions. No progression of evaluable disease. No new lesions. Stable: Does not qualify for complete response, partial response or progression. | until disease progression, up to 13 months post treatment |
| Duration of Response | Duration of response refers to duration of single partial response observed per Response Evaluation Criteria in Solid Tumors (RECIST): Complete Response (CR): Complete disappearance of all measurable and evaluable disease. No new lesions. Partial Response (PR): greater than or equal to 50% decrease under baseline in the sum of the products of perpendicular diameters of all measurable lesions. No progression of evaluable disease. No new lesions. Stable: Does not qualify for complete response, partial response or progression. Progression: 25% increase or an increase of 10 sq. cm (whichever is smaller) in the sum of products of measurable lesions over smallest sum observed (over baseline if no decrease), OR appearance of any lesion which had disappeared, or clear worsening of any evaluable disease, or appearance of any new lesion/site, or failure to return for evaluation due to deteriorating condition (unless deterioration is clearly unrelated to this cancer). | until disease progression up to 13 months post treatment |
Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
recurrent breast cancer, stage IV breast cancer, male breast cancer
|
NCT00716235
|
Characterization of Executive Functions and Patterns of Eye Movements in Children With Developmental Disabilities
|
The purpose of this study is to characterize the profile of executive functions and eye movements in several populations of children with developmental disabilities.
|
Abnormal Executive function (EF) profile was considered a major characteristic of Attention deficit / hyperactivity disorder (ADHD) and autism, and is frequently implicated in Developmental coordination disorder (DCD) children as well. The scientific literature implies that the EF profile among these three groups share some common abnormalities, but differ significantly in specific features. Abnormal EF profile may be a core feature of the developmental trajectory of each syndrome.~The fine measurement of eye movements may shed light on the underlying mechanisms of specific disorders, and point to abnormal attention, information processing, or motor organization. Gaze is an important component of social interaction. Eye contact and recognition of other's gaze direction are crucial to empathy assessment.~The current study will embark in the assessment of a wide range of EF in these populations and in a matched control group, as well as their relation to other important parameters such as daily function skills and comorbid neurobehavioral characteristics. It will also assess the pattern of eye movements in response to various visual stimuli in these populations. The main purpose is to characterize the similarities and differences of each of these populations, in terms of EF and eye movements.~Assessment methods:~Clinical parameters:~Intelligence tests (according to the child's age)~Communication: DSM-IV, ADOS, Stony Brook questionnaire~Motor / Coordination: Movement Advanced Battery for Children (M-ABC)~Attention: Conners Rating Scales - Revised (CRS-R 3rd ed.)~Sleep: Sleep habits questionnaire~Executive functions will be assessed using the following methods:~NEPSI-II~BRIEF questionnaire~Wisconsin Card Sorting Test~Tower of Hanoi~Eye movements will be measured using an infra-red video camera produced by ISCAN inc. the following visual stimuli will be presented:~Human faces presenting various emotions~Various objects~Saccade and anti-saccade tasks
|
Characterization of Executive Functions and Patterns of Eye Movements in Children With Developmental Disabilities
|
Attention Deficit Hyperactivity Disorder, Autistic Disorder, Developmental Coordination Disorder
|
Inclusion Criteria:~Age of 4-10 years~A medical diagnosis according to the relevant study group~Normal vision without glasses or contact lens.~Exclusion Criteria - clinical groups:~Intelligence Quotient below 70~A known brain damage~A known hearing impairment~Regular use of medications (except for psychostimulants)~Evidence for a known genetic syndrome~History of fetal CMV infection, birth asphyxia, major head injury or epilepsy~Exclusion Criteria - control group:~Intelligence Quotient below 70~Regular use of medications~Evidence for a neurological / psychiatric disorder, birth injury, developmental delay, head injury, or other medical disorders that affect the central nervous system~Family History - first degree) of autism, DCD, ADHD or other neurological/psychiatric disorder
|
4 Years
|
10 Years
|
All
|
Accepts Healthy Volunteers
|
| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
|
ASD, ADHD, PDD, DCD, Executive Functions
|
Attention Deficit Disorder with Hyperactivity, Autistic Disorder, Developmental Disabilities, Motor Skills Disorders, Attention Deficit and Disruptive Behavior Disorders, Neurodevelopmental Disorders, Mental Disorders, Autism Spectrum Disorder, Child Development Disorders, Pervasive
|
| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| DCD<br>Children with a diagnosis of DCD | |
| Autism<br>Children with a diagnosis of Autism disorder | |
| ADHD<br>Children with a diagnosis of ADHD | |
| Control<br>Control group - children with no neurological or psychiatric problems | |
|
Characterization of Executive Functions and Patterns of Eye Movements in Children With Developmental Disabilities
Study Overview
=================
Brief Summary
-----------------
The purpose of this study is to characterize the profile of executive functions and eye movements in several populations of children with developmental disabilities.
Detailed Description
-----------------
Abnormal Executive function (EF) profile was considered a major characteristic of Attention deficit / hyperactivity disorder (ADHD) and autism, and is frequently implicated in Developmental coordination disorder (DCD) children as well. The scientific literature implies that the EF profile among these three groups share some common abnormalities, but differ significantly in specific features. Abnormal EF profile may be a core feature of the developmental trajectory of each syndrome. The fine measurement of eye movements may shed light on the underlying mechanisms of specific disorders, and point to abnormal attention, information processing, or motor organization. Gaze is an important component of social interaction. Eye contact and recognition of other's gaze direction are crucial to empathy assessment. The current study will embark in the assessment of a wide range of EF in these populations and in a matched control group, as well as their relation to other important parameters such as daily function skills and comorbid neurobehavioral characteristics. It will also assess the pattern of eye movements in response to various visual stimuli in these populations. The main purpose is to characterize the similarities and differences of each of these populations, in terms of EF and eye movements. Assessment methods: Clinical parameters: Intelligence tests (according to the child's age) Communication: DSM-IV, ADOS, Stony Brook questionnaire Motor / Coordination: Movement Advanced Battery for Children (M-ABC) Attention: Conners Rating Scales - Revised (CRS-R 3rd ed.) Sleep: Sleep habits questionnaire Executive functions will be assessed using the following methods: NEPSI-II BRIEF questionnaire Wisconsin Card Sorting Test Tower of Hanoi Eye movements will be measured using an infra-red video camera produced by ISCAN inc. the following visual stimuli will be presented: Human faces presenting various emotions Various objects Saccade and anti-saccade tasks
Official Title
-----------------
Characterization of Executive Functions and Patterns of Eye Movements in Children With Developmental Disabilities
Conditions
-----------------
Attention Deficit Hyperactivity Disorder, Autistic Disorder, Developmental Coordination Disorder
Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Age of 4-10 years A medical diagnosis according to the relevant study group Normal vision without glasses or contact lens. Exclusion Criteria - clinical groups: Intelligence Quotient below 70 A known brain damage A known hearing impairment Regular use of medications (except for psychostimulants) Evidence for a known genetic syndrome History of fetal CMV infection, birth asphyxia, major head injury or epilepsy Exclusion Criteria - control group: Intelligence Quotient below 70 Regular use of medications Evidence for a neurological / psychiatric disorder, birth injury, developmental delay, head injury, or other medical disorders that affect the central nervous system Family History - first degree) of autism, DCD, ADHD or other neurological/psychiatric disorder
Ages Eligible for Study
-----------------
Minimum Age: 4 Years
Maximum Age: 10 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 |
| --- | --- |
| DCD<br>Children with a diagnosis of DCD | |
| Autism<br>Children with a diagnosis of Autism disorder | |
| ADHD<br>Children with a diagnosis of ADHD | |
| Control<br>Control group - children with no neurological or psychiatric problems | |
What is the study measuring?
-----------------
Primary Outcome Measures
| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
ASD, ADHD, PDD, DCD, Executive Functions
|
|||
NCT00755911
|
Treatment of Alveolar Bone Defects Using Aastrom Biosciences Autologous Tissue Repair Cell Therapy
|
The purpose of this research is to determine if a subject's own bone marrow tissue can help regenerate bone in the area of his/her jaw where a tooth has been removed using Tissue Repair Cell (TRC) Therapy.
|
A sample of the subject's bone marrow tissue will be collected and sent to a laboratory where it will be processed to form cells. The new cells are transplanted into the tooth socket after the tooth has been removed. The researchers are testing to see if these cells (TRC) will help form bone. The research will also determine if the implant the subject receives will be more stable in the area with new bone growth.
|
Treatment of Alveolar Bone Defects Using Aastrom Biosciences Autologous Tissue Repair Cell Therapy
|
Alveolar Bone Loss
|
* Biological: Tissue Repair Cells (TRC)
* Device: Control
|
Inclusion Criteria:~Age range: 20 to 70 years~Gender: Male and female~Patients must be able and willing to follow study procedures and instructions~Patients must have read, understood and signed an informed consent form~Patients must require tooth extraction as a result of caries, periodontal disease, or tooth fracture~Exclusion Criteria:~Allergies or hypersensitivities to study related medications: amoxicillin, dexamethasone, chlorhexidine, ibuprofen, ranitidine~Hematologic disorders/ blood dyscrasias~Active infectious disease~Liver or kidney dysfunction/failure- Patients will have blood drawn for serum laboratory tests, including creatinine, blood urea nitrogen (BUN), aspartate aminotransferase (AST), alanine aminotransferase test (ALT), and bilirubin. All of these must be within normal limits for a patient to be included in the study. Current University of Michigan Health System normal lab values are as follows: Creatinine (male 0.7-1.3 mg/dl; female 0.5-1.0 mg/dl); BUN (8-20 mg/dl); AST (8-30 IU/L); ALT (7-35 IU/L); Bilirubin (0.2-1.2 mg/dl).~Endocrine disorders/dysfunctions (i.e Type I and II diabetes)~Cancer - The explicit definition of cancer used to exclude patients is consistent with that described by the National Cancer Institute (NCI), National Institutes of Health. According to NCI, cancer is any disease in which abnormal cells divide without control and invade nearby tissues (invasive disease). These include carcinomas, sarcomas, leukemias, and lymphomas. Any patient with a history of these invasive diseases will be excluded from the study.~Patients who currently use bisphosphonates or have a history of bisphosphonate use will be excluded from the trial.~HIV+~Metabolic Bone Diseases-Patients with metabolic bone diseases such as Paget's disease, hypercalcemia, moderate to severe vitamin D3 abnormalities or any other metabolic bone disease including osteoporosis and osteoporotic fractures will be excluded. The following scale will be used to determine osteoporosis in patients who have had a bone mass density (BMD) determination: Normal = T score at or above -1.0 SD; Osteopenia = T score between -1.0 and -2.5 SD; Osteoporosis = T score at or below -2.5 standard deviation (SD). Although a dexa scan will not be required, all post-menopausal women receiving osteoporosis/osteopenia related therapy will receive a dexa scan as part of their standard medical care.~Additionally, individuals who have a medical history significant for diabetes will not be included in the study.~Laboratory values that will define normal renal and hepatic function, as well as criteria for exclusion of metabolic bone disease are consistent with those established by the University of Michigan Health System (UMHS). Normal clinical values will be used to help assure the health of all subjects in this trial.~Individuals who have a BMI outside normal limits or a BMI that deems them overweight (BMI >25) will be excluded due to potential difficulties in locating appropriate surgical entry of the iliac crest during bone marrow aspiration procedure.~The following additional exclusion criteria for regenerative sites are in alignment with those described and adapted for using bone morphogenetic protein (BMPs) to regenerate buccal wall defects (Fiorellini, Howell et al. 2005):~Patients < 20 and > 60 years of age~Pregnant women- Female patients who are of childbearing potential are excluded except those who are using hormonal or barrier methods of birth control (oral or parenteral contraceptives, transdermal patch, diaphragm plus spermicide, or condoms). Pregnancy status will be determined with a urine test and patients who are pregnant, as determined by a positive test, will be excluded from the study~Patients with acute sinusitis~Patients with congenital or metabolic bone disorders~Current smokers (have smoked within 6 mos. of study onset)~Presence of < 4 mm of bone from apex of tooth to the alveolar crest~< 2 mm bone from apex to floor of maxillary sinus
|
20 Years
|
70 Years
|
All
|
No
|
Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
|
| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Bone Regeneration | The primary objective of this study is to determine whether the placement of Tissue Repair Cells (TRCs) at the time of tooth extraction can safely and effectively promote bone regeneration in alveolar bone defects created by tooth extraction.~Safety was assessed through adverse event reporting~Bone regeneration was assessed through measures of bone mineral density and bone volume fraction of biopsied regenerated bone tissue. Bone regeneration was also measured through radiographic analysis of relative bone height gain (% of the bone height regenerated relative to the height before tooth extraction) | 12 months after tooth extraction |
|
| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Number of Participants Who Successfully Received Dental Implant Fixtures | The secondary objective is to determine if Tissue Repair Cell therapy regenerates bone enabling the installation and stability of dental implant fixtures | 12 months after tooth extraction |
|
dental, tooth, implant, extraction, Oral, Surgical, Procedures
|
Gelatin Sponge, Absorbable, Hemostatics, Coagulants
|
| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Tissue Repair Cells (TRC)<br>Subjects will receive Tissue Repair Cell (TRC) therapy plus Gelfoam carrier | Biological: Tissue Repair Cells (TRC)<br>* 30-50 ml of bone marrow is aspirated from subject and processed into TRC autologous bone marrow tissue graft. 10ml of TRC will be absorbed onto gelfoam carrier and placed in extraction socket.<br>* Other names: Tissue Repair Cells, Bone Repair Cells, ixmyelocel-t;Device: Control<br>* Control subjects only receive standard gelfoam carrier. It promotes healing after tooth extraction<br>* Other names: Gelfoam;|
| Sham Comparator: Control<br>Subjects will receive the control treatment, consisting of Gelfoam carrier without Tissue Repair Cell (TRC) therapy. | Device: Control<br>* Control subjects only receive standard gelfoam carrier. It promotes healing after tooth extraction<br>* Other names: Gelfoam;|
|
Treatment of Alveolar Bone Defects Using Aastrom Biosciences Autologous Tissue Repair Cell Therapy
Study Overview
=================
Brief Summary
-----------------
The purpose of this research is to determine if a subject's own bone marrow tissue can help regenerate bone in the area of his/her jaw where a tooth has been removed using Tissue Repair Cell (TRC) Therapy.
Detailed Description
-----------------
A sample of the subject's bone marrow tissue will be collected and sent to a laboratory where it will be processed to form cells. The new cells are transplanted into the tooth socket after the tooth has been removed. The researchers are testing to see if these cells (TRC) will help form bone. The research will also determine if the implant the subject receives will be more stable in the area with new bone growth.
Official Title
-----------------
Treatment of Alveolar Bone Defects Using Aastrom Biosciences Autologous Tissue Repair Cell Therapy
Conditions
-----------------
Alveolar Bone Loss
Intervention / Treatment
-----------------
* Biological: Tissue Repair Cells (TRC)
* Device: Control
Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Age range: 20 to 70 years Gender: Male and female Patients must be able and willing to follow study procedures and instructions Patients must have read, understood and signed an informed consent form Patients must require tooth extraction as a result of caries, periodontal disease, or tooth fracture Exclusion Criteria: Allergies or hypersensitivities to study related medications: amoxicillin, dexamethasone, chlorhexidine, ibuprofen, ranitidine Hematologic disorders/ blood dyscrasias Active infectious disease Liver or kidney dysfunction/failure- Patients will have blood drawn for serum laboratory tests, including creatinine, blood urea nitrogen (BUN), aspartate aminotransferase (AST), alanine aminotransferase test (ALT), and bilirubin. All of these must be within normal limits for a patient to be included in the study. Current University of Michigan Health System normal lab values are as follows: Creatinine (male 0.7-1.3 mg/dl; female 0.5-1.0 mg/dl); BUN (8-20 mg/dl); AST (8-30 IU/L); ALT (7-35 IU/L); Bilirubin (0.2-1.2 mg/dl). Endocrine disorders/dysfunctions (i.e Type I and II diabetes) Cancer - The explicit definition of cancer used to exclude patients is consistent with that described by the National Cancer Institute (NCI), National Institutes of Health. According to NCI, cancer is any disease in which abnormal cells divide without control and invade nearby tissues (invasive disease). These include carcinomas, sarcomas, leukemias, and lymphomas. Any patient with a history of these invasive diseases will be excluded from the study. Patients who currently use bisphosphonates or have a history of bisphosphonate use will be excluded from the trial. HIV+ Metabolic Bone Diseases-Patients with metabolic bone diseases such as Paget's disease, hypercalcemia, moderate to severe vitamin D3 abnormalities or any other metabolic bone disease including osteoporosis and osteoporotic fractures will be excluded. The following scale will be used to determine osteoporosis in patients who have had a bone mass density (BMD) determination: Normal = T score at or above -1.0 SD; Osteopenia = T score between -1.0 and -2.5 SD; Osteoporosis = T score at or below -2.5 standard deviation (SD). Although a dexa scan will not be required, all post-menopausal women receiving osteoporosis/osteopenia related therapy will receive a dexa scan as part of their standard medical care. Additionally, individuals who have a medical history significant for diabetes will not be included in the study. Laboratory values that will define normal renal and hepatic function, as well as criteria for exclusion of metabolic bone disease are consistent with those established by the University of Michigan Health System (UMHS). Normal clinical values will be used to help assure the health of all subjects in this trial. Individuals who have a BMI outside normal limits or a BMI that deems them overweight (BMI >25) will be excluded due to potential difficulties in locating appropriate surgical entry of the iliac crest during bone marrow aspiration procedure. The following additional exclusion criteria for regenerative sites are in alignment with those described and adapted for using bone morphogenetic protein (BMPs) to regenerate buccal wall defects (Fiorellini, Howell et al. 2005): Patients < 20 and > 60 years of age Pregnant women- Female patients who are of childbearing potential are excluded except those who are using hormonal or barrier methods of birth control (oral or parenteral contraceptives, transdermal patch, diaphragm plus spermicide, or condoms). Pregnancy status will be determined with a urine test and patients who are pregnant, as determined by a positive test, will be excluded from the study Patients with acute sinusitis Patients with congenital or metabolic bone disorders Current smokers (have smoked within 6 mos. of study onset) Presence of < 4 mm of bone from apex of tooth to the alveolar crest < 2 mm bone from apex to floor of maxillary sinus
Ages Eligible for Study
-----------------
Minimum Age: 20 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: Tissue Repair Cells (TRC)<br>Subjects will receive Tissue Repair Cell (TRC) therapy plus Gelfoam carrier | Biological: Tissue Repair Cells (TRC)<br>* 30-50 ml of bone marrow is aspirated from subject and processed into TRC autologous bone marrow tissue graft. 10ml of TRC will be absorbed onto gelfoam carrier and placed in extraction socket.<br>* Other names: Tissue Repair Cells, Bone Repair Cells, ixmyelocel-t;Device: Control<br>* Control subjects only receive standard gelfoam carrier. It promotes healing after tooth extraction<br>* Other names: Gelfoam;|
| Sham Comparator: Control<br>Subjects will receive the control treatment, consisting of Gelfoam carrier without Tissue Repair Cell (TRC) therapy. | Device: Control<br>* Control subjects only receive standard gelfoam carrier. It promotes healing after tooth extraction<br>* Other names: Gelfoam;|
What is the study measuring?
-----------------
Primary Outcome Measures
| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Bone Regeneration | The primary objective of this study is to determine whether the placement of Tissue Repair Cells (TRCs) at the time of tooth extraction can safely and effectively promote bone regeneration in alveolar bone defects created by tooth extraction. Safety was assessed through adverse event reporting Bone regeneration was assessed through measures of bone mineral density and bone volume fraction of biopsied regenerated bone tissue. Bone regeneration was also measured through radiographic analysis of relative bone height gain (% of the bone height regenerated relative to the height before tooth extraction) | 12 months after tooth extraction |
Secondary Outcome Measures
| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Number of Participants Who Successfully Received Dental Implant Fixtures | The secondary objective is to determine if Tissue Repair Cell therapy regenerates bone enabling the installation and stability of dental implant fixtures | 12 months after tooth extraction |
Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
dental, tooth, implant, extraction, Oral, Surgical, Procedures
|
NCT04018859
|
Platelet-rich Plasma for Eyebrows
|
The purpose of this study is to evaluate the effect of autologous platelet-rich plasma (PRP) in the treatment of mild to moderate eyebrow hypotrichosis.~This is a randomized clinical trial to evaluate the effect of autologous platelet rich plasma in subjects with mild to moderate eyebrow hypotrichosis. Approximately 40 subjects will be randomized to receive platelet-rich plasma (PRP) or saline injections. The study is designed as an 9-month study. This study was a pilot study designed to determine feasibility of this procedure.~Subjects currently living in the Chicago metropolitan area and meet inclusion/exclusion criteria will be considered for enrollment.
|
A Pilot Clinical Trial Investigating the Effect of Autologous Platelet-rich Plasma in Subjects With Mild to Moderate Eyebrow Hypotrichosis
|
Eyebrow Hypotrichosis
|
* Device: Platelet Rich Plasma Prep System
* Drug: Saline
|
Inclusion Criteria:~Males or females 18-85 years old.~Subjects are in good health as judged by the investigator.~Patients with mild to moderate eyebrow hypotrichosis (modified GEyA grades of 3 and 4 at the time of screening, see Appendix A).~Those who have less eyebrows and therefore, desire to enhance eyebrows (modified GEyA grades of 3 and 4 at the time of screening, see Appendix A).~Subjects who are willing and have the ability to understand and provide informed consent for participation in the study and are able to communicate with the investigator~Exclusion Criteria:~Patients with uncontrolled systemic disease (including alopecia areata or any other form of alopecia) which could inhibit hair growth~Patients with thrombocytopenia, platelet dysfunction, hypofibrinogenemia, anemia, cancer, active infections with Pseudomonas, Klebsiella, or Enterococcus, history of trichotillomania, thyroid diseases, eye diseases, atopic dermatitis, seborrheic dermatitis, lupus erythematosus, scleroderma, leprosy, or syphilis.~Patients who have started used agents that may affect eyebrow hair growth (e.g. minoxidil or bimatoprost) within 6 months of screening. Patients who have been using agents that may affect eyebrow hair growth for at least 12 months may be included if the patient agrees to continue their current dosing regimen for the duration of the study.~Known disease, infection, or abnormality in the treatment area or hair shaft~Patients with tattoos, scars, hyperpigmentation, or other features which could prevent accurate evaluation of hair growth in the eyebrow area.~Evidence of another skin condition affecting the treatment area that would interfere with clinical assessments~Unwilling to refrain from washing face or using face care products 24 hours before and after treatment visits~History of a clinically significant hematologic disorder as determined by the investigator.~Subjects currently receiving anticoagulant or anti-platelet therapy.~Subject is known to be HIV positive.~Known genetic disorders affecting fibroblasts or collagen, such as achondroplasia, osteogenesis imperfecta, etc.~Pregnant or breast feeding~Uncooperative patients or patients with neurological disorders who are incapable of following directions or who are predictably unwilling to return for follow-up examinations.~Subjects who are unable to understand the protocol or give informed consent (including non-English speaking patients).
|
18 Years
|
85 Years
|
All
|
Accepts Healthy Volunteers
|
Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Triple
|
| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Clinical change of eyebrow hypotrichosis, as determined by scoring photographs | | Baseline to 6 months |
|
Hypotrichosis, Hair Diseases, Skin Diseases
|
| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Platelet-Rich Plasma<br>Participants will receive intradermal injections of 2-3mL autologous PRP to eyebrows.Three treatments will be performed 1 month apart. | Device: Platelet Rich Plasma Prep System<br>* intradermal injections of platelet rich plasma to the eyebrows<br>|
| Placebo Comparator: Placebo (sterile saline)<br>Participants will receive intradermal injections of 2-3mL sterile saline to eyebrows.Three treatments will be performed 1 month apart. | Drug: Saline<br>* intradermal injections to the eyebrows<br>|
|
Platelet-rich Plasma for Eyebrows
Study Overview
=================
Brief Summary
-----------------
The purpose of this study is to evaluate the effect of autologous platelet-rich plasma (PRP) in the treatment of mild to moderate eyebrow hypotrichosis. This is a randomized clinical trial to evaluate the effect of autologous platelet rich plasma in subjects with mild to moderate eyebrow hypotrichosis. Approximately 40 subjects will be randomized to receive platelet-rich plasma (PRP) or saline injections. The study is designed as an 9-month study. This study was a pilot study designed to determine feasibility of this procedure. Subjects currently living in the Chicago metropolitan area and meet inclusion/exclusion criteria will be considered for enrollment.
Official Title
-----------------
A Pilot Clinical Trial Investigating the Effect of Autologous Platelet-rich Plasma in Subjects With Mild to Moderate Eyebrow Hypotrichosis
Conditions
-----------------
Eyebrow Hypotrichosis
Intervention / Treatment
-----------------
* Device: Platelet Rich Plasma Prep System
* Drug: Saline
Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Males or females 18-85 years old. Subjects are in good health as judged by the investigator. Patients with mild to moderate eyebrow hypotrichosis (modified GEyA grades of 3 and 4 at the time of screening, see Appendix A). Those who have less eyebrows and therefore, desire to enhance eyebrows (modified GEyA grades of 3 and 4 at the time of screening, see Appendix A). Subjects who are willing and have the ability to understand and provide informed consent for participation in the study and are able to communicate with the investigator Exclusion Criteria: Patients with uncontrolled systemic disease (including alopecia areata or any other form of alopecia) which could inhibit hair growth Patients with thrombocytopenia, platelet dysfunction, hypofibrinogenemia, anemia, cancer, active infections with Pseudomonas, Klebsiella, or Enterococcus, history of trichotillomania, thyroid diseases, eye diseases, atopic dermatitis, seborrheic dermatitis, lupus erythematosus, scleroderma, leprosy, or syphilis. Patients who have started used agents that may affect eyebrow hair growth (e.g. minoxidil or bimatoprost) within 6 months of screening. Patients who have been using agents that may affect eyebrow hair growth for at least 12 months may be included if the patient agrees to continue their current dosing regimen for the duration of the study. Known disease, infection, or abnormality in the treatment area or hair shaft Patients with tattoos, scars, hyperpigmentation, or other features which could prevent accurate evaluation of hair growth in the eyebrow area. Evidence of another skin condition affecting the treatment area that would interfere with clinical assessments Unwilling to refrain from washing face or using face care products 24 hours before and after treatment visits History of a clinically significant hematologic disorder as determined by the investigator. Subjects currently receiving anticoagulant or anti-platelet therapy. Subject is known to be HIV positive. Known genetic disorders affecting fibroblasts or collagen, such as achondroplasia, osteogenesis imperfecta, etc. Pregnant or breast feeding Uncooperative patients or patients with neurological disorders who are incapable of following directions or who are predictably unwilling to return for follow-up examinations. Subjects who are unable to understand the protocol or give informed consent (including non-English speaking patients).
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?
-----------------
Design Details
Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Triple
Arms and Interventions
| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Platelet-Rich Plasma<br>Participants will receive intradermal injections of 2-3mL autologous PRP to eyebrows.Three treatments will be performed 1 month apart. | Device: Platelet Rich Plasma Prep System<br>* intradermal injections of platelet rich plasma to the eyebrows<br>|
| Placebo Comparator: Placebo (sterile saline)<br>Participants will receive intradermal injections of 2-3mL sterile saline to eyebrows.Three treatments will be performed 1 month apart. | Drug: Saline<br>* intradermal injections to the eyebrows<br>|
What is the study measuring?
-----------------
Primary Outcome Measures
| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Clinical change of eyebrow hypotrichosis, as determined by scoring photographs | | Baseline to 6 months |
|
|||
NCT05088642
|
A Trial of Hetrombopag in Healthy and Hepatic Impairment Subjects
|
This is a single-dose, open-label, phase I clinical study evaluating the PK of hetrombopag in subjects with mild hepatic impairment (Child-Pugh Class A), subjects with moderate hepatic impairment (Child-Pugh Class B), as well as age-, weight-, and gender-matched subjects with normal hepatic function.
|
A Phase I Clinical Study Evaluating the Pharmacokinetics and Safety of Hetrombopag Olamine Tablets in Subjects With Mild Hepatic Impairment (Child-Pugh Class A), Moderate Hepatic Impairment (Child-Pugh Class B), and Normal Hepatic Function
|
Sever Aplastic Anaemia
|
* Drug: Hetrombopag Olamine Tablet
|
Inclusion Criteria:~Sign the informed consent form before the study and fully understand the study content, process, and possible adverse reactions; able to complete the study as required by the clinical study protocol;~Subjects (and their partners) are willing to adopt effective contraceptive measures from screening to 6 months after the last study administration. See Appendix 1 for specific contraceptive measures;~Aged 18-65 years (inclusive), male or female;~Body mass index (BMI = weight (kg)/height2 (m2)): 18-30 kg/m2 (inclusive);~For subjects with normal hepatic function: normal or abnormal but not clinically significant laboratory findings (hematology, blood biochemistry, urinalysis, and coagulation function);~For subjects with normal hepatic function: no history of severe primary disorders involving major organs, including but not limited to the gastrointestinal, respiratory, renal, hepatic, neural, hematological, endocrine, neoplastic, immunological, psychiatric, or cardiovascular and cerebrovascular disorders.~Subjects with hepatic insufficiency must also meet the following inclusion criteria:~Have not received medication within 4 weeks before screening, or have received stable medication for at least 4 weeks for hepatic impairment and/or other concurrent diseases requiring long-term treatment;~With Child-Pugh Class A or B hepatic insufficiency caused by prior primary liver disorders (except drug-induced liver diseases).~Exclusion Criteria:~Average daily consumption of > 5 cigarettes within 3 months before screening;~Allergic constitution, or allergy to any component of hetrombopag olamine tablets;~Average daily alcohol consumption of > 15 g for females (e.g., 145 mL of wine, 497 mL of beer, or 43 mL of low-alcohol liquor) and > 25 g for males (e.g., 290 mL of wine, 994 mL of beer, or 86 mL of low-alcohol liquor) within 3 months before screening;~History of drug abuse within 3 months before screening;~Have donated or lost ≥ 400 mL of blood, or have received blood transfusion within 3 months before screening;~Have undergone major surgery within 6 months before screening, or with incomplete healing of surgical incision;~History of deep vein thrombosis or other thromboembolic events, or clinical symptoms suggesting thrombophilia;~Have received TPO receptor agonists (such as eltrombopag and romiplostim) or TPO within 1 month before screening;~Have taken Chinese herbal medicines or any drug that affects the PK of hetrombopag within 14 days before study administration (see Appendix 2 for drug-drug interaction evaluation);~Hypertension [systolic blood pressure (SBP) ≥ 160 mmHg and/or diastolic blood pressure (DBP) ≥ 100 mmHg, confirmed by a re-measurement];~Female subjects who are in lactation or have a positive serum pregnancy test result at screening or during the study;~Abnormal and clinically significant 12-lead ECG results (such as tachycardia/bradycardia requiring pharmacological treatment, second- or third-degree atrioventricular block or QTcF interval prolongation (≥ 470 ms for males, ≥ 480 ms for females) (corrected according to Fridericia's formula), or other clinically significant abnormalities assessed by the clinician);~Estimated glomerular filtration rate (eGFR) < 60 mL/min/1.73 m2 calculated using the Modification of Diet in Renal Disease (MDRD) equation;~Have malignant tumors or history of malignant tumors within 5 years before screening (except treated non-melanoma skin cancer without sign of recurrence and resected cervical intraepithelial neoplasia);~For subjects with normal hepatic function: have participated in any drug or medical device clinical trials within 3 months before screening; for subjects with hepatic insufficiency: have participated in any drug or medical device clinical trials within 1 month before screening;~For subjects with normal hepatic function: test positive for hepatitis B surface antigen, hepatitis C antibody or hepatitis C core antigen, HIV antibody, or syphilis antibody in screening;~Probably undergo surgery or be hospitalized during the study;~Have consumed alcohol (or positive for breath alcohol test), grapefruit/grapefruit juice, or any food or beverage containing methylxanthine (such as coffee, tea, cola, chocolate, and energy drink), have participated in strenuous physical activities, or have other factors that may affect drug absorption, distribution, metabolism, and excretion within 1 day before study administration;~Positive for urine drug screening (morphine or marijuana);~Subjects judged by the investigator as unsuitable for participating in this study.~Additional exclusion criteria for subjects with hepatic insufficiency (those who meet any of the followings are ineligible):~History of liver transplant;~Liver failure, or liver cirrhosis complicated with hepatic encephalopathy, hepatocellular carcinoma, esophageal and gastric varices hemorrhage, and other complications that, in the opinion of the investigator, make subjects unsuitable for participating in this study;~History of any serious diseases, other than primary liver diseases, or history of disorders and/or clinically significant abnormal laboratory findings that, as judged by the investigator, may affect the results of the study, including but not limited to the history of diseases in the circulatory system, endocrine system, nervous system, digestive system, urinary system or blood, immune, mental and metabolic diseases.~Positive for HIV antibody screening; a rapid plasma reagin (RPR) test is required for a subject who tests positive for syphilis antibodies, and the subject should be excluded if the RPR result is also positive.
|
18 Years
|
65 Years
|
All
|
No
|
Primary Purpose: Treatment
Allocation: Non-Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
|
| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Peak plasma concentration (Cmax) | | 0-120 hours post dose |
| Area Under the plasma concentration vs time curve (AUC0-120). | | 0-120 hours post dose |
| Area under the blood concentration vs time curve (AUC0-inf). | | 0-infinity |
|
| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Time to Reach Maximum Drug Concentration in Plasma After Single Dose (Tmax) | | 0-120 hours post dose |
| Half-life Associated With the Terminal Slope (t½) | | 0-120 hours post dose |
| The number of volunteers with adverse events as a measure of safety and tolerability | | up to Day 6 |
|
Anemia, Anemia, Aplastic, Hematologic Diseases, Bone Marrow Failure Disorders, Bone Marrow Diseases
|
| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Mild hepatic impairment (Child-Pugh Class A)<br> | Drug: Hetrombopag Olamine Tablet<br>* Hetrombopag Olamine Tablet<br>|
| Experimental: Moderate hepatic impairment (Child-Pugh Class B)<br> | Drug: Hetrombopag Olamine Tablet<br>* Hetrombopag Olamine Tablet<br>|
| Experimental: Normal hepatic function<br> | Drug: Hetrombopag Olamine Tablet<br>* Hetrombopag Olamine Tablet<br>|
|
A Trial of Hetrombopag in Healthy and Hepatic Impairment Subjects
Study Overview
=================
Brief Summary
-----------------
This is a single-dose, open-label, phase I clinical study evaluating the PK of hetrombopag in subjects with mild hepatic impairment (Child-Pugh Class A), subjects with moderate hepatic impairment (Child-Pugh Class B), as well as age-, weight-, and gender-matched subjects with normal hepatic function.
Official Title
-----------------
A Phase I Clinical Study Evaluating the Pharmacokinetics and Safety of Hetrombopag Olamine Tablets in Subjects With Mild Hepatic Impairment (Child-Pugh Class A), Moderate Hepatic Impairment (Child-Pugh Class B), and Normal Hepatic Function
Conditions
-----------------
Sever Aplastic Anaemia
Intervention / Treatment
-----------------
* Drug: Hetrombopag Olamine Tablet
Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Sign the informed consent form before the study and fully understand the study content, process, and possible adverse reactions; able to complete the study as required by the clinical study protocol; Subjects (and their partners) are willing to adopt effective contraceptive measures from screening to 6 months after the last study administration. See Appendix 1 for specific contraceptive measures; Aged 18-65 years (inclusive), male or female; Body mass index (BMI = weight (kg)/height2 (m2)): 18-30 kg/m2 (inclusive); For subjects with normal hepatic function: normal or abnormal but not clinically significant laboratory findings (hematology, blood biochemistry, urinalysis, and coagulation function); For subjects with normal hepatic function: no history of severe primary disorders involving major organs, including but not limited to the gastrointestinal, respiratory, renal, hepatic, neural, hematological, endocrine, neoplastic, immunological, psychiatric, or cardiovascular and cerebrovascular disorders. Subjects with hepatic insufficiency must also meet the following inclusion criteria: Have not received medication within 4 weeks before screening, or have received stable medication for at least 4 weeks for hepatic impairment and/or other concurrent diseases requiring long-term treatment; With Child-Pugh Class A or B hepatic insufficiency caused by prior primary liver disorders (except drug-induced liver diseases). Exclusion Criteria: Average daily consumption of > 5 cigarettes within 3 months before screening; Allergic constitution, or allergy to any component of hetrombopag olamine tablets; Average daily alcohol consumption of > 15 g for females (e.g., 145 mL of wine, 497 mL of beer, or 43 mL of low-alcohol liquor) and > 25 g for males (e.g., 290 mL of wine, 994 mL of beer, or 86 mL of low-alcohol liquor) within 3 months before screening; History of drug abuse within 3 months before screening; Have donated or lost ≥ 400 mL of blood, or have received blood transfusion within 3 months before screening; Have undergone major surgery within 6 months before screening, or with incomplete healing of surgical incision; History of deep vein thrombosis or other thromboembolic events, or clinical symptoms suggesting thrombophilia; Have received TPO receptor agonists (such as eltrombopag and romiplostim) or TPO within 1 month before screening; Have taken Chinese herbal medicines or any drug that affects the PK of hetrombopag within 14 days before study administration (see Appendix 2 for drug-drug interaction evaluation); Hypertension [systolic blood pressure (SBP) ≥ 160 mmHg and/or diastolic blood pressure (DBP) ≥ 100 mmHg, confirmed by a re-measurement]; Female subjects who are in lactation or have a positive serum pregnancy test result at screening or during the study; Abnormal and clinically significant 12-lead ECG results (such as tachycardia/bradycardia requiring pharmacological treatment, second- or third-degree atrioventricular block or QTcF interval prolongation (≥ 470 ms for males, ≥ 480 ms for females) (corrected according to Fridericia's formula), or other clinically significant abnormalities assessed by the clinician); Estimated glomerular filtration rate (eGFR) < 60 mL/min/1.73 m2 calculated using the Modification of Diet in Renal Disease (MDRD) equation; Have malignant tumors or history of malignant tumors within 5 years before screening (except treated non-melanoma skin cancer without sign of recurrence and resected cervical intraepithelial neoplasia); For subjects with normal hepatic function: have participated in any drug or medical device clinical trials within 3 months before screening; for subjects with hepatic insufficiency: have participated in any drug or medical device clinical trials within 1 month before screening; For subjects with normal hepatic function: test positive for hepatitis B surface antigen, hepatitis C antibody or hepatitis C core antigen, HIV antibody, or syphilis antibody in screening; Probably undergo surgery or be hospitalized during the study; Have consumed alcohol (or positive for breath alcohol test), grapefruit/grapefruit juice, or any food or beverage containing methylxanthine (such as coffee, tea, cola, chocolate, and energy drink), have participated in strenuous physical activities, or have other factors that may affect drug absorption, distribution, metabolism, and excretion within 1 day before study administration; Positive for urine drug screening (morphine or marijuana); Subjects judged by the investigator as unsuitable for participating in this study. Additional exclusion criteria for subjects with hepatic insufficiency (those who meet any of the followings are ineligible): History of liver transplant; Liver failure, or liver cirrhosis complicated with hepatic encephalopathy, hepatocellular carcinoma, esophageal and gastric varices hemorrhage, and other complications that, in the opinion of the investigator, make subjects unsuitable for participating in this study; History of any serious diseases, other than primary liver diseases, or history of disorders and/or clinically significant abnormal laboratory findings that, as judged by the investigator, may affect the results of the study, including but not limited to the history of diseases in the circulatory system, endocrine system, nervous system, digestive system, urinary system or blood, immune, mental and metabolic diseases. Positive for HIV antibody screening; a rapid plasma reagin (RPR) test is required for a subject who tests positive for syphilis antibodies, and the subject should be excluded if the RPR result is also positive.
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: Parallel Assignment
Masking: None (Open Label)
Arms and Interventions
| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Mild hepatic impairment (Child-Pugh Class A)<br> | Drug: Hetrombopag Olamine Tablet<br>* Hetrombopag Olamine Tablet<br>|
| Experimental: Moderate hepatic impairment (Child-Pugh Class B)<br> | Drug: Hetrombopag Olamine Tablet<br>* Hetrombopag Olamine Tablet<br>|
| Experimental: Normal hepatic function<br> | Drug: Hetrombopag Olamine Tablet<br>* Hetrombopag Olamine Tablet<br>|
What is the study measuring?
-----------------
Primary Outcome Measures
| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Peak plasma concentration (Cmax) | | 0-120 hours post dose |
| Area Under the plasma concentration vs time curve (AUC0-120). | | 0-120 hours post dose |
| Area under the blood concentration vs time curve (AUC0-inf). | | 0-infinity |
Secondary Outcome Measures
| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Time to Reach Maximum Drug Concentration in Plasma After Single Dose (Tmax) | | 0-120 hours post dose |
| Half-life Associated With the Terminal Slope (t½) | | 0-120 hours post dose |
| The number of volunteers with adverse events as a measure of safety and tolerability | | up to Day 6 |
|
||
NCT02525965
|
The Influence of Resection Margin on the Recurrence of Early-stage Hepatocellular Carcinoma
|
Before the surgery, the investigators predict the risk of microvascular invasion (MVI) presence for the early-stage hepatocellular carcinoma according to the nomogram the investigators have created. Patients with a high risk of microvascular invasion were randomly chose to give the treatment of a wide resection margin, which establish an individualized anti-recurrence program based on the high-grade evidence-based medicine.
|
Although liver resection is still the first line of treatment for hepatocellular carcinoma (HCC) presently, 5-year overall recurrence rates > 70%, the same with early-stage hepatocellular carcinoma, for some studies reported the rates > 40%. Recurrence is also the first cause of death in these patients, so recurrence is the most important factors affecting surgical results of HCC. For the precaution of cancer recurrence, there are no proven techniques for clinical reference at present.~For now, there has been many controversies on the impact about the width of liver resection margin on curative effect. Poon has proven that there is no significant difference in recurrence rate between resection margin > 1cm and resection margin < 1cm. However, Shi et al published a randomized controlled trial: for patients with a solitary tumor, resection margin > 2cm can reduce the recurrence rate after hepatectomy. This is also the only randomized clinical trial study which proves increaseing resection margin will benefit the clinical results at present. A meta analysis consist of 18 studies proves that whether the resection margin has a relationship with a benefit clinical result still needs a further verification.~On the other hand, because microvascular invasion (MVI) is the direct evidence of the micro metastasis in hepatocellular carcinoma, it will decrease recurrence rate for the patients with a high MVI risk, if the investigators increase the resection margin width during the surgery? Shanghai Eastern Hepatobiliary Surgery Hospital which the investigators affiliated with had ever conducted a retrospective analysis on consecutive 3263 patients with HCC hepatectomy, the results indicated that a wide resection margin（≥1cm）can benefit those patients with microvascular invasion , nevertheless, the benefit will not present if patients are without microvascular invasion.~Further and better proofs still needs to approval this consequence, of course. In the past，another study of the ours, published online in the Journal of the American Medical Association Surgery, established a nomogram to predict the presence of microvascular invasion in the early-stage hepatocellular carcinoma, it will efficiently predict the occurrence of microvascular invasion in the hepatocellular carcinoma (HCC) fulfilled the Milan criteria. In consideration of the above basis, the investigators will implement a randomized controlled trial to certificate whether it could really reduce the recurrence rate after liver resection for participants with a high MVI risk during the surgery, if the method participants chose is a wide resection margin.
|
The Influence of Resection Margin on the Recurrence of Early-stage Hepatocellular Carcinoma After Hepatectomy: a Randomized Controlled Trial
|
Hepatocellular Carcinoma
|
* Procedure: Wide resection margin >1cm
* Procedure: Narrow resection margin <1cm
|
Inclusion Criteria:~Male or female patients > 18 years and <=70 years of age.~Diagnosed with HCC according to the criteria of American Association for the Study of Liver Diseases (AASLD).~Fulfill the Milan criteria.~High-risk of microvascular invasion (MVI).~Nomogram score >200.~Performance status score is 0-1 before the surgery.~Without or mild liver cirrhosis and the liver function is Child A class.~Without any other treatments such as TACE、PEI、PRFA before the surgery.~Exclusion Criteria:~Patients with macro tumor thrombus or extrahepatic metastasis.~Patients with apparent cardiac, pulmonary, cerebral and renal dysfunction.~Subjects accepting other trial drugs or participating in other clinical trials.~Patients refuse to join our trial.~Female with pregnancy or during the lactation period.
|
18 Years
|
70 Years
|
All
|
No
|
Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Triple
|
| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Overall survival rates of each group | | 3 years |
|
| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Occurrence rate of recurrence of each group | | 3 years |
|
Wide resection margin, Recurrence, Early-stage hepatocellular carcinoma
|
Carcinoma, Carcinoma, Hepatocellular, Recurrence, Neoplasms, Glandular and Epithelial, Neoplasms by Histologic Type, Neoplasms, Adenocarcinoma, Liver Neoplasms, Digestive System Neoplasms, Neoplasms by Site, Digestive System Diseases, Liver Diseases, Disease Attributes, Pathologic Processes
|
| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Wide resection margin >1cm<br>Surgical removal of lesions choosing the method of wide resection margin >1cm | Procedure: Wide resection margin >1cm<br>* Surgical removal of lesions choosing the method of wide resection margin >1cm<br>|
| Active Comparator: Narrow resection margin <1cm<br>Surgical removal of lesions choosing the method of narrow resection margin <1cm | Procedure: Narrow resection margin <1cm<br>* Surgical removal of lesions choosing the method of wide resection margin <1cm<br>|
|
The Influence of Resection Margin on the Recurrence of Early-stage Hepatocellular Carcinoma
Study Overview
=================
Brief Summary
-----------------
Before the surgery, the investigators predict the risk of microvascular invasion (MVI) presence for the early-stage hepatocellular carcinoma according to the nomogram the investigators have created. Patients with a high risk of microvascular invasion were randomly chose to give the treatment of a wide resection margin, which establish an individualized anti-recurrence program based on the high-grade evidence-based medicine.
Detailed Description
-----------------
Although liver resection is still the first line of treatment for hepatocellular carcinoma (HCC) presently, 5-year overall recurrence rates > 70%, the same with early-stage hepatocellular carcinoma, for some studies reported the rates > 40%. Recurrence is also the first cause of death in these patients, so recurrence is the most important factors affecting surgical results of HCC. For the precaution of cancer recurrence, there are no proven techniques for clinical reference at present. For now, there has been many controversies on the impact about the width of liver resection margin on curative effect. Poon has proven that there is no significant difference in recurrence rate between resection margin > 1cm and resection margin < 1cm. However, Shi et al published a randomized controlled trial: for patients with a solitary tumor, resection margin > 2cm can reduce the recurrence rate after hepatectomy. This is also the only randomized clinical trial study which proves increaseing resection margin will benefit the clinical results at present. A meta analysis consist of 18 studies proves that whether the resection margin has a relationship with a benefit clinical result still needs a further verification. On the other hand, because microvascular invasion (MVI) is the direct evidence of the micro metastasis in hepatocellular carcinoma, it will decrease recurrence rate for the patients with a high MVI risk, if the investigators increase the resection margin width during the surgery? Shanghai Eastern Hepatobiliary Surgery Hospital which the investigators affiliated with had ever conducted a retrospective analysis on consecutive 3263 patients with HCC hepatectomy, the results indicated that a wide resection margin（≥1cm）can benefit those patients with microvascular invasion , nevertheless, the benefit will not present if patients are without microvascular invasion. Further and better proofs still needs to approval this consequence, of course. In the past，another study of the ours, published online in the Journal of the American Medical Association Surgery, established a nomogram to predict the presence of microvascular invasion in the early-stage hepatocellular carcinoma, it will efficiently predict the occurrence of microvascular invasion in the hepatocellular carcinoma (HCC) fulfilled the Milan criteria. In consideration of the above basis, the investigators will implement a randomized controlled trial to certificate whether it could really reduce the recurrence rate after liver resection for participants with a high MVI risk during the surgery, if the method participants chose is a wide resection margin.
Official Title
-----------------
The Influence of Resection Margin on the Recurrence of Early-stage Hepatocellular Carcinoma After Hepatectomy: a Randomized Controlled Trial
Conditions
-----------------
Hepatocellular Carcinoma
Intervention / Treatment
-----------------
* Procedure: Wide resection margin >1cm
* Procedure: Narrow resection margin <1cm
Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Male or female patients > 18 years and <=70 years of age. Diagnosed with HCC according to the criteria of American Association for the Study of Liver Diseases (AASLD). Fulfill the Milan criteria. High-risk of microvascular invasion (MVI). Nomogram score >200. Performance status score is 0-1 before the surgery. Without or mild liver cirrhosis and the liver function is Child A class. Without any other treatments such as TACE、PEI、PRFA before the surgery. Exclusion Criteria: Patients with macro tumor thrombus or extrahepatic metastasis. Patients with apparent cardiac, pulmonary, cerebral and renal dysfunction. Subjects accepting other trial drugs or participating in other clinical trials. Patients refuse to join our trial. Female with pregnancy or during the lactation period.
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: Triple
Arms and Interventions
| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Wide resection margin >1cm<br>Surgical removal of lesions choosing the method of wide resection margin >1cm | Procedure: Wide resection margin >1cm<br>* Surgical removal of lesions choosing the method of wide resection margin >1cm<br>|
| Active Comparator: Narrow resection margin <1cm<br>Surgical removal of lesions choosing the method of narrow resection margin <1cm | Procedure: Narrow resection margin <1cm<br>* Surgical removal of lesions choosing the method of wide resection margin <1cm<br>|
What is the study measuring?
-----------------
Primary Outcome Measures
| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Overall survival rates of each group | | 3 years |
Secondary Outcome Measures
| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Occurrence rate of recurrence of each group | | 3 years |
Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Wide resection margin, Recurrence, Early-stage hepatocellular carcinoma
|
NCT00410930
|
Efficacy and Safety of Subcutaneous Immunotherapy in Birch Pollen Allergic Patients
|
To compare versus placebo the efficacy and safety of recombinant Bet v1, natural purified Bet v1 and birch pollen licenced extract used for subcutaneous immunotherapy.
|
Double-Blind Placebo-Controlled Study of Subcutaneous Immunotherapy in Birch Pollen Allergic Patients
|
Allergy
|
* Biological: Subcutaneous immunotherapy - Recombinant birch pollen
|
Inclusion Criteria:~Patients aged 18-50 with seasonal rhinoconjunctivitis for at least 2 years, and/or mild asthma range 1 and 2 GINA.~Positive history of birch pollen allergy (clinical history, positive skin prick test, birch specific IgE, presence of birch pollen)~Compliant patients~Written consent.~Exclusion Criteria:~Perennial rhinoconjunctivitis and/or asthma due to cosensitization with: animal danders, mites, alternaria cladosporium~Uncontrolled seasonal asthma : severe asthma permanent or not range 3 and 4 of GINA.~Patients treated with beta-blockers or under continuous oral corticosteroids.~Pregnant women
|
18 Years
|
50 Years
|
All
|
No
|
Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double
|
| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Reduction of symptom and medication scores. | | |
|
Immunotherapy, major allergen, birch
|
Immunomodulating Agents, Immunologic Factors, Physiological Effects of Drugs
|
| Intervention/Treatment |
| --- |
|Biological: Subcutaneous immunotherapy - Recombinant birch pollen|nan|
|
Efficacy and Safety of Subcutaneous Immunotherapy in Birch Pollen Allergic Patients
Study Overview
=================
Brief Summary
-----------------
To compare versus placebo the efficacy and safety of recombinant Bet v1, natural purified Bet v1 and birch pollen licenced extract used for subcutaneous immunotherapy.
Official Title
-----------------
Double-Blind Placebo-Controlled Study of Subcutaneous Immunotherapy in Birch Pollen Allergic Patients
Conditions
-----------------
Allergy
Intervention / Treatment
-----------------
* Biological: Subcutaneous immunotherapy - Recombinant birch pollen
Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Patients aged 18-50 with seasonal rhinoconjunctivitis for at least 2 years, and/or mild asthma range 1 and 2 GINA. Positive history of birch pollen allergy (clinical history, positive skin prick test, birch specific IgE, presence of birch pollen) Compliant patients Written consent. Exclusion Criteria: Perennial rhinoconjunctivitis and/or asthma due to cosensitization with: animal danders, mites, alternaria cladosporium Uncontrolled seasonal asthma : severe asthma permanent or not range 3 and 4 of GINA. Patients treated with beta-blockers or under continuous oral corticosteroids. Pregnant women
Ages Eligible for Study
-----------------
Minimum Age: 18 Years
Maximum 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: Randomized
Intervention Model: Parallel Assignment
Masking: Double
Arms and Interventions
| Intervention/Treatment |
| --- |
|Biological: Subcutaneous immunotherapy - Recombinant birch pollen|nan|
What is the study measuring?
-----------------
Primary Outcome Measures
| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Reduction of symptom and medication scores. | | |
Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Immunotherapy, major allergen, birch
|
||
NCT00034463
|
ALIMTA (Pemetrexed) in Patients With Locally Advanced or Metastatic Cancer
|
This is a non-randomized, phase 1, study with the primary objective of determining the toxicities and establishing the maximum tolerated dose of ALIMTA when administered as a 10 minute infusion every 21 days with folic acid or multi-vitamin supplementation therapy in lightly or heavily pre-treated patients with locally advanced or metastatic cancer.
|
A Phase 1 Trial of ALIMTA (Pemetrexed) in Patients With Locally Advanced or Metastatic Cancer
|
Metastases, Cancer
|
* Drug: ALIMTA
* Drug: folic acid
* Drug: multi-vitamins
|
Inclusion Criteria:~Histologic or cytologic diagnosis of metastatic or locally advanced cancer~Prior chemotherapy is allowed~Adequate bone marrow, liver and kidney function~Exclusion Criteria:~Prior treatment with ALIMTA~Brain metastasis~Pregnancy or breast feeding
|
18 Years
| null |
All
|
No
|
Primary Purpose: Treatment
|
| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
|
metastatic cancer, chemotherapy
|
Folic Acid, Vitamins, Micronutrients, Physiological Effects of Drugs, Hematinics, Vitamin B Complex
|
| Intervention/Treatment |
| --- |
|Drug: ALIMTA|nan|
|Drug: folic acid|nan|
|Drug: multi-vitamins|nan|
|
ALIMTA (Pemetrexed) in Patients With Locally Advanced or Metastatic Cancer
Study Overview
=================
Brief Summary
-----------------
This is a non-randomized, phase 1, study with the primary objective of determining the toxicities and establishing the maximum tolerated dose of ALIMTA when administered as a 10 minute infusion every 21 days with folic acid or multi-vitamin supplementation therapy in lightly or heavily pre-treated patients with locally advanced or metastatic cancer.
Official Title
-----------------
A Phase 1 Trial of ALIMTA (Pemetrexed) in Patients With Locally Advanced or Metastatic Cancer
Conditions
-----------------
Metastases, Cancer
Intervention / Treatment
-----------------
* Drug: ALIMTA
* Drug: folic acid
* Drug: multi-vitamins
Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Histologic or cytologic diagnosis of metastatic or locally advanced cancer Prior chemotherapy is allowed Adequate bone marrow, liver and kidney function Exclusion Criteria: Prior treatment with ALIMTA Brain metastasis Pregnancy or breast feeding
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
Arms and Interventions
| Intervention/Treatment |
| --- |
|Drug: ALIMTA|nan|
|Drug: folic acid|nan|
|Drug: multi-vitamins|nan|
What is the study measuring?
-----------------
Primary Outcome Measures
| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
metastatic cancer, chemotherapy
|
||
NCT00677118
|
Adjuvant Chemotherapy in Patients With Locoregionally Advanced Nasopharyngeal Carcinoma
|
The purpose of this study is to compare concurrent chemoradiotherapy plus adjuvant chemotherapy with concurrent chemoradiotherapy in patients with locoregionally advanced NPC, in order to evaluate the value of adjuvant chemotherapy in nasopharyngeal carcinoma (NPC) patients.
|
Patients presented with non-keratinizing NPC and stage T3-4N1M0/TxN2-3M0 are randomly assigned to receive concurrent chemoradiotherapy plus adjuvant chemotherapy (investigational arm)or concurrent chemoradiotherapy (control arm). Patients in both arms receive radical radiotherapy and cisplatin (40mg/m2 on day 1) weekly during radiotherapy. Patients in the investigational arm receive cisplatin (80mg/m2 on day 1) and fluorouracil (800mg/m2 on Day 1 to 5) every four weeks for three cycles after completion of radiotherapy. Patients are stratified according to the treatment centers. The primary end point was failure-free survival (FFS). Secondary end points included overall survival (OS), distant failure-free survival (D-FFS), locoregional failure-free survival (LR-FFS), the initial response rates after treatments, toxic effects and treatment compliance. All efficacy analyses were conducted in the intention-to-treat population; the safety population included only patients who received their randomly assigned treatment.
|
A Multicenter Prospective Randomized Trial Comparing Concurrent Chemoradiotherapy Plus Adjuvant Chemotherapy With Concurrent Chemoradiotherapy in Patients With Locoregionally Advanced Nasopharyngeal Carcinoma
|
Nasopharyngeal Carcinoma
|
* Drug: Cisplatin,fluorouracil
* Drug: Cisplatin
|
Inclusion Criteria:~Patients with newly histologically confirmed non-keratinizing carcinoma (according to World Health Organization (WHO) histologically type)~Tumor staged as N2-3or T3-4N1 (according to 6th American Joint Committee on Cancer staging system)~No evidence of distant metastasis (M0)~Performance status: KPS ≥70~With normal liver function test (Alanine Aminotransferase、Aspartate Aminotransferase ≤2.5×upper limit of normal)~Renal: creatinine clearance ≥60ml/min~Adequate marrow: leucocyte count ≥4000/μL, hemoglobin ≥80g/L and platelet count ≥100000/μL~Written informed consent~Exclusion Criteria:~WHO Type keratinizing squamous cell carcinoma or basaloid squamous cell carcinoma.~Age ≥70 or <18~With a history of renal disease~Prior malignancy~Previous chemotherapy or radiotherapy~Patient is pregnant or lactating~Unstable cardiac disease requiring treatment.~Emotion disturbance
|
18 Years
|
69 Years
|
All
|
No
|
Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
|
| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Failure-free survival | Failure-free survival is calculated from the date of randomization to the date of the first failure at any site. | 2-yr |
|
| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Overall survival, distant failure-free survival and locoregional failure-free survival | Overall survival is calculated from randomization to death from any cause. For distant failure-free survival and locoregional failure-free survival analyses, the latencies to the first remote or local failure, respectively, are recorded. | 2-yr |
|
Nasopharyngeal carcinoma, Concurrent chemoradiotherapy, Adjuvant chemotherapy, Clinical trial
|
Cisplatin, Fluorouracil, Antineoplastic Agents, Antimetabolites, Molecular Mechanisms of Pharmacological Action, Antimetabolites, Antineoplastic, Immunosuppressive Agents, Immunologic Factors, Physiological Effects of Drugs
|
| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Concurrent and adjuvant<br>Concurrent chemoradiotherapy plus adjuvant chemotherapy | Drug: Cisplatin,fluorouracil<br>* Patients receive radical radiotherapy and cisplatin (40mg/m2 on day 1) weekly during radiotherapy, then receive cisplatin (80mg/m2 on day 1) and fluorouracil (800mg/m2 on Day 1 to 5) every four weeks for three cycles after completion of radiotherapy.<br>* Other names: Cisplatin and fluorouracil;|
| Active Comparator: Concurrent<br>Concurrent chemoradiotherapy | Drug: Cisplatin<br>* Patients receive radical radiotherapy and cisplatin (40mg/m2 on day 1) weekly during radiotherapy.<br>|
|
Adjuvant Chemotherapy in Patients With Locoregionally Advanced Nasopharyngeal Carcinoma
Study Overview
=================
Brief Summary
-----------------
The purpose of this study is to compare concurrent chemoradiotherapy plus adjuvant chemotherapy with concurrent chemoradiotherapy in patients with locoregionally advanced NPC, in order to evaluate the value of adjuvant chemotherapy in nasopharyngeal carcinoma (NPC) patients.
Detailed Description
-----------------
Patients presented with non-keratinizing NPC and stage T3-4N1M0/TxN2-3M0 are randomly assigned to receive concurrent chemoradiotherapy plus adjuvant chemotherapy (investigational arm)or concurrent chemoradiotherapy (control arm). Patients in both arms receive radical radiotherapy and cisplatin (40mg/m2 on day 1) weekly during radiotherapy. Patients in the investigational arm receive cisplatin (80mg/m2 on day 1) and fluorouracil (800mg/m2 on Day 1 to 5) every four weeks for three cycles after completion of radiotherapy. Patients are stratified according to the treatment centers. The primary end point was failure-free survival (FFS). Secondary end points included overall survival (OS), distant failure-free survival (D-FFS), locoregional failure-free survival (LR-FFS), the initial response rates after treatments, toxic effects and treatment compliance. All efficacy analyses were conducted in the intention-to-treat population; the safety population included only patients who received their randomly assigned treatment.
Official Title
-----------------
A Multicenter Prospective Randomized Trial Comparing Concurrent Chemoradiotherapy Plus Adjuvant Chemotherapy With Concurrent Chemoradiotherapy in Patients With Locoregionally Advanced Nasopharyngeal Carcinoma
Conditions
-----------------
Nasopharyngeal Carcinoma
Intervention / Treatment
-----------------
* Drug: Cisplatin,fluorouracil
* Drug: Cisplatin
Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Patients with newly histologically confirmed non-keratinizing carcinoma (according to World Health Organization (WHO) histologically type) Tumor staged as N2-3or T3-4N1 (according to 6th American Joint Committee on Cancer staging system) No evidence of distant metastasis (M0) Performance status: KPS ≥70 With normal liver function test (Alanine Aminotransferase、Aspartate Aminotransferase ≤2.5×upper limit of normal) Renal: creatinine clearance ≥60ml/min Adequate marrow: leucocyte count ≥4000/μL, hemoglobin ≥80g/L and platelet count ≥100000/μL Written informed consent Exclusion Criteria: WHO Type keratinizing squamous cell carcinoma or basaloid squamous cell carcinoma. Age ≥70 or <18 With a history of renal disease Prior malignancy Previous chemotherapy or radiotherapy Patient is pregnant or lactating Unstable cardiac disease requiring treatment. Emotion disturbance
Ages Eligible for Study
-----------------
Minimum Age: 18 Years
Maximum Age: 69 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: Concurrent and adjuvant<br>Concurrent chemoradiotherapy plus adjuvant chemotherapy | Drug: Cisplatin,fluorouracil<br>* Patients receive radical radiotherapy and cisplatin (40mg/m2 on day 1) weekly during radiotherapy, then receive cisplatin (80mg/m2 on day 1) and fluorouracil (800mg/m2 on Day 1 to 5) every four weeks for three cycles after completion of radiotherapy.<br>* Other names: Cisplatin and fluorouracil;|
| Active Comparator: Concurrent<br>Concurrent chemoradiotherapy | Drug: Cisplatin<br>* Patients receive radical radiotherapy and cisplatin (40mg/m2 on day 1) weekly during radiotherapy.<br>|
What is the study measuring?
-----------------
Primary Outcome Measures
| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Failure-free survival | Failure-free survival is calculated from the date of randomization to the date of the first failure at any site. | 2-yr |
Secondary Outcome Measures
| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Overall survival, distant failure-free survival and locoregional failure-free survival | Overall survival is calculated from randomization to death from any cause. For distant failure-free survival and locoregional failure-free survival analyses, the latencies to the first remote or local failure, respectively, are recorded. | 2-yr |
Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Nasopharyngeal carcinoma, Concurrent chemoradiotherapy, Adjuvant chemotherapy, Clinical trial
|
NCT04903028
|
RTMS Targets Neural Circuits for Smoking Cessation
|
Cigarette smoking is a significant public health concern. Transcranial magnetic stimulation (TMS) is a non-invasive form of brain stimulation that has already displayed remarkable potential for producing novel, non-pharmacological interventions for depression and cigarette smokers. In this study, we will use brain MRI to guide TMS therapy for smoking cessation.
|
Smoking cessation is difficult, despite the demonstrated efficacy of several pharmacotherapeutic agents and cognitive behavioral therapies. This may be due to imbalanced neuronal circuits, including elevated functional connectivity in the drive-reward circuit (medial orbital frontal cortex [mOFC] to nucleus accumbens [NAc]) and decreased functional connectivity in the executive control circuit (dorsolateral prefrontal cortex[ DLPFC] to NAc). Repetitive transcranial magnetic stimulation (rTMS) is a new class of therapeutics that has already displayed remarkable potential for producing novel, non-pharmacological interventions for neuropsychiatric disorders. Previous studies have reported that rTMS decreased cue craving, reduced cigarette consumption, and increased smoking quit rate in tobacco use disorders(TUDs). However, the treatment parameters and exact mechanism for rTMS increasing smoking quit rate need further refinement. The goal of this study is to develop a circuit-based precision rTMS therapy for smoking cessation further. In the 2-year UG3 phase, investigators will recruit 45 TUDs. Participants will undergo a baseline cue-exposure fMRI and a resisting-to smoke fMRI session. Participants will be randomized into three groups: 1) Sham rTMS over the left mOFC or the left DLPFC. 2) Active, inhibitory low-frequency rTMS (LF-rTMS) over the left mOFC (1 Hz, 900 pulses, E-field modeling, 15 minutes, smoking cue exposure fMRI-guided target). Or 3) Active, high-frequency rTMS (HF-rTMS) over the left DLPFC (10 Hz, 3000 pulses, E-field modeling,15 minutes, resisting-to-smoke fMRI guided target). Fifteen sessions of rTMS will be completed over three weeks, after which the investigators will acquire fMRI scans. The investigators will also test the imbalanced function of drive-reward and executive control before and after 3 weeks of treatments to compare the imbalanced function between groups.
|
RTMS Manipulates Imbalanced Drive-reward and Executive Control Circuitry for Smoking Cessation
|
Tobacco Use, Cigarette Smoking
|
* Device: Sham rTMS
* Device: Active rTMS 10 Hz DLPFC
* Device: Active rTMS 1 Hz mOFC
|
Inclusion Criteria:~Be between the ages of 18 and 60 years old.~Smoke 10 or more cigarettes per day and have a carbon monoxide (CO) level > 10 ppm indicative of recent smoking.~Have not received substance abuse treatment within the previous 30 days.~Meet the criteria for tobacco use disorder as determined by DSM-5.~Be in stable mental and physical health.~If female, test non-pregnant and use adequate birth control.~Show no evidence of focal or diffuse brain lesions on MRI.~Be willing to provide informed consent.~Be able to comply with protocol requirements and likely to complete all study procedures.~Be motivated to quit smoking (based on responses of very likely, or somewhat likely in the motivation questionnaire).~Exclusion Criteria:~Current moderate to severe substance use of any psychoactive substances other than nicotine or caffeine, as defined by DSM-V criteria.~Contraindications to MRI (e.g., presence of metal in the skull, orbital or intracranial cavity, or having claustrophobia).~Contraindication to rTMS.~History of autoimmune, endocrine, viral, or vascular disorders affecting the brain.~History or MRI evidence of neurological disorder that would lead to local or diffuse brain lesions or significant physical impairment.~Unstable cardiac disease, uncontrolled hypertension, severe renal or liver insufficiency, or sleep apnea.~Lifetime history of major Axis I disorders such as: bipolar affective disorder (BPAD), schizophrenia, post-traumatic stress disorder (PTSD), dementia, suicidal ideation or major depression.~Self-report of >21 standard alcohol drinks per week in any week in the 30 days prior to screening.~Use of other forms of nicotine delivery, such as nicotine patches, electronic cigarettes, gum, nasal spray, inhalers, and nicotine lozenges.~Use of other tobacco products, including cigars, cigarillos, chew, snuff, and pouches/snus.~Previous treatment with TMS.
|
18 Years
|
60 Years
|
All
|
Accepts Healthy Volunteers
|
Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Interventional Model Description: Forty-five treatment-seeking TUDs between the ages of 18 and 60 will be randomly divided into three groups on a 1:1:1 basis (15 participants/condition). The first condition will receive E-sham rTMS (half will get 1Hz sham; half will get 10Hz sham), the second condition will receive active 1Hz personalized-fMRI and E-field-modeling guided rTMS (900 pulses/session) over the left mOFC, and the third condition will receive active 10 Hz personalized-fMRI and E-field modeling guided rTMS (3000 pulses/session) over the left DLPFC.
Masking: Triple
|
| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Mean number of cigarettes smoked per day | The primary objective is to compare 1 Hz-mOFC rTMS to 10 Hz-DLPFC rTMS. Cigarettes smoked per day will be the primary outcome measure. | 3-week rTMS treatment |
| Changes of brain connectivity | Compared to sham rTMS, either active rTMS significantly increase the negative correlation between DLPFC and NAc, DLPFC and mOFC, while decrease the correlation coefficient between NAc and mOFC. | Pre and post 3-week treatment |
|
| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| The percentage of participants who have quit by their target quit date | Quit smoke rate on the target quit the date will be measured during the phase. | 4-week follow-up |
|
| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Sham Comparator: Sham rTMS<br>Participants will be fitted with two electrodes on the scalp just below the hairline. Electrodes will be connected to an Epix VT® Transcutaneous Electrical Nerve Stimulation Device with adjustable output amplitude and powered by a 9-V battery. We will use electrode stimulation with 10 Hz over DLPFC, total 3000 pulses or 1 Hz over mOFC total 900 pulses. The sham-TMS scalp discomfort was matched to that of active TMS. During real TMS there was no current flowing through the scalp electrodes. | Device: Sham rTMS<br>* Two electrodes on the scalp will be connected to transcutaneous electrical nerve stimulation.<br>|
| Active Comparator: Active rTMS 10 Hz DLPFC<br>A stimulation frequency of 10 Hz, pulse train duration (on time) of 5 seconds, inter-train interval (off time) of 10 seconds (15 second cycle time), E-field-modeling to determine TMS intensity and coil orientation, total of 60 trains, session time of 15 minutes, and 3000-total pulses per day, will be delivered over the left DLPFC. | Device: Active rTMS 10 Hz DLPFC<br>* 10 Hz repetitive transcranial magnetic stimulation (rTMS) will be delivered over left dorsolateral prefrontal cortex (DLPFC).<br>|
| Active Comparator: Active rTMS 1 Hz mOFC<br>A stimulation frequency of 1Hz, E-field-modeling to determine TMS intensity and coil orientation, session time of 15 minutes, and 900-total pulses per day, will be the same for all subjects (both active and sham). TMS will be delivered over the left mOFC. | Device: Active rTMS 1 Hz mOFC<br>* 1 Hz repetitive transcranial magnetic stimulation (rTMS) will be delivered over left medial orbitofrontal cortex (mOFC).<br>|
|
RTMS Targets Neural Circuits for Smoking Cessation
Study Overview
=================
Brief Summary
-----------------
Cigarette smoking is a significant public health concern. Transcranial magnetic stimulation (TMS) is a non-invasive form of brain stimulation that has already displayed remarkable potential for producing novel, non-pharmacological interventions for depression and cigarette smokers. In this study, we will use brain MRI to guide TMS therapy for smoking cessation.
Detailed Description
-----------------
Smoking cessation is difficult, despite the demonstrated efficacy of several pharmacotherapeutic agents and cognitive behavioral therapies. This may be due to imbalanced neuronal circuits, including elevated functional connectivity in the drive-reward circuit (medial orbital frontal cortex [mOFC] to nucleus accumbens [NAc]) and decreased functional connectivity in the executive control circuit (dorsolateral prefrontal cortex[ DLPFC] to NAc). Repetitive transcranial magnetic stimulation (rTMS) is a new class of therapeutics that has already displayed remarkable potential for producing novel, non-pharmacological interventions for neuropsychiatric disorders. Previous studies have reported that rTMS decreased cue craving, reduced cigarette consumption, and increased smoking quit rate in tobacco use disorders(TUDs). However, the treatment parameters and exact mechanism for rTMS increasing smoking quit rate need further refinement. The goal of this study is to develop a circuit-based precision rTMS therapy for smoking cessation further. In the 2-year UG3 phase, investigators will recruit 45 TUDs. Participants will undergo a baseline cue-exposure fMRI and a resisting-to smoke fMRI session. Participants will be randomized into three groups: 1) Sham rTMS over the left mOFC or the left DLPFC. 2) Active, inhibitory low-frequency rTMS (LF-rTMS) over the left mOFC (1 Hz, 900 pulses, E-field modeling, 15 minutes, smoking cue exposure fMRI-guided target). Or 3) Active, high-frequency rTMS (HF-rTMS) over the left DLPFC (10 Hz, 3000 pulses, E-field modeling,15 minutes, resisting-to-smoke fMRI guided target). Fifteen sessions of rTMS will be completed over three weeks, after which the investigators will acquire fMRI scans. The investigators will also test the imbalanced function of drive-reward and executive control before and after 3 weeks of treatments to compare the imbalanced function between groups.
Official Title
-----------------
RTMS Manipulates Imbalanced Drive-reward and Executive Control Circuitry for Smoking Cessation
Conditions
-----------------
Tobacco Use, Cigarette Smoking
Intervention / Treatment
-----------------
* Device: Sham rTMS
* Device: Active rTMS 10 Hz DLPFC
* Device: Active rTMS 1 Hz mOFC
Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Be between the ages of 18 and 60 years old. Smoke 10 or more cigarettes per day and have a carbon monoxide (CO) level > 10 ppm indicative of recent smoking. Have not received substance abuse treatment within the previous 30 days. Meet the criteria for tobacco use disorder as determined by DSM-5. Be in stable mental and physical health. If female, test non-pregnant and use adequate birth control. Show no evidence of focal or diffuse brain lesions on MRI. Be willing to provide informed consent. Be able to comply with protocol requirements and likely to complete all study procedures. Be motivated to quit smoking (based on responses of very likely, or somewhat likely in the motivation questionnaire). Exclusion Criteria: Current moderate to severe substance use of any psychoactive substances other than nicotine or caffeine, as defined by DSM-V criteria. Contraindications to MRI (e.g., presence of metal in the skull, orbital or intracranial cavity, or having claustrophobia). Contraindication to rTMS. History of autoimmune, endocrine, viral, or vascular disorders affecting the brain. History or MRI evidence of neurological disorder that would lead to local or diffuse brain lesions or significant physical impairment. Unstable cardiac disease, uncontrolled hypertension, severe renal or liver insufficiency, or sleep apnea. Lifetime history of major Axis I disorders such as: bipolar affective disorder (BPAD), schizophrenia, post-traumatic stress disorder (PTSD), dementia, suicidal ideation or major depression. Self-report of >21 standard alcohol drinks per week in any week in the 30 days prior to screening. Use of other forms of nicotine delivery, such as nicotine patches, electronic cigarettes, gum, nasal spray, inhalers, and nicotine lozenges. Use of other tobacco products, including cigars, cigarillos, chew, snuff, and pouches/snus. Previous treatment with TMS.
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
Interventional Model Description: Forty-five treatment-seeking TUDs between the ages of 18 and 60 will be randomly divided into three groups on a 1:1:1 basis (15 participants/condition). The first condition will receive E-sham rTMS (half will get 1Hz sham; half will get 10Hz sham), the second condition will receive active 1Hz personalized-fMRI and E-field-modeling guided rTMS (900 pulses/session) over the left mOFC, and the third condition will receive active 10 Hz personalized-fMRI and E-field modeling guided rTMS (3000 pulses/session) over the left DLPFC.
Masking: Triple
Arms and Interventions
| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Sham Comparator: Sham rTMS<br>Participants will be fitted with two electrodes on the scalp just below the hairline. Electrodes will be connected to an Epix VT® Transcutaneous Electrical Nerve Stimulation Device with adjustable output amplitude and powered by a 9-V battery. We will use electrode stimulation with 10 Hz over DLPFC, total 3000 pulses or 1 Hz over mOFC total 900 pulses. The sham-TMS scalp discomfort was matched to that of active TMS. During real TMS there was no current flowing through the scalp electrodes. | Device: Sham rTMS<br>* Two electrodes on the scalp will be connected to transcutaneous electrical nerve stimulation.<br>|
| Active Comparator: Active rTMS 10 Hz DLPFC<br>A stimulation frequency of 10 Hz, pulse train duration (on time) of 5 seconds, inter-train interval (off time) of 10 seconds (15 second cycle time), E-field-modeling to determine TMS intensity and coil orientation, total of 60 trains, session time of 15 minutes, and 3000-total pulses per day, will be delivered over the left DLPFC. | Device: Active rTMS 10 Hz DLPFC<br>* 10 Hz repetitive transcranial magnetic stimulation (rTMS) will be delivered over left dorsolateral prefrontal cortex (DLPFC).<br>|
| Active Comparator: Active rTMS 1 Hz mOFC<br>A stimulation frequency of 1Hz, E-field-modeling to determine TMS intensity and coil orientation, session time of 15 minutes, and 900-total pulses per day, will be the same for all subjects (both active and sham). TMS will be delivered over the left mOFC. | Device: Active rTMS 1 Hz mOFC<br>* 1 Hz repetitive transcranial magnetic stimulation (rTMS) will be delivered over left medial orbitofrontal cortex (mOFC).<br>|
What is the study measuring?
-----------------
Primary Outcome Measures
| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Mean number of cigarettes smoked per day | The primary objective is to compare 1 Hz-mOFC rTMS to 10 Hz-DLPFC rTMS. Cigarettes smoked per day will be the primary outcome measure. | 3-week rTMS treatment |
| Changes of brain connectivity | Compared to sham rTMS, either active rTMS significantly increase the negative correlation between DLPFC and NAc, DLPFC and mOFC, while decrease the correlation coefficient between NAc and mOFC. | Pre and post 3-week treatment |
Secondary Outcome Measures
| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| The percentage of participants who have quit by their target quit date | Quit smoke rate on the target quit the date will be measured during the phase. | 4-week follow-up |
|
||
NCT01940952
|
Zydena on Cognitive Function of Alzheimer's Disease Patients
|
The purpose of this study is to determine whether Zydena (Udenafil) has positive effect on cognitive function in patients with Alzheimer's disease.~This study is a randomized, double blind, placebo-controlled multicenter study.
|
Efficacy of Zydena (Udenafil) on Cognitive Function of Alzheimer's Disease Patients: A Randomized, Double Blind, Placebo-controlled Multicenter Study
|
Alzheimer's Disease
|
* Drug: Zydena (Udenafil) 50mg + Donepezil 5mg or 10mg
* Drug: Placebo + Donepezil 5mg or 10mg
* Drug: Zydena (Udenafil) 100mg + Donepezil 5mg or 10mg
|
Inclusion Criteria:~Signed written informed consent;~Male or female subjects 50 to 90 years of age;~Diagnosis of probable Alzheimer's disease according to National Institute of Neurological Disorders and Stroke and the Alzheimer's Disease and Related Disorders Association (NINCDS/ADRDA) criteria;~A Mini-Mental State Examination (MMSE) score of ≥10 and ≤26;~Global Clinical Dementia Rating ≥ 0.5;~Mild to moderate (not severe) white matter hyperintensities on brain MRI performed within three years from screening;~Good enough hearing and visual function to complete neuropsychological tests~Caregivers living with patients or spending 10 or more hours a week with patients;~Stable dose of donepezil (5mg to 10mg) for at least 60 days;~If patients have been on memantine, it should be washed out for at least 60 days;~Medications including anxiolytics, antipsychotics, and hypnotics may be taken if the dose has been stable for at least two weeks~Exclusion Criteria:~History of stroke within 6 months;~Previous diagnosis of severe (more than 80%) intracranial artery stenosis;~History of heart failure, ischemic heart disease (myocardial infarction, unstable angina, and stable angina), hypertrophic cardiomyopathy, and life-threatening arrhythmia;~Previous history of coronary artery bypass graft surgery;~Severe symptom of orthostatic hypotension (orthostatic syncope or presyncope), especially when patients take alpha-adrenergic blocker (Alfuzosin, Doxazosin, Naftopidil, Tamsulosin, Terazosin, Arotinolol, Carvedilol, Labetalol, Trazodone, typical and atypical antipsychotics);~Uncontrolled diabetes mellitus;~Proliferative diabetic retinopathy;~Severe hypotension (blood pressure less than 90/50mmHg) or severe hypertension (blood pressure more than 170/100mmHg);~Hepatic dysfunction (AST or ALT more than three times of upper normal limit) or renal dysfunction (serum creatinine more than 2.5mg/dL);~Retinitis pigmentosa;~Previous history of active peptic ulceration within one year before screening;~Hematodyscrasia susceptible to priapism including sickle cell anemia, multiple myeloma, leukemia, and various bleeding disorders;~History of drug abuse;~Medication including nitrates/nitric oxide donor (ex: nitroglycerin, isosorbide mononitrate, isosorbide dinitrate, amyl nitrate/nitrite, and Sodium nitroprusside), androgen (ex: testosterone), anti-androgen, and anticoagulants;~Current cancer chemotherapy;~Usage of PDE5i (Zydena, Viagra®, Levitra®, or Cialis®) within two weeks before study start;~History of hypersensitive reaction to PDE5i (Zydena, Viagra®, Levitra®, or Cialis®)
|
50 Years
|
90 Years
|
All
|
No
|
Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple
|
| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change in cognitive function | measured by ADAS-cog | from baseline to Week 12 and Week 24 after the administration of the medication |
|
| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change in cognitive function | Measured by MMSE, Clinical Dementia Rating Sum of Boxes, ADCS-ADL, COWAT, Digit Symbol Coding, Trail Making Test-E | from baseline to Week 12 and Week 24 |
| Change in behavioral symptoms | Measured by Neuropsychiatric Inventory | from baseline to Week 12 and Week 24 |
| Change in brain function | Measured by FDG-PET | from baseline to Week 12 and Week 24 |
|
Donepezil, Udenafil, Cholinesterase Inhibitors, Enzyme Inhibitors, Molecular Mechanisms of Pharmacological Action, Cholinergic Agents, Neurotransmitter Agents, Physiological Effects of Drugs, Nootropic Agents, Phosphodiesterase 5 Inhibitors, Phosphodiesterase Inhibitors
|
| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: Zydena 50mg<br>Zydena (Udenafil) 50mg + Donepezil 5mg or 10mg | Drug: Zydena (Udenafil) 50mg + Donepezil 5mg or 10mg<br> <br> * Other names: Zydena 50mg;|
| Placebo Comparator: Placebo<br>Placebo + Donepezil 5mg or 10mg | Drug: Placebo + Donepezil 5mg or 10mg<br> <br> * Other names: Placebo;|
| Active Comparator: Zydena 100mg<br>Zydena (Udenafil) 100mg + Donepezil 5mg or 10mg | Drug: Zydena (Udenafil) 100mg + Donepezil 5mg or 10mg<br> <br> * Other names: Zydena 100mg;|
|
Zydena on Cognitive Function of Alzheimer's Disease Patients
Study Overview
=================
Brief Summary
-----------------
The purpose of this study is to determine whether Zydena (Udenafil) has positive effect on cognitive function in patients with Alzheimer's disease. This study is a randomized, double blind, placebo-controlled multicenter study.
Official Title
-----------------
Efficacy of Zydena (Udenafil) on Cognitive Function of Alzheimer's Disease Patients: A Randomized, Double Blind, Placebo-controlled Multicenter Study
Conditions
-----------------
Alzheimer's Disease
Intervention / Treatment
-----------------
* Drug: Zydena (Udenafil) 50mg + Donepezil 5mg or 10mg
* Drug: Placebo + Donepezil 5mg or 10mg
* Drug: Zydena (Udenafil) 100mg + Donepezil 5mg or 10mg
Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Signed written informed consent; Male or female subjects 50 to 90 years of age; Diagnosis of probable Alzheimer's disease according to National Institute of Neurological Disorders and Stroke and the Alzheimer's Disease and Related Disorders Association (NINCDS/ADRDA) criteria; A Mini-Mental State Examination (MMSE) score of ≥10 and ≤26; Global Clinical Dementia Rating ≥ 0.5; Mild to moderate (not severe) white matter hyperintensities on brain MRI performed within three years from screening; Good enough hearing and visual function to complete neuropsychological tests Caregivers living with patients or spending 10 or more hours a week with patients; Stable dose of donepezil (5mg to 10mg) for at least 60 days; If patients have been on memantine, it should be washed out for at least 60 days; Medications including anxiolytics, antipsychotics, and hypnotics may be taken if the dose has been stable for at least two weeks Exclusion Criteria: History of stroke within 6 months; Previous diagnosis of severe (more than 80%) intracranial artery stenosis; History of heart failure, ischemic heart disease (myocardial infarction, unstable angina, and stable angina), hypertrophic cardiomyopathy, and life-threatening arrhythmia; Previous history of coronary artery bypass graft surgery; Severe symptom of orthostatic hypotension (orthostatic syncope or presyncope), especially when patients take alpha-adrenergic blocker (Alfuzosin, Doxazosin, Naftopidil, Tamsulosin, Terazosin, Arotinolol, Carvedilol, Labetalol, Trazodone, typical and atypical antipsychotics); Uncontrolled diabetes mellitus; Proliferative diabetic retinopathy; Severe hypotension (blood pressure less than 90/50mmHg) or severe hypertension (blood pressure more than 170/100mmHg); Hepatic dysfunction (AST or ALT more than three times of upper normal limit) or renal dysfunction (serum creatinine more than 2.5mg/dL); Retinitis pigmentosa; Previous history of active peptic ulceration within one year before screening; Hematodyscrasia susceptible to priapism including sickle cell anemia, multiple myeloma, leukemia, and various bleeding disorders; History of drug abuse; Medication including nitrates/nitric oxide donor (ex: nitroglycerin, isosorbide mononitrate, isosorbide dinitrate, amyl nitrate/nitrite, and Sodium nitroprusside), androgen (ex: testosterone), anti-androgen, and anticoagulants; Current cancer chemotherapy; Usage of PDE5i (Zydena, Viagra®, Levitra®, or Cialis®) within two weeks before study start; History of hypersensitive reaction to PDE5i (Zydena, Viagra®, Levitra®, or Cialis®)
Ages Eligible for Study
-----------------
Minimum Age: 50 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: Quadruple
Arms and Interventions
| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: Zydena 50mg<br>Zydena (Udenafil) 50mg + Donepezil 5mg or 10mg | Drug: Zydena (Udenafil) 50mg + Donepezil 5mg or 10mg<br> <br> * Other names: Zydena 50mg;|
| Placebo Comparator: Placebo<br>Placebo + Donepezil 5mg or 10mg | Drug: Placebo + Donepezil 5mg or 10mg<br> <br> * Other names: Placebo;|
| Active Comparator: Zydena 100mg<br>Zydena (Udenafil) 100mg + Donepezil 5mg or 10mg | Drug: Zydena (Udenafil) 100mg + Donepezil 5mg or 10mg<br> <br> * Other names: Zydena 100mg;|
What is the study measuring?
-----------------
Primary Outcome Measures
| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change in cognitive function | measured by ADAS-cog | from baseline to Week 12 and Week 24 after the administration of the medication |
Secondary Outcome Measures
| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change in cognitive function | Measured by MMSE, Clinical Dementia Rating Sum of Boxes, ADCS-ADL, COWAT, Digit Symbol Coding, Trail Making Test-E | from baseline to Week 12 and Week 24 |
| Change in behavioral symptoms | Measured by Neuropsychiatric Inventory | from baseline to Week 12 and Week 24 |
| Change in brain function | Measured by FDG-PET | from baseline to Week 12 and Week 24 |
|
||
NCT00405457
|
Efficacy and Safety of a New Multi-dose Lubricant Eye Drop Concomitant With Restasis® (Cyclosporine A) for the Treatment of Dry Eye Symptoms
|
To evaluate the efficacy, safety and tolerability of a combination of Optive® Artificial Tears with Restasis®.The primary hypothesis is that the Ocular Surface Disease Index (OSDI) score and symptoms will be the same or lower than baseline after treatment in these patients. The patients will tolerate the combination of Restasis® and Optive® with a low incidence of clinical adverse events.
|
Efficacy and Safety of a New Multi-dose Lubricant Eye Drop Concomitant With Restasis® (Cyclosporine A) for the Treatment of Dry Eye Symptoms
|
Dry Eye
|
* Drug: Restasis, Optive Tears
|
Inclusion Criteria:~· Males or females > 18 years old~Patients currently taking Restasis® for at least 3 months in duration and using artificial tears as needed for dry eye.~Likely to complete all study visits and able to provide informed consent~Exclusion Criteria:~· Patients using Restasis® for less than 3 months.~Known contraindications to any study medication or ingredients~Female of child bearing potential not using reliable methods of birth control, or pregnant or lactating females.~Other active uncontrolled ocular diseases or uncontrolled systemic disease
|
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 |
| --- | --- | --- |
| efficacy | | 1 yr 3 months |
|
| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| dry eye symptoms | | 1 yr 3 months |
|
Cyclosporine, Cyclosporins, Enzyme Inhibitors, Molecular Mechanisms of Pharmacological Action, Immunosuppressive Agents, Immunologic Factors, Physiological Effects of Drugs, Antifungal Agents, Anti-Infective Agents, Dermatologic Agents, Antirheumatic Agents, Calcineurin Inhibitors
|
| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Other: A<br> | Drug: Restasis, Optive Tears<br>* Restasis and Optive Tears use twice daily more frequently if needed<br>|
|
Efficacy and Safety of a New Multi-dose Lubricant Eye Drop Concomitant With Restasis® (Cyclosporine A) for the Treatment of Dry Eye Symptoms
Study Overview
=================
Brief Summary
-----------------
To evaluate the efficacy, safety and tolerability of a combination of Optive® Artificial Tears with Restasis®.The primary hypothesis is that the Ocular Surface Disease Index (OSDI) score and symptoms will be the same or lower than baseline after treatment in these patients. The patients will tolerate the combination of Restasis® and Optive® with a low incidence of clinical adverse events.
Official Title
-----------------
Efficacy and Safety of a New Multi-dose Lubricant Eye Drop Concomitant With Restasis® (Cyclosporine A) for the Treatment of Dry Eye Symptoms
Conditions
-----------------
Dry Eye
Intervention / Treatment
-----------------
* Drug: Restasis, Optive Tears
Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: · Males or females > 18 years old Patients currently taking Restasis® for at least 3 months in duration and using artificial tears as needed for dry eye. Likely to complete all study visits and able to provide informed consent Exclusion Criteria: · Patients using Restasis® for less than 3 months. Known contraindications to any study medication or ingredients Female of child bearing potential not using reliable methods of birth control, or pregnant or lactating females. Other active uncontrolled ocular diseases or uncontrolled systemic disease
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
| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Other: A<br> | Drug: Restasis, Optive Tears<br>* Restasis and Optive Tears use twice daily more frequently if needed<br>|
What is the study measuring?
-----------------
Primary Outcome Measures
| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| efficacy | | 1 yr 3 months |
Secondary Outcome Measures
| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| dry eye symptoms | | 1 yr 3 months |
|
||
NCT04201600
|
Glucose Variability and Cognition in Prediabetes
|
This study examines the association of variability in glucose values over a 10-day period with cognitive function and functional status among individuals with prediabetes, aged 50 or older.
|
Type 2 diabetes (T2DM) is now widely considered a major public health epidemic. T2DM is highly prevalent worldwide, is among the leading causes of death, and is an independent risk factor for dementia and less severe forms of cognitive dysfunction. The investigators are utilizing novel technology to understand the role of variability in glucose on neurocognition and functional status among middle-aged and older adults at risk for diabetes. The central hypothesis is that even before diabetes onset, variability in glucose will be associated with worse cognitive function and lower functional status. Participants will be asked to wear a glucose monitoring device over a 10-day period in their home environment. Assessment of functional status and neurocognitive function, in addition to sociodemographic factors, health habits and mood will also occur over two study visits.
|
Relations of Glucose Variability With Cognitive Function and Functional Status Among Older Adults at Risk for Diabetes
|
Glucose Metabolism Disorders (Including Diabetes Mellitus), Cognitive Decline, Functional Status, PreDiabetes, Aging, Depression
|
* Device: Continuous Glucose Monitoring System (CGMS)
|
Inclusion Criteria:~Aged 50 years and older~At least 8th grade education~Exclusion Criteria:~Diagnosed type 1 or type 2 diabetes~Current use of mediation for diabetes (oral hypoglycemic agents, insulin), or with diabetic properties (e.g., steroids)~Chronic disorders (cardiovascular disease, peripheral vascular disease, stroke, transient ischemic attack, chronic kidney disease, past year cancer)~Neurological disorders (e.g., Parkinson's, epilepsy, multiple sclerosis)~History of dementia or suspected dementia~Known HIV~Serious mental illness, psychosis, or use of psychotropic medication~Heavy alcohol use
|
50 Years
| null |
All
|
Accepts Healthy Volunteers
|
| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Aggregate Executive Functioning Score | Scores on the following standard neurocognitive tests will be z-transformed based on their respective means and standard deviations and combined into one aggregate total score such that higher values mean better executive functioning:~Trails Making A and B, The Stroop-Color Word Test, Digit Span subscale of the Wechsler Adult Intelligence Scale - Revised (WAIS-IV), Digit Symbol Substitution Test (DSST) | Day 10 |
| Aggregate Memory Score | Scores on the following standard neurocognitive tests will be z-transformed based on their respective means and standard deviations and combined into one aggregate total score such that higher values mean better memory ability:~California Verbal Learning Test, Benton Visual Retention Test | Day 10 |
| Aggregate Language Score | Scores on the following standard neurocognitive tests will be z-transformed based on their respective means and standard deviations and combined into one aggregate total score such that higher values mean better language abilities:~Boston Naming Test, Controlled Oral Word Association Test (COWA) | Day 10 |
|
| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Aggregate Physical Functioning Score | Scores on the following standard neurocognitive tests will be summed into one aggregate total score such that higher values mean better physical functioning:~gait speed, short physical performance battery (SPPB), handgrip strength, and four-square step test | Day 10 |
| Activities of Daily Living (ADL) total score | Responses on this standard measure will be scored according to guidelines to create a total score for functional status | Day 10 |
| Instrumental Activities of Daily Living (IADL) total score | Responses on this standard measure will be scored according to guidelines to create a total score for functional status | Day 10 |
|
Glucose Variability, Continuous Glucose Monitoring System (CGMS), Prediabetes, Aging, Physical Functioning, Neurocognition, Cognitive Decline
|
Prediabetic State, Glucose Intolerance, Metabolic Diseases, Glucose Metabolism Disorders, Cognitive Dysfunction, Diabetes Mellitus, Endocrine System Diseases, Hyperglycemia, Cognition Disorders, Neurocognitive Disorders, Mental Disorders
|
| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Middle-aged and Older adults with Prediabetes<br>Middle-aged and Older adults with Prediabetes | Device: Continuous Glucose Monitoring System (CGMS)<br>* Continuous Glucose Monitoring System (CGMS)- minimally invasive sensors that measure glucose concentrations at 5-min intervals over several days.<br>|
|
Glucose Variability and Cognition in Prediabetes
Study Overview
=================
Brief Summary
-----------------
This study examines the association of variability in glucose values over a 10-day period with cognitive function and functional status among individuals with prediabetes, aged 50 or older.
Detailed Description
-----------------
Type 2 diabetes (T2DM) is now widely considered a major public health epidemic. T2DM is highly prevalent worldwide, is among the leading causes of death, and is an independent risk factor for dementia and less severe forms of cognitive dysfunction. The investigators are utilizing novel technology to understand the role of variability in glucose on neurocognition and functional status among middle-aged and older adults at risk for diabetes. The central hypothesis is that even before diabetes onset, variability in glucose will be associated with worse cognitive function and lower functional status. Participants will be asked to wear a glucose monitoring device over a 10-day period in their home environment. Assessment of functional status and neurocognitive function, in addition to sociodemographic factors, health habits and mood will also occur over two study visits.
Official Title
-----------------
Relations of Glucose Variability With Cognitive Function and Functional Status Among Older Adults at Risk for Diabetes
Conditions
-----------------
Glucose Metabolism Disorders (Including Diabetes Mellitus), Cognitive Decline, Functional Status, PreDiabetes, Aging, Depression
Intervention / Treatment
-----------------
* Device: Continuous Glucose Monitoring System (CGMS)
Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Aged 50 years and older At least 8th grade education Exclusion Criteria: Diagnosed type 1 or type 2 diabetes Current use of mediation for diabetes (oral hypoglycemic agents, insulin), or with diabetic properties (e.g., steroids) Chronic disorders (cardiovascular disease, peripheral vascular disease, stroke, transient ischemic attack, chronic kidney disease, past year cancer) Neurological disorders (e.g., Parkinson's, epilepsy, multiple sclerosis) History of dementia or suspected dementia Known HIV Serious mental illness, psychosis, or use of psychotropic medication Heavy alcohol use
Ages Eligible for Study
-----------------
Minimum Age: 50 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 |
| --- | --- |
| Middle-aged and Older adults with Prediabetes<br>Middle-aged and Older adults with Prediabetes | Device: Continuous Glucose Monitoring System (CGMS)<br>* Continuous Glucose Monitoring System (CGMS)- minimally invasive sensors that measure glucose concentrations at 5-min intervals over several days.<br>|
What is the study measuring?
-----------------
Primary Outcome Measures
| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Aggregate Executive Functioning Score | Scores on the following standard neurocognitive tests will be z-transformed based on their respective means and standard deviations and combined into one aggregate total score such that higher values mean better executive functioning: Trails Making A and B, The Stroop-Color Word Test, Digit Span subscale of the Wechsler Adult Intelligence Scale - Revised (WAIS-IV), Digit Symbol Substitution Test (DSST) | Day 10 |
| Aggregate Memory Score | Scores on the following standard neurocognitive tests will be z-transformed based on their respective means and standard deviations and combined into one aggregate total score such that higher values mean better memory ability: California Verbal Learning Test, Benton Visual Retention Test | Day 10 |
| Aggregate Language Score | Scores on the following standard neurocognitive tests will be z-transformed based on their respective means and standard deviations and combined into one aggregate total score such that higher values mean better language abilities: Boston Naming Test, Controlled Oral Word Association Test (COWA) | Day 10 |
Secondary Outcome Measures
| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Aggregate Physical Functioning Score | Scores on the following standard neurocognitive tests will be summed into one aggregate total score such that higher values mean better physical functioning: gait speed, short physical performance battery (SPPB), handgrip strength, and four-square step test | Day 10 |
| Activities of Daily Living (ADL) total score | Responses on this standard measure will be scored according to guidelines to create a total score for functional status | Day 10 |
| Instrumental Activities of Daily Living (IADL) total score | Responses on this standard measure will be scored according to guidelines to create a total score for functional status | Day 10 |
Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Glucose Variability, Continuous Glucose Monitoring System (CGMS), Prediabetes, Aging, Physical Functioning, Neurocognition, Cognitive Decline
|
|
NCT00354627
|
The TMC125-C214 Study Provides Early Access to TMC125 for HIV-1 Infected Patients Who Have Failed Multiple Antiretroviral Regimens and Will Also Gather Information on the Long-term Safety and Tolerability of TMC125 Combined With Other Antiretroviral Drugs
|
The purpose of this study is to provide early access of TMC125 to HIV-1 infected patients who have failed multiple antiretroviral (ARV) regimens. Information on safety and tolerability aspects of TMC125 in combination with other ARVs in treatment-experienced HIV-1 patients with limited treatment options will be assessed. Available data regarding the effectiveness of the drug will also be collected. To be eligible, patients should be failing their current ARV regimen or be on a treatment interruption, should have previously received 2 different protease inhibitor (PI) containing regimens and be at least 3-class experienced (protease inhibitors [PI], nucleoside/tide reverse transcriptase inhibitors [N[t]RTIs] and non-nucleoside reverse transcriptase inhibitors [NNRTIs]) or at least 2-class experienced (PIs and N[t]RTIs) with primary NNRTI resistance. TMC125 will be administered in combination with an investigator-selected background of additional ARVs from the list of allowed medications.
|
This is an open label trial with primary objective to provide early access to TMC125 for treatment-experienced HIV-1 infected patients who have failed multiple antiretroviral (ARV) regimens and have limited treatment options with currently approved ARVs. The secondary objective of this trial is to gather information on the safety and tolerability aspects of TMC125 in combination with other ARVs. Available efficacy data will also be collected. Patients should be at least 3-class experienced or 2-class experienced with primary non-nucleoside reverse transcriptase inhibitor (NNRTI) resistance. They should also have previously received 2 different protease inhibitor-based regimens (low-dose ritonavir is not counted as a protease inhibitor (PI) regimen), be on a treatment interruption or not be virologically suppressed on their current regimen, and not be able to use currently approved NNRTIs due to resistance (primary or acquired) and/or intolerance. Patients must also meet all in- and exclusion criteria. TMC125 (200mg twice daily) will be provided once the patient has been confirmed eligible for entry. Once treatment with TMC125 in combination with other ARVs has been initiated, patients must be instructed to follow the recommended visit schedule based on routine clinical care. Safety and tolerability of the entire antiretroviral therapy (ART) regimen, including TMC125, should be monitored by the investigator as per standard clinical practice. However, it is recommended that visits be planned 4 and 12 weeks following initiation of TMC125 in combination with other ARVs and every 12 weeks thereafter while on therapy during this trial. Adverse events (AEs) leading to treatment interruption or discontinuation and all serious adverse events (SAEs), with the exception of Acquired Immunodeficiency Syndrome (AIDS) defining illnesses (CDC class C) unless fatal or considered to be related to TMC125, will be collected. Other adverse events will be collected only if required as per local regulations. The background ARVs may be changed at any time during the trial, at the discretion of the investigator due to the development of resistance, intolerance, toxicity, etc. while continuing treatment with TMC125 if in the investigator's assessment the patient still benefits from treatment with TMC125. If changes in the background regimen are made, it is recommended that a follow-up visit be planned 4 weeks after the change in therapy. Treatment with investigational medication will be continued until virologic failure, treatment-limiting toxicity, subject lost to follow-up, patient's withdrawal, pregnancy, discontinuation of TMC125 development or when TMC125 has become commercially available in the patient's country. Patients will be instructed to orally take two 100 mg tablets of TMC125 following a meal every 12 hours. TMC125 (200 mg twice daily) must be used in combination with other antiretroviral drugs. Treatment with investigational medication will continue until virologic failure, treatment-limiting toxicity, patient lost to follow-up, withdrawal, pregnancy, discontinuation of TMC125 development or when TMC125 becomes commercially available in the patient's country.
|
Early Access of TMC125 in Combination With Other Antiretrovirals in Treatment-experienced HIV-1 Infected Subjects With Limited Treatment Options
|
HIV-1
|
* Drug: TMC125
|
Inclusion Criteria:~Patient is at least 3-class experienced (3 classes of licensed oral antiretrovirals: nucleoside/tide reverse transcriptase inhibitors [N[t]RTI], protease inhibitors [PI], non-nucleoside reverse transcriptase inhibitors [NNRTI])~Patients with primary NNRTI resistance can be included if they are experienced with at least 2 classes of ARVs (PIs, N[t]RTIs) and meet all the other inclusion criteria~Patient has previously received 2 different PI-based regimens~Patient is unable to use currently approved NNRTIs due to resistance (primary or acquired) and/or intolerance~Patient, if currently receiving an ARV regimen, is not achieving adequate virologic suppression on his/her current regimen.~Exclusion Criteria:~Prior or current participation in DUET trials (TMC125-C206 or TMC125-C216).~Use of disallowed concomitant therapy, including disallowed antiretrovirals (ARV)~Use of investigational ARVs (with exceptions)~Any active clinically significant disease (e.g., cardiac dysfunction, pancreatitis, acute viral infection) or findings during screening of medical history or physical examination that is not either resolved or stabilized for at least 30 days before the Screening Phase~Pregnant or breast-feeding female~Female patient of childbearing potential not using effective non-hormonal birth control methods~Patients with specific laboratory abnormalities~Patients with clinical or laboratory evidence of significantly decreased hepatic function or decompensation.
|
18 Years
| null |
All
|
No
|
Primary Purpose: Treatment
Intervention Model: Single Group Assignment
Masking: None (Open Label)
|
| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| The primary objective of TMC125-C214 is to provide early access to TMC125 for treatment-experienced HIV-1 infected patients who have failed multiple antiretroviral (ARV) regimens and have limited treatment options with currently approved ARVs. | | pregnancy, discontinuation of TMC125 development or when TMC125 has become commercially available in the patient's country. |
|
| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| The secondary objective of this trial is to gather information on the safety and tolerability aspects of TMC125 in combination with other ARVs. Available efficacy data will also be collected. | | pregnancy, discontinuation of TMC125 development or when TMC125 has become commercially available in the patient's country. |
|
HIV-1, Early Access Program (EAP), TMC125, treatment-experienced, failing multiple antiretroviral (ARV) regimens, limited to no treatment options
|
Etravirine, Reverse Transcriptase Inhibitors, Nucleic Acid Synthesis Inhibitors, Enzyme Inhibitors, Molecular Mechanisms of Pharmacological Action, Antiviral Agents, Anti-Infective Agents
|
| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: TMC125<br>TMC125 200 mg b.i.d. till commercially available. | Drug: TMC125<br>* 200 mg b.i.d. till commercially available.<br>|
|
The TMC125-C214 Study Provides Early Access to TMC125 for HIV-1 Infected Patients Who Have Failed Multiple Antiretroviral Regimens and Will Also Gather Information on the Long-term Safety and Tolerability of TMC125 Combined With Other Antiretroviral Drugs
Study Overview
=================
Brief Summary
-----------------
The purpose of this study is to provide early access of TMC125 to HIV-1 infected patients who have failed multiple antiretroviral (ARV) regimens. Information on safety and tolerability aspects of TMC125 in combination with other ARVs in treatment-experienced HIV-1 patients with limited treatment options will be assessed. Available data regarding the effectiveness of the drug will also be collected. To be eligible, patients should be failing their current ARV regimen or be on a treatment interruption, should have previously received 2 different protease inhibitor (PI) containing regimens and be at least 3-class experienced (protease inhibitors [PI], nucleoside/tide reverse transcriptase inhibitors [N[t]RTIs] and non-nucleoside reverse transcriptase inhibitors [NNRTIs]) or at least 2-class experienced (PIs and N[t]RTIs) with primary NNRTI resistance. TMC125 will be administered in combination with an investigator-selected background of additional ARVs from the list of allowed medications.
Detailed Description
-----------------
This is an open label trial with primary objective to provide early access to TMC125 for treatment-experienced HIV-1 infected patients who have failed multiple antiretroviral (ARV) regimens and have limited treatment options with currently approved ARVs. The secondary objective of this trial is to gather information on the safety and tolerability aspects of TMC125 in combination with other ARVs. Available efficacy data will also be collected. Patients should be at least 3-class experienced or 2-class experienced with primary non-nucleoside reverse transcriptase inhibitor (NNRTI) resistance. They should also have previously received 2 different protease inhibitor-based regimens (low-dose ritonavir is not counted as a protease inhibitor (PI) regimen), be on a treatment interruption or not be virologically suppressed on their current regimen, and not be able to use currently approved NNRTIs due to resistance (primary or acquired) and/or intolerance. Patients must also meet all in- and exclusion criteria. TMC125 (200mg twice daily) will be provided once the patient has been confirmed eligible for entry. Once treatment with TMC125 in combination with other ARVs has been initiated, patients must be instructed to follow the recommended visit schedule based on routine clinical care. Safety and tolerability of the entire antiretroviral therapy (ART) regimen, including TMC125, should be monitored by the investigator as per standard clinical practice. However, it is recommended that visits be planned 4 and 12 weeks following initiation of TMC125 in combination with other ARVs and every 12 weeks thereafter while on therapy during this trial. Adverse events (AEs) leading to treatment interruption or discontinuation and all serious adverse events (SAEs), with the exception of Acquired Immunodeficiency Syndrome (AIDS) defining illnesses (CDC class C) unless fatal or considered to be related to TMC125, will be collected. Other adverse events will be collected only if required as per local regulations. The background ARVs may be changed at any time during the trial, at the discretion of the investigator due to the development of resistance, intolerance, toxicity, etc. while continuing treatment with TMC125 if in the investigator's assessment the patient still benefits from treatment with TMC125. If changes in the background regimen are made, it is recommended that a follow-up visit be planned 4 weeks after the change in therapy. Treatment with investigational medication will be continued until virologic failure, treatment-limiting toxicity, subject lost to follow-up, patient's withdrawal, pregnancy, discontinuation of TMC125 development or when TMC125 has become commercially available in the patient's country. Patients will be instructed to orally take two 100 mg tablets of TMC125 following a meal every 12 hours. TMC125 (200 mg twice daily) must be used in combination with other antiretroviral drugs. Treatment with investigational medication will continue until virologic failure, treatment-limiting toxicity, patient lost to follow-up, withdrawal, pregnancy, discontinuation of TMC125 development or when TMC125 becomes commercially available in the patient's country.
Official Title
-----------------
Early Access of TMC125 in Combination With Other Antiretrovirals in Treatment-experienced HIV-1 Infected Subjects With Limited Treatment Options
Conditions
-----------------
HIV-1
Intervention / Treatment
-----------------
* Drug: TMC125
Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Patient is at least 3-class experienced (3 classes of licensed oral antiretrovirals: nucleoside/tide reverse transcriptase inhibitors [N[t]RTI], protease inhibitors [PI], non-nucleoside reverse transcriptase inhibitors [NNRTI]) Patients with primary NNRTI resistance can be included if they are experienced with at least 2 classes of ARVs (PIs, N[t]RTIs) and meet all the other inclusion criteria Patient has previously received 2 different PI-based regimens Patient is unable to use currently approved NNRTIs due to resistance (primary or acquired) and/or intolerance Patient, if currently receiving an ARV regimen, is not achieving adequate virologic suppression on his/her current regimen. Exclusion Criteria: Prior or current participation in DUET trials (TMC125-C206 or TMC125-C216). Use of disallowed concomitant therapy, including disallowed antiretrovirals (ARV) Use of investigational ARVs (with exceptions) Any active clinically significant disease (e.g., cardiac dysfunction, pancreatitis, acute viral infection) or findings during screening of medical history or physical examination that is not either resolved or stabilized for at least 30 days before the Screening Phase Pregnant or breast-feeding female Female patient of childbearing potential not using effective non-hormonal birth control methods Patients with specific laboratory abnormalities Patients with clinical or laboratory evidence of significantly decreased hepatic function or decompensation.
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: TMC125<br>TMC125 200 mg b.i.d. till commercially available. | Drug: TMC125<br>* 200 mg b.i.d. till commercially available.<br>|
What is the study measuring?
-----------------
Primary Outcome Measures
| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| The primary objective of TMC125-C214 is to provide early access to TMC125 for treatment-experienced HIV-1 infected patients who have failed multiple antiretroviral (ARV) regimens and have limited treatment options with currently approved ARVs. | | pregnancy, discontinuation of TMC125 development or when TMC125 has become commercially available in the patient's country. |
Secondary Outcome Measures
| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| The secondary objective of this trial is to gather information on the safety and tolerability aspects of TMC125 in combination with other ARVs. Available efficacy data will also be collected. | | pregnancy, discontinuation of TMC125 development or when TMC125 has become commercially available in the patient's country. |
Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
HIV-1, Early Access Program (EAP), TMC125, treatment-experienced, failing multiple antiretroviral (ARV) regimens, limited to no treatment options
|
NCT05151809
|
National Database on Primary Biliary Cholangitis
|
Primary biliary cholangitis (PBC) is a rare, autoimmune, cholestatic liver disease. No data about the disease epidemiology exist in Italy. Therefore this study aims to develop a national PBC patient database linked to a biological sample storage.
|
Primary biliary cholangitis (PBC) is an immune-mediated liver disease characterized by chronic inflammation of the intrahepatic bile ducts, causing progressive ductopenia, cholestasis, and if not effectively treated, leading to fibrosis, cirrhosis and liver failure. Nowadays almost all patients with PBC are diagnosed at an early disease stage and receive treatment with ursodeoxycholic acid (UDCA) which is currently the only drug approved for the treatment of patients with PBC. However, approximately 20% to 30% (up to >50% in patients presenting under the age of 40 years) still does not have a benefit from UDCA and has a reduced prognosis as compared to healthy individuals. Major steps forwards in the field of PBC have been done in the last decade, however there are still significant areas of unmet clinical need in PBC: the lack of knowledge on etiopathogenesis; a poor understanding of disease sub-phenotypes; the lack of biomarkers of disease progression that allow risk stratification needed in clinical management and trials design, among the others. In the current evolving research landscape with the availability of the -omics technologies generating libraries of genome-wide data, metabolomics and proteomics data, among the others, the prospects of discovering the gene and molecular underpinnings of PBC are more promising than ever. Scientists envision an era of personalized medicine when more and more people will obtain their own genetic and metabolic maps, enabling them to identify their status as carriers of specific risk profiles.~Based on these premises, the current project aims to build up a research, nation-wide infrastructure (around 60 Italian participating centres will be involved) to study the biology of PBC and, in particular, to explore why a significant group of, typically young patients fail primary therapy with UDCA, placing them at risk of developing progressive disease and needing liver transplantation (LT). The investigators will recruit patients and organise the collection of important clinical information and laboratory investigation, together with biological samples. Data will be collected in the form of electronic Case Report Forms (REDCap cloud) that will be completed by clinicians at baseline and thereafter on an annual basis. The clinical information will allow us to identify patients' clinical profiles. The biological samples will allow to understand key aspects of people's make up, including patient genes and the way their immune system works, and the differences in make up between people with different clinical phenotypes.~This research infrastructure would represent an invaluable resource for successful translational research in this field. Specifically, it would serve investigators conducting research; clinicians treating patients; epidemiologists gathering demographic data; and the drug and device industry seeking new markets. It also can represent a necessary infrastructure for the implementation of the European Reference Networks (ERN) for rare diseases, main pillars of the current EU policy framework on National Plans for research and development. The Italian PBC database would also be crucial for drug development, specifically to assess the feasibility of clinical trials, to facilitate the planning of appropriate clinical trials, to support the enrolment of patients and to assess the impact of new interventions.
|
Multicenter, Nationwide, Observational, Retrospective and Prospective Study Based on the Development of a Patients Database Linked to a Biological Sample Storage
|
Primary Biliary Cholangitis
|
* Other: Clinical information
|
Inclusion Criteria:~All PBC patients living in Italy and aged at least 18 years can be included in the database. According to well-established criteria, PBC is diagnosed in subjects who fulfill two of the three of following criteria:~elevated alkaline phosphatase and /or GGT;~positive anti-mitochondrial autoantibodies (titer ≥ 1:40) or PBC-specific antinuclear antibodies (gp-210 and sp100);~characteristic histological features of florid bile ducts lesions and granulomatous lesion.~Exclusion Criteria:~The patient has explicitly declared his/her unwillingness to participate to the study
|
18 Years
| null |
All
|
No
|
| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Phenotypes and sub-phenotypes of PBC Italian patients | Identify and define distinct phenotypes and sub-phenotypes of PBC patients at higher risk of disease progression. | Overall duration of the study (10 years) |
|
| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Response to UDCA therapy | Defined as Alkaline Phosphatase Level<1 x upper limit of normal. The investigators will fit a multivariate analysis using logistic regression using baseline variables. | Overall duration of the study (10 years) |
| Identification of factors influencing the progression of PBC | The investigators will calculate the time from the diagnosis of PBC to an event (liver decompensation, liver transplantation or death). They will then fit a multivariate analysis using Cox's proportional hazards regression model of diverse explanatory variables available at baseline. | Overall duration of the study (10 years) |
| Safety and long-term efficacy of novel therapies | The investigators will evaluate prospectively laboratory investigation and the treatment response to novel therapies that are entering the clinical practice, e.g. obeticholic acid, fibrates. | Overall duration of the study (10 years) |
|
Primary Biliary Cholangitis, Disease phenotypes, National Database
|
Cholangitis, Liver Cirrhosis, Biliary, Bile Duct Diseases, Biliary Tract Diseases, Digestive System Diseases, Cholestasis, Intrahepatic, Cholestasis, Liver Diseases, Liver Cirrhosis, Fibrosis, Pathologic Processes
|
| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| PBC population residing in Italy<br>All PBC patients living in Italy and aged at least 18 years can be included in the database. According to well-established criteria, PBC is diagnosed in subjects who fulfill two of the three of following criteria:~elevated alkaline phosphatase and /or GGT;~positive anti-mitochondrial autoantibodies (titer ≥ 1:40) or PBC-specific antinuclear antibodies (gp-210 and sp100);~characteristic histological features of florid bile ducts lesions and granulomatous lesion. | Other: Clinical information<br>* The investigators will recruit PBC patients and collect important clinical information and laboratory investigation, together with biological samples.<br>* Other names: Biological samples;|
|
National Database on Primary Biliary Cholangitis
Study Overview
=================
Brief Summary
-----------------
Primary biliary cholangitis (PBC) is a rare, autoimmune, cholestatic liver disease. No data about the disease epidemiology exist in Italy. Therefore this study aims to develop a national PBC patient database linked to a biological sample storage.
Detailed Description
-----------------
Primary biliary cholangitis (PBC) is an immune-mediated liver disease characterized by chronic inflammation of the intrahepatic bile ducts, causing progressive ductopenia, cholestasis, and if not effectively treated, leading to fibrosis, cirrhosis and liver failure. Nowadays almost all patients with PBC are diagnosed at an early disease stage and receive treatment with ursodeoxycholic acid (UDCA) which is currently the only drug approved for the treatment of patients with PBC. However, approximately 20% to 30% (up to >50% in patients presenting under the age of 40 years) still does not have a benefit from UDCA and has a reduced prognosis as compared to healthy individuals. Major steps forwards in the field of PBC have been done in the last decade, however there are still significant areas of unmet clinical need in PBC: the lack of knowledge on etiopathogenesis; a poor understanding of disease sub-phenotypes; the lack of biomarkers of disease progression that allow risk stratification needed in clinical management and trials design, among the others. In the current evolving research landscape with the availability of the -omics technologies generating libraries of genome-wide data, metabolomics and proteomics data, among the others, the prospects of discovering the gene and molecular underpinnings of PBC are more promising than ever. Scientists envision an era of personalized medicine when more and more people will obtain their own genetic and metabolic maps, enabling them to identify their status as carriers of specific risk profiles. Based on these premises, the current project aims to build up a research, nation-wide infrastructure (around 60 Italian participating centres will be involved) to study the biology of PBC and, in particular, to explore why a significant group of, typically young patients fail primary therapy with UDCA, placing them at risk of developing progressive disease and needing liver transplantation (LT). The investigators will recruit patients and organise the collection of important clinical information and laboratory investigation, together with biological samples. Data will be collected in the form of electronic Case Report Forms (REDCap cloud) that will be completed by clinicians at baseline and thereafter on an annual basis. The clinical information will allow us to identify patients' clinical profiles. The biological samples will allow to understand key aspects of people's make up, including patient genes and the way their immune system works, and the differences in make up between people with different clinical phenotypes. This research infrastructure would represent an invaluable resource for successful translational research in this field. Specifically, it would serve investigators conducting research; clinicians treating patients; epidemiologists gathering demographic data; and the drug and device industry seeking new markets. It also can represent a necessary infrastructure for the implementation of the European Reference Networks (ERN) for rare diseases, main pillars of the current EU policy framework on National Plans for research and development. The Italian PBC database would also be crucial for drug development, specifically to assess the feasibility of clinical trials, to facilitate the planning of appropriate clinical trials, to support the enrolment of patients and to assess the impact of new interventions.
Official Title
-----------------
Multicenter, Nationwide, Observational, Retrospective and Prospective Study Based on the Development of a Patients Database Linked to a Biological Sample Storage
Conditions
-----------------
Primary Biliary Cholangitis
Intervention / Treatment
-----------------
* Other: Clinical information
Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: All PBC patients living in Italy and aged at least 18 years can be included in the database. According to well-established criteria, PBC is diagnosed in subjects who fulfill two of the three of following criteria: elevated alkaline phosphatase and /or GGT; positive anti-mitochondrial autoantibodies (titer ≥ 1:40) or PBC-specific antinuclear antibodies (gp-210 and sp100); characteristic histological features of florid bile ducts lesions and granulomatous lesion. Exclusion Criteria: The patient has explicitly declared his/her unwillingness to participate to 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?
-----------------
Arms and Interventions
| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| PBC population residing in Italy<br>All PBC patients living in Italy and aged at least 18 years can be included in the database. According to well-established criteria, PBC is diagnosed in subjects who fulfill two of the three of following criteria: elevated alkaline phosphatase and /or GGT; positive anti-mitochondrial autoantibodies (titer ≥ 1:40) or PBC-specific antinuclear antibodies (gp-210 and sp100); characteristic histological features of florid bile ducts lesions and granulomatous lesion. | Other: Clinical information<br>* The investigators will recruit PBC patients and collect important clinical information and laboratory investigation, together with biological samples.<br>* Other names: Biological samples;|
What is the study measuring?
-----------------
Primary Outcome Measures
| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Phenotypes and sub-phenotypes of PBC Italian patients | Identify and define distinct phenotypes and sub-phenotypes of PBC patients at higher risk of disease progression. | Overall duration of the study (10 years) |
Secondary Outcome Measures
| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Response to UDCA therapy | Defined as Alkaline Phosphatase Level<1 x upper limit of normal. The investigators will fit a multivariate analysis using logistic regression using baseline variables. | Overall duration of the study (10 years) |
| Identification of factors influencing the progression of PBC | The investigators will calculate the time from the diagnosis of PBC to an event (liver decompensation, liver transplantation or death). They will then fit a multivariate analysis using Cox's proportional hazards regression model of diverse explanatory variables available at baseline. | Overall duration of the study (10 years) |
| Safety and long-term efficacy of novel therapies | The investigators will evaluate prospectively laboratory investigation and the treatment response to novel therapies that are entering the clinical practice, e.g. obeticholic acid, fibrates. | Overall duration of the study (10 years) |
Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Primary Biliary Cholangitis, Disease phenotypes, National Database
|
|
NCT01413048
|
Clinical Trial to Evaluate the Antihypertensive Effect of AGSCT101 in Patient With Hypertension
|
The purpose of this study is to evaluate the antihypertensive effect of AGSCT101 tablet in patient with stage 1 to 2 essential hypertension.
|
This study is 2,8 weeks, multi-center, randomized, double-blind, active clinical trial to evaluate the efficacy and safety of AGSCT101 versus Carvedilol in patient with stage 1 to 2 essential hypertension.
|
Phase III Clinical Trial to Evaluate the Antihypertensive Effect of AGSCT101 Versus Carvedilol in Patient With Stage 1 to 2 Essential Hypertension
|
Essential Hypertension
|
* Drug: Carvedilol 25mg
* Drug: AGSCT101 12.5mg
|
Inclusion Criteria:~Male or female outpatients ≥ 19 years of age~Mild to moderate essential hypertension: sDBP 90 ~ 109, sSBP 140 ~ 179~Subjects who agree to participate in this sudy and give written informed consent~Subjects considered to understand the study, be cooperative, and able to be followed-up until the end of the study~Exclusion Criteria:~The sitting DBP is more than 110mmHg or the sitting SBP over 180mmHg~Patients with postural hypotension~Patients with severe renal(Creatinine more 1.5mg/dl), gastrointestinal, hematological or hepatic(AST, ALT more 3 times more than upper limit of normal)disease~Female of childbearing potential who does not undergo hysterectomy or is not post-menopausal~Patients judged to have a history of alcohol or drug abuse by the investigator~Patients with a history of myocardial infarction, severe coronary artery disease or clinically significant heart failure or valvular defect in last 6 months~Patients with uncontrolled diabetes mellitus~Patients participated other clinical trial 12 weeks before Screening Patients judged to be inappropriate for this study by the investigator with other reasons
|
19 Years
| null |
All
|
No
|
Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double
|
| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change from baseline in diastolic blood pressure (DBP) | | 8 weeks |
|
| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change from baseline in diastolic blood pressure (DBP) | | 2 weeks |
| Change from baseline in systolic blood pressure (SBP) | | 2, 8 weeks |
| Proportion of patients who reach overall blood pressure control (defined as BP <140/90) | | 8 weeks |
| Incidence of adverse effects | | 8 weeks |
|
Essential Hypertension, Hypertension
|
Carvedilol, Adrenergic beta-Antagonists, Adrenergic Antagonists, Adrenergic Agents, Neurotransmitter Agents, Molecular Mechanisms of Pharmacological Action, Physiological Effects of Drugs, Antihypertensive Agents, Antioxidants, Protective Agents, Calcium Channel Blockers, Membrane Transport Modulators, Calcium-Regulating Hormones and Agents, Vasodilator Agents, Adrenergic alpha-1 Receptor Antagonists, Adrenergic alpha-Antagonists
|
| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: AGSCT101<br> | Drug: AGSCT101 12.5mg<br>* Tablet, q.d.<br>|
| Active Comparator: Carvedilol<br> | Drug: Carvedilol 25mg<br>* Tablet, q.d.<br>|
|
Clinical Trial to Evaluate the Antihypertensive Effect of AGSCT101 in Patient With Hypertension
Study Overview
=================
Brief Summary
-----------------
The purpose of this study is to evaluate the antihypertensive effect of AGSCT101 tablet in patient with stage 1 to 2 essential hypertension.
Detailed Description
-----------------
This study is 2,8 weeks, multi-center, randomized, double-blind, active clinical trial to evaluate the efficacy and safety of AGSCT101 versus Carvedilol in patient with stage 1 to 2 essential hypertension.
Official Title
-----------------
Phase III Clinical Trial to Evaluate the Antihypertensive Effect of AGSCT101 Versus Carvedilol in Patient With Stage 1 to 2 Essential Hypertension
Conditions
-----------------
Essential Hypertension
Intervention / Treatment
-----------------
* Drug: Carvedilol 25mg
* Drug: AGSCT101 12.5mg
Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Male or female outpatients ≥ 19 years of age Mild to moderate essential hypertension: sDBP 90 109, sSBP 140 179 Subjects who agree to participate in this sudy and give written informed consent Subjects considered to understand the study, be cooperative, and able to be followed-up until the end of the study Exclusion Criteria: The sitting DBP is more than 110mmHg or the sitting SBP over 180mmHg Patients with postural hypotension Patients with severe renal(Creatinine more 1.5mg/dl), gastrointestinal, hematological or hepatic(AST, ALT more 3 times more than upper limit of normal)disease Female of childbearing potential who does not undergo hysterectomy or is not post-menopausal Patients judged to have a history of alcohol or drug abuse by the investigator Patients with a history of myocardial infarction, severe coronary artery disease or clinically significant heart failure or valvular defect in last 6 months Patients with uncontrolled diabetes mellitus Patients participated other clinical trial 12 weeks before Screening Patients judged to be inappropriate for this study by the investigator with other reasons
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
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double
Arms and Interventions
| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: AGSCT101<br> | Drug: AGSCT101 12.5mg<br>* Tablet, q.d.<br>|
| Active Comparator: Carvedilol<br> | Drug: Carvedilol 25mg<br>* Tablet, q.d.<br>|
What is the study measuring?
-----------------
Primary Outcome Measures
| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change from baseline in diastolic blood pressure (DBP) | | 8 weeks |
Secondary Outcome Measures
| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change from baseline in diastolic blood pressure (DBP) | | 2 weeks |
| Change from baseline in systolic blood pressure (SBP) | | 2, 8 weeks |
| Proportion of patients who reach overall blood pressure control (defined as BP <140/90) | | 8 weeks |
| Incidence of adverse effects | | 8 weeks |
Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Essential Hypertension, Hypertension
|
NCT04786184
|
Capnography-Assisted Learned Monitored (CALM) Breathing Therapy for COPD
|
This pilot study is part of a phased approach to refine, optimize, and test the feasibility of CALM Breathing. Preliminary participant feedback from the Capnography-Assisted Respiratory Therapy (CART) study was applied to adapt and design CALM Breathing (including its dose, schedule, delivery, and home program). This pilot builds on initial lessons learned and identifies intervention areas still needing greater development to assure the success of a future large trial, targeting a subpopulation at risk, that is, those with COPD and anxiety sensitivity.
|
The purpose of this study is to evaluate an experimental breathing therapy for adults with chronic obstructive pulmonary disease (COPD) called Capnography-Assisted Learned, Monitored (CALM) Breathing. CALM Breathing is an experimental therapy that uses exercises combined with breathing feedback. CALM Breathing promotes self-regulated breathing to relieve symptoms. In sessions, biofeedback of breathing is predominately provided by two devices that are cleared by the Food and Drug Administration (FDA) to measure carbon dioxide at the end of a breath and breathing rate. A capnograph uses tubing at the nose to evaluate levels of carbon dioxide and breathing rate from exhaled air and to display breathing patterns. A pulse oximeter for home use also evaluates breathing rate at the fingertip with a sensor that detects blood flow changes. The investigators are studying CALM Breathing to see if it can relieve shortness of breath and other symptoms; reduce stress; and improve quality of life and exercise tolerance in adults with COPD. The investigators are planning to recruit up to approximately 65 subjects with COPD at Columbia University Irving Medical Center. Participants will be assigned by chance into one of two treatment groups: 1) CALM Breathing or Usual Care (Waitlist). Participants will have an equal chance of being assigned to either group. CALM Breathing is a 4-week therapy program that uses breathing exercises with biofeedback to reduce shortness of breath and other symptoms related to COPD. Biofeedback uses sensors to give information about breathing pattern and airflow to help participants better self-regulate their breathing. Participants assigned by chance to CALM Breathing, will participate in eight breathing therapy sessions, provided twice per week; each session will each take approximately 1-hour. All participants will receive 16-20 standard care pulmonary rehabilitation sessions beginning at approximately week 6-10. Participants will complete three study evaluation visits (at baseline, ~6 weeks, and at a 3-month follow-up).
|
Capnography-Assisted Learned Monitored (CALM) Breathing Therapy for COPD
|
COPD
|
* Behavioral: CALM Breathing
* Behavioral: Traditional outpatient PR
|
Inclusion Criteria:~be adult males or females~have a diagnosis of COPD as defined by FEV1/FVC of < 0.70 on spirometry testing or as shown on a chest computed tomography (CT)~receive standard care of pharmacotherapy with bronchodilators (e.g. long-acting beta-agonists, LABAs, or long-acting muscarinic antagonists, or LAMAs) as prescribed by their physician~are in stable medical condition as determined by pulmonary rehabilitation physician (i.e., not in need of acute higher level of care such as hospitalization)~have dyspnea [as documented in their medical record or based on self-report; e.g., ≥1 on modified Medical Research Council questionnaire (mMRC) dyspnea; or ≥2 dyspnea score on item: Over the last 4 weeks, I have had shortness of breath: almost every day = 4, several days a week = 3, a few days a month = 2, only with lung/respiratory infections = 1, not at all = 0; or yes response of binary presence of dyspnea-related avoidance of activities: Have you avoided any activities due to shortness of breath?)]~have elevated dyspnea-related anxiety symptoms:~DMQ-CAT dyspnea anxiety score ≤50; or~DMQ-CAT activity avoidance ≤50;~VAS dyspnea anxiety scale score of ≥20, administered with 6-minute walk test;~ASI-16: item #10, It scares me when I become short of breath (at least some);~require ≤ 24 hours per day of supplemental oxygen~Mini-Mental State Examination score ≥24~speak, read, and write English~are stably medicated for at least 4 weeks prior to study entry with long-acting anti-anxiety medication (e.g., selective serotonin reuptake inhibitors, SSRIs, and serotonin norepinephrine reuptake inhibitors, SNRIs), benzodiazepines, or cannabis if prescribed, with no plans to change psychotropic medication dose~have not received any pulmonary rehabilitation training in the past 12 months.~Exclusion Criteria:~are not eligible for pulmonary rehabilitation~are actively being treated for cancer~have morbid obesity (Body Mass Index (BMI) > 40)~have hypercapnia of ETCO2 > 50 mmHg at rest~have a musculoskeletal disorder severe enough to interfere with walking or ability to exercise or have neuromuscular disease~have had a seizure in the past 3 months~reside in an acute hospital, sub-acute care, assisted living, or nursing home~are active smokers~are pregnant~have any clinically significant cardiac disease or any electrocardiogram (ECG) abnormality obtained during the screening, which in the opinion of the investigator may put the patient at risk or interfere with study assessments~have low literacy as indicated by scores of 4 or 5 (often and always) on the Single Item Literacy Screener (SILS) that asks, How often do you need to have someone help you when you read instructions, pamphlets, or other written material from your doctor or pharmacy?~have a diagnosis or medical history of schizophrenia, psychotic disorders, or bipolar disorder as diagnosed by study psychologist~have alcohol or substance abuse or dependence within the past 6 months as evaluated by study psychologist~have serious suicidal risk (suicidal ideation or suicidal behaviors within the past year) as defined by a score of >1 on psychologist interview-administered Clinician Suicide Assessment Checklist, which is a Modified Columbia-Suicide Severity Rating Scale-CSSRS~Take prescribed opioids ≥50 MME (morphine mg equivalents) per day. A dosage threshold of ≥50 MME significantly increases the risk of fatal respiratory depression and necessitates additional precautions. Participants' opioid medication dose will be confirmed by their prescribing physician (e.g., their primary care or pain management doctor).~Actively take both prescribed opioids and benzodiazepines. Combining benzodiazepines and opioids significantly increases the risk of respiratory failure in patients with chronic obstructive pulmonary disease.
|
18 Years
| null |
All
|
No
|
Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Interventional Model Description: A prospective RCT: In Phase I, participants will be randomized 1:1 to one of two groups: CALM Breathing (N = 25) and Wait-List control (N = 25). In Phase II, both groups will be offered Columbia University's 10-week PR program (care as usual). Access to timely initiation of PR will be facilitated. We will use a hybrid design to evaluate feasibility and acceptability.
Masking: Single
|
| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Total Number of Participants with High Attendance Rate of CALM Breathing Treatment Sessions | High attendance rate is defined as greater than or equal to 70% (where 100% = all 8 sessions attended). | 3 months |
| Acceptability Aim #2 CALM Breathing Attendance | The acceptability of the CALM Breathing therapy will be evaluated based on mixed methods data collected from CALM Breathing attendance, drop-out, and satisfaction ratings, and from semi-structured interviews.~Acceptability will be determined in part by whether or not we achieve a ≥70% CALM Breathing attendance. | 3 months |
| Acceptability Aim #2 Drop-Out Rate | The acceptability of the CALM Breathing therapy will be evaluated based on mixed methods data collected from CALM Breathing attendance, drop-out, and satisfaction ratings, and from semi-structured interviews.~Acceptability will be determined in part by whether or not we achieve a CALM Breathing drop-out rate of ≤10-15%. | 3 months |
| Acceptability Aim #2 CALM Breathing Satisfaction | The acceptability of the CALM Breathing therapy will be evaluated based on mixed methods data collected from CALM Breathing attendance, drop-out, and satisfaction ratings, and semi-structured interviews.~Acceptability will be determined in part by whether or not we achieve a mean of ≥2 good satisfaction rating for CALM Breathing treatment overall (item 8 of FACIT; (0-4 scale). Higher scores indicate more satisfaction. Single FACIT Treatment Satisfaction items (6 and 8) ask: (1) Would you recommend this treatment to others with your illness? (with 0-2 rating scale, 0 = No, 1 = Maybe, 2 = Yes); and (2) How do you rate this treatment [CALM Breathing] overall? (with 0-4 rating scale, 0 = poor and 4 = excellent). The investigators will also ask, How do you rate the CALM Breathing home exercises overall? (and use the same FACIT 0-4 rating scale). | 3 months |
|
| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Chronic Respiratory Disease Questionnaire (CRQ) Score | This questionnaire measures the impact of chronic obstructive pulmonary disease (COPD) on a person's life. It consists of 20 items across 4 domains (dyspnea, fatigue, emotional function, and master). Items are on a 7-point Likert scale (1 - 7) and are scored from 1 (most severe) to 7 (no impairment) (better outcome). For this trial, questions 4a- 4e are included which is the dyspnea domain. The 5 scores are summated and divided by the number of items. The range is 1-7. Higher scores indicate better outcomes. | 3 months |
| Dyspnea management Questionnaire Computer Adaptive test (DMQ-CAT) Score | The DMQ-CAT is a 71-item questionnaire that measures dyspnea anxiety. Raw scores range from 0 (low) to 6 (high). These raw scores are transformed into item response theory (IRT) calibrations with a mean score of 50 and a standard deviation of ±10. The full range is 0 to 100. The DQM-CAT software automatically scores these scales. Higher scores indicate better outcomes. | 3 months |
| Modified Borg Scale Score | The Modified Borg Scale is most commonly used to assess symptoms of breathlessness. On the 11-item scale, a score of 0 indicates No Exertion and a score of 10 indicates Maximal exertion (10-point scale). The full range is 0-10. Higher scores indicate worse outcomes (i.e. more exertion). An average of the pre-Tx, post-Tx, and 3-month 6-Minute Walk Test Modified Borg Scale Scores could be reported (taken from all participants). | 3 months |
| Generalized Anxiety Disorder-7 (GAD-7) Score | The General Anxiety Disorder-7 is a 7-item screening tool and symptom severity measure for the four most common anxiety disorders. This is calculated by assigning scores of 0 (not at all), 1 (several days'), 2 (more than half the days), or 3 (nearly every day). GAD-7 total score for the seven items ranges from 0 to 21. Higher scores indicate worse outcomes (i.e. greater anxiety). | 3 months |
| Perceived Stress Scale Score (PSS) | The PSS is a 10-item classic stress assessment instrument. Individual scores on the PSS can range from 0 to 40 with higher scores indicating higher perceived stress. | 3 months |
| 6 mile Walking Distance Score (6MinWT) | This is a sub-maximal exercise test used to assess aerobic capacity and endurance. The distance covered over a time of 6 minutes is used as the outcome by which to compare changes in performance capacity. | 3 months |
| Physical Activity Scale for the Elderly (PASE) | This 12-item questionnaire uses frequency, duration, and intensity level of activity over the previous week to assign a score, ranging from 0 to 793, with higher scores indicating greater physical activity. | 3 months |
| COPD Assessment Test (CAT) | The CAT quantifies the impact of COPD symptoms on patients' overall health. Participants assign a score ranging from 0 to 5 for each of the 8 areas. A score of 0 means there is no impairment in that area. A score of 5 means severe impairment. Your overall score will range from 0 to 40. The score is a composite score. | 3 months |
| Patient-Reported Outcomes Measurement Information System (PROMIS-24). | This is a 10-item tool used to measure patient-reported outcomes (PROs) relevant across common medical conditions. The response options are presented as a 5-point rating scale, with higher scores indicating a healthier patient (better outcome). Scores are standardized to the general population using the T-Score, with the average T-score for the US population is 50 points, with a SD of 10 points. | 3 months |
| End-tidal CO2 | This measures the partial pressure of CO2 at the end of an exhaled breath. | 3 months |
| Respiratory Rate (RR) | The RR will be measured as total number of breaths per minute. | 3 months |
| Predicted Forced Expiratory Volume (FEV1) Percentage | Percent of predicted forced expiratory volume (FEV) in 1 second. | 3 months |
| Forced vital capacity (FVC) | FVC measures the total amount of air exhaled during the FEV test. | 3 months |
| Ratio of FEV1/FVC | Ratio of FEV1/FVC based on American Thoracic Society (ATS) guidelines and will be calculated from the FEV1 and FVC values. This is used to confirm diagnosis of COPD. | 3 months |
| Pulmonary Rehabilitation Engagement | Uptake; treatment initiation; attrition; and patient activation using the Patient Activation Measure. | 3 months |
|
Breathing, Anxiety
|
Respiratory Aspiration, Respiration Disorders, Respiratory Tract Diseases, Pathologic Processes
|
| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: CALM Breathing<br> | Behavioral: CALM Breathing<br>* CALM Breathing is a mind-body breathing therapy that links CO2 changes to dyspnea and anxiety symptoms and targets breathing efficiency and self-efficacy in COPD. CALM Breathing: Individual interoception- based breathing therapy with capnography (non- exercise training) Home Program: Monitored home- based breathing exercises; RR biofeedback; goal setting; exercise logging. Coaching: Motivational interviewing. Personnel: PT, EP, occupational therapist, or nurse. Frequency: 1-hour sessions, twice per week for 4 weeks. Exercises: • 10 core breathing exercises with ETCO2 biofeedback in recovery postures at rest and with body movement (gentle stretches and brief low-moderate intensity physical activity). • Breathing biofeedback (ETCO2, RR, airflow pattern). Education: Education on anxiety; COPD Patient Guide.<br>|
| Active Comparator: Wait-List Control<br> | Behavioral: Traditional outpatient PR<br>* After referral to Columbia's outpatient pulmonary rehabilitation (PR) program, participants randomized to the Wait-List control group will be put on a PR wait list (usual care). In Phase II, all participants will receive PR of 1-hour sessions, twice per week for 10 weeks. Traditional outpatient PR: Group exercise training (ET) combined with pursed lips breathing (PLB) training; 1:2 therapist to patient ratio. Home Program: Unmonitored walking exercise 1-2 days/week; no biofeedback monitoring. Coaching: Traditional monitoring and verbal cueing. Personnel: PT or EP. Frequency:~1-hour sessions, twice per week for 10 weeks. Exercises: • ET of muscles of ambulation with exercise equipment, such as on a treadmill or cycle ergometer (30-min), plus 15-min strengthening and posture exercises; O2 supplementation as needed. No breathing biofeedback. • PLB instruction only during exercise training. Education: Verbal and written information.<br>|
|
Capnography-Assisted Learned Monitored (CALM) Breathing Therapy for COPD
Study Overview
=================
Brief Summary
-----------------
This pilot study is part of a phased approach to refine, optimize, and test the feasibility of CALM Breathing. Preliminary participant feedback from the Capnography-Assisted Respiratory Therapy (CART) study was applied to adapt and design CALM Breathing (including its dose, schedule, delivery, and home program). This pilot builds on initial lessons learned and identifies intervention areas still needing greater development to assure the success of a future large trial, targeting a subpopulation at risk, that is, those with COPD and anxiety sensitivity.
Detailed Description
-----------------
The purpose of this study is to evaluate an experimental breathing therapy for adults with chronic obstructive pulmonary disease (COPD) called Capnography-Assisted Learned, Monitored (CALM) Breathing. CALM Breathing is an experimental therapy that uses exercises combined with breathing feedback. CALM Breathing promotes self-regulated breathing to relieve symptoms. In sessions, biofeedback of breathing is predominately provided by two devices that are cleared by the Food and Drug Administration (FDA) to measure carbon dioxide at the end of a breath and breathing rate. A capnograph uses tubing at the nose to evaluate levels of carbon dioxide and breathing rate from exhaled air and to display breathing patterns. A pulse oximeter for home use also evaluates breathing rate at the fingertip with a sensor that detects blood flow changes. The investigators are studying CALM Breathing to see if it can relieve shortness of breath and other symptoms; reduce stress; and improve quality of life and exercise tolerance in adults with COPD. The investigators are planning to recruit up to approximately 65 subjects with COPD at Columbia University Irving Medical Center. Participants will be assigned by chance into one of two treatment groups: 1) CALM Breathing or Usual Care (Waitlist). Participants will have an equal chance of being assigned to either group. CALM Breathing is a 4-week therapy program that uses breathing exercises with biofeedback to reduce shortness of breath and other symptoms related to COPD. Biofeedback uses sensors to give information about breathing pattern and airflow to help participants better self-regulate their breathing. Participants assigned by chance to CALM Breathing, will participate in eight breathing therapy sessions, provided twice per week; each session will each take approximately 1-hour. All participants will receive 16-20 standard care pulmonary rehabilitation sessions beginning at approximately week 6-10. Participants will complete three study evaluation visits (at baseline, 6 weeks, and at a 3-month follow-up).
Official Title
-----------------
Capnography-Assisted Learned Monitored (CALM) Breathing Therapy for COPD
Conditions
-----------------
COPD
Intervention / Treatment
-----------------
* Behavioral: CALM Breathing
* Behavioral: Traditional outpatient PR
Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: be adult males or females have a diagnosis of COPD as defined by FEV1/FVC of < 0.70 on spirometry testing or as shown on a chest computed tomography (CT) receive standard care of pharmacotherapy with bronchodilators (e.g. long-acting beta-agonists, LABAs, or long-acting muscarinic antagonists, or LAMAs) as prescribed by their physician are in stable medical condition as determined by pulmonary rehabilitation physician (i.e., not in need of acute higher level of care such as hospitalization) have dyspnea [as documented in their medical record or based on self-report; e.g., ≥1 on modified Medical Research Council questionnaire (mMRC) dyspnea; or ≥2 dyspnea score on item: Over the last 4 weeks, I have had shortness of breath: almost every day = 4, several days a week = 3, a few days a month = 2, only with lung/respiratory infections = 1, not at all = 0; or yes response of binary presence of dyspnea-related avoidance of activities: Have you avoided any activities due to shortness of breath?)] have elevated dyspnea-related anxiety symptoms: DMQ-CAT dyspnea anxiety score ≤50; or DMQ-CAT activity avoidance ≤50; VAS dyspnea anxiety scale score of ≥20, administered with 6-minute walk test; ASI-16: item #10, It scares me when I become short of breath (at least some); require ≤ 24 hours per day of supplemental oxygen Mini-Mental State Examination score ≥24 speak, read, and write English are stably medicated for at least 4 weeks prior to study entry with long-acting anti-anxiety medication (e.g., selective serotonin reuptake inhibitors, SSRIs, and serotonin norepinephrine reuptake inhibitors, SNRIs), benzodiazepines, or cannabis if prescribed, with no plans to change psychotropic medication dose have not received any pulmonary rehabilitation training in the past 12 months. Exclusion Criteria: are not eligible for pulmonary rehabilitation are actively being treated for cancer have morbid obesity (Body Mass Index (BMI) > 40) have hypercapnia of ETCO2 > 50 mmHg at rest have a musculoskeletal disorder severe enough to interfere with walking or ability to exercise or have neuromuscular disease have had a seizure in the past 3 months reside in an acute hospital, sub-acute care, assisted living, or nursing home are active smokers are pregnant have any clinically significant cardiac disease or any electrocardiogram (ECG) abnormality obtained during the screening, which in the opinion of the investigator may put the patient at risk or interfere with study assessments have low literacy as indicated by scores of 4 or 5 (often and always) on the Single Item Literacy Screener (SILS) that asks, How often do you need to have someone help you when you read instructions, pamphlets, or other written material from your doctor or pharmacy? have a diagnosis or medical history of schizophrenia, psychotic disorders, or bipolar disorder as diagnosed by study psychologist have alcohol or substance abuse or dependence within the past 6 months as evaluated by study psychologist have serious suicidal risk (suicidal ideation or suicidal behaviors within the past year) as defined by a score of >1 on psychologist interview-administered Clinician Suicide Assessment Checklist, which is a Modified Columbia-Suicide Severity Rating Scale-CSSRS Take prescribed opioids ≥50 MME (morphine mg equivalents) per day. A dosage threshold of ≥50 MME significantly increases the risk of fatal respiratory depression and necessitates additional precautions. Participants' opioid medication dose will be confirmed by their prescribing physician (e.g., their primary care or pain management doctor). Actively take both prescribed opioids and benzodiazepines. Combining benzodiazepines and opioids significantly increases the risk of respiratory failure in patients with chronic obstructive pulmonary disease.
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: A prospective RCT: In Phase I, participants will be randomized 1:1 to one of two groups: CALM Breathing (N = 25) and Wait-List control (N = 25). In Phase II, both groups will be offered Columbia University's 10-week PR program (care as usual). Access to timely initiation of PR will be facilitated. We will use a hybrid design to evaluate feasibility and acceptability.
Masking: Single
Arms and Interventions
| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: CALM Breathing<br> | Behavioral: CALM Breathing<br>* CALM Breathing is a mind-body breathing therapy that links CO2 changes to dyspnea and anxiety symptoms and targets breathing efficiency and self-efficacy in COPD. CALM Breathing: Individual interoception- based breathing therapy with capnography (non- exercise training) Home Program: Monitored home- based breathing exercises; RR biofeedback; goal setting; exercise logging. Coaching: Motivational interviewing. Personnel: PT, EP, occupational therapist, or nurse. Frequency: 1-hour sessions, twice per week for 4 weeks. Exercises: • 10 core breathing exercises with ETCO2 biofeedback in recovery postures at rest and with body movement (gentle stretches and brief low-moderate intensity physical activity). • Breathing biofeedback (ETCO2, RR, airflow pattern). Education: Education on anxiety; COPD Patient Guide.<br>|
| Active Comparator: Wait-List Control<br> | Behavioral: Traditional outpatient PR<br>* After referral to Columbia's outpatient pulmonary rehabilitation (PR) program, participants randomized to the Wait-List control group will be put on a PR wait list (usual care). In Phase II, all participants will receive PR of 1-hour sessions, twice per week for 10 weeks. Traditional outpatient PR: Group exercise training (ET) combined with pursed lips breathing (PLB) training; 1:2 therapist to patient ratio. Home Program: Unmonitored walking exercise 1-2 days/week; no biofeedback monitoring. Coaching: Traditional monitoring and verbal cueing. Personnel: PT or EP. Frequency: 1-hour sessions, twice per week for 10 weeks. Exercises: • ET of muscles of ambulation with exercise equipment, such as on a treadmill or cycle ergometer (30-min), plus 15-min strengthening and posture exercises; O2 supplementation as needed. No breathing biofeedback. • PLB instruction only during exercise training. Education: Verbal and written information.<br>|
What is the study measuring?
-----------------
Primary Outcome Measures
| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Total Number of Participants with High Attendance Rate of CALM Breathing Treatment Sessions | High attendance rate is defined as greater than or equal to 70% (where 100% = all 8 sessions attended). | 3 months |
| Acceptability Aim #2 CALM Breathing Attendance | The acceptability of the CALM Breathing therapy will be evaluated based on mixed methods data collected from CALM Breathing attendance, drop-out, and satisfaction ratings, and from semi-structured interviews. Acceptability will be determined in part by whether or not we achieve a ≥70% CALM Breathing attendance. | 3 months |
| Acceptability Aim #2 Drop-Out Rate | The acceptability of the CALM Breathing therapy will be evaluated based on mixed methods data collected from CALM Breathing attendance, drop-out, and satisfaction ratings, and from semi-structured interviews. Acceptability will be determined in part by whether or not we achieve a CALM Breathing drop-out rate of ≤10-15%. | 3 months |
| Acceptability Aim #2 CALM Breathing Satisfaction | The acceptability of the CALM Breathing therapy will be evaluated based on mixed methods data collected from CALM Breathing attendance, drop-out, and satisfaction ratings, and semi-structured interviews. Acceptability will be determined in part by whether or not we achieve a mean of ≥2 good satisfaction rating for CALM Breathing treatment overall (item 8 of FACIT; (0-4 scale). Higher scores indicate more satisfaction. Single FACIT Treatment Satisfaction items (6 and 8) ask: (1) Would you recommend this treatment to others with your illness? (with 0-2 rating scale, 0 = No, 1 = Maybe, 2 = Yes); and (2) How do you rate this treatment [CALM Breathing] overall? (with 0-4 rating scale, 0 = poor and 4 = excellent). The investigators will also ask, How do you rate the CALM Breathing home exercises overall? (and use the same FACIT 0-4 rating scale). | 3 months |
Secondary Outcome Measures
| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Chronic Respiratory Disease Questionnaire (CRQ) Score | This questionnaire measures the impact of chronic obstructive pulmonary disease (COPD) on a person's life. It consists of 20 items across 4 domains (dyspnea, fatigue, emotional function, and master). Items are on a 7-point Likert scale (1 - 7) and are scored from 1 (most severe) to 7 (no impairment) (better outcome). For this trial, questions 4a- 4e are included which is the dyspnea domain. The 5 scores are summated and divided by the number of items. The range is 1-7. Higher scores indicate better outcomes. | 3 months |
| Dyspnea management Questionnaire Computer Adaptive test (DMQ-CAT) Score | The DMQ-CAT is a 71-item questionnaire that measures dyspnea anxiety. Raw scores range from 0 (low) to 6 (high). These raw scores are transformed into item response theory (IRT) calibrations with a mean score of 50 and a standard deviation of ±10. The full range is 0 to 100. The DQM-CAT software automatically scores these scales. Higher scores indicate better outcomes. | 3 months |
| Modified Borg Scale Score | The Modified Borg Scale is most commonly used to assess symptoms of breathlessness. On the 11-item scale, a score of 0 indicates No Exertion and a score of 10 indicates Maximal exertion (10-point scale). The full range is 0-10. Higher scores indicate worse outcomes (i.e. more exertion). An average of the pre-Tx, post-Tx, and 3-month 6-Minute Walk Test Modified Borg Scale Scores could be reported (taken from all participants). | 3 months |
| Generalized Anxiety Disorder-7 (GAD-7) Score | The General Anxiety Disorder-7 is a 7-item screening tool and symptom severity measure for the four most common anxiety disorders. This is calculated by assigning scores of 0 (not at all), 1 (several days'), 2 (more than half the days), or 3 (nearly every day). GAD-7 total score for the seven items ranges from 0 to 21. Higher scores indicate worse outcomes (i.e. greater anxiety). | 3 months |
| Perceived Stress Scale Score (PSS) | The PSS is a 10-item classic stress assessment instrument. Individual scores on the PSS can range from 0 to 40 with higher scores indicating higher perceived stress. | 3 months |
| 6 mile Walking Distance Score (6MinWT) | This is a sub-maximal exercise test used to assess aerobic capacity and endurance. The distance covered over a time of 6 minutes is used as the outcome by which to compare changes in performance capacity. | 3 months |
| Physical Activity Scale for the Elderly (PASE) | This 12-item questionnaire uses frequency, duration, and intensity level of activity over the previous week to assign a score, ranging from 0 to 793, with higher scores indicating greater physical activity. | 3 months |
| COPD Assessment Test (CAT) | The CAT quantifies the impact of COPD symptoms on patients' overall health. Participants assign a score ranging from 0 to 5 for each of the 8 areas. A score of 0 means there is no impairment in that area. A score of 5 means severe impairment. Your overall score will range from 0 to 40. The score is a composite score. | 3 months |
| Patient-Reported Outcomes Measurement Information System (PROMIS-24). | This is a 10-item tool used to measure patient-reported outcomes (PROs) relevant across common medical conditions. The response options are presented as a 5-point rating scale, with higher scores indicating a healthier patient (better outcome). Scores are standardized to the general population using the T-Score, with the average T-score for the US population is 50 points, with a SD of 10 points. | 3 months |
| End-tidal CO2 | This measures the partial pressure of CO2 at the end of an exhaled breath. | 3 months |
| Respiratory Rate (RR) | The RR will be measured as total number of breaths per minute. | 3 months |
| Predicted Forced Expiratory Volume (FEV1) Percentage | Percent of predicted forced expiratory volume (FEV) in 1 second. | 3 months |
| Forced vital capacity (FVC) | FVC measures the total amount of air exhaled during the FEV test. | 3 months |
| Ratio of FEV1/FVC | Ratio of FEV1/FVC based on American Thoracic Society (ATS) guidelines and will be calculated from the FEV1 and FVC values. This is used to confirm diagnosis of COPD. | 3 months |
| Pulmonary Rehabilitation Engagement | Uptake; treatment initiation; attrition; and patient activation using the Patient Activation Measure. | 3 months |
Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Breathing, Anxiety
|
NCT01976468
|
Metastases of Cutaneous Squamous Cell Carcinoma in Organ Transplant Recipients. The SCOPE-ITSCC Metastases Study
|
The investigators hypothesize that a low number of SCC in OTR will metastasize.
|
In a large international multicenter prospective observational study a total number of 1000 OTR (organ transplant recipients) with a histologically proven cutaneous SCC (squamous cell carcinoma) will be included in 10 centers and followed during 2 years to establish the cumulative incidence of metastases in OTR with cutaneous SCC.
|
Metastases of Cutaneous Squamous Cell Carcinoma in Organ Transplant Recipients. The SCOPE-ITSCC Metastases Study
|
Squamous Cell Carcinoma
|
* Other: SCC metastasis
|
Inclusion criteria:~Organ-transplant recipients (OTR).~Histologically proven cutaneous invasive SCC at time of inclusion~Exclusion criteria:~Lack of consent.~History of metastases of cutaneous SCC
|
18 Years
| null |
All
|
No
|
| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| SCC metastasis detection | | two years |
|
Carcinoma, Carcinoma, Squamous Cell, Neoplasm Metastasis, Neoplasms, Glandular and Epithelial, Neoplasms by Histologic Type, Neoplasms, Neoplasms, Squamous Cell, Neoplastic Processes, Pathologic Processes
|
| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| SCC metastasis<br>organ transplant recipients | Other: SCC metastasis<br>* occurrence of SCC metastasis<br>|
|
Metastases of Cutaneous Squamous Cell Carcinoma in Organ Transplant Recipients. The SCOPE-ITSCC Metastases Study
Study Overview
=================
Brief Summary
-----------------
The investigators hypothesize that a low number of SCC in OTR will metastasize.
Detailed Description
-----------------
In a large international multicenter prospective observational study a total number of 1000 OTR (organ transplant recipients) with a histologically proven cutaneous SCC (squamous cell carcinoma) will be included in 10 centers and followed during 2 years to establish the cumulative incidence of metastases in OTR with cutaneous SCC.
Official Title
-----------------
Metastases of Cutaneous Squamous Cell Carcinoma in Organ Transplant Recipients. The SCOPE-ITSCC Metastases Study
Conditions
-----------------
Squamous Cell Carcinoma
Intervention / Treatment
-----------------
* Other: SCC metastasis
Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion criteria: Organ-transplant recipients (OTR). Histologically proven cutaneous invasive SCC at time of inclusion Exclusion criteria: Lack of consent. History of metastases of cutaneous SCC
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 |
| --- | --- |
| SCC metastasis<br>organ transplant recipients | Other: SCC metastasis<br>* occurrence of SCC metastasis<br>|
What is the study measuring?
-----------------
Primary Outcome Measures
| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| SCC metastasis detection | | two years |
|
|||
NCT01058304
|
Group Physical Therapy for Knee Osteoarthritis
|
Pain management is a priority for the Department of Veterans Affairs (VA) health care system, and knee osteoarthritis (OA) is a main cause of chronic pain. Veterans who receive care within the VA health care system have higher rates and more severe OA than both the general population of adults and veterans who receive health care elsewhere. Physical therapy (PT) is a primary part of treatment for knee OA, but in the VA health care system PT appointments are a limited resource, and veterans often do not receive enough visits to promote long-term improvements in pain and physical function. New models of delivery, such as the group-based approach examined in this study, are needed to expand PT services in a cost-effective manner.
|
Knee osteoarthritis (OA) is one of the most common health problems and a leading cause of disability among veterans. Physical therapy (PT) and ongoing exercise are associated with reduced pain and improved physical function among patients with knee OA, yet the majority of veterans with OA are physically inactive. Furthermore, PT services are a limited resource in the VA health care system, with demand exceeding supply. VA patients with knee OA generally receive only one or two PT visits. Prior research indicates this amount of clinical contact time is not sufficient to provide patients with the assessment, instruction, and support needed to adopt and maintain an exercise program, particularly in the context of a chronic pain condition. Therefore development, testing, and implementation of mechanisms to cost-effectively expand PT services for knee OA may play a key role in improving pain and other outcomes in this large group of veterans. This research examines a group-based approach to delivering PT for knee OA, which can extend services to more veterans, for a greater number of sessions per veteran, at lower staffing costs. The objective of this study is to compare the effectiveness of a group-based PT program for knee OA with usual individual PT care for knee OA.~This study will be a randomized controlled trial of a 12-week, group-based PT program among N=320 veterans with symptomatic knee OA at the Durham VA Medical Center (VAMC). Participants will be randomly assigned to the group-based PT program or individual PT (usual care). The group PT arm will include 6 1-hour visits (every other week) led by a physical therapist and exercise physiologist or physical therapy assistant, with 8 participants per group. The individual PT arm, modeled after typical PT care for knee OA at the Durham VAMC and other health care settings, will include 2 1-hour visits with a physical therapist, 2-3 weeks apart. The group PT sessions will include group instruction in joint care (activity pacing and joint projection), group discussion of exercise successes and barriers, group exercise, and scheduled individual consultations with the physical therapist (2 per participant, 15-20 minutes each) to address specific functional and therapeutic needs. While the individual PT sessions will differ in structure, they will include the same informational, assessment, and therapeutic content as the group sessions. Both groups will be given instructions for the same home exercise program. The primary outcome for this study will be the Western Ontario and McMasters Universities Osteoarthritis Index (WOMAC). The secondary outcome will be objectively assessed physical function (Short Physical Performance Test Protocol). These outcomes will be assessed at baseline and 12-week follow-up. The WOMAC will also be assessed via telephone at 24-week follow-up to examine whether any observed intervention effects are maintained. Mixed linear models will be used to compare outcomes for the two study arms. We will also conduct an economic analysis of the group-based PT program.
|
Group Physical Therapy for Veterans With Knee Osteoarthritis
|
Osteoarthritis
|
* Other: Group Physical Therapy for Knee OA
* Other: Individual Physical Therapy for Knee OA
|
Inclusion Criteria:~Physician diagnosis of knee osteoarthritis in VA medical records~Current knee symptoms~No PT care for knee osteoarthritis in past 6 months~Exclusion Criteria:~Diagnosis of systemic rheumatic disease~Hospitalized for a stroke, transient ischemic attack, aneurysm, myocardial infarction, coronary artery revascularization, or mental health condition in the past 3 months~Diagnosis of psychosis~Diagnosis of dementia~Current chest pain~On waiting list for / planning arthroplasty within study period (i.e., next 6 months)~Resident in nursing home~Currently participating in another OA-related or lifestyle interventional study~Knee ligament/meniscus injury (past 1 year)~Cancer that has spread~Gout in knees~Multiple Sclerosis
| null | null |
All
|
No
|
Primary Purpose: Health Services Research
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
|
| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Western Ontario and McMasters Universities Osteoarthritis Index (WOMAC) | WOMAC is a measure of lower extremity pain (5 items), stiffness (2 items), and function (17 items). All items are rated on a Likert scale of 0 (no symptoms) to 4 (extreme symptoms). The total score ranges from 0-96, with higher scores indicating worse symptoms.~Note that the baseline mean is a common baseline mean generated from the mixed model used for the primary study analysis. The raw mean for this outcome, overall and by study group, is presented in the table of baseline participant characteristics. | 12-weeks, 24-weeks |
|
| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Short Performance Physical Battery (SPPB) | This battery of objective physical function tests examines participants' balance (3 tests), gait speed (8-foot walk), and time to rise from a chair and return to the seated position five times. For each test, the possible range if scores is 0-4, for a total range of 0-20 for all five tests, with higher scores indicating better function.~Note that the baseline mean is a common baseline mean generated from the mixed model used for the primary study analysis. The raw mean for this outcome, overall and by study group, is presented in the table of baseline participant characteristics. | 12 weeks |
|
osteoarthritis, knee, physical therapy (specialty), veterans
|
Osteoarthritis, Osteoarthritis, Knee, Arthritis, Joint Diseases, Musculoskeletal Diseases, Rheumatic Diseases
|
| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Group Physical Therapy for Knee OA<br>Group Physical Therapy for Knee OA | Other: Group Physical Therapy for Knee OA<br>* The group PT arm will include 6 1 to 1 hour visits (every other week) led by a physical therapist and exercise physiologist or PT Assistant, with 8 participants per group. The group PT sessions will include group instruction in joint care (activity pacing and joint projection), group discussion of exercise successes and barriers, group exercise, and scheduled individual consultations with the physical therapist (2 per participant, 15-20 minutes each) to address specific functional and therapeutic needs. Participants will also be given instructions for a home exercise program.<br>|
| Active Comparator: Individual Physical Therapy for Knee OA<br>Individual Physical Therapy for Knee OA | Other: Individual Physical Therapy for Knee OA<br>* The individual PT arm, modeled after typical PT care for knee OA at the Durham VAMC and other health care settings, will include 2 1-hour visits with a physical therapist, 2-3 weeks apart. While the individual PT sessions will differ in structure from the group PT sessions they will include the same informational, assessment, and therapeutic content as the group sessions. Participants in this group will also be given instructions for the same home exercise program.<br>|
|
Group Physical Therapy for Knee Osteoarthritis
Study Overview
=================
Brief Summary
-----------------
Pain management is a priority for the Department of Veterans Affairs (VA) health care system, and knee osteoarthritis (OA) is a main cause of chronic pain. Veterans who receive care within the VA health care system have higher rates and more severe OA than both the general population of adults and veterans who receive health care elsewhere. Physical therapy (PT) is a primary part of treatment for knee OA, but in the VA health care system PT appointments are a limited resource, and veterans often do not receive enough visits to promote long-term improvements in pain and physical function. New models of delivery, such as the group-based approach examined in this study, are needed to expand PT services in a cost-effective manner.
Detailed Description
-----------------
Knee osteoarthritis (OA) is one of the most common health problems and a leading cause of disability among veterans. Physical therapy (PT) and ongoing exercise are associated with reduced pain and improved physical function among patients with knee OA, yet the majority of veterans with OA are physically inactive. Furthermore, PT services are a limited resource in the VA health care system, with demand exceeding supply. VA patients with knee OA generally receive only one or two PT visits. Prior research indicates this amount of clinical contact time is not sufficient to provide patients with the assessment, instruction, and support needed to adopt and maintain an exercise program, particularly in the context of a chronic pain condition. Therefore development, testing, and implementation of mechanisms to cost-effectively expand PT services for knee OA may play a key role in improving pain and other outcomes in this large group of veterans. This research examines a group-based approach to delivering PT for knee OA, which can extend services to more veterans, for a greater number of sessions per veteran, at lower staffing costs. The objective of this study is to compare the effectiveness of a group-based PT program for knee OA with usual individual PT care for knee OA. This study will be a randomized controlled trial of a 12-week, group-based PT program among N=320 veterans with symptomatic knee OA at the Durham VA Medical Center (VAMC). Participants will be randomly assigned to the group-based PT program or individual PT (usual care). The group PT arm will include 6 1-hour visits (every other week) led by a physical therapist and exercise physiologist or physical therapy assistant, with 8 participants per group. The individual PT arm, modeled after typical PT care for knee OA at the Durham VAMC and other health care settings, will include 2 1-hour visits with a physical therapist, 2-3 weeks apart. The group PT sessions will include group instruction in joint care (activity pacing and joint projection), group discussion of exercise successes and barriers, group exercise, and scheduled individual consultations with the physical therapist (2 per participant, 15-20 minutes each) to address specific functional and therapeutic needs. While the individual PT sessions will differ in structure, they will include the same informational, assessment, and therapeutic content as the group sessions. Both groups will be given instructions for the same home exercise program. The primary outcome for this study will be the Western Ontario and McMasters Universities Osteoarthritis Index (WOMAC). The secondary outcome will be objectively assessed physical function (Short Physical Performance Test Protocol). These outcomes will be assessed at baseline and 12-week follow-up. The WOMAC will also be assessed via telephone at 24-week follow-up to examine whether any observed intervention effects are maintained. Mixed linear models will be used to compare outcomes for the two study arms. We will also conduct an economic analysis of the group-based PT program.
Official Title
-----------------
Group Physical Therapy for Veterans With Knee Osteoarthritis
Conditions
-----------------
Osteoarthritis
Intervention / Treatment
-----------------
* Other: Group Physical Therapy for Knee OA
* Other: Individual Physical Therapy for Knee OA
Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Physician diagnosis of knee osteoarthritis in VA medical records Current knee symptoms No PT care for knee osteoarthritis in past 6 months Exclusion Criteria: Diagnosis of systemic rheumatic disease Hospitalized for a stroke, transient ischemic attack, aneurysm, myocardial infarction, coronary artery revascularization, or mental health condition in the past 3 months Diagnosis of psychosis Diagnosis of dementia Current chest pain On waiting list for / planning arthroplasty within study period (i.e., next 6 months) Resident in nursing home Currently participating in another OA-related or lifestyle interventional study Knee ligament/meniscus injury (past 1 year) Cancer that has spread Gout in knees Multiple Sclerosis
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: Group Physical Therapy for Knee OA<br>Group Physical Therapy for Knee OA | Other: Group Physical Therapy for Knee OA<br>* The group PT arm will include 6 1 to 1 hour visits (every other week) led by a physical therapist and exercise physiologist or PT Assistant, with 8 participants per group. The group PT sessions will include group instruction in joint care (activity pacing and joint projection), group discussion of exercise successes and barriers, group exercise, and scheduled individual consultations with the physical therapist (2 per participant, 15-20 minutes each) to address specific functional and therapeutic needs. Participants will also be given instructions for a home exercise program.<br>|
| Active Comparator: Individual Physical Therapy for Knee OA<br>Individual Physical Therapy for Knee OA | Other: Individual Physical Therapy for Knee OA<br>* The individual PT arm, modeled after typical PT care for knee OA at the Durham VAMC and other health care settings, will include 2 1-hour visits with a physical therapist, 2-3 weeks apart. While the individual PT sessions will differ in structure from the group PT sessions they will include the same informational, assessment, and therapeutic content as the group sessions. Participants in this group will also be given instructions for the same home exercise program.<br>|
What is the study measuring?
-----------------
Primary Outcome Measures
| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Western Ontario and McMasters Universities Osteoarthritis Index (WOMAC) | WOMAC is a measure of lower extremity pain (5 items), stiffness (2 items), and function (17 items). All items are rated on a Likert scale of 0 (no symptoms) to 4 (extreme symptoms). The total score ranges from 0-96, with higher scores indicating worse symptoms. Note that the baseline mean is a common baseline mean generated from the mixed model used for the primary study analysis. The raw mean for this outcome, overall and by study group, is presented in the table of baseline participant characteristics. | 12-weeks, 24-weeks |
Secondary Outcome Measures
| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Short Performance Physical Battery (SPPB) | This battery of objective physical function tests examines participants' balance (3 tests), gait speed (8-foot walk), and time to rise from a chair and return to the seated position five times. For each test, the possible range if scores is 0-4, for a total range of 0-20 for all five tests, with higher scores indicating better function. Note that the baseline mean is a common baseline mean generated from the mixed model used for the primary study analysis. The raw mean for this outcome, overall and by study group, is presented in the table of baseline participant characteristics. | 12 weeks |
Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
osteoarthritis, knee, physical therapy (specialty), veterans
|
NCT00938496
|
Non-Interventional Study of Zoladex in Endometriosis
|
This is a prospective, open label NIS, which is to assess the efficacy of Zoladex in adjuvant setting after operation in moderate to severe endometriosis patients.
|
A Non-interventional Study of Postoperative Treatment With Goserelin Acetate (Zoladex) in Moderate to Severe Endometriosis Patient
|
Endometriosis
|
Inclusion Criteria:~Advanced endometriosis confirmed histologically (r-AFS score III-IV) with conservative laparoscopy or laparotomy.~Patient who has the indication of Zoladex and has been prescribed Zoladex according to physician's judgement, irrespective of the inclusion in the study.~Patient has been already prescribed Zoladex within 1 month after operation.~Exclusion Criteria:~Have used hormone treatment prior to 3 months of recruitment.~Involvement in the planning and conduct of the study (applies to both AstraZeneca staff or staff at the study site).~Previous enrolment in the present study.
|
18 Years
| null |
Female
|
No
|
| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Symptom recurrence rate and total recurrence rate | | 18 months |
|
| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Pregnancy rate | | 18 months |
| Zoladex administration time | | 6 months |
| Add-back therapy information | | 18 months |
|
Endometriosis, Genital Diseases, Female, Female Urogenital Diseases, Female Urogenital Diseases and Pregnancy Complications, Urogenital Diseases, Genital Diseases
|
Non-Interventional Study of Zoladex in Endometriosis
Study Overview
=================
Brief Summary
-----------------
This is a prospective, open label NIS, which is to assess the efficacy of Zoladex in adjuvant setting after operation in moderate to severe endometriosis patients.
Official Title
-----------------
A Non-interventional Study of Postoperative Treatment With Goserelin Acetate (Zoladex) in Moderate to Severe Endometriosis Patient
Conditions
-----------------
Endometriosis
Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Advanced endometriosis confirmed histologically (r-AFS score III-IV) with conservative laparoscopy or laparotomy. Patient who has the indication of Zoladex and has been prescribed Zoladex according to physician's judgement, irrespective of the inclusion in the study. Patient has been already prescribed Zoladex within 1 month after operation. Exclusion Criteria: Have used hormone treatment prior to 3 months of recruitment. Involvement in the planning and conduct of the study (applies to both AstraZeneca staff or staff at the study site). Previous enrolment in the present study.
Ages Eligible for Study
-----------------
Minimum Age: 18 Years
Sexes Eligible for Study
-----------------
Female
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 |
| --- | --- | --- |
| Symptom recurrence rate and total recurrence rate | | 18 months |
Secondary Outcome Measures
| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Pregnancy rate | | 18 months |
| Zoladex administration time | | 6 months |
| Add-back therapy information | | 18 months |
|
|||||
NCT04581161
|
Proportional Open Ventilation (POV) Device and Its Efficacy in Managing Acute Respiratory Failure in COVID-19 Patients
|
To evaluate the use of Life2000® Ventilator, a novel proportional open ventilation system in critical care use of acute onset of respiratory failure (ARF) and mild to moderate forms of acute respiratory distress syndrome (ARDS) in COVID-19 patients and its ability to provide effective ventilatory benefits and or delay patients from progressing to more aggressive forms of invasive mechanical ventilation (IMV).
|
A Novel Proportional Open Ventilation (POV) Device and Its Efficacy in Managing Acute Respiratory Failure in COVID-19 Patients
|
Acute Respiratory Failure, Covid19
|
* Device: Life2000® Ventilator
|
Inclusion Criteria:~Patients who meet all of the following inclusion criteria and no exclusion criteria will be included in the study:~A diagnosed or suspected COVID-19 patient requiring non-invasive ventilatory support and admitted to hospital~PaO2/FiO2 ≤ 300 (corrected for altitude)~RR ≤ 30/min during early use of oxygen~Adults of 18 years and older~Provision of written informed consent to participate in study by subject or legal representative.~Exclusion Criteria:~Patients who meet one or more of the following exclusion criteria will not be eligible for the study:~Patients under the age of 18~Patients who are not diagnosed or suspected of having an acute COVID-19 illness~Patients who do not require non-invasive ventilatory interventions, PaO2/FiO2 > 300 (corrected for altitude) and tolerating supplemental oxygen with SpO2 saturations ≥ 92%.~Patients who require immediate IMV upon admission or have a RR > 30/min on early oxygen intervention.~Thoracoabdominal desynchrony and paradoxical breathing at admission~Patients in immediate need of or on vasopressors upon ICU admission~Patients or legal representatives who are unwilling or unable to provide written consent.
|
18 Years
| null |
All
|
No
|
Primary Purpose: Treatment
Allocation: Non-Randomized
Intervention Model: Single Group Assignment
Interventional Model Description: Subjects in the active treatment group will receive ventilatory support with Life2000® Ventilator following the labeled instructions for the device.~POV support (Life2000) will be administered in six (6) to ten (ten) enrolled subjects based on clinical protocol flowchart (Appendix C). Specifically, if it is determined that a COVID-19 subject who would currently be considered for HFNC under current standard of treatment, will be eligible for POV treatment.~The prescribed therapy regimen, including duration of therapy will be documented and COVID-19 patients who fail therapy and require IMV will be recorded.
Masking: None (Open Label)
|
| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Life2000® Compared to HFNC (AIRVO) | Compared to HFNC (AIRVO), does the Life2000® Ventilator provide clinically relevant ventilatory support to COVID-19 patients with mild to moderate ARF or ARDS to prevent IMV. | Time frame measured will include date that patient is admitted to hospital until date patient is discharged from hospital or death occurs with an anticipated 30 day time period, but shall not exceed 90 day time period. |
|
| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| PEEP level | What level of PEEP is required to ensure adequate ventilation in COVID-19 patients with mild to moderate ARF/ARDS. | Time frame measured will include date that patient is admitted to hospital until date patient is discharged from hospital or death occurs with an anticipated 30 day time period, but shall not exceed 90 day time period. |
|
ARDS, PEEP, Respiratory Rate
|
COVID-19, Respiratory Insufficiency, Respiratory Distress Syndrome, Pneumonia, Viral, Pneumonia, Respiratory Tract Infections, Infections, Virus Diseases, Coronavirus Infections, Coronaviridae Infections, Nidovirales Infections, RNA Virus Infections, Lung Diseases, Respiratory Tract Diseases, Respiration Disorders
|
| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Life2000® Ventilator<br>Subjects in the active treatment group will receive ventilatory support with Life2000® Ventilator following the labeled instructions for the device. | Device: Life2000® Ventilator<br>* POV support (Life2000) will be administered in six (6) to ten (ten) enrolled subjects based on clinical protocol flowchart (Appendix C). Specifically, if it is determined that a COVID-19 subject who would currently be considered for HFNC under current standard of treatment, will be eligible for POV treatment.~The prescribed therapy regimen, including duration of therapy will be documented and COVID-19 patients who fail therapy and require IMV will be recorded.<br>|
| No Intervention: Control Group<br>Subjects in the control group will be identified from the population of patients previously admitted to the study site with COVID-19 infection who required non-invasive oxygen therapy with HFNC but were not treated with NIV therapy. Subject data will be collected retrospectively from the medical record. | |
|
Proportional Open Ventilation (POV) Device and Its Efficacy in Managing Acute Respiratory Failure in COVID-19 Patients
Study Overview
=================
Brief Summary
-----------------
To evaluate the use of Life2000® Ventilator, a novel proportional open ventilation system in critical care use of acute onset of respiratory failure (ARF) and mild to moderate forms of acute respiratory distress syndrome (ARDS) in COVID-19 patients and its ability to provide effective ventilatory benefits and or delay patients from progressing to more aggressive forms of invasive mechanical ventilation (IMV).
Official Title
-----------------
A Novel Proportional Open Ventilation (POV) Device and Its Efficacy in Managing Acute Respiratory Failure in COVID-19 Patients
Conditions
-----------------
Acute Respiratory Failure, Covid19
Intervention / Treatment
-----------------
* Device: Life2000® Ventilator
Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Patients who meet all of the following inclusion criteria and no exclusion criteria will be included in the study: A diagnosed or suspected COVID-19 patient requiring non-invasive ventilatory support and admitted to hospital PaO2/FiO2 ≤ 300 (corrected for altitude) RR ≤ 30/min during early use of oxygen Adults of 18 years and older Provision of written informed consent to participate in study by subject or legal representative. Exclusion Criteria: Patients who meet one or more of the following exclusion criteria will not be eligible for the study: Patients under the age of 18 Patients who are not diagnosed or suspected of having an acute COVID-19 illness Patients who do not require non-invasive ventilatory interventions, PaO2/FiO2 > 300 (corrected for altitude) and tolerating supplemental oxygen with SpO2 saturations ≥ 92%. Patients who require immediate IMV upon admission or have a RR > 30/min on early oxygen intervention. Thoracoabdominal desynchrony and paradoxical breathing at admission Patients in immediate need of or on vasopressors upon ICU admission Patients or legal representatives who are unwilling or unable to provide written consent.
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
Interventional Model Description: Subjects in the active treatment group will receive ventilatory support with Life2000® Ventilator following the labeled instructions for the device. POV support (Life2000) will be administered in six (6) to ten (ten) enrolled subjects based on clinical protocol flowchart (Appendix C). Specifically, if it is determined that a COVID-19 subject who would currently be considered for HFNC under current standard of treatment, will be eligible for POV treatment. The prescribed therapy regimen, including duration of therapy will be documented and COVID-19 patients who fail therapy and require IMV will be recorded.
Masking: None (Open Label)
Arms and Interventions
| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Life2000® Ventilator<br>Subjects in the active treatment group will receive ventilatory support with Life2000® Ventilator following the labeled instructions for the device. | Device: Life2000® Ventilator<br>* POV support (Life2000) will be administered in six (6) to ten (ten) enrolled subjects based on clinical protocol flowchart (Appendix C). Specifically, if it is determined that a COVID-19 subject who would currently be considered for HFNC under current standard of treatment, will be eligible for POV treatment. The prescribed therapy regimen, including duration of therapy will be documented and COVID-19 patients who fail therapy and require IMV will be recorded.<br>|
| No Intervention: Control Group<br>Subjects in the control group will be identified from the population of patients previously admitted to the study site with COVID-19 infection who required non-invasive oxygen therapy with HFNC but were not treated with NIV therapy. Subject data will be collected retrospectively from the medical record. | |
What is the study measuring?
-----------------
Primary Outcome Measures
| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Life2000® Compared to HFNC (AIRVO) | Compared to HFNC (AIRVO), does the Life2000® Ventilator provide clinically relevant ventilatory support to COVID-19 patients with mild to moderate ARF or ARDS to prevent IMV. | Time frame measured will include date that patient is admitted to hospital until date patient is discharged from hospital or death occurs with an anticipated 30 day time period, but shall not exceed 90 day time period. |
Secondary Outcome Measures
| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| PEEP level | What level of PEEP is required to ensure adequate ventilation in COVID-19 patients with mild to moderate ARF/ARDS. | Time frame measured will include date that patient is admitted to hospital until date patient is discharged from hospital or death occurs with an anticipated 30 day time period, but shall not exceed 90 day time period. |
Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
ARDS, PEEP, Respiratory Rate
|
|
NCT01097434
|
Test Safety of Biodegradable and Permanent Limus-Eluting Stents Assessed by Optical Coherence Tomography
|
The objective of the study is to assess the superiority of the biodegradable polymer based limus-eluting stent (Nobori®) compared with the permanent polymer based everolimus-eluting stent (XIENCE V®) regarding absolute percentage of uncovered stent strut segments.
|
The mid-term efficacy of drug-eluting stents has been well-established, but there is an ongoing debate on the potential of an increased incidence of late stent thrombosis, particularly after discontinuation of thienopyridine therapy, as well as of delayed onset of restenosis or catch-up phenomenon with permanent polymer-based DES. The extent of strut coverage with reduction of exposed thrombogenic material has been shown to be associated with the inflammatory reaction grade and with the incidence of stent thrombosis. The optical coherence tomography (OCT) is an intravascular imaging modality based on light. The principle is similar to intravascular ultrasound, but due to the much shorter wave length of light, it offers a much better resolution up to 10µm, enabling the exact determination of strut coverage, neointimal thickness, vessel size, presence of dissections, and even the presence of inflammation.
|
Randomized Comparison of Limus-Eluting Stents With Biodegradable or Permanent Polymer Coating Regarding Stent Coverage Assessed by Optical Coherence Tomography
|
Coronary Heart Disease
|
* Device: Biodegradable polymer limus-eluting stents
* Device: Permanent polymer limus-eluting stent
|
Inclusion Criteria:~Patients older than age 18 with ischemic symptoms or evidence of myocardial ischemia in the presence of ≥ 50% stenosis located in native coronary vessels~Written, informed consent by the patient or her/his legally-authorized representative for participation in the study~In women with childbearing potential a negative pregnancy test is mandatory~Exclusion Criteria:~Lesion length >16mm requiring a stent length >18mm~Target lesion located in the left main trunk~In-stent restenosis~Acute myocardial infarction~Malignancies or other comorbid conditions (for example severe liver, renal and pancreatic disease) with life expectancy less than 12 months or that may result in protocol non-compliance~Known allergy to the study medications: rapamycin, everolimus, biolimus, stainless steel or cobalt chrome~Inability to take dual antiplatelet therapy for at least 6 months~Pregnancy (present, suspected or planned) or positive pregnancy test~Previous enrollment in this trial~Patient's inability to fully cooperate with the study protocol
|
18 Years
| null |
All
|
No
|
Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
|
| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Percentage of uncovered stent strut segments assessed by OCT | | 6-8 months |
|
| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Percentage of malposed stent strut segments assessed by OCT | | 6-8 months |
|
Heart Diseases, Coronary Disease, Coronary Artery Disease, Myocardial Ischemia, Cardiovascular Diseases, Vascular Diseases, Arteriosclerosis, Arterial Occlusive Diseases
|
| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: Arm 1<br>Biodegradable polymer limus-eluting stents | Device: Biodegradable polymer limus-eluting stents<br>* due randomization biodegradable polymer limus-eluting stents will be implanted<br>* Other names: Nobori®;|
| Active Comparator: Arm 2<br>Permanent polymer limus-eluting stent | Device: Permanent polymer limus-eluting stent<br>* due randomization permanent polymer limus-eluting stent will be implanted<br>* Other names: Xience-V®;|
|
Test Safety of Biodegradable and Permanent Limus-Eluting Stents Assessed by Optical Coherence Tomography
Study Overview
=================
Brief Summary
-----------------
The objective of the study is to assess the superiority of the biodegradable polymer based limus-eluting stent (Nobori®) compared with the permanent polymer based everolimus-eluting stent (XIENCE V®) regarding absolute percentage of uncovered stent strut segments.
Detailed Description
-----------------
The mid-term efficacy of drug-eluting stents has been well-established, but there is an ongoing debate on the potential of an increased incidence of late stent thrombosis, particularly after discontinuation of thienopyridine therapy, as well as of delayed onset of restenosis or catch-up phenomenon with permanent polymer-based DES. The extent of strut coverage with reduction of exposed thrombogenic material has been shown to be associated with the inflammatory reaction grade and with the incidence of stent thrombosis. The optical coherence tomography (OCT) is an intravascular imaging modality based on light. The principle is similar to intravascular ultrasound, but due to the much shorter wave length of light, it offers a much better resolution up to 10µm, enabling the exact determination of strut coverage, neointimal thickness, vessel size, presence of dissections, and even the presence of inflammation.
Official Title
-----------------
Randomized Comparison of Limus-Eluting Stents With Biodegradable or Permanent Polymer Coating Regarding Stent Coverage Assessed by Optical Coherence Tomography
Conditions
-----------------
Coronary Heart Disease
Intervention / Treatment
-----------------
* Device: Biodegradable polymer limus-eluting stents
* Device: Permanent polymer limus-eluting stent
Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Patients older than age 18 with ischemic symptoms or evidence of myocardial ischemia in the presence of ≥ 50% stenosis located in native coronary vessels Written, informed consent by the patient or her/his legally-authorized representative for participation in the study In women with childbearing potential a negative pregnancy test is mandatory Exclusion Criteria: Lesion length >16mm requiring a stent length >18mm Target lesion located in the left main trunk In-stent restenosis Acute myocardial infarction Malignancies or other comorbid conditions (for example severe liver, renal and pancreatic disease) with life expectancy less than 12 months or that may result in protocol non-compliance Known allergy to the study medications: rapamycin, everolimus, biolimus, stainless steel or cobalt chrome Inability to take dual antiplatelet therapy for at least 6 months Pregnancy (present, suspected or planned) or positive pregnancy test Previous enrollment in this trial Patient's inability to fully cooperate with the study protocol
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: Arm 1<br>Biodegradable polymer limus-eluting stents | Device: Biodegradable polymer limus-eluting stents<br>* due randomization biodegradable polymer limus-eluting stents will be implanted<br>* Other names: Nobori®;|
| Active Comparator: Arm 2<br>Permanent polymer limus-eluting stent | Device: Permanent polymer limus-eluting stent<br>* due randomization permanent polymer limus-eluting stent will be implanted<br>* Other names: Xience-V®;|
What is the study measuring?
-----------------
Primary Outcome Measures
| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Percentage of uncovered stent strut segments assessed by OCT | | 6-8 months |
Secondary Outcome Measures
| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Percentage of malposed stent strut segments assessed by OCT | | 6-8 months |
|
|
NCT00564447
|
Study of AzaSite (Azithromycin) Versus Vigamox in the Conjunctiva of Healthy Volunteers
|
The purpose of this study is to evaluate the drug concentrations of AzaSite™ compared to Vigamox at various time points in conjunctiva tissue of healthy volunteers
|
A Single-Center, Open-Label, Randomized Study of the Pharmacokinetics of AzaSite Ophthalmic Solution Versus Vigamox in the Conjunctiva of Healthy Volunteers Following a Single Ocular Administration
|
Bacterial Infections, Eye Infections
|
* Drug: Azithromycin
* Drug: Moxifloxacin
|
Inclusion Criteria:~Have best corrected visual acuity of 0.60 logMAR or better in each eye as measured using Early Treatment of Diabetic Retinopathy Study chart~Exclusion Criteria:~Have a known allergy and/or sensitivity to the test article(s) or its components or any therapies associated with the trial~Have active signs or symptoms of any clinically significant ocular disorder (other than refractive disorders)~Have a known bleeding disorder or history of bleeding complications after surgical or dental procedures~Take aspirin, or take any other blood thinners or anti-coagulants (e.g. warfarin) including prescription, over the counter, or homeopathic therapies~Have undergone any ocular surgical intervention within 3 months prior to Visit 1 or anticipate having ocular surgery during the study
|
18 Years
| null |
All
|
Accepts Healthy Volunteers
|
Primary Purpose: Supportive Care
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
|
| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Assessment of Pharmacokinetic Parameters | | Up to 24 hours |
| Assessment of Pharmacokinetic Parameters | Conjunctiva Concentration of Azithromycin and Moxifloxacin | Over 24 hours |
|
Azithromycin, Moxifloxacin, Anti-Bacterial Agents, Anti-Infective Agents, Topoisomerase II Inhibitors, Topoisomerase Inhibitors, Enzyme Inhibitors, Molecular Mechanisms of Pharmacological Action, Antineoplastic Agents
|
| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Azithromycin-30 minutes Post dose<br> | Drug: Azithromycin<br>* azithromycin topical solution 1% given as a single drop in a single eye<br>* Other names: AzaSite;|
| Experimental: Azithromycin-2 hours post dose<br> | Drug: Azithromycin<br>* azithromycin topical solution 1% given as a single drop in a single eye<br>* Other names: AzaSite;|
| Experimental: Azithromycin-12 hours post dose<br> | Drug: Azithromycin<br>* azithromycin topical solution 1% given as a single drop in a single eye<br>* Other names: AzaSite;|
| Experimental: Azithromycin-24 hours post dose<br> | Drug: Azithromycin<br>* azithromycin topical solution 1% given as a single drop in a single eye<br>* Other names: AzaSite;|
| Experimental: Moxifloxacin-30 minutes post dose<br> | Drug: Moxifloxacin<br>* Moxifloxacin topical solution given as a single drop in a single eye<br>* Other names: Vigamox;|
| Experimental: Moxifloxacin-2 hours post dose<br> | Drug: Moxifloxacin<br>* Moxifloxacin topical solution given as a single drop in a single eye<br>* Other names: Vigamox;|
| Experimental: Moxifloxacin-12 hours post dose<br> | Drug: Moxifloxacin<br>* Moxifloxacin topical solution given as a single drop in a single eye<br>* Other names: Vigamox;|
| Experimental: Moxafloxacin-24 hours post dose<br> | Drug: Moxifloxacin<br>* Moxifloxacin topical solution given as a single drop in a single eye<br>* Other names: Vigamox;|
|
Study of AzaSite (Azithromycin) Versus Vigamox in the Conjunctiva of Healthy Volunteers
Study Overview
=================
Brief Summary
-----------------
The purpose of this study is to evaluate the drug concentrations of AzaSite™ compared to Vigamox at various time points in conjunctiva tissue of healthy volunteers
Official Title
-----------------
A Single-Center, Open-Label, Randomized Study of the Pharmacokinetics of AzaSite Ophthalmic Solution Versus Vigamox in the Conjunctiva of Healthy Volunteers Following a Single Ocular Administration
Conditions
-----------------
Bacterial Infections, Eye Infections
Intervention / Treatment
-----------------
* Drug: Azithromycin
* Drug: Moxifloxacin
Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Have best corrected visual acuity of 0.60 logMAR or better in each eye as measured using Early Treatment of Diabetic Retinopathy Study chart Exclusion Criteria: Have a known allergy and/or sensitivity to the test article(s) or its components or any therapies associated with the trial Have active signs or symptoms of any clinically significant ocular disorder (other than refractive disorders) Have a known bleeding disorder or history of bleeding complications after surgical or dental procedures Take aspirin, or take any other blood thinners or anti-coagulants (e.g. warfarin) including prescription, over the counter, or homeopathic therapies Have undergone any ocular surgical intervention within 3 months prior to Visit 1 or anticipate having ocular surgery during the study
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: Supportive Care
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Arms and Interventions
| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Azithromycin-30 minutes Post dose<br> | Drug: Azithromycin<br>* azithromycin topical solution 1% given as a single drop in a single eye<br>* Other names: AzaSite;|
| Experimental: Azithromycin-2 hours post dose<br> | Drug: Azithromycin<br>* azithromycin topical solution 1% given as a single drop in a single eye<br>* Other names: AzaSite;|
| Experimental: Azithromycin-12 hours post dose<br> | Drug: Azithromycin<br>* azithromycin topical solution 1% given as a single drop in a single eye<br>* Other names: AzaSite;|
| Experimental: Azithromycin-24 hours post dose<br> | Drug: Azithromycin<br>* azithromycin topical solution 1% given as a single drop in a single eye<br>* Other names: AzaSite;|
| Experimental: Moxifloxacin-30 minutes post dose<br> | Drug: Moxifloxacin<br>* Moxifloxacin topical solution given as a single drop in a single eye<br>* Other names: Vigamox;|
| Experimental: Moxifloxacin-2 hours post dose<br> | Drug: Moxifloxacin<br>* Moxifloxacin topical solution given as a single drop in a single eye<br>* Other names: Vigamox;|
| Experimental: Moxifloxacin-12 hours post dose<br> | Drug: Moxifloxacin<br>* Moxifloxacin topical solution given as a single drop in a single eye<br>* Other names: Vigamox;|
| Experimental: Moxafloxacin-24 hours post dose<br> | Drug: Moxifloxacin<br>* Moxifloxacin topical solution given as a single drop in a single eye<br>* Other names: Vigamox;|
What is the study measuring?
-----------------
Primary Outcome Measures
| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Assessment of Pharmacokinetic Parameters | | Up to 24 hours |
| Assessment of Pharmacokinetic Parameters | Conjunctiva Concentration of Azithromycin and Moxifloxacin | Over 24 hours |
|
|||
NCT02503488
|
Decreasing Youth Involvement in Violence in Burundi
|
The purpose of the current study is to examine the psychological well-being of youth within the context of participation in political violence during the 2015 election period in Burundi. In detail, the investigators are interested in fostering improved outcomes in a peace-building initiative aimed at youth in Burundi by reducing the mental health-related stress of the initiative's most severely affected participants. In addition, the investigators are interested in learning more about the youth experience of involvement in the Burundian political system in an effort to understand the links between youth engagement in political violence and past experiences of traumatic events.
|
The African Great Lakes Region is marked by several countries which have been ravaged by violence for several years. One of these countries is Burundi, a small state bordered by Rwanda, Tanzania and the Democratic Republic of the Congo. This country has been stricken by more than a decade of civil war, which ended only in 2006.~Today, many people still struggle in coping with the aftermath of the war. Political parties remain largely drawn along ethnic lines. These identities are often manipulated in order to incite violence and intimidation against opposing parties or groups. Violence between rival youth wings was a disturbing feature of the 2010 elections in Burundi, with similar conditions manifesting themselves in advance of the 2015 presidential election.~Further complicating the situation in Burundi, one of the problems people in war-affected populations often face is the high impairment due to mental health problems. Studies in crisis regions have shown that multiple experiences of traumatic life events seriously damages mental health and can lead to disorders such as Posttraumatic Stress Disorder (PTSD) or depression. Further, the risk of developing PTSD rapidly increases with the number of traumatic events experienced, as the occurrence of PTSD is more likely when the accumulation of trauma exceeds a certain limit. This phenomenon has been described as the building block effect. This means, people in the context of armed conflicts and war are especially at risk to develop PTSD, as the total load of perceived stress is much higher than anywhere else. Furthermore, recent studies have revealed that combatants and other populations living in violent and insecure circumstances may adapt to their environment by developing an attraction to perpetrating violence, i.e. appetitive aggression. While appetitive aggression helps individuals to survive in violent environments by reducing their likelihood of developing trauma-related symptoms, it increases the risk of getting involved in the perpetration of violence.~In order to address the mental health needs of the participants in the present study, the investigators will be utilizing an intervention, Narrative Exposure Therapy for Forensic Offender Rehabilitation (FORNET), that has been demonstrated to reduce posttraumatic symptomology and readiness for aggressive behavior.~Objectives:~The aim of the present study is to investigate the intersection of politics and mental health within the context of Burundi. Specifically, the study will be seeking to answer the following research questions:~Mental Health Barriers to Participation in Peace Building Initiatives: What, if any, role does the presence of mental health issues such as PTSD and depression play in effective participation in peace-building efforts? Can FORNET contribute to peace building programs?~Links Between Mental Health Issues and Political Participation: What is the role of mental health issues in shaping the readiness to resort to violence as a result of political beliefs and attitudes toward members of other political parties in a post-conflict setting?~Appetitive Aggression. Does the concept of appetitive aggression influence the manner of political participation? Does appetitive aggression have a relationship to the perpetration of politically-motivated violence?~Trauma-related disorders. Do trauma-related disorders such as PTSD and depression influence the manner of political participation? Do they have a relationship to the perpetration of politically-motivated violence?
|
Decreasing Youth Involvement in Violence in Burundi
|
Depression, Posttraumatic Stress Disorder, Aggression
|
* Behavioral: Narrative Exposure Therapy for Forensic Offender Rehab
* Behavioral: Treatment as Usual
|
Inclusion Criteria:~High degree of symptoms of posttraumatic stress disorder according to the Posttraumatic Symptom Scale~High degree of appetitive aggression~Violent behavior during the past three months~Exclusion Criteria:~Current use of mind altering drugs~Psychotic symptoms
|
18 Years
|
40 Years
|
All
|
No
|
Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single
|
| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change in Baseline PTSD Scores at 3-months-followup and 9-months-followup | Will be assessed using the PSS-I | Baseline, 3 months, 9 months |
| Change in Baseline Depression Scores at 3-months-followup and 9-months-followup | Will be assessed using the Patient Health Questionnaire-9 | Baseline, 3 months, 9 months |
| Change in Baseline Appetitive Aggression Scores at 3-months-followup and 9-months-followup | Assesses attitudes towards the perception and disposition of different forms of violence using the Appetitive Aggression Scale for Children (AAS-C). | Baseline, 3 months, 9 months |
|
| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change in Baseline Physical State at 3-months-followup and 9-months-followup | Will be assessed using a structured list of a range of ailments | Baseline, 3 months, 9 months |
| Change in Social Integration Scores at 3-months-followup and 9-months-followup | Will assess levels of participant integration with family and community using scores between 0-4, with higher scores indicating higher levels of social integration. | Baseline, 3 months, 9 months |
| Change in Scores on the Attitudes Toward Members of Other Political Parties Scale at 3-months-followup and 9-months-followup | Will assess nature of attitudes towards other political parties with which the participant is not affiliated. | Baseline, 3 months, 9 months |
|
Appetitive Aggression
|
Stress Disorders, Post-Traumatic, Aggression, Behavioral Symptoms, Stress Disorders, Traumatic, Trauma and Stressor Related Disorders, Mental Disorders
|
| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Program Group<br>The treatment arm will consist of 20 randomly selected participants who will receive Narrative Exposure Therapy for Forensic Offender Rehabilitation (FORNET) for their traumatic symptomology, aggression, and depression. FORNET consists of a guided exposure of the participant's traumatic experiences in chronological order and integrating them into a coherent biographical memory.The intervention addresses the participant's positive, negative, and violent memories of events that have taken place during their lifetime, and also provides participants an opportunity to asses their current situation and future plans. FORNET can be completed in six sessions and each session lasts 90 minutes on average. | Behavioral: Narrative Exposure Therapy for Forensic Offender Rehab<br>* See arm description.<br>* Other names: FORNET;|
| Active Comparator: Treatment As Usual (TAU)<br>Participants in the TAU group will receive group and individual psycho-social support from trained peer-support workers, with 10 sessions occurring throughout the course of the intervention for each participant. In addition, there will be sensitisation trainings as well as mentoring for establishing greater financial independence. Last, TAU will include one-day events promoting social cohesion and peace. | Behavioral: Treatment as Usual<br>* See arm description<br>* Other names: TAU;|
|
Decreasing Youth Involvement in Violence in Burundi
Study Overview
=================
Brief Summary
-----------------
The purpose of the current study is to examine the psychological well-being of youth within the context of participation in political violence during the 2015 election period in Burundi. In detail, the investigators are interested in fostering improved outcomes in a peace-building initiative aimed at youth in Burundi by reducing the mental health-related stress of the initiative's most severely affected participants. In addition, the investigators are interested in learning more about the youth experience of involvement in the Burundian political system in an effort to understand the links between youth engagement in political violence and past experiences of traumatic events.
Detailed Description
-----------------
The African Great Lakes Region is marked by several countries which have been ravaged by violence for several years. One of these countries is Burundi, a small state bordered by Rwanda, Tanzania and the Democratic Republic of the Congo. This country has been stricken by more than a decade of civil war, which ended only in 2006. Today, many people still struggle in coping with the aftermath of the war. Political parties remain largely drawn along ethnic lines. These identities are often manipulated in order to incite violence and intimidation against opposing parties or groups. Violence between rival youth wings was a disturbing feature of the 2010 elections in Burundi, with similar conditions manifesting themselves in advance of the 2015 presidential election. Further complicating the situation in Burundi, one of the problems people in war-affected populations often face is the high impairment due to mental health problems. Studies in crisis regions have shown that multiple experiences of traumatic life events seriously damages mental health and can lead to disorders such as Posttraumatic Stress Disorder (PTSD) or depression. Further, the risk of developing PTSD rapidly increases with the number of traumatic events experienced, as the occurrence of PTSD is more likely when the accumulation of trauma exceeds a certain limit. This phenomenon has been described as the building block effect. This means, people in the context of armed conflicts and war are especially at risk to develop PTSD, as the total load of perceived stress is much higher than anywhere else. Furthermore, recent studies have revealed that combatants and other populations living in violent and insecure circumstances may adapt to their environment by developing an attraction to perpetrating violence, i.e. appetitive aggression. While appetitive aggression helps individuals to survive in violent environments by reducing their likelihood of developing trauma-related symptoms, it increases the risk of getting involved in the perpetration of violence. In order to address the mental health needs of the participants in the present study, the investigators will be utilizing an intervention, Narrative Exposure Therapy for Forensic Offender Rehabilitation (FORNET), that has been demonstrated to reduce posttraumatic symptomology and readiness for aggressive behavior. Objectives: The aim of the present study is to investigate the intersection of politics and mental health within the context of Burundi. Specifically, the study will be seeking to answer the following research questions: Mental Health Barriers to Participation in Peace Building Initiatives: What, if any, role does the presence of mental health issues such as PTSD and depression play in effective participation in peace-building efforts? Can FORNET contribute to peace building programs? Links Between Mental Health Issues and Political Participation: What is the role of mental health issues in shaping the readiness to resort to violence as a result of political beliefs and attitudes toward members of other political parties in a post-conflict setting? Appetitive Aggression. Does the concept of appetitive aggression influence the manner of political participation? Does appetitive aggression have a relationship to the perpetration of politically-motivated violence? Trauma-related disorders. Do trauma-related disorders such as PTSD and depression influence the manner of political participation? Do they have a relationship to the perpetration of politically-motivated violence?
Official Title
-----------------
Decreasing Youth Involvement in Violence in Burundi
Conditions
-----------------
Depression, Posttraumatic Stress Disorder, Aggression
Intervention / Treatment
-----------------
* Behavioral: Narrative Exposure Therapy for Forensic Offender Rehab
* Behavioral: Treatment as Usual
Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: High degree of symptoms of posttraumatic stress disorder according to the Posttraumatic Symptom Scale High degree of appetitive aggression Violent behavior during the past three months Exclusion Criteria: Current use of mind altering drugs Psychotic symptoms
Ages Eligible for Study
-----------------
Minimum Age: 18 Years
Maximum Age: 40 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: Program Group<br>The treatment arm will consist of 20 randomly selected participants who will receive Narrative Exposure Therapy for Forensic Offender Rehabilitation (FORNET) for their traumatic symptomology, aggression, and depression. FORNET consists of a guided exposure of the participant's traumatic experiences in chronological order and integrating them into a coherent biographical memory.The intervention addresses the participant's positive, negative, and violent memories of events that have taken place during their lifetime, and also provides participants an opportunity to asses their current situation and future plans. FORNET can be completed in six sessions and each session lasts 90 minutes on average. | Behavioral: Narrative Exposure Therapy for Forensic Offender Rehab<br>* See arm description.<br>* Other names: FORNET;|
| Active Comparator: Treatment As Usual (TAU)<br>Participants in the TAU group will receive group and individual psycho-social support from trained peer-support workers, with 10 sessions occurring throughout the course of the intervention for each participant. In addition, there will be sensitisation trainings as well as mentoring for establishing greater financial independence. Last, TAU will include one-day events promoting social cohesion and peace. | Behavioral: Treatment as Usual<br>* See arm description<br>* Other names: TAU;|
What is the study measuring?
-----------------
Primary Outcome Measures
| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change in Baseline PTSD Scores at 3-months-followup and 9-months-followup | Will be assessed using the PSS-I | Baseline, 3 months, 9 months |
| Change in Baseline Depression Scores at 3-months-followup and 9-months-followup | Will be assessed using the Patient Health Questionnaire-9 | Baseline, 3 months, 9 months |
| Change in Baseline Appetitive Aggression Scores at 3-months-followup and 9-months-followup | Assesses attitudes towards the perception and disposition of different forms of violence using the Appetitive Aggression Scale for Children (AAS-C). | Baseline, 3 months, 9 months |
Secondary Outcome Measures
| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change in Baseline Physical State at 3-months-followup and 9-months-followup | Will be assessed using a structured list of a range of ailments | Baseline, 3 months, 9 months |
| Change in Social Integration Scores at 3-months-followup and 9-months-followup | Will assess levels of participant integration with family and community using scores between 0-4, with higher scores indicating higher levels of social integration. | Baseline, 3 months, 9 months |
| Change in Scores on the Attitudes Toward Members of Other Political Parties Scale at 3-months-followup and 9-months-followup | Will assess nature of attitudes towards other political parties with which the participant is not affiliated. | Baseline, 3 months, 9 months |
Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Appetitive Aggression
|
NCT01178723
|
The Effects of Breakfast Size on Hormonal Profile in Adults With Type 2 Diabetes Mellitus
|
Studies has found a connection between breakfast consumption and obesity and obesity-related complications, but only few studies examined the effect of breakfast size.~The purpose of this study is to examine the effect of breakfast size on several parameters in adults with Type 2 diabetes mellitus.
|
The prevalence of obesity has rapidly increased during recent decades, while the prevalence of skipping breakfast has increased.~Several studies have reported inverse relationships between the consumption of breakfast and BMI and weight gain. A study that examined the effect of breakfast size, found that an increased percentage of daily energy consumed at breakfast was associated with relatively lower weight gain. Preliminary results of clinical research (unpublished) show a connection between a large breakfast and weight loss and increased feeling of satiety throughout the day.~The purpose of this study is to examine the effect of breakfast size on blood glucose balance, and its correlation with hormonal profile (including appetite hormones), adipokines and pro-inflammatory cytokines, weight and body composition and lipid profile in adults with type 2 diabetes.~The study will use a randomized-controlled, non-blinded, prospective design, including 48 participants with type 2 diabetes, who are not insulin dependent.~The research group will receive instructions to eat a large breakfast compared with the control group that will receive instructions to eat a small breakfast.~The estimated duration of the study is about three months.
| null |
Diabetes Mellitus, Type 2
|
* Dietary Supplement: breakfast size
|
Inclusion Criteria:~Men and women ages: 30-70~Type 2 diabetics who are treated on a diet and / or pills~Patients who receive a stable drug treatment (no change in the type/dosage of drugs during the three months preceding the research)~Obese or overweight (35> BMI> 25)~Patients who did not participate in another research for at least 30 days~Patients who agree to sign a consent form and participate in research~Patients with high compliance.~Exclusion Criteria:~Patients under the age 30 or over 70~Type 1 I diabetics~Patients who are insulin dependent~Type 2 diabetics who are treated with injections~BMI less than 25 or BMI over 35~Patients who had Bariatric surgery~Patients with food absorption disorders~Active malignant disease~Thyroid function disorder~Active psychiatric illness~Pregnancy / breastfeeding
|
30 Years
|
70 Years
|
All
|
No
|
Primary Purpose: Supportive Care
Allocation: Randomized
Intervention Model: Single Group Assignment
Masking: None (Open Label)
|
| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| blood glucose balance | HBA1C, C-peptid, insulin, glucose, HOMA-IR, Glycomark | three months |
|
| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| anthropometric parameters | weight, height, body composition | three months |
| Adipokines and hormones | insulin, leptin, ghrelin, adiponectin, GLP-1, cortisol | three months |
| pro-inflammatory cytokines | TNF-α, IL-6, MCP-1, CRP | three months |
| lipid profile | triglycerides, cholesterol, LDL, HDL | three months |
|
breakfast size, blood glucose balance, hormonal profile, appetite hormones, adipokines, pro-inflammatory cytokines
|
Diabetes Mellitus, Diabetes Mellitus, Type 2, Glucose Metabolism Disorders, Metabolic Diseases, Endocrine System Diseases
|
| Intervention/Treatment |
| --- |
|Dietary Supplement: breakfast size|The research group will receive instructions to eat a large breakfast, Dividing the total daily calories recommended to the patient to: breakfast - 1/8 of the total daily calories , lunch - 1/3 of the total daily calories and supper- 1/3 of the total daily calories.~(the rest of the calories will be snacks between the meals) In contrast, the control group that will receive instructions to eat a small breakfast.~Dividing the total daily calories recommended to the patient to: breakfast - 1/3 of the total daily calories , lunch - 1/4 of the total daily calories and supper- 1/4 of the total daily calories (the rest of the calories will snacks between the meals).~The instructions will be adapted to each patient individually|
|
The Effects of Breakfast Size on Hormonal Profile in Adults With Type 2 Diabetes Mellitus
Study Overview
=================
Brief Summary
-----------------
Studies has found a connection between breakfast consumption and obesity and obesity-related complications, but only few studies examined the effect of breakfast size. The purpose of this study is to examine the effect of breakfast size on several parameters in adults with Type 2 diabetes mellitus.
Detailed Description
-----------------
The prevalence of obesity has rapidly increased during recent decades, while the prevalence of skipping breakfast has increased. Several studies have reported inverse relationships between the consumption of breakfast and BMI and weight gain. A study that examined the effect of breakfast size, found that an increased percentage of daily energy consumed at breakfast was associated with relatively lower weight gain. Preliminary results of clinical research (unpublished) show a connection between a large breakfast and weight loss and increased feeling of satiety throughout the day. The purpose of this study is to examine the effect of breakfast size on blood glucose balance, and its correlation with hormonal profile (including appetite hormones), adipokines and pro-inflammatory cytokines, weight and body composition and lipid profile in adults with type 2 diabetes. The study will use a randomized-controlled, non-blinded, prospective design, including 48 participants with type 2 diabetes, who are not insulin dependent. The research group will receive instructions to eat a large breakfast compared with the control group that will receive instructions to eat a small breakfast. The estimated duration of the study is about three months.
Conditions
-----------------
Diabetes Mellitus, Type 2
Intervention / Treatment
-----------------
* Dietary Supplement: breakfast size
Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Men and women ages: 30-70 Type 2 diabetics who are treated on a diet and / or pills Patients who receive a stable drug treatment (no change in the type/dosage of drugs during the three months preceding the research) Obese or overweight (35> BMI> 25) Patients who did not participate in another research for at least 30 days Patients who agree to sign a consent form and participate in research Patients with high compliance. Exclusion Criteria: Patients under the age 30 or over 70 Type 1 I diabetics Patients who are insulin dependent Type 2 diabetics who are treated with injections BMI less than 25 or BMI over 35 Patients who had Bariatric surgery Patients with food absorption disorders Active malignant disease Thyroid function disorder Active psychiatric illness Pregnancy / breastfeeding
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: Supportive Care
Allocation: Randomized
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Arms and Interventions
| Intervention/Treatment |
| --- |
|Dietary Supplement: breakfast size|The research group will receive instructions to eat a large breakfast, Dividing the total daily calories recommended to the patient to: breakfast - 1/8 of the total daily calories , lunch - 1/3 of the total daily calories and supper- 1/3 of the total daily calories. (the rest of the calories will be snacks between the meals) In contrast, the control group that will receive instructions to eat a small breakfast. Dividing the total daily calories recommended to the patient to: breakfast - 1/3 of the total daily calories , lunch - 1/4 of the total daily calories and supper- 1/4 of the total daily calories (the rest of the calories will snacks between the meals). The instructions will be adapted to each patient individually|
What is the study measuring?
-----------------
Primary Outcome Measures
| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| blood glucose balance | HBA1C, C-peptid, insulin, glucose, HOMA-IR, Glycomark | three months |
Secondary Outcome Measures
| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| anthropometric parameters | weight, height, body composition | three months |
| Adipokines and hormones | insulin, leptin, ghrelin, adiponectin, GLP-1, cortisol | three months |
| pro-inflammatory cytokines | TNF-α, IL-6, MCP-1, CRP | three months |
| lipid profile | triglycerides, cholesterol, LDL, HDL | three months |
Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
breakfast size, blood glucose balance, hormonal profile, appetite hormones, adipokines, pro-inflammatory cytokines
|
NCT00078754
|
A Comparison of Fluoxetine and Divalproex for the Treatment of Intermittent Explosive Disorder
|
This study will compare the medications fluoxetine (Prozac®) and divalproex (Depakote®) for the treatment of aggressive behavior in individuals with Intermittent Explosive Disorder (IED).
|
IED is a condition characterized by a failure to resist aggressive impulses. IED is a behavioral defined condition for which effective treatments have not been identified. Research suggests that serotonin (5-HT), a chemical that helps regulate mood and emotions, may play a role in the response to pharmacological IED treatments. This study will examine the relationship between 5-HT receptors and response to treatment with fluoxetine or divalproex. In addition, this study will examine people with IED and those without the condition to determine whether there are differences in their 5-HT receptor and transporter systems.~Participants in this study will be randomly assigned to receive either fluoxetine, divalproex, or placebo for 12 weeks. Scale ratings will be used to assess the aggression levels of participants. Biologic evaluations of the 5-HT system will be conducted throughout the study.
|
Fluoxetine and Divalproex: Treatment Correlates in IED
|
Intermittent Explosive Disorder
|
* Drug: Fluoxetine
* Drug: Divalproex
* Drug: Placebo
|
Inclusion Criteria:~Diagnosis of Intermittent Explosive Disorder (IED)~In good physical health~Overt Aggression Scale-Modified (OAS-M) score of 15 or higher at screening~Willing and able to comply with the study requirements~Exclusion Criteria:~Life history of bipolar disorder, schizophrenia, organic mental syndrome, or mental retardation~Current major depressive disorder, with a Hamilton Depression (HAM-D) Scale score higher than 18~Current alcohol or drug abuse or dependence~Active medical conditions that will interfere with the study~Thymoleptic or neuroleptic treatments~Presence of the following serious and active medical conditions: demyelinating or progressive degenerative disorders; central nervous system infection; progressive degenerative neurological disorder; ischemic heart disease; respiratory, renal, or liver disease; Type I diabetes; malignant neoplasm; hyper- or hypo-coagulopathy; Acquired Immune Deficiency Syndrome (AIDS); or seizure disorder. Participants with a history of more than two febrile seizures prior to 1 year of age are eligible.~Chronic, ongoing treatment with the following classes of medications: antidepressants, neuroleptics, mood stabilizers, antianxiety agents, hypnotics, narcotics or synthetic narcotics, barbiturates, stimulants, anti-migraine agents, anti-epileptics, non-beta-blocking or Ca-channel blocking anti-arrhythmic agents prescribed to treat cardiac arrhythmia, anticoagulants, immunomodulators, anti-neoplastic agents, or HIV antiviral agents~Ongoing psychotherapeutic treatment for the treatment of IED or anger that was started less than 3 months before study entry~Hypersensitivity to fluoxetine or divalproex~Pregnancy
|
21 Years
|
55 Years
|
All
|
No
|
Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double
|
| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Overt Aggression Scale-Modified for Outpatient Use (OAS-M) | OAS-M is a validated instrument that measures aggression. Anti-aggressive effect of the drug/placebo was measured by the aggression score from OAS-M. Possible scores for aggression range from 0 (no aggression) to infinity (because the score is calculated by the number of times an aggressive behavior occurred, which theoretically has no possible maximum). Therefore the bigger number, the worse anti-aggression effect, thus the worse outcome. In each weekly visit, OAS-M score was calculated for the past week. | Measured at Week 12 |
|
| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| OAS-M | Overt Aggression Scale Modified for Outpatient Use. Minimum value = 0 Maximum value = Infinity. Higher scores means worse outcome. | Measured at Week 12 |
|
Valproic Acid, Fluoxetine, Selective Serotonin Reuptake Inhibitors, Neurotransmitter Uptake Inhibitors, Membrane Transport Modulators, Molecular Mechanisms of Pharmacological Action, Neurotransmitter Agents, Serotonin Agents, Physiological Effects of Drugs, Antidepressive Agents, Second-Generation, Antidepressive Agents, Psychotropic Drugs, Cytochrome P-450 CYP2D6 Inhibitors, Cytochrome P-450 Enzyme Inhibitors, Enzyme Inhibitors, Anticonvulsants, GABA Agents, Antimanic Agents, Tranquilizing Agents, Central Nervous System Depressants
|
| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: A<br>Participants will to receive treatment with fluoxetine for 12 weeks | Drug: Fluoxetine<br>* Fluoxetine capsules by mouth, up to 60 mg daily<br>|
| Experimental: B<br>Participants will to receive treatment with divalproex for 12 weeks | Drug: Divalproex<br>* Divalproex ER capsules by mouth, up to 3000 mg daily<br>|
| Placebo Comparator: C<br>Participants will to receive treatment with placebo for 12 weeks | Drug: Placebo<br>* Placebo capsules by mouth, up to 8 capsules daily<br>|
|
A Comparison of Fluoxetine and Divalproex for the Treatment of Intermittent Explosive Disorder
Study Overview
=================
Brief Summary
-----------------
This study will compare the medications fluoxetine (Prozac®) and divalproex (Depakote®) for the treatment of aggressive behavior in individuals with Intermittent Explosive Disorder (IED).
Detailed Description
-----------------
IED is a condition characterized by a failure to resist aggressive impulses. IED is a behavioral defined condition for which effective treatments have not been identified. Research suggests that serotonin (5-HT), a chemical that helps regulate mood and emotions, may play a role in the response to pharmacological IED treatments. This study will examine the relationship between 5-HT receptors and response to treatment with fluoxetine or divalproex. In addition, this study will examine people with IED and those without the condition to determine whether there are differences in their 5-HT receptor and transporter systems. Participants in this study will be randomly assigned to receive either fluoxetine, divalproex, or placebo for 12 weeks. Scale ratings will be used to assess the aggression levels of participants. Biologic evaluations of the 5-HT system will be conducted throughout the study.
Official Title
-----------------
Fluoxetine and Divalproex: Treatment Correlates in IED
Conditions
-----------------
Intermittent Explosive Disorder
Intervention / Treatment
-----------------
* Drug: Fluoxetine
* Drug: Divalproex
* Drug: Placebo
Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Diagnosis of Intermittent Explosive Disorder (IED) In good physical health Overt Aggression Scale-Modified (OAS-M) score of 15 or higher at screening Willing and able to comply with the study requirements Exclusion Criteria: Life history of bipolar disorder, schizophrenia, organic mental syndrome, or mental retardation Current major depressive disorder, with a Hamilton Depression (HAM-D) Scale score higher than 18 Current alcohol or drug abuse or dependence Active medical conditions that will interfere with the study Thymoleptic or neuroleptic treatments Presence of the following serious and active medical conditions: demyelinating or progressive degenerative disorders; central nervous system infection; progressive degenerative neurological disorder; ischemic heart disease; respiratory, renal, or liver disease; Type I diabetes; malignant neoplasm; hyper- or hypo-coagulopathy; Acquired Immune Deficiency Syndrome (AIDS); or seizure disorder. Participants with a history of more than two febrile seizures prior to 1 year of age are eligible. Chronic, ongoing treatment with the following classes of medications: antidepressants, neuroleptics, mood stabilizers, antianxiety agents, hypnotics, narcotics or synthetic narcotics, barbiturates, stimulants, anti-migraine agents, anti-epileptics, non-beta-blocking or Ca-channel blocking anti-arrhythmic agents prescribed to treat cardiac arrhythmia, anticoagulants, immunomodulators, anti-neoplastic agents, or HIV antiviral agents Ongoing psychotherapeutic treatment for the treatment of IED or anger that was started less than 3 months before study entry Hypersensitivity to fluoxetine or divalproex Pregnancy
Ages Eligible for Study
-----------------
Minimum Age: 21 Years
Maximum Age: 55 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: A<br>Participants will to receive treatment with fluoxetine for 12 weeks | Drug: Fluoxetine<br>* Fluoxetine capsules by mouth, up to 60 mg daily<br>|
| Experimental: B<br>Participants will to receive treatment with divalproex for 12 weeks | Drug: Divalproex<br>* Divalproex ER capsules by mouth, up to 3000 mg daily<br>|
| Placebo Comparator: C<br>Participants will to receive treatment with placebo for 12 weeks | Drug: Placebo<br>* Placebo capsules by mouth, up to 8 capsules daily<br>|
What is the study measuring?
-----------------
Primary Outcome Measures
| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Overt Aggression Scale-Modified for Outpatient Use (OAS-M) | OAS-M is a validated instrument that measures aggression. Anti-aggressive effect of the drug/placebo was measured by the aggression score from OAS-M. Possible scores for aggression range from 0 (no aggression) to infinity (because the score is calculated by the number of times an aggressive behavior occurred, which theoretically has no possible maximum). Therefore the bigger number, the worse anti-aggression effect, thus the worse outcome. In each weekly visit, OAS-M score was calculated for the past week. | Measured at Week 12 |
Secondary Outcome Measures
| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| OAS-M | Overt Aggression Scale Modified for Outpatient Use. Minimum value = 0 Maximum value = Infinity. Higher scores means worse outcome. | Measured at Week 12 |
|
|
NCT04840511
|
The Effect of Perioperative Lidocaine Infusion on Neutrophil Extracellular Trapping
|
This study will be done to investigate perioperative lidocaine infusion on neutrophil extracellular trapping in the patients undergoing the robot-assisted prostatectomy.
|
Neutrophil extracellular trapping by analyzing the meyloperoxidase, neutrophil elastase, citrullinated histone3
|
The Effect of Perioperative Lidocaine Infusion on Neutrophil Extracellular Trapping in the Patients Undergoing the Robot-assisted Prostatectomy
|
Urologic Cancer
|
* Drug: lidocaine group
* Drug: control group
|
Inclusion Criteria:~patients scheduled robot-assisted prostatectomy~Exclusion Criteria:~lidocaine allergy Hx~hemodynamic unstable patients~weight < 40kg~arrhythmia or bradycardia
|
20 Years
|
75 Years
|
Male
|
No
|
Primary Purpose: Supportive Care
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple
|
| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Concentration of citrullinated histone3 | This will be obtained using ELISA. | 24 hours after surgery |
|
| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Concentration of meyloperoxidase | This will be obtained using ELISA. | 24 hours after surgery |
| Concentration of neutrophil elastase | This will be obtained using ELISA. | 24 hours after surgery |
|
Lidocaine, Anesthetics, Local, Anesthetics, Central Nervous System Depressants, Physiological Effects of Drugs, Sensory System Agents, Peripheral Nervous System Agents, Anti-Arrhythmia Agents, Voltage-Gated Sodium Channel Blockers, Sodium Channel Blockers, Membrane Transport Modulators, Molecular Mechanisms of Pharmacological Action
|
| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: lidocaine group<br>The study group receives perioperative lidocaine infusion with general anesthesia for robot-assisted prostatectomy | Drug: lidocaine group<br>* lidocaine 1.5 mg/kg bolus (infused over 10 min) followed by 2.0 mg/kg/h during operation and 1.0 mg/kg/h during postoperative 24 hours (no more than 120 mg/h)<br>* Other names: lidocaine;|
| Placebo Comparator: control group<br>The control group receives normal saline infusion with with general anesthesia for robot-assisted prostatectomy | Drug: control group<br>* normal saline 0.15 ml bolus followed by 0.2 ml/kg/hr during operation and 0.1 ml/kg/hr during postoperative 24 hours<br>* Other names: normal saline;|
|
The Effect of Perioperative Lidocaine Infusion on Neutrophil Extracellular Trapping
Study Overview
=================
Brief Summary
-----------------
This study will be done to investigate perioperative lidocaine infusion on neutrophil extracellular trapping in the patients undergoing the robot-assisted prostatectomy.
Detailed Description
-----------------
Neutrophil extracellular trapping by analyzing the meyloperoxidase, neutrophil elastase, citrullinated histone3
Official Title
-----------------
The Effect of Perioperative Lidocaine Infusion on Neutrophil Extracellular Trapping in the Patients Undergoing the Robot-assisted Prostatectomy
Conditions
-----------------
Urologic Cancer
Intervention / Treatment
-----------------
* Drug: lidocaine group
* Drug: control group
Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: patients scheduled robot-assisted prostatectomy Exclusion Criteria: lidocaine allergy Hx hemodynamic unstable patients weight < 40kg arrhythmia or bradycardia
Ages Eligible for Study
-----------------
Minimum Age: 20 Years
Maximum Age: 75 Years
Sexes Eligible for Study
-----------------
Male
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: lidocaine group<br>The study group receives perioperative lidocaine infusion with general anesthesia for robot-assisted prostatectomy | Drug: lidocaine group<br>* lidocaine 1.5 mg/kg bolus (infused over 10 min) followed by 2.0 mg/kg/h during operation and 1.0 mg/kg/h during postoperative 24 hours (no more than 120 mg/h)<br>* Other names: lidocaine;|
| Placebo Comparator: control group<br>The control group receives normal saline infusion with with general anesthesia for robot-assisted prostatectomy | Drug: control group<br>* normal saline 0.15 ml bolus followed by 0.2 ml/kg/hr during operation and 0.1 ml/kg/hr during postoperative 24 hours<br>* Other names: normal saline;|
What is the study measuring?
-----------------
Primary Outcome Measures
| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Concentration of citrullinated histone3 | This will be obtained using ELISA. | 24 hours after surgery |
Secondary Outcome Measures
| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Concentration of meyloperoxidase | This will be obtained using ELISA. | 24 hours after surgery |
| Concentration of neutrophil elastase | This will be obtained using ELISA. | 24 hours after surgery |
|
|
NCT00891527
|
Pilot Study Using Avastin and Gleevec to Treat the Progression of Intraluminal Pulmonary Vein Stenosis
|
The objective of this study is to conduct a pilot study using biologic agents Avastin and Gleevec to treat progression of multivessel intraluminal pulmonary vein stenosis in children.
|
Intraluminal pulmonary vein stenosis is rare but life threatening disease that affects both infants and children. It can be isolated to a single pulmonary vein, but most often occurs in multiple vessels simultaneously. It can occur as a complicating feature of complex congenital heart disease, but can also occur in isolation in infants with otherwise normal hearts. Response to conventional surgical or transcatheter-based therapies is usually short-lived. Typically within 3 to 4 weeks the obstruction recurs. Repeat surgical attempts provide only temporary relief and eventually all of these infants die without lung transplantation.~While the cause of this disease is unknown the mechanism of progressive obstruction has recently been determined through biopsy and autopsy reviews to result from neo-proliferative cells identified as myofibroblasts which have cell markers VEGF and PDGF. Chemotherapeutic agents Avastin and Gleevec have shown to inhibit myo-proliferation through these markers. The overall objective of this protocol is to conduct a pilot study using the biologic agents Avastin and Gleevec to treat progression of intraluminal pulmonary vein stenosis (PVS). From this pilot group of 10 patients we will attempt to provide an enhanced characterization of the progressive primary disease process, as well as its secondary manifestations. Results will be analyzed descriptively; data gathered from this pilot study will be used to inform further study examining safety and efficacy outcomes. Initial study was limited to 10 patients, but was later expanded to 50 enrolled patients.~The study objectives will be accomplished by achievement of the following Specific Aims:~To describe the feasibility of administration of Gleevec® with or without Avastin® to treat the progression of intraluminal PVS in patients with multivessel disease. Patients with PVS in conjunction with congenital heart disease (CHD) will receive Gleevec® alone, with Avastin® added if significant progression occurs; patients with primary PVS and PVS in conjunction with lung disease will be treated with both drugs simultaneously.~To characterize the time to progression and the proportion of patients who survive 48 weeks after enrollment.~To describe the toxicity associated with administration of Gleevec® with or without Avastin® during a 48 week course of treatment among patients with multivessel PVS.~Patients will be treated with Gleevec® with or without Avastin® for a period of 48 weeks, and will be followed until 72 weeks. Clinical status will be assessed by serial lab testing, monthly echocardiography and lung scans, and baseline and q24 week CT angiography or angiography. Obstruction of individual pulmonary veins will be assessed using a standard score, and patients will be classified as stabilized, recurred or progressed based on changes in the individual vein scores.
|
Adjunct Targeted Biologic Inhibition in Children With Multivessel Intraluminal Pulmonary Vein Stenosis
|
Pulmonary Veno Occlusive Disease
|
* Drug: Bevacizumab (Avastin) and Imatinib Mesylate (Gleevec)
|
Eligibility Criteria: (Both groups)~Evidence of intraluminal pulmonary vein stenosis in > 1 vessel~Evidence of myofibroblast neo-proliferation, if biopsies were obtained~Acceptable organ function includes:~Creatinine < 1.5 x normal for age. Bilirubin < 1.5 x normal for age. ALT < or = 5x normal ANC > or = 1,500/mm3, Hemoglobin > or = 10g/dl, Platelets > or = 100,000/mm3.~Group A Eligibility Criteria: (begin treatment with Gleevec® only)~Significant concomitant congenital heart defect~Disease severity for each vessel Category 5 or lower or Category 6 or 7 in no more than 1 vessel~Group B Eligibility Criteria: (begin treatment with Gleevec® and Avastin®)~Primary PVS (i.e. without concomitant congenital heart defect or lung disease)~Significant concomitant lung disease~Patients with PVS and underlying CHD who have category 6 or 7 disease in at least 2 of their pulmonary veins even after surgical or cath-based interventions.~Accepted organ function includes:~Urine protein < 1
| null | 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 Survival at 48 Weeks | | 48 weeks |
|
| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Number of Patients With Disease Progression at 48 Weeks | Patients will be classified as having disease progression if at least 2 pulmonary veins have significantly worsened at 48 weeks. This determination is based on the study defined Pulmonary Vein Status Scale, which categorizes pulmonary veins on a scale from 1- None: No narrowing of the luminal contour, to 7- Distal atretic: Complete obliteration of the luminal contour extending >5mm within the vessel segment. | 48 weeks |
| Number of Patients With Disease Stabilization at 48 Weeks | | 48 weeks |
|
Pulmonary Vein Stenosis,, Avastin and Gleevec,, Targeting VEGF and PDGF
|
Bevacizumab, Imatinib Mesylate, Antineoplastic Agents, Immunological, Antineoplastic Agents, Angiogenesis Inhibitors, Angiogenesis Modulating Agents, Growth Substances, Physiological Effects of Drugs, Growth Inhibitors, Protein Kinase Inhibitors, Enzyme Inhibitors, Molecular Mechanisms of Pharmacological Action
|
| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Avastin and/or Gleevec<br>Patients were all treated with Gleevec (imatinib mesylate) and those without congenital heart disease and those who progressed were also treated with Avastin (bevacizumab). | Drug: Bevacizumab (Avastin) and Imatinib Mesylate (Gleevec)<br>* Imatinib Mesylate Orange to grayish orange, opaque, 100mg capsules dissolved in 50-100mls of mineral water or apple juice. Given at 340mg/m2 once daily, preferably with a meal.~Bevacizumab Clear to slightly opalescent liquid. Given at 10mg/kg once every 2 weeks IV. The calculated dose should be placed in an IV bag and diluted with 0.9% sodium chloride to obtain a final volume of 25-100mls. The vials contain no antibacterial preservatives. Once diluted, must be administered within 8 hrs. Initially administered over 90 mins. If no adverse reactions occur, 2nd dose administered over 60 mins. If still no adverse reactions, subsequent doses administered over 30 mins. If infusion-related adverse reactions occur, further infusions administered over the shortest period that was well tolerated.<br>* Other names: Imatinib Mesylate (Gleevec, STI571), NSC 716051, IND 61,135;|
|
Pilot Study Using Avastin and Gleevec to Treat the Progression of Intraluminal Pulmonary Vein Stenosis
Study Overview
=================
Brief Summary
-----------------
The objective of this study is to conduct a pilot study using biologic agents Avastin and Gleevec to treat progression of multivessel intraluminal pulmonary vein stenosis in children.
Detailed Description
-----------------
Intraluminal pulmonary vein stenosis is rare but life threatening disease that affects both infants and children. It can be isolated to a single pulmonary vein, but most often occurs in multiple vessels simultaneously. It can occur as a complicating feature of complex congenital heart disease, but can also occur in isolation in infants with otherwise normal hearts. Response to conventional surgical or transcatheter-based therapies is usually short-lived. Typically within 3 to 4 weeks the obstruction recurs. Repeat surgical attempts provide only temporary relief and eventually all of these infants die without lung transplantation. While the cause of this disease is unknown the mechanism of progressive obstruction has recently been determined through biopsy and autopsy reviews to result from neo-proliferative cells identified as myofibroblasts which have cell markers VEGF and PDGF. Chemotherapeutic agents Avastin and Gleevec have shown to inhibit myo-proliferation through these markers. The overall objective of this protocol is to conduct a pilot study using the biologic agents Avastin and Gleevec to treat progression of intraluminal pulmonary vein stenosis (PVS). From this pilot group of 10 patients we will attempt to provide an enhanced characterization of the progressive primary disease process, as well as its secondary manifestations. Results will be analyzed descriptively; data gathered from this pilot study will be used to inform further study examining safety and efficacy outcomes. Initial study was limited to 10 patients, but was later expanded to 50 enrolled patients. The study objectives will be accomplished by achievement of the following Specific Aims: To describe the feasibility of administration of Gleevec® with or without Avastin® to treat the progression of intraluminal PVS in patients with multivessel disease. Patients with PVS in conjunction with congenital heart disease (CHD) will receive Gleevec® alone, with Avastin® added if significant progression occurs; patients with primary PVS and PVS in conjunction with lung disease will be treated with both drugs simultaneously. To characterize the time to progression and the proportion of patients who survive 48 weeks after enrollment. To describe the toxicity associated with administration of Gleevec® with or without Avastin® during a 48 week course of treatment among patients with multivessel PVS. Patients will be treated with Gleevec® with or without Avastin® for a period of 48 weeks, and will be followed until 72 weeks. Clinical status will be assessed by serial lab testing, monthly echocardiography and lung scans, and baseline and q24 week CT angiography or angiography. Obstruction of individual pulmonary veins will be assessed using a standard score, and patients will be classified as stabilized, recurred or progressed based on changes in the individual vein scores.
Official Title
-----------------
Adjunct Targeted Biologic Inhibition in Children With Multivessel Intraluminal Pulmonary Vein Stenosis
Conditions
-----------------
Pulmonary Veno Occlusive Disease
Intervention / Treatment
-----------------
* Drug: Bevacizumab (Avastin) and Imatinib Mesylate (Gleevec)
Participation Criteria
=================
Eligibility Criteria
-----------------
Eligibility Criteria: (Both groups) Evidence of intraluminal pulmonary vein stenosis in > 1 vessel Evidence of myofibroblast neo-proliferation, if biopsies were obtained Acceptable organ function includes: Creatinine < 1.5 x normal for age. Bilirubin < 1.5 x normal for age. ALT < or = 5x normal ANC > or = 1,500/mm3, Hemoglobin > or = 10g/dl, Platelets > or = 100,000/mm3. Group A Eligibility Criteria: (begin treatment with Gleevec® only) Significant concomitant congenital heart defect Disease severity for each vessel Category 5 or lower or Category 6 or 7 in no more than 1 vessel Group B Eligibility Criteria: (begin treatment with Gleevec® and Avastin®) Primary PVS (i.e. without concomitant congenital heart defect or lung disease) Significant concomitant lung disease Patients with PVS and underlying CHD who have category 6 or 7 disease in at least 2 of their pulmonary veins even after surgical or cath-based interventions. Accepted organ function includes: Urine protein < 1
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: Avastin and/or Gleevec<br>Patients were all treated with Gleevec (imatinib mesylate) and those without congenital heart disease and those who progressed were also treated with Avastin (bevacizumab). | Drug: Bevacizumab (Avastin) and Imatinib Mesylate (Gleevec)<br>* Imatinib Mesylate Orange to grayish orange, opaque, 100mg capsules dissolved in 50-100mls of mineral water or apple juice. Given at 340mg/m2 once daily, preferably with a meal. Bevacizumab Clear to slightly opalescent liquid. Given at 10mg/kg once every 2 weeks IV. The calculated dose should be placed in an IV bag and diluted with 0.9% sodium chloride to obtain a final volume of 25-100mls. The vials contain no antibacterial preservatives. Once diluted, must be administered within 8 hrs. Initially administered over 90 mins. If no adverse reactions occur, 2nd dose administered over 60 mins. If still no adverse reactions, subsequent doses administered over 30 mins. If infusion-related adverse reactions occur, further infusions administered over the shortest period that was well tolerated.<br>* Other names: Imatinib Mesylate (Gleevec, STI571), NSC 716051, IND 61,135;|
What is the study measuring?
-----------------
Primary Outcome Measures
| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Number of Patients With Survival at 48 Weeks | | 48 weeks |
Secondary Outcome Measures
| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Number of Patients With Disease Progression at 48 Weeks | Patients will be classified as having disease progression if at least 2 pulmonary veins have significantly worsened at 48 weeks. This determination is based on the study defined Pulmonary Vein Status Scale, which categorizes pulmonary veins on a scale from 1- None: No narrowing of the luminal contour, to 7- Distal atretic: Complete obliteration of the luminal contour extending >5mm within the vessel segment. | 48 weeks |
| Number of Patients With Disease Stabilization at 48 Weeks | | 48 weeks |
Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Pulmonary Vein Stenosis,, Avastin and Gleevec,, Targeting VEGF and PDGF
|
NCT01895257
|
Comparing HAI-90Y (SIR-spheres)+Chemotx LV5FU2 Versus Chemotx LV5FU2 Alone to Treat Colorectal Cancer
|
The investigators propose to conduct a randomised phase III trial evaluating a maintenance strategy comparing hepatic arterial injection of Yttrium-90 resin microspheres plus continuing simplified chemotherapy with/without targeted therapy versus continuing simplified chemotherapy with/without targeted therapy alone for patient with dominant or exclusive and unresectable liver mCRC controlled after 3-6 months of chemotherapy induction.
|
The aim of the study is to investigate whether an intensified maintenance treatment of SIRT + simplified maintenance chemotherapy has a benefit in terms of time to progression (TTP) compared to simplified chemotherapy maintenance alone, in patients with stable disease after 3-6 months induction therapy. We would like to demonstrate the feasibility and safety of this approach and to investigate if this strategy has the potential to increase the outcome of the patient.~Primary end-point:~- Time to first progression (TTP1 overall)~Secondary end-points:~Time to global progression (TTP1 + TTP2), Time to second progression (TTP2), TTP1 liver only~Progression Free Survival (PFS)~Overall Survival (OS)~Safety~Ro resection rate~Quality of Life~Exploratory analysis:~- Prediction and evaluation of SIR-spheres treatment response (only for Belgian centres)
|
A Randomised Phase III Trial Comparing Hepatic Arterial Injection of Yttrium-90 Resin Microspheres (SIR-spheres) Plus Systemic Maintenance Therapy Versus Systemic Maintenance Therapy Alone for Patients With Unresectable Liver Metastases From Colorectal Cancer Which Are Controlled After Induction Systemic Therapy
|
Colorectal Cancer
|
* Device: HAI-90Y radioembolization (SIR-spheres injection)
* Drug: systemic chemotherapy LV5FU2
|
Inclusion criteria:~Willing and able to provide written informed consent~Histologically confirmed adenocarcinoma of the colon or rectum, with or without primary tumour in situ. Unequivocal and measurable (RECIST 1.1) CT evidence of liver metastases which are not treatable by surgical resection and/or local ablation with curative intent at the time of trial entry.~Partial response or stable disease (RECIST 1.1 criteria, controlled metastatic disease) after chemotherapy induction with oxaliplatin and/or irinotecan based induction chemotherapy (doublet or triplet combinations) +/- targeted therapies during 3 to 6 months.~Trial inclusion must be performed between 3 and 6 months since the date of the first course of chemotherapy (induction) administration.~Limited extra-hepatic metastases in the lung and/or lymph nodes are permitted. Metastases in the lung must either be not more than five nodules in number with no individual nodule more than 1 cm in diameter or 1 single lesion of up to 1.7 cm in diameter. Involvement of lymph nodes in 1 single anatomic region (pelvis, abdomen or chest) are permitted provided their longest diameter measures less than 2 cm.~All imaging evidence used as part of the screening process must be within 28 days prior to the time of randomisation.~Suitable for either treatment regimen as determined by clinical assessment undertaken by the Investigator.~Patients may have received adjuvant chemotherapy or (neo-) adjuvant chemo-radiotherapy to the pelvis, provided the last dose of chemotherapy was administered at least 6 months prior to begin chemotherapy induction. Previous radiotherapy to the pelvis is not an exclusion criterion.~WHO performance status 0 - 1~Adequate hematological, renal and hepatic function as follows:~Hematological Neutrophils > 1.5 x 109/L Platelets > 100 x 109/L Renal Creatinine < 1.5 x ULN (Upper Limit Normal) Hepatic Bilirubin ≤ 1.0 X ULN Albumin ≥ 30g/L ALT ≤ 5.0 x ULN AST ≤ 5.0 x ULN LDH ≤ 2.5 x ULN The date of blood tests must be within 28 days prior to the time of randomisation.~Age 18 years or older.~Female patients must either be postmenopausal, sterile (surgically or radiation- or chemically-induced), or if sexually active using an acceptable method of contraception.~Male patients must be surgically sterile or if sexually active and having a pre-menopausal partner must be using an acceptable method of contraception.~Life expectancy of at least 3 months without any active treatment.~Exclusion criteria~Evidence of ascites, cirrhosis, portal hypertension, main portal venous tumour involvement or thrombosis as determined by clinical or radiological assessment.~More than 6 months since last chemotherapy administration before trial inclusion.~Previous radiotherapy delivered to the upper abdomen.~Non-malignant disease that would render the patient unsuitable for treatment according to this protocol.~Prior major liver resection: remnant liver < 50% of the initial liver volume. Patient with a biliary stent can be included.~Liver tumor involvement > 80% before study inclusion (not at diagnosis but when trial inclusion for the patient is planned).~Resectable metastatic disease at trial inclusion.~Progressive disease during first-line metastatic chemotherapy. Adjuvant chemotherapy for colorectal cancer is not an exclusion criterion provided that it was completed more than 6 months prior to start of 1st line chemotherapy.~No oxaliplatin or irinotecan use during the first 3 to 6 months induction chemotherapy.~Pregnant or breast feeding.~Concurrent or prior history of cancer other than adequately treated non melanoma skin cancer or carcinoma in situ of the cervix.~Severe allergy to non-ionic contrast agents which would prevent contrast media use during the study.
|
18 Years
|
99 Years
|
All
|
No
|
Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
|
| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Time to progression (TTP1 overall) | Time to first progression (TTP1 overall) | Up to 36 months |
|
| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Time to global progression (TTP1 + TTP2) | - Time to global progression (TTP1 + TTP2), Time to second progression (TTP2), TTP1 liver only | Up to 42 months |
| PFS | Progression free survival | Up to 42 months |
| Safety | | Up to 42 months |
| R0 resection rate | | Up to 42 months |
| Quality of life | Using~EORTC QLQ C30~EQ-5D | Up to 42 months |
| Overall Survival (OS) | | Up to 42 months |
|
Safety, TTP1, TTP2, PFS, R0 resection rate, Quality of life, Overall Survival
|
Fluorouracil, Leucovorin, Levoleucovorin, Antidotes, Protective Agents, Physiological Effects of Drugs, Vitamin B Complex, Vitamins, Micronutrients, Antimetabolites, Molecular Mechanisms of Pharmacological Action, Antimetabolites, Antineoplastic, Antineoplastic Agents, Immunosuppressive Agents, Immunologic Factors
|
| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: A: systemic chemotherapy LV5FU2 alone<br>Modified LV5FU2 as described in protocol (6.2.1) D1-2 +/- bevacizumab or cetuximab or panitumumab (according its previous use) every 2 weeks | Drug: systemic chemotherapy LV5FU2<br>* Systemic chemotherapy with modified LV5FU2 will be administered according to the following regimen.~Cycle 1 onwards:~Day 1 Hour 0: Leucovorin L (levoleucovorin) 200 mg/m2 (or folinic acid 400 mg/m²) in 250 ml glucose 5%, 2-hour IV infusion Hour + 2: 5-FU bolus 400 mg/m2, IV bolus Hour + 2: 5-FU continuous infusion 2400 mg/m2, 46-hour cont. IV infusion Day 14 End of cycle. To be repeated every 14 days until evidence of treatment failure.<br>* Other names: 5-Fluoro-Uracil;|
| Active Comparator: B:SIR-spheres+systemic chemotherapy LV5FU2<br>ARM B: (Hepatic Arterial Infusion) HAI-90Y radioembolization (SIR-spheres injection) + modified LV5FU2 +/- bevacizumab or cetuximab or panitumumab according its previous use (refer to protocol). | Device: HAI-90Y radioembolization (SIR-spheres injection)<br>* Patients randomised to receive the combination of SIR-Spheres microspheres plus systemic chemotherapy LV5FU2 need to be assessed in order to determine their suitability for SIRT.~Hepatic Angiogram~Liver-Lung Break-Through Nuclear Scan<br>* Other names: SIRT;|
|
Comparing HAI-90Y (SIR-spheres)+Chemotx LV5FU2 Versus Chemotx LV5FU2 Alone to Treat Colorectal Cancer
Study Overview
=================
Brief Summary
-----------------
The investigators propose to conduct a randomised phase III trial evaluating a maintenance strategy comparing hepatic arterial injection of Yttrium-90 resin microspheres plus continuing simplified chemotherapy with/without targeted therapy versus continuing simplified chemotherapy with/without targeted therapy alone for patient with dominant or exclusive and unresectable liver mCRC controlled after 3-6 months of chemotherapy induction.
Detailed Description
-----------------
The aim of the study is to investigate whether an intensified maintenance treatment of SIRT + simplified maintenance chemotherapy has a benefit in terms of time to progression (TTP) compared to simplified chemotherapy maintenance alone, in patients with stable disease after 3-6 months induction therapy. We would like to demonstrate the feasibility and safety of this approach and to investigate if this strategy has the potential to increase the outcome of the patient. Primary end-point: - Time to first progression (TTP1 overall) Secondary end-points: Time to global progression (TTP1 + TTP2), Time to second progression (TTP2), TTP1 liver only Progression Free Survival (PFS) Overall Survival (OS) Safety Ro resection rate Quality of Life Exploratory analysis: - Prediction and evaluation of SIR-spheres treatment response (only for Belgian centres)
Official Title
-----------------
A Randomised Phase III Trial Comparing Hepatic Arterial Injection of Yttrium-90 Resin Microspheres (SIR-spheres) Plus Systemic Maintenance Therapy Versus Systemic Maintenance Therapy Alone for Patients With Unresectable Liver Metastases From Colorectal Cancer Which Are Controlled After Induction Systemic Therapy
Conditions
-----------------
Colorectal Cancer
Intervention / Treatment
-----------------
* Device: HAI-90Y radioembolization (SIR-spheres injection)
* Drug: systemic chemotherapy LV5FU2
Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion criteria: Willing and able to provide written informed consent Histologically confirmed adenocarcinoma of the colon or rectum, with or without primary tumour in situ. Unequivocal and measurable (RECIST 1.1) CT evidence of liver metastases which are not treatable by surgical resection and/or local ablation with curative intent at the time of trial entry. Partial response or stable disease (RECIST 1.1 criteria, controlled metastatic disease) after chemotherapy induction with oxaliplatin and/or irinotecan based induction chemotherapy (doublet or triplet combinations) +/- targeted therapies during 3 to 6 months. Trial inclusion must be performed between 3 and 6 months since the date of the first course of chemotherapy (induction) administration. Limited extra-hepatic metastases in the lung and/or lymph nodes are permitted. Metastases in the lung must either be not more than five nodules in number with no individual nodule more than 1 cm in diameter or 1 single lesion of up to 1.7 cm in diameter. Involvement of lymph nodes in 1 single anatomic region (pelvis, abdomen or chest) are permitted provided their longest diameter measures less than 2 cm. All imaging evidence used as part of the screening process must be within 28 days prior to the time of randomisation. Suitable for either treatment regimen as determined by clinical assessment undertaken by the Investigator. Patients may have received adjuvant chemotherapy or (neo-) adjuvant chemo-radiotherapy to the pelvis, provided the last dose of chemotherapy was administered at least 6 months prior to begin chemotherapy induction. Previous radiotherapy to the pelvis is not an exclusion criterion. WHO performance status 0 - 1 Adequate hematological, renal and hepatic function as follows: Hematological Neutrophils > 1.5 x 109/L Platelets > 100 x 109/L Renal Creatinine < 1.5 x ULN (Upper Limit Normal) Hepatic Bilirubin ≤ 1.0 X ULN Albumin ≥ 30g/L ALT ≤ 5.0 x ULN AST ≤ 5.0 x ULN LDH ≤ 2.5 x ULN The date of blood tests must be within 28 days prior to the time of randomisation. Age 18 years or older. Female patients must either be postmenopausal, sterile (surgically or radiation- or chemically-induced), or if sexually active using an acceptable method of contraception. Male patients must be surgically sterile or if sexually active and having a pre-menopausal partner must be using an acceptable method of contraception. Life expectancy of at least 3 months without any active treatment. Exclusion criteria Evidence of ascites, cirrhosis, portal hypertension, main portal venous tumour involvement or thrombosis as determined by clinical or radiological assessment. More than 6 months since last chemotherapy administration before trial inclusion. Previous radiotherapy delivered to the upper abdomen. Non-malignant disease that would render the patient unsuitable for treatment according to this protocol. Prior major liver resection: remnant liver < 50% of the initial liver volume. Patient with a biliary stent can be included. Liver tumor involvement > 80% before study inclusion (not at diagnosis but when trial inclusion for the patient is planned). Resectable metastatic disease at trial inclusion. Progressive disease during first-line metastatic chemotherapy. Adjuvant chemotherapy for colorectal cancer is not an exclusion criterion provided that it was completed more than 6 months prior to start of 1st line chemotherapy. No oxaliplatin or irinotecan use during the first 3 to 6 months induction chemotherapy. Pregnant or breast feeding. Concurrent or prior history of cancer other than adequately treated non melanoma skin cancer or carcinoma in situ of the cervix. Severe allergy to non-ionic contrast agents which would prevent contrast media use during the study.
Ages Eligible for Study
-----------------
Minimum Age: 18 Years
Maximum Age: 99 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: A: systemic chemotherapy LV5FU2 alone<br>Modified LV5FU2 as described in protocol (6.2.1) D1-2 +/- bevacizumab or cetuximab or panitumumab (according its previous use) every 2 weeks | Drug: systemic chemotherapy LV5FU2<br>* Systemic chemotherapy with modified LV5FU2 will be administered according to the following regimen. Cycle 1 onwards: Day 1 Hour 0: Leucovorin L (levoleucovorin) 200 mg/m2 (or folinic acid 400 mg/m²) in 250 ml glucose 5%, 2-hour IV infusion Hour + 2: 5-FU bolus 400 mg/m2, IV bolus Hour + 2: 5-FU continuous infusion 2400 mg/m2, 46-hour cont. IV infusion Day 14 End of cycle. To be repeated every 14 days until evidence of treatment failure.<br>* Other names: 5-Fluoro-Uracil;|
| Active Comparator: B:SIR-spheres+systemic chemotherapy LV5FU2<br>ARM B: (Hepatic Arterial Infusion) HAI-90Y radioembolization (SIR-spheres injection) + modified LV5FU2 +/- bevacizumab or cetuximab or panitumumab according its previous use (refer to protocol). | Device: HAI-90Y radioembolization (SIR-spheres injection)<br>* Patients randomised to receive the combination of SIR-Spheres microspheres plus systemic chemotherapy LV5FU2 need to be assessed in order to determine their suitability for SIRT. Hepatic Angiogram Liver-Lung Break-Through Nuclear Scan<br>* Other names: SIRT;|
What is the study measuring?
-----------------
Primary Outcome Measures
| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Time to progression (TTP1 overall) | Time to first progression (TTP1 overall) | Up to 36 months |
Secondary Outcome Measures
| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Time to global progression (TTP1 + TTP2) | - Time to global progression (TTP1 + TTP2), Time to second progression (TTP2), TTP1 liver only | Up to 42 months |
| PFS | Progression free survival | Up to 42 months |
| Safety | | Up to 42 months |
| R0 resection rate | | Up to 42 months |
| Quality of life | Using EORTC QLQ C30 EQ-5D | Up to 42 months |
| Overall Survival (OS) | | Up to 42 months |
Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Safety, TTP1, TTP2, PFS, R0 resection rate, Quality of life, Overall Survival
|
NCT03139708
|
The Effect of Brimonidine on Intraocular Pressure When Dilating Routine Patients
|
This an interventional study looking at two different sequences of pre-operative eye drops, to determine which order is more effective in reducing intraocular pressure with pupil dilation.
|
Twenty healthy participants will be separated into two groups of 10 volunteers each. In both groups, the participant's right eye will serve as a control with only Tropicamide/phenylephrine given. In one group of 10 participants the left eyes will receive Alphagan prior to Tropicamide/phenylephrine. In the other group of 10 eyes, the left eyes will have Tropicamide/phenylephrine administered prior to Alphagan. The investigator will observe the intraocular benefits of the addition of Alphagan over the Tropicamide/phenylephrine alone and determine if pre-treating is any better than post-treating. In addition, the investigator will monitor pupil response, as it is known that Alphagan may have some effect on the pupil dilation.
|
The Effect of Brimonidine on Intraocular Pressure When Dilating Routine Patients, Pressure Control and Pupil Effects
|
Intraocular Pressure
|
* Drug: Alphagan
* Drug: Phenylephrine
* Drug: Tropicamide
|
Inclusion Criteria:~Healthy with no major medical conditions. Contact lens wear is ok but must be not worn on the day of the study~Exclusion Criteria:~Diabetic, history of glaucoma~history of iris trauma~history of eye surgery except LASIK or Photorefractive keratectomy laser eye surgery~Anisocoria~pregnancy
|
18 Years
|
50 Years
|
All
|
Accepts Healthy Volunteers
|
Primary Purpose: Prevention
Allocation: Non-Randomized
Intervention Model: Parallel Assignment
Masking: Single
|
| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change in intraocular pressure from baseline to 15 min after last drop given, 30 min, 1 hour, and 4 hours. | Baseline (pre drops), 15 min after last drop given, 30 min, 1 hour, and 4 hours. | 5 time points all occuring during one time visit: Baseline (pre drops), 15 min after last drop given, 30 min, 1 hour, and 4 hours. |
|
| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change in pupil size pupil size from baseline to 15 min after last drop given, 30 min, 1 hour, and 4 hours. | Baseline (pre drop), 15 min after last drop given, 30 min, 1 hour, and 4 hours. The investigator will measure the pupils under bright light conditions (photopic) and dim light conditions (scotopic) | 5 time points all occuring during one time visit: Baseline (pre drops), 15 min after last drop given, 30 min, 1 hour, and 4 hours. |
| Change in pupil's reaction to light from baseline to 15 min after last drop given,30 min, 1 hour, and 4 hours. | Baseline (pre drop), 15 min after last drop given, 30 min, 1 hour, and 4 hours. Pupil reaction will be measure either as none, poor, or brisk. | 5 time points all occuring during one time visit: Baseline (pre drops), 15 min after last drop given, 30 min, 1 hour, and 4 hours. |
|
Mydriasis, Cycloplegics
|
Adrenergic Agonists, Adrenergic Agents, Sympathomimetics, Vasoconstrictor Agents, Brimonidine Tartrate, Phenylephrine, Oxymetazoline, Tropicamide, Cardiotonic Agents, Mydriatics, Autonomic Agents, Peripheral Nervous System Agents, Physiological Effects of Drugs, Nasal Decongestants, Respiratory System Agents, Adrenergic alpha-1 Receptor Agonists, Adrenergic alpha-Agonists, Neurotransmitter Agents, Molecular Mechanisms of Pharmacological Action, Protective Agents, Antihypertensive Agents, Adrenergic alpha-2 Receptor Agonists, Muscarinic Antagonists, Cholinergic Antagonists, Cholinergic Agents
|
| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Alphagan plus<br>Alphagan plus group is one drop Brimonidine then, Tropicamide and Phenylephrine ophthalmic one drop,times one. | Drug: Alphagan<br>* Arm: Experimental: Alphagan plus Alphagan plus group is one drop Brimonidine then, Tropicamide and Phenylephrine ophthalmic one drop,times one.~Arm: Experimental: Tropicamide and Phenylephrine plus Tropicamide and Phenylephrine plus intervention is one drop of each then Brimonidine one drop, times one.<br>* Other names: Brimonidine;Drug: Phenylephrine<br>* Arm: Experimental: Alphagan plus Alphagan plus group is one drop Brimonidine then, Tropicamide and Phenylephrine ophthalmic one drop,times one.~Arm: Experimental: Tropicamide and Phenylephrine plus Tropicamide and Phenylephrine plus intervention is one drop of each then Brimonidine one drop, times one.~Arm: Active Comparator: Tropicamide and Phenylephrine only Tropicamide and Phenylephrine only arm is given one drop of each times one.<br>Drug: Tropicamide<br>* Arm: Experimental: Alphagan plus Alphagan plus group is one drop Brimonidine then, Tropicamide and Phenylephrine ophthalmic one drop,times one.~Arm: Experimental: Tropicamide and Phenylephrine plus Tropicamide and Phenylephrine plus intervention is one drop of each then Brimonidine one drop, times one.~Arm: Active Comparator: Tropicamide and Phenylephrine only Tropicamide and Phenylephrine only arm is given one drop of each times one.<br>|
| Experimental: Tropicamide and Phenylephrine plus<br>Tropicamide and Phenylephrine plus intervention is one drop of each then Brimonidine one drop, times one. | Drug: Alphagan<br>* Arm: Experimental: Alphagan plus Alphagan plus group is one drop Brimonidine then, Tropicamide and Phenylephrine ophthalmic one drop,times one.~Arm: Experimental: Tropicamide and Phenylephrine plus Tropicamide and Phenylephrine plus intervention is one drop of each then Brimonidine one drop, times one.<br>* Other names: Brimonidine;Drug: Phenylephrine<br>* Arm: Experimental: Alphagan plus Alphagan plus group is one drop Brimonidine then, Tropicamide and Phenylephrine ophthalmic one drop,times one.~Arm: Experimental: Tropicamide and Phenylephrine plus Tropicamide and Phenylephrine plus intervention is one drop of each then Brimonidine one drop, times one.~Arm: Active Comparator: Tropicamide and Phenylephrine only Tropicamide and Phenylephrine only arm is given one drop of each times one.<br>Drug: Tropicamide<br>* Arm: Experimental: Alphagan plus Alphagan plus group is one drop Brimonidine then, Tropicamide and Phenylephrine ophthalmic one drop,times one.~Arm: Experimental: Tropicamide and Phenylephrine plus Tropicamide and Phenylephrine plus intervention is one drop of each then Brimonidine one drop, times one.~Arm: Active Comparator: Tropicamide and Phenylephrine only Tropicamide and Phenylephrine only arm is given one drop of each times one.<br>|
| Active Comparator: Tropicamide and Phenylephrine only<br>Tropicamide and Phenylephrine only arm is given one drop of each times one. | Drug: Phenylephrine<br>* Arm: Experimental: Alphagan plus Alphagan plus group is one drop Brimonidine then, Tropicamide and Phenylephrine ophthalmic one drop,times one.~Arm: Experimental: Tropicamide and Phenylephrine plus Tropicamide and Phenylephrine plus intervention is one drop of each then Brimonidine one drop, times one.~Arm: Active Comparator: Tropicamide and Phenylephrine only Tropicamide and Phenylephrine only arm is given one drop of each times one.<br>Drug: Tropicamide<br>* Arm: Experimental: Alphagan plus Alphagan plus group is one drop Brimonidine then, Tropicamide and Phenylephrine ophthalmic one drop,times one.~Arm: Experimental: Tropicamide and Phenylephrine plus Tropicamide and Phenylephrine plus intervention is one drop of each then Brimonidine one drop, times one.~Arm: Active Comparator: Tropicamide and Phenylephrine only Tropicamide and Phenylephrine only arm is given one drop of each times one.<br>|
|
The Effect of Brimonidine on Intraocular Pressure When Dilating Routine Patients
Study Overview
=================
Brief Summary
-----------------
This an interventional study looking at two different sequences of pre-operative eye drops, to determine which order is more effective in reducing intraocular pressure with pupil dilation.
Detailed Description
-----------------
Twenty healthy participants will be separated into two groups of 10 volunteers each. In both groups, the participant's right eye will serve as a control with only Tropicamide/phenylephrine given. In one group of 10 participants the left eyes will receive Alphagan prior to Tropicamide/phenylephrine. In the other group of 10 eyes, the left eyes will have Tropicamide/phenylephrine administered prior to Alphagan. The investigator will observe the intraocular benefits of the addition of Alphagan over the Tropicamide/phenylephrine alone and determine if pre-treating is any better than post-treating. In addition, the investigator will monitor pupil response, as it is known that Alphagan may have some effect on the pupil dilation.
Official Title
-----------------
The Effect of Brimonidine on Intraocular Pressure When Dilating Routine Patients, Pressure Control and Pupil Effects
Conditions
-----------------
Intraocular Pressure
Intervention / Treatment
-----------------
* Drug: Alphagan
* Drug: Phenylephrine
* Drug: Tropicamide
Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Healthy with no major medical conditions. Contact lens wear is ok but must be not worn on the day of the study Exclusion Criteria: Diabetic, history of glaucoma history of iris trauma history of eye surgery except LASIK or Photorefractive keratectomy laser eye surgery Anisocoria pregnancy
Ages Eligible for Study
-----------------
Minimum Age: 18 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: Non-Randomized
Intervention Model: Parallel Assignment
Masking: Single
Arms and Interventions
| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Alphagan plus<br>Alphagan plus group is one drop Brimonidine then, Tropicamide and Phenylephrine ophthalmic one drop,times one. | Drug: Alphagan<br>* Arm: Experimental: Alphagan plus Alphagan plus group is one drop Brimonidine then, Tropicamide and Phenylephrine ophthalmic one drop,times one. Arm: Experimental: Tropicamide and Phenylephrine plus Tropicamide and Phenylephrine plus intervention is one drop of each then Brimonidine one drop, times one.<br>* Other names: Brimonidine;Drug: Phenylephrine<br>* Arm: Experimental: Alphagan plus Alphagan plus group is one drop Brimonidine then, Tropicamide and Phenylephrine ophthalmic one drop,times one. Arm: Experimental: Tropicamide and Phenylephrine plus Tropicamide and Phenylephrine plus intervention is one drop of each then Brimonidine one drop, times one. Arm: Active Comparator: Tropicamide and Phenylephrine only Tropicamide and Phenylephrine only arm is given one drop of each times one.<br>Drug: Tropicamide<br>* Arm: Experimental: Alphagan plus Alphagan plus group is one drop Brimonidine then, Tropicamide and Phenylephrine ophthalmic one drop,times one. Arm: Experimental: Tropicamide and Phenylephrine plus Tropicamide and Phenylephrine plus intervention is one drop of each then Brimonidine one drop, times one. Arm: Active Comparator: Tropicamide and Phenylephrine only Tropicamide and Phenylephrine only arm is given one drop of each times one.<br>|
| Experimental: Tropicamide and Phenylephrine plus<br>Tropicamide and Phenylephrine plus intervention is one drop of each then Brimonidine one drop, times one. | Drug: Alphagan<br>* Arm: Experimental: Alphagan plus Alphagan plus group is one drop Brimonidine then, Tropicamide and Phenylephrine ophthalmic one drop,times one. Arm: Experimental: Tropicamide and Phenylephrine plus Tropicamide and Phenylephrine plus intervention is one drop of each then Brimonidine one drop, times one.<br>* Other names: Brimonidine;Drug: Phenylephrine<br>* Arm: Experimental: Alphagan plus Alphagan plus group is one drop Brimonidine then, Tropicamide and Phenylephrine ophthalmic one drop,times one. Arm: Experimental: Tropicamide and Phenylephrine plus Tropicamide and Phenylephrine plus intervention is one drop of each then Brimonidine one drop, times one. Arm: Active Comparator: Tropicamide and Phenylephrine only Tropicamide and Phenylephrine only arm is given one drop of each times one.<br>Drug: Tropicamide<br>* Arm: Experimental: Alphagan plus Alphagan plus group is one drop Brimonidine then, Tropicamide and Phenylephrine ophthalmic one drop,times one. Arm: Experimental: Tropicamide and Phenylephrine plus Tropicamide and Phenylephrine plus intervention is one drop of each then Brimonidine one drop, times one. Arm: Active Comparator: Tropicamide and Phenylephrine only Tropicamide and Phenylephrine only arm is given one drop of each times one.<br>|
| Active Comparator: Tropicamide and Phenylephrine only<br>Tropicamide and Phenylephrine only arm is given one drop of each times one. | Drug: Phenylephrine<br>* Arm: Experimental: Alphagan plus Alphagan plus group is one drop Brimonidine then, Tropicamide and Phenylephrine ophthalmic one drop,times one. Arm: Experimental: Tropicamide and Phenylephrine plus Tropicamide and Phenylephrine plus intervention is one drop of each then Brimonidine one drop, times one. Arm: Active Comparator: Tropicamide and Phenylephrine only Tropicamide and Phenylephrine only arm is given one drop of each times one.<br>Drug: Tropicamide<br>* Arm: Experimental: Alphagan plus Alphagan plus group is one drop Brimonidine then, Tropicamide and Phenylephrine ophthalmic one drop,times one. Arm: Experimental: Tropicamide and Phenylephrine plus Tropicamide and Phenylephrine plus intervention is one drop of each then Brimonidine one drop, times one. Arm: Active Comparator: Tropicamide and Phenylephrine only Tropicamide and Phenylephrine only arm is given one drop of each times one.<br>|
What is the study measuring?
-----------------
Primary Outcome Measures
| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change in intraocular pressure from baseline to 15 min after last drop given, 30 min, 1 hour, and 4 hours. | Baseline (pre drops), 15 min after last drop given, 30 min, 1 hour, and 4 hours. | 5 time points all occuring during one time visit: Baseline (pre drops), 15 min after last drop given, 30 min, 1 hour, and 4 hours. |
Secondary Outcome Measures
| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change in pupil size pupil size from baseline to 15 min after last drop given, 30 min, 1 hour, and 4 hours. | Baseline (pre drop), 15 min after last drop given, 30 min, 1 hour, and 4 hours. The investigator will measure the pupils under bright light conditions (photopic) and dim light conditions (scotopic) | 5 time points all occuring during one time visit: Baseline (pre drops), 15 min after last drop given, 30 min, 1 hour, and 4 hours. |
| Change in pupil's reaction to light from baseline to 15 min after last drop given,30 min, 1 hour, and 4 hours. | Baseline (pre drop), 15 min after last drop given, 30 min, 1 hour, and 4 hours. Pupil reaction will be measure either as none, poor, or brisk. | 5 time points all occuring during one time visit: Baseline (pre drops), 15 min after last drop given, 30 min, 1 hour, and 4 hours. |
Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Mydriasis, Cycloplegics
|
NCT01238380
|
Using Pharmacogenetics to Improve Treatment in Early-onset Diabetes
|
Monogenic diabetes is an unusual form of diabetes. It usually presents in patients under the age of 30, so is often misdiagnosed as Type 1 diabetes which is more common. Patients with monogenic diabetes can often be treated with tablets rather than insulin injections, leading to better control of their diabetes, and fewer side-effects and complications. Less than 5% of people with monogenic diabetes in the UK have been identified, meaning up to 20,000 patients may still be misdiagnosed and receiving inappropriate treatment. We want to identify the best way of ensuring that people diagnosed with diabetes under the age of 30 have all the necessary tests to ensure they have the correct treatment for their particular type of diabetes. A small number of people may, as part of this study, be found to have a specific genetic cause of their diabetes and in these cases we will measure the success and benefits of changing their treatment, usually from insulin injections to sulphonylurea tablets.
|
Aim:The aim of this project is to identify a patient pathway which ensures that patients with young-onset diabetes (diagnosed <30 years) have a systematic series of investigations which allow for appropriate genetic testing and hence appropriate alteration of therapy if required.~Objectives:~To establish and test a care pathway to detect monogenic diabetes in patients with diabetes diagnosed before the age of 30 years and currently under the age of 50 years. This will indicate the prevalence of monogenic diabetes.~To measure the success, cost and potential economic benefit of changing the treatment of those patients identified with monogenic diabetes from their initial therapy, typically insulin injections, to appropriate treatment, usually oral sulphonylureas.~To obtain the necessary data to enable the development of an appropriate health economic model.~This project will provide evidence for a cost-based model for a systematic care pathway for the diagnosis and treatment of diabetes diagnosed < 30 years. The pathway will select subjects by clinical, biochemical (urinary C peptide) and immunological (pancreatic autoantibodies) criteria for genetic testing. The present approach relies on clinicians recognising the possibility of a monogenic cause and arranging genetic testing. In the UK less than 5% of the estimated cases of monogenic diabetes have been identified and this means that up to 20,000 diabetic patients are receiving inappropriate treatment. Patients confirmed by molecular genetic testing to have monogenic diabetes may benefit from changing from insulin and other therapies, to treatment with sulphonylurea tablets or diet alone. Systematic targeted use of molecular genetic testing in young-onset diabetes will result in stratified treatment according to aetiology with improved efficacy, quality of life and long term complication risk, while reducing side effects and cost.~This project aims to develop a pathway of testing in patients diagnosed under the age of 30 years, to identify those who should receive genetic testing. This will consist of three stages: 1) a urine test that can determine if a patient is making their own insulin; 2) for those who are making their own insulin, a further blood test will be carried out testing for antibodies which are seen in Type 1 diabetes; 3) in those who are negative for the antibodies, a genetic test will be carried out to determine whether they have monogenic diabetes. Individuals who are found to have monogenic diabetes may have their treatment changed.~Project Plan This project will be based in Exeter and undertaken in collaboration with colleagues at Ninewells Hospital Trust and the University of Dundee in Scotland. Within the defined geographical regions of Tayside and Devon, all patients with diabetes diagnosed under 30 years of age, and who are currently aged less than 50 years, will be invited to participate in the study. We estimate that from a total population of 800,000 (400,000 in Devon and 400,000 in Tayside) a potential group of 3,000 patients will be identified, of which approximately 90% (n=2700) are likely to be insulin treated.~Initial procedure following recruitment:~Participants will be provided with a written patient information sheet, a consent form, a urine sample container and written instructions for sample collection. Baseline data will be collected either face to face or by telephone by a member of the research team. Participants will be asked to provide a single urine sample 2 hours after their main meal of the day. Baseline data on all subjects will include age, age at diagnosis, duration of diabetes, height, weight, initial/current treatment, and any family history of diabetes. Permission to access their medical records will be obtained in order to clarify or confirm relevant clinical data. The participant will be asked to return the completed consent form and the urine sample to the research team or through routine NHS courier service if samples are returned to local GPs.~In Tayside, patients with a clinical diagnosis of Type 1 diabetes, aged over 16 years old, will initially be recruited into the Scottish Diabetes Research Network Type 1 Diabetes Bioresource (Ethics ref: 10/S140243). Those diagnosed under 30 years of age, who are currently aged less than 50 years old, will be asked to return a post-meal urine sample to the research team and will proceed as for other UNITED study participants.~Following this initial urine test, participants found to be UCPCR negative will be informed of their result via a standardised letter. This will complete their involvement with the project.~Participants found to be UCPCR positive will be informed of their result by a member of the research team and given the opportunity to discuss the implications for the next stage of the project.~UCPCR positive patients:~Participants will be invited to the Peninsula Clinical Research Facility (PCRF), Ninewells Clinical Research Centre (NCRC), or a suitable local venue where blood samples for pancreatic auto-antibodies (GAD and IA2), DNA extraction and HbA1c will be taken by a member of the research team.~Following this initial antibody screen those participants found to be antibody positive will be informed of their result via a standardised letter (Stage2/GADpos/Vs1/0810). This will complete their involvement with the project.~Those participants found to be antibody negative will be informed of their result in person by a member of the research team and given the opportunity to discuss the implications for the next stage of the project.~UCPCR positive and Antibody negative patients:~Participants who are now known to be UCPCR positive and antibody negative will be offered genetic screening for monogenic diabetes. Information will be provided by the research team, who will be trained in genetic counselling, about the implications of genetic testing and the possible consequences of a positive or negative result for the individual and in the case of a positive result the implications for other family members.~Those participants found to be negative following genetic screening will be informed of their result by a member of the research team. This will be followed up by a standardised letter (Stage2/neg-gen-test/Vs1/0810) and this will complete their involvement with the project.~Those participants with a positive result following genetic screening will be informed of their results in person by a member of the research team, and given the opportunity to discuss the implications for the next stage of the project.~The participants in the subsequent stages of the project are those now defined as:~UCPCR positive~antibody negative~confirmed to have a diagnosis of monogenic diabetes following molecular genetic testing.~It is anticipated that participants may require a review and revision of their current treatment. This review will be by the NHS Clinician who manages the participant's diabetes. They will be informed by NHS Clinical experts in monogenic diabetes.~Transfer of patients identified with monogenic diabetes to alternative treatment Following the review, all participants who are not on the appropriate treatment will be transferred to sulphonylureas for HNF1A/HNF4A and no treatment for GCK mutations. As these subjects will only be identified after they have gone through the screening program, in order to increase numbers in this part of the project and to enable accurate assessment of potential costs and benefits of the transfer, we will also recruit patients for this assessment by including patients with monogenic diabetes diagnosed outside of the project. At present the diagnostic lab is identifying approximately 10 new UK patients per month. Referring Clinicians will be sent written information on the project via a standardised letter (MODY referring Clinician covering letter - Vs1/0810) which will accompany test result. Participants identified through this route will allow us to recruit additional patients to ensure that there are sufficient data to achieve good confidence limits for the estimates required for the future development of a health economic model.~The assessment of success of treatment transfer on glycaemic control and quality of life:~Participants will be asked to fill in baseline standardised questionnaires (ADDQoL, EQ5D and the DTSQs) to assess patient reported outcomes including: the impact of diabetes on their quality of life, their current health status and their treatment satisfaction while on their current treatment. Child participants be asked to fill in age appropriate versions of the study questionnaires: the ADDQoL-Teen,(for teenagers up to 16 years), the ADDQoL-Junior (for 5-8 year olds), ADDQoL- Junior Plus (for 9-12 year olds), the EQ-5D youth/children (age 7-12 years), DTSQ-Teen (teenagers up to 16 years of age). Where appropriate those with parental responsibility will be asked to provide information by completing the DTSQ-Parent.~Following treatment change, participants will be followed up by the diabetes specialist research nurses as often as the participant requires in order to assess their treatment needs, or to provide emotional support. This may initially be daily for the first week, then tailing off gradually as the individual becomes confident on their new treatment and their blood glucose levels stablise. The timings will be dependent on individual need.~Post treatment questionnaire follow up:~1 month - repeat DTSQs and EQ5D 6 month - repeat DTSQs and EQ5D and ADDQoL 12 months repeat DTSQs followed by DTSQc, EQ5D and ADDQoL.~Blood samples for HbA1C will be taken at 3, 6 and 12 months.~Participant involvement in the study will be complete 12 months following initial treatment change. During this 12 month period the clinical care of these participants will remain the responsibility of their NHS clinician. These clinicians will be informed by NHS experts in monogenic diabetes.~Development of Heath Economic model prototype A health economic model will be developed to compare the likely costs and effects of the new care pathway with current practice. This will be informed by a systematic review of the current relevant economic literature and build on existing economic models for diabetes. It will also be informed by results from this project.~Funding:This study has been funded by a grant from the Health Innovation Challenge Fund (HICF) which is a joint venture between the Department of Health and the Wellcome Trust. Project funding will be administered by the University of Exeter. A collaboration agreement between the University of Exeter and the University of Dundee will be established to determine the distribution of funding between the two organisations.
|
Using Pharmacogenetics to Improve Treatment in Early-onset Diabetes
|
Diabetes
|
* Other: patient care pathway
|
Inclusion Criteria:~clinical diagnosis of diabetes~diagnosed under 30 years of ages~current age less than 50 years~willing and able to provide informed consent.~Exclusion Criteria:~age over 50 years~age at diagnosis over 30 years~adult with incapacity to consent~child with incapacity to assent
| null |
50 Years
|
All
|
No
|
| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Identification of patients with monogenic diabetes | The aim of this project is to identify the prevalence of patients with monogenic diabetes resulting from mutations in the HNF1A/HNF4A/GCK genes, amongst patients with early-onset diabetes, diagnosed less than 30 years. | Within 4 years from start of project |
|
| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| To examine the impact of making a diagnosis of monogenic diabetes on patients' treatment, glucose control and quality of life. | To measure the impact of making a molecular genetic diagnosis of monogenic diabetes by examining at baseline, 1 month, 6 months and 12 months the following parameters:~i) treatment - both type and dose; ii) glucose control - measured by HbA1c at 3, 6 and 12 months post-treatment change; iii) quality of life - by appropriate protocols. | Within 4 years of the project start date. |
| To develop a health economic model of the care pathway leading to testing of monogenic diabetes. | To develop a health economic model that can measure the success, cost and potential economic benefit of using the care pathway to identify patients with monogenic diabetes and potentially change their treatment. This will allow assessment of when testing is appropriate on health economic grounds. | Within 4 years of the project start date. |
|
Monogenic diabetes, HNF1A, HNF4A, GCK, genetic testing, health economic model
|
Diabetes Mellitus, Glucose Metabolism Disorders, Metabolic Diseases, Endocrine System Diseases
|
| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Diabetes diagnosed under 30 years<br>Patients currently under 50 years of age diagnosed with diabetes under 30 years. | Other: patient care pathway<br>* Stage 1: Urinary c-peptide creatinine ratio (UCPCR); if positive progress to Stage 2.~Stage 2: Pancreatic auto-antibodies measurement (GAD65 & IA2); if negative progress to genetic testing.~Genetic testing for HNF1A, HNF4A, GCK. If positive, progress to Stage 3.~Stage 3: review and potential change of diabetes treatment. Monitor success via use of three standardised health and quality of life questionnaires and Hba1c pre-treatment change and at 1, 3, 6 and 12 months post-treatment change.<br>|
|
Using Pharmacogenetics to Improve Treatment in Early-onset Diabetes
Study Overview
=================
Brief Summary
-----------------
Monogenic diabetes is an unusual form of diabetes. It usually presents in patients under the age of 30, so is often misdiagnosed as Type 1 diabetes which is more common. Patients with monogenic diabetes can often be treated with tablets rather than insulin injections, leading to better control of their diabetes, and fewer side-effects and complications. Less than 5% of people with monogenic diabetes in the UK have been identified, meaning up to 20,000 patients may still be misdiagnosed and receiving inappropriate treatment. We want to identify the best way of ensuring that people diagnosed with diabetes under the age of 30 have all the necessary tests to ensure they have the correct treatment for their particular type of diabetes. A small number of people may, as part of this study, be found to have a specific genetic cause of their diabetes and in these cases we will measure the success and benefits of changing their treatment, usually from insulin injections to sulphonylurea tablets.
Detailed Description
-----------------
Aim:The aim of this project is to identify a patient pathway which ensures that patients with young-onset diabetes (diagnosed <30 years) have a systematic series of investigations which allow for appropriate genetic testing and hence appropriate alteration of therapy if required. Objectives: To establish and test a care pathway to detect monogenic diabetes in patients with diabetes diagnosed before the age of 30 years and currently under the age of 50 years. This will indicate the prevalence of monogenic diabetes. To measure the success, cost and potential economic benefit of changing the treatment of those patients identified with monogenic diabetes from their initial therapy, typically insulin injections, to appropriate treatment, usually oral sulphonylureas. To obtain the necessary data to enable the development of an appropriate health economic model. This project will provide evidence for a cost-based model for a systematic care pathway for the diagnosis and treatment of diabetes diagnosed < 30 years. The pathway will select subjects by clinical, biochemical (urinary C peptide) and immunological (pancreatic autoantibodies) criteria for genetic testing. The present approach relies on clinicians recognising the possibility of a monogenic cause and arranging genetic testing. In the UK less than 5% of the estimated cases of monogenic diabetes have been identified and this means that up to 20,000 diabetic patients are receiving inappropriate treatment. Patients confirmed by molecular genetic testing to have monogenic diabetes may benefit from changing from insulin and other therapies, to treatment with sulphonylurea tablets or diet alone. Systematic targeted use of molecular genetic testing in young-onset diabetes will result in stratified treatment according to aetiology with improved efficacy, quality of life and long term complication risk, while reducing side effects and cost. This project aims to develop a pathway of testing in patients diagnosed under the age of 30 years, to identify those who should receive genetic testing. This will consist of three stages: 1) a urine test that can determine if a patient is making their own insulin; 2) for those who are making their own insulin, a further blood test will be carried out testing for antibodies which are seen in Type 1 diabetes; 3) in those who are negative for the antibodies, a genetic test will be carried out to determine whether they have monogenic diabetes. Individuals who are found to have monogenic diabetes may have their treatment changed. Project Plan This project will be based in Exeter and undertaken in collaboration with colleagues at Ninewells Hospital Trust and the University of Dundee in Scotland. Within the defined geographical regions of Tayside and Devon, all patients with diabetes diagnosed under 30 years of age, and who are currently aged less than 50 years, will be invited to participate in the study. We estimate that from a total population of 800,000 (400,000 in Devon and 400,000 in Tayside) a potential group of 3,000 patients will be identified, of which approximately 90% (n=2700) are likely to be insulin treated. Initial procedure following recruitment: Participants will be provided with a written patient information sheet, a consent form, a urine sample container and written instructions for sample collection. Baseline data will be collected either face to face or by telephone by a member of the research team. Participants will be asked to provide a single urine sample 2 hours after their main meal of the day. Baseline data on all subjects will include age, age at diagnosis, duration of diabetes, height, weight, initial/current treatment, and any family history of diabetes. Permission to access their medical records will be obtained in order to clarify or confirm relevant clinical data. The participant will be asked to return the completed consent form and the urine sample to the research team or through routine NHS courier service if samples are returned to local GPs. In Tayside, patients with a clinical diagnosis of Type 1 diabetes, aged over 16 years old, will initially be recruited into the Scottish Diabetes Research Network Type 1 Diabetes Bioresource (Ethics ref: 10/S140243). Those diagnosed under 30 years of age, who are currently aged less than 50 years old, will be asked to return a post-meal urine sample to the research team and will proceed as for other UNITED study participants. Following this initial urine test, participants found to be UCPCR negative will be informed of their result via a standardised letter. This will complete their involvement with the project. Participants found to be UCPCR positive will be informed of their result by a member of the research team and given the opportunity to discuss the implications for the next stage of the project. UCPCR positive patients: Participants will be invited to the Peninsula Clinical Research Facility (PCRF), Ninewells Clinical Research Centre (NCRC), or a suitable local venue where blood samples for pancreatic auto-antibodies (GAD and IA2), DNA extraction and HbA1c will be taken by a member of the research team. Following this initial antibody screen those participants found to be antibody positive will be informed of their result via a standardised letter (Stage2/GADpos/Vs1/0810). This will complete their involvement with the project. Those participants found to be antibody negative will be informed of their result in person by a member of the research team and given the opportunity to discuss the implications for the next stage of the project. UCPCR positive and Antibody negative patients: Participants who are now known to be UCPCR positive and antibody negative will be offered genetic screening for monogenic diabetes. Information will be provided by the research team, who will be trained in genetic counselling, about the implications of genetic testing and the possible consequences of a positive or negative result for the individual and in the case of a positive result the implications for other family members. Those participants found to be negative following genetic screening will be informed of their result by a member of the research team. This will be followed up by a standardised letter (Stage2/neg-gen-test/Vs1/0810) and this will complete their involvement with the project. Those participants with a positive result following genetic screening will be informed of their results in person by a member of the research team, and given the opportunity to discuss the implications for the next stage of the project. The participants in the subsequent stages of the project are those now defined as: UCPCR positive antibody negative confirmed to have a diagnosis of monogenic diabetes following molecular genetic testing. It is anticipated that participants may require a review and revision of their current treatment. This review will be by the NHS Clinician who manages the participant's diabetes. They will be informed by NHS Clinical experts in monogenic diabetes. Transfer of patients identified with monogenic diabetes to alternative treatment Following the review, all participants who are not on the appropriate treatment will be transferred to sulphonylureas for HNF1A/HNF4A and no treatment for GCK mutations. As these subjects will only be identified after they have gone through the screening program, in order to increase numbers in this part of the project and to enable accurate assessment of potential costs and benefits of the transfer, we will also recruit patients for this assessment by including patients with monogenic diabetes diagnosed outside of the project. At present the diagnostic lab is identifying approximately 10 new UK patients per month. Referring Clinicians will be sent written information on the project via a standardised letter (MODY referring Clinician covering letter - Vs1/0810) which will accompany test result. Participants identified through this route will allow us to recruit additional patients to ensure that there are sufficient data to achieve good confidence limits for the estimates required for the future development of a health economic model. The assessment of success of treatment transfer on glycaemic control and quality of life: Participants will be asked to fill in baseline standardised questionnaires (ADDQoL, EQ5D and the DTSQs) to assess patient reported outcomes including: the impact of diabetes on their quality of life, their current health status and their treatment satisfaction while on their current treatment. Child participants be asked to fill in age appropriate versions of the study questionnaires: the ADDQoL-Teen,(for teenagers up to 16 years), the ADDQoL-Junior (for 5-8 year olds), ADDQoL- Junior Plus (for 9-12 year olds), the EQ-5D youth/children (age 7-12 years), DTSQ-Teen (teenagers up to 16 years of age). Where appropriate those with parental responsibility will be asked to provide information by completing the DTSQ-Parent. Following treatment change, participants will be followed up by the diabetes specialist research nurses as often as the participant requires in order to assess their treatment needs, or to provide emotional support. This may initially be daily for the first week, then tailing off gradually as the individual becomes confident on their new treatment and their blood glucose levels stablise. The timings will be dependent on individual need. Post treatment questionnaire follow up: 1 month - repeat DTSQs and EQ5D 6 month - repeat DTSQs and EQ5D and ADDQoL 12 months repeat DTSQs followed by DTSQc, EQ5D and ADDQoL. Blood samples for HbA1C will be taken at 3, 6 and 12 months. Participant involvement in the study will be complete 12 months following initial treatment change. During this 12 month period the clinical care of these participants will remain the responsibility of their NHS clinician. These clinicians will be informed by NHS experts in monogenic diabetes. Development of Heath Economic model prototype A health economic model will be developed to compare the likely costs and effects of the new care pathway with current practice. This will be informed by a systematic review of the current relevant economic literature and build on existing economic models for diabetes. It will also be informed by results from this project. Funding:This study has been funded by a grant from the Health Innovation Challenge Fund (HICF) which is a joint venture between the Department of Health and the Wellcome Trust. Project funding will be administered by the University of Exeter. A collaboration agreement between the University of Exeter and the University of Dundee will be established to determine the distribution of funding between the two organisations.
Official Title
-----------------
Using Pharmacogenetics to Improve Treatment in Early-onset Diabetes
Conditions
-----------------
Diabetes
Intervention / Treatment
-----------------
* Other: patient care pathway
Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: clinical diagnosis of diabetes diagnosed under 30 years of ages current age less than 50 years willing and able to provide informed consent. Exclusion Criteria: age over 50 years age at diagnosis over 30 years adult with incapacity to consent child with incapacity to assent
Ages Eligible for Study
-----------------
Maximum Age: 50 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 |
| --- | --- |
| Diabetes diagnosed under 30 years<br>Patients currently under 50 years of age diagnosed with diabetes under 30 years. | Other: patient care pathway<br>* Stage 1: Urinary c-peptide creatinine ratio (UCPCR); if positive progress to Stage 2. Stage 2: Pancreatic auto-antibodies measurement (GAD65 & IA2); if negative progress to genetic testing. Genetic testing for HNF1A, HNF4A, GCK. If positive, progress to Stage 3. Stage 3: review and potential change of diabetes treatment. Monitor success via use of three standardised health and quality of life questionnaires and Hba1c pre-treatment change and at 1, 3, 6 and 12 months post-treatment change.<br>|
What is the study measuring?
-----------------
Primary Outcome Measures
| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Identification of patients with monogenic diabetes | The aim of this project is to identify the prevalence of patients with monogenic diabetes resulting from mutations in the HNF1A/HNF4A/GCK genes, amongst patients with early-onset diabetes, diagnosed less than 30 years. | Within 4 years from start of project |
Secondary Outcome Measures
| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| To examine the impact of making a diagnosis of monogenic diabetes on patients' treatment, glucose control and quality of life. | To measure the impact of making a molecular genetic diagnosis of monogenic diabetes by examining at baseline, 1 month, 6 months and 12 months the following parameters: i) treatment - both type and dose; ii) glucose control - measured by HbA1c at 3, 6 and 12 months post-treatment change; iii) quality of life - by appropriate protocols. | Within 4 years of the project start date. |
| To develop a health economic model of the care pathway leading to testing of monogenic diabetes. | To develop a health economic model that can measure the success, cost and potential economic benefit of using the care pathway to identify patients with monogenic diabetes and potentially change their treatment. This will allow assessment of when testing is appropriate on health economic grounds. | Within 4 years of the project start date. |
Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Monogenic diabetes, HNF1A, HNF4A, GCK, genetic testing, health economic model
|
|
NCT04123132
|
Evaluation of Kinesophobia in Patients With Metabolic Syndrome
|
Metabolic syndrome (MS) is a public health problem characterized by central obesity, increased blood pressure and triglyceride levels, decreased blood HDL levels and the presence of insulin resistance (1).Kinesiophobia is a fear of irrational movement that develops because of its belief in susceptibility to injury and is associated with low levels of physical activity. Considering that exercise improves metabolic processes in people with MS, we aimed to evaluate the presence of kinesophobia in patients with MS.~Patients aged 45-65 years diagnosed with metabolic syndrome and healthy controls will be included in the study. Patients with rheumatic and neurological diseases,history of trauma, gonarthrosis, lumbar disc hernia, previous fractures, fibromyalgia and those who have experienced pain for the last week will be excluded. The participants will be filled in the Short Form-36 (SF-36), the Hospital Anxiety and Depression Scale, and the Tampa Kinesiophobia Scale. 48 patients with MS and 48 healthy participants will be included in the study.
|
Evaluation of Kinesophobia in Patients With Metabolic Syndrome
|
Kinesiophobia, Metabolic Syndrome
|
* Other: Kinesiophobia
|
Inclusion Criteria:~Patients with metabolic syndrome~Exclusion Criteria:~Patients with rheumatic disease~Patients with neurologic disease~Patients with history of trauma~Patients with gonartrosis~Pateints with fibromialgia
|
45 Years
|
65 Years
|
All
|
Accepts Healthy Volunteers
|
| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Tampa Kinesiophobia Scale | People takes between 17-68 total a score. The score of the person shows high kinesiophobia on the scale | 3 months |
|
kinesiophobia, metabolic syndrome, exercise
|
Insulin Resistance, Hyperinsulinism, Glucose Metabolism Disorders, Metabolic Diseases, Metabolic Syndrome, Syndrome, Kinesiophobia, Disease, Pathologic Processes, Phobic Disorders, Anxiety Disorders, Mental Disorders
|
| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Patients with metabolic syndrome<br> | Other: Kinesiophobia<br>* The presence of kinesiofobia in patients with metabolic syndrome<br>|
| Healthy controls<br> | |
|
Evaluation of Kinesophobia in Patients With Metabolic Syndrome
Study Overview
=================
Brief Summary
-----------------
Metabolic syndrome (MS) is a public health problem characterized by central obesity, increased blood pressure and triglyceride levels, decreased blood HDL levels and the presence of insulin resistance (1).Kinesiophobia is a fear of irrational movement that develops because of its belief in susceptibility to injury and is associated with low levels of physical activity. Considering that exercise improves metabolic processes in people with MS, we aimed to evaluate the presence of kinesophobia in patients with MS. Patients aged 45-65 years diagnosed with metabolic syndrome and healthy controls will be included in the study. Patients with rheumatic and neurological diseases,history of trauma, gonarthrosis, lumbar disc hernia, previous fractures, fibromyalgia and those who have experienced pain for the last week will be excluded. The participants will be filled in the Short Form-36 (SF-36), the Hospital Anxiety and Depression Scale, and the Tampa Kinesiophobia Scale. 48 patients with MS and 48 healthy participants will be included in the study.
Official Title
-----------------
Evaluation of Kinesophobia in Patients With Metabolic Syndrome
Conditions
-----------------
Kinesiophobia, Metabolic Syndrome
Intervention / Treatment
-----------------
* Other: Kinesiophobia
Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Patients with metabolic syndrome Exclusion Criteria: Patients with rheumatic disease Patients with neurologic disease Patients with history of trauma Patients with gonartrosis Pateints with fibromialgia
Ages Eligible for Study
-----------------
Minimum Age: 45 Years
Maximum Age: 65 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 |
| --- | --- |
| Patients with metabolic syndrome<br> | Other: Kinesiophobia<br>* The presence of kinesiofobia in patients with metabolic syndrome<br>|
| Healthy controls<br> | |
What is the study measuring?
-----------------
Primary Outcome Measures
| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Tampa Kinesiophobia Scale | People takes between 17-68 total a score. The score of the person shows high kinesiophobia on the scale | 3 months |
Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
kinesiophobia, metabolic syndrome, exercise
|
|||
NCT01198977
|
Telehealth-Based Exercise Program to Treat Fatigue in MS
|
This is a clinical trial examining a brief motivational intervention to improve adherence to exercise among individuals with MS to improve fatigue.
|
This is a 2-arm single blind parallel group RCT comparing a brief telephone based motivational intervention to an informational control to improve adherence to exercise among individuals with MS. The primary outcome is improvement in fatigue.
|
Telehealth-Based Exercise Program to Treat Fatigue in MS
|
Multiple Sclerosis
|
* Behavioral: Brief telephone-based counseling
* Other: Education counseling
|
Inclusion Criteria:~Multiple Sclerosis~Veteran receiving services in VA VISN 20~Fatigue~Ability to ambulate~cell phone or Household phone line~Individual with multiple sclerosis verified by MS provider~ambulatory~Exclusion Criteria:~Current alcohol dependence or other substance dependence~No working phone
|
18 Years
|
80 Years
|
All
|
No
|
Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single
|
| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Fatigue | Modified Fatigue Inventory Scale (MFIS) at baseline, 3-month, 6-month MFIS consisted of 21 items, ranging from 0 (never) to 4 (almost always). The total score was 0 to 84. | baseline, 3 months, 6 months |
|
| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Depression | Depression Module of the Patient Health Questionnaire (PHQ-9). 9-item self-report instrument designed to identify depressive symptoms consistent with criteria for major depressive episode in the Diagnostic and Statistical Manual for Mental Disorders, 4th Edition. Each item is rated over the last 2 weeks: 0 (not at all), 1 (several days), 2 (more than half the days), or 3 (nearly every day).~Total Score for 9 items = 27. | baseline, 3 months, 6 months |
|
multiple sclerosis, Fatigue, exercise, telemedicine, motivational interviewing, counseling, depression, physical activity
|
Nervous System Diseases, Demyelinating Diseases, Autoimmune Diseases, Immune System Diseases, Multiple Sclerosis, Sclerosis, Fatigue, Pathologic Processes, Demyelinating Autoimmune Diseases, CNS, Autoimmune Diseases of the Nervous System
|
| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: Brief telephone-based counseling<br>Telephone based counseling and instructional video | Behavioral: Brief telephone-based counseling<br>* Brief telephone-based counseling using Motivational Interviewing and physical activity goal setting and problem solving<br>|
| Placebo Comparator: Education Counseling<br>Mailed Physical Activity information and instructional video only | Other: Education counseling<br>* Mailed informational video of exercise programs<br>|
|
Telehealth-Based Exercise Program to Treat Fatigue in MS
Study Overview
=================
Brief Summary
-----------------
This is a clinical trial examining a brief motivational intervention to improve adherence to exercise among individuals with MS to improve fatigue.
Detailed Description
-----------------
This is a 2-arm single blind parallel group RCT comparing a brief telephone based motivational intervention to an informational control to improve adherence to exercise among individuals with MS. The primary outcome is improvement in fatigue.
Official Title
-----------------
Telehealth-Based Exercise Program to Treat Fatigue in MS
Conditions
-----------------
Multiple Sclerosis
Intervention / Treatment
-----------------
* Behavioral: Brief telephone-based counseling
* Other: Education counseling
Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Multiple Sclerosis Veteran receiving services in VA VISN 20 Fatigue Ability to ambulate cell phone or Household phone line Individual with multiple sclerosis verified by MS provider ambulatory Exclusion Criteria: Current alcohol dependence or other substance dependence No working phone
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: Single
Arms and Interventions
| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: Brief telephone-based counseling<br>Telephone based counseling and instructional video | Behavioral: Brief telephone-based counseling<br>* Brief telephone-based counseling using Motivational Interviewing and physical activity goal setting and problem solving<br>|
| Placebo Comparator: Education Counseling<br>Mailed Physical Activity information and instructional video only | Other: Education counseling<br>* Mailed informational video of exercise programs<br>|
What is the study measuring?
-----------------
Primary Outcome Measures
| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Fatigue | Modified Fatigue Inventory Scale (MFIS) at baseline, 3-month, 6-month MFIS consisted of 21 items, ranging from 0 (never) to 4 (almost always). The total score was 0 to 84. | baseline, 3 months, 6 months |
Secondary Outcome Measures
| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Depression | Depression Module of the Patient Health Questionnaire (PHQ-9). 9-item self-report instrument designed to identify depressive symptoms consistent with criteria for major depressive episode in the Diagnostic and Statistical Manual for Mental Disorders, 4th Edition. Each item is rated over the last 2 weeks: 0 (not at all), 1 (several days), 2 (more than half the days), or 3 (nearly every day). Total Score for 9 items = 27. | baseline, 3 months, 6 months |
Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
multiple sclerosis, Fatigue, exercise, telemedicine, motivational interviewing, counseling, depression, physical activity
|
NCT05081817
|
Accuracy Comparison of Two CGMs in Hospitalized Patients
|
The purpose of the study is to determine the accuracy of two different continuous blood sugar monitoring systems in hospitalized patients by comparing them standard laboratory blood sugar testing in the hospital.
|
Comparative Accuracy of Two Subcutaneous Continuous Glucose Monitoring Devices in Hospitalized Patients Requiring Continuous Intravenous Insulin Infusion
|
Type 1 Diabetes, Type 2 Diabetes
|
Inclusion Criteria:~All genders, admitted to UC San Diego Hillcrest Medical Center with an anticipated remaining length of stay of ≥24 hours~Age ≥18 years at the time of consent~Requiring standard of care intravenous insulin infusion therapy at the time of consent with an anticipated duration of intravenous insulin infusion ≥12 hours~Willingness to provide informed consent and follow all study procedures~Exclusion Criteria:~Current bleeding disorder, treatment with anticoagulants, or platelet count below 50,000/mL at enrollment~Lack of appropriate sites for sensor placement (sites must be free of scars, skin irritation, surgical wounds, dressings, etc.)~Planned magnetic resonance imaging (MRI) study within 24 hours of enrollment~Any other condition that, based on Investigator's judgment, would jeopardize patient safety during trial participation or would affect the study outcome
|
18 Years
| null |
All
|
No
|
| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Difference in glucose measurement | Difference between glucose as measured by continuous glucose monitor versus laboratory | 5 Days |
|
Diabetes Mellitus, Glucose Metabolism Disorders, Metabolic Diseases, Endocrine System Diseases
|
| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| ICU<br>ICU patients on insulin drip | |
|
Accuracy Comparison of Two CGMs in Hospitalized Patients
Study Overview
=================
Brief Summary
-----------------
The purpose of the study is to determine the accuracy of two different continuous blood sugar monitoring systems in hospitalized patients by comparing them standard laboratory blood sugar testing in the hospital.
Official Title
-----------------
Comparative Accuracy of Two Subcutaneous Continuous Glucose Monitoring Devices in Hospitalized Patients Requiring Continuous Intravenous Insulin Infusion
Conditions
-----------------
Type 1 Diabetes, Type 2 Diabetes
Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: All genders, admitted to UC San Diego Hillcrest Medical Center with an anticipated remaining length of stay of ≥24 hours Age ≥18 years at the time of consent Requiring standard of care intravenous insulin infusion therapy at the time of consent with an anticipated duration of intravenous insulin infusion ≥12 hours Willingness to provide informed consent and follow all study procedures Exclusion Criteria: Current bleeding disorder, treatment with anticoagulants, or platelet count below 50,000/mL at enrollment Lack of appropriate sites for sensor placement (sites must be free of scars, skin irritation, surgical wounds, dressings, etc.) Planned magnetic resonance imaging (MRI) study within 24 hours of enrollment Any other condition that, based on Investigator's judgment, would jeopardize patient safety during trial participation or would affect the study outcome
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 |
| --- | --- |
| ICU<br>ICU patients on insulin drip | |
What is the study measuring?
-----------------
Primary Outcome Measures
| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Difference in glucose measurement | Difference between glucose as measured by continuous glucose monitor versus laboratory | 5 Days |
|
|||||
NCT03859076
|
UH3 Phase - Mindfulness-Based Blood Pressure Reduction (MB-BP) : Stage 2a RCT
|
The primary aim is to identify the impacts of a behavioral intervention called Mindfulness-Based Blood Pressure Reduction (MB-BP) vs. enhanced usual care on the primary self-regulation target, specifically an assay of self-related processes (Multidimensional Assessment of Interoceptive Awareness) (MAIA) at 6 months, via a randomized controlled trial.
|
Effects of mindfulness interventions customized for prehypertensive/hypertensive patients are poorly understood. Until methodologically rigorous studies to evaluate customized interventions for hypertension are performed, it will be unknown whether the observed preliminary effects of general mindfulness interventions on blood pressure reduction could be much more effective with a tailored approach. Consequently, this study proposes to conduct a behavioral intervention study to evaluate whether Mindfulness-Based Stress Reduction (MBSR) customized to prehypertensive and hypertensive patients has the potential to provide clinically relevant reductions in blood pressure.~This customized intervention is called Mindfulness-Based Blood Pressure Reduction (MB-BP). The study follows the NIH Stage Model for Behavioral Intervention Development, where targets likely proximally affected by the intervention are identified, that should also have effect on the longer-term outcomes (e.g. blood pressure, mortality). The selected targets, consistent with theoretical frameworks and early evidence how mindfulness interventions could influence mental and physical health outcomes, are measures of self-regulation including (1) attention control (specifically the Sustained Attention Response Task and Mindful Attention Awareness Scale), (2) emotion regulation (specifically the Pittsburgh Stress Battery and the Perceived Stress Scale), and (3) self-awareness (specifically the Heart Beat Detection Task and Multidimensional Assessment of Interoceptive Awareness). Based on the degree of target engagement, MB-BP can be further customized to better engage with the targets as needed.
|
Mindfulness Based Blood Pressure Reduction: Stage 2a Randomized Controlled Trial
|
Hypertension, Prehypertension
|
* Behavioral: MB-BP
* Other: Enhanced Usual Care Control
|
Inclusion Criteria:~Elevated blood pressure or hypertension defined as ≥120 mmHg systolic or ≥80 mmHg diastolic pressure.~Able to speak, read, and write in English.~All adults (≥18 years of age), genders and racial/ethnic groups are eligible to be included.~Exclusion Criteria:~Exclusion criteria follow standard guidelines and recommendations:~current regular mindfulness meditation practice (>once/week)~serious medical illness or cognitive condition (e.g., dementia) precluding regular class attendance and/or participation~current substance abuse, suicidal ideation or eating disorder~history of bipolar or psychotic disorders or self-injurious behaviors.
|
18 Years
| null |
All
|
No
|
Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Triple
|
| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Self-Regulation Primary Outcome: Multidimensional Assessment of Interoceptive Awareness (MAIA) | a validated measure of body awareness - a 32 item self-report measure composed of the following 8 subscales: (i) Noticing, (ii) Not-Distracting, (iii) Not-Worrying, (iv) Attention Regulation, (v) Emotional Awareness, (vi) Self-Regulation, (vii) Body Listening, and (viii) Trusting. Individuals rate items using a 6 point Likert scale from 0 ('Never') to 5 ('Always'). Total scores are obtained through reverse coding items 5, 6, 7, 8, 9 and summing all items. Higher scores indicate higher levels of positive awareness. | 6 month follow-up |
|
| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Heartbeat Detection Task | Behavioral measure of self-awareness | Baseline, 10 weeks, 6 months |
| Interoceptive Awareness fMRI Task | Those who elect to take part in the fMRI study will undergo an fMRI scanning session for approximately 40 minutes. Scans will be acquired with a 3T scanner while the subject is in the resting state. Participants will undergo a separate informed consent and screening process for the fMRI imaging, so that they can be in the MB-BP study without imaging if they prefer. | Baseline, 10-week follow-up |
| Difficulties in Emotion Regulation Scale (DERS) | Behavioral measure of emotion regulation - The Difficulties in Emotion Regulation Scale is a 36-item self-report measure of six facets of emotion regulation. Items are rated on a scale of 1-5, with 1 being (almost never [0-10%]); 2 (sometimes [11-35%]); 3 (about half the time [36-65%]); 4 (most of the time [66-90%]); and 5 being (almost always [91-100%]). Higher scores indicate more difficulty in emotion regulation. | Baseline, 10 weeks, 6 months |
| Pittsburgh Stress Battery | Behavioral measure of stress reactivity | Baseline, 10 weeks, 6 months |
| Perceived Stress Scale (PSS-14) | 14-item self-report measure of perceived stress - Participants indicate how often they have found their lives unpredictable, uncontrollable, and overloaded in the last month. Items are rated on a 4 point Likert scale with 0 being (Never); 1 (Almost Never); 2 (Sometimes); 3 (Fairly often) and 4 (Very often). PSS-14 scores are obtained by reversing the scores on the seven positive items, e.g., 0=4, 1=3, 2=2, etc., and then summing across all 14 items. Items 4, 5, 6, 7, 9, 10, and 13 are the positively stated items. | Baseline, 10 weeks, 6 months |
| Anxiety Symptoms - self-report | Assessed via the Beck Anxiety Inventory (BAI) scale. The BAI is a 21-item self-report measure of anxiety. Participants indicate how much they have been bothered by an anxiety symptom during the past month. Items are rated on a 3-point Likert scale with 0 being Never); 2 (Mildly but it didn't bother me much); 2 (Moderately - it wasn't pleasant at times); 3 (Severely- it bothered me a lot). The total score is calculated by finding the sum of the 21 items. A score of 0-21= low anxiety, Score of 22-35 = moderate anxiety, Score of 36 and above = potentially concerning levels of anxiety. | Baseline, 10 weeks, 6 months |
| Depressive Symptoms - self-report | Assessed via Center for Epidemiologic Studies Depression Scale Revised (CESD-R). The CESD-R is a 20-item self-report measure of depression in nine different groups according to the DSM-5. The symptom groups are Sadness (items 2,4,6), Loss of Interest (items 8, 10), Appetite (1,18), Sleep (5,11,19), Thinking/Concentration (3,20), Guilt (9,17), Tired (7,16), Movement (12,13), and Suicidal Ideation (14,15). Response values for each question are 0 (Not at all or less than one day); 1 (1-2 days); 2 (3-4 days); 3 (5-7 days); 4 (Nearly every day for 2 weeks). The total score is calculated as a sum of responses to all 20 questions. | Baseline, 10 weeks, 6 months |
| Sustained Attention to Response Task (SART) | Behavioral measure of attention control - The Sustained Attention to Response Task (SART) is a computer-based go/no-go task that requires participants to withhold behavioral response to a single, infrequent target (often the digit 3) presented amongst a background of frequent non-targets (0-2, 4-9). After each block, two probe questions are presented in succession. The first asks, Where was your attention focused during this block of trials? Participants respond on a 6-point Likert scale, where 1 represents, on task, and 6, off task. A second question asks, How aware were you of where your attention was during this block of trials? Participants respond on a similar scale, where 1 represents, aware, and 6, unaware. | 6 month follow-up |
| Self-Compassion | Assessed using the 12-item validated Self-Compassion Scale Short Form (SCS-SF); Participants indicate how they typically act towards themselves in difficult times using a 5-point Likert scale with 1 being Almost Never to 5 being Almost Always. The total self-compassion score is calculated by reverse scoring the negative subscale items -self-judgment, isolation, and over-identification (i.e., 1 = 5, 2 = 4, 3 = 3, 4 = 2, 5 = 1) then computing a total mean. | 6 months |
| Self-Efficacy | Assessed using the validated Self-Control Scale short form and the SECD-6 Scale. The Self Control Scale measures self-control. The scale consists of 36 items, measured on a scale from 1, not at all like me to 5, very much like me. | Baseline, 10 weeks, 6 months |
| Dietary Approaches to Stop Hypertension (DASH)-consistent diet | Self-report via Willet Food Frequency Questionnaire. Participants are asked to fill in the circle indicating how often on average they have used the food item during the past year. Response categories include Never, or less than once per month, 1-3 per month; 1 per week; 2-4 per week; 5-6 per week; 1 per day; 2-3 per day; 4-5 per day; 6+ per day. | 6 month follow-up |
| Alcohol consumption - self report | Self-report via Willet Food Frequency Questionnaire. Participants are asked to fill in the circle indicating how often on average they have used the food item during the past year. Response categories include Never, or less than once per month, 1-3 per month; 1 per week; 2-4 per week; 5-6 per week; 1 per day; 2-3 per day; 4-5 per day; 6+ per day. | 6 month-follow up |
| Electronically-Measured Antihypertensive Medication Adherence | Measured continuously using electronic medication bottle caps (eCAPS, Ottawa, Canada) | 6 months |
| Body Mass Index | Height and weight directly assessed using standard epidemiologic methods, with change evaluated in participants considered overweight or obese (BMI≥25kg/m) | Baseline, 10 weeks, 6 months |
| Physical Activity - self report | Assessed via the International Physical Activity Questionnaire (IPAQ). The IPAQ is a 27-item self-reported measure of physical activity. Duration (minutes) and frequency (days) of physical activity in the last seven days is measured in 5 domains (1: job related; 2: transportation; 3: housework, house maintenance, caring for family; 4: Recreation, sport, and leisure time; 5: Time spent sitting). Overall score is calculated using responses to all questions. Amount of physical activity places participant in 1 of 3 categories: 1) Low/inactive; 2) Moderate; 3) High. | Baseline, 10 weeks, 6 months |
|
mindfulness, blood pressure, hypertension, prehypertension, self regulation, Science of Behavior Change, attention control, self awareness, emotion regulation
|
Hypertension, Prehypertension, Vascular Diseases, Cardiovascular Diseases
|
| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: MB-BP Intervention<br>MB-BP customizes Mindfulness-Based Stress Reduction (MBSR) to participants with hypertension. It consists of nine 2.5-hour weekly group sessions & a 7.5-hour one-day session. Content includes education on hypertension risk factors, hypertension health effects, & specific mindfulness modules focused on awareness of BP determinants such as diet, physical activity, anti-hypertensive medication adherence, alcohol consumption, & stress reactivity. Students learn a range of mindfulness skills (body scan exercises, meditation and yoga). Participants are given a home BP monitor. Participants with uncontrolled hypertension are offered to have their physicians notified; for those without a physician, the investigator works to provide access within health insurance constraints. | Behavioral: MB-BP<br>* MB-BP customizes Mindfulness-Based Stress Reduction (MBSR) to participants with hypertension. It consists of nine 2.5-hour weekly group sessions & a 7.5-hour one-day session. Content includes education on hypertension risk factors, hypertension health effects, & specific mindfulness modules focused on awareness of BP determinants such as diet, physical activity, anti-hypertensive medication adherence, alcohol consumption, & stress reactivity. Students learn a range of mindfulness skills (body scan exercises, meditation and yoga). Participants are given a home BP monitor. Participants with uncontrolled hypertension are offered to have their physicians notified; for those without a physician, the investigator works to provide access within health insurance constraints.<br>|
| Active Comparator: Enhanced Usual Care Control<br>Those in the control group receive an educational brochure from the American Heart Association (product code 50-1731) and a validated home blood pressure monitor (Omron, Model PB786N), that has an evidence-based approach to lower blood pressure. All participants who have uncontrolled hypertension (blood pressure >140/90 mmHg) will be offered to have their physicians notified, if not already being overseen for it. For participants with uncontrolled hypertension who do not have a physician, the investigator works to provide access within constraints of their health insurance. Additionally, participants randomized to the control group are asked to refrain from engaging in any type of formal mindfulness practice more than weekly during the first six months of study involvement. | Other: Enhanced Usual Care Control<br>* Those in the control group receive an educational brochure from the American Heart Association (product code 50-1731) and a validated home blood pressure monitor (Omron, Model PB786N), that has an evidence-based approach to lower blood pressure. All participants who have uncontrolled hypertension (blood pressure >140/90 mmHg) will be offered to have their physicians notified, if not already being overseen for it. For participants with uncontrolled hypertension who do not have a physician, the investigator works to provide access within constraints of their health insurance. Additionally, participants randomized to the control group are asked to refrain from engaging in any type of formal mindfulness practice more than weekly during the first six months of study involvement.<br>|
|
UH3 Phase - Mindfulness-Based Blood Pressure Reduction (MB-BP) : Stage 2a RCT
Study Overview
=================
Brief Summary
-----------------
The primary aim is to identify the impacts of a behavioral intervention called Mindfulness-Based Blood Pressure Reduction (MB-BP) vs. enhanced usual care on the primary self-regulation target, specifically an assay of self-related processes (Multidimensional Assessment of Interoceptive Awareness) (MAIA) at 6 months, via a randomized controlled trial.
Detailed Description
-----------------
Effects of mindfulness interventions customized for prehypertensive/hypertensive patients are poorly understood. Until methodologically rigorous studies to evaluate customized interventions for hypertension are performed, it will be unknown whether the observed preliminary effects of general mindfulness interventions on blood pressure reduction could be much more effective with a tailored approach. Consequently, this study proposes to conduct a behavioral intervention study to evaluate whether Mindfulness-Based Stress Reduction (MBSR) customized to prehypertensive and hypertensive patients has the potential to provide clinically relevant reductions in blood pressure. This customized intervention is called Mindfulness-Based Blood Pressure Reduction (MB-BP). The study follows the NIH Stage Model for Behavioral Intervention Development, where targets likely proximally affected by the intervention are identified, that should also have effect on the longer-term outcomes (e.g. blood pressure, mortality). The selected targets, consistent with theoretical frameworks and early evidence how mindfulness interventions could influence mental and physical health outcomes, are measures of self-regulation including (1) attention control (specifically the Sustained Attention Response Task and Mindful Attention Awareness Scale), (2) emotion regulation (specifically the Pittsburgh Stress Battery and the Perceived Stress Scale), and (3) self-awareness (specifically the Heart Beat Detection Task and Multidimensional Assessment of Interoceptive Awareness). Based on the degree of target engagement, MB-BP can be further customized to better engage with the targets as needed.
Official Title
-----------------
Mindfulness Based Blood Pressure Reduction: Stage 2a Randomized Controlled Trial
Conditions
-----------------
Hypertension, Prehypertension
Intervention / Treatment
-----------------
* Behavioral: MB-BP
* Other: Enhanced Usual Care Control
Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Elevated blood pressure or hypertension defined as ≥120 mmHg systolic or ≥80 mmHg diastolic pressure. Able to speak, read, and write in English. All adults (≥18 years of age), genders and racial/ethnic groups are eligible to be included. Exclusion Criteria: Exclusion criteria follow standard guidelines and recommendations: current regular mindfulness meditation practice (>once/week) serious medical illness or cognitive condition (e.g., dementia) precluding regular class attendance and/or participation current substance abuse, suicidal ideation or eating disorder history of bipolar or psychotic disorders or self-injurious behaviors.
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: Triple
Arms and Interventions
| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: MB-BP Intervention<br>MB-BP customizes Mindfulness-Based Stress Reduction (MBSR) to participants with hypertension. It consists of nine 2.5-hour weekly group sessions & a 7.5-hour one-day session. Content includes education on hypertension risk factors, hypertension health effects, & specific mindfulness modules focused on awareness of BP determinants such as diet, physical activity, anti-hypertensive medication adherence, alcohol consumption, & stress reactivity. Students learn a range of mindfulness skills (body scan exercises, meditation and yoga). Participants are given a home BP monitor. Participants with uncontrolled hypertension are offered to have their physicians notified; for those without a physician, the investigator works to provide access within health insurance constraints. | Behavioral: MB-BP<br>* MB-BP customizes Mindfulness-Based Stress Reduction (MBSR) to participants with hypertension. It consists of nine 2.5-hour weekly group sessions & a 7.5-hour one-day session. Content includes education on hypertension risk factors, hypertension health effects, & specific mindfulness modules focused on awareness of BP determinants such as diet, physical activity, anti-hypertensive medication adherence, alcohol consumption, & stress reactivity. Students learn a range of mindfulness skills (body scan exercises, meditation and yoga). Participants are given a home BP monitor. Participants with uncontrolled hypertension are offered to have their physicians notified; for those without a physician, the investigator works to provide access within health insurance constraints.<br>|
| Active Comparator: Enhanced Usual Care Control<br>Those in the control group receive an educational brochure from the American Heart Association (product code 50-1731) and a validated home blood pressure monitor (Omron, Model PB786N), that has an evidence-based approach to lower blood pressure. All participants who have uncontrolled hypertension (blood pressure >140/90 mmHg) will be offered to have their physicians notified, if not already being overseen for it. For participants with uncontrolled hypertension who do not have a physician, the investigator works to provide access within constraints of their health insurance. Additionally, participants randomized to the control group are asked to refrain from engaging in any type of formal mindfulness practice more than weekly during the first six months of study involvement. | Other: Enhanced Usual Care Control<br>* Those in the control group receive an educational brochure from the American Heart Association (product code 50-1731) and a validated home blood pressure monitor (Omron, Model PB786N), that has an evidence-based approach to lower blood pressure. All participants who have uncontrolled hypertension (blood pressure >140/90 mmHg) will be offered to have their physicians notified, if not already being overseen for it. For participants with uncontrolled hypertension who do not have a physician, the investigator works to provide access within constraints of their health insurance. Additionally, participants randomized to the control group are asked to refrain from engaging in any type of formal mindfulness practice more than weekly during the first six months of study involvement.<br>|
What is the study measuring?
-----------------
Primary Outcome Measures
| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Self-Regulation Primary Outcome: Multidimensional Assessment of Interoceptive Awareness (MAIA) | a validated measure of body awareness - a 32 item self-report measure composed of the following 8 subscales: (i) Noticing, (ii) Not-Distracting, (iii) Not-Worrying, (iv) Attention Regulation, (v) Emotional Awareness, (vi) Self-Regulation, (vii) Body Listening, and (viii) Trusting. Individuals rate items using a 6 point Likert scale from 0 ('Never') to 5 ('Always'). Total scores are obtained through reverse coding items 5, 6, 7, 8, 9 and summing all items. Higher scores indicate higher levels of positive awareness. | 6 month follow-up |
Secondary Outcome Measures
| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Heartbeat Detection Task | Behavioral measure of self-awareness | Baseline, 10 weeks, 6 months |
| Interoceptive Awareness fMRI Task | Those who elect to take part in the fMRI study will undergo an fMRI scanning session for approximately 40 minutes. Scans will be acquired with a 3T scanner while the subject is in the resting state. Participants will undergo a separate informed consent and screening process for the fMRI imaging, so that they can be in the MB-BP study without imaging if they prefer. | Baseline, 10-week follow-up |
| Difficulties in Emotion Regulation Scale (DERS) | Behavioral measure of emotion regulation - The Difficulties in Emotion Regulation Scale is a 36-item self-report measure of six facets of emotion regulation. Items are rated on a scale of 1-5, with 1 being (almost never [0-10%]); 2 (sometimes [11-35%]); 3 (about half the time [36-65%]); 4 (most of the time [66-90%]); and 5 being (almost always [91-100%]). Higher scores indicate more difficulty in emotion regulation. | Baseline, 10 weeks, 6 months |
| Pittsburgh Stress Battery | Behavioral measure of stress reactivity | Baseline, 10 weeks, 6 months |
| Perceived Stress Scale (PSS-14) | 14-item self-report measure of perceived stress - Participants indicate how often they have found their lives unpredictable, uncontrollable, and overloaded in the last month. Items are rated on a 4 point Likert scale with 0 being (Never); 1 (Almost Never); 2 (Sometimes); 3 (Fairly often) and 4 (Very often). PSS-14 scores are obtained by reversing the scores on the seven positive items, e.g., 0=4, 1=3, 2=2, etc., and then summing across all 14 items. Items 4, 5, 6, 7, 9, 10, and 13 are the positively stated items. | Baseline, 10 weeks, 6 months |
| Anxiety Symptoms - self-report | Assessed via the Beck Anxiety Inventory (BAI) scale. The BAI is a 21-item self-report measure of anxiety. Participants indicate how much they have been bothered by an anxiety symptom during the past month. Items are rated on a 3-point Likert scale with 0 being Never); 2 (Mildly but it didn't bother me much); 2 (Moderately - it wasn't pleasant at times); 3 (Severely- it bothered me a lot). The total score is calculated by finding the sum of the 21 items. A score of 0-21= low anxiety, Score of 22-35 = moderate anxiety, Score of 36 and above = potentially concerning levels of anxiety. | Baseline, 10 weeks, 6 months |
| Depressive Symptoms - self-report | Assessed via Center for Epidemiologic Studies Depression Scale Revised (CESD-R). The CESD-R is a 20-item self-report measure of depression in nine different groups according to the DSM-5. The symptom groups are Sadness (items 2,4,6), Loss of Interest (items 8, 10), Appetite (1,18), Sleep (5,11,19), Thinking/Concentration (3,20), Guilt (9,17), Tired (7,16), Movement (12,13), and Suicidal Ideation (14,15). Response values for each question are 0 (Not at all or less than one day); 1 (1-2 days); 2 (3-4 days); 3 (5-7 days); 4 (Nearly every day for 2 weeks). The total score is calculated as a sum of responses to all 20 questions. | Baseline, 10 weeks, 6 months |
| Sustained Attention to Response Task (SART) | Behavioral measure of attention control - The Sustained Attention to Response Task (SART) is a computer-based go/no-go task that requires participants to withhold behavioral response to a single, infrequent target (often the digit 3) presented amongst a background of frequent non-targets (0-2, 4-9). After each block, two probe questions are presented in succession. The first asks, Where was your attention focused during this block of trials? Participants respond on a 6-point Likert scale, where 1 represents, on task, and 6, off task. A second question asks, How aware were you of where your attention was during this block of trials? Participants respond on a similar scale, where 1 represents, aware, and 6, unaware. | 6 month follow-up |
| Self-Compassion | Assessed using the 12-item validated Self-Compassion Scale Short Form (SCS-SF); Participants indicate how they typically act towards themselves in difficult times using a 5-point Likert scale with 1 being Almost Never to 5 being Almost Always. The total self-compassion score is calculated by reverse scoring the negative subscale items -self-judgment, isolation, and over-identification (i.e., 1 = 5, 2 = 4, 3 = 3, 4 = 2, 5 = 1) then computing a total mean. | 6 months |
| Self-Efficacy | Assessed using the validated Self-Control Scale short form and the SECD-6 Scale. The Self Control Scale measures self-control. The scale consists of 36 items, measured on a scale from 1, not at all like me to 5, very much like me. | Baseline, 10 weeks, 6 months |
| Dietary Approaches to Stop Hypertension (DASH)-consistent diet | Self-report via Willet Food Frequency Questionnaire. Participants are asked to fill in the circle indicating how often on average they have used the food item during the past year. Response categories include Never, or less than once per month, 1-3 per month; 1 per week; 2-4 per week; 5-6 per week; 1 per day; 2-3 per day; 4-5 per day; 6+ per day. | 6 month follow-up |
| Alcohol consumption - self report | Self-report via Willet Food Frequency Questionnaire. Participants are asked to fill in the circle indicating how often on average they have used the food item during the past year. Response categories include Never, or less than once per month, 1-3 per month; 1 per week; 2-4 per week; 5-6 per week; 1 per day; 2-3 per day; 4-5 per day; 6+ per day. | 6 month-follow up |
| Electronically-Measured Antihypertensive Medication Adherence | Measured continuously using electronic medication bottle caps (eCAPS, Ottawa, Canada) | 6 months |
| Body Mass Index | Height and weight directly assessed using standard epidemiologic methods, with change evaluated in participants considered overweight or obese (BMI≥25kg/m) | Baseline, 10 weeks, 6 months |
| Physical Activity - self report | Assessed via the International Physical Activity Questionnaire (IPAQ). The IPAQ is a 27-item self-reported measure of physical activity. Duration (minutes) and frequency (days) of physical activity in the last seven days is measured in 5 domains (1: job related; 2: transportation; 3: housework, house maintenance, caring for family; 4: Recreation, sport, and leisure time; 5: Time spent sitting). Overall score is calculated using responses to all questions. Amount of physical activity places participant in 1 of 3 categories: 1) Low/inactive; 2) Moderate; 3) High. | Baseline, 10 weeks, 6 months |
Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
mindfulness, blood pressure, hypertension, prehypertension, self regulation, Science of Behavior Change, attention control, self awareness, emotion regulation
|
NCT01449812
|
Immunogenicity and Safety Study of Booster Dose of GSK Biologicals' IPV (Poliorix™) and DTPa/Hib (Infanrix+Hib™) Vaccine
|
The purpose of this booster study is to evaluate the immune persistence in healthy Chinese subjects primed in study NCT01086423 with GSK Biologicals' Infanrix-IPV+Hib™ (DTPa-IPV/Hib) vaccine. The study will also evaluate the safety and immune response of these subjects to a booster dose of Infanrix-Hib™ (DTPa/Hib) and Poliorix™ (IPV) vaccine.~This protocol posting deals with objectives & outcome measures of the booster phase. The objectives & outcome measures of the primary phase are presented in a separate protocol posting (NCT number = NCT01086423).
|
Immunogenicity and Safety of a Booster Dose of GlaxoSmithKline Biologicals' IPV (Poliorix™) and DTPa/Hib (Infanrix+Hib™) in Healthy Chinese Toddlers
|
Acellular Pertussis, Tetanus, Diphtheria, Haemophilus Influenzae Type b
|
* Biological: Infanrix+Hib™
* Biological: Poliorix™
|
Inclusion Criteria:~A male or female child between, and including, 18 and 24 months of age at the time of the booster vaccination.~Subjects who completed the full three-dose primary vaccination course in study NCT01086423.~Subjects who the investigator believes that their parent(s)/ Legally Acceptable Representative(s) LAR(s) can and will comply with the requirements of the protocol~Written informed consent obtained from the parent(s)/LAR(s) of the subject.~Healthy subjects as established by medical history and clinical examination before entering into the study.~Exclusion Criteria:~Child in care~Use of any investigational or non-registered product other than the study vaccine(s) within 30 days preceding the booster dose of the study vaccine, or planned use during the study period.~Chronic administration of immunosuppressants or other immune-modifying drugs within six months prior to the booster dose.~Administration of a vaccine not foreseen by the study protocol within 30 days prior to the booster vaccination, or planned administration during the study period.~Participation in another clinical study within three months prior to enrolment in the present booster study or at any time during the present booster study, in which the subject has been or will be exposed to an investigational or a non-investigational product.~Evidence of previous diphtheria, tetanus, pertussis, poliomyelitis and Haemophilus influenzae type b, vaccination or disease since the conclusion visit of primary study NCT01086423.~Serious chronic illness.~Administration of immunoglobulins and/or any blood products within the 90 days preceding the booster dose of study vaccine or planned administration during the study period.~Occurrence of any of the following adverse events after a previous administration of a DTP vaccine.~Encephalopathy~Temperature of ≥ 40.0°C (axillary temperature) within 48 hours of vaccination, not due to another identifiable cause.~Collapse or shock-like state within 48 hours of vaccination.~Persistent, inconsolable crying occurring within 48 hours of vaccination and lasting ≥ 3 hours.~Seizures with or without fever occurring within 3 days of vaccination.~The following condition is temporary or self-limiting, and a subject may be vaccinated once the condition has resolved if no other exclusion criteria is met:~Acute disease and/or fever at the time of enrolment.
|
18 Months
|
24 Months
|
All
|
Accepts Healthy Volunteers
|
Primary Purpose: Prevention
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
|
| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Number of Seroprotected Subjects Against Diphtheria (D) and Tetanus (T) Toxoids | A seroprotected subject was defined as a vaccinated subject with anti-D and anti-T antibody concentrations greater than or equal to (≥) 0.1 international units per milliliter (IU/mL). | Before the booster vaccination (At Day 0) |
| Anti-D and Anti-T Antibody Concentrations | Antibody concentrations were presented as geometric mean concentrations (GMCs) for the seroprotection cut-off of ≥0.1 IU/mL. | Before the booster vaccination (At Day 0) |
| Number of Seroprotected Subjects Against Polyribosyl-ribitol-phosphate (Anti-PRP) | A seroprotected subject was defined as a vaccinated subject with anti-PRP antibody concentration ≥ 0.15 micrograms per milliliter (µg/mL). | Before the booster vaccination (At Day 0) |
| Anti-PRP Antibody Concentrations | Antibody concentrations were presented as geometric mean concentrations (GMCs) for the seroprotection cut-off of ≥ 0.15 µg/mL. | Before the booster vaccination (At Day 0) |
| Number of Seroprotected Subjects Against Polio Type 1, 2 and 3 | A seroprotected subject was defined as a vaccinated subject with anti-polio type 1, 2 and 3 antibody concentrations ≥ the cut-off value of 8 Estimated Dose 50% (ED50). ED50 is the estimated serum dilution reducing the signal generated by viral infection with 50%. | Before the booster vaccination (At Day 0) |
| Anti-polio Type 1, 2 and 3 Antibody Titers | Antibody titers were presented as geometric mean titers (GMTs) for the seroprotection cut-off of ≥ 8. | Before the booster vaccination (At Day 0) |
| Number of Seropositive Subjects for Anti-pertussis Toxoid (Anti-PT), Anti-filamentous Haemagglutinin (Anti-FHA) and Anti-pertactin (Anti-PRN) | A seropositive subject was defined as a vaccinated subject with anti-PT, anti-FHA and anti-PRN antibody concentration ≥ 5 enzyme-linked immunosorbent assay (ELISA) units per milliliter (EL.U/ml). | Before the booster vaccination (At Day 0) |
| Anti-PT, Anti-FHA and Anti-PRN Antibody Concentrations | Antibody concentrations were presented as geometric mean concentrations (GMCs) for the seropositivity cut-off of ≥ 5 EL.U/mL. | Before the booster vaccination (At Day 0) |
| Number of Seroprotected Subjects Against Diphteria (D) and Tetanus (T) Toxoids | A seroprotected subject was defined as a vaccinated subject with anti-D and anti-T antibody concentrations greater than or equal to (≥) 0.1 IU/mL. | Before the booster vaccination (At Day 0) |
| Number of Seroprotected Subjects Against Diphteria (D) and Tetanus (T) Toxoids | A seroprotected subject was defined as a vaccinated subject with anti-D and anti-T antibody concentrations ≥ 0.1 IU/mL. | One month after the booster vaccination (At Month 1) |
| Anti-D and Anti-T Antibody Concentrations | Antibody concentrations were presented as geometric mean concentrations (GMCs) for the seroprotection cut-off of ≥ 0.1 IU/mL. | Before the booster vaccination (At Day 0) |
| Anti-D and Anti-T Antibody Concentrations | Antibody concentrations were presented as GMCs for the seroprotection cut-off of ≥ 0.1 IU/mL. | One month after the booster vaccination (At Month 1) |
| Number of Seroprotected Subjects Against Polyribosyl-ribitol-phosphate (PRP) | A seroprotected subject was defined as a vaccinated subject with anti-PRP antibody concentration ≥ 0.15 µg/mL. | Before the booster vaccination (At Day 0) |
| Number of Seroprotected Subjects Against PRP | A seroprotected subject was defined as a vaccinated subject with anti-PRP antibody concentrations ≥ 0.15 µg/mL. | One month after the booster vaccination (At Month 1) |
| Anti-PRP Antibody Concentrations | Antibody concentrations were presented as geometric mean concentrations (GMCs) for the seroprotection cut-off of ≥ 0.15 micrograms per milliliter (µg/mL). | Before the booster vaccination (At Day 0) |
| Anti-PRP Antibody Concentrations | Antibody concentrations were presented as geometric mean concentrations (GMCs) for the seroprotection cut-off of ≥ 0.15 µg/mL. | One month after the booster vaccination (At Month 1) |
| Number of Seroprotected Subjects for Anti-polio Type 1, 2 and 3 | A seroprotected subject was defined as a vaccinated subject with anti-polivirus antibody concentration ≥ 8 ED50. ED50 is the estimated serum dilution reducing the signal generated by viral infection with 50%. | Before the booster vaccination (At Day 0) |
| Number of Seroprotected Subjects Against Polio Type 1, 2 and 3 | A seroprotected subject was defined as a vaccinated subject with anti-polivirus antibody concentrations ≥ 8 ED50. ED50 is the estimated serum dilution reducing the signal generated by viral infection with 50%. | One month after the booster vaccination (At Month 1) |
| Anti-polio Type 1, 2 and 3 Antibody Titers | Antibody titers were presented as geometric mean titers (GMTs) for the seroprotection cut-off of ≥ the value of 8. | Before the booster vaccination (At Day 0) |
| Anti-polio Type 1, 2 and 3 Antibody Titers | Antibody titers were presented as geometric mean titers (GMTs) for the seroprotection cut-off of ≥ 8. | One month after the booster vaccination (At Month 1) |
| Number of Seropositive Subjects for Anti-PT, Anti-FHA and Anti-PRN | A seropositive subject was defined as a vaccinated subject with anti-PT, anti-FHA and anti-PRN antibody concentrations ≥ 5 ELISA units per milliliter (EL.U/mL). | Before the booster vaccination (At Day 0) |
| Number of Seropositive Subjects for Anti-PT, Anti-FHA and Anti-PRN | A seropositive subject was defined as a vaccinated subject with anti-PT, anti-FHA and anti-PRN antibody concentrations ≥ 5 EL.U/mL. | One month after the booster vaccination (At Month 1) |
| Anti-PT, Anti-FHA and Anti-PRN Antibody Concentrations | Antibody concentrations were presented as geometric mean concentrations (GMCs) for the seropositivity cut-off value of ≥ 5 EL.U/mL. | Before the booster vaccination (At Day 0) |
| Anti-PT, Anti-FHA and Anti-PRN Antibody Concentrattions | Antibody concentrations were presented as geometric mean concentrations (GMCs) for the seropositivity cut-off of ≥ 5 EL.U/mL. | One month after the booster vaccination (At Month 1) |
| Number of Subjects With a Booster Response to Anti-PT, Anti-FHA and Anti-PRN | Booster response was defined as the appearance of antibodies in subjects who were initially seronegative (i.e. with concentrations < cut-off value) or at least maintenance of pre-vaccination antibody concentrations in subjects who were initially seropositive (i.e. with concentrations ≥ cut-off value), taking into consideration the decreasing maternal antibodies. | One month after the booster vaccination (At Month 1) |
|
| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Number of Subjects With Any Solicited Local Symptoms | Assessed solicited local symptoms were pain, redness and swelling. Any = occurrence of the symptom regardless of intensity grade. | During the 4-day (Days 0-3) post-vaccination period |
| Number of Subjects With Any Solicited General Symptoms | Assessed solicited general symptoms were drowsiness, irritability, loss of appetite and fever [defined as axillary temperature equal to or above 37.1 degrees Celsius (°C)]. Any = occurrence of the symptom regardless of intensity grade and relationship to vaccination. | During the 4-day (Days 0-3) post-vaccination period |
| Number of Subjects With Any Unsolicited Adverse Events (AEs) | An unsolicited AE covers any untoward medical occurrence in a clinical investigation subject temporally associated with the use of a medicinal product, whether or not considered related to the medicinal product and reported in addition to those solicited during the clinical study and any solicited symptom with onset outside the specified period of follow-up for solicited symptoms. Any was defined as the occurrence of any unsolicited AE regardless of intensity grade or relation to vaccination. | During the 31-day (Days 0-30) post-vaccination period |
| Number of Subjects With Serious Adverse Events (SAEs) | Serious adverse events (SAEs) assessed include medical occurrences that result in death, are life threatening, require hospitalization or prolongation of hospitalization or result in disability/incapacity. | During the entire study period (from Month 0 up to Month 1) |
|
combination vaccine, booster vaccination
|
Diphtheria, Bacterial Infections, Bacterial Infections and Mycoses, Infections, Gram-Positive Bacterial Infections, Corynebacterium Infections, Actinomycetales Infections
|
| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: INFANRIX+HIB/POLIORIX 1 GROUP<br>Healthy male or female children between, and including, 18 and 24 months of age at the time of booster vaccination, who were primed with 3 doses of the Infanrix-IPV/Hib™ vaccine at 2, 3 and 4 months of age in the DTPA-IPV-056 (112584) primary study, additionally received 1 dose of Poliorix™ and of Infanrix+Hib™ vaccines, administered intramuscularly into the upper sides of the left and right thighs, respectively. | Biological: Infanrix+Hib™<br>* Intramuscular, one dose<br>* Other names: DTPa /Hib;Biological: Poliorix™<br>* Intramuscular, one dose<br>* Other names: IPV;|
| Experimental: INFANRIX+HIB/POLIORIX 2 GROUP<br>Healthy male or female children between, and including, 18 and 24 months of age at the time of booster vaccination, who were primed with 3 doses of the Infanrix-IPV/Hib™ vaccine at 3, 4 and 5 months of age in the DTPA-IPV-056 (112584) primary study, additionally received 1 dose of Poliorix™ and of Infanrix+Hib™ vaccines, administered intramuscularly into the upper sides of the left and right thighs, respectively. | Biological: Infanrix+Hib™<br>* Intramuscular, one dose<br>* Other names: DTPa /Hib;Biological: Poliorix™<br>* Intramuscular, one dose<br>* Other names: IPV;|
| Active Comparator: CONTROL GROUP<br>Healthy male or female children between, and including, 18 and 24 months of age at the time of booster vaccination, who were primed with 3 doses of the Infanrix+Hib™ and of Poliorix™ vaccines at 2, 3 and 4 months of age in the DTPA-IPV-056 (112584) primary study, additionally received 1 dose of Poliorix™ and of Infanrix+Hib™ vaccines, administered intramuscularly into the upper sides of the left and right thighs, respectively. | Biological: Infanrix+Hib™<br>* Intramuscular, one dose<br>* Other names: DTPa /Hib;Biological: Poliorix™<br>* Intramuscular, one dose<br>* Other names: IPV;|
|
Immunogenicity and Safety Study of Booster Dose of GSK Biologicals' IPV (Poliorix™) and DTPa/Hib (Infanrix+Hib™) Vaccine
Study Overview
=================
Brief Summary
-----------------
The purpose of this booster study is to evaluate the immune persistence in healthy Chinese subjects primed in study NCT01086423 with GSK Biologicals' Infanrix-IPV+Hib™ (DTPa-IPV/Hib) vaccine. The study will also evaluate the safety and immune response of these subjects to a booster dose of Infanrix-Hib™ (DTPa/Hib) and Poliorix™ (IPV) vaccine. This protocol posting deals with objectives & outcome measures of the booster phase. The objectives & outcome measures of the primary phase are presented in a separate protocol posting (NCT number = NCT01086423).
Official Title
-----------------
Immunogenicity and Safety of a Booster Dose of GlaxoSmithKline Biologicals' IPV (Poliorix™) and DTPa/Hib (Infanrix+Hib™) in Healthy Chinese Toddlers
Conditions
-----------------
Acellular Pertussis, Tetanus, Diphtheria, Haemophilus Influenzae Type b
Intervention / Treatment
-----------------
* Biological: Infanrix+Hib™
* Biological: Poliorix™
Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: A male or female child between, and including, 18 and 24 months of age at the time of the booster vaccination. Subjects who completed the full three-dose primary vaccination course in study NCT01086423. Subjects who the investigator believes that their parent(s)/ Legally Acceptable Representative(s) LAR(s) can and will comply with the requirements of the protocol Written informed consent obtained from the parent(s)/LAR(s) of the subject. Healthy subjects as established by medical history and clinical examination before entering into the study. Exclusion Criteria: Child in care Use of any investigational or non-registered product other than the study vaccine(s) within 30 days preceding the booster dose of the study vaccine, or planned use during the study period. Chronic administration of immunosuppressants or other immune-modifying drugs within six months prior to the booster dose. Administration of a vaccine not foreseen by the study protocol within 30 days prior to the booster vaccination, or planned administration during the study period. Participation in another clinical study within three months prior to enrolment in the present booster study or at any time during the present booster study, in which the subject has been or will be exposed to an investigational or a non-investigational product. Evidence of previous diphtheria, tetanus, pertussis, poliomyelitis and Haemophilus influenzae type b, vaccination or disease since the conclusion visit of primary study NCT01086423. Serious chronic illness. Administration of immunoglobulins and/or any blood products within the 90 days preceding the booster dose of study vaccine or planned administration during the study period. Occurrence of any of the following adverse events after a previous administration of a DTP vaccine. Encephalopathy Temperature of ≥ 40.0°C (axillary temperature) within 48 hours of vaccination, not due to another identifiable cause. Collapse or shock-like state within 48 hours of vaccination. Persistent, inconsolable crying occurring within 48 hours of vaccination and lasting ≥ 3 hours. Seizures with or without fever occurring within 3 days of vaccination. The following condition is temporary or self-limiting, and a subject may be vaccinated once the condition has resolved if no other exclusion criteria is met: Acute disease and/or fever at the time of enrolment.
Ages Eligible for Study
-----------------
Minimum Age: 18 Months
Maximum Age: 24 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: None (Open Label)
Arms and Interventions
| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: INFANRIX+HIB/POLIORIX 1 GROUP<br>Healthy male or female children between, and including, 18 and 24 months of age at the time of booster vaccination, who were primed with 3 doses of the Infanrix-IPV/Hib™ vaccine at 2, 3 and 4 months of age in the DTPA-IPV-056 (112584) primary study, additionally received 1 dose of Poliorix™ and of Infanrix+Hib™ vaccines, administered intramuscularly into the upper sides of the left and right thighs, respectively. | Biological: Infanrix+Hib™<br>* Intramuscular, one dose<br>* Other names: DTPa /Hib;Biological: Poliorix™<br>* Intramuscular, one dose<br>* Other names: IPV;|
| Experimental: INFANRIX+HIB/POLIORIX 2 GROUP<br>Healthy male or female children between, and including, 18 and 24 months of age at the time of booster vaccination, who were primed with 3 doses of the Infanrix-IPV/Hib™ vaccine at 3, 4 and 5 months of age in the DTPA-IPV-056 (112584) primary study, additionally received 1 dose of Poliorix™ and of Infanrix+Hib™ vaccines, administered intramuscularly into the upper sides of the left and right thighs, respectively. | Biological: Infanrix+Hib™<br>* Intramuscular, one dose<br>* Other names: DTPa /Hib;Biological: Poliorix™<br>* Intramuscular, one dose<br>* Other names: IPV;|
| Active Comparator: CONTROL GROUP<br>Healthy male or female children between, and including, 18 and 24 months of age at the time of booster vaccination, who were primed with 3 doses of the Infanrix+Hib™ and of Poliorix™ vaccines at 2, 3 and 4 months of age in the DTPA-IPV-056 (112584) primary study, additionally received 1 dose of Poliorix™ and of Infanrix+Hib™ vaccines, administered intramuscularly into the upper sides of the left and right thighs, respectively. | Biological: Infanrix+Hib™<br>* Intramuscular, one dose<br>* Other names: DTPa /Hib;Biological: Poliorix™<br>* Intramuscular, one dose<br>* Other names: IPV;|
What is the study measuring?
-----------------
Primary Outcome Measures
| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Number of Seroprotected Subjects Against Diphtheria (D) and Tetanus (T) Toxoids | A seroprotected subject was defined as a vaccinated subject with anti-D and anti-T antibody concentrations greater than or equal to (≥) 0.1 international units per milliliter (IU/mL). | Before the booster vaccination (At Day 0) |
| Anti-D and Anti-T Antibody Concentrations | Antibody concentrations were presented as geometric mean concentrations (GMCs) for the seroprotection cut-off of ≥0.1 IU/mL. | Before the booster vaccination (At Day 0) |
| Number of Seroprotected Subjects Against Polyribosyl-ribitol-phosphate (Anti-PRP) | A seroprotected subject was defined as a vaccinated subject with anti-PRP antibody concentration ≥ 0.15 micrograms per milliliter (µg/mL). | Before the booster vaccination (At Day 0) |
| Anti-PRP Antibody Concentrations | Antibody concentrations were presented as geometric mean concentrations (GMCs) for the seroprotection cut-off of ≥ 0.15 µg/mL. | Before the booster vaccination (At Day 0) |
| Number of Seroprotected Subjects Against Polio Type 1, 2 and 3 | A seroprotected subject was defined as a vaccinated subject with anti-polio type 1, 2 and 3 antibody concentrations ≥ the cut-off value of 8 Estimated Dose 50% (ED50). ED50 is the estimated serum dilution reducing the signal generated by viral infection with 50%. | Before the booster vaccination (At Day 0) |
| Anti-polio Type 1, 2 and 3 Antibody Titers | Antibody titers were presented as geometric mean titers (GMTs) for the seroprotection cut-off of ≥ 8. | Before the booster vaccination (At Day 0) |
| Number of Seropositive Subjects for Anti-pertussis Toxoid (Anti-PT), Anti-filamentous Haemagglutinin (Anti-FHA) and Anti-pertactin (Anti-PRN) | A seropositive subject was defined as a vaccinated subject with anti-PT, anti-FHA and anti-PRN antibody concentration ≥ 5 enzyme-linked immunosorbent assay (ELISA) units per milliliter (EL.U/ml). | Before the booster vaccination (At Day 0) |
| Anti-PT, Anti-FHA and Anti-PRN Antibody Concentrations | Antibody concentrations were presented as geometric mean concentrations (GMCs) for the seropositivity cut-off of ≥ 5 EL.U/mL. | Before the booster vaccination (At Day 0) |
| Number of Seroprotected Subjects Against Diphteria (D) and Tetanus (T) Toxoids | A seroprotected subject was defined as a vaccinated subject with anti-D and anti-T antibody concentrations greater than or equal to (≥) 0.1 IU/mL. | Before the booster vaccination (At Day 0) |
| Number of Seroprotected Subjects Against Diphteria (D) and Tetanus (T) Toxoids | A seroprotected subject was defined as a vaccinated subject with anti-D and anti-T antibody concentrations ≥ 0.1 IU/mL. | One month after the booster vaccination (At Month 1) |
| Anti-D and Anti-T Antibody Concentrations | Antibody concentrations were presented as geometric mean concentrations (GMCs) for the seroprotection cut-off of ≥ 0.1 IU/mL. | Before the booster vaccination (At Day 0) |
| Anti-D and Anti-T Antibody Concentrations | Antibody concentrations were presented as GMCs for the seroprotection cut-off of ≥ 0.1 IU/mL. | One month after the booster vaccination (At Month 1) |
| Number of Seroprotected Subjects Against Polyribosyl-ribitol-phosphate (PRP) | A seroprotected subject was defined as a vaccinated subject with anti-PRP antibody concentration ≥ 0.15 µg/mL. | Before the booster vaccination (At Day 0) |
| Number of Seroprotected Subjects Against PRP | A seroprotected subject was defined as a vaccinated subject with anti-PRP antibody concentrations ≥ 0.15 µg/mL. | One month after the booster vaccination (At Month 1) |
| Anti-PRP Antibody Concentrations | Antibody concentrations were presented as geometric mean concentrations (GMCs) for the seroprotection cut-off of ≥ 0.15 micrograms per milliliter (µg/mL). | Before the booster vaccination (At Day 0) |
| Anti-PRP Antibody Concentrations | Antibody concentrations were presented as geometric mean concentrations (GMCs) for the seroprotection cut-off of ≥ 0.15 µg/mL. | One month after the booster vaccination (At Month 1) |
| Number of Seroprotected Subjects for Anti-polio Type 1, 2 and 3 | A seroprotected subject was defined as a vaccinated subject with anti-polivirus antibody concentration ≥ 8 ED50. ED50 is the estimated serum dilution reducing the signal generated by viral infection with 50%. | Before the booster vaccination (At Day 0) |
| Number of Seroprotected Subjects Against Polio Type 1, 2 and 3 | A seroprotected subject was defined as a vaccinated subject with anti-polivirus antibody concentrations ≥ 8 ED50. ED50 is the estimated serum dilution reducing the signal generated by viral infection with 50%. | One month after the booster vaccination (At Month 1) |
| Anti-polio Type 1, 2 and 3 Antibody Titers | Antibody titers were presented as geometric mean titers (GMTs) for the seroprotection cut-off of ≥ the value of 8. | Before the booster vaccination (At Day 0) |
| Anti-polio Type 1, 2 and 3 Antibody Titers | Antibody titers were presented as geometric mean titers (GMTs) for the seroprotection cut-off of ≥ 8. | One month after the booster vaccination (At Month 1) |
| Number of Seropositive Subjects for Anti-PT, Anti-FHA and Anti-PRN | A seropositive subject was defined as a vaccinated subject with anti-PT, anti-FHA and anti-PRN antibody concentrations ≥ 5 ELISA units per milliliter (EL.U/mL). | Before the booster vaccination (At Day 0) |
| Number of Seropositive Subjects for Anti-PT, Anti-FHA and Anti-PRN | A seropositive subject was defined as a vaccinated subject with anti-PT, anti-FHA and anti-PRN antibody concentrations ≥ 5 EL.U/mL. | One month after the booster vaccination (At Month 1) |
| Anti-PT, Anti-FHA and Anti-PRN Antibody Concentrations | Antibody concentrations were presented as geometric mean concentrations (GMCs) for the seropositivity cut-off value of ≥ 5 EL.U/mL. | Before the booster vaccination (At Day 0) |
| Anti-PT, Anti-FHA and Anti-PRN Antibody Concentrattions | Antibody concentrations were presented as geometric mean concentrations (GMCs) for the seropositivity cut-off of ≥ 5 EL.U/mL. | One month after the booster vaccination (At Month 1) |
| Number of Subjects With a Booster Response to Anti-PT, Anti-FHA and Anti-PRN | Booster response was defined as the appearance of antibodies in subjects who were initially seronegative (i.e. with concentrations < cut-off value) or at least maintenance of pre-vaccination antibody concentrations in subjects who were initially seropositive (i.e. with concentrations ≥ cut-off value), taking into consideration the decreasing maternal antibodies. | One month after the booster vaccination (At Month 1) |
Secondary Outcome Measures
| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Number of Subjects With Any Solicited Local Symptoms | Assessed solicited local symptoms were pain, redness and swelling. Any = occurrence of the symptom regardless of intensity grade. | During the 4-day (Days 0-3) post-vaccination period |
| Number of Subjects With Any Solicited General Symptoms | Assessed solicited general symptoms were drowsiness, irritability, loss of appetite and fever [defined as axillary temperature equal to or above 37.1 degrees Celsius (°C)]. Any = occurrence of the symptom regardless of intensity grade and relationship to vaccination. | During the 4-day (Days 0-3) post-vaccination period |
| Number of Subjects With Any Unsolicited Adverse Events (AEs) | An unsolicited AE covers any untoward medical occurrence in a clinical investigation subject temporally associated with the use of a medicinal product, whether or not considered related to the medicinal product and reported in addition to those solicited during the clinical study and any solicited symptom with onset outside the specified period of follow-up for solicited symptoms. Any was defined as the occurrence of any unsolicited AE regardless of intensity grade or relation to vaccination. | During the 31-day (Days 0-30) post-vaccination period |
| Number of Subjects With Serious Adverse Events (SAEs) | Serious adverse events (SAEs) assessed include medical occurrences that result in death, are life threatening, require hospitalization or prolongation of hospitalization or result in disability/incapacity. | During the entire study period (from Month 0 up to Month 1) |
Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
combination vaccine, booster vaccination
|
|
NCT02454413
|
Microbial Evaluation of Denture Cleaning and Overnight Storage
|
Clinical guidelines for denture care are available, but evidence for optimal nocturnal storage is missing. The investigators (Duyck J., Vandamme K., Teughels W.) therefore performed a study (submitted for publication) to evaluate the effect of different overnight storage protocols on denture biofilm formation and maturation. The results of this study showed that the use of cleansing tablets (Corega Tabs Anti-bacteria®, GlaxoSmithKline Consumer Healthcare SA, Genval, Belgium) for acrylic removable denture overnight storage reduces denture biofilm mass and pathogenicity compared to dry and water preservation. As no mechanical denture cleaning was performed in the aforementioned study, the aim of the proposed study is to evaluate the combined effect of mechanical cleaning and overnight storage condition on the microbial composition and Candida albicans colonization of denture biofilm formation. This information is required to develop a clinical guideline on acrylic denture cleaning and overnight storage aiming to reduce the risk posed by pathogenic microorganisms, particularly in bedridden and immunocompromised patients.~It is hypothetised that mechanical denture cleaning will decrease the impact of overnight denture storage condition on biofilm formation on acrylic removable dentures.
|
Aim of the study~The presence of a biofilm - i.e. structured microbial communities that are attached to a surface and encased in an exopolymer matrix - on acrylic removable dentures has been associated with serious systemic conditions, especially in the dependent elderly [1]. Oral bacteria have been implicated in bacterial endocarditis [2], aspiration pneumonia [3, 4], chronic obstructive pulmonary disease [5, 6], amongst other diseases [1, 7]. Ample evidence is provided regarding the relationship between proper oral hygiene and overall systemic health.~Plaque on dentures is a complex aggregate containing more than 108 organisms per milligram, and involving more than 600 prokaryote species [8]. The different species collaborate to form a symbiotic biofilm. The biofilms in dentate patients have been studied extensively, but there have been few studies on the biofilm microbiota of complete acrylic dentures [10-18]. It appears that distinct biofilms, with associated pathogenic risks, are present in 'healthy' versus denture stomatitis affected participants [15, 16, 18]. Not only poor denture cleaning but also inappropriate habits, such as wearing dentures overnight have proved to be associated with the prevalence of Candida-associated stomatitis [19, 20]. Therefore, the overnight removal of the acrylic removable dentures is advised in clinical settings. Although evidence-based guidelines for denture care and maintenance are available [21], guidelines for nocturnal storage conditions of dentures are missing. The investigators therefore performed a study (submitted for publication) to evaluate the effect of different overnight storage protocols on denture biofilm formation and maturation. The results of this study showed that the use of cleansing tablets (Corega Tabs Anti-bacteria®, GlaxoSmithKline Consumer Healthcare SA, Genval, Belgium) for acrylic removable denture overnight storage reduces denture biofilm mass and pathogenicity compared to dry and water preservation.~As no mechanical denture cleaning was performed in the aforementioned study, the aim of the proposed study is to evaluate the combined effect of mechanical cleaning and overnight storage condition on the microbial composition and Candida albicans colonization of denture biofilm formation. This information is required to develop a clinical guideline on acrylic denture cleaning and overnight storage aiming to reduce the risk posed by pathogenic microorganisms, particularly in bedridden and immunocompromised patients.~Research questions~•What is the effect of mechanical cleaning on biofilm formation on removable acrylic dentures?~Is ultrasonic cleaning more efficient compared to denture brushing with respect to prevention of biofilm formation on removable acrylic dentures?~What is the effect of overnight storage in water with a cleansing tablet on biofilm formation on mechanically cleaned removable acrylic dentures?~Materials & Methods~Participants -number: 30 -Inclusion criteria: Institutionalised frail elder Fully edentulous in lower and upper jaw Removable denture wearer in lower and upper jaw Good oral health~-Exclusion criteria: Current or history of corticosteroid treatment within the 3 months prior to the study Current or history of antimicrobial treatment within the 3 months prior to the study Inability to provide informed consent Inability to comply with the study requirements~Test conditions Denture cleaning method Denture overnight storage condition~1Brushing with water and soap Immersion in water with a cleansing tablet 2Brushing with water and soap Immersion in water without a cleansing tablet (= neg control) 3Ultrasonic cleaning Immersion in water with a cleansing tablet 4Ultrasonic cleaning Immersion in water without a cleansing tablet~This study was approved by the Institutional Ethics Committee (S54968, University Hospitals Leuven, Belgium) and registered in the Belgian Clinical Trials database (Identifier: B322201316863).~Study design~-Cross-over study with randomized sequence of the 4 test conditions This implies that all 4 test conditions will be executed within each of the 30 study participants.~The sequence of the test conditions for the individual participants will be randomized.~Double blind (both the participants as well as the investigators do not know the test conditions)~All test conditions will be applied for 5 days. This means that all patients will undergo 4 test periods of 5 days.~Each test period will be preceded by a wash-out period of 2 days in which the standard of care will be applied. This standard of care is denture cleaning through brushing with water and soap and overnight storage in water.~All dentures will be decalcified using vinegar prior to the start of the study.~At the start of the study, all dentures will be mechanically cleaned by means of denture brushing and additional ultrasonic cleaning. After mechanical cleaning, the dentures will also be desinfected using a 1% chlorhexidine digluconate gel (Corsodyl gel, GlaxoSmithKline Consumer Healthcare SA, Genval, Belgium).~After mechanical denture cleaning and desinfection at the start of each test period, control samples (n=4) will be taken to evaluate the effectiveness of the cleaning and desinfection procedures.~After each test period, test samples (n=4) will be taken~The participants will be asked not to clean their dentures themselves. 2 care takers involved in the study will do the denture cleaning and will apply the appropriate overnight storage condition.~Outcome measures:~Clinical health of the denture bearing mucosa Method: clinical evaluation Microbial analyses Method: qualitative and quantitative PCR analyses for 20 selected oral bacteria (Aa, Pg, Tf, Td, Pi, Fn, Pm, Pn, Cg, Cr, En, Ec, Cs, Cc, Sm, Sg, Sc, Ao, Av, Vp) and for Candida Albicans.~Biofilm sampling will be performed in a 5-mm diameter circular region of interest, situated bucco-distally to the lower second premolars (Figure 1). In order to standardize the position and dimensions of this region and to ensure optimal reproducibility of the microbial sampling, a custom-made mold of each lower prosthesis with placeholder rings will be made (Optosil®, Heraeus Kulzer GmbH, Hanau, Germany) (Figure 1). The placeholder rings will be placed in such a way that the transition between artificial teeth and gums is situated centrally. These molds will fabricated following denture disinfection at the start of the study, and will be re-used throughout the study because of the absence of dimensional changes over time when preserved properly (i.e. dry and in plastic bag). The molds and rings will be desinfected after each microbial sampling.~Denture plaque score Method: Denture plaque will be scored independently by 2 investigators using 4% erythrosine disclosing solution according to Augsburger and Elahi [22] (score range 0-4)~•Study protocol Time point Action Microbial sampling Day 0 (morning) calculus removal using vinegar mechanical denture cleaning ° Day 0-2 standard of carei Day 3 (morning) Mechanical denture cleaning° and desinfectionii control sample 1* Day 3-7 test period 1 Day 7 (evening) Mechanical denture cleaning° and desinfectionii test sample 1** Day 8-9 standard of carei (wash-out period) Day 10 (morning) Mechanical denture cleaning° and desinfectionii control sample 2* Day 10-14 test period 2 Day 14 (evening) Mechanical denture cleaning° and desinfectionii test sample 2** Day 15-16 standard of carei (wash-out period) Day 17 (morning) Mechanical denture cleaning° and desinfectionii control 3* Day 17-21 test period 3 Day 21 (evening) Mechanical denture cleaning° and desinfectionii test sample 3** Day 22-23 standard of carei (wash-out period) Day 24 (morning) Mechanical denture cleaning° and desinfectionii control 4* Day 24-28 test period 4 Day 28 (evening) Mechanical denture cleaning° and desinfectionii END OF THE STUDY test sample 4**~°mechanical denture cleaning: brushing with water and soap + additional ultrasonic cleaning i standard of care: denture brushing with water and soap and overnight storage in tab water iidesinfection with 1% chlorhexidine digluconate gel (Corsodyl gel, GlaxoSmithKline Consumer Healthcare SA, Genval, Belgium)~*control sampling: after mechanical cleaning and desinfection~**test sampling: before mechanical cleaning desinfection
|
ASSESSMENT OF THE IMPACT OF CLEANING METHODS AND OVERNIGHT DENTURE STORAGE ON BIOFILM FORMATION ON REMOVABLE ACRYLIC DENTURES.
|
Denture Hygiene
|
* Other: denture brushing with water and soap
* Other: ultrasonic denture cleaning
* Other: cleansing tablet
|
Inclusion Criteria:~Institutionalised frail elder~Fully edentulous in lower and upper jaw~Removable denture wearer in lower and upper jaw~Good oral health~Exclusion Criteria:~Current or history of corticosteroid treatment within the 3 months prior to the study~Current or history of antimicrobial treatment within the 3 months prior to the study~Inability to provide informed consent~Inability to comply with the study requirements
|
65 Years
| null |
All
|
Accepts Healthy Volunteers
|
Primary Purpose: Supportive Care
Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: Triple
|
| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Biofilm (quantity and quality) on the removable acrylic denture | | sample taken at day 5 of the test period |
|
| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Oral health status | | oral health control at day 5 of the test period |
|
dentures hygiene, biofilm formation, oral health
|
| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Sham Comparator: brush + water<br>denture brushing with water and soap + overnight storage in water | Other: denture brushing with water and soap<br>* denture brushing with water and soap<br>|
| Active Comparator: brush + cleansing tablet<br>denture brushing with water and soap + overnight storage in water with a cleansing tablet | Other: denture brushing with water and soap<br>* denture brushing with water and soap<br>Other: cleansing tablet<br>* addition of a cleansing tablet to the water in which the dentures are stored overnight<br>|
| Sham Comparator: ultrasonic cleaning + water<br>ultrasonic denture cleaning + overnight storage in water | Other: ultrasonic denture cleaning<br>* ultrasonic denture cleaning<br>|
| Active Comparator: ultrasonic cleaning + cleansing tablet<br>ultrasonic denture cleaning + overnight storage in water with a cleansing tablet | Other: ultrasonic denture cleaning<br>* ultrasonic denture cleaning<br>Other: cleansing tablet<br>* addition of a cleansing tablet to the water in which the dentures are stored overnight<br>|
|
Microbial Evaluation of Denture Cleaning and Overnight Storage
Study Overview
=================
Brief Summary
-----------------
Clinical guidelines for denture care are available, but evidence for optimal nocturnal storage is missing. The investigators (Duyck J., Vandamme K., Teughels W.) therefore performed a study (submitted for publication) to evaluate the effect of different overnight storage protocols on denture biofilm formation and maturation. The results of this study showed that the use of cleansing tablets (Corega Tabs Anti-bacteria®, GlaxoSmithKline Consumer Healthcare SA, Genval, Belgium) for acrylic removable denture overnight storage reduces denture biofilm mass and pathogenicity compared to dry and water preservation. As no mechanical denture cleaning was performed in the aforementioned study, the aim of the proposed study is to evaluate the combined effect of mechanical cleaning and overnight storage condition on the microbial composition and Candida albicans colonization of denture biofilm formation. This information is required to develop a clinical guideline on acrylic denture cleaning and overnight storage aiming to reduce the risk posed by pathogenic microorganisms, particularly in bedridden and immunocompromised patients. It is hypothetised that mechanical denture cleaning will decrease the impact of overnight denture storage condition on biofilm formation on acrylic removable dentures.
Detailed Description
-----------------
Aim of the study The presence of a biofilm - i.e. structured microbial communities that are attached to a surface and encased in an exopolymer matrix - on acrylic removable dentures has been associated with serious systemic conditions, especially in the dependent elderly [1]. Oral bacteria have been implicated in bacterial endocarditis [2], aspiration pneumonia [3, 4], chronic obstructive pulmonary disease [5, 6], amongst other diseases [1, 7]. Ample evidence is provided regarding the relationship between proper oral hygiene and overall systemic health. Plaque on dentures is a complex aggregate containing more than 108 organisms per milligram, and involving more than 600 prokaryote species [8]. The different species collaborate to form a symbiotic biofilm. The biofilms in dentate patients have been studied extensively, but there have been few studies on the biofilm microbiota of complete acrylic dentures [10-18]. It appears that distinct biofilms, with associated pathogenic risks, are present in 'healthy' versus denture stomatitis affected participants [15, 16, 18]. Not only poor denture cleaning but also inappropriate habits, such as wearing dentures overnight have proved to be associated with the prevalence of Candida-associated stomatitis [19, 20]. Therefore, the overnight removal of the acrylic removable dentures is advised in clinical settings. Although evidence-based guidelines for denture care and maintenance are available [21], guidelines for nocturnal storage conditions of dentures are missing. The investigators therefore performed a study (submitted for publication) to evaluate the effect of different overnight storage protocols on denture biofilm formation and maturation. The results of this study showed that the use of cleansing tablets (Corega Tabs Anti-bacteria®, GlaxoSmithKline Consumer Healthcare SA, Genval, Belgium) for acrylic removable denture overnight storage reduces denture biofilm mass and pathogenicity compared to dry and water preservation. As no mechanical denture cleaning was performed in the aforementioned study, the aim of the proposed study is to evaluate the combined effect of mechanical cleaning and overnight storage condition on the microbial composition and Candida albicans colonization of denture biofilm formation. This information is required to develop a clinical guideline on acrylic denture cleaning and overnight storage aiming to reduce the risk posed by pathogenic microorganisms, particularly in bedridden and immunocompromised patients. Research questions •What is the effect of mechanical cleaning on biofilm formation on removable acrylic dentures? Is ultrasonic cleaning more efficient compared to denture brushing with respect to prevention of biofilm formation on removable acrylic dentures? What is the effect of overnight storage in water with a cleansing tablet on biofilm formation on mechanically cleaned removable acrylic dentures? Materials & Methods Participants -number: 30 -Inclusion criteria: Institutionalised frail elder Fully edentulous in lower and upper jaw Removable denture wearer in lower and upper jaw Good oral health -Exclusion criteria: Current or history of corticosteroid treatment within the 3 months prior to the study Current or history of antimicrobial treatment within the 3 months prior to the study Inability to provide informed consent Inability to comply with the study requirements Test conditions Denture cleaning method Denture overnight storage condition 1Brushing with water and soap Immersion in water with a cleansing tablet 2Brushing with water and soap Immersion in water without a cleansing tablet (= neg control) 3Ultrasonic cleaning Immersion in water with a cleansing tablet 4Ultrasonic cleaning Immersion in water without a cleansing tablet This study was approved by the Institutional Ethics Committee (S54968, University Hospitals Leuven, Belgium) and registered in the Belgian Clinical Trials database (Identifier: B322201316863). Study design -Cross-over study with randomized sequence of the 4 test conditions This implies that all 4 test conditions will be executed within each of the 30 study participants. The sequence of the test conditions for the individual participants will be randomized. Double blind (both the participants as well as the investigators do not know the test conditions) All test conditions will be applied for 5 days. This means that all patients will undergo 4 test periods of 5 days. Each test period will be preceded by a wash-out period of 2 days in which the standard of care will be applied. This standard of care is denture cleaning through brushing with water and soap and overnight storage in water. All dentures will be decalcified using vinegar prior to the start of the study. At the start of the study, all dentures will be mechanically cleaned by means of denture brushing and additional ultrasonic cleaning. After mechanical cleaning, the dentures will also be desinfected using a 1% chlorhexidine digluconate gel (Corsodyl gel, GlaxoSmithKline Consumer Healthcare SA, Genval, Belgium). After mechanical denture cleaning and desinfection at the start of each test period, control samples (n=4) will be taken to evaluate the effectiveness of the cleaning and desinfection procedures. After each test period, test samples (n=4) will be taken The participants will be asked not to clean their dentures themselves. 2 care takers involved in the study will do the denture cleaning and will apply the appropriate overnight storage condition. Outcome measures: Clinical health of the denture bearing mucosa Method: clinical evaluation Microbial analyses Method: qualitative and quantitative PCR analyses for 20 selected oral bacteria (Aa, Pg, Tf, Td, Pi, Fn, Pm, Pn, Cg, Cr, En, Ec, Cs, Cc, Sm, Sg, Sc, Ao, Av, Vp) and for Candida Albicans. Biofilm sampling will be performed in a 5-mm diameter circular region of interest, situated bucco-distally to the lower second premolars (Figure 1). In order to standardize the position and dimensions of this region and to ensure optimal reproducibility of the microbial sampling, a custom-made mold of each lower prosthesis with placeholder rings will be made (Optosil®, Heraeus Kulzer GmbH, Hanau, Germany) (Figure 1). The placeholder rings will be placed in such a way that the transition between artificial teeth and gums is situated centrally. These molds will fabricated following denture disinfection at the start of the study, and will be re-used throughout the study because of the absence of dimensional changes over time when preserved properly (i.e. dry and in plastic bag). The molds and rings will be desinfected after each microbial sampling. Denture plaque score Method: Denture plaque will be scored independently by 2 investigators using 4% erythrosine disclosing solution according to Augsburger and Elahi [22] (score range 0-4) •Study protocol Time point Action Microbial sampling Day 0 (morning) calculus removal using vinegar mechanical denture cleaning ° Day 0-2 standard of carei Day 3 (morning) Mechanical denture cleaning° and desinfectionii control sample 1* Day 3-7 test period 1 Day 7 (evening) Mechanical denture cleaning° and desinfectionii test sample 1** Day 8-9 standard of carei (wash-out period) Day 10 (morning) Mechanical denture cleaning° and desinfectionii control sample 2* Day 10-14 test period 2 Day 14 (evening) Mechanical denture cleaning° and desinfectionii test sample 2** Day 15-16 standard of carei (wash-out period) Day 17 (morning) Mechanical denture cleaning° and desinfectionii control 3* Day 17-21 test period 3 Day 21 (evening) Mechanical denture cleaning° and desinfectionii test sample 3** Day 22-23 standard of carei (wash-out period) Day 24 (morning) Mechanical denture cleaning° and desinfectionii control 4* Day 24-28 test period 4 Day 28 (evening) Mechanical denture cleaning° and desinfectionii END OF THE STUDY test sample 4** °mechanical denture cleaning: brushing with water and soap + additional ultrasonic cleaning i standard of care: denture brushing with water and soap and overnight storage in tab water iidesinfection with 1% chlorhexidine digluconate gel (Corsodyl gel, GlaxoSmithKline Consumer Healthcare SA, Genval, Belgium) *control sampling: after mechanical cleaning and desinfection **test sampling: before mechanical cleaning desinfection
Official Title
-----------------
ASSESSMENT OF THE IMPACT OF CLEANING METHODS AND OVERNIGHT DENTURE STORAGE ON BIOFILM FORMATION ON REMOVABLE ACRYLIC DENTURES.
Conditions
-----------------
Denture Hygiene
Intervention / Treatment
-----------------
* Other: denture brushing with water and soap
* Other: ultrasonic denture cleaning
* Other: cleansing tablet
Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Institutionalised frail elder Fully edentulous in lower and upper jaw Removable denture wearer in lower and upper jaw Good oral health Exclusion Criteria: Current or history of corticosteroid treatment within the 3 months prior to the study Current or history of antimicrobial treatment within the 3 months prior to the study Inability to provide informed consent Inability to comply with the study requirements
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: Supportive Care
Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: Triple
Arms and Interventions
| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Sham Comparator: brush + water<br>denture brushing with water and soap + overnight storage in water | Other: denture brushing with water and soap<br>* denture brushing with water and soap<br>|
| Active Comparator: brush + cleansing tablet<br>denture brushing with water and soap + overnight storage in water with a cleansing tablet | Other: denture brushing with water and soap<br>* denture brushing with water and soap<br>Other: cleansing tablet<br>* addition of a cleansing tablet to the water in which the dentures are stored overnight<br>|
| Sham Comparator: ultrasonic cleaning + water<br>ultrasonic denture cleaning + overnight storage in water | Other: ultrasonic denture cleaning<br>* ultrasonic denture cleaning<br>|
| Active Comparator: ultrasonic cleaning + cleansing tablet<br>ultrasonic denture cleaning + overnight storage in water with a cleansing tablet | Other: ultrasonic denture cleaning<br>* ultrasonic denture cleaning<br>Other: cleansing tablet<br>* addition of a cleansing tablet to the water in which the dentures are stored overnight<br>|
What is the study measuring?
-----------------
Primary Outcome Measures
| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Biofilm (quantity and quality) on the removable acrylic denture | | sample taken at day 5 of the test period |
Secondary Outcome Measures
| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Oral health status | | oral health control at day 5 of the test period |
Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
dentures hygiene, biofilm formation, oral health
|
|
NCT04621994
|
Cesarean Wound Closure: Dermabond Versus Steri Strips
|
The purpose of this study is to determine overall patient satisfaction with their cesarean section scar with application of Steri-strips vs. Dermabond following subcuticular skin closure of pfannenstiel incision
|
Cesarean Wound Closure: Dermabond Versus Steri Strips
|
Scar
|
* Other: Dermabond
* Other: Steri Strips
|
Inclusion Criteria:~Women age 18-45 who are undergoing planned or unscheduled cesarean section at Regional One Health~Gestational age > 24 weeks~Planned Pfannenstiel incision~Willing to consent to the study~Exclusion Criteria:~Emergency or urgent cesarean section~Vertical skin incision~Intrapartum intraamniotic infection~Diabetes~Unwilling to consent to the study
|
18 Years
|
45 Years
|
Female
|
Accepts Healthy Volunteers
|
Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
|
| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Patient and Observer Scar Assessment Scale Surveys (POSAS) | Validated scale comparing a scar to normal skin. Score ranges from 6 to 60 with the higher numbers less like normal skin. | at 1 weeks postpartum |
| Patient and Observer Scar Assessment Scale Surveys | Validated scale comparing a scar to normal skin. Score ranges from 6 to 60 with the higher numbers less like normal skin. | at 6 weeks postpartum |
|
| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Number of patients with wound infection | | through 6 weeks postpartum |
| Number of patients with wound separation or dehiscence | | through 6 weeks postpartum |
|
| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: Steri Strips Arm<br> | Other: Steri Strips<br>* Steri Strips will be applied after subcuticular skin closure as routinely done at our institution<br>|
| Experimental: Dermabond Arm<br> | Other: Dermabond<br>* Dermabond will be applied after subcuticular skin closure in lieu of Steri Strips<br>|
|
Cesarean Wound Closure: Dermabond Versus Steri Strips
Study Overview
=================
Brief Summary
-----------------
The purpose of this study is to determine overall patient satisfaction with their cesarean section scar with application of Steri-strips vs. Dermabond following subcuticular skin closure of pfannenstiel incision
Official Title
-----------------
Cesarean Wound Closure: Dermabond Versus Steri Strips
Conditions
-----------------
Scar
Intervention / Treatment
-----------------
* Other: Dermabond
* Other: Steri Strips
Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Women age 18-45 who are undergoing planned or unscheduled cesarean section at Regional One Health Gestational age > 24 weeks Planned Pfannenstiel incision Willing to consent to the study Exclusion Criteria: Emergency or urgent cesarean section Vertical skin incision Intrapartum intraamniotic infection Diabetes Unwilling to consent to the study
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?
-----------------
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: Steri Strips Arm<br> | Other: Steri Strips<br>* Steri Strips will be applied after subcuticular skin closure as routinely done at our institution<br>|
| Experimental: Dermabond Arm<br> | Other: Dermabond<br>* Dermabond will be applied after subcuticular skin closure in lieu of Steri Strips<br>|
What is the study measuring?
-----------------
Primary Outcome Measures
| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Patient and Observer Scar Assessment Scale Surveys (POSAS) | Validated scale comparing a scar to normal skin. Score ranges from 6 to 60 with the higher numbers less like normal skin. | at 1 weeks postpartum |
| Patient and Observer Scar Assessment Scale Surveys | Validated scale comparing a scar to normal skin. Score ranges from 6 to 60 with the higher numbers less like normal skin. | at 6 weeks postpartum |
Secondary Outcome Measures
| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Number of patients with wound infection | | through 6 weeks postpartum |
| Number of patients with wound separation or dehiscence | | through 6 weeks postpartum |
|
|||
NCT02052245
|
Pre/Term Milk Profiling
|
This study aims for an in-depth characterization of human milk of mothers who delivered prematurely to decipher differences with milk of mothers who delivered at the expected term, with a particular focus on milk proteins
|
Longitudinal Composition of Human Milk for Term and Preterm Infants
|
Preterm Milk, Term Milk
|
Inclusion Criteria:~Having obtained informed consent~Group 1 (term delivery): Gestational age between 37 0/7 and not above 41 6/7 weeks~Group 2 (preterm delivery): Gestational age between 28 0/7 and 32 6/7 weeks~Age: Mother ≥ 18 years old~Partial or total breast feeding~Having a freezer compartment at home (approx. -18°C)~Good understanding of the French language~Exclusion Criteria:~Suffering from diabetes (type I or II) before pregnancy~Alcohol consumption: more than 1 standard drink / day~Drug addicted~Subject who cannot be expected to comply with the study procedures.~Currently participating in an interventional therapeutic clinical trial
|
18 Years
| null |
Female
|
Accepts Healthy Volunteers
|
| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Quantification of total protein concentration in human milk | | from delivery, up to 4 months |
|
| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Quantification of total lipids and carbohydrates | | From delivery, up to 4 months |
| Determination of Calcium and Phosphorous content | | From delivery, up to 4 months |
| Determination of peptide profiles and content | | From delivery, up to 4 months |
| Determination of miRNA content | | From delivery, up to 4 months |
|
Premature Birth, Obstetric Labor, Premature, Obstetric Labor Complications, Pregnancy Complications, Female Urogenital Diseases and Pregnancy Complications, Urogenital Diseases
|
| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Subject delivering preterm baby<br> | |
| Subject delivering term baby<br> | |
|
Pre/Term Milk Profiling
Study Overview
=================
Brief Summary
-----------------
This study aims for an in-depth characterization of human milk of mothers who delivered prematurely to decipher differences with milk of mothers who delivered at the expected term, with a particular focus on milk proteins
Official Title
-----------------
Longitudinal Composition of Human Milk for Term and Preterm Infants
Conditions
-----------------
Preterm Milk, Term Milk
Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Having obtained informed consent Group 1 (term delivery): Gestational age between 37 0/7 and not above 41 6/7 weeks Group 2 (preterm delivery): Gestational age between 28 0/7 and 32 6/7 weeks Age: Mother ≥ 18 years old Partial or total breast feeding Having a freezer compartment at home (approx. -18°C) Good understanding of the French language Exclusion Criteria: Suffering from diabetes (type I or II) before pregnancy Alcohol consumption: more than 1 standard drink / day Drug addicted Subject who cannot be expected to comply with the study procedures. Currently participating in an interventional therapeutic clinical trial
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?
-----------------
Arms and Interventions
| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Subject delivering preterm baby<br> | |
| Subject delivering term baby<br> | |
What is the study measuring?
-----------------
Primary Outcome Measures
| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Quantification of total protein concentration in human milk | | from delivery, up to 4 months |
Secondary Outcome Measures
| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Quantification of total lipids and carbohydrates | | From delivery, up to 4 months |
| Determination of Calcium and Phosphorous content | | From delivery, up to 4 months |
| Determination of peptide profiles and content | | From delivery, up to 4 months |
| Determination of miRNA content | | From delivery, up to 4 months |
|
||||
NCT02437344
|
Glutamatergic Modulation to Facilitate Naltrexone Initiation in Opioid Dependence
|
Opioid dependence is a substantial problem associated with significant morbidity and mortality. Extended-release naltrexone has been found effective at reducing opioid use and maintaining abstinence, but its use has been limited by the difficulties encountered with treatment initiation, which involves detoxification from opioids and oral naltrexone titration. Improving the likelihood of a successful transition to naltrexone is therefore an important public health goal.~N-methyl-D-aspartate receptor (NMDA) antagonism has been found to alleviate the signs and symptoms of withdrawal from opioids, as well as to address adaptations associated with chronic opioid use, such as opioid-induced hyperalgesia (increased pain sensitivity). These benefits may persist for at least 72 hours after a single dose. NMDA antagonism may therefore facilitate a rapid transition to naltrexone by reducing discomfort, improving motivation, and ameliorating adaptations associated with drug dependence, such as craving and arousal.~The purpose of this trial is to assess the feasibility of NMDA antagonist-assisted naltrexone initiation in opioid dependent individuals. After administration of extended-release naltrexone, participants will be followed for 4 weeks, and transitioned to appropriate care subsequently (oral naltrexone, extended-release naltrexone).
|
Glutamatergic Modulation to Facilitate Naltrexone Initiation in Opioid Dependence
|
Opioid Dependence
|
* Drug: CI-581aa
* Drug: Naltrexone titration and XR-NTX initiation
|
Inclusion Criteria:~Active opioid dependence, with at least one positive utox result; no history of opioid overdose; and not currently using methadone or buprenorphine~Physically healthy~No adverse reactions to study medications~21-60 years of age~Capacity to consent and comply with study procedures~Seeking treatment~Exclusion Criteria:~Meets DSM IV criteria for current major depression, bipolar disorder, schizophrenia, any psychotic illness, including substance-induced psychosis, and current substance-induced mood disorder with HAMD > 12.~Physiological dependence on another substance requiring medical management, such as alcohol or benzodiazepines, excluding caffeine, nicotine, and cannabis~Pregnant or interested in becoming pregnant~Delirium, Dementia, Amnesia, Cognitive Disorders, or dissociative disorders~Current suicide risk or a history of suicide attempt within the past 2 years~On psychotropic or other medication whose effect could be disrupted by participation in the study~Recent history of significant violence (past 2 years).~Heart disease as indicated by history, abnormal ECG, previous cardiac surgery.~Unstable physical disorders which might make participation hazardous such as end-stage AIDS, hypertension (>140/90), anemia, active hepatitis or other liver disease (transaminase levels < 2 X the upper limit of normal will be considered acceptable), or untreated diabetes~Previous history of CI-581 abuse, and/or a history of adverse reaction/experience wtih prior exposure to CI-581 or benzodiazepines~BMI > 35, or a history of unmanaged obstructive sleep apnea~First degree relative with a psychotic disorder (bipolar disorder with psychotic features, schizophrenia, schizoaffective disorder, or psychosis NOS)~History of opioid overdose over the past 2 years requiring medical intervention~Currently using methadone or buprenorphine
|
21 Years
|
60 Years
|
All
|
No
|
Primary Purpose: Treatment
Intervention Model: Single Group Assignment
Masking: None (Open Label)
|
| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Successful Naltrexone Initiation | The proportion of participants enrolled in the trial and receiving the infusion to receive XR-NTX | 2 weeks |
|
| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Withdrawal: Subjective Opioid Withdrawal Scale (SOWS) Scores at Baseline and Administered Subsequently | Subjective Opioid Withdrawal Scale (SOWS) is a scale out of 64 points assessing withdrawal severity that is administered serially, every several hours, over the course of the naltrexone initiation. The questionnaire assesses symptoms that the patient rates on a scale of 0 (not at all) to 4 (extremely). The difference in total (sum) scores between baseline and end-of-induction will be reported. Scores range from 0 to 64. | 4 days |
|
Naltrexone, Alcohol Deterrents, Narcotic Antagonists, Physiological Effects of Drugs, Sensory System Agents, Peripheral Nervous System Agents
|
| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: CI-581aa<br>CI-581aa will be administered 24 hours after last opioid use, and followed by naltrexone dosing | Drug: CI-581aa<br>* 92 minute infusion of CI-581aa<br>* Other names: NMDA antagonist;Drug: Naltrexone titration and XR-NTX initiation<br>* participants will be provided a titration of naltrexone that culminates in the injection of XR-NTX<br>* Other names: naltrexone;|
|
Glutamatergic Modulation to Facilitate Naltrexone Initiation in Opioid Dependence
Study Overview
=================
Brief Summary
-----------------
Opioid dependence is a substantial problem associated with significant morbidity and mortality. Extended-release naltrexone has been found effective at reducing opioid use and maintaining abstinence, but its use has been limited by the difficulties encountered with treatment initiation, which involves detoxification from opioids and oral naltrexone titration. Improving the likelihood of a successful transition to naltrexone is therefore an important public health goal. N-methyl-D-aspartate receptor (NMDA) antagonism has been found to alleviate the signs and symptoms of withdrawal from opioids, as well as to address adaptations associated with chronic opioid use, such as opioid-induced hyperalgesia (increased pain sensitivity). These benefits may persist for at least 72 hours after a single dose. NMDA antagonism may therefore facilitate a rapid transition to naltrexone by reducing discomfort, improving motivation, and ameliorating adaptations associated with drug dependence, such as craving and arousal. The purpose of this trial is to assess the feasibility of NMDA antagonist-assisted naltrexone initiation in opioid dependent individuals. After administration of extended-release naltrexone, participants will be followed for 4 weeks, and transitioned to appropriate care subsequently (oral naltrexone, extended-release naltrexone).
Official Title
-----------------
Glutamatergic Modulation to Facilitate Naltrexone Initiation in Opioid Dependence
Conditions
-----------------
Opioid Dependence
Intervention / Treatment
-----------------
* Drug: CI-581aa
* Drug: Naltrexone titration and XR-NTX initiation
Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Active opioid dependence, with at least one positive utox result; no history of opioid overdose; and not currently using methadone or buprenorphine Physically healthy No adverse reactions to study medications 21-60 years of age Capacity to consent and comply with study procedures Seeking treatment Exclusion Criteria: Meets DSM IV criteria for current major depression, bipolar disorder, schizophrenia, any psychotic illness, including substance-induced psychosis, and current substance-induced mood disorder with HAMD > 12. Physiological dependence on another substance requiring medical management, such as alcohol or benzodiazepines, excluding caffeine, nicotine, and cannabis Pregnant or interested in becoming pregnant Delirium, Dementia, Amnesia, Cognitive Disorders, or dissociative disorders Current suicide risk or a history of suicide attempt within the past 2 years On psychotropic or other medication whose effect could be disrupted by participation in the study Recent history of significant violence (past 2 years). Heart disease as indicated by history, abnormal ECG, previous cardiac surgery. Unstable physical disorders which might make participation hazardous such as end-stage AIDS, hypertension (>140/90), anemia, active hepatitis or other liver disease (transaminase levels < 2 X the upper limit of normal will be considered acceptable), or untreated diabetes Previous history of CI-581 abuse, and/or a history of adverse reaction/experience wtih prior exposure to CI-581 or benzodiazepines BMI > 35, or a history of unmanaged obstructive sleep apnea First degree relative with a psychotic disorder (bipolar disorder with psychotic features, schizophrenia, schizoaffective disorder, or psychosis NOS) History of opioid overdose over the past 2 years requiring medical intervention Currently using methadone or buprenorphine
Ages Eligible for Study
-----------------
Minimum Age: 21 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
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Arms and Interventions
| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: CI-581aa<br>CI-581aa will be administered 24 hours after last opioid use, and followed by naltrexone dosing | Drug: CI-581aa<br>* 92 minute infusion of CI-581aa<br>* Other names: NMDA antagonist;Drug: Naltrexone titration and XR-NTX initiation<br>* participants will be provided a titration of naltrexone that culminates in the injection of XR-NTX<br>* Other names: naltrexone;|
What is the study measuring?
-----------------
Primary Outcome Measures
| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Successful Naltrexone Initiation | The proportion of participants enrolled in the trial and receiving the infusion to receive XR-NTX | 2 weeks |
Secondary Outcome Measures
| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Withdrawal: Subjective Opioid Withdrawal Scale (SOWS) Scores at Baseline and Administered Subsequently | Subjective Opioid Withdrawal Scale (SOWS) is a scale out of 64 points assessing withdrawal severity that is administered serially, every several hours, over the course of the naltrexone initiation. The questionnaire assesses symptoms that the patient rates on a scale of 0 (not at all) to 4 (extremely). The difference in total (sum) scores between baseline and end-of-induction will be reported. Scores range from 0 to 64. | 4 days |
|
||
NCT02105662
|
An Efficacy and Safety Study of Grazoprevir (MK-5172) + Elbasvir (MK-8742) in the Treatment of Chronic Hepatitis C Virus in Participants Who Are Co-Infected With Human Immunodeficiency Virus:C-EDGE CO-INFXN (MK-5172-061)
|
The purpose of this study is to assess the efficacy and safety of grazoprevir (MK-5172) 100 mg in combination with elbasvir (MK-8742) 50 mg in the treatment of chronic hepatitis C virus (HCV) in participants who are co-infected with human immunodeficiency virus (HIV). The primary hypothesis is that the percentage of participants who receive grazoprevir + elbasvir and achieve Sustained Virologic Response after 12 weeks of therapy (SVR12) will be greater than 70%.
|
A Phase III Open-Label Clinical Trial to Study the Efficacy and Safety of the Combination Regimen Grazoprevir (GZR) and Elbasvir (EBR) in Treatment-Naïve Subjects With Chronic HCV GT1, GT4, and GT6 Infection Who Are Co-Infected With HIV
|
Chronic Hepatitis C
|
* Drug: Grazoprevir 100 mg/Elbasvir 50 mg fixed-dose combination tablets
|
Inclusion Criteria:~Documented chronic HCV genotype (GT) 1, GT4, or GT6 infection with no evidence of non-typeable or mixed GT infection (positive for anti-HCV antibody, HCV RNA, or any of the listed GTs at least 6 months prior to screening must be confirmed by screening lab results)~Treatment naïve for all anti-HCV treatments~HIV-1 infection documented by laboratory test~Currently naïve to treatment with any antiretroviral therapy (ART) and have no plans to initiate ART during this study OR on a HIV ART for at least 8 weeks prior to study entry~Has not experienced any alteration(s) in HIV therapy within 4 weeks of randomization~Has at least one viable antiretroviral regimen alternative beyond the current regimen in the event of HIV virologic failure or the development of anti-retroviral drug resistance~Participants of reproductive potential must agree to remain abstinent from heterosexual activity OR use (or have their partner use) acceptable contraception during heterosexual activity while receiving study drug and for 14 days after last dose of study drug.~Exclusion Criteria:~Evidence of decompensated liver disease manifested by the presence or history of ascites, esophageal or gastric variceal bleeding, hepatic encephalopathy or other signs of symptoms of advanced liver disease~Co-infected with hepatitis B virus~History of malignancy <=5 years prior to study start except for adequately treated basal cell or squamous cell skin cancer or in situ cervical cancer or is under evaluation for other active or suspected malignancy~Taking or planning to take any HIV therapy that includes a ritonavir-boosted or unboosted protease inhibitor, efavirenz or etravirine~Currently participating or has participated in a study with an investigational compound within 30 days of study start and is not willing to refrain from participating in another study during this study~Clinically-relevant drug or alcohol abuse within 12 months of study start~Pregnant, breast feeding, or expecting to conceive or donate eggs from Day 1 of the study throughout treatment and 14 days after the last dose of study medication, or longer if dictated by local regulations~Organ transplants (including hematopoietic stem cell transplants) other than cornea and hair~Poor venous access~History of gastric surgery (e.g., stapling, bypass) or history of malabsorption disorders (e.g., celiac sprue disease)~Medical condition requiring, or likely to require, chronic systemic administration of corticosteroids during this study~History of opportunistic infection in the 6 months prior to study start~Use of HIV drugs other than a dual nucleoside reverse transcriptase inhibitor (NRTI) backbone of tenofovir or abacavir and either emtricitibine or lamivudine PLUS raltegravir (or dolutegravir or rilpivirine)
|
18 Years
| null |
All
|
No
|
Primary Purpose: Treatment
Intervention Model: Single Group Assignment
Masking: None (Open Label)
|
| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Percentage of Participants Achieving Sustained Virologic Response 12 Weeks After the End of All Study Therapy (SVR12) | Blood was drawn from each participant to assess Hepatitis C Virus ribonucleic acid (HCV RNA) plasma levels using the Roche COBAS™ Taqman™ HCV Test, v2.0 (High Pure System). The Roche COBAS Taqman HCV Test, v2.0 assay (High Pure System) had a lower limit of quantification of 15 IU/mL and a limit of detection of 9.3 IU/mL (in plasma). SVR12 was defined as undetectable (<9.3 IU/mL) HCV RNA at 12 weeks after the end of all study therapy. | 12 weeks after end of all therapy (Study Week 24) |
| Percentage of Participants Experiencing Adverse Events (AEs) During the Treatment Period and First 14 Follow-up Days | An AE is defined as any untoward medical occurrence in a participant administered a pharmaceutical product and which does not necessarily have to have a causal relationship with this treatment. An AE can therefore be any unfavourable and unintended sign (including an abnormal laboratory finding, for example), symptom, or disease temporally associated with the use of a medicinal product or protocol-specified procedure, whether or not considered related to the medicinal product or protocol -specified procedure. Any worsening (i.e., any clinically significant adverse change in frequency and/or intensity) of a preexisting condition that is temporally associated with the use of the Sponsor's product, is also an AE. | Treatment Period plus first 14 follow-up days (up to 14 weeks) |
| Percentage of Participants Discontinuing Study Therapy Due to AEs During the Treatment Period | An AE is defined as any untoward medical occurrence in a participant administered a pharmaceutical product and which does not necessarily have to have a causal relationship with this treatment. An AE can therefore be any unfavourable and unintended sign (including an abnormal laboratory finding, for example), symptom, or disease temporally associated with the use of a medicinal product or protocol-specified procedure, whether or not considered related to the medicinal product or protocol -specified procedure. Any worsening (i.e., any clinically significant adverse change in frequency and/or intensity) of a preexisting condition that is temporally associated with the use of the Sponsor's product, is also an AE. | Treatment Period (up to 12 weeks) |
|
| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Percentage of Participants Achieving Sustained Virologic Response 24 Weeks After the End of All Study Therapy (SVR24) | Blood was drawn from each participant to assess HCV RNA plasma levels using the Roche COBAS™ Taqman™ HCV Test, v2.0 (High Pure System). The Roche COBAS Taqman HCV Test, v2.0 assay (High Pure System) had a lower limit of quantification of 15 IU/mL and a limit of detection of 9.3 IU/mL (in plasma). SVR24 was defined as undetectable (<9.3 IU/mL) HCV RNA at 24 weeks after the end of all study therapy. | 24 weeks after end of all therapy (Study Week 36) |
|
Grazoprevir, Antiviral Agents, Anti-Infective Agents
|
| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Grazoprevir+Elbasvir<br>Participants receive a fixed-dose combination (FDC) of grazoprevir 100 mg plus elbasvir 50 mg once daily for 12 weeks and are followed-up for 24 weeks. | Drug: Grazoprevir 100 mg/Elbasvir 50 mg fixed-dose combination tablets<br>* MK-5172A FDC tablet: MK-5172 (100 mg)/MK-8742 (50 mg)<br>* Other names: MK-5172A;|
|
An Efficacy and Safety Study of Grazoprevir (MK-5172) + Elbasvir (MK-8742) in the Treatment of Chronic Hepatitis C Virus in Participants Who Are Co-Infected With Human Immunodeficiency Virus:C-EDGE CO-INFXN (MK-5172-061)
Study Overview
=================
Brief Summary
-----------------
The purpose of this study is to assess the efficacy and safety of grazoprevir (MK-5172) 100 mg in combination with elbasvir (MK-8742) 50 mg in the treatment of chronic hepatitis C virus (HCV) in participants who are co-infected with human immunodeficiency virus (HIV). The primary hypothesis is that the percentage of participants who receive grazoprevir + elbasvir and achieve Sustained Virologic Response after 12 weeks of therapy (SVR12) will be greater than 70%.
Official Title
-----------------
A Phase III Open-Label Clinical Trial to Study the Efficacy and Safety of the Combination Regimen Grazoprevir (GZR) and Elbasvir (EBR) in Treatment-Naïve Subjects With Chronic HCV GT1, GT4, and GT6 Infection Who Are Co-Infected With HIV
Conditions
-----------------
Chronic Hepatitis C
Intervention / Treatment
-----------------
* Drug: Grazoprevir 100 mg/Elbasvir 50 mg fixed-dose combination tablets
Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Documented chronic HCV genotype (GT) 1, GT4, or GT6 infection with no evidence of non-typeable or mixed GT infection (positive for anti-HCV antibody, HCV RNA, or any of the listed GTs at least 6 months prior to screening must be confirmed by screening lab results) Treatment naïve for all anti-HCV treatments HIV-1 infection documented by laboratory test Currently naïve to treatment with any antiretroviral therapy (ART) and have no plans to initiate ART during this study OR on a HIV ART for at least 8 weeks prior to study entry Has not experienced any alteration(s) in HIV therapy within 4 weeks of randomization Has at least one viable antiretroviral regimen alternative beyond the current regimen in the event of HIV virologic failure or the development of anti-retroviral drug resistance Participants of reproductive potential must agree to remain abstinent from heterosexual activity OR use (or have their partner use) acceptable contraception during heterosexual activity while receiving study drug and for 14 days after last dose of study drug. Exclusion Criteria: Evidence of decompensated liver disease manifested by the presence or history of ascites, esophageal or gastric variceal bleeding, hepatic encephalopathy or other signs of symptoms of advanced liver disease Co-infected with hepatitis B virus History of malignancy <=5 years prior to study start except for adequately treated basal cell or squamous cell skin cancer or in situ cervical cancer or is under evaluation for other active or suspected malignancy Taking or planning to take any HIV therapy that includes a ritonavir-boosted or unboosted protease inhibitor, efavirenz or etravirine Currently participating or has participated in a study with an investigational compound within 30 days of study start and is not willing to refrain from participating in another study during this study Clinically-relevant drug or alcohol abuse within 12 months of study start Pregnant, breast feeding, or expecting to conceive or donate eggs from Day 1 of the study throughout treatment and 14 days after the last dose of study medication, or longer if dictated by local regulations Organ transplants (including hematopoietic stem cell transplants) other than cornea and hair Poor venous access History of gastric surgery (e.g., stapling, bypass) or history of malabsorption disorders (e.g., celiac sprue disease) Medical condition requiring, or likely to require, chronic systemic administration of corticosteroids during this study History of opportunistic infection in the 6 months prior to study start Use of HIV drugs other than a dual nucleoside reverse transcriptase inhibitor (NRTI) backbone of tenofovir or abacavir and either emtricitibine or lamivudine PLUS raltegravir (or dolutegravir or rilpivirine)
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: Grazoprevir+Elbasvir<br>Participants receive a fixed-dose combination (FDC) of grazoprevir 100 mg plus elbasvir 50 mg once daily for 12 weeks and are followed-up for 24 weeks. | Drug: Grazoprevir 100 mg/Elbasvir 50 mg fixed-dose combination tablets<br>* MK-5172A FDC tablet: MK-5172 (100 mg)/MK-8742 (50 mg)<br>* Other names: MK-5172A;|
What is the study measuring?
-----------------
Primary Outcome Measures
| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Percentage of Participants Achieving Sustained Virologic Response 12 Weeks After the End of All Study Therapy (SVR12) | Blood was drawn from each participant to assess Hepatitis C Virus ribonucleic acid (HCV RNA) plasma levels using the Roche COBAS™ Taqman™ HCV Test, v2.0 (High Pure System). The Roche COBAS Taqman HCV Test, v2.0 assay (High Pure System) had a lower limit of quantification of 15 IU/mL and a limit of detection of 9.3 IU/mL (in plasma). SVR12 was defined as undetectable (<9.3 IU/mL) HCV RNA at 12 weeks after the end of all study therapy. | 12 weeks after end of all therapy (Study Week 24) |
| Percentage of Participants Experiencing Adverse Events (AEs) During the Treatment Period and First 14 Follow-up Days | An AE is defined as any untoward medical occurrence in a participant administered a pharmaceutical product and which does not necessarily have to have a causal relationship with this treatment. An AE can therefore be any unfavourable and unintended sign (including an abnormal laboratory finding, for example), symptom, or disease temporally associated with the use of a medicinal product or protocol-specified procedure, whether or not considered related to the medicinal product or protocol -specified procedure. Any worsening (i.e., any clinically significant adverse change in frequency and/or intensity) of a preexisting condition that is temporally associated with the use of the Sponsor's product, is also an AE. | Treatment Period plus first 14 follow-up days (up to 14 weeks) |
| Percentage of Participants Discontinuing Study Therapy Due to AEs During the Treatment Period | An AE is defined as any untoward medical occurrence in a participant administered a pharmaceutical product and which does not necessarily have to have a causal relationship with this treatment. An AE can therefore be any unfavourable and unintended sign (including an abnormal laboratory finding, for example), symptom, or disease temporally associated with the use of a medicinal product or protocol-specified procedure, whether or not considered related to the medicinal product or protocol -specified procedure. Any worsening (i.e., any clinically significant adverse change in frequency and/or intensity) of a preexisting condition that is temporally associated with the use of the Sponsor's product, is also an AE. | Treatment Period (up to 12 weeks) |
Secondary Outcome Measures
| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Percentage of Participants Achieving Sustained Virologic Response 24 Weeks After the End of All Study Therapy (SVR24) | Blood was drawn from each participant to assess HCV RNA plasma levels using the Roche COBAS™ Taqman™ HCV Test, v2.0 (High Pure System). The Roche COBAS Taqman HCV Test, v2.0 assay (High Pure System) had a lower limit of quantification of 15 IU/mL and a limit of detection of 9.3 IU/mL (in plasma). SVR24 was defined as undetectable (<9.3 IU/mL) HCV RNA at 24 weeks after the end of all study therapy. | 24 weeks after end of all therapy (Study Week 36) |
|
||
NCT00098670
|
Fludarabine, Rituximab, and Alemtuzumab in Treating Patients With Chronic Lymphocytic Leukemia
|
This phase II trial is studying how well giving fludarabine together with rituximab followed by alemtuzumab works in treating patients with chronic lymphocytic leukemia. Monoclonal antibodies, such as rituximab and alemtuzumab, can block cancer growth in different ways. Some block the ability of cancer cells to grow and spread. Others can find cancer cells and help kill them or carry cancer-killing substances to them. Drugs used in chemotherapy, such as fludarabine, work in different ways to stop the growth of cancer cells, either by killing the cells or by stopping them from dividing. Giving fludarabine together with rituximab followed by alemtuzumab may kill more cancer cells.
|
PRIMARY OBJECTIVES:~I. To determine the rate of complete response and toxicity of concurrent treatment with fludarabine and rituximab followed by consolidative alemtuzumab in patients with previously untreated, but symptomatic, CLL.~II. To determine if alemtuzumab improves the CR rate with acceptable toxicity when administered as consolidation therapy following induction therapy with fludarabine and rituximab.~III. To estimate the progression-free and overall survival of high risk (VH gene unmutated and those with p53 dysfunction) and low-risk (others) patients following therapy with fludarabine and rituximab induction and consolidative alemtuzumab.~IV. To determine the frequency of molecular (PCR) remission following fludarabine and rituximab induction therapy and alemtuzumab consolidation therapy and if this serves as a surrogate marker for prolonged progression-free and overall survival.~SECONDARY OBJECTIVES:~I. To determine the effect of concurrent treatment with fludarabine and rituximab followed by consolidative alemtuzumab on recovery of T-cells, NK cells, and serum immunoglobulin levels.~II. To determine clinical and molecular features that predict for poor response to fludarabine and rituximab induction and subsequent alemtuzumab consolidation therapy.~III. To assess preliminarily the molecular features of CLL at relapse in patients responding to chemoimmunotherapy for CLL.~IV. To determine the frequency of patients who remain at high risk for progression of CLL despite this therapy and who are thus eligible for nonmyeloablative stem cell transplantation studies such as CALGB 109901.~V. To perform limited rituximab pharmacokinetics to determine the ideal schedule of administration for a subsequent rituximab maintenance treatment approach following induction therapy with fludarabine and rituximab.~OUTLINE:~Patients receive induction therapy comprising rituximab IV over 4 hours on days 1, 3, and 5 of course 1 and day 1 of all subsequent courses and fludarabine IV over 30 minutes on days 1-5. Treatment repeats every 28 days for up to 6 courses in the absence of disease progression.~Approximately 4 months after completion of induction therapy, patients achieving a partial response, nodular partial response, or stable disease receive consolidation therapy comprising alemtuzumab subcutaneously on days 1-3. Treatment repeats weekly for up to 6 courses in the absence of disease progression.~Patients are followed at 2 months, every 3 months for 1 year, and then every 6 months for 7 years from study entry.
|
A Phase II Study of Fludarabine + Rituximab Induction Followed by Alemtuzumab (Campath-1H, NSC #715969, IND #10864) Administered Subcutaneously as Consolidation in Untreated Patients With B-Cell Chronic Lymphocytic Leukemia
|
B-cell Chronic Lymphocytic Leukemia, Stage I Chronic Lymphocytic Leukemia, Stage II Chronic Lymphocytic Leukemia, Stage III Chronic Lymphocytic Leukemia, Stage IV Chronic Lymphocytic Leukemia
|
* Biological: alemtuzumab
* Biological: rituximab
* Drug: fludarabine phosphate
|
Inclusion Criteria:~Specific Diagnosis of B-Cell CLL~An absolute lymphocytosis of > 5,000/μL~Morphologically, the lymphocytes must appear mature with < 55% prolymphocytes~Bone marrow examination must include at least a unilateral aspirate and biopsy; the aspirate smear must show > 30% of all nucleated cells to be lymphoid or the bone marrow core biopsy must show lymphoid infiltrates compatible with marrow involvement by CLL; the overall cellularity must be normocellular or hypercellular~Local institution lymphocyte phenotype must reveal a predominant B-cell monoclonal population sharing a B-cell marker (CD19, CD20, CD23) with the CD5 antigen, in the absence of other pan-T-cell markers; additionally, the B-cells must be monoclonal with regard to expression of either κ or λ and have surface immunoglobulin expression of low density; patients with bright surface immunoglobulin levels must have CD23 co-expression~Patients must be in the intermediate- or high-risk categories of the modified three-stage Rai staging system (i.e., stages I, II, III, or IV)~Patients in the intermediate-risk group must have evidence of active disease as demonstrated by at least one of the following criteria:~Massive or progressive splenomegaly, hepatomegaly and/or lymphadenopathy;~Presence of weight loss > 10% over the preceding 6 month period;~Grade 2 or 3 fatigue;~Fevers > 100.5°F or night sweats for greater than 2 weeks without evidence of infection;~Progressive lymphocytosis with an increase of > 50% over a 2 month period or an anticipated doubling time of less than 6 months~No prior therapy for CLL including corticosteroids for autoimmune complications that have developed since the initial diagnosis of CLL~No medical condition requiring chronic use of oral corticosteroids~Performance Status 0 - 2~Due to alterations in host immunity, patients with HIV may not be enrolled~Due to the unknown teratogenic potential of alemtuzumab, pregnant or nursing women may not be enrolled; women and men of reproductive potential should agree to use an effective means of birth control~Creatinine =< 1.5 x upper limit of institutional normal value~Coomb's Testing NEGATIVE
|
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 Participants With a Complete Response After Treatment With Fludarabine & Rituximab Followed by Alemtuzumab | A complete response, as defined by the National Cancer Institute Working Group (NCIWG):~- CR: no lymphadenopathy, hepatomegaly, splenomegaly or constitutional symptoms; normal complete blood count; confirmed by bone marrow (BM) aspirate & biopsy | Duration of treatment (up to 13.5 months) |
|
| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Number of Participants With a Complete or Partial Response After Induction Therapy With Fludarabine & Rituximab | Response, as defined by the National Cancer Institute Working Group (NCIWG):~CR: no lymphadenopathy, hepatomegaly, splenomegaly or constitutional symptoms; normal complete blood count; confirmed by bone marrow (BM) aspirate & biopsy~PR: 50% decrease in peripheral blood lymphocytes, lymphadenopathy, liver/spleen size, presence/absence of constitutional symptoms; plus ≥1 of the following: ≥1500/μL polymorphonuclear leukocytes, >100,000/μL platelets, >11.0 g/dL hemoglobin or 50% improvement for these parameters without transfusions | Up to 9 months |
| 2 Year Progression Free Survival | Percentage of patients who were alive and progression free at 2 years. The 2-year progression free survival was estimated using the Kaplan Meier method. | 2 years from registration |
| 2 Year Survival | Percentage of participants who were alive at 2 years. The 2 year survival was estimated using the Kaplan Meier method. | 2 years from registration |
| Number of Participants With Severe Non-Hematologic Adverse Events During Treatment With Alemtuzumab | The National Cancer Institute (NCI) Common Toxicity Criteria (CTC) Version 2.0 was used to evaluate toxicity. Severe Adverse events are defined as grade 3, 4 or 5, at least possibly related to treatment.~Grade 1: mild; Grade 2: moderate; Grade 3: Severe; Grade 4: Life Threatening; Grade 5: Death. | 6 weeks beginning at study week 36 |
|
Rituximab, Antineoplastic Agents, Immunological, Alemtuzumab, Fludarabine, Fludarabine phosphate, Antibodies, Immunoglobulins, Antibodies, Monoclonal, Immunologic Factors, Physiological Effects of Drugs, Antineoplastic Agents, Antirheumatic Agents, Antimetabolites, Antineoplastic, Antimetabolites, Molecular Mechanisms of Pharmacological Action, Immunosuppressive Agents
|
| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Treatment (alemtuzumab, rituximab, fludarabine phosphate)<br>Patients receive induction therapy comprising rituximab IV over 4 hours on days 1, 3, and 5 of course 1 and day 1 of all subsequent courses and fludarabine IV over 30 minutes on days 1-5. Treatment repeats every 28 days for up to 6 courses in the absence of disease progression.~Approximately 4 months after completion of induction therapy, patients achieving a partial response, nodular partial response, or stable disease receive consolidation therapy comprising alemtuzumab subcutaneously on days 1-3. Treatment repeats weekly for up to 6 courses in the absence of disease progression. | Biological: alemtuzumab<br>* Given SC<br>* Other names: Monoclonal Antibody CD52;Biological: rituximab<br>* Given IV<br>* Other names: Rituxan;Drug: fludarabine phosphate<br>* Given IV<br>* Other names: Fludara;|
|
Fludarabine, Rituximab, and Alemtuzumab in Treating Patients With Chronic Lymphocytic Leukemia
Study Overview
=================
Brief Summary
-----------------
This phase II trial is studying how well giving fludarabine together with rituximab followed by alemtuzumab works in treating patients with chronic lymphocytic leukemia. Monoclonal antibodies, such as rituximab and alemtuzumab, can block cancer growth in different ways. Some block the ability of cancer cells to grow and spread. Others can find cancer cells and help kill them or carry cancer-killing substances to them. Drugs used in chemotherapy, such as fludarabine, work in different ways to stop the growth of cancer cells, either by killing the cells or by stopping them from dividing. Giving fludarabine together with rituximab followed by alemtuzumab may kill more cancer cells.
Detailed Description
-----------------
PRIMARY OBJECTIVES: I. To determine the rate of complete response and toxicity of concurrent treatment with fludarabine and rituximab followed by consolidative alemtuzumab in patients with previously untreated, but symptomatic, CLL. II. To determine if alemtuzumab improves the CR rate with acceptable toxicity when administered as consolidation therapy following induction therapy with fludarabine and rituximab. III. To estimate the progression-free and overall survival of high risk (VH gene unmutated and those with p53 dysfunction) and low-risk (others) patients following therapy with fludarabine and rituximab induction and consolidative alemtuzumab. IV. To determine the frequency of molecular (PCR) remission following fludarabine and rituximab induction therapy and alemtuzumab consolidation therapy and if this serves as a surrogate marker for prolonged progression-free and overall survival. SECONDARY OBJECTIVES: I. To determine the effect of concurrent treatment with fludarabine and rituximab followed by consolidative alemtuzumab on recovery of T-cells, NK cells, and serum immunoglobulin levels. II. To determine clinical and molecular features that predict for poor response to fludarabine and rituximab induction and subsequent alemtuzumab consolidation therapy. III. To assess preliminarily the molecular features of CLL at relapse in patients responding to chemoimmunotherapy for CLL. IV. To determine the frequency of patients who remain at high risk for progression of CLL despite this therapy and who are thus eligible for nonmyeloablative stem cell transplantation studies such as CALGB 109901. V. To perform limited rituximab pharmacokinetics to determine the ideal schedule of administration for a subsequent rituximab maintenance treatment approach following induction therapy with fludarabine and rituximab. OUTLINE: Patients receive induction therapy comprising rituximab IV over 4 hours on days 1, 3, and 5 of course 1 and day 1 of all subsequent courses and fludarabine IV over 30 minutes on days 1-5. Treatment repeats every 28 days for up to 6 courses in the absence of disease progression. Approximately 4 months after completion of induction therapy, patients achieving a partial response, nodular partial response, or stable disease receive consolidation therapy comprising alemtuzumab subcutaneously on days 1-3. Treatment repeats weekly for up to 6 courses in the absence of disease progression. Patients are followed at 2 months, every 3 months for 1 year, and then every 6 months for 7 years from study entry.
Official Title
-----------------
A Phase II Study of Fludarabine + Rituximab Induction Followed by Alemtuzumab (Campath-1H, NSC #715969, IND #10864) Administered Subcutaneously as Consolidation in Untreated Patients With B-Cell Chronic Lymphocytic Leukemia
Conditions
-----------------
B-cell Chronic Lymphocytic Leukemia, Stage I Chronic Lymphocytic Leukemia, Stage II Chronic Lymphocytic Leukemia, Stage III Chronic Lymphocytic Leukemia, Stage IV Chronic Lymphocytic Leukemia
Intervention / Treatment
-----------------
* Biological: alemtuzumab
* Biological: rituximab
* Drug: fludarabine phosphate
Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Specific Diagnosis of B-Cell CLL An absolute lymphocytosis of > 5,000/μL Morphologically, the lymphocytes must appear mature with < 55% prolymphocytes Bone marrow examination must include at least a unilateral aspirate and biopsy; the aspirate smear must show > 30% of all nucleated cells to be lymphoid or the bone marrow core biopsy must show lymphoid infiltrates compatible with marrow involvement by CLL; the overall cellularity must be normocellular or hypercellular Local institution lymphocyte phenotype must reveal a predominant B-cell monoclonal population sharing a B-cell marker (CD19, CD20, CD23) with the CD5 antigen, in the absence of other pan-T-cell markers; additionally, the B-cells must be monoclonal with regard to expression of either κ or λ and have surface immunoglobulin expression of low density; patients with bright surface immunoglobulin levels must have CD23 co-expression Patients must be in the intermediate- or high-risk categories of the modified three-stage Rai staging system (i.e., stages I, II, III, or IV) Patients in the intermediate-risk group must have evidence of active disease as demonstrated by at least one of the following criteria: Massive or progressive splenomegaly, hepatomegaly and/or lymphadenopathy; Presence of weight loss > 10% over the preceding 6 month period; Grade 2 or 3 fatigue; Fevers > 100.5°F or night sweats for greater than 2 weeks without evidence of infection; Progressive lymphocytosis with an increase of > 50% over a 2 month period or an anticipated doubling time of less than 6 months No prior therapy for CLL including corticosteroids for autoimmune complications that have developed since the initial diagnosis of CLL No medical condition requiring chronic use of oral corticosteroids Performance Status 0 - 2 Due to alterations in host immunity, patients with HIV may not be enrolled Due to the unknown teratogenic potential of alemtuzumab, pregnant or nursing women may not be enrolled; women and men of reproductive potential should agree to use an effective means of birth control Creatinine =< 1.5 x upper limit of institutional normal value Coomb's Testing NEGATIVE
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: Treatment (alemtuzumab, rituximab, fludarabine phosphate)<br>Patients receive induction therapy comprising rituximab IV over 4 hours on days 1, 3, and 5 of course 1 and day 1 of all subsequent courses and fludarabine IV over 30 minutes on days 1-5. Treatment repeats every 28 days for up to 6 courses in the absence of disease progression. Approximately 4 months after completion of induction therapy, patients achieving a partial response, nodular partial response, or stable disease receive consolidation therapy comprising alemtuzumab subcutaneously on days 1-3. Treatment repeats weekly for up to 6 courses in the absence of disease progression. | Biological: alemtuzumab<br>* Given SC<br>* Other names: Monoclonal Antibody CD52;Biological: rituximab<br>* Given IV<br>* Other names: Rituxan;Drug: fludarabine phosphate<br>* Given IV<br>* Other names: Fludara;|
What is the study measuring?
-----------------
Primary Outcome Measures
| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Number of Participants With a Complete Response After Treatment With Fludarabine & Rituximab Followed by Alemtuzumab | A complete response, as defined by the National Cancer Institute Working Group (NCIWG): - CR: no lymphadenopathy, hepatomegaly, splenomegaly or constitutional symptoms; normal complete blood count; confirmed by bone marrow (BM) aspirate & biopsy | Duration of treatment (up to 13.5 months) |
Secondary Outcome Measures
| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Number of Participants With a Complete or Partial Response After Induction Therapy With Fludarabine & Rituximab | Response, as defined by the National Cancer Institute Working Group (NCIWG): CR: no lymphadenopathy, hepatomegaly, splenomegaly or constitutional symptoms; normal complete blood count; confirmed by bone marrow (BM) aspirate & biopsy PR: 50% decrease in peripheral blood lymphocytes, lymphadenopathy, liver/spleen size, presence/absence of constitutional symptoms; plus ≥1 of the following: ≥1500/μL polymorphonuclear leukocytes, >100,000/μL platelets, >11.0 g/dL hemoglobin or 50% improvement for these parameters without transfusions | Up to 9 months |
| 2 Year Progression Free Survival | Percentage of patients who were alive and progression free at 2 years. The 2-year progression free survival was estimated using the Kaplan Meier method. | 2 years from registration |
| 2 Year Survival | Percentage of participants who were alive at 2 years. The 2 year survival was estimated using the Kaplan Meier method. | 2 years from registration |
| Number of Participants With Severe Non-Hematologic Adverse Events During Treatment With Alemtuzumab | The National Cancer Institute (NCI) Common Toxicity Criteria (CTC) Version 2.0 was used to evaluate toxicity. Severe Adverse events are defined as grade 3, 4 or 5, at least possibly related to treatment. Grade 1: mild; Grade 2: moderate; Grade 3: Severe; Grade 4: Life Threatening; Grade 5: Death. | 6 weeks beginning at study week 36 |
|
|
NCT03605329
|
Evaluation of the Severity of Cardiovascular Autonomic Neuropathy in Type 1 Diabetic Patients With OSAS
|
The links between obstructive sleep apnea syndrome (OSAS) and type 1 diabetes (T1D) are poorly studied. This study proposes to evaluate the severity of cardiovascular autonomic neuropathy (CAN) related to T1D in case of associated OSAS. This issue has significant diagnostic and therapeutic implications because of the increased cardiovascular risk in case of confirmed CAN in T1D patients.
|
Cardiovascular autonomic neuropathy (CAN) is a common complication of type 1 diabetes (T1D) and is associated with increased cardiovascular risk. Otherwise, some studies have found a high frequence of obstructive sleep apnea syndrome (OSAs) in T1D. Cardiac autonomic modulations are deeply altered in OSAS. The combination of T1D and OSAS could therefore increase the severity of CAN and worsen the cardiovascular prognosis.~The most common method used to explore CAN is the study of heart rate variability (HRV). HRV is a practical, non-invasive and reproducible measure of autonomic nervous system function. HRV abnormalities are a predictor of hypertension and increased mortality in T1D.~Th investigators therefore propose to explore the severity of NAC in case of OSAS associated with T1D, and the hypothesis is that cardiovascular damage is increased in the presence of these two pathologies.~The patients included in this study will be patients with type 1 diabetes diagnosed for more than 5 years.~After overnight polysomnography, cardiovascular autonomic neuropathy will be evaluated by different methods: study of HRV, cardiovascular autonomic reflex test (Ewing), measurements of urinary levels of catecholamines and measurements of sweat gland dysfunction using Sudoscan.~The severity of CAN will be evaluated in T1D patients with moderate to severe OSAS (apnea hypopnea index (IAH) ≥15 / hour) compared to T1D patients with IAH <15 / hour.~Furthermore, glycemic holter will describe the links between glycemic variability, sleep architecture and CAN. Biological oxidative stress assays will improve physiopathological knowledge between T1D, OSAS and CAN. Finally, a 24-hour monitoring of blood pressure will be performed.~An ancillary study is planned to evaluate the evolution of markers of the autonomic nervous system after three months of treatment with CPAP in 15 patients with severe OSAS (AHI ≥30 / hour) having previously participated in the main study. Fifteen patients with IAH <30 / hour will also be reassessed at three months to assess the intra-individual variability of the HRV.
|
Evaluation of the Severity of Cardiovascular Autonomic Neuropathy in Type 1 Diabetic Patients With Obstructive Sleep Apnea Syndrome
|
Sleep Apnea, Obstructive, Diabetes Mellitus, Type 1
|
* Other: to explore the severity of NAC in case of OSAS
|
Inclusion criteria:~Type 1 diabetes patients with a diabetes duration of at least 5 years~Age between 18 and 60 years old.~Exclusion criteria:~OSAS treated with CPAP~Chronic alcoholism~Neuromuscular disease~Drugs interfering with sinus variability (betablockers, antiarrhythmics, ivabradine), presence of pacemaker~Pregant woman
|
18 Years
|
60 Years
|
All
|
No
|
Primary Purpose: Other
Intervention Model: Single Group Assignment
Masking: None (Open Label)
|
| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| study of heart rate variability (HRV) | heart rate variability (LF/HF ratio) in type 1 diabetic patients with sleep apnea syndrome (AHI>15/h) in comparison with T1D patients with AHI <15/hour. | day 1 |
|
| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Evaluation of the severity of CAN | measurements of urinary levels of catecholamines | day 1 |
| measurements of sweat gland dysfunction | Sudoscan | day 1 |
| Characterization of the sleep architecture of T1D patients | overnight polysomnography | day 1 |
| monitoring of blood pressure | a 24-hour monitoring of blood pressure | day 1 |
|
Sleep Apnea, Obstructive, diabetes
|
Sleep Disorders, Intrinsic, Dyssomnias, Sleep Wake Disorders, Apnea, Sleep Apnea Syndromes, Sleep Apnea, Obstructive, Diabetes Mellitus, Type 1, Respiration Disorders, Respiratory Tract Diseases, Signs and Symptoms, Respiratory, Nervous System Diseases, Diabetes Mellitus, Glucose Metabolism Disorders, Metabolic Diseases, Endocrine System Diseases, Autoimmune Diseases, Immune System Diseases
|
| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Other: Type 1 diabetic patients with OSAS<br>to explore the severity of NAC in case of OSAS | Other: to explore the severity of NAC in case of OSAS<br>* After overnight polysomnography, cardiovascular autonomic neuropathy will be evaluated by different methods: study of HRV, cardiovascular autonomic reflex test (Ewing), measurements of urinary levels of catecholamines and measurements of sweat gland dysfunction using Sudoscan.~The severity of CAN will be evaluated in T1D patients with moderate to severe OSAS (apnea hypopnea index (IAH) ≥15 / hour) compared to T1D patients with IAH <15 / hour.<br>|
|
Evaluation of the Severity of Cardiovascular Autonomic Neuropathy in Type 1 Diabetic Patients With OSAS
Study Overview
=================
Brief Summary
-----------------
The links between obstructive sleep apnea syndrome (OSAS) and type 1 diabetes (T1D) are poorly studied. This study proposes to evaluate the severity of cardiovascular autonomic neuropathy (CAN) related to T1D in case of associated OSAS. This issue has significant diagnostic and therapeutic implications because of the increased cardiovascular risk in case of confirmed CAN in T1D patients.
Detailed Description
-----------------
Cardiovascular autonomic neuropathy (CAN) is a common complication of type 1 diabetes (T1D) and is associated with increased cardiovascular risk. Otherwise, some studies have found a high frequence of obstructive sleep apnea syndrome (OSAs) in T1D. Cardiac autonomic modulations are deeply altered in OSAS. The combination of T1D and OSAS could therefore increase the severity of CAN and worsen the cardiovascular prognosis. The most common method used to explore CAN is the study of heart rate variability (HRV). HRV is a practical, non-invasive and reproducible measure of autonomic nervous system function. HRV abnormalities are a predictor of hypertension and increased mortality in T1D. Th investigators therefore propose to explore the severity of NAC in case of OSAS associated with T1D, and the hypothesis is that cardiovascular damage is increased in the presence of these two pathologies. The patients included in this study will be patients with type 1 diabetes diagnosed for more than 5 years. After overnight polysomnography, cardiovascular autonomic neuropathy will be evaluated by different methods: study of HRV, cardiovascular autonomic reflex test (Ewing), measurements of urinary levels of catecholamines and measurements of sweat gland dysfunction using Sudoscan. The severity of CAN will be evaluated in T1D patients with moderate to severe OSAS (apnea hypopnea index (IAH) ≥15 / hour) compared to T1D patients with IAH <15 / hour. Furthermore, glycemic holter will describe the links between glycemic variability, sleep architecture and CAN. Biological oxidative stress assays will improve physiopathological knowledge between T1D, OSAS and CAN. Finally, a 24-hour monitoring of blood pressure will be performed. An ancillary study is planned to evaluate the evolution of markers of the autonomic nervous system after three months of treatment with CPAP in 15 patients with severe OSAS (AHI ≥30 / hour) having previously participated in the main study. Fifteen patients with IAH <30 / hour will also be reassessed at three months to assess the intra-individual variability of the HRV.
Official Title
-----------------
Evaluation of the Severity of Cardiovascular Autonomic Neuropathy in Type 1 Diabetic Patients With Obstructive Sleep Apnea Syndrome
Conditions
-----------------
Sleep Apnea, Obstructive, Diabetes Mellitus, Type 1
Intervention / Treatment
-----------------
* Other: to explore the severity of NAC in case of OSAS
Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion criteria: Type 1 diabetes patients with a diabetes duration of at least 5 years Age between 18 and 60 years old. Exclusion criteria: OSAS treated with CPAP Chronic alcoholism Neuromuscular disease Drugs interfering with sinus variability (betablockers, antiarrhythmics, ivabradine), presence of pacemaker Pregant woman
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: Other
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Arms and Interventions
| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Other: Type 1 diabetic patients with OSAS<br>to explore the severity of NAC in case of OSAS | Other: to explore the severity of NAC in case of OSAS<br>* After overnight polysomnography, cardiovascular autonomic neuropathy will be evaluated by different methods: study of HRV, cardiovascular autonomic reflex test (Ewing), measurements of urinary levels of catecholamines and measurements of sweat gland dysfunction using Sudoscan. The severity of CAN will be evaluated in T1D patients with moderate to severe OSAS (apnea hypopnea index (IAH) ≥15 / hour) compared to T1D patients with IAH <15 / hour.<br>|
What is the study measuring?
-----------------
Primary Outcome Measures
| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| study of heart rate variability (HRV) | heart rate variability (LF/HF ratio) in type 1 diabetic patients with sleep apnea syndrome (AHI>15/h) in comparison with T1D patients with AHI <15/hour. | day 1 |
Secondary Outcome Measures
| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Evaluation of the severity of CAN | measurements of urinary levels of catecholamines | day 1 |
| measurements of sweat gland dysfunction | Sudoscan | day 1 |
| Characterization of the sleep architecture of T1D patients | overnight polysomnography | day 1 |
| monitoring of blood pressure | a 24-hour monitoring of blood pressure | day 1 |
Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Sleep Apnea, Obstructive, diabetes
|
NCT01412866
|
Electronic Decision Support Systems for Smokers With Severe Mental Illness
|
This randomized clinical trial among SMI smokers assessed whether the EDSS with carbon monoxide monitor and health-checklist feedback lead to higher rates of initiation of smoking cessation treatment, days of smoking abstinence and Fagerstrom Dependence scores, compared to use of the EDSS with checklist feedback alone.
|
Up to 80% of Americans with serious mental illnesses (SMI; schizophrenia and severe mood disorders) smoke cigarettes, and most suffer related health consequences. Although combined treatment with medication and psychosocial therapy can help people with SMI to quit smoking, it is rarely used. Motivational interventions can enhance the use of combined treatment, but motivational interventions are expensive and unavailable. To fill this gap, Dartmouth and Thresholds investigators have developed an easy-to-use, web-based electronic decision support system (EDSS) that aims to educate and motivate smokers with SMI. Preliminary testing has demonstrated excellent usability and increased engagement in smoking cessation treatments.~One critical issue is the use of personalized health feedback. Motivational interventions for smoking cessation for smokers with SMI, including our EDSS, have included personal feedback from a breath monitor that measures carbon monoxide, a toxic component of cigarette smoke. Feedback regarding carbon monoxide is thought to motivate the user by personalizing the health risks of smoking. The carbon monoxide monitor is, however, expensive, difficult to implement, and largely unavailable in public mental health and primary care clinics. Further, research on use of carbon monoxide monitoring in the general population is equivocal. Another motivational strategy to personalize the negative health effects of smoking is a health checklist with feedback. Health checklists have been shown to be effective, are easy to use, have no expense, but have not been assessed separately from carbon monoxide monitor feedback among SMI smokers. Testing the effect of feedback from the health checklist compared to feedback from the carbon monoxide monitor is an essential next step in the development of this tool.~Aim 1. The investigators propose a randomized clinical trial among SMI smokers to assess whether the EDSS with carbon monoxide monitor and health-checklist feedback will lead to higher rates of initiation of smoking cessation treatment than the EDSS with health-checklist feedback alone.~Aim 1.a. To explore whether use of the EDSS with carbon monoxide monitor and health-checklist feedback leads to higher rates of the distal outcomes, days of smoking abstinence and Fagerstrom Dependence scores, than use of the EDSS with checklist feedback alone.
|
Electronic Decision Support Systems for Smokers With Severe Mental Illness
|
Severe Mental Illness, Nicotine Dependence, Schizophrenia, Tobacco Use Disorder
|
* Behavioral: EDSS with CO feedback and health checklist
* Behavioral: EDSS with health checklist feedback alon
|
Inclusion Criteria:~adult age 18-75~in treatment for severe mental illness,~current smoker,~physically able to use a computer~Exclusion Criteria:~Using smoking cessation treatment in past month,~substance dependence with current use
|
18 Years
|
75 Years
|
All
|
No
|
Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single
|
| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Initiation of Smoking Cessation Treatment | Started smoking cessation treatment | 2 months |
|
| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Days of Nicotine Abstinence | | 6 months |
|
schizophrenia, severe mental illness, nicotine, smoking, motivation, electronic decision support system, motivational interviewing
|
Tobacco Use Disorder, Schizophrenia, Mental Disorders, Schizophrenia Spectrum and Other Psychotic Disorders, Substance-Related Disorders, Chemically-Induced Disorders
|
| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: EDSS with CO monitor<br>Web-based electronic decision support system (EDSS) with carbon monoxide (CO) monitor and health-checklist | Behavioral: EDSS with CO feedback and health checklist<br>* Web-based electronic decision support system with CO feedback and health-checklist<br>|
| Active Comparator: EDSS without CO monitor<br>Web-based electronic decision support system (EDSS) with health-checklist only | Behavioral: EDSS with health checklist feedback alon<br>* Web-based electronic decision support system (EDSS) with health-checklist feedback alone (without CO feedback)<br>|
|
Electronic Decision Support Systems for Smokers With Severe Mental Illness
Study Overview
=================
Brief Summary
-----------------
This randomized clinical trial among SMI smokers assessed whether the EDSS with carbon monoxide monitor and health-checklist feedback lead to higher rates of initiation of smoking cessation treatment, days of smoking abstinence and Fagerstrom Dependence scores, compared to use of the EDSS with checklist feedback alone.
Detailed Description
-----------------
Up to 80% of Americans with serious mental illnesses (SMI; schizophrenia and severe mood disorders) smoke cigarettes, and most suffer related health consequences. Although combined treatment with medication and psychosocial therapy can help people with SMI to quit smoking, it is rarely used. Motivational interventions can enhance the use of combined treatment, but motivational interventions are expensive and unavailable. To fill this gap, Dartmouth and Thresholds investigators have developed an easy-to-use, web-based electronic decision support system (EDSS) that aims to educate and motivate smokers with SMI. Preliminary testing has demonstrated excellent usability and increased engagement in smoking cessation treatments. One critical issue is the use of personalized health feedback. Motivational interventions for smoking cessation for smokers with SMI, including our EDSS, have included personal feedback from a breath monitor that measures carbon monoxide, a toxic component of cigarette smoke. Feedback regarding carbon monoxide is thought to motivate the user by personalizing the health risks of smoking. The carbon monoxide monitor is, however, expensive, difficult to implement, and largely unavailable in public mental health and primary care clinics. Further, research on use of carbon monoxide monitoring in the general population is equivocal. Another motivational strategy to personalize the negative health effects of smoking is a health checklist with feedback. Health checklists have been shown to be effective, are easy to use, have no expense, but have not been assessed separately from carbon monoxide monitor feedback among SMI smokers. Testing the effect of feedback from the health checklist compared to feedback from the carbon monoxide monitor is an essential next step in the development of this tool. Aim 1. The investigators propose a randomized clinical trial among SMI smokers to assess whether the EDSS with carbon monoxide monitor and health-checklist feedback will lead to higher rates of initiation of smoking cessation treatment than the EDSS with health-checklist feedback alone. Aim 1.a. To explore whether use of the EDSS with carbon monoxide monitor and health-checklist feedback leads to higher rates of the distal outcomes, days of smoking abstinence and Fagerstrom Dependence scores, than use of the EDSS with checklist feedback alone.
Official Title
-----------------
Electronic Decision Support Systems for Smokers With Severe Mental Illness
Conditions
-----------------
Severe Mental Illness, Nicotine Dependence, Schizophrenia, Tobacco Use Disorder
Intervention / Treatment
-----------------
* Behavioral: EDSS with CO feedback and health checklist
* Behavioral: EDSS with health checklist feedback alon
Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: adult age 18-75 in treatment for severe mental illness, current smoker, physically able to use a computer Exclusion Criteria: Using smoking cessation treatment in past month, substance dependence with current use
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: Single
Arms and Interventions
| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: EDSS with CO monitor<br>Web-based electronic decision support system (EDSS) with carbon monoxide (CO) monitor and health-checklist | Behavioral: EDSS with CO feedback and health checklist<br>* Web-based electronic decision support system with CO feedback and health-checklist<br>|
| Active Comparator: EDSS without CO monitor<br>Web-based electronic decision support system (EDSS) with health-checklist only | Behavioral: EDSS with health checklist feedback alon<br>* Web-based electronic decision support system (EDSS) with health-checklist feedback alone (without CO feedback)<br>|
What is the study measuring?
-----------------
Primary Outcome Measures
| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Initiation of Smoking Cessation Treatment | Started smoking cessation treatment | 2 months |
Secondary Outcome Measures
| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Days of Nicotine Abstinence | | 6 months |
Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
schizophrenia, severe mental illness, nicotine, smoking, motivation, electronic decision support system, motivational interviewing
|
NCT04387032
|
Impact of Manipulation of Sacroiliac Joints on the Static Balance of the Body
|
The study can be identified as an experimental study with a quasi-randomized control. It consisted of HVLA manipulation on blocked sacroiliac joints (SIJ) and it was checked whether it affected the appropriate parameters determining the pressure center (COP). The value of the parameters were examined twice, before (PRE) and after (POST) manipulation. The results were compared with the control group (people without hypomobility SIJ) in which sham manipulation was performed, and COP parameters (PRE and POST) were measured twice. In addition, PRE and POST results were compared within the group, i.e. separately in the experimental group (E) and separately in the control group (C) to check the effect of HVLA manipulation and placebo manipulation.~The first hypothesis assumes that persons belonging to the experimental group are characterized by significantly higher values of COP parameters before manipulation than values in the control group. The second hypothesis assumes that COP parameters will normalize as a result of sacroiliac joint mobilization performed in the experimental group.
|
The aim of the project was to determine the effectiveness of HVLA manipulation in maintaining static body balance. To implement it, it was necessary to conduct an experiment consisting in performing HVLA manipulation in people with SIJs hypomobility and checking whether it affects the COP parameters. It was assumed to measure these parameters twice (before (PRE) and after (POST) manipulation) and compare them with the measurements in the C group (sham manipulation).~The sample size necessary to power the study was determined at the test planning stage, using the G * Power 3.1.9 software. The standard threshold α = .05 was established; then the acceptable power level of the 1-β = .90 test and the expected moderate effect size η2 = .30 were determined for within-between interaction. The calculated total expected size of the sample is N = 32, i.e. 16 subjects in one research group, assuming that their number will not decrease during the study. With a higher test power 1-β = .95 and a moderate achieved result for observed effect size η2 = .25, the sample should have to consist of 26 subjects per subgroup. It was decided to examine a slightly larger number of available entities due to the possibility of excluding incorrect data.~Poznan University of Physical Education's students were invited to the research, electronically. Before starting the research, they were informed about the purpose and manner of conducting the research, and the type of methods used. Participation in the experiment was voluntary and free. Participants could withdraw from cooperation in the research at any time. They obtained assurance that the data obtained will be used only for scientific purposes and their processing will be fully anonymous.~Among 202 students of the Poznań University of Physical Education who responded to the invitation to the study project interview has been conducted, as a result of which 22 people were excluded from further actions due to disqualification criteria. Then sacroiliac mobility tests has been performed which made it possible to recognize hypomobility in 72 people. From the group of people with hypomobility, 36 people were randomly selected and included in the E group. From among people without hypomobility, 31 people were randomly selected for the C group. An random number table was used in the draw. The subjects did not know any group they were assigned to.~Subsequently, the examination of each project participant consisted of performing podometric measurements and SIJs mobilization in the E group or placebo in the C group, and re-performing functional tests and podometrics in both groups after the procedure. At the stage of analyzing data rejected 8 people who did not meet the assumed criteria, thus finally there were 30 people in the experimental group and 29 in the control group.~Functional tests~Qualification of the subjects to the E and C group was conducted by a researcher who had seven years of experience in using manual therapy techniques. The following tests of SIJs mobility were performed:~Standing forward flexion test: the symmetry of posterior superior iliac spine (PSIS) displacement during forward flexion is assessed. In the case of hamstrings tension, the result may be false positive, so it should be repeated in a sitting position or with slightly bent knees.~One leg standing / Stork / Gillet test: the hip joint is bent in the standing position, the downward and medial displacement of PSIS in relation to S2 is observed.~Measurement of the Derbolowsky symptom (Pidellou symptom / long sitting test): was performed as determined by Bemis and Daniel. It allows determining the dysfunctional side and the rotation of iliac bone. The level of medial ankles during lifting of the torso from lying back position to straight sit with simultaneous traction of legs is observed.~Lower limb adduction test: the patient is lying back, upper anterior iliac spine stabilization (ASIS) is required. The adduction of the bent at the hip and knee joint lower limb follows it. On the limited side, the adduction angle will be smaller compared to the healthy side. The test has screening character, because blockage of the joint may occur without limitation of adduction in the case of hip over-mobility, but due to the simplicity of implementation, it is a valuable indicator.~The majority of SIJs mobility tests are burdened with the accuracy and reliability errors in situations when they are performed individually. However, performing more tests increases the accuracy of the diagnosis. For this reason, there were performed four SIJs mobility tests, as well as complementary measurements of PSIS, ASIS, and iliac crest levels before (PRE) and after (POST) treatment to determine its effectiveness.~Podometric measurement After conducting functional tests, the study participants were directed to a podometric measurement, which was performed twice - PRE and POST. The measurement was carried out using the Medicapteurs PEL 38 platform, which allows conducting both static and dynamic measurements, and it cooperates with the TWINN software in Windows. The equipment was designed and tested in leading medical centers in Europe and put into use in the USA by Physical Support Systems. The platform has 1024 sensors with a total measuring surface of 320x320 [mm] and the appropriate resolution for testing the distribution of foot pressure and tracking the position of COP. The platform was calibrated automatically accordingly to the bodyweight of each participant, and the measurement was taken in a standing (Frankfurt) position with upper limbs hanging freely. Participants were asked to maintain a stable position without unnecessary movements and to look straight ahead at eye level. During the study, patients did not have visual access to a graphical record of the measurement carried out to avoid attempts to correct body posture. Each measurement was conducted for 30 seconds, recording the current COP position at a frequency of 10 frames per second.~Experimental manipulation Persons with blocked SIJ on one or both sides, constituting an E group, were manipulated on the blocked joints. People without blocked SIJs constituted a C group that underwent placebo manipulation.~The procedure of experimental manipulation: the patient lay on the healthy side with the straight lower limb, and the torso turned towards the dysfunctional side, whose lower limb was bent in the hip and knee joint, and the hands rest on the lower ribs on the same side. The therapist allowed the initial loosening of the tissues and chose the movement barrier with his stabilizing hand. Then, with the treatment hand, he introduced the HVLA thrust through the iliac bone towards the bottom, while giving the iliac bone a posterior or anterior rotation - meaning, the opposite to the occurring dysfunction. If during the manipulation, no cavitation sound was heard, the HVLA thrust was repeated once. In the C group, the placebo procedure was the same, but no external force was introduced in the form of a therapeutic impulse.~Statistical methods The collected data were analyzed in a statistical program Statistica version 13. The normality of the distribution of all measured variables on the quantitative scale in both groups was checked by the Shapiro-Wilk test .~In order to study the effect of the manipulation on the measured variables, there was carried out quantitative analysis of variance with repeated measures, plus a number of comparisons using the Student's t-test for dependent and independent attempts, and in some cases for the characteristics whose distribution differed from the standard - with the use of non-parametric the Mann-Whitney U-test for independent pairs or Wilcoxon test for dependent pairs. The Cohen d effect power measure was also used in data analysis.
|
The Influence of the Sacroiliac Joint Manipulation on Changes in the Values of the Center of Pressure in the Process of Maintaining Static Body Balance
|
Asymptomatic Condition, Sacroiliac Disorder
|
* Other: HVLA Manipulations
* Other: Sham Manipulation
|
Inclusion Criteria:~Student at the Poznan University of Physical Education;~age 19-24;~asymptomaticity in the form of no pain symptoms in the LS segment of the spine;~written consent to participate in the study;~presenting no disqualification criteria;~no health contraindications to perform manipulation;~no hypomobility of the SI joints, negative mobility test results PRE (to the control group);~occurrence of hypomobility of the SI joint on one or both sides PRE (to the experimental group);~noting the sound of cavitation during the procedure (in the experimental group);~confirmation of a treatment effectiveness by noting negative results of SI joints mobility tests POST (in the experimental group).~Exclusion Criteria:~Persons who were characterized by LBP, neurological symptoms, rheumatic problems, orthopedic, or ongoing treatment in the lumbar spine and pelvis area were excluded. Pregnancy and the anatomical difference in the length of the lower limbs exceeding 5mm were also an excluding criterion.
|
19 Years
|
24 Years
|
All
|
Accepts Healthy Volunteers
|
Primary Purpose: Prevention
Allocation: Non-Randomized
Intervention Model: Parallel Assignment
Interventional Model Description: Experimental group - HVLA manipulations on blocked sacroiliac joints (SIJs) Control group (people without hypomobile SIJs), in which we performed sham manipulation
Masking: Double
|
| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| COP X PRE | deflection of the COP in the X axis before manipulation | PRE (immediately before the intervention) |
| COP X POST | deflection of the COP in the X axis after manipulation | POST (immediately after the intervention) |
| COP Y PRE | deflection of the COP in the Y axis before manipulation | PRE (immediately before the intervention) |
| COP Y POST | deflection of the COP in the Y axis after manipulation | POST (immediately after the intervention) |
| COP Length PRE | path travelled by COP before manipulation; | PRE (immediately before the intervention) |
| COP Length POST | path travelled by COP after manipulation; | POSt (immediately after the intervention) |
| COP Area PRE | COP area before manipulation | PRE (immediately before the intervention) |
| COP Area POST | COP area after manipulation | POST (immediately after the intervention) |
| COP Av.Q-speed PRE | the average speed of COP before manipulation | PRE (immediately before the intervention) |
| COP Av.Q-speed POST | the average speed of COP after manipulation | POST (immediately after the intervention) |
|
manual therapy, HVLA manipulation, sacroiliac joint, center of pressure (COP), hypomobility
|
Asymptomatic Diseases, Disease Attributes, Pathologic Processes
|
| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Experimental group<br>Experimental group (students with hypomobile SIJs) | Other: HVLA Manipulations<br>* The procedure of experimental manipulation: the patient lay on the healthy side with the straight lower limb, and the torso turned towards the dysfunctional side, whose lower limb was bent in the hip and knee joint, and the hands rest on the lower ribs on the same side. The therapist allowed the initial loosening of the tissues and chose the movement barrier with his stabilizing hand. Then, with the treatment hand, he introduced the HVLA thrust through the iliac bone towards the bottom, while giving the iliac bone a posterior or anterior rotation - meaning, the opposite to the occurring dysfunction. If during the manipulation, no cavitation sound was heard, the HVLA thrust was repeated once.<br>* Other names: manual therapy;|
| Sham Comparator: Control group<br>control group (students without hypomobile SIJs) | Other: Sham Manipulation<br>* The sham procedure was the same, but no external force was introduced in the form of a therapeutic impulse.<br>|
|
Impact of Manipulation of Sacroiliac Joints on the Static Balance of the Body
Study Overview
=================
Brief Summary
-----------------
The study can be identified as an experimental study with a quasi-randomized control. It consisted of HVLA manipulation on blocked sacroiliac joints (SIJ) and it was checked whether it affected the appropriate parameters determining the pressure center (COP). The value of the parameters were examined twice, before (PRE) and after (POST) manipulation. The results were compared with the control group (people without hypomobility SIJ) in which sham manipulation was performed, and COP parameters (PRE and POST) were measured twice. In addition, PRE and POST results were compared within the group, i.e. separately in the experimental group (E) and separately in the control group (C) to check the effect of HVLA manipulation and placebo manipulation. The first hypothesis assumes that persons belonging to the experimental group are characterized by significantly higher values of COP parameters before manipulation than values in the control group. The second hypothesis assumes that COP parameters will normalize as a result of sacroiliac joint mobilization performed in the experimental group.
Detailed Description
-----------------
The aim of the project was to determine the effectiveness of HVLA manipulation in maintaining static body balance. To implement it, it was necessary to conduct an experiment consisting in performing HVLA manipulation in people with SIJs hypomobility and checking whether it affects the COP parameters. It was assumed to measure these parameters twice (before (PRE) and after (POST) manipulation) and compare them with the measurements in the C group (sham manipulation). The sample size necessary to power the study was determined at the test planning stage, using the G * Power 3.1.9 software. The standard threshold α = .05 was established; then the acceptable power level of the 1-β = .90 test and the expected moderate effect size η2 = .30 were determined for within-between interaction. The calculated total expected size of the sample is N = 32, i.e. 16 subjects in one research group, assuming that their number will not decrease during the study. With a higher test power 1-β = .95 and a moderate achieved result for observed effect size η2 = .25, the sample should have to consist of 26 subjects per subgroup. It was decided to examine a slightly larger number of available entities due to the possibility of excluding incorrect data. Poznan University of Physical Education's students were invited to the research, electronically. Before starting the research, they were informed about the purpose and manner of conducting the research, and the type of methods used. Participation in the experiment was voluntary and free. Participants could withdraw from cooperation in the research at any time. They obtained assurance that the data obtained will be used only for scientific purposes and their processing will be fully anonymous. Among 202 students of the Poznań University of Physical Education who responded to the invitation to the study project interview has been conducted, as a result of which 22 people were excluded from further actions due to disqualification criteria. Then sacroiliac mobility tests has been performed which made it possible to recognize hypomobility in 72 people. From the group of people with hypomobility, 36 people were randomly selected and included in the E group. From among people without hypomobility, 31 people were randomly selected for the C group. An random number table was used in the draw. The subjects did not know any group they were assigned to. Subsequently, the examination of each project participant consisted of performing podometric measurements and SIJs mobilization in the E group or placebo in the C group, and re-performing functional tests and podometrics in both groups after the procedure. At the stage of analyzing data rejected 8 people who did not meet the assumed criteria, thus finally there were 30 people in the experimental group and 29 in the control group. Functional tests Qualification of the subjects to the E and C group was conducted by a researcher who had seven years of experience in using manual therapy techniques. The following tests of SIJs mobility were performed: Standing forward flexion test: the symmetry of posterior superior iliac spine (PSIS) displacement during forward flexion is assessed. In the case of hamstrings tension, the result may be false positive, so it should be repeated in a sitting position or with slightly bent knees. One leg standing / Stork / Gillet test: the hip joint is bent in the standing position, the downward and medial displacement of PSIS in relation to S2 is observed. Measurement of the Derbolowsky symptom (Pidellou symptom / long sitting test): was performed as determined by Bemis and Daniel. It allows determining the dysfunctional side and the rotation of iliac bone. The level of medial ankles during lifting of the torso from lying back position to straight sit with simultaneous traction of legs is observed. Lower limb adduction test: the patient is lying back, upper anterior iliac spine stabilization (ASIS) is required. The adduction of the bent at the hip and knee joint lower limb follows it. On the limited side, the adduction angle will be smaller compared to the healthy side. The test has screening character, because blockage of the joint may occur without limitation of adduction in the case of hip over-mobility, but due to the simplicity of implementation, it is a valuable indicator. The majority of SIJs mobility tests are burdened with the accuracy and reliability errors in situations when they are performed individually. However, performing more tests increases the accuracy of the diagnosis. For this reason, there were performed four SIJs mobility tests, as well as complementary measurements of PSIS, ASIS, and iliac crest levels before (PRE) and after (POST) treatment to determine its effectiveness. Podometric measurement After conducting functional tests, the study participants were directed to a podometric measurement, which was performed twice - PRE and POST. The measurement was carried out using the Medicapteurs PEL 38 platform, which allows conducting both static and dynamic measurements, and it cooperates with the TWINN software in Windows. The equipment was designed and tested in leading medical centers in Europe and put into use in the USA by Physical Support Systems. The platform has 1024 sensors with a total measuring surface of 320x320 [mm] and the appropriate resolution for testing the distribution of foot pressure and tracking the position of COP. The platform was calibrated automatically accordingly to the bodyweight of each participant, and the measurement was taken in a standing (Frankfurt) position with upper limbs hanging freely. Participants were asked to maintain a stable position without unnecessary movements and to look straight ahead at eye level. During the study, patients did not have visual access to a graphical record of the measurement carried out to avoid attempts to correct body posture. Each measurement was conducted for 30 seconds, recording the current COP position at a frequency of 10 frames per second. Experimental manipulation Persons with blocked SIJ on one or both sides, constituting an E group, were manipulated on the blocked joints. People without blocked SIJs constituted a C group that underwent placebo manipulation. The procedure of experimental manipulation: the patient lay on the healthy side with the straight lower limb, and the torso turned towards the dysfunctional side, whose lower limb was bent in the hip and knee joint, and the hands rest on the lower ribs on the same side. The therapist allowed the initial loosening of the tissues and chose the movement barrier with his stabilizing hand. Then, with the treatment hand, he introduced the HVLA thrust through the iliac bone towards the bottom, while giving the iliac bone a posterior or anterior rotation - meaning, the opposite to the occurring dysfunction. If during the manipulation, no cavitation sound was heard, the HVLA thrust was repeated once. In the C group, the placebo procedure was the same, but no external force was introduced in the form of a therapeutic impulse. Statistical methods The collected data were analyzed in a statistical program Statistica version 13. The normality of the distribution of all measured variables on the quantitative scale in both groups was checked by the Shapiro-Wilk test . In order to study the effect of the manipulation on the measured variables, there was carried out quantitative analysis of variance with repeated measures, plus a number of comparisons using the Student's t-test for dependent and independent attempts, and in some cases for the characteristics whose distribution differed from the standard - with the use of non-parametric the Mann-Whitney U-test for independent pairs or Wilcoxon test for dependent pairs. The Cohen d effect power measure was also used in data analysis.
Official Title
-----------------
The Influence of the Sacroiliac Joint Manipulation on Changes in the Values of the Center of Pressure in the Process of Maintaining Static Body Balance
Conditions
-----------------
Asymptomatic Condition, Sacroiliac Disorder
Intervention / Treatment
-----------------
* Other: HVLA Manipulations
* Other: Sham Manipulation
Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Student at the Poznan University of Physical Education; age 19-24; asymptomaticity in the form of no pain symptoms in the LS segment of the spine; written consent to participate in the study; presenting no disqualification criteria; no health contraindications to perform manipulation; no hypomobility of the SI joints, negative mobility test results PRE (to the control group); occurrence of hypomobility of the SI joint on one or both sides PRE (to the experimental group); noting the sound of cavitation during the procedure (in the experimental group); confirmation of a treatment effectiveness by noting negative results of SI joints mobility tests POST (in the experimental group). Exclusion Criteria: Persons who were characterized by LBP, neurological symptoms, rheumatic problems, orthopedic, or ongoing treatment in the lumbar spine and pelvis area were excluded. Pregnancy and the anatomical difference in the length of the lower limbs exceeding 5mm were also an excluding criterion.
Ages Eligible for Study
-----------------
Minimum Age: 19 Years
Maximum Age: 24 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: Non-Randomized
Intervention Model: Parallel Assignment
Interventional Model Description: Experimental group - HVLA manipulations on blocked sacroiliac joints (SIJs) Control group (people without hypomobile SIJs), in which we performed sham manipulation
Masking: Double
Arms and Interventions
| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Experimental group<br>Experimental group (students with hypomobile SIJs) | Other: HVLA Manipulations<br>* The procedure of experimental manipulation: the patient lay on the healthy side with the straight lower limb, and the torso turned towards the dysfunctional side, whose lower limb was bent in the hip and knee joint, and the hands rest on the lower ribs on the same side. The therapist allowed the initial loosening of the tissues and chose the movement barrier with his stabilizing hand. Then, with the treatment hand, he introduced the HVLA thrust through the iliac bone towards the bottom, while giving the iliac bone a posterior or anterior rotation - meaning, the opposite to the occurring dysfunction. If during the manipulation, no cavitation sound was heard, the HVLA thrust was repeated once.<br>* Other names: manual therapy;|
| Sham Comparator: Control group<br>control group (students without hypomobile SIJs) | Other: Sham Manipulation<br>* The sham procedure was the same, but no external force was introduced in the form of a therapeutic impulse.<br>|
What is the study measuring?
-----------------
Primary Outcome Measures
| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| COP X PRE | deflection of the COP in the X axis before manipulation | PRE (immediately before the intervention) |
| COP X POST | deflection of the COP in the X axis after manipulation | POST (immediately after the intervention) |
| COP Y PRE | deflection of the COP in the Y axis before manipulation | PRE (immediately before the intervention) |
| COP Y POST | deflection of the COP in the Y axis after manipulation | POST (immediately after the intervention) |
| COP Length PRE | path travelled by COP before manipulation; | PRE (immediately before the intervention) |
| COP Length POST | path travelled by COP after manipulation; | POSt (immediately after the intervention) |
| COP Area PRE | COP area before manipulation | PRE (immediately before the intervention) |
| COP Area POST | COP area after manipulation | POST (immediately after the intervention) |
| COP Av.Q-speed PRE | the average speed of COP before manipulation | PRE (immediately before the intervention) |
| COP Av.Q-speed POST | the average speed of COP after manipulation | POST (immediately after the intervention) |
Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
manual therapy, HVLA manipulation, sacroiliac joint, center of pressure (COP), hypomobility
|
|
NCT05511207
|
Clinical Validation of a Hybrid BCI-controlled FES for Upper Limb Rehabilitation After Stroke
|
The RECOMMENCER project aims at developing and testing a novel hybrid Brain Computer Interface device based on cortico-muscular connectivity, that will be employed to activate Functional Electrical Stimulation (FES) of upper limb muscles. After the technical implementation of the device and its preliminary testing on healthy subject, the investigators will evaluate the effects of a 1 month training with the device (RECOM) on post-stroke patients undergoing standard rehabilitation (add-on). The proposed intervention will be compared with an active physiotherapy training including FES (CTRL) which will be focused on upper limb with similar intensity as the target intervention (also delivered in add-on).
|
Brain-Computer Interface (BCI) systems for upper limb rehabilitation have proven some efficacy in the context of several randomized controlled trials (RCT). Such systems rely on the possibility reinforce motor-related brain activity (derived eg from electroencephalography, EEG) harnessing neuroplasticity phenomena ultimately leading to favorable motor outcome. Up to now, no hybrid BCI (hBCI) has been tested successfully for this purpose in a clinical trial. Hybrid BCIs include signals from the periphery (most commonly muscles, via surface electromyography, EMG) and are usually employed to improve BCI performances. In a rehabilitative context, the investigators aim to employ EMG signals to characterize common post-stroke abnormalities (spasticity, co-contractions, motor overflow) and possibly include those in a novel hBCI paradigm to promote both volitional control (EEG) over upper limb movement and close to normal muscular activation (EMG). To do so, the investigators propose cortico-muscular coherence (CMC) as a hybrid feature for BCI control. CMC is a measure of EEG-EMG synchronization during movement and has been described extensively in post-stroke patients in relation to their residual motor ability. With respect to previous literature, the proposed approach foresees the estimation of CMC as a multimodal integrated EEG-EMG network, comprising multiple EEG electrodes over the scalp bilaterally and several upper limb muscles bilaterally, so as to capture the above mentioned motor abnormalities (eg abnormal recruitment of non-target muscles). The investigators have already tested such feature on healthy subjects and stroke patients offline and verified its capability to detect upper limb movements online (studies published and/or submitted, see references). An already available BCI prototype was adapted with the parameters derived from such offline studies (see references). The RECOM intervention will be validated within a RCT (single blinded, for evaluators) on stroke patients undergoing rehabilitation (add-on). Before and after the intervention, all patients will undergo an extensive clinical evaluation (see outcome measures) and neurophysiological assessment. The latter will consist in a high density EEG-EMG recording during simple/complex upper limb movements. The recording will include a cinematic analysis (inertial measurement units - IMUs). The investigators hypothesize a better functional motor outcome in the affected upper limb for the RECOM group, which will be described by means of common clinical/functional scales combined with EEG/EMG and cinematic evaluation. Furthermore, aspects related to acceptability and usability of the novel system will be evaluated. In detail mood, motivation and satisfaction will be evaluated before (mood motivation) and after (satisfaction) each training session by means of Visual Analogue Scales; workload will be evaluated at the end of second and last training session by means of the Nasa-Task Load Index.
|
RECOMmENceR: RE-establishing COrtico Muscular COMunication to ENhance Recovery. Clinical Validation of BCI-controlled Functional Electrical Stimulation for Upper Limb Rehabilitation After Stroke
|
Stroke Sequelae, Motor Disorders
|
* Device: RECOM - hBCI training
* Other: CTRL - upper limb training with FES
|
Inclusion Criteria:~unilateral stroke event at least 3 months before recruitment~reduced strength in the upper limb~Exclusion Criteria:~concomitant diseases affecting upper limb function~spasticity in the upper limb (4-5 of MAS)~severe neuropsychological deficit preventing active participation to the study~contraindication to FES or EEG/EMG recording
|
18 Years
|
80 Years
|
All
|
No
|
Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Interventional Model Description: Eligible patients admitted to Fondazione Santa Lucia will be randomized in equal proportions between target intervention (RECOM) and control (CTRL)
Masking: Single
|
| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Changes in Fugl-Meyer Assessment (FMA) - upper limb section | Commonly employed functional scale for post-stroke motor function. The scale ranges from 0 (maximum possible impairment) to 66 (no impairment). | Pre-Randomization, Post Training (within 48 hours) |
| Changes in Action Research Arm Test (ARAT) | Commonly employed functional scale for post-stroke upper limb function. Consists of 19 items with a four scale point. Total scores on the ARAT may range from 0-57 points, with a maximum score of 57 points indicating better performance. | Pre-Randomization, Post Training (within 48 hours) |
|
| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Changes in Modified Ashworth Scale for Spasticity (MAS) | Measure of arm spasticity (at shoulder + elbow + hand) as measured by means of MAS (score from 0 to 5 points, where 0 is equal to absence of spasticity, 5 is equal to high degree of spasticity) | Pre-Randomization, Post Training (within 48 hours) |
| Changes Box and Block Test (BBT) | The BBT is composed of a wooden box divided in two compartments by a partition and 150 blocks. The BBT administration consists of asking the client to move, one by one, the maximum number of blocks from one compartment of a box to another of equal size, within 60 seconds. | Pre-Randomization, Post Training (within 48 hours) |
| Changes Numeric Rating Scale for pain in the upper limb (NRS) | Measure of arm perceived pain by means of Numeric Rating Scale (score from 0 to 10 points where 0 is equal to NO PAIN and 10 is equal to UNSPEAKABLE PAIN) | Pre-Randomization, Post Training (within 48 hours) |
| Changes in Manual Muscle Test (MMT) strength in upper limb segments | Evaluation of residual strength in upper limb muscles - shoulder abduction, elbow flexion and extension, wrist flexion and extension (each segment ranging from 0 - no muscular activation to 5 - full movement against resistance). | Pre-Randomization, Post Training (within 48 hours) |
| Changes in NIH Stroke Scale | Measure of severity of stroke symptoms as for the National Institute of Health Stroke Scale-NIHSS (composed by 11 items with a total score ranging from 0 to a maximum depending on each item, where 0 is normal and maximum is pathological response) | Pre-Randomization, Post Training (within 48 hours) |
|
stroke, eeg, emg, cortico-muscular coherence, brain computer interface
|
Stroke, Motor Disorders, Cerebrovascular Disorders, Brain Diseases, Central Nervous System Diseases, Nervous System Diseases, Vascular Diseases, Cardiovascular Diseases, Mental Disorders
|
| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: RECOM - hBCI training<br>Patients in the RECOM group will receive treatment in add-on to standard rehabilitation as follows. The RECOM device is a h-BCI system that controls FES of upper limb muscles: the patient is asked to attempt simple upper limb movements (eg extension of fingers); the device recognizes (in correct trials) close-to-normal EEG-EMG activation and initiates FES of extensor muscles in the forearm. RECOM training consists in a set of trial repetition for a total duration per session of approximately 20-30 minutes (excluding set up time and calibration). FES parameters will be set specifically for each patients according to standard guidelines to achieve full movement and so as to avoid any kind of discomfort for the patients. The intervention regimen will be 2-3 times per week for 4 consecutive weeks. | Device: RECOM - hBCI training<br>* The RECOM device is a h-BCI system that controls FES of upper limb muscles: the patient is asked to attempt simple upper limb movements (eg extension of fingers); the device recognizes (in correct trials) close-to-normal EEG-EMG activation and initiates FES of extensor muscles in the forearm. RECOM training consists in a set of trial repetition for a total duration per session of approximately 20-30 minutes (excluding set up time and calibration). FES parameters will be set specifically for each patients according to standard guidelines to achieve full movement and so as to avoid any kind of discomfort for the patients. The intervention regimen will be 2-3 times per week for 4 consecutive weeks.<br>|
| Active Comparator: CTRL - upper limb training with FES<br>Patients in the CTRL group will receive treatment in add-on to standard rehabilitation as follows. An expert physiotherapist will define a set of active exercises focused on upper limb function; the exercises will be combined with FES of forearm muscles. FES parameters will be set specifically for each patients according to standard guidelines to achieve the full required movement and so as to avoid any kind of discomfort for the patients. Session duration will be approximately 20-30 minutes (excluding FES calibration time). The intervention regimen will be 2-3 times per week for 4 consecutive weeks. | Other: CTRL - upper limb training with FES<br>* An expert physiotherapist will define a set of active exercises focused on upper limb function; the exercises will be combined with FES of forearm muscles. FES parameters will be set specifically for each patients according to standard guidelines to achieve the full required movement and so as to avoid any kind of discomfort for the patients. Session duration will be approximately 20-30 minutes (excluding FES calibration time). The intervention regimen will be 2-3 times per week for 4 consecutive weeks.<br>|
|
Clinical Validation of a Hybrid BCI-controlled FES for Upper Limb Rehabilitation After Stroke
Study Overview
=================
Brief Summary
-----------------
The RECOMMENCER project aims at developing and testing a novel hybrid Brain Computer Interface device based on cortico-muscular connectivity, that will be employed to activate Functional Electrical Stimulation (FES) of upper limb muscles. After the technical implementation of the device and its preliminary testing on healthy subject, the investigators will evaluate the effects of a 1 month training with the device (RECOM) on post-stroke patients undergoing standard rehabilitation (add-on). The proposed intervention will be compared with an active physiotherapy training including FES (CTRL) which will be focused on upper limb with similar intensity as the target intervention (also delivered in add-on).
Detailed Description
-----------------
Brain-Computer Interface (BCI) systems for upper limb rehabilitation have proven some efficacy in the context of several randomized controlled trials (RCT). Such systems rely on the possibility reinforce motor-related brain activity (derived eg from electroencephalography, EEG) harnessing neuroplasticity phenomena ultimately leading to favorable motor outcome. Up to now, no hybrid BCI (hBCI) has been tested successfully for this purpose in a clinical trial. Hybrid BCIs include signals from the periphery (most commonly muscles, via surface electromyography, EMG) and are usually employed to improve BCI performances. In a rehabilitative context, the investigators aim to employ EMG signals to characterize common post-stroke abnormalities (spasticity, co-contractions, motor overflow) and possibly include those in a novel hBCI paradigm to promote both volitional control (EEG) over upper limb movement and close to normal muscular activation (EMG). To do so, the investigators propose cortico-muscular coherence (CMC) as a hybrid feature for BCI control. CMC is a measure of EEG-EMG synchronization during movement and has been described extensively in post-stroke patients in relation to their residual motor ability. With respect to previous literature, the proposed approach foresees the estimation of CMC as a multimodal integrated EEG-EMG network, comprising multiple EEG electrodes over the scalp bilaterally and several upper limb muscles bilaterally, so as to capture the above mentioned motor abnormalities (eg abnormal recruitment of non-target muscles). The investigators have already tested such feature on healthy subjects and stroke patients offline and verified its capability to detect upper limb movements online (studies published and/or submitted, see references). An already available BCI prototype was adapted with the parameters derived from such offline studies (see references). The RECOM intervention will be validated within a RCT (single blinded, for evaluators) on stroke patients undergoing rehabilitation (add-on). Before and after the intervention, all patients will undergo an extensive clinical evaluation (see outcome measures) and neurophysiological assessment. The latter will consist in a high density EEG-EMG recording during simple/complex upper limb movements. The recording will include a cinematic analysis (inertial measurement units - IMUs). The investigators hypothesize a better functional motor outcome in the affected upper limb for the RECOM group, which will be described by means of common clinical/functional scales combined with EEG/EMG and cinematic evaluation. Furthermore, aspects related to acceptability and usability of the novel system will be evaluated. In detail mood, motivation and satisfaction will be evaluated before (mood motivation) and after (satisfaction) each training session by means of Visual Analogue Scales; workload will be evaluated at the end of second and last training session by means of the Nasa-Task Load Index.
Official Title
-----------------
RECOMmENceR: RE-establishing COrtico Muscular COMunication to ENhance Recovery. Clinical Validation of BCI-controlled Functional Electrical Stimulation for Upper Limb Rehabilitation After Stroke
Conditions
-----------------
Stroke Sequelae, Motor Disorders
Intervention / Treatment
-----------------
* Device: RECOM - hBCI training
* Other: CTRL - upper limb training with FES
Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: unilateral stroke event at least 3 months before recruitment reduced strength in the upper limb Exclusion Criteria: concomitant diseases affecting upper limb function spasticity in the upper limb (4-5 of MAS) severe neuropsychological deficit preventing active participation to the study contraindication to FES or EEG/EMG recording
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
Interventional Model Description: Eligible patients admitted to Fondazione Santa Lucia will be randomized in equal proportions between target intervention (RECOM) and control (CTRL)
Masking: Single
Arms and Interventions
| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: RECOM - hBCI training<br>Patients in the RECOM group will receive treatment in add-on to standard rehabilitation as follows. The RECOM device is a h-BCI system that controls FES of upper limb muscles: the patient is asked to attempt simple upper limb movements (eg extension of fingers); the device recognizes (in correct trials) close-to-normal EEG-EMG activation and initiates FES of extensor muscles in the forearm. RECOM training consists in a set of trial repetition for a total duration per session of approximately 20-30 minutes (excluding set up time and calibration). FES parameters will be set specifically for each patients according to standard guidelines to achieve full movement and so as to avoid any kind of discomfort for the patients. The intervention regimen will be 2-3 times per week for 4 consecutive weeks. | Device: RECOM - hBCI training<br>* The RECOM device is a h-BCI system that controls FES of upper limb muscles: the patient is asked to attempt simple upper limb movements (eg extension of fingers); the device recognizes (in correct trials) close-to-normal EEG-EMG activation and initiates FES of extensor muscles in the forearm. RECOM training consists in a set of trial repetition for a total duration per session of approximately 20-30 minutes (excluding set up time and calibration). FES parameters will be set specifically for each patients according to standard guidelines to achieve full movement and so as to avoid any kind of discomfort for the patients. The intervention regimen will be 2-3 times per week for 4 consecutive weeks.<br>|
| Active Comparator: CTRL - upper limb training with FES<br>Patients in the CTRL group will receive treatment in add-on to standard rehabilitation as follows. An expert physiotherapist will define a set of active exercises focused on upper limb function; the exercises will be combined with FES of forearm muscles. FES parameters will be set specifically for each patients according to standard guidelines to achieve the full required movement and so as to avoid any kind of discomfort for the patients. Session duration will be approximately 20-30 minutes (excluding FES calibration time). The intervention regimen will be 2-3 times per week for 4 consecutive weeks. | Other: CTRL - upper limb training with FES<br>* An expert physiotherapist will define a set of active exercises focused on upper limb function; the exercises will be combined with FES of forearm muscles. FES parameters will be set specifically for each patients according to standard guidelines to achieve the full required movement and so as to avoid any kind of discomfort for the patients. Session duration will be approximately 20-30 minutes (excluding FES calibration time). The intervention regimen will be 2-3 times per week for 4 consecutive weeks.<br>|
What is the study measuring?
-----------------
Primary Outcome Measures
| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Changes in Fugl-Meyer Assessment (FMA) - upper limb section | Commonly employed functional scale for post-stroke motor function. The scale ranges from 0 (maximum possible impairment) to 66 (no impairment). | Pre-Randomization, Post Training (within 48 hours) |
| Changes in Action Research Arm Test (ARAT) | Commonly employed functional scale for post-stroke upper limb function. Consists of 19 items with a four scale point. Total scores on the ARAT may range from 0-57 points, with a maximum score of 57 points indicating better performance. | Pre-Randomization, Post Training (within 48 hours) |
Secondary Outcome Measures
| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Changes in Modified Ashworth Scale for Spasticity (MAS) | Measure of arm spasticity (at shoulder + elbow + hand) as measured by means of MAS (score from 0 to 5 points, where 0 is equal to absence of spasticity, 5 is equal to high degree of spasticity) | Pre-Randomization, Post Training (within 48 hours) |
| Changes Box and Block Test (BBT) | The BBT is composed of a wooden box divided in two compartments by a partition and 150 blocks. The BBT administration consists of asking the client to move, one by one, the maximum number of blocks from one compartment of a box to another of equal size, within 60 seconds. | Pre-Randomization, Post Training (within 48 hours) |
| Changes Numeric Rating Scale for pain in the upper limb (NRS) | Measure of arm perceived pain by means of Numeric Rating Scale (score from 0 to 10 points where 0 is equal to NO PAIN and 10 is equal to UNSPEAKABLE PAIN) | Pre-Randomization, Post Training (within 48 hours) |
| Changes in Manual Muscle Test (MMT) strength in upper limb segments | Evaluation of residual strength in upper limb muscles - shoulder abduction, elbow flexion and extension, wrist flexion and extension (each segment ranging from 0 - no muscular activation to 5 - full movement against resistance). | Pre-Randomization, Post Training (within 48 hours) |
| Changes in NIH Stroke Scale | Measure of severity of stroke symptoms as for the National Institute of Health Stroke Scale-NIHSS (composed by 11 items with a total score ranging from 0 to a maximum depending on each item, where 0 is normal and maximum is pathological response) | Pre-Randomization, Post Training (within 48 hours) |
Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
stroke, eeg, emg, cortico-muscular coherence, brain computer interface
|
NCT01915121
|
An Educational Intervention for Patients With Bladder Cancer
|
The study main objectives are to enhance treatment decision making and improve quality of life and post-treatment health care among patients diagnosed with invasive bladder cancer.~Bladder cancer (BL Ca) is the 5th most commonly diagnosed cancer in the US . BL Ca is more common among men than women and 90% of all patients are over the age of 55. Surgery to remove the bladder followed by one of three diversion techniques (i.e., ileal conduit, continent reservoir, and neobladder) is the standard therapy following invasive bladder cancer. The emotional, functional, physical, and social impact of invasive Bl Ca treatment on patients' QOL and adjustment can be devastating. This impact significantly varies by treatment option. Treatment decision making in for BL Ca is difficult at best and potentially susceptible to a number of cognitive and affective factors (e.g., patients' emotional reaction, values, and expectations). Thus, in addition to adjusting to a potential life-threatening disease, having to cope with uncertainty about the efficacy and outcomes of different treatment options adds to the overall distress and may impair effective decision-making. In spite of increasing efforts in health communication and patient education, no study has examined treatment decision making among invasive bladder patients or has provided an educational intervention to facilitate treatment decision making among this population. To this end, and guided by the Self-Regulation theory (SRT) that emphasizes the role of cognitive and emotional factors in decision making, we have designed and pilot tested the acceptability of a preliminary educational and training experiential intervention (ETE) to address this gap in the literature. The ETE intervention uses new and innovative educational strategies and methods to educate patients about their treatment options and to facilitate their treatment decision making.
|
The goals of the study are: 1) to further enhance the design and application of the ETE intervention, and 2) to provide data on the efficacy of the refined ETE intervention in a randomized-controlled study (RCT). To achieve these 2 goals, the study is divided in to 2 phases.~PHASE 1: To enhance and refine the design and application of the preliminary ETE intervention:~Aim 1-a: To explore knowledge, beliefs, values and expectations about treatment options, treatment decision making, and quality of life (QOL) among patients with BL Ca.~To achieve Aim 1-a of Phase 1, as a first step, 2 focus groups (FG; N = 10 each) of invasive BL Ca patients will be conducted to a) examine knowledge, beliefs, values, expectations, and affective responses about treatment options and treatment decision making, b) record difficulties and problems in post-surgical health care (e.g., using stoma appliances and catheters), and c) explore concerns patients have as they live with the impact of treatment. The ETE intervention will be refined based on FG results.~Aim 1-b: To explore patients' acceptability of the refined ETE intervention. To achieve Aim 1-b of Phase 1, additional 2 FG (FG; N = 10 each) of BL Ca survivors will be conducted to solicit input about the design and acceptability of the refined ETE intervention.~PHASE 2: Aim 2. To assess the efficacy of the ETE intervention in small RCT To achieve Aim 2 of Phase 2, a two-group RCT (standard care (SC) plus time and attention control condition, N = 62 patients; SC plus ETE intervention N = 62 patients) will be conducted to examine the efficacy of the ETE intervention. Phase 2 will provide a) a test of the efficacy of the refined ETE intervention for reducing decisional conflict and regret, and improving QOL and post-treatment stoma and pouch care controlling for potential clinical and socio-demographic covariates (e.g., treatment type, age).
|
An Educational Intervention for Patients With Bladder Cancer 121193-MRSG-11-103-01-CPPB American Cancer Society
|
Bladder Cancer
|
* Behavioral: Education Intervention
* Behavioral: Nutrition Intervention
|
Phase 1 (Focus groups/ In-depth Interview)~Inclusion Criteria:~treatment of invasive Bladder Cancer a with cystectomy and one of the three major urinary diversion methods~English speaking~between the ages of 18 and 85~able and willing to provide informed consent~may have received neoadjuvant or adjuvant chemotherapy, radiation therapy, and immunotherapy (BCG)~Exclusion Criteria:~metastatic disease or cancer recurrence~presence of other primary cancers~no access to a telephone~Phase 2 (randomized-controlled-study)~Additional Exclusion Criteria:~- treatment decision is made and /beginning/completion of treatment.
|
18 Years
|
85 Years
|
All
|
No
|
Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single
|
| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Decisional Regret Scale | The intervention is designed to enhance treatment decision making. | Baseline |
| Decisional Regret Scale | The intervention is designed to enhance treatment decision making. | 1 month follow up |
| Decisional Regret Scale | The intervention is designed to enhance treatment decision making. | 3 month follow up |
| Decisional Regret Scale | The intervention is designed to enhance treatment decision making. | 6 month follow up |
| Decisional Self-Efficacy Scale | The intervention is designed to enhance treatment decision making. | Baseline |
| Decisional Self-Efficacy Scale | The intervention is designed to enhance treatment decision making. | 1 month follow up |
| Decisional Self-Efficacy Scale | The intervention is designed to enhance treatment decision making. | 3 month follow up |
| Decisional Self-Efficacy Scale | The intervention is designed to enhance treatment decision making. | 6 month follow up |
| Treatment-related Values | The intervention is designed to enhance treatment decision making. | Baseline |
| Treatment-related Values | The intervention is designed to enhance treatment decision making. | 1 month follow up |
| Treatment-related Values | The intervention is designed to enhance treatment decision making. | 3 month follow up |
| Treatment-related Values | The intervention is designed to enhance treatment decision making. | 6 month follow up |
| Decisional Regret Scale | Bladder Cancer knowledge Scale~The intervention is designed to enhance treatment decision making. | Baseline |
| Decisional Regret Scale | Bladder Cancer knowledge Scale~The intervention is designed to enhance treatment decision making. | 1 month follow up |
| Decisional Regret Scale | Bladder Cancer knowledge Scale~The intervention is designed to enhance treatment decision making. | 3 month follow up |
| Decisional Regret Scale | Bladder Cancer knowledge Scale~The intervention is designed to enhance treatment decision making. | 6 month follow up |
|
| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| quality of life | FACT-BL, Emotional, physical, function, and social Wellbeing Subscales | Baseline |
| quality of life | FACT-BL, Emotional, physical, function, and social Wellbeing Subscales | 1 month follow up |
| quality of life | FACT-BL, Emotional, physical, function, and social Wellbeing Subscales | 3 month follow up |
| quality of life | FACT-BL, Emotional, physical, function, and social Wellbeing Subscales | 6 month follow up |
| post-surgical self-care | FACT-BL Ca additional concern | Baseline |
| post-surgical self-care | FACT-BL Ca additional concern | 1 month follow up |
| post-surgical self-care | FACT-BL Ca additional concern | 3 month follow up |
| post-surgical self-care | FACT-BL Ca additional concern | 6 month follow up |
| CES-D scale Illness Perception Questionnaire (IPQ) | | Baseline |
| CES-D scale Illness Perception Questionnaire (IPQ) | | 1 month follow up |
| CES-D scale Illness Perception Questionnaire (IPQ) | | 3 month follow up |
| CES-D scale Illness Perception Questionnaire (IPQ) | | 6 month follow up |
| Cancer worries scale | | Baseline |
| Cancer worries scale | | 1 month follow up |
| Cancer worries scale | | 3 month follow up |
| Cancer worries scale | | 6 month follow up |
|
Bladder Cancer, Intervention, Education, Randomized Controlled Trials
|
Urinary Bladder Neoplasms, Urologic Neoplasms, Urogenital Neoplasms, Neoplasms by Site, Neoplasms, Female Urogenital Diseases, Female Urogenital Diseases and Pregnancy Complications, Urogenital Diseases, Urinary Bladder Diseases, Urologic Diseases, Male Urogenital Diseases
|
| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: Education Intervention<br>In this session, participant will be provided with information about bladder cancer treatment options, and training tools directly related to Bladder Cancer. | Behavioral: Education Intervention<br>* 1-hour educational and training sessions. In this session, participant will be provided with information about bladder cancer treatment options, and training tools directly related to Bladder Cancer. In 4 to 5 days following the session, participants will be asked to schedule the time to talk about experience and how the intervention affects their treatment decision making and to answer some questions about the educational and training session they attended. Participants will then be called after 1-month, 3-month, and 6-month after their bladder cancer treatment to follow up.<br>|
| Placebo Comparator: Nutrition Intervention<br>In this session, participant will be provided with information about nutrition information directly related to bladder cancer recovery | Behavioral: Nutrition Intervention<br>* 1-hour educational and training sessions. In this session, participant will be provided with nutrition information directly related to Bladder Cancer recovery. In 4 to 5 days following the session, participants will be asked to schedule the time to talk about experience and how the intervention affects their treatment decision making and to answer some questions about the educational and training session they attended. Participants will then be called after 1-month, 3-month, and 6-month after their bladder cancer treatment to follow up.<br>|
|
An Educational Intervention for Patients With Bladder Cancer
Study Overview
=================
Brief Summary
-----------------
The study main objectives are to enhance treatment decision making and improve quality of life and post-treatment health care among patients diagnosed with invasive bladder cancer. Bladder cancer (BL Ca) is the 5th most commonly diagnosed cancer in the US . BL Ca is more common among men than women and 90% of all patients are over the age of 55. Surgery to remove the bladder followed by one of three diversion techniques (i.e., ileal conduit, continent reservoir, and neobladder) is the standard therapy following invasive bladder cancer. The emotional, functional, physical, and social impact of invasive Bl Ca treatment on patients' QOL and adjustment can be devastating. This impact significantly varies by treatment option. Treatment decision making in for BL Ca is difficult at best and potentially susceptible to a number of cognitive and affective factors (e.g., patients' emotional reaction, values, and expectations). Thus, in addition to adjusting to a potential life-threatening disease, having to cope with uncertainty about the efficacy and outcomes of different treatment options adds to the overall distress and may impair effective decision-making. In spite of increasing efforts in health communication and patient education, no study has examined treatment decision making among invasive bladder patients or has provided an educational intervention to facilitate treatment decision making among this population. To this end, and guided by the Self-Regulation theory (SRT) that emphasizes the role of cognitive and emotional factors in decision making, we have designed and pilot tested the acceptability of a preliminary educational and training experiential intervention (ETE) to address this gap in the literature. The ETE intervention uses new and innovative educational strategies and methods to educate patients about their treatment options and to facilitate their treatment decision making.
Detailed Description
-----------------
The goals of the study are: 1) to further enhance the design and application of the ETE intervention, and 2) to provide data on the efficacy of the refined ETE intervention in a randomized-controlled study (RCT). To achieve these 2 goals, the study is divided in to 2 phases. PHASE 1: To enhance and refine the design and application of the preliminary ETE intervention: Aim 1-a: To explore knowledge, beliefs, values and expectations about treatment options, treatment decision making, and quality of life (QOL) among patients with BL Ca. To achieve Aim 1-a of Phase 1, as a first step, 2 focus groups (FG; N = 10 each) of invasive BL Ca patients will be conducted to a) examine knowledge, beliefs, values, expectations, and affective responses about treatment options and treatment decision making, b) record difficulties and problems in post-surgical health care (e.g., using stoma appliances and catheters), and c) explore concerns patients have as they live with the impact of treatment. The ETE intervention will be refined based on FG results. Aim 1-b: To explore patients' acceptability of the refined ETE intervention. To achieve Aim 1-b of Phase 1, additional 2 FG (FG; N = 10 each) of BL Ca survivors will be conducted to solicit input about the design and acceptability of the refined ETE intervention. PHASE 2: Aim 2. To assess the efficacy of the ETE intervention in small RCT To achieve Aim 2 of Phase 2, a two-group RCT (standard care (SC) plus time and attention control condition, N = 62 patients; SC plus ETE intervention N = 62 patients) will be conducted to examine the efficacy of the ETE intervention. Phase 2 will provide a) a test of the efficacy of the refined ETE intervention for reducing decisional conflict and regret, and improving QOL and post-treatment stoma and pouch care controlling for potential clinical and socio-demographic covariates (e.g., treatment type, age).
Official Title
-----------------
An Educational Intervention for Patients With Bladder Cancer 121193-MRSG-11-103-01-CPPB American Cancer Society
Conditions
-----------------
Bladder Cancer
Intervention / Treatment
-----------------
* Behavioral: Education Intervention
* Behavioral: Nutrition Intervention
Participation Criteria
=================
Eligibility Criteria
-----------------
Phase 1 (Focus groups/ In-depth Interview) Inclusion Criteria: treatment of invasive Bladder Cancer a with cystectomy and one of the three major urinary diversion methods English speaking between the ages of 18 and 85 able and willing to provide informed consent may have received neoadjuvant or adjuvant chemotherapy, radiation therapy, and immunotherapy (BCG) Exclusion Criteria: metastatic disease or cancer recurrence presence of other primary cancers no access to a telephone Phase 2 (randomized-controlled-study) Additional Exclusion Criteria: - treatment decision is made and /beginning/completion of treatment.
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: Education Intervention<br>In this session, participant will be provided with information about bladder cancer treatment options, and training tools directly related to Bladder Cancer. | Behavioral: Education Intervention<br>* 1-hour educational and training sessions. In this session, participant will be provided with information about bladder cancer treatment options, and training tools directly related to Bladder Cancer. In 4 to 5 days following the session, participants will be asked to schedule the time to talk about experience and how the intervention affects their treatment decision making and to answer some questions about the educational and training session they attended. Participants will then be called after 1-month, 3-month, and 6-month after their bladder cancer treatment to follow up.<br>|
| Placebo Comparator: Nutrition Intervention<br>In this session, participant will be provided with information about nutrition information directly related to bladder cancer recovery | Behavioral: Nutrition Intervention<br>* 1-hour educational and training sessions. In this session, participant will be provided with nutrition information directly related to Bladder Cancer recovery. In 4 to 5 days following the session, participants will be asked to schedule the time to talk about experience and how the intervention affects their treatment decision making and to answer some questions about the educational and training session they attended. Participants will then be called after 1-month, 3-month, and 6-month after their bladder cancer treatment to follow up.<br>|
What is the study measuring?
-----------------
Primary Outcome Measures
| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Decisional Regret Scale | The intervention is designed to enhance treatment decision making. | Baseline |
| Decisional Regret Scale | The intervention is designed to enhance treatment decision making. | 1 month follow up |
| Decisional Regret Scale | The intervention is designed to enhance treatment decision making. | 3 month follow up |
| Decisional Regret Scale | The intervention is designed to enhance treatment decision making. | 6 month follow up |
| Decisional Self-Efficacy Scale | The intervention is designed to enhance treatment decision making. | Baseline |
| Decisional Self-Efficacy Scale | The intervention is designed to enhance treatment decision making. | 1 month follow up |
| Decisional Self-Efficacy Scale | The intervention is designed to enhance treatment decision making. | 3 month follow up |
| Decisional Self-Efficacy Scale | The intervention is designed to enhance treatment decision making. | 6 month follow up |
| Treatment-related Values | The intervention is designed to enhance treatment decision making. | Baseline |
| Treatment-related Values | The intervention is designed to enhance treatment decision making. | 1 month follow up |
| Treatment-related Values | The intervention is designed to enhance treatment decision making. | 3 month follow up |
| Treatment-related Values | The intervention is designed to enhance treatment decision making. | 6 month follow up |
| Decisional Regret Scale | Bladder Cancer knowledge Scale The intervention is designed to enhance treatment decision making. | Baseline |
| Decisional Regret Scale | Bladder Cancer knowledge Scale The intervention is designed to enhance treatment decision making. | 1 month follow up |
| Decisional Regret Scale | Bladder Cancer knowledge Scale The intervention is designed to enhance treatment decision making. | 3 month follow up |
| Decisional Regret Scale | Bladder Cancer knowledge Scale The intervention is designed to enhance treatment decision making. | 6 month follow up |
Secondary Outcome Measures
| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| quality of life | FACT-BL, Emotional, physical, function, and social Wellbeing Subscales | Baseline |
| quality of life | FACT-BL, Emotional, physical, function, and social Wellbeing Subscales | 1 month follow up |
| quality of life | FACT-BL, Emotional, physical, function, and social Wellbeing Subscales | 3 month follow up |
| quality of life | FACT-BL, Emotional, physical, function, and social Wellbeing Subscales | 6 month follow up |
| post-surgical self-care | FACT-BL Ca additional concern | Baseline |
| post-surgical self-care | FACT-BL Ca additional concern | 1 month follow up |
| post-surgical self-care | FACT-BL Ca additional concern | 3 month follow up |
| post-surgical self-care | FACT-BL Ca additional concern | 6 month follow up |
| CES-D scale Illness Perception Questionnaire (IPQ) | | Baseline |
| CES-D scale Illness Perception Questionnaire (IPQ) | | 1 month follow up |
| CES-D scale Illness Perception Questionnaire (IPQ) | | 3 month follow up |
| CES-D scale Illness Perception Questionnaire (IPQ) | | 6 month follow up |
| Cancer worries scale | | Baseline |
| Cancer worries scale | | 1 month follow up |
| Cancer worries scale | | 3 month follow up |
| Cancer worries scale | | 6 month follow up |
Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Bladder Cancer, Intervention, Education, Randomized Controlled Trials
|
NCT01885338
|
N-acetylcysteine (NAC) for Improving Cognitive Dysfunction in Schizophrenia
|
This study will evaluate the effect of the dietary supplement N-acetylcysteine (NAC) on electrophysiologic (EEG) markers related to cognition, as well as performance on psychological tests measuring cognition. The primary hypothesis is that participants treated with NAC will show improvements in cognitive function, as measured by EEG and performance-based tests.
|
Schizophrenia is a serious mental illness associated with substantial social and occupational dysfunction. While positive psychotic symptoms of schizophrenia often respond to antipsychotic medications, negative symptoms and cognitive impairment are difficult to treat, necessitating novel interventions. Cognitive deficits are an important treatment target because the degree of cognitive impairment is a critical predictor of work, education, and social functioning.~Glutamatergic receptors are among the most promising biological targets for cognitive-enhancing drugs in schizophrenia. Abnormal glutamatergic signaling has long been thought to be important in the pathophysiology of schizophrenia; specifically, reduced NMDA glutamatergic receptor activity on thalamic inhibitory neurons disinhibits glutamatergic neurons projecting to the cortex, which can cause secondary dopaminergic abnormalities and lead to characteristic symptoms, including cognitive deficits. Many electrophysiological (EEG) biomarkers related to cognitive dysfunction in schizophrenia are thought to be linked to deficient NMDA glutamatergic neurotransmission. Additionally, neuroplasticity is thought to involve glutamatergic signaling. This pattern of linkages suggests that correcting impaired NMDA glutamatergic transmission in schizophrenia could lead to enhanced cognitive function and learning.~In this pilot study, we will focus on a promising dietary supplement approach to address glutamatergic deficits, evaluating its effects by EEG biomarkers and performance-based neurocognitive assessments. N-acetylcysteine (NAC) is a modified amino acid that is commonly used as a dietary supplement because of its antioxidant properties. NAC modulates glutamatergic signaling as follows: In the CNS, glial cells take up NAC via cystine-glutamate antiporters, which in turn leads to increased glutamate efflux into the extracellular space. Extracellular glutamate binds to non-synaptic glutamate receptors such as the metabotropic glutamate receptors (mGluR) type 2/3 and type 5. The net result of these events is a normalization of pathologically elevated cortical glutamate levels.~We will assess EEG biomarkers associated with cognitive deficits in schizophrenia, including a recently-described biomarker for visual cortical plasticity. We will also perform a comprehensive assessment of neurocognition with the MATRICS battery, which could suggest whether certain cognitive domains are sensitive to improvement with NAC therapy.~Our primary aim is to determine whether NAC administration will improve NMDA-dependent EEG abnormalities in schizophrenia. We have 3 hypotheses: (1) NAC administration will increase mismatch negativity amplitude as compared to placebo; (2) NAC administration will increase P300 amplitude as compared to placebo; and (3) NAC administration will increase gamma oscillation power and phase synchronization as compared to placebo. We also will examine whether NAC will improve measures of visual neuroplasticity, performance-based measures of neurocognition, and clinical symptoms of schizophrenia.
|
Dietary Supplement N-acetylcysteine (NAC) as a Novel Complementary Medicine to Improve Cognitive Disfunction in Schizophrenia
|
Schizophrenia
|
* Drug: N-acetylcysteine (NAC)
* Drug: Inactive placebo capsule
|
Inclusion Criteria:~Meets DSM-IV-TR criteria for schizophrenia.~At least 3 months since any psychiatric hospitalization~At least 1 month since meeting criteria for having a major depressive episode~At least 6 months since any behaviors suggesting any potential danger to self or others~Currently prescribed an antipsychotic medication, with dose not varying >50% over 3 months prior to study participation~No acute medical problems that could interfere with study participation~Chronic medical problems consistently treated and stable for at least 3 months prior to participation~Ability to provide informed consent and cooperate with study procedures~Exclusion Criteria:~Documented history of IQ less than 70 or severe learning disability~History of treatment with electroconvulsive therapy within 6 months prior to study participation~History of neurological or neuropsychiatric condition (e.g., stroke, severe traumatic brain injury, epilepsy, etc.) that could confound assessments~Documented history of persistent substance abuse or dependence within 3 months prior to study participation
|
18 Years
|
65 Years
|
All
|
No
|
Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple
|
| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| EEG: Change in Mismatch Negativity Amplitude | A passive attention auditory oddball paradigm will be used to assess MMN. | Change from baseline to 8 weeks |
| EEG: Change in P300 Amplitude | P300 will be measured using an active attention auditory oddball paradigm. | Change from baseline to 8 weeks |
| EEG: Change in Gamma Synchrony Evoked Power and Phase Synchronization | Stimuli will consist of 1-msec 93-dB clicks presented in 500-msec trains presented at 40 Hz, in 3 separate blocks with 200 trials per block. Continuous data will be epoched at -100 to 700 ms relative to stimulus onset and baseline corrected to the average of the prestimulus interval. For evoked gamma power analyses, averages will be computed on a minimum of 120 artifact-free epochs in each block. The averaged epochs across the click trains (0-512 msec) will be transformed into power spectra by fast Fourier transform (FFT). The 40-Hz power spectra will be averaged across 36-45 Hz. Time/frequency intertrial coherence analyses will be performed to assess intertrial coherence of the stimulus-driven EEG signals. In this analysis, coherence ranges from 0 (non-phase-locked random activity) to 1 (activity that is fully locked in phase across individual trials). Responses at electrode Fz will be analyzed. | Change from baseline to 8 weeks |
|
| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| EEG: Change in Visual Cortical Plasticity | The paradigm involves assessing visual evoked potentials (VEPs) before and after exposure to tetanizing visual high-frequency stimulation (HFS). | Change from baseline to 8 weeks |
| Change in MATRICS Consensus Cognitive Battery composite score | The MCCB was developed as a standardized method to assess cognition in clinical trials of potential cognitive-enhancing drugs. It consists of ten tests which assess seven cognitive domains (processing speed, attention, working memory, verbal learning, visual learning, problem solving and reasoning, and social cognition). | Change from baseline to 8 weeks |
| Change in Positive and Negative Syndrome Scale (PANSS) total score | This is a widely-used instrument that assesses 30 different symptoms (categorized into positive, negative, and general psychopathology) on a scale from 1 to 7, based on clinical interview. | Change from baseline to 8 weeks |
| Change in Clinical Assessment Interview for Negative Symptoms (CAINS) scores | The CAINS is comprised of two subscales that assess the major negative symptom subdomains: 1) Motivation and Pleasure and 2) Expression. This instrument is administered in a semi-structured clinical interview and each of 13 items is rated on a scale ranging from 0 (no impairment) to 4 (severe deficit). | Change from baseline to 8 weeks |
|
Schizophrenia, Cognition, Neurocognition, N-Acetylcysteine, NAC, EEG
|
Acetylcysteine, N-monoacetylcystine, Antiviral Agents, Anti-Infective Agents, Expectorants, Respiratory System Agents, Free Radical Scavengers, Antioxidants, Molecular Mechanisms of Pharmacological Action, Protective Agents, Physiological Effects of Drugs, Antidotes
|
| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: N-acetylcysteine (NAC)<br>Capsules containing N-acetylcysteine 600mg, with inactive ingredients of cellulose, L-leucine, and silica used as filler. Dosage is 2 capsules by mouth twice daily for 8 weeks. | Drug: N-acetylcysteine (NAC)<br> <br> * Other names: NAC;|
| Placebo Comparator: Inactive placebo capsule<br>A placebo capsule is used that is identical to the active treatment but lacks NAC. The inactive ingredients in the placebo capsule are cellulose, L-leucine, and silica. Dose is 2 capsules by mouth twice daily for 8 weeks. | Drug: Inactive placebo capsule<br> <br> * Other names: Sugar pill;|
|
N-acetylcysteine (NAC) for Improving Cognitive Dysfunction in Schizophrenia
Study Overview
=================
Brief Summary
-----------------
This study will evaluate the effect of the dietary supplement N-acetylcysteine (NAC) on electrophysiologic (EEG) markers related to cognition, as well as performance on psychological tests measuring cognition. The primary hypothesis is that participants treated with NAC will show improvements in cognitive function, as measured by EEG and performance-based tests.
Detailed Description
-----------------
Schizophrenia is a serious mental illness associated with substantial social and occupational dysfunction. While positive psychotic symptoms of schizophrenia often respond to antipsychotic medications, negative symptoms and cognitive impairment are difficult to treat, necessitating novel interventions. Cognitive deficits are an important treatment target because the degree of cognitive impairment is a critical predictor of work, education, and social functioning. Glutamatergic receptors are among the most promising biological targets for cognitive-enhancing drugs in schizophrenia. Abnormal glutamatergic signaling has long been thought to be important in the pathophysiology of schizophrenia; specifically, reduced NMDA glutamatergic receptor activity on thalamic inhibitory neurons disinhibits glutamatergic neurons projecting to the cortex, which can cause secondary dopaminergic abnormalities and lead to characteristic symptoms, including cognitive deficits. Many electrophysiological (EEG) biomarkers related to cognitive dysfunction in schizophrenia are thought to be linked to deficient NMDA glutamatergic neurotransmission. Additionally, neuroplasticity is thought to involve glutamatergic signaling. This pattern of linkages suggests that correcting impaired NMDA glutamatergic transmission in schizophrenia could lead to enhanced cognitive function and learning. In this pilot study, we will focus on a promising dietary supplement approach to address glutamatergic deficits, evaluating its effects by EEG biomarkers and performance-based neurocognitive assessments. N-acetylcysteine (NAC) is a modified amino acid that is commonly used as a dietary supplement because of its antioxidant properties. NAC modulates glutamatergic signaling as follows: In the CNS, glial cells take up NAC via cystine-glutamate antiporters, which in turn leads to increased glutamate efflux into the extracellular space. Extracellular glutamate binds to non-synaptic glutamate receptors such as the metabotropic glutamate receptors (mGluR) type 2/3 and type 5. The net result of these events is a normalization of pathologically elevated cortical glutamate levels. We will assess EEG biomarkers associated with cognitive deficits in schizophrenia, including a recently-described biomarker for visual cortical plasticity. We will also perform a comprehensive assessment of neurocognition with the MATRICS battery, which could suggest whether certain cognitive domains are sensitive to improvement with NAC therapy. Our primary aim is to determine whether NAC administration will improve NMDA-dependent EEG abnormalities in schizophrenia. We have 3 hypotheses: (1) NAC administration will increase mismatch negativity amplitude as compared to placebo; (2) NAC administration will increase P300 amplitude as compared to placebo; and (3) NAC administration will increase gamma oscillation power and phase synchronization as compared to placebo. We also will examine whether NAC will improve measures of visual neuroplasticity, performance-based measures of neurocognition, and clinical symptoms of schizophrenia.
Official Title
-----------------
Dietary Supplement N-acetylcysteine (NAC) as a Novel Complementary Medicine to Improve Cognitive Disfunction in Schizophrenia
Conditions
-----------------
Schizophrenia
Intervention / Treatment
-----------------
* Drug: N-acetylcysteine (NAC)
* Drug: Inactive placebo capsule
Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Meets DSM-IV-TR criteria for schizophrenia. At least 3 months since any psychiatric hospitalization At least 1 month since meeting criteria for having a major depressive episode At least 6 months since any behaviors suggesting any potential danger to self or others Currently prescribed an antipsychotic medication, with dose not varying >50% over 3 months prior to study participation No acute medical problems that could interfere with study participation Chronic medical problems consistently treated and stable for at least 3 months prior to participation Ability to provide informed consent and cooperate with study procedures Exclusion Criteria: Documented history of IQ less than 70 or severe learning disability History of treatment with electroconvulsive therapy within 6 months prior to study participation History of neurological or neuropsychiatric condition (e.g., stroke, severe traumatic brain injury, epilepsy, etc.) that could confound assessments Documented history of persistent substance abuse or dependence within 3 months prior to study participation
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: Quadruple
Arms and Interventions
| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: N-acetylcysteine (NAC)<br>Capsules containing N-acetylcysteine 600mg, with inactive ingredients of cellulose, L-leucine, and silica used as filler. Dosage is 2 capsules by mouth twice daily for 8 weeks. | Drug: N-acetylcysteine (NAC)<br> <br> * Other names: NAC;|
| Placebo Comparator: Inactive placebo capsule<br>A placebo capsule is used that is identical to the active treatment but lacks NAC. The inactive ingredients in the placebo capsule are cellulose, L-leucine, and silica. Dose is 2 capsules by mouth twice daily for 8 weeks. | Drug: Inactive placebo capsule<br> <br> * Other names: Sugar pill;|
What is the study measuring?
-----------------
Primary Outcome Measures
| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| EEG: Change in Mismatch Negativity Amplitude | A passive attention auditory oddball paradigm will be used to assess MMN. | Change from baseline to 8 weeks |
| EEG: Change in P300 Amplitude | P300 will be measured using an active attention auditory oddball paradigm. | Change from baseline to 8 weeks |
| EEG: Change in Gamma Synchrony Evoked Power and Phase Synchronization | Stimuli will consist of 1-msec 93-dB clicks presented in 500-msec trains presented at 40 Hz, in 3 separate blocks with 200 trials per block. Continuous data will be epoched at -100 to 700 ms relative to stimulus onset and baseline corrected to the average of the prestimulus interval. For evoked gamma power analyses, averages will be computed on a minimum of 120 artifact-free epochs in each block. The averaged epochs across the click trains (0-512 msec) will be transformed into power spectra by fast Fourier transform (FFT). The 40-Hz power spectra will be averaged across 36-45 Hz. Time/frequency intertrial coherence analyses will be performed to assess intertrial coherence of the stimulus-driven EEG signals. In this analysis, coherence ranges from 0 (non-phase-locked random activity) to 1 (activity that is fully locked in phase across individual trials). Responses at electrode Fz will be analyzed. | Change from baseline to 8 weeks |
Secondary Outcome Measures
| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| EEG: Change in Visual Cortical Plasticity | The paradigm involves assessing visual evoked potentials (VEPs) before and after exposure to tetanizing visual high-frequency stimulation (HFS). | Change from baseline to 8 weeks |
| Change in MATRICS Consensus Cognitive Battery composite score | The MCCB was developed as a standardized method to assess cognition in clinical trials of potential cognitive-enhancing drugs. It consists of ten tests which assess seven cognitive domains (processing speed, attention, working memory, verbal learning, visual learning, problem solving and reasoning, and social cognition). | Change from baseline to 8 weeks |
| Change in Positive and Negative Syndrome Scale (PANSS) total score | This is a widely-used instrument that assesses 30 different symptoms (categorized into positive, negative, and general psychopathology) on a scale from 1 to 7, based on clinical interview. | Change from baseline to 8 weeks |
| Change in Clinical Assessment Interview for Negative Symptoms (CAINS) scores | The CAINS is comprised of two subscales that assess the major negative symptom subdomains: 1) Motivation and Pleasure and 2) Expression. This instrument is administered in a semi-structured clinical interview and each of 13 items is rated on a scale ranging from 0 (no impairment) to 4 (severe deficit). | Change from baseline to 8 weeks |
Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Schizophrenia, Cognition, Neurocognition, N-Acetylcysteine, NAC, EEG
|
NCT04002557
|
Optimising Consultation Summaries to Promote Good Health
|
Patient participation in decision making about their care promotes patient satisfaction and confidence. Further more, allowing patients to see letters written about them enables trust, encourages patients to be involved in decision making process and allow patient understanding.~Little is known about how young people value these letters in the same way. Only one brief questionnaire study focused on adolescent views and found that young people wished to receive consultation summaries.~This research aims explore the views of adolescent patients related to consultation summaries that they receive following a doctor's appointment. The investigator will use patients attending a specialist diabetes clinic as our cohort and conduct a qualitative study using focus groups.
|
Patient participation in decision making processes about their care promotes patient satisfaction and confidence. As part of this, allowing patients to see letters written about them enables trust, encourages patients to be involved in decision making process and allow patient understanding. Given this, the 2000 NHS plan made it a requirement that all medical correspondence between health professionals is shared with patients.~It is estimated that 40-80% of information discussed during a consultation is forgotten immediately. Written summaries have shown to be an effective method of improving patient recall of information by 20.8%.~The literature on the benefits/disadvantages of consultation summaries is largely focused on adult patients with little research done to explore the views of adolescent population. Where the patient is a child, the literature is only focussed on parents of children and not the children themselves. Limited research has shown that parents/care givers report clinic letters being useful in assisting with better understanding and management of their child's condition.~Little is known about how young people value these letters in the same way. Only one brief questionnaire study focused on adolescent views and found that young people wished to receive consultation summaries.~Adolescence is an important time of an individual's life. This is the time when many independent health behaviours are established. During adolescence, young people start showing more interest in their own health and often wish to participate in decision making processes regarding their care. The role of health workers at this stage is to appreciate young people as individuals . Clinic summaries addressed directly to young people might play an important role in assisting with establishment of health behaviours and promoting good health in young people.~The aim of this research is to understand the views of adolescent patients on consultation summaries and identify factors can improve these summaries and subsequently their health and well-being.
|
Optimising Consultation Summaries to Promote Good Health/Views of Adolescents Attending Diabetes Clinic
|
Type1 Diabetes
|
* Other: No intervention
|
Inclusion Criteria:~Adolescents aged 12-18 years attending UCLH adolescent diabetes outpatient clinic~Exclusion Criteria:~Young people who cannot speak English (effective communication with colleagues during the study is the major aspect of valid data collection)~Young people who refuse to participate in focus group discussions
|
12 Years
|
18 Years
|
All
| null |
| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Young people's beliefs about good health as assessed by interview with open questions | The aim of this research is to understand the views of adolescent patients on consultation summaries and identify factors can improve these summaries and subsequently their health and well-being. | 3 months |
|
diabetes, clinic letter, clinic summary, post-consultation letter
|
Diabetes Mellitus, Diabetes Mellitus, Type 1, Glucose Metabolism Disorders, Metabolic Diseases, Endocrine System Diseases, Autoimmune Diseases, Immune System Diseases
|
| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Focus group<br>This is a qualitative study using focus group discussions with young people aged 12-18 who are receiving consultation summaries.~Patients attending a single diabetes service will be invited to enrol. This service serves a population from a wide geographic area and socio-economic backgrounds.~Interviews will be conducted by a qualitative researcher with relevant experience. They will be held on the day of a participant's clinic appointment within the same hospital or on the day agreed with the participant. | Other: No intervention<br>* Interviews contain no intervention, purely observational.<br>|
|
Optimising Consultation Summaries to Promote Good Health
Study Overview
=================
Brief Summary
-----------------
Patient participation in decision making about their care promotes patient satisfaction and confidence. Further more, allowing patients to see letters written about them enables trust, encourages patients to be involved in decision making process and allow patient understanding. Little is known about how young people value these letters in the same way. Only one brief questionnaire study focused on adolescent views and found that young people wished to receive consultation summaries. This research aims explore the views of adolescent patients related to consultation summaries that they receive following a doctor's appointment. The investigator will use patients attending a specialist diabetes clinic as our cohort and conduct a qualitative study using focus groups.
Detailed Description
-----------------
Patient participation in decision making processes about their care promotes patient satisfaction and confidence. As part of this, allowing patients to see letters written about them enables trust, encourages patients to be involved in decision making process and allow patient understanding. Given this, the 2000 NHS plan made it a requirement that all medical correspondence between health professionals is shared with patients. It is estimated that 40-80% of information discussed during a consultation is forgotten immediately. Written summaries have shown to be an effective method of improving patient recall of information by 20.8%. The literature on the benefits/disadvantages of consultation summaries is largely focused on adult patients with little research done to explore the views of adolescent population. Where the patient is a child, the literature is only focussed on parents of children and not the children themselves. Limited research has shown that parents/care givers report clinic letters being useful in assisting with better understanding and management of their child's condition. Little is known about how young people value these letters in the same way. Only one brief questionnaire study focused on adolescent views and found that young people wished to receive consultation summaries. Adolescence is an important time of an individual's life. This is the time when many independent health behaviours are established. During adolescence, young people start showing more interest in their own health and often wish to participate in decision making processes regarding their care. The role of health workers at this stage is to appreciate young people as individuals . Clinic summaries addressed directly to young people might play an important role in assisting with establishment of health behaviours and promoting good health in young people. The aim of this research is to understand the views of adolescent patients on consultation summaries and identify factors can improve these summaries and subsequently their health and well-being.
Official Title
-----------------
Optimising Consultation Summaries to Promote Good Health/Views of Adolescents Attending Diabetes Clinic
Conditions
-----------------
Type1 Diabetes
Intervention / Treatment
-----------------
* Other: No intervention
Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Adolescents aged 12-18 years attending UCLH adolescent diabetes outpatient clinic Exclusion Criteria: Young people who cannot speak English (effective communication with colleagues during the study is the major aspect of valid data collection) Young people who refuse to participate in focus group discussions
Ages Eligible for Study
-----------------
Minimum Age: 12 Years
Maximum Age: 18 Years
Sexes Eligible for Study
-----------------
All
Study Plan
=================
How is the study designed?
-----------------
Arms and Interventions
| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Focus group<br>This is a qualitative study using focus group discussions with young people aged 12-18 who are receiving consultation summaries. Patients attending a single diabetes service will be invited to enrol. This service serves a population from a wide geographic area and socio-economic backgrounds. Interviews will be conducted by a qualitative researcher with relevant experience. They will be held on the day of a participant's clinic appointment within the same hospital or on the day agreed with the participant. | Other: No intervention<br>* Interviews contain no intervention, purely observational.<br>|
What is the study measuring?
-----------------
Primary Outcome Measures
| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Young people's beliefs about good health as assessed by interview with open questions | The aim of this research is to understand the views of adolescent patients on consultation summaries and identify factors can improve these summaries and subsequently their health and well-being. | 3 months |
Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
diabetes, clinic letter, clinic summary, post-consultation letter
|
||
NCT02016339
|
Intensive Versus Standard Follow up to Improve Continuous Positive Airway Pressure (CPAP) Compliance
|
The purpose of this study was to compare the effects on sleepiness, quality of life, depression, hospitalization and deaths rate, of intensive vs standard interventions, on CPAP adherence, 2 years after CPAP initiation.
|
There is limited data concerning long-term randomized clinical trials proving the long-term efficacy of intensive use, follow programs on improving CPAP use. Therefore the investigators aimed to compare the effects on sleepiness, quality of life, depression, hospitalization and deaths rate, of intensive vs standard interventions, on CPAP adherence, 2 years after CPAP initiation.
|
Intensive Versus Standard Follow up to Improve Continuous Positive Airway Pressure Compliance: The Greek Experience
|
Sleep Apnea
|
* Behavioral: Standard care
* Behavioral: Intensive care
|
Inclusion Criteria:~newly diagnosed obstructive sleep apnea syndrome by polysomnography according to standard criteria,~with moderate to severe sleep apnea,~no history of previously CPAP therapy and~with an above-elementary school education.~Exclusion Criteria:~refusal to participate,~refusal to CPAP therapy,~previous CPAP treatment,~central sleep apnoea syndrome,~Cheyne-stokes breathing pattern,~obesity hypoventilation syndrome,~restrictive ventilator syndromes,~congestive heart failure,~history of life-threatening arrhythmias,~cardiomyopathy,~long term oxygen therapy,~family or personal history of mental illness,~with drug or alcohol abuse,~severe cognitive impairment,~concurrent oncologic diseases and~history of narcolepsy.
|
18 Years
|
65 Years
|
All
|
No
|
Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single
|
| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Effect of intensive intervention on CPAP adherence | | 24 months |
|
| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Effect of intensive intervention on sleepiness. | | 24 months |
| Effect of intensive intervention on mood. | | 24 months |
| Effect of intensive intervention on quality of life | | 24 months |
|
Sleep Apnea Syndromes, Apnea, Respiration Disorders, Respiratory Tract Diseases, Sleep Disorders, Intrinsic, Dyssomnias, Sleep Wake Disorders, Nervous System Diseases
|
| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: Standard Care<br>24 hour consultation telephone line to the sleep nurses will be open for the patients. Patients were reviewed at 1 month and at 3 month intervals during the first year and every 6 months thereafter in the CPAP clinic. Additional visits or phone calls by sleep specialist if doubts about a patient's compliance or willingness to continue with the therapy | Behavioral: Standard care<br>* 24-h consultation telephone line to the sleep nurses to answer questions regarding CPAP usage. Patients were reviewed at 1 month and at 3 month intervals during the first year and every 6 months thereafter in the CPAP clinic by the nurse. Additional visits or phone calls by sleep specialist if doubts about a patient's compliance or willingness to continue with the therapy.<br>|
| Active Comparator: Intensive care<br>Standard group care plus:~Involvement of the patient's partner or family. Extra education on sleep apnea syndrome and CPAP by sleep specialists via a 15-min videotape. 10- to 15-min lecture from the sleep clinic's nurses. Phone calls by nurses at 2 and 7 days. Early review of patients by sleep specialists at 15 and 30 days. Home visits by sleep nurses, if there doubts about a patients adherence. | Behavioral: Intensive care<br>* Standard group care plus: Involvement of the patient's partner or family necessary. Extra education on sleep apnea and CPAP by sleep specialists via a 15-min videotape. 10- to 15-min lecture from the sleep clinic's nurses after CPAP titration study. Phone calls by nurses at 2 and 7 days. Early review of patients by sleep specialists at 15 and 30 days. Home visits by sleep nurses, if there doubts about a patients adherence<br>|
|
Intensive Versus Standard Follow up to Improve Continuous Positive Airway Pressure (CPAP) Compliance
Study Overview
=================
Brief Summary
-----------------
The purpose of this study was to compare the effects on sleepiness, quality of life, depression, hospitalization and deaths rate, of intensive vs standard interventions, on CPAP adherence, 2 years after CPAP initiation.
Detailed Description
-----------------
There is limited data concerning long-term randomized clinical trials proving the long-term efficacy of intensive use, follow programs on improving CPAP use. Therefore the investigators aimed to compare the effects on sleepiness, quality of life, depression, hospitalization and deaths rate, of intensive vs standard interventions, on CPAP adherence, 2 years after CPAP initiation.
Official Title
-----------------
Intensive Versus Standard Follow up to Improve Continuous Positive Airway Pressure Compliance: The Greek Experience
Conditions
-----------------
Sleep Apnea
Intervention / Treatment
-----------------
* Behavioral: Standard care
* Behavioral: Intensive care
Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: newly diagnosed obstructive sleep apnea syndrome by polysomnography according to standard criteria, with moderate to severe sleep apnea, no history of previously CPAP therapy and with an above-elementary school education. Exclusion Criteria: refusal to participate, refusal to CPAP therapy, previous CPAP treatment, central sleep apnoea syndrome, Cheyne-stokes breathing pattern, obesity hypoventilation syndrome, restrictive ventilator syndromes, congestive heart failure, history of life-threatening arrhythmias, cardiomyopathy, long term oxygen therapy, family or personal history of mental illness, with drug or alcohol abuse, severe cognitive impairment, concurrent oncologic diseases and history of narcolepsy.
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: Single
Arms and Interventions
| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: Standard Care<br>24 hour consultation telephone line to the sleep nurses will be open for the patients. Patients were reviewed at 1 month and at 3 month intervals during the first year and every 6 months thereafter in the CPAP clinic. Additional visits or phone calls by sleep specialist if doubts about a patient's compliance or willingness to continue with the therapy | Behavioral: Standard care<br>* 24-h consultation telephone line to the sleep nurses to answer questions regarding CPAP usage. Patients were reviewed at 1 month and at 3 month intervals during the first year and every 6 months thereafter in the CPAP clinic by the nurse. Additional visits or phone calls by sleep specialist if doubts about a patient's compliance or willingness to continue with the therapy.<br>|
| Active Comparator: Intensive care<br>Standard group care plus: Involvement of the patient's partner or family. Extra education on sleep apnea syndrome and CPAP by sleep specialists via a 15-min videotape. 10- to 15-min lecture from the sleep clinic's nurses. Phone calls by nurses at 2 and 7 days. Early review of patients by sleep specialists at 15 and 30 days. Home visits by sleep nurses, if there doubts about a patients adherence. | Behavioral: Intensive care<br>* Standard group care plus: Involvement of the patient's partner or family necessary. Extra education on sleep apnea and CPAP by sleep specialists via a 15-min videotape. 10- to 15-min lecture from the sleep clinic's nurses after CPAP titration study. Phone calls by nurses at 2 and 7 days. Early review of patients by sleep specialists at 15 and 30 days. Home visits by sleep nurses, if there doubts about a patients adherence<br>|
What is the study measuring?
-----------------
Primary Outcome Measures
| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Effect of intensive intervention on CPAP adherence | | 24 months |
Secondary Outcome Measures
| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Effect of intensive intervention on sleepiness. | | 24 months |
| Effect of intensive intervention on mood. | | 24 months |
| Effect of intensive intervention on quality of life | | 24 months |
|
|
NCT04867785
|
A Study of LY3437943 in Participants With Type 2 Diabetes
|
The main purpose of this study is to evaluate the efficacy and safety of LY3437943 in participants with type 2 diabetes (T2D) who failed to achieve adequate glycemic control on diet and exercise alone or on a stable dose of metformin. This study will last about 43 weeks.
|
A Phase 2 Study of Once-Weekly LY3437943 Compared With Placebo and Dulaglutide in Participants With Type 2 Diabetes
|
Type 2 Diabetes
|
* Drug: LY3437943
* Drug: Dulaglutide
* Drug: Placebo
|
Inclusion Criteria:~Have Type 2 Diabetes (T2D)~Have an HbA1c value at screening of ≥7.0% and ≤10.5% and treated with diet and exercise alone or with a stable dose of metformin (either immediate release or extended release, 1000 milligram (mg)/day and not more than the locally approved dose) for at least 3 months prior to screening.~Exclusion Criteria:~Have type 1 diabetes mellitus (T1DM)~Have ketoacidosis~Have retinopathy, maculopathy~Have history of pancreatitis~Have obesity induced by other endocrine disorders~Have uncontrolled hypertension~Have acute or chronic hepatitis~Have chronic kidney disease~Have an autoimmune abnormality for example, lupus or rheumatoid arthritis~Have an active or untreated malignancy
|
18 Years
|
75 Years
|
All
|
No
|
Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double
|
| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change From Baseline in Hemoglobin A1c (HbA1c) | Change in HbA1c (%) from baseline in LY3437943 relative to placebo. HbA1c is the glycosylated fraction of hemoglobin A. HbA1c is measured primarily to identify average plasma glucose concentration over prolonged periods of time. Least squares (LS) mean was calculated using mixed model repeated measures (MMRM) for post-baseline measures: Variable = Treatment*Time + Strata*Time + Baseline*Time. | Baseline, 24 Weeks |
|
| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change From Baseline in HbA1c | Change in HbA1c (%) from baseline in LY3437943 relative to dulaglutide. LSMean was calculated using MMRM for post-baseline measures: Variable = Treatment*Time + Strata*Time + Baseline*Time. | Baseline, 24 Weeks |
| Change From Baseline in HbA1c | Change in HbA1c (%) from baseline in LY3437943 relative to placebo and dulaglutide. LSMean was calculated using MMRM for post-baseline measures: Variable = Treatment*Time + Baseline HbA1c Group (<=8.5%, >8.5%)*Time + Baseline Body Mass Index (BMI) Group (<30 kilograms/square meter (kg/m2), >=30 kg/m2)*Time + Baseline*Time. | Baseline, 36 Weeks |
| Percentage of Participants Reaching HbA1c <7.0% | Percentage of participants reaching HbA1c <7.0% in LY3437943 relative to placebo and dulaglutide. Estimated percentage was determined by logistic regression model with an intercept term, treatment group, baseline BMI stratum [<30 kg/m2, ≥30 kg/m2] as fixed effects, and baseline HbA1c value as a covariate. | Week 24 |
| Percentage of Participant Reaching HbA1c <7.0% | Percentage of participants reaching HbA1c <7.0% in LY3437943 relative to placebo and dulaglutide. Estimated percentage was determined by logistic regression model with an intercept term, treatment group, baseline BMI stratum [<30 kg/m2, ≥30 kg/m2] as fixed effects, and baseline HbA1c value as a covariate. | Week 36 |
| Change From Baseline in Fasting Blood Glucose (FBG) | Change in FBG from baseline in LY3437943 relative to placebo and dulaglutide. LSMean was calculated using MMRM for post-baseline measures: Variable = Treatment*Time + Strata*Time + Baseline*Time. | Baseline, 24 Weeks |
| Change From Baseline in Fasting Blood Glucose (FBG) | Change in FBG from baseline in LY3437943 relative to placebo and dulaglutide. LSMean was calculated using MMRM for post-baseline measures: Variable = Treatment*Time + Baseline HbA1c Group (<=8.5%, >8.5%)*Time + Baseline BMI Group (<30kg/m2, >=30kg/m2)*Time + Baseline*Time. | Baseline, 36 Weeks |
| Change From Baseline in Body Weight | Change in body weight from baseline in LY3437943 relative to placebo and dulaglutide. LSMean was calculated using MMRM for post-baseline measures: Variable = Treatment*Time + Strata*Time + Baseline*Time. | Baseline, 24 Weeks |
| Change From Baseline in Body Weight | Change in body weight from baseline in LY3437943 relative to placebo and dulaglutide. LSMean was calculated using MMRM for post-baseline measures: Variable = Treatment*Time + Baseline HbA1c Group (<=8.5%, >8.5%)*Time + Baseline BMI Group (<30kg/m2, >=30kg/m2)*Time + Baseline*Time. | Baseline, 36 Weeks |
| Population PK: Average Steady-State Plasma Concentration (Cav,ss) of LY3437943 | The average steady-state plasma concentration of LY3437943 was evaluated using sparse sampling methodology/Population PK (PopPK) modeling. | Predose: Week 0, 1, 4, 12, 24, 30; Postdose: Week 2, 8, 16, 20, 36 |
|
Dulaglutide, Hypoglycemic Agents, Physiological Effects of Drugs
|
| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: 0.5 milligrams (mg) LY3437943<br>Participants received 0.5 mg LY3437943 administered as SC (subcutaneous) injection once weekly (QW). | Drug: LY3437943<br>* Administered SC<br>|
| Experimental: 4 mg LY3437943 (2 mg)<br>Participants received 2 mg LY3437943 starting dose followed by 4 mg LY3437943 administered as SC injection QW. | Drug: LY3437943<br>* Administered SC<br>|
| Experimental: 4 mg LY3437943 (4 mg)<br>Participants received 4 mg LY3437943 administered as SC injection QW. | Drug: LY3437943<br>* Administered SC<br>|
| Experimental: 8 mg LY3437943 (2 mg)<br>Participants received 2 mg LY3437943 starting dose followed by 4 mg LY3437943 and then 8 mg LY3437943 administered as SC injection QW. | Drug: LY3437943<br>* Administered SC<br>|
| Experimental: 8 mg LY3437943 (4 mg)<br>Participants received 4 mg LY3437943 starting dose followed by 8 mg LY3437943 administered as a SC injection QW. | Drug: LY3437943<br>* Administered SC<br>|
| Experimental: 12 mg LY3437943 (2 mg)<br>Participants received 2 mg LY3437943 starting dose followed by 4 mg LY3437943, then 8 mg LY3437943, then 12 mg LY3437943 administered as a SC injection QW. | Drug: LY3437943<br>* Administered SC<br>|
| Active Comparator: 1.5 mg Dulaglutide<br>Participants received 1.5 mg dulaglutide administered as SC single-dose pen injection QW. | Drug: Dulaglutide<br>* Administered SC<br>|
| Placebo Comparator: Placebo<br>Participants received placebo administered as SC injection QW. | Drug: Placebo<br>* Administered SC<br>|
|
A Study of LY3437943 in Participants With Type 2 Diabetes
Study Overview
=================
Brief Summary
-----------------
The main purpose of this study is to evaluate the efficacy and safety of LY3437943 in participants with type 2 diabetes (T2D) who failed to achieve adequate glycemic control on diet and exercise alone or on a stable dose of metformin. This study will last about 43 weeks.
Official Title
-----------------
A Phase 2 Study of Once-Weekly LY3437943 Compared With Placebo and Dulaglutide in Participants With Type 2 Diabetes
Conditions
-----------------
Type 2 Diabetes
Intervention / Treatment
-----------------
* Drug: LY3437943
* Drug: Dulaglutide
* Drug: Placebo
Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Have Type 2 Diabetes (T2D) Have an HbA1c value at screening of ≥7.0% and ≤10.5% and treated with diet and exercise alone or with a stable dose of metformin (either immediate release or extended release, 1000 milligram (mg)/day and not more than the locally approved dose) for at least 3 months prior to screening. Exclusion Criteria: Have type 1 diabetes mellitus (T1DM) Have ketoacidosis Have retinopathy, maculopathy Have history of pancreatitis Have obesity induced by other endocrine disorders Have uncontrolled hypertension Have acute or chronic hepatitis Have chronic kidney disease Have an autoimmune abnormality for example, lupus or rheumatoid arthritis Have an active or untreated malignancy
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: Double
Arms and Interventions
| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: 0.5 milligrams (mg) LY3437943<br>Participants received 0.5 mg LY3437943 administered as SC (subcutaneous) injection once weekly (QW). | Drug: LY3437943<br>* Administered SC<br>|
| Experimental: 4 mg LY3437943 (2 mg)<br>Participants received 2 mg LY3437943 starting dose followed by 4 mg LY3437943 administered as SC injection QW. | Drug: LY3437943<br>* Administered SC<br>|
| Experimental: 4 mg LY3437943 (4 mg)<br>Participants received 4 mg LY3437943 administered as SC injection QW. | Drug: LY3437943<br>* Administered SC<br>|
| Experimental: 8 mg LY3437943 (2 mg)<br>Participants received 2 mg LY3437943 starting dose followed by 4 mg LY3437943 and then 8 mg LY3437943 administered as SC injection QW. | Drug: LY3437943<br>* Administered SC<br>|
| Experimental: 8 mg LY3437943 (4 mg)<br>Participants received 4 mg LY3437943 starting dose followed by 8 mg LY3437943 administered as a SC injection QW. | Drug: LY3437943<br>* Administered SC<br>|
| Experimental: 12 mg LY3437943 (2 mg)<br>Participants received 2 mg LY3437943 starting dose followed by 4 mg LY3437943, then 8 mg LY3437943, then 12 mg LY3437943 administered as a SC injection QW. | Drug: LY3437943<br>* Administered SC<br>|
| Active Comparator: 1.5 mg Dulaglutide<br>Participants received 1.5 mg dulaglutide administered as SC single-dose pen injection QW. | Drug: Dulaglutide<br>* Administered SC<br>|
| Placebo Comparator: Placebo<br>Participants received placebo administered as SC injection QW. | Drug: Placebo<br>* Administered SC<br>|
What is the study measuring?
-----------------
Primary Outcome Measures
| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change From Baseline in Hemoglobin A1c (HbA1c) | Change in HbA1c (%) from baseline in LY3437943 relative to placebo. HbA1c is the glycosylated fraction of hemoglobin A. HbA1c is measured primarily to identify average plasma glucose concentration over prolonged periods of time. Least squares (LS) mean was calculated using mixed model repeated measures (MMRM) for post-baseline measures: Variable = Treatment*Time + Strata*Time + Baseline*Time. | Baseline, 24 Weeks |
Secondary Outcome Measures
| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change From Baseline in HbA1c | Change in HbA1c (%) from baseline in LY3437943 relative to dulaglutide. LSMean was calculated using MMRM for post-baseline measures: Variable = Treatment*Time + Strata*Time + Baseline*Time. | Baseline, 24 Weeks |
| Change From Baseline in HbA1c | Change in HbA1c (%) from baseline in LY3437943 relative to placebo and dulaglutide. LSMean was calculated using MMRM for post-baseline measures: Variable = Treatment*Time + Baseline HbA1c Group (<=8.5%, >8.5%)*Time + Baseline Body Mass Index (BMI) Group (<30 kilograms/square meter (kg/m2), >=30 kg/m2)*Time + Baseline*Time. | Baseline, 36 Weeks |
| Percentage of Participants Reaching HbA1c <7.0% | Percentage of participants reaching HbA1c <7.0% in LY3437943 relative to placebo and dulaglutide. Estimated percentage was determined by logistic regression model with an intercept term, treatment group, baseline BMI stratum [<30 kg/m2, ≥30 kg/m2] as fixed effects, and baseline HbA1c value as a covariate. | Week 24 |
| Percentage of Participant Reaching HbA1c <7.0% | Percentage of participants reaching HbA1c <7.0% in LY3437943 relative to placebo and dulaglutide. Estimated percentage was determined by logistic regression model with an intercept term, treatment group, baseline BMI stratum [<30 kg/m2, ≥30 kg/m2] as fixed effects, and baseline HbA1c value as a covariate. | Week 36 |
| Change From Baseline in Fasting Blood Glucose (FBG) | Change in FBG from baseline in LY3437943 relative to placebo and dulaglutide. LSMean was calculated using MMRM for post-baseline measures: Variable = Treatment*Time + Strata*Time + Baseline*Time. | Baseline, 24 Weeks |
| Change From Baseline in Fasting Blood Glucose (FBG) | Change in FBG from baseline in LY3437943 relative to placebo and dulaglutide. LSMean was calculated using MMRM for post-baseline measures: Variable = Treatment*Time + Baseline HbA1c Group (<=8.5%, >8.5%)*Time + Baseline BMI Group (<30kg/m2, >=30kg/m2)*Time + Baseline*Time. | Baseline, 36 Weeks |
| Change From Baseline in Body Weight | Change in body weight from baseline in LY3437943 relative to placebo and dulaglutide. LSMean was calculated using MMRM for post-baseline measures: Variable = Treatment*Time + Strata*Time + Baseline*Time. | Baseline, 24 Weeks |
| Change From Baseline in Body Weight | Change in body weight from baseline in LY3437943 relative to placebo and dulaglutide. LSMean was calculated using MMRM for post-baseline measures: Variable = Treatment*Time + Baseline HbA1c Group (<=8.5%, >8.5%)*Time + Baseline BMI Group (<30kg/m2, >=30kg/m2)*Time + Baseline*Time. | Baseline, 36 Weeks |
| Population PK: Average Steady-State Plasma Concentration (Cav,ss) of LY3437943 | The average steady-state plasma concentration of LY3437943 was evaluated using sparse sampling methodology/Population PK (PopPK) modeling. | Predose: Week 0, 1, 4, 12, 24, 30; Postdose: Week 2, 8, 16, 20, 36 |
|
||
NCT03020355
|
Comparison of Blood Loss in Using vs Not Using Placental Cord Drainage After Spontaneous Vaginal Delivery
|
Comparison of effectiveness of placental blood drainage after spontaneous vaginal delivery in decreasing the duration, blood loss,and complications of the third stage, against no drainage of placental blood.
|
The patients will prospectively randomized equally into two groups (100 each in the study and control groups).~Group-A (Study group)-Placental blood was drained.~Group-B (Control group)-Placental blood was not drained.~In all the patients detailed medical and obstetric history will taken. In each patient, the pre-delivery pulse rate, blood pressure, and Hb gm% will noted. Immediately after vaginal delivery, after clamping and cutting the cord-the cord will unclamped and the blood will drained until the flow ceased. In the control group, the clamped cord will not released. Blood lost in the third stage of labour will measured by collecting the blood measuring bag.
|
Comparison of Blood Loss in Using vs Not Using Placental Cord Drainage After Spontaneous Vaginal Delivery
|
Placental Blood Drainage
|
* Procedure: Placental Blood Drainage
* Procedure: not Placental Blood Drainage
|
Inclusion Criteria:~Singleton pregnancy~Vertex presentation~Gestational age of 37 weeks (or) more~No major medical (or) obstetric complications~Spontaneous vaginal delivery~Exclusion Criteria:~Hb\7 gm/dl~History of APH~Instrumental delivery~Multiple pregnancy~Malpresentations~Large baby (more than 3.5 kg)~Polyhydramnios~Known coagulations disorders~Previous surgeries on the uterus
|
15 Years
|
50 Years
|
Female
|
Accepts Healthy Volunteers
|
Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
|
| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Blood lost | | through delivery completion, an average of 30 minutes |
|
| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| The duration of the third stage | The duration of the third stage will calculated using a stop watch. | through the duration of the third stage, an average 45 minutes |
|
Hemorrhage, Pathologic Processes
|
| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Placental Blood Drainage<br>Immediately after vaginal delivery, after clamping and cutting the cord-the cord will unclamped and the blood will drained until the flow ceased. | Procedure: Placental Blood Drainage<br>* Immediately after vaginal delivery, after clamping and cutting the cord-the cord will unclamped and the blood will drained until the flow ceased.<br>|
| Active Comparator: not Placental Blood Drainage<br>In the control group, the clamped cord will not released. | Procedure: not Placental Blood Drainage<br>* In the control group, the clamped cord will not released.<br>|
|
Comparison of Blood Loss in Using vs Not Using Placental Cord Drainage After Spontaneous Vaginal Delivery
Study Overview
=================
Brief Summary
-----------------
Comparison of effectiveness of placental blood drainage after spontaneous vaginal delivery in decreasing the duration, blood loss,and complications of the third stage, against no drainage of placental blood.
Detailed Description
-----------------
The patients will prospectively randomized equally into two groups (100 each in the study and control groups). Group-A (Study group)-Placental blood was drained. Group-B (Control group)-Placental blood was not drained. In all the patients detailed medical and obstetric history will taken. In each patient, the pre-delivery pulse rate, blood pressure, and Hb gm% will noted. Immediately after vaginal delivery, after clamping and cutting the cord-the cord will unclamped and the blood will drained until the flow ceased. In the control group, the clamped cord will not released. Blood lost in the third stage of labour will measured by collecting the blood measuring bag.
Official Title
-----------------
Comparison of Blood Loss in Using vs Not Using Placental Cord Drainage After Spontaneous Vaginal Delivery
Conditions
-----------------
Placental Blood Drainage
Intervention / Treatment
-----------------
* Procedure: Placental Blood Drainage
* Procedure: not Placental Blood Drainage
Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Singleton pregnancy Vertex presentation Gestational age of 37 weeks (or) more No major medical (or) obstetric complications Spontaneous vaginal delivery Exclusion Criteria: Hb\7 gm/dl History of APH Instrumental delivery Multiple pregnancy Malpresentations Large baby (more than 3.5 kg) Polyhydramnios Known coagulations disorders Previous surgeries on the uterus
Ages Eligible for Study
-----------------
Minimum Age: 15 Years
Maximum Age: 50 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 |
| --- | --- |
| Experimental: Placental Blood Drainage<br>Immediately after vaginal delivery, after clamping and cutting the cord-the cord will unclamped and the blood will drained until the flow ceased. | Procedure: Placental Blood Drainage<br>* Immediately after vaginal delivery, after clamping and cutting the cord-the cord will unclamped and the blood will drained until the flow ceased.<br>|
| Active Comparator: not Placental Blood Drainage<br>In the control group, the clamped cord will not released. | Procedure: not Placental Blood Drainage<br>* In the control group, the clamped cord will not released.<br>|
What is the study measuring?
-----------------
Primary Outcome Measures
| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Blood lost | | through delivery completion, an average of 30 minutes |
Secondary Outcome Measures
| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| The duration of the third stage | The duration of the third stage will calculated using a stop watch. | through the duration of the third stage, an average 45 minutes |
|
|
NCT02715141
|
Molecular Stool Testing for Colorectal Cancer Surveillance
|
Rationale: Since January 2014 the Dutch screening programme for bowel cancer has been implemented. Screening will increase the demand for surveillance. Although patients in whom adenomas have been removed are at increased risk of progressing to cancer, solid evidence on the reduction of death from CRC through the current colonoscopy-based surveillance is lacking. Furthermore, colonoscopy-based surveillance leads to high logistic demands, high individual burden and high costs. Therefore, there is need for new surveillance strategies. Stool-based molecular testing (Cologuard®, consisting of a stool DNA test and an immunochemical assay for human hemoglobin) or Faecal Immunochemical Testing (FIT) may serve as an alternative for colonoscopy surveillance.~The aim of this study is to compare the accuracy of an established molecular stool test (Cologuard®) and FIT to colonoscopy for detection of advanced adenomas or CRC (advanced neoplasia) in a surveillance population. These outcomes will be used to model various strategies of stool-based molecular surveillance to inform health policy decisions.
|
BACKGROUND: Since January 2014 the Dutch screening programme for colorectal carcinoma (CRC) has been implemented. Screening will increase the demand for surveillance. However, solid evidence on the reduction of death from CRC through the current colonoscopy-based surveillance is lacking. Furthermore, colonoscopy-based surveillance leads to high logistic demands, high patient burden and high costs. Therefore, there is need for new surveillance strategies. Stool-based molecular testing (Cologuard®) or Faecal Immunochemical Testing (FIT) may serve as an alternative for colonoscopy surveillance.~OBJECTIVES:~To compare the accuracy of an established molecular stool test (Cologuard®) and FIT to colonoscopy for detection of advanced adenomas or CRC (advanced neoplasia) in a surveillance population.~To model various strategies of stool-based molecular surveillance to inform health policy decisions.~MATERIALS AND METHODS: In this prospective observational cross-sectional cohort study, individuals aged 50-75 years that are scheduled for surveillance colonoscopy will be invited to participate. They are asked to collect a whole-stool sample prior to the surveillance colonoscopy. The sample will be used to test for the presence of molecular stool markers. The results of the molecular stool test and FIT will be compared to the colonoscopy findings.~EXPECTED RESULTS: Frequent surveillance using stool-based molecular testing is more cost-effective than the current colonoscopy-based surveillance.
|
Molecular Stool Testing for Colorectal Cancer Surveillance
|
Colorectal Cancer
|
* Behavioral: Collection of stool sample
|
Inclusion Criteria:~Subjects in the age group 50-75 years. The lower age limit is set at 50 years because of the high probability of familiar predisposition when advanced neoplasm is present in a younger age group.26 The upper age limit of 75 years is in correspondence with the recommended stop-age for surveillance according to the current guideline.9~Subjects with an indication for surveillance colonoscopy according to the previous guideline ('Follow up after polypectomy', 2002; summarized in 2008) or current ('Colonoscopy Surveillance', 2013) guideline. This includes subjects with a history of CRC or polypectomy, as well as subjects under surveillance for familial colorectal carcinoma (FCC).~Subjects who have sufficient comprehension of the Dutch language.~Subjects who have given their informed consent.~Exclusion criteria:~Subjects with inflammatory bowel disease (IBD)~Subjects with Lynch syndrome, familial adenomatous polyposis (FAP), attenuated FAP (AFAP), MUTYH associated polyposis (MAP) and serrated polyposis syndrome (SPS)~Subjects with a previous colonoscopy < 6 months (rescopy)~Subjects with proctocolectomy~Subjects with life expectancy < 3 years
|
50 Years
|
75 Years
|
All
|
No
|
| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| accuracy of molecular stool test (Cologuard) and FIT | The accuracy (sensitivity, specificity, PPV and NPV) of the molecular stool test (Cologuard®) and FIT compared to colonoscopy in the detection of advanced neoplasia in a surveillance population. | Patient inclusion for the calculation of the accuracies is expected to take 2-3 years. |
| cost-effectiveness of stool-based surveillance strategies using the ASCCA (Adenoma and Serrated pathway to Colorectal CAncer) model | Cost-effectiveness of multiple surveillance strategies, using test performance data as input in the ASCCA (Adenoma and Serrated pathway to Colorectal CAncer) model. | This will be calculated when all accuracy data (outcome 1) are available. This is expected to be 6 months after end of study. |
| life time health effects of stool-based surveillance strategies using the ASCCA (Adenoma and Serrated pathway to Colorectal CAncer) model | The ASCCA model will be used to predict outcomes, including cancer incidence and mortality, for different surveillance strategies. | This will be calculated when all accuracy data (outcome 1) are available. This is expected to be 6 months after end of study. |
|
| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| risk of CRC | Risk factors for detecting advanced colonic neoplasia have been identified, of which the most established include gender, age, BMI, family history, physical activity, nutritional habits and smoking. Participants will be asked to complete a validated online questionnaire evaluating these risk factors. | up to one month after surveillance colonoscopy |
| presence of Cologuard marker pannel on resected tissue of polyps | A challenge associated with the use of molecular markers is to find a panel of markers that represents the heterogeneity of the tumour. Therefore it is of interest to analyse whether the markers included in the Cologuard are present in the tissue of resected polyps. | Analysis will be performed during the study and approximately 1 year after end of study |
| presence of previously identified progression biomarker on resected tissue samples of polyps | The identification of biomarkers involved in the progression from colorectal adenoma to carcinoma (progression biomarkers) could aid better risk-stratification of adenomas and thereby decrease over-diagnosis and over-treatment . As a secondary objective we will therefore analyse previously identified progression biomarkers in the tissue samples of polyps obtained during colonoscopy. | Analysis will be performed during the study and approximately 1 year after end of study |
|
surveillance, molecular stool testing
|
Colorectal Neoplasms, Intestinal Neoplasms, Gastrointestinal Neoplasms, Digestive System Neoplasms, Neoplasms by Site, Neoplasms, Digestive System Diseases, Gastrointestinal Diseases, Colonic Diseases, Intestinal Diseases, Rectal Diseases
|
| Intervention/Treatment |
| --- |
|Behavioral: Collection of stool sample|Collection of stool sample prior to the scheduled surveillance colonoscopy.|
|
Molecular Stool Testing for Colorectal Cancer Surveillance
Study Overview
=================
Brief Summary
-----------------
Rationale: Since January 2014 the Dutch screening programme for bowel cancer has been implemented. Screening will increase the demand for surveillance. Although patients in whom adenomas have been removed are at increased risk of progressing to cancer, solid evidence on the reduction of death from CRC through the current colonoscopy-based surveillance is lacking. Furthermore, colonoscopy-based surveillance leads to high logistic demands, high individual burden and high costs. Therefore, there is need for new surveillance strategies. Stool-based molecular testing (Cologuard®, consisting of a stool DNA test and an immunochemical assay for human hemoglobin) or Faecal Immunochemical Testing (FIT) may serve as an alternative for colonoscopy surveillance. The aim of this study is to compare the accuracy of an established molecular stool test (Cologuard®) and FIT to colonoscopy for detection of advanced adenomas or CRC (advanced neoplasia) in a surveillance population. These outcomes will be used to model various strategies of stool-based molecular surveillance to inform health policy decisions.
Detailed Description
-----------------
BACKGROUND: Since January 2014 the Dutch screening programme for colorectal carcinoma (CRC) has been implemented. Screening will increase the demand for surveillance. However, solid evidence on the reduction of death from CRC through the current colonoscopy-based surveillance is lacking. Furthermore, colonoscopy-based surveillance leads to high logistic demands, high patient burden and high costs. Therefore, there is need for new surveillance strategies. Stool-based molecular testing (Cologuard®) or Faecal Immunochemical Testing (FIT) may serve as an alternative for colonoscopy surveillance. OBJECTIVES: To compare the accuracy of an established molecular stool test (Cologuard®) and FIT to colonoscopy for detection of advanced adenomas or CRC (advanced neoplasia) in a surveillance population. To model various strategies of stool-based molecular surveillance to inform health policy decisions. MATERIALS AND METHODS: In this prospective observational cross-sectional cohort study, individuals aged 50-75 years that are scheduled for surveillance colonoscopy will be invited to participate. They are asked to collect a whole-stool sample prior to the surveillance colonoscopy. The sample will be used to test for the presence of molecular stool markers. The results of the molecular stool test and FIT will be compared to the colonoscopy findings. EXPECTED RESULTS: Frequent surveillance using stool-based molecular testing is more cost-effective than the current colonoscopy-based surveillance.
Official Title
-----------------
Molecular Stool Testing for Colorectal Cancer Surveillance
Conditions
-----------------
Colorectal Cancer
Intervention / Treatment
-----------------
* Behavioral: Collection of stool sample
Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Subjects in the age group 50-75 years. The lower age limit is set at 50 years because of the high probability of familiar predisposition when advanced neoplasm is present in a younger age group.26 The upper age limit of 75 years is in correspondence with the recommended stop-age for surveillance according to the current guideline.9 Subjects with an indication for surveillance colonoscopy according to the previous guideline ('Follow up after polypectomy', 2002; summarized in 2008) or current ('Colonoscopy Surveillance', 2013) guideline. This includes subjects with a history of CRC or polypectomy, as well as subjects under surveillance for familial colorectal carcinoma (FCC). Subjects who have sufficient comprehension of the Dutch language. Subjects who have given their informed consent. Exclusion criteria: Subjects with inflammatory bowel disease (IBD) Subjects with Lynch syndrome, familial adenomatous polyposis (FAP), attenuated FAP (AFAP), MUTYH associated polyposis (MAP) and serrated polyposis syndrome (SPS) Subjects with a previous colonoscopy < 6 months (rescopy) Subjects with proctocolectomy Subjects with life expectancy < 3 years
Ages Eligible for Study
-----------------
Minimum Age: 50 Years
Maximum Age: 75 Years
Sexes Eligible for Study
-----------------
All
Accepts Healthy Volunteers
-----------------
No
Study Plan
=================
How is the study designed?
-----------------
Arms and Interventions
| Intervention/Treatment |
| --- |
|Behavioral: Collection of stool sample|Collection of stool sample prior to the scheduled surveillance colonoscopy.|
What is the study measuring?
-----------------
Primary Outcome Measures
| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| accuracy of molecular stool test (Cologuard) and FIT | The accuracy (sensitivity, specificity, PPV and NPV) of the molecular stool test (Cologuard®) and FIT compared to colonoscopy in the detection of advanced neoplasia in a surveillance population. | Patient inclusion for the calculation of the accuracies is expected to take 2-3 years. |
| cost-effectiveness of stool-based surveillance strategies using the ASCCA (Adenoma and Serrated pathway to Colorectal CAncer) model | Cost-effectiveness of multiple surveillance strategies, using test performance data as input in the ASCCA (Adenoma and Serrated pathway to Colorectal CAncer) model. | This will be calculated when all accuracy data (outcome 1) are available. This is expected to be 6 months after end of study. |
| life time health effects of stool-based surveillance strategies using the ASCCA (Adenoma and Serrated pathway to Colorectal CAncer) model | The ASCCA model will be used to predict outcomes, including cancer incidence and mortality, for different surveillance strategies. | This will be calculated when all accuracy data (outcome 1) are available. This is expected to be 6 months after end of study. |
Secondary Outcome Measures
| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| risk of CRC | Risk factors for detecting advanced colonic neoplasia have been identified, of which the most established include gender, age, BMI, family history, physical activity, nutritional habits and smoking. Participants will be asked to complete a validated online questionnaire evaluating these risk factors. | up to one month after surveillance colonoscopy |
| presence of Cologuard marker pannel on resected tissue of polyps | A challenge associated with the use of molecular markers is to find a panel of markers that represents the heterogeneity of the tumour. Therefore it is of interest to analyse whether the markers included in the Cologuard are present in the tissue of resected polyps. | Analysis will be performed during the study and approximately 1 year after end of study |
| presence of previously identified progression biomarker on resected tissue samples of polyps | The identification of biomarkers involved in the progression from colorectal adenoma to carcinoma (progression biomarkers) could aid better risk-stratification of adenomas and thereby decrease over-diagnosis and over-treatment . As a secondary objective we will therefore analyse previously identified progression biomarkers in the tissue samples of polyps obtained during colonoscopy. | Analysis will be performed during the study and approximately 1 year after end of study |
Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
surveillance, molecular stool testing
|
|
NCT03559751
|
Evaluation of the Abuse Liability of Very Low Nicotine (VLN) Cigarettes
|
This study is designed to evaluate the abuse liability of very low nicotine cigarettes compared to nicotine gum and usual brand cigarettes
|
This study will be a randomized, two-part, 3-way crossover designed to evaluate the abuse liability, pharmacokinetics (PK), and product use behavior associated with study products, including VLN cigarettes, subjects' own-brand cigarettes, and nicotine polacrilex gum in healthy adult male and female exclusive smokers. Subjects will participate in a standard Screening visit and one 7-day Confined Assessment Phase, which will include a product trial session (Day -1), and two study parts (Part A and Part B). Following the Screening visit, eligible subjects will check-in to the study site on Day -1. Following the polacrilex gum training session, subjects will be required to abstain from nicotine- and tobacco-containing products for approximately 20 hours until the first product use session on Days 1 to 3; use of other nicotine-containing products will be prohibited throughout the study. No additional tobacco or nicotine products will be provided after the second product use on Days 4 to 6.~On Day 1, subjects will be randomized to one of three product sequence groups in Part A, which will consist of an ad libitum product use session for each of the following study products for 4 hours in a randomized crossover manner (Days 1 to 3; one product per day):~Product A: VLN cigarette~Product B: Own-brand filtered standard king size cigarette~Product C: 4 mg Nicotine polacrilex gum~A pharmacodynamic measure (use product again Visual Analog Scale (VAS)) will be administered at the end of each ad libitum product use period. Product use behaviors (i.e., number of units consumed,duration of gum in mouth) will be collected throughout each ad libitum product use period. Upon completion of Part A, subjects will be randomized to one of three product sequence groups in Part B, which will consist of 3 study days (Days 4 to 6), with one product per day. Each study day will consist of: 1) Controlled Product Use Session (10 puffs from their own-brand cigarette or VLN cigarette [maximum 3 ± 2 seconds per puff] at approximately 30 ± 5-second interpuff intervals, or chew the nicotine polacrilex gum using the chew and park method for 10 minutes); and 2) Uncontrolled Product Use Session (ad libitum use for 10 minutes). The Controlled Product Use Session and Uncontrolled Product Use Session will be separated by approximately 6 hours. During Part B, pharmacodynamic measures, PK, and product use behavior (Uncontrolled only) will be collected at various time points each day.
|
Evaluation of the Abuse Liability of Very Low Nicotine (VLN) Cigarettes With Characterization of Nicotine Exposure Profiles in Adult Smokers
|
Tobacco Use
|
* Other: VLN cigarettes (A)
* Other: Usual Brand Cigarettes (B)
* Drug: Nicotine gum (C)
|
Inclusion Criteria:~Subjects will be required to meet each one of the following inclusion criteria in order to be eligible for participation in the study:~Must provide written informed consent prior to the initiation of any protocol-specific procedures.~Male and female adults, between 22 to 65 years of age, inclusive.~Body mass index (BMI) within 18.0 to 35.0 kg/m2, inclusive (minimum weight of at least 50.0 kg at Screening).~Healthy, as determined by no clinically significant medical history, physical examination, 12-lead ECG, vital signs or laboratory (including hematology, clinical chemistry, urinalysis, and serology) findings at Screening, as judged by an investigator.~Smoking history of an average of at least 10 manufactured filtered standard (i.e., not slim) king size combustible cigarettes daily for at least 1 year prior to Screening. Brief periods (i.e., up to 7 consecutive days) of non-smoking during the 3 months prior to Screening (e.g., due to illness or participation in a study where smoking was prohibited) will be permitted.~Self-reporting of desire to smoke within approximately 30 minutes of waking.~Positive urine cotinine (≥500 ng/mL) at Screening.~Negative pregnancy test at Screening and Day -1 (check-in) for all female subjects.~Female subjects of non-childbearing potential must be surgically sterile or 1 year postmenopausal (as confirmed by serum Follicle Stimulating Hormone (FSH) > 35 U/L). A subject is considered to be surgically sterile if she has had a tubal ligation, hysterectomy, bilateral salpingo-oophorectomy or bilateral oophorectomy, or hysterectomy with bilateral salpingo-oophorectomy. If the subject is of childbearing potential, she must be using a medically accepted method of contraception and agree to continued use of this method for the duration of the study and for 30 days after completion of the study. Acceptable methods of contraception include abstinence, birth control pill, or an intrauterine device (known to have a failure rate of less than 1% per year) or double barrier method of contraception (e.g., male condom in addition to a diaphragm, contraceptive sponge or spermicide).~Able to speak, read, and understand English sufficiently to allow completion of all study assessments.~Must be willing to comply with the requirements and restrictions of the study.~Exclusion Criteria:~Subjects will not be eligible to participate in this study if any one of the following exclusion criteria is met:~Inability to tolerate 4 mg nicotine polacrilex gum during product use trial on Day -1 (check-in) or dentition prevents subjects from chewing gum.~History or presence of any clinically significant cardiac, psychiatric, endocrine, hematologic, hepatic, immunologic, metabolic, urologic, pulmonary, neurologic, dermatologic, renal, or other major disease at Screening, which in the opinion of an investigator would jeopardize the safety of the subject or the validity of the study results.~History or presence of any type of malignant tumors.~Clinically significant abnormal findings on the vital signs, physical examination (including oral exam), medical history, or clinical laboratory results, in the opinion of an investigator.~Positive serology test results for human immunodeficiency virus (HIV-1/HIV-2) Antibodies, hepatitis B surface antigen (HbsAg), or hepatitis C Antibody (HCVAb).~An acute illness (e.g., upper respiratory infection, viral infection) requiring treatment within 2 weeks prior to Day -1 (check-in).~Drug or alcohol abuse or dependence within the 24 months prior to Screening (except nicotine), as defined by the Diagnostic and Statistical Manual of Mental Disorders, 4th edition text revision (DSM-IV-TR), or any self-reported dependence or addiction within the subject's lifetime (except nicotine or caffeine).~Subjects who have ever been in treatment for substance use disorder(s) or who are currently~Positive urine drug screen (UDS) or urine alcohol test at Screening or Day -1 (check-in).~History or any current conditions that may interfere with drug absorption, distribution, metabolism, or excretion.~History of severe allergic reaction (including anaphylaxis) to any substance, or previous status asthmaticus, or food allergies/intolerances/restrictions, or special dietary needs which, in the judgment of an investigator, contraindicates the subject's participation in the study.~Requires concomitant treatment with prescription or non-prescription products that contain pseudoephedrine (e.g., nasal/sinus decongestants).~Self-reported use of nicotine polacrilex gum, or other nicotine replacement therapy products in the 30 days prior to Day -1 (check-in). Isolated incidents within 30 days prior to Day -1 (check-in) may be permitted at the discretion of the investigator.~Subject has unsuitable or difficult venous access or is unwilling or unable to undergo direct venipuncture or catheter insertion.~Subject has donated or lost 100 to 499 mL whole blood within 30 days or more than 499 mL whole blood within 56 days preceding entry into the Confined Assessment Phase.~Subject is an employee of the sponsor or research site personnel directly affiliated with this study or their immediate family member defined as a spouse, parent, child or sibling, whether biological or legally adopted.~Subject is lactating and or breast feeding.~A subject who, in the opinion of an investigator, is considered unsuitable or unlikely to comply with the study protocol for any reason.
|
22 Years
|
65 Years
|
All
|
Accepts Healthy Volunteers
|
Primary Purpose: Other
Allocation: Randomized
Intervention Model: Crossover Assignment
Interventional Model Description: In part A each subject will have the opportunity to use either their own brand cigarette, nicotine gum or VLN cigarettes ad libitum for 4 hours after which they will answer a questionnaire on using the product again. In Part B the subjects will have a controlled use session with each product followed by and uncontrolled session.
Masking: None (Open Label)
|
| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Emax_urge(controlled) | The maximum reduction in Visual Analog Scale (VAS) score for the question Urges to smoke (Tobacco/Nicotine Withdrawal Questionnaire) between pre-use and post-use (i.e., VASpre-use1 - VASpost-use1) during the first product use in Part B. | 3 days - administered at the end of each product use session (Use of each product on a different day) |
| Emax_plst(controlled) | The largest VAS score recorded for the response to the question Is the product Pleasant right now? (Direct Effects of Product Questionnaire) during the first product use in Part B. | 3 days - administered at the end of each product use session (Use of each product on a different day) |
|
| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Cmax(controlled); Maximum Nicotine Concentration | Maximum measured plasma nicotine concentration during the Controlled Use Session. | Pre, 2,5,7,10,12,15,20,30,45,60,90,120,150 ,and 180 minutes |
| T1/2(controlled); Terminal Half Life | Apparent first-order terminal nicotine elimination half-life calculated as 0.693/Kel of the plasma concentration-time curve from time zero (defined as the start of controlled use) to 180 minutes | Pre, 2,5,7,10,12,15,20,30,45,60,90,120,150 ,and 180 minutes |
| Kel(controlled); Elimination Rate Constant | Apparent first-order terminal nicotine elimination rate constant calculated from a semi-log plot of the plasma concentration-time curve of the Controlled Use Session. | Pre, 2,5,7,10,12,15,20,30,45,60,90,120,150 ,and 180 minutes |
| Tmax(controlled); Maximum Time | Time of the maximum measured plasma nicotine concentration during the Controlled Use Session. | Pre, 2,5,7,10,12,15,20,30,45,60,90,120,150 ,and 180 minutes |
| AUC(controlled); Area under the nicotine concentration-time curve | Area under the nicotine concentration-time curve calculated using linear trapezoidal summation from time zero (defined as the start of controlled use) to 180 minutes (or the last quantifiable concentration during that interval). | Pre, 2,5,7,10,12,15,20,30,45,60,90,120,150 ,and 180 minutes |
| Cmax(uncontrolled); Maximum Nicotine Concentration | Maximum measured plasma nicotine concentration during the Uncontrolled Use Session. | Pre, 2,5,7,10,12,15,20,30,45,60,90,120,150 ,and 180 minutes |
| T1/2(uncontrolled); Terminal Half Life | Apparent first-order terminal nicotine elimination half-life calculated as 0.693/Kel of the plasma concentration-time curve from time zero (defined as the start of uncontrolled use) to 540 minutes. | Pre, 2,5,7,10,12,15,20,30,45,60,90,120,150 ,and 180 minutes |
| Kel(uncontrolled); Elimination Rate Constant | Apparent first-order terminal nicotine elimination rate constant calculated from a semi-log plot of the plasma concentration-time curve of the Controlled Use Session. | Pre, 2,5,7,10,12,15,20,30,45,60,90,120,150 ,and 180 minutes |
| Tmax(uncontrolled); Maximum Time | Time of the maximum measured plasma nicotine concentration during the Uncontrolled Use Session. | Pre, 2,5,7,10,12,15,20,30,45,60,90,120,150 ,and 180 minutes |
| AUC(uncontrolled); Area under the nicotine concentration-time curve | Area under the nicotine concentration-time curve calculated using linear trapezoidal summation from time 360 (defined as the start of uncontrolled use) to 540 minutes (or the last quantifiable concentration during that interval). | Pre, 2,5,7,10,12,15,20,30,45,60,90,120,150 ,and 180 minutes |
| Emax_urge (Uncontrolled) | The largest VAS score recorded for the response to Urges to Smoke (Tobacco/nicotine withdrawal questionnaire) during the product use in Uncontrolled Section of Part B. | pre, 5, 15, 30, 60, and 90 minutes |
| Emax_anx (Controlled) | The largest VAS score recorded for the response to Anxious (Tobacco/nicotine withdrawal questionnaire) during the product use in Controlled Section of Part B. | pre, 5, 15, 30, 60, and 90 minutes |
| Emax_anx (Uncontrolled) | The largest VAS score recorded for the response to Anxious (Tobacco/nicotine withdrawal questionnaire) during the product use in Uncontrolled Section of Part B. | pre, 5, 15, 30, 60, and 90 minutes |
| Emax_diffct (Controlled) | The largest VAS score recorded for the response to Difficulty Concentrating (Tobacco/nicotine withdrawal questionnaire) during the product use in Controlled Section of Part B. | pre, 5, 15, 30, 60, and 90 minutes |
| Emax_diffct (Uncontrolled) | The largest VAS score recorded for the response to Difficulty Concentrating (Tobacco/nicotine withdrawal questionnaire) during the product use in Uncontrolled Section of Part B. | pre, 5, 15, 30, 60, and 90 minutes |
| Emax_impat (Controlled) | The largest VAS score recorded for the response to Impatient (Tobacco/nicotine withdrawal questionnaire) during the product use in Controlled Section of Part B. | pre, 5, 15, 30, 60, and 90 minutes |
| Emax_impat (Uncontrolled) | The largest VAS score recorded for the response to Impatient (Tobacco/nicotine withdrawal questionnaire) during the product use in Uncontrolled Section of Part B. | pre, 5, 15, 30, 60, and 90 minutes |
| Emax_crav (Controlled) | The largest VAS score recorded for the response to Craving a Cigarette (Tobacco/nicotine withdrawal questionnaire) during the product use in Controlled Section of Part B. | pre, 5, 15, 30, 60, and 90 minutes |
| Emax_crav (Uncontrolled) | The largest VAS score recorded for the response to Craving a Cigarette (Tobacco/nicotine withdrawal questionnaire) during the product use in Uncontrolled Section of Part B. | pre, 5, 15, 30, 60, and 90 minutes |
| Emax_plas (Uncontrolled) | The largest VAS score recorded for the response to Pleasant (Direct effects of product questionnaire) during the product use in Uncontrolled Section of Part B. | pre, 5, 15, 30, 60, and 90 minutes |
| Emax_stf (Uncontrolled) | The largest VAS score recorded for the response to Satisfying (Direct effects of product questionnaire) during the product use in Uncontrolled Section of Part B. | pre, 5, 15, 30, 60, and 90 minutes |
| Emax_stf (Controlled) | The largest VAS score recorded for the response to Satisfying (Direct effects of product questionnaire) during the product use in Controlled Section of Part B. | pre, 5, 15, 30, 60, and 90 minutes |
| Emax_calm (Uncontrolled) | The largest VAS score recorded for the response to Calm (Direct effects of product questionnaire) during the product use in Controlled Section of Part B. | pre, 5, 15, 30, 60, and 90 minutes |
| Emax_calm (Controlled) | The largest VAS score recorded for the response to Calm (Direct effects of product questionnaire) during the product use in Uncontrolled Section of Part B. | pre, 5, 15, 30, 60, and 90 minutes |
| Emax_conc (Uncontrolled) | The largest VAS score recorded for the response to Concentrate (Direct effects of product questionnaire) during the product use in Uncontrolled Section of Part B. | pre, 5, 15, 30, 60, and 90 minutes |
| Emax_conc (controlled) | The largest VAS score recorded for the response to Concentrate (Direct effects of product questionnaire) during the product use in controlled Section of Part B. | pre, 5, 15, 30, 60, and 90 minutes |
| Emax_awake (Uncontrolled) | The largest VAS score recorded for the response to Awake (Direct effects of product questionnaire) during the product use in Uncontrolled Section of Part B. | pre, 5, 15, 30, 60, and 90 minutes |
| Emax_awake (controlled) | The largest VAS score recorded for the response to Awake (Direct effects of product questionnaire) during the product use in controlled Section of Part B. | pre, 5, 15, 30, 60, and 90 minutes |
| Emax_sick (Uncontrolled) | The largest VAS score recorded for the response to Sick (Direct effects of product questionnaire) during the product use in Uncontrolled Section of Part B. | pre, 5, 15, 30, 60, and 90 minutes |
| Emax_sick (Controlled) | The largest VAS score recorded for the response to Sick (Direct effects of product questionnaire) during the product use in Controlled Section of Part B. | pre, 5, 15, 30, 60, and 90 minutes |
| Emax_hunger (Uncontrolled) | The largest VAS score recorded for the response to Hunger (Direct effects of product questionnaire) during the product use in Uncontrolled Section of Part B. | pre, 5, 15, 30, 60, and 90 minutes |
| Emax_hunger (Controlled) | The largest VAS score recorded for the response to Hunger (Direct effects of product questionnaire) during the product use in Controlled Section of Part B. | pre, 5, 15, 30, 60, and 90 minutes |
| Emax_more (Uncontrolled) | The largest VAS score recorded for the response to More (Direct effects of product questionnaire) during the product use in Uncontrolled Section of Part B. | pre, 5, 15, 30, 60, and 90 minutes |
| Emax_more (Controlled) | The largest VAS score recorded for the response to More (Direct effects of product questionnaire) during the product use in Controlled Section of Part B. | pre, 5, 15, 30, 60, and 90 minutes |
| Inhalations | Number of product inhalations (cigarettes only) during uncontrolled use sessions | 3 product use days (Use of each product on a different day) |
| Puff durations | Duration of inhalations (cigarettes only) during uncontrolled use sessions | 2 product use days (Use of each product on a different day) |
| Gum durations | Duration of gum in mouth during uncontrolled use sessions | 1 product use day |
| Use Product Again | The VAS score recorded for the response to Use Product Again (Use product again questionnaire) during the ad libitum product use in Part A. | 1 product use day |
|
Abuse liability
|
Nicotine, Nicotinic Agonists, Cholinergic Agonists, Cholinergic Agents, Neurotransmitter Agents, Ganglionic Stimulants, Autonomic Agents, Peripheral Nervous System Agents, Physiological Effects of Drugs, Molecular Mechanisms of Pharmacological Action
|
| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: VLN Cigarettes (A)<br>Subjects will smoke VLN cigarettes | Other: Usual Brand Cigarettes (B)<br>* Usual brand king size non-menthol cigarettes<br>Drug: Nicotine gum (C)<br>* 4 mg nicotine gum<br>|
| Experimental: Usual Brand Cigarettes (B)<br>Subjects will smoke their usual brand cigarettes | Other: VLN cigarettes (A)<br>* 0.4mg nicotine / g tobacco king size filter cigarette<br>Drug: Nicotine gum (C)<br>* 4 mg nicotine gum<br>|
| Experimental: Nicotine Gum (C)<br>Subjects will chew nicotine gum | Other: VLN cigarettes (A)<br>* 0.4mg nicotine / g tobacco king size filter cigarette<br>Other: Usual Brand Cigarettes (B)<br>* Usual brand king size non-menthol cigarettes<br>|
|
Evaluation of the Abuse Liability of Very Low Nicotine (VLN) Cigarettes
Study Overview
=================
Brief Summary
-----------------
This study is designed to evaluate the abuse liability of very low nicotine cigarettes compared to nicotine gum and usual brand cigarettes
Detailed Description
-----------------
This study will be a randomized, two-part, 3-way crossover designed to evaluate the abuse liability, pharmacokinetics (PK), and product use behavior associated with study products, including VLN cigarettes, subjects' own-brand cigarettes, and nicotine polacrilex gum in healthy adult male and female exclusive smokers. Subjects will participate in a standard Screening visit and one 7-day Confined Assessment Phase, which will include a product trial session (Day -1), and two study parts (Part A and Part B). Following the Screening visit, eligible subjects will check-in to the study site on Day -1. Following the polacrilex gum training session, subjects will be required to abstain from nicotine- and tobacco-containing products for approximately 20 hours until the first product use session on Days 1 to 3; use of other nicotine-containing products will be prohibited throughout the study. No additional tobacco or nicotine products will be provided after the second product use on Days 4 to 6. On Day 1, subjects will be randomized to one of three product sequence groups in Part A, which will consist of an ad libitum product use session for each of the following study products for 4 hours in a randomized crossover manner (Days 1 to 3; one product per day): Product A: VLN cigarette Product B: Own-brand filtered standard king size cigarette Product C: 4 mg Nicotine polacrilex gum A pharmacodynamic measure (use product again Visual Analog Scale (VAS)) will be administered at the end of each ad libitum product use period. Product use behaviors (i.e., number of units consumed,duration of gum in mouth) will be collected throughout each ad libitum product use period. Upon completion of Part A, subjects will be randomized to one of three product sequence groups in Part B, which will consist of 3 study days (Days 4 to 6), with one product per day. Each study day will consist of: 1) Controlled Product Use Session (10 puffs from their own-brand cigarette or VLN cigarette [maximum 3 ± 2 seconds per puff] at approximately 30 ± 5-second interpuff intervals, or chew the nicotine polacrilex gum using the chew and park method for 10 minutes); and 2) Uncontrolled Product Use Session (ad libitum use for 10 minutes). The Controlled Product Use Session and Uncontrolled Product Use Session will be separated by approximately 6 hours. During Part B, pharmacodynamic measures, PK, and product use behavior (Uncontrolled only) will be collected at various time points each day.
Official Title
-----------------
Evaluation of the Abuse Liability of Very Low Nicotine (VLN) Cigarettes With Characterization of Nicotine Exposure Profiles in Adult Smokers
Conditions
-----------------
Tobacco Use
Intervention / Treatment
-----------------
* Other: VLN cigarettes (A)
* Other: Usual Brand Cigarettes (B)
* Drug: Nicotine gum (C)
Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Subjects will be required to meet each one of the following inclusion criteria in order to be eligible for participation in the study: Must provide written informed consent prior to the initiation of any protocol-specific procedures. Male and female adults, between 22 to 65 years of age, inclusive. Body mass index (BMI) within 18.0 to 35.0 kg/m2, inclusive (minimum weight of at least 50.0 kg at Screening). Healthy, as determined by no clinically significant medical history, physical examination, 12-lead ECG, vital signs or laboratory (including hematology, clinical chemistry, urinalysis, and serology) findings at Screening, as judged by an investigator. Smoking history of an average of at least 10 manufactured filtered standard (i.e., not slim) king size combustible cigarettes daily for at least 1 year prior to Screening. Brief periods (i.e., up to 7 consecutive days) of non-smoking during the 3 months prior to Screening (e.g., due to illness or participation in a study where smoking was prohibited) will be permitted. Self-reporting of desire to smoke within approximately 30 minutes of waking. Positive urine cotinine (≥500 ng/mL) at Screening. Negative pregnancy test at Screening and Day -1 (check-in) for all female subjects. Female subjects of non-childbearing potential must be surgically sterile or 1 year postmenopausal (as confirmed by serum Follicle Stimulating Hormone (FSH) > 35 U/L). A subject is considered to be surgically sterile if she has had a tubal ligation, hysterectomy, bilateral salpingo-oophorectomy or bilateral oophorectomy, or hysterectomy with bilateral salpingo-oophorectomy. If the subject is of childbearing potential, she must be using a medically accepted method of contraception and agree to continued use of this method for the duration of the study and for 30 days after completion of the study. Acceptable methods of contraception include abstinence, birth control pill, or an intrauterine device (known to have a failure rate of less than 1% per year) or double barrier method of contraception (e.g., male condom in addition to a diaphragm, contraceptive sponge or spermicide). Able to speak, read, and understand English sufficiently to allow completion of all study assessments. Must be willing to comply with the requirements and restrictions of the study. Exclusion Criteria: Subjects will not be eligible to participate in this study if any one of the following exclusion criteria is met: Inability to tolerate 4 mg nicotine polacrilex gum during product use trial on Day -1 (check-in) or dentition prevents subjects from chewing gum. History or presence of any clinically significant cardiac, psychiatric, endocrine, hematologic, hepatic, immunologic, metabolic, urologic, pulmonary, neurologic, dermatologic, renal, or other major disease at Screening, which in the opinion of an investigator would jeopardize the safety of the subject or the validity of the study results. History or presence of any type of malignant tumors. Clinically significant abnormal findings on the vital signs, physical examination (including oral exam), medical history, or clinical laboratory results, in the opinion of an investigator. Positive serology test results for human immunodeficiency virus (HIV-1/HIV-2) Antibodies, hepatitis B surface antigen (HbsAg), or hepatitis C Antibody (HCVAb). An acute illness (e.g., upper respiratory infection, viral infection) requiring treatment within 2 weeks prior to Day -1 (check-in). Drug or alcohol abuse or dependence within the 24 months prior to Screening (except nicotine), as defined by the Diagnostic and Statistical Manual of Mental Disorders, 4th edition text revision (DSM-IV-TR), or any self-reported dependence or addiction within the subject's lifetime (except nicotine or caffeine). Subjects who have ever been in treatment for substance use disorder(s) or who are currently Positive urine drug screen (UDS) or urine alcohol test at Screening or Day -1 (check-in). History or any current conditions that may interfere with drug absorption, distribution, metabolism, or excretion. History of severe allergic reaction (including anaphylaxis) to any substance, or previous status asthmaticus, or food allergies/intolerances/restrictions, or special dietary needs which, in the judgment of an investigator, contraindicates the subject's participation in the study. Requires concomitant treatment with prescription or non-prescription products that contain pseudoephedrine (e.g., nasal/sinus decongestants). Self-reported use of nicotine polacrilex gum, or other nicotine replacement therapy products in the 30 days prior to Day -1 (check-in). Isolated incidents within 30 days prior to Day -1 (check-in) may be permitted at the discretion of the investigator. Subject has unsuitable or difficult venous access or is unwilling or unable to undergo direct venipuncture or catheter insertion. Subject has donated or lost 100 to 499 mL whole blood within 30 days or more than 499 mL whole blood within 56 days preceding entry into the Confined Assessment Phase. Subject is an employee of the sponsor or research site personnel directly affiliated with this study or their immediate family member defined as a spouse, parent, child or sibling, whether biological or legally adopted. Subject is lactating and or breast feeding. A subject who, in the opinion of an investigator, is considered unsuitable or unlikely to comply with the study protocol for any reason.
Ages Eligible for Study
-----------------
Minimum Age: 22 Years
Maximum 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: Other
Allocation: Randomized
Intervention Model: Crossover Assignment
Interventional Model Description: In part A each subject will have the opportunity to use either their own brand cigarette, nicotine gum or VLN cigarettes ad libitum for 4 hours after which they will answer a questionnaire on using the product again. In Part B the subjects will have a controlled use session with each product followed by and uncontrolled session.
Masking: None (Open Label)
Arms and Interventions
| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: VLN Cigarettes (A)<br>Subjects will smoke VLN cigarettes | Other: Usual Brand Cigarettes (B)<br>* Usual brand king size non-menthol cigarettes<br>Drug: Nicotine gum (C)<br>* 4 mg nicotine gum<br>|
| Experimental: Usual Brand Cigarettes (B)<br>Subjects will smoke their usual brand cigarettes | Other: VLN cigarettes (A)<br>* 0.4mg nicotine / g tobacco king size filter cigarette<br>Drug: Nicotine gum (C)<br>* 4 mg nicotine gum<br>|
| Experimental: Nicotine Gum (C)<br>Subjects will chew nicotine gum | Other: VLN cigarettes (A)<br>* 0.4mg nicotine / g tobacco king size filter cigarette<br>Other: Usual Brand Cigarettes (B)<br>* Usual brand king size non-menthol cigarettes<br>|
What is the study measuring?
-----------------
Primary Outcome Measures
| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Emax_urge(controlled) | The maximum reduction in Visual Analog Scale (VAS) score for the question Urges to smoke (Tobacco/Nicotine Withdrawal Questionnaire) between pre-use and post-use (i.e., VASpre-use1 - VASpost-use1) during the first product use in Part B. | 3 days - administered at the end of each product use session (Use of each product on a different day) |
| Emax_plst(controlled) | The largest VAS score recorded for the response to the question Is the product Pleasant right now? (Direct Effects of Product Questionnaire) during the first product use in Part B. | 3 days - administered at the end of each product use session (Use of each product on a different day) |
Secondary Outcome Measures
| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Cmax(controlled); Maximum Nicotine Concentration | Maximum measured plasma nicotine concentration during the Controlled Use Session. | Pre, 2,5,7,10,12,15,20,30,45,60,90,120,150 ,and 180 minutes |
| T1/2(controlled); Terminal Half Life | Apparent first-order terminal nicotine elimination half-life calculated as 0.693/Kel of the plasma concentration-time curve from time zero (defined as the start of controlled use) to 180 minutes | Pre, 2,5,7,10,12,15,20,30,45,60,90,120,150 ,and 180 minutes |
| Kel(controlled); Elimination Rate Constant | Apparent first-order terminal nicotine elimination rate constant calculated from a semi-log plot of the plasma concentration-time curve of the Controlled Use Session. | Pre, 2,5,7,10,12,15,20,30,45,60,90,120,150 ,and 180 minutes |
| Tmax(controlled); Maximum Time | Time of the maximum measured plasma nicotine concentration during the Controlled Use Session. | Pre, 2,5,7,10,12,15,20,30,45,60,90,120,150 ,and 180 minutes |
| AUC(controlled); Area under the nicotine concentration-time curve | Area under the nicotine concentration-time curve calculated using linear trapezoidal summation from time zero (defined as the start of controlled use) to 180 minutes (or the last quantifiable concentration during that interval). | Pre, 2,5,7,10,12,15,20,30,45,60,90,120,150 ,and 180 minutes |
| Cmax(uncontrolled); Maximum Nicotine Concentration | Maximum measured plasma nicotine concentration during the Uncontrolled Use Session. | Pre, 2,5,7,10,12,15,20,30,45,60,90,120,150 ,and 180 minutes |
| T1/2(uncontrolled); Terminal Half Life | Apparent first-order terminal nicotine elimination half-life calculated as 0.693/Kel of the plasma concentration-time curve from time zero (defined as the start of uncontrolled use) to 540 minutes. | Pre, 2,5,7,10,12,15,20,30,45,60,90,120,150 ,and 180 minutes |
| Kel(uncontrolled); Elimination Rate Constant | Apparent first-order terminal nicotine elimination rate constant calculated from a semi-log plot of the plasma concentration-time curve of the Controlled Use Session. | Pre, 2,5,7,10,12,15,20,30,45,60,90,120,150 ,and 180 minutes |
| Tmax(uncontrolled); Maximum Time | Time of the maximum measured plasma nicotine concentration during the Uncontrolled Use Session. | Pre, 2,5,7,10,12,15,20,30,45,60,90,120,150 ,and 180 minutes |
| AUC(uncontrolled); Area under the nicotine concentration-time curve | Area under the nicotine concentration-time curve calculated using linear trapezoidal summation from time 360 (defined as the start of uncontrolled use) to 540 minutes (or the last quantifiable concentration during that interval). | Pre, 2,5,7,10,12,15,20,30,45,60,90,120,150 ,and 180 minutes |
| Emax_urge (Uncontrolled) | The largest VAS score recorded for the response to Urges to Smoke (Tobacco/nicotine withdrawal questionnaire) during the product use in Uncontrolled Section of Part B. | pre, 5, 15, 30, 60, and 90 minutes |
| Emax_anx (Controlled) | The largest VAS score recorded for the response to Anxious (Tobacco/nicotine withdrawal questionnaire) during the product use in Controlled Section of Part B. | pre, 5, 15, 30, 60, and 90 minutes |
| Emax_anx (Uncontrolled) | The largest VAS score recorded for the response to Anxious (Tobacco/nicotine withdrawal questionnaire) during the product use in Uncontrolled Section of Part B. | pre, 5, 15, 30, 60, and 90 minutes |
| Emax_diffct (Controlled) | The largest VAS score recorded for the response to Difficulty Concentrating (Tobacco/nicotine withdrawal questionnaire) during the product use in Controlled Section of Part B. | pre, 5, 15, 30, 60, and 90 minutes |
| Emax_diffct (Uncontrolled) | The largest VAS score recorded for the response to Difficulty Concentrating (Tobacco/nicotine withdrawal questionnaire) during the product use in Uncontrolled Section of Part B. | pre, 5, 15, 30, 60, and 90 minutes |
| Emax_impat (Controlled) | The largest VAS score recorded for the response to Impatient (Tobacco/nicotine withdrawal questionnaire) during the product use in Controlled Section of Part B. | pre, 5, 15, 30, 60, and 90 minutes |
| Emax_impat (Uncontrolled) | The largest VAS score recorded for the response to Impatient (Tobacco/nicotine withdrawal questionnaire) during the product use in Uncontrolled Section of Part B. | pre, 5, 15, 30, 60, and 90 minutes |
| Emax_crav (Controlled) | The largest VAS score recorded for the response to Craving a Cigarette (Tobacco/nicotine withdrawal questionnaire) during the product use in Controlled Section of Part B. | pre, 5, 15, 30, 60, and 90 minutes |
| Emax_crav (Uncontrolled) | The largest VAS score recorded for the response to Craving a Cigarette (Tobacco/nicotine withdrawal questionnaire) during the product use in Uncontrolled Section of Part B. | pre, 5, 15, 30, 60, and 90 minutes |
| Emax_plas (Uncontrolled) | The largest VAS score recorded for the response to Pleasant (Direct effects of product questionnaire) during the product use in Uncontrolled Section of Part B. | pre, 5, 15, 30, 60, and 90 minutes |
| Emax_stf (Uncontrolled) | The largest VAS score recorded for the response to Satisfying (Direct effects of product questionnaire) during the product use in Uncontrolled Section of Part B. | pre, 5, 15, 30, 60, and 90 minutes |
| Emax_stf (Controlled) | The largest VAS score recorded for the response to Satisfying (Direct effects of product questionnaire) during the product use in Controlled Section of Part B. | pre, 5, 15, 30, 60, and 90 minutes |
| Emax_calm (Uncontrolled) | The largest VAS score recorded for the response to Calm (Direct effects of product questionnaire) during the product use in Controlled Section of Part B. | pre, 5, 15, 30, 60, and 90 minutes |
| Emax_calm (Controlled) | The largest VAS score recorded for the response to Calm (Direct effects of product questionnaire) during the product use in Uncontrolled Section of Part B. | pre, 5, 15, 30, 60, and 90 minutes |
| Emax_conc (Uncontrolled) | The largest VAS score recorded for the response to Concentrate (Direct effects of product questionnaire) during the product use in Uncontrolled Section of Part B. | pre, 5, 15, 30, 60, and 90 minutes |
| Emax_conc (controlled) | The largest VAS score recorded for the response to Concentrate (Direct effects of product questionnaire) during the product use in controlled Section of Part B. | pre, 5, 15, 30, 60, and 90 minutes |
| Emax_awake (Uncontrolled) | The largest VAS score recorded for the response to Awake (Direct effects of product questionnaire) during the product use in Uncontrolled Section of Part B. | pre, 5, 15, 30, 60, and 90 minutes |
| Emax_awake (controlled) | The largest VAS score recorded for the response to Awake (Direct effects of product questionnaire) during the product use in controlled Section of Part B. | pre, 5, 15, 30, 60, and 90 minutes |
| Emax_sick (Uncontrolled) | The largest VAS score recorded for the response to Sick (Direct effects of product questionnaire) during the product use in Uncontrolled Section of Part B. | pre, 5, 15, 30, 60, and 90 minutes |
| Emax_sick (Controlled) | The largest VAS score recorded for the response to Sick (Direct effects of product questionnaire) during the product use in Controlled Section of Part B. | pre, 5, 15, 30, 60, and 90 minutes |
| Emax_hunger (Uncontrolled) | The largest VAS score recorded for the response to Hunger (Direct effects of product questionnaire) during the product use in Uncontrolled Section of Part B. | pre, 5, 15, 30, 60, and 90 minutes |
| Emax_hunger (Controlled) | The largest VAS score recorded for the response to Hunger (Direct effects of product questionnaire) during the product use in Controlled Section of Part B. | pre, 5, 15, 30, 60, and 90 minutes |
| Emax_more (Uncontrolled) | The largest VAS score recorded for the response to More (Direct effects of product questionnaire) during the product use in Uncontrolled Section of Part B. | pre, 5, 15, 30, 60, and 90 minutes |
| Emax_more (Controlled) | The largest VAS score recorded for the response to More (Direct effects of product questionnaire) during the product use in Controlled Section of Part B. | pre, 5, 15, 30, 60, and 90 minutes |
| Inhalations | Number of product inhalations (cigarettes only) during uncontrolled use sessions | 3 product use days (Use of each product on a different day) |
| Puff durations | Duration of inhalations (cigarettes only) during uncontrolled use sessions | 2 product use days (Use of each product on a different day) |
| Gum durations | Duration of gum in mouth during uncontrolled use sessions | 1 product use day |
| Use Product Again | The VAS score recorded for the response to Use Product Again (Use product again questionnaire) during the ad libitum product use in Part A. | 1 product use day |
Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Abuse liability
|
NCT03397888
|
The Effect o f Hepatic Impairment on the Pharmacokinetics and Pharmacodynamics of Betrixiban, an Oral FXa Antagonist
|
Single center, prospective open label PK and PD study of betrixaban in subjects with mild and moderate hepatic impairment vs healthy volunteers.
|
The Effect o f Hepatic Impairment on the Pharmacokinetics and Pharmacodynamics of Betrixiban, an Oral FXa Antagonist
|
Hepatic Impairment
|
* Drug: Betrixaban
|
Inclusion Criteria:~Cohorts 1 & 2: Man or a woman 18 to 70 with stable chronic hepatic impairment disease due to cirrhosis confirmed by biopsy, ultrasound, CT or MRI (Cohort 1 - Mild impairment, Child-Pugh Category A; Cohort 2 - Moderate Impairment, Child-Pugh Category B). Cohort 3: essentially healthy man or woman without liver disease whose sex, age and weight match patients in Cohorts 1 & 2 in order to result in similar average demographics.~Body Mass Index between 18 and 35 kg*m-2 and weighs at least 50 kg.~Contraception. Men must agree to acceptable methods of contraception. Women of child-bearing potential must agree to two acceptable forms of contraception. Post-menopausal women must have had no regular menstrual bleeding for at least one year prior to initial dosing and confirmed by an elevated plasma Follicle-stimulating hormone level test at screening for women not in receipt of hormone replacement therapy (HRT). Women who report surgical sterilization must have had the procedure at least six months prior to dosing, supported by clinical documentation.~The subject has clinical unremarkable medical history, physical examination, ECG, laboratory values and vital signs, as determined by the investigator. Subjects in Cohorts 1 & 2 may have: abnormal liver function tests, INR up to 2.2, PT up to 6 seconds over control, aPPT up to 45 seconds and platelets down to 45,000/uL.~The subject smokes <12 cigarettes per day or equivalent and agrees to no or reduced tobacco products while domiciled.~The subject is able to read and give written informed consent and signed the IRB approved consent form.~The subject has adequate venous access for blood sampling.~Exclusion Criteria:~The subject has a history, symptoms of, or risk factors for bleeding or a stool specimen within 6 months of dosing positive for occult blood.~The subject has an absolute/relative contraindication to anticoagulation due to: history of intracranial bleeding, severe active bleeding, recent brain, eye, or spinal cord surgery or major surgery within 6 months of dosing.~The subject has a history of or risk factors for a hypercoagulable or thrombotic condition.~The subject has a history of any clinically significant cardiac, endocrinologic, hematologic, hepatic (except for Cohorts 1 & 2), immunologic, metabolic, urologic, pulmonary, neurologic, dermatologic, psychiatric, renal or other major disease other than the underlying disease in Cohorts 1 & 2.~The subject has a calculated creatinine clearance of <60mL/min as determined by Cockcroft-Gault method.~Concomitant medication use:~For all subjects, illicit drugs, oral contraceptives, and hormone replacement therapy are excluded within 30 days prior to Day -1.~For all subjects, over the counter drugs, including dietary supplements and herbal products are excluded within 14 days prior to Day -1.~Subjects enrolled in Cohort 3 will be excluded if the subject has taken any prescription drugs in the 30 days prior to dosing. Furthermore, the subject will be excluded if he/she does not agree to refrain from concomitant drugs throughout the study unless medically necessary as determined by the Investigator.~Subjects enrolled in Cohort 1 and 2 may continue taking stable preexisting medications throughout the study with the exception of strong P-gp inhibitors. Strong P-gp inhibitors include but are not limited to: amiodarone, azithromycin, clarithromycin, erythromycin, ketoconazole, and verapamil. Prescribed stable acetaminophen use up to 2,000 mg per day is allowable. Any acetaminophen use with alcohol within 48 hours of dosing is prohibited. Furthermore, the subject will be excluded if he/she does not agree to refrain from additional concomitant drugs throughout the study unless medically necessary as determined by the Investigator.~The subject has a history of severe trauma or bone fracture within 6 months prior to dosing; or planned surgery within 1 month after dosing.~The subject has a history of blood donation of more than 500mL within 3 months prior to dosing.~The subject has received an investigational drug product within 30 days or 5 half-lives of the investigational compound, whichever is greater, from Day -1.~The subject has positive screen for drugs of abuse at Day -1.~The subject does not agree to withhold from alcohol consumption from 48 hours prior to dosing through discharge.~The subject has a medical or surgical condition which may impair drug absorption.~The subject is pregnant or breastfeeding.~The subject has any condition which could interfere with or for which the treatment might interfere with the conduct of the study, or would, in the opinion of the Investigator, increase the risk of the subject's participation in the study.
|
18 Years
|
70 Years
|
All
|
Accepts Healthy Volunteers
|
Primary Purpose: Prevention
Allocation: Non-Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
|
| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| PK - Plasma half-life (t1/2) | Plasma half-life (t1/2), distribution half-life and terminal half-life. | Day 1 through Day 6 |
| PK - Tmax | Time to maximum observed plasma concentration (Tmax). | Day 1 through Day 6 |
| PK - Cmax | Maximum observed plasma concentration (Cmax) | Day 1 through Day 6 |
| PK - AUC (0-last) | Area under the plasma concentration-time curve from 0 to last measurable concentration (AUC (0-last)). | Day 1 through Day 6 |
| PK - (AUC(0-∞)). | Total area under the plasma concentration-time curve from time 0 to infinity (AUC(0-∞)). | Day 1 through Day 6 |
| PK - Volume of distribution | Apparent volume of distribution (Vd/F). | Day 1 through Day 6 |
| PK - Total clearance | Apparent total clearance (CL/F). | Day 1 through Day 6 |
|
| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Safety - Treatment Emergent AEs | Safety evaluation will study the adverse event (AE) profile | Day -1 through up to Day 21 |
| Safety - Demographics | Safety will be evaluated by assessment of Demographics | Day -30 through Day -2 (Screening) |
| Safety - Vital Signs Temperature | Safety will be evaluated by assessment of Temperature - Celsius | Day -30 through up to Day 21 |
| Safety - Vital Signs Respiratory Rate | Safety will be evaluated by assessment of Respiratory Rate - Breaths per Minute | Day -30 through up to Day 21 |
| Safety - Vital Signs Heart Rate | Safety will be evaluated by assessment of Heart Rate - Beats per Minute | Day -30 through up to Day 21 |
| Safety - Vital Signs Blood Pressure | Safety will be evaluated by assessment of Blood Pressure - mmHg | Day -30 through up to Day 21 |
| Safety - 12 Lead ECG - PR | Safety will be evaluated by assessment of 12 ECG - PR (ms) | Day -30 through up to Day 21 |
| Safety - 12 Lead ECG - RR | Safety will be evaluated by assessment of 12 ECG - RR (ms) | Day -30 through up to Day 21 |
| Safety - 12 Lead ECG - WRS | Safety will be evaluated by assessment of 12 ECG - WRS (ms) | Day -30 through up to Day 21 |
| Safety - 12 Lead ECG - QT | Safety will be evaluated by assessment of 12 ECG - QT (ms) | Day -30 through up to Day 21 |
| Safety - 12 Lead ECG - QTcF | Safety will be evaluated by assessment of 12 ECG - QTcF (ms) | Day -30 through up to Day 21 |
| Safety - 12 Lead ECG - QTcB | Safety will be evaluated by assessment of 12 ECG - QTcB (ms) | Day -30 through up to Day 21 |
| Safety - Physical Exam - Height | Safety will be evaluated by assessment Physical Exam - Height (centimeters) | Day -30 through up to Day 21 |
| Safety - Physical Exam - Weight | Safety will be evaluated by assessment Physical Exam - Weight (kilogram) | Day -30 through up to Day 21 |
| Safety - Lab - Hematology - hemoglobin | Safety will be evaluated by analyzing Hematology - hemoglobin (g/dL) | Day -30 through up to Day 21 |
| Safety - Lab - Hematology - hematocrit | Safety will be evaluated by analyzing Hematology - hematocrit (%) | Day -30 through up to Day 21 |
| Safety - Lab - Hematology - white blood cell [WBC] | Safety will be evaluated by analyzing Hematology - WBC (K/UL) | Day -30 through up to Day 21 |
| Safety - Lab - Hematology - Platelet Count | Safety will be evaluated by analyzing Platelet Count (Plt/mL) | Day -30 through up to Day 21 |
| Safety - Lab - Hematology - Absolute Neutrophil Count | Safety will be evaluated by analyzing Absolute Neutrophil Count (K/UL) | Day -30 through up to Day 21 |
| Safety - Lab - Hematology - Absolute Basophils | Safety will be evaluated by analyzing Absolute Basophils (K/UL) | Day -30 through up to Day 21 |
| Safety - Lab - Hematology - Eosinophil's | Safety will be evaluated by analyzing Eosinophil's (K/UL) | Day -30 through up to Day 21 |
| Safety - Lab - Hematology - Lymphocytes | Safety will be evaluated by analyzing Lymphocytes (K/UL) | Day -30 through up to Day 21 |
| Safety - Lab - Hematology - Mean Corpuscular Hemoglobin | Safety will be evaluated by analyzing Mean Corpuscular Hemoglobin (PG) | Day -30 through up to Day 21 |
| Safety - Lab - Hematology - Mean Corpuscular Hemoglobin Concentration | Safety will be evaluated by analyzing Mean Corpuscular Hemoglobin Concentration (g/dL) | Day -30 through up to Day 21 |
| Safety - Lab - Hematology - Mean Corpuscular Hemoglobin Volume | Safety will be evaluated by analyzing Mean Corpuscular Hemoglobin Volume (FL) | Day -30 through up to Day 21 |
| Safety - Lab - Hematology - Monocytes | Safety will be evaluated by analyzing Monocytes (K/UL) | Day -30 through up to Day 21 |
| Safety - Lab - Hematology - Neutrophils | Safety will be evaluated by analyzing Neutrophils (K/UL) | Day -30 through up to Day 21 |
| Safety - Lab - Hematology - Red Blood Cell Count | Safety will be evaluated by analyzing Red Blood Cell Count (MIL/UL) | Day -30 through up to Day 21 |
| Safety - Lab - Hematology - Red Cell Distribution Width | Safety will be evaluated by analyzing Red Cell Distribution Width (%) | Day -30 through up to Day 21 |
| Safety - Lab - Hematology - Reticulocyte | Safety will be evaluated by analyzing Reticulocyte (K/UL) | Day -30 through up to Day 21 |
| Safety- Lab - Coagulation - PT | Safety will be evaluated by analyzing Coagulation - PT (seconds) | Day -30 through up to Day 21 |
| Safety- Lab - Coagulation - INR | Safety will be evaluated by analyzing Coagulation - INR (no unit) | Day -30 through up to Day 21 |
| Safety- Lab - Coagulation - aPTT | Safety will be evaluated by analyzing Coagulation - aPTT (seconds) | Day -30 through up to Day 21 |
| Safety- Lab - Coagulation - Factor V Leiden | Safety will be evaluated by analyzing Coagulation - Factor V Leiden (positive/negative) | Day -30 through up to Day 21 |
| Safety - Lab - Serum Chemistry - Sodium | Safety will be evaluated by analyzing Serum Chemistry - Sodium (mEq/L) | Day -30 through up to Day 21 |
| Safety - Lab - Serum Chemistry - Potassium | Safety will be evaluated by analyzing Serum Chemistry - Potassium (mEq/L) | Day -30 through up to Day 21 |
| Safety - Lab - Serum Chemistry - Chloride | Safety will be evaluated by analyzing Serum Chemistry - Chloride (mEq/L) | Day -30 through up to Day 21 |
| Safety - Lab - Serum Chemistry - Carbon Dioxide | Safety will be evaluated by analyzing Serum Chemistry - Carbon Dioxide (mEq/L) | Day -30 through up to Day 21 |
| Safety - Lab - Serum Chemistry - Glucose | Safety will be evaluated by analyzing Serum Chemistry - Glucose (mg/dL) | Day -30 through up to Day 21 |
| Safety - Lab - Serum Chemistry - Blood Urea Nitrogen | Safety will be evaluated by analyzing Serum Chemistry - Blood Urea Nitrogen (mg/dL) | Day -30 through up to Day 21 |
| Safety - Lab - Serum Chemistry - Creatinine | Safety will be evaluated by analyzing Serum Chemistry - Creatinine (mg/dL) | Day -30 through up to Day 21 |
| Safety - Lab - Serum Chemistry - AST | Safety will be evaluated by analyzing Serum Chemistry - AST (U/L) | Day -30 through up to Day 21 |
| Safety - Lab - Serum Chemistry - ALT | Safety will be evaluated by analyzing Serum Chemistry - ALT (U/L) | Day -30 through up to Day 21 |
| Safety - Lab - Serum Chemistry - GGT | Safety will be evaluated by analyzing Serum Chemistry - GGT (U/L) | Day -30 through up to Day 21 |
| Safety - Lab - Serum Chemistry - Total Protein | Safety will be evaluated by analyzing Serum Chemistry - Total Protein (g/dL) | Day -30 through up to Day 21 |
| Safety - Lab - Serum Chemistry - Albumin | Safety will be evaluated by analyzing Serum Chemistry - Albumin(g/dL) | Day -30 through up to Day 21 |
| Safety - Lab - Serum Chemistry - Alkaline Phosphatase | Safety will be evaluated by analyzing Serum Chemistry - Alkaline Phosphatase (U/L) | Day -30 through up to Day 21 |
| Safety - Lab - Serum Chemistry - Calcium | Safety will be evaluated by analyzing Serum Chemistry - Calcium (mg/dL) | Day -30 through up to Day 21 |
| Safety - Lab - Serum Chemistry - Phosphorus | Safety will be evaluated by analyzing Serum Chemistry - Phosphorus (mg/dL) | Day -30 through up to Day 21 |
| Safety - Lab - Serum Chemistry - Total Bilirubin | Safety will be evaluated by analyzing Serum Chemistry - Total Bilirubin (mg/dL) | Day -30 through up to Day 21 |
| Safety - Lab - Serum Chemistry - Fractionated Bilirubin | Safety will be evaluated by analyzing Serum Chemistry - Fractionated Bilirubin(mg/dL) | Day -30 through up to Day 21 |
| Safety - Lab - Serum Chemistry - Uric Acid | Safety will be evaluated by analyzing Serum Chemistry - Uric Acid (mg/dL) | Day -30 through up to Day 21 |
| Safety - Lab - Serum Chemistry - LDH | Safety will be evaluated by analyzing Serum Chemistry LDH (U/L) | Day -30 through up to Day 21 |
| Safety - Lab - Urine toxicology Panel - Amphetamines | Safety will be evaluated by analyzing Urine toxicology Panel - Amphetamines (NG/ML) | Day -30 through Day -1 |
| Safety - Lab - Urine toxicology Panel - Barbiturates | Safety will be evaluated by analyzing Urine toxicology Panel - Barbiturates (NG/ML) | Day -30 through Day -1 |
| Safety - Lab - Urine toxicology Panel - Cannabinoids | Safety will be evaluated by analyzing Urine toxicology Panel - Cannabinoids (NG/ML) | Day -30 through Day -1 |
| Safety - Lab - Urine toxicology Panel - Cocaine | Safety will be evaluated by analyzing Urine toxicology Panel - Cocaine (NG/ML) | Day -30 through Day -1 |
| Safety - Lab - Urine toxicology Panel - Ethanol | Safety will be evaluated by analyzing Urine toxicology Panel - Ethanol (MG/DL) | Day -30 through Day -1 |
| Safety - Lab - Urine toxicology Panel - Opiates | Safety will be evaluated by analyzing Urine toxicology Panel - Opiates (NG/ML) | Day -30 through Day -1 |
| Safety - Lab - Urinalysis - Specific Gravity | Safety will be evaluated by analyzing Urinalysis - Specific Gravity (no unit) | Day -30 through up to Day 21 |
| Safety - Lab - Urinalysis - pH | Safety will be evaluated by analyzing Urinalysis - pH (no unit) | Day -30 through up to Day 21 |
| Safety - Lab - Urinalysis - Glucose | Safety will be evaluated by analyzing Urinalysis - Glucose (no unit) | Day -30 through up to Day 21 |
| Safety - Lab - Urinalysis - Protein | Safety will be evaluated by analyzing Urinalysis - Protein (no unit) | Day -30 through up to Day 21 |
| Safety - Lab - Urinalysis - Hemoglobin | Safety will be evaluated by analyzing Urinalysis - Hemoglobin (no unit) | Day -30 through up to Day 21 |
| Safety - Lab - Urinalysis - Leukocyte esterase | Safety will be evaluated by analyzing Urinalysis - Leukocyte esterase (no unit) | Day -30 through up to Day 21 |
| Safety - Lab - Urinalysis - Nitrate | Safety will be evaluated by analyzing Urinalysis - Nitrate (no unit) | Day -30 through up to Day 21 |
| Safety - Urine Occult Blood Testing | Safety will be evaluated by assessment of Urine Occult Blood Testing (positive/negative) | Day -30 through Day -2 (screening) |
| Safety - Fecal Occult Blood Testing | Safety will be evaluated by assessment of Fecal Occult Blood Testing (positive/negative) | Day -30 through Day -2 (screening) |
| Safety - Lab - Blood Virology - HIV I | Safety will be evaluated by analyzing Blood Virology - HIV I (positive/negative) | Day-30 through Day -2 (Screening) |
| Safety - Lab - Blood Virology - HIV II | Safety will be evaluated by analyzing Blood Virology - HIV II (positive/negative) | Day-30 through Day -2 (Screening) |
| Safety - Lab - Blood Virology - Hepatitis B | Safety will be evaluated by analyzing Blood Virology - Hepatitis B (positive/negative) | Day-30 through Day -2 (Screening) |
| Safety - Lab - Blood Virology - Hepatitis C | Safety will be evaluated by analyzing Blood Virology - Hepatitis C (positive/negative) | Day-30 through Day -2 (Screening) |
| Safety - Lab - Serum Pregnancy | Safety will be evaluated by analyzing Serum Pregnancy | Day -30 through up to Day 21 |
| PD - Anti-Factor Xa Concentration | Anti-fXa will be analyzed for changes/percent changes from baseline over time. | Day 1 through Day 6 |
| PD - Thrombin Concentrations | Thrombin will be analyzed for changes/percent changes from baseline over time. | Day 1 through Day 6 |
|
Betrixaban, Factor Xa Inhibitors, Antithrombins, Serine Proteinase Inhibitors, Protease Inhibitors, Enzyme Inhibitors, Molecular Mechanisms of Pharmacological Action, Anticoagulants
|
| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Cohort 1<br>Mild Impairment, Child-Pugh Category A | Drug: Betrixaban<br>* 80 mg capsule<br>|
| Experimental: Cohort 2<br>Moderate Impairment, Child-Pugh Category B | Drug: Betrixaban<br>* 80 mg capsule<br>|
| Experimental: Cohort 3<br>Essentially Healthy man or woman without liver disease matched to Cohorts 1 & 2 for age, sex and weight. | Drug: Betrixaban<br>* 80 mg capsule<br>|
|
The Effect o f Hepatic Impairment on the Pharmacokinetics and Pharmacodynamics of Betrixiban, an Oral FXa Antagonist
Study Overview
=================
Brief Summary
-----------------
Single center, prospective open label PK and PD study of betrixaban in subjects with mild and moderate hepatic impairment vs healthy volunteers.
Official Title
-----------------
The Effect o f Hepatic Impairment on the Pharmacokinetics and Pharmacodynamics of Betrixiban, an Oral FXa Antagonist
Conditions
-----------------
Hepatic Impairment
Intervention / Treatment
-----------------
* Drug: Betrixaban
Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Cohorts 1 & 2: Man or a woman 18 to 70 with stable chronic hepatic impairment disease due to cirrhosis confirmed by biopsy, ultrasound, CT or MRI (Cohort 1 - Mild impairment, Child-Pugh Category A; Cohort 2 - Moderate Impairment, Child-Pugh Category B). Cohort 3: essentially healthy man or woman without liver disease whose sex, age and weight match patients in Cohorts 1 & 2 in order to result in similar average demographics. Body Mass Index between 18 and 35 kg*m-2 and weighs at least 50 kg. Contraception. Men must agree to acceptable methods of contraception. Women of child-bearing potential must agree to two acceptable forms of contraception. Post-menopausal women must have had no regular menstrual bleeding for at least one year prior to initial dosing and confirmed by an elevated plasma Follicle-stimulating hormone level test at screening for women not in receipt of hormone replacement therapy (HRT). Women who report surgical sterilization must have had the procedure at least six months prior to dosing, supported by clinical documentation. The subject has clinical unremarkable medical history, physical examination, ECG, laboratory values and vital signs, as determined by the investigator. Subjects in Cohorts 1 & 2 may have: abnormal liver function tests, INR up to 2.2, PT up to 6 seconds over control, aPPT up to 45 seconds and platelets down to 45,000/uL. The subject smokes <12 cigarettes per day or equivalent and agrees to no or reduced tobacco products while domiciled. The subject is able to read and give written informed consent and signed the IRB approved consent form. The subject has adequate venous access for blood sampling. Exclusion Criteria: The subject has a history, symptoms of, or risk factors for bleeding or a stool specimen within 6 months of dosing positive for occult blood. The subject has an absolute/relative contraindication to anticoagulation due to: history of intracranial bleeding, severe active bleeding, recent brain, eye, or spinal cord surgery or major surgery within 6 months of dosing. The subject has a history of or risk factors for a hypercoagulable or thrombotic condition. The subject has a history of any clinically significant cardiac, endocrinologic, hematologic, hepatic (except for Cohorts 1 & 2), immunologic, metabolic, urologic, pulmonary, neurologic, dermatologic, psychiatric, renal or other major disease other than the underlying disease in Cohorts 1 & 2. The subject has a calculated creatinine clearance of <60mL/min as determined by Cockcroft-Gault method. Concomitant medication use: For all subjects, illicit drugs, oral contraceptives, and hormone replacement therapy are excluded within 30 days prior to Day -1. For all subjects, over the counter drugs, including dietary supplements and herbal products are excluded within 14 days prior to Day -1. Subjects enrolled in Cohort 3 will be excluded if the subject has taken any prescription drugs in the 30 days prior to dosing. Furthermore, the subject will be excluded if he/she does not agree to refrain from concomitant drugs throughout the study unless medically necessary as determined by the Investigator. Subjects enrolled in Cohort 1 and 2 may continue taking stable preexisting medications throughout the study with the exception of strong P-gp inhibitors. Strong P-gp inhibitors include but are not limited to: amiodarone, azithromycin, clarithromycin, erythromycin, ketoconazole, and verapamil. Prescribed stable acetaminophen use up to 2,000 mg per day is allowable. Any acetaminophen use with alcohol within 48 hours of dosing is prohibited. Furthermore, the subject will be excluded if he/she does not agree to refrain from additional concomitant drugs throughout the study unless medically necessary as determined by the Investigator. The subject has a history of severe trauma or bone fracture within 6 months prior to dosing; or planned surgery within 1 month after dosing. The subject has a history of blood donation of more than 500mL within 3 months prior to dosing. The subject has received an investigational drug product within 30 days or 5 half-lives of the investigational compound, whichever is greater, from Day -1. The subject has positive screen for drugs of abuse at Day -1. The subject does not agree to withhold from alcohol consumption from 48 hours prior to dosing through discharge. The subject has a medical or surgical condition which may impair drug absorption. The subject is pregnant or breastfeeding. The subject has any condition which could interfere with or for which the treatment might interfere with the conduct of the study, or would, in the opinion of the Investigator, increase the risk of the subject's participation in the study.
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: Non-Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Arms and Interventions
| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Cohort 1<br>Mild Impairment, Child-Pugh Category A | Drug: Betrixaban<br>* 80 mg capsule<br>|
| Experimental: Cohort 2<br>Moderate Impairment, Child-Pugh Category B | Drug: Betrixaban<br>* 80 mg capsule<br>|
| Experimental: Cohort 3<br>Essentially Healthy man or woman without liver disease matched to Cohorts 1 & 2 for age, sex and weight. | Drug: Betrixaban<br>* 80 mg capsule<br>|
What is the study measuring?
-----------------
Primary Outcome Measures
| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| PK - Plasma half-life (t1/2) | Plasma half-life (t1/2), distribution half-life and terminal half-life. | Day 1 through Day 6 |
| PK - Tmax | Time to maximum observed plasma concentration (Tmax). | Day 1 through Day 6 |
| PK - Cmax | Maximum observed plasma concentration (Cmax) | Day 1 through Day 6 |
| PK - AUC (0-last) | Area under the plasma concentration-time curve from 0 to last measurable concentration (AUC (0-last)). | Day 1 through Day 6 |
| PK - (AUC(0-∞)). | Total area under the plasma concentration-time curve from time 0 to infinity (AUC(0-∞)). | Day 1 through Day 6 |
| PK - Volume of distribution | Apparent volume of distribution (Vd/F). | Day 1 through Day 6 |
| PK - Total clearance | Apparent total clearance (CL/F). | Day 1 through Day 6 |
Secondary Outcome Measures
| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Safety - Treatment Emergent AEs | Safety evaluation will study the adverse event (AE) profile | Day -1 through up to Day 21 |
| Safety - Demographics | Safety will be evaluated by assessment of Demographics | Day -30 through Day -2 (Screening) |
| Safety - Vital Signs Temperature | Safety will be evaluated by assessment of Temperature - Celsius | Day -30 through up to Day 21 |
| Safety - Vital Signs Respiratory Rate | Safety will be evaluated by assessment of Respiratory Rate - Breaths per Minute | Day -30 through up to Day 21 |
| Safety - Vital Signs Heart Rate | Safety will be evaluated by assessment of Heart Rate - Beats per Minute | Day -30 through up to Day 21 |
| Safety - Vital Signs Blood Pressure | Safety will be evaluated by assessment of Blood Pressure - mmHg | Day -30 through up to Day 21 |
| Safety - 12 Lead ECG - PR | Safety will be evaluated by assessment of 12 ECG - PR (ms) | Day -30 through up to Day 21 |
| Safety - 12 Lead ECG - RR | Safety will be evaluated by assessment of 12 ECG - RR (ms) | Day -30 through up to Day 21 |
| Safety - 12 Lead ECG - WRS | Safety will be evaluated by assessment of 12 ECG - WRS (ms) | Day -30 through up to Day 21 |
| Safety - 12 Lead ECG - QT | Safety will be evaluated by assessment of 12 ECG - QT (ms) | Day -30 through up to Day 21 |
| Safety - 12 Lead ECG - QTcF | Safety will be evaluated by assessment of 12 ECG - QTcF (ms) | Day -30 through up to Day 21 |
| Safety - 12 Lead ECG - QTcB | Safety will be evaluated by assessment of 12 ECG - QTcB (ms) | Day -30 through up to Day 21 |
| Safety - Physical Exam - Height | Safety will be evaluated by assessment Physical Exam - Height (centimeters) | Day -30 through up to Day 21 |
| Safety - Physical Exam - Weight | Safety will be evaluated by assessment Physical Exam - Weight (kilogram) | Day -30 through up to Day 21 |
| Safety - Lab - Hematology - hemoglobin | Safety will be evaluated by analyzing Hematology - hemoglobin (g/dL) | Day -30 through up to Day 21 |
| Safety - Lab - Hematology - hematocrit | Safety will be evaluated by analyzing Hematology - hematocrit (%) | Day -30 through up to Day 21 |
| Safety - Lab - Hematology - white blood cell [WBC] | Safety will be evaluated by analyzing Hematology - WBC (K/UL) | Day -30 through up to Day 21 |
| Safety - Lab - Hematology - Platelet Count | Safety will be evaluated by analyzing Platelet Count (Plt/mL) | Day -30 through up to Day 21 |
| Safety - Lab - Hematology - Absolute Neutrophil Count | Safety will be evaluated by analyzing Absolute Neutrophil Count (K/UL) | Day -30 through up to Day 21 |
| Safety - Lab - Hematology - Absolute Basophils | Safety will be evaluated by analyzing Absolute Basophils (K/UL) | Day -30 through up to Day 21 |
| Safety - Lab - Hematology - Eosinophil's | Safety will be evaluated by analyzing Eosinophil's (K/UL) | Day -30 through up to Day 21 |
| Safety - Lab - Hematology - Lymphocytes | Safety will be evaluated by analyzing Lymphocytes (K/UL) | Day -30 through up to Day 21 |
| Safety - Lab - Hematology - Mean Corpuscular Hemoglobin | Safety will be evaluated by analyzing Mean Corpuscular Hemoglobin (PG) | Day -30 through up to Day 21 |
| Safety - Lab - Hematology - Mean Corpuscular Hemoglobin Concentration | Safety will be evaluated by analyzing Mean Corpuscular Hemoglobin Concentration (g/dL) | Day -30 through up to Day 21 |
| Safety - Lab - Hematology - Mean Corpuscular Hemoglobin Volume | Safety will be evaluated by analyzing Mean Corpuscular Hemoglobin Volume (FL) | Day -30 through up to Day 21 |
| Safety - Lab - Hematology - Monocytes | Safety will be evaluated by analyzing Monocytes (K/UL) | Day -30 through up to Day 21 |
| Safety - Lab - Hematology - Neutrophils | Safety will be evaluated by analyzing Neutrophils (K/UL) | Day -30 through up to Day 21 |
| Safety - Lab - Hematology - Red Blood Cell Count | Safety will be evaluated by analyzing Red Blood Cell Count (MIL/UL) | Day -30 through up to Day 21 |
| Safety - Lab - Hematology - Red Cell Distribution Width | Safety will be evaluated by analyzing Red Cell Distribution Width (%) | Day -30 through up to Day 21 |
| Safety - Lab - Hematology - Reticulocyte | Safety will be evaluated by analyzing Reticulocyte (K/UL) | Day -30 through up to Day 21 |
| Safety- Lab - Coagulation - PT | Safety will be evaluated by analyzing Coagulation - PT (seconds) | Day -30 through up to Day 21 |
| Safety- Lab - Coagulation - INR | Safety will be evaluated by analyzing Coagulation - INR (no unit) | Day -30 through up to Day 21 |
| Safety- Lab - Coagulation - aPTT | Safety will be evaluated by analyzing Coagulation - aPTT (seconds) | Day -30 through up to Day 21 |
| Safety- Lab - Coagulation - Factor V Leiden | Safety will be evaluated by analyzing Coagulation - Factor V Leiden (positive/negative) | Day -30 through up to Day 21 |
| Safety - Lab - Serum Chemistry - Sodium | Safety will be evaluated by analyzing Serum Chemistry - Sodium (mEq/L) | Day -30 through up to Day 21 |
| Safety - Lab - Serum Chemistry - Potassium | Safety will be evaluated by analyzing Serum Chemistry - Potassium (mEq/L) | Day -30 through up to Day 21 |
| Safety - Lab - Serum Chemistry - Chloride | Safety will be evaluated by analyzing Serum Chemistry - Chloride (mEq/L) | Day -30 through up to Day 21 |
| Safety - Lab - Serum Chemistry - Carbon Dioxide | Safety will be evaluated by analyzing Serum Chemistry - Carbon Dioxide (mEq/L) | Day -30 through up to Day 21 |
| Safety - Lab - Serum Chemistry - Glucose | Safety will be evaluated by analyzing Serum Chemistry - Glucose (mg/dL) | Day -30 through up to Day 21 |
| Safety - Lab - Serum Chemistry - Blood Urea Nitrogen | Safety will be evaluated by analyzing Serum Chemistry - Blood Urea Nitrogen (mg/dL) | Day -30 through up to Day 21 |
| Safety - Lab - Serum Chemistry - Creatinine | Safety will be evaluated by analyzing Serum Chemistry - Creatinine (mg/dL) | Day -30 through up to Day 21 |
| Safety - Lab - Serum Chemistry - AST | Safety will be evaluated by analyzing Serum Chemistry - AST (U/L) | Day -30 through up to Day 21 |
| Safety - Lab - Serum Chemistry - ALT | Safety will be evaluated by analyzing Serum Chemistry - ALT (U/L) | Day -30 through up to Day 21 |
| Safety - Lab - Serum Chemistry - GGT | Safety will be evaluated by analyzing Serum Chemistry - GGT (U/L) | Day -30 through up to Day 21 |
| Safety - Lab - Serum Chemistry - Total Protein | Safety will be evaluated by analyzing Serum Chemistry - Total Protein (g/dL) | Day -30 through up to Day 21 |
| Safety - Lab - Serum Chemistry - Albumin | Safety will be evaluated by analyzing Serum Chemistry - Albumin(g/dL) | Day -30 through up to Day 21 |
| Safety - Lab - Serum Chemistry - Alkaline Phosphatase | Safety will be evaluated by analyzing Serum Chemistry - Alkaline Phosphatase (U/L) | Day -30 through up to Day 21 |
| Safety - Lab - Serum Chemistry - Calcium | Safety will be evaluated by analyzing Serum Chemistry - Calcium (mg/dL) | Day -30 through up to Day 21 |
| Safety - Lab - Serum Chemistry - Phosphorus | Safety will be evaluated by analyzing Serum Chemistry - Phosphorus (mg/dL) | Day -30 through up to Day 21 |
| Safety - Lab - Serum Chemistry - Total Bilirubin | Safety will be evaluated by analyzing Serum Chemistry - Total Bilirubin (mg/dL) | Day -30 through up to Day 21 |
| Safety - Lab - Serum Chemistry - Fractionated Bilirubin | Safety will be evaluated by analyzing Serum Chemistry - Fractionated Bilirubin(mg/dL) | Day -30 through up to Day 21 |
| Safety - Lab - Serum Chemistry - Uric Acid | Safety will be evaluated by analyzing Serum Chemistry - Uric Acid (mg/dL) | Day -30 through up to Day 21 |
| Safety - Lab - Serum Chemistry - LDH | Safety will be evaluated by analyzing Serum Chemistry LDH (U/L) | Day -30 through up to Day 21 |
| Safety - Lab - Urine toxicology Panel - Amphetamines | Safety will be evaluated by analyzing Urine toxicology Panel - Amphetamines (NG/ML) | Day -30 through Day -1 |
| Safety - Lab - Urine toxicology Panel - Barbiturates | Safety will be evaluated by analyzing Urine toxicology Panel - Barbiturates (NG/ML) | Day -30 through Day -1 |
| Safety - Lab - Urine toxicology Panel - Cannabinoids | Safety will be evaluated by analyzing Urine toxicology Panel - Cannabinoids (NG/ML) | Day -30 through Day -1 |
| Safety - Lab - Urine toxicology Panel - Cocaine | Safety will be evaluated by analyzing Urine toxicology Panel - Cocaine (NG/ML) | Day -30 through Day -1 |
| Safety - Lab - Urine toxicology Panel - Ethanol | Safety will be evaluated by analyzing Urine toxicology Panel - Ethanol (MG/DL) | Day -30 through Day -1 |
| Safety - Lab - Urine toxicology Panel - Opiates | Safety will be evaluated by analyzing Urine toxicology Panel - Opiates (NG/ML) | Day -30 through Day -1 |
| Safety - Lab - Urinalysis - Specific Gravity | Safety will be evaluated by analyzing Urinalysis - Specific Gravity (no unit) | Day -30 through up to Day 21 |
| Safety - Lab - Urinalysis - pH | Safety will be evaluated by analyzing Urinalysis - pH (no unit) | Day -30 through up to Day 21 |
| Safety - Lab - Urinalysis - Glucose | Safety will be evaluated by analyzing Urinalysis - Glucose (no unit) | Day -30 through up to Day 21 |
| Safety - Lab - Urinalysis - Protein | Safety will be evaluated by analyzing Urinalysis - Protein (no unit) | Day -30 through up to Day 21 |
| Safety - Lab - Urinalysis - Hemoglobin | Safety will be evaluated by analyzing Urinalysis - Hemoglobin (no unit) | Day -30 through up to Day 21 |
| Safety - Lab - Urinalysis - Leukocyte esterase | Safety will be evaluated by analyzing Urinalysis - Leukocyte esterase (no unit) | Day -30 through up to Day 21 |
| Safety - Lab - Urinalysis - Nitrate | Safety will be evaluated by analyzing Urinalysis - Nitrate (no unit) | Day -30 through up to Day 21 |
| Safety - Urine Occult Blood Testing | Safety will be evaluated by assessment of Urine Occult Blood Testing (positive/negative) | Day -30 through Day -2 (screening) |
| Safety - Fecal Occult Blood Testing | Safety will be evaluated by assessment of Fecal Occult Blood Testing (positive/negative) | Day -30 through Day -2 (screening) |
| Safety - Lab - Blood Virology - HIV I | Safety will be evaluated by analyzing Blood Virology - HIV I (positive/negative) | Day-30 through Day -2 (Screening) |
| Safety - Lab - Blood Virology - HIV II | Safety will be evaluated by analyzing Blood Virology - HIV II (positive/negative) | Day-30 through Day -2 (Screening) |
| Safety - Lab - Blood Virology - Hepatitis B | Safety will be evaluated by analyzing Blood Virology - Hepatitis B (positive/negative) | Day-30 through Day -2 (Screening) |
| Safety - Lab - Blood Virology - Hepatitis C | Safety will be evaluated by analyzing Blood Virology - Hepatitis C (positive/negative) | Day-30 through Day -2 (Screening) |
| Safety - Lab - Serum Pregnancy | Safety will be evaluated by analyzing Serum Pregnancy | Day -30 through up to Day 21 |
| PD - Anti-Factor Xa Concentration | Anti-fXa will be analyzed for changes/percent changes from baseline over time. | Day 1 through Day 6 |
| PD - Thrombin Concentrations | Thrombin will be analyzed for changes/percent changes from baseline over time. | Day 1 through Day 6 |
|
||
NCT02729857
|
Postprandial Response After Intake of Meals With Different Fatty Acid Composition
|
The aim of the study is to understand more about how different fatty acids modulate postprandial lipid metabolism and inflammatory response.
|
Postprandial Response After Intake of Meals With Different Fatty Acid Composition in Patients With Familial Hypercholesterolemia and Healthy Subjects
|
Healthy, Familial Hypercholesterolemia
|
* Dietary Supplement: SFA muffin
* Dietary Supplement: PUFA muffin
|
Inclusion Criteria:~18 - 30 years of age~Healthy or diagnosed with familial hypercholesterolemia (FH) (mutation in gene coding for LDL-receptor). FH subjects can be included if they are:~Untreated~Treated with low dose statin (<20 mg atorvastatin, <10-20 mg simvastatin or <5-10 mg rosuvastatin)~Treated with high dose statin and willing to use low dose statin during the last 4 weeks prior to both study visits (total 8 week period)~Treated with high dose statins and willing to discontinue statin treatment during the last 4 weeks prior to both study visits (total 8 week period)~BMI 18.5 - 30 kg/m2~Stabile weight the last three months prior to the first study visit (weight change less than ± 5 % of body weight)~Exclusion Criteria:~CRP >10 mg/L~TG >4 mmol/L~Comorbidities including diabetes type I and II, coronary heart disease, haemophilia, anaemia, gastro intestinal disease, renal failure and hyperthyroidism~Pregnant or lactating~Allergic or intolerant to gluten or egg~Not willing to stop using n-3 fatty acid supplements during the last 4 weeks prior to both study visits~Using medications affecting lipid metabolism or inflammation, except statins for FH subjects~Hormone treatment (except contraception and thyroxin (stabile dose last 3 months))~Donating blood 2 months within or during study period~Tobacco smoking~Large alcohol consumption (>40g daily)
|
18 Years
|
30 Years
|
All
|
Accepts Healthy Volunteers
|
Primary Purpose: Prevention
Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: Quadruple
|
| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change in levels of circulating triglycerides | | Measured at baseline and 2,4 and 6 hours after intake of test meal |
|
| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Changes in markers of lipid- and glucose metabolism | Changes in levels of total cholesterol, low-density lipoprotein, high-density lipoprotein, apolipoprotein (apo) B, apo A1, apo CIII, apo B48, lipoprotein (a), free fatty acids, total fatty acid composition, LDL-receptor-related protein with 11 ligand-binding repeats (LR11), HbA1c, glucose, insulin and troponin. | Measured at baseline and 2,4 and 6 hours after intake of test meal |
| Changes in circulating levels of inflammatory markers | Changes in levels of inflammatory markers in circulation such as i.e. cytokines and hsCRP | Measured at baseline and 2,4 and 6 hours after intake of test meal |
| Changes in PBMC gene expression levels of markers of inflammation and lipid metabolism | Changes in levels of markers of inflammation and lipid metabolism at PBMC gene expression level | Measured at baseline and 2, 4 and 6 hours after intake of test meal |
| Changes in lipid classes and lipoprotein size | | Measured at baseline and 2,4 and 6 hours after intake of test meal |
| Changes in plasma and urine metabolomics | Changes in metabolites such as glucose, lactate, pyruvate, citrate and amino acids will be measured in plasma and urine. | Measured in plasma at baseline and 2,4 and 6 hours after intake of test meal. Measured in urine at fasting state and during the 6 hour postprandial phase. |
| Check DNA for single nuclear polymorphisms | | Measured at baseline and 2,4 and 6 hours after intake of test meal |
| Changes in PBMC Whole genome transcriptomics | | Measured at baseline and 4 and 6 hours after intake of test meal |
|
Hyperlipidemias, Dyslipidemias, Metabolic Diseases, Lipid Metabolism, Inborn Errors, Metabolism, Inborn Errors, Genetic Diseases, Inborn, Hyperlipoproteinemias, Hyperlipoproteinemia Type II, Hypercholesterolemia, Lipid Metabolism Disorders
|
| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Familial hypercholesterolemia<br>Subjects diagnosed with familial hypercholesterolemia receive in randomized order muffin with saturated fat (SFA muffin) and polyunsaturated fat (PUFA muffin) at baseline | Dietary Supplement: SFA muffin<br>* Muffin rich in saturated fat.<br>Dietary Supplement: PUFA muffin<br>* Muffin rich in polyunsaturated fat.<br>|
| Active Comparator: Healthy<br>Subjects with no chronic diseases receive in randomized order muffin with saturated fat (SFA muffin) and polyunsaturated fat (PUFA muffin) at baseline | Dietary Supplement: SFA muffin<br>* Muffin rich in saturated fat.<br>Dietary Supplement: PUFA muffin<br>* Muffin rich in polyunsaturated fat.<br>|
|
Postprandial Response After Intake of Meals With Different Fatty Acid Composition
Study Overview
=================
Brief Summary
-----------------
The aim of the study is to understand more about how different fatty acids modulate postprandial lipid metabolism and inflammatory response.
Official Title
-----------------
Postprandial Response After Intake of Meals With Different Fatty Acid Composition in Patients With Familial Hypercholesterolemia and Healthy Subjects
Conditions
-----------------
Healthy, Familial Hypercholesterolemia
Intervention / Treatment
-----------------
* Dietary Supplement: SFA muffin
* Dietary Supplement: PUFA muffin
Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: 18 - 30 years of age Healthy or diagnosed with familial hypercholesterolemia (FH) (mutation in gene coding for LDL-receptor). FH subjects can be included if they are: Untreated Treated with low dose statin (<20 mg atorvastatin, <10-20 mg simvastatin or <5-10 mg rosuvastatin) Treated with high dose statin and willing to use low dose statin during the last 4 weeks prior to both study visits (total 8 week period) Treated with high dose statins and willing to discontinue statin treatment during the last 4 weeks prior to both study visits (total 8 week period) BMI 18.5 - 30 kg/m2 Stabile weight the last three months prior to the first study visit (weight change less than ± 5 % of body weight) Exclusion Criteria: CRP >10 mg/L TG >4 mmol/L Comorbidities including diabetes type I and II, coronary heart disease, haemophilia, anaemia, gastro intestinal disease, renal failure and hyperthyroidism Pregnant or lactating Allergic or intolerant to gluten or egg Not willing to stop using n-3 fatty acid supplements during the last 4 weeks prior to both study visits Using medications affecting lipid metabolism or inflammation, except statins for FH subjects Hormone treatment (except contraception and thyroxin (stabile dose last 3 months)) Donating blood 2 months within or during study period Tobacco smoking Large alcohol consumption (>40g daily)
Ages Eligible for Study
-----------------
Minimum Age: 18 Years
Maximum Age: 30 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: Quadruple
Arms and Interventions
| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Familial hypercholesterolemia<br>Subjects diagnosed with familial hypercholesterolemia receive in randomized order muffin with saturated fat (SFA muffin) and polyunsaturated fat (PUFA muffin) at baseline | Dietary Supplement: SFA muffin<br>* Muffin rich in saturated fat.<br>Dietary Supplement: PUFA muffin<br>* Muffin rich in polyunsaturated fat.<br>|
| Active Comparator: Healthy<br>Subjects with no chronic diseases receive in randomized order muffin with saturated fat (SFA muffin) and polyunsaturated fat (PUFA muffin) at baseline | Dietary Supplement: SFA muffin<br>* Muffin rich in saturated fat.<br>Dietary Supplement: PUFA muffin<br>* Muffin rich in polyunsaturated fat.<br>|
What is the study measuring?
-----------------
Primary Outcome Measures
| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change in levels of circulating triglycerides | | Measured at baseline and 2,4 and 6 hours after intake of test meal |
Secondary Outcome Measures
| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Changes in markers of lipid- and glucose metabolism | Changes in levels of total cholesterol, low-density lipoprotein, high-density lipoprotein, apolipoprotein (apo) B, apo A1, apo CIII, apo B48, lipoprotein (a), free fatty acids, total fatty acid composition, LDL-receptor-related protein with 11 ligand-binding repeats (LR11), HbA1c, glucose, insulin and troponin. | Measured at baseline and 2,4 and 6 hours after intake of test meal |
| Changes in circulating levels of inflammatory markers | Changes in levels of inflammatory markers in circulation such as i.e. cytokines and hsCRP | Measured at baseline and 2,4 and 6 hours after intake of test meal |
| Changes in PBMC gene expression levels of markers of inflammation and lipid metabolism | Changes in levels of markers of inflammation and lipid metabolism at PBMC gene expression level | Measured at baseline and 2, 4 and 6 hours after intake of test meal |
| Changes in lipid classes and lipoprotein size | | Measured at baseline and 2,4 and 6 hours after intake of test meal |
| Changes in plasma and urine metabolomics | Changes in metabolites such as glucose, lactate, pyruvate, citrate and amino acids will be measured in plasma and urine. | Measured in plasma at baseline and 2,4 and 6 hours after intake of test meal. Measured in urine at fasting state and during the 6 hour postprandial phase. |
| Check DNA for single nuclear polymorphisms | | Measured at baseline and 2,4 and 6 hours after intake of test meal |
| Changes in PBMC Whole genome transcriptomics | | Measured at baseline and 4 and 6 hours after intake of test meal |
|
||
NCT03882177
|
StAT-TB (Statin Adjunctive Therapy for TB): A Phase 2b Dose-finding Study of Pravastatin in Adults With Tuberculosis
|
The purpose of this study is to assess the safety, tolerability, and pharmacokinetics of pravastatin adjunctive therapy when combined with the standard tuberculosis (TB) treatment regimen in adults with TB.
|
This study will assess the safety, tolerability, and pharmacokinetics of pravastatin adjunctive therapy when combined with the standard TB treatment regimen in adults with drug-sensitive TB. The pharmacokinetic data for pravastatin will be used to choose a dose to be studied as adjunctive TB treatment in subsequent trials.~This study is a dose-escalation trial, and participants will be sequentially enrolled into four study arms. Participants will receive standard anti-TB therapy (Rifafour) and pravastatin daily for 14 days. Pravastatin will be given alone on Day 1, and pravastatin + Rifafour will be given on Days 2-15.~Total study duration for participants will be 30 days, during which time participants will attend several study visits. Study visits may include sputum specimen collection, blood and urine collection, lung function testing, and pharmacokinetic assessments. All study participants will be referred appropriately to continue standard TB treatment at study completion.
|
StAT-TB (Statin Adjunctive Therapy for TB): A Phase 2b Dose-finding Study of Pravastatin in Adults With Tuberculosis
|
Tuberculosis, Pulmonary Tuberculosis
|
* Drug: Pravastatin
* Drug: Rifafour
* Dietary Supplement: Vitamin B6
|
Inclusion Criteria:~18 years of age or older~Clinical signs and symptoms of pulmonary tuberculosis~Abnormal chest radiograph consistent with pulmonary tuberculosis~At least one sputum positive for M. tuberculosis by Xpert MTB/RIF with a cycle threshold (Ct) less than 28.~Documentation of HIV status~Weight greater than or equal to 45 kg~Karnofsky score of at least 60~Ability to provide informed consent~Ability to adhere to study follow-up visits~Negative pregnancy test in women of child-bearing age~Ability to adhere to contraceptive requirements and willing to use two forms of contraception: 1) a double barrier method to prevent pregnancy (i.e. use of a condom with either diaphragm or cervical cap) or 2) use of an intrauterine device in combination with a barrier contraceptive. The participant must be willing to continue these contraceptive measures throughout the duration of the study and until one week after the last dose of study medication or one week after discontinuation from study medication in case of premature discontinuation.~Five days or fewer of anti-tuberculosis treatment within the previous 3 months~Exclusion Criteria:~A history of severe adverse reactions to any statin or any other study agent or contraindications to use of statins.~Current use of statins or other lipid-lower agents;~Clinical indication for statin therapy based on cardiovascular risk:~Familial hypercholesterolemia~Previous history of myocardial infarction or stroke~For HIV-positive individuals, a CD4+ T-cell count less than 350/mm^3~Use of antiretroviral drugs~Hemoglobin concentration less than 8 g/dL;~Baseline creatinine kinase elevation more than three times the upper limit of normal~Abnormal baseline laboratory values~Baseline alanine aminotransferase (ALT) concentration more than 2.5 times the upper limit of normal (Grade 1)~Serum creatinine concentration more than twice the upper limit of normal;~Serum total bilirubin level greater than twice the upper limit of normal~Platelet count less than 100,000/mm^3~Absolute neutrophil count (ANC) less than 1,000/mm^3~Pregnant or breastfeeding;~Silico-tuberculosis.~Currently receiving TB treatment~Serologies or PCR positive for viral hepatitis (Hepatitis, B, C)~Concomitant disorders or conditions for which isoniazid, rifampin, pyrazinamide, or ethambutol is contraindicated. These include cirrhosis, acute liver disease of any cause, acute uncontrolled gouty arthritis and peripheral neuropathy.~Any medical or psychological condition which, in the view of the study investigator, makes study participation inadvisable.~Infection with an isolate determined to be resistant to rifampin by GeneXpert.~More than five days of anti-tuberculosis treatment within the previous 3 months~Planned or current use of cyclosporine, tacrolimus, erythromycin or colchicine~Central nervous system (CNS) TB~Extra-pulmonary TB only, not in combination with pulmonary TB~History of TB
|
18 Years
| null |
All
|
No
|
Primary Purpose: Treatment
Allocation: Non-Randomized
Intervention Model: Sequential Assignment
Masking: None (Open Label)
|
| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Frequency of Grade 3 or Higher Adverse Events | Graded using the DAIDS table for Grading the Severity of Adult and Pediatric Adverse Events, Corrected Version 2.1, July 2017 | Measured through Day 30 |
|
| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Number of Participants Who Permanently Discontinue Assigned Study Regimen for Any Reason | (Other than new recognition of participant ineligibility based on absence of M. tuberculosis growth in baseline sputum cultures, or growth of M. tuberculosis resistant to rifampin by GeneXpert) | Measured through Day 14 |
|
Vitamin B 6, Pyridoxal, Pyridoxine, Vitamins, Pravastatin, Micronutrients, Physiological Effects of Drugs, Vitamin B Complex, Anticholesteremic Agents, Hypolipidemic Agents, Antimetabolites, Molecular Mechanisms of Pharmacological Action, Lipid Regulating Agents, Hydroxymethylglutaryl-CoA Reductase Inhibitors, Enzyme Inhibitors
|
| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Arm 1: Pravastatin (40 mg) and Rifafour<br>Participants will receive pravastatin (40 mg) and Rifafour daily for 14 days. Pravastatin will be given alone on Day 1, and pravastatin + Rifafour will be given on Days 2-15.~Vitamin B6 will be added to each of the regimens. | Drug: Pravastatin<br>* Tablets, administered orally<br>Drug: Rifafour<br>* Fixed-dose combination (isoniazid, rifampin, pyrazinamide, and ethambutol) tablets, administered orally<br>Dietary Supplement: Vitamin B6<br>* Administered orally.<br>|
| Experimental: Arm 2: Pravastatin (80 mg) and Rifafour<br>Participants will receive pravastatin (80 mg) and Rifafour daily for 14 days. Pravastatin will be given alone on Day 1, and pravastatin + Rifafour will be given on Days 2-15.~Vitamin B6 will be added to each of the regimens. | Drug: Pravastatin<br>* Tablets, administered orally<br>Drug: Rifafour<br>* Fixed-dose combination (isoniazid, rifampin, pyrazinamide, and ethambutol) tablets, administered orally<br>Dietary Supplement: Vitamin B6<br>* Administered orally.<br>|
| Experimental: Arm 3: Pravastatin (120 mg) and Rifafour<br>Participants will receive pravastatin (120 mg) and Rifafour daily for 14 days. Pravastatin will be given alone on Day 1, and pravastatin + Rifafour will be given on Days 2-15.~Vitamin B6 will be added to each of the regimens.~(Arm 3 will only be recruited if pravastatin 80 mg is well tolerated and safe, yet drug exposures are significantly reduced due to the known interaction with rifampin.) | Drug: Pravastatin<br>* Tablets, administered orally<br>Drug: Rifafour<br>* Fixed-dose combination (isoniazid, rifampin, pyrazinamide, and ethambutol) tablets, administered orally<br>Dietary Supplement: Vitamin B6<br>* Administered orally.<br>|
| Experimental: Arm 4: Pravastatin (160 mg) and Rifafour<br>Participants will receive pravastatin (160 mg) and Rifafour daily for 14 days. Pravastatin will be given alone on Day 1, and pravastatin + Rifafour will be given on Days 2-15.~Vitamin B6 will be added to each of the regimens.~(Arm 4 will only be recruited if pravastatin 120 mg is well tolerated and safe, yet drug exposures are significantly reduced due to the known interaction with rifampin.) | Drug: Pravastatin<br>* Tablets, administered orally<br>Drug: Rifafour<br>* Fixed-dose combination (isoniazid, rifampin, pyrazinamide, and ethambutol) tablets, administered orally<br>Dietary Supplement: Vitamin B6<br>* Administered orally.<br>|
|
StAT-TB (Statin Adjunctive Therapy for TB): A Phase 2b Dose-finding Study of Pravastatin in Adults With Tuberculosis
Study Overview
=================
Brief Summary
-----------------
The purpose of this study is to assess the safety, tolerability, and pharmacokinetics of pravastatin adjunctive therapy when combined with the standard tuberculosis (TB) treatment regimen in adults with TB.
Detailed Description
-----------------
This study will assess the safety, tolerability, and pharmacokinetics of pravastatin adjunctive therapy when combined with the standard TB treatment regimen in adults with drug-sensitive TB. The pharmacokinetic data for pravastatin will be used to choose a dose to be studied as adjunctive TB treatment in subsequent trials. This study is a dose-escalation trial, and participants will be sequentially enrolled into four study arms. Participants will receive standard anti-TB therapy (Rifafour) and pravastatin daily for 14 days. Pravastatin will be given alone on Day 1, and pravastatin + Rifafour will be given on Days 2-15. Total study duration for participants will be 30 days, during which time participants will attend several study visits. Study visits may include sputum specimen collection, blood and urine collection, lung function testing, and pharmacokinetic assessments. All study participants will be referred appropriately to continue standard TB treatment at study completion.
Official Title
-----------------
StAT-TB (Statin Adjunctive Therapy for TB): A Phase 2b Dose-finding Study of Pravastatin in Adults With Tuberculosis
Conditions
-----------------
Tuberculosis, Pulmonary Tuberculosis
Intervention / Treatment
-----------------
* Drug: Pravastatin
* Drug: Rifafour
* Dietary Supplement: Vitamin B6
Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: 18 years of age or older Clinical signs and symptoms of pulmonary tuberculosis Abnormal chest radiograph consistent with pulmonary tuberculosis At least one sputum positive for M. tuberculosis by Xpert MTB/RIF with a cycle threshold (Ct) less than 28. Documentation of HIV status Weight greater than or equal to 45 kg Karnofsky score of at least 60 Ability to provide informed consent Ability to adhere to study follow-up visits Negative pregnancy test in women of child-bearing age Ability to adhere to contraceptive requirements and willing to use two forms of contraception: 1) a double barrier method to prevent pregnancy (i.e. use of a condom with either diaphragm or cervical cap) or 2) use of an intrauterine device in combination with a barrier contraceptive. The participant must be willing to continue these contraceptive measures throughout the duration of the study and until one week after the last dose of study medication or one week after discontinuation from study medication in case of premature discontinuation. Five days or fewer of anti-tuberculosis treatment within the previous 3 months Exclusion Criteria: A history of severe adverse reactions to any statin or any other study agent or contraindications to use of statins. Current use of statins or other lipid-lower agents; Clinical indication for statin therapy based on cardiovascular risk: Familial hypercholesterolemia Previous history of myocardial infarction or stroke For HIV-positive individuals, a CD4+ T-cell count less than 350/mm^3 Use of antiretroviral drugs Hemoglobin concentration less than 8 g/dL; Baseline creatinine kinase elevation more than three times the upper limit of normal Abnormal baseline laboratory values Baseline alanine aminotransferase (ALT) concentration more than 2.5 times the upper limit of normal (Grade 1) Serum creatinine concentration more than twice the upper limit of normal; Serum total bilirubin level greater than twice the upper limit of normal Platelet count less than 100,000/mm^3 Absolute neutrophil count (ANC) less than 1,000/mm^3 Pregnant or breastfeeding; Silico-tuberculosis. Currently receiving TB treatment Serologies or PCR positive for viral hepatitis (Hepatitis, B, C) Concomitant disorders or conditions for which isoniazid, rifampin, pyrazinamide, or ethambutol is contraindicated. These include cirrhosis, acute liver disease of any cause, acute uncontrolled gouty arthritis and peripheral neuropathy. Any medical or psychological condition which, in the view of the study investigator, makes study participation inadvisable. Infection with an isolate determined to be resistant to rifampin by GeneXpert. More than five days of anti-tuberculosis treatment within the previous 3 months Planned or current use of cyclosporine, tacrolimus, erythromycin or colchicine Central nervous system (CNS) TB Extra-pulmonary TB only, not in combination with pulmonary TB History of TB
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: Sequential Assignment
Masking: None (Open Label)
Arms and Interventions
| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Arm 1: Pravastatin (40 mg) and Rifafour<br>Participants will receive pravastatin (40 mg) and Rifafour daily for 14 days. Pravastatin will be given alone on Day 1, and pravastatin + Rifafour will be given on Days 2-15. Vitamin B6 will be added to each of the regimens. | Drug: Pravastatin<br>* Tablets, administered orally<br>Drug: Rifafour<br>* Fixed-dose combination (isoniazid, rifampin, pyrazinamide, and ethambutol) tablets, administered orally<br>Dietary Supplement: Vitamin B6<br>* Administered orally.<br>|
| Experimental: Arm 2: Pravastatin (80 mg) and Rifafour<br>Participants will receive pravastatin (80 mg) and Rifafour daily for 14 days. Pravastatin will be given alone on Day 1, and pravastatin + Rifafour will be given on Days 2-15. Vitamin B6 will be added to each of the regimens. | Drug: Pravastatin<br>* Tablets, administered orally<br>Drug: Rifafour<br>* Fixed-dose combination (isoniazid, rifampin, pyrazinamide, and ethambutol) tablets, administered orally<br>Dietary Supplement: Vitamin B6<br>* Administered orally.<br>|
| Experimental: Arm 3: Pravastatin (120 mg) and Rifafour<br>Participants will receive pravastatin (120 mg) and Rifafour daily for 14 days. Pravastatin will be given alone on Day 1, and pravastatin + Rifafour will be given on Days 2-15. Vitamin B6 will be added to each of the regimens. (Arm 3 will only be recruited if pravastatin 80 mg is well tolerated and safe, yet drug exposures are significantly reduced due to the known interaction with rifampin.) | Drug: Pravastatin<br>* Tablets, administered orally<br>Drug: Rifafour<br>* Fixed-dose combination (isoniazid, rifampin, pyrazinamide, and ethambutol) tablets, administered orally<br>Dietary Supplement: Vitamin B6<br>* Administered orally.<br>|
| Experimental: Arm 4: Pravastatin (160 mg) and Rifafour<br>Participants will receive pravastatin (160 mg) and Rifafour daily for 14 days. Pravastatin will be given alone on Day 1, and pravastatin + Rifafour will be given on Days 2-15. Vitamin B6 will be added to each of the regimens. (Arm 4 will only be recruited if pravastatin 120 mg is well tolerated and safe, yet drug exposures are significantly reduced due to the known interaction with rifampin.) | Drug: Pravastatin<br>* Tablets, administered orally<br>Drug: Rifafour<br>* Fixed-dose combination (isoniazid, rifampin, pyrazinamide, and ethambutol) tablets, administered orally<br>Dietary Supplement: Vitamin B6<br>* Administered orally.<br>|
What is the study measuring?
-----------------
Primary Outcome Measures
| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Frequency of Grade 3 or Higher Adverse Events | Graded using the DAIDS table for Grading the Severity of Adult and Pediatric Adverse Events, Corrected Version 2.1, July 2017 | Measured through Day 30 |
Secondary Outcome Measures
| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Number of Participants Who Permanently Discontinue Assigned Study Regimen for Any Reason | (Other than new recognition of participant ineligibility based on absence of M. tuberculosis growth in baseline sputum cultures, or growth of M. tuberculosis resistant to rifampin by GeneXpert) | Measured through Day 14 |
|
|
NCT00284531
|
Use of Daclizumab for the Prevention of Allograft Rejection in Pediatric Heart Transplant Patients
|
This protocol is designed to obtain information on the drug levels, metabolism, and safety of daclizumab (Zenapax(R)) in children and adolescents undergoing cardiac transplantation. In addition to the drug safety and metabolism information, the number and severity of rejection episodes in patients undergoing cardiac transplantation using the standard immunosuppressive drugs plus daclizumab will be compared with patients who have previously undergone cardiac transplantation at the Baylor College of Medicine and received the same standard immunosuppressive drugs without daclizumab.
|
Initial studies in renal and recent studies in adult cardiac transplant patients have shown Zenapax(R) to be both efficacious and safe when used in several different dosing schedules. Little data is available regarding pharmacokinetics, safety and appropriate dosing in pediatric heart transplant patients. Yet this ever-increasing group of patients presents a significant challenge for the prevention of primary rejection and the appropriate maintenance of immunosuppression. Induction of long term allograft acceptance through peripheral tolerance has been shown in animal models to be more easily induced in young animals. Once established however, allograft rejection and immunologic responses in the young are quite vigorous. This dichotomy makes young allograft recipients a particularly attractive population for the study of immune modulators targeted at preventing proliferative expansion of alloreactive T cell clones. This is precisely the mode of action of anti-IL2R monoclonal reagents such as Zenapax(R).~Although some pharmacokinetic data have been generated in adult heart transplant patients on multidrug immunosuppressive regimens including both Zenapax(R) and mycophenolate mofetil (MMF), detailed pharmacokinetic data on this combination in multidrug immunosuppressive regimens is not available for pediatric heart transplant subjects.~Objectives:~Determination of pharmacokinetics of Zenapax(R) in pediatric patients receiving a uniform multidrug immunosuppressive regimen for primary induction.~Determine whether there are any unusual drug interactions peculiar to the pediatric population that would require dosing modification.~Secondary objectives:~Investigate long term effects of Zenapax(R) containing induction regimen on pediatric patients.
|
Use of Zenapax (Daclizumab) for the Prevention of Primary Acute Cardiac Rejection in Children and Adolescents. Ind Number: 10100
|
Cardiac Transplantation
|
* Drug: Daclizumab
|
Inclusion Criteria:~Patients must be undergoing their first cardiac allograft transplant.~Male or female must be less than or equal to 18 years of age.~Women of childbearing potential must have a negative serum pregnancy test within 48 hours prior to transplantation. The sensitivity must be equal to at least 50 mIU/ml. (Urine test is allowed in addition to serum test in patients where serum results are delayed.)~Women of childbearing potential must use two reliable forms of contraception simultaneously.~Effective contraception must be used before beginning study drug therapy, and for 4 months following discontinuation of study drug therapy.~Patients and/or their guardians must be willing and be capable of understanding the purpose and risks of the study and must sign a statement of informed consent.~Exclusion Criteria:~Patients with a history of hypersensitivity reactions to any of the constituents of the Zenapax(R) preparation or having had hypersensitivity reactions to human or murine immune globulin preparations in the past.~Women lactating, pregnant or of childbearing potential not using, or who are unwilling to use two reliable forms of contraception simultaneously during the study~History of a psychological illness or condition which would interfere with the patient's ability to understand the requirements of the study~White blood count < 2500/mm^3, platelets < 50,000 /mm^3 or hemoglobin < 6 g/dL.~HIV-1 infection or the presence of positive hepatitis B surface antigen (HBsAg) or chronic hepatitis C.~Active peptic ulcer disease~Severe diarrhea or other gastrointestinal disorders which might interfere with the ability to absorb oral medication~Malignancies within the past 5 years, excluding skin carcinomas (basal or squamous cell) that have been adequately treated~Patients who have received within the past 30 days or require concomitant treatment with other investigational drugs or immunosuppressive medications that are prohibited for this study~Inability to start microemulsion form of cyclosporine within 72 hours
|
1 Month
|
18 Years
|
All
|
No
|
Primary Purpose: Treatment
Allocation: Non-Randomized
Intervention Model: Single Group Assignment
Masking: None (Open Label)
|
| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Drug levels at scheduled time points | | |
| Receptor saturation at scheduled time points | | |
| Number of rejection episodes in 1 year | | |
|
| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Changes in T cell subsets over observation period | | |
| Numbers of bacterial and opportunistic infections | | |
| Evidence for autoimmune disease over observation period | | |
|
cardiac transplantation, allograft rejection, anti-CD25
|
Daclizumab, Immunosuppressive Agents, Immunologic Factors, Physiological Effects of Drugs
|
| Intervention/Treatment |
| --- |
|Drug: Daclizumab|nan|
|
Use of Daclizumab for the Prevention of Allograft Rejection in Pediatric Heart Transplant Patients
Study Overview
=================
Brief Summary
-----------------
This protocol is designed to obtain information on the drug levels, metabolism, and safety of daclizumab (Zenapax(R)) in children and adolescents undergoing cardiac transplantation. In addition to the drug safety and metabolism information, the number and severity of rejection episodes in patients undergoing cardiac transplantation using the standard immunosuppressive drugs plus daclizumab will be compared with patients who have previously undergone cardiac transplantation at the Baylor College of Medicine and received the same standard immunosuppressive drugs without daclizumab.
Detailed Description
-----------------
Initial studies in renal and recent studies in adult cardiac transplant patients have shown Zenapax(R) to be both efficacious and safe when used in several different dosing schedules. Little data is available regarding pharmacokinetics, safety and appropriate dosing in pediatric heart transplant patients. Yet this ever-increasing group of patients presents a significant challenge for the prevention of primary rejection and the appropriate maintenance of immunosuppression. Induction of long term allograft acceptance through peripheral tolerance has been shown in animal models to be more easily induced in young animals. Once established however, allograft rejection and immunologic responses in the young are quite vigorous. This dichotomy makes young allograft recipients a particularly attractive population for the study of immune modulators targeted at preventing proliferative expansion of alloreactive T cell clones. This is precisely the mode of action of anti-IL2R monoclonal reagents such as Zenapax(R). Although some pharmacokinetic data have been generated in adult heart transplant patients on multidrug immunosuppressive regimens including both Zenapax(R) and mycophenolate mofetil (MMF), detailed pharmacokinetic data on this combination in multidrug immunosuppressive regimens is not available for pediatric heart transplant subjects. Objectives: Determination of pharmacokinetics of Zenapax(R) in pediatric patients receiving a uniform multidrug immunosuppressive regimen for primary induction. Determine whether there are any unusual drug interactions peculiar to the pediatric population that would require dosing modification. Secondary objectives: Investigate long term effects of Zenapax(R) containing induction regimen on pediatric patients.
Official Title
-----------------
Use of Zenapax (Daclizumab) for the Prevention of Primary Acute Cardiac Rejection in Children and Adolescents. Ind Number: 10100
Conditions
-----------------
Cardiac Transplantation
Intervention / Treatment
-----------------
* Drug: Daclizumab
Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Patients must be undergoing their first cardiac allograft transplant. Male or female must be less than or equal to 18 years of age. Women of childbearing potential must have a negative serum pregnancy test within 48 hours prior to transplantation. The sensitivity must be equal to at least 50 mIU/ml. (Urine test is allowed in addition to serum test in patients where serum results are delayed.) Women of childbearing potential must use two reliable forms of contraception simultaneously. Effective contraception must be used before beginning study drug therapy, and for 4 months following discontinuation of study drug therapy. Patients and/or their guardians must be willing and be capable of understanding the purpose and risks of the study and must sign a statement of informed consent. Exclusion Criteria: Patients with a history of hypersensitivity reactions to any of the constituents of the Zenapax(R) preparation or having had hypersensitivity reactions to human or murine immune globulin preparations in the past. Women lactating, pregnant or of childbearing potential not using, or who are unwilling to use two reliable forms of contraception simultaneously during the study History of a psychological illness or condition which would interfere with the patient's ability to understand the requirements of the study White blood count < 2500/mm^3, platelets < 50,000 /mm^3 or hemoglobin < 6 g/dL. HIV-1 infection or the presence of positive hepatitis B surface antigen (HBsAg) or chronic hepatitis C. Active peptic ulcer disease Severe diarrhea or other gastrointestinal disorders which might interfere with the ability to absorb oral medication Malignancies within the past 5 years, excluding skin carcinomas (basal or squamous cell) that have been adequately treated Patients who have received within the past 30 days or require concomitant treatment with other investigational drugs or immunosuppressive medications that are prohibited for this study Inability to start microemulsion form of cyclosporine within 72 hours
Ages Eligible for Study
-----------------
Minimum Age: 1 Month
Maximum 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 |
| --- |
|Drug: Daclizumab|nan|
What is the study measuring?
-----------------
Primary Outcome Measures
| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Drug levels at scheduled time points | | |
| Receptor saturation at scheduled time points | | |
| Number of rejection episodes in 1 year | | |
Secondary Outcome Measures
| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Changes in T cell subsets over observation period | | |
| Numbers of bacterial and opportunistic infections | | |
| Evidence for autoimmune disease over observation period | | |
Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
cardiac transplantation, allograft rejection, anti-CD25
|
NCT04365348
|
The Psychological Impact of COVID-19 Outbreak on COVID-19 Survivors and Their Families
|
Patients with COVID-19 diagnoses are treated under isolation in hospitals and with high-stress level. Currently, there is little information on the mental health implications of exposure amongst COVID-19 survivors and their family members. Research exploring the psychological impact amongst survivors of exposure to COVID-19 is desperately needed to understand the effects, mental health toll, and support required in survivors of COVID-19. This study aims to assess the psychological impact of the COVID-19 outbreak on COVID-19 survivors and their family members.
|
Since the 2019 coronavirus disease (COVID-19) was first reported, it has been rapidly transmitted and has aroused enormous global attention. Infected patients may develop severe and even fatal respiratory symptoms such as acute respiratory distress syndrome (ARDS) and acute respiratory failure, ending up in intensive care. Patients with COVID-19 diagnoses are treated under isolation in hospitals and with high-stress level. The stress and psychological impact on patients were also correlated significantly with several adverse psychological effects, such as fatigue, fear of social contact, poor sleep, loneliness, and depressed mood. The psychological impact of COVID-19 may also evolve and last for a prolonged period after discharge from the hospital. However, there is currently little information on the mental health implications of exposure amongst COVID-19 survivors and their family members. Research exploring the psychological impact amongst survivors of exposure to COVID-19 is desperately needed to understand the effects, mental health toll, and support required in survivors of COVID-19. This study aims to assess the psychological impact of the COVID-19 outbreak on COVID-19 survivors and their family members.
|
Exploring the Psychological Impact of the COVID-19 Outbreak on COVID-19 Survivors and Their Families
|
Mental Health Wellness 1
|
Inclusion Criteria:~COVID-19 survivors (i.e., diagnosed with COVID-19 and discharged from the hospital) and/or a family member of a COVID-19 survivor;~Aged 18 years or above;~No medical diagnosis of psychiatric illness~Exclusion Criteria:~• Refusal to give consent
|
18 Years
|
100 Years
|
All
|
No
|
| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Stress level | measured by the 10-item Perceived Stress Scale | 1 month |
|
| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Stress level | measured by the 10-item Perceived Stress Scale | 3 months |
| Negative emotion | measured by the 13-item Hospital Anxiety and Depression Scale | 3 months |
| Psychological response to trauma | measured by the 22-item Impact of Event Scale -Revised | 1 month and 3 months |
| Severity of insomnia symptoms and the associated daytime impairment | measured by the 7-item Insomnia Severity Index | 1 month and 3 months |
| Resilience | measured by the 2-item Connor-Davidson Resilience Scale | 1 month and 3 months |
| Quality of family functioning | measured by 3-item Family Functioning Subscale | 1 month and 3 months |
| Social support | measured by 6-item social support questionnaire | 1 month and 3 months |
| Psychological effects | measured by 10-item outcome-based questionnaire | 1 month and 3 months |
|
Stress, Anxiety, Depression, Families
|
COVID-19, Pneumonia, Pneumonia, Viral, Respiratory Tract Infections, Infections, Virus Diseases, Coronavirus Infections, Coronaviridae Infections, Nidovirales Infections, RNA Virus Infections, Lung Diseases, Respiratory Tract Diseases
|
The Psychological Impact of COVID-19 Outbreak on COVID-19 Survivors and Their Families
Study Overview
=================
Brief Summary
-----------------
Patients with COVID-19 diagnoses are treated under isolation in hospitals and with high-stress level. Currently, there is little information on the mental health implications of exposure amongst COVID-19 survivors and their family members. Research exploring the psychological impact amongst survivors of exposure to COVID-19 is desperately needed to understand the effects, mental health toll, and support required in survivors of COVID-19. This study aims to assess the psychological impact of the COVID-19 outbreak on COVID-19 survivors and their family members.
Detailed Description
-----------------
Since the 2019 coronavirus disease (COVID-19) was first reported, it has been rapidly transmitted and has aroused enormous global attention. Infected patients may develop severe and even fatal respiratory symptoms such as acute respiratory distress syndrome (ARDS) and acute respiratory failure, ending up in intensive care. Patients with COVID-19 diagnoses are treated under isolation in hospitals and with high-stress level. The stress and psychological impact on patients were also correlated significantly with several adverse psychological effects, such as fatigue, fear of social contact, poor sleep, loneliness, and depressed mood. The psychological impact of COVID-19 may also evolve and last for a prolonged period after discharge from the hospital. However, there is currently little information on the mental health implications of exposure amongst COVID-19 survivors and their family members. Research exploring the psychological impact amongst survivors of exposure to COVID-19 is desperately needed to understand the effects, mental health toll, and support required in survivors of COVID-19. This study aims to assess the psychological impact of the COVID-19 outbreak on COVID-19 survivors and their family members.
Official Title
-----------------
Exploring the Psychological Impact of the COVID-19 Outbreak on COVID-19 Survivors and Their Families
Conditions
-----------------
Mental Health Wellness 1
Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: COVID-19 survivors (i.e., diagnosed with COVID-19 and discharged from the hospital) and/or a family member of a COVID-19 survivor; Aged 18 years or above; No medical diagnosis of psychiatric illness Exclusion Criteria: • Refusal to give consent
Ages Eligible for Study
-----------------
Minimum Age: 18 Years
Maximum Age: 100 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 |
| --- | --- | --- |
| Stress level | measured by the 10-item Perceived Stress Scale | 1 month |
Secondary Outcome Measures
| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Stress level | measured by the 10-item Perceived Stress Scale | 3 months |
| Negative emotion | measured by the 13-item Hospital Anxiety and Depression Scale | 3 months |
| Psychological response to trauma | measured by the 22-item Impact of Event Scale -Revised | 1 month and 3 months |
| Severity of insomnia symptoms and the associated daytime impairment | measured by the 7-item Insomnia Severity Index | 1 month and 3 months |
| Resilience | measured by the 2-item Connor-Davidson Resilience Scale | 1 month and 3 months |
| Quality of family functioning | measured by 3-item Family Functioning Subscale | 1 month and 3 months |
| Social support | measured by 6-item social support questionnaire | 1 month and 3 months |
| Psychological effects | measured by 10-item outcome-based questionnaire | 1 month and 3 months |
Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Stress, Anxiety, Depression, Families
|
|||
NCT02097420
|
HALO: A Single Arm Prospective Investigation of the SJM™ Masters HP™ 15mm Rotatable Mechanical Heart Valve
|
The purpose of the study is to provide evidence of safety and effectiveness of the study valve. The rationale is to offer a replacement mitral valve for patients with anatomy that is too small for the currently commercially available valves ranging in size from 16mm to 37mm.~20 subjects were enrolled as part of the IDE cohort and an additional 3 were enrolled under continued access.
|
The study is a single arm, prospective, non-randomized, multi-center clinical investigation.~The objective of this study is to evaluate the safety and effectiveness of the 15mm MHV in subjects five years or less of age with a diseased, damaged, or malfunctioning mitral heart valve. The objective will be evaluated by assessing valve-related adverse events, subject survival, subject growth, and echocardiogram assessment of hemodynamic function through the five year follow-up visit as long as the valve remains implanted.
|
HALO Clinical Study: A Single Arm, Prospective, Non-randomized, Multi Center Investigation of the SJM™ Masters HP™ 15mm Rotatable Mechanical Heart Valve
|
Mitral Valve Disease, Damaged Mitral Valve, Malfunctioning Mitral Heart Valve, Mitral Valve Replacement
|
* Device: Mitral valve replacement SJM™ Masters HP™ 15mm Rotatable Mechanical Heart Valve
|
IDE Cohort -~Inclusion Criteria:~Subject requires mitral valve replacement.*~Subject's legally authorized representative gives written consent to participate in the clinical study.~Subject is willing and able to return for data collection and follow-up for the duration of the clinical study.~Subjects undergoing concomitant procedures (e.g. valve repair) are eligible for this study other than those noted in the exclusion criteria.~Exclusion Criteria:~1. Subject is > 5 years of age.~Subject has a contraindication to anticoagulant/antiplatelet medication.~Subject has a prosthetic valve(s) at a site other than the mitral valve prior to the study procedure.*~Subject requires concomitant replacement of the tricuspid, pulmonary, or aortic valve.~Subject has active endocarditis.~Subject has active myocarditis.~Subject has had an acute preoperative neurological deficit that has not returned to baseline or stabilized ≥ 30 days prior to the study procedure.~Subject has had an acute cardiac adverse event that has not returned to baseline or stabilized ≥48 hours prior to the study procedure.~Subject has a non-cardiac illness resulting in a life expectancy of < 1 year.~Subject has a known requirement for additional cardiac surgery within 12 months after the study procedure.~Subject has been previously enrolled and implanted in this study.~Subject is participating in another study for an investigational drug and/or device.~Subject has any other medical condition that in the opinion of the Investigator will interfere with the study results.~Subjects who have undergone a previous Ross procedure of the pulmonary valve are eligible for this study.~Continued Access Cohort-~Prospective Inclusion Criteria:~Subject requires mitral valve replacement.*~Subject's legally authorized representative gives written consent to participate in the clinical study.~Subject is willing and able to return for data collection and follow-up for the duration of the clinical study.~Subjects undergoing concomitant procedures (e.g. valve repair) are eligible for this study.~Prospective Exclusion Criteria:~Subject is > 5 years of age.~Subject has a contraindication to anticoagulant/antiplatelet medication.~Retrospective Eligibility Criteria:~The subject must have been ≤ 5 years of age at the time of mitral valve replacement with the 15mm MHV.~An implant was attempted with the 15mm MHV, where implant attempt is defined as the device physically contacting the subject's cardiac anatomy.~The legally authorized representative signs the study informed consent for this protocol allowing access to all relevant historical medical information and prospective follow-up (if applicable).~Either~the legally authorized representative and site agree to follow the subject per the assessment schedule and complete all required assessments per this protocol from the time of consent going forward.~OR~the subject's status is deceased or explanted, but an implant with 15mm MHV was attempted.
| null |
5 Years
|
All
|
No
|
Primary Purpose: Treatment
Intervention Model: Single Group Assignment
Masking: None (Open Label)
|
| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Primary Effectiveness Endpoint: Kaplan-Meier Percentage of Participants Who Remained Alive or Had Valve Explanted Due to Anatomical Growth | The Kaplan-Meier method is a statistical method that summarizes the rate at which subjects survive or are free from a specified event. The method uses whether or not a subject had the specified event and their time to the specified event or the end of their follow-up to calculate the rate.~Kaplan-Meier event rates with 95% confidence intervals would be calculated for overall survival. All follow-up time through 365 days post implant would be considered. If a subject discontinues prior to one year post implant, all available data would be included. | 12 months |
| Primary Effectiveness Endpoint: Peak Gradient as Assessed by Echocardiography | Peak gradient as assessed by echocardiography at 12 months post implant or when the valve is removed/replaced due to anatomical growth of the subject, whichever occurs first. | 12 months |
| Primary Effectiveness Endpoint: Mean Gradient as Assessed by Echocardiography | Mean gradient as assessed by echocardiography at 12 months post implant or when the valve is removed/replaced due to anatomical growth of the subject, whichever occurs first. | 12 months |
| Primary Effectiveness Endpoint: Number of Participants With Valvular Regurgitation | Valvular regurgitation as assessed by echocardiography at 12 months post implant or when the valve is removed/replaced due to anatomical growth of the subject, whichever occurs first. | 12 months |
| Primary Safety Endpoint: Rate of Total Valve-related Adverse Events | Kaplan-Meier event rates with 95% confidence intervals would be calculated for valve-related adverse events. All follow-up time through 365 days post implant would be considered. If a subject discontinues prior to one year post implant, all available data would be included. | 12 months |
|
| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Percentage Change in Height Percentiles From Baseline to 12 Months | Percentiles would be summarized by visit interval from baseline to 12 months for all available data. Summary statistics including number of subjects, mean and standard deviation are provided at the 12-month visit. | 12 months |
| Percentage Change in Weight Percentiles From Baseline to 12 Months | Percentiles would be summarized by visit interval from baseline to 12 months for all available data.Summary statistics including number of subjects, mean, standard deviation, and difference between visits were used for this endpoint. | 12 months |
|
Mitral valve
|
| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Other: Single device arm<br>Mitral valve replacement | Device: Mitral valve replacement SJM™ Masters HP™ 15mm Rotatable Mechanical Heart Valve<br>* Implantation of the SJM™ Masters HP™ 15mm Rotatable Mechanical Heart Valve in the mitral and aortic positions<br>|
|
HALO: A Single Arm Prospective Investigation of the SJM™ Masters HP™ 15mm Rotatable Mechanical Heart Valve
Study Overview
=================
Brief Summary
-----------------
The purpose of the study is to provide evidence of safety and effectiveness of the study valve. The rationale is to offer a replacement mitral valve for patients with anatomy that is too small for the currently commercially available valves ranging in size from 16mm to 37mm. 20 subjects were enrolled as part of the IDE cohort and an additional 3 were enrolled under continued access.
Detailed Description
-----------------
The study is a single arm, prospective, non-randomized, multi-center clinical investigation. The objective of this study is to evaluate the safety and effectiveness of the 15mm MHV in subjects five years or less of age with a diseased, damaged, or malfunctioning mitral heart valve. The objective will be evaluated by assessing valve-related adverse events, subject survival, subject growth, and echocardiogram assessment of hemodynamic function through the five year follow-up visit as long as the valve remains implanted.
Official Title
-----------------
HALO Clinical Study: A Single Arm, Prospective, Non-randomized, Multi Center Investigation of the SJM™ Masters HP™ 15mm Rotatable Mechanical Heart Valve
Conditions
-----------------
Mitral Valve Disease, Damaged Mitral Valve, Malfunctioning Mitral Heart Valve, Mitral Valve Replacement
Intervention / Treatment
-----------------
* Device: Mitral valve replacement SJM™ Masters HP™ 15mm Rotatable Mechanical Heart Valve
Participation Criteria
=================
Eligibility Criteria
-----------------
IDE Cohort - Inclusion Criteria: Subject requires mitral valve replacement.* Subject's legally authorized representative gives written consent to participate in the clinical study. Subject is willing and able to return for data collection and follow-up for the duration of the clinical study. Subjects undergoing concomitant procedures (e.g. valve repair) are eligible for this study other than those noted in the exclusion criteria. Exclusion Criteria: 1. Subject is > 5 years of age. Subject has a contraindication to anticoagulant/antiplatelet medication. Subject has a prosthetic valve(s) at a site other than the mitral valve prior to the study procedure.* Subject requires concomitant replacement of the tricuspid, pulmonary, or aortic valve. Subject has active endocarditis. Subject has active myocarditis. Subject has had an acute preoperative neurological deficit that has not returned to baseline or stabilized ≥ 30 days prior to the study procedure. Subject has had an acute cardiac adverse event that has not returned to baseline or stabilized ≥48 hours prior to the study procedure. Subject has a non-cardiac illness resulting in a life expectancy of < 1 year. Subject has a known requirement for additional cardiac surgery within 12 months after the study procedure. Subject has been previously enrolled and implanted in this study. Subject is participating in another study for an investigational drug and/or device. Subject has any other medical condition that in the opinion of the Investigator will interfere with the study results. Subjects who have undergone a previous Ross procedure of the pulmonary valve are eligible for this study. Continued Access Cohort- Prospective Inclusion Criteria: Subject requires mitral valve replacement.* Subject's legally authorized representative gives written consent to participate in the clinical study. Subject is willing and able to return for data collection and follow-up for the duration of the clinical study. Subjects undergoing concomitant procedures (e.g. valve repair) are eligible for this study. Prospective Exclusion Criteria: Subject is > 5 years of age. Subject has a contraindication to anticoagulant/antiplatelet medication. Retrospective Eligibility Criteria: The subject must have been ≤ 5 years of age at the time of mitral valve replacement with the 15mm MHV. An implant was attempted with the 15mm MHV, where implant attempt is defined as the device physically contacting the subject's cardiac anatomy. The legally authorized representative signs the study informed consent for this protocol allowing access to all relevant historical medical information and prospective follow-up (if applicable). Either the legally authorized representative and site agree to follow the subject per the assessment schedule and complete all required assessments per this protocol from the time of consent going forward. OR the subject's status is deceased or explanted, but an implant with 15mm MHV was attempted.
Ages Eligible for Study
-----------------
Maximum Age: 5 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 |
| --- | --- |
| Other: Single device arm<br>Mitral valve replacement | Device: Mitral valve replacement SJM™ Masters HP™ 15mm Rotatable Mechanical Heart Valve<br>* Implantation of the SJM™ Masters HP™ 15mm Rotatable Mechanical Heart Valve in the mitral and aortic positions<br>|
What is the study measuring?
-----------------
Primary Outcome Measures
| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Primary Effectiveness Endpoint: Kaplan-Meier Percentage of Participants Who Remained Alive or Had Valve Explanted Due to Anatomical Growth | The Kaplan-Meier method is a statistical method that summarizes the rate at which subjects survive or are free from a specified event. The method uses whether or not a subject had the specified event and their time to the specified event or the end of their follow-up to calculate the rate. Kaplan-Meier event rates with 95% confidence intervals would be calculated for overall survival. All follow-up time through 365 days post implant would be considered. If a subject discontinues prior to one year post implant, all available data would be included. | 12 months |
| Primary Effectiveness Endpoint: Peak Gradient as Assessed by Echocardiography | Peak gradient as assessed by echocardiography at 12 months post implant or when the valve is removed/replaced due to anatomical growth of the subject, whichever occurs first. | 12 months |
| Primary Effectiveness Endpoint: Mean Gradient as Assessed by Echocardiography | Mean gradient as assessed by echocardiography at 12 months post implant or when the valve is removed/replaced due to anatomical growth of the subject, whichever occurs first. | 12 months |
| Primary Effectiveness Endpoint: Number of Participants With Valvular Regurgitation | Valvular regurgitation as assessed by echocardiography at 12 months post implant or when the valve is removed/replaced due to anatomical growth of the subject, whichever occurs first. | 12 months |
| Primary Safety Endpoint: Rate of Total Valve-related Adverse Events | Kaplan-Meier event rates with 95% confidence intervals would be calculated for valve-related adverse events. All follow-up time through 365 days post implant would be considered. If a subject discontinues prior to one year post implant, all available data would be included. | 12 months |
Secondary Outcome Measures
| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Percentage Change in Height Percentiles From Baseline to 12 Months | Percentiles would be summarized by visit interval from baseline to 12 months for all available data. Summary statistics including number of subjects, mean and standard deviation are provided at the 12-month visit. | 12 months |
| Percentage Change in Weight Percentiles From Baseline to 12 Months | Percentiles would be summarized by visit interval from baseline to 12 months for all available data.Summary statistics including number of subjects, mean, standard deviation, and difference between visits were used for this endpoint. | 12 months |
Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Mitral valve
|
|
NCT04509388
|
Effects of Drink Composition on the Appearance of Ingested Water in Body Fluids
|
To determine the effects of amino acids on the rate of water absorption and availability as a precursor fluid for sweat. Young and healthy (male or female) volunteers will take part in three experimental trials. In each trial, volunteers will be given one of two commercially available sports drinks or a commercially available sport drink with added amino acids in a double-blinded, randomised, crossover design. Each drink will be a single 550 mL bolus. All beverages will be labelled with deuterium (D2O). Trials will be compared for temporal accumulation of deuterium in plasma over the course of 60 minutes and in urine (60 min). Whole blood measurements of haemoglobin and haematocrit will also be made and plasma volume changes calculated. It is hypothesised that the amino acid trial will increase the rate of fluid absorption.
|
Effects of Drink Composition on the Appearance of Ingested Water in Body Fluids
|
Rate of Water Appearance/Delivery in the Blood, Water Balance
|
* Other: Composition of Sports Drink
|
Inclusion Criteria:~Generally fit and healthy (determined by health screen questionnaire)~Recreationally active (minimum 3 hours of physical activity per week including walking)~Exclusion Criteria:~Any cardiovascular, gastrointestinal, renal or acute/chronic health conditions that may influence the outcomes~Smoking (including vaping)~BMI of greater than 30 (combined with a body fat percentage greater than 20%) or BMI lower than 17.5
|
18 Years
|
50 Years
|
All
|
Accepts Healthy Volunteers
|
Primary Purpose: Basic Science
Allocation: Randomized
Intervention Model: Crossover Assignment
Interventional Model Description: Double-blind, randomised, crossover design
Masking: Double
|
| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Time at which drink absorption rate was maximum (t1) | Determined from D2O values in venous blood samples collected before and after drink ingestion | 60 minutes |
| Time at which drink absorption rate returned to 0 (t2) | Determined from D2O values in venous blood samples collected before and after drink ingestion | 60 minutes |
| Time at which 50% of drink was absorbed (t1/2) | Determined from D2O values in venous blood samples collected before and after drink ingestion | 60 minutes |
| Maximum absorption rate of drink | Determined from D2O values in venous blood samples collected before and after drink ingestion | 60 minutes |
| Area under the curve for D2O | Determined from D2O values in venous blood samples collected before and after drink ingestion | 60 minutes |
|
| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Plasma volume | Determined from haemoglobin and haematocrit measures in venous blood samples collected before and after drink ingestion | 60 minutes |
| Plasma osmolality | Determined from venous blood samples collected before and after drink ingestion | 60 minutes |
| Plasma sodium concentration | Determined from venous blood samples collected before and after drink ingestion | 60 minutes |
| Plasma potassium concentration | Determined from venous blood samples collected before and after drink ingestion | 60 minutes |
| Plasma glucose concentration | Determined from venous blood samples collected before and after drink ingestion | 60 minutes |
| Plasma lactate concentration | Determined from venous blood samples collected before and after drink ingestion | 60 minutes |
| Plasma creatinine concentration | Determined from venous blood samples collected before and after drink ingestion | 60 minutes |
| Plasma amino acid concentration | Determined from venous blood samples collected before and after drink ingestion | 60 minutes |
| Urinary D2O concentration | Determined from urine samples collected before and after drink ingestion | 60 minutes |
| Urinary specific gravity | Determined from urine samples collected before and after drink ingestion | 60 minutes |
|
| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Placebo Comparator: Commercially Available Sports Drink A<br>A commercially available sports water, with small amounts of flavouring, sweetener and electrolytes | Other: Composition of Sports Drink<br>* The composition of sport drinks will be manipulated to determine the effect of drink composition on the appearance of ingested water in body fluid.<br>|
| Experimental: Commercially Available Sports Drink B<br>A commercially available sports water, with small amounts of flavouring, sweetener and electrolytes. | Other: Composition of Sports Drink<br>* The composition of sport drinks will be manipulated to determine the effect of drink composition on the appearance of ingested water in body fluid.<br>|
| Experimental: Commercially Available Sports Drink A with added Amino Acids<br>The same as sports drink A above (a commercially available sports water, with small amounts of flavouring, sweetener and electrolytes), but with the addition of a small amount of amino acids (~0.7 g/100 ml). | Other: Composition of Sports Drink<br>* The composition of sport drinks will be manipulated to determine the effect of drink composition on the appearance of ingested water in body fluid.<br>|
|
Effects of Drink Composition on the Appearance of Ingested Water in Body Fluids
Study Overview
=================
Brief Summary
-----------------
To determine the effects of amino acids on the rate of water absorption and availability as a precursor fluid for sweat. Young and healthy (male or female) volunteers will take part in three experimental trials. In each trial, volunteers will be given one of two commercially available sports drinks or a commercially available sport drink with added amino acids in a double-blinded, randomised, crossover design. Each drink will be a single 550 mL bolus. All beverages will be labelled with deuterium (D2O). Trials will be compared for temporal accumulation of deuterium in plasma over the course of 60 minutes and in urine (60 min). Whole blood measurements of haemoglobin and haematocrit will also be made and plasma volume changes calculated. It is hypothesised that the amino acid trial will increase the rate of fluid absorption.
Official Title
-----------------
Effects of Drink Composition on the Appearance of Ingested Water in Body Fluids
Conditions
-----------------
Rate of Water Appearance/Delivery in the Blood, Water Balance
Intervention / Treatment
-----------------
* Other: Composition of Sports Drink
Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Generally fit and healthy (determined by health screen questionnaire) Recreationally active (minimum 3 hours of physical activity per week including walking) Exclusion Criteria: Any cardiovascular, gastrointestinal, renal or acute/chronic health conditions that may influence the outcomes Smoking (including vaping) BMI of greater than 30 (combined with a body fat percentage greater than 20%) or BMI lower than 17.5
Ages Eligible for Study
-----------------
Minimum Age: 18 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: Basic Science
Allocation: Randomized
Intervention Model: Crossover Assignment
Interventional Model Description: Double-blind, randomised, crossover design
Masking: Double
Arms and Interventions
| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Placebo Comparator: Commercially Available Sports Drink A<br>A commercially available sports water, with small amounts of flavouring, sweetener and electrolytes | Other: Composition of Sports Drink<br>* The composition of sport drinks will be manipulated to determine the effect of drink composition on the appearance of ingested water in body fluid.<br>|
| Experimental: Commercially Available Sports Drink B<br>A commercially available sports water, with small amounts of flavouring, sweetener and electrolytes. | Other: Composition of Sports Drink<br>* The composition of sport drinks will be manipulated to determine the effect of drink composition on the appearance of ingested water in body fluid.<br>|
| Experimental: Commercially Available Sports Drink A with added Amino Acids<br>The same as sports drink A above (a commercially available sports water, with small amounts of flavouring, sweetener and electrolytes), but with the addition of a small amount of amino acids ( 0.7 g/100 ml). | Other: Composition of Sports Drink<br>* The composition of sport drinks will be manipulated to determine the effect of drink composition on the appearance of ingested water in body fluid.<br>|
What is the study measuring?
-----------------
Primary Outcome Measures
| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Time at which drink absorption rate was maximum (t1) | Determined from D2O values in venous blood samples collected before and after drink ingestion | 60 minutes |
| Time at which drink absorption rate returned to 0 (t2) | Determined from D2O values in venous blood samples collected before and after drink ingestion | 60 minutes |
| Time at which 50% of drink was absorbed (t1/2) | Determined from D2O values in venous blood samples collected before and after drink ingestion | 60 minutes |
| Maximum absorption rate of drink | Determined from D2O values in venous blood samples collected before and after drink ingestion | 60 minutes |
| Area under the curve for D2O | Determined from D2O values in venous blood samples collected before and after drink ingestion | 60 minutes |
Secondary Outcome Measures
| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Plasma volume | Determined from haemoglobin and haematocrit measures in venous blood samples collected before and after drink ingestion | 60 minutes |
| Plasma osmolality | Determined from venous blood samples collected before and after drink ingestion | 60 minutes |
| Plasma sodium concentration | Determined from venous blood samples collected before and after drink ingestion | 60 minutes |
| Plasma potassium concentration | Determined from venous blood samples collected before and after drink ingestion | 60 minutes |
| Plasma glucose concentration | Determined from venous blood samples collected before and after drink ingestion | 60 minutes |
| Plasma lactate concentration | Determined from venous blood samples collected before and after drink ingestion | 60 minutes |
| Plasma creatinine concentration | Determined from venous blood samples collected before and after drink ingestion | 60 minutes |
| Plasma amino acid concentration | Determined from venous blood samples collected before and after drink ingestion | 60 minutes |
| Urinary D2O concentration | Determined from urine samples collected before and after drink ingestion | 60 minutes |
| Urinary specific gravity | Determined from urine samples collected before and after drink ingestion | 60 minutes |
|
|||
NCT00200460
|
A Study Evaluating the Effects of Nebivolol on Blood Pressure in Hypertensive Patients
|
The purpose of this study is to evaluate the effects of various doses of nebivolol in patients with mild to moderate hypertension.
|
This was a multi-center, randomized, double-blind, parallel group, placebo-controlled study of nebivolol over a range of doses in patients with mild to moderate hypertension. The study consisted of 2 phases: screening/washout/single-blind placebo run-in followed by randomization/double-blind treatment. During the double-blind phase, patients received nebivolol or placebo. Patients had 7 scheduled clinical visits during the study.
|
A Double-Blind, Multi-Center, Randomized, Placebo-Controlled, Parallel Group Dosing Study Evaluating the Effects of Nebivolol on Blood Pressure in Patients With Mild to Moderate Hypertension
|
Hypertension
|
* Drug: Nebivolol
|
Inclusion Criteria:~An average sitting diastolic blood pressure of greater then or equal to 95 mmHg and less then or equal to 109 mmHg at baseline~Exclusion Criteria:~Recent myocardial infarction or stroke~Secondary hypertension~Contraindications to beta-blocker treatment or discontinuation of current antihypertensive therapy~Pregnancy, nursing, or women of child-bearing potential not using appropriate contraception
|
18 Years
| null |
All
|
No
|
Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double
|
| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| The change of the average sitting diastolic blood pressure taken at trough drug plasma level at the end of treatment compared to baseline | | |
|
| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| - Sitting SBP | | |
| - Supine SBP and DBP | | |
| - Standing SBP and DBP | | |
| - Response rate | | |
| - Correlation between plasma levels | | |
|
Nebivolol, Hypertension, Beta-Blocker
|
Nebivolol, Antihypertensive Agents, Vasodilator Agents, Adrenergic beta-1 Receptor Agonists, Adrenergic beta-Agonists, Adrenergic Agonists, Adrenergic Agents, Neurotransmitter Agents, Molecular Mechanisms of Pharmacological Action, Physiological Effects of Drugs
|
| Intervention/Treatment |
| --- |
|Drug: Nebivolol|nan|
|
A Study Evaluating the Effects of Nebivolol on Blood Pressure in Hypertensive Patients
Study Overview
=================
Brief Summary
-----------------
The purpose of this study is to evaluate the effects of various doses of nebivolol in patients with mild to moderate hypertension.
Detailed Description
-----------------
This was a multi-center, randomized, double-blind, parallel group, placebo-controlled study of nebivolol over a range of doses in patients with mild to moderate hypertension. The study consisted of 2 phases: screening/washout/single-blind placebo run-in followed by randomization/double-blind treatment. During the double-blind phase, patients received nebivolol or placebo. Patients had 7 scheduled clinical visits during the study.
Official Title
-----------------
A Double-Blind, Multi-Center, Randomized, Placebo-Controlled, Parallel Group Dosing Study Evaluating the Effects of Nebivolol on Blood Pressure in Patients With Mild to Moderate Hypertension
Conditions
-----------------
Hypertension
Intervention / Treatment
-----------------
* Drug: Nebivolol
Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: An average sitting diastolic blood pressure of greater then or equal to 95 mmHg and less then or equal to 109 mmHg at baseline Exclusion Criteria: Recent myocardial infarction or stroke Secondary hypertension Contraindications to beta-blocker treatment or discontinuation of current antihypertensive therapy Pregnancy, nursing, or women of child-bearing potential not using appropriate contraception
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: Nebivolol|nan|
What is the study measuring?
-----------------
Primary Outcome Measures
| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| The change of the average sitting diastolic blood pressure taken at trough drug plasma level at the end of treatment compared to baseline | | |
Secondary Outcome Measures
| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| - Sitting SBP | | |
| - Supine SBP and DBP | | |
| - Standing SBP and DBP | | |
| - Response rate | | |
| - Correlation between plasma levels | | |
Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Nebivolol, Hypertension, Beta-Blocker
|
NCT01925183
|
Individualized Triple-therapy Using Boceprevir in HIV-positive Patients With Hepatitis C
|
Response-guided triple-therapy with boceprevir (BOC) in combination with pegylated interferon (PEGIFN) and ribavirin (RBV) is the current standard of care for HIV-negative patients infected with hepatitis C genotype (HCV-GT) 1. In contrast, in HIV-positive patients, a fixed treatment duration of 48 weeks is used.~The aim of this study is to assess efficacy and safety of response-guided triple-therapy with BOC in combination with PEGIFN and RBV in HIV-positive patients. Thus, treatment duration will be individualized based on HCV-RNA negativity at treatment week 8 (W8). All patients will receive 4 weeks of PEGIFN/RBV lead-in. Patients with undetectable HCV-RNA at W8 will be treated with 24 weeks of BOC/PEGIFN/RBV triple-therapy resulting in a total treatment duration of 28 weeks, while patients with detectable HCV-RNA at W8 will receive 44 weeks of BOC/PEGIFN/RBV triple-therapy and a total treatment duration of 48 weeks.
|
Response-guided Triple-therapy Using Boceprevir in Combination With PEGIFN/RBV in HIV/HCV-coinfected Patients
|
Hepatitis C, Chronic, HIV
|
* Drug: Pegylated interferon alpha-2a
* Drug: Ribavirin
* Drug: Boceprevir
|
Inclusion Criteria:~Confirmed HIV infection (anti-HIV1/2 antibody positive).~Chronic HCV infection (anti-HCV positive, HCV-RNA detectable for >6 months).~HCV-GT 1 infection.~Age ≥18 years and ≤65 years.~No prior treatment with BOC/PEGIFN/RBV.~CD4+ cell count >200 cells/µL.~Stable antiretroviral therapy (ART) including tenofovir/emtricitabine (Truvada®, Gilead) and raltegravir (Isentress®, MSD) with HIV-RNA <50 copies/mL.~Valid result on transient elastography or liver biopsy within 6 months prior to enrollment.~Female patients of childbearing potential must agree to use an effective contraceptive during treatment and for 4 months after treatment has been concluded.~Male patients or their female partners must agree to use an effective contraceptive during treatment and for 7 months after treatment has been concluded.~Exclusion Criteria:~HCV-GT other than HCV-GT 1.~Cirrhotic patients (as defined by METAVIR F4 in liver biopsy or liver stiffness >12.3 kPa) with decompensated liver disease (Child-Pugh stage B/C).~Chronic liver diseases other than hepatitis C virus infection (hepatitis B virus infection: HBsAg positivity, nonalcoholic steatohepatitis, autoimmune hepatitis, primary biliary cirrhosis, hemochromatosis, Wilson's disease, alpha-1 antitrypsin deficiency, cystic fibrosis).~Significant cardiac disease (ejection fraction <40% at echocardiography).~Significant pulmonary disease (COPD stage GOLD III/IV).~Significant renal disease (serum creatinine >1.5 mg/dL).~Subjects taking medication(s) that is/are highly dependent on CYP3A4/5 for clearance, and for which elevated plasma concentrations are associated with serious and/or life-threatening events such as but not limited to, orally administered midazolam, pimozide, amiodarone, flecainide, propafenone, quinidine, and ergot derivatives (dihydroergotamine, ergonovine, ergotamine, methylergonovine).~Contraindications for boceprevir (Victrelis®, MSD), pegylated interferon alpha-2a (Pegasys®, Roche) or ribavirin (Copegus®, Roche), as listed in section 4.3 of the respective summary of product characteristics (SmPCs).~Ongoing alcohol abuse (average daily alcohol consumption >50g).~Ongoing illicit drug abuse.~Unwillingness to give written informed consent.~Pregnancy and breastfeeding.~Women wishing to become pregnant.
|
18 Years
|
64 Years
|
All
|
No
|
Primary Purpose: Treatment
Allocation: Non-Randomized
Intervention Model: Single Group Assignment
Masking: None (Open Label)
|
| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Proportion of Subjects With Sustained Virologic Response (SVR12) | Defined as HCV-RNA negativity by a sensitive assay | Follow-up week 12 (FU12) |
| Proportions of Subjects With Adverse Events (AEs) and Serious Adverse Events (SAEs) | | Baseline (BL) to Follow-up week 12 (FU12) |
|
Boceprevir, HIV/HCV-coinfection, HIV/HCV coinfection, HIV/HCV, Response-guided therapy
|
Antimetabolites, Antiviral Agents, Interferons, Ribavirin, Interferon-alpha, Interferon alpha-2, Peginterferon alfa-2a, Antineoplastic Agents, Anti-Infective Agents, Molecular Mechanisms of Pharmacological Action, Immunologic Factors, Physiological Effects of Drugs
|
| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: 28 weeks of treatment duration<br>All patients will receive 4 weeks of PEGIFN/RBV lead-in. Patients with undetectable HCV-RNA at treatment week 8 will be treated with 24 weeks of BOC/PEGIFN/RBV triple-therapy resulting in a total treatment duration of 28 weeks. | Drug: Pegylated interferon alpha-2a<br>* 180mcg once weekly; subcutaneous injection<br>* Other names: Pegasys®, Roche;Drug: Ribavirin<br>* 600mg two times daily (BID) (e.g. 3x200mg at 6am, 3x200mg at 6pm) in patients ≥75kg body weight; 2x200mg at 6am and 3x200mg at 6pm in patients <75kg; orally<br>* Other names: Copegus®, Roche;Drug: Boceprevir<br>* 800mg three times daily (TID) (e.g. 4x200mg at 6am, 4x200mg at 2pm, 4x200mg at 10pm); orally<br>* Other names: Victrelis®, MSD;|
| Experimental: 48 weeks of treatment duration<br>All patients will receive 4 weeks of PEGIFN/RBV lead-in. Patients with detectable HCV-RNA at treatment week 8 will receive 44 weeks of BOC/PEGIFN/RBV triple-therapy and a total treatment duration of 48 weeks | Drug: Pegylated interferon alpha-2a<br>* 180mcg once weekly; subcutaneous injection<br>* Other names: Pegasys®, Roche;Drug: Ribavirin<br>* 600mg two times daily (BID) (e.g. 3x200mg at 6am, 3x200mg at 6pm) in patients ≥75kg body weight; 2x200mg at 6am and 3x200mg at 6pm in patients <75kg; orally<br>* Other names: Copegus®, Roche;Drug: Boceprevir<br>* 800mg three times daily (TID) (e.g. 4x200mg at 6am, 4x200mg at 2pm, 4x200mg at 10pm); orally<br>* Other names: Victrelis®, MSD;|
|
Individualized Triple-therapy Using Boceprevir in HIV-positive Patients With Hepatitis C
Study Overview
=================
Brief Summary
-----------------
Response-guided triple-therapy with boceprevir (BOC) in combination with pegylated interferon (PEGIFN) and ribavirin (RBV) is the current standard of care for HIV-negative patients infected with hepatitis C genotype (HCV-GT) 1. In contrast, in HIV-positive patients, a fixed treatment duration of 48 weeks is used. The aim of this study is to assess efficacy and safety of response-guided triple-therapy with BOC in combination with PEGIFN and RBV in HIV-positive patients. Thus, treatment duration will be individualized based on HCV-RNA negativity at treatment week 8 (W8). All patients will receive 4 weeks of PEGIFN/RBV lead-in. Patients with undetectable HCV-RNA at W8 will be treated with 24 weeks of BOC/PEGIFN/RBV triple-therapy resulting in a total treatment duration of 28 weeks, while patients with detectable HCV-RNA at W8 will receive 44 weeks of BOC/PEGIFN/RBV triple-therapy and a total treatment duration of 48 weeks.
Official Title
-----------------
Response-guided Triple-therapy Using Boceprevir in Combination With PEGIFN/RBV in HIV/HCV-coinfected Patients
Conditions
-----------------
Hepatitis C, Chronic, HIV
Intervention / Treatment
-----------------
* Drug: Pegylated interferon alpha-2a
* Drug: Ribavirin
* Drug: Boceprevir
Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Confirmed HIV infection (anti-HIV1/2 antibody positive). Chronic HCV infection (anti-HCV positive, HCV-RNA detectable for >6 months). HCV-GT 1 infection. Age ≥18 years and ≤65 years. No prior treatment with BOC/PEGIFN/RBV. CD4+ cell count >200 cells/µL. Stable antiretroviral therapy (ART) including tenofovir/emtricitabine (Truvada®, Gilead) and raltegravir (Isentress®, MSD) with HIV-RNA <50 copies/mL. Valid result on transient elastography or liver biopsy within 6 months prior to enrollment. Female patients of childbearing potential must agree to use an effective contraceptive during treatment and for 4 months after treatment has been concluded. Male patients or their female partners must agree to use an effective contraceptive during treatment and for 7 months after treatment has been concluded. Exclusion Criteria: HCV-GT other than HCV-GT 1. Cirrhotic patients (as defined by METAVIR F4 in liver biopsy or liver stiffness >12.3 kPa) with decompensated liver disease (Child-Pugh stage B/C). Chronic liver diseases other than hepatitis C virus infection (hepatitis B virus infection: HBsAg positivity, nonalcoholic steatohepatitis, autoimmune hepatitis, primary biliary cirrhosis, hemochromatosis, Wilson's disease, alpha-1 antitrypsin deficiency, cystic fibrosis). Significant cardiac disease (ejection fraction <40% at echocardiography). Significant pulmonary disease (COPD stage GOLD III/IV). Significant renal disease (serum creatinine >1.5 mg/dL). Subjects taking medication(s) that is/are highly dependent on CYP3A4/5 for clearance, and for which elevated plasma concentrations are associated with serious and/or life-threatening events such as but not limited to, orally administered midazolam, pimozide, amiodarone, flecainide, propafenone, quinidine, and ergot derivatives (dihydroergotamine, ergonovine, ergotamine, methylergonovine). Contraindications for boceprevir (Victrelis®, MSD), pegylated interferon alpha-2a (Pegasys®, Roche) or ribavirin (Copegus®, Roche), as listed in section 4.3 of the respective summary of product characteristics (SmPCs). Ongoing alcohol abuse (average daily alcohol consumption >50g). Ongoing illicit drug abuse. Unwillingness to give written informed consent. Pregnancy and breastfeeding. Women wishing to become pregnant.
Ages Eligible for Study
-----------------
Minimum Age: 18 Years
Maximum Age: 64 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 |
| --- | --- |
| Experimental: 28 weeks of treatment duration<br>All patients will receive 4 weeks of PEGIFN/RBV lead-in. Patients with undetectable HCV-RNA at treatment week 8 will be treated with 24 weeks of BOC/PEGIFN/RBV triple-therapy resulting in a total treatment duration of 28 weeks. | Drug: Pegylated interferon alpha-2a<br>* 180mcg once weekly; subcutaneous injection<br>* Other names: Pegasys®, Roche;Drug: Ribavirin<br>* 600mg two times daily (BID) (e.g. 3x200mg at 6am, 3x200mg at 6pm) in patients ≥75kg body weight; 2x200mg at 6am and 3x200mg at 6pm in patients <75kg; orally<br>* Other names: Copegus®, Roche;Drug: Boceprevir<br>* 800mg three times daily (TID) (e.g. 4x200mg at 6am, 4x200mg at 2pm, 4x200mg at 10pm); orally<br>* Other names: Victrelis®, MSD;|
| Experimental: 48 weeks of treatment duration<br>All patients will receive 4 weeks of PEGIFN/RBV lead-in. Patients with detectable HCV-RNA at treatment week 8 will receive 44 weeks of BOC/PEGIFN/RBV triple-therapy and a total treatment duration of 48 weeks | Drug: Pegylated interferon alpha-2a<br>* 180mcg once weekly; subcutaneous injection<br>* Other names: Pegasys®, Roche;Drug: Ribavirin<br>* 600mg two times daily (BID) (e.g. 3x200mg at 6am, 3x200mg at 6pm) in patients ≥75kg body weight; 2x200mg at 6am and 3x200mg at 6pm in patients <75kg; orally<br>* Other names: Copegus®, Roche;Drug: Boceprevir<br>* 800mg three times daily (TID) (e.g. 4x200mg at 6am, 4x200mg at 2pm, 4x200mg at 10pm); orally<br>* Other names: Victrelis®, MSD;|
What is the study measuring?
-----------------
Primary Outcome Measures
| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Proportion of Subjects With Sustained Virologic Response (SVR12) | Defined as HCV-RNA negativity by a sensitive assay | Follow-up week 12 (FU12) |
| Proportions of Subjects With Adverse Events (AEs) and Serious Adverse Events (SAEs) | | Baseline (BL) to Follow-up week 12 (FU12) |
Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Boceprevir, HIV/HCV-coinfection, HIV/HCV coinfection, HIV/HCV, Response-guided therapy
|
||
NCT00617240
|
Strategies to Reduce Antipsychotic-Associated Weight Gain in Youth
|
The purpose of this pilot study is to determine whether starting metformin in conjunction with a second-generation antipsychotic (SGA) and providing information about healthy eating and activity will prevent or reduce the amount of weight gain and the metabolic changes in adolescent youth typically seen with second-generation antipsychotic medication.
|
This is a 24 week, placebo-controlled, random assignment pilot study in which participants will be randomized in a 1:1 ratio to receive either flexible-dose treatment with metformin for 6 months as well as a newly initiated second generation antipsychotic medication or to receive placebo and the newly initiated antipsychotic medication. All subjects will also be provided healthy lifestyle instruction. The study involves monthly visits for the duration of the study. Participants may be treated as inpatients or outpatients throughout the course of the study. Participants will receive a psychiatric evaluation, physical exam, lab work, ECG, medication treatment, and psychiatric care.~The goal is to evaluate the safety and efficacy of means to prevent and treat weight gain and the associated endocrine, metabolic, and inflammatory changes caused by antipsychotic medications. Behavioral treatments to reduce weight gain and metabolic problems after weight gain has occurred have had little impact. Such interventions must be intensive and sustained over months, if not years to be effective. Although basic lifestyle instruction (diet and physical activity) should be the standard of care for all children and adolescents at risk for becoming overweight, pharmacologic interventions may be the best option for substantially augmenting behavioral approaches to weight management.
|
Metformin Mitigation of Atypical Antipsychotic-Induced Metabolic Dysregulation in Adolescent Youth
|
Weight Gain
|
* Drug: metformin
* Drug: placebo
|
Inclusion Criteria:~Subjects will be between the ages of 10 and 17, male or female, any race or ethnicity~Any SPMI pediatric diagnosis that meets DSM-IV criteria and frequently is treated with a SGA- typically but not limited to psychotic, mood, pervasive developmental, oppositional defiant, and conduct disorders~SGA-naïve or less than 2 weeks exposure to any SGA, except ziprasidone~Legal guardian able and willing to give written informed consent~If competent, subject able and willing to assent for their own participation~Exclusion Criteria:~Previous trial of metformin~Recommendation for treatment with clozapine or ziprasidone~Current use of insulin or any oral hypoglycemic agent~Current use of a medication known to mitigate weight gain - amantidine, histamine (H2) antagonists (cimetidine, ranitidine, nizatidine), topiramate, orlistat, sibutramine, stimulants (dextroamphetamine, methylphenidate)~Any current or past diagnosis of an eating disorder~Diabetes mellitus~Current active thyroid (TSH >18 microIU/ml; T4 total >18 mcg/dl), hepatic (2 LFTs >4x upper limits of normal), renal (serum Creatinine >1.4 mg/dL in females and serum Creatinine >1.5 mg/dL in males), cardiac, gastrointestinal, or adrenal disease~Current substance abuse/dependence within past 2 weeks; a positive urine tox screen at baseline in the absence of meeting criteria for abuse/dependence will not preclude enrollment.~Pregnancy or breast feeding
|
10 Years
|
17 Years
|
All
|
No
|
Primary Purpose: Prevention
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple
|
| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change From Baseline to Week 24 in Body Mass Index (BMI) | Change in BMI-Body Mass Index (BMI) is a measure of body fat based on height, weight,gender and chronological age. Change in BMI is calculated as 24 weeks BMI minus the baseline BMI. | 0-24 weeks |
| Change From Baseline to Week 24 in Weight | Change in weight is calculated as 24 weeks weight minus the baseline weight. | 24 weeks |
| Change From Baseline to Week 24 in Fat Mass | Fat mass is a measure of excess body fat. Change in Fat Mass is calculated as 24 weeks fat mass minus the baseline fat mass. | 24 weeks |
|
| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change From Baseline to Week 24 in Insulin Level | Insulin is a peptide hormone and regulates carbohydrate and fat metabolism in the body.Change in Insulin level is calculated as the 24 weeks insulin level minus the baseline insulin level. | 24 weeks |
| Change From Baseline to Week 24 in Cholesterol Level | According to the lipid hypothesis, abnormal cholesterol levels are strongly associated with cardiovascular disease because these promote atherosclerosis.Cholesterol levels are measured in milligrams (mg) of cholesterol per deciliter(dL) of blood.Change in cholesterol levels is measured at 24 weeks minus the levels at baseline. | 24 weeks |
| Change From Baseline to Week 24 in Triglycerides | In the human body, high levels of triglyceride fats in the bloodstream have been linked to atherosclerosis and, by extension, the risk of heart disease and stroke. A change in triglycerides is calculated from 24 weeks minus baseline levels. | 24 weeks |
| Incidence of Metabolic Syndrome | Metabolic syndrome is a combination of the medical disorders that, when co-occurring, increase the risk of developing cardiovascular disease and diabetes. | 24 weeks |
|
antipsychotic, metformin, children, adolescents
|
Metformin, Hypoglycemic Agents, Physiological Effects of Drugs
|
| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: 1<br>metformin in doses from 250mg to 2000mg/day for 26 weeks | Drug: metformin<br>* 500mg tablets, 250mg to 2000mg/day, po, BID to TID, 26 weeks<br>* Other names: Glucophage;|
| Placebo Comparator: 2<br>Matched placebo to metformin, doses between 250/0mg and 2000/0mg per day | Drug: placebo<br>* 500/0mg tablets, 250-2000mg/day divided BID to TID, po, 26 weeks<br>|
|
Strategies to Reduce Antipsychotic-Associated Weight Gain in Youth
Study Overview
=================
Brief Summary
-----------------
The purpose of this pilot study is to determine whether starting metformin in conjunction with a second-generation antipsychotic (SGA) and providing information about healthy eating and activity will prevent or reduce the amount of weight gain and the metabolic changes in adolescent youth typically seen with second-generation antipsychotic medication.
Detailed Description
-----------------
This is a 24 week, placebo-controlled, random assignment pilot study in which participants will be randomized in a 1:1 ratio to receive either flexible-dose treatment with metformin for 6 months as well as a newly initiated second generation antipsychotic medication or to receive placebo and the newly initiated antipsychotic medication. All subjects will also be provided healthy lifestyle instruction. The study involves monthly visits for the duration of the study. Participants may be treated as inpatients or outpatients throughout the course of the study. Participants will receive a psychiatric evaluation, physical exam, lab work, ECG, medication treatment, and psychiatric care. The goal is to evaluate the safety and efficacy of means to prevent and treat weight gain and the associated endocrine, metabolic, and inflammatory changes caused by antipsychotic medications. Behavioral treatments to reduce weight gain and metabolic problems after weight gain has occurred have had little impact. Such interventions must be intensive and sustained over months, if not years to be effective. Although basic lifestyle instruction (diet and physical activity) should be the standard of care for all children and adolescents at risk for becoming overweight, pharmacologic interventions may be the best option for substantially augmenting behavioral approaches to weight management.
Official Title
-----------------
Metformin Mitigation of Atypical Antipsychotic-Induced Metabolic Dysregulation in Adolescent Youth
Conditions
-----------------
Weight Gain
Intervention / Treatment
-----------------
* Drug: metformin
* Drug: placebo
Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Subjects will be between the ages of 10 and 17, male or female, any race or ethnicity Any SPMI pediatric diagnosis that meets DSM-IV criteria and frequently is treated with a SGA- typically but not limited to psychotic, mood, pervasive developmental, oppositional defiant, and conduct disorders SGA-naïve or less than 2 weeks exposure to any SGA, except ziprasidone Legal guardian able and willing to give written informed consent If competent, subject able and willing to assent for their own participation Exclusion Criteria: Previous trial of metformin Recommendation for treatment with clozapine or ziprasidone Current use of insulin or any oral hypoglycemic agent Current use of a medication known to mitigate weight gain - amantidine, histamine (H2) antagonists (cimetidine, ranitidine, nizatidine), topiramate, orlistat, sibutramine, stimulants (dextroamphetamine, methylphenidate) Any current or past diagnosis of an eating disorder Diabetes mellitus Current active thyroid (TSH >18 microIU/ml; T4 total >18 mcg/dl), hepatic (2 LFTs >4x upper limits of normal), renal (serum Creatinine >1.4 mg/dL in females and serum Creatinine >1.5 mg/dL in males), cardiac, gastrointestinal, or adrenal disease Current substance abuse/dependence within past 2 weeks; a positive urine tox screen at baseline in the absence of meeting criteria for abuse/dependence will not preclude enrollment. Pregnancy or breast feeding
Ages Eligible for Study
-----------------
Minimum Age: 10 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: Prevention
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple
Arms and Interventions
| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: 1<br>metformin in doses from 250mg to 2000mg/day for 26 weeks | Drug: metformin<br>* 500mg tablets, 250mg to 2000mg/day, po, BID to TID, 26 weeks<br>* Other names: Glucophage;|
| Placebo Comparator: 2<br>Matched placebo to metformin, doses between 250/0mg and 2000/0mg per day | Drug: placebo<br>* 500/0mg tablets, 250-2000mg/day divided BID to TID, po, 26 weeks<br>|
What is the study measuring?
-----------------
Primary Outcome Measures
| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change From Baseline to Week 24 in Body Mass Index (BMI) | Change in BMI-Body Mass Index (BMI) is a measure of body fat based on height, weight,gender and chronological age. Change in BMI is calculated as 24 weeks BMI minus the baseline BMI. | 0-24 weeks |
| Change From Baseline to Week 24 in Weight | Change in weight is calculated as 24 weeks weight minus the baseline weight. | 24 weeks |
| Change From Baseline to Week 24 in Fat Mass | Fat mass is a measure of excess body fat. Change in Fat Mass is calculated as 24 weeks fat mass minus the baseline fat mass. | 24 weeks |
Secondary Outcome Measures
| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change From Baseline to Week 24 in Insulin Level | Insulin is a peptide hormone and regulates carbohydrate and fat metabolism in the body.Change in Insulin level is calculated as the 24 weeks insulin level minus the baseline insulin level. | 24 weeks |
| Change From Baseline to Week 24 in Cholesterol Level | According to the lipid hypothesis, abnormal cholesterol levels are strongly associated with cardiovascular disease because these promote atherosclerosis.Cholesterol levels are measured in milligrams (mg) of cholesterol per deciliter(dL) of blood.Change in cholesterol levels is measured at 24 weeks minus the levels at baseline. | 24 weeks |
| Change From Baseline to Week 24 in Triglycerides | In the human body, high levels of triglyceride fats in the bloodstream have been linked to atherosclerosis and, by extension, the risk of heart disease and stroke. A change in triglycerides is calculated from 24 weeks minus baseline levels. | 24 weeks |
| Incidence of Metabolic Syndrome | Metabolic syndrome is a combination of the medical disorders that, when co-occurring, increase the risk of developing cardiovascular disease and diabetes. | 24 weeks |
Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
antipsychotic, metformin, children, adolescents
|
NCT02081560
|
Colistin Pharmacokinetics in Continuous Renal Replacement Therapy
|
The blood concentration of the antibiotic colistin is determined in patients in whom kidney function is reduced such that a renal replacement therapy is needed.~Hypothesis:no dose reduction is needed in patients undergoing continuous renal replacement therapy over 24h because colistin is sufficiently removed by this procedure.
|
After administration of intravenous Colistin multiple blood samples are drawn over one dosing interval on day 1, 3, and 5 of treatment.~Patients are monitored for signs of neuro- and nephrotoxicity
|
Colistimethate and Colistin Pharmacokinetics in Critically Ill Patients Undergoing Continuous Renal Replacement Therapy (CRRT)
|
Infection
|
* Drug: Colistin
|
Inclusion Criteria:~male or female aged 18 years or older~hospitalised on the ICU~gram-negative infection requiring antibiotic therapy with intravenous colistin as part of their routine medical care~clinical necessity for continuous venovenous renal replacement therapy~Exclusion Criteria:~History of hypersensitivity to colistin or to other polymyxins~Personal or family history of Myasthenia Gravis
|
18 Years
| null |
All
|
No
|
Primary Purpose: Treatment
Intervention Model: Single Group Assignment
Masking: None (Open Label)
|
| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Area under the curve (AUC) | | predose, and 0.5, 1, 2, 4, 6, 8 hours after administration |
|
| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Sings of neurotoxicity and nephrotoxicity | Clinical investigation daily by assessing clinical signs and questioning the patient regarding sign of neuropathy and difficulty breathing in non intubated patients. Questioning the treating physician in intubated patients regarding objective signs of increased ventilation support. | Expected average of follow up is about 14 days. |
| Sings of neurotoxicity and nephrotoxicity | Clinical investigation daily by assessing clinical signs and questioning the patient regarding sign of neuropathy and difficulty breathing in non intubated patients. Questioning the treating physician in intubated patients regarding objective signs of increased ventilation support. The patients will be followed for the duration of colistin administration at the dose studied. | Expected average of follow up is about 14 days. |
|
pharmacokinetics, antibiotic, Gram negative, continuous renal replacement therapy
|
Colistin, Anti-Bacterial Agents, Anti-Infective Agents
|
| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Other: colistin pharmacokinetics<br>Intravenous colistin 9 million units loading dose and 3 million units q8h maintenance dose as long as treatment of infection is required | Drug: Colistin<br>* Colistin i.v. three times daily as long a necessary for infection treatment<br>|
|
Colistin Pharmacokinetics in Continuous Renal Replacement Therapy
Study Overview
=================
Brief Summary
-----------------
The blood concentration of the antibiotic colistin is determined in patients in whom kidney function is reduced such that a renal replacement therapy is needed. Hypothesis:no dose reduction is needed in patients undergoing continuous renal replacement therapy over 24h because colistin is sufficiently removed by this procedure.
Detailed Description
-----------------
After administration of intravenous Colistin multiple blood samples are drawn over one dosing interval on day 1, 3, and 5 of treatment. Patients are monitored for signs of neuro- and nephrotoxicity
Official Title
-----------------
Colistimethate and Colistin Pharmacokinetics in Critically Ill Patients Undergoing Continuous Renal Replacement Therapy (CRRT)
Conditions
-----------------
Infection
Intervention / Treatment
-----------------
* Drug: Colistin
Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: male or female aged 18 years or older hospitalised on the ICU gram-negative infection requiring antibiotic therapy with intravenous colistin as part of their routine medical care clinical necessity for continuous venovenous renal replacement therapy Exclusion Criteria: History of hypersensitivity to colistin or to other polymyxins Personal or family history of Myasthenia Gravis
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 |
| --- | --- |
| Other: colistin pharmacokinetics<br>Intravenous colistin 9 million units loading dose and 3 million units q8h maintenance dose as long as treatment of infection is required | Drug: Colistin<br>* Colistin i.v. three times daily as long a necessary for infection treatment<br>|
What is the study measuring?
-----------------
Primary Outcome Measures
| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Area under the curve (AUC) | | predose, and 0.5, 1, 2, 4, 6, 8 hours after administration |
Secondary Outcome Measures
| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Sings of neurotoxicity and nephrotoxicity | Clinical investigation daily by assessing clinical signs and questioning the patient regarding sign of neuropathy and difficulty breathing in non intubated patients. Questioning the treating physician in intubated patients regarding objective signs of increased ventilation support. | Expected average of follow up is about 14 days. |
| Sings of neurotoxicity and nephrotoxicity | Clinical investigation daily by assessing clinical signs and questioning the patient regarding sign of neuropathy and difficulty breathing in non intubated patients. Questioning the treating physician in intubated patients regarding objective signs of increased ventilation support. The patients will be followed for the duration of colistin administration at the dose studied. | Expected average of follow up is about 14 days. |
Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
pharmacokinetics, antibiotic, Gram negative, continuous renal replacement therapy
|
NCT00002423
|
A Study to Compare Two Anti-HIV Drug Combinations That Include Amprenavir in HIV-Infected Patients Who Have Failed Anti-HIV Drug Combinations That Did Not Include Amprenavir
|
This study will compare the safety and effectiveness of two anti-HIV drug combinations in fighting HIV infection in patients whose viral loads (levels of HIV in the blood) rose with other anti-HIV drug treatments.
|
Patients experiencing virologic failure while receiving an IDV-containing antiretroviral regimen will receive the 3TC/ABC/APV/NFV combination. Patients experiencing virologic failure while receiving an NFV-containing antiretroviral regimen will receive the 3TC/ABC/APV/IDV combination.
|
A Phase II, Open-Label Trial for Treatment of HIV Infection in Subjects Who Have Failed Initial Combination Therapy With Regimens Containing Indinavir or Nelfinavir: Combination Therapy With 3TC (150 Mg BID), Abacavir (300 Mg BID) and Amprenavir (1200 Mg BID) Plus Either Nelfinavir (1250 Mg BID) or Indinavir (800 Mg TID) for 48 Weeks
|
HIV Infections
|
* Drug: Indinavir sulfate
* Drug: Abacavir sulfate
* Drug: Amprenavir
* Drug: Nelfinavir mesylate
* Drug: Lamivudine
|
Inclusion Criteria~You may be eligible for this trial if you:~Are HIV-positive.~Are 13 years of age or older.~Are currently taking anti-HIV drugs, 1 of which must be NFV or IDV, and have taken these same drugs for at least 12 weeks.~In the last 16 weeks your viral load (level of HIV in the blood) dropped below 400 copies/ml and has since increased to at least 1,000 copies/ml, even though you continue to take your anti-HIV drugs.~Have the written consent of a parent or legal guardian if you are under age 18.~Agree to practice abstinence or use effective barrier methods of birth control (unless you are physically incapable of becoming pregnant).~Are willing to complete the 48-week study.~Exclusion Criteria~You will not be eligible for this trial if you:~Have ever taken the following anti-HIV drugs: ABC, APV, efavirenz (EFV), delavirdine (DLV), nevirapine (NVP), or loviride.~Have certain AIDS-related infections or diseases, have other serious medical conditions such as diabetes and certain types of heart trouble, or have a history of lymphoma.~Have had certain types of hepatitis in the past 6 months.~Have received an HIV vaccine in the past 3 months or a flu vaccine in the past 30 days.~Have certain digestion problems that make it difficult to take anti-HIV drugs by mouth.~Have received certain other drugs or treatments in the past 30 days, or will need certain drugs or treatments during the study.
|
13 Years
| null |
All
|
No
|
Primary Purpose: Treatment
|
| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
|
Drug Therapy, Combination, HIV Protease Inhibitors, Lamivudine, Indinavir, Nelfinavir, VX 478, Reverse Transcriptase Inhibitors, Anti-HIV Agents, Viral Load, abacavir
|
Abacavir, Nelfinavir, Indinavir, Amprenavir, Reverse Transcriptase Inhibitors, Nucleic Acid Synthesis Inhibitors, Enzyme Inhibitors, Molecular Mechanisms of Pharmacological Action, Antiviral Agents, Anti-Infective Agents, Anti-HIV Agents, Anti-Retroviral Agents, HIV Protease Inhibitors, Viral Protease Inhibitors, Protease Inhibitors, Antibiotics, Antitubercular, Antitubercular Agents, Anti-Bacterial Agents, Lamivudine
|
| Intervention/Treatment |
| --- |
|Drug: Indinavir sulfate|nan|
|Drug: Abacavir sulfate|nan|
|Drug: Amprenavir|nan|
|Drug: Nelfinavir mesylate|nan|
|Drug: Lamivudine|nan|
|
A Study to Compare Two Anti-HIV Drug Combinations That Include Amprenavir in HIV-Infected Patients Who Have Failed Anti-HIV Drug Combinations That Did Not Include Amprenavir
Study Overview
=================
Brief Summary
-----------------
This study will compare the safety and effectiveness of two anti-HIV drug combinations in fighting HIV infection in patients whose viral loads (levels of HIV in the blood) rose with other anti-HIV drug treatments.
Detailed Description
-----------------
Patients experiencing virologic failure while receiving an IDV-containing antiretroviral regimen will receive the 3TC/ABC/APV/NFV combination. Patients experiencing virologic failure while receiving an NFV-containing antiretroviral regimen will receive the 3TC/ABC/APV/IDV combination.
Official Title
-----------------
A Phase II, Open-Label Trial for Treatment of HIV Infection in Subjects Who Have Failed Initial Combination Therapy With Regimens Containing Indinavir or Nelfinavir: Combination Therapy With 3TC (150 Mg BID), Abacavir (300 Mg BID) and Amprenavir (1200 Mg BID) Plus Either Nelfinavir (1250 Mg BID) or Indinavir (800 Mg TID) for 48 Weeks
Conditions
-----------------
HIV Infections
Intervention / Treatment
-----------------
* Drug: Indinavir sulfate
* Drug: Abacavir sulfate
* Drug: Amprenavir
* Drug: Nelfinavir mesylate
* Drug: Lamivudine
Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria You may be eligible for this trial if you: Are HIV-positive. Are 13 years of age or older. Are currently taking anti-HIV drugs, 1 of which must be NFV or IDV, and have taken these same drugs for at least 12 weeks. In the last 16 weeks your viral load (level of HIV in the blood) dropped below 400 copies/ml and has since increased to at least 1,000 copies/ml, even though you continue to take your anti-HIV drugs. Have the written consent of a parent or legal guardian if you are under age 18. Agree to practice abstinence or use effective barrier methods of birth control (unless you are physically incapable of becoming pregnant). Are willing to complete the 48-week study. Exclusion Criteria You will not be eligible for this trial if you: Have ever taken the following anti-HIV drugs: ABC, APV, efavirenz (EFV), delavirdine (DLV), nevirapine (NVP), or loviride. Have certain AIDS-related infections or diseases, have other serious medical conditions such as diabetes and certain types of heart trouble, or have a history of lymphoma. Have had certain types of hepatitis in the past 6 months. Have received an HIV vaccine in the past 3 months or a flu vaccine in the past 30 days. Have certain digestion problems that make it difficult to take anti-HIV drugs by mouth. Have received certain other drugs or treatments in the past 30 days, or will need certain drugs or treatments during the study.
Ages Eligible for Study
-----------------
Minimum Age: 13 Years
Sexes Eligible for Study
-----------------
All
Accepts Healthy Volunteers
-----------------
No
Study Plan
=================
How is the study designed?
-----------------
Design Details
Primary Purpose: Treatment
Arms and Interventions
| Intervention/Treatment |
| --- |
|Drug: Indinavir sulfate|nan|
|Drug: Abacavir sulfate|nan|
|Drug: Amprenavir|nan|
|Drug: Nelfinavir mesylate|nan|
|Drug: Lamivudine|nan|
What is the study measuring?
-----------------
Primary Outcome Measures
| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Drug Therapy, Combination, HIV Protease Inhibitors, Lamivudine, Indinavir, Nelfinavir, VX 478, Reverse Transcriptase Inhibitors, Anti-HIV Agents, Viral Load, abacavir
|
|
NCT00507195
|
Postanesthesia Cognitive Recovery and Neuropsychologic Complications
|
The study proposes to analyze the difference in the rapidity of the recovery of post operative cognition immediately after extubation and 20, 40 and 60 minutes post extubation and neuropsychological complications (delirium) after 48 hours following general anesthesia using a prospective, randomized approach. Patients undergoing any type of surgery with the exception of cranial, cardiac or thoracic surgery can be enrolled in the study.
|
The rationale for this study comparing different types of anesthetic maintenance is based on the amount of systemic metabolic breakdown and the low repartion rates within the various tissues and the very rapid elimination of desflurane in respect to the other common inhalation and intravenous anesthetics as possible factors in the rate of recovery of cognitive function and the appearance of post operative delirium. After general anesthesia with desflurane there is less residual hypnotic agent for elimination in the circulation and tissue with respect to the amount given than with propofol or sevoflurance (1-3).~Perioperative cerebral injury correlated with surgical intervention and anesthesia can result in a decline in cognitive function (4) defining the entity of post operative cognitive dysfunction (POCD).~In this study it is possible to distinguish:~Early POCD: attributable to anesthesia~Long-Term POCD: could be attributable to of cognition associated with advanced age rather than to procedural effects (surgery, anesthesia, or confinement to a hospital bed)~The prevalence of POCD is higher in patients with advanced age (>70) and in cases where general anesthesia is used for highly invasive surgery (orthopedic, abdominal and thoracic surgery) (5-7). A consensus does not exist regarding tests for evaluation of POCD. In this protocol we propose to use three scales concurrently that are commonly used for evaluation of cognitive function.~Regarding neuropsychological complications, the scope of this study is to evaluate the prevalence of post operative delirium with onset during the 48 hours following the end of the surgical intervention.~Delirium fundamentally consists of three basic neuropsychological disorders:~Visual or auditory hallucination~Spatial-temporal disorientation~Inappropriate language~Post operative delirium entails:~An increase in morbidity and mortality~An increase risk of neurological damage~Significant discomfort for the patient, families and staff (6)~Some conditions predispose patients to the onset of post operative delirium: advanced age (>70 years old), alcohol abuse, abnormalities in the pre-operative cognitive state, and electrolyte or chemical imbalance (Na, K, glucose, etc.)~Protocol~After the induction of anesthesia, carried out using routine clinical practice determined by the anesthesiologist the patient will be assigned to either the control group or the comparison group (the assignment will have been made prior to induction). The control group will receive either propofol or sevoflurance (with or without N2O at the discretion of the anesthesiologist based on clinical needs). The comparison group will be given desflurane (end tidal 5.0 - 6.0%) for maintenance of anesthesia (with or without N2O at the discretion of the anesthesiologist based on clinical needs). According to a randomized sequence patients will be assigned in a consecutive manor to the maintenance with the control technique or with desflurane.~The objective of the study is to observe if there are differences in the point of recovery of cognition, evaluated with the appropriate test in the immediate post operative period and the onset of post operative delirium (visual or auditory hallucination, spatial or temporal disorientation, or inappropriate language) within 48 hours following surgery.~Normal care should be used in the administration of benzodiazapam premedication to patients at high risk for developing post operative delirium, but their use doe not represent criteria for exclusion from the study. In addition hypotension should be avoided (maintenance of a mean blood pressure of greater than 70 mmHg) as also intraoperative hyper ventilation (avoid hypocapnia).~Every collaborator would initially enroll 10 patients (5 control group receiving propofol or sevoflurance and 5 comparison group receiving desflurane) in order to become confident with the method of the protocol and with the evaluation methods used for measuring cognitive function.~Every collaborator and those relevant to the core study will be cited in the list of coauthors. The databases consisting of the protocol data will be at the disposal of the collaborators for further scientific work.~Statistical Analysis~The diagnostic characteristics of the patients registered will be described according to categorical variables across a table of frequency. Continuous variables will be subjected to summary statistics such as average, standard deviation, median, minimum and maximum. The differences between the groups will be subjected to verification of the significance through non-parametric (Chi Square and Fisher Exact Test for the non-continuous variables and the Mann-Whitney or the Kruskall-Wallis for associations between the continuous variables. The incidence of cardiovascular or respiratory complications, nausea and/or vomiting, shivering, neurological complications and delirium will be tabulated through table of frequency.~Criteria for Enrollment~The study includes patients of any age and ASA physical status undergoing elective surgery. All patients must have a Glascow Coma Score (GCS) equal to 15 before the intervention and they must have undergone the following:~Informed consent about anesthesia~Preoperative evaluation including determination of ASA physical status and GCS~Laboratory testing~Preoperative evaluation~Routine laboratory tests~Treatment and testing appropriate to the patient's condition~ECG~Chest x-ray~After the induction of anesthesia which can be done according to the normal routine of the individual anesthesiologist, the patient will then be assigned according to a randomized sequence to one of the two groups:~1a) Anesthesia with propofol (total intravenous anesthesia - TVA)~1b) Anesthesia with sevoflurane (with or without N2O) 2) Anesthesia with desflurane (with or without N2O)~The anesthesiologist can use other agents (oppiods, _________, antihypertensives etc.) according to the clinical need in the judgment of the anesthesiologist. The type and quantity of drugs used in the Perioperative period must be reported on the anesthesia record.~Intra operative monitoring~ECG~Blood pressure (invasive or non-invasive)~SpO2~EtCO2~Et halogenated agent~Urine output~Tests Before anesthetizing the patient they will be given three cognitive tests: SOMCT, RLAS and MMSE. The same tests will be followed (repeated at emergence, after 20, 40, and 60 minutes after extubation. This will permit the evaluation of the level of recovery of cognition compared to the value obtained before anesthesia with that obtained in the three successive administrations of the tests after wake-up.~The Short Orientation Memory Concentration Test (SOMCT) investigates the patient's capacity to know the current year or month or only one of the two and to repeat in numerical order the inverse sequence of the months of the year. These variables permit the assignment of a numerical score from 0 to 28 based upon the patient's cognitive function. Higher scores indicate better cognitive function (12).~The Rancho Los Amigos Scale (RLAS) is a scale utilized to quantify the behavioral and cognitive state after acute cerebral injury. Each state corresponds to one of eight levels (I - VIII). Higher scores indicate a good state of behavior and cognition.~The Mini Mental State Examination (MMSE) is a test that is usually administered to adults or the elderly who one suspects might have a memory or character disturbance (13). This test requires the use of a pencil, a watch and some sheets of paper. The maximum attainable score is 30. A compiled score of between 24 - 30 could indicate a psychological decline in cognitive function of little importance. On the other hand scores below 24 can denote cognitive disturbance much more severe as the score decreases.~The Wake-up The start of the study period coincides with the suspension of the hypnotics (propofol/sevoflurane or desflurane). At this moment the timing of extubation begins which is at the discretion of the anesthesiologists who would evaluate the patient as usual for extubation criteria (respiratory dynamics, ability to maintain SpO2 >95%, Et CO2 between 30 - 40 mmHg, muscle strength, the presence of laryngeal reflexes, and swallowing, etc.) At that point the anesthesiologist will bring the flow of fresh gas to a value greater than that of the minute ventilation and change the circuit to an open system. The time between the suspension of anesthesia and extubation will be recorded on the patient's anesthetic record.~In order to evaluate memory quickly at termination of the anesthetic (after extubation) it would be necessary to inform the patient of the correct time and day in the immediate wake up period.~The patient is evaluated according to the Aldrete score (11) 5 minutes after the extubation ane every 5 minutes after until an Aldrete score of 9-10 is obtrained. The patient that reaches a score of 9-10 (capacity to move their extremities spontaneously and under command, to breath and cough, have a mean blood pressure between 20% of the preoperative level, to arouse themselves and the capacity to maintain an SpO2 greater than 90%) can begin to undergo cognitive testing.~At the same time interval of evaluation of the recovery of cognition, the patient will be evaluated (and treated?) for pain through use of an analogue visual scale (VAS 0 = no pain, 10 = maximum pain imaginable). The patient will then be asked for the information furnished at awakening.~During the same period the blood pressure, heart rate, ECG, SpO2 will be measured to evaluate cardiovascular, respiratory function, and the patient evaluated for nausea/vomiting, shivering and any neurological abnormalities. Episodes of hypotension (mean blood pressure less than 50 mmHg for a period greater than 5 minutes), hypertension (meant blood pressure greater than 100 mmHg for a period greater than 5 minutes) will be recorded and treated if necessary.~At 24 and 48 hours the presence of delirium will be evaluated, and in particular the appearance of alteration of spatial or temporal orientation, auditory or visual hallucinations or any inappropriate language, will be noted.~Information compiled for Patient Records~General Data This section has the aim to identify the researcher and to classify the patient. Information will be obtained regarding the patients age, sex, height and weight and the name of the medical center and the date of the intervention.~Preoperative data Needed therapy and medical condition including cardiac, respiratory, neurologic and metabolic problems prior to surgery will be recorded.~Intra-operative data This data records factors related to the intervention including anesthetic techniques utilized, fluid administered, duration of anesthesia and surgery, type of surgery and the patient's position. It is of great importance to report episodes of hypertension (systolic blood pressure <90 mmHg ) or hypertension (diastolic pressure >100 mmHg) that is protracted (duration longer than 5 minutes).~Post operative data This is data that relates to the wake up of the patients based on the three groups studied. The evaluation at wake-up and the results from the Aldrete score, the SOMCT, RLAS, and the MMSE according to the order specified in the discription of the protocol. It is important to indicated episodes of protracted hypo or hypertension and episodes of hypoxia (SpO2 < 95%) as well as the intensity of pain using the VAS (and treatment?).
|
Post Operative Cognitive Recovery and Neuropsychological Complications After General Anesthesia. A Comparison Between Different Techniques of Anesthesia: A Multi-Center Observational Study
|
Anesthesia Recovery Period, Delirium, Dementia, Cognitive Disorders, Neurobehavioural Manifestation, Mental Competency
|
* Drug: Hypnotics: propofol, sevoflurane, desflurane,desflurane,midazolam
|
Inclusion Criteria:~Adult age patients undergoing general anesthesia~Exclusion Criteria:~Cerebral and cardiac surgery~Surgical procedures required postoperative delayed extubation
|
18 Years
| null |
All
|
No
|
| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
|
Postanethesia cognitive recovery, Postoperative delirium, hypnotics, propofol, sevoflurane, desflurane, postoperative cognitive recovery
|
Midazolam, Propofol, Hypnotics and Sedatives, Sevoflurane, Desflurane, Central Nervous System Depressants, Physiological Effects of Drugs, Anesthetics, Intravenous, Anesthetics, General, Anesthetics, Adjuvants, Anesthesia, Anti-Anxiety Agents, Tranquilizing Agents, Psychotropic Drugs, GABA Modulators, GABA Agents, Neurotransmitter Agents, Molecular Mechanisms of Pharmacological Action, Platelet Aggregation Inhibitors, Anesthetics, Inhalation
|
| Intervention/Treatment |
| --- |
|Drug: Hypnotics: propofol, sevoflurane, desflurane,desflurane,midazolam|nan|
|
Postanesthesia Cognitive Recovery and Neuropsychologic Complications
Study Overview
=================
Brief Summary
-----------------
The study proposes to analyze the difference in the rapidity of the recovery of post operative cognition immediately after extubation and 20, 40 and 60 minutes post extubation and neuropsychological complications (delirium) after 48 hours following general anesthesia using a prospective, randomized approach. Patients undergoing any type of surgery with the exception of cranial, cardiac or thoracic surgery can be enrolled in the study.
Detailed Description
-----------------
The rationale for this study comparing different types of anesthetic maintenance is based on the amount of systemic metabolic breakdown and the low repartion rates within the various tissues and the very rapid elimination of desflurane in respect to the other common inhalation and intravenous anesthetics as possible factors in the rate of recovery of cognitive function and the appearance of post operative delirium. After general anesthesia with desflurane there is less residual hypnotic agent for elimination in the circulation and tissue with respect to the amount given than with propofol or sevoflurance (1-3). Perioperative cerebral injury correlated with surgical intervention and anesthesia can result in a decline in cognitive function (4) defining the entity of post operative cognitive dysfunction (POCD). In this study it is possible to distinguish: Early POCD: attributable to anesthesia Long-Term POCD: could be attributable to of cognition associated with advanced age rather than to procedural effects (surgery, anesthesia, or confinement to a hospital bed) The prevalence of POCD is higher in patients with advanced age (>70) and in cases where general anesthesia is used for highly invasive surgery (orthopedic, abdominal and thoracic surgery) (5-7). A consensus does not exist regarding tests for evaluation of POCD. In this protocol we propose to use three scales concurrently that are commonly used for evaluation of cognitive function. Regarding neuropsychological complications, the scope of this study is to evaluate the prevalence of post operative delirium with onset during the 48 hours following the end of the surgical intervention. Delirium fundamentally consists of three basic neuropsychological disorders: Visual or auditory hallucination Spatial-temporal disorientation Inappropriate language Post operative delirium entails: An increase in morbidity and mortality An increase risk of neurological damage Significant discomfort for the patient, families and staff (6) Some conditions predispose patients to the onset of post operative delirium: advanced age (>70 years old), alcohol abuse, abnormalities in the pre-operative cognitive state, and electrolyte or chemical imbalance (Na, K, glucose, etc.) Protocol After the induction of anesthesia, carried out using routine clinical practice determined by the anesthesiologist the patient will be assigned to either the control group or the comparison group (the assignment will have been made prior to induction). The control group will receive either propofol or sevoflurance (with or without N2O at the discretion of the anesthesiologist based on clinical needs). The comparison group will be given desflurane (end tidal 5.0 - 6.0%) for maintenance of anesthesia (with or without N2O at the discretion of the anesthesiologist based on clinical needs). According to a randomized sequence patients will be assigned in a consecutive manor to the maintenance with the control technique or with desflurane. The objective of the study is to observe if there are differences in the point of recovery of cognition, evaluated with the appropriate test in the immediate post operative period and the onset of post operative delirium (visual or auditory hallucination, spatial or temporal disorientation, or inappropriate language) within 48 hours following surgery. Normal care should be used in the administration of benzodiazapam premedication to patients at high risk for developing post operative delirium, but their use doe not represent criteria for exclusion from the study. In addition hypotension should be avoided (maintenance of a mean blood pressure of greater than 70 mmHg) as also intraoperative hyper ventilation (avoid hypocapnia). Every collaborator would initially enroll 10 patients (5 control group receiving propofol or sevoflurance and 5 comparison group receiving desflurane) in order to become confident with the method of the protocol and with the evaluation methods used for measuring cognitive function. Every collaborator and those relevant to the core study will be cited in the list of coauthors. The databases consisting of the protocol data will be at the disposal of the collaborators for further scientific work. Statistical Analysis The diagnostic characteristics of the patients registered will be described according to categorical variables across a table of frequency. Continuous variables will be subjected to summary statistics such as average, standard deviation, median, minimum and maximum. The differences between the groups will be subjected to verification of the significance through non-parametric (Chi Square and Fisher Exact Test for the non-continuous variables and the Mann-Whitney or the Kruskall-Wallis for associations between the continuous variables. The incidence of cardiovascular or respiratory complications, nausea and/or vomiting, shivering, neurological complications and delirium will be tabulated through table of frequency. Criteria for Enrollment The study includes patients of any age and ASA physical status undergoing elective surgery. All patients must have a Glascow Coma Score (GCS) equal to 15 before the intervention and they must have undergone the following: Informed consent about anesthesia Preoperative evaluation including determination of ASA physical status and GCS Laboratory testing Preoperative evaluation Routine laboratory tests Treatment and testing appropriate to the patient's condition ECG Chest x-ray After the induction of anesthesia which can be done according to the normal routine of the individual anesthesiologist, the patient will then be assigned according to a randomized sequence to one of the two groups: 1a) Anesthesia with propofol (total intravenous anesthesia - TVA) 1b) Anesthesia with sevoflurane (with or without N2O) 2) Anesthesia with desflurane (with or without N2O) The anesthesiologist can use other agents (oppiods, _________, antihypertensives etc.) according to the clinical need in the judgment of the anesthesiologist. The type and quantity of drugs used in the Perioperative period must be reported on the anesthesia record. Intra operative monitoring ECG Blood pressure (invasive or non-invasive) SpO2 EtCO2 Et halogenated agent Urine output Tests Before anesthetizing the patient they will be given three cognitive tests: SOMCT, RLAS and MMSE. The same tests will be followed (repeated at emergence, after 20, 40, and 60 minutes after extubation. This will permit the evaluation of the level of recovery of cognition compared to the value obtained before anesthesia with that obtained in the three successive administrations of the tests after wake-up. The Short Orientation Memory Concentration Test (SOMCT) investigates the patient's capacity to know the current year or month or only one of the two and to repeat in numerical order the inverse sequence of the months of the year. These variables permit the assignment of a numerical score from 0 to 28 based upon the patient's cognitive function. Higher scores indicate better cognitive function (12). The Rancho Los Amigos Scale (RLAS) is a scale utilized to quantify the behavioral and cognitive state after acute cerebral injury. Each state corresponds to one of eight levels (I - VIII). Higher scores indicate a good state of behavior and cognition. The Mini Mental State Examination (MMSE) is a test that is usually administered to adults or the elderly who one suspects might have a memory or character disturbance (13). This test requires the use of a pencil, a watch and some sheets of paper. The maximum attainable score is 30. A compiled score of between 24 - 30 could indicate a psychological decline in cognitive function of little importance. On the other hand scores below 24 can denote cognitive disturbance much more severe as the score decreases. The Wake-up The start of the study period coincides with the suspension of the hypnotics (propofol/sevoflurane or desflurane). At this moment the timing of extubation begins which is at the discretion of the anesthesiologists who would evaluate the patient as usual for extubation criteria (respiratory dynamics, ability to maintain SpO2 >95%, Et CO2 between 30 - 40 mmHg, muscle strength, the presence of laryngeal reflexes, and swallowing, etc.) At that point the anesthesiologist will bring the flow of fresh gas to a value greater than that of the minute ventilation and change the circuit to an open system. The time between the suspension of anesthesia and extubation will be recorded on the patient's anesthetic record. In order to evaluate memory quickly at termination of the anesthetic (after extubation) it would be necessary to inform the patient of the correct time and day in the immediate wake up period. The patient is evaluated according to the Aldrete score (11) 5 minutes after the extubation ane every 5 minutes after until an Aldrete score of 9-10 is obtrained. The patient that reaches a score of 9-10 (capacity to move their extremities spontaneously and under command, to breath and cough, have a mean blood pressure between 20% of the preoperative level, to arouse themselves and the capacity to maintain an SpO2 greater than 90%) can begin to undergo cognitive testing. At the same time interval of evaluation of the recovery of cognition, the patient will be evaluated (and treated?) for pain through use of an analogue visual scale (VAS 0 = no pain, 10 = maximum pain imaginable). The patient will then be asked for the information furnished at awakening. During the same period the blood pressure, heart rate, ECG, SpO2 will be measured to evaluate cardiovascular, respiratory function, and the patient evaluated for nausea/vomiting, shivering and any neurological abnormalities. Episodes of hypotension (mean blood pressure less than 50 mmHg for a period greater than 5 minutes), hypertension (meant blood pressure greater than 100 mmHg for a period greater than 5 minutes) will be recorded and treated if necessary. At 24 and 48 hours the presence of delirium will be evaluated, and in particular the appearance of alteration of spatial or temporal orientation, auditory or visual hallucinations or any inappropriate language, will be noted. Information compiled for Patient Records General Data This section has the aim to identify the researcher and to classify the patient. Information will be obtained regarding the patients age, sex, height and weight and the name of the medical center and the date of the intervention. Preoperative data Needed therapy and medical condition including cardiac, respiratory, neurologic and metabolic problems prior to surgery will be recorded. Intra-operative data This data records factors related to the intervention including anesthetic techniques utilized, fluid administered, duration of anesthesia and surgery, type of surgery and the patient's position. It is of great importance to report episodes of hypertension (systolic blood pressure <90 mmHg ) or hypertension (diastolic pressure >100 mmHg) that is protracted (duration longer than 5 minutes). Post operative data This is data that relates to the wake up of the patients based on the three groups studied. The evaluation at wake-up and the results from the Aldrete score, the SOMCT, RLAS, and the MMSE according to the order specified in the discription of the protocol. It is important to indicated episodes of protracted hypo or hypertension and episodes of hypoxia (SpO2 < 95%) as well as the intensity of pain using the VAS (and treatment?).
Official Title
-----------------
Post Operative Cognitive Recovery and Neuropsychological Complications After General Anesthesia. A Comparison Between Different Techniques of Anesthesia: A Multi-Center Observational Study
Conditions
-----------------
Anesthesia Recovery Period, Delirium, Dementia, Cognitive Disorders, Neurobehavioural Manifestation, Mental Competency
Intervention / Treatment
-----------------
* Drug: Hypnotics: propofol, sevoflurane, desflurane,desflurane,midazolam
Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Adult age patients undergoing general anesthesia Exclusion Criteria: Cerebral and cardiac surgery Surgical procedures required postoperative delayed extubation
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 |
| --- |
|Drug: Hypnotics: propofol, sevoflurane, desflurane,desflurane,midazolam|nan|
What is the study measuring?
-----------------
Primary Outcome Measures
| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Postanethesia cognitive recovery, Postoperative delirium, hypnotics, propofol, sevoflurane, desflurane, postoperative cognitive recovery
|
||
NCT04439149
|
Testing GSK2636771 as a Potential Targeted Treatment in Cancers With PTEN Genetic Changes (MATCH-Subprotocol N)
|
This phase II MATCH treatment trial identifies the effects of GSK2636771 in patients whose cancer has a genetic change called PTEN mutation or deletion. GSK2636771 may block a protein called PI3K-beta, which may be needed for growth of cancer cells that express PTEN mutations. Researchers hope to learn if GSK2636771 will shrink this type of cancer or stop its growth.
|
PRIMARY OBJECTIVE:~I. To evaluate the proportion of patients with objective response (OR) to targeted study agent(s) in patients with advanced refractory cancers/lymphomas/multiple myeloma.~SECONDARY OBJECTIVES:~I. To evaluate the proportion of patients alive and progression free at 6 months of treatment with targeted study agent in patients with advanced refractory cancers/lymphomas/multiple myeloma.~II. To evaluate time until death or disease progression. III. To identify potential predictive biomarkers beyond the genomic alteration by which treatment is assigned or resistance mechanisms using additional genomic, ribonucleic acid (RNA), protein and imaging-based assessment platforms.~IV. To assess whether radiomic phenotypes obtained from pre-treatment imaging and changes from pre- through post-therapy imaging can predict objective response and progression free survival and to evaluate the association between pre-treatment radiomic phenotypes and targeted gene mutation patterns of tumor biopsy specimens.~OUTLINE:~Patients receive PI3K-beta inhibitor GSK2636771 (GSK2636771) orally (PO) once daily (QD) on days 1-28. Cycles repeat every 28 days in the absence of disease progression or unacceptable toxicity.~After completion of study treatment, patients are followed up every 3 months if less than 2 years from study entry, and then every 6 months for year 3 from study entry.
|
MATCH Treatment Subprotocol N: Phase II Study of PI3K Beta Specific Inhibitor, GSK2636771, in Patients With Tumors With PTEN Mutation or Deletion, With PTEN Expression on IHC
|
Refractory Multiple Myeloma, Advanced Lymphoma, Advanced Malignant Solid Neoplasm, Hematopoietic and Lymphoid Cell Neoplasm, Refractory Lymphoma, Refractory Malignant Solid Neoplasm
|
* Drug: PI3K-beta Inhibitor GSK2636771
|
Inclusion Criteria:~Patients must have met applicable eligibility criteria in the Master MATCH Protocol prior to registration to treatment subprotocol~Patients must have an electrocardiogram (ECG) within 8 weeks prior to treatment assignment and must have no clinically important abnormalities in rhythm, conduction or morphology of resting ECG (e.g. complete left bundle branch block, third degree heart block)~Patients must have PTEN gene mutation/deletion~There must be evidence of PTEN expression by immunohistochemistry (IHC) (any amount of staining will be considered positive for expression)~Patients with complete loss of PTEN by IHC, regardless of PTEN mutations/deletion status, will be enrolled into MATCH subprotocol EAY131-P, not this subprotocol (EAY131-N)~Patients must have hemoglobin >= 9 g/dL~Patients must have a serum creatinine that =< 1.5 x upper limit of normal (ULN) or have a 24-hour creatinine clearance of >= 50 mL/min~Exclusion Criteria:~Patients must not have known hypersensitivity to GSK2636771 or compounds of similar chemical or biologic composition.~Patients must not have tumors harboring co-existing aberrations activating the PI3K/MTOR and MAPK pathways, such as PIK3CA, PIK3R1, BRAF, KRAS and AKT1, TSC1/2, mTOR, NF2, NRAS, HRAS, NF1~Patients must not have received prior treatment with agents targeting the PI3K beta, AKT, or mTOR pathways:~This includes (but is not limited to):~mTOR inhibitors: temsirolimus, everolimus, ridaforolimus, sirolimus, salirasib, CC-223, INK128, DS-3078, CC-115, AZD-2014~Dual PI3K/mTOR inhibitors: BEZ235, XL-765, GDC 0980, PF-04691502, GSK 2126458, Quinacrine, PKI-587, P-P7170, LY3023414, GDC 0084, DS 7423, CBLC-137~Pan-PI3K inhibitors: BKM-120 (buparlisib), PX-866, XL-147, GDC-0941 (pictilisib), BAY-806946, ZSTK-474, WX 037, SRX5000, SRX2523, AMG511, PQR308, BAY 94-9343~PI3K inhibitors with beta isoform activity: prior GSK2636771 is not allowed, nor is GS-9820, PQR3XX, KAR4139~The following treatments are allowed:~BYL719 (PI3Kalpha inhibitor)~GDC-0032 (PI3Kalpha inhibitor)~INK1117 (PI3Kalpha inhibitor)~Idelalisib (PI3Kdelta inhibitor)~IPI-125 (PI3K gamma delta inhibitor)~TGR1202 (PI3Kdelta inhibitor)~SRX2558 (PI3Kdelta inhibitor)~RP6530 (PI3K gamma delta inhibitor)~PWT143 (PI3Kdelta inhibitor)~IPI443 (PI3K gamma delta inhibitor)~GNE293 (PI3Kdelta inhibitor)~Patients with a history of interstitial lung disease or pneumonitis are excluded~Patients must not have any congenital platelet function defects and cannot be on any of the following anti-platelet drugs: clopidogrel, ticlopidine, prasugrel, that act at platelet purinergic receptors~Any need for starting anti-platelet therapy in a patient enrolled to this arm will have to be evaluated by the subprotocol chair
|
18 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 (ORR) | ORR is defined as the percentage of patients whose tumors have a complete or partial response to treatment among eligible and treated patients. Objective response rate is defined consistent with Response Evaluation Criteria in Solid Tumors version 1.1, the Cheson (2014) criteria for lymphoma patients, and the Response Assessment in Neuro-Oncology criteria for glioblastoma patients. For each treatment arm, 90% two-sided binomial exact confidence interval will be calculated for ORR. | Tumor assessments occurred at baseline, then every 2 cycles for the first 26 cycles and every 3 cycles thereafter until disease progression, up to 3 years post registration |
|
| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Overall survival (OS) | OS is defined as time from treatment start date to date of death from any cause. Patients alive at the time of analysis are censored at last contact date. OS w ill be evaluated specifically for each drug (or step) using the Kaplan-Meier method. | Assessed every 3 months for =< 2 years and every 6 months for year 3 |
| Progression free survival (PFS) | Progression free survival is defined as time from treatment start date to date of progression or death from any cause, whichever occurs first. PFS will be estimated using the Kaplan-Meier method. | Assessed at baseline, then every 2 cycles for the first 26 cycles and every 3 cycles thereafter until disease progression, up to 3 years post registration |
|
GSK2636771, Antineoplastic Agents, Protein Kinase Inhibitors, Enzyme Inhibitors, Molecular Mechanisms of Pharmacological Action
|
| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Treatment (GSK2636771)<br>Patients receive PI3K-beta inhibitor GSK2636771 PO QD on days 1-28. Cycles repeat every 28 days in the absence of disease progression or unacceptable toxicity. | Drug: PI3K-beta Inhibitor GSK2636771<br>* Given PO<br>* Other names: GSK2636771;|
|
Testing GSK2636771 as a Potential Targeted Treatment in Cancers With PTEN Genetic Changes (MATCH-Subprotocol N)
Study Overview
=================
Brief Summary
-----------------
This phase II MATCH treatment trial identifies the effects of GSK2636771 in patients whose cancer has a genetic change called PTEN mutation or deletion. GSK2636771 may block a protein called PI3K-beta, which may be needed for growth of cancer cells that express PTEN mutations. Researchers hope to learn if GSK2636771 will shrink this type of cancer or stop its growth.
Detailed Description
-----------------
PRIMARY OBJECTIVE: I. To evaluate the proportion of patients with objective response (OR) to targeted study agent(s) in patients with advanced refractory cancers/lymphomas/multiple myeloma. SECONDARY OBJECTIVES: I. To evaluate the proportion of patients alive and progression free at 6 months of treatment with targeted study agent in patients with advanced refractory cancers/lymphomas/multiple myeloma. II. To evaluate time until death or disease progression. III. To identify potential predictive biomarkers beyond the genomic alteration by which treatment is assigned or resistance mechanisms using additional genomic, ribonucleic acid (RNA), protein and imaging-based assessment platforms. IV. To assess whether radiomic phenotypes obtained from pre-treatment imaging and changes from pre- through post-therapy imaging can predict objective response and progression free survival and to evaluate the association between pre-treatment radiomic phenotypes and targeted gene mutation patterns of tumor biopsy specimens. OUTLINE: Patients receive PI3K-beta inhibitor GSK2636771 (GSK2636771) orally (PO) once daily (QD) on days 1-28. Cycles repeat every 28 days in the absence of disease progression or unacceptable toxicity. After completion of study treatment, patients are followed up every 3 months if less than 2 years from study entry, and then every 6 months for year 3 from study entry.
Official Title
-----------------
MATCH Treatment Subprotocol N: Phase II Study of PI3K Beta Specific Inhibitor, GSK2636771, in Patients With Tumors With PTEN Mutation or Deletion, With PTEN Expression on IHC
Conditions
-----------------
Refractory Multiple Myeloma, Advanced Lymphoma, Advanced Malignant Solid Neoplasm, Hematopoietic and Lymphoid Cell Neoplasm, Refractory Lymphoma, Refractory Malignant Solid Neoplasm
Intervention / Treatment
-----------------
* Drug: PI3K-beta Inhibitor GSK2636771
Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Patients must have met applicable eligibility criteria in the Master MATCH Protocol prior to registration to treatment subprotocol Patients must have an electrocardiogram (ECG) within 8 weeks prior to treatment assignment and must have no clinically important abnormalities in rhythm, conduction or morphology of resting ECG (e.g. complete left bundle branch block, third degree heart block) Patients must have PTEN gene mutation/deletion There must be evidence of PTEN expression by immunohistochemistry (IHC) (any amount of staining will be considered positive for expression) Patients with complete loss of PTEN by IHC, regardless of PTEN mutations/deletion status, will be enrolled into MATCH subprotocol EAY131-P, not this subprotocol (EAY131-N) Patients must have hemoglobin >= 9 g/dL Patients must have a serum creatinine that =< 1.5 x upper limit of normal (ULN) or have a 24-hour creatinine clearance of >= 50 mL/min Exclusion Criteria: Patients must not have known hypersensitivity to GSK2636771 or compounds of similar chemical or biologic composition. Patients must not have tumors harboring co-existing aberrations activating the PI3K/MTOR and MAPK pathways, such as PIK3CA, PIK3R1, BRAF, KRAS and AKT1, TSC1/2, mTOR, NF2, NRAS, HRAS, NF1 Patients must not have received prior treatment with agents targeting the PI3K beta, AKT, or mTOR pathways: This includes (but is not limited to): mTOR inhibitors: temsirolimus, everolimus, ridaforolimus, sirolimus, salirasib, CC-223, INK128, DS-3078, CC-115, AZD-2014 Dual PI3K/mTOR inhibitors: BEZ235, XL-765, GDC 0980, PF-04691502, GSK 2126458, Quinacrine, PKI-587, P-P7170, LY3023414, GDC 0084, DS 7423, CBLC-137 Pan-PI3K inhibitors: BKM-120 (buparlisib), PX-866, XL-147, GDC-0941 (pictilisib), BAY-806946, ZSTK-474, WX 037, SRX5000, SRX2523, AMG511, PQR308, BAY 94-9343 PI3K inhibitors with beta isoform activity: prior GSK2636771 is not allowed, nor is GS-9820, PQR3XX, KAR4139 The following treatments are allowed: BYL719 (PI3Kalpha inhibitor) GDC-0032 (PI3Kalpha inhibitor) INK1117 (PI3Kalpha inhibitor) Idelalisib (PI3Kdelta inhibitor) IPI-125 (PI3K gamma delta inhibitor) TGR1202 (PI3Kdelta inhibitor) SRX2558 (PI3Kdelta inhibitor) RP6530 (PI3K gamma delta inhibitor) PWT143 (PI3Kdelta inhibitor) IPI443 (PI3K gamma delta inhibitor) GNE293 (PI3Kdelta inhibitor) Patients with a history of interstitial lung disease or pneumonitis are excluded Patients must not have any congenital platelet function defects and cannot be on any of the following anti-platelet drugs: clopidogrel, ticlopidine, prasugrel, that act at platelet purinergic receptors Any need for starting anti-platelet therapy in a patient enrolled to this arm will have to be evaluated by the subprotocol chair
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: Treatment (GSK2636771)<br>Patients receive PI3K-beta inhibitor GSK2636771 PO QD on days 1-28. Cycles repeat every 28 days in the absence of disease progression or unacceptable toxicity. | Drug: PI3K-beta Inhibitor GSK2636771<br>* Given PO<br>* Other names: GSK2636771;|
What is the study measuring?
-----------------
Primary Outcome Measures
| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Objective response rate (ORR) | ORR is defined as the percentage of patients whose tumors have a complete or partial response to treatment among eligible and treated patients. Objective response rate is defined consistent with Response Evaluation Criteria in Solid Tumors version 1.1, the Cheson (2014) criteria for lymphoma patients, and the Response Assessment in Neuro-Oncology criteria for glioblastoma patients. For each treatment arm, 90% two-sided binomial exact confidence interval will be calculated for ORR. | Tumor assessments occurred at baseline, then every 2 cycles for the first 26 cycles and every 3 cycles thereafter until disease progression, up to 3 years post registration |
Secondary Outcome Measures
| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Overall survival (OS) | OS is defined as time from treatment start date to date of death from any cause. Patients alive at the time of analysis are censored at last contact date. OS w ill be evaluated specifically for each drug (or step) using the Kaplan-Meier method. | Assessed every 3 months for =< 2 years and every 6 months for year 3 |
| Progression free survival (PFS) | Progression free survival is defined as time from treatment start date to date of progression or death from any cause, whichever occurs first. PFS will be estimated using the Kaplan-Meier method. | Assessed at baseline, then every 2 cycles for the first 26 cycles and every 3 cycles thereafter until disease progression, up to 3 years post registration |
|
|
NCT04771975
|
Connecting Breast Cancer Survivors for Exercise
|
Phase 1: The purpose of this study is to examine interpersonal and individual effects of partnering BCS with a peer and a qualified exercise professional (QEP) on self-reported exercise volume (MVPA; primary outcome), and device-measured exercise volume (MVPA; Fitbit), social support, and HRQOL (secondary outcomes). Cost-effectiveness and intervention adherence will also be explored as tertiary outcomes. The effects of a peer and QEP-support intervention group, labelled MatchQEP, will be compared to a control group of BCS who are matched with a peer, but not a QEP, labelled Match.~Phase 2: The purpose of this study is to examine whether the addition of 8-weekly QEP-lead resistance training Zoom sessions with an exercise partner interacts with social support (i.e., tangible, informational, emotional) and how this interaction relates to overall exercise volume as an extension of Phase 1 (one year after phase 1 was completed). A secondary aim of Phase 2 is to examine the direct influence of resistance training on body image, self-efficacy, the physical self, and body functionality among the participants.
|
The purpose of this project is to examine naturally occurring social support as related to daily exercise behavior. In our ecological momentary assessment (EMA) study, the function of social support (tangible, informational, emotional) was be explored as independent variables, and exercise dose (minutes, intensity) and type (aerobic, resistance training, flexibility) will be examined as dependent variables. The associations will be used to inform motivational and behaviour change messaging in ActiveMatch, a program developed and run by the PI of this study, Dr. Catherine Sabiston. It is generally hypothesized that the provision of social support will be associated with greater exercise behaviour. In phase 1 of Connect for exercise, the RCT portion of this study, the addition of qualified exercise professional (QEP) support will be evaluated compared to social support from a participant match (exercise partner) alone. In Phase 2 of the Connect for exercise trial (pre-post design with no control group), we will examine whether the addition of 8-weekly QEP-lead resistance training Zoom sessions with an exercise partner interacts with social support (i.e., tangible, informational, emotional) and how this interaction relates to overall exercise volume (completed one-year post phase 1 completion). A secondary aim of Phase 2 is to examine the direct influence of resistance training on body image, self-efficacy, the physical self, and body functionality among the participants. There is evidence that resistance training improves these outcomes in women (Santa Barbara et al., 2017), but the relationship is understudied in breast cancer survivors. Improvements in these outcomes have, in turn, been related to increases in PA and sustainable positive PA outcomes. Considering the decreases in body image and body functionality appreciation reported by BCS during and after treatment (Resaei et al., 2016), this relationship warrants further investigation.
|
Connecting Breast Cancer Survivors for Exercise: A Randomized Controlled Trial Phase I and II
|
Breast Cancer, Breast Neoplasms
|
* Behavioral: Exercise Counselling
* Behavioral: Partner Matching
* Behavioral: Resistance training sessions led by a QEP
|
Phase 1 and phase 2:~Inclusion Criteria:~Female~Breast cancer survivors~Stage 1-4 cancer~Aged >18 years~Have been cleared for exercise~Have consistent access to an Internet-connected device~Currently exercise ≤ 150 minutes per week.~Exclusion Criteria:~Report contraindications to exercise such as physical disability~Had recent or planned reconstructive surgery~Have no consistent access to an Internet-connected device~Are currently meeting exercise guidelines (performing > 150 minutes of moderate-to- vigorous exercise)~Have not been cleared to participate in exercise
|
18 Years
| null |
Female
|
No
|
Primary Purpose: Supportive Care
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double
|
| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Phase 1 and Phase 2: Change in exercise volume | The Godin Leisure Time Exercise Questionnaire will be used to measure exercise volume over 1 week. It is a self-report measure which asks respondents to give weekly frequencies and durations of strenuous, moderate, and mild aerobic activities and resistance training sessions. Together responses are summed to determine a total weekly leisure activity score. It is shown to be reliable and valid (r=.53) when classifying respondents into 'insufficiently active' and 'active' categories (Amireault & Godin, 2015; Amireault et al., 2015; Amireault et al., 2015; Godin & Shephard, 1985b). Respondents are classified as 'active' by exceeding a score of 24 on this scale (Amireault & Godin, 2015; Amireault et al., 2015; Amireault et al., 2015). | Baseline, 10-weeks post baseline. |
| Phase 1 and Phase 2: Change in exercise volume | The Godin Leisure Time Exercise Questionnaire will be used to measure exercise volume over 1 week. It is a self-report measure which asks respondents to give weekly frequencies and durations of strenuous, moderate, and mild aerobic activities and resistance training sessions. Together responses are summed to determine a total weekly leisure activity score. It is shown to be reliable and valid (r=.53) when classifying respondents into 'insufficiently active' and 'active' categories (Amireault & Godin, 2015; Amireault et al., 2015; Amireault et al., 2015; Godin & Shephard, 1985b). Respondents are classified as 'active' by exceeding a score of 24 on this scale (Amireault & Godin, 2015; Amireault et al., 2015; Amireault et al., 2015). | 14-weeks post baseline |
| Phase 1 and Phase 2: Change in exercise volume | The Godin Leisure Time Exercise Questionnaire will be used to measure exercise volume over 1 week. It is a self-report measure which asks respondents to give weekly frequencies and durations of strenuous, moderate, and mild aerobic activities and resistance training sessions. Together responses are summed to determine a total weekly leisure activity score. It is shown to be reliable and valid (r=.53) when classifying respondents into 'insufficiently active' and 'active' categories (Amireault & Godin, 2015; Amireault et al., 2015; Amireault et al., 2015; Godin & Shephard, 1985b). Respondents are classified as 'active' by exceeding a score of 24 on this scale (Amireault & Godin, 2015; Amireault et al., 2015; Amireault et al., 2015). | 26-weeks post baseline |
|
| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Phase 1 and Phase 2: Change in exercise volume | Exercise volume will also be assessed using a tracking device (Fitbit Inspire® 2 accelerometer). Adherence to Fitbit's use in cancer survivors is high [58,59] and Fitbit exercise data has demonstrated high correlation to Actigraph measures in this population [58]. Fitbit devices will be mailed to BCS at study inception and will be required to be worn for 7 consecutive days during the four primary data collections to determine their average daily and weekly minutes of MVPA and step count. BCS are not required to wear the device outside of the data collection timeframes, but can wear them if they choose. | Baseline, 10-weeks post-baseline, 14-weeks post-baseline, 26-weeks post-baseline |
| Phase 1: Change in social support | A 14-item breast cancer-specific version of the Social Support Survey (SSS) will be used to assess seven dimensions of social support including: listening support, task challenge, emotional support, esteem support, reality confirmation, tangible assistance, and understanding breast cancer support. Respondents will be asked to score questions on a five-point Likert scale for each type of support rated from 1=very dissatisfied to 5=very satisfied. Higher scores represent a better outcome. | Baseline, 10-weeks post-baseline, 14-weeks post-baseline, 26-weeks post-baseline |
| Phase 1: Change in health-related quality of life assessed by the Short-Form-12 | The Short-Form-12 (SF-12) will be used to assess HRQOL. The SF-12 is a self-administered questionnaire including 12 items addressing eight domains of health: physical functioning, role-physical, bodily pain, general health, vitality, social functioning, role-emotional, and mental health. A composite index is scaled from 0 to 100 and normalized to approximately 50 with a higher score indicating better health. | Baseline, 10-weeks post-baseline, 14-weeks post-baseline, 26-weeks post-baseline |
| Phase 1: Change in quality of life assessed by the EuroQol-5 Dimension-3 level (EQ-5D-3L) | The EQ-5D-3L will also be used to assess HRQOL. The EQ-5D-3L is a two-part measure. The first part using a three-level scale (1=no problems, 2=some problems, 3=unable) to assess five dimensions of health: mobility, self-care, usual activities, pain/discomfort, and anxiety/depression. Lower scores represent better HRQOL. The second part assesses responder's perception of their health on a visual analogue scale from 0 (worst imaginable health) to 10 (best imaginable health). | Baseline, 10-weeks post-baseline, 14-weeks post-baseline, 26-weeks post-baseline |
| Phase 1 and Phase 2: Cost of intervention arms | The costs of the MatchQEP program will be calculated and compared to traditional face-to face costs of QEP services. Program costs related to MatchQEP include labour, equipment, and consumables. The cost of training staff will also be excluded as staff will already be qualified for their role. Labour costs will by calculated by assessing the number of contact hours between the QEP and survivor over the 10-week program, and the unit cost of 1 hour of work by the QEP. For each 1-hour contact session, 1.5 hours of labour will be allocated to account for preparation time needed by the QEP during the phone sessions. Equipment related costs to run the MatchQEP program will include any form of device that a survivor may purchase for use at home based on the QEP recommendations (for example TheraBand or weights) and a computer and telephone for the QEP. | 10-weeks (post intervention) |
| Phase 1: Use of health care resources | The use of health care resources will be compared between the two groups at follow up time points using a piloted questionnaire assessing number of health care facility visits, doctor visits, procedures received, support services used, loss of work, and prescription medications used. | 10-weeks post-baseline, 14-weeks post-baseline, 26-weeks post-baseline |
| Phase 1 and Phase 2: Intervention adherence | The QEP will track MatchQEP group adherence by completing a weekly session log. The QEP will record attendance of each BCS at the virtual QEP session as well as whether each individual completed the goals set from the previous session. MatchQEP group adherence is defined as the number of sessions attended divided by the total number of sessions.~Match group adherence will be determined by the number of times the peers connect during the 10-week intervention period. | 10-weeks post-baseline |
| Phase 2: Resistance Exercise Self-Efficacy | Guide for constructing self-efficacy scales | Baseline, 8-weeks post-baseline, 26-weeks post-baseline |
| Phase 2: Physical Self | Physical Self-Description Questionnaire: | Baseline, 8-weeks post-baseline, 26-weeks post-baseline |
| Phase 2: Body Functionality appreciation | Functionality Appreciation Scale: | Baseline, 8-weeks post-baseline, 26-weeks post-baseline |
|
exercise, physical activity, oncology, breast cancer, survivorship, social support, resistance training, body image, physical self, body functionality
|
Breast Neoplasms, Neoplasms by Site, Neoplasms, Breast Diseases, Skin Diseases
|
| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: MatchQEP group<br>Phase 1: All participants will receive an 'Exercise Peer Support Guide' that provides suggestions for supporting their exercise partner and a one-page document describing current exercise guidelines for cancer survivors [16-18]. All participants will also be given a Fitbit device, which will be used for device-measured MVPA.~Participants in the MatchQEP group will receive exercise information and program sessions tailored by a qualified exercise professional (QEP) specifically for each BCS in the dyad. Dyads will meet with the QEP via Zoom once per week for 10 weeks for up to 60 minutes. For four weeks following the 10-week intervention period, the QEP will be available for consultation (i.e., a post-intervention tapering period) as needed by the MatchQEP group participants.~Phase 2: Was not an RCT (i.e., all Phase 1 participants were approached to participate in Phase 2). Phase 2 is a pre-post intervention design, with no control group. | Behavioral: Exercise Counselling<br>* Phase 1: See previous description for MatchQEP (Intervention) group. Phase 2: Was not an RCT (i.e., all Phase 1 participants were approached to participate in Phase 2). Phase 2 is a pre-post intervention design, with no control group. Phase 2 participants had the option to extend their time in the study for an additional 8-weeks, which includes an online virtual (zoom) resistance training program with a qualified exercise professional (QEP) with a new study partner. The 8-week program was open to all participants from Phase 1 who choose to continue in the study, regardless of initial randomization status. Behavioural and exercise counselling were offered to phase 2 participants.<br>* Other names: QEP support;Behavioral: Partner Matching<br>* Phase 1: All participants will be matched with another participant (fellow BCS) and will facilitate / support exercise with their partner for the duration of the study.~Phase 2: Was not an RCT (i.e., all Phase 1 participants were approached to participate in Phase 2). Phase 2 is a pre-post intervention design, with no control group. Phase 2 participants were rematched with different partner for this phase of the trial.~Participants will be matched based on personal and cancer-related characteristics.<br>Behavioral: Resistance training sessions led by a QEP<br>* Phase 2: participants were offered the option to extend their time in the study for an additional 8-weeks, which includes an online virtual (zoom) resistance training program with a qualified exercise professional (QEP) with a new study partner.<br>|
| Active Comparator: Match group<br>Phase 1: All participants will receive an 'Exercise Peer Support Guide' that provides suggestions for supporting their exercise partner and a one-page document describing current exercise guidelines for cancer survivors [16-18]. All participants will also be given a Fitbit device, which will be used for device-measured MVPA.~Participants in the Match (control) group will independently communicate and support each other around exercise for 10 weeks. They will not have any contact with a QEP during this time.~Phase 2: Was not an RCT (i.e., all Phase 1 participants were approached to participate in Phase 2). Phase 2 is a pre-post intervention design, with no control group. | Behavioral: Partner Matching<br>* Phase 1: All participants will be matched with another participant (fellow BCS) and will facilitate / support exercise with their partner for the duration of the study.~Phase 2: Was not an RCT (i.e., all Phase 1 participants were approached to participate in Phase 2). Phase 2 is a pre-post intervention design, with no control group. Phase 2 participants were rematched with different partner for this phase of the trial.~Participants will be matched based on personal and cancer-related characteristics.<br>Behavioral: Resistance training sessions led by a QEP<br>* Phase 2: participants were offered the option to extend their time in the study for an additional 8-weeks, which includes an online virtual (zoom) resistance training program with a qualified exercise professional (QEP) with a new study partner.<br>|
|
Connecting Breast Cancer Survivors for Exercise
Study Overview
=================
Brief Summary
-----------------
Phase 1: The purpose of this study is to examine interpersonal and individual effects of partnering BCS with a peer and a qualified exercise professional (QEP) on self-reported exercise volume (MVPA; primary outcome), and device-measured exercise volume (MVPA; Fitbit), social support, and HRQOL (secondary outcomes). Cost-effectiveness and intervention adherence will also be explored as tertiary outcomes. The effects of a peer and QEP-support intervention group, labelled MatchQEP, will be compared to a control group of BCS who are matched with a peer, but not a QEP, labelled Match. Phase 2: The purpose of this study is to examine whether the addition of 8-weekly QEP-lead resistance training Zoom sessions with an exercise partner interacts with social support (i.e., tangible, informational, emotional) and how this interaction relates to overall exercise volume as an extension of Phase 1 (one year after phase 1 was completed). A secondary aim of Phase 2 is to examine the direct influence of resistance training on body image, self-efficacy, the physical self, and body functionality among the participants.
Detailed Description
-----------------
The purpose of this project is to examine naturally occurring social support as related to daily exercise behavior. In our ecological momentary assessment (EMA) study, the function of social support (tangible, informational, emotional) was be explored as independent variables, and exercise dose (minutes, intensity) and type (aerobic, resistance training, flexibility) will be examined as dependent variables. The associations will be used to inform motivational and behaviour change messaging in ActiveMatch, a program developed and run by the PI of this study, Dr. Catherine Sabiston. It is generally hypothesized that the provision of social support will be associated with greater exercise behaviour. In phase 1 of Connect for exercise, the RCT portion of this study, the addition of qualified exercise professional (QEP) support will be evaluated compared to social support from a participant match (exercise partner) alone. In Phase 2 of the Connect for exercise trial (pre-post design with no control group), we will examine whether the addition of 8-weekly QEP-lead resistance training Zoom sessions with an exercise partner interacts with social support (i.e., tangible, informational, emotional) and how this interaction relates to overall exercise volume (completed one-year post phase 1 completion). A secondary aim of Phase 2 is to examine the direct influence of resistance training on body image, self-efficacy, the physical self, and body functionality among the participants. There is evidence that resistance training improves these outcomes in women (Santa Barbara et al., 2017), but the relationship is understudied in breast cancer survivors. Improvements in these outcomes have, in turn, been related to increases in PA and sustainable positive PA outcomes. Considering the decreases in body image and body functionality appreciation reported by BCS during and after treatment (Resaei et al., 2016), this relationship warrants further investigation.
Official Title
-----------------
Connecting Breast Cancer Survivors for Exercise: A Randomized Controlled Trial Phase I and II
Conditions
-----------------
Breast Cancer, Breast Neoplasms
Intervention / Treatment
-----------------
* Behavioral: Exercise Counselling
* Behavioral: Partner Matching
* Behavioral: Resistance training sessions led by a QEP
Participation Criteria
=================
Eligibility Criteria
-----------------
Phase 1 and phase 2: Inclusion Criteria: Female Breast cancer survivors Stage 1-4 cancer Aged >18 years Have been cleared for exercise Have consistent access to an Internet-connected device Currently exercise ≤ 150 minutes per week. Exclusion Criteria: Report contraindications to exercise such as physical disability Had recent or planned reconstructive surgery Have no consistent access to an Internet-connected device Are currently meeting exercise guidelines (performing > 150 minutes of moderate-to- vigorous exercise) Have not been cleared to participate in exercise
Ages Eligible for Study
-----------------
Minimum Age: 18 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: Double
Arms and Interventions
| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: MatchQEP group<br>Phase 1: All participants will receive an 'Exercise Peer Support Guide' that provides suggestions for supporting their exercise partner and a one-page document describing current exercise guidelines for cancer survivors [16-18]. All participants will also be given a Fitbit device, which will be used for device-measured MVPA. Participants in the MatchQEP group will receive exercise information and program sessions tailored by a qualified exercise professional (QEP) specifically for each BCS in the dyad. Dyads will meet with the QEP via Zoom once per week for 10 weeks for up to 60 minutes. For four weeks following the 10-week intervention period, the QEP will be available for consultation (i.e., a post-intervention tapering period) as needed by the MatchQEP group participants. Phase 2: Was not an RCT (i.e., all Phase 1 participants were approached to participate in Phase 2). Phase 2 is a pre-post intervention design, with no control group. | Behavioral: Exercise Counselling<br>* Phase 1: See previous description for MatchQEP (Intervention) group. Phase 2: Was not an RCT (i.e., all Phase 1 participants were approached to participate in Phase 2). Phase 2 is a pre-post intervention design, with no control group. Phase 2 participants had the option to extend their time in the study for an additional 8-weeks, which includes an online virtual (zoom) resistance training program with a qualified exercise professional (QEP) with a new study partner. The 8-week program was open to all participants from Phase 1 who choose to continue in the study, regardless of initial randomization status. Behavioural and exercise counselling were offered to phase 2 participants.<br>* Other names: QEP support;Behavioral: Partner Matching<br>* Phase 1: All participants will be matched with another participant (fellow BCS) and will facilitate / support exercise with their partner for the duration of the study. Phase 2: Was not an RCT (i.e., all Phase 1 participants were approached to participate in Phase 2). Phase 2 is a pre-post intervention design, with no control group. Phase 2 participants were rematched with different partner for this phase of the trial. Participants will be matched based on personal and cancer-related characteristics.<br>Behavioral: Resistance training sessions led by a QEP<br>* Phase 2: participants were offered the option to extend their time in the study for an additional 8-weeks, which includes an online virtual (zoom) resistance training program with a qualified exercise professional (QEP) with a new study partner.<br>|
| Active Comparator: Match group<br>Phase 1: All participants will receive an 'Exercise Peer Support Guide' that provides suggestions for supporting their exercise partner and a one-page document describing current exercise guidelines for cancer survivors [16-18]. All participants will also be given a Fitbit device, which will be used for device-measured MVPA. Participants in the Match (control) group will independently communicate and support each other around exercise for 10 weeks. They will not have any contact with a QEP during this time. Phase 2: Was not an RCT (i.e., all Phase 1 participants were approached to participate in Phase 2). Phase 2 is a pre-post intervention design, with no control group. | Behavioral: Partner Matching<br>* Phase 1: All participants will be matched with another participant (fellow BCS) and will facilitate / support exercise with their partner for the duration of the study. Phase 2: Was not an RCT (i.e., all Phase 1 participants were approached to participate in Phase 2). Phase 2 is a pre-post intervention design, with no control group. Phase 2 participants were rematched with different partner for this phase of the trial. Participants will be matched based on personal and cancer-related characteristics.<br>Behavioral: Resistance training sessions led by a QEP<br>* Phase 2: participants were offered the option to extend their time in the study for an additional 8-weeks, which includes an online virtual (zoom) resistance training program with a qualified exercise professional (QEP) with a new study partner.<br>|
What is the study measuring?
-----------------
Primary Outcome Measures
| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Phase 1 and Phase 2: Change in exercise volume | The Godin Leisure Time Exercise Questionnaire will be used to measure exercise volume over 1 week. It is a self-report measure which asks respondents to give weekly frequencies and durations of strenuous, moderate, and mild aerobic activities and resistance training sessions. Together responses are summed to determine a total weekly leisure activity score. It is shown to be reliable and valid (r=.53) when classifying respondents into 'insufficiently active' and 'active' categories (Amireault & Godin, 2015; Amireault et al., 2015; Amireault et al., 2015; Godin & Shephard, 1985b). Respondents are classified as 'active' by exceeding a score of 24 on this scale (Amireault & Godin, 2015; Amireault et al., 2015; Amireault et al., 2015). | Baseline, 10-weeks post baseline. |
| Phase 1 and Phase 2: Change in exercise volume | The Godin Leisure Time Exercise Questionnaire will be used to measure exercise volume over 1 week. It is a self-report measure which asks respondents to give weekly frequencies and durations of strenuous, moderate, and mild aerobic activities and resistance training sessions. Together responses are summed to determine a total weekly leisure activity score. It is shown to be reliable and valid (r=.53) when classifying respondents into 'insufficiently active' and 'active' categories (Amireault & Godin, 2015; Amireault et al., 2015; Amireault et al., 2015; Godin & Shephard, 1985b). Respondents are classified as 'active' by exceeding a score of 24 on this scale (Amireault & Godin, 2015; Amireault et al., 2015; Amireault et al., 2015). | 14-weeks post baseline |
| Phase 1 and Phase 2: Change in exercise volume | The Godin Leisure Time Exercise Questionnaire will be used to measure exercise volume over 1 week. It is a self-report measure which asks respondents to give weekly frequencies and durations of strenuous, moderate, and mild aerobic activities and resistance training sessions. Together responses are summed to determine a total weekly leisure activity score. It is shown to be reliable and valid (r=.53) when classifying respondents into 'insufficiently active' and 'active' categories (Amireault & Godin, 2015; Amireault et al., 2015; Amireault et al., 2015; Godin & Shephard, 1985b). Respondents are classified as 'active' by exceeding a score of 24 on this scale (Amireault & Godin, 2015; Amireault et al., 2015; Amireault et al., 2015). | 26-weeks post baseline |
Secondary Outcome Measures
| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Phase 1 and Phase 2: Change in exercise volume | Exercise volume will also be assessed using a tracking device (Fitbit Inspire® 2 accelerometer). Adherence to Fitbit's use in cancer survivors is high [58,59] and Fitbit exercise data has demonstrated high correlation to Actigraph measures in this population [58]. Fitbit devices will be mailed to BCS at study inception and will be required to be worn for 7 consecutive days during the four primary data collections to determine their average daily and weekly minutes of MVPA and step count. BCS are not required to wear the device outside of the data collection timeframes, but can wear them if they choose. | Baseline, 10-weeks post-baseline, 14-weeks post-baseline, 26-weeks post-baseline |
| Phase 1: Change in social support | A 14-item breast cancer-specific version of the Social Support Survey (SSS) will be used to assess seven dimensions of social support including: listening support, task challenge, emotional support, esteem support, reality confirmation, tangible assistance, and understanding breast cancer support. Respondents will be asked to score questions on a five-point Likert scale for each type of support rated from 1=very dissatisfied to 5=very satisfied. Higher scores represent a better outcome. | Baseline, 10-weeks post-baseline, 14-weeks post-baseline, 26-weeks post-baseline |
| Phase 1: Change in health-related quality of life assessed by the Short-Form-12 | The Short-Form-12 (SF-12) will be used to assess HRQOL. The SF-12 is a self-administered questionnaire including 12 items addressing eight domains of health: physical functioning, role-physical, bodily pain, general health, vitality, social functioning, role-emotional, and mental health. A composite index is scaled from 0 to 100 and normalized to approximately 50 with a higher score indicating better health. | Baseline, 10-weeks post-baseline, 14-weeks post-baseline, 26-weeks post-baseline |
| Phase 1: Change in quality of life assessed by the EuroQol-5 Dimension-3 level (EQ-5D-3L) | The EQ-5D-3L will also be used to assess HRQOL. The EQ-5D-3L is a two-part measure. The first part using a three-level scale (1=no problems, 2=some problems, 3=unable) to assess five dimensions of health: mobility, self-care, usual activities, pain/discomfort, and anxiety/depression. Lower scores represent better HRQOL. The second part assesses responder's perception of their health on a visual analogue scale from 0 (worst imaginable health) to 10 (best imaginable health). | Baseline, 10-weeks post-baseline, 14-weeks post-baseline, 26-weeks post-baseline |
| Phase 1 and Phase 2: Cost of intervention arms | The costs of the MatchQEP program will be calculated and compared to traditional face-to face costs of QEP services. Program costs related to MatchQEP include labour, equipment, and consumables. The cost of training staff will also be excluded as staff will already be qualified for their role. Labour costs will by calculated by assessing the number of contact hours between the QEP and survivor over the 10-week program, and the unit cost of 1 hour of work by the QEP. For each 1-hour contact session, 1.5 hours of labour will be allocated to account for preparation time needed by the QEP during the phone sessions. Equipment related costs to run the MatchQEP program will include any form of device that a survivor may purchase for use at home based on the QEP recommendations (for example TheraBand or weights) and a computer and telephone for the QEP. | 10-weeks (post intervention) |
| Phase 1: Use of health care resources | The use of health care resources will be compared between the two groups at follow up time points using a piloted questionnaire assessing number of health care facility visits, doctor visits, procedures received, support services used, loss of work, and prescription medications used. | 10-weeks post-baseline, 14-weeks post-baseline, 26-weeks post-baseline |
| Phase 1 and Phase 2: Intervention adherence | The QEP will track MatchQEP group adherence by completing a weekly session log. The QEP will record attendance of each BCS at the virtual QEP session as well as whether each individual completed the goals set from the previous session. MatchQEP group adherence is defined as the number of sessions attended divided by the total number of sessions. Match group adherence will be determined by the number of times the peers connect during the 10-week intervention period. | 10-weeks post-baseline |
| Phase 2: Resistance Exercise Self-Efficacy | Guide for constructing self-efficacy scales | Baseline, 8-weeks post-baseline, 26-weeks post-baseline |
| Phase 2: Physical Self | Physical Self-Description Questionnaire: | Baseline, 8-weeks post-baseline, 26-weeks post-baseline |
| Phase 2: Body Functionality appreciation | Functionality Appreciation Scale: | Baseline, 8-weeks post-baseline, 26-weeks post-baseline |
Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
exercise, physical activity, oncology, breast cancer, survivorship, social support, resistance training, body image, physical self, body functionality
|
NCT02698826
|
Reoxygenation After Cardiac Arrest II (REOX II Study)
|
The broad objective of this study is to test the association between hyperoxia exposure after resuscitation from cardiac arrest and outcome. After obtaining written informed consent subjects enrolled in REOX II will undergo a rapid faction of inspired oxygen (FiO2) optimization protocol to prevent exposure to hyperoxia. We will compare outcomes between subjects enrolled in REOX I (observational study only) and REOX II (intervention: rapid FiO2 optimization protocol). Our overarching hypothesis is that exposure to hyperoxia after return of spontaneous circulation (ROSC) is associated with increased oxidative stress and worsened neurological and cognitive outcomes.
|
Specific Aim 1: Test if initiation of the rapid FiO2 optimization protocol following ROSC from cardiac arrest is associated with the degree of in vivo oxidative stress during the post-resuscitation phase of therapy.~Approach: We will conduct a multicenter interventional study (FiO2 optimization protocol) of adult patients resuscitated from cardiac arrest. We will record data pertaining to oxygenation parameters and other factors and measure biomarkers of oxidative stress [isoprostanes (IsoPs) and isofurans (IsoFs)] in the plasma at 0 and 6 hours after ROSC using gas chromatography negative ion chemical ionization mass spectrometry. We will compare plasma IsoPs/IsoFs at each time point between subjects enrolled in REOX II (i.e. receive the study intervention, rapid FiO2 optimization) and REOX I (i.e. do not receive the study intervention) using t-test or Mann-Whitney U as appropriate with corrections for multiple comparisons.~Specific Aim 2: Test if initiation of the rapid FiO2 optimization protocol following ROSC from cardiac arrest is associated with a decrease in neurological disability at hospital discharge.~Approach: In the study described above, we will determine the Modified Rankin Scale (mRS) at hospital discharge. We will compare proportions of good neurological outcome [defined as a mRS ≤ 3] between subjects enrolled in REOX II (i.e. receive the study intervention, rapid FiO2 optimization) vs. those enrolled in REOX I (i.e. do not receive the study intervention), using binomial test.~Specific Aim 3: Test if initiation of the rapid FiO2 optimization protocol following ROSC from cardiac arrest is associated with neuropsychological outcomes among survivors at 180 days.~Approach: In the study described above, we will assess neuropsychological outcome among survivors at 180 days. Neuropsychological testing will use validated instruments across five cognitive domains (attention, Wechsler Adult Intelligence Scale-IV-digit span; (2) reasoning, Wechsler Adult Intelligence Scale-IV-similarities; (3) immediate and delayed memory, Wechsler Memory Scale-III-logical memory I and II; (4) verbal fluency, Controlled Oral Word Association Test; and (5) executive functioning, Hayling Sentence Completion Test). Among survivors, we will compare the 180-day neuropsychological measures (composite z-scores for each cognitive domain) between the same two groups using t-test or Mann-Whitney U as appropriate with corrections for multiple comparisons. We will also compare the proportions of patients able to return to work between the two groups using binomial test
|
Reoxygenation After Cardiac Arrest II (REOX II Study)
|
Cardiac Arrest
|
* Other: Protocol for rapid FiO2 optimization
|
Inclusion Criteria:~Age >17 years~Cardiac arrest~Return of spontaneous circulation~Not following commands immediately after ROSC~Endotracheal intubation~Clinician intent to treat with therapeutic hypothermia (or absence of clinician intent to withhold therapeutic hypothermia)~Exclusion Criteria:~Presumed etiology of arrest is trauma~Presumed etiology of arrest is hemorrhage~Presumed etiology of arrest is sepsis~Permanent resident of nursing home or other long-term care facility~Any other condition, that in the opinion of the investigator, would preclude the subject from being a suitable candidate, e.g. end stage chronic illness with no reasonable expectation of survival to hospital discharge
|
18 Years
| null |
All
|
No
|
Primary Purpose: Treatment
Intervention Model: Single Group Assignment
Masking: None (Open Label)
|
| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Plasma Isofurans (pg/mL)/Isoprostanes (pg/mL) Ratio | | Change in the isofurans/isoprostanes ratio between 0 and 6 hours post-ROSC |
|
| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Modified Rankin Scale (mRS) (Primary Neurological Outcome) | 0: No symptoms at all~No significant disability despite symptoms; able to carry out all usual duties and activities~Slight disability; unable to carry out all previous activities, but able to look after own affairs without assistance~Moderate disability; requiring some help, but able to walk without assistance~Moderately severe disability; unable to walk without assistance and unable to attend to own bodily needs without assistance~Severe disability; bedridden, incontinent and requiring constant nursing care and attention~Dead | Upon hospital discharge, on average two weeks |
|
Cardiac Arrest, Hyperoxia, Ischemia-reperfusion Injury, Reactive Oxygen Species, Oxidative Stress, Neuropsychological Tests
|
Heart Arrest, Heart Diseases, Cardiovascular Diseases
|
| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Adult patients resuscitated from cardiac arrest<br>Rapid FiO2 optimization protocol | Other: Protocol for rapid FiO2 optimization<br>* We plan to test a protocol for FiO2 optimization for mechanically ventilated post-cardiac arrest subjects, with a therapeutic goal of partial pressure of arterial oxygen (PaO2) of 60-99 mmHg, based on the PaO2 range that was associated with the lowest risk of poor outcome in our previously published work. We also use PaO2 (measured by arterial blood gas [ABG] analysis) as the ultimate goal rather than arterial oxygen saturation (SaO2) measured by pulse oximetry because an SaO2 value <100% on pulse oximetry monitoring does not always exclude supranormal PaO2. The protocol in this application begins with very rapid reduction of FiO2 as much as possible according to SaO2 values, and when FiO2 is maximally reduced by SaO2 an ABG is measured, followed by finer adjustment of FiO2 to achieve a PaO2 60-99 mmHg. The protocol not only prescribes each downward titration of FiO2 but it also includes detailed limbs for upward titration of FiO2 to account for potential overshoot in FiO2 reduction.<br>|
|
Reoxygenation After Cardiac Arrest II (REOX II Study)
Study Overview
=================
Brief Summary
-----------------
The broad objective of this study is to test the association between hyperoxia exposure after resuscitation from cardiac arrest and outcome. After obtaining written informed consent subjects enrolled in REOX II will undergo a rapid faction of inspired oxygen (FiO2) optimization protocol to prevent exposure to hyperoxia. We will compare outcomes between subjects enrolled in REOX I (observational study only) and REOX II (intervention: rapid FiO2 optimization protocol). Our overarching hypothesis is that exposure to hyperoxia after return of spontaneous circulation (ROSC) is associated with increased oxidative stress and worsened neurological and cognitive outcomes.
Detailed Description
-----------------
Specific Aim 1: Test if initiation of the rapid FiO2 optimization protocol following ROSC from cardiac arrest is associated with the degree of in vivo oxidative stress during the post-resuscitation phase of therapy. Approach: We will conduct a multicenter interventional study (FiO2 optimization protocol) of adult patients resuscitated from cardiac arrest. We will record data pertaining to oxygenation parameters and other factors and measure biomarkers of oxidative stress [isoprostanes (IsoPs) and isofurans (IsoFs)] in the plasma at 0 and 6 hours after ROSC using gas chromatography negative ion chemical ionization mass spectrometry. We will compare plasma IsoPs/IsoFs at each time point between subjects enrolled in REOX II (i.e. receive the study intervention, rapid FiO2 optimization) and REOX I (i.e. do not receive the study intervention) using t-test or Mann-Whitney U as appropriate with corrections for multiple comparisons. Specific Aim 2: Test if initiation of the rapid FiO2 optimization protocol following ROSC from cardiac arrest is associated with a decrease in neurological disability at hospital discharge. Approach: In the study described above, we will determine the Modified Rankin Scale (mRS) at hospital discharge. We will compare proportions of good neurological outcome [defined as a mRS ≤ 3] between subjects enrolled in REOX II (i.e. receive the study intervention, rapid FiO2 optimization) vs. those enrolled in REOX I (i.e. do not receive the study intervention), using binomial test. Specific Aim 3: Test if initiation of the rapid FiO2 optimization protocol following ROSC from cardiac arrest is associated with neuropsychological outcomes among survivors at 180 days. Approach: In the study described above, we will assess neuropsychological outcome among survivors at 180 days. Neuropsychological testing will use validated instruments across five cognitive domains (attention, Wechsler Adult Intelligence Scale-IV-digit span; (2) reasoning, Wechsler Adult Intelligence Scale-IV-similarities; (3) immediate and delayed memory, Wechsler Memory Scale-III-logical memory I and II; (4) verbal fluency, Controlled Oral Word Association Test; and (5) executive functioning, Hayling Sentence Completion Test). Among survivors, we will compare the 180-day neuropsychological measures (composite z-scores for each cognitive domain) between the same two groups using t-test or Mann-Whitney U as appropriate with corrections for multiple comparisons. We will also compare the proportions of patients able to return to work between the two groups using binomial test
Official Title
-----------------
Reoxygenation After Cardiac Arrest II (REOX II Study)
Conditions
-----------------
Cardiac Arrest
Intervention / Treatment
-----------------
* Other: Protocol for rapid FiO2 optimization
Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Age >17 years Cardiac arrest Return of spontaneous circulation Not following commands immediately after ROSC Endotracheal intubation Clinician intent to treat with therapeutic hypothermia (or absence of clinician intent to withhold therapeutic hypothermia) Exclusion Criteria: Presumed etiology of arrest is trauma Presumed etiology of arrest is hemorrhage Presumed etiology of arrest is sepsis Permanent resident of nursing home or other long-term care facility Any other condition, that in the opinion of the investigator, would preclude the subject from being a suitable candidate, e.g. end stage chronic illness with no reasonable expectation of survival to hospital discharge
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: Adult patients resuscitated from cardiac arrest<br>Rapid FiO2 optimization protocol | Other: Protocol for rapid FiO2 optimization<br>* We plan to test a protocol for FiO2 optimization for mechanically ventilated post-cardiac arrest subjects, with a therapeutic goal of partial pressure of arterial oxygen (PaO2) of 60-99 mmHg, based on the PaO2 range that was associated with the lowest risk of poor outcome in our previously published work. We also use PaO2 (measured by arterial blood gas [ABG] analysis) as the ultimate goal rather than arterial oxygen saturation (SaO2) measured by pulse oximetry because an SaO2 value <100% on pulse oximetry monitoring does not always exclude supranormal PaO2. The protocol in this application begins with very rapid reduction of FiO2 as much as possible according to SaO2 values, and when FiO2 is maximally reduced by SaO2 an ABG is measured, followed by finer adjustment of FiO2 to achieve a PaO2 60-99 mmHg. The protocol not only prescribes each downward titration of FiO2 but it also includes detailed limbs for upward titration of FiO2 to account for potential overshoot in FiO2 reduction.<br>|
What is the study measuring?
-----------------
Primary Outcome Measures
| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Plasma Isofurans (pg/mL)/Isoprostanes (pg/mL) Ratio | | Change in the isofurans/isoprostanes ratio between 0 and 6 hours post-ROSC |
Secondary Outcome Measures
| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Modified Rankin Scale (mRS) (Primary Neurological Outcome) | 0: No symptoms at all No significant disability despite symptoms; able to carry out all usual duties and activities Slight disability; unable to carry out all previous activities, but able to look after own affairs without assistance Moderate disability; requiring some help, but able to walk without assistance Moderately severe disability; unable to walk without assistance and unable to attend to own bodily needs without assistance Severe disability; bedridden, incontinent and requiring constant nursing care and attention Dead | Upon hospital discharge, on average two weeks |
Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Cardiac Arrest, Hyperoxia, Ischemia-reperfusion Injury, Reactive Oxygen Species, Oxidative Stress, Neuropsychological Tests
|
NCT01922752
|
To Determine the Maximum Tolerated Dose of Oral CEP-37440 in Patients With Advanced or Metastatic Solid Tumors
|
The primary objective is to determine the maximum tolerated dose (MTD), safety, and tolerability of oral CEP-37440 administered daily to patients with advanced or metastatic solid tumors.
|
An Open-Label Study to Determine the Maximum Tolerated Dose of Oral CEP-37440 Administered as a Single Agent in Patients With Advanced or Metastatic Solid Tumors
|
Solid Tumors
|
* Drug: CEP-37440
|
Inclusion Criteria:~Patients must have histologic or cytologic evidence of a solid neoplasm for which no standard therapy is available, or have progressed despite standard therapy, or are intolerant to standard therapy.~Patients must have evidence of recurrent, locally advanced, or metastatic disease.~Patients can either have had no prior anticancer therapy, multiple lines of either prior chemotherapy/biologic therapy/experimental therapy or, if the patient has anaplastic lymphoma kinase (ALK)-positive non-small cell lung cancer (NSCLC), prior crizotinib.~Patients must have a predicted life expectancy of more than 3 months.~Patients must have presence of at least 1 lesion that is measurable or evaluable using RECIST v1.1.~Patients must have an ECOG performance score of 0, 1, or 2.~Patients with central nervous system (CNS) metastases will be allowed on this study. Patients may have received surgical and/or radiation treatment. The metastases must be neurologically stable, on or off corticosteroids. Patients can have low level, asymptomatic brain lesions that do not require surgical/radiation intervention acutely. Patients with symptomatic lesions with impending neurologic compromise should be appropriately treated with high dose steroids/radiation and may be re-evaluated for this study when neurologically stable.~Patients must have completed any prior anticancer treatment and must have recovered from any acute toxicities. The period between the last dose of prior treatment and the first dose of study drug treatment must be at least 1 week for radiotherapy and at least 2 to 3 weeks for all other modalities of therapy including chemotherapy, monoclonal antibody therapy, immunotherapy, other investigational drugs, or other kinase inhibitors.~Other criteria apply.~Exclusion Criteria:~The patient has ongoing or active infection requiring parenteral antibiotics.~The patient has uncontrolled hypertension despite adequate therapy (ie, systolic blood pressure higher than 150 mm Hg or diastolic blood pressure higher than 90 mm Hg found on 2 separate occasions separated by 1 week).~The patient has uncontrolled diabetes mellitus (despite therapeutic intervention) and occurrence of more than 2 episodes of ketoacidosis in the 12 months prior to the first dose of study drug.~The patient has an active second malignancy other than curatively resected basal cell carcinoma of the skin, squamous cell carcinoma of the skin, in situ carcinoma of the cervix, or other cancers for which they are treated with curative intent, and no known active disease in the 3 years prior to enrollment.~The patient has a primary brain tumor. Patients may have brain metastases from another primary site.~The patient has QTcF interval greater than 450 msec, has a known history of QTcF prolongation, is taking medications known to prolong QTcF, or has a history of torsade de pointes.~The patient has a prior ALK-inhibitor-related toxicity or any other prior therapy-related acute toxicity that has not resolved prior to the first dose of study drug.~Other criteria apply.
|
18 Years
| null |
All
|
No
|
Primary Purpose: Treatment
Intervention Model: Single Group Assignment
Masking: None (Open Label)
|
| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Response Evaluation Criteria in Solid Tumors (RECIST v1.1) | | 8 months |
|
| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Time to Response (TTR) | The time interval from the date of first dose to the first documented response (complete or partial response) | 8 months |
| Number of participants with adverse events | | From signing of the informed consent to the end of the follow-up visit (approximately Month 10) |
| Time to Progression (TTP) | The time interval from date of first dose to first documented disease progression | 8 months |
| Progression-free Survival (PFS) | Time interval from date of first does to first documented disease progression or death from any cause (whichever occurs first) | 10 months |
| Time to New Metastases (TTNM) | Time interval from date of first dose to first documented new metastatic lesion not reported at baseline | 8 months |
|
CEP-37440, Advanced solid tumors, Metastatic solid tumors
|
Neoplasms
|
| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: CEP-37440<br> | Drug: CEP-37440<br>* CEP-37440 will be supplied as 25 mg and 100 mg capsules and will be orally administrated daily.~Patients will be enrolled sequentially in dose escalating cohorts to receive CEP-37440 until a maximum tolerated dose has been defined.<br>|
|
To Determine the Maximum Tolerated Dose of Oral CEP-37440 in Patients With Advanced or Metastatic Solid Tumors
Study Overview
=================
Brief Summary
-----------------
The primary objective is to determine the maximum tolerated dose (MTD), safety, and tolerability of oral CEP-37440 administered daily to patients with advanced or metastatic solid tumors.
Official Title
-----------------
An Open-Label Study to Determine the Maximum Tolerated Dose of Oral CEP-37440 Administered as a Single Agent in Patients With Advanced or Metastatic Solid Tumors
Conditions
-----------------
Solid Tumors
Intervention / Treatment
-----------------
* Drug: CEP-37440
Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Patients must have histologic or cytologic evidence of a solid neoplasm for which no standard therapy is available, or have progressed despite standard therapy, or are intolerant to standard therapy. Patients must have evidence of recurrent, locally advanced, or metastatic disease. Patients can either have had no prior anticancer therapy, multiple lines of either prior chemotherapy/biologic therapy/experimental therapy or, if the patient has anaplastic lymphoma kinase (ALK)-positive non-small cell lung cancer (NSCLC), prior crizotinib. Patients must have a predicted life expectancy of more than 3 months. Patients must have presence of at least 1 lesion that is measurable or evaluable using RECIST v1.1. Patients must have an ECOG performance score of 0, 1, or 2. Patients with central nervous system (CNS) metastases will be allowed on this study. Patients may have received surgical and/or radiation treatment. The metastases must be neurologically stable, on or off corticosteroids. Patients can have low level, asymptomatic brain lesions that do not require surgical/radiation intervention acutely. Patients with symptomatic lesions with impending neurologic compromise should be appropriately treated with high dose steroids/radiation and may be re-evaluated for this study when neurologically stable. Patients must have completed any prior anticancer treatment and must have recovered from any acute toxicities. The period between the last dose of prior treatment and the first dose of study drug treatment must be at least 1 week for radiotherapy and at least 2 to 3 weeks for all other modalities of therapy including chemotherapy, monoclonal antibody therapy, immunotherapy, other investigational drugs, or other kinase inhibitors. Other criteria apply. Exclusion Criteria: The patient has ongoing or active infection requiring parenteral antibiotics. The patient has uncontrolled hypertension despite adequate therapy (ie, systolic blood pressure higher than 150 mm Hg or diastolic blood pressure higher than 90 mm Hg found on 2 separate occasions separated by 1 week). The patient has uncontrolled diabetes mellitus (despite therapeutic intervention) and occurrence of more than 2 episodes of ketoacidosis in the 12 months prior to the first dose of study drug. The patient has an active second malignancy other than curatively resected basal cell carcinoma of the skin, squamous cell carcinoma of the skin, in situ carcinoma of the cervix, or other cancers for which they are treated with curative intent, and no known active disease in the 3 years prior to enrollment. The patient has a primary brain tumor. Patients may have brain metastases from another primary site. The patient has QTcF interval greater than 450 msec, has a known history of QTcF prolongation, is taking medications known to prolong QTcF, or has a history of torsade de pointes. The patient has a prior ALK-inhibitor-related toxicity or any other prior therapy-related acute toxicity that has not resolved prior to the first dose of study drug. Other criteria apply.
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: CEP-37440<br> | Drug: CEP-37440<br>* CEP-37440 will be supplied as 25 mg and 100 mg capsules and will be orally administrated daily. Patients will be enrolled sequentially in dose escalating cohorts to receive CEP-37440 until a maximum tolerated dose has been defined.<br>|
What is the study measuring?
-----------------
Primary Outcome Measures
| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Response Evaluation Criteria in Solid Tumors (RECIST v1.1) | | 8 months |
Secondary Outcome Measures
| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Time to Response (TTR) | The time interval from the date of first dose to the first documented response (complete or partial response) | 8 months |
| Number of participants with adverse events | | From signing of the informed consent to the end of the follow-up visit (approximately Month 10) |
| Time to Progression (TTP) | The time interval from date of first dose to first documented disease progression | 8 months |
| Progression-free Survival (PFS) | Time interval from date of first does to first documented disease progression or death from any cause (whichever occurs first) | 10 months |
| Time to New Metastases (TTNM) | Time interval from date of first dose to first documented new metastatic lesion not reported at baseline | 8 months |
Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
CEP-37440, Advanced solid tumors, Metastatic solid tumors
|
|
NCT02910609
|
International Experience in Timing And Choices for Ductal Closure in Patent Ductus Arteriosus:INTERPDA Trial
|
The three options for the treatment of patent ductus arterioles (PDA) in preterm infants are conservative approach, pharmacological intervention and surgical ligation. There is not any randomized-controlled trial that demonstrates the superiority of these approaches in preterm infants.
|
Patent ductus arteriosus (PDA), of which incidence is inversely related to gestational age and birth weight, is one of the the most common conditions among preterm infants.~In recent years, the use of antenatal steroids, postnatal surfactant, noninvasive ventilation strategies and low oxygen saturation targets have affected the incidence of hemodynamically significant PDA (HSPDA). There is not any consensus about the best approach on the clinical management of PDA in preterm infants. Over past years, the management of HSPDA shifted to aggressive medical and surgical intervention from conservative treatment, but conservative treatment approach has been mainly concerned again nowadays.~Today, the three options for the treatment of PDA in preterm infants are conservative approach, pharmacological intervention and surgical ligation. There is not any randomized-controlled trial that demonstrates the superiority of these approaches in preterm infants. Many countries including developed countries only give recommendations, instead of publishing guidelines, on screening, timing of treatment and treatment choices of PDA, because of the differences on management of PDA between the centers even within a single center.~Timing of PDA treatment and treatment choices at preterm infants born before 28 gestation weeks' differ in our country also in many countries over the world. In this study, it is aimed to record the managements of PDA detected beyond postnatal 3 days, to compare the effects of the managements at postnatal 3-7 days and after 7 days on closure, surgical ligation rates and side effects of drugs.
|
International Experience in Timing And Choices of Treatment For Ductal Closure in Patent Ductus Arteriosus: INTERPDA Trial
|
Patent Ductus Arteriosus
|
* Device: Echocardiography
|
Inclusion Criteria:~Infants born at 24 0/7-28 6/7 gestation weeks'~PDA detected with ductal diameter equal or greater than 1.5 mm and LA/Ao equal or greater than 1.5 on echocardiography at or after postnatal 72 hours of life~Exclusion Criteria:~Infants died before 72 hours of life~Infants detected PDA but treated before 72 hours of life
|
1 Day
|
28 Days
|
All
|
No
|
| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Spontan closure rate | Rate of patients with spontaneous ductal closure | 3 months |
|
| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Surgical ligation rate | rate of patients who need surgical ligation for hemodynamically significant ductus | 3 months |
| Complications of prematurity | | 3 months |
|
preterm, patent ductus arterioles, treatment
|
Ductus Arteriosus, Patent, Heart Defects, Congenital, Cardiovascular Abnormalities, Cardiovascular Diseases, Heart Diseases, Congenital Abnormalities
|
| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Management at PN 3-7 days<br>Preterm infants with hemodynamically significant PDA confirmed by echocardiography and are treated at 3-7 days of their life | Device: Echocardiography<br>* Echocardiography is a kind of ultrasound test that shows the inner structure and functions of the heart in both groups.<br>|
| Management after PN 7 days<br>Preterm infants with hemodynamically significant PDA confirmed by echocardiography and are treated beyond 7 days of their life | Device: Echocardiography<br>* Echocardiography is a kind of ultrasound test that shows the inner structure and functions of the heart in both groups.<br>|
|
International Experience in Timing And Choices for Ductal Closure in Patent Ductus Arteriosus:INTERPDA Trial
Study Overview
=================
Brief Summary
-----------------
The three options for the treatment of patent ductus arterioles (PDA) in preterm infants are conservative approach, pharmacological intervention and surgical ligation. There is not any randomized-controlled trial that demonstrates the superiority of these approaches in preterm infants.
Detailed Description
-----------------
Patent ductus arteriosus (PDA), of which incidence is inversely related to gestational age and birth weight, is one of the the most common conditions among preterm infants. In recent years, the use of antenatal steroids, postnatal surfactant, noninvasive ventilation strategies and low oxygen saturation targets have affected the incidence of hemodynamically significant PDA (HSPDA). There is not any consensus about the best approach on the clinical management of PDA in preterm infants. Over past years, the management of HSPDA shifted to aggressive medical and surgical intervention from conservative treatment, but conservative treatment approach has been mainly concerned again nowadays. Today, the three options for the treatment of PDA in preterm infants are conservative approach, pharmacological intervention and surgical ligation. There is not any randomized-controlled trial that demonstrates the superiority of these approaches in preterm infants. Many countries including developed countries only give recommendations, instead of publishing guidelines, on screening, timing of treatment and treatment choices of PDA, because of the differences on management of PDA between the centers even within a single center. Timing of PDA treatment and treatment choices at preterm infants born before 28 gestation weeks' differ in our country also in many countries over the world. In this study, it is aimed to record the managements of PDA detected beyond postnatal 3 days, to compare the effects of the managements at postnatal 3-7 days and after 7 days on closure, surgical ligation rates and side effects of drugs.
Official Title
-----------------
International Experience in Timing And Choices of Treatment For Ductal Closure in Patent Ductus Arteriosus: INTERPDA Trial
Conditions
-----------------
Patent Ductus Arteriosus
Intervention / Treatment
-----------------
* Device: Echocardiography
Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Infants born at 24 0/7-28 6/7 gestation weeks' PDA detected with ductal diameter equal or greater than 1.5 mm and LA/Ao equal or greater than 1.5 on echocardiography at or after postnatal 72 hours of life Exclusion Criteria: Infants died before 72 hours of life Infants detected PDA but treated before 72 hours of life
Ages Eligible for Study
-----------------
Minimum Age: 1 Day
Maximum Age: 28 Days
Sexes Eligible for Study
-----------------
All
Accepts Healthy Volunteers
-----------------
No
Study Plan
=================
How is the study designed?
-----------------
Arms and Interventions
| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Management at PN 3-7 days<br>Preterm infants with hemodynamically significant PDA confirmed by echocardiography and are treated at 3-7 days of their life | Device: Echocardiography<br>* Echocardiography is a kind of ultrasound test that shows the inner structure and functions of the heart in both groups.<br>|
| Management after PN 7 days<br>Preterm infants with hemodynamically significant PDA confirmed by echocardiography and are treated beyond 7 days of their life | Device: Echocardiography<br>* Echocardiography is a kind of ultrasound test that shows the inner structure and functions of the heart in both groups.<br>|
What is the study measuring?
-----------------
Primary Outcome Measures
| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Spontan closure rate | Rate of patients with spontaneous ductal closure | 3 months |
Secondary Outcome Measures
| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Surgical ligation rate | rate of patients who need surgical ligation for hemodynamically significant ductus | 3 months |
| Complications of prematurity | | 3 months |
Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
preterm, patent ductus arterioles, treatment
|
|
NCT03229421
|
Dermatologic Manifestations of Zika Virus
|
The purpose of this study is to determine whether any diagnostic patterns exist in the symptom presentation of Zika Virus.
|
The study has both retrospective and prospective components. The retrospective review includes medical records with laboratory confirmed Zika Virus diagnosis and the prospective component will enroll adults presenting with febrile illness and rash and ask them to complete a survey about their symptoms. Diagnostic testing will be completed to confirm infection source.
|
Survey of Symptoms and Dermatologic Characterization Associated With Zika Virus
|
Zika Virus Symptoms and the Associated Exanthema
|
* Other: Survey
|
Inclusion Criteria:~Adults aged 18 years and older presenting with febrile illness and rash~Exclusion Criteria:~Patients aged 17 years or younger
|
18 Years
| null |
All
|
No
|
| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Number of days with specific symptoms | Number of days reported experiencing specific symptoms due to Zika Virus infection and and associated characteristics such as location and intensity | 20 minutes |
|
| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Frequency measures of initial clinical presentations | Frequency of reported symptoms at initial clinical presentation. | 20 minutes |
|
Zika Virus
|
Zika Virus Infection, Exanthema, Virus Diseases, Infections, Arbovirus Infections, Vector Borne Diseases, Flavivirus Infections, Flaviviridae Infections, RNA Virus Infections, Skin Diseases
|
| Intervention/Treatment |
| --- |
|Other: Survey|18 question symptom assessment tool including non-identifying demographic information questions.|
|
Dermatologic Manifestations of Zika Virus
Study Overview
=================
Brief Summary
-----------------
The purpose of this study is to determine whether any diagnostic patterns exist in the symptom presentation of Zika Virus.
Detailed Description
-----------------
The study has both retrospective and prospective components. The retrospective review includes medical records with laboratory confirmed Zika Virus diagnosis and the prospective component will enroll adults presenting with febrile illness and rash and ask them to complete a survey about their symptoms. Diagnostic testing will be completed to confirm infection source.
Official Title
-----------------
Survey of Symptoms and Dermatologic Characterization Associated With Zika Virus
Conditions
-----------------
Zika Virus Symptoms and the Associated Exanthema
Intervention / Treatment
-----------------
* Other: Survey
Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Adults aged 18 years and older presenting with febrile illness and rash Exclusion Criteria: Patients aged 17 years or younger
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 |
| --- |
|Other: Survey|18 question symptom assessment tool including non-identifying demographic information questions.|
What is the study measuring?
-----------------
Primary Outcome Measures
| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Number of days with specific symptoms | Number of days reported experiencing specific symptoms due to Zika Virus infection and and associated characteristics such as location and intensity | 20 minutes |
Secondary Outcome Measures
| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Frequency measures of initial clinical presentations | Frequency of reported symptoms at initial clinical presentation. | 20 minutes |
Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Zika Virus
|
|
NCT00003410
|
Motexafin Gadolinium With MRI-Guided Surgery in Treating Patients With High-Grade Gliomas
|
RATIONALE: New imaging procedures such as the use of gadolinium texaphyrin with MRI may improve the ability to detect the extent of gliomas.~PURPOSE: Phase I trial to study the effectiveness of gadolinium texaphyrin used with MRI-guided surgery in treating patients with high-grade glioma.
|
OBJECTIVES: I. Determine the maximum tolerated dose of gadolinium texaphyrin as a tumor retained contrast agent in MRI guided neurosurgery in patients with radiological diagnosis of high grade glioma. I. Determine the intratumoral pharmacology and quantitative pharmacokinetics of gadolinium texaphyrin using MRI imaging in these patients. II. Develop a scale that will relate MRI signal characteristics from intratumoral gadolinium texaphyrin with absolute intratumoral levels of gadolinium texaphyrin in these patients. III. Investigate the distribution of gadolinium texaphyrin in high grade gliomas in comparison with biologically active tumor as delineated by elevated choline-containing material detected by proton magnetic resonance spectroscopic imaging.~OUTLINE: This is a dose escalation study. Patients receive gadolinium texaphyrin by IV infusion 20 minutes to 2 hours prior to magnetic resonance imaging and surgery. The maximum tolerated dose for a single dose of gadolinium texaphyrin is determined by cohorts of 3 patients who are treated at one of five escalating doses. Patients in each cohort are followed for a minimum of 4 weeks each before the next cohort begins. If good contrast enhancement is assessed at the fourth dose level (cohort 4), dose escalation stops. Patients are followed at days 1 and 2, at weeks 1, 2, and 4, and at 3 months after surgery.~PROJECTED ACCRUAL: A total of 6-18 patients will be accrued into this study.
|
Pilot Trial of Gadolium Texaphyrin for Magnetic Resonance Imaging-Guided Resection of High Grade Gliomas
|
Brain and Central Nervous System Tumors
|
* Drug: motexafin gadolinium
* Procedure: magnetic resonance imaging
* Procedure: surgical procedure
|
DISEASE CHARACTERISTICS: Radiological diagnosis of probable high grade glioma, or biopsy proven high grade glioma, undergoing neurosurgery (biopsy or tumor resection) with interactive MRI guided control Must have an enhancing cerebral lesion No radiological diagnosis of metastases due to multiple lesions~PATIENT CHARACTERISTICS: Age: 18 and over Performance status: Karnofsky 50-100% while on steroids Life expectancy: Not specified Hematopoietic: WBC at least 3,000/mm3 Granulocyte count at least 1,500/mm3 Platelet count at least 100,000/mm3 Prothrombin time no greater than 1.5 times upper limit of normal (ULN) Active partial thromboplastin time no greater than 1.5 times ULN Hepatic: Bilirubin no greater than 2 mg/dL AST and ALT no greater than 2 times ULN Renal: Creatinine less than 1.5 mg/dL Cardiovascular: No severe cardiac disease Pulmonary: No severe pulmonary disease Other: No other significant life threatening disease No known glucose-6-phosphate dehydrogenase deficiency or porphyria No other active malignancy No intractable seizures Not pregnant or nursing Effective contraception required of all fertile patients~PRIOR CONCURRENT THERAPY: Biologic therapy: Not specified Chemotherapy: Not specified Endocrine therapy: Concurrent steroids allowed Radiotherapy: Concurrent radiotherapy allowed Surgery: See Disease Characteristics Other: At least 48 hours since prior MRI scan with contrast No concurrent active agent or investigational drug No concurrent use of other study treatment Concurrent antiseizure medication allowed
|
18 Years
| null |
All
|
No
|
Primary Purpose: Diagnostic
|
| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
|
adult glioblastoma, adult giant cell glioblastoma, adult gliosarcoma
|
Motexafin gadolinium, Antineoplastic Agents, Photosensitizing Agents, Dermatologic Agents
|
| Intervention/Treatment |
| --- |
|Drug: motexafin gadolinium|nan|
|Procedure: magnetic resonance imaging|nan|
|Procedure: surgical procedure|nan|
|
Motexafin Gadolinium With MRI-Guided Surgery in Treating Patients With High-Grade Gliomas
Study Overview
=================
Brief Summary
-----------------
RATIONALE: New imaging procedures such as the use of gadolinium texaphyrin with MRI may improve the ability to detect the extent of gliomas. PURPOSE: Phase I trial to study the effectiveness of gadolinium texaphyrin used with MRI-guided surgery in treating patients with high-grade glioma.
Detailed Description
-----------------
OBJECTIVES: I. Determine the maximum tolerated dose of gadolinium texaphyrin as a tumor retained contrast agent in MRI guided neurosurgery in patients with radiological diagnosis of high grade glioma. I. Determine the intratumoral pharmacology and quantitative pharmacokinetics of gadolinium texaphyrin using MRI imaging in these patients. II. Develop a scale that will relate MRI signal characteristics from intratumoral gadolinium texaphyrin with absolute intratumoral levels of gadolinium texaphyrin in these patients. III. Investigate the distribution of gadolinium texaphyrin in high grade gliomas in comparison with biologically active tumor as delineated by elevated choline-containing material detected by proton magnetic resonance spectroscopic imaging. OUTLINE: This is a dose escalation study. Patients receive gadolinium texaphyrin by IV infusion 20 minutes to 2 hours prior to magnetic resonance imaging and surgery. The maximum tolerated dose for a single dose of gadolinium texaphyrin is determined by cohorts of 3 patients who are treated at one of five escalating doses. Patients in each cohort are followed for a minimum of 4 weeks each before the next cohort begins. If good contrast enhancement is assessed at the fourth dose level (cohort 4), dose escalation stops. Patients are followed at days 1 and 2, at weeks 1, 2, and 4, and at 3 months after surgery. PROJECTED ACCRUAL: A total of 6-18 patients will be accrued into this study.
Official Title
-----------------
Pilot Trial of Gadolium Texaphyrin for Magnetic Resonance Imaging-Guided Resection of High Grade Gliomas
Conditions
-----------------
Brain and Central Nervous System Tumors
Intervention / Treatment
-----------------
* Drug: motexafin gadolinium
* Procedure: magnetic resonance imaging
* Procedure: surgical procedure
Participation Criteria
=================
Eligibility Criteria
-----------------
DISEASE CHARACTERISTICS: Radiological diagnosis of probable high grade glioma, or biopsy proven high grade glioma, undergoing neurosurgery (biopsy or tumor resection) with interactive MRI guided control Must have an enhancing cerebral lesion No radiological diagnosis of metastases due to multiple lesions PATIENT CHARACTERISTICS: Age: 18 and over Performance status: Karnofsky 50-100% while on steroids Life expectancy: Not specified Hematopoietic: WBC at least 3,000/mm3 Granulocyte count at least 1,500/mm3 Platelet count at least 100,000/mm3 Prothrombin time no greater than 1.5 times upper limit of normal (ULN) Active partial thromboplastin time no greater than 1.5 times ULN Hepatic: Bilirubin no greater than 2 mg/dL AST and ALT no greater than 2 times ULN Renal: Creatinine less than 1.5 mg/dL Cardiovascular: No severe cardiac disease Pulmonary: No severe pulmonary disease Other: No other significant life threatening disease No known glucose-6-phosphate dehydrogenase deficiency or porphyria No other active malignancy No intractable seizures Not pregnant or nursing Effective contraception required of all fertile patients PRIOR CONCURRENT THERAPY: Biologic therapy: Not specified Chemotherapy: Not specified Endocrine therapy: Concurrent steroids allowed Radiotherapy: Concurrent radiotherapy allowed Surgery: See Disease Characteristics Other: At least 48 hours since prior MRI scan with contrast No concurrent active agent or investigational drug No concurrent use of other study treatment Concurrent antiseizure medication allowed
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: Diagnostic
Arms and Interventions
| Intervention/Treatment |
| --- |
|Drug: motexafin gadolinium|nan|
|Procedure: magnetic resonance imaging|nan|
|Procedure: surgical procedure|nan|
What is the study measuring?
-----------------
Primary Outcome Measures
| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
adult glioblastoma, adult giant cell glioblastoma, adult gliosarcoma
|
|
NCT05610852
|
Single-Center Study Of Single-Port Transvesical Partial Prostatectomy Versus
|
This study aims to compare the novel single-port robotic partial prostatectomy to High-intensity focused ultrasound (HIFU) in patients with low to intermediate risk localized prostate cancer. These interventions have become acceptable focal therapies prevalent with beneficial oncologic outcomes and therefore need to be examined further.
|
The primary objective is to evaluate the in-field recurrence rates and recurrence free survival - defined as the absence of clinically significant prostate cancer within the treated zone (identified by prostate MRI and subsequent targeted prostate biopsy).~Secondary objectives of interest are:~Perioperative parameters such as operative time, perioperative complications, analgesic requirement, postoperative hospital stay, foley catheter duration~Functional outcomes such as time to urinary continence, urinary continence, and erectile dysfunction~Oncologic outcomes such as biochemical recurrence rates (defined in section 2.1), recurrence free survival, presence of secondary intervention for prostate cancer (HIFU, radiation, surgery, ADT)
|
Prospective Single-Center Randomized Study Of Single-Port Transvesical Partial Prostatectomy Versus High Intensity Focused Ultrasound (HIFU)
|
Prostate Adenocarcinoma, Prostate Cancer
|
* Procedure: Transvesical Single Port Robotic Partial Prostatectomy
* Procedure: High-intensity focused ultrasound (HIFU)
|
Inclusion Criteria:~Subjects must have histologically or cytologically: Biopsy-confirmed prostate cancer, stage T1a, T2a, T2b, or T2c prostate cancer using MRI staging, with a region of interest (ROI) PIRADs grade 3 or greater, Serum PSA 10 ng/ml or less, Region of interest on MRI of grade 3 or greater~The MRI performed must include at least:~A T2-weighted sequence in sections ≤ 4 mm, centered on the prostate and seminal vesicles, at least in the axial plane. Alternatively, a 3D T2-weighted sequence can be realized,~A diffusion sequence of ≤ 4 mm slice in the axial plane. An ADC card will be provided and calculated from at least two values of b, the maximum value of b being ≥ 600 s / mm2,~A dynamic sequence after gadolinium injection. It will be a sequence of echo T1-weighted gradient of slice ≤ 4 mm, centered on the prostate and seminal vesicles in the axial plane, with or without fat saturation. A first series will be performed without contrast injection, and will be repeated iteratively for the arrival of a bolus of gadolinium chelates. The time resolution (that is to say, the acquisition time of one dynamic series will be ≤ 20 seconds). The number of chained dynamic series is calculated so that the total length of the dynamic acquisition be at least 3 minutes~A total dose of 0.1 mmol / kg of gadolinium chelate will be injected at a rate of 3-4 mL / s by using an automatic injector, in a vein of the hand of the forearm or elbow.~If necessary, subtracted images are calculated~Clinically significant prostate cancer defined as Gleason score 3+4 or less in any core~Biopsies for preoperative diagnosis of prostate cancer will have included: At least 12 randomized samples (2 samples per sextant), At least two targeted sampling on each target score MRI ESUR ≥ 3/5~Life expectancy greater than 10 years.~Age >18 years.~Subjects must have the ability to understand and the willingness to sign a written informed consent document.~Exclusion Criteria:~Patients with any prior extensive pelvic surgery, pelvic fractures, hemorrhoid, fissure surgery, cardiac pacemaker, or metal prosthesis~Prior treatment for prostate cancer such as radiotherapy, focal or hormonal therapy~Uncorrected coagulopathy or history of Latex allergy~Active soft tissue or urinary infection, indwelling Foley catheter or severe irritative or obstructive symptoms~Poor surgical risk (defined as American Society of Anesthesiology score > 3).~Any condition or history of illness or surgery that, in the opinion of the investigator, might confound the results of the study or pose additional risk to the patient (e.g. significant cardiovascular conditions that significantly affect the life expectancy, chronic opiate use, pain syndrome, or drug abuse.)~Prostate size larger than 80 grams.~Subjects with prostatic Calcification (>0.5 cc) close to the area to be treated.~Subjects with extraprostatic extension or cribriform pattern on biopsy.~Subjectes with sexual dysfunction defined as SHIM score < 17~Subjects with 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 would limit compliance with study requirements.
|
19 Years
| null |
Male
|
No
|
Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
|
| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Recurrence free survival Recurrence free survival | Number of patients with absence of clinically significant prostate cancer on prostate MRI and targeted prostate biopsy | 1 year after treatment |
| Recurrence free survival | Number of patients with absence of clinically significant prostate cancer on prostate MRI and targeted prostate biopsy | 2 years after treatment |
| Recurrence free survival | Number of patients with absence of clinically significant prostate cancer on prostate MRI and targeted prostate biopsy | 3 years after treatment |
|
| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Operative time | Minutes from incision to closing during surgery (median) | At initial treatment (postoperative day 0) |
| Postoperative Complications | Clavien-dindo classification number (1-5), number (percent) | Within 3 months after treatment. |
| Analgesic requirment | Units of oral morphine equivalent dosing (mg), median | Once at first follow up (up to 7 days after initial treatment) |
| Postoperative hospital stay | Time that patient is observed in the hospital after surgery, in hours (median) | Up to 1 day after initial treatment |
| Foley catheter duration | Time at which the foley catheter is removed after treatment, in days (median) | Up to 7 days after initial treatment |
| Time to urinary continence | Time at which the patient becomes continent in days (median) | Assessed at each visit for up to 1 year after treatment |
| Urinary continence | Continence defined as using 1 pad for security or less for stress urinary incontince, recorded as yes or no (percent) | Assessed at each visit for up to 1 year after treatment |
| Erectile dysfunction | Assessed using scores from a validated survey (IIEF-5). Recorded as the the score from 5 (impotent) to 25 (no impotence), median. | Assessed at each visit for up to 3 years |
| Biochemical recurrence | PSA recurrence defined as PSA nadir after treatment +1ng/ml within 12 months or PSA Nadir + 1.5ng/ml from 12-36 months. Recorded as yes or no (percent) | Assessed at each visit for up to 3 years |
| Secondary interventions | Time point at which the patient undergoes treatment for prostate cancer recurrence | Assessed at the time of clinic visits up to 3 years after treatment. |
|
High Intensity Focused Ultrasound (HIFU), Single-Port Transvesical Partial Prostatectomy
|
Adenocarcinoma, Neoplasms, Carcinoma, Neoplasms, Glandular and Epithelial, Neoplasms by Histologic Type
|
| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: Transvesical Single Port Robotic Partial Prostatectomy<br>Participants will have a multiparametric prostate MRI and diagnostic prostate biopsy with confirmed localized prostate tumor prior to Prostatectomy. Prostatectomy consists of a single treatment. All participants will have a postoperative visit at 3 days after surgery, followed by phone calls at 1 week, 2 weeks and 4 weeks, followed by office visits at 6 weeks, 3 months, 6 months, 9 months, 1 year, 2 years and 3 years. Participants will be followed indefinitely as per standard of care. | Procedure: Transvesical Single Port Robotic Partial Prostatectomy<br>* A foley catheter is inserted on the sterile field. A suprapubic midline incision is made and the da Vinci SP surgical system is docked percutaneously directly to the bladder. Prior to the operation, a radiologist identifies and segments tumors and the urethra. A transrectal ultrasound probe is inserted and secured into a fixed position. The Koelis software is utilized to fuse MRI and ultrasound images to identify the target lesion in real-time, allowing for intraoperative guidance. The ultrasound probe rotates automatically, allowing for localization of the tumor intraoperatively. Then depending on the area of the tumor, a Hemi or quadrant resection is completed while preserving the nerves, vas deferens, and seminal vesicles. The urethrovesical anastomosis is then performed.<br>|
| Active Comparator: High-intensity focused ultrasound (HIFU)<br>Participants will have a multiparametric prostate MRI and diagnostic prostate biopsy with confirmed localized prostate tumor prior to HIFU. HIFU consists of a single treatment. All participants will have a postoperative visit at 3 days after surgery, followed by phone calls at 1 week, 2 weeks and 4 weeks, followed by office visits at 6 weeks, 3 months, 6 months, 9 months, 1 year, 2 years and 3 years. Participants will be followed indefinitely as per standard of care. | Procedure: High-intensity focused ultrasound (HIFU)<br>* Three contoured measurements are required for the MR fusion system to reproduce the volume of the prostate. Following this, the area to be targeted will be selected in graded fashion from the anterior to posterior of the prostate. Once planning of ROI (region of interest) is complete, the HIFU treatment may begin. Quadrant or hemi ablation will be performed based on the size and complexity of the tumor. The distal margin of the ablation will be kept at least 4 mm away from the external sphincter. The rectal temperature and its distance from the probe will be carefully monitored throughout the procedure.<br>|
|
Single-Center Study Of Single-Port Transvesical Partial Prostatectomy Versus
Study Overview
=================
Brief Summary
-----------------
This study aims to compare the novel single-port robotic partial prostatectomy to High-intensity focused ultrasound (HIFU) in patients with low to intermediate risk localized prostate cancer. These interventions have become acceptable focal therapies prevalent with beneficial oncologic outcomes and therefore need to be examined further.
Detailed Description
-----------------
The primary objective is to evaluate the in-field recurrence rates and recurrence free survival - defined as the absence of clinically significant prostate cancer within the treated zone (identified by prostate MRI and subsequent targeted prostate biopsy). Secondary objectives of interest are: Perioperative parameters such as operative time, perioperative complications, analgesic requirement, postoperative hospital stay, foley catheter duration Functional outcomes such as time to urinary continence, urinary continence, and erectile dysfunction Oncologic outcomes such as biochemical recurrence rates (defined in section 2.1), recurrence free survival, presence of secondary intervention for prostate cancer (HIFU, radiation, surgery, ADT)
Official Title
-----------------
Prospective Single-Center Randomized Study Of Single-Port Transvesical Partial Prostatectomy Versus High Intensity Focused Ultrasound (HIFU)
Conditions
-----------------
Prostate Adenocarcinoma, Prostate Cancer
Intervention / Treatment
-----------------
* Procedure: Transvesical Single Port Robotic Partial Prostatectomy
* Procedure: High-intensity focused ultrasound (HIFU)
Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Subjects must have histologically or cytologically: Biopsy-confirmed prostate cancer, stage T1a, T2a, T2b, or T2c prostate cancer using MRI staging, with a region of interest (ROI) PIRADs grade 3 or greater, Serum PSA 10 ng/ml or less, Region of interest on MRI of grade 3 or greater The MRI performed must include at least: A T2-weighted sequence in sections ≤ 4 mm, centered on the prostate and seminal vesicles, at least in the axial plane. Alternatively, a 3D T2-weighted sequence can be realized, A diffusion sequence of ≤ 4 mm slice in the axial plane. An ADC card will be provided and calculated from at least two values of b, the maximum value of b being ≥ 600 s / mm2, A dynamic sequence after gadolinium injection. It will be a sequence of echo T1-weighted gradient of slice ≤ 4 mm, centered on the prostate and seminal vesicles in the axial plane, with or without fat saturation. A first series will be performed without contrast injection, and will be repeated iteratively for the arrival of a bolus of gadolinium chelates. The time resolution (that is to say, the acquisition time of one dynamic series will be ≤ 20 seconds). The number of chained dynamic series is calculated so that the total length of the dynamic acquisition be at least 3 minutes A total dose of 0.1 mmol / kg of gadolinium chelate will be injected at a rate of 3-4 mL / s by using an automatic injector, in a vein of the hand of the forearm or elbow. If necessary, subtracted images are calculated Clinically significant prostate cancer defined as Gleason score 3+4 or less in any core Biopsies for preoperative diagnosis of prostate cancer will have included: At least 12 randomized samples (2 samples per sextant), At least two targeted sampling on each target score MRI ESUR ≥ 3/5 Life expectancy greater than 10 years. Age >18 years. Subjects must have the ability to understand and the willingness to sign a written informed consent document. Exclusion Criteria: Patients with any prior extensive pelvic surgery, pelvic fractures, hemorrhoid, fissure surgery, cardiac pacemaker, or metal prosthesis Prior treatment for prostate cancer such as radiotherapy, focal or hormonal therapy Uncorrected coagulopathy or history of Latex allergy Active soft tissue or urinary infection, indwelling Foley catheter or severe irritative or obstructive symptoms Poor surgical risk (defined as American Society of Anesthesiology score > 3). Any condition or history of illness or surgery that, in the opinion of the investigator, might confound the results of the study or pose additional risk to the patient (e.g. significant cardiovascular conditions that significantly affect the life expectancy, chronic opiate use, pain syndrome, or drug abuse.) Prostate size larger than 80 grams. Subjects with prostatic Calcification (>0.5 cc) close to the area to be treated. Subjects with extraprostatic extension or cribriform pattern on biopsy. Subjectes with sexual dysfunction defined as SHIM score < 17 Subjects with 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 would limit compliance with study requirements.
Ages Eligible for Study
-----------------
Minimum Age: 19 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: None (Open Label)
Arms and Interventions
| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: Transvesical Single Port Robotic Partial Prostatectomy<br>Participants will have a multiparametric prostate MRI and diagnostic prostate biopsy with confirmed localized prostate tumor prior to Prostatectomy. Prostatectomy consists of a single treatment. All participants will have a postoperative visit at 3 days after surgery, followed by phone calls at 1 week, 2 weeks and 4 weeks, followed by office visits at 6 weeks, 3 months, 6 months, 9 months, 1 year, 2 years and 3 years. Participants will be followed indefinitely as per standard of care. | Procedure: Transvesical Single Port Robotic Partial Prostatectomy<br>* A foley catheter is inserted on the sterile field. A suprapubic midline incision is made and the da Vinci SP surgical system is docked percutaneously directly to the bladder. Prior to the operation, a radiologist identifies and segments tumors and the urethra. A transrectal ultrasound probe is inserted and secured into a fixed position. The Koelis software is utilized to fuse MRI and ultrasound images to identify the target lesion in real-time, allowing for intraoperative guidance. The ultrasound probe rotates automatically, allowing for localization of the tumor intraoperatively. Then depending on the area of the tumor, a Hemi or quadrant resection is completed while preserving the nerves, vas deferens, and seminal vesicles. The urethrovesical anastomosis is then performed.<br>|
| Active Comparator: High-intensity focused ultrasound (HIFU)<br>Participants will have a multiparametric prostate MRI and diagnostic prostate biopsy with confirmed localized prostate tumor prior to HIFU. HIFU consists of a single treatment. All participants will have a postoperative visit at 3 days after surgery, followed by phone calls at 1 week, 2 weeks and 4 weeks, followed by office visits at 6 weeks, 3 months, 6 months, 9 months, 1 year, 2 years and 3 years. Participants will be followed indefinitely as per standard of care. | Procedure: High-intensity focused ultrasound (HIFU)<br>* Three contoured measurements are required for the MR fusion system to reproduce the volume of the prostate. Following this, the area to be targeted will be selected in graded fashion from the anterior to posterior of the prostate. Once planning of ROI (region of interest) is complete, the HIFU treatment may begin. Quadrant or hemi ablation will be performed based on the size and complexity of the tumor. The distal margin of the ablation will be kept at least 4 mm away from the external sphincter. The rectal temperature and its distance from the probe will be carefully monitored throughout the procedure.<br>|
What is the study measuring?
-----------------
Primary Outcome Measures
| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Recurrence free survival Recurrence free survival | Number of patients with absence of clinically significant prostate cancer on prostate MRI and targeted prostate biopsy | 1 year after treatment |
| Recurrence free survival | Number of patients with absence of clinically significant prostate cancer on prostate MRI and targeted prostate biopsy | 2 years after treatment |
| Recurrence free survival | Number of patients with absence of clinically significant prostate cancer on prostate MRI and targeted prostate biopsy | 3 years after treatment |
Secondary Outcome Measures
| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Operative time | Minutes from incision to closing during surgery (median) | At initial treatment (postoperative day 0) |
| Postoperative Complications | Clavien-dindo classification number (1-5), number (percent) | Within 3 months after treatment. |
| Analgesic requirment | Units of oral morphine equivalent dosing (mg), median | Once at first follow up (up to 7 days after initial treatment) |
| Postoperative hospital stay | Time that patient is observed in the hospital after surgery, in hours (median) | Up to 1 day after initial treatment |
| Foley catheter duration | Time at which the foley catheter is removed after treatment, in days (median) | Up to 7 days after initial treatment |
| Time to urinary continence | Time at which the patient becomes continent in days (median) | Assessed at each visit for up to 1 year after treatment |
| Urinary continence | Continence defined as using 1 pad for security or less for stress urinary incontince, recorded as yes or no (percent) | Assessed at each visit for up to 1 year after treatment |
| Erectile dysfunction | Assessed using scores from a validated survey (IIEF-5). Recorded as the the score from 5 (impotent) to 25 (no impotence), median. | Assessed at each visit for up to 3 years |
| Biochemical recurrence | PSA recurrence defined as PSA nadir after treatment +1ng/ml within 12 months or PSA Nadir + 1.5ng/ml from 12-36 months. Recorded as yes or no (percent) | Assessed at each visit for up to 3 years |
| Secondary interventions | Time point at which the patient undergoes treatment for prostate cancer recurrence | Assessed at the time of clinic visits up to 3 years after treatment. |
Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
High Intensity Focused Ultrasound (HIFU), Single-Port Transvesical Partial Prostatectomy
|
NCT05550454
|
Cardiac Arrest and Ventilation Method
|
Comparison of Manual Ventilation and Automatic Mechanical Ventilation during CPR, Pilot & Feasibility Study (CAVE-I trial)
|
This is a preliminary randomized clinical trials comparing the effectiveness of the automatic mechanical ventilation method compared to manual ventilation methods commonly performed during advanced cardiac life support (ACLS) in emergency room for out-of-hospital cardiac arrest.
|
Comparison of Manual Ventilation and Automatic Mechanical Ventilation During Cardiopulmonary Resuscitation, Pilot & Feasibility Study
|
Out-Of-Hospital Cardiac Arrest, Advanced Cardiac Life Support, Ventilation
|
* Device: Automatic Mechanical Ventilation
* Device: Manual Ventilation
|
Inclusion Criteria:~Out-of-hospital cardiac arrest (OHCA)~Transferred by only EMS without prehospital return of spontaneous circulation (ROSC)~ACLS for at least 20 minutes in the emergency room~Arterial blood gas analysis at least once during ACLS~Exclusion Criteria:~In-hospital cardiac arrest (IHCA)~Not transferred by Emergency Medical Service~ROSC gained before arriving at the ER~OHCA caused by trauma~ACLS is not performed for more than 20 minutes because the death is obvious~Not able to intubate the trachea
|
18 Years
| null |
All
|
No
|
Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Interventional Model Description: It is a study conducted by random assignment to two groups of manual ventilation and automatic mechanical ventilation.
Masking: None (Open Label)
|
| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| ROSC: return of spontaneous circulation | Rate of any ROSC after ACLS | Within 20 minutes of ACLS |
|
| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Arterial blood gas analysis (ABGA) parameters | PH (no unit), PO2 in mmHg, PCO2 in mmHg, HCO3 in mEq/L | The first test was conducted within 5 minutes of ACLS, and the second test 10 minutes after the first test. |
| Ventilation parameters | Tidal volume (TV) and Minute volume (MV) during the entire ACLS | During the entire ACLS time after randomization and endotracheal intubation |
|
Heart Arrest, Out-of-Hospital Cardiac Arrest, Heart Diseases, Cardiovascular Diseases
|
| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Automatic Mechanical Ventilation<br>Automatic Mechanical Ventilation during ACLS | Device: Automatic Mechanical Ventilation<br>* Ventilation settings:~Mode: (S)Continuous Mandatory Ventilation Rate: 10 b/min. Tidal Volume: 500 ml (male), 450 ml (female) I:E=1:1 Positive end expiratory pressure (PEEP): 5 cmH2O Flow trigger: off Oxygen: 100% Alarms: Pressure 70 cmH20, Tidal volume 100 ~ 1,000 ml<br>|
| Active Comparator: Manual Ventilation<br>Standard care with manual ventilation, Ambu-bagging, during ACLS | Device: Manual Ventilation<br>* Ambu-bagging (It is recommended in the guidelines as a ventilation method.) Methods: 10 times per minutes by medical personnel<br>|
|
Cardiac Arrest and Ventilation Method
Study Overview
=================
Brief Summary
-----------------
Comparison of Manual Ventilation and Automatic Mechanical Ventilation during CPR, Pilot & Feasibility Study (CAVE-I trial)
Detailed Description
-----------------
This is a preliminary randomized clinical trials comparing the effectiveness of the automatic mechanical ventilation method compared to manual ventilation methods commonly performed during advanced cardiac life support (ACLS) in emergency room for out-of-hospital cardiac arrest.
Official Title
-----------------
Comparison of Manual Ventilation and Automatic Mechanical Ventilation During Cardiopulmonary Resuscitation, Pilot & Feasibility Study
Conditions
-----------------
Out-Of-Hospital Cardiac Arrest, Advanced Cardiac Life Support, Ventilation
Intervention / Treatment
-----------------
* Device: Automatic Mechanical Ventilation
* Device: Manual Ventilation
Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Out-of-hospital cardiac arrest (OHCA) Transferred by only EMS without prehospital return of spontaneous circulation (ROSC) ACLS for at least 20 minutes in the emergency room Arterial blood gas analysis at least once during ACLS Exclusion Criteria: In-hospital cardiac arrest (IHCA) Not transferred by Emergency Medical Service ROSC gained before arriving at the ER OHCA caused by trauma ACLS is not performed for more than 20 minutes because the death is obvious Not able to intubate the trachea
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: It is a study conducted by random assignment to two groups of manual ventilation and automatic mechanical ventilation.
Masking: None (Open Label)
Arms and Interventions
| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Automatic Mechanical Ventilation<br>Automatic Mechanical Ventilation during ACLS | Device: Automatic Mechanical Ventilation<br>* Ventilation settings: Mode: (S)Continuous Mandatory Ventilation Rate: 10 b/min. Tidal Volume: 500 ml (male), 450 ml (female) I:E=1:1 Positive end expiratory pressure (PEEP): 5 cmH2O Flow trigger: off Oxygen: 100% Alarms: Pressure 70 cmH20, Tidal volume 100 1,000 ml<br>|
| Active Comparator: Manual Ventilation<br>Standard care with manual ventilation, Ambu-bagging, during ACLS | Device: Manual Ventilation<br>* Ambu-bagging (It is recommended in the guidelines as a ventilation method.) Methods: 10 times per minutes by medical personnel<br>|
What is the study measuring?
-----------------
Primary Outcome Measures
| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| ROSC: return of spontaneous circulation | Rate of any ROSC after ACLS | Within 20 minutes of ACLS |
Secondary Outcome Measures
| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Arterial blood gas analysis (ABGA) parameters | PH (no unit), PO2 in mmHg, PCO2 in mmHg, HCO3 in mEq/L | The first test was conducted within 5 minutes of ACLS, and the second test 10 minutes after the first test. |
| Ventilation parameters | Tidal volume (TV) and Minute volume (MV) during the entire ACLS | During the entire ACLS time after randomization and endotracheal intubation |
|
|
NCT04857294
|
Unilateral TMJ Discectomy Without Interposal Material in Patients With Disc Perforation or Fragmentation
|
Temporomandibular joint (TMJ) discectomy is one of the most popular surgical techniques for painful TMJ. Previous studies have demonstrated predictable results of discectomy with optimal results in pain reduction and maximum mouth opening (MMO) improvement. However, those studies had most of the times varied inclusion criteria. A 4-year prospective study was designed including patients treated with unilateral TMJ discectomy without interposal material as the first surgical procedure for two specific intra-articular diagnosis: disc perforation and disc fragmentation.
|
Temporomandibular disorders (TMD) are the most prevalent orofacial pain source of nondental origin. Those disorders can be due to a heterogeneous group of pathologies affecting the temporomandibular joint (TMJ), the jaw muscles, or both. TMD symptoms prevalence has been reported between 10 to 33% of the population. The most common symptoms include pain, joint sounds, limitation of mandibular movement, facial deformities, condyle dislocation and recurrent headaches. These symptoms can negatively affect the quality of life. Surgical treatments for TMD are reserved for specific cases, however with the popularization of mini-invasive surgical techniques such as TMJ arthroscopy, more patients have been eligible for these mini-invasive techniques, amplifying the scope of TMJ surgery. In diagnostics such as ankylosis, tumors and growth abnormalities, TMJ open surgery is strongly recommended. However, those diagnosis and relatively uncommon. TMJ internal derangement involving disc position/integrity and osteoarthrosis are more frequent, but the surgical indication is relative.~From all the open surgery techniques, TMJ discectomy without interposal material is probably one of the most popular procedures. Recently, was showed that bilateral discectomy can induce severe TMJ changes detected with both imaging and histopathologic analysis in black Merino sheep. Besides, the critical histological and imaging results, functional masticatory alterations were not influenced by TMJ degenerative changes. Also, in other preclinical study, disc and fibrocartilage removal lead to traumatic TMJ ankylosis. It is interesting to observe the role of the condyle and temporal fibrocartilage, balancing the disc function. In humans, short-term studies on TMJ discectomy were associated with good results. In fact, in other retrospective study was showed discectomy without replacement is effective improving the preoperative maximum mouth opening (MMO). Despite the good clinical outcome, some studies have observed degenerative changes in imaging analysis. Together, clinical and preclinical results showed TMJ discectomy is a suboptimal technique, and an effective disc substitute, acting as a cushion between the condyle and temporal fossa could, in theory, improve these results. Despite extensive research in the field of tissue engineering, currently no appropriate disc substitute has demonstrated safety and efficacy. In fact, the last guidelines do not recommend disc replacement because nonvalid option showed superiority over discectomy alone. While there is no effective disc substitute, discectomy is often used when the disc is partial or total damaged and cannot be salvaged and/or and when symptoms fail to improve with other techniques. The inclusion criteria heterogeneity in previous studies, retrospective studies and non-randomization makes it difficult to draw clear conclusions about this technique. The investigators designed a rigorous prospective study for patients with: 1) unilateral TMJ disc perforation or 2) unilateral TMJ disc fragmentation. Those patients were proposed to unilateral TMJ discectomy. Most of the times, when the disc is damaged, the bone fibrocartilage is distorted and the authors wanted to understand the role of discectomy is those patients.
|
Unilateral TMJ Discectomy Without Interposal Material in Patients With Disc Perforation or Fragmentation
|
Temporomandibular Disorders
|
* Procedure: TMJ unilateral discectomy
|
Inclusion Criteria:~Age > 18 years old;~Unilateral TMJ pain >7 (0-10 VAS) and/or MMO < 30mm;~MRI presenting unilateral disc perforation or disc fragmentation~Clinical and imaging examination with criteria for unilateral TMJ discectomy~Exclusion Criteria:~Previous TMJ surgical intervention;~Concomitant contralateral surgery;~Age < 18 years old
|
18 Years
| null |
All
|
Accepts Healthy Volunteers
|
Primary Purpose: Treatment
Intervention Model: Single Group Assignment
Interventional Model Description: Prospective Study
Masking: None (Open Label)
|
| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Pain (Visual Analogue Scale (0,10) | VAS, 0-10, with 0 being no pain and 10 having maximum unbearable pain | Pre-surgery |
| Pain (Visual Analogue Scale (0,10) | VAS, 0-10, with 0 being no pain and 10 having maximum unbearable pain | Through study completion, an average of 2 years |
|
| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Maximum mouth opening (MMO, mm) | Mouth opening measured with a ruler (mm) | Pre-surgery |
| Maximum mouth opening (MMO, mm) | Mouth opening measured with a ruler (mm) | Through study completion, an average of 2 years |
| Muscle tenderness (0-3 scale) | 0-3, corresponding to a muscle tenderness scale in masseter and temporalis muscle (0-whithout muscle tenderness, 3 - maximum muscle tenderness) | Pre-surgery |
| Muscle tenderness (0-3 scale) | 0-3, corresponding to a muscle tenderness scale in masseter and temporalis muscle (0-whithout muscle tenderness, 3 - maximum muscle tenderness) | Through study completion, an average of 2 years |
|
Temporomandibular, TMJ Discectomy, TMJ Meniscectomy, TMJ Surgery
|
Jaw Diseases, Temporomandibular Joint Disorders, Temporomandibular Joint Dysfunction Syndrome, Craniomandibular Disorders, Mandibular Diseases, Musculoskeletal Diseases, Joint Diseases, Muscular Diseases, Stomatognathic Diseases, Myofascial Pain Syndromes
|
| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Discectomy<br>Unilateral Discectomy | Procedure: TMJ unilateral discectomy<br>* All patients underwent general anesthesia with nasotracheal intubation, managed in most cases with intravenous anesthesia protocol, usually with remifentanil infusion. Intraoperative steroids, usually dexamethasone, were administered primarily to minimize postoperative swelling. A classic preauricular incision or a root of helix inter tragus notch incision (RHITNI) was used in most cases, as previously described. No bandage or special care was performed after the surgery. No air washing restrictions were recommended.<br>|
|
Unilateral TMJ Discectomy Without Interposal Material in Patients With Disc Perforation or Fragmentation
Study Overview
=================
Brief Summary
-----------------
Temporomandibular joint (TMJ) discectomy is one of the most popular surgical techniques for painful TMJ. Previous studies have demonstrated predictable results of discectomy with optimal results in pain reduction and maximum mouth opening (MMO) improvement. However, those studies had most of the times varied inclusion criteria. A 4-year prospective study was designed including patients treated with unilateral TMJ discectomy without interposal material as the first surgical procedure for two specific intra-articular diagnosis: disc perforation and disc fragmentation.
Detailed Description
-----------------
Temporomandibular disorders (TMD) are the most prevalent orofacial pain source of nondental origin. Those disorders can be due to a heterogeneous group of pathologies affecting the temporomandibular joint (TMJ), the jaw muscles, or both. TMD symptoms prevalence has been reported between 10 to 33% of the population. The most common symptoms include pain, joint sounds, limitation of mandibular movement, facial deformities, condyle dislocation and recurrent headaches. These symptoms can negatively affect the quality of life. Surgical treatments for TMD are reserved for specific cases, however with the popularization of mini-invasive surgical techniques such as TMJ arthroscopy, more patients have been eligible for these mini-invasive techniques, amplifying the scope of TMJ surgery. In diagnostics such as ankylosis, tumors and growth abnormalities, TMJ open surgery is strongly recommended. However, those diagnosis and relatively uncommon. TMJ internal derangement involving disc position/integrity and osteoarthrosis are more frequent, but the surgical indication is relative. From all the open surgery techniques, TMJ discectomy without interposal material is probably one of the most popular procedures. Recently, was showed that bilateral discectomy can induce severe TMJ changes detected with both imaging and histopathologic analysis in black Merino sheep. Besides, the critical histological and imaging results, functional masticatory alterations were not influenced by TMJ degenerative changes. Also, in other preclinical study, disc and fibrocartilage removal lead to traumatic TMJ ankylosis. It is interesting to observe the role of the condyle and temporal fibrocartilage, balancing the disc function. In humans, short-term studies on TMJ discectomy were associated with good results. In fact, in other retrospective study was showed discectomy without replacement is effective improving the preoperative maximum mouth opening (MMO). Despite the good clinical outcome, some studies have observed degenerative changes in imaging analysis. Together, clinical and preclinical results showed TMJ discectomy is a suboptimal technique, and an effective disc substitute, acting as a cushion between the condyle and temporal fossa could, in theory, improve these results. Despite extensive research in the field of tissue engineering, currently no appropriate disc substitute has demonstrated safety and efficacy. In fact, the last guidelines do not recommend disc replacement because nonvalid option showed superiority over discectomy alone. While there is no effective disc substitute, discectomy is often used when the disc is partial or total damaged and cannot be salvaged and/or and when symptoms fail to improve with other techniques. The inclusion criteria heterogeneity in previous studies, retrospective studies and non-randomization makes it difficult to draw clear conclusions about this technique. The investigators designed a rigorous prospective study for patients with: 1) unilateral TMJ disc perforation or 2) unilateral TMJ disc fragmentation. Those patients were proposed to unilateral TMJ discectomy. Most of the times, when the disc is damaged, the bone fibrocartilage is distorted and the authors wanted to understand the role of discectomy is those patients.
Official Title
-----------------
Unilateral TMJ Discectomy Without Interposal Material in Patients With Disc Perforation or Fragmentation
Conditions
-----------------
Temporomandibular Disorders
Intervention / Treatment
-----------------
* Procedure: TMJ unilateral discectomy
Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Age > 18 years old; Unilateral TMJ pain >7 (0-10 VAS) and/or MMO < 30mm; MRI presenting unilateral disc perforation or disc fragmentation Clinical and imaging examination with criteria for unilateral TMJ discectomy Exclusion Criteria: Previous TMJ surgical intervention; Concomitant contralateral surgery; Age < 18 years old
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: Treatment
Intervention Model: Single Group Assignment
Interventional Model Description: Prospective Study
Masking: None (Open Label)
Arms and Interventions
| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Discectomy<br>Unilateral Discectomy | Procedure: TMJ unilateral discectomy<br>* All patients underwent general anesthesia with nasotracheal intubation, managed in most cases with intravenous anesthesia protocol, usually with remifentanil infusion. Intraoperative steroids, usually dexamethasone, were administered primarily to minimize postoperative swelling. A classic preauricular incision or a root of helix inter tragus notch incision (RHITNI) was used in most cases, as previously described. No bandage or special care was performed after the surgery. No air washing restrictions were recommended.<br>|
What is the study measuring?
-----------------
Primary Outcome Measures
| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Pain (Visual Analogue Scale (0,10) | VAS, 0-10, with 0 being no pain and 10 having maximum unbearable pain | Pre-surgery |
| Pain (Visual Analogue Scale (0,10) | VAS, 0-10, with 0 being no pain and 10 having maximum unbearable pain | Through study completion, an average of 2 years |
Secondary Outcome Measures
| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Maximum mouth opening (MMO, mm) | Mouth opening measured with a ruler (mm) | Pre-surgery |
| Maximum mouth opening (MMO, mm) | Mouth opening measured with a ruler (mm) | Through study completion, an average of 2 years |
| Muscle tenderness (0-3 scale) | 0-3, corresponding to a muscle tenderness scale in masseter and temporalis muscle (0-whithout muscle tenderness, 3 - maximum muscle tenderness) | Pre-surgery |
| Muscle tenderness (0-3 scale) | 0-3, corresponding to a muscle tenderness scale in masseter and temporalis muscle (0-whithout muscle tenderness, 3 - maximum muscle tenderness) | Through study completion, an average of 2 years |
Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Temporomandibular, TMJ Discectomy, TMJ Meniscectomy, TMJ Surgery
|
NCT00810316
|
Evaluate Pharmacokinetics Of Two Different Pharmaceutical Oral Formulations Of Alprazolam And A Clonazepam Tablet In Mexican Healthy Population
|
To estimate the pharmacokinetics of single doses of benzodiazepines in Mexican adult healthy volunteers: a) alprazolam tablet extended release, b) alprazolam tablet immediate release, and clonazepam tablet.
|
To determine pharmacokinetics of alprazolam and clonazepam in Latin-American population; in Mexico, both drugs are still widely used as first or second choice in the treatment of anxiety disorders.
|
Evaluate The Pharmacokinetics Of Two Alprazolam Formulations (Immediate Release And Extended Release Tablets) And A Clonazepam Tablet In A Healthy Mexican Population
|
Pharmacokinetics
|
* Drug: Alprazolam
* Drug: Alprazolam XR
* Drug: Clonazepam
|
Inclusion Criteria:~Healthy male or female volunteers aged between 18 and 40 years old.~Exclusion Criteria:~Subjects presenting changes on their vital signs constants registered at volunteers' screening.~Volunteers with any of the following: noncompliance of proposed inclusion criteria; requiring another drug product throughout the study conduction; pregnant or nursing females; history of cardiovascular, renal, hepatic, muscular, metabolic, gastrointestinal, neurological, endocrine, psychiatric, hematopoietic or any other anemia kind, disease, asthma, or organic disorder; history of dyspepsia, gastritis, esophagitis, duodenal or gastric ulcer or any condition possibly affecting drug absorption; history of acute narrow or glaucoma; exposed to drug products known as hepatic enzyme or inductors; who had received any drug product within 14 days or 5 half lives; who had been hospitalized due to any problem within 60 days prior to study start; history of sensitivity to BZD; who had drink alcohol or any beverage containing xanthines or who had taken smoked food or grapefruit juice within 72 hours prior to start hospitalization period, who had blood donated or lost 450 mL or more within 60 days prior to study start; requiring any special diet regardless the cause.
|
18 Years
|
40 Years
|
All
|
Accepts Healthy Volunteers
|
Primary Purpose: Other
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single
|
| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| AUC last: Area under the curve of plasma concentration from administration up to time t (last sampling timepoint) calculated by trapezoid method. | | Sampling times: 0 to 96 hours |
| AUC inf: Area under the curve of plasma concentration from administration up to infinitum extrapolated time. | | Sampling times: 0 to 96 hours |
| Cmax: Maximum plasma concentration graphically obtained, based on plasma concentration versus time profile. | | Sampling times: 0 to 96 hours |
| t 1/2: Half life time. | | Sampling times: 0 to 96 hours |
| Tmax: Time from administration up to maximum plasma concentration, graphically obtained based on plasma concentration versus time profile. | | Sampling times: 0 to 96 hours |
|
| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| No Secondary Outcomes | | |
|
Alprazolam, Alprazolam extended release, Clonazepam, Pharmacokinetics, Mexican population, Healthy
|
Clonazepam, Alprazolam, Hypnotics and Sedatives, Central Nervous System Depressants, Physiological Effects of Drugs, Anti-Anxiety Agents, Tranquilizing Agents, Psychotropic Drugs, GABA Modulators, GABA Agents, Neurotransmitter Agents, Molecular Mechanisms of Pharmacological Action, Anticonvulsants
|
| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Other: Treatment A<br> | Drug: Alprazolam<br>* Administration of a single oral dose tablet of 1 mg of alprazolam immediate release on Day 1 morning, between 8-9 am with 250 ml of water in at least 10 hours of fasting conditions<br>* Other names: Tafil, Xanax;|
| Other: Treatment B<br> | Drug: Alprazolam XR<br>* Administration of a single oral dose tablet of 1 mg of alprazolam modified release on Day 1 morning, between 8-9 am with 250 ml of water in at least 10 hours of fasting conditions<br>* Other names: Tafil AP, Xanax XR;|
| Other: Treatment C<br> | Drug: Clonazepam<br>* Administration of a single oral dose of two tablets of 0.5 mg of clonazepam on Day 1 morning, between 8-9 am with 250 ml of water in at least 10 hours of fasting conditions<br>* Other names: Rivotril;|
|
Evaluate Pharmacokinetics Of Two Different Pharmaceutical Oral Formulations Of Alprazolam And A Clonazepam Tablet In Mexican Healthy Population
Study Overview
=================
Brief Summary
-----------------
To estimate the pharmacokinetics of single doses of benzodiazepines in Mexican adult healthy volunteers: a) alprazolam tablet extended release, b) alprazolam tablet immediate release, and clonazepam tablet.
Detailed Description
-----------------
To determine pharmacokinetics of alprazolam and clonazepam in Latin-American population; in Mexico, both drugs are still widely used as first or second choice in the treatment of anxiety disorders.
Official Title
-----------------
Evaluate The Pharmacokinetics Of Two Alprazolam Formulations (Immediate Release And Extended Release Tablets) And A Clonazepam Tablet In A Healthy Mexican Population
Conditions
-----------------
Pharmacokinetics
Intervention / Treatment
-----------------
* Drug: Alprazolam
* Drug: Alprazolam XR
* Drug: Clonazepam
Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Healthy male or female volunteers aged between 18 and 40 years old. Exclusion Criteria: Subjects presenting changes on their vital signs constants registered at volunteers' screening. Volunteers with any of the following: noncompliance of proposed inclusion criteria; requiring another drug product throughout the study conduction; pregnant or nursing females; history of cardiovascular, renal, hepatic, muscular, metabolic, gastrointestinal, neurological, endocrine, psychiatric, hematopoietic or any other anemia kind, disease, asthma, or organic disorder; history of dyspepsia, gastritis, esophagitis, duodenal or gastric ulcer or any condition possibly affecting drug absorption; history of acute narrow or glaucoma; exposed to drug products known as hepatic enzyme or inductors; who had received any drug product within 14 days or 5 half lives; who had been hospitalized due to any problem within 60 days prior to study start; history of sensitivity to BZD; who had drink alcohol or any beverage containing xanthines or who had taken smoked food or grapefruit juice within 72 hours prior to start hospitalization period, who had blood donated or lost 450 mL or more within 60 days prior to study start; requiring any special diet regardless the cause.
Ages Eligible for Study
-----------------
Minimum Age: 18 Years
Maximum Age: 40 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: Parallel Assignment
Masking: Single
Arms and Interventions
| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Other: Treatment A<br> | Drug: Alprazolam<br>* Administration of a single oral dose tablet of 1 mg of alprazolam immediate release on Day 1 morning, between 8-9 am with 250 ml of water in at least 10 hours of fasting conditions<br>* Other names: Tafil, Xanax;|
| Other: Treatment B<br> | Drug: Alprazolam XR<br>* Administration of a single oral dose tablet of 1 mg of alprazolam modified release on Day 1 morning, between 8-9 am with 250 ml of water in at least 10 hours of fasting conditions<br>* Other names: Tafil AP, Xanax XR;|
| Other: Treatment C<br> | Drug: Clonazepam<br>* Administration of a single oral dose of two tablets of 0.5 mg of clonazepam on Day 1 morning, between 8-9 am with 250 ml of water in at least 10 hours of fasting conditions<br>* Other names: Rivotril;|
What is the study measuring?
-----------------
Primary Outcome Measures
| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| AUC last: Area under the curve of plasma concentration from administration up to time t (last sampling timepoint) calculated by trapezoid method. | | Sampling times: 0 to 96 hours |
| AUC inf: Area under the curve of plasma concentration from administration up to infinitum extrapolated time. | | Sampling times: 0 to 96 hours |
| Cmax: Maximum plasma concentration graphically obtained, based on plasma concentration versus time profile. | | Sampling times: 0 to 96 hours |
| t 1/2: Half life time. | | Sampling times: 0 to 96 hours |
| Tmax: Time from administration up to maximum plasma concentration, graphically obtained based on plasma concentration versus time profile. | | Sampling times: 0 to 96 hours |
Secondary Outcome Measures
| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| No Secondary Outcomes | | |
Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Alprazolam, Alprazolam extended release, Clonazepam, Pharmacokinetics, Mexican population, Healthy
|
NCT03539250
|
Dose Constraints for the Temporal Lobes of Intensity-modulated Radiotherapy Treatment Plans for Nasopharyngeal Carcinoma
|
Radiation-induced temporal lobe injury (TLI) is usually devastating to patients; however, there is a poor understanding of TLI in nasopharyngeal carcinoma (NPC) patients treated with IMRT. Knowledge of the dose tolerance of the TL is essential, in order to predict the safety of intensity-modulated radiotherapy (IMRT) treatment plans. In our previous studies, D1cc (the dose to 1ml of the TL volume) and Dmax (the maximum point dose) were the significant predictors of TLI development. The purpose of this study is to evaluate the feasibility of dose constraints based on D1cc and Dmax for the temporal lobes following IMRT for NPC.
|
The prescribe dose was 66-70Gy to the PTV of the GTVnx, 60Gy to the PTV of CTV1(i.e., high-risk regions),54-56Gy to the PTV of CTV2(i.e., low-risk regions),and 64-66Gy to the PTV of the GTVnd for the metastatic cervical lymph nodes in 30-33 fractions. For the GTV and CTV, the target volumes that received more than 95% of the prescribed dose was used to reflect the target coverage. Subdivision of the PTVnx into regions with different prescribed absorbed doses (PTVsv1,PTVsv2, PTVsv2 is the overlaps between PTVnx and temporal lobe) can be used in cases for which the PTVnx overlaps temporal lobe. When the volume of PTVsv2 is less than 0.2 cubic centimeter (cc), the prescribe dose for PTVsv2 is as the same as that of the PTVsv1, D1cc 63.1Gy, Dmax 72.9Gy for TL (32 fractions). When the volume of PTVsv2 is between 0.2 cc and 0.5cc, the prescribe dose for PTVsv2 is 66Gy, D1cc 63.1Gy, Dmax 72.9Gy for TL (32 fractions). When the volume of PTVsv2 is between 0.5 cc and 1cc, the prescribe dose for PTVsv2 is 66Gy, D1cc 65.8Gy, Dmax 75.2Gy for TL (32 fractions).
|
Dose Constraints for the Temporal Lobes During the Optimization of Intensity-modulated Radiotherapy Treatment Plans for Nasopharyngeal Carcinoma
|
Injury; Temporal Region
|
* Radiation: IMRT
|
Inclusion Criteria:~Newly-diagnosed and confirmed histopathologic diagnosis of nasopharyngeal squamous cell carcinoma, types WHO II-III, Stage I-IVA (AJCC staging, 2017, 8th edition), treated with intensity-modulated radiotherapy.~No head and neck surgery of the primary tumor or lymph nodes except for incisional or excisional biopsies.~Age between 18 years and 70 years.~Karnofsky score ≥80~WBC≥ 4,000/ul, platelets≥ 100,000/ul; serum creatinine≤ 1.6 mg/dl or 24hr. calculated creatinine clearance ≥ 60ml/min.~Must undergo pre-treatment evaluation of tumor extent and tumor measurement. Tumor may be measurable or evaluable.~Signed study-specific consent form prior to study entry.~Exclusion Criteria:~Stage IVB~Evidence of distant metastases~Previous irradiation for head and neck tumor ≤ 6 months prior to study entry~Previous chemotherapy ≤ 6 months prior to study entry~Patient is on other experimental therapeutic cancer treatment~Other malignancy except non-melanoma skin cancer or a carcinoma not of head and neck origin and controlled at least 5 years~Active untreated infection~Major medical or psychiatric illness, which in the investigator's opinions, would interfere with either the completion of therapy and follow-up or with full and complete understanding of the risks and potential complications of the therapy~Pregnant women
|
18 Years
|
70 Years
|
All
|
No
|
Primary Purpose: Treatment
Intervention Model: Single Group Assignment
Masking: None (Open Label)
|
| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| The incidence of radiation-induced temporal lobe injury at 5 years | The incidence of radiation-induced temporal lobe injury at 5 years will be calculated | 5 years |
|
| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Local recurrence-free survival at 5 years | Local recurrence-free survival at 5 years will be calculated | 5 years |
|
Radiation-induced temporal lobe injury;NPC, Nasopharyngeal carcinoma, Intensity-modulated radiotherapy
|
Carcinoma, Nasopharyngeal Carcinoma, Neoplasms, Glandular and Epithelial, Neoplasms by Histologic Type, Neoplasms, Nasopharyngeal Neoplasms, Pharyngeal Neoplasms, Otorhinolaryngologic Neoplasms, Head and Neck Neoplasms, Neoplasms by Site, Nasopharyngeal Diseases, Pharyngeal Diseases, Stomatognathic Diseases, Otorhinolaryngologic Diseases
|
| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: IMRT with and without chemotherapy<br>Subdivision of the PTVnx into regions with different prescribed absorbed doses (PTVsv1,PTVsv2, PTVsv2 is the overlaps between PTVnx and temporal lobe) can be used in cases for which the PTVnx overlaps temporal lobe. When the volume of PTVsv2 is less than 0.2 cubic centimeter (cc), the prescribe dose for PTVsv2 is as the same as that of the PTVsv1, D1cc 63.1Gy, Dmax 72.9Gy for TL (32 fractions). When the volume of PTVsv2 is between 0.2 cc and 0.5cc, the prescribe dose for PTVsv2 is 66Gy, D1cc 63.1Gy, Dmax 72.9Gy for TL (32 fractions). When the volume of PTVsv2 is between 0.5 cc and 1cc, the prescribe dose for PTVsv2 is 66Gy, D1cc 65.8Gy, Dmax 75.2Gy for TL (32 fractions). | Radiation: IMRT<br>* IMRT with and without chemotherapy<br>|
|
Dose Constraints for the Temporal Lobes of Intensity-modulated Radiotherapy Treatment Plans for Nasopharyngeal Carcinoma
Study Overview
=================
Brief Summary
-----------------
Radiation-induced temporal lobe injury (TLI) is usually devastating to patients; however, there is a poor understanding of TLI in nasopharyngeal carcinoma (NPC) patients treated with IMRT. Knowledge of the dose tolerance of the TL is essential, in order to predict the safety of intensity-modulated radiotherapy (IMRT) treatment plans. In our previous studies, D1cc (the dose to 1ml of the TL volume) and Dmax (the maximum point dose) were the significant predictors of TLI development. The purpose of this study is to evaluate the feasibility of dose constraints based on D1cc and Dmax for the temporal lobes following IMRT for NPC.
Detailed Description
-----------------
The prescribe dose was 66-70Gy to the PTV of the GTVnx, 60Gy to the PTV of CTV1(i.e., high-risk regions),54-56Gy to the PTV of CTV2(i.e., low-risk regions),and 64-66Gy to the PTV of the GTVnd for the metastatic cervical lymph nodes in 30-33 fractions. For the GTV and CTV, the target volumes that received more than 95% of the prescribed dose was used to reflect the target coverage. Subdivision of the PTVnx into regions with different prescribed absorbed doses (PTVsv1,PTVsv2, PTVsv2 is the overlaps between PTVnx and temporal lobe) can be used in cases for which the PTVnx overlaps temporal lobe. When the volume of PTVsv2 is less than 0.2 cubic centimeter (cc), the prescribe dose for PTVsv2 is as the same as that of the PTVsv1, D1cc 63.1Gy, Dmax 72.9Gy for TL (32 fractions). When the volume of PTVsv2 is between 0.2 cc and 0.5cc, the prescribe dose for PTVsv2 is 66Gy, D1cc 63.1Gy, Dmax 72.9Gy for TL (32 fractions). When the volume of PTVsv2 is between 0.5 cc and 1cc, the prescribe dose for PTVsv2 is 66Gy, D1cc 65.8Gy, Dmax 75.2Gy for TL (32 fractions).
Official Title
-----------------
Dose Constraints for the Temporal Lobes During the Optimization of Intensity-modulated Radiotherapy Treatment Plans for Nasopharyngeal Carcinoma
Conditions
-----------------
Injury; Temporal Region
Intervention / Treatment
-----------------
* Radiation: IMRT
Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Newly-diagnosed and confirmed histopathologic diagnosis of nasopharyngeal squamous cell carcinoma, types WHO II-III, Stage I-IVA (AJCC staging, 2017, 8th edition), treated with intensity-modulated radiotherapy. No head and neck surgery of the primary tumor or lymph nodes except for incisional or excisional biopsies. Age between 18 years and 70 years. Karnofsky score ≥80 WBC≥ 4,000/ul, platelets≥ 100,000/ul; serum creatinine≤ 1.6 mg/dl or 24hr. calculated creatinine clearance ≥ 60ml/min. Must undergo pre-treatment evaluation of tumor extent and tumor measurement. Tumor may be measurable or evaluable. Signed study-specific consent form prior to study entry. Exclusion Criteria: Stage IVB Evidence of distant metastases Previous irradiation for head and neck tumor ≤ 6 months prior to study entry Previous chemotherapy ≤ 6 months prior to study entry Patient is on other experimental therapeutic cancer treatment Other malignancy except non-melanoma skin cancer or a carcinoma not of head and neck origin and controlled at least 5 years Active untreated infection Major medical or psychiatric illness, which in the investigator's opinions, would interfere with either the completion of therapy and follow-up or with full and complete understanding of the risks and potential complications of the therapy Pregnant women
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
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Arms and Interventions
| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: IMRT with and without chemotherapy<br>Subdivision of the PTVnx into regions with different prescribed absorbed doses (PTVsv1,PTVsv2, PTVsv2 is the overlaps between PTVnx and temporal lobe) can be used in cases for which the PTVnx overlaps temporal lobe. When the volume of PTVsv2 is less than 0.2 cubic centimeter (cc), the prescribe dose for PTVsv2 is as the same as that of the PTVsv1, D1cc 63.1Gy, Dmax 72.9Gy for TL (32 fractions). When the volume of PTVsv2 is between 0.2 cc and 0.5cc, the prescribe dose for PTVsv2 is 66Gy, D1cc 63.1Gy, Dmax 72.9Gy for TL (32 fractions). When the volume of PTVsv2 is between 0.5 cc and 1cc, the prescribe dose for PTVsv2 is 66Gy, D1cc 65.8Gy, Dmax 75.2Gy for TL (32 fractions). | Radiation: IMRT<br>* IMRT with and without chemotherapy<br>|
What is the study measuring?
-----------------
Primary Outcome Measures
| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| The incidence of radiation-induced temporal lobe injury at 5 years | The incidence of radiation-induced temporal lobe injury at 5 years will be calculated | 5 years |
Secondary Outcome Measures
| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Local recurrence-free survival at 5 years | Local recurrence-free survival at 5 years will be calculated | 5 years |
Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Radiation-induced temporal lobe injury;NPC, Nasopharyngeal carcinoma, Intensity-modulated radiotherapy
|
NCT01560702
|
Comparative Study of Autologous Blood Injection Versus Diluted Epinephrine in Treating Actively Bleeding Gastroduodenal Ulcers
|
Endoscopic injection of autologous blood can control bleeding from gastroduodenal ulcers.
|
To test the hypothesis that endoscopic injection of autologous blood is superior to endoscopic injection of diluted epinephrine in controlling bleeding from gastroduodenal ulcers.
|
Endoscopic Injection of Autologous Blood Versus Diluted Epinephrine for Control of Actively Bleeding Gastroduodenal Ulcers
|
Blood, Injection, Injury Type Phobia, Gastrointestinal Ulcer Haemorrhage, Adverse Reaction to Epinephrine
|
* Drug: Epinephrine
* Biological: Blood
|
Inclusion Criteria:~all adult patients with gastroduodenal ulcer~Exclusion Criteria:~Patients with non ulcer bleeding.~Patients with malignancy.~Patients with bleeding disorders or under coagulation therapy.~Patients with known allergy to epinephrine.
|
16 Years
|
60 Years
|
All
|
No
|
Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
|
| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| hemostasis from the ulcer after injection and/or stoppage of haematemesis and melena one day after the procedure. | | 12 months |
|
| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| development of re-bleeding after 24 hours after the procedure (occurrence of hematemesis or melena or drop of hemoglobin level >2gm/dl). | | 12 months |
|
autologous blood, epinephrine, endoscopy, ulcer, hemostasis
|
Epinephrine, 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: Autologous blood<br>Patients will be injected by autologous blood at the edge of actively bleeding ulcer | Biological: Blood<br>* 5-20 cc autologous blood immediately withdrawn from the patient will be injected at edges of the actively bleeding ulcer.<br>|
| Other: Epinephrine injection<br>Patients will be injected by diluted epinephrine at the edge of actively bleeding ulcer | Drug: Epinephrine<br>* 10-30 cc of 1/10000 diluted epinephrine will be injected at edges of an actively bleeding ulcer.<br>|
|
Comparative Study of Autologous Blood Injection Versus Diluted Epinephrine in Treating Actively Bleeding Gastroduodenal Ulcers
Study Overview
=================
Brief Summary
-----------------
Endoscopic injection of autologous blood can control bleeding from gastroduodenal ulcers.
Detailed Description
-----------------
To test the hypothesis that endoscopic injection of autologous blood is superior to endoscopic injection of diluted epinephrine in controlling bleeding from gastroduodenal ulcers.
Official Title
-----------------
Endoscopic Injection of Autologous Blood Versus Diluted Epinephrine for Control of Actively Bleeding Gastroduodenal Ulcers
Conditions
-----------------
Blood, Injection, Injury Type Phobia, Gastrointestinal Ulcer Haemorrhage, Adverse Reaction to Epinephrine
Intervention / Treatment
-----------------
* Drug: Epinephrine
* Biological: Blood
Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: all adult patients with gastroduodenal ulcer Exclusion Criteria: Patients with non ulcer bleeding. Patients with malignancy. Patients with bleeding disorders or under coagulation therapy. Patients with known allergy to epinephrine.
Ages Eligible for Study
-----------------
Minimum Age: 16 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: Parallel Assignment
Masking: None (Open Label)
Arms and Interventions
| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: Autologous blood<br>Patients will be injected by autologous blood at the edge of actively bleeding ulcer | Biological: Blood<br>* 5-20 cc autologous blood immediately withdrawn from the patient will be injected at edges of the actively bleeding ulcer.<br>|
| Other: Epinephrine injection<br>Patients will be injected by diluted epinephrine at the edge of actively bleeding ulcer | Drug: Epinephrine<br>* 10-30 cc of 1/10000 diluted epinephrine will be injected at edges of an actively bleeding ulcer.<br>|
What is the study measuring?
-----------------
Primary Outcome Measures
| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| hemostasis from the ulcer after injection and/or stoppage of haematemesis and melena one day after the procedure. | | 12 months |
Secondary Outcome Measures
| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| development of re-bleeding after 24 hours after the procedure (occurrence of hematemesis or melena or drop of hemoglobin level >2gm/dl). | | 12 months |
Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
autologous blood, epinephrine, endoscopy, ulcer, hemostasis
|
Subsets and Splits
No community queries yet
The top public SQL queries from the community will appear here once available.