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NCT02269046
|
Acupuncture and Moxibustion for Hyperlipemia
|
The purpose of this study is to evaluate the effect of 12 weeks of acupuncture and moxibustion compared with active control, on absolute and percent change from baseline in low-density lipoprotein cholesterol (LDL-C) among those with hyperlipidemia.
|
A Multi-center, Randomized, Stratified, Active-controlled Trial to Evaluate the Effects of Acupuncture and Moxibustion for Hyperlipidemias
|
Hyperlipidemias
|
* Other: acupuncture and moxibustion
* Drug: Simvastatin
* Other: Therapeutic Lifestyle Change
|
Inclusion Criteria:~Subject signed the informed consent~Male or female ≥18 to ≤75 years of age~Fasting TG ≤400 mg/dL~Fasting LDL-C as determined by central laboratory on admission and meeting the following LDL-C values based on risk factor status:~0-1 Risk Factor Group: LDL-C ≥160 mg/dL~2+ Risk Factor Group: LDL-C ≥130 mg/dL~CHD or CHD risk equivalents: LDL-C ≥100 mg/dL~Major Risk factors: （1）Cigarette smoking;（2）Hypertension (BP ≥140/90 mmHg or on anti-hypertensive medication);（3）Low HDL cholesterol (HDL-C <40 mg/dL);（4）Family history of premature CHD (CHD in male first degree relative <55 years; CHD in female first degree relative <65 years);（5）Age (men ≥45 years; women ≥55 years)~CHD and CHD equivalents:（1）Other clinical forms of atherosclerotic disease (peripheral arterial disease, abdominal aortic aneurysm, and symptomatic carotid artery disease);（2）Diabetes;（3）Multiple risk factors that confer a 10-year risk for CHD >20%~Exclusion Criteria:~CHD or CHD risk equivalent and not receiving statin therapy, with LDL-C at screening ≤99 mg/dL~NYHA II, III or IV heart failure, or last known left ventricular ejection fraction <30%~Uncontrolled cardiac arrhythmia, atrial fibrillation with rapid ventricular response, or not controlled supraventricular tachycardia in the past 3 months prior to randomization~Myocardial infarction, unstable angina, percutaneous coronary intervention (PCI), coronary artery bypass graft (CABG) or stroke within 3 months prior to randomization~Planned cardiac surgery or revascularization~Type 1 diabetes or newly diagnosed type 2 diabetes or poorly controlled type 2 diabetes~Uncontrolled hypertension defined as sitting systolic blood pressure (SBP) >160 mmHg or diastolic BP (DBP) >100 mmHg~Subjects taken red yeast rice, niacin >200 mg/d, or omega-3 fatty acids >1000 mg/d or prescription lipid-regulating drugs other than statins or ezetimibe, such as fibrates and derivatives, or bile-acid sequestering resins in the last 6 weeks prior to LDL-C screening~Subjects taken systemic cyclosporine, systemic steroids, vitamin A derivatives and retinol derivatives for the treatment of dermatologic conditions in the last 3 months prior to LDL-C screening~Hyperthyroidism or hypothyroidism~Moderate to severe renal dysfunction~Active liver disease or hepatic dysfunction~CK >3 times the ULN at screening or at end of lipid stabilization period, confirmed by a repeat measurement at least 1 week apart~Known active infection or major hematologic, renal, metabolic, gastrointestinal or endocrine dysfunction in the judgment of the investigator~Deep vein thrombosis or pulmonary embolism within 3 months prior to randomization~Current therapeutic anticoagulation with vitamin K antagonist, heparin, low-molecular weight heparin, direct thrombin inhibitor~Currently enrolled in another investigational device or drug study~Female subject during pregnant or breast feeding period~History of malignancy (except non-melanoma skin cancers, cervical in-situ carcinoma, breast ductal carcinoma in situ, or stage 1 prostate carcinoma)~Known sensitivity to any of the products to be administered during dosing~Subjects couldn't provide the written informed consent and/or comply with all required study procedures
|
20 Years
|
75 Years
|
All
|
No
|
Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single
|
| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| low-density lipoprotein cholesterol (LDL-C) | To evaluate the effect of 12 weeks of acupuncture compared with active control, on percent change from baseline in low-density lipoprotein cholesterol (LDL-C) among those with hyperlipidemia. | 12 weeks |
|
| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| high-density lipoprotein cholesterol (HDL-C) | | 12 weeks |
| total cholesterol (TC) | | 12 weeks |
| triglyceride(TG) | | 12 weeks |
| the rate of subjects achieving LDL-C goal | | 12 weeks |
|
acupuncture, moxibustion, hyperlipidemias, effectiveness
|
Lipid Regulating Agents, Simvastatin, Anticholesteremic Agents, Hypolipidemic Agents, Antimetabolites, Molecular Mechanisms of Pharmacological Action, Hydroxymethylglutaryl-CoA Reductase Inhibitors, Enzyme Inhibitors
|
| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Acupuncture and moxibustion<br>therapeutic lifestyle change~Group I:Juque (RN14), Tianshu (ST25, bilateral), Fenglong (ST40, bilateral), Zusanli (ST 36, bilateral), Sanyinjiao (SP6, bilateral)~Group II: Pishu (BL20, bilateral), Xinshu (BL15, bilateral), Ganshu (BL18, bilateral), Shenshu (BL23, bilateral)~Group I and II will change alternatively every other week .~Once per day five days per week. | Other: acupuncture and moxibustion<br>* Warm needling acupuncture on Fenglong (ST40, bilateral), Zusanli (ST36, bilateral), Sanyinjiao (SP6, bilateral) and Cake-seperated moxibustion on Juque (RN14), Tianshu (ST25, bilateral), Pishu (BL20, bilateral), Xinshu (BL15, bilateral), Ganshu (BL18, bilateral), Shenshu (BL23, bilateral)<br>Other: Therapeutic Lifestyle Change<br>* Reduced intakes of saturated fats (<7% of total calories) and cholesterol (<200 mg per day)~Therapeutic options for enhancing LDL lowering~Weight reduction~Increased physical activity<br>|
| Active Comparator: Simvastatin<br>therapeutic lifestyle change~simvastatin~oral administration with 10mg per day~seven days per week for 12 weeks. | Drug: Simvastatin<br>* 10mg/d,p.o,12 weeks.<br>Other: Therapeutic Lifestyle Change<br>* Reduced intakes of saturated fats (<7% of total calories) and cholesterol (<200 mg per day)~Therapeutic options for enhancing LDL lowering~Weight reduction~Increased physical activity<br>|
| Other: waiting list<br>- therapeutic lifestyle change | Other: Therapeutic Lifestyle Change<br>* Reduced intakes of saturated fats (<7% of total calories) and cholesterol (<200 mg per day)~Therapeutic options for enhancing LDL lowering~Weight reduction~Increased physical activity<br>|
|
Acupuncture and Moxibustion for Hyperlipemia
Study Overview
=================
Brief Summary
-----------------
The purpose of this study is to evaluate the effect of 12 weeks of acupuncture and moxibustion compared with active control, on absolute and percent change from baseline in low-density lipoprotein cholesterol (LDL-C) among those with hyperlipidemia.
Official Title
-----------------
A Multi-center, Randomized, Stratified, Active-controlled Trial to Evaluate the Effects of Acupuncture and Moxibustion for Hyperlipidemias
Conditions
-----------------
Hyperlipidemias
Intervention / Treatment
-----------------
* Other: acupuncture and moxibustion
* Drug: Simvastatin
* Other: Therapeutic Lifestyle Change
Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Subject signed the informed consent Male or female ≥18 to ≤75 years of age Fasting TG ≤400 mg/dL Fasting LDL-C as determined by central laboratory on admission and meeting the following LDL-C values based on risk factor status: 0-1 Risk Factor Group: LDL-C ≥160 mg/dL 2+ Risk Factor Group: LDL-C ≥130 mg/dL CHD or CHD risk equivalents: LDL-C ≥100 mg/dL Major Risk factors: （1）Cigarette smoking;（2）Hypertension (BP ≥140/90 mmHg or on anti-hypertensive medication);（3）Low HDL cholesterol (HDL-C <40 mg/dL);（4）Family history of premature CHD (CHD in male first degree relative <55 years; CHD in female first degree relative <65 years);（5）Age (men ≥45 years; women ≥55 years) CHD and CHD equivalents:（1）Other clinical forms of atherosclerotic disease (peripheral arterial disease, abdominal aortic aneurysm, and symptomatic carotid artery disease);（2）Diabetes;（3）Multiple risk factors that confer a 10-year risk for CHD >20% Exclusion Criteria: CHD or CHD risk equivalent and not receiving statin therapy, with LDL-C at screening ≤99 mg/dL NYHA II, III or IV heart failure, or last known left ventricular ejection fraction <30% Uncontrolled cardiac arrhythmia, atrial fibrillation with rapid ventricular response, or not controlled supraventricular tachycardia in the past 3 months prior to randomization Myocardial infarction, unstable angina, percutaneous coronary intervention (PCI), coronary artery bypass graft (CABG) or stroke within 3 months prior to randomization Planned cardiac surgery or revascularization Type 1 diabetes or newly diagnosed type 2 diabetes or poorly controlled type 2 diabetes Uncontrolled hypertension defined as sitting systolic blood pressure (SBP) >160 mmHg or diastolic BP (DBP) >100 mmHg Subjects taken red yeast rice, niacin >200 mg/d, or omega-3 fatty acids >1000 mg/d or prescription lipid-regulating drugs other than statins or ezetimibe, such as fibrates and derivatives, or bile-acid sequestering resins in the last 6 weeks prior to LDL-C screening Subjects taken systemic cyclosporine, systemic steroids, vitamin A derivatives and retinol derivatives for the treatment of dermatologic conditions in the last 3 months prior to LDL-C screening Hyperthyroidism or hypothyroidism Moderate to severe renal dysfunction Active liver disease or hepatic dysfunction CK >3 times the ULN at screening or at end of lipid stabilization period, confirmed by a repeat measurement at least 1 week apart Known active infection or major hematologic, renal, metabolic, gastrointestinal or endocrine dysfunction in the judgment of the investigator Deep vein thrombosis or pulmonary embolism within 3 months prior to randomization Current therapeutic anticoagulation with vitamin K antagonist, heparin, low-molecular weight heparin, direct thrombin inhibitor Currently enrolled in another investigational device or drug study Female subject during pregnant or breast feeding period History of malignancy (except non-melanoma skin cancers, cervical in-situ carcinoma, breast ductal carcinoma in situ, or stage 1 prostate carcinoma) Known sensitivity to any of the products to be administered during dosing Subjects couldn't provide the written informed consent and/or comply with all required study procedures
Ages Eligible for Study
-----------------
Minimum Age: 20 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: Acupuncture and moxibustion<br>therapeutic lifestyle change Group I:Juque (RN14), Tianshu (ST25, bilateral), Fenglong (ST40, bilateral), Zusanli (ST 36, bilateral), Sanyinjiao (SP6, bilateral) Group II: Pishu (BL20, bilateral), Xinshu (BL15, bilateral), Ganshu (BL18, bilateral), Shenshu (BL23, bilateral) Group I and II will change alternatively every other week . Once per day five days per week. | Other: acupuncture and moxibustion<br>* Warm needling acupuncture on Fenglong (ST40, bilateral), Zusanli (ST36, bilateral), Sanyinjiao (SP6, bilateral) and Cake-seperated moxibustion on Juque (RN14), Tianshu (ST25, bilateral), Pishu (BL20, bilateral), Xinshu (BL15, bilateral), Ganshu (BL18, bilateral), Shenshu (BL23, bilateral)<br>Other: Therapeutic Lifestyle Change<br>* Reduced intakes of saturated fats (<7% of total calories) and cholesterol (<200 mg per day) Therapeutic options for enhancing LDL lowering Weight reduction Increased physical activity<br>|
| Active Comparator: Simvastatin<br>therapeutic lifestyle change simvastatin oral administration with 10mg per day seven days per week for 12 weeks. | Drug: Simvastatin<br>* 10mg/d,p.o,12 weeks.<br>Other: Therapeutic Lifestyle Change<br>* Reduced intakes of saturated fats (<7% of total calories) and cholesterol (<200 mg per day) Therapeutic options for enhancing LDL lowering Weight reduction Increased physical activity<br>|
| Other: waiting list<br>- therapeutic lifestyle change | Other: Therapeutic Lifestyle Change<br>* Reduced intakes of saturated fats (<7% of total calories) and cholesterol (<200 mg per day) Therapeutic options for enhancing LDL lowering Weight reduction Increased physical activity<br>|
What is the study measuring?
-----------------
Primary Outcome Measures
| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| low-density lipoprotein cholesterol (LDL-C) | To evaluate the effect of 12 weeks of acupuncture compared with active control, on percent change from baseline in low-density lipoprotein cholesterol (LDL-C) among those with hyperlipidemia. | 12 weeks |
Secondary Outcome Measures
| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| high-density lipoprotein cholesterol (HDL-C) | | 12 weeks |
| total cholesterol (TC) | | 12 weeks |
| triglyceride(TG) | | 12 weeks |
| the rate of subjects achieving LDL-C goal | | 12 weeks |
Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
acupuncture, moxibustion, hyperlipidemias, effectiveness
|
|
NCT02741297
|
VELOCITY: A Study to Characterize Real-World Outcomes of Spinal Cord Stimulation
|
The primary objective of this study is to characterize the real-world outcomes of spinal cord stimulation (SCS) therapy as an aid in the management of chronic intractable pain of the trunk, including unilateral or bilateral pain associated with the following: failed back surgery syndrome, intractable low back pain using the Boston Scientific (BSC) PRECISION Spinal Cord Stimulator System with MultiWave Technology.
|
The purpose of this study is to characterize the real-world outcomes of spinal cord stimulation (SCS) therapy as an aid in the management of chronic intractable pain of the trunk, including unilateral or bilateral pain associated with the following: failed back surgery syndrome, intractable low back pain using the Boston Scientific (BSC) PRECISION Spinal Cord Stimulator System with MultiWave Technology.
|
A Multi-Center Controlled Study to Characterize the Real-world Outcomes of High Rate Spinal Cord Stimulation Therapy Using Boston Scientific (BSC) PRECISION Spinal Cord Stimulator System
|
Chronic Pain
|
* Device: Spinal Cord Stimulation (SCS) System
|
Key Inclusion Criteria:~Complaint of persistent or recurrent low back pain for at least 180 days prior to Screening~Willing and able to comply with all protocol-required procedures and assessments/evaluations~Subject signed a valid, ethics committee (EC)-approved informed consent form (ICF) provided in local language~Key Exclusion Criteria:~High surgical risk~Previous spinal cord stimulation trial or is already implanted with an active implantable device(s) (e.g. pacemaker, drug pump, implantable pulse generator)~A female who is pregnant, is breastfeeding, or is of childbearing potential and planning to get pregnant during the course of the study or not using adequate contraception.~Participating (or intends to participate) in another drug or device clinical trial that may influence the data that will be collected for this study~Any diagnosis or condition that, in the clinician's best judgment, might confound reporting of study outcomes
|
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 Low Back Pain Responders | Percentage of low back pain responders at 3 months post-activation with no increase in opioids from Baseline to 3 months post-activation | 3 months |
|
Spinal Cord Stimulation, Chronic Pain
|
Chronic Pain, Pain, Neurologic Manifestations
|
| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Spinal Cord Stimulation (SCS) System<br>Boston Scientific (BSC) PRECISION SCS System with MultiWave Technology | Device: Spinal Cord Stimulation (SCS) System<br>* Boston Scientific (BSC) PRECISION SCS System with MultiWave Technology<br>|
|
VELOCITY: A Study to Characterize Real-World Outcomes of Spinal Cord Stimulation
Study Overview
=================
Brief Summary
-----------------
The primary objective of this study is to characterize the real-world outcomes of spinal cord stimulation (SCS) therapy as an aid in the management of chronic intractable pain of the trunk, including unilateral or bilateral pain associated with the following: failed back surgery syndrome, intractable low back pain using the Boston Scientific (BSC) PRECISION Spinal Cord Stimulator System with MultiWave Technology.
Detailed Description
-----------------
The purpose of this study is to characterize the real-world outcomes of spinal cord stimulation (SCS) therapy as an aid in the management of chronic intractable pain of the trunk, including unilateral or bilateral pain associated with the following: failed back surgery syndrome, intractable low back pain using the Boston Scientific (BSC) PRECISION Spinal Cord Stimulator System with MultiWave Technology.
Official Title
-----------------
A Multi-Center Controlled Study to Characterize the Real-world Outcomes of High Rate Spinal Cord Stimulation Therapy Using Boston Scientific (BSC) PRECISION Spinal Cord Stimulator System
Conditions
-----------------
Chronic Pain
Intervention / Treatment
-----------------
* Device: Spinal Cord Stimulation (SCS) System
Participation Criteria
=================
Eligibility Criteria
-----------------
Key Inclusion Criteria: Complaint of persistent or recurrent low back pain for at least 180 days prior to Screening Willing and able to comply with all protocol-required procedures and assessments/evaluations Subject signed a valid, ethics committee (EC)-approved informed consent form (ICF) provided in local language Key Exclusion Criteria: High surgical risk Previous spinal cord stimulation trial or is already implanted with an active implantable device(s) (e.g. pacemaker, drug pump, implantable pulse generator) A female who is pregnant, is breastfeeding, or is of childbearing potential and planning to get pregnant during the course of the study or not using adequate contraception. Participating (or intends to participate) in another drug or device clinical trial that may influence the data that will be collected for this study Any diagnosis or condition that, in the clinician's best judgment, might confound reporting of study outcomes
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: Spinal Cord Stimulation (SCS) System<br>Boston Scientific (BSC) PRECISION SCS System with MultiWave Technology | Device: Spinal Cord Stimulation (SCS) System<br>* Boston Scientific (BSC) PRECISION SCS System with MultiWave Technology<br>|
What is the study measuring?
-----------------
Primary Outcome Measures
| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Percentage of Low Back Pain Responders | Percentage of low back pain responders at 3 months post-activation with no increase in opioids from Baseline to 3 months post-activation | 3 months |
Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Spinal Cord Stimulation, Chronic Pain
|
|
NCT05307068
|
IL-10, IL-12 and IL-18 Levels in the Gingival Crevicular Fluid of Patients With Periodontitis and Healthy Controls
|
Periodontitis is a multifactorial chronic inflammatory disease characterized by the destruction of the tissues supporting the tooth. The incidence and rate of progression of periodontal destruction involves a complex interaction between periodontopathic bacteria and immune system cells. The complex cytokine network that mediates the immune response includes pro-inflammatory cytokines, anti-inflammatory cytokines, and specific cytokine receptors. Cytokines act as messengers to initiate, mediate, and control immune and inflammatory responses. It is known that the interaction of pro- and anti-inflammatory cytokines plays a very important role in the progression of periodontitis .~The immune response to infection is regulated by the balance between T helper (Th)1 and Th2-type cytokines. Since Th1, Th2, and monocyte-derived cytokines in gingival tissues and gingival crevicular fluid (GCF) play a role in periodontal inflammation, even a minimal imbalance in cytokine production may affect the induction of bone and collagen resorption in periodontal disease. For this reason, cytokines in inflamed periodontal tissues, which are the focus of many studies, are of great importance in the progression of periodontal disease.~In this study, our aim is to evaluate the local cytokine response in relation to the clinical periodontal status by determining the IL-10, IL-12 and IL-18 concentrations in the gingival crevicular fluid of individuals with grade B-C stage III-IV periodontitis according to the 2017 Classification of Periodontal and Peri-implant Diseases and Conditions. In this way, besides clinical and radiographic determinations in the diagnosis of periodontal disease, IL-10, IL-12 and IL-18 are measured to evaluate whether these markers have an effect on the diagnosis of the disease.
|
Interleukin-10 (IL-10) is one of the most potent anti-inflammatory cytokines, as it induces T cell anergy (non-responsiveness to an antigen) and reduces the production of some pro-inflammatory cytokines. Altered expression of IL-10, however, genetic predisposition and the presence of specific periodontal bacteria may contribute to the disruption of the Th1/Th2 balance and the development of aggressive periodontitis.~Interleukin-12 (IL-12) is a heterodimer comprised of p35 and p40 subunits, which form the bioactive IL-12 (p70). IL-12 is an essential mediator of the early innate immune response and a key inducer of cellular immunity. Its most important task is to stimulate T cells and interferon-γ (IFN-γ) production by natural killer cells, thereby promoting Th1 responses. The importance of IL-12 is not limited to initiating an immune response, it may contribute to the maintenance of immunity. Because in the absence of IL-12, Th1 responses are rapidly lost.~Interleukin-18 (IL-18) is a pro-inflammatory cytokine belonging to the IL-1 cytokine family. This cytokine was originally identified as a natural killer and a cytokine that induces IFN-γ produced by T cells. IL-18 acts synergistically with IL-12 to support IFN-γ production and Th1 cell growth, but does not depend on IL-12 for its activity.~When this information is brought together, the evaluation of the effects of IL-10, IL-12 and IL-18 concentrations in the gingival crevicular fluid on periodontal disease together with clinical parameters has been the point of our study.~It is planned to include 30 periodontally healthy individuals with grade B-C stage III-IV periodontitis according to the 2017 Classification of Periodontal and Peri-implant Diseases and Conditions, who applied to Istanbul University Faculty of Dentistry Periodontology Department, after clinical and radiographic evaluations. All individuals to be included will be informed about the purpose and method of the study and their consent will be obtained.~Before the study, it will be ensured that the oral condition of the individual is not caused by any other factor (unknown systemic disease, blood disease, etc.). The individuals included in the study; systemic and oral anamnesis, smoking status, systemic disease status will be recorded and the following clinical measurements will be made.~Gingival crevicular fluid (GCF) samples will be taken from individuals suitable for the study model, and periodontal indices will be recorded. The levels of IL-10, IL-12 and IL-18 will be determined in the GCF samples taken. The researcher will not include individuals who have been included in other studies that have passed or will be approved by the ethics committee, and will not include individuals who will be included in this study, undertakes not to include it in its work.~Clinical measurements include Plaque Index (PI), Gingival Index (GI), Bleeding on Probing (BOP), Probing Depth (PD), Free Gingival Margin (FGM), Clinical Attachment Level Measurement (CAL), Mobility parameters. The measurements were made by the same researcher from six different points of all teeth: mesio-buccal, mid-buccal, disto-buccal, mesio-lingual/palatinal, mid-lingual/palatinal, disto-lingual/palatinal. It will be measured and recorded by a single person with the Williams (Hu-Friedy, USA) type periodontal probe. These measurements are non-invasive and will enable us to determine the periodontal status. After the clinical examination and measurements of the patients who met the inclusion criteria and signed the voluntary consent form, the gingival crevicular fluid samples to be taken from the patients will be analyzed and the results will be evaluated. Samples will be isolated from the gingival groove with the aid of absorbent paper strips (Periopaper®, Proflow Inc., Amitiyville, NY, USA) and biochemical analyzes will be made in the samples obtained by ELISA method in accordance with the protocols included in the kit. Biochemical analyzes will be carried out at Istanbul University, Istanbul Faculty of Medicine, Department of Medical Biochemistry.~The clinical evaluation methods planned to be applied in the study are listed below:~Plaque Index~Probing Depth~Bleeding on Probing~Clinical Attachment Level Measurement~Free Gingival Margin~Gingival Index~Mobility Samples of paper strips (Periopaper®, Proflow Inc., Amitiyville, NY, USA) placed in the gingival groove will be placed in eppendorf tubes for laboratory examination in the session 1 week after the exact periodontal status is determined by periodontal measurements. Samples will be taken from areas with the deepest probable pocket depth. While obtaining gingival crevicular fluid samples, the area will be isolated with cotton pads and the microbial dental plaque on the tooth will be removed with cotton pellets, and then a short-term drying process will be done with air freshener from a 20 cm distance at a right angle. Then, standard absorbent 2x8 mm paper strips will be placed from the approximal regions to the entrance of the groove with slight resistance and after waiting for 30 seconds, each paper strip will be placed in an eppendorf tube and stored at -80°C. (New Brunswick Scientific Ultra Low Temperature Freezer). Samples will be taken from 6 teeth in each patient.~In case of bleeding from the gingival groove during sample collection, the sample will not be taken from that area.~GCF samples taken and stored at -80°C will be analyzed at Istanbul University, Istanbul Medical Faculty, Department of Medical Biochemistry. IL-10, IL-12 and IL-18 levels of GCF samples will be determined by ELISA method.~In the light of the data, the clinical conditions and biochemical analyzes of the patients will be compared and the relationship between them will be examined.~According to the 2017 Classification of Periodontal and Peri-implant Diseases and Conditions, an average of 11 units difference between the results obtained from interleukin biomarkers in the group of individuals with grade B-C stage III-IV periodontitis and healthy individuals, and a minimal sample to find the estimated 15-unit standard deviation significant size (assuming Type I error 5%, Type II error 20% assuming Power 0.80): 30 people for each group. Considering the wrong samples, 30+30 people will be taken into each group (30 healthy controls, 30 Periodontitis cases) Our study will be carried out on systemically healthy patients aged 18-65 years who were diagnosed with Grade B-C stage III-IV periodontitis according to the 2017 Classification of Periodontal and Peri-implant Diseases and Conditions in the Periodontology Clinic of Istanbul University Faculty of Dentistry.~After the clinical examination and measurements of the patients who met the inclusion criteria and signed the voluntary consent form, the gingival crevicular fluid samples taken from the patients will be analyzed and the results will be evaluated. The samples will be isolated from the gingival crevicular with the help of the absorbent periopaper and biochemically analyzed with ELISA kits.~Periodontitis group:~18-65 years old~Not having any systemic disease (diseases that do not affect the periodontal status)~Non-smoker~Have not received antibiotic treatment and/or used immunosuppressant medication in the last 6 months~Have not received any periodontal treatment in the last 6 months~No pregnancy and lactation~Not using any medication regularly~Having at least 20 teeth~Grade B-C stage III-IV periodontal disease according to the 2017 Classification of Periodontal and Peri-implant Diseases and Conditions~Healthy Group:~In patients who applied to Istanbul University Faculty of Dentistry, Department of Periodontology, periodontally healthy individuals who do not meet the above disease criteria, who do not have a history of periodontitis in any way, will be included in the study. Consisted of individuals with clinically healthy gingiva on an intact periodontium who had a BOP score less than 10% and PD≤3mm, showed no attachment loss or radiographic bone loss.
|
Investigation of the Relationships and Clinical Parameters Between IL-10, IL-12 and IL-18 Levels in the Gingival Crevicular Fluid of Individuals With Grade B-C Stage III-IV Periodontitis
|
Periodontitis
|
* Other: No intervention was applied to the groups the samples will be collected in terms of the diagnosis ( periodontitis, healthy)
|
Inclusion Criteria for grade B-C stage III-IV periodontitis group:~18-65 years old~Not having any systemic disease (diseases that do not affect the periodontal status)~Non-smoker~Have not received antibiotic treatment and/or used immunosuppressant medication in the last 6 months~Have not received any periodontal treatment in the last 6 months~No pregnancy and lactation~Not using any medication regularly~Having at least 20 teeth~Grade B-C stage III-IV periodontal disease according to the 2017 Classification of Periodontal and Peri-implant Diseases and Conditions~Inclusion Criteria for periodontal healthy group:~•In patients who applied to Istanbul University Faculty of Dentistry, Department of Periodontology, periodontally healthy individuals who do not meet the above disease criteria, who do not have a history of periodontitis in any way, will be included in the study. Consisted of individuals with clinically healthy gingiva on an intact periodontium who had a BOP score less than 10% and PD≤3mm, showed no attachment loss or radiographic bone loss.~Exclusion Criteria:~Those with systemic modifying disease affecting periodontal status~Smoker~Have received antibiotic therapy or immunosuppressive therapy in the last 6 months~Previously received periodontal treatment in the last 6 months~Pregnancy and breastfeeding status~Regular use of drugs that will affect systemic health
|
18 Years
|
65 Years
|
All
|
Accepts Healthy Volunteers
|
| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Measurement of GCF samples | Measurement of IL-10, IL-12, IL-18 levels in GCF with grade B-C stage III-IV periodontitis individuals | GCF samples were collected after first week of clinical periodontal measurement. GCF was obtained using paper strips from the deepest gingival groove |
|
| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Measurement of GCF samples | Measurement of IL-10, IL-12, IL-18 levels in GCF with periodontal healthy individuals | GCF samples were collected after first week of clinical periodontal measurement. GCF was obtained using paper strips from the deepest gingival groove |
|
periodontitis, healthy gingiva, grade b, grade c, stage III, stage IV
|
Periodontitis, Periodontal Diseases, Mouth Diseases, Stomatognathic Diseases
|
| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Grade B-C stage III-IV periodontitis group<br>Grade B: Moderate Moderate bone loss is observed compared to biofilm and % Root Bone Loss/age 0.25 to 1.0 is determined as grade B.~Stage III: Severe Consisted of individuals with interdental AL ≥5 mm, radiographic bone lose extending to middle or apical third of the root, PD≥6 mm and tooth loss due to periodontitis of ≤4.~Grade C: Rapid Rapid bone loss is observed compared to biofilm and % Root Bone Loss/age >1.0 is determined as grade C.~Stage IV:Advanced Consisted of individuals with interdental AL ≥5 mm, radiographic bone lose extending to middle or apical third of the root, PD≥6 mm and tooth loss due to periodontitis of ≥5. Need for complex rehabilition due to: Masticatory dysfunction, Secondary occlusal trauma(tooth mobility degree ≥2) Severe ridge defect,Bite collapse, drifting, flaring. Less than 20 remaining teeth (10 opposing pairs) | Other: No intervention was applied to the groups the samples will be collected in terms of the diagnosis ( periodontitis, healthy)<br>* No intervention was applied to the groups the samples will be collected in terms of the diagnosis (periodontitis, healthy)<br>|
| Healthy control group<br>Consisted of individuals with clinically healthy gingiva on an intact periodontium who had a BOP score less than 10% and PD≤3mm, showed no attachment loss or radiographic bone loss. | Other: No intervention was applied to the groups the samples will be collected in terms of the diagnosis ( periodontitis, healthy)<br>* No intervention was applied to the groups the samples will be collected in terms of the diagnosis (periodontitis, healthy)<br>|
|
IL-10, IL-12 and IL-18 Levels in the Gingival Crevicular Fluid of Patients With Periodontitis and Healthy Controls
Study Overview
=================
Brief Summary
-----------------
Periodontitis is a multifactorial chronic inflammatory disease characterized by the destruction of the tissues supporting the tooth. The incidence and rate of progression of periodontal destruction involves a complex interaction between periodontopathic bacteria and immune system cells. The complex cytokine network that mediates the immune response includes pro-inflammatory cytokines, anti-inflammatory cytokines, and specific cytokine receptors. Cytokines act as messengers to initiate, mediate, and control immune and inflammatory responses. It is known that the interaction of pro- and anti-inflammatory cytokines plays a very important role in the progression of periodontitis . The immune response to infection is regulated by the balance between T helper (Th)1 and Th2-type cytokines. Since Th1, Th2, and monocyte-derived cytokines in gingival tissues and gingival crevicular fluid (GCF) play a role in periodontal inflammation, even a minimal imbalance in cytokine production may affect the induction of bone and collagen resorption in periodontal disease. For this reason, cytokines in inflamed periodontal tissues, which are the focus of many studies, are of great importance in the progression of periodontal disease. In this study, our aim is to evaluate the local cytokine response in relation to the clinical periodontal status by determining the IL-10, IL-12 and IL-18 concentrations in the gingival crevicular fluid of individuals with grade B-C stage III-IV periodontitis according to the 2017 Classification of Periodontal and Peri-implant Diseases and Conditions. In this way, besides clinical and radiographic determinations in the diagnosis of periodontal disease, IL-10, IL-12 and IL-18 are measured to evaluate whether these markers have an effect on the diagnosis of the disease.
Detailed Description
-----------------
Interleukin-10 (IL-10) is one of the most potent anti-inflammatory cytokines, as it induces T cell anergy (non-responsiveness to an antigen) and reduces the production of some pro-inflammatory cytokines. Altered expression of IL-10, however, genetic predisposition and the presence of specific periodontal bacteria may contribute to the disruption of the Th1/Th2 balance and the development of aggressive periodontitis. Interleukin-12 (IL-12) is a heterodimer comprised of p35 and p40 subunits, which form the bioactive IL-12 (p70). IL-12 is an essential mediator of the early innate immune response and a key inducer of cellular immunity. Its most important task is to stimulate T cells and interferon-γ (IFN-γ) production by natural killer cells, thereby promoting Th1 responses. The importance of IL-12 is not limited to initiating an immune response, it may contribute to the maintenance of immunity. Because in the absence of IL-12, Th1 responses are rapidly lost. Interleukin-18 (IL-18) is a pro-inflammatory cytokine belonging to the IL-1 cytokine family. This cytokine was originally identified as a natural killer and a cytokine that induces IFN-γ produced by T cells. IL-18 acts synergistically with IL-12 to support IFN-γ production and Th1 cell growth, but does not depend on IL-12 for its activity. When this information is brought together, the evaluation of the effects of IL-10, IL-12 and IL-18 concentrations in the gingival crevicular fluid on periodontal disease together with clinical parameters has been the point of our study. It is planned to include 30 periodontally healthy individuals with grade B-C stage III-IV periodontitis according to the 2017 Classification of Periodontal and Peri-implant Diseases and Conditions, who applied to Istanbul University Faculty of Dentistry Periodontology Department, after clinical and radiographic evaluations. All individuals to be included will be informed about the purpose and method of the study and their consent will be obtained. Before the study, it will be ensured that the oral condition of the individual is not caused by any other factor (unknown systemic disease, blood disease, etc.). The individuals included in the study; systemic and oral anamnesis, smoking status, systemic disease status will be recorded and the following clinical measurements will be made. Gingival crevicular fluid (GCF) samples will be taken from individuals suitable for the study model, and periodontal indices will be recorded. The levels of IL-10, IL-12 and IL-18 will be determined in the GCF samples taken. The researcher will not include individuals who have been included in other studies that have passed or will be approved by the ethics committee, and will not include individuals who will be included in this study, undertakes not to include it in its work. Clinical measurements include Plaque Index (PI), Gingival Index (GI), Bleeding on Probing (BOP), Probing Depth (PD), Free Gingival Margin (FGM), Clinical Attachment Level Measurement (CAL), Mobility parameters. The measurements were made by the same researcher from six different points of all teeth: mesio-buccal, mid-buccal, disto-buccal, mesio-lingual/palatinal, mid-lingual/palatinal, disto-lingual/palatinal. It will be measured and recorded by a single person with the Williams (Hu-Friedy, USA) type periodontal probe. These measurements are non-invasive and will enable us to determine the periodontal status. After the clinical examination and measurements of the patients who met the inclusion criteria and signed the voluntary consent form, the gingival crevicular fluid samples to be taken from the patients will be analyzed and the results will be evaluated. Samples will be isolated from the gingival groove with the aid of absorbent paper strips (Periopaper®, Proflow Inc., Amitiyville, NY, USA) and biochemical analyzes will be made in the samples obtained by ELISA method in accordance with the protocols included in the kit. Biochemical analyzes will be carried out at Istanbul University, Istanbul Faculty of Medicine, Department of Medical Biochemistry. The clinical evaluation methods planned to be applied in the study are listed below: Plaque Index Probing Depth Bleeding on Probing Clinical Attachment Level Measurement Free Gingival Margin Gingival Index Mobility Samples of paper strips (Periopaper®, Proflow Inc., Amitiyville, NY, USA) placed in the gingival groove will be placed in eppendorf tubes for laboratory examination in the session 1 week after the exact periodontal status is determined by periodontal measurements. Samples will be taken from areas with the deepest probable pocket depth. While obtaining gingival crevicular fluid samples, the area will be isolated with cotton pads and the microbial dental plaque on the tooth will be removed with cotton pellets, and then a short-term drying process will be done with air freshener from a 20 cm distance at a right angle. Then, standard absorbent 2x8 mm paper strips will be placed from the approximal regions to the entrance of the groove with slight resistance and after waiting for 30 seconds, each paper strip will be placed in an eppendorf tube and stored at -80°C. (New Brunswick Scientific Ultra Low Temperature Freezer). Samples will be taken from 6 teeth in each patient. In case of bleeding from the gingival groove during sample collection, the sample will not be taken from that area. GCF samples taken and stored at -80°C will be analyzed at Istanbul University, Istanbul Medical Faculty, Department of Medical Biochemistry. IL-10, IL-12 and IL-18 levels of GCF samples will be determined by ELISA method. In the light of the data, the clinical conditions and biochemical analyzes of the patients will be compared and the relationship between them will be examined. According to the 2017 Classification of Periodontal and Peri-implant Diseases and Conditions, an average of 11 units difference between the results obtained from interleukin biomarkers in the group of individuals with grade B-C stage III-IV periodontitis and healthy individuals, and a minimal sample to find the estimated 15-unit standard deviation significant size (assuming Type I error 5%, Type II error 20% assuming Power 0.80): 30 people for each group. Considering the wrong samples, 30+30 people will be taken into each group (30 healthy controls, 30 Periodontitis cases) Our study will be carried out on systemically healthy patients aged 18-65 years who were diagnosed with Grade B-C stage III-IV periodontitis according to the 2017 Classification of Periodontal and Peri-implant Diseases and Conditions in the Periodontology Clinic of Istanbul University Faculty of Dentistry. After the clinical examination and measurements of the patients who met the inclusion criteria and signed the voluntary consent form, the gingival crevicular fluid samples taken from the patients will be analyzed and the results will be evaluated. The samples will be isolated from the gingival crevicular with the help of the absorbent periopaper and biochemically analyzed with ELISA kits. Periodontitis group: 18-65 years old Not having any systemic disease (diseases that do not affect the periodontal status) Non-smoker Have not received antibiotic treatment and/or used immunosuppressant medication in the last 6 months Have not received any periodontal treatment in the last 6 months No pregnancy and lactation Not using any medication regularly Having at least 20 teeth Grade B-C stage III-IV periodontal disease according to the 2017 Classification of Periodontal and Peri-implant Diseases and Conditions Healthy Group: In patients who applied to Istanbul University Faculty of Dentistry, Department of Periodontology, periodontally healthy individuals who do not meet the above disease criteria, who do not have a history of periodontitis in any way, will be included in the study. Consisted of individuals with clinically healthy gingiva on an intact periodontium who had a BOP score less than 10% and PD≤3mm, showed no attachment loss or radiographic bone loss.
Official Title
-----------------
Investigation of the Relationships and Clinical Parameters Between IL-10, IL-12 and IL-18 Levels in the Gingival Crevicular Fluid of Individuals With Grade B-C Stage III-IV Periodontitis
Conditions
-----------------
Periodontitis
Intervention / Treatment
-----------------
* Other: No intervention was applied to the groups the samples will be collected in terms of the diagnosis ( periodontitis, healthy)
Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria for grade B-C stage III-IV periodontitis group: 18-65 years old Not having any systemic disease (diseases that do not affect the periodontal status) Non-smoker Have not received antibiotic treatment and/or used immunosuppressant medication in the last 6 months Have not received any periodontal treatment in the last 6 months No pregnancy and lactation Not using any medication regularly Having at least 20 teeth Grade B-C stage III-IV periodontal disease according to the 2017 Classification of Periodontal and Peri-implant Diseases and Conditions Inclusion Criteria for periodontal healthy group: •In patients who applied to Istanbul University Faculty of Dentistry, Department of Periodontology, periodontally healthy individuals who do not meet the above disease criteria, who do not have a history of periodontitis in any way, will be included in the study. Consisted of individuals with clinically healthy gingiva on an intact periodontium who had a BOP score less than 10% and PD≤3mm, showed no attachment loss or radiographic bone loss. Exclusion Criteria: Those with systemic modifying disease affecting periodontal status Smoker Have received antibiotic therapy or immunosuppressive therapy in the last 6 months Previously received periodontal treatment in the last 6 months Pregnancy and breastfeeding status Regular use of drugs that will affect systemic health
Ages Eligible for Study
-----------------
Minimum Age: 18 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 |
| --- | --- |
| Grade B-C stage III-IV periodontitis group<br>Grade B: Moderate Moderate bone loss is observed compared to biofilm and % Root Bone Loss/age 0.25 to 1.0 is determined as grade B. Stage III: Severe Consisted of individuals with interdental AL ≥5 mm, radiographic bone lose extending to middle or apical third of the root, PD≥6 mm and tooth loss due to periodontitis of ≤4. Grade C: Rapid Rapid bone loss is observed compared to biofilm and % Root Bone Loss/age >1.0 is determined as grade C. Stage IV:Advanced Consisted of individuals with interdental AL ≥5 mm, radiographic bone lose extending to middle or apical third of the root, PD≥6 mm and tooth loss due to periodontitis of ≥5. Need for complex rehabilition due to: Masticatory dysfunction, Secondary occlusal trauma(tooth mobility degree ≥2) Severe ridge defect,Bite collapse, drifting, flaring. Less than 20 remaining teeth (10 opposing pairs) | Other: No intervention was applied to the groups the samples will be collected in terms of the diagnosis ( periodontitis, healthy)<br>* No intervention was applied to the groups the samples will be collected in terms of the diagnosis (periodontitis, healthy)<br>|
| Healthy control group<br>Consisted of individuals with clinically healthy gingiva on an intact periodontium who had a BOP score less than 10% and PD≤3mm, showed no attachment loss or radiographic bone loss. | Other: No intervention was applied to the groups the samples will be collected in terms of the diagnosis ( periodontitis, healthy)<br>* No intervention was applied to the groups the samples will be collected in terms of the diagnosis (periodontitis, healthy)<br>|
What is the study measuring?
-----------------
Primary Outcome Measures
| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Measurement of GCF samples | Measurement of IL-10, IL-12, IL-18 levels in GCF with grade B-C stage III-IV periodontitis individuals | GCF samples were collected after first week of clinical periodontal measurement. GCF was obtained using paper strips from the deepest gingival groove |
Secondary Outcome Measures
| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Measurement of GCF samples | Measurement of IL-10, IL-12, IL-18 levels in GCF with periodontal healthy individuals | GCF samples were collected after first week of clinical periodontal measurement. GCF was obtained using paper strips from the deepest gingival groove |
Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
periodontitis, healthy gingiva, grade b, grade c, stage III, stage IV
|
|
NCT05288439
|
A Study of How Proton Beam Radiotherapy (PBRT) Affects Brain Function and Quality of Life in Children and Young Adults Undergoing Treatment for a Brain Tumor
|
The researchers are doing this study to find out if there are differences in the resting state brain networks of children and young adults (ages 6-25) after treatment with proton beam radiation therapy (PBRT). The researchers will use resting state functional connectivity magnetic resonance imagining (rs-fcMRI) scanning to detect these differences. The researchers will also check for differences in participants' thinking and quality of life through a cognitive assessment and a questionnaire. Both people undergoing PBRT for a brain tumor and healthy people will take part in this study so that the researchers can compare the brain networks (connections in the brain that are involved in certain function, such as memory or attention), thinking patterns, and quality of life of these two groups of participants.~The study researchers think that rs-fcMRI scans may be an effective way to look at the brain networks after treatment with PBRT and see if this treatment causes differences in those networks, including damage to the brain (neurotoxicity). rs-fcMRI scans take images when a patient is in a resting state, which means the patient is not performing a task or thinking about anything in particular.~This study will provide valuable information about how PBRT affects brain networks, thinking (cognitive) abilities, and quality of life in children and young adults. The study results may have an impact on future treatment approaches for brain cancer and the use of PBRT in children and young adults.
|
Neuroimaging Biomarkers of Impaired Neurocognitive Functioning After Cranial Proton Beam Radiotherapy For Treatment of Brain Tumors In Pediatric Patients
|
Brain Tumor, Metastatic Brain Tumor
|
* Diagnostic Test: Resting-state functional connectivity MRI
* Other: Neurocognitive battery with quality-of-life assessment
|
Inclusion Criteria:~Patients Treated for Brain Tumors:~The patient has been diagnosed with a primary or metastatic brain tumor~The patient has been recommended to receive cranial PBRT for a primary or metastatic brain tumor~The patient is between the ages of 6 through 25 at time of consent~As per medical record or patient report (based on prior tolerance of MRI), the participant is able to tolerate MRI without sedation (i.e., general anesthesia). Patients will take medications as prescribed or directed by the patient's physician. If in accordance with their prescribed regimen, agents that may impact the CNS, such as benzodiazepines and/or antihistamines, should be avoided on the day of imaging and neurocognitive assessment.~Healthy Control Participants:~The control has no major medical illness, as determined by medical interview by study physician~As per parent report, the control is between the ages of 6 through 25 at time of consent~As per parent report, the control is able to tolerate an MRI without sedation (i.e., general anesthesia). Participants should only take medications as prescribed or directed by their physician. They should not take additional medications, such as antihistamines, for the purpose of tolerating MR imaging.~Exclusion Criteria:~As per self or parent report, the participant has completed any portion of the neuropsychological battery used in this study within the last year.~As per medical record or self or parent report, there is an existing diagnosis of intellectual disability and/or prior IQ testing that documents Full Scale IQ standard score <70 at baseline.~As per medical record, there is an existing diagnosis of psychiatric disorder or untreated mood disturbance, prior stroke or intracranial hemorrhage, or neurodegenerative disease.~The participant has an MRI contraindication (e.g., implanted ferromagnetic devices, claustrophobia) as per radiology clinical operating procedures.~As per self or parent report, non-fluency in English language as demonstrated by current educational placement in a non-English-speaking classroom setting.
|
6 Years
|
25 Years
|
All
|
Accepts Healthy Volunteers
|
Primary Purpose: Diagnostic
Allocation: Non-Randomized
Intervention Model: Parallel Assignment
Interventional Model Description: This prospective, cross-sectional, pilot clinical trial will incorporate rs-fcMRI and a full post- PBRT cognitive battery including quality of life assessment for pediatric patients using a multidisciplinary team.
Masking: None (Open Label)
|
| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| differences in the resting state brain networks of children and young adults | A single rs-fcMRI sequence will be added to the MRI performed as standard of care follow-up 3-5 months after completion of cranial PBRT in pediatric patients treated for brain tumors to assess for early post-PBRT network disruption.~Using resting state functional connectivity magnetic resonance imagining (rs-fcMRI) scanning to detect these differences. | 1 year |
|
Proton Beam Radiotherapy (PBRT), Cognitive battery assessment, Quality of life assessment
|
Neoplasms, Brain Neoplasms, Central Nervous System Neoplasms, Nervous System Neoplasms, Neoplasms by Site, Brain Diseases, Central Nervous System Diseases, Nervous System Diseases
|
| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: patients<br>A full neurocognitive battery with quality-of-life assessment will be conducted and an rs-fcMRI sequence will be added to the brain MRI performed as standard of care follow-up between 3-5 months post-PBRT. | Diagnostic Test: Resting-state functional connectivity MRI<br>* participants will undergo functional MRI<br>Other: Neurocognitive battery with quality-of-life assessment<br>* Cognitive and quality of life assessments performed by a trained neuropsychologist<br>|
| Experimental: healthy matched controls<br>Healthy participants will be asked to complete the MRI scan and undergo neurocognitive assessment. | Diagnostic Test: Resting-state functional connectivity MRI<br>* participants will undergo functional MRI<br>Other: Neurocognitive battery with quality-of-life assessment<br>* Cognitive and quality of life assessments performed by a trained neuropsychologist<br>|
|
A Study of How Proton Beam Radiotherapy (PBRT) Affects Brain Function and Quality of Life in Children and Young Adults Undergoing Treatment for a Brain Tumor
Study Overview
=================
Brief Summary
-----------------
The researchers are doing this study to find out if there are differences in the resting state brain networks of children and young adults (ages 6-25) after treatment with proton beam radiation therapy (PBRT). The researchers will use resting state functional connectivity magnetic resonance imagining (rs-fcMRI) scanning to detect these differences. The researchers will also check for differences in participants' thinking and quality of life through a cognitive assessment and a questionnaire. Both people undergoing PBRT for a brain tumor and healthy people will take part in this study so that the researchers can compare the brain networks (connections in the brain that are involved in certain function, such as memory or attention), thinking patterns, and quality of life of these two groups of participants. The study researchers think that rs-fcMRI scans may be an effective way to look at the brain networks after treatment with PBRT and see if this treatment causes differences in those networks, including damage to the brain (neurotoxicity). rs-fcMRI scans take images when a patient is in a resting state, which means the patient is not performing a task or thinking about anything in particular. This study will provide valuable information about how PBRT affects brain networks, thinking (cognitive) abilities, and quality of life in children and young adults. The study results may have an impact on future treatment approaches for brain cancer and the use of PBRT in children and young adults.
Official Title
-----------------
Neuroimaging Biomarkers of Impaired Neurocognitive Functioning After Cranial Proton Beam Radiotherapy For Treatment of Brain Tumors In Pediatric Patients
Conditions
-----------------
Brain Tumor, Metastatic Brain Tumor
Intervention / Treatment
-----------------
* Diagnostic Test: Resting-state functional connectivity MRI
* Other: Neurocognitive battery with quality-of-life assessment
Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Patients Treated for Brain Tumors: The patient has been diagnosed with a primary or metastatic brain tumor The patient has been recommended to receive cranial PBRT for a primary or metastatic brain tumor The patient is between the ages of 6 through 25 at time of consent As per medical record or patient report (based on prior tolerance of MRI), the participant is able to tolerate MRI without sedation (i.e., general anesthesia). Patients will take medications as prescribed or directed by the patient's physician. If in accordance with their prescribed regimen, agents that may impact the CNS, such as benzodiazepines and/or antihistamines, should be avoided on the day of imaging and neurocognitive assessment. Healthy Control Participants: The control has no major medical illness, as determined by medical interview by study physician As per parent report, the control is between the ages of 6 through 25 at time of consent As per parent report, the control is able to tolerate an MRI without sedation (i.e., general anesthesia). Participants should only take medications as prescribed or directed by their physician. They should not take additional medications, such as antihistamines, for the purpose of tolerating MR imaging. Exclusion Criteria: As per self or parent report, the participant has completed any portion of the neuropsychological battery used in this study within the last year. As per medical record or self or parent report, there is an existing diagnosis of intellectual disability and/or prior IQ testing that documents Full Scale IQ standard score <70 at baseline. As per medical record, there is an existing diagnosis of psychiatric disorder or untreated mood disturbance, prior stroke or intracranial hemorrhage, or neurodegenerative disease. The participant has an MRI contraindication (e.g., implanted ferromagnetic devices, claustrophobia) as per radiology clinical operating procedures. As per self or parent report, non-fluency in English language as demonstrated by current educational placement in a non-English-speaking classroom setting.
Ages Eligible for Study
-----------------
Minimum Age: 6 Years
Maximum Age: 25 Years
Sexes Eligible for Study
-----------------
All
Accepts Healthy Volunteers
-----------------
Accepts Healthy Volunteers
Study Plan
=================
How is the study designed?
-----------------
Design Details
Primary Purpose: Diagnostic
Allocation: Non-Randomized
Intervention Model: Parallel Assignment
Interventional Model Description: This prospective, cross-sectional, pilot clinical trial will incorporate rs-fcMRI and a full post- PBRT cognitive battery including quality of life assessment for pediatric patients using a multidisciplinary team.
Masking: None (Open Label)
Arms and Interventions
| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: patients<br>A full neurocognitive battery with quality-of-life assessment will be conducted and an rs-fcMRI sequence will be added to the brain MRI performed as standard of care follow-up between 3-5 months post-PBRT. | Diagnostic Test: Resting-state functional connectivity MRI<br>* participants will undergo functional MRI<br>Other: Neurocognitive battery with quality-of-life assessment<br>* Cognitive and quality of life assessments performed by a trained neuropsychologist<br>|
| Experimental: healthy matched controls<br>Healthy participants will be asked to complete the MRI scan and undergo neurocognitive assessment. | Diagnostic Test: Resting-state functional connectivity MRI<br>* participants will undergo functional MRI<br>Other: Neurocognitive battery with quality-of-life assessment<br>* Cognitive and quality of life assessments performed by a trained neuropsychologist<br>|
What is the study measuring?
-----------------
Primary Outcome Measures
| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| differences in the resting state brain networks of children and young adults | A single rs-fcMRI sequence will be added to the MRI performed as standard of care follow-up 3-5 months after completion of cranial PBRT in pediatric patients treated for brain tumors to assess for early post-PBRT network disruption. Using resting state functional connectivity magnetic resonance imagining (rs-fcMRI) scanning to detect these differences. | 1 year |
Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Proton Beam Radiotherapy (PBRT), Cognitive battery assessment, Quality of life assessment
|
||
NCT04350840
|
Seoul National University Hospital Gangnam-Real Time Optical Diagnosis Program 2: Gangnam-READI2
|
Accurate optical diagnosis of colorectal polyps could allow a resect and discard strategy based on the results of the optical biopsy. Even though intensive training for optical diagnosis, there is still wide variability in individual endoscopists to meet the PIVI thresholds. The investigators with experience of prior optical diagnosis training perform new education and drill to apply proper high confidence according to their decision time. After the education program, the investigators prospectively evaluate real-time optical biopsy analysis of polyps in 8 academic gastroenterologists.
|
This study is an extension of the Gangnam-READI program (NCT02516748) in Seoul National University Hospital Healthcare System Gangnam Center. This study is composed of two periods. First, an education program on predicting polyp histology and real-time optical diagnosis will be performed by 8 endoscopists From February to March 2020. In the second period from April 2020 till October 2020(total 6 months), real-time optical diagnosis with time drill for diminutive and small colorectal polyps will be activated. Endoscopists will have 3 seconds rule to make high confidence diagnosis and have feedbacks on their accuracy of optical diagnosis for polyps per 3 months. The performance will be evaluated by comparing the optically predicted diagnosis with the actual histologic diagnosis. Negative predictive value for the prediction of non-neoplastic polyp and concordance of surveillance intervals for diminutive polyps diagnosed optically with high confidence will be measured. In addition, the characteristics of the endoscopist affecting the performance of optical diagnosis were investigated.
|
Performance of Real-time Optical Diagnosis for Colon Polyp According to the Confidence Rate of Endoscopists
|
Colon Polyp
|
* Behavioral: feedback
|
Inclusion Criteria:~Board-certified gastroenterologists~Endoscopists who finished ex-vivo optical diagnosis training~Exclusion Criteria:~Inflammatory bowel disease~Previous colon cancer history~Previous colon op. history~Melanosis coli
| null | null |
All
|
Accepts Healthy Volunteers
|
Primary Purpose: Diagnostic
Intervention Model: Sequential Assignment
Masking: None (Open Label)
|
| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| PIVI threshold | Negative predictive value for the prediction of nonneoplastic polyp and concordance of surveillance intervals for diminutive polyps diagnosed optically with high confidence | 12 months |
|
Polyps, Pathological Conditions, Anatomical, Colonic Polyps, Intestinal Polyps
|
| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Feedback<br>Participating endoscopists will make high confidence diagnosis according to their judgment time | Behavioral: feedback<br>* feedback of optical diagnosis performance per 3 month<br>|
|
Seoul National University Hospital Gangnam-Real Time Optical Diagnosis Program 2: Gangnam-READI2
Study Overview
=================
Brief Summary
-----------------
Accurate optical diagnosis of colorectal polyps could allow a resect and discard strategy based on the results of the optical biopsy. Even though intensive training for optical diagnosis, there is still wide variability in individual endoscopists to meet the PIVI thresholds. The investigators with experience of prior optical diagnosis training perform new education and drill to apply proper high confidence according to their decision time. After the education program, the investigators prospectively evaluate real-time optical biopsy analysis of polyps in 8 academic gastroenterologists.
Detailed Description
-----------------
This study is an extension of the Gangnam-READI program (NCT02516748) in Seoul National University Hospital Healthcare System Gangnam Center. This study is composed of two periods. First, an education program on predicting polyp histology and real-time optical diagnosis will be performed by 8 endoscopists From February to March 2020. In the second period from April 2020 till October 2020(total 6 months), real-time optical diagnosis with time drill for diminutive and small colorectal polyps will be activated. Endoscopists will have 3 seconds rule to make high confidence diagnosis and have feedbacks on their accuracy of optical diagnosis for polyps per 3 months. The performance will be evaluated by comparing the optically predicted diagnosis with the actual histologic diagnosis. Negative predictive value for the prediction of non-neoplastic polyp and concordance of surveillance intervals for diminutive polyps diagnosed optically with high confidence will be measured. In addition, the characteristics of the endoscopist affecting the performance of optical diagnosis were investigated.
Official Title
-----------------
Performance of Real-time Optical Diagnosis for Colon Polyp According to the Confidence Rate of Endoscopists
Conditions
-----------------
Colon Polyp
Intervention / Treatment
-----------------
* Behavioral: feedback
Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Board-certified gastroenterologists Endoscopists who finished ex-vivo optical diagnosis training Exclusion Criteria: Inflammatory bowel disease Previous colon cancer history Previous colon op. history Melanosis coli
Sexes Eligible for Study
-----------------
All
Accepts Healthy Volunteers
-----------------
Accepts Healthy Volunteers
Study Plan
=================
How is the study designed?
-----------------
Design Details
Primary Purpose: Diagnostic
Intervention Model: Sequential Assignment
Masking: None (Open Label)
Arms and Interventions
| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Feedback<br>Participating endoscopists will make high confidence diagnosis according to their judgment time | Behavioral: feedback<br>* feedback of optical diagnosis performance per 3 month<br>|
What is the study measuring?
-----------------
Primary Outcome Measures
| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| PIVI threshold | Negative predictive value for the prediction of nonneoplastic polyp and concordance of surveillance intervals for diminutive polyps diagnosed optically with high confidence | 12 months |
|
||
NCT01983046
|
Rectal Short Chain Fatty Acids Combinations and Substrate and Energy Metabolism
|
Gut microbiota is being increasingly recognized as an important factor in fat distribution, insulin sensitivity and glucose and lipid metabolism. Accordingly, the intestinal microbiota could play an important role in the development of obesity and type 2 diabetes mellitus. The role of gut-derived short-chain fatty acids (SCFA), the formation of which is enhanced by microbial fermentation of fiber, is still controversial. One study found that an increase in the formation of SCFA stimulated energy extraction from diet, with subsequent weight gain. In contrast, supplementation of non-fermentable carbohydrates, which lead to an increase in SCFA formation, had beneficial effects on body weight control and insulin sensitivity. Of note, a study showed that butyrate supplementation in mice prevented diet-induced obesity and insulin resistance. At the present time, our understanding of the effects of SCFA on human metabolism (in gut or systemically) is still limited. Yet, in light of the health claims of certain dietary fibers (prebiotics), a detailed picture of the physiology of human SCFA metabolism and its interaction with the microbiome is of pivotal importance. We hypothesize that the differential availability of SCFA impacts human metabolism differently. To determine whether rectal administration of SCFA is a good model for studying the metabolic effects of SCFA we first have performed a pilot study (METC 11-3-079). In this pilot study we have determined if rectal administration of sodium acetate has the same effects on substrate and energy metabolism compared to proximal administration. Our results indicate that the primary outcome parameter fat oxidation was significantly changed during post-absorptive conditions, when sodium acetate in a concentration of 180mM was administered in the distal part of the colon. In contrast, no effect on energy expenditure or substrate oxidation was seen when sodium acetate was administered in the proximal colon. Consequently, the distal part of the colon seems to be a good model to determine effects of gut-derived SCFA on the human substrate and energy metabolism. Therefore, we will administer in this study the SCFA rectally by using enemas. We will administer different combinations of SCFA to healthy, overweight male volunteers and examine effects on metabolism. This study is an important part of a Gastrointestinal Health TIFN project (GH003 WP 1.2), which will provide more insight in how increased availability of a beneficial SCFA mixture might serve as a basis for rational nutritional strategies in the prevention and treatment of obesity and type 2 diabetes mellitus. To obtain rational nutritional strategies, a next step in this TIFN project will be focusing on dietary ingredients modulating intestinal microbiota and subsequent SCFA production.
|
The Effects of Rectal Administration of SCFA on Human Substrate and Energy Metabolism
|
Obesity, Type 2 Diabetes
|
* Drug: Three different mixture of acetate, butyrate and propionate and palcebo
|
Inclusion Criteria:~Overweight~Obese men~Exclusion Criteria:~Athletes~Diabetes mellitus
|
20 Years
|
50 Years
|
Male
|
Accepts Healthy Volunteers
|
Primary Purpose: Diagnostic
Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: Double
|
| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| fat oxidation | we will measure fat oxidation and energy expenditure by using the ventilated hood system | 4 hours total (2 hours fasting, 2 hours postprandial) |
|
| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Hormones that influence energy metabolism | | 4 hours total (2 hours fasting and 2 hours postprandial) |
| Circulating metabolites | | 4 hours total (2 hours fasting and 2 hours postprandial) |
| Hormones that influence energy metabolism - Circulating metabolites - Inflammatory markers - plasma SCFA content; - Indirect markers of insulin sensitivity - Appetite (VAS-scoring). | | 4 hours total (2 hours fasting and 2 hours postprandial) |
|
| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Placebo Comparator: placebo<br>placebo | Drug: Three different mixture of acetate, butyrate and propionate and palcebo<br> <br> |
| Active Comparator: high acetate ratio<br>high acetate ratio | Drug: Three different mixture of acetate, butyrate and propionate and palcebo<br> <br> |
| Active Comparator: high butyrate ratio<br>high butyrate ratio | Drug: Three different mixture of acetate, butyrate and propionate and palcebo<br> <br> |
| Active Comparator: high propionate ratio<br>high propionate ratio | Drug: Three different mixture of acetate, butyrate and propionate and palcebo<br> <br> |
|
Rectal Short Chain Fatty Acids Combinations and Substrate and Energy Metabolism
Study Overview
=================
Brief Summary
-----------------
Gut microbiota is being increasingly recognized as an important factor in fat distribution, insulin sensitivity and glucose and lipid metabolism. Accordingly, the intestinal microbiota could play an important role in the development of obesity and type 2 diabetes mellitus. The role of gut-derived short-chain fatty acids (SCFA), the formation of which is enhanced by microbial fermentation of fiber, is still controversial. One study found that an increase in the formation of SCFA stimulated energy extraction from diet, with subsequent weight gain. In contrast, supplementation of non-fermentable carbohydrates, which lead to an increase in SCFA formation, had beneficial effects on body weight control and insulin sensitivity. Of note, a study showed that butyrate supplementation in mice prevented diet-induced obesity and insulin resistance. At the present time, our understanding of the effects of SCFA on human metabolism (in gut or systemically) is still limited. Yet, in light of the health claims of certain dietary fibers (prebiotics), a detailed picture of the physiology of human SCFA metabolism and its interaction with the microbiome is of pivotal importance. We hypothesize that the differential availability of SCFA impacts human metabolism differently. To determine whether rectal administration of SCFA is a good model for studying the metabolic effects of SCFA we first have performed a pilot study (METC 11-3-079). In this pilot study we have determined if rectal administration of sodium acetate has the same effects on substrate and energy metabolism compared to proximal administration. Our results indicate that the primary outcome parameter fat oxidation was significantly changed during post-absorptive conditions, when sodium acetate in a concentration of 180mM was administered in the distal part of the colon. In contrast, no effect on energy expenditure or substrate oxidation was seen when sodium acetate was administered in the proximal colon. Consequently, the distal part of the colon seems to be a good model to determine effects of gut-derived SCFA on the human substrate and energy metabolism. Therefore, we will administer in this study the SCFA rectally by using enemas. We will administer different combinations of SCFA to healthy, overweight male volunteers and examine effects on metabolism. This study is an important part of a Gastrointestinal Health TIFN project (GH003 WP 1.2), which will provide more insight in how increased availability of a beneficial SCFA mixture might serve as a basis for rational nutritional strategies in the prevention and treatment of obesity and type 2 diabetes mellitus. To obtain rational nutritional strategies, a next step in this TIFN project will be focusing on dietary ingredients modulating intestinal microbiota and subsequent SCFA production.
Official Title
-----------------
The Effects of Rectal Administration of SCFA on Human Substrate and Energy Metabolism
Conditions
-----------------
Obesity, Type 2 Diabetes
Intervention / Treatment
-----------------
* Drug: Three different mixture of acetate, butyrate and propionate and palcebo
Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Overweight Obese men Exclusion Criteria: Athletes Diabetes mellitus
Ages Eligible for Study
-----------------
Minimum Age: 20 Years
Maximum Age: 50 Years
Sexes Eligible for Study
-----------------
Male
Accepts Healthy Volunteers
-----------------
Accepts Healthy Volunteers
Study Plan
=================
How is the study designed?
-----------------
Design Details
Primary Purpose: Diagnostic
Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: Double
Arms and Interventions
| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Placebo Comparator: placebo<br>placebo | Drug: Three different mixture of acetate, butyrate and propionate and palcebo<br> <br> |
| Active Comparator: high acetate ratio<br>high acetate ratio | Drug: Three different mixture of acetate, butyrate and propionate and palcebo<br> <br> |
| Active Comparator: high butyrate ratio<br>high butyrate ratio | Drug: Three different mixture of acetate, butyrate and propionate and palcebo<br> <br> |
| Active Comparator: high propionate ratio<br>high propionate ratio | Drug: Three different mixture of acetate, butyrate and propionate and palcebo<br> <br> |
What is the study measuring?
-----------------
Primary Outcome Measures
| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| fat oxidation | we will measure fat oxidation and energy expenditure by using the ventilated hood system | 4 hours total (2 hours fasting, 2 hours postprandial) |
Secondary Outcome Measures
| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Hormones that influence energy metabolism | | 4 hours total (2 hours fasting and 2 hours postprandial) |
| Circulating metabolites | | 4 hours total (2 hours fasting and 2 hours postprandial) |
| Hormones that influence energy metabolism - Circulating metabolites - Inflammatory markers - plasma SCFA content; - Indirect markers of insulin sensitivity - Appetite (VAS-scoring). | | 4 hours total (2 hours fasting and 2 hours postprandial) |
|
|||
NCT03655769
|
fMRI Analysis of Aging and Awareness in Conditioning
|
Cathodal Transcranial direct current stimulation (tDCS) was administered to the right parietal region in order to determine if this stimulation could disrupt awareness of the conditioned stimulus (CS) - unconditioned stimulus (US) relationship in a classical conditioning experiment.
|
Functional Magnetic Resonance Imaging (fMRI) Analysis of Aging and Awareness in Conditioning
|
Transcranial Direct Current Stimulation
|
* Device: transcranial direct current stimulation
* Device: sham transcranial direct current stimulation
|
Inclusion Criteria:~Educational attainment of at least eight years and English as the native language~Mini-Mental State Examination (MMSE) score of 26~Normal episodic memory (i.e., CERAD word List Recall > 5)~Informed consent; 5) age of 20-30~Exclusion Criteria:~Disturbed consciousness~Other neurological or systemic disorder which can cause dementia or cognitive dysfunction~Prior history of a major psychiatric disorder~History of definite stroke~Focal lesion on MRI exam~Use of anxiolytic, antidepressant, neuroleptic, or sedative medication~Predominately left-handed~Has MRI contraindication such as pacemaker, implanted pumps, shrapnel, etc. (full MRI screening form will be filled out).
|
20 Years
|
30 Years
|
All
|
Accepts Healthy Volunteers
|
Primary Purpose: Basic Science
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single
|
| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| CS-US Awareness | To assess CS-US awareness, we used a questionnaire The questionnaire consists of 7 true/false questions about the sequence and co-occurrence of the conditioned stimulus (CS, a 1000 Hz tone) and unconditioned stimulus (US, a 100 ms puff of air to the eye). The score can thus range from 0 to 7. Higher score values indicate better awareness of the sequence and co-occurrence of the CS and US | recorded immediately after the 20 minutes of tDCS stimulation |
|
| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Line bisection test of left-hemifield neglect | The subject is given a sheet of paper with a number of horizontal lines on it. The subject is instructed to cut each line in half by drawing a small pencil mark through each line. The test is scored by measuring the percent deviation, which is calculated by the following formula:~Percent deviation=100 x (measured left half - true half)/true half This yields positive numbers for marks placed to the right of center, and negative numbers for marks placed to the left of center. Patients with right hemisphere damage and contralateral neglect show higher positive line bisection scores compared to healthy controls or patients without right hemisphere damage and vice versa. | recorded immediately after primary awareness questionnaire |
| Eyeblink conditioned responding | Eyeblink conditioning is recorded while the subject watches a silent movie. For conditioning, the conditioned stimulus (CS) is a 1350 ms 1000 Hz tone. This tone co-terminates with a 100 ms left corneal airpuff (5 psi). 30 CS-US presentations are delivered at an average rate of one every 18 sec. Conditioned responses (CRs) are defined as follows: the difference between the maximum and minimum responses in a 500 ms pre-US time window must exceed four times the standard deviation of the mean of the baseline period (250 ms pre-CS presentation). The 500 ms pre-US time window was selected to minimize the inclusion of voluntary and alpha responses as CRs. Performance is expressed as % CRs, that is, the percent of trials in which a CR occurred. Greater numbers indicate greater amounts of learning. | recorded during the tDCS administration |
|
| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Sham Comparator: sham tDCS<br>tDCS delivered for only 30 sec to replicate tingling sensation and blind subject | Device: sham transcranial direct current stimulation<br>* transcranial direct current stimulation applied at 2 mA over the right parietal region for 30 sec<br>|
| Experimental: cathodal tDCS<br>cathodal tDCS, 2 milliamps (mA), delivered to right parietal region | Device: transcranial direct current stimulation<br>* transcranial direct current stimulation applied at 2 mA over the right parietal region for 20 min<br>|
|
fMRI Analysis of Aging and Awareness in Conditioning
Study Overview
=================
Brief Summary
-----------------
Cathodal Transcranial direct current stimulation (tDCS) was administered to the right parietal region in order to determine if this stimulation could disrupt awareness of the conditioned stimulus (CS) - unconditioned stimulus (US) relationship in a classical conditioning experiment.
Official Title
-----------------
Functional Magnetic Resonance Imaging (fMRI) Analysis of Aging and Awareness in Conditioning
Conditions
-----------------
Transcranial Direct Current Stimulation
Intervention / Treatment
-----------------
* Device: transcranial direct current stimulation
* Device: sham transcranial direct current stimulation
Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Educational attainment of at least eight years and English as the native language Mini-Mental State Examination (MMSE) score of 26 Normal episodic memory (i.e., CERAD word List Recall > 5) Informed consent; 5) age of 20-30 Exclusion Criteria: Disturbed consciousness Other neurological or systemic disorder which can cause dementia or cognitive dysfunction Prior history of a major psychiatric disorder History of definite stroke Focal lesion on MRI exam Use of anxiolytic, antidepressant, neuroleptic, or sedative medication Predominately left-handed Has MRI contraindication such as pacemaker, implanted pumps, shrapnel, etc. (full MRI screening form will be filled out).
Ages Eligible for Study
-----------------
Minimum Age: 20 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: Basic Science
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single
Arms and Interventions
| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Sham Comparator: sham tDCS<br>tDCS delivered for only 30 sec to replicate tingling sensation and blind subject | Device: sham transcranial direct current stimulation<br>* transcranial direct current stimulation applied at 2 mA over the right parietal region for 30 sec<br>|
| Experimental: cathodal tDCS<br>cathodal tDCS, 2 milliamps (mA), delivered to right parietal region | Device: transcranial direct current stimulation<br>* transcranial direct current stimulation applied at 2 mA over the right parietal region for 20 min<br>|
What is the study measuring?
-----------------
Primary Outcome Measures
| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| CS-US Awareness | To assess CS-US awareness, we used a questionnaire The questionnaire consists of 7 true/false questions about the sequence and co-occurrence of the conditioned stimulus (CS, a 1000 Hz tone) and unconditioned stimulus (US, a 100 ms puff of air to the eye). The score can thus range from 0 to 7. Higher score values indicate better awareness of the sequence and co-occurrence of the CS and US | recorded immediately after the 20 minutes of tDCS stimulation |
Secondary Outcome Measures
| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Line bisection test of left-hemifield neglect | The subject is given a sheet of paper with a number of horizontal lines on it. The subject is instructed to cut each line in half by drawing a small pencil mark through each line. The test is scored by measuring the percent deviation, which is calculated by the following formula: Percent deviation=100 x (measured left half - true half)/true half This yields positive numbers for marks placed to the right of center, and negative numbers for marks placed to the left of center. Patients with right hemisphere damage and contralateral neglect show higher positive line bisection scores compared to healthy controls or patients without right hemisphere damage and vice versa. | recorded immediately after primary awareness questionnaire |
| Eyeblink conditioned responding | Eyeblink conditioning is recorded while the subject watches a silent movie. For conditioning, the conditioned stimulus (CS) is a 1350 ms 1000 Hz tone. This tone co-terminates with a 100 ms left corneal airpuff (5 psi). 30 CS-US presentations are delivered at an average rate of one every 18 sec. Conditioned responses (CRs) are defined as follows: the difference between the maximum and minimum responses in a 500 ms pre-US time window must exceed four times the standard deviation of the mean of the baseline period (250 ms pre-CS presentation). The 500 ms pre-US time window was selected to minimize the inclusion of voluntary and alpha responses as CRs. Performance is expressed as % CRs, that is, the percent of trials in which a CR occurred. Greater numbers indicate greater amounts of learning. | recorded during the tDCS administration |
|
|||
NCT05332795
|
The Impact of Metformin on the Outcome of Gouty Arthritis in a Cohort of Egyptian Gouty Patients.
|
Objective:~To study the impact of metformin on the outcome of gouty arthritis in a cohort of Egyptian gouty patients, and to evaluate its effect on local joint inflammation, inflammatory cytokines (IL-1β and IL-6), and life quality.~Methods:~A prospective randomized, single-blinded parallel randomized control study included 100 patients with active inflammatory gouty arthritis were randomized to receive metformin (1000mg/day) or placebo in addition to the traditional lines of treatment of gout. The clinical and laboratory data of the patients will be analyze at baseline, then after 3, and 6 months, with the assessment of gout disease activity, in addition, serum IL-1β and IL-6, the number of attacks per year, treatment satisfaction, quality of life, and disability index were evaluated at the 6th month from starting metformin and placebo therapy.
|
Background: Metformin has anti-inflammatory properties, as it suppresses the inflammatory process by down-regulating the transcription factor, nuclear factor kappa B (NF-kB), through AMP-activated protein kinase (AMPK)-dependent and independent pathways.~Objective:~To study the impact of metformin on the outcome of gouty arthritis in a cohort of Egyptian gouty patients, and to evaluate its effect on local joint inflammation, inflammatory cytokines (IL-1β and IL-6), and life quality.~Methods:~A prospective randomized, single-blinded parallel randomized control study included 100 patients with active inflammatory gouty arthritis were randomized to receive metformin (1000mg/day) or placebo in addition to the traditional lines of treatment of gout. The clinical and laboratory data of the patients will be analyzed at baseline, then after 3, and 6 months, with the assessment of gout disease activity, in addition, serum IL-1β and IL-6, the number of attacks per year, treatment satisfaction, quality of life, and disability index were evaluated at the 6th month from starting metformin and placebo therapy.
|
The Impact of Metformin on the Outcome of Gouty Arthritis in a Cohort of Egyptian Gouty Patients.
|
Gouty Arthritis
|
* Drug: Metformin
* Drug: Placebo
|
Inclusion Criteria:~gouty patients who fulfilled the American College of Rheumatology clinical criteria.~gouty patients with active inflammatory arthritis.~Exclusion Criteria:~Patients with any type of inflammatory arthritis.~Patients with systemic disease as diabetes, hypertension,~Patients with hyperlipidemia, coronary artery disease,~Patients with renal or hepatic insults,~pregnant and lactating females
|
35 Years
|
65 Years
|
All
|
No
|
Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single
|
| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Serological remission criteria | by measuring serum uric acid for patients of the present study, it must be less than 6 mg/dL. | at 6 months post intervention. |
| Articular remission criteria | by examining the number of swollen and tender joints score, they must be less than 2 tender and swollen joints.. | at 6 months post intervention. |
| Clinical remission criteria | by assessing the grade of joint pain, it must be reduced from the first visit(regarding Visual analogue scale | at 6 months post intervention. |
|
| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Gout Impact Scale (GIS) | by measuring GIS score, as higher scores in the GIS (range 0-100) imply a greater restriction of activity and a greater impact of gout and vice versa. | at 6 months post intervention. |
|
Metformin, Hypoglycemic Agents, Physiological Effects of Drugs
|
| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: group 1: gouty patients on metformin.<br>metformin users: include gouty patients, who will receive metformin tablets (1000 mg) once daily for about 3 months. | Drug: Metformin<br>* gouty patients, will receive metformin tablets (1000 mg) once daily for about 3 months.<br>|
| Placebo Comparator: gouty patients on placebo.<br>placebo users: include gouty patients, who were on placebo tablets once daily for about 3 months. | Drug: Placebo<br>* gouty patients, will receive placebo tablets once daily for about 3 months.<br>|
|
The Impact of Metformin on the Outcome of Gouty Arthritis in a Cohort of Egyptian Gouty Patients.
Study Overview
=================
Brief Summary
-----------------
Objective: To study the impact of metformin on the outcome of gouty arthritis in a cohort of Egyptian gouty patients, and to evaluate its effect on local joint inflammation, inflammatory cytokines (IL-1β and IL-6), and life quality. Methods: A prospective randomized, single-blinded parallel randomized control study included 100 patients with active inflammatory gouty arthritis were randomized to receive metformin (1000mg/day) or placebo in addition to the traditional lines of treatment of gout. The clinical and laboratory data of the patients will be analyze at baseline, then after 3, and 6 months, with the assessment of gout disease activity, in addition, serum IL-1β and IL-6, the number of attacks per year, treatment satisfaction, quality of life, and disability index were evaluated at the 6th month from starting metformin and placebo therapy.
Detailed Description
-----------------
Background: Metformin has anti-inflammatory properties, as it suppresses the inflammatory process by down-regulating the transcription factor, nuclear factor kappa B (NF-kB), through AMP-activated protein kinase (AMPK)-dependent and independent pathways. Objective: To study the impact of metformin on the outcome of gouty arthritis in a cohort of Egyptian gouty patients, and to evaluate its effect on local joint inflammation, inflammatory cytokines (IL-1β and IL-6), and life quality. Methods: A prospective randomized, single-blinded parallel randomized control study included 100 patients with active inflammatory gouty arthritis were randomized to receive metformin (1000mg/day) or placebo in addition to the traditional lines of treatment of gout. The clinical and laboratory data of the patients will be analyzed at baseline, then after 3, and 6 months, with the assessment of gout disease activity, in addition, serum IL-1β and IL-6, the number of attacks per year, treatment satisfaction, quality of life, and disability index were evaluated at the 6th month from starting metformin and placebo therapy.
Official Title
-----------------
The Impact of Metformin on the Outcome of Gouty Arthritis in a Cohort of Egyptian Gouty Patients.
Conditions
-----------------
Gouty Arthritis
Intervention / Treatment
-----------------
* Drug: Metformin
* Drug: Placebo
Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: gouty patients who fulfilled the American College of Rheumatology clinical criteria. gouty patients with active inflammatory arthritis. Exclusion Criteria: Patients with any type of inflammatory arthritis. Patients with systemic disease as diabetes, hypertension, Patients with hyperlipidemia, coronary artery disease, Patients with renal or hepatic insults, pregnant and lactating females
Ages Eligible for Study
-----------------
Minimum Age: 35 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: group 1: gouty patients on metformin.<br>metformin users: include gouty patients, who will receive metformin tablets (1000 mg) once daily for about 3 months. | Drug: Metformin<br>* gouty patients, will receive metformin tablets (1000 mg) once daily for about 3 months.<br>|
| Placebo Comparator: gouty patients on placebo.<br>placebo users: include gouty patients, who were on placebo tablets once daily for about 3 months. | Drug: Placebo<br>* gouty patients, will receive placebo tablets once daily for about 3 months.<br>|
What is the study measuring?
-----------------
Primary Outcome Measures
| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Serological remission criteria | by measuring serum uric acid for patients of the present study, it must be less than 6 mg/dL. | at 6 months post intervention. |
| Articular remission criteria | by examining the number of swollen and tender joints score, they must be less than 2 tender and swollen joints.. | at 6 months post intervention. |
| Clinical remission criteria | by assessing the grade of joint pain, it must be reduced from the first visit(regarding Visual analogue scale | at 6 months post intervention. |
Secondary Outcome Measures
| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Gout Impact Scale (GIS) | by measuring GIS score, as higher scores in the GIS (range 0-100) imply a greater restriction of activity and a greater impact of gout and vice versa. | at 6 months post intervention. |
|
|
NCT03906032
|
Comparison of Sliding Hip Screw to Intra Medullary Nailing in the Treatment of Intertrochanteric Hip Fracture
|
Shortening of the abductor lever arm is a particular concern with the SHS, and the resultant biomechanical alterations impairs gait, including decreased cadence and increased double support time on the injured side.~The use of a IM nail device may stop this shortening and improve functional parameters in this patient cohort
|
Published work in this field to date has not demonstrated a clear advantage of nailing over hip screw in intertrochanteric proximal femoral fractures. The current lierature focus on outcome questionnaires, pain scores and basic functional tests alone does not delineate the functional benefits clearly enough. A key factor in whether a person, post hip fracture, returns to independent living is gait speed. The cost implications on the healthcare provider of having 30% of this ever increasing group losing their independence and requiring admission to a care facility post hip fracture is a growing problem.~Shortening of the abductor lever arm is a particular concern with the SHS, and the resultant biomechanical alterations impairs gait, including decreased cadence and increased double support time on the injured side.~The difference in cost between a nail and a SHS is a driver to prevent routine use of nailing in this population unless a clear benefit is demonstrated. Fracture union is not a problem for the most part and, as such, the focus must be on achieving better functional outcome, less morbidity and less mortality in this group.~The key question to answer is whether a IM Nail (TFNA) results in a greater functional benefit in A1/A2 intertrochanteric fractures compared with the SHS.
|
Prospective Randomized Controlled Comparison of Sliding Hip Screw to Intra Medullary Nailing in the Treatment of Intertrochanteric Hip Fracture
|
Hip Fractures, Gait, Unsteady, Function
|
* Device: TFNA IM Nail
* Device: Sliding hip screw
|
Inclusion Criteria:~OTA Hip fracture grade A1 and A2~Greater than 60 years old~Exclusion Criteria:~Polytrauma, high-energy hip fractures, pathological fractures,~Reverse oblique and sub-trochanteric femoral fractures~less than 60 years old
|
60 Years
| null |
All
|
Accepts Healthy Volunteers
|
Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Triple
|
| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Blood Loss | Haemaglobin (Hb) day two measurement. | Mathematical model Day 2 Hb |
| Blood Loss | Haematocrit (Hct) at day two measurement. | Mathematical model Day 2 Hct |
| Mortality | Absolute | At any time point to 1 year post op |
| Analgesia Use | rate of opiate use | 5 days |
| Timed up and go test | Tested measure of mobility and the change between baseline and subsequent time points | 6 weeks, 6 months, 1 year |
| Harris Hip score | Functional scale of hip pain and the change between baseline and subsequents time points. Maximum score: 100 points indicating excellent function, minimum score 0 points indicating poor function. | 6 weeks, 6 months, 1 year |
| Kinmeatic Gait parameters at Hip | Rate of change in hip kinmeatic profile between baseline and subsequent time points | 6 weeks, 6 months, 1 year |
|
| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Length of stay | the duration of hospital stay after this procedure has wide variability between 3 days and weeks to months. | Through to study completion at one year post operatively. |
|
Timed up and go, mobility, functional outcome
|
Gait Disorders, Neurologic, Fractures, Bone, Hip Fractures, Wounds and Injuries, Femoral Fractures, Hip Injuries, Leg Injuries, Neurologic Manifestations, Nervous System Diseases
|
| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Intra-medullary hip Nail<br>Surgery | Device: TFNA IM Nail<br>* IM nail<br>|
| Active Comparator: Sliding hip screw<br>Surgery | Device: Sliding hip screw<br>* SHS surgical fixation<br>|
|
Comparison of Sliding Hip Screw to Intra Medullary Nailing in the Treatment of Intertrochanteric Hip Fracture
Study Overview
=================
Brief Summary
-----------------
Shortening of the abductor lever arm is a particular concern with the SHS, and the resultant biomechanical alterations impairs gait, including decreased cadence and increased double support time on the injured side. The use of a IM nail device may stop this shortening and improve functional parameters in this patient cohort
Detailed Description
-----------------
Published work in this field to date has not demonstrated a clear advantage of nailing over hip screw in intertrochanteric proximal femoral fractures. The current lierature focus on outcome questionnaires, pain scores and basic functional tests alone does not delineate the functional benefits clearly enough. A key factor in whether a person, post hip fracture, returns to independent living is gait speed. The cost implications on the healthcare provider of having 30% of this ever increasing group losing their independence and requiring admission to a care facility post hip fracture is a growing problem. Shortening of the abductor lever arm is a particular concern with the SHS, and the resultant biomechanical alterations impairs gait, including decreased cadence and increased double support time on the injured side. The difference in cost between a nail and a SHS is a driver to prevent routine use of nailing in this population unless a clear benefit is demonstrated. Fracture union is not a problem for the most part and, as such, the focus must be on achieving better functional outcome, less morbidity and less mortality in this group. The key question to answer is whether a IM Nail (TFNA) results in a greater functional benefit in A1/A2 intertrochanteric fractures compared with the SHS.
Official Title
-----------------
Prospective Randomized Controlled Comparison of Sliding Hip Screw to Intra Medullary Nailing in the Treatment of Intertrochanteric Hip Fracture
Conditions
-----------------
Hip Fractures, Gait, Unsteady, Function
Intervention / Treatment
-----------------
* Device: TFNA IM Nail
* Device: Sliding hip screw
Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: OTA Hip fracture grade A1 and A2 Greater than 60 years old Exclusion Criteria: Polytrauma, high-energy hip fractures, pathological fractures, Reverse oblique and sub-trochanteric femoral fractures less than 60 years old
Ages Eligible for Study
-----------------
Minimum Age: 60 Years
Sexes Eligible for Study
-----------------
All
Accepts Healthy Volunteers
-----------------
Accepts Healthy Volunteers
Study Plan
=================
How is the study designed?
-----------------
Design Details
Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Triple
Arms and Interventions
| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Intra-medullary hip Nail<br>Surgery | Device: TFNA IM Nail<br>* IM nail<br>|
| Active Comparator: Sliding hip screw<br>Surgery | Device: Sliding hip screw<br>* SHS surgical fixation<br>|
What is the study measuring?
-----------------
Primary Outcome Measures
| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Blood Loss | Haemaglobin (Hb) day two measurement. | Mathematical model Day 2 Hb |
| Blood Loss | Haematocrit (Hct) at day two measurement. | Mathematical model Day 2 Hct |
| Mortality | Absolute | At any time point to 1 year post op |
| Analgesia Use | rate of opiate use | 5 days |
| Timed up and go test | Tested measure of mobility and the change between baseline and subsequent time points | 6 weeks, 6 months, 1 year |
| Harris Hip score | Functional scale of hip pain and the change between baseline and subsequents time points. Maximum score: 100 points indicating excellent function, minimum score 0 points indicating poor function. | 6 weeks, 6 months, 1 year |
| Kinmeatic Gait parameters at Hip | Rate of change in hip kinmeatic profile between baseline and subsequent time points | 6 weeks, 6 months, 1 year |
Secondary Outcome Measures
| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Length of stay | the duration of hospital stay after this procedure has wide variability between 3 days and weeks to months. | Through to study completion at one year post operatively. |
Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Timed up and go, mobility, functional outcome
|
NCT03819803
|
Fecal Microbiota Transplantation in aGvHD After ASCT
|
Acute graft-versus-host-disease (aGvHD) is a typical complication after allogeneic hematopoetic stem cell transplantation (ASCT). About 30-60% of patients after ASCT are affected by aGvHD, which constitutes a relevant burden of morbidity and mortality in these patients.~Fecal microbiota transplantation (FMT) is a therapeutic concept to treat intestinal dysbiosis of various origin by infusion of the stool microbiota of a healthy donor into the gastrointestinal tract (GI) of a patient. FMT can be performed endoscopically by colonoscopic deployment of the donor microbiota into the patient´s caecum and terminal ileum.~Patients with gastrointestinal aGvHD (GI-aGvHD) are known to comprise a significant dysbiotic colonic microbiota that can be attenuated by FMT.
|
Fecal Microbiota Transplantation in Patients With Acute Gastrointestinal Graft-versus-host-disease After Allogeneic Stem Cell Transplantation
|
Graft Versus Host Disease in GI Tract
|
* Biological: Fecal microbiota transplantation
|
Inclusion Criteria:~first episode of histologically confirmed, steroid-refractory GI-aGvHD~reduced bacterial diversity in the patient´s stool microbiota evidenced by 16s-rDNA measurement~eligibility for repeated colonoscopic procedures~informed consent~Exclusion Criteria:~complications during a previous colonoscopy~recurrent episode of GI-aGvHD~lacking cardiopulmonary fitness for repeated colonoscopic procedures~septic infection~acute extraintestinal organ failure (excluding bone marrow)~mechanical ileus
|
18 Years
|
70 Years
|
All
|
No
|
Primary Purpose: Treatment
Intervention Model: Single Group Assignment
Interventional Model Description: Patients with acute gastrointestinal graft-versus-host disease refractory to steroid treatment
Masking: None (Open Label)
|
| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| GI-aGvHD remission | Sustained remission of GI-aGvHD (CR or PR) | 90 days after first FMT |
|
| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| GI-aGvHD remission | Sustained remission of GI-aGvHD (CR or PR) | 45, 180 and 365 days after first FMT |
| Disease-free survival | GI-aGvHD free survival | 180 and 365 days after first FMT |
| Recurrence of GI-GvHD | Recurrence of GI-GvHD | 365 days after remission |
| Patient survival | Survival (death or alive) | 180 and 365 days after first FMT |
| SUSAR (Suspected Unexpected Serious Adverse Reaction) | Number of lethal or non-lethal SUSAR's | within 48 hours after a FMT |
| SAE (Serious Adverse Event) | Number of lethal or non-lethal SAE's | within 48 hours after a FMT |
|
Graft vs Host Disease, Immune System Diseases
|
| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Steroid refractory GI-aGvHD<br>Patients with GI-aGvHD not sufficiently responding to GvHD therapy with corticosteroids.~Intervention: Fecal microbiota transplantation | Biological: Fecal microbiota transplantation<br>* 200 ml of a tested stool suspension of a healthy donor is instilled into the patient´s caecum or terminal ileum<br>|
|
Fecal Microbiota Transplantation in aGvHD After ASCT
Study Overview
=================
Brief Summary
-----------------
Acute graft-versus-host-disease (aGvHD) is a typical complication after allogeneic hematopoetic stem cell transplantation (ASCT). About 30-60% of patients after ASCT are affected by aGvHD, which constitutes a relevant burden of morbidity and mortality in these patients. Fecal microbiota transplantation (FMT) is a therapeutic concept to treat intestinal dysbiosis of various origin by infusion of the stool microbiota of a healthy donor into the gastrointestinal tract (GI) of a patient. FMT can be performed endoscopically by colonoscopic deployment of the donor microbiota into the patient´s caecum and terminal ileum. Patients with gastrointestinal aGvHD (GI-aGvHD) are known to comprise a significant dysbiotic colonic microbiota that can be attenuated by FMT.
Official Title
-----------------
Fecal Microbiota Transplantation in Patients With Acute Gastrointestinal Graft-versus-host-disease After Allogeneic Stem Cell Transplantation
Conditions
-----------------
Graft Versus Host Disease in GI Tract
Intervention / Treatment
-----------------
* Biological: Fecal microbiota transplantation
Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: first episode of histologically confirmed, steroid-refractory GI-aGvHD reduced bacterial diversity in the patient´s stool microbiota evidenced by 16s-rDNA measurement eligibility for repeated colonoscopic procedures informed consent Exclusion Criteria: complications during a previous colonoscopy recurrent episode of GI-aGvHD lacking cardiopulmonary fitness for repeated colonoscopic procedures septic infection acute extraintestinal organ failure (excluding bone marrow) mechanical ileus
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
Interventional Model Description: Patients with acute gastrointestinal graft-versus-host disease refractory to steroid treatment
Masking: None (Open Label)
Arms and Interventions
| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Steroid refractory GI-aGvHD<br>Patients with GI-aGvHD not sufficiently responding to GvHD therapy with corticosteroids. Intervention: Fecal microbiota transplantation | Biological: Fecal microbiota transplantation<br>* 200 ml of a tested stool suspension of a healthy donor is instilled into the patient´s caecum or terminal ileum<br>|
What is the study measuring?
-----------------
Primary Outcome Measures
| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| GI-aGvHD remission | Sustained remission of GI-aGvHD (CR or PR) | 90 days after first FMT |
Secondary Outcome Measures
| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| GI-aGvHD remission | Sustained remission of GI-aGvHD (CR or PR) | 45, 180 and 365 days after first FMT |
| Disease-free survival | GI-aGvHD free survival | 180 and 365 days after first FMT |
| Recurrence of GI-GvHD | Recurrence of GI-GvHD | 365 days after remission |
| Patient survival | Survival (death or alive) | 180 and 365 days after first FMT |
| SUSAR (Suspected Unexpected Serious Adverse Reaction) | Number of lethal or non-lethal SUSAR's | within 48 hours after a FMT |
| SAE (Serious Adverse Event) | Number of lethal or non-lethal SAE's | within 48 hours after a FMT |
|
||
NCT00205790
|
GORE-TEX PROPATEN Vascular Graft Study
|
To demonstrate equivalence in patency performance of GORE-TEX PROPATEN Vascular Grafts and Thin Walled GORE-TEX Stretch Vascular Grafts in a peripheral bypass application to support a claim of substantial equivalence.
|
Comparison of Primary Patency Between GORE-TEX PROPATEN Vascular Grafts and Thin Walled GORE-TEX Stretch Vascular Grafts
|
Peripheral Vascular Diseases
|
* Device: Vascular graft
|
Inclusion Criteria:~Patient requires primary above-knee bypass where the proximal anastomosis will be to the common femoral or proximal superficial femoral artery and the distal anastomosis will be the popliteal artery proximal to the medial head of the gastrocnemius;~Patient has Grade III or IV occlusive vascular disease;~Patient has a postoperative life expectancy greater than one year;~Patient is at least 21 years of age;~Patient is able to comply with all study requirements and be available for follow-up visits at 1 month, 6 months and 12 months post procedure;~Patient is willing and able to provide written, informed consent.~Exclusion Criteria:~Patient had a previous bypass in the diseased extremity (below iliacs);~Patient has known coagulation disorders including hypercoagulability;~Patient has had any previous instance of Heparin Induced Thrombocytopenia type 2 (HIT-2) or has known hypersensitivity to heparin;~Patient has an acute embolic arterial occlusion;~Patient requires sequential extremity revascularizations or other procedures that require use of additional vascular grafts;~Patient had percutaneous transluminal angioplasty to the implant site within the previous 30 days;~Patient is in need of, or is scheduled for, a cardiac surgical procedure or a different vascular surgical procedure;~Patient has active infection in the region of graft placement; or~Patient has an incomplete preoperative assessment (as outlined in this protocol) due to an emergency procedure, a traumatic injury or any other reason.
|
21 Years
| null |
All
|
No
|
Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single
|
| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Primary patency at 12 months | | |
| Major device complication rates at 12 months | | |
|
| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Technical failures | | |
| Secondary patency | | |
|
Vascular Diseases, Peripheral Vascular Diseases, Peripheral Arterial Disease, Cardiovascular Diseases, Atherosclerosis, Arteriosclerosis, Arterial Occlusive Diseases
|
| Intervention/Treatment |
| --- |
|Device: Vascular graft|nan|
|
GORE-TEX PROPATEN Vascular Graft Study
Study Overview
=================
Brief Summary
-----------------
To demonstrate equivalence in patency performance of GORE-TEX PROPATEN Vascular Grafts and Thin Walled GORE-TEX Stretch Vascular Grafts in a peripheral bypass application to support a claim of substantial equivalence.
Official Title
-----------------
Comparison of Primary Patency Between GORE-TEX PROPATEN Vascular Grafts and Thin Walled GORE-TEX Stretch Vascular Grafts
Conditions
-----------------
Peripheral Vascular Diseases
Intervention / Treatment
-----------------
* Device: Vascular graft
Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Patient requires primary above-knee bypass where the proximal anastomosis will be to the common femoral or proximal superficial femoral artery and the distal anastomosis will be the popliteal artery proximal to the medial head of the gastrocnemius; Patient has Grade III or IV occlusive vascular disease; Patient has a postoperative life expectancy greater than one year; Patient is at least 21 years of age; Patient is able to comply with all study requirements and be available for follow-up visits at 1 month, 6 months and 12 months post procedure; Patient is willing and able to provide written, informed consent. Exclusion Criteria: Patient had a previous bypass in the diseased extremity (below iliacs); Patient has known coagulation disorders including hypercoagulability; Patient has had any previous instance of Heparin Induced Thrombocytopenia type 2 (HIT-2) or has known hypersensitivity to heparin; Patient has an acute embolic arterial occlusion; Patient requires sequential extremity revascularizations or other procedures that require use of additional vascular grafts; Patient had percutaneous transluminal angioplasty to the implant site within the previous 30 days; Patient is in need of, or is scheduled for, a cardiac surgical procedure or a different vascular surgical procedure; Patient has active infection in the region of graft placement; or Patient has an incomplete preoperative assessment (as outlined in this protocol) due to an emergency procedure, a traumatic injury or any other reason.
Ages Eligible for Study
-----------------
Minimum Age: 21 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
| Intervention/Treatment |
| --- |
|Device: Vascular graft|nan|
What is the study measuring?
-----------------
Primary Outcome Measures
| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Primary patency at 12 months | | |
| Major device complication rates at 12 months | | |
Secondary Outcome Measures
| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Technical failures | | |
| Secondary patency | | |
|
||
NCT01018433
|
Treatment for Non-Suicidal Self-Injury in Young Adults
|
The purpose of this study is to investigate an intervention specifically for non-suicidal self-injury (NSSI) in young adults. The goal of this 9-session outpatient intervention is to reduce the frequency and severity of NSSI. During Phase I, 12 patients will be treated in an open pilot trial. During Phase II, 60 patients will be treated in a randomized controlled pilot study in order to determine the feasibility and acceptability of the intervention and to investigate change in NSSI frequency and severity over time.
|
Non-suicidal self-injury (NSSI), deliberate harm to the body without suicidal intent, is highly prevalent in young adults, with 1 in 10 college students engaging in over 100 episodes in their lifetimes. Consequences of NSSI are severe, including physical injury ranging in medical severity, distress from shame associated with the behavior, social isolation, psychological symptoms, and increased risk and lethality of NSSI over time. Despite the prevalence and significant consequences of NSSI, no empirically supported treatments specific to NSSI exist. The purpose of this study is to develop, implement, and evaluate an intervention specifically for NSSI in young adults, the Treatment for Self-Injurious Behaviors (T-SIB). This time-limited intervention will integrate theoretically-based strategies whose utility has been identified through empirical research with the goal of reducing frequency and severity of NSSI. The research plan consists of 2 phases. During Phase 1, 12 patients will be treated in an open pilot trial. During Phase 2, 60 patients will be treated in a randomized controlled pilot study to determine the feasibility and acceptability of T-SIB, investigate change in NSSI frequency and severity between T-SIB and treatment as usual (TAU) through a 3-month follow up period, and evaluate the research design of the randomized controlled pilot study to inform both the utility and design of a larger randomized clinical trial.
|
Development of an Intervention for Non-Suicidal Self-Injury in Young Adults
|
Non-suicidal Self-injury
|
* Behavioral: T-SIB
* Other: Treatment as usual
|
Inclusion Criteria:~Ages 18-29~NSSI within the past month OR history of NSSI and urge to self-injure within the past month~Exclusion Criteria:~Psychotic symptoms~Severe suicidal ideation
|
18 Years
|
29 Years
|
All
|
Accepts Healthy Volunteers
|
Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single
|
| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| NSSI frequency and severity | | Baseline, Mid-Treatment, Post-Treatment, 3-month Follow Up |
|
| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| BDI-II BAI MSI-BPD CSI SPSI-R SCL-90-R URICA | | Baseline, Post-Intervention, 3 month follow up |
|
self-injury, non-suicidal self-injury, deliberate self-harm, self-mutilation
|
Wounds and Injuries, Self-Injurious Behavior, Behavioral Symptoms
|
| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: T-SIB<br>Treatment for self-injurious behaviors; study intervention | Behavioral: T-SIB<br>* Treatment for self-injurious behaviors; study psychotherapy<br>|
| Other: Treatment as Usual<br> | Other: Treatment as usual<br>* Can include other psychotherapy and pharmacotherapy<br>* Other names: TAU;|
|
Treatment for Non-Suicidal Self-Injury in Young Adults
Study Overview
=================
Brief Summary
-----------------
The purpose of this study is to investigate an intervention specifically for non-suicidal self-injury (NSSI) in young adults. The goal of this 9-session outpatient intervention is to reduce the frequency and severity of NSSI. During Phase I, 12 patients will be treated in an open pilot trial. During Phase II, 60 patients will be treated in a randomized controlled pilot study in order to determine the feasibility and acceptability of the intervention and to investigate change in NSSI frequency and severity over time.
Detailed Description
-----------------
Non-suicidal self-injury (NSSI), deliberate harm to the body without suicidal intent, is highly prevalent in young adults, with 1 in 10 college students engaging in over 100 episodes in their lifetimes. Consequences of NSSI are severe, including physical injury ranging in medical severity, distress from shame associated with the behavior, social isolation, psychological symptoms, and increased risk and lethality of NSSI over time. Despite the prevalence and significant consequences of NSSI, no empirically supported treatments specific to NSSI exist. The purpose of this study is to develop, implement, and evaluate an intervention specifically for NSSI in young adults, the Treatment for Self-Injurious Behaviors (T-SIB). This time-limited intervention will integrate theoretically-based strategies whose utility has been identified through empirical research with the goal of reducing frequency and severity of NSSI. The research plan consists of 2 phases. During Phase 1, 12 patients will be treated in an open pilot trial. During Phase 2, 60 patients will be treated in a randomized controlled pilot study to determine the feasibility and acceptability of T-SIB, investigate change in NSSI frequency and severity between T-SIB and treatment as usual (TAU) through a 3-month follow up period, and evaluate the research design of the randomized controlled pilot study to inform both the utility and design of a larger randomized clinical trial.
Official Title
-----------------
Development of an Intervention for Non-Suicidal Self-Injury in Young Adults
Conditions
-----------------
Non-suicidal Self-injury
Intervention / Treatment
-----------------
* Behavioral: T-SIB
* Other: Treatment as usual
Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Ages 18-29 NSSI within the past month OR history of NSSI and urge to self-injure within the past month Exclusion Criteria: Psychotic symptoms Severe suicidal ideation
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: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single
Arms and Interventions
| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: T-SIB<br>Treatment for self-injurious behaviors; study intervention | Behavioral: T-SIB<br>* Treatment for self-injurious behaviors; study psychotherapy<br>|
| Other: Treatment as Usual<br> | Other: Treatment as usual<br>* Can include other psychotherapy and pharmacotherapy<br>* Other names: TAU;|
What is the study measuring?
-----------------
Primary Outcome Measures
| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| NSSI frequency and severity | | Baseline, Mid-Treatment, Post-Treatment, 3-month Follow Up |
Secondary Outcome Measures
| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| BDI-II BAI MSI-BPD CSI SPSI-R SCL-90-R URICA | | Baseline, Post-Intervention, 3 month follow up |
Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
self-injury, non-suicidal self-injury, deliberate self-harm, self-mutilation
|
NCT03897062
|
Suvorexant in the Management Comorbid Sleep Disorder and Alcohol Dependence
|
Suvorexant (trade name Belsomra) is an orexin receptor antagonist that has TGA approval for the treatment of insomnia, characterised by difficulties with sleep onset and/or sleep maintenance. It may also have a role in addictions as the orexins play a critical role in drug addiction and reward-related behaviours. Orexins appear to be involved in both alcohol withdrawal and in alcohol seeking triggered by external cues (eg contexts or stressors) through both OX1 and OX2 receptor signalling. Chief investigator, Professor Lawrence was the first to demonstrate a role for endogenous orexin signaling in alcohol-seeking. Alcohol is known to effect the sleep of healthy and alcohol dependent individuals with effects on daytime sleepiness, physiological functions during sleep, and the development of sleep disorders. There are various estimates of the co-occurrence of insomnia and alcohol use disorder ranging from 36-72%. In alcohol dependent individuals sleep is disturbed both while drinking and for months of abstinence and abstinent sleep disturbance is predictive of relapse.~This proposal aims to evaluate the use of suvorexant as a safe and effective pharmacotherapy to treat sleep disorders in alcohol dependent patients undergoing acute alcohol withdrawal and thereafter for six months. The study will also examine the effectiveness of suvorexant in reducing craving for alcohol and promoting duration of abstinence. This will be the first double blind controlled trial of suvorexant in the management of the alcohol withdrawal syndrome and maintenance of abstinence post withdrawal.
|
Study Procedures Baseline On Day 1, prior to commencement of treatment baseline data will be collected on demographics, ISI questionnaire plus 2 short questions 1) how many hours sleep has the participant had for the past week; 2) how would the participant rate their sleep quality in the past week. The investigators will also determine previous drug use history, physical examination, urine drug screen and measures of alcohol dependence severity, psychological and social functioning (ATOPv7).~Treatment Period Treatment will begin immediately after collection of Baseline data. Suvorexant will not be given if breath alcohol concentration is above zero. Both groups will be treated using the St Vincent's Hospital standard protocol for management of alcohol withdrawal, in which benzodiazepines are provided as required according to the symptoms listed in the Clinical Institute Withdrawal Assessment for Alcohol scale (CIWA-Ar). That is, if the CIWA-Ar score is > 10 then benzodiazepines (BZD) are administered. Note, BZD will not be given for management of insomnia. Physicians involved in patient care, nurses and participants will be blinded to treatment assignment. Participants will be monitored for signs of adverse events (i.e. distress, significant alcohol withdrawal, and adverse response to suvorexant) approximately 4 hourly for the first 24 - 48 hrs of residential stay and then according to clinical assessment. All clinical observations will be made by a suitably qualified and experienced medical professional. Where any adverse events are observed, monitoring will be increased to meet clinical needs and treatment discontinued if required. Alcohol withdrawal severity will be assessed using the Clinical Institute Withdrawal Assessment - Alcohol revised (CIWA-Ar).~Note, during in-patient assessment there will be no consumption of alcohol (7-10 days). Upon release to outpatients the investigators will advise participants not to consume alcohol and will provide follow-up support to help maintain abstinence. If patients resume heavy drinking and are deemed to have relapsed i.e. daily alcohol consumption greater than 5 standard drinks each day, the investigators will tell them to cease the medication and they will be withdrawn from the study. Data collected to this point will be included in the study.~Follow-up Treatment Subsequent follow-up would occur weekly for 4 weeks post inpatient treatment and then every 4 weeks to week 25. Patients will continue the same dose of Suvorexant/placebo for the duration of the follow-up period. At the end of the 25 week trial patients will continue to receive treatment as usual. If they wish to continue to receive suvorexant they can get a prescription from their GP (suvorexant has been added to the pharmaceutical benefits scheme).~Data Collection Baseline~Name, date of birth, gender, contact details.~ISI Insomnia Severity Index questionnaire (modified)~Substance use history, medical history including current medications.~Psychosocial status (data routinely collected through national minimum data set)~Past history withdrawal symptoms (delirium tremens, seizures etc)~DSM 5 criteria for alcohol use disorder (AUD)~Structured clinical Interview for DSm-5 (SCID-5)~Pittsburgh Sleep Quality Index (PSQI)~Epworth Sleepiness Scale~K10 (Kessler Psychological Distress Scale), 10 questions about psychological distress symptoms: baseline and daily while in alcohol withdrawal then at monthly follow up~ATOP Australian Treatment Outcome Profile~Breath alcohol reading~Liver function test~Urine drug screen~In-patient withdrawal:~Actigraphy measures of sleep patterns (Externally worn non-invasive accelerometer and light exposure recorder worn continually, from the first day of admission to discharge).~Portable Polysomnography (Multichannel recoding of the electrophysiological markers of sleep). Polysomnography (PSG) records brain activity, eye movements and muscle tone to identify stages of sleep. In addition leg movements, heart rhythm, pulse rate, oxygen saturation, nasal breath flow, snore and chest movements are used to identify respiratory activity and lower leg muscle activity is also monitored for disturbing movements. (Day 1 and Day 7)~Epworth Sleepiness Scale (excessive daytime sleepiness)~Sleep diary during their stay (seven-ten days)~ISI Insomnia questionnaire (Day 7 only)~Clinical Information (as per open ended questioning for all AE's)~CIWA-Ar (revised Clinical Institute Withdrawal Assessment for Alcohol scale), 10-item assessment of severity of alcohol withdrawal: baseline and every 2 - 4 hours, performed by trained staff~Craving for alcohol using Obsessive Compulsive Drinking Scale~Kessler 10 measure of psychological distress (Day 7 last 3 days)~At weekly follow-up, for weeks 2 to 5 and at monthly follow-up from week 9 to 25~Pittsburgh Sleep Quality Index (sleep quality) (Wk5,9,13,17,21,25)~Epworth Sleepiness Scale on admission (excessive daytime sleepiness)~Sleep diary & ISI insomnia questionnaire~Additional 2 short questions will be collected:~how many hours sleep has the participant had for the past week;~how would the participant rate their sleep quality in the past week;~Clinical Information (as per open ended questioning for SAE safety data suvorexant form)~Alcohol and other substance use (self report)~ATOP Australian Treatment Outcome Profile (Wk5,9,13,17,21,25)~K10 (Kessler Psychological Distress Scale)~Breath alcohol reading~Urine drug screen~Liver/renal function tests (Wk 2,5,9,13,17,21,25)~Craving for alcohol using Obsessive Compulsive Drinking Scale~Any differences between objective and subjective sleep measures will be documented and reflected back to patients on an individual basis. During the consent process all patients will be informed that this is a trial and that there will be no additional (other than the trial) medication provided for insomnia.
|
A Placebo-controlled, Double -Blind Randomised Trial of Suvorexant in the Management Comorbid Sleep Disorder and Alcohol Dependence
|
Insomnia, Alcohol Use Disorder
|
* Drug: Suvorexant 20 mg
* Other: placebo
|
Inclusion Criteria:~Over 18 years of age and not more than 75 years of age~DSM-5 diagnosis of insomnia~Alcohol dependent (SCID-5)~Willing to comply with treatment and follow-up requirements of study~Able to give informed consent~Exclusion Criteria:~Consumes less than 6 standard drinks per day.~Not alcohol dependent (SCID-5)~Unstable major psychiatric disorder e.g. active psychosis, significant PTSD.~Currently taking medication having major interaction with suvorexant~Pregnant (urine βHCG positive) or not using adequate contraception.~Breast feeding.~Severe hepatic impairment (Liver enzyme levels >five times normal level)~Severe renal impairment (urine creatinine clearance < 30ml/h)~Severe medical disorder e.g. epilepsy, cardiovascular disorder~Participating in another pharmacotherapy trial e.g. lorcaserin~Highly dependent on medical care.~Driver of any vehicle (car or commercial vehicle)~Inability to take oral medication.~No consent to participate in the study~Known sensitivity to suvorexant.~Less than 18 years of age~Over 75 years of age.
|
18 Years
|
75 Years
|
All
|
No
|
Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Interventional Model Description: A placebo-controlled, double-blind randomised trial
Masking: Single
|
| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Sleep measure | Change in polysomnography sleep efficiency measure from baseline and at end of inpatient stay. Portable Polysomnography is multichannel recording of the electrophysiological markers of sleep. Polysomnography (PSG) records brain activity, eye movements and muscle tone to identify stages of sleep. Sleep efficiency measure is number of minutes of sleep divided by the number of minutes in bed {%}). | 7-10 days |
|
| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Sleep measure | Changed ISI scores from baseline at end of inpatient stay plus at 5 weeks, 9, 13, 17, 21, 25 weeks. The ISI is 7 questions (0-4) with a maximum score of 28 for severe insomnia. The investigators anticipate a change in total score. | 25 weeks |
| Sleep quality: Pittsburgh Sleep Quality Index (PSQI) | Changed Pittsburgh Sleep Quality Index (PSQI) scores from baseline at end of inpatient stay plus at 5 weeks, 9, 13, 17, 21, 25 weeks. The PSQI is a battery of 9 questions (scores 0-3). A total score of 5 or more indicates poor sleep. The investigators anticipate a change in total score. | 25 weeks |
| Sleepiness measure | Changed Epworth Sleepiness Scale scores from baseline at end of inpatient stay plus at 5 weeks, 9, 13, 17, 21, 25 weeks. There are 8 questions with scores of 0-3, maximum score of 24 indicates excessive sleepiness. A change in total score is anticipated. | 25 weeks |
| Abstinence measure | Abstinence rates from baseline at 5 weeks, 9, 13, 17, 21, 25 weeks (%) | 25 weeks |
| Relapse measure | Relapse to heavy drinking (>5 drinks/day) from baseline to 5 weeks, 9, 13, 17, 21, 25 weeks | 25 weeks |
| Craving measure | Change in alcohol craving measures using the Obsessive Compulsive Drinking Scale from baseline at 5 weeks, 9, 13, 17, 21, 25 weeks. This scale is made up of 14 questions (0-4 range). The higher the total score, the greater the craving. The investigators anticipate a change in total score. | 25 weeks |
| Liver function measure | Liver function change [Aspartate aminotransferase (AST) and Gamma-glutamyltransferase (GGT) levels] from baseline at 5 weeks, 9, 13, 17, 21, 25 weeks (%) | 25 weeks |
| Urine drug screen | Urine drug screens negative for drugs other than alcohol from baseline at 5 weeks, 9, 13, 17, 21, 25 weeks (%) | 25 weeks |
|
suvorexant, insomnia, alcohol use disorder, withdrawal, craving
|
Suvorexant, Sleep Aids, Pharmaceutical, Hypnotics and Sedatives, Central Nervous System Depressants, Physiological Effects of Drugs, Orexin Receptor Antagonists, Neurotransmitter Agents, Molecular Mechanisms of Pharmacological Action
|
| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: Treatment group<br>Patients (n=64): 20mg tablets of suvorexant nocte daily for six months | Drug: Suvorexant 20 mg<br>* Placebo controlled double blind suvorexant vs placebo<br>|
| Placebo Comparator: Placebo group<br>Placebo control group: Patients (n=64): 1 placebo tablet nocte daily for six months in addition to treatment as usual | Other: placebo<br>* Placebo controlled double blind suvorexant vs placebo<br>|
|
Suvorexant in the Management Comorbid Sleep Disorder and Alcohol Dependence
Study Overview
=================
Brief Summary
-----------------
Suvorexant (trade name Belsomra) is an orexin receptor antagonist that has TGA approval for the treatment of insomnia, characterised by difficulties with sleep onset and/or sleep maintenance. It may also have a role in addictions as the orexins play a critical role in drug addiction and reward-related behaviours. Orexins appear to be involved in both alcohol withdrawal and in alcohol seeking triggered by external cues (eg contexts or stressors) through both OX1 and OX2 receptor signalling. Chief investigator, Professor Lawrence was the first to demonstrate a role for endogenous orexin signaling in alcohol-seeking. Alcohol is known to effect the sleep of healthy and alcohol dependent individuals with effects on daytime sleepiness, physiological functions during sleep, and the development of sleep disorders. There are various estimates of the co-occurrence of insomnia and alcohol use disorder ranging from 36-72%. In alcohol dependent individuals sleep is disturbed both while drinking and for months of abstinence and abstinent sleep disturbance is predictive of relapse. This proposal aims to evaluate the use of suvorexant as a safe and effective pharmacotherapy to treat sleep disorders in alcohol dependent patients undergoing acute alcohol withdrawal and thereafter for six months. The study will also examine the effectiveness of suvorexant in reducing craving for alcohol and promoting duration of abstinence. This will be the first double blind controlled trial of suvorexant in the management of the alcohol withdrawal syndrome and maintenance of abstinence post withdrawal.
Detailed Description
-----------------
Study Procedures Baseline On Day 1, prior to commencement of treatment baseline data will be collected on demographics, ISI questionnaire plus 2 short questions 1) how many hours sleep has the participant had for the past week; 2) how would the participant rate their sleep quality in the past week. The investigators will also determine previous drug use history, physical examination, urine drug screen and measures of alcohol dependence severity, psychological and social functioning (ATOPv7). Treatment Period Treatment will begin immediately after collection of Baseline data. Suvorexant will not be given if breath alcohol concentration is above zero. Both groups will be treated using the St Vincent's Hospital standard protocol for management of alcohol withdrawal, in which benzodiazepines are provided as required according to the symptoms listed in the Clinical Institute Withdrawal Assessment for Alcohol scale (CIWA-Ar). That is, if the CIWA-Ar score is > 10 then benzodiazepines (BZD) are administered. Note, BZD will not be given for management of insomnia. Physicians involved in patient care, nurses and participants will be blinded to treatment assignment. Participants will be monitored for signs of adverse events (i.e. distress, significant alcohol withdrawal, and adverse response to suvorexant) approximately 4 hourly for the first 24 - 48 hrs of residential stay and then according to clinical assessment. All clinical observations will be made by a suitably qualified and experienced medical professional. Where any adverse events are observed, monitoring will be increased to meet clinical needs and treatment discontinued if required. Alcohol withdrawal severity will be assessed using the Clinical Institute Withdrawal Assessment - Alcohol revised (CIWA-Ar). Note, during in-patient assessment there will be no consumption of alcohol (7-10 days). Upon release to outpatients the investigators will advise participants not to consume alcohol and will provide follow-up support to help maintain abstinence. If patients resume heavy drinking and are deemed to have relapsed i.e. daily alcohol consumption greater than 5 standard drinks each day, the investigators will tell them to cease the medication and they will be withdrawn from the study. Data collected to this point will be included in the study. Follow-up Treatment Subsequent follow-up would occur weekly for 4 weeks post inpatient treatment and then every 4 weeks to week 25. Patients will continue the same dose of Suvorexant/placebo for the duration of the follow-up period. At the end of the 25 week trial patients will continue to receive treatment as usual. If they wish to continue to receive suvorexant they can get a prescription from their GP (suvorexant has been added to the pharmaceutical benefits scheme). Data Collection Baseline Name, date of birth, gender, contact details. ISI Insomnia Severity Index questionnaire (modified) Substance use history, medical history including current medications. Psychosocial status (data routinely collected through national minimum data set) Past history withdrawal symptoms (delirium tremens, seizures etc) DSM 5 criteria for alcohol use disorder (AUD) Structured clinical Interview for DSm-5 (SCID-5) Pittsburgh Sleep Quality Index (PSQI) Epworth Sleepiness Scale K10 (Kessler Psychological Distress Scale), 10 questions about psychological distress symptoms: baseline and daily while in alcohol withdrawal then at monthly follow up ATOP Australian Treatment Outcome Profile Breath alcohol reading Liver function test Urine drug screen In-patient withdrawal: Actigraphy measures of sleep patterns (Externally worn non-invasive accelerometer and light exposure recorder worn continually, from the first day of admission to discharge). Portable Polysomnography (Multichannel recoding of the electrophysiological markers of sleep). Polysomnography (PSG) records brain activity, eye movements and muscle tone to identify stages of sleep. In addition leg movements, heart rhythm, pulse rate, oxygen saturation, nasal breath flow, snore and chest movements are used to identify respiratory activity and lower leg muscle activity is also monitored for disturbing movements. (Day 1 and Day 7) Epworth Sleepiness Scale (excessive daytime sleepiness) Sleep diary during their stay (seven-ten days) ISI Insomnia questionnaire (Day 7 only) Clinical Information (as per open ended questioning for all AE's) CIWA-Ar (revised Clinical Institute Withdrawal Assessment for Alcohol scale), 10-item assessment of severity of alcohol withdrawal: baseline and every 2 - 4 hours, performed by trained staff Craving for alcohol using Obsessive Compulsive Drinking Scale Kessler 10 measure of psychological distress (Day 7 last 3 days) At weekly follow-up, for weeks 2 to 5 and at monthly follow-up from week 9 to 25 Pittsburgh Sleep Quality Index (sleep quality) (Wk5,9,13,17,21,25) Epworth Sleepiness Scale on admission (excessive daytime sleepiness) Sleep diary & ISI insomnia questionnaire Additional 2 short questions will be collected: how many hours sleep has the participant had for the past week; how would the participant rate their sleep quality in the past week; Clinical Information (as per open ended questioning for SAE safety data suvorexant form) Alcohol and other substance use (self report) ATOP Australian Treatment Outcome Profile (Wk5,9,13,17,21,25) K10 (Kessler Psychological Distress Scale) Breath alcohol reading Urine drug screen Liver/renal function tests (Wk 2,5,9,13,17,21,25) Craving for alcohol using Obsessive Compulsive Drinking Scale Any differences between objective and subjective sleep measures will be documented and reflected back to patients on an individual basis. During the consent process all patients will be informed that this is a trial and that there will be no additional (other than the trial) medication provided for insomnia.
Official Title
-----------------
A Placebo-controlled, Double -Blind Randomised Trial of Suvorexant in the Management Comorbid Sleep Disorder and Alcohol Dependence
Conditions
-----------------
Insomnia, Alcohol Use Disorder
Intervention / Treatment
-----------------
* Drug: Suvorexant 20 mg
* Other: placebo
Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Over 18 years of age and not more than 75 years of age DSM-5 diagnosis of insomnia Alcohol dependent (SCID-5) Willing to comply with treatment and follow-up requirements of study Able to give informed consent Exclusion Criteria: Consumes less than 6 standard drinks per day. Not alcohol dependent (SCID-5) Unstable major psychiatric disorder e.g. active psychosis, significant PTSD. Currently taking medication having major interaction with suvorexant Pregnant (urine βHCG positive) or not using adequate contraception. Breast feeding. Severe hepatic impairment (Liver enzyme levels >five times normal level) Severe renal impairment (urine creatinine clearance < 30ml/h) Severe medical disorder e.g. epilepsy, cardiovascular disorder Participating in another pharmacotherapy trial e.g. lorcaserin Highly dependent on medical care. Driver of any vehicle (car or commercial vehicle) Inability to take oral medication. No consent to participate in the study Known sensitivity to suvorexant. Less than 18 years of age Over 75 years of age.
Ages Eligible for Study
-----------------
Minimum Age: 18 Years
Maximum Age: 75 Years
Sexes Eligible for Study
-----------------
All
Accepts Healthy Volunteers
-----------------
No
Study Plan
=================
How is the study designed?
-----------------
Design Details
Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Interventional Model Description: A placebo-controlled, double-blind randomised trial
Masking: Single
Arms and Interventions
| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: Treatment group<br>Patients (n=64): 20mg tablets of suvorexant nocte daily for six months | Drug: Suvorexant 20 mg<br>* Placebo controlled double blind suvorexant vs placebo<br>|
| Placebo Comparator: Placebo group<br>Placebo control group: Patients (n=64): 1 placebo tablet nocte daily for six months in addition to treatment as usual | Other: placebo<br>* Placebo controlled double blind suvorexant vs placebo<br>|
What is the study measuring?
-----------------
Primary Outcome Measures
| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Sleep measure | Change in polysomnography sleep efficiency measure from baseline and at end of inpatient stay. Portable Polysomnography is multichannel recording of the electrophysiological markers of sleep. Polysomnography (PSG) records brain activity, eye movements and muscle tone to identify stages of sleep. Sleep efficiency measure is number of minutes of sleep divided by the number of minutes in bed {%}). | 7-10 days |
Secondary Outcome Measures
| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Sleep measure | Changed ISI scores from baseline at end of inpatient stay plus at 5 weeks, 9, 13, 17, 21, 25 weeks. The ISI is 7 questions (0-4) with a maximum score of 28 for severe insomnia. The investigators anticipate a change in total score. | 25 weeks |
| Sleep quality: Pittsburgh Sleep Quality Index (PSQI) | Changed Pittsburgh Sleep Quality Index (PSQI) scores from baseline at end of inpatient stay plus at 5 weeks, 9, 13, 17, 21, 25 weeks. The PSQI is a battery of 9 questions (scores 0-3). A total score of 5 or more indicates poor sleep. The investigators anticipate a change in total score. | 25 weeks |
| Sleepiness measure | Changed Epworth Sleepiness Scale scores from baseline at end of inpatient stay plus at 5 weeks, 9, 13, 17, 21, 25 weeks. There are 8 questions with scores of 0-3, maximum score of 24 indicates excessive sleepiness. A change in total score is anticipated. | 25 weeks |
| Abstinence measure | Abstinence rates from baseline at 5 weeks, 9, 13, 17, 21, 25 weeks (%) | 25 weeks |
| Relapse measure | Relapse to heavy drinking (>5 drinks/day) from baseline to 5 weeks, 9, 13, 17, 21, 25 weeks | 25 weeks |
| Craving measure | Change in alcohol craving measures using the Obsessive Compulsive Drinking Scale from baseline at 5 weeks, 9, 13, 17, 21, 25 weeks. This scale is made up of 14 questions (0-4 range). The higher the total score, the greater the craving. The investigators anticipate a change in total score. | 25 weeks |
| Liver function measure | Liver function change [Aspartate aminotransferase (AST) and Gamma-glutamyltransferase (GGT) levels] from baseline at 5 weeks, 9, 13, 17, 21, 25 weeks (%) | 25 weeks |
| Urine drug screen | Urine drug screens negative for drugs other than alcohol from baseline at 5 weeks, 9, 13, 17, 21, 25 weeks (%) | 25 weeks |
Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
suvorexant, insomnia, alcohol use disorder, withdrawal, craving
|
NCT03221673
|
Arkansas Active Kids! -Objective 3
|
This is a cross-sectional study aiming to identify how daily activities affect children's body fitness and general health. Also, the study will address how specific behaviors (such as diet and sleep) as well as neighborhood and home environment affect children's metabolic health and fitness level.
|
The purpose of this study is to determine how daily activities, home, neighborhood and school environments affect Arkansas children's health. Children from Central Arkansas ages 7-10 years will be recruited to participate in a variety of physical activity tests including strength, flexibility, balance and endurance. During these tests, participants will perform tasks such as cycling on a stationary bike and extending and flexing their knees on a special type of chair. Body composition will be measured and blood, saliva, urine and stool samples collected. Participants and parents will be asked to complete questionnaires on physical activity, home and neighborhood environment as well as sleeping habits. Finally, participants will wear an accelerometer based monitor that will track their physical activity and sleeping patterns. One in person visit will take place at Arkansas Children's Nutrition Center (Little Rock, AR) and will last up to 8 hours. Reimbursement will be provided.
|
Relationship of Physical Activity and Diet With Socio-demographic, Environmental, and Metabolic Factors in Arkansas Public School Children
|
Child, Physical Activity
|
Inclusion Criteria:~Ages 7 to 10 years~Boys or girls~All ethnicities~All BMIs (all body types)~Exclusion Criteria:~Severe persistent asthma (determined by daily use of oral/inhaled corticosteroid to keep asthma symptoms under control and/or frequent use of rescue inhaler)~Type 2 diabetes mellitus~Other pre-existing medical conditions or medications as determined by the investigators to affect the outcomes of interest
|
7 Years
|
10 Years
|
All
|
Accepts Healthy Volunteers
|
| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Correlation between fitness level and metabolic health | A fitness test will be performed to determine peak oxygen uptake (VO2 peak, ml/kg per min). Correlations between peak VO2 and different markers of cardiometabolic health (IL-6, triglycerides, non-esterified fatty acids, glucose, insulin concentrations, etc.) will be determined. Other indicators of fitness level such as strength, flexibility and balance will be measured and correlations assessed. | June 2016-August 2018 |
|
| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Correlation between home and neighborhood environments and fitness level | Home and neighborhood environments will be assessed via interviewer administered questionnaires. Scores obtained from these questionnaires will be correlated with peak oxygen consumption, strength, flexibility and balance scores. | June 2016-August 2018 |
|
Arkansas, Exercise, Children, Physical activity, Sedentary
|
Arkansas Active Kids! -Objective 3
Study Overview
=================
Brief Summary
-----------------
This is a cross-sectional study aiming to identify how daily activities affect children's body fitness and general health. Also, the study will address how specific behaviors (such as diet and sleep) as well as neighborhood and home environment affect children's metabolic health and fitness level.
Detailed Description
-----------------
The purpose of this study is to determine how daily activities, home, neighborhood and school environments affect Arkansas children's health. Children from Central Arkansas ages 7-10 years will be recruited to participate in a variety of physical activity tests including strength, flexibility, balance and endurance. During these tests, participants will perform tasks such as cycling on a stationary bike and extending and flexing their knees on a special type of chair. Body composition will be measured and blood, saliva, urine and stool samples collected. Participants and parents will be asked to complete questionnaires on physical activity, home and neighborhood environment as well as sleeping habits. Finally, participants will wear an accelerometer based monitor that will track their physical activity and sleeping patterns. One in person visit will take place at Arkansas Children's Nutrition Center (Little Rock, AR) and will last up to 8 hours. Reimbursement will be provided.
Official Title
-----------------
Relationship of Physical Activity and Diet With Socio-demographic, Environmental, and Metabolic Factors in Arkansas Public School Children
Conditions
-----------------
Child, Physical Activity
Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Ages 7 to 10 years Boys or girls All ethnicities All BMIs (all body types) Exclusion Criteria: Severe persistent asthma (determined by daily use of oral/inhaled corticosteroid to keep asthma symptoms under control and/or frequent use of rescue inhaler) Type 2 diabetes mellitus Other pre-existing medical conditions or medications as determined by the investigators to affect the outcomes of interest
Ages Eligible for Study
-----------------
Minimum Age: 7 Years
Maximum Age: 10 Years
Sexes Eligible for Study
-----------------
All
Accepts Healthy Volunteers
-----------------
Accepts Healthy Volunteers
Study Plan
=================
How is the study designed?
-----------------
What is the study measuring?
-----------------
Primary Outcome Measures
| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Correlation between fitness level and metabolic health | A fitness test will be performed to determine peak oxygen uptake (VO2 peak, ml/kg per min). Correlations between peak VO2 and different markers of cardiometabolic health (IL-6, triglycerides, non-esterified fatty acids, glucose, insulin concentrations, etc.) will be determined. Other indicators of fitness level such as strength, flexibility and balance will be measured and correlations assessed. | June 2016-August 2018 |
Secondary Outcome Measures
| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Correlation between home and neighborhood environments and fitness level | Home and neighborhood environments will be assessed via interviewer administered questionnaires. Scores obtained from these questionnaires will be correlated with peak oxygen consumption, strength, flexibility and balance scores. | June 2016-August 2018 |
Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Arkansas, Exercise, Children, Physical activity, Sedentary
|
||||
NCT00708461
|
Environmental Intervention for Weight Gain Prevention
|
The primary aim of this research is to evaluate the efficacy of a multicomponent worksite-based, environmental intervention in reducing weight increase and obesity over time in working adults.
|
This study is a randomized trial designed to evaluate the effectiveness of a multi-component worksite intervention with strong environmental components to prevent weight gain. Six worksites will be randomized to either an intervention or a no-treatment control group. The intervention will be comprised of 1) changing the availability, portion sizes, and prices of foods and beverages sold to employees in their worksites in ways that encourage healthier food choices; 2) increasing the availability of physical activity opportunities at the worksite by implementing walking programs and increasing stairwell access and attractiveness; 3) placing scales in the work environment to encourage body weight monitoring and to enable workers to set goals for their weight; and 4) to provide educational materials to all employees to make them aware of the environmental intervention and of behavioral practices likely to be effective in preventing weight gain. The intervention will be implemented for a 2-year period in each intervention site. Effectiveness will be evaluated by assessing body weight, eating behavior and physical activity in a cohort of employees in both control and intervention sites at baseline and again 2 years later. Weight trends in these populations will also be compared to data from national and state-level annual surveys of weight in representative population samples. Data will be collected on the effects of specific intervention components via aggregate measures of food choice and physical activity.
|
Environmental Intervention for Weight Gain Prevention
|
Obesity
|
* Behavioral: weight gain prevention
|
Inclusion Criteria:~age 18 or older~generally in good health~part- or full-time employee in one of the participating worksites~Exclusion Criteria:~work on site <50% of the time~work second or third shift
|
18 Years
|
70 Years
|
All
|
Accepts Healthy Volunteers
|
Primary Purpose: Prevention
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
|
| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change in Body Mass Index (BMI) | Assessed in kilograms per meter squared. | Baseline to 24 months |
|
obesity, obesity prevention, worksite, environment, intervention
|
Obesity, Weight Gain, Overweight, Overnutrition, Nutrition Disorders, Body Weight, Body Weight Changes
|
| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Worksite Environmental Intervention<br>Changes to healthy food availability, physical activity opportunities and promotion, body weight scale access, and media enhancements to target weight gain prevention | Behavioral: weight gain prevention<br>* Changes in the food environment that increase the availability of healthy foods and beverages, reduce food and beverage portion sizes, reduce prices on healthy food items, and increase prices on less healthy food items.~Changes in the activity environment that increase cues and incentives for walking at work and at home, using stairs, and to increase exposure of employees to information about active recreational opportunities at work and at home.~Changes to the environment to increase cues and incentives for regular weight monitoring by providing scales at convenient locations.~Changes in the informational environment that increase frequency of exposure of the employee population to accurate information about healthy food and activity choices.<br>* Other names: obesity prevention;|
| No Intervention: No-contact control<br>No-treatment control condition. Worksites were offered program materials upon completion of programs at intervention sites. | |
|
Environmental Intervention for Weight Gain Prevention
Study Overview
=================
Brief Summary
-----------------
The primary aim of this research is to evaluate the efficacy of a multicomponent worksite-based, environmental intervention in reducing weight increase and obesity over time in working adults.
Detailed Description
-----------------
This study is a randomized trial designed to evaluate the effectiveness of a multi-component worksite intervention with strong environmental components to prevent weight gain. Six worksites will be randomized to either an intervention or a no-treatment control group. The intervention will be comprised of 1) changing the availability, portion sizes, and prices of foods and beverages sold to employees in their worksites in ways that encourage healthier food choices; 2) increasing the availability of physical activity opportunities at the worksite by implementing walking programs and increasing stairwell access and attractiveness; 3) placing scales in the work environment to encourage body weight monitoring and to enable workers to set goals for their weight; and 4) to provide educational materials to all employees to make them aware of the environmental intervention and of behavioral practices likely to be effective in preventing weight gain. The intervention will be implemented for a 2-year period in each intervention site. Effectiveness will be evaluated by assessing body weight, eating behavior and physical activity in a cohort of employees in both control and intervention sites at baseline and again 2 years later. Weight trends in these populations will also be compared to data from national and state-level annual surveys of weight in representative population samples. Data will be collected on the effects of specific intervention components via aggregate measures of food choice and physical activity.
Official Title
-----------------
Environmental Intervention for Weight Gain Prevention
Conditions
-----------------
Obesity
Intervention / Treatment
-----------------
* Behavioral: weight gain prevention
Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: age 18 or older generally in good health part- or full-time employee in one of the participating worksites Exclusion Criteria: work on site <50% of the time work second or third shift
Ages Eligible for Study
-----------------
Minimum Age: 18 Years
Maximum Age: 70 Years
Sexes Eligible for Study
-----------------
All
Accepts Healthy Volunteers
-----------------
Accepts Healthy Volunteers
Study Plan
=================
How is the study designed?
-----------------
Design Details
Primary Purpose: Prevention
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Arms and Interventions
| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Worksite Environmental Intervention<br>Changes to healthy food availability, physical activity opportunities and promotion, body weight scale access, and media enhancements to target weight gain prevention | Behavioral: weight gain prevention<br>* Changes in the food environment that increase the availability of healthy foods and beverages, reduce food and beverage portion sizes, reduce prices on healthy food items, and increase prices on less healthy food items. Changes in the activity environment that increase cues and incentives for walking at work and at home, using stairs, and to increase exposure of employees to information about active recreational opportunities at work and at home. Changes to the environment to increase cues and incentives for regular weight monitoring by providing scales at convenient locations. Changes in the informational environment that increase frequency of exposure of the employee population to accurate information about healthy food and activity choices.<br>* Other names: obesity prevention;|
| No Intervention: No-contact control<br>No-treatment control condition. Worksites were offered program materials upon completion of programs at intervention sites. | |
What is the study measuring?
-----------------
Primary Outcome Measures
| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change in Body Mass Index (BMI) | Assessed in kilograms per meter squared. | Baseline to 24 months |
Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
obesity, obesity prevention, worksite, environment, intervention
|
|
NCT05503160
|
Primary Hormone-sensitive Breast Cancer: Need-driven Health Care Improvement by Patient-centred Digital Application
|
The investigators designed a prospective, 2-armed, cluster-randomized multicenter clinical trial on the effect of a by a digital application triggered intervention on quality of life and therapy-adherence among breast cancer patients, compared to standard of care.
|
With validated questionnaires, patient reported outcome monitoring data on quality of life, distress and therapy-adherence are collected. In case of pathologic values, the attending breast center gets advised to intervene according to individual requirements.~For women with breast cancer, disease and therapy come along with loss of quality of life. Therapy and its side effects often result in unauthorized discontinuation of therapy by patients. Non-adherence rates to endocrine therapy (ET) range from 31% to 73%. These patients have a poorer prognosis due to recurrence, progression and cancer deaths. Positive effects to increase therapy-adherence were shown for bidirectional communication. Furthermore the use of apps with reminder functions can increase adherence to cancer therapy. The intention within this project is to improve care of patients with primary breast cancer.
|
Primäres Hormon-Sensitives Mammakarzinom: Bedarfsgerechte Optimierung Der Versorgung Durch Eine Patientenzentrierte, Digitale Anwendung
|
New Healthcare Approach
|
* Behavioral: Intervention
|
Inclusion Criteria:~primary, hormone-sensitive breast cancer~indication for adjuvant endocrine therapy (aromatase-inhibitor, tamoxifen, GnRH-analogue allone or in combination with tamoxifen/ aromatas inhibitor; combination of endocrine therapy with CDK 4/6-inhibitor/ antibody therapy/ radiotherapy)~start of endocrine therapy <= 3 months ago~patients with public health ensurance~patients who are legally competent and able to understand and follow instructions of the study staff~present informed consent~Exclusion Criteria:~no use of internet or digital applications~advanced, metastatic breast cancer~simultaneous serious disease~life expectancy < 2 years
|
18 Years
| null |
Female
|
No
|
Primary Purpose: Supportive Care
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
|
| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Quality of Life (QOL) | Change in EORTC QLQ-C30 subscale | 24 Months |
|
| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Quality of Life (QOL) | Change in EORTC QLQ-BR23 | 24 Months |
| Quality of Life (QOL) | Change in EORTC QLQ-BR23 | 6, 12, 18 Months |
| Quality of Life (QOL) | Change in EORTC QLQ-C30 | 6, 12, 18 Months |
| Adherence | Number of days missing tablets | 24 Months |
| Mental health | Change in GAD-2 | 24 Months |
| Mental health | Change in Distress thermometer | 24 Months |
| Mental health | Change in PHQ-2 | 24 Months |
| Adverse effect of therapy | Count of side effects cat. 3/4 | 24 Months |
| Assessment of new digital form of care | Usefulness of application | 24 Months |
| Progression free survival | PFS rate | 24 Months |
| Overal survival | OS rate | 24 Months |
| Total cost | Cost difference | 24 Months |
| Disease-specific costs | Cost difference | 24 Months |
| Effectiveness (QOL) | Change in EORTC QLQ-C30 subscale | 24 Months |
| Efficiency (QALY) | Qaly-Index from EQ-5D-5L | 24 Months |
| Patient Satisfaction | Short Assessment of Patient Satisfaction - Satisfaction Index | 6, 24 Months |
| Stakeholder perspective | Stakeholder perspective questionnaires | 12, 24 Months |
| Number of Interventions | Automatically initiated reasons for interventions | 24 Months |
|
quality of life, adherence
|
Hypersensitivity, Immune System Diseases
|
| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: Intervention<br>With validated questionnaires, patient reported outcome monitoring data on quality of life, distress and therapy-adherence are collected. In case of pathologic values, the attending breast center gets advised to intervene according to individual requirements. | Behavioral: Intervention<br>* Structured (video-)call by qualified nursing staff with breast cancer patients, with the intention to overcome side effects, distress or non-adherence to endocrine therapy.<br>|
| No Intervention: Control<br>Standard of care | |
|
Primary Hormone-sensitive Breast Cancer: Need-driven Health Care Improvement by Patient-centred Digital Application
Study Overview
=================
Brief Summary
-----------------
The investigators designed a prospective, 2-armed, cluster-randomized multicenter clinical trial on the effect of a by a digital application triggered intervention on quality of life and therapy-adherence among breast cancer patients, compared to standard of care.
Detailed Description
-----------------
With validated questionnaires, patient reported outcome monitoring data on quality of life, distress and therapy-adherence are collected. In case of pathologic values, the attending breast center gets advised to intervene according to individual requirements. For women with breast cancer, disease and therapy come along with loss of quality of life. Therapy and its side effects often result in unauthorized discontinuation of therapy by patients. Non-adherence rates to endocrine therapy (ET) range from 31% to 73%. These patients have a poorer prognosis due to recurrence, progression and cancer deaths. Positive effects to increase therapy-adherence were shown for bidirectional communication. Furthermore the use of apps with reminder functions can increase adherence to cancer therapy. The intention within this project is to improve care of patients with primary breast cancer.
Official Title
-----------------
Primäres Hormon-Sensitives Mammakarzinom: Bedarfsgerechte Optimierung Der Versorgung Durch Eine Patientenzentrierte, Digitale Anwendung
Conditions
-----------------
New Healthcare Approach
Intervention / Treatment
-----------------
* Behavioral: Intervention
Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: primary, hormone-sensitive breast cancer indication for adjuvant endocrine therapy (aromatase-inhibitor, tamoxifen, GnRH-analogue allone or in combination with tamoxifen/ aromatas inhibitor; combination of endocrine therapy with CDK 4/6-inhibitor/ antibody therapy/ radiotherapy) start of endocrine therapy <= 3 months ago patients with public health ensurance patients who are legally competent and able to understand and follow instructions of the study staff present informed consent Exclusion Criteria: no use of internet or digital applications advanced, metastatic breast cancer simultaneous serious disease life expectancy < 2 years
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: None (Open Label)
Arms and Interventions
| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: Intervention<br>With validated questionnaires, patient reported outcome monitoring data on quality of life, distress and therapy-adherence are collected. In case of pathologic values, the attending breast center gets advised to intervene according to individual requirements. | Behavioral: Intervention<br>* Structured (video-)call by qualified nursing staff with breast cancer patients, with the intention to overcome side effects, distress or non-adherence to endocrine therapy.<br>|
| No Intervention: Control<br>Standard of care | |
What is the study measuring?
-----------------
Primary Outcome Measures
| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Quality of Life (QOL) | Change in EORTC QLQ-C30 subscale | 24 Months |
Secondary Outcome Measures
| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Quality of Life (QOL) | Change in EORTC QLQ-BR23 | 24 Months |
| Quality of Life (QOL) | Change in EORTC QLQ-BR23 | 6, 12, 18 Months |
| Quality of Life (QOL) | Change in EORTC QLQ-C30 | 6, 12, 18 Months |
| Adherence | Number of days missing tablets | 24 Months |
| Mental health | Change in GAD-2 | 24 Months |
| Mental health | Change in Distress thermometer | 24 Months |
| Mental health | Change in PHQ-2 | 24 Months |
| Adverse effect of therapy | Count of side effects cat. 3/4 | 24 Months |
| Assessment of new digital form of care | Usefulness of application | 24 Months |
| Progression free survival | PFS rate | 24 Months |
| Overal survival | OS rate | 24 Months |
| Total cost | Cost difference | 24 Months |
| Disease-specific costs | Cost difference | 24 Months |
| Effectiveness (QOL) | Change in EORTC QLQ-C30 subscale | 24 Months |
| Efficiency (QALY) | Qaly-Index from EQ-5D-5L | 24 Months |
| Patient Satisfaction | Short Assessment of Patient Satisfaction - Satisfaction Index | 6, 24 Months |
| Stakeholder perspective | Stakeholder perspective questionnaires | 12, 24 Months |
| Number of Interventions | Automatically initiated reasons for interventions | 24 Months |
Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
quality of life, adherence
|
NCT00857038
|
Doxycycline and Airway Inflammation in Chronic Obstructive Pulmonary Disease (COPD)
|
COPD is a progressive pulmonary disease that is characterized by an inflammatory process in the airways and the lungs which leads to progressive airway obstruction. The inflammation is associated with tissue loss and remodelling. The investigators hypothesized that doxycycline reduces neutrophilic airway inflammation in patients with COPD. Therefore the investigators will conduct a randomized trial of doxycycline in 30 patients.
|
Rationale:~COPD is a disease characterized by chronic inflammation and irreversible airway obstruction. Chronic inflammation lead to degradation of extracellular matrix and hereby destruction of lung parenchyma. Tetracyclines are known for their anti-inflammatory properties in diseases such as rheumatoid arthritis.~Objective:~To assess the effect of doxycycline on markers of neutrophilic inflammation and proteolytic activity in induced sputum of stable GOLD II and III COPD patients.~Study population:~Thirty patients with stable GOLD II COPD.~Intervention:~Placebo versus doxycycline in randomised design.
|
Doxycycline and Airway Inflammation in COPD: A Randomised Placebo Controlled Trial Studying the Effects of Doxycycline on Airway Inflammation in Patients With Moderate and Severe Stable COPD.
|
Chronic Obstructive Pulmonary Disease, Inflammation, Pulmonary Emphysema
|
* Drug: Doxycycline
* Drug: Placebo
|
Inclusion Criteria:~GOLD II or III COPD (GOLD II: FEV1/FVC < 70%; 50% < FEV1 < 80% predicted, GOLD III: FEV1/FVC < 70%; 30% < FEV1 < 50% predicted ).~Stable disease (no exacerbations in the last 3 months).~Age > 40 yrs.~Written informed consent.~Exclusion Criteria:~Infections and/or use of antibiotics in the last month.~Bacterial colonization of the airways, proven by sputum cultures or broncho-alveolar lavage (BAL).~Allergy for tetracyclines or a history of substantial side-effects.~Active respiratory diseases other than COPD (e.g. sarcoidosis, tuberculosis, lung cancer, bronchiectasis).~Acute exacerbation of COPD as defined by Anthonisen et al. [10].~Signs and/or symptoms of a current respiratory or non-respiratory infection.~Use of oral or intravenous corticosteroids or other immunosuppressive drugs within the last month.
|
41 Years
| null |
All
|
No
|
Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Triple
|
| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| myeloperoxidase in induced sputum | | 3 weeks |
|
| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| MMP-8, MMP-9, IL-6 levels and differential cell counts in induced sputum. | | 3 weeks |
| Lung function (FEV1) | | 3 weeks |
| Symptom scores | | 3 weeks |
|
COPD, Inflammation, Neutrophilic, Myeloperoxidase, Doxycycline
|
Doxycycline, Anti-Bacterial Agents, Anti-Infective Agents, Antimalarials, Antiprotozoal Agents, Antiparasitic Agents
|
| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: 1<br>Doxycycline 100mg daily | Drug: Doxycycline<br>* Doxycycline tablets, 100mg daily<br>|
| Placebo Comparator: 2<br>Placebo | Drug: Placebo<br>* Placebo tablets 100mg<br>|
|
Doxycycline and Airway Inflammation in Chronic Obstructive Pulmonary Disease (COPD)
Study Overview
=================
Brief Summary
-----------------
COPD is a progressive pulmonary disease that is characterized by an inflammatory process in the airways and the lungs which leads to progressive airway obstruction. The inflammation is associated with tissue loss and remodelling. The investigators hypothesized that doxycycline reduces neutrophilic airway inflammation in patients with COPD. Therefore the investigators will conduct a randomized trial of doxycycline in 30 patients.
Detailed Description
-----------------
Rationale: COPD is a disease characterized by chronic inflammation and irreversible airway obstruction. Chronic inflammation lead to degradation of extracellular matrix and hereby destruction of lung parenchyma. Tetracyclines are known for their anti-inflammatory properties in diseases such as rheumatoid arthritis. Objective: To assess the effect of doxycycline on markers of neutrophilic inflammation and proteolytic activity in induced sputum of stable GOLD II and III COPD patients. Study population: Thirty patients with stable GOLD II COPD. Intervention: Placebo versus doxycycline in randomised design.
Official Title
-----------------
Doxycycline and Airway Inflammation in COPD: A Randomised Placebo Controlled Trial Studying the Effects of Doxycycline on Airway Inflammation in Patients With Moderate and Severe Stable COPD.
Conditions
-----------------
Chronic Obstructive Pulmonary Disease, Inflammation, Pulmonary Emphysema
Intervention / Treatment
-----------------
* Drug: Doxycycline
* Drug: Placebo
Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: GOLD II or III COPD (GOLD II: FEV1/FVC < 70%; 50% < FEV1 < 80% predicted, GOLD III: FEV1/FVC < 70%; 30% < FEV1 < 50% predicted ). Stable disease (no exacerbations in the last 3 months). Age > 40 yrs. Written informed consent. Exclusion Criteria: Infections and/or use of antibiotics in the last month. Bacterial colonization of the airways, proven by sputum cultures or broncho-alveolar lavage (BAL). Allergy for tetracyclines or a history of substantial side-effects. Active respiratory diseases other than COPD (e.g. sarcoidosis, tuberculosis, lung cancer, bronchiectasis). Acute exacerbation of COPD as defined by Anthonisen et al. [10]. Signs and/or symptoms of a current respiratory or non-respiratory infection. Use of oral or intravenous corticosteroids or other immunosuppressive drugs within the last month.
Ages Eligible for Study
-----------------
Minimum Age: 41 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: 1<br>Doxycycline 100mg daily | Drug: Doxycycline<br>* Doxycycline tablets, 100mg daily<br>|
| Placebo Comparator: 2<br>Placebo | Drug: Placebo<br>* Placebo tablets 100mg<br>|
What is the study measuring?
-----------------
Primary Outcome Measures
| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| myeloperoxidase in induced sputum | | 3 weeks |
Secondary Outcome Measures
| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| MMP-8, MMP-9, IL-6 levels and differential cell counts in induced sputum. | | 3 weeks |
| Lung function (FEV1) | | 3 weeks |
| Symptom scores | | 3 weeks |
Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
COPD, Inflammation, Neutrophilic, Myeloperoxidase, Doxycycline
|
NCT00183911
|
Study of 5-Fluorouracil and Leucovorin and Intra-abdominal Floxuridine Chemoradiation in Patients With Fully Resected Locally Advanced Gastric Adenocarcinoma
|
The purpose of this study is to evaluate the side effects of a new treatment for stomach cancer which may potentially improve the prognosis of this cancer.~Our principle objective is to improve the results of standard chemotherapy and radiation after surgery of patients with gastric cancer. The intra-abdominal (intraperitoneal) administration of floxuridine (FUDR) is a procedure that we have studied and have determined it is a safe treatment. In this study, we want to evaluate the side effects of this treatment when it is given after surgery but before standard intravenous chemotherapy and radiation.~Study treatment will start with surgical removal of the part of the stomach with cancer, together with surrounding tissues and lymph nodes. After surgery, patients will get treatment with a chemotherapy drug, FUDR, administered directly into the abdomen. This is called intraperitoneal chemotherapy. After this treatment patients will receive repeated intravenous injection of two drugs, 5-fluorouracil and leucovorin alone or combined with irradiation of the abdomen.
|
Phase II Study of Adjuvant Intraperitoneal FUDR Treatment Added to Chemoradiation (5-Fluorouracil/Leucovorin Plus Total Dose 4500 cGy of External Beam Radiotherapy) in Patients With Fully Resected Locally Advanced Gastric Adenocarcinoma
|
Gastric Adenocarcinoma, Gastric Cancer
|
* Drug: floxuridine, 5-Fluorouracil, leucovorin
* Procedure: External Beam Radiotherapy
* Procedure: Surgery
|
Inclusion Criteria:~Histologic dx of locally advanced gastric adenocarcinoma (requires upper endoscopy with bx of lesion and CT scan of chest, abdomen, and pelvis with iv and oral contrast or other methods of imaging to confirm absence of metastatic dz) (Untreated patients with histologically documented gastric/GEJ ca stages IB-IV [M0] are eligible)~Based on post-op pathological findings, diagnosis and staging has to confirm stage IB-IV (M0) adenocarcinoma of stomach or GEJ.~Patients who underwent emergency surgery for indications such as GI obstruction, perforation, or hemorrhage, or patients with surgery already performed, are eligible provided surgery is considered curative~ECOG performance status 0-2~AGC greater than or equal to 1.5; platelets greater than or equal to 100,000; Hgb greater than or equal to 9.0· Total bilirubin less than or eqal to 2.0; SGOT/SGPT less than or equal to 2.5 x uln; alk phos less than or equal to 2.5 x uln~BUN less than or equal to 30; creatinine less than or equal to 1.5 or CrCl >60 ml/min~Negative b-HCG pregnancy test (females with reproductive potential)~PT, aPTT, and thrombin time within range of normal~Evidence of at least unilateral renal function as established by CT scan with contrast or nephrogram. (If only one kidney is present, at least 2/3 of the functioning kidney must be excluded from any RT port)~Exclusion Criteria:~Prior radiation therapy, chemotherapy or immunotherapy~Presence of another active invasive malignancy (Except for adequately treated basal cell or squamous cell skin ca, in-situ cervical ca, or other cancer for which patient has been disease-free for at least 5 yrs)~Active or uncontrolled infection, including HIV~Psychiatric disorders that would interfere with informed consent· Pregnant or nursing women (Patients of reproductive age must agree to use effective contraceptive method)~Any other severe concurrent disease, which in the judgment of MD would make patient inappropriate for study
|
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 |
| --- | --- | --- |
|
Leucovorin, Fluorouracil, Floxuridine, Antimetabolites, Molecular Mechanisms of Pharmacological Action, Antimetabolites, Antineoplastic, Antineoplastic Agents, Immunosuppressive Agents, Immunologic Factors, Physiological Effects of Drugs, Antidotes, Protective Agents, Vitamin B Complex, Vitamins, Micronutrients
|
| Intervention/Treatment |
| --- |
|Drug: floxuridine, 5-Fluorouracil, leucovorin|nan|
|Procedure: External Beam Radiotherapy|nan|
|Procedure: Surgery|nan|
|
Study of 5-Fluorouracil and Leucovorin and Intra-abdominal Floxuridine Chemoradiation in Patients With Fully Resected Locally Advanced Gastric Adenocarcinoma
Study Overview
=================
Brief Summary
-----------------
The purpose of this study is to evaluate the side effects of a new treatment for stomach cancer which may potentially improve the prognosis of this cancer. Our principle objective is to improve the results of standard chemotherapy and radiation after surgery of patients with gastric cancer. The intra-abdominal (intraperitoneal) administration of floxuridine (FUDR) is a procedure that we have studied and have determined it is a safe treatment. In this study, we want to evaluate the side effects of this treatment when it is given after surgery but before standard intravenous chemotherapy and radiation. Study treatment will start with surgical removal of the part of the stomach with cancer, together with surrounding tissues and lymph nodes. After surgery, patients will get treatment with a chemotherapy drug, FUDR, administered directly into the abdomen. This is called intraperitoneal chemotherapy. After this treatment patients will receive repeated intravenous injection of two drugs, 5-fluorouracil and leucovorin alone or combined with irradiation of the abdomen.
Official Title
-----------------
Phase II Study of Adjuvant Intraperitoneal FUDR Treatment Added to Chemoradiation (5-Fluorouracil/Leucovorin Plus Total Dose 4500 cGy of External Beam Radiotherapy) in Patients With Fully Resected Locally Advanced Gastric Adenocarcinoma
Conditions
-----------------
Gastric Adenocarcinoma, Gastric Cancer
Intervention / Treatment
-----------------
* Drug: floxuridine, 5-Fluorouracil, leucovorin
* Procedure: External Beam Radiotherapy
* Procedure: Surgery
Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Histologic dx of locally advanced gastric adenocarcinoma (requires upper endoscopy with bx of lesion and CT scan of chest, abdomen, and pelvis with iv and oral contrast or other methods of imaging to confirm absence of metastatic dz) (Untreated patients with histologically documented gastric/GEJ ca stages IB-IV [M0] are eligible) Based on post-op pathological findings, diagnosis and staging has to confirm stage IB-IV (M0) adenocarcinoma of stomach or GEJ. Patients who underwent emergency surgery for indications such as GI obstruction, perforation, or hemorrhage, or patients with surgery already performed, are eligible provided surgery is considered curative ECOG performance status 0-2 AGC greater than or equal to 1.5; platelets greater than or equal to 100,000; Hgb greater than or equal to 9.0· Total bilirubin less than or eqal to 2.0; SGOT/SGPT less than or equal to 2.5 x uln; alk phos less than or equal to 2.5 x uln BUN less than or equal to 30; creatinine less than or equal to 1.5 or CrCl >60 ml/min Negative b-HCG pregnancy test (females with reproductive potential) PT, aPTT, and thrombin time within range of normal Evidence of at least unilateral renal function as established by CT scan with contrast or nephrogram. (If only one kidney is present, at least 2/3 of the functioning kidney must be excluded from any RT port) Exclusion Criteria: Prior radiation therapy, chemotherapy or immunotherapy Presence of another active invasive malignancy (Except for adequately treated basal cell or squamous cell skin ca, in-situ cervical ca, or other cancer for which patient has been disease-free for at least 5 yrs) Active or uncontrolled infection, including HIV Psychiatric disorders that would interfere with informed consent· Pregnant or nursing women (Patients of reproductive age must agree to use effective contraceptive method) Any other severe concurrent disease, which in the judgment of MD would make patient inappropriate for study
Ages Eligible for Study
-----------------
Minimum Age: 18 Years
Sexes Eligible for Study
-----------------
All
Accepts Healthy Volunteers
-----------------
No
Study Plan
=================
How is the study designed?
-----------------
Design Details
Primary Purpose: Treatment
Allocation: Non-Randomized
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Arms and Interventions
| Intervention/Treatment |
| --- |
|Drug: floxuridine, 5-Fluorouracil, leucovorin|nan|
|Procedure: External Beam Radiotherapy|nan|
|Procedure: Surgery|nan|
What is the study measuring?
-----------------
Primary Outcome Measures
| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
|
|||
NCT03512561
|
Impact of the Presurgical Visit of Nursing on the Well-being of the Surgical Patient.
|
.A surgical intervention involves the participant and his / her family in a very stressful situation with a biopsychosocial alteration of the participant, often presenting a lack of knowledge of the surgical process from admission to hospital discharge. Researchers (nursing) began to make prior visits to the surgical procedure to reduce anxiety and provide information about the surgical process. The importance of the presurgical nursing visit (PNV) is sought, how to achieve a better health education throughout the surgical process, improve communication between professionals through standardized records, contributing to an optimal approach to the participant, increasing well-being, health and the satisfaction of the participant
|
In our Center, PNVs are carried out in the Ambulatory Area (External Consultations) in a specific and personalized nursing consultation, within an established and multidisciplinary program. One week before surgery, the patient and a family / primary caregiver are cited.~The PNV conducts a semi-structured interview; the content may vary according to the type of surgery, but in general it can be understood as all those nursing interventions; how to provide information, support, advice and training to the patient and his family (primary caregiver).~It is an innovative experience since it has been carried out for a short time. The PNV have been gradually restructured and continue to grow, since their establishment has been positively valued in the different services thanks to the experience gained and the numerous bibliographic references that demonstrate the beneficial results for the patient and the health system.~A total of 356 participants have been calculated (surveys answered in more than 3 months), taking into account an approximate population of 1,172 programmed interventions carried out in 1 year, with a confidence interval of 95%, accuracy of 3% a proportion of 5% and with an expected loss of 15%.~Sample:~Arthralplasia of knee / hip N 480 n 92 Cystectomies N 24 n 19 Esophagogastric with coloplasty N 24 n 19 Hysterectomy N 24 n 19 Colon / rectum N 192 n 65 Lumpectomy with sentinel lymph nodes N 222 n 74 Caesarean section N 206 n 68
|
Impact of the Presurgical Visit of Nursing on the Well-being of the Patient Before a Surgical Process at the Parc Taulí Health Corporation.
|
Nurse's Role, Preoperative Care, Patient Satisfaction
|
Inclusion Criteria:~Patients who have undergone the pre-surgical nursing visit (personalized).~Patients over 18 years of age~Live accompanied and / or with own resources of help.~Having signed the informed consent.~Exclusion Criteria:~Not having signed the informed consent.~Not having done the questionnaires after pre-surgical nursing visit (STAI, EQ-5D-5L)~For surgical complications that do not allow the telephone survey, or focal groups.
|
18 Years
| null |
All
|
No
|
| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| The participant is satisfied throughout the surgical process, in relation to information, health education and personalized attention to the presurgical nursing visit (PNV) | Number of participants who are satisfied with the experience of the surgical procedure and if this is what is explained in the presurgical nursing visit, for the evaluation of the importance of the visit in the surgical process. | 3 months |
|
| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| The participant feels well-being due to the care received by the professionals throughout the surgical process. | Number of participants who perceive welfare linked to the quality of care of the surgical process. | 3 month |
| The participant has preoperative and postoperative anxiety in more than three months, relating it to the information provided in the presurgical nursing visit. | Number of participants who perceive pre and postsurgical anxiety and if it is linked to the information provided during the visit. | 3 months |
| The participant perceives better quality of presurgical and postoperative life in more than three months; in relation to the training given during the pre-surgical nursing visit. | Number of participants who perceive an improvement in the quality of life and if it is linked to the information provided during the visit. | 3 months |
|
Impact of the Presurgical Visit of Nursing on the Well-being of the Surgical Patient.
Study Overview
=================
Brief Summary
-----------------
.A surgical intervention involves the participant and his / her family in a very stressful situation with a biopsychosocial alteration of the participant, often presenting a lack of knowledge of the surgical process from admission to hospital discharge. Researchers (nursing) began to make prior visits to the surgical procedure to reduce anxiety and provide information about the surgical process. The importance of the presurgical nursing visit (PNV) is sought, how to achieve a better health education throughout the surgical process, improve communication between professionals through standardized records, contributing to an optimal approach to the participant, increasing well-being, health and the satisfaction of the participant
Detailed Description
-----------------
In our Center, PNVs are carried out in the Ambulatory Area (External Consultations) in a specific and personalized nursing consultation, within an established and multidisciplinary program. One week before surgery, the patient and a family / primary caregiver are cited. The PNV conducts a semi-structured interview; the content may vary according to the type of surgery, but in general it can be understood as all those nursing interventions; how to provide information, support, advice and training to the patient and his family (primary caregiver). It is an innovative experience since it has been carried out for a short time. The PNV have been gradually restructured and continue to grow, since their establishment has been positively valued in the different services thanks to the experience gained and the numerous bibliographic references that demonstrate the beneficial results for the patient and the health system. A total of 356 participants have been calculated (surveys answered in more than 3 months), taking into account an approximate population of 1,172 programmed interventions carried out in 1 year, with a confidence interval of 95%, accuracy of 3% a proportion of 5% and with an expected loss of 15%. Sample: Arthralplasia of knee / hip N 480 n 92 Cystectomies N 24 n 19 Esophagogastric with coloplasty N 24 n 19 Hysterectomy N 24 n 19 Colon / rectum N 192 n 65 Lumpectomy with sentinel lymph nodes N 222 n 74 Caesarean section N 206 n 68
Official Title
-----------------
Impact of the Presurgical Visit of Nursing on the Well-being of the Patient Before a Surgical Process at the Parc Taulí Health Corporation.
Conditions
-----------------
Nurse's Role, Preoperative Care, Patient Satisfaction
Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Patients who have undergone the pre-surgical nursing visit (personalized). Patients over 18 years of age Live accompanied and / or with own resources of help. Having signed the informed consent. Exclusion Criteria: Not having signed the informed consent. Not having done the questionnaires after pre-surgical nursing visit (STAI, EQ-5D-5L) For surgical complications that do not allow the telephone survey, or focal groups.
Ages Eligible for Study
-----------------
Minimum Age: 18 Years
Sexes Eligible for Study
-----------------
All
Accepts Healthy Volunteers
-----------------
No
Study Plan
=================
How is the study designed?
-----------------
What is the study measuring?
-----------------
Primary Outcome Measures
| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| The participant is satisfied throughout the surgical process, in relation to information, health education and personalized attention to the presurgical nursing visit (PNV) | Number of participants who are satisfied with the experience of the surgical procedure and if this is what is explained in the presurgical nursing visit, for the evaluation of the importance of the visit in the surgical process. | 3 months |
Secondary Outcome Measures
| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| The participant feels well-being due to the care received by the professionals throughout the surgical process. | Number of participants who perceive welfare linked to the quality of care of the surgical process. | 3 month |
| The participant has preoperative and postoperative anxiety in more than three months, relating it to the information provided in the presurgical nursing visit. | Number of participants who perceive pre and postsurgical anxiety and if it is linked to the information provided during the visit. | 3 months |
| The participant perceives better quality of presurgical and postoperative life in more than three months; in relation to the training given during the pre-surgical nursing visit. | Number of participants who perceive an improvement in the quality of life and if it is linked to the information provided during the visit. | 3 months |
|
|||||
NCT01630967
|
Efficacy Study of Switching to a Lutenizing Hormone-releasing Hormone (LHRH) Antagonist From a LHRH Agonist to Treat Progressive Castrate Resistant Prostate Cancer (CRPC)
|
Men with castrate resistant prostate cancer who are switched from a luteinizing hormone-releasing hormone (LHRH) antagonists from a LHRH agonist will experience a fall in prostate-specific antigen (PSA).
|
To determine the proportion of patients with castrate resistant Prostate Cancer who have a PSA decline of ≥50% from baseline PSA when switched from an LHRH agonist to an LHRH antagonist.
|
A Phase II Single Arm Study of Degarelix in Men With Castrate Resistant Prostate Cancer With a Rising Prostate-Specific Antigen (PSA) Despite LHRH Agonist Therapy.
|
Prostate Neoplasm
|
* Drug: Degarelix
|
Inclusion Criteria:~histologically confirmed adenocarcinoma of the prostate~currently receiving LHRH agonist~Anti-androgen oral therapy is permitted but will be discontinued upon enrollment~PSA > 2 ng/ml~rising PSA despite LHRH agonist~patients may or may not have clinical evidence off metastases. If metastases are present, they must be asymptomatic and in bone or lymph node only~Prior chemotherapy allowed~ECOG performance status 0-1~Exclusion Criteria:~Patients with a history of other active malignancies, except: adequately treated non-melanoma skin cancer, superficial bladder cancer, or other solid tumours curatively treated with no evidence of disease for ≥ 3 years.~Other serious illness, psychiatric or medical condition that would not permit the patient to be managed according to the protocol including: i)Significant cardiovascular condition including but not limited to: uncontrolled hypertension, unstable angina, significant congestive heart failure or myocardial infarction, deep venous thrombosis, pulmonary embolus or cerebrovascular attack within the last 6 months. ii) History of significant neurological disorder that would impair the ability to obtain consent
|
18 Years
| null |
Male
|
No
|
Primary Purpose: Treatment
Intervention Model: Single Group Assignment
Masking: None (Open Label)
|
| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 50% fall in PSA | Proportion of patients with castrate resistant prostate cancer (CRPC) who have a PSA decline of ≥50% from baseline when switched from an LHRH agonist to an LHRH antagonist | 8 weekly |
|
| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Luteinizing hormone (LH) | Circulating androgen and pituitary hormones will be measured during the course of the study (8 weekly). | 8 weekly |
| Follicle stimulating hormone (FSH) | Circulating androgen and pituitary hormones will be measured during the course of the study (8 weekly). | 8 weekly |
| Testosterone (TT) | Circulating androgen and pituitary hormones will be measured during the course of the study (8 weekly). | 8 weekly |
| dehydroepiandrosterone (DHEA) | Circulating androgen and pituitary hormones will be measured during the course of the study (8 weekly). | 8 weekly |
| dehydroepiandrosterone-sulfate (DHEA-S) | Circulating androgen and pituitary hormones will be measured during the course of the study (8 weekly). | 8 weekly |
| androstenedione (AED) | Circulating androgen and pituitary hormones will be measured during the course of the study (8 weekly). | 8 weekly |
| dihydrotestosterone (DHT) | Circulating androgen and pituitary hormones will be measured during the course of the study (8 weekly). | 8 weekly |
|
castrate resistance, PSA progression, LHRH antagonism
|
Prostatic Neoplasms, Genital Neoplasms, Male, Urogenital Neoplasms, Neoplasms by Site, Neoplasms, Genital Diseases, Male, Genital Diseases, Urogenital Diseases, Prostatic Diseases, Male Urogenital Diseases
|
| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Degarelix<br>Degarelix 240mg subcutaneously loading dose, then 80mg sc every month until disease progression. | Drug: Degarelix<br>* Standard dosing and schedule for administration of degarelix will be used. 240mg s.c. loading dose, 80mg s.c. monthly maintenance dose.<br>* Other names: Firmagon;|
|
Efficacy Study of Switching to a Lutenizing Hormone-releasing Hormone (LHRH) Antagonist From a LHRH Agonist to Treat Progressive Castrate Resistant Prostate Cancer (CRPC)
Study Overview
=================
Brief Summary
-----------------
Men with castrate resistant prostate cancer who are switched from a luteinizing hormone-releasing hormone (LHRH) antagonists from a LHRH agonist will experience a fall in prostate-specific antigen (PSA).
Detailed Description
-----------------
To determine the proportion of patients with castrate resistant Prostate Cancer who have a PSA decline of ≥50% from baseline PSA when switched from an LHRH agonist to an LHRH antagonist.
Official Title
-----------------
A Phase II Single Arm Study of Degarelix in Men With Castrate Resistant Prostate Cancer With a Rising Prostate-Specific Antigen (PSA) Despite LHRH Agonist Therapy.
Conditions
-----------------
Prostate Neoplasm
Intervention / Treatment
-----------------
* Drug: Degarelix
Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: histologically confirmed adenocarcinoma of the prostate currently receiving LHRH agonist Anti-androgen oral therapy is permitted but will be discontinued upon enrollment PSA > 2 ng/ml rising PSA despite LHRH agonist patients may or may not have clinical evidence off metastases. If metastases are present, they must be asymptomatic and in bone or lymph node only Prior chemotherapy allowed ECOG performance status 0-1 Exclusion Criteria: Patients with a history of other active malignancies, except: adequately treated non-melanoma skin cancer, superficial bladder cancer, or other solid tumours curatively treated with no evidence of disease for ≥ 3 years. Other serious illness, psychiatric or medical condition that would not permit the patient to be managed according to the protocol including: i)Significant cardiovascular condition including but not limited to: uncontrolled hypertension, unstable angina, significant congestive heart failure or myocardial infarction, deep venous thrombosis, pulmonary embolus or cerebrovascular attack within the last 6 months. ii) History of significant neurological disorder that would impair the ability to obtain consent
Ages Eligible for Study
-----------------
Minimum Age: 18 Years
Sexes Eligible for Study
-----------------
Male
Accepts Healthy Volunteers
-----------------
No
Study Plan
=================
How is the study designed?
-----------------
Design Details
Primary Purpose: Treatment
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Arms and Interventions
| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Degarelix<br>Degarelix 240mg subcutaneously loading dose, then 80mg sc every month until disease progression. | Drug: Degarelix<br>* Standard dosing and schedule for administration of degarelix will be used. 240mg s.c. loading dose, 80mg s.c. monthly maintenance dose.<br>* Other names: Firmagon;|
What is the study measuring?
-----------------
Primary Outcome Measures
| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 50% fall in PSA | Proportion of patients with castrate resistant prostate cancer (CRPC) who have a PSA decline of ≥50% from baseline when switched from an LHRH agonist to an LHRH antagonist | 8 weekly |
Secondary Outcome Measures
| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Luteinizing hormone (LH) | Circulating androgen and pituitary hormones will be measured during the course of the study (8 weekly). | 8 weekly |
| Follicle stimulating hormone (FSH) | Circulating androgen and pituitary hormones will be measured during the course of the study (8 weekly). | 8 weekly |
| Testosterone (TT) | Circulating androgen and pituitary hormones will be measured during the course of the study (8 weekly). | 8 weekly |
| dehydroepiandrosterone (DHEA) | Circulating androgen and pituitary hormones will be measured during the course of the study (8 weekly). | 8 weekly |
| dehydroepiandrosterone-sulfate (DHEA-S) | Circulating androgen and pituitary hormones will be measured during the course of the study (8 weekly). | 8 weekly |
| androstenedione (AED) | Circulating androgen and pituitary hormones will be measured during the course of the study (8 weekly). | 8 weekly |
| dihydrotestosterone (DHT) | Circulating androgen and pituitary hormones will be measured during the course of the study (8 weekly). | 8 weekly |
Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
castrate resistance, PSA progression, LHRH antagonism
|
NCT00507663
|
Elder Surgery - Functional Recovery Following Beta Blockade
|
This study proposes a prospective randomized study of elders undergoing elective major abdominal surgery to assess recovery following a unique anesthetic regimen incorporating a adrenergic receptor antagonist. The purposes of this study are to:~to determine if using atenolol, a beta-blocker drug commonly used to treat high blood pressure and heart disease, as part of your anesthetic regimen will decrease complications that sometimes occur in elderly patients who are undergoing surgery and being given anesthesia.~to see if it improves or quickens your recovery from anesthesia and surgery.~to help investigators design better ways to administer anesthesia during surgery, especially in elderly patients, so that the complications and the time to recover from surgery and anesthesia can be decreased.
|
Increasing numbers of aged patients with multiple chronic diseases are undergoing major surgery. In the first third the last century, surgery was considered a desperate measure and patients greater than 50 years of age were felt incapable of sustaining the rigors of an inguinal hernia repair. Advances in anesthesia during the last century have allowed surgeons to develop an extraordinary array of procedures with excellent outcomes. Over 5.5 million patients aged 60 and over had major procedures in 1994. Centenarians routinely undergo surgical procedures.~Notwithstanding the enthusiasm for surgical treatments, morbidity, mortality, and recovery times for elderly patients are still substantially greater than for younger patients. Some morbidities, such as postoperative delirium and cognitive dysfunction appear to predominantly affect elderly patients. In a previous study, Dr. Valerie Lawrence, a co-investigator on this proposal, demonstrated that recovery from major surgery, as measured by the ability to accomplish standard activities of daily living, takes an average of 6 weeks while more complicated instrumental activities of daily living take an average of 3 months to return to baseline in elderly surgical patients. These data have profound implications for initiatives to control length of hospital stay, utilization of resources and costs of care. Evidence suggests that family members are requiring extra time off work to care for family members discharged earlier from hospitals.~Published reports and our preliminary data support the notion that intraoperative administration of adrenergic receptor antagonists (blockers) will improve functional recovery following surgery under general anesthesia. There is value in targeting functional status for elders undergoing surgery, because there is a direct relationship between functional status and utilization of health resources. Maximizing postoperative recovery, as opposed to minimizing morbidity and mortality, associated with surgical interventions in the elderly is consistent with the goal of prolonging active life expectancy expounded by Healthy People 2002.
|
Elder Surgery - Functional Recovery Following Beta Blockade
|
Post Operative Cognitive Dysfunction
|
* Drug: Atenolol
|
Inclusion Criteria:~Patients 65 years of age or older~Patients undergoing elective major abdominal surgery (including but not limited to bowel, gastric, esophageal, pancreatic, gynecologic, urologic, and major intra-abdominal vascular procedures).~Procedures requiring general anesthesia~Laparoscopic-assisted major abdominal procedures~Procedures requiring a 2-3 day postoperative stay will be included.~Exclusion Criteria:~Unable to give informed consent to participate~Folstein Mini-Mental State Examination Score < 17~Gastrostomy tube placement~Laparoscopic cholecystectomy, laparoscopic Nissen fundoplication, or any type of Hernia repair~Appendectomy~Emergency surgery~Contraindications to adrenergic antagonists (third-degree heart block, decompensated congestive heart failure, active bronchospasm)~Surgery within the previous month~Major systemic infections~Allergies to or incompatibilities with any drug used in this study~Principle language other than English or Spanish~Residence greater than 100 miles away from Manhattan~Chronic debilitated state from which significant functional improvement following surgery is not anticipated (e.g., some nursing home residents, known metastatic cancer with poor prognosis)~Chronic opioid usage~Immunosuppression (subsequent opportunistic infections may obscure postoperative recovery).
|
65 Years
| null |
All
|
No
|
Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double
|
| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Long Term Functional Recovery | self reported Activities of Daily Living (ADL) and Instrumental Activities of Daily Living (IADL). | at 3 weeks after surgery |
|
| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Timed Up and Go test | assesses basic functional mobility | preoperatively |
| Timed Up and Go test | assesses basic functional mobility | once at 7-10 days postoperatively |
| Timed Up and Go test | assesses basic functional mobility | 1 month postoperatively |
| Timed Up and Go test | assesses basic functional mobility | 3 months postoperatively |
| Timed Up and Go test | assesses basic functional mobility | 6 months postoperatively |
| Hand grip strength | performance-based measure of upper extremity strength. | preoperatively |
| Hand grip strength | performance-based measure of upper extremity strength. | once at 7-10 days postoperatively |
| Hand grip strength | performance-based measure of upper extremity strength. | 1 month postoperatively |
| Hand grip strength | performance-based measure of upper extremity strength. | 3 months postoperatively |
| Hand grip strength | performance-based measure of upper extremity strength. | 6 months postoperatively |
|
beta blocker, functional recovery
|
Atenolol, Anti-Arrhythmia Agents, Antihypertensive Agents, Sympatholytics, Autonomic Agents, Peripheral Nervous System Agents, Physiological Effects of Drugs, Adrenergic beta-1 Receptor Antagonists, Adrenergic beta-Antagonists, Adrenergic Antagonists, Adrenergic Agents, Neurotransmitter Agents, Molecular Mechanisms of Pharmacological Action
|
| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Atenolol<br>Atenolol given prior to and for up to 7 days after surgery | Drug: Atenolol<br>* Patients with a standing prescription for β-blockers will be continued on that medication. Pts not currently receiving a beta blocker will be given 50mg of atenolol on the morning of surgery, 50-100mg, twice per day, on the first postoperative day until postoperative day 7.<br>* Other names: Tenormin;|
| No Intervention: routine care<br>routine clinical care | |
|
Elder Surgery - Functional Recovery Following Beta Blockade
Study Overview
=================
Brief Summary
-----------------
This study proposes a prospective randomized study of elders undergoing elective major abdominal surgery to assess recovery following a unique anesthetic regimen incorporating a adrenergic receptor antagonist. The purposes of this study are to: to determine if using atenolol, a beta-blocker drug commonly used to treat high blood pressure and heart disease, as part of your anesthetic regimen will decrease complications that sometimes occur in elderly patients who are undergoing surgery and being given anesthesia. to see if it improves or quickens your recovery from anesthesia and surgery. to help investigators design better ways to administer anesthesia during surgery, especially in elderly patients, so that the complications and the time to recover from surgery and anesthesia can be decreased.
Detailed Description
-----------------
Increasing numbers of aged patients with multiple chronic diseases are undergoing major surgery. In the first third the last century, surgery was considered a desperate measure and patients greater than 50 years of age were felt incapable of sustaining the rigors of an inguinal hernia repair. Advances in anesthesia during the last century have allowed surgeons to develop an extraordinary array of procedures with excellent outcomes. Over 5.5 million patients aged 60 and over had major procedures in 1994. Centenarians routinely undergo surgical procedures. Notwithstanding the enthusiasm for surgical treatments, morbidity, mortality, and recovery times for elderly patients are still substantially greater than for younger patients. Some morbidities, such as postoperative delirium and cognitive dysfunction appear to predominantly affect elderly patients. In a previous study, Dr. Valerie Lawrence, a co-investigator on this proposal, demonstrated that recovery from major surgery, as measured by the ability to accomplish standard activities of daily living, takes an average of 6 weeks while more complicated instrumental activities of daily living take an average of 3 months to return to baseline in elderly surgical patients. These data have profound implications for initiatives to control length of hospital stay, utilization of resources and costs of care. Evidence suggests that family members are requiring extra time off work to care for family members discharged earlier from hospitals. Published reports and our preliminary data support the notion that intraoperative administration of adrenergic receptor antagonists (blockers) will improve functional recovery following surgery under general anesthesia. There is value in targeting functional status for elders undergoing surgery, because there is a direct relationship between functional status and utilization of health resources. Maximizing postoperative recovery, as opposed to minimizing morbidity and mortality, associated with surgical interventions in the elderly is consistent with the goal of prolonging active life expectancy expounded by Healthy People 2002.
Official Title
-----------------
Elder Surgery - Functional Recovery Following Beta Blockade
Conditions
-----------------
Post Operative Cognitive Dysfunction
Intervention / Treatment
-----------------
* Drug: Atenolol
Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Patients 65 years of age or older Patients undergoing elective major abdominal surgery (including but not limited to bowel, gastric, esophageal, pancreatic, gynecologic, urologic, and major intra-abdominal vascular procedures). Procedures requiring general anesthesia Laparoscopic-assisted major abdominal procedures Procedures requiring a 2-3 day postoperative stay will be included. Exclusion Criteria: Unable to give informed consent to participate Folstein Mini-Mental State Examination Score < 17 Gastrostomy tube placement Laparoscopic cholecystectomy, laparoscopic Nissen fundoplication, or any type of Hernia repair Appendectomy Emergency surgery Contraindications to adrenergic antagonists (third-degree heart block, decompensated congestive heart failure, active bronchospasm) Surgery within the previous month Major systemic infections Allergies to or incompatibilities with any drug used in this study Principle language other than English or Spanish Residence greater than 100 miles away from Manhattan Chronic debilitated state from which significant functional improvement following surgery is not anticipated (e.g., some nursing home residents, known metastatic cancer with poor prognosis) Chronic opioid usage Immunosuppression (subsequent opportunistic infections may obscure postoperative recovery).
Ages Eligible for Study
-----------------
Minimum Age: 65 Years
Sexes Eligible for Study
-----------------
All
Accepts Healthy Volunteers
-----------------
No
Study Plan
=================
How is the study designed?
-----------------
Design Details
Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double
Arms and Interventions
| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Atenolol<br>Atenolol given prior to and for up to 7 days after surgery | Drug: Atenolol<br>* Patients with a standing prescription for β-blockers will be continued on that medication. Pts not currently receiving a beta blocker will be given 50mg of atenolol on the morning of surgery, 50-100mg, twice per day, on the first postoperative day until postoperative day 7.<br>* Other names: Tenormin;|
| No Intervention: routine care<br>routine clinical care | |
What is the study measuring?
-----------------
Primary Outcome Measures
| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Long Term Functional Recovery | self reported Activities of Daily Living (ADL) and Instrumental Activities of Daily Living (IADL). | at 3 weeks after surgery |
Secondary Outcome Measures
| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Timed Up and Go test | assesses basic functional mobility | preoperatively |
| Timed Up and Go test | assesses basic functional mobility | once at 7-10 days postoperatively |
| Timed Up and Go test | assesses basic functional mobility | 1 month postoperatively |
| Timed Up and Go test | assesses basic functional mobility | 3 months postoperatively |
| Timed Up and Go test | assesses basic functional mobility | 6 months postoperatively |
| Hand grip strength | performance-based measure of upper extremity strength. | preoperatively |
| Hand grip strength | performance-based measure of upper extremity strength. | once at 7-10 days postoperatively |
| Hand grip strength | performance-based measure of upper extremity strength. | 1 month postoperatively |
| Hand grip strength | performance-based measure of upper extremity strength. | 3 months postoperatively |
| Hand grip strength | performance-based measure of upper extremity strength. | 6 months postoperatively |
Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
beta blocker, functional recovery
|
NCT00020397
|
Vaccine Therapy in Treating Patients With Refractory Metastatic Melanoma
|
RATIONALE: Vaccines may make the body build an immune response to kill tumor cells.~PURPOSE: Randomized phase II trial to study the effectiveness of vaccine therapy in treating patients who have refractory metastatic melanoma.
|
OBJECTIVES:~Determine whether an immunologic response can be obtained after administration of ESO-1 peptide vaccine comprising class I , II, or both peptides in HLA-A*201 or HLA-DPB1*04 positive patients with refractory metastatic melanoma expressing ESO-1.~Determine the toxicity of this vaccine in these patients.~Determine whether prior immunization with this vaccine results in increased clinical responsiveness in patients treated with interleukin-2.~OUTLINE: Patients are assigned to 1 of 3 groups according to HLA type.~Group 1 (HLA-A*201 and HLA-DPB1*04 positive): Patients receive ESO-1 peptide vaccine comprising class I (ESO-1:157-165 [165V]) and class II (ESO-1:161-180) peptides subcutaneously once every 3 weeks for 4 courses in the absence of disease progression or unacceptable toxicity.~Group 2 (HLA-A*201 positive and HLA-DPB1*04 negative):Patients receive ESO-1 peptide vaccine as in group I comprising class I peptide only.~Group 3 (HLA-A*201 negative and HLA-DPB1*04 positive):Patients receive ESO-1 peptide vaccine as in group I comprising class II peptide only.~Patients who develop disease progression discontinue vaccinations and receive high-dose interleukin (IL-2) IV over 15 minutes every 8 hours for up to 4 days (maximum of 12 doses). Treatment with IL-2 repeats every 10-14 days for 4 courses in the absence of disease progression (after at least 2 courses) or unacceptable toxicity.~Patients who have stable disease or a mixed or partial response to vaccination or IL-2 therapy may be eligible for additional vaccine therapy. Patients who have a complete response to vaccine therapy are eligible for 1 additional treatment.~Patients are followed at 3 weeks.~PROJECTED ACCRUAL: A total of 45-90 patients (15-30 per treatment group) will be accrued for this study within 1 year.
|
Immunization Of HLA-A*0201 or HLA-DPB1*04 Patients With Metastatic Melanoma Using Epitopes From The ESO-1 Antigen
|
Melanoma (Skin)
|
* Biological: NY-ESO-1 peptide vaccine
* Biological: aldesleukin
|
DISEASE CHARACTERISTICS:~Diagnosis of metastatic melanoma that expresses ESO-1 antigen~Must have progressed during prior standard treatment~Measurable or evaluable disease~HLA-A*201 or HLA-DPB1*04 positive~PATIENT CHARACTERISTICS:~Age:~16 and over~Performance status:~ECOG 0-2~Life expectancy:~More than 3 months~Hematopoietic:~WBC at least 3,000/mm^3~Platelet count at least 90,000/mm^3~Hepatic:~SGOT and SGPT less than 3 times normal~Bilirubin no greater than 1.6 mg/dL (3.0 mg/dL for patients with Gilbert's syndrome)~Hepatitis B surface antigen negative~Renal:~Creatinine no greater than 2.0 mg/dL~Cardiovascular:~No cardiac ischemia*~No myocardial infarction*~No cardiac arrhythmias* NOTE: *For interleukin-2 (IL-2) administration~Pulmonary:~No obstructive or restrictive pulmonary disease (for IL-2 administration)~Immunologic:~No autoimmune disease~No active primary or secondary immunodeficiency~HIV negative~No active systemic infections~Other:~Not pregnant~Negative pregnancy test~Fertile patients must use effective contraception~No other active major medical illness (for IL-2 administration)~PRIOR CONCURRENT THERAPY:~Biologic therapy:~No prior ESO-1 immunization~Chemotherapy:~Recovered from any prior chemotherapy~Endocrine therapy:~No concurrent systemic steroid therapy~Radiotherapy:~Recovered from any prior radiotherapy~Surgery:~Not specified~Other:~At least 3 weeks since any prior systemic therapy for cancer~No other concurrent systemic therapy for cancer
|
16 Years
| null |
All
|
No
|
Primary Purpose: Treatment
Masking: None (Open Label)
|
| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
|
recurrent melanoma, stage IV melanoma
|
Aldesleukin, Antineoplastic Agents, Anti-HIV Agents, Anti-Retroviral Agents, Antiviral Agents, Anti-Infective Agents
|
| Intervention/Treatment |
| --- |
|Biological: NY-ESO-1 peptide vaccine|nan|
|Biological: aldesleukin|nan|
|
Vaccine Therapy in Treating Patients With Refractory Metastatic Melanoma
Study Overview
=================
Brief Summary
-----------------
RATIONALE: Vaccines may make the body build an immune response to kill tumor cells. PURPOSE: Randomized phase II trial to study the effectiveness of vaccine therapy in treating patients who have refractory metastatic melanoma.
Detailed Description
-----------------
OBJECTIVES: Determine whether an immunologic response can be obtained after administration of ESO-1 peptide vaccine comprising class I , II, or both peptides in HLA-A*201 or HLA-DPB1*04 positive patients with refractory metastatic melanoma expressing ESO-1. Determine the toxicity of this vaccine in these patients. Determine whether prior immunization with this vaccine results in increased clinical responsiveness in patients treated with interleukin-2. OUTLINE: Patients are assigned to 1 of 3 groups according to HLA type. Group 1 (HLA-A*201 and HLA-DPB1*04 positive): Patients receive ESO-1 peptide vaccine comprising class I (ESO-1:157-165 [165V]) and class II (ESO-1:161-180) peptides subcutaneously once every 3 weeks for 4 courses in the absence of disease progression or unacceptable toxicity. Group 2 (HLA-A*201 positive and HLA-DPB1*04 negative):Patients receive ESO-1 peptide vaccine as in group I comprising class I peptide only. Group 3 (HLA-A*201 negative and HLA-DPB1*04 positive):Patients receive ESO-1 peptide vaccine as in group I comprising class II peptide only. Patients who develop disease progression discontinue vaccinations and receive high-dose interleukin (IL-2) IV over 15 minutes every 8 hours for up to 4 days (maximum of 12 doses). Treatment with IL-2 repeats every 10-14 days for 4 courses in the absence of disease progression (after at least 2 courses) or unacceptable toxicity. Patients who have stable disease or a mixed or partial response to vaccination or IL-2 therapy may be eligible for additional vaccine therapy. Patients who have a complete response to vaccine therapy are eligible for 1 additional treatment. Patients are followed at 3 weeks. PROJECTED ACCRUAL: A total of 45-90 patients (15-30 per treatment group) will be accrued for this study within 1 year.
Official Title
-----------------
Immunization Of HLA-A*0201 or HLA-DPB1*04 Patients With Metastatic Melanoma Using Epitopes From The ESO-1 Antigen
Conditions
-----------------
Melanoma (Skin)
Intervention / Treatment
-----------------
* Biological: NY-ESO-1 peptide vaccine
* Biological: aldesleukin
Participation Criteria
=================
Eligibility Criteria
-----------------
DISEASE CHARACTERISTICS: Diagnosis of metastatic melanoma that expresses ESO-1 antigen Must have progressed during prior standard treatment Measurable or evaluable disease HLA-A*201 or HLA-DPB1*04 positive PATIENT CHARACTERISTICS: Age: 16 and over Performance status: ECOG 0-2 Life expectancy: More than 3 months Hematopoietic: WBC at least 3,000/mm^3 Platelet count at least 90,000/mm^3 Hepatic: SGOT and SGPT less than 3 times normal Bilirubin no greater than 1.6 mg/dL (3.0 mg/dL for patients with Gilbert's syndrome) Hepatitis B surface antigen negative Renal: Creatinine no greater than 2.0 mg/dL Cardiovascular: No cardiac ischemia* No myocardial infarction* No cardiac arrhythmias* NOTE: *For interleukin-2 (IL-2) administration Pulmonary: No obstructive or restrictive pulmonary disease (for IL-2 administration) Immunologic: No autoimmune disease No active primary or secondary immunodeficiency HIV negative No active systemic infections Other: Not pregnant Negative pregnancy test Fertile patients must use effective contraception No other active major medical illness (for IL-2 administration) PRIOR CONCURRENT THERAPY: Biologic therapy: No prior ESO-1 immunization Chemotherapy: Recovered from any prior chemotherapy Endocrine therapy: No concurrent systemic steroid therapy Radiotherapy: Recovered from any prior radiotherapy Surgery: Not specified Other: At least 3 weeks since any prior systemic therapy for cancer No other concurrent systemic therapy for cancer
Ages Eligible for Study
-----------------
Minimum Age: 16 Years
Sexes Eligible for Study
-----------------
All
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 |
| --- |
|Biological: NY-ESO-1 peptide vaccine|nan|
|Biological: aldesleukin|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
-----------------
recurrent melanoma, stage IV melanoma
|
|
NCT01557751
|
Acute Pain Genomic Study
|
In preparation for future large-scale genome wide association studies, reliable methods must be developed for measuring perceived pain and for estimating the effects of potentially confounding factors such as appropriate covariates. The major objectives of our pilot investigation are to develop optimal methods to characterize the primary endpoint of the study-knee pain, and to gather preliminary data on genetic markers in the human genome that are associated with a certain pain phenotype. The specific issues for this study will be to carry out a preliminary gene association analysis of acute perioperative pain in individuals undergoing total knee replacement and to define a pain phenotype that is composed of multidimensional domains such as opioid consumption, inflammatory markers, anxiety level, degree of catastrophizing, etc. This pain phenotype has to be sensitive enough to pick up changes in pain experience that can be attributed to single nucleotide polymorphisms.
|
In spite of advances in postoperative management and the standardization of postoperative care, there is a wide variability in the degree of pain relief achieved which cannot be accounted for. The aim of this study is to devise a method for defining a pain phenotype sensitive enough to detect differences in genetic makeup between individuals who undergo a standard surgical procedure (total knee replacement). This methodology will serve as a pilot study for future genome wide association studies. Given the multidimensional aspects of pain experience, the phenotype will be combined of various dimensions comprising postoperative pain. Reports about single nucleotide polymorphisms (SNPs), which account for some of the variability of pain, have been reported in the literature using different pain models. To test the sensitivity of our method of phenotyping, the investigators aim to determine if variability in our clinical phenotypes can be explained by some of the SNPs published in the literature. Patients scheduled for elective unilateral primary total knee arthroplasty will be asked to report on various clinical pain variables, fill psychometric questionnaires, be subjected to quantitative sensory testing, genotyped for a genes associated with pain, and additional SNPs. A composite pain profile will be composed for each patient initially examining five candidate genes and related SNPs to find out the SNPs that are significantly associated with given pain phenotypes. Samples will be banked for future study of other genes associated with pain. Other clinical variables will be collected (e.g. opioid consumption). At six and twelve months, psychological questionnaires and pain questionnaires will be sent to patient. A model using pain during physical therapy as the dependent variable will be fit to the data. Knee joint fluid, urine, and serum will be collected from approximately 30% of the subjects who provide their additional consent cytokine and other inflammatory marker analysis. All biological specimens will be banked for future analysis. This is a pilot, preliminary study which will assess patients prospectively and attempt to correlate markers on genes and single nucleotide polymorphisms with patient phenotypes. This method which will serve as the foundation for a future genome wide association study of pain. This is a preliminary, developmental, prospective follow-up study to develop a tool that will be sensitive and specific enough to be used in a large-scale candidate genome association pain study.
|
Preliminary Studies for Whole Genome Association Study (WGAS) in Acute Perioperative Pain
|
Osteoarthritis, Postoperative Pain
|
* Genetic: Whole blood for genotyping
|
Inclusion Criteria:~Age >18~Undergoing a primary, unilateral total knee arthroplasty for the first time~Willing and able to provide informed consent~Caucasian~Non-hispanic~Exclusion Criteria:~Contraindication or refusal for peripheral nerve blocks~Any chronic pain condition which may confound the study per investigator's opinion~Chronic opioid dependence per investigator's opinion~Any diagnosis for total knee arthroplasty other than degenerative joint disease or osteoarthritis~Evidence of clinical dementia, dementia, delirium, or any cognitive disorder which inhibits the subject's ability to comprehend and cooperate with researchers~Revision or any knee surgery that is not a primary, unilateral, elective total knee arthroplasty being performed for the first time~Any criteria that in the investigator's opinion would prohibit the subject from following~Hispanic ethnicity~Any race other than caucasian~Subjects with knee flexion contracture (which is clinically defined for the purpose of our protocol as more than 15 degrees of knee contracture)~Pregnancy
|
18 Years
| null |
All
|
No
|
Primary Purpose: Diagnostic
Intervention Model: Single Group Assignment
Masking: None (Open Label)
|
| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| NRS-Pain With Movement on POD 2 | The primary endpoint is the pain reported by subjects, using the NRS-Pain with movement on the second day after surgery.The assumption behind this study is that certain genetic variants (e.g. single-nucleotide polymorphism (SNP) are responsible for part of total variation of certain clinical phenotypes (e.g. post-operative pain here).~Numeric Rating Score Pain Assessment (0-10 scale where 0 indicates no pain at all and 10 indicates the worst pain imaginable) on Post Op Day 2, Pain with Movement | Postoperative day (POD) 2 |
|
Total knee arthroplasty, Total knee replacement, Genetics of pain
|
Osteoarthritis, Pain, Postoperative, Arthritis, Joint Diseases, Musculoskeletal Diseases, Rheumatic Diseases, Postoperative Complications, Pathologic Processes, Pain, Neurologic Manifestations
|
| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Other: Total knee arthroplasty subjects who are genotyped<br>All patients will have whole blood drawn for genotyping, and participate in the various assessments (psychosocial questionnaires, qualitative sensory testing, etc). | Genetic: Whole blood for genotyping<br>* This study requires genotyping by extracting DNA from blood sample. A blood sample will be drawn once during visit 2 (day of surgery) or any other time prior to that after the signing of informed consent. Four vacutainers of which hold 8.5 mL will be drawn during this time totaling approximately 34 mL of blood which completes the genomic sampling portion of the study.<br>|
|
Acute Pain Genomic Study
Study Overview
=================
Brief Summary
-----------------
In preparation for future large-scale genome wide association studies, reliable methods must be developed for measuring perceived pain and for estimating the effects of potentially confounding factors such as appropriate covariates. The major objectives of our pilot investigation are to develop optimal methods to characterize the primary endpoint of the study-knee pain, and to gather preliminary data on genetic markers in the human genome that are associated with a certain pain phenotype. The specific issues for this study will be to carry out a preliminary gene association analysis of acute perioperative pain in individuals undergoing total knee replacement and to define a pain phenotype that is composed of multidimensional domains such as opioid consumption, inflammatory markers, anxiety level, degree of catastrophizing, etc. This pain phenotype has to be sensitive enough to pick up changes in pain experience that can be attributed to single nucleotide polymorphisms.
Detailed Description
-----------------
In spite of advances in postoperative management and the standardization of postoperative care, there is a wide variability in the degree of pain relief achieved which cannot be accounted for. The aim of this study is to devise a method for defining a pain phenotype sensitive enough to detect differences in genetic makeup between individuals who undergo a standard surgical procedure (total knee replacement). This methodology will serve as a pilot study for future genome wide association studies. Given the multidimensional aspects of pain experience, the phenotype will be combined of various dimensions comprising postoperative pain. Reports about single nucleotide polymorphisms (SNPs), which account for some of the variability of pain, have been reported in the literature using different pain models. To test the sensitivity of our method of phenotyping, the investigators aim to determine if variability in our clinical phenotypes can be explained by some of the SNPs published in the literature. Patients scheduled for elective unilateral primary total knee arthroplasty will be asked to report on various clinical pain variables, fill psychometric questionnaires, be subjected to quantitative sensory testing, genotyped for a genes associated with pain, and additional SNPs. A composite pain profile will be composed for each patient initially examining five candidate genes and related SNPs to find out the SNPs that are significantly associated with given pain phenotypes. Samples will be banked for future study of other genes associated with pain. Other clinical variables will be collected (e.g. opioid consumption). At six and twelve months, psychological questionnaires and pain questionnaires will be sent to patient. A model using pain during physical therapy as the dependent variable will be fit to the data. Knee joint fluid, urine, and serum will be collected from approximately 30% of the subjects who provide their additional consent cytokine and other inflammatory marker analysis. All biological specimens will be banked for future analysis. This is a pilot, preliminary study which will assess patients prospectively and attempt to correlate markers on genes and single nucleotide polymorphisms with patient phenotypes. This method which will serve as the foundation for a future genome wide association study of pain. This is a preliminary, developmental, prospective follow-up study to develop a tool that will be sensitive and specific enough to be used in a large-scale candidate genome association pain study.
Official Title
-----------------
Preliminary Studies for Whole Genome Association Study (WGAS) in Acute Perioperative Pain
Conditions
-----------------
Osteoarthritis, Postoperative Pain
Intervention / Treatment
-----------------
* Genetic: Whole blood for genotyping
Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Age >18 Undergoing a primary, unilateral total knee arthroplasty for the first time Willing and able to provide informed consent Caucasian Non-hispanic Exclusion Criteria: Contraindication or refusal for peripheral nerve blocks Any chronic pain condition which may confound the study per investigator's opinion Chronic opioid dependence per investigator's opinion Any diagnosis for total knee arthroplasty other than degenerative joint disease or osteoarthritis Evidence of clinical dementia, dementia, delirium, or any cognitive disorder which inhibits the subject's ability to comprehend and cooperate with researchers Revision or any knee surgery that is not a primary, unilateral, elective total knee arthroplasty being performed for the first time Any criteria that in the investigator's opinion would prohibit the subject from following Hispanic ethnicity Any race other than caucasian Subjects with knee flexion contracture (which is clinically defined for the purpose of our protocol as more than 15 degrees of knee contracture) Pregnancy
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: Total knee arthroplasty subjects who are genotyped<br>All patients will have whole blood drawn for genotyping, and participate in the various assessments (psychosocial questionnaires, qualitative sensory testing, etc). | Genetic: Whole blood for genotyping<br>* This study requires genotyping by extracting DNA from blood sample. A blood sample will be drawn once during visit 2 (day of surgery) or any other time prior to that after the signing of informed consent. Four vacutainers of which hold 8.5 mL will be drawn during this time totaling approximately 34 mL of blood which completes the genomic sampling portion of the study.<br>|
What is the study measuring?
-----------------
Primary Outcome Measures
| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| NRS-Pain With Movement on POD 2 | The primary endpoint is the pain reported by subjects, using the NRS-Pain with movement on the second day after surgery.The assumption behind this study is that certain genetic variants (e.g. single-nucleotide polymorphism (SNP) are responsible for part of total variation of certain clinical phenotypes (e.g. post-operative pain here). Numeric Rating Score Pain Assessment (0-10 scale where 0 indicates no pain at all and 10 indicates the worst pain imaginable) on Post Op Day 2, Pain with Movement | Postoperative day (POD) 2 |
Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Total knee arthroplasty, Total knee replacement, Genetics of pain
|
|
NCT00598819
|
A Prospective Study of a New Device for Monitoring Cerebral Oxygenation on Healthy Volunteers
|
The purpose of this study is to determine whether a new cerebral oxygen monitoring device is effective and comparatively similar to the current approved devices.
|
Cerebral oxygenation monitoring is an innovative way to monitoring cardiac surgery patients intraoperatively to reduce the incidence of postoperative hypoxic side effects. There are a number of approved devices already in the market that have proved their effectivity.
|
A Prospective Study With a New Device for the Monitoring of Cerebral Oxygenation on Healthy Volunteers
|
Cerebral Ischemia
|
* Device: CDI 1000 COM
|
INCLUSION CRITERIA:~Healthy male or Female Volunteers~18 years old or older~Capable and willing to operate a bicycle~Understand enough about the risks and benefits of the study to be able to make an informed decision before agreeing to be in the study~EXLUSION CRITERIA:~History of Cerebrovascular Disease~History of Skin Problems on Forehead (Skin Rashes, Acne, Allergies, etc.)~Pregnancy
|
18 Years
| null |
All
|
Accepts Healthy Volunteers
|
Primary Purpose: Diagnostic
Intervention Model: Single Group Assignment
Masking: None (Open Label)
|
| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Harm to Skin From Attachment of Sensor to Forehead: Cuts, Bruising, Rash or Allergic Reactions to Adhesive. | Measurement of reactions to the sensor's attachment to the skin on the forehead. Measurement of the outcome is either reaction or no reaction. This means that all subjects are either measured as having a reaction at all or having no reaction at all. Measurement and reactions assessment performed by the investigator. | attachment of sensor to 24 hours post-removal |
| Overheating of Skin Underneath Sensor. | The Principal measure for this outcome was discomfort and potential harm from overheating while attached to an active study participant. The investigator of the study asked to the participant if he/she felt:~• Discomfort in the sensor application zone; Itching, Burning sensation and/or Pain. The skin was examined before and after the sensor application. All the assessments were performed by the principal investigator of the study. | placement of sensor to 10 minutes post-removal. |
| Overheating of Skin Underneath Sensor | The Principal measure for this outcome was discomfort and potential harm from overheating while attached to an active study participant. The investigator of the study asked to the participant if he/she felt:~• Discomfort in the sensor application zone; Itching, Burning sensation and/or Pain. The skin was examined before and after the sensor application. All the assessments were performed by the principal investigator of the study. | placement of sensor to immediately post-removal |
|
| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Sensor Fits Well on Subjects Forehead | How well the sensor seems to fit on the subject's forehead in terms of curvature, comfort and adherence. The fitting assessment was assessed visually and determined based in the size of the sensor and the length of forehead covered, also the adhesion test was performed by hanging weight of 2 LBS on the sensor for 10 min, recording if the sensor kept attached to the skin or not. All tests and measures were assessed by the investigator. All the characteristics of the sensor (curvature, comfort and adherence) were recorded on each subjects as yes or no. | placement of sensor to end of study observation |
| Sensor Attachment Under Stress | The Principal measure for this outcome was discomfort and potential harm from overheating while attached to an active study participant. The investigator of the study asked to the participant if he/she felt:~• Discomfort in the sensor application zone; Itching, Burning sensation and/or Pain. The skin was examined before and after the sensor application. All the assessments were performed by the principal investigator of the study. | addition of stress on sensor to removal. |
|
Cerebral Oxygenation, Oxygen Monitoring
|
Brain Ischemia, Cerebral Infarction, Ischemia, Pathologic Processes, Cerebrovascular Disorders, Brain Diseases, Central Nervous System Diseases, Nervous System Diseases, Vascular Diseases, Cardiovascular Diseases, Brain Infarction, Stroke, Infarction, Necrosis
|
| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Healthy Volunteers<br>Healthy subjects testing the device. | Device: CDI 1000 COM<br>* CDI 1000 COM sensors were attached to subject's forehead for a 12 hour period.<br>* Other names: Terumo CDI 1000 COM;|
|
A Prospective Study of a New Device for Monitoring Cerebral Oxygenation on Healthy Volunteers
Study Overview
=================
Brief Summary
-----------------
The purpose of this study is to determine whether a new cerebral oxygen monitoring device is effective and comparatively similar to the current approved devices.
Detailed Description
-----------------
Cerebral oxygenation monitoring is an innovative way to monitoring cardiac surgery patients intraoperatively to reduce the incidence of postoperative hypoxic side effects. There are a number of approved devices already in the market that have proved their effectivity.
Official Title
-----------------
A Prospective Study With a New Device for the Monitoring of Cerebral Oxygenation on Healthy Volunteers
Conditions
-----------------
Cerebral Ischemia
Intervention / Treatment
-----------------
* Device: CDI 1000 COM
Participation Criteria
=================
Eligibility Criteria
-----------------
INCLUSION CRITERIA: Healthy male or Female Volunteers 18 years old or older Capable and willing to operate a bicycle Understand enough about the risks and benefits of the study to be able to make an informed decision before agreeing to be in the study EXLUSION CRITERIA: History of Cerebrovascular Disease History of Skin Problems on Forehead (Skin Rashes, Acne, Allergies, etc.) Pregnancy
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: Diagnostic
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Arms and Interventions
| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Healthy Volunteers<br>Healthy subjects testing the device. | Device: CDI 1000 COM<br>* CDI 1000 COM sensors were attached to subject's forehead for a 12 hour period.<br>* Other names: Terumo CDI 1000 COM;|
What is the study measuring?
-----------------
Primary Outcome Measures
| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Harm to Skin From Attachment of Sensor to Forehead: Cuts, Bruising, Rash or Allergic Reactions to Adhesive. | Measurement of reactions to the sensor's attachment to the skin on the forehead. Measurement of the outcome is either reaction or no reaction. This means that all subjects are either measured as having a reaction at all or having no reaction at all. Measurement and reactions assessment performed by the investigator. | attachment of sensor to 24 hours post-removal |
| Overheating of Skin Underneath Sensor. | The Principal measure for this outcome was discomfort and potential harm from overheating while attached to an active study participant. The investigator of the study asked to the participant if he/she felt: • Discomfort in the sensor application zone; Itching, Burning sensation and/or Pain. The skin was examined before and after the sensor application. All the assessments were performed by the principal investigator of the study. | placement of sensor to 10 minutes post-removal. |
| Overheating of Skin Underneath Sensor | The Principal measure for this outcome was discomfort and potential harm from overheating while attached to an active study participant. The investigator of the study asked to the participant if he/she felt: • Discomfort in the sensor application zone; Itching, Burning sensation and/or Pain. The skin was examined before and after the sensor application. All the assessments were performed by the principal investigator of the study. | placement of sensor to immediately post-removal |
Secondary Outcome Measures
| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Sensor Fits Well on Subjects Forehead | How well the sensor seems to fit on the subject's forehead in terms of curvature, comfort and adherence. The fitting assessment was assessed visually and determined based in the size of the sensor and the length of forehead covered, also the adhesion test was performed by hanging weight of 2 LBS on the sensor for 10 min, recording if the sensor kept attached to the skin or not. All tests and measures were assessed by the investigator. All the characteristics of the sensor (curvature, comfort and adherence) were recorded on each subjects as yes or no. | placement of sensor to end of study observation |
| Sensor Attachment Under Stress | The Principal measure for this outcome was discomfort and potential harm from overheating while attached to an active study participant. The investigator of the study asked to the participant if he/she felt: • Discomfort in the sensor application zone; Itching, Burning sensation and/or Pain. The skin was examined before and after the sensor application. All the assessments were performed by the principal investigator of the study. | addition of stress on sensor to removal. |
Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Cerebral Oxygenation, Oxygen Monitoring
|
NCT04208126
|
Early Versus Late Initiation of ECMO (Extracorporal Membrane Oxygenation) Trial (ELIEO-Trial)
|
This trial is a prospective randomized multicenter trial that assigns patients to either a treatment for Acute Respiratory Distress Syndrome (ARDS) with an Extracorporal Membrane Oxygenation (ECMO) immediately after admission to the intensive care unit or conservative treatment. The later can undergo ECMO following failure of conservative therapy as a rescue therapy. Patients will be included within 96h of the onset of symptoms of ARDS and will be randomized according to standard procedure. Follow-up will be performed until hospital discharge.
|
Patients suffering acute ARDS defined according to the Berlin Definition starting from severe stage with acute onset and (i) ratio partial arterial pressure of oxygen fraction of inspired oxygen inspired oxygen fraction (PaO2/ FiO2) ≤ 200 (ii) Bilateral opacities consistent with pulmonary edema on frontal chest radiograph, and (iii) requirement for positive pressure ventilation via an endotracheal tube or non-invasive ventilation (iv) no clinical evidence of left atrial hypertension, or if measured, a Pulmonary Arterial Wedge Pressure (PAOP) less than or equal to 18 mm Hg will be treated by ECMO either within 24 hours to referral to an ARDS ECMO center or as rescue therapy after failure of conventional therapy.~Outcome measures have been chosen according to robustness and sensitivity to change. They are of high clinical impact and reflect the treatment effect desired by clinicians. Primary efficacy endpoint: All cause mortality by 28-days. Key secondary endpoints are: 1) 90 day all cause mortality 3) ICU length of stay 4) duration of mechanical ventilation support 5) frequency and duration of renal replacement therapy 6) bleeding requiring transfusions in the ICU 7) SOFA score
|
Early Versus Late Initiation of ECMO Trial (ELIEO-Trial)
|
Acute Respiratory Distress Syndrome
|
* Device: ECMO
|
Inclusion Criteria:~ARDS as defined according to the Berlin Definition1~The term acute onset is defined as follow: the duration of the hypoxemia criterion and the chest radiograph criterion must be ≤ 7 days at the time of randomization.~Patients must be enrolled within 96 hours of onset of ARDS and no later than 7 days from the initiation of mechanical ventilation.~Exclusion Criteria:~Age less than 18 years~More than 7 days since initiation of mechanical ventilation~more than 96 hours since meeting inclusion criteria~patient, surrogate or physician not committed to full intensive care support~pregnancy
|
18 Years
| null |
All
|
No
|
Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Interventional Model Description: This trial is a prospective randomized multicenter trial that assigns patients to either a treatment for ARDS with an ECMO immediately after admission to the intensive care unit or conservative treatment.
Masking: Single
|
| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 28 day all cause mortality | 28 day all cause mortality | 28 day after study inclusion |
| 90 day all cause mortality | 90 day all cause mortality | 90 day after study inclusion |
|
| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Sepsis-related organ failure assessment score (SOFA) Organ Failure Scores | SOFA Organ Failure Scores | 1-14, 28 and 90 days after study inclusion |
| Delirium | Occurence of Delirium (positive Confusion Assessment Method for the Intensive Care Unit (CAM-ICU)) | 28 and 90 day after discharge of ICU |
| discharge location | discharge location: a) home, b) skilled nursing facility, c) rehabilitation unit | 28 and 90 day after discharge of ICU |
|
Acute Respiratory Distress Syndrome, Extracorporal membrane Oxygenation, Outcome, Ventilation Therapy, QOL
|
Respiratory Distress Syndrome, Respiratory Distress Syndrome, Newborn, Acute Lung Injury, Lung Diseases, Respiratory Tract Diseases, Respiration Disorders, Infant, Premature, Diseases, Infant, Newborn, Diseases, Lung Injury
|
| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: Early ECMO<br>ECMO is placed immediately after admission to the intensive care unit | Device: ECMO<br>* ECMO implantation immediately after ICU admission<br>|
| No Intervention: Control<br>Conservative therapy unless failure of therapy. | |
|
Early Versus Late Initiation of ECMO (Extracorporal Membrane Oxygenation) Trial (ELIEO-Trial)
Study Overview
=================
Brief Summary
-----------------
This trial is a prospective randomized multicenter trial that assigns patients to either a treatment for Acute Respiratory Distress Syndrome (ARDS) with an Extracorporal Membrane Oxygenation (ECMO) immediately after admission to the intensive care unit or conservative treatment. The later can undergo ECMO following failure of conservative therapy as a rescue therapy. Patients will be included within 96h of the onset of symptoms of ARDS and will be randomized according to standard procedure. Follow-up will be performed until hospital discharge.
Detailed Description
-----------------
Patients suffering acute ARDS defined according to the Berlin Definition starting from severe stage with acute onset and (i) ratio partial arterial pressure of oxygen fraction of inspired oxygen inspired oxygen fraction (PaO2/ FiO2) ≤ 200 (ii) Bilateral opacities consistent with pulmonary edema on frontal chest radiograph, and (iii) requirement for positive pressure ventilation via an endotracheal tube or non-invasive ventilation (iv) no clinical evidence of left atrial hypertension, or if measured, a Pulmonary Arterial Wedge Pressure (PAOP) less than or equal to 18 mm Hg will be treated by ECMO either within 24 hours to referral to an ARDS ECMO center or as rescue therapy after failure of conventional therapy. Outcome measures have been chosen according to robustness and sensitivity to change. They are of high clinical impact and reflect the treatment effect desired by clinicians. Primary efficacy endpoint: All cause mortality by 28-days. Key secondary endpoints are: 1) 90 day all cause mortality 3) ICU length of stay 4) duration of mechanical ventilation support 5) frequency and duration of renal replacement therapy 6) bleeding requiring transfusions in the ICU 7) SOFA score
Official Title
-----------------
Early Versus Late Initiation of ECMO Trial (ELIEO-Trial)
Conditions
-----------------
Acute Respiratory Distress Syndrome
Intervention / Treatment
-----------------
* Device: ECMO
Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: ARDS as defined according to the Berlin Definition1 The term acute onset is defined as follow: the duration of the hypoxemia criterion and the chest radiograph criterion must be ≤ 7 days at the time of randomization. Patients must be enrolled within 96 hours of onset of ARDS and no later than 7 days from the initiation of mechanical ventilation. Exclusion Criteria: Age less than 18 years More than 7 days since initiation of mechanical ventilation more than 96 hours since meeting inclusion criteria patient, surrogate or physician not committed to full intensive care support pregnancy
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: This trial is a prospective randomized multicenter trial that assigns patients to either a treatment for ARDS with an ECMO immediately after admission to the intensive care unit or conservative treatment.
Masking: Single
Arms and Interventions
| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: Early ECMO<br>ECMO is placed immediately after admission to the intensive care unit | Device: ECMO<br>* ECMO implantation immediately after ICU admission<br>|
| No Intervention: Control<br>Conservative therapy unless failure of therapy. | |
What is the study measuring?
-----------------
Primary Outcome Measures
| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 28 day all cause mortality | 28 day all cause mortality | 28 day after study inclusion |
| 90 day all cause mortality | 90 day all cause mortality | 90 day after study inclusion |
Secondary Outcome Measures
| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Sepsis-related organ failure assessment score (SOFA) Organ Failure Scores | SOFA Organ Failure Scores | 1-14, 28 and 90 days after study inclusion |
| Delirium | Occurence of Delirium (positive Confusion Assessment Method for the Intensive Care Unit (CAM-ICU)) | 28 and 90 day after discharge of ICU |
| discharge location | discharge location: a) home, b) skilled nursing facility, c) rehabilitation unit | 28 and 90 day after discharge of ICU |
Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Acute Respiratory Distress Syndrome, Extracorporal membrane Oxygenation, Outcome, Ventilation Therapy, QOL
|
NCT01156610
|
Tobacco Treatment Outreach to Reduce Disparities for Primary Care Populations
|
The objectives of this project are to develop and evaluate a multi-level approach to tobacco treatment for low-SES and minority patients. The components of this intervention would include Integrated Voice Response(IVR)-facilitated systematic outreach, linkage to a tobacco treatment specialist, free Nicotine Replacement Therapy (NRT) directed at the patient, and integration of this program with both an individual's primary care physician through an electronic health record (EHR), as well as referral to community resources to address the socio-contextual barriers to tobacco cessation. To achieve these objectives, this intervention will test an innovative model of systematic outreach to low-SES and minority smokers using systematic phone outreach (including cell phones which are particularly prevalent among minority and low-SES groups), coordinated with the PCP, using both a cost-effective technology and a dedicated tobacco treatment specialist to increase smoking cessation in these populations. The proposed intervention will have multiple levels of influence (patient, PCP) and provide linkages to community resources. If successful, this model could be generalized to other health systems with an EHR, which are increasingly being promoted to improve the safety and quality of health care.~Hypothesis 1 (Reach and Effectiveness): An EHR-linked, IVR-mediated personalized treatment program for low-SES and minority smokers can reach these patients to increase quit rates and use of tobacco treatment effectively.~Hypothesis 2 (Adoption and Implementation): An EHR-linked, IVR-mediated personalized treatment program for low-SES and minority smokers can be adopted across a variety of practice settings and be consistently implemented across diverse patient populations.
|
Because 70% of smokers have seen a PCP within the past year, primary care represents a valuable platform for reducing disparities in tobacco use that could be made more effective. The current national focus on expanding the use of EHRs also makes the proposed model to identify smokers with the goal of reducing disparities in tobacco use particularly timely. The adoption of EHRs in practices serving minorities is similar to that in all practices, suggesting that there is not a digital divide for PCP practices. In addition, the proposed intervention is novel because it addresses tobacco use at multiple levels (i.e., individual, health care setting, community), and is designed to provide smokers with tools to address socio-contextual contributors to disparities in tobacco use. Finally, the intervention will be informed by a broad approach using community resources for tobacco cessation. Conceptual models and empiric data suggest that this type of broad approach is needed to reach low-SES and minority smokers to reduce disparities in tobacco use. Telephone outreach may be particularly effective for minority and low-SES populations because cell phone penetration is higher in these populations. While disparities in tobacco use are rooted in social and economic problems that extend beyond the domain of health care and traditional treatment models, the health care system still represents a critical opportunity to initiate intervention.~Although smoking has declined over the past decades, substantial socioeconomic disparities in smoking prevalence, risk of addiction, and tobacco-related disease remain in the US, particularly among different racial, ethnic, and socioeconomic groups. Despite relatively similar rates of tobacco use, for example, African Americans (a term used interchangeably with blacks throughout this proposal) suffer from a higher burden of tobacco-related disease, particularly lung cancer, than whites. Importantly, low socioeconomic status (SES) and minority smokers also have a relatively more difficult time quitting for several reasons, including more limited access to treatment, misinformation about the risks and benefits of treatment, more environmental exposure, lack of social support, and other life stressors.~Primary care physicians (PCPs) are an important source of tobacco treatment, as the majority of smokers visit a PCP each year. While the US Public Health Service strongly recommends that clinicians identify and treat every tobacco user, such an approach is largely dependent on busy clinicians to provide counseling and treatment during a brief visit. Minority and low-SES smokers are more likely than whites to report that they did not receive counseling or treatment during a visit. For these reasons it is important to offer systematic opportunities for tobacco treatment beyond the provider's office, in addition to improving best practices for cessation treatment. Interactive Voice Response (IVR) is a phone technology that allows a computer to detect voice responses during a normal phone call (including calls from mobile phones). This technology offers a low-cost, efficient way to reach out proactively to large populations, independent of a visit. IVR scripts can be translated into other languages, facilitating systematic outreach to diverse populations. This technology can provide direct linkage to a tobacco treatment specialist, who can provide personalized advice for cessation, mood management, and stress reduction, and provide a course of free nicotine replacement treatment (NRT), as well as linkage to relevant community resources. Smokers who use NRT as part of their cessation plan are more likely to succeed than those who do not, and free NRT is a particularly important intervention for low-SES and minority smokers.~Specific Aim 1: To develop an EHR-linked, IVR-mediated personalized tobacco treatment program for low-SES and minority smokers. To develop this program, we will first conduct formative qualitative research to identify the particular barriers to smoking cessation faced by these populations and subsequently, to create a Community Resource Guide to address socio-cultural barriers to cessation.~Specific Aim 2: To measure the effectiveness of this personalized treatment program by conducting a randomized controlled trial of low-SES and minority smokers in 12 clinics from the Partners Primary Care Practice Based Research Network (PPC-PBRN). Patients in the intervention group will be offered three contacts with a tobacco treatment specialist over a 12 week period, a free 6-week supply of nicotine patches, and linkage to local resources using the Community Resource Guide. Patients in the control group will receive visit-based best practices care facilitated by EHR decision support (received by both the intervention and the control group). The primary outcome of this trial will be the 7-day abstinence rate at 6 months.~Specific Aim 3: To evaluate facilitators and barriers to the reach, adoption, and implementation of this personalized tobacco treatment program.~This project fits well with other projects in the Lung Cancer Disparities Center (LCDC), complementing the other projects that seek to explain disparities in lung cancer at the molecular, neighborhood, and societal levels. Over 80% of those diagnosed with lung cancer are current or ex-smokers, supporting the critical importance of smoking cessation to reducing disparities in lung cancer.1 Our project adds another layer by focusing on the individual/ clinical interface to reduce disparities in tobacco use.
|
Tobacco Treatment Outreach to Reduce Disparities for Primary Care Populations
|
Smoking, Smoking Cessation
|
* Behavioral: Tobacco Treatment
|
Inclusion Criteria:~Must be 18 years of age or older.~Must be a current smoker.~Must receive primary care at one of the participating clinics.~Must have had a PCP visit within the last month at a participating clinic.~Must have a working phone number listed in Partner's database.~Must report race /ethnicity as African American or Hispanic or live in a low-SES block group (a census block group with a median income of < $65,000).~Must speak English or Spanish.~Exclusion Criteria:~Hearing impaired patients who cannot use the telephone.
|
18 Years
| null |
All
|
Accepts Healthy Volunteers
|
Primary Purpose: Health Services Research
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
|
| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 7-day point prevalence of smoking six months following completion of the intervention protocol (nine months post randomization). | The difference between intervention and control patients (smokers) who report nine months after randomization that they are now quitters (i.e., that they have not smoked for the past seven days but did smoke on enrollment). Self-reported smoking status has established validity when compared with measured serum cotinine levels and yields similar population prevalence estimates. | 2 years |
|
| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Use of any Tobacco Treatment | The difference between intervention and control patients who report using any pharmacologic tobacco treatment (NRT replacement, bupropion, varenicline) or any behavioral treatment (state quitline, local tobacco program). | 2 years |
| Use of Community Resources to Facilitate Smoking Cessation | The difference between intervention and control patients who report using community resources. | 2 years |
| Patient Report of Socio-cultural Barriers to Tobacco Cessation | The difference between the percentage of intervention and control patients who report key socio-cultural barriers to tobacco cessation. | 2 years |
| Quit Attempts | The difference between intervention and control patients who report making one or more quit attempts lasting >= 1 day during the nine months after randomization. An increasing number of quit attempts is related to ultimately quitting smoking. We will also examine difference in the number of quit attempts reported by the intervention and control groups within the nine months after randomization. | 2 years |
|
Smoking, Smoking Cessation, Electronic Health Record, Telephone
|
| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Integrated Cessation Counseling<br>IVR System: IVR will be used for two purposes: (1) to facilitate access to treatment for low-SES and minority smokers and (2) perform six-month outcome assessment.~Tobacco Treatment Specialist Calls: A tobacco treatment specialist will make four attempts to contact the patient by phone within 14 days. On contacting the patient, the specialist will screen the patient for readiness to quit, provide brief (10 to 15 minutes) counseling tailored to the patient's readiness to quit, and provide information and support for use of medications that could be or were prescribed and about relevant community resources.~NRT: Patients who do not have a contraindication and smoke > 10 cigarettes per day, will be offered a free 6-week kit of generic nicotine patches (2 weeks of 21 mg patches, 2 weeks of 14 mg patches, and 2 weeks of 7 mg patches). Individuals who smoke 5-10 cigarettes/day will be offered a 6-week course, starting with the 14 mg patch. Those with a contraindication will not get NRT. | Behavioral: Tobacco Treatment<br>* Comparison of integrated cessation counseling tools with the normal standard of care.~Both the intervention and control clinics will be provided with tools for visit-based best practices for tobacco cessation. The LMR will provide smoking status icons and tobacco treatment reminders for the primary care physicians at the time of a visit. In addition, physicians in both arms have access to decision support around medications prescribed, including bupropion and varenicline. Physicians can refer patients to tobacco cessation groups that meet periodically at each of the sites or to the Massachusetts tobacco quitline.~Outcome Assessment: Six month IVR Call: Patients in both the intervention and control practices who have not opted-out will be called six months after completing the 12-week treatment protocol. The outcome assessment script will be largely the same for intervention and control practices (except for the questions related to satisfaction with the intervention protocol).<br>|
| Active Comparator: Usual Care<br>IVR Call: Similar to the initial IVR call for the intervention arms, the initial control arm call will confirm the participant's identify and provide a brief description of the study (obtaining information about health behaviors), with the opportunity for the individual to accept or decline participation. Following this introduction, the IVR script will confirm smoking status. The phone script will collect specific information about current smoking (cigarettes/day), prior quit attempts, and motivation to quit during the next month. No further contact will be made with patients in the control clinics until the outcome assessment call. In the control practices, the IVR machine will also generate a text note documenting the information obtained for the patients' EHR for use by the patient's health care providers as part of their visit-based best practices. | Behavioral: Tobacco Treatment<br>* Comparison of integrated cessation counseling tools with the normal standard of care.~Both the intervention and control clinics will be provided with tools for visit-based best practices for tobacco cessation. The LMR will provide smoking status icons and tobacco treatment reminders for the primary care physicians at the time of a visit. In addition, physicians in both arms have access to decision support around medications prescribed, including bupropion and varenicline. Physicians can refer patients to tobacco cessation groups that meet periodically at each of the sites or to the Massachusetts tobacco quitline.~Outcome Assessment: Six month IVR Call: Patients in both the intervention and control practices who have not opted-out will be called six months after completing the 12-week treatment protocol. The outcome assessment script will be largely the same for intervention and control practices (except for the questions related to satisfaction with the intervention protocol).<br>|
|
Tobacco Treatment Outreach to Reduce Disparities for Primary Care Populations
Study Overview
=================
Brief Summary
-----------------
The objectives of this project are to develop and evaluate a multi-level approach to tobacco treatment for low-SES and minority patients. The components of this intervention would include Integrated Voice Response(IVR)-facilitated systematic outreach, linkage to a tobacco treatment specialist, free Nicotine Replacement Therapy (NRT) directed at the patient, and integration of this program with both an individual's primary care physician through an electronic health record (EHR), as well as referral to community resources to address the socio-contextual barriers to tobacco cessation. To achieve these objectives, this intervention will test an innovative model of systematic outreach to low-SES and minority smokers using systematic phone outreach (including cell phones which are particularly prevalent among minority and low-SES groups), coordinated with the PCP, using both a cost-effective technology and a dedicated tobacco treatment specialist to increase smoking cessation in these populations. The proposed intervention will have multiple levels of influence (patient, PCP) and provide linkages to community resources. If successful, this model could be generalized to other health systems with an EHR, which are increasingly being promoted to improve the safety and quality of health care. Hypothesis 1 (Reach and Effectiveness): An EHR-linked, IVR-mediated personalized treatment program for low-SES and minority smokers can reach these patients to increase quit rates and use of tobacco treatment effectively. Hypothesis 2 (Adoption and Implementation): An EHR-linked, IVR-mediated personalized treatment program for low-SES and minority smokers can be adopted across a variety of practice settings and be consistently implemented across diverse patient populations.
Detailed Description
-----------------
Because 70% of smokers have seen a PCP within the past year, primary care represents a valuable platform for reducing disparities in tobacco use that could be made more effective. The current national focus on expanding the use of EHRs also makes the proposed model to identify smokers with the goal of reducing disparities in tobacco use particularly timely. The adoption of EHRs in practices serving minorities is similar to that in all practices, suggesting that there is not a digital divide for PCP practices. In addition, the proposed intervention is novel because it addresses tobacco use at multiple levels (i.e., individual, health care setting, community), and is designed to provide smokers with tools to address socio-contextual contributors to disparities in tobacco use. Finally, the intervention will be informed by a broad approach using community resources for tobacco cessation. Conceptual models and empiric data suggest that this type of broad approach is needed to reach low-SES and minority smokers to reduce disparities in tobacco use. Telephone outreach may be particularly effective for minority and low-SES populations because cell phone penetration is higher in these populations. While disparities in tobacco use are rooted in social and economic problems that extend beyond the domain of health care and traditional treatment models, the health care system still represents a critical opportunity to initiate intervention. Although smoking has declined over the past decades, substantial socioeconomic disparities in smoking prevalence, risk of addiction, and tobacco-related disease remain in the US, particularly among different racial, ethnic, and socioeconomic groups. Despite relatively similar rates of tobacco use, for example, African Americans (a term used interchangeably with blacks throughout this proposal) suffer from a higher burden of tobacco-related disease, particularly lung cancer, than whites. Importantly, low socioeconomic status (SES) and minority smokers also have a relatively more difficult time quitting for several reasons, including more limited access to treatment, misinformation about the risks and benefits of treatment, more environmental exposure, lack of social support, and other life stressors. Primary care physicians (PCPs) are an important source of tobacco treatment, as the majority of smokers visit a PCP each year. While the US Public Health Service strongly recommends that clinicians identify and treat every tobacco user, such an approach is largely dependent on busy clinicians to provide counseling and treatment during a brief visit. Minority and low-SES smokers are more likely than whites to report that they did not receive counseling or treatment during a visit. For these reasons it is important to offer systematic opportunities for tobacco treatment beyond the provider's office, in addition to improving best practices for cessation treatment. Interactive Voice Response (IVR) is a phone technology that allows a computer to detect voice responses during a normal phone call (including calls from mobile phones). This technology offers a low-cost, efficient way to reach out proactively to large populations, independent of a visit. IVR scripts can be translated into other languages, facilitating systematic outreach to diverse populations. This technology can provide direct linkage to a tobacco treatment specialist, who can provide personalized advice for cessation, mood management, and stress reduction, and provide a course of free nicotine replacement treatment (NRT), as well as linkage to relevant community resources. Smokers who use NRT as part of their cessation plan are more likely to succeed than those who do not, and free NRT is a particularly important intervention for low-SES and minority smokers. Specific Aim 1: To develop an EHR-linked, IVR-mediated personalized tobacco treatment program for low-SES and minority smokers. To develop this program, we will first conduct formative qualitative research to identify the particular barriers to smoking cessation faced by these populations and subsequently, to create a Community Resource Guide to address socio-cultural barriers to cessation. Specific Aim 2: To measure the effectiveness of this personalized treatment program by conducting a randomized controlled trial of low-SES and minority smokers in 12 clinics from the Partners Primary Care Practice Based Research Network (PPC-PBRN). Patients in the intervention group will be offered three contacts with a tobacco treatment specialist over a 12 week period, a free 6-week supply of nicotine patches, and linkage to local resources using the Community Resource Guide. Patients in the control group will receive visit-based best practices care facilitated by EHR decision support (received by both the intervention and the control group). The primary outcome of this trial will be the 7-day abstinence rate at 6 months. Specific Aim 3: To evaluate facilitators and barriers to the reach, adoption, and implementation of this personalized tobacco treatment program. This project fits well with other projects in the Lung Cancer Disparities Center (LCDC), complementing the other projects that seek to explain disparities in lung cancer at the molecular, neighborhood, and societal levels. Over 80% of those diagnosed with lung cancer are current or ex-smokers, supporting the critical importance of smoking cessation to reducing disparities in lung cancer.1 Our project adds another layer by focusing on the individual/ clinical interface to reduce disparities in tobacco use.
Official Title
-----------------
Tobacco Treatment Outreach to Reduce Disparities for Primary Care Populations
Conditions
-----------------
Smoking, Smoking Cessation
Intervention / Treatment
-----------------
* Behavioral: Tobacco Treatment
Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Must be 18 years of age or older. Must be a current smoker. Must receive primary care at one of the participating clinics. Must have had a PCP visit within the last month at a participating clinic. Must have a working phone number listed in Partner's database. Must report race /ethnicity as African American or Hispanic or live in a low-SES block group (a census block group with a median income of < $65,000). Must speak English or Spanish. Exclusion Criteria: Hearing impaired patients who cannot use the telephone.
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: Health Services Research
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Arms and Interventions
| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Integrated Cessation Counseling<br>IVR System: IVR will be used for two purposes: (1) to facilitate access to treatment for low-SES and minority smokers and (2) perform six-month outcome assessment. Tobacco Treatment Specialist Calls: A tobacco treatment specialist will make four attempts to contact the patient by phone within 14 days. On contacting the patient, the specialist will screen the patient for readiness to quit, provide brief (10 to 15 minutes) counseling tailored to the patient's readiness to quit, and provide information and support for use of medications that could be or were prescribed and about relevant community resources. NRT: Patients who do not have a contraindication and smoke > 10 cigarettes per day, will be offered a free 6-week kit of generic nicotine patches (2 weeks of 21 mg patches, 2 weeks of 14 mg patches, and 2 weeks of 7 mg patches). Individuals who smoke 5-10 cigarettes/day will be offered a 6-week course, starting with the 14 mg patch. Those with a contraindication will not get NRT. | Behavioral: Tobacco Treatment<br>* Comparison of integrated cessation counseling tools with the normal standard of care. Both the intervention and control clinics will be provided with tools for visit-based best practices for tobacco cessation. The LMR will provide smoking status icons and tobacco treatment reminders for the primary care physicians at the time of a visit. In addition, physicians in both arms have access to decision support around medications prescribed, including bupropion and varenicline. Physicians can refer patients to tobacco cessation groups that meet periodically at each of the sites or to the Massachusetts tobacco quitline. Outcome Assessment: Six month IVR Call: Patients in both the intervention and control practices who have not opted-out will be called six months after completing the 12-week treatment protocol. The outcome assessment script will be largely the same for intervention and control practices (except for the questions related to satisfaction with the intervention protocol).<br>|
| Active Comparator: Usual Care<br>IVR Call: Similar to the initial IVR call for the intervention arms, the initial control arm call will confirm the participant's identify and provide a brief description of the study (obtaining information about health behaviors), with the opportunity for the individual to accept or decline participation. Following this introduction, the IVR script will confirm smoking status. The phone script will collect specific information about current smoking (cigarettes/day), prior quit attempts, and motivation to quit during the next month. No further contact will be made with patients in the control clinics until the outcome assessment call. In the control practices, the IVR machine will also generate a text note documenting the information obtained for the patients' EHR for use by the patient's health care providers as part of their visit-based best practices. | Behavioral: Tobacco Treatment<br>* Comparison of integrated cessation counseling tools with the normal standard of care. Both the intervention and control clinics will be provided with tools for visit-based best practices for tobacco cessation. The LMR will provide smoking status icons and tobacco treatment reminders for the primary care physicians at the time of a visit. In addition, physicians in both arms have access to decision support around medications prescribed, including bupropion and varenicline. Physicians can refer patients to tobacco cessation groups that meet periodically at each of the sites or to the Massachusetts tobacco quitline. Outcome Assessment: Six month IVR Call: Patients in both the intervention and control practices who have not opted-out will be called six months after completing the 12-week treatment protocol. The outcome assessment script will be largely the same for intervention and control practices (except for the questions related to satisfaction with the intervention protocol).<br>|
What is the study measuring?
-----------------
Primary Outcome Measures
| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 7-day point prevalence of smoking six months following completion of the intervention protocol (nine months post randomization). | The difference between intervention and control patients (smokers) who report nine months after randomization that they are now quitters (i.e., that they have not smoked for the past seven days but did smoke on enrollment). Self-reported smoking status has established validity when compared with measured serum cotinine levels and yields similar population prevalence estimates. | 2 years |
Secondary Outcome Measures
| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Use of any Tobacco Treatment | The difference between intervention and control patients who report using any pharmacologic tobacco treatment (NRT replacement, bupropion, varenicline) or any behavioral treatment (state quitline, local tobacco program). | 2 years |
| Use of Community Resources to Facilitate Smoking Cessation | The difference between intervention and control patients who report using community resources. | 2 years |
| Patient Report of Socio-cultural Barriers to Tobacco Cessation | The difference between the percentage of intervention and control patients who report key socio-cultural barriers to tobacco cessation. | 2 years |
| Quit Attempts | The difference between intervention and control patients who report making one or more quit attempts lasting >= 1 day during the nine months after randomization. An increasing number of quit attempts is related to ultimately quitting smoking. We will also examine difference in the number of quit attempts reported by the intervention and control groups within the nine months after randomization. | 2 years |
Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Smoking, Smoking Cessation, Electronic Health Record, Telephone
|
|
NCT03987932
|
NEAT!2 Sedentary Behavior Reduction for Individuals With Past or Present Knee Symptoms, Injuries, or Surgeries
|
This study will evaluate the effectiveness of an mHealth sedentary reduction program over a 6-month period of time in adults with past or present knee symptoms, injuries, or surgeries.
|
Sedentary behavior, in excess, is associated with numerous health consequences including poor physical function. Older adults with symptomatic knee pain spend the majority of their waking hours engaging in sedentary behaviors. To reduce the risk of disability, improve quality of life, and prevent deterioration in physical function, it is imperative the investigators develop ways to reduce sedentary time. Smartphone ownership among older adults is increasing and may provide a scalable opportunity to disseminate a sedentary reduction intervention. Therefore, this study aims to evaluate and compare changes in sedentary behavior and physical function between an mHealth sedentary reduction, mHealth intervention plus coaching, and delayed mHealth group. Sedentary behavior and physical function will be assessed at baseline, 1 month, 3 months, and 6 months after randomization.
|
NEAT!2 Sedentary Behavior Reduction Intervention for Individuals With Past or Present Knee Symptoms, Injuries, or Surgeries
|
Sedentary Lifestyle, Knee Osteoarthritis, Knee Injuries, Knee Pain Chronic
|
* Behavioral: NEAT!2
* Behavioral: NEAT!2+Calls
* Behavioral: Delayed NEAT!2
|
Inclusion Criteria:~Be at least 40 years of age~Own an Android or Apple smartphone~Have their smartphone near them (in their pocket, in their hand, or within 10 feet of them) for >50% of their waking day~Be willing to download the study application and be compatible on their smartphone~Spend at least 7 hours/day sitting~Have at least 4 days of valid accelerometer data at baseline~Have knee pain (at least one knee with pain, aching, or stiffness on most days for one month of the last 12 months), knee injury, or knee replacement within the last 5 years~Read, speak, and understand English~Exclusion Criteria:~Have any contraindications to activity~Have a mobility limiting comorbidity~Have a scheduled surgery within the next 6 months
|
40 Years
| null |
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 Sedentary Behavior at 1 Month | Daily sedentary behavior objectively measured by activpal | Baseline to 1 month |
| Change in Sedentary Behavior at 3 Months | Daily sedentary behavior objectively measured by activpal | Baseline to 3 months |
|
| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change in Timed Up & Go at 1 Month | Physical function assessed by Timed Up & Go (seconds) | Baseline to 1 month |
| Change in Chair Stands at 1 Month | Physical function assessed by Chair Stand Test (# stands in 30 seconds) | Baseline to 1 month |
| Change in 6 Minute Walk at 1 Month | Physical function assessed by 6 minute walk (total feet) | Baseline to 1 month |
| Change in Timed Up & Go at 3 Months | Physical function assessed by Timed Up & Go (seconds) | Baseline to 3 months |
| Change in Chair Stands at 3 Months | Physical function assessed by Chair Stand Test (# stands in 30 seconds) | Baseline to 3 months |
| Change in 6 Minute Walk at 3 Months | Physical function assessed by 6 minute walk (total feet) | Baseline to 3 months |
|
Wounds and Injuries, Knee Injuries, Leg Injuries
|
| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: NEAT!2<br>Participants will be asked to use the NEAT!2 app for 3 months after randomization. App use between 4-6 months is optional. | Behavioral: NEAT!2<br>* Participants randomized to NEAT!2 will have their NEAT!2 app turned on after randomization. When 30 minutes of continuous non-movement or sedentary time is detected, the NEAT!2 app will provide a vibration or audio notification as well as display a reminder on the phone's lock/home screen. Participants will be asked to use the app for the 3 months of the intervention. Participants will be given an initial goal to reduce total sedentary time by 30 minutes/day, ultimately progressing to a 90 minute/day reduction by 3 months. After the 3-month assessment, participants randomized to NEAT!2 will have the option to continue using the app until 6 months.<br>|
| Experimental: NEAT!2+Calls<br>Participants will be asked to use the NEAT!2 app for 3 months after randomization. In addition, participants will receive bi-weekly coaching calls over 3 months. App use between 4-6 months is optional. | Behavioral: NEAT!2+Calls<br>* Participants in this group will have their NEAT!2 app turned on after randomization. In addition, to receiving the identical app and given the same goals as participants randomized to NEAT!2, NEAT!2+Calls participants will receive 10-15 minute bi-weekly coaching calls. After the 3-month assessment, participants will have the option to continue using the app until 6 months. During this time, participants will not receive any coaching calls.<br>|
| Other: Delayed NEAT!2<br>Participants will receive the NEAT!2 app to use between 3 and 6 months. | Behavioral: Delayed NEAT!2<br>* Participants randomized to Delayed NEAT!2 will not receive any contact or app between baseline and 3 months. However, after completing the 3-month assessment, participants will receive the NEAT!2 application. Participants will then have the option to use the app between 3 and 6 months.<br>|
|
NEAT!2 Sedentary Behavior Reduction for Individuals With Past or Present Knee Symptoms, Injuries, or Surgeries
Study Overview
=================
Brief Summary
-----------------
This study will evaluate the effectiveness of an mHealth sedentary reduction program over a 6-month period of time in adults with past or present knee symptoms, injuries, or surgeries.
Detailed Description
-----------------
Sedentary behavior, in excess, is associated with numerous health consequences including poor physical function. Older adults with symptomatic knee pain spend the majority of their waking hours engaging in sedentary behaviors. To reduce the risk of disability, improve quality of life, and prevent deterioration in physical function, it is imperative the investigators develop ways to reduce sedentary time. Smartphone ownership among older adults is increasing and may provide a scalable opportunity to disseminate a sedentary reduction intervention. Therefore, this study aims to evaluate and compare changes in sedentary behavior and physical function between an mHealth sedentary reduction, mHealth intervention plus coaching, and delayed mHealth group. Sedentary behavior and physical function will be assessed at baseline, 1 month, 3 months, and 6 months after randomization.
Official Title
-----------------
NEAT!2 Sedentary Behavior Reduction Intervention for Individuals With Past or Present Knee Symptoms, Injuries, or Surgeries
Conditions
-----------------
Sedentary Lifestyle, Knee Osteoarthritis, Knee Injuries, Knee Pain Chronic
Intervention / Treatment
-----------------
* Behavioral: NEAT!2
* Behavioral: NEAT!2+Calls
* Behavioral: Delayed NEAT!2
Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Be at least 40 years of age Own an Android or Apple smartphone Have their smartphone near them (in their pocket, in their hand, or within 10 feet of them) for >50% of their waking day Be willing to download the study application and be compatible on their smartphone Spend at least 7 hours/day sitting Have at least 4 days of valid accelerometer data at baseline Have knee pain (at least one knee with pain, aching, or stiffness on most days for one month of the last 12 months), knee injury, or knee replacement within the last 5 years Read, speak, and understand English Exclusion Criteria: Have any contraindications to activity Have a mobility limiting comorbidity Have a scheduled surgery within the next 6 months
Ages Eligible for Study
-----------------
Minimum 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: Prevention
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Arms and Interventions
| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: NEAT!2<br>Participants will be asked to use the NEAT!2 app for 3 months after randomization. App use between 4-6 months is optional. | Behavioral: NEAT!2<br>* Participants randomized to NEAT!2 will have their NEAT!2 app turned on after randomization. When 30 minutes of continuous non-movement or sedentary time is detected, the NEAT!2 app will provide a vibration or audio notification as well as display a reminder on the phone's lock/home screen. Participants will be asked to use the app for the 3 months of the intervention. Participants will be given an initial goal to reduce total sedentary time by 30 minutes/day, ultimately progressing to a 90 minute/day reduction by 3 months. After the 3-month assessment, participants randomized to NEAT!2 will have the option to continue using the app until 6 months.<br>|
| Experimental: NEAT!2+Calls<br>Participants will be asked to use the NEAT!2 app for 3 months after randomization. In addition, participants will receive bi-weekly coaching calls over 3 months. App use between 4-6 months is optional. | Behavioral: NEAT!2+Calls<br>* Participants in this group will have their NEAT!2 app turned on after randomization. In addition, to receiving the identical app and given the same goals as participants randomized to NEAT!2, NEAT!2+Calls participants will receive 10-15 minute bi-weekly coaching calls. After the 3-month assessment, participants will have the option to continue using the app until 6 months. During this time, participants will not receive any coaching calls.<br>|
| Other: Delayed NEAT!2<br>Participants will receive the NEAT!2 app to use between 3 and 6 months. | Behavioral: Delayed NEAT!2<br>* Participants randomized to Delayed NEAT!2 will not receive any contact or app between baseline and 3 months. However, after completing the 3-month assessment, participants will receive the NEAT!2 application. Participants will then have the option to use the app between 3 and 6 months.<br>|
What is the study measuring?
-----------------
Primary Outcome Measures
| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change in Sedentary Behavior at 1 Month | Daily sedentary behavior objectively measured by activpal | Baseline to 1 month |
| Change in Sedentary Behavior at 3 Months | Daily sedentary behavior objectively measured by activpal | Baseline to 3 months |
Secondary Outcome Measures
| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change in Timed Up & Go at 1 Month | Physical function assessed by Timed Up & Go (seconds) | Baseline to 1 month |
| Change in Chair Stands at 1 Month | Physical function assessed by Chair Stand Test (# stands in 30 seconds) | Baseline to 1 month |
| Change in 6 Minute Walk at 1 Month | Physical function assessed by 6 minute walk (total feet) | Baseline to 1 month |
| Change in Timed Up & Go at 3 Months | Physical function assessed by Timed Up & Go (seconds) | Baseline to 3 months |
| Change in Chair Stands at 3 Months | Physical function assessed by Chair Stand Test (# stands in 30 seconds) | Baseline to 3 months |
| Change in 6 Minute Walk at 3 Months | Physical function assessed by 6 minute walk (total feet) | Baseline to 3 months |
|
|
NCT03933891
|
Magnetic Resonance Technics for the Assessment of Liver Function Before and After TIPS
|
Portal hypertension is the end-stage fatal complications of liver cirrhosis. Decompensated cirrhosis patients can pass through transjugular intrahepatic portosystemic shunt to effectively prevent bleeding and refractory ascites. However, the occurrence of hepatic encephalopathy and liver function failure, infection, bleeding again are main lethality postoperative complications after TIPS. The accurate TIPS shunt is necessary to reduce the incidence of complications and improve the patients' survival rate and survival quality. Hepatic venous pressure gradient (HVPG) is standard to evaluate TIPS preoperative and postoperative hemodynamic change and is also the most important the predictors of decompensation and varicose vein bleeding of liver cirrhosis. Whether there is a kind of noninvasive monitoring method can guide TIPS accurate shunt and evaluate the prognosis of patients.~Magnetic resonance imaging (MRI) has a high soft tissue resolution, time and spatial resolution, abdominal MRI can noninvasively, dynamically detect the liver, spleen, portal system functions, the changes of portal system hemodynamics, blood supply of liver tissue, perfusion and liver cell function, etc.~In order to analyze the liver function and survival of liver cirrhosis patients after transjugular intrahepatic portosystemic shunt, advanced magnetic resonance techniques are used before and after transjugular intrahepatic portosystemic shunt. We will combine a variety of advanced magnetic resonance imaging technology, long-term and dynamic monitor TIPS preoperative and postoperative liver function, blood flow, perfusion, the change of tissue elasticity, and analysis the incidence of hepatic encephalopathy, hemorrhage, hepatic failure and survival rate with MRI changes. Finally, we will develop new prediction index, guide TIPS precision shunts, evaluate a variety of the value of imaging technology in the application of patients with TIPS to find the most sensitive technology, and discover the correlation between MRI function parameters with patient's survival. In order to analyze the liver function and survival of liver cirrhosis patients after transjugular intrahepatic portosystemic shunt, advanced magnetic resonance techniques are used to evaluate liver function, blood flow, elasticity, perfusion of before and after transjugular intrahepatic portosystemic shunt.
|
Portal hypertension is the end-stage fatal complications of liver cirrhosis. Decompensated cirrhosis patients can pass through transjugular intrahepatic portosystemic shunt to effectively prevent bleeding and refractory ascites. However, the occurrence of hepatic encephalopathy and liver function failure, infection, bleeding again are main lethality postoperative complications after TIPS. The accurate TIPS shunt is necessary to reduce the incidence of complications and improve the patients' survival rate and survival quality. Hepatic venous pressure gradient (HVPG) is standard to evaluate TIPS preoperative and postoperative hemodynamic change and is also the most important the predictors of decompensation and varicose vein bleeding of liver cirrhosis. Whether there is a kind of noninvasive monitoring method can guide TIPS accurate shunt and evaluate the prognosis of patients.~Magnetic resonance imaging (MRI) has a high soft tissue resolution, time and spatial resolution, abdominal MRI can noninvasively, dynamically detect the liver, spleen, portal system functions, the changes of portal system hemodynamics, blood supply of liver tissue, perfusion and liver cell function, etc. Magnetic resonance 4D-flow imaging, can accurately measure the portal vein system blood vessels and shunt channels, blood volume, flow velocity parameters of blood flow can be detected. Recent studies have confirmed that the 4D-flow technology can accurately, long-term follow-up monitoring TIPS preoperative, postoperative portal vein blood flow, which have better sensitivity and more accurate than ultrasound to detect blood flow. Magnetic resonance perfusion imaging of the liver can quantitatively obtain liver tissue microcirculation status, monitor portal vein and hepatic artery blood perfusion, the liver perfusion has a significant correlation with Child-Pugh score and degree of liver fibrosis and cirrhosis of the liver. Compared with the traditional magnetic resonance imaging contrast agents, liver specific contrast agents have small renal toxicity, uptake by liver cell specificity, recent studies have found that magnetic resonance imaging with liver cell specificity contrast agents have significantly correlated with the stage of fibrosis of the liver and liver function, and has been used in the clinical staging of liver fibrosis and early detection of hepatocellular carcinoma (HCC). Magnetic resonance elastography (MRE) is a new imaging technology in recent years and a unique image method. As a noninvasive and quantitative method to detect elastic properties of the organ. Plenty of research results showed that in patients with liver cirrhosis, liver and spleen of elasticity have significant correlation with the degree of portal hypertension. So far, a variety of functional imaging methods grade and guide prognosis of patients with cirrhosis, which have been confirmed to have significant clinical value. MRE has been written for the latest diagnosis and treatment of portal hypertension guidelines.~In order to analyze the liver function and survival of liver cirrhosis patients after transjugular intrahepatic portosystemic shunt, advanced magnetic resonance techniques are used before and after transjugular intrahepatic portosystemic shunt. Researchers will combine a variety of advanced magnetic resonance imaging technology, long-term and dynamic monitor TIPS preoperative and postoperative liver function, blood flow, perfusion, the change of tissue elasticity, and analysis the incidence of hepatic encephalopathy, hemorrhage, hepatic failure and survival rate with MRI changes. Finally, Researchers will develop a new predictive index, guide TIPS precision shunts, evaluate a variety of the value of imaging technology in the application of patients with TIPS to find the most sensitive technology, and discover the correlation between MRI function parameters with patient's survival. In order to analyze the liver function and survival of liver cirrhosis patients after transjugular intrahepatic portosystemic shunt, advanced magnetic resonance techniques are used to evaluate liver function, blood flow, elasticity, perfusion of before and after transjugular intrahepatic portosystemic shunt.~Materials and Methods Patients Inclusion criteria: 18-75 years old; liver cirrhosis (diagnosis by imaging, laboratory examination, clinical symptoms and liver biopsy); history of endoscopy confirmed esophageal varicose vein hemorrhage (5 days or longer); the Child-Pugh, B or C less 13; willing to participate in this clinical study, and sign an Informed consent. Exclusion criteria: Child-Pugh ≥12 or MELD ≥18; non-cirrhotic portal hypertension (including regional portal hypertension); total bilirubin over 2 times upper; combined liver cancer or other malignant tumor; infection, uncontrolled sepsis, etc; There are other contraindications to TIPS, EVL and NSBB treatment; heart, lung, kidney and other organs severe disease; women during pregnancy or lactation.~The patients' information Basic information: name, age, gender, work, BMI, rural/urban; Past medical history: the presence of a stool and hemoptysis, ligation hemostasis under gastroscopy history; History of ascites; Hepatic encephalopathy history; Drugs make: diuretics, B-blocker; With or without cardiopulmonary dysfunction history. Cause: alcoholic liver cirrhosis; HBV/HCV related cirrhosis of the liver; AIH, PBC, others. TIPS surgery reason: gastrointestinal bleeding, ascites, other. TIPS postoperative complications: hepatic encephalopathy, ascites, varicose vein bleeding, kidney failure, liver failure. Before and after TIPS, 96 hours, 1 month, 3 months, 6 months and 12 months, then each half year to follow-up until to 5 years. Physical signs and symptoms, Child-Pugh score, MELD score, ammonia and platelet are collected. Before and after TIPS, 96 hours, 6 months and 12 months, multi parameters MRI is performed. MRI scan parameters: 4D-flow sequence: the respiratory gating and cardiac switch control, phase code acquisition of three- space, to obtain parameters of blood flow parameters mapping images. Imaging parameters: imaging volume, 32 × 32 ×24 cm2 to get the isotropic spatial resolution 1.25 mm. TR/TE: 6.4ms/2.2ms, Flip Angle: 16 °. Imaging time is about 12 minutes, depending on the respiratory gating. MRE: simple principle is on the basis of common MRI scans, install a non-magnetic voltage sensor on patients to produce mechanical vibration that transfer into tissues and organs. Particle produce displacement in the direction of propagation of mechanical vibration. The size of the displacement associated with the level of organization elasticity. Imaging parameters are as follows: 3.0 T MR (GE), 12 channels of the surface phased array coil, respiratory gating, single-shot spin echo planar imaging sequence with flow compensation movement encoding gradient, Mechanical wave frequency, 25, 30, 40, 50, and 60 Hz; the spatial resolution: 2 × 2× 2.5 mm3, FOV: 384 x 256; repetition time: 1820 ms; echo time: 54 ms; Matrix: 192 x 128; Perfusion MRI: a 2D fast spoiled gradient echo multi flip-angle T1 map was produced before contrast agent injection with FOV: 60×60×40 mm3; thickness: 2.0 mm; TR：12.4 ms; TE：2.1 ms; matrix: 256 × 128; NEX: 1; with different flip angle 5°, 10°, 20°, 30°, 40°, 50°. The parameters of DCE-MRI were the same as those above, except the flip angle was 30°, after six phase baseline images, 0.025mM/kg Gd of Gd-EOB-DTPA, then 40 phase images were acquired. Liver specificity contrast agents enhanced imaging parameters: 3.0T MR, 12 channels on the surface phased array coil, VIBE: Volume Interpolated Breath-hold Examination, repetition time: 3.1 ms; echo time: 1.16 ms; reconstruction resolution size: 1.3 ×1. 3 × 1.3 mm3; The scanning resolution: 1.7 ×1. 3 ×1. 3 mm3. The MR functions parameters are collected: the liver, the spleen elasticity; 4 D-flow: the superior mesenteric vein (SMV), splenic vein (SV), portal vein (PV) of flow volume, pulse wave velocity (PWV); Perfusion: rCBV, rCBF, MTT; T1 mapping: liver, spleen and kidney T1 values; Magnetic resonance liver cell specificity of contrast agents enhancement: arterial phase, portal phase, liver and gall T1WI signal value of liver tissue. The MR function parameter changes as followed after TIPS will be analyzed. The MR function parameters with chemical biomarkers to predict survival will be analyzed.
|
Advanced Magnetic Resonance Technics for the Assessment of Liver Function Before and After Transjugular Intrahepatic Portosystemic Shunt
|
Liver Cirrhosis, Transjugular Intrahepatic Portosystemic Shunt (TIPS), Functional Magnetic Resonance Imaging
|
* Procedure: TIPS
|
Inclusion Criteria:~18-75 years old;~Liver cirrhosis (diagnosis by imaging, laboratory examination, clinical symptoms and liver biopsy);~History of endoscopy confirmed esophageal varicose vein hemorrhage (5 days or higher);~The Child-Pugh, B or C less 13;~Willing to participate in this clinical study, and sign an informed consent.~Exclusion Criteria:~Child-Pugh ≥12 or MELD ≥18;~Non-cirrhotic portal hypertension (including regional portal hypertension); total bilirubin over 2 times upper;~Combined liver cancer or other malignant tumor;~Infection, uncontrolled sepsis, etc.;~Heart, lung, kidney and other organs, severe disease;~Women during pregnancy or lactation.
|
18 Years
|
75 Years
|
All
|
No
|
| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| mortality rate | | 5 years |
| Incidence of hepatic encephalopathy | | 5 years |
| Varices rebleeding rate | | 5 years |
|
TIPS, functional MRI, liver corrhosis, portal hypertension, HVPG
|
Liver Cirrhosis, Fibrosis, Pathologic Processes, Liver Diseases, Digestive System Diseases
|
| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Decompensated liver cirrhosis with TIPS<br> | Procedure: TIPS<br>* TIPS: Established distributary channel between the portal vein and hepatic vein via the jugular vein, portal vein blood directly shunts into the systemic circulation to reduce portal vein pressure to effectively prevent bleeding and refractory ascites.<br>|
|
Magnetic Resonance Technics for the Assessment of Liver Function Before and After TIPS
Study Overview
=================
Brief Summary
-----------------
Portal hypertension is the end-stage fatal complications of liver cirrhosis. Decompensated cirrhosis patients can pass through transjugular intrahepatic portosystemic shunt to effectively prevent bleeding and refractory ascites. However, the occurrence of hepatic encephalopathy and liver function failure, infection, bleeding again are main lethality postoperative complications after TIPS. The accurate TIPS shunt is necessary to reduce the incidence of complications and improve the patients' survival rate and survival quality. Hepatic venous pressure gradient (HVPG) is standard to evaluate TIPS preoperative and postoperative hemodynamic change and is also the most important the predictors of decompensation and varicose vein bleeding of liver cirrhosis. Whether there is a kind of noninvasive monitoring method can guide TIPS accurate shunt and evaluate the prognosis of patients. Magnetic resonance imaging (MRI) has a high soft tissue resolution, time and spatial resolution, abdominal MRI can noninvasively, dynamically detect the liver, spleen, portal system functions, the changes of portal system hemodynamics, blood supply of liver tissue, perfusion and liver cell function, etc. In order to analyze the liver function and survival of liver cirrhosis patients after transjugular intrahepatic portosystemic shunt, advanced magnetic resonance techniques are used before and after transjugular intrahepatic portosystemic shunt. We will combine a variety of advanced magnetic resonance imaging technology, long-term and dynamic monitor TIPS preoperative and postoperative liver function, blood flow, perfusion, the change of tissue elasticity, and analysis the incidence of hepatic encephalopathy, hemorrhage, hepatic failure and survival rate with MRI changes. Finally, we will develop new prediction index, guide TIPS precision shunts, evaluate a variety of the value of imaging technology in the application of patients with TIPS to find the most sensitive technology, and discover the correlation between MRI function parameters with patient's survival. In order to analyze the liver function and survival of liver cirrhosis patients after transjugular intrahepatic portosystemic shunt, advanced magnetic resonance techniques are used to evaluate liver function, blood flow, elasticity, perfusion of before and after transjugular intrahepatic portosystemic shunt.
Detailed Description
-----------------
Portal hypertension is the end-stage fatal complications of liver cirrhosis. Decompensated cirrhosis patients can pass through transjugular intrahepatic portosystemic shunt to effectively prevent bleeding and refractory ascites. However, the occurrence of hepatic encephalopathy and liver function failure, infection, bleeding again are main lethality postoperative complications after TIPS. The accurate TIPS shunt is necessary to reduce the incidence of complications and improve the patients' survival rate and survival quality. Hepatic venous pressure gradient (HVPG) is standard to evaluate TIPS preoperative and postoperative hemodynamic change and is also the most important the predictors of decompensation and varicose vein bleeding of liver cirrhosis. Whether there is a kind of noninvasive monitoring method can guide TIPS accurate shunt and evaluate the prognosis of patients. Magnetic resonance imaging (MRI) has a high soft tissue resolution, time and spatial resolution, abdominal MRI can noninvasively, dynamically detect the liver, spleen, portal system functions, the changes of portal system hemodynamics, blood supply of liver tissue, perfusion and liver cell function, etc. Magnetic resonance 4D-flow imaging, can accurately measure the portal vein system blood vessels and shunt channels, blood volume, flow velocity parameters of blood flow can be detected. Recent studies have confirmed that the 4D-flow technology can accurately, long-term follow-up monitoring TIPS preoperative, postoperative portal vein blood flow, which have better sensitivity and more accurate than ultrasound to detect blood flow. Magnetic resonance perfusion imaging of the liver can quantitatively obtain liver tissue microcirculation status, monitor portal vein and hepatic artery blood perfusion, the liver perfusion has a significant correlation with Child-Pugh score and degree of liver fibrosis and cirrhosis of the liver. Compared with the traditional magnetic resonance imaging contrast agents, liver specific contrast agents have small renal toxicity, uptake by liver cell specificity, recent studies have found that magnetic resonance imaging with liver cell specificity contrast agents have significantly correlated with the stage of fibrosis of the liver and liver function, and has been used in the clinical staging of liver fibrosis and early detection of hepatocellular carcinoma (HCC). Magnetic resonance elastography (MRE) is a new imaging technology in recent years and a unique image method. As a noninvasive and quantitative method to detect elastic properties of the organ. Plenty of research results showed that in patients with liver cirrhosis, liver and spleen of elasticity have significant correlation with the degree of portal hypertension. So far, a variety of functional imaging methods grade and guide prognosis of patients with cirrhosis, which have been confirmed to have significant clinical value. MRE has been written for the latest diagnosis and treatment of portal hypertension guidelines. In order to analyze the liver function and survival of liver cirrhosis patients after transjugular intrahepatic portosystemic shunt, advanced magnetic resonance techniques are used before and after transjugular intrahepatic portosystemic shunt. Researchers will combine a variety of advanced magnetic resonance imaging technology, long-term and dynamic monitor TIPS preoperative and postoperative liver function, blood flow, perfusion, the change of tissue elasticity, and analysis the incidence of hepatic encephalopathy, hemorrhage, hepatic failure and survival rate with MRI changes. Finally, Researchers will develop a new predictive index, guide TIPS precision shunts, evaluate a variety of the value of imaging technology in the application of patients with TIPS to find the most sensitive technology, and discover the correlation between MRI function parameters with patient's survival. In order to analyze the liver function and survival of liver cirrhosis patients after transjugular intrahepatic portosystemic shunt, advanced magnetic resonance techniques are used to evaluate liver function, blood flow, elasticity, perfusion of before and after transjugular intrahepatic portosystemic shunt. Materials and Methods Patients Inclusion criteria: 18-75 years old; liver cirrhosis (diagnosis by imaging, laboratory examination, clinical symptoms and liver biopsy); history of endoscopy confirmed esophageal varicose vein hemorrhage (5 days or longer); the Child-Pugh, B or C less 13; willing to participate in this clinical study, and sign an Informed consent. Exclusion criteria: Child-Pugh ≥12 or MELD ≥18; non-cirrhotic portal hypertension (including regional portal hypertension); total bilirubin over 2 times upper; combined liver cancer or other malignant tumor; infection, uncontrolled sepsis, etc; There are other contraindications to TIPS, EVL and NSBB treatment; heart, lung, kidney and other organs severe disease; women during pregnancy or lactation. The patients' information Basic information: name, age, gender, work, BMI, rural/urban; Past medical history: the presence of a stool and hemoptysis, ligation hemostasis under gastroscopy history; History of ascites; Hepatic encephalopathy history; Drugs make: diuretics, B-blocker; With or without cardiopulmonary dysfunction history. Cause: alcoholic liver cirrhosis; HBV/HCV related cirrhosis of the liver; AIH, PBC, others. TIPS surgery reason: gastrointestinal bleeding, ascites, other. TIPS postoperative complications: hepatic encephalopathy, ascites, varicose vein bleeding, kidney failure, liver failure. Before and after TIPS, 96 hours, 1 month, 3 months, 6 months and 12 months, then each half year to follow-up until to 5 years. Physical signs and symptoms, Child-Pugh score, MELD score, ammonia and platelet are collected. Before and after TIPS, 96 hours, 6 months and 12 months, multi parameters MRI is performed. MRI scan parameters: 4D-flow sequence: the respiratory gating and cardiac switch control, phase code acquisition of three- space, to obtain parameters of blood flow parameters mapping images. Imaging parameters: imaging volume, 32 × 32 ×24 cm2 to get the isotropic spatial resolution 1.25 mm. TR/TE: 6.4ms/2.2ms, Flip Angle: 16 °. Imaging time is about 12 minutes, depending on the respiratory gating. MRE: simple principle is on the basis of common MRI scans, install a non-magnetic voltage sensor on patients to produce mechanical vibration that transfer into tissues and organs. Particle produce displacement in the direction of propagation of mechanical vibration. The size of the displacement associated with the level of organization elasticity. Imaging parameters are as follows: 3.0 T MR (GE), 12 channels of the surface phased array coil, respiratory gating, single-shot spin echo planar imaging sequence with flow compensation movement encoding gradient, Mechanical wave frequency, 25, 30, 40, 50, and 60 Hz; the spatial resolution: 2 × 2× 2.5 mm3, FOV: 384 x 256; repetition time: 1820 ms; echo time: 54 ms; Matrix: 192 x 128; Perfusion MRI: a 2D fast spoiled gradient echo multi flip-angle T1 map was produced before contrast agent injection with FOV: 60×60×40 mm3; thickness: 2.0 mm; TR：12.4 ms; TE：2.1 ms; matrix: 256 × 128; NEX: 1; with different flip angle 5°, 10°, 20°, 30°, 40°, 50°. The parameters of DCE-MRI were the same as those above, except the flip angle was 30°, after six phase baseline images, 0.025mM/kg Gd of Gd-EOB-DTPA, then 40 phase images were acquired. Liver specificity contrast agents enhanced imaging parameters: 3.0T MR, 12 channels on the surface phased array coil, VIBE: Volume Interpolated Breath-hold Examination, repetition time: 3.1 ms; echo time: 1.16 ms; reconstruction resolution size: 1.3 ×1. 3 × 1.3 mm3; The scanning resolution: 1.7 ×1. 3 ×1. 3 mm3. The MR functions parameters are collected: the liver, the spleen elasticity; 4 D-flow: the superior mesenteric vein (SMV), splenic vein (SV), portal vein (PV) of flow volume, pulse wave velocity (PWV); Perfusion: rCBV, rCBF, MTT; T1 mapping: liver, spleen and kidney T1 values; Magnetic resonance liver cell specificity of contrast agents enhancement: arterial phase, portal phase, liver and gall T1WI signal value of liver tissue. The MR function parameter changes as followed after TIPS will be analyzed. The MR function parameters with chemical biomarkers to predict survival will be analyzed.
Official Title
-----------------
Advanced Magnetic Resonance Technics for the Assessment of Liver Function Before and After Transjugular Intrahepatic Portosystemic Shunt
Conditions
-----------------
Liver Cirrhosis, Transjugular Intrahepatic Portosystemic Shunt (TIPS), Functional Magnetic Resonance Imaging
Intervention / Treatment
-----------------
* Procedure: TIPS
Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: 18-75 years old; Liver cirrhosis (diagnosis by imaging, laboratory examination, clinical symptoms and liver biopsy); History of endoscopy confirmed esophageal varicose vein hemorrhage (5 days or higher); The Child-Pugh, B or C less 13; Willing to participate in this clinical study, and sign an informed consent. Exclusion Criteria: Child-Pugh ≥12 or MELD ≥18; Non-cirrhotic portal hypertension (including regional portal hypertension); total bilirubin over 2 times upper; Combined liver cancer or other malignant tumor; Infection, uncontrolled sepsis, etc.; Heart, lung, kidney and other organs, severe disease; Women during pregnancy or lactation.
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?
-----------------
Arms and Interventions
| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Decompensated liver cirrhosis with TIPS<br> | Procedure: TIPS<br>* TIPS: Established distributary channel between the portal vein and hepatic vein via the jugular vein, portal vein blood directly shunts into the systemic circulation to reduce portal vein pressure to effectively prevent bleeding and refractory ascites.<br>|
What is the study measuring?
-----------------
Primary Outcome Measures
| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| mortality rate | | 5 years |
| Incidence of hepatic encephalopathy | | 5 years |
| Varices rebleeding rate | | 5 years |
Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
TIPS, functional MRI, liver corrhosis, portal hypertension, HVPG
|
||
NCT00498342
|
The Effect of Administration on N-Acetylcysteine on Serum Creatinine Levels in Patients With Chronic Kidney Disease
|
Primary outcome: Serum creatinine change at 4 hours and 48 hours following 4 doses of N-acetylcysteine (total 4800 mg) compared to baseline serum creatinine.~Secondary outcome: Serum Cystatin C change at 4 hours and 48 hours post 4 doses of N-acetylcysteine compared to baseline serum Cystatin C.
|
N-acetylcysteine has been reported to lower serum creatinine in normal individuals. The mechanism of this effect is unknown but possible stimulation of tubular secretion of creatinine has been hypothesized based upon a lack of effect on Cystatin C levels. If this effect also occurs in subjects with chronic kidney disease, interpretation of clinical trials using N-acetylcysteine for prophylaxis of acute kidney injury would be confounded. To answer whether such confounding occurs, 50 patients with stable chronic kidney disease (Stage 3-5) will be given 4 doses of N-acetylcysteine, 1200 mg each, with measurement of serum creatinine and Cystatin C before, 4 hours and 48 hours after the last dose. No other interventions, including changes in medications, will be permitted during the study.
|
The Effect of Administration on N-Acetylcysteine on Serum Creatinine Levels in Patients With Chronic Kidney Disease
|
Chronic Kidney Disease
|
* Drug: N-acetylcysteine
|
Inclusion Criteria:~Estimated GFR 10-59 ml/min/1.73m2 by 4 variable MDRD equation~Less than a 10% difference between the baseline creatinine and the recruitment creatinine obtained within 3 months of the trial~Exclusion Criteria:~Unable to give informed consent~Unwillingness to return for follow-up blood sampling~Unstable renal function~Subjects taking H2-blockers
|
18 Years
|
89 Years
|
All
|
No
|
Allocation: Non-Randomized
Intervention Model: Single Group Assignment
Masking: None (Open Label)
|
| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Serum creatinine change at 4 hours and 48 hours following 4 doses of N-acetylcysteine (total 4800 mg) compared to baseline serum creatinine | | 48 hours |
|
| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Serum Cystatin C change at 4 hours and 48 hours post 4 doses of N-acetylcysteine compared to baseline serum Cystatin C | | 48 hours |
|
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
|
| Intervention/Treatment |
| --- |
|Drug: N-acetylcysteine|nan|
|
The Effect of Administration on N-Acetylcysteine on Serum Creatinine Levels in Patients With Chronic Kidney Disease
Study Overview
=================
Brief Summary
-----------------
Primary outcome: Serum creatinine change at 4 hours and 48 hours following 4 doses of N-acetylcysteine (total 4800 mg) compared to baseline serum creatinine. Secondary outcome: Serum Cystatin C change at 4 hours and 48 hours post 4 doses of N-acetylcysteine compared to baseline serum Cystatin C.
Detailed Description
-----------------
N-acetylcysteine has been reported to lower serum creatinine in normal individuals. The mechanism of this effect is unknown but possible stimulation of tubular secretion of creatinine has been hypothesized based upon a lack of effect on Cystatin C levels. If this effect also occurs in subjects with chronic kidney disease, interpretation of clinical trials using N-acetylcysteine for prophylaxis of acute kidney injury would be confounded. To answer whether such confounding occurs, 50 patients with stable chronic kidney disease (Stage 3-5) will be given 4 doses of N-acetylcysteine, 1200 mg each, with measurement of serum creatinine and Cystatin C before, 4 hours and 48 hours after the last dose. No other interventions, including changes in medications, will be permitted during the study.
Official Title
-----------------
The Effect of Administration on N-Acetylcysteine on Serum Creatinine Levels in Patients With Chronic Kidney Disease
Conditions
-----------------
Chronic Kidney Disease
Intervention / Treatment
-----------------
* Drug: N-acetylcysteine
Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Estimated GFR 10-59 ml/min/1.73m2 by 4 variable MDRD equation Less than a 10% difference between the baseline creatinine and the recruitment creatinine obtained within 3 months of the trial Exclusion Criteria: Unable to give informed consent Unwillingness to return for follow-up blood sampling Unstable renal function Subjects taking H2-blockers
Ages Eligible for Study
-----------------
Minimum Age: 18 Years
Maximum Age: 89 Years
Sexes Eligible for Study
-----------------
All
Accepts Healthy Volunteers
-----------------
No
Study Plan
=================
How is the study designed?
-----------------
Design Details
Allocation: Non-Randomized
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Arms and Interventions
| Intervention/Treatment |
| --- |
|Drug: N-acetylcysteine|nan|
What is the study measuring?
-----------------
Primary Outcome Measures
| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Serum creatinine change at 4 hours and 48 hours following 4 doses of N-acetylcysteine (total 4800 mg) compared to baseline serum creatinine | | 48 hours |
Secondary Outcome Measures
| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Serum Cystatin C change at 4 hours and 48 hours post 4 doses of N-acetylcysteine compared to baseline serum Cystatin C | | 48 hours |
|
|
NCT02252367
|
Effect of 12 Weeks Treatment With Tadalafil vs Placebo on Lower Urinary Tract Symptoms
|
At present time several preclinical and clinical study have demonstrated the safety and efficacy of PDE5 (phosphodiesterase type 5)-inhibitors for LUTS/BPH (lower urinary tract symptoms/benign prostatic hyperplasia) patients with or without erectile dysfunction. However, the link between clinical outcomes (symptoms scores), functional activity (urodynamic findings) and molecular pathways, in particular regarding inflammatory pattern (molecular analyses), has not been previously investigated.~Aim of present study is to assess, for the first time in literature, changes in pressure flow study (PFS) and changes in molecular profile of prostatic tissue (inflammatory and tissue remodeling markers) in men treated for 12 weeks with tadalafil 5 mg compared with placebo and to correlate these data with changes in symptoms scores (IPSS, International Prostatic Symptoms Score) in men with LUTS secondary to BPH refractory to alpha blockers.
|
Double-blind, Placebo-controlled Study on Men With Lower Urinary Tract Symptoms to Assess Changes in Pressure Flow Study and in Molecular Profile of Prostatic Tissue After 12 Weeks Treatment With Tadalafil.
|
Prostatic Hyperplasia, Lower Urinary Tract Symptoms
|
* Drug: Tadalafil
* Other: Placebo
|
Inclusion Criteria:~adult male subjects planned to undergo simple prostatectomy (TURP, Transurethral resection of the prostate, or open prostatectomy) for benign prostatic hyperplasia;~treatment with alpha-blockers (Tamsulosin 0.4 mg/die)~being capable of giving informed consent.~Exclusion Criteria:~participation in another clinical study;~known or suspected presence of prostatic cancer or PSA (prostate specific antigen) value >10 ng/mL;~suspected lack of the participant's compliance;~known severe allergies or hypersensitivity to the study drug (active substance or excipients of the formulation);~nown neurogenic bladder (i.e. Parkinson's disease);~suspected or proven urinary infections;~presence of bladder stone.
|
18 Years
| null |
Male
|
No
|
Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple
|
| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Improvement of LUTS/BPH symptoms | BPH-associated inflammatory symptoms will be assessed by using the National Institute of Health Chronic Prostatitis Symptom Index (NIH-CPSI). BPH-associated LUTS will be assessed by using International Prostate Symptom Score (IPSS). | 12 weeks |
|
| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Improvement of pressure flow study (PFS) parameters | Maximum flow rate (Qmax), average flow rate (Qave), voided volume (Vcomp), post void residual volume (PVR) will be evaluated. An abdominal ultrasound immediately after voiding for uroflowmetry will be performed in order to determine the PVR. | 12 weeks |
| Volumetric change of the prostate | Prostate volume as assessed by transrectal ultrasound | 12 weeks |
| Change in prostate inhomogeneity and in the number of prostatic macrocalcifications | BPH-associated prostate inhomogeneity and presence of micro-calcifications will be assessed by using male genital tract male genital tract colour-Doppler ultrasonography. | 12 weeks |
| Variation in genic expression of prostatic inflammation markers | BPH-associated prostate inflammation, fibrosis, and hypoxia will be measured by immunohistochemical and quantitative RT-PCR (qRT-PCR) analyses of inflammatory-, fibrosis- and hypoxia-related markers. | 12 weeks |
| Variation in serum inflammation markers CRP (C-reactive protein) and ESR (Erythrocyte Sedimentation Rate) | CRP measured on serum and ESR measured on blood drawn at baseline and after 12 weeks | 12 weeks |
| Improvement in metabolic profile | Metabolic parameters will be evaluated (glycaemia, insulinemia, total cholesterol, HDL, triglycerides, HbA1c, mean arterial pressure, waist circumference, body mass index) | 12 weeks |
| Variation in seminal plasma IL-8 (interleukin-8) levels | Seminal IL-8, a chemokine involved in male genital tract infection/inflammation, will be evaluated. | 12 weeks |
| Improvement in erectile function | Erectile function will be assessed by using the International Index of Erectile Function-5 (IIEF-5) score. | 12 weeks |
|
BPH/LUTS, Phosphodiesterase 5 Inhibitors
|
Tadalafil, Phosphodiesterase 5 Inhibitors, Phosphodiesterase Inhibitors, Enzyme Inhibitors, Molecular Mechanisms of Pharmacological Action, Vasodilator Agents, Urological Agents
|
| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Tadalafil<br>43 male subjects affected by BPH (benign prostatic hyperplasia) planned for simple prostatectomy will be randomized to tadalafil 5 mg - 1 film-coated tablet orally once daily for 12 weeks. | Drug: Tadalafil<br>* Tadalafil 5 mg once daily for 12 weeks.<br>* Other names: Cialis;|
| Placebo Comparator: Placebo<br>43 male subjects affected by BPH (benign prostatic hyperplasia) planned for simple prostatectomy will be randomized to placebo. | Other: Placebo<br>* Placebo tablet once daily for 12 weeks.<br>|
|
Effect of 12 Weeks Treatment With Tadalafil vs Placebo on Lower Urinary Tract Symptoms
Study Overview
=================
Brief Summary
-----------------
At present time several preclinical and clinical study have demonstrated the safety and efficacy of PDE5 (phosphodiesterase type 5)-inhibitors for LUTS/BPH (lower urinary tract symptoms/benign prostatic hyperplasia) patients with or without erectile dysfunction. However, the link between clinical outcomes (symptoms scores), functional activity (urodynamic findings) and molecular pathways, in particular regarding inflammatory pattern (molecular analyses), has not been previously investigated. Aim of present study is to assess, for the first time in literature, changes in pressure flow study (PFS) and changes in molecular profile of prostatic tissue (inflammatory and tissue remodeling markers) in men treated for 12 weeks with tadalafil 5 mg compared with placebo and to correlate these data with changes in symptoms scores (IPSS, International Prostatic Symptoms Score) in men with LUTS secondary to BPH refractory to alpha blockers.
Official Title
-----------------
Double-blind, Placebo-controlled Study on Men With Lower Urinary Tract Symptoms to Assess Changes in Pressure Flow Study and in Molecular Profile of Prostatic Tissue After 12 Weeks Treatment With Tadalafil.
Conditions
-----------------
Prostatic Hyperplasia, Lower Urinary Tract Symptoms
Intervention / Treatment
-----------------
* Drug: Tadalafil
* Other: Placebo
Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: adult male subjects planned to undergo simple prostatectomy (TURP, Transurethral resection of the prostate, or open prostatectomy) for benign prostatic hyperplasia; treatment with alpha-blockers (Tamsulosin 0.4 mg/die) being capable of giving informed consent. Exclusion Criteria: participation in another clinical study; known or suspected presence of prostatic cancer or PSA (prostate specific antigen) value >10 ng/mL; suspected lack of the participant's compliance; known severe allergies or hypersensitivity to the study drug (active substance or excipients of the formulation); nown neurogenic bladder (i.e. Parkinson's disease); suspected or proven urinary infections; presence of bladder stone.
Ages Eligible for Study
-----------------
Minimum Age: 18 Years
Sexes Eligible for Study
-----------------
Male
Accepts Healthy Volunteers
-----------------
No
Study Plan
=================
How is the study designed?
-----------------
Design Details
Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple
Arms and Interventions
| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Tadalafil<br>43 male subjects affected by BPH (benign prostatic hyperplasia) planned for simple prostatectomy will be randomized to tadalafil 5 mg - 1 film-coated tablet orally once daily for 12 weeks. | Drug: Tadalafil<br>* Tadalafil 5 mg once daily for 12 weeks.<br>* Other names: Cialis;|
| Placebo Comparator: Placebo<br>43 male subjects affected by BPH (benign prostatic hyperplasia) planned for simple prostatectomy will be randomized to placebo. | Other: Placebo<br>* Placebo tablet once daily for 12 weeks.<br>|
What is the study measuring?
-----------------
Primary Outcome Measures
| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Improvement of LUTS/BPH symptoms | BPH-associated inflammatory symptoms will be assessed by using the National Institute of Health Chronic Prostatitis Symptom Index (NIH-CPSI). BPH-associated LUTS will be assessed by using International Prostate Symptom Score (IPSS). | 12 weeks |
Secondary Outcome Measures
| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Improvement of pressure flow study (PFS) parameters | Maximum flow rate (Qmax), average flow rate (Qave), voided volume (Vcomp), post void residual volume (PVR) will be evaluated. An abdominal ultrasound immediately after voiding for uroflowmetry will be performed in order to determine the PVR. | 12 weeks |
| Volumetric change of the prostate | Prostate volume as assessed by transrectal ultrasound | 12 weeks |
| Change in prostate inhomogeneity and in the number of prostatic macrocalcifications | BPH-associated prostate inhomogeneity and presence of micro-calcifications will be assessed by using male genital tract male genital tract colour-Doppler ultrasonography. | 12 weeks |
| Variation in genic expression of prostatic inflammation markers | BPH-associated prostate inflammation, fibrosis, and hypoxia will be measured by immunohistochemical and quantitative RT-PCR (qRT-PCR) analyses of inflammatory-, fibrosis- and hypoxia-related markers. | 12 weeks |
| Variation in serum inflammation markers CRP (C-reactive protein) and ESR (Erythrocyte Sedimentation Rate) | CRP measured on serum and ESR measured on blood drawn at baseline and after 12 weeks | 12 weeks |
| Improvement in metabolic profile | Metabolic parameters will be evaluated (glycaemia, insulinemia, total cholesterol, HDL, triglycerides, HbA1c, mean arterial pressure, waist circumference, body mass index) | 12 weeks |
| Variation in seminal plasma IL-8 (interleukin-8) levels | Seminal IL-8, a chemokine involved in male genital tract infection/inflammation, will be evaluated. | 12 weeks |
| Improvement in erectile function | Erectile function will be assessed by using the International Index of Erectile Function-5 (IIEF-5) score. | 12 weeks |
Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
BPH/LUTS, Phosphodiesterase 5 Inhibitors
|
|
NCT00406705
|
The Effect of Breathing Helium-Hyperoxia During Pulmonary Rehabilitation in Patients With COPD
|
The purpose of this study is to examine whether breathing helium-hyperoxia during exercise in a pulmonary rehabilitation program can improve the exercise tolerance and health related quality of life of patients with Chronic Obstructive Pulmonary Disease (COPD).
|
It is well accepted that the exercise training as part of a comprehensive pulmonary rehabilitation program can improve exercise tolerance, functional status and quality of life in patients with COPD. It is feasible that if patients were able to perform a greater volume or intensity of exercise during rehabilitation then the outcomes of the program would be improved. Recent research has demonstrated that breathing a helium-hyperoxic gas mixture can significantly reduce dynamic hyperinflation and dyspnea during exercise in patients with COPD and can increase exercise tolerance to a greater extent than breathing room air or a nitrogen-based hyperoxic gas. If patients with COPD were to breathe a helium-hyperoxic gas during exercise they should be able to tolerate a greater intensity of exercise while maintaining similar levels of exertional symptoms to those observed at lower exercise intensities breathing room air. As a result patients randomized to the helium-hyperoxia condition should obtain greater improvements in exercise tolerance than those receiving usual care (i.e. breathing room air)~Comparisons: Standard pulmonary rehabilitation of patients with COPD receiving either usual care (air breathing) or helium-hyperoxia (40% O2, 60% Helium).
|
A Randomized Controlled Trial to Study the Effect of Exercise Training Breathing Helium-Hyperoxia on The Exercise Tolerance and Quality of Life of Patients With Chronic Obstructive Pulmonary Disease
|
Chronic Obstructive Pulmonary Disease, COPD, Emphysema, Lung Diseases, Bronchitis, Chronic
|
* Behavioral: Helium-Hyperoxia
|
Inclusion Criteria:~FEV1/FVC<70% predicted;~FEV1<70% predicted;~RV>140% predicted.~Exclusion Criteria:~Cardiovascular contraindications to exercise;~Musculoskeletal abnormalities that limit exercise tolerance;~SpO2<85% during a constant work rate test;~On supplemental oxygen.~Exacerbation within the last month
| null | null |
All
|
No
|
Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double
|
| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Constant-load exercise tolerance after 6 weeks of exercise rehabilitation | | |
|
| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Maximum oxygen consumption after 6 weeks of exercise rehabilitation | | |
| Quality of Life measured after 6 weeks of exercise rehabilitation | | |
| Dyspnea at an isotime during constant-load exercise after 6 weeks of exercise rehabilitation | | |
|
Dyspnea, Exercise Tolerance, Rehabilitation, Helium
|
Emphysema, Bronchitis, Bronchitis, Chronic, Lung Diseases, Lung Diseases, Obstructive, Pulmonary Disease, Chronic Obstructive, Hyperoxia, Respiratory Tract Diseases, Chronic Disease, Disease Attributes, Pathologic Processes, Respiratory Tract Infections, Infections, Bronchial Diseases, Signs and Symptoms, Respiratory
|
| Intervention/Treatment |
| --- |
|Behavioral: Helium-Hyperoxia|nan|
|
The Effect of Breathing Helium-Hyperoxia During Pulmonary Rehabilitation in Patients With COPD
Study Overview
=================
Brief Summary
-----------------
The purpose of this study is to examine whether breathing helium-hyperoxia during exercise in a pulmonary rehabilitation program can improve the exercise tolerance and health related quality of life of patients with Chronic Obstructive Pulmonary Disease (COPD).
Detailed Description
-----------------
It is well accepted that the exercise training as part of a comprehensive pulmonary rehabilitation program can improve exercise tolerance, functional status and quality of life in patients with COPD. It is feasible that if patients were able to perform a greater volume or intensity of exercise during rehabilitation then the outcomes of the program would be improved. Recent research has demonstrated that breathing a helium-hyperoxic gas mixture can significantly reduce dynamic hyperinflation and dyspnea during exercise in patients with COPD and can increase exercise tolerance to a greater extent than breathing room air or a nitrogen-based hyperoxic gas. If patients with COPD were to breathe a helium-hyperoxic gas during exercise they should be able to tolerate a greater intensity of exercise while maintaining similar levels of exertional symptoms to those observed at lower exercise intensities breathing room air. As a result patients randomized to the helium-hyperoxia condition should obtain greater improvements in exercise tolerance than those receiving usual care (i.e. breathing room air) Comparisons: Standard pulmonary rehabilitation of patients with COPD receiving either usual care (air breathing) or helium-hyperoxia (40% O2, 60% Helium).
Official Title
-----------------
A Randomized Controlled Trial to Study the Effect of Exercise Training Breathing Helium-Hyperoxia on The Exercise Tolerance and Quality of Life of Patients With Chronic Obstructive Pulmonary Disease
Conditions
-----------------
Chronic Obstructive Pulmonary Disease, COPD, Emphysema, Lung Diseases, Bronchitis, Chronic
Intervention / Treatment
-----------------
* Behavioral: Helium-Hyperoxia
Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: FEV1/FVC<70% predicted; FEV1<70% predicted; RV>140% predicted. Exclusion Criteria: Cardiovascular contraindications to exercise; Musculoskeletal abnormalities that limit exercise tolerance; SpO2<85% during a constant work rate test; On supplemental oxygen. Exacerbation within the last month
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 |
| --- |
|Behavioral: Helium-Hyperoxia|nan|
What is the study measuring?
-----------------
Primary Outcome Measures
| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Constant-load exercise tolerance after 6 weeks of exercise rehabilitation | | |
Secondary Outcome Measures
| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Maximum oxygen consumption after 6 weeks of exercise rehabilitation | | |
| Quality of Life measured after 6 weeks of exercise rehabilitation | | |
| Dyspnea at an isotime during constant-load exercise after 6 weeks of exercise rehabilitation | | |
Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Dyspnea, Exercise Tolerance, Rehabilitation, Helium
|
NCT02146339
|
Impact of Milk Polar Lipids on Lipids Digestion, Absorption and Metabolism
|
Polar lipids have a specific chemical structure: they are an essential component of human cell membranes, play a major role in the nervous system and also influence the metabolic pathways including the cholesterol metabolism.~Polar lipids are used in food-processing industry for their emulsification properties. The most famous emulsifier is soya lecithin but milk also naturally contains natural emulsifiers such as polar lipids. Milk polar lipids are rich in sphingomyelin and they may have beneficial effects on lipid metabolism in the context of metabolic diseases of nutritional origin.~The purpose of this research is to study the variation of sphingomyelin content at the ileum's end after the consumption of different doses of milk polar lipids, and consequences on the intestinal absorption and metabolism of fatty acids and cholesterol.~The subjects will be taking three different test meals varying by their milk polar lipids content.~It is a bi-centric study with a centre in LYON (Centre de Recherche en Nutrition Humaine Rhône-Alpes) and CLERMONT-FERRAND (Centre de Recherche en Nutrition Humaine Auvergne).
|
Impact of Milk Polar Lipids Content in a Test Meal on Lipid Composition of Ileostomy Fluid and Consequences on Postprandial Dietary Cholesterol and Fatty Acid Metabolism.
|
Cardiometabolic Risk
|
* Other: Cheese n°1- cheese n°2 - cheese n°3
* Other: Cheese n°1- cheese n°3 - cheese n°2
* Other: cheese n°2 - cheese n°1- cheese n°3
* Other: Cheese n°2- cheese n°3 - cheese n°1
* Other: Cheese n°3 - cheese n°1- cheese n°2
* Other: Cheese n°3- cheese n°2 - cheese n°1
|
Inclusion Criteria:~Men and women aged between 18 and 75 years~Having undergone a temporary or permanent ileostomy,~Considered to have well-functioning ileostomy~Normal (or not clinically significant) lipid parameters~Exclusion Criteria:~Ileostomy due to an ongoing digestive cancer~Ileostomy due to a Chrohn's disease~Dairy products allergy or intolerance~Medication that could interfere with lipid metabolism
|
18 Years
|
75 Years
|
All
|
No
|
Primary Purpose: Basic Science
Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: Quadruple
|
| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Ileal sphingomyelin output | The total sphingomyelin output will be measured in the ileostomy fluids over 8 hours after the consumption of the 3 different test meals. | up to Day 63 |
|
| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Plasma lipids and isotopic tracers | Plasma lipids and isotopic tracers will be measured after the consumption of the 3 different test meals. Fasting and postprandial measurements over 8 hours depending on parameters. | A least Day 7, Day 35 and Day 63 |
| Plasma glucose and insulin | Plasma glucose and insulin will be measured after the consumption of the 3 different test meals. Fasting and postprandial measurements over 8 hours. | At least Day 7, Day 35 and Day 63 |
| Energy expenditure and substrate oxidation with indirect calorimetry | Energy metabolism and 13CO2 will be measured after the consumption of the 3 different test meals. Fasting and during all the postprandial period (8 h). | At least Day7, Day 35 and Day 63 |
|
nutrition, milk, polar lipids, cardiometabolic risk
|
| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Unfortified-3g-5g milk polar lipid fortified cheese product<br>Each subject will receive a single dose of each cheese product (100 g) containing no or 3g or 5g of milk polar lipids, 300 mg of [1,1,1]-13C-triolein and 45 mg of 2H6-cholesterol. The wash-out period is four weeks. | Other: Cheese n°1- cheese n°2 - cheese n°3<br>* Each subject will receive a single dose of cheese n°1, then cheese n°2 after a wash-out period of 4 weeks, then cheese n°3 after a wash-out period of 4 weeks.~Cheese n°1 = unfortified cheese product Cheese n°2 = 3 g milk polar lipid fortified cheese product Cheese n°3 = 5 g milk polar lipid fortified cheese product<br>|
| Experimental: Unfortified-5g-3g milk polar lipid fortified cheese product<br>Each subject will receive a single dose of each cheese product (100 g) containing no or 3g or 5g of milk polar lipids, 300 mg of [1,1,1]-13C-triolein and 45 mg of 2H6-cholesterol. The wash-out period is four weeks. | Other: Cheese n°1- cheese n°3 - cheese n°2<br>* Each subject will receive a single dose of cheese n°1, then cheese n°3 after a wash-out period of 4 weeks, then cheese n°2 after a wash-out period of 4 weeks.~Cheese n°1 = unfortified cheese product Cheese n°2 = 3 g milk polar lipid fortified cheese product Cheese n°3 = 5 g milk polar lipid fortified cheese product<br>|
| Experimental: 3g-5g milk polar lipid fortified-unfortified cheese product<br>Each subject will receive a single dose of each cheese product (100 g) containing no or 3g or 5g of milk polar lipids, 300 mg of [1,1,1]-13C-triolein and 45 mg of 2H6-cholesterol. The wash-out period is four weeks. | Other: Cheese n°2- cheese n°3 - cheese n°1<br>* Each subject will receive a single dose of cheese n°2, then cheese n°3 after a wash-out period of 4 weeks, then cheese n°1 after a wash-out period of 4 weeks.~Cheese n°1 = unfortified cheese product Cheese n°2 = 3 g milk polar lipid fortified cheese product Cheese n°3 = 5 g milk polar lipid fortified cheese product<br>|
| Other: 3g-Unfortified-5g milk polar lipid fortified cheese product<br>Each subject will receive a single dose of cheese n°1, then cheese n°2 after a wash-out period of 4 weeks, then cheese n°3 after a wash-out period of 4 weeks.~Cheese n°1 = unfortified cheese product Cheese n°2 = 3 g milk polar lipid fortified cheese product Cheese n°3 = 5 g milk polar lipid fortified cheese product | Other: cheese n°2 - cheese n°1- cheese n°3<br>* Each subject will receive a single dose of cheese n°2, then cheese n°1 after a wash-out period of 4 weeks, then cheese n°3 after a wash-out period of 4 weeks.~Cheese n°1 = unfortified cheese product Cheese n°2 = 3 g milk polar lipid fortified cheese product Cheese n°3 = 5 g milk polar lipid fortified cheese product<br>|
| Experimental: 5g-unfortified-3g milk polar lipid fortified cheese product<br>Each subject will receive a single dose of each cheese product (100 g) containing no or 3g or 5g of milk polar lipids, 300 mg of [1,1,1]-13C-triolein and 45 mg of 2H6-cholesterol. The wash-out period is four weeks. | Other: Cheese n°3 - cheese n°1- cheese n°2<br>* Each subject will receive a single dose of cheese n°3, then cheese n°1 after a wash-out period of 4 weeks, then cheese n°2 after a wash-out period of 4 weeks.~Cheese n°1 = unfortified cheese product Cheese n°2 = 3 g milk polar lipid fortified cheese product Cheese n°3 = 5 g milk polar lipid fortified cheese product<br>|
| Other: 5g-3g milk polar lipid fortified-unfortified cheese product<br>Each subject will receive a single dose of each cheese product (100 g) containing no or 3g or 5g of milk polar lipids, 300 mg of [1,1,1]-13C-triolein and 45 mg of 2H6-cholesterol. The wash-out period is four weeks. | Other: Cheese n°3- cheese n°2 - cheese n°1<br>* Each subject will receive a single dose of cheese n°3, then cheese n°2 after a wash-out period of 4 weeks, then cheese n°1 after a wash-out period of 4 weeks.~Cheese n°1 = unfortified cheese product Cheese n°2 = 3 g milk polar lipid fortified cheese product Cheese n°3 = 5 g milk polar lipid fortified cheese product<br>|
|
Impact of Milk Polar Lipids on Lipids Digestion, Absorption and Metabolism
Study Overview
=================
Brief Summary
-----------------
Polar lipids have a specific chemical structure: they are an essential component of human cell membranes, play a major role in the nervous system and also influence the metabolic pathways including the cholesterol metabolism. Polar lipids are used in food-processing industry for their emulsification properties. The most famous emulsifier is soya lecithin but milk also naturally contains natural emulsifiers such as polar lipids. Milk polar lipids are rich in sphingomyelin and they may have beneficial effects on lipid metabolism in the context of metabolic diseases of nutritional origin. The purpose of this research is to study the variation of sphingomyelin content at the ileum's end after the consumption of different doses of milk polar lipids, and consequences on the intestinal absorption and metabolism of fatty acids and cholesterol. The subjects will be taking three different test meals varying by their milk polar lipids content. It is a bi-centric study with a centre in LYON (Centre de Recherche en Nutrition Humaine Rhône-Alpes) and CLERMONT-FERRAND (Centre de Recherche en Nutrition Humaine Auvergne).
Official Title
-----------------
Impact of Milk Polar Lipids Content in a Test Meal on Lipid Composition of Ileostomy Fluid and Consequences on Postprandial Dietary Cholesterol and Fatty Acid Metabolism.
Conditions
-----------------
Cardiometabolic Risk
Intervention / Treatment
-----------------
* Other: Cheese n°1- cheese n°2 - cheese n°3
* Other: Cheese n°1- cheese n°3 - cheese n°2
* Other: cheese n°2 - cheese n°1- cheese n°3
* Other: Cheese n°2- cheese n°3 - cheese n°1
* Other: Cheese n°3 - cheese n°1- cheese n°2
* Other: Cheese n°3- cheese n°2 - cheese n°1
Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Men and women aged between 18 and 75 years Having undergone a temporary or permanent ileostomy, Considered to have well-functioning ileostomy Normal (or not clinically significant) lipid parameters Exclusion Criteria: Ileostomy due to an ongoing digestive cancer Ileostomy due to a Chrohn's disease Dairy products allergy or intolerance Medication that could interfere with lipid metabolism
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: Basic Science
Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: Quadruple
Arms and Interventions
| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Unfortified-3g-5g milk polar lipid fortified cheese product<br>Each subject will receive a single dose of each cheese product (100 g) containing no or 3g or 5g of milk polar lipids, 300 mg of [1,1,1]-13C-triolein and 45 mg of 2H6-cholesterol. The wash-out period is four weeks. | Other: Cheese n°1- cheese n°2 - cheese n°3<br>* Each subject will receive a single dose of cheese n°1, then cheese n°2 after a wash-out period of 4 weeks, then cheese n°3 after a wash-out period of 4 weeks. Cheese n°1 = unfortified cheese product Cheese n°2 = 3 g milk polar lipid fortified cheese product Cheese n°3 = 5 g milk polar lipid fortified cheese product<br>|
| Experimental: Unfortified-5g-3g milk polar lipid fortified cheese product<br>Each subject will receive a single dose of each cheese product (100 g) containing no or 3g or 5g of milk polar lipids, 300 mg of [1,1,1]-13C-triolein and 45 mg of 2H6-cholesterol. The wash-out period is four weeks. | Other: Cheese n°1- cheese n°3 - cheese n°2<br>* Each subject will receive a single dose of cheese n°1, then cheese n°3 after a wash-out period of 4 weeks, then cheese n°2 after a wash-out period of 4 weeks. Cheese n°1 = unfortified cheese product Cheese n°2 = 3 g milk polar lipid fortified cheese product Cheese n°3 = 5 g milk polar lipid fortified cheese product<br>|
| Experimental: 3g-5g milk polar lipid fortified-unfortified cheese product<br>Each subject will receive a single dose of each cheese product (100 g) containing no or 3g or 5g of milk polar lipids, 300 mg of [1,1,1]-13C-triolein and 45 mg of 2H6-cholesterol. The wash-out period is four weeks. | Other: Cheese n°2- cheese n°3 - cheese n°1<br>* Each subject will receive a single dose of cheese n°2, then cheese n°3 after a wash-out period of 4 weeks, then cheese n°1 after a wash-out period of 4 weeks. Cheese n°1 = unfortified cheese product Cheese n°2 = 3 g milk polar lipid fortified cheese product Cheese n°3 = 5 g milk polar lipid fortified cheese product<br>|
| Other: 3g-Unfortified-5g milk polar lipid fortified cheese product<br>Each subject will receive a single dose of cheese n°1, then cheese n°2 after a wash-out period of 4 weeks, then cheese n°3 after a wash-out period of 4 weeks. Cheese n°1 = unfortified cheese product Cheese n°2 = 3 g milk polar lipid fortified cheese product Cheese n°3 = 5 g milk polar lipid fortified cheese product | Other: cheese n°2 - cheese n°1- cheese n°3<br>* Each subject will receive a single dose of cheese n°2, then cheese n°1 after a wash-out period of 4 weeks, then cheese n°3 after a wash-out period of 4 weeks. Cheese n°1 = unfortified cheese product Cheese n°2 = 3 g milk polar lipid fortified cheese product Cheese n°3 = 5 g milk polar lipid fortified cheese product<br>|
| Experimental: 5g-unfortified-3g milk polar lipid fortified cheese product<br>Each subject will receive a single dose of each cheese product (100 g) containing no or 3g or 5g of milk polar lipids, 300 mg of [1,1,1]-13C-triolein and 45 mg of 2H6-cholesterol. The wash-out period is four weeks. | Other: Cheese n°3 - cheese n°1- cheese n°2<br>* Each subject will receive a single dose of cheese n°3, then cheese n°1 after a wash-out period of 4 weeks, then cheese n°2 after a wash-out period of 4 weeks. Cheese n°1 = unfortified cheese product Cheese n°2 = 3 g milk polar lipid fortified cheese product Cheese n°3 = 5 g milk polar lipid fortified cheese product<br>|
| Other: 5g-3g milk polar lipid fortified-unfortified cheese product<br>Each subject will receive a single dose of each cheese product (100 g) containing no or 3g or 5g of milk polar lipids, 300 mg of [1,1,1]-13C-triolein and 45 mg of 2H6-cholesterol. The wash-out period is four weeks. | Other: Cheese n°3- cheese n°2 - cheese n°1<br>* Each subject will receive a single dose of cheese n°3, then cheese n°2 after a wash-out period of 4 weeks, then cheese n°1 after a wash-out period of 4 weeks. Cheese n°1 = unfortified cheese product Cheese n°2 = 3 g milk polar lipid fortified cheese product Cheese n°3 = 5 g milk polar lipid fortified cheese product<br>|
What is the study measuring?
-----------------
Primary Outcome Measures
| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Ileal sphingomyelin output | The total sphingomyelin output will be measured in the ileostomy fluids over 8 hours after the consumption of the 3 different test meals. | up to Day 63 |
Secondary Outcome Measures
| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Plasma lipids and isotopic tracers | Plasma lipids and isotopic tracers will be measured after the consumption of the 3 different test meals. Fasting and postprandial measurements over 8 hours depending on parameters. | A least Day 7, Day 35 and Day 63 |
| Plasma glucose and insulin | Plasma glucose and insulin will be measured after the consumption of the 3 different test meals. Fasting and postprandial measurements over 8 hours. | At least Day 7, Day 35 and Day 63 |
| Energy expenditure and substrate oxidation with indirect calorimetry | Energy metabolism and 13CO2 will be measured after the consumption of the 3 different test meals. Fasting and during all the postprandial period (8 h). | At least Day7, Day 35 and Day 63 |
Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
nutrition, milk, polar lipids, cardiometabolic risk
|
||
NCT00763282
|
Self-Management to Prevent Ulcers in Veterans With SCI (Spinal Cord Injury)
|
Pressure ulcers (PrUs) are the most frequent significant medical complication after spinal cord injury (SCI). PrU prevalence, morbidity, mortality, and recurrence rates are high, and most persons with SCI will have at least one serious PrU during their lifetime. VA costs of treating the almost 3,500 unique Veterans with SCI and a severe ulcer at an SCI Center in FY10 was just under $400 million.
|
Background:~Pressure ulcers (PrUs) are the most frequent significant medical complication after spinal cord injury (SCI). PrU prevalence, morbidity, mortality, and recurrence rates are high, and most persons with SCI will have at least one serious PrU during their lifetime. VA costs of treating the almost 3,500 unique Veterans with SCI and a severe ulcer at an SCI Center in 2010 was just under $400 million.~Objectives:~The primary objective of this randomized clinical trial (RCT) was to determine whether a multi-component self-management (SM) intervention increases the use of skin-protective behaviors and reduces skin worsening in Veterans with SCI, compared to an education control (ED) intervention. Secondary outcomes included PrU knowledge, self-management skills, communication with providers, self-efficacy, community integration and days on bedrest. Another objective was to conduct focus group interviews with patients and providers and to analyze transcripts of SM group sessions to determine barriers and facilitators with regard to spinal cord injury and pressure ulcer prevention.~Methods:~This was a multi-site efficacy intervention study with a single blind prospective randomized design. Descriptive statistics were used to summarize demographic and key variables. Supplemental focus group interviews were conducted with patients with SCI (n=35) and SCI providers (n=39). Focus group interviews and SM group calls were transcribed verbatim and analyzed using constant comparative techniques.~Study participants included Veterans hospitalized for Stage III/IV PrUs at or below the level of injury, from six VA SCI Centers around the country (Long Beach, Houston, Milwaukee, Augusta, Hines and St. Louis). Prior to discharge, PrU risk factors were identified and 1:1 PrU education was provided. Randomization and the behavioral interventions began at discharge. The number of randomized subjects were 72 in the ED group and 72 in the SM group (n=144). The analytic sample included subjects with complete data (n=92).~The intervention included 8 site coordinator-initiated calls using didactic (ED) or Motivational Interviewing (MI) strategies to address PrU risk factors. The second component included telephone group calls that included either didactic information about SCI or SM skills including: 1) knowledge about the medical condition; 2) self-monitoring; 3) problem-solving skills; 4) skill for managing the effects of the condition; 5) adherence to necessary health behaviors; and 6) self-advocacy with health care providers. ED subjects received general health information and were not instructed in any specific problem solving, self-monitoring or SM techniques. The ED intervention was comparable to the SM with respect to natural history/ time, dosing, measurement processes, attention, therapeutic alliance, social support, and in receiving a manualized treatment with specific therapist procedures. Self-reported outcome data were obtained by phone at 3 and 6 months, and from mailed photos of study ulcers.~Status:~Study is complete. Additional analyses are ongoing and future manuscripts are planned.
|
Self-Management to Prevent Ulcers in Veterans With Spinal Cord Injury
|
Pressure Ulcers, Spinal Cord Injuries
|
* Behavioral: Self Management (SM)
* Behavioral: Motivational Interviewing (MI)
* Behavioral: Education (ED)
|
Inclusion Criteria:~over 18 years of age,~SCI of at least six month's duration,~hospitalized for a Stage III or IV PrU,~cognitively intact,~available for telephone follow-up, and~discharged to a community setting or able to direct own care.~Exclusion Criteria:~We excluded patients with a terminal diagnosis, severe psychiatric comorbidities (eg, current psychosis), cognitive impairments that limited their ability to consent or participate, severe hearing loss, and wounds not expected to heal. People discharged to nursing homes unable to direct their own care were also excluded.
|
18 Years
| null |
All
|
No
|
Primary Purpose: Prevention
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single
|
| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Percent of Possible Self-Reported Skin Care Behaviors | Skin Behavior Change was calculated as the percentage of Self-Reported Behavior at 3 and 6 months (minus the percentage at baseline).~The study reported the number of guideline-recommended skin care behaviors, assessed by the Skin Care Behavior Checklist, a self-reported measure of adherence to 8 guideline recommended skin care behaviors. The average percentage of the 8 behaviors adhered to for each participant was measured by intervention arms at admission (baseline), 3 and 6 months post-discharge. | Admission (Baseline), 3 months, 6 months |
| Skin Behavior Change | Self-reported improvement in skin care behaviors in the SM+MI versus ED control intervention arms.~The study reported the number of guideline-recommended skin care behaviors, assessed by the Skin Care Behavior Checklist, a self-report measure of adherence to 8 skin care behaviors for each participant.The difference in the average percentage of the 8 behaviors adhered to by each participant was measured for the different intervention arms from admission (baseline) to 3 and 6 months post-discharge. | Admission (Baseline), 3 months, 6 months |
| Any Skin Worsening | Skin worsening was defined as when a participant with an open wound at the time of discharge is found to have >20% wound area at 3 or 6 months post-discharge (including new wounds and reopened wounds). Worsening was also defined as a when a participant with a closed wound at discharge is found to have a new or reopened wound at 3 or 6 months post-discharge. | 6 months |
| Skin Status | Skin worsening was defined as when a participant with an open wound at the time of discharge is found to have >20% wound area at 3 or 6 months post-discharge (including new wounds and reopened wounds). Worsening was also defined as a when a participant with a closed wound at discharge is found to have a new or reopened wound at 3 or 6 months post-discharge. | Admission (Baseline), 3 months, 6 months |
|
| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Mean Number of Skin-related Admissions | Post-discharge skin-related hospitalizations were for both groups (SM+MI vs. ED) but not as study-related or as an adverse event. This study examined an outpatient intervention during which rehospitalization could be triggered by the participants' early reporting of skin breakdown. | Discharge to end of study (6 months) |
|
Spinal cord injuries, Pressure ulcers, Health behavior, self management, Rehabilitation, Outcome assessment, QUERI, Veterans
|
Spinal Cord Injuries, Pressure Ulcer, Ulcer, Wounds and Injuries, Pathologic Processes, Spinal Cord Diseases, Central Nervous System Diseases, Nervous System Diseases, Trauma, Nervous System, Skin Ulcer, Skin Diseases
|
| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: SM+MI<br>Self Management (SM) + Motivational Interviewing (MI). Self Management and Motivational Interviewing (SM+MI) participants were assigned to both a self-management and motivational interview group. Motivational Interviewing (MI) is an evidence-based form of counseling to help individuals to engage in behavior change. Self Management (SM) consists of: 1) on-site decisional support to promote provider adherence to ulcer management guidelines, 2) enhanced, interactive PrU education, 3) chronic disease self-management skill building via telephone based groups, 4) proactive care management using MI to support ongoing self-management activities, and 5) distance technology. | Behavioral: Self Management (SM)<br>* Self Management (SM) consists of: 1) on-site decisional support to promote provider adherence to ulcer management guidelines, 2) enhanced, interactive PrU education, 3) chronic disease self-management skill building via telephone based groups, 4) proactive care management using MI to support ongoing self-management activities, and 5) distance technology.<br>Behavioral: Motivational Interviewing (MI)<br>* Self Management and Motivational Interviewing (SM+MI) participants were assigned to both a self-management and motivational interview group. An education control intervention (ED) designed to be a credible intervention that is comparable to the SM will control for potential effects of natural history/time, treatment dosing, measurement processes, attention, the non-specific effects of therapeutic alliance, social support, and of receiving a manualized treatment with specific therapist procedures.<br>|
| Active Comparator: ED<br>Education (ED). An education control intervention (ED) designed to be a credible intervention that is comparable to the SM will control for potential effects of natural history/time, treatment dosing, measurement processes, attention, the non-specific effects of therapeutic alliance, social support, and of receiving a manualized treatment with specific therapist procedures. The ED intervention will differ only in that subjects will not be instructed in any specific problem solving, self-monitoring, or SM techniques, with the exception of encouraging them to become informed consumers of SCI care. | Behavioral: Education (ED)<br>* The ED intervention differs only in that subjects will not be instructed in any specific problem solving, self-monitoring, or SM techniques, with the exception of encouraging them to become informed consumers of SCI care.<br>|
|
Self-Management to Prevent Ulcers in Veterans With SCI (Spinal Cord Injury)
Study Overview
=================
Brief Summary
-----------------
Pressure ulcers (PrUs) are the most frequent significant medical complication after spinal cord injury (SCI). PrU prevalence, morbidity, mortality, and recurrence rates are high, and most persons with SCI will have at least one serious PrU during their lifetime. VA costs of treating the almost 3,500 unique Veterans with SCI and a severe ulcer at an SCI Center in FY10 was just under $400 million.
Detailed Description
-----------------
Background: Pressure ulcers (PrUs) are the most frequent significant medical complication after spinal cord injury (SCI). PrU prevalence, morbidity, mortality, and recurrence rates are high, and most persons with SCI will have at least one serious PrU during their lifetime. VA costs of treating the almost 3,500 unique Veterans with SCI and a severe ulcer at an SCI Center in 2010 was just under $400 million. Objectives: The primary objective of this randomized clinical trial (RCT) was to determine whether a multi-component self-management (SM) intervention increases the use of skin-protective behaviors and reduces skin worsening in Veterans with SCI, compared to an education control (ED) intervention. Secondary outcomes included PrU knowledge, self-management skills, communication with providers, self-efficacy, community integration and days on bedrest. Another objective was to conduct focus group interviews with patients and providers and to analyze transcripts of SM group sessions to determine barriers and facilitators with regard to spinal cord injury and pressure ulcer prevention. Methods: This was a multi-site efficacy intervention study with a single blind prospective randomized design. Descriptive statistics were used to summarize demographic and key variables. Supplemental focus group interviews were conducted with patients with SCI (n=35) and SCI providers (n=39). Focus group interviews and SM group calls were transcribed verbatim and analyzed using constant comparative techniques. Study participants included Veterans hospitalized for Stage III/IV PrUs at or below the level of injury, from six VA SCI Centers around the country (Long Beach, Houston, Milwaukee, Augusta, Hines and St. Louis). Prior to discharge, PrU risk factors were identified and 1:1 PrU education was provided. Randomization and the behavioral interventions began at discharge. The number of randomized subjects were 72 in the ED group and 72 in the SM group (n=144). The analytic sample included subjects with complete data (n=92). The intervention included 8 site coordinator-initiated calls using didactic (ED) or Motivational Interviewing (MI) strategies to address PrU risk factors. The second component included telephone group calls that included either didactic information about SCI or SM skills including: 1) knowledge about the medical condition; 2) self-monitoring; 3) problem-solving skills; 4) skill for managing the effects of the condition; 5) adherence to necessary health behaviors; and 6) self-advocacy with health care providers. ED subjects received general health information and were not instructed in any specific problem solving, self-monitoring or SM techniques. The ED intervention was comparable to the SM with respect to natural history/ time, dosing, measurement processes, attention, therapeutic alliance, social support, and in receiving a manualized treatment with specific therapist procedures. Self-reported outcome data were obtained by phone at 3 and 6 months, and from mailed photos of study ulcers. Status: Study is complete. Additional analyses are ongoing and future manuscripts are planned.
Official Title
-----------------
Self-Management to Prevent Ulcers in Veterans With Spinal Cord Injury
Conditions
-----------------
Pressure Ulcers, Spinal Cord Injuries
Intervention / Treatment
-----------------
* Behavioral: Self Management (SM)
* Behavioral: Motivational Interviewing (MI)
* Behavioral: Education (ED)
Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: over 18 years of age, SCI of at least six month's duration, hospitalized for a Stage III or IV PrU, cognitively intact, available for telephone follow-up, and discharged to a community setting or able to direct own care. Exclusion Criteria: We excluded patients with a terminal diagnosis, severe psychiatric comorbidities (eg, current psychosis), cognitive impairments that limited their ability to consent or participate, severe hearing loss, and wounds not expected to heal. People discharged to nursing homes unable to direct their own care were also excluded.
Ages Eligible for Study
-----------------
Minimum Age: 18 Years
Sexes Eligible for Study
-----------------
All
Accepts Healthy Volunteers
-----------------
No
Study Plan
=================
How is the study designed?
-----------------
Design Details
Primary Purpose: Prevention
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single
Arms and Interventions
| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: SM+MI<br>Self Management (SM) + Motivational Interviewing (MI). Self Management and Motivational Interviewing (SM+MI) participants were assigned to both a self-management and motivational interview group. Motivational Interviewing (MI) is an evidence-based form of counseling to help individuals to engage in behavior change. Self Management (SM) consists of: 1) on-site decisional support to promote provider adherence to ulcer management guidelines, 2) enhanced, interactive PrU education, 3) chronic disease self-management skill building via telephone based groups, 4) proactive care management using MI to support ongoing self-management activities, and 5) distance technology. | Behavioral: Self Management (SM)<br>* Self Management (SM) consists of: 1) on-site decisional support to promote provider adherence to ulcer management guidelines, 2) enhanced, interactive PrU education, 3) chronic disease self-management skill building via telephone based groups, 4) proactive care management using MI to support ongoing self-management activities, and 5) distance technology.<br>Behavioral: Motivational Interviewing (MI)<br>* Self Management and Motivational Interviewing (SM+MI) participants were assigned to both a self-management and motivational interview group. An education control intervention (ED) designed to be a credible intervention that is comparable to the SM will control for potential effects of natural history/time, treatment dosing, measurement processes, attention, the non-specific effects of therapeutic alliance, social support, and of receiving a manualized treatment with specific therapist procedures.<br>|
| Active Comparator: ED<br>Education (ED). An education control intervention (ED) designed to be a credible intervention that is comparable to the SM will control for potential effects of natural history/time, treatment dosing, measurement processes, attention, the non-specific effects of therapeutic alliance, social support, and of receiving a manualized treatment with specific therapist procedures. The ED intervention will differ only in that subjects will not be instructed in any specific problem solving, self-monitoring, or SM techniques, with the exception of encouraging them to become informed consumers of SCI care. | Behavioral: Education (ED)<br>* The ED intervention differs only in that subjects will not be instructed in any specific problem solving, self-monitoring, or SM techniques, with the exception of encouraging them to become informed consumers of SCI care.<br>|
What is the study measuring?
-----------------
Primary Outcome Measures
| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Percent of Possible Self-Reported Skin Care Behaviors | Skin Behavior Change was calculated as the percentage of Self-Reported Behavior at 3 and 6 months (minus the percentage at baseline). The study reported the number of guideline-recommended skin care behaviors, assessed by the Skin Care Behavior Checklist, a self-reported measure of adherence to 8 guideline recommended skin care behaviors. The average percentage of the 8 behaviors adhered to for each participant was measured by intervention arms at admission (baseline), 3 and 6 months post-discharge. | Admission (Baseline), 3 months, 6 months |
| Skin Behavior Change | Self-reported improvement in skin care behaviors in the SM+MI versus ED control intervention arms. The study reported the number of guideline-recommended skin care behaviors, assessed by the Skin Care Behavior Checklist, a self-report measure of adherence to 8 skin care behaviors for each participant.The difference in the average percentage of the 8 behaviors adhered to by each participant was measured for the different intervention arms from admission (baseline) to 3 and 6 months post-discharge. | Admission (Baseline), 3 months, 6 months |
| Any Skin Worsening | Skin worsening was defined as when a participant with an open wound at the time of discharge is found to have >20% wound area at 3 or 6 months post-discharge (including new wounds and reopened wounds). Worsening was also defined as a when a participant with a closed wound at discharge is found to have a new or reopened wound at 3 or 6 months post-discharge. | 6 months |
| Skin Status | Skin worsening was defined as when a participant with an open wound at the time of discharge is found to have >20% wound area at 3 or 6 months post-discharge (including new wounds and reopened wounds). Worsening was also defined as a when a participant with a closed wound at discharge is found to have a new or reopened wound at 3 or 6 months post-discharge. | Admission (Baseline), 3 months, 6 months |
Secondary Outcome Measures
| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Mean Number of Skin-related Admissions | Post-discharge skin-related hospitalizations were for both groups (SM+MI vs. ED) but not as study-related or as an adverse event. This study examined an outpatient intervention during which rehospitalization could be triggered by the participants' early reporting of skin breakdown. | Discharge to end of study (6 months) |
Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Spinal cord injuries, Pressure ulcers, Health behavior, self management, Rehabilitation, Outcome assessment, QUERI, Veterans
|
NCT00765011
|
TPF Plus Radiotherapy and Cetuximab to Avoid Total Laryngectomy in Patients With Larynx Cancer
|
A Phase II Trial With Radiotherapy Plus Cetuximab to Evaluate Specific Survival Free of Laryngectomy in Patients With Resectable and Locally Advanced Larynx Cancer, After Treatment With TPF Chemotherapy.
|
This study is being sponsored by a cooperative medical group.
|
A Phase II Trial With Radiotherapy Plus Cetuximab to Evaluate Specific Survival Free of Laryngectomy in Patients With Resectable and Locally Advanced Larynx Cancer, After Treatment With TPF
|
Head and Neck Cancer
|
* Drug: TPF, radiotherapy and cetuximab
* Procedure: H&N surgery
|
Inclusion Criteria:~Signed Informed Consent Form.~Men or women, age (18 and 70).~ECOG scale:0-1.~Life expectancy superior to 3 months.~Larynx squamous carcinoma histologically demonstrated.~Patients with larynx squamous carcinoma, stage III-IVA, with resectable disease whose surgery will imply a total laryngectomy. The T should be a T3, T4A, or a T2 not candidate for a partial laryngectomy. In case of T2 of any of both locations it will be required a III or IVA stadium.~Patients to be able to receive treatment with TPF followed by normofractionated radiotherapy with cetuximab.~Measurable disease (OMS criteria).~Neutrophils superior or equal to 1500/mm3, platelets superior or equal to 150.000/mm3, hemoglobin superior or equal to 10 g/dl.~Adequate renal function: creatinin lower or equal to 120 µmol/l (1,4mg/dl)~Adequate hepatic function: bilirubin lower or equal to 1 x UNL, AST and ALT lower or equal to 2,5 UNL, alkaline phosphatase lower or equal to 5 UNL.~Seric calcium adjusted to albumine lower or equal to 1,25 UNL.~Adequate nutritional condition: loss of weight <20% with relation to the theoretical weight and albumin superior or equal to 35 g/L.~Use of an effective contraceptive method.~Exclusion Criteria:~Metastatic disease~Surgical treatment, previous radiotherapy and/or chemotherapy for the study disease.~Other tumour locations in H&N that are not larynx.~Other stages that are not III or IVa without metastasis and resectable disease.~The following cases, which will be considered candidates for radical surgery, will not be included in the study:~Tumors of the subglottis.~Tumors of glottis or supraglottis with subglottal extension~Tumor that destroys the thyroid cartilage and/or cricoid and it extends to thyroid gland or soft necks's tissues.~Tumor of supraglottis with a superior extension to 1 cm towards the tongue base (the extension will be measured since the vallecula).~Other previous and/or synchronic squamous carcinoma.~Diagnosis of another neoplasia in the last 5 years, excepting carcinoma in situ of uterine neck and/or a cutaneous carcinoma basocellular properly treated.~Active infection(at needs endovenous antibiotics), including active tuberculosis and diagnosed HIV.~Not controlled hypertension defined as arterial systolic tension superior or equal to 180 mm Hg and/or diastolic arterial tension superior or equal to 130 mm Hg baseline.~Pregnancy or breastfeeding.~Immunity systemic treatment, chronic and concomitant, or hormonal treatment of the cancer.~Other antineoplasic concomitant treatments.~Coronary clinically significant arteriopathy or precedents of myocardial infarction in the last 12 months or high risk of not controlled arrhythmia or cardiac not controlled insufficiency.~Pulmonary obstructive chronic disease that had needed 3 or more hospitalizations in the last 12 months.~Active non controlled peptic ulcer.~Presence of a psychological or medical disease that could prevent to accomplish the study by the patient or to grant his/her signature in the informed consent form.~Known drugs abuse (excepting excessive consumption of alcohol).~Known allergic reaction to some of the components of the treatment of the study.~Previous treatment with monoclonal antibodies or other transduction of the sign inhibitors or treatment directed against the EGFR.~Any experimental treatment in 30 days before entry in the study.
|
18 Years
|
70 Years
|
All
|
No
|
Primary Purpose: Prevention
Allocation: Non-Randomized
Intervention Model: Single Group Assignment
Masking: None (Open Label)
|
| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Specific survival free of total laryngectomy | Time from the start of TPF treatment to death caused by the disease or by the treatment of the disease, or even to surgery involving total laryngectomy. Deaths caused by other reasons were considered censored data on the date of death. | Three years after the end of treatment with radiotherapy and cetuximab |
|
Head and Neck Cancer
|
Cetuximab, Antineoplastic Agents, Immunological, Antineoplastic Agents
|
| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Group A<br>TPF plus concomitant treatment with cetuximab and conventional radiotherapy | Drug: TPF, radiotherapy and cetuximab<br>* 3 cycles of: cisplatin: 75mg/m2, i.v., 1 hour, once daily docetaxel: 75 mg/m2, i.v., 1 hour, once daily 5-fluorouracilo: 750 mg/m2, i.v., 24 hours, 5 days Radiotherapy: 70Gy,divided into daily doses of 2 Gray (total days:35) Cetuximab: 400 mg/m2, i.v, 2 hours, 1 day Cetuximab: 250 mg/m2, i.v, 1 hour, 7 days<br>* Other names: TPF plus radiotherapy and cetuximab;|
| Other: Grupo B<br>Surgery | Procedure: H&N surgery<br>* Rescue surgery<br>* Other names: Rescue surgery;|
|
TPF Plus Radiotherapy and Cetuximab to Avoid Total Laryngectomy in Patients With Larynx Cancer
Study Overview
=================
Brief Summary
-----------------
A Phase II Trial With Radiotherapy Plus Cetuximab to Evaluate Specific Survival Free of Laryngectomy in Patients With Resectable and Locally Advanced Larynx Cancer, After Treatment With TPF Chemotherapy.
Detailed Description
-----------------
This study is being sponsored by a cooperative medical group.
Official Title
-----------------
A Phase II Trial With Radiotherapy Plus Cetuximab to Evaluate Specific Survival Free of Laryngectomy in Patients With Resectable and Locally Advanced Larynx Cancer, After Treatment With TPF
Conditions
-----------------
Head and Neck Cancer
Intervention / Treatment
-----------------
* Drug: TPF, radiotherapy and cetuximab
* Procedure: H&N surgery
Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Signed Informed Consent Form. Men or women, age (18 and 70). ECOG scale:0-1. Life expectancy superior to 3 months. Larynx squamous carcinoma histologically demonstrated. Patients with larynx squamous carcinoma, stage III-IVA, with resectable disease whose surgery will imply a total laryngectomy. The T should be a T3, T4A, or a T2 not candidate for a partial laryngectomy. In case of T2 of any of both locations it will be required a III or IVA stadium. Patients to be able to receive treatment with TPF followed by normofractionated radiotherapy with cetuximab. Measurable disease (OMS criteria). Neutrophils superior or equal to 1500/mm3, platelets superior or equal to 150.000/mm3, hemoglobin superior or equal to 10 g/dl. Adequate renal function: creatinin lower or equal to 120 µmol/l (1,4mg/dl) Adequate hepatic function: bilirubin lower or equal to 1 x UNL, AST and ALT lower or equal to 2,5 UNL, alkaline phosphatase lower or equal to 5 UNL. Seric calcium adjusted to albumine lower or equal to 1,25 UNL. Adequate nutritional condition: loss of weight <20% with relation to the theoretical weight and albumin superior or equal to 35 g/L. Use of an effective contraceptive method. Exclusion Criteria: Metastatic disease Surgical treatment, previous radiotherapy and/or chemotherapy for the study disease. Other tumour locations in H&N that are not larynx. Other stages that are not III or IVa without metastasis and resectable disease. The following cases, which will be considered candidates for radical surgery, will not be included in the study: Tumors of the subglottis. Tumors of glottis or supraglottis with subglottal extension Tumor that destroys the thyroid cartilage and/or cricoid and it extends to thyroid gland or soft necks's tissues. Tumor of supraglottis with a superior extension to 1 cm towards the tongue base (the extension will be measured since the vallecula). Other previous and/or synchronic squamous carcinoma. Diagnosis of another neoplasia in the last 5 years, excepting carcinoma in situ of uterine neck and/or a cutaneous carcinoma basocellular properly treated. Active infection(at needs endovenous antibiotics), including active tuberculosis and diagnosed HIV. Not controlled hypertension defined as arterial systolic tension superior or equal to 180 mm Hg and/or diastolic arterial tension superior or equal to 130 mm Hg baseline. Pregnancy or breastfeeding. Immunity systemic treatment, chronic and concomitant, or hormonal treatment of the cancer. Other antineoplasic concomitant treatments. Coronary clinically significant arteriopathy or precedents of myocardial infarction in the last 12 months or high risk of not controlled arrhythmia or cardiac not controlled insufficiency. Pulmonary obstructive chronic disease that had needed 3 or more hospitalizations in the last 12 months. Active non controlled peptic ulcer. Presence of a psychological or medical disease that could prevent to accomplish the study by the patient or to grant his/her signature in the informed consent form. Known drugs abuse (excepting excessive consumption of alcohol). Known allergic reaction to some of the components of the treatment of the study. Previous treatment with monoclonal antibodies or other transduction of the sign inhibitors or treatment directed against the EGFR. Any experimental treatment in 30 days before entry in the study.
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: Prevention
Allocation: Non-Randomized
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Arms and Interventions
| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Group A<br>TPF plus concomitant treatment with cetuximab and conventional radiotherapy | Drug: TPF, radiotherapy and cetuximab<br>* 3 cycles of: cisplatin: 75mg/m2, i.v., 1 hour, once daily docetaxel: 75 mg/m2, i.v., 1 hour, once daily 5-fluorouracilo: 750 mg/m2, i.v., 24 hours, 5 days Radiotherapy: 70Gy,divided into daily doses of 2 Gray (total days:35) Cetuximab: 400 mg/m2, i.v, 2 hours, 1 day Cetuximab: 250 mg/m2, i.v, 1 hour, 7 days<br>* Other names: TPF plus radiotherapy and cetuximab;|
| Other: Grupo B<br>Surgery | Procedure: H&N surgery<br>* Rescue surgery<br>* Other names: Rescue surgery;|
What is the study measuring?
-----------------
Primary Outcome Measures
| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Specific survival free of total laryngectomy | Time from the start of TPF treatment to death caused by the disease or by the treatment of the disease, or even to surgery involving total laryngectomy. Deaths caused by other reasons were considered censored data on the date of death. | Three years after the end of treatment with radiotherapy and cetuximab |
Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Head and Neck Cancer
|
|
NCT04556331
|
Sowing the Seeds of Confidence: Brief Online Group Parenting Programme for Anxious Parents of 1-3 Year Olds
|
To pilot a brief group early intervention aimed at reducing or preventing the intergenerational transmission of anxiety, with parents whose child is between 12 and 47 months. To explore feasibility and acceptability of such an intervention with this population.
|
All participants will attend two group sessions of 'psychoeducation' (psychologically informed information about the topic of transmitting anxiety) and cognitive-behavioural strategies aimed at reducing the transmission of anxiety from parent to young child. The two sessions will be delivered online via Microsoft Teams, last 2 hours each and will run one week apart. Outcome and acceptability measures will be collected before, immediately after, and 6 weeks after the intervention. Feasibility data (e.g. drop-out rate) will be recorded.
|
Brief Online Group Parenting Programme for Anxious Parents of 1-3 Year Olds With the Aim of Reducing Transmission of Anxiety Through Generations: A Feasibility Study
|
Anxiety, Parenting
|
* Behavioral: Parenting programme (cognitive behavioural) aimed at reducing generational transmission of anxiety
|
Inclusion Criteria:~current or recent (within 2 years) primary diagnosis of anxiety disorder or self-report of clinically impairing anxiety problem within last 2 years,~parent of child aged 12-47 months at time of intervention,~access to an internet connection and smart phone/computer will be required to take part,~male or female,~resident in England,~and over the age of 18~Exclusion Criteria:~current severe co-morbid diagnoses, e.g. psychosis or acute suicidal risk (as the nature of the intervention is brief and in a group, the level of support needed to keep those with severe mental health disorders safe will not be available),~current alcohol or drugs misuse
|
18 Years
| null |
All
|
Accepts Healthy Volunteers
|
Primary Purpose: Prevention
Intervention Model: Single Group Assignment
Masking: None (Open Label)
|
| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Number of participants who consented to take part as percentage of those who expressed initial interest. | Percentage of count (people consent to take part / people expressing interest in response to advertising). To indicate feasibility of larger trial. | Total across recruitment period (up to 11 weeks, October 2020 to mid December 2020) |
| Actual attendance at each session as percentage of expected attendance | Percentage of count (people scheduled to attend each session / people who actually attended). To indicate feasibility of larger trial. | Total across intervention period (up to 9 weeks, mid October 2020 to mid December 2020) |
| Number of participants who provided completed questionnaire measures | Percentage of recruited participants who completed questionnaire measures at each of the three collection timepoints. | Total across intervention and 6 week follow-up period (up to 15 weeks, mid October 2020 to January 2021) |
| Acceptability of Intervention Measure (AIM) and Intervention Appropriateness Measure (IAM) (Weiner, Lewis et al. 2017) | Validated measure of acceptability of an intervention - Acceptability of Intervention Measure (AIM) and Intervention Appropriateness Measure (IAM) (Weiner, Lewis et al. 2017) | Collected twice: immediately after intervention attendance (same day) and after 6 weeks. |
| Open text questions about participants' views on the acceptability | Open text questions to gather qualitative information about participants' perspectives on usefulness, accessibility and unintended negative consequences | Collected twice: immediately after intervention attendance (same day) and after 6 weeks. |
|
| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change in score on Brief Infant Toddler Social and Emotional Assessment (Briggs-Gowan, Carter et al. 2002) | Parent report measure of child social, emotional and behavioural difficulties. This is a 42-item parent-report screening tool validated with parents of children aged 12 to 47 months. Maximum score is 84 and minimum score is 0. The higher the score the worse the outcome. | Collected three times to access change: Before intervention, immediately after end of intervention (same day) and 6 weeks after. |
| Change in score on Depression Anxiety Stress Scale (Henry and Crawford 2005) | Parent report questionnaire measure of stress, anxiety and depression in parents. This is a 21-item scale. The minimum score is 0 and the maximum score is 63, higher score is a worse outcome. | Collected three times to access change: Before intervention, immediately after end of intervention (same day) and 6 weeks after. |
| Bespoke questionnaire about self-reported use and confidence in behaviours specifically targeted in intervention. | Bespoke questionnaire about 8 specific parenting behaviours targeted in the intervention, each rated on a 5-point Likert scale (4 are reverse scored). Minimum score is 0 and maximum score is 40. The higher the score the 'worse' the outcome. | Collected three times to access change: Before intervention, immediately after end of intervention (same day) and 6 weeks after. |
|
Anxiety Disorders, Mental Disorders
|
| Intervention/Treatment |
| --- |
|Behavioral: Parenting programme (cognitive behavioural) aimed at reducing generational transmission of anxiety|'Psychoeducation' (psychologically informed information about the topic of transmitting anxiety) and cognitive-behavioural strategies aimed at reducing the transmission of anxiety from parent to young child. These will be shared with a group of maximum 8 remotely delivered, in a didactic format.|
|
Sowing the Seeds of Confidence: Brief Online Group Parenting Programme for Anxious Parents of 1-3 Year Olds
Study Overview
=================
Brief Summary
-----------------
To pilot a brief group early intervention aimed at reducing or preventing the intergenerational transmission of anxiety, with parents whose child is between 12 and 47 months. To explore feasibility and acceptability of such an intervention with this population.
Detailed Description
-----------------
All participants will attend two group sessions of 'psychoeducation' (psychologically informed information about the topic of transmitting anxiety) and cognitive-behavioural strategies aimed at reducing the transmission of anxiety from parent to young child. The two sessions will be delivered online via Microsoft Teams, last 2 hours each and will run one week apart. Outcome and acceptability measures will be collected before, immediately after, and 6 weeks after the intervention. Feasibility data (e.g. drop-out rate) will be recorded.
Official Title
-----------------
Brief Online Group Parenting Programme for Anxious Parents of 1-3 Year Olds With the Aim of Reducing Transmission of Anxiety Through Generations: A Feasibility Study
Conditions
-----------------
Anxiety, Parenting
Intervention / Treatment
-----------------
* Behavioral: Parenting programme (cognitive behavioural) aimed at reducing generational transmission of anxiety
Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: current or recent (within 2 years) primary diagnosis of anxiety disorder or self-report of clinically impairing anxiety problem within last 2 years, parent of child aged 12-47 months at time of intervention, access to an internet connection and smart phone/computer will be required to take part, male or female, resident in England, and over the age of 18 Exclusion Criteria: current severe co-morbid diagnoses, e.g. psychosis or acute suicidal risk (as the nature of the intervention is brief and in a group, the level of support needed to keep those with severe mental health disorders safe will not be available), current alcohol or drugs misuse
Ages Eligible for Study
-----------------
Minimum Age: 18 Years
Sexes Eligible for Study
-----------------
All
Accepts Healthy Volunteers
-----------------
Accepts Healthy Volunteers
Study Plan
=================
How is the study designed?
-----------------
Design Details
Primary Purpose: Prevention
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Arms and Interventions
| Intervention/Treatment |
| --- |
|Behavioral: Parenting programme (cognitive behavioural) aimed at reducing generational transmission of anxiety|'Psychoeducation' (psychologically informed information about the topic of transmitting anxiety) and cognitive-behavioural strategies aimed at reducing the transmission of anxiety from parent to young child. These will be shared with a group of maximum 8 remotely delivered, in a didactic format.|
What is the study measuring?
-----------------
Primary Outcome Measures
| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Number of participants who consented to take part as percentage of those who expressed initial interest. | Percentage of count (people consent to take part / people expressing interest in response to advertising). To indicate feasibility of larger trial. | Total across recruitment period (up to 11 weeks, October 2020 to mid December 2020) |
| Actual attendance at each session as percentage of expected attendance | Percentage of count (people scheduled to attend each session / people who actually attended). To indicate feasibility of larger trial. | Total across intervention period (up to 9 weeks, mid October 2020 to mid December 2020) |
| Number of participants who provided completed questionnaire measures | Percentage of recruited participants who completed questionnaire measures at each of the three collection timepoints. | Total across intervention and 6 week follow-up period (up to 15 weeks, mid October 2020 to January 2021) |
| Acceptability of Intervention Measure (AIM) and Intervention Appropriateness Measure (IAM) (Weiner, Lewis et al. 2017) | Validated measure of acceptability of an intervention - Acceptability of Intervention Measure (AIM) and Intervention Appropriateness Measure (IAM) (Weiner, Lewis et al. 2017) | Collected twice: immediately after intervention attendance (same day) and after 6 weeks. |
| Open text questions about participants' views on the acceptability | Open text questions to gather qualitative information about participants' perspectives on usefulness, accessibility and unintended negative consequences | Collected twice: immediately after intervention attendance (same day) and after 6 weeks. |
Secondary Outcome Measures
| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change in score on Brief Infant Toddler Social and Emotional Assessment (Briggs-Gowan, Carter et al. 2002) | Parent report measure of child social, emotional and behavioural difficulties. This is a 42-item parent-report screening tool validated with parents of children aged 12 to 47 months. Maximum score is 84 and minimum score is 0. The higher the score the worse the outcome. | Collected three times to access change: Before intervention, immediately after end of intervention (same day) and 6 weeks after. |
| Change in score on Depression Anxiety Stress Scale (Henry and Crawford 2005) | Parent report questionnaire measure of stress, anxiety and depression in parents. This is a 21-item scale. The minimum score is 0 and the maximum score is 63, higher score is a worse outcome. | Collected three times to access change: Before intervention, immediately after end of intervention (same day) and 6 weeks after. |
| Bespoke questionnaire about self-reported use and confidence in behaviours specifically targeted in intervention. | Bespoke questionnaire about 8 specific parenting behaviours targeted in the intervention, each rated on a 5-point Likert scale (4 are reverse scored). Minimum score is 0 and maximum score is 40. The higher the score the 'worse' the outcome. | Collected three times to access change: Before intervention, immediately after end of intervention (same day) and 6 weeks after. |
|
|
NCT04649892
|
Predicting Response to Naltrexone With Eye Tracking in Videogame Disorder
|
It is a double blind controlled study to test the hypothesis that it's possible to predict the response to naltrexone in Videogame Disorder with the use of Eye Tracking device, during a period of 12 weeks
|
This will be a double blind controlled study in which the investigators will select a specific sample of individuals diagnosed with a video game disorder representing a picture of genuine dependence on this technology. The sample will be submitted to the use of naltrexone over a period of 12 weeks and it wiil be assessed whether there was a response to this intervention and whether that response can be predicted through attentional bias analysis using the Eye Tracking device.
|
Predicting Response to Naltrexone With Eye Tracking in Videogame Disorder
|
Gaming Disorder
|
* Drug: Naltrexone
* Drug: Placebo
* Behavioral: Psychoeducational
* Device: Eye-tracking
|
Inclusion Criteria:~Patients will be evaluated initially in a clinical interview by a specialized psychiatrist and then by a second interviewer who will use a semi-structured interview to check the DSM-5 criteria for Video Game Disorder (VGD) modeled in the standard format of Schedules for clinical assessment in neuropsychiatry (SCID). Only a specific subgroup of VGD will be included in our sample, which will be called VGDa, a sample that represent a framework of behavioral dependence in essence. Patients in this sample must necessarily have the following symptoms: salience, withdrawal, relapse, conflict, mood modification and fissure. The criteria to delimit this subgroup are listed below:~Patients diagnosed with Internet Gaming Disorder according to DSM-5~Patients who have a score of 4 or higher on the following questions on the IGDS9-SF scale (Internet Gaming Disorder Scale 9 - Short Form):~Question 1: Salience assessment. Question 2: Abstinence assessment. Question 4: Relapse assessment. Question 6: Conflict assessment. Question 8: Mood modification assessment.~Patients with craving according to the adaptation of the Gambling Follow-up Scale (GFS) described below.~An adaptation of the GFS scale, originally used to evaluate patients with Gambling Disorder, was made in order to allow the evaluation of the craving symptom in a patient with VGD. It will only be used the fourth question on this scale as follows.~4) In the past 4 weeks, how was your desire to play?~I felt an irresistible urge to play.~I felt a strong desire to play, sometimes resistable, sometimes not.~I felt a strong desire to play, but resistable most of the time.~I felt a slight desire to play.~I didn't feel like playing. It will considered that the patient has craving if he answers this question by selecting items 1, 2 or 3.~Patients must meet the following criteria before randomization:~Have read and signed the informed consent form after the nature of the study has been fully explained and before carrying out any procedures related to the study;~Age between 18 and 60 years old, inclusive;~Female patients must be:~In post-menopause for at least one year, or;~Being surgically incapable of becoming pregnant (undergoing bilateral hysterectomy or oophorectomy or tubal ligation or otherwise being unable to become pregnant), or;~Be practicing an acceptable method of birth control (defined as: hormonal contraceptives, spermicide plus barrier, a single vasectomized partner and / or intrauterine device).~If a patient with the potential to become pregnant is practicing an acceptable method of birth control (as mentioned above), she must have a negative urine pregnancy test at the enrollment stage, as well as, at baseline, before receiving the study drug.~Exclusion Criteria:~- Established contraindication to naltrexone (opioid dependence, in the process of opioid withdrawal or current use of opioid analgesics) or hypersensitivity to naltrexone;~Exposure to any other drug or experimental device in the 30 days prior to inclusion, except for occasional use of benzodiazepines;~Pregnancy, breastfeeding or patients who intend to become pregnant during the study;~Evidence of renal failure, defined as serum creatinine levels> 133 mmol / L in men and> 124 mmol / L in women, which correspond to> 1.51 mg / dl and> 1.41 mg / dl, respectively on Week 1 of inclusion;~Evidence of clinically significant liver failure (defined as AST or ALT> 2 times the upper limit of normal) in Week 1 of inclusion;~Significant cardiovascular disease, including a history of myocardial infarction in the last 5 years, stroke, clinically significant heart valve disease, unstable angina, clinically abnormal ECG, arrhythmia or congestive heart failure, determining functional class III or IV (NYHA, 1964);~Uncontrolled hypertension (defined as a diastolic blood pressure of 100 mm / Hg and / or a systolic blood pressure of 180 mm / Hg with or without medication). Hypertensive patients receiving medication should be receiving the same dose of the same antihypertensive medication for at least two months;~Evidence of uncontrolled thyroid disorders, including hyper or hypothyroidism or abnormal TSH level. Patients who are known to have thyroid hormone replacement need to have had a stable dose for at least three months prior to inclusion and a normal TSH level upon inclusion~History or current comorbidity with bipolar affective disorder, obsessive compulsive disorder, psychotic disorder, schizophrenia or severe depression, additionally verified through the Patient Health Questionnaire 9 (PQH-9> 19), current suicide risk, or any other neuropsychiatric condition in severe cognitive impairment;~Current or previous history (in the previous two years) of abuse / dependence on alcohol or other psychoactive substance (except nicotine);~If at any moment the clinician responsible for the patient identifies suicidal ideation with risk of self-harm, or death;~Clinically significant hematological or immunological disorder;~Patients currently receiving psychotropic medications, except for the episodic use of benzodiazepines;~Illiteracy, or any other condition that prevents the reading and understanding of the research instruments;~Do not have a telephone line available for remote monitoring;~Living alone, or not being able to present a family member capable of providing collateral information on gaming behavior;~To be followed up in another therapeutic program.~The Mini International Neuropsychiatric Interview (MINI) will be used to verify the psychiatric exclusion diagnoses. This is a structured diagnostic interview, with quick application - approximately 45 minutes - compatible with the DSM-IV criteria. Its objective is the verification and standardization of the main Psychiatric Disorders of Axis 1 of DSM IV. It is performed by clinicians after rapid training (1 to 3 hours). The translated and adapted Brazilian version showed globally satisfactory reliability.
|
18 Years
|
60 Years
|
All
|
No
|
Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Interventional Model Description: Participants will be randomly allocated to two groups:~Naltrexone and brief psychoeducational intervention~Placebo and brief psychoeducational intervention This will be double-blind controlled study.
Masking: Triple
|
| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Adpated Internet Gaming Disorder Scale-Short Form (IGDS9-SF) | IGDS9-SF is 9 items scale in which the patient must answer how often he performs a certain behavior in the last 12 months, the score ranges from 9 to 45, patients with 21 points or more are diagnosed with Video Game Disorder according to the Brazilian validation carried out in 2020.~As the IGDS9-SF is a diagnostic scale, the adaptations described below were necessary to use it to assess the response to the intervention:~Reduction of the time interval to which the scale questions refer, from 12 months to the last 12 weeks.~Adaptation of the text of each item in order to reflect the interaction with the video game and its repercussions in the last 12 weeks.~To validate these changes, the investigators will perform a cross-validation with the Gambling Follow-up Scale adapted for video games described in the next item.~The application of the adapted IGDS9-SF will occur at the beginning of the follow-up, before the intervention, and at the end of the intervention. | 12 Weeks. |
| Gambling Follow-Up Scale adapted to Videogames (Gaming Follow-up Scale) | The Gambling Follow-up Scale (GFS) is a self-administered scale of ten items for assessing pathological gamblers throughout treatment. For the use of GFS in this study, the third and fifth questions were excluded, which assessed the financial impact due to gambling, a rare situation in patients with Video Game Disorder (VGD). The eighth question were adapted in order to assess whether the patient had time to dedicate himself to his basic needs, a question that is more congruent to the psychopathology of VGD. And finally, the text of all the questions were adapted by exchanging the word gambling for video games.~This adapted scale will be applied at the beginning of patient follow-up, before the intervention, being reapplied in 4 weeks and at the end of the intervention in the 12th week.~To validate this adaptation, the investigators will do a cross-validation with the adapted IGDS9-SF scale described in the previous item. | 12 Weeks |
|
| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Gaming Timeline Follow-Back Method (TFB) | TFB is a retrospective interview technique designed to assess alcohol consumption. It has been used in a similar way to address other impulsive behaviors, for example, gambling. In this study it will be used to assess the patient's dedication to the video game.~With this technique, the interviewer obtains information about the days and the amount of resources and time invested in the behavior. Initially, the interviewer identifies relevant dates for the patient in this period and uses them as markers that facilitate the recall of information. It helps and encourages the patient to recall, retrospectively, information about episodes of excessive gaming and write them down on a calendar sheet. Thus, a diary of the activity is obtained in the desired period. | 12 weeks |
| Short Impulsive Behavior Scale (UPPS-P) | The Short UPPS-P, like the original UPPS-P, is a Likert scale with 4 possible answers for each item (from Strongly Agree to Strongly Disagree). This scale takes the form of self-report and has 20 items, which then produce scores for the five factors of impulsivity. Each factor ranges from 4 to 16, being the lower values indicative of dysfunctionality. This brief version was successfully validated in English, successfully replicating the internal consistency and the correlations between the factors of the original scale with the benefit of saving about 66% of the time required for application. | 12 weeks |
| Social Adjustment Scale self-report version (SAS) | SAS is considered the most carefully developed social adjustment scale, showing the highest levels of reliability and validity. It is widely used and cited in the scientific literature, being useful to assess social adjustment in a wide variety of populations, both clinical and non-clinical. SAS allows an assessment of social adjustment in seven areas: work outside the home, work at home, studies, social life and leisure, relationship with family, spouse, children, home life and financial situation. It consists of 54 questions with 5 possible answers, with higher scores indicating greater impairment. In this study, it will be used to verify the effect of experimental treatment on social adjustment as a secondary outcome. | 12 weeks |
| Global Clinical Scale | The Global Clinical Scale will be used to assess global severity, considering the frequency and intensity of symptoms. It is applied by a trained person. Its score varies between 1 (normal, not sick) and 7 (extremely sick). The criterion used for improvement (positive response to treatment) is 1 = improved and 2 = greatly improved. | 12 weeks |
| Rotter's Locus of Control Scale | The prediction analysis in this study will be based on individual variation characteristics, more specifically on the internal-external control locus trait, for this the Rotter scale translated and adapted to Brazilian Portuguese will be used. It consists of 29 questions with 2 possible answers, with higher scores indicating External Locus of Control and lower scores indicating Internal Locus of Control | 12 weeks |
| Eye tracking | The purpose of this intervention is to carry out assessments of the visual tracking patterns and verify their correlation with the clinical response of the individuals who underwent the intervention.~The slide shows projected in the test will consist of neutral and video game related images. Each attempt will contain two images (video games and neutrals) and will last for 8 seconds, with 25 attempts in total. Each of the four eye tracking sessions will contain an exclusive slide show (that is, new images each time) and the order of presentation will be random. The dependent variables that will be measured will include: total number of fixations, average length of stay and duration of the first fixation in a video game figure. | 12 weeks |
| Mini International Neuropsychiatric Interview (MINI) | Compared with several reference criteria, in different contexts (psychiatric units and primary care centers), this structured diagnostic interview showed psychometric qualities similar to more complex standardized diagnostic interviews and allows a reduction of at least 50% in the evaluation time, with duration 15 to 30 minutes. It will be used in this study to describe and control DSM-IV Axis 1 psychiatric disorders. MINI has a translated and adapted version for Brazil and will be used in this study to control psychiatric comorbidities. | 12 weeks |
| PHQ-9 Patient Health Questionnaire | PHQ-9 is one of the most studied psychometric assessment tools for assessing depression in medicine. It is part of a more comprehensive and entirely self-administered test, the PHQ, developed with the aim of screening for frequent mental disorders in the context of primary care such as depression, alcohol use anxiety, somatoform disorders and eating disorders.~PHQ-9 consists of nine questions, which correspond to the DSM-5's nine diagnostic criteria for depression. Each item receives a score from 0 to 3, indicating the frequency of the presence of symptoms in the last two weeks. The total score ranges from 0 to 27 and represents the sum of the responses of the nine items. | 12 weeks |
| Beck Anxiety Inventory (BAI) | The Beck Anxiety Inventory is a self-administered scale composed of 21 questions that measure the intensity of anxiety symptoms in the last week (0 = absent to 3 = severe) through descriptive statements and does not aim at diagnostic aspects. The proposed cut-off note for the Portuguese version, in samples from psychiatric patients, suggests:~<10 = minimum; 10-19 = light 20-30 = moderate; 31-63 = severe. This scale will be used in this study to control the associated anxious symptoms. | 12 weeks |
| Ugvalg for Kliniske Undersgelser (UKU) scale of side effects | The UKU is a detailed scale for assessing drug side effects comprising the following 4 groups of psychic, neurological, autonomic and other side effects. Each item is evaluated on a scale from zero (absent) to 3 (severe). For each item, the causal relationship with the medication in use (unlikely, possible and probable) is marked. There is also an item of global assessment of the interference of side effects on the patient's daily performance (0 = no side effects, 3 = side effects markedly interfering with performance). There is also another item that assesses the consequence of interference: from 0 = no action to 3 = discontinuation of medication. | 12 weeks |
|
Videogame disorder, Gaming disorder, eye tracking, naltrexone, problematic videogame users
|
Naltrexone, Alcohol Deterrents, Narcotic Antagonists, Physiological Effects of Drugs, Sensory System Agents, Peripheral Nervous System Agents
|
| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Naltrexone<br>A 12 week Naltrexone flexible dose administration plus 4 sessions of a psychoeducational intervention and 4 eye-tracking sessions | Drug: Naltrexone<br>* Patients will receive daily doses of Naltrexone, starting at 50mg and increasing 25mg per week until reaching 200mg or the maximum tolerated by the patient<br>* Other names: Active drug;Behavioral: Psychoeducational<br>* Participants will also attend to 4 sessions of psychoeducational intervention in weeks 2, 4, 6, and 8<br>Device: Eye-tracking<br>* The attentional bias of the participants will be assessed using the Eye-tracking device in 4 moments throughout the study:~Before taking the first dose of naltrexone or placebo.~One hour after taking the first dose of naltrexone or placebo.~One week after continuous and daily use of naltrexone or placebo.~At the end of the intervention, after 12 weeks of continuous and daily use of naltrexone or placebo.<br>* Other names: Tobii eye-tracker;|
| Placebo Comparator: Placebo<br>A 12 week placebo matching tablets plus 4 sessions of a psychoeducational intervention and 4 eye-tracking sessions | Drug: Placebo<br>* Patients will receive daily doses placebo matching tablets for the 12 weeks of the study. Throughout this period, possible adverse effects will be monitored weekly.<br>* Other names: Inactive drug;Behavioral: Psychoeducational<br>* Participants will also attend to 4 sessions of psychoeducational intervention in weeks 2, 4, 6, and 8<br>Device: Eye-tracking<br>* The attentional bias of the participants will be assessed using the Eye-tracking device in 4 moments throughout the study:~Before taking the first dose of naltrexone or placebo.~One hour after taking the first dose of naltrexone or placebo.~One week after continuous and daily use of naltrexone or placebo.~At the end of the intervention, after 12 weeks of continuous and daily use of naltrexone or placebo.<br>* Other names: Tobii eye-tracker;|
|
Predicting Response to Naltrexone With Eye Tracking in Videogame Disorder
Study Overview
=================
Brief Summary
-----------------
It is a double blind controlled study to test the hypothesis that it's possible to predict the response to naltrexone in Videogame Disorder with the use of Eye Tracking device, during a period of 12 weeks
Detailed Description
-----------------
This will be a double blind controlled study in which the investigators will select a specific sample of individuals diagnosed with a video game disorder representing a picture of genuine dependence on this technology. The sample will be submitted to the use of naltrexone over a period of 12 weeks and it wiil be assessed whether there was a response to this intervention and whether that response can be predicted through attentional bias analysis using the Eye Tracking device.
Official Title
-----------------
Predicting Response to Naltrexone With Eye Tracking in Videogame Disorder
Conditions
-----------------
Gaming Disorder
Intervention / Treatment
-----------------
* Drug: Naltrexone
* Drug: Placebo
* Behavioral: Psychoeducational
* Device: Eye-tracking
Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Patients will be evaluated initially in a clinical interview by a specialized psychiatrist and then by a second interviewer who will use a semi-structured interview to check the DSM-5 criteria for Video Game Disorder (VGD) modeled in the standard format of Schedules for clinical assessment in neuropsychiatry (SCID). Only a specific subgroup of VGD will be included in our sample, which will be called VGDa, a sample that represent a framework of behavioral dependence in essence. Patients in this sample must necessarily have the following symptoms: salience, withdrawal, relapse, conflict, mood modification and fissure. The criteria to delimit this subgroup are listed below: Patients diagnosed with Internet Gaming Disorder according to DSM-5 Patients who have a score of 4 or higher on the following questions on the IGDS9-SF scale (Internet Gaming Disorder Scale 9 - Short Form): Question 1: Salience assessment. Question 2: Abstinence assessment. Question 4: Relapse assessment. Question 6: Conflict assessment. Question 8: Mood modification assessment. Patients with craving according to the adaptation of the Gambling Follow-up Scale (GFS) described below. An adaptation of the GFS scale, originally used to evaluate patients with Gambling Disorder, was made in order to allow the evaluation of the craving symptom in a patient with VGD. It will only be used the fourth question on this scale as follows. 4) In the past 4 weeks, how was your desire to play? I felt an irresistible urge to play. I felt a strong desire to play, sometimes resistable, sometimes not. I felt a strong desire to play, but resistable most of the time. I felt a slight desire to play. I didn't feel like playing. It will considered that the patient has craving if he answers this question by selecting items 1, 2 or 3. Patients must meet the following criteria before randomization: Have read and signed the informed consent form after the nature of the study has been fully explained and before carrying out any procedures related to the study; Age between 18 and 60 years old, inclusive; Female patients must be: In post-menopause for at least one year, or; Being surgically incapable of becoming pregnant (undergoing bilateral hysterectomy or oophorectomy or tubal ligation or otherwise being unable to become pregnant), or; Be practicing an acceptable method of birth control (defined as: hormonal contraceptives, spermicide plus barrier, a single vasectomized partner and / or intrauterine device). If a patient with the potential to become pregnant is practicing an acceptable method of birth control (as mentioned above), she must have a negative urine pregnancy test at the enrollment stage, as well as, at baseline, before receiving the study drug. Exclusion Criteria: - Established contraindication to naltrexone (opioid dependence, in the process of opioid withdrawal or current use of opioid analgesics) or hypersensitivity to naltrexone; Exposure to any other drug or experimental device in the 30 days prior to inclusion, except for occasional use of benzodiazepines; Pregnancy, breastfeeding or patients who intend to become pregnant during the study; Evidence of renal failure, defined as serum creatinine levels> 133 mmol / L in men and> 124 mmol / L in women, which correspond to> 1.51 mg / dl and> 1.41 mg / dl, respectively on Week 1 of inclusion; Evidence of clinically significant liver failure (defined as AST or ALT> 2 times the upper limit of normal) in Week 1 of inclusion; Significant cardiovascular disease, including a history of myocardial infarction in the last 5 years, stroke, clinically significant heart valve disease, unstable angina, clinically abnormal ECG, arrhythmia or congestive heart failure, determining functional class III or IV (NYHA, 1964); Uncontrolled hypertension (defined as a diastolic blood pressure of 100 mm / Hg and / or a systolic blood pressure of 180 mm / Hg with or without medication). Hypertensive patients receiving medication should be receiving the same dose of the same antihypertensive medication for at least two months; Evidence of uncontrolled thyroid disorders, including hyper or hypothyroidism or abnormal TSH level. Patients who are known to have thyroid hormone replacement need to have had a stable dose for at least three months prior to inclusion and a normal TSH level upon inclusion History or current comorbidity with bipolar affective disorder, obsessive compulsive disorder, psychotic disorder, schizophrenia or severe depression, additionally verified through the Patient Health Questionnaire 9 (PQH-9> 19), current suicide risk, or any other neuropsychiatric condition in severe cognitive impairment; Current or previous history (in the previous two years) of abuse / dependence on alcohol or other psychoactive substance (except nicotine); If at any moment the clinician responsible for the patient identifies suicidal ideation with risk of self-harm, or death; Clinically significant hematological or immunological disorder; Patients currently receiving psychotropic medications, except for the episodic use of benzodiazepines; Illiteracy, or any other condition that prevents the reading and understanding of the research instruments; Do not have a telephone line available for remote monitoring; Living alone, or not being able to present a family member capable of providing collateral information on gaming behavior; To be followed up in another therapeutic program. The Mini International Neuropsychiatric Interview (MINI) will be used to verify the psychiatric exclusion diagnoses. This is a structured diagnostic interview, with quick application - approximately 45 minutes - compatible with the DSM-IV criteria. Its objective is the verification and standardization of the main Psychiatric Disorders of Axis 1 of DSM IV. It is performed by clinicians after rapid training (1 to 3 hours). The translated and adapted Brazilian version showed globally satisfactory reliability.
Ages Eligible for Study
-----------------
Minimum Age: 18 Years
Maximum Age: 60 Years
Sexes Eligible for Study
-----------------
All
Accepts Healthy Volunteers
-----------------
No
Study Plan
=================
How is the study designed?
-----------------
Design Details
Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Interventional Model Description: Participants will be randomly allocated to two groups: Naltrexone and brief psychoeducational intervention Placebo and brief psychoeducational intervention This will be double-blind controlled study.
Masking: Triple
Arms and Interventions
| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Naltrexone<br>A 12 week Naltrexone flexible dose administration plus 4 sessions of a psychoeducational intervention and 4 eye-tracking sessions | Drug: Naltrexone<br>* Patients will receive daily doses of Naltrexone, starting at 50mg and increasing 25mg per week until reaching 200mg or the maximum tolerated by the patient<br>* Other names: Active drug;Behavioral: Psychoeducational<br>* Participants will also attend to 4 sessions of psychoeducational intervention in weeks 2, 4, 6, and 8<br>Device: Eye-tracking<br>* The attentional bias of the participants will be assessed using the Eye-tracking device in 4 moments throughout the study: Before taking the first dose of naltrexone or placebo. One hour after taking the first dose of naltrexone or placebo. One week after continuous and daily use of naltrexone or placebo. At the end of the intervention, after 12 weeks of continuous and daily use of naltrexone or placebo.<br>* Other names: Tobii eye-tracker;|
| Placebo Comparator: Placebo<br>A 12 week placebo matching tablets plus 4 sessions of a psychoeducational intervention and 4 eye-tracking sessions | Drug: Placebo<br>* Patients will receive daily doses placebo matching tablets for the 12 weeks of the study. Throughout this period, possible adverse effects will be monitored weekly.<br>* Other names: Inactive drug;Behavioral: Psychoeducational<br>* Participants will also attend to 4 sessions of psychoeducational intervention in weeks 2, 4, 6, and 8<br>Device: Eye-tracking<br>* The attentional bias of the participants will be assessed using the Eye-tracking device in 4 moments throughout the study: Before taking the first dose of naltrexone or placebo. One hour after taking the first dose of naltrexone or placebo. One week after continuous and daily use of naltrexone or placebo. At the end of the intervention, after 12 weeks of continuous and daily use of naltrexone or placebo.<br>* Other names: Tobii eye-tracker;|
What is the study measuring?
-----------------
Primary Outcome Measures
| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Adpated Internet Gaming Disorder Scale-Short Form (IGDS9-SF) | IGDS9-SF is 9 items scale in which the patient must answer how often he performs a certain behavior in the last 12 months, the score ranges from 9 to 45, patients with 21 points or more are diagnosed with Video Game Disorder according to the Brazilian validation carried out in 2020. As the IGDS9-SF is a diagnostic scale, the adaptations described below were necessary to use it to assess the response to the intervention: Reduction of the time interval to which the scale questions refer, from 12 months to the last 12 weeks. Adaptation of the text of each item in order to reflect the interaction with the video game and its repercussions in the last 12 weeks. To validate these changes, the investigators will perform a cross-validation with the Gambling Follow-up Scale adapted for video games described in the next item. The application of the adapted IGDS9-SF will occur at the beginning of the follow-up, before the intervention, and at the end of the intervention. | 12 Weeks. |
| Gambling Follow-Up Scale adapted to Videogames (Gaming Follow-up Scale) | The Gambling Follow-up Scale (GFS) is a self-administered scale of ten items for assessing pathological gamblers throughout treatment. For the use of GFS in this study, the third and fifth questions were excluded, which assessed the financial impact due to gambling, a rare situation in patients with Video Game Disorder (VGD). The eighth question were adapted in order to assess whether the patient had time to dedicate himself to his basic needs, a question that is more congruent to the psychopathology of VGD. And finally, the text of all the questions were adapted by exchanging the word gambling for video games. This adapted scale will be applied at the beginning of patient follow-up, before the intervention, being reapplied in 4 weeks and at the end of the intervention in the 12th week. To validate this adaptation, the investigators will do a cross-validation with the adapted IGDS9-SF scale described in the previous item. | 12 Weeks |
Secondary Outcome Measures
| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Gaming Timeline Follow-Back Method (TFB) | TFB is a retrospective interview technique designed to assess alcohol consumption. It has been used in a similar way to address other impulsive behaviors, for example, gambling. In this study it will be used to assess the patient's dedication to the video game. With this technique, the interviewer obtains information about the days and the amount of resources and time invested in the behavior. Initially, the interviewer identifies relevant dates for the patient in this period and uses them as markers that facilitate the recall of information. It helps and encourages the patient to recall, retrospectively, information about episodes of excessive gaming and write them down on a calendar sheet. Thus, a diary of the activity is obtained in the desired period. | 12 weeks |
| Short Impulsive Behavior Scale (UPPS-P) | The Short UPPS-P, like the original UPPS-P, is a Likert scale with 4 possible answers for each item (from Strongly Agree to Strongly Disagree). This scale takes the form of self-report and has 20 items, which then produce scores for the five factors of impulsivity. Each factor ranges from 4 to 16, being the lower values indicative of dysfunctionality. This brief version was successfully validated in English, successfully replicating the internal consistency and the correlations between the factors of the original scale with the benefit of saving about 66% of the time required for application. | 12 weeks |
| Social Adjustment Scale self-report version (SAS) | SAS is considered the most carefully developed social adjustment scale, showing the highest levels of reliability and validity. It is widely used and cited in the scientific literature, being useful to assess social adjustment in a wide variety of populations, both clinical and non-clinical. SAS allows an assessment of social adjustment in seven areas: work outside the home, work at home, studies, social life and leisure, relationship with family, spouse, children, home life and financial situation. It consists of 54 questions with 5 possible answers, with higher scores indicating greater impairment. In this study, it will be used to verify the effect of experimental treatment on social adjustment as a secondary outcome. | 12 weeks |
| Global Clinical Scale | The Global Clinical Scale will be used to assess global severity, considering the frequency and intensity of symptoms. It is applied by a trained person. Its score varies between 1 (normal, not sick) and 7 (extremely sick). The criterion used for improvement (positive response to treatment) is 1 = improved and 2 = greatly improved. | 12 weeks |
| Rotter's Locus of Control Scale | The prediction analysis in this study will be based on individual variation characteristics, more specifically on the internal-external control locus trait, for this the Rotter scale translated and adapted to Brazilian Portuguese will be used. It consists of 29 questions with 2 possible answers, with higher scores indicating External Locus of Control and lower scores indicating Internal Locus of Control | 12 weeks |
| Eye tracking | The purpose of this intervention is to carry out assessments of the visual tracking patterns and verify their correlation with the clinical response of the individuals who underwent the intervention. The slide shows projected in the test will consist of neutral and video game related images. Each attempt will contain two images (video games and neutrals) and will last for 8 seconds, with 25 attempts in total. Each of the four eye tracking sessions will contain an exclusive slide show (that is, new images each time) and the order of presentation will be random. The dependent variables that will be measured will include: total number of fixations, average length of stay and duration of the first fixation in a video game figure. | 12 weeks |
| Mini International Neuropsychiatric Interview (MINI) | Compared with several reference criteria, in different contexts (psychiatric units and primary care centers), this structured diagnostic interview showed psychometric qualities similar to more complex standardized diagnostic interviews and allows a reduction of at least 50% in the evaluation time, with duration 15 to 30 minutes. It will be used in this study to describe and control DSM-IV Axis 1 psychiatric disorders. MINI has a translated and adapted version for Brazil and will be used in this study to control psychiatric comorbidities. | 12 weeks |
| PHQ-9 Patient Health Questionnaire | PHQ-9 is one of the most studied psychometric assessment tools for assessing depression in medicine. It is part of a more comprehensive and entirely self-administered test, the PHQ, developed with the aim of screening for frequent mental disorders in the context of primary care such as depression, alcohol use anxiety, somatoform disorders and eating disorders. PHQ-9 consists of nine questions, which correspond to the DSM-5's nine diagnostic criteria for depression. Each item receives a score from 0 to 3, indicating the frequency of the presence of symptoms in the last two weeks. The total score ranges from 0 to 27 and represents the sum of the responses of the nine items. | 12 weeks |
| Beck Anxiety Inventory (BAI) | The Beck Anxiety Inventory is a self-administered scale composed of 21 questions that measure the intensity of anxiety symptoms in the last week (0 = absent to 3 = severe) through descriptive statements and does not aim at diagnostic aspects. The proposed cut-off note for the Portuguese version, in samples from psychiatric patients, suggests: <10 = minimum; 10-19 = light 20-30 = moderate; 31-63 = severe. This scale will be used in this study to control the associated anxious symptoms. | 12 weeks |
| Ugvalg for Kliniske Undersgelser (UKU) scale of side effects | The UKU is a detailed scale for assessing drug side effects comprising the following 4 groups of psychic, neurological, autonomic and other side effects. Each item is evaluated on a scale from zero (absent) to 3 (severe). For each item, the causal relationship with the medication in use (unlikely, possible and probable) is marked. There is also an item of global assessment of the interference of side effects on the patient's daily performance (0 = no side effects, 3 = side effects markedly interfering with performance). There is also another item that assesses the consequence of interference: from 0 = no action to 3 = discontinuation of medication. | 12 weeks |
Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Videogame disorder, Gaming disorder, eye tracking, naltrexone, problematic videogame users
|
NCT00078442
|
Safety and Tolerability of Pegylated Interferon (PEG-IFN) Alfa-2a in HIV Infected People
|
Recombinant interferon (IFN) may be useful in the treatment of HIV. However, the high doses of IFN necessary to keep HIV under control limit its use due to toxic side effects. The purpose of this study is to test the safety and tolerability of weekly recombinant pegylated interferon (PEG-IFN) alfa-2a in HIV infected people who are currently on antiretroviral therapy (ART) interruption or who have not started taking anti-HIV drugs.
|
IFN is an immune response enhancer and is produced in the body in response to viral infection. PEG-IFN may have less harmful side effects than non-pegylated IFN. Recombinant PEG-IFN alfa-2a is a synthetic version of IFN and is used in hepatitis C virus treatment. PEG-IFN alfa-2a has demonstrated potentially useful antiviral properties in HIV treatment; however, due to the high doses that must be administered to maintain viral suppression, toxicity (especially to the blood) is a concern. This study will evaluate the safety, tolerability, and antiretroviral activity of PEG-IFN alfa-2a in HIV infected patients who have received ART in the past but are currently off ART or who are ART naive.~The study will last 18 weeks. Participants will receive weekly injections of 180 mcg PEG-IFN alfa-2a at the clinic for 12 weeks. After Week 12, participants will be followed off-treatment until Week 18. Physical exams will be performed weekly. Blood collection to monitor viral load, PEG-IFN alfa-2a serum levels, and CD4 and CD8 counts will be conducted at selected weeks during the study. Filgrastim will be given to patients who exhibit neutropenic toxicity.
|
A Phase II Open-Label Pilot Trial of the Antiretroviral Activity, Safety, and Tolerability of Pegylated Interferon Alfa-2A (40KD) [PegasysTM] in HIV-1 Infected Subjects
|
HIV Infections
|
* Drug: Pegylated interferon alfa-2a
|
Inclusion Criteria:~HIV infected~CD4 count of 300 cells/ml or greater within 30 days of study entry~HIV viral load of 5000 copies/ml or greater within 30 days of study entry~Received ART previously but have currently interrupted treatment within 12 weeks prior to study entry OR ART naive~Willing to delay initiation or re-initiation of antiretroviral medications for the duration of the study~Agree to use acceptable forms of contraception~Exclusion Criteria:~Previous use of interferon alfa~Known allergy or sensitivity to PEG-IFN alfa-2a or its formulation~Active drug or alcohol abuse that would interfere with the study~Acute therapy for a serious infection within 30 days of study entry~Use of non-protocol-specified immunomodulatory therapy within 60 days of study entry~Active immunization within 30 days of study entry~History of severe psychiatric disease such as major depression, suicidal attempt, hospitalization for psychiatric disease, or a period of disability due to psychiatric disease~History of poorly controlled thyroid disease, including history of elevated thyroid stimulating hormone (TSH) levels with elevated antibodies to thyroid peroxidase and any clinical manifestations of thyroid disease~History of clinically significant heart disease that could be worsened by acute anemia~History of severe seizure disorder or current anticonvulsant use~Hepatitis C antibody positive within 60 days prior to study entry~Hepatitis B surface antigen positive within 60 days prior to study entry~Known sensitivity to E. coli derived products, such as filgrastim~Any past evidence of chronic liver disease~Any past or current evidence of immunologically-mediated disease~Evidence of chronic pulmonary disease~Severe eye problems due to diabetes, hypertension, cytomegalovirus infection, or macular degeneration~History of major organ transplantation with an existing functional graft~History or other evidence of severe illness, cancer, or other conditions that would make the patient unsuitable for the study~Hemoglobin abnormalities or any other cause of or tendency for breakdown of red blood cells~Any medical condition that would prevent successful completion of the study~Use of certain medications~Pregnant or breastfeeding
|
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 |
| --- | --- | --- |
| CD4 count | | Throughout study |
| CD8 count | | Throughout study |
| Laboratory and clinical adverse effects | | Throughout study |
|
Treatment Experienced, Treatment Interruption, Treatment Naive
|
Interferons, Interferon-alpha, Interferon alpha-2, Peginterferon alfa-2a, Antineoplastic Agents, Antiviral Agents, Anti-Infective Agents, Immunologic Factors, Physiological Effects of Drugs
|
| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: 1<br>Participants will receive weekly injections of 180 mcg PEG-IFN alfa-2a at the clinic for 12 weeks. After Week 12, participants will be followed off-treatment until Week 18. | Drug: Pegylated interferon alfa-2a<br>* Recombinant PEG-IFN alfa-2a is a synthetic version of IFN and is used in hepatitis C virus treatment<br>|
|
Safety and Tolerability of Pegylated Interferon (PEG-IFN) Alfa-2a in HIV Infected People
Study Overview
=================
Brief Summary
-----------------
Recombinant interferon (IFN) may be useful in the treatment of HIV. However, the high doses of IFN necessary to keep HIV under control limit its use due to toxic side effects. The purpose of this study is to test the safety and tolerability of weekly recombinant pegylated interferon (PEG-IFN) alfa-2a in HIV infected people who are currently on antiretroviral therapy (ART) interruption or who have not started taking anti-HIV drugs.
Detailed Description
-----------------
IFN is an immune response enhancer and is produced in the body in response to viral infection. PEG-IFN may have less harmful side effects than non-pegylated IFN. Recombinant PEG-IFN alfa-2a is a synthetic version of IFN and is used in hepatitis C virus treatment. PEG-IFN alfa-2a has demonstrated potentially useful antiviral properties in HIV treatment; however, due to the high doses that must be administered to maintain viral suppression, toxicity (especially to the blood) is a concern. This study will evaluate the safety, tolerability, and antiretroviral activity of PEG-IFN alfa-2a in HIV infected patients who have received ART in the past but are currently off ART or who are ART naive. The study will last 18 weeks. Participants will receive weekly injections of 180 mcg PEG-IFN alfa-2a at the clinic for 12 weeks. After Week 12, participants will be followed off-treatment until Week 18. Physical exams will be performed weekly. Blood collection to monitor viral load, PEG-IFN alfa-2a serum levels, and CD4 and CD8 counts will be conducted at selected weeks during the study. Filgrastim will be given to patients who exhibit neutropenic toxicity.
Official Title
-----------------
A Phase II Open-Label Pilot Trial of the Antiretroviral Activity, Safety, and Tolerability of Pegylated Interferon Alfa-2A (40KD) [PegasysTM] in HIV-1 Infected Subjects
Conditions
-----------------
HIV Infections
Intervention / Treatment
-----------------
* Drug: Pegylated interferon alfa-2a
Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: HIV infected CD4 count of 300 cells/ml or greater within 30 days of study entry HIV viral load of 5000 copies/ml or greater within 30 days of study entry Received ART previously but have currently interrupted treatment within 12 weeks prior to study entry OR ART naive Willing to delay initiation or re-initiation of antiretroviral medications for the duration of the study Agree to use acceptable forms of contraception Exclusion Criteria: Previous use of interferon alfa Known allergy or sensitivity to PEG-IFN alfa-2a or its formulation Active drug or alcohol abuse that would interfere with the study Acute therapy for a serious infection within 30 days of study entry Use of non-protocol-specified immunomodulatory therapy within 60 days of study entry Active immunization within 30 days of study entry History of severe psychiatric disease such as major depression, suicidal attempt, hospitalization for psychiatric disease, or a period of disability due to psychiatric disease History of poorly controlled thyroid disease, including history of elevated thyroid stimulating hormone (TSH) levels with elevated antibodies to thyroid peroxidase and any clinical manifestations of thyroid disease History of clinically significant heart disease that could be worsened by acute anemia History of severe seizure disorder or current anticonvulsant use Hepatitis C antibody positive within 60 days prior to study entry Hepatitis B surface antigen positive within 60 days prior to study entry Known sensitivity to E. coli derived products, such as filgrastim Any past evidence of chronic liver disease Any past or current evidence of immunologically-mediated disease Evidence of chronic pulmonary disease Severe eye problems due to diabetes, hypertension, cytomegalovirus infection, or macular degeneration History of major organ transplantation with an existing functional graft History or other evidence of severe illness, cancer, or other conditions that would make the patient unsuitable for the study Hemoglobin abnormalities or any other cause of or tendency for breakdown of red blood cells Any medical condition that would prevent successful completion of the study Use of certain medications Pregnant or breastfeeding
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 |
| --- | --- |
| Experimental: 1<br>Participants will receive weekly injections of 180 mcg PEG-IFN alfa-2a at the clinic for 12 weeks. After Week 12, participants will be followed off-treatment until Week 18. | Drug: Pegylated interferon alfa-2a<br>* Recombinant PEG-IFN alfa-2a is a synthetic version of IFN and is used in hepatitis C virus treatment<br>|
What is the study measuring?
-----------------
Primary Outcome Measures
| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| CD4 count | | Throughout study |
| CD8 count | | Throughout study |
| Laboratory and clinical adverse effects | | Throughout study |
Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Treatment Experienced, Treatment Interruption, Treatment Naive
|
|
NCT01348503
|
Lenalidomide in Combination With a Fixed Dose of Sorafenib for the Treatment of Hepatocellular Carcinoma
|
The purpose of this study is to evaluate the combination of Revlimid® (lenalidomide) and Nexavar® (sorafenib) for the treatment of hepatocellular carcinoma that can't be cured with surgery.
|
A Phase I Open-label Dose-escalation Study With Lenalidomide in Combination With a Fixed Dose of Sorafenib for the Treatment of Hepatocellular Carcinoma
|
Hepatocellular Carcinoma
|
* Drug: Lenalidomide
* Drug: Sorafenib
|
Inclusion Criteria:~Clinical or pathological diagnosis of unresectable hepatocellular carcinoma (HCC) based on radiologic criteria, elevated alpha fetoprotein and/or tissue biopsy~All previous cancer therapy, including radiation, hormonal therapy and surgery, must have been discontinued at least 28 days prior to treatment in this study~Child-Pugh Liver Function Class A/B9~Eastern Cooperative Oncology Group (ECOG) performance status of </= 2 at study entry~Laboratory test results within protocol-specific ranges~Disease free of prior malignancies for >/= 5 years with exception of currently treated basal cell, squamous cell carcinoma of the skin, or carcinoma in situ of the cervix or breast.~All study participants must be registered into the mandatory RevAssist® program, and be willing and able to comply with the requirements of RevAssist® (Revlimid is only available under a restricted distribution program called RevAssist.)~Females of childbearing potential must have two negative pregnancy tests before starting lenalidomide and must agree to use two methods of birth control and submit to pregnancy tests throughout the study.~Able to take aspirin daily as prophylactic anticoagulation~Age >18 years at the time of signing the informed consent form~Life expectancy of at least 30 days~Exclusion Criteria:~No serious medical condition, laboratory abnormality, or psychiatric illness (including no evidence of hepatic encephalopathy) that would prevent the subject from signing the informed consent form~No pregnant or breast feeding females. (Lactating females must agree not to breast feed while taking lenalidomide)~No patients who have undergone surgical resection or received chemotherapy, percutaneous ethanol injection, radiation therapy or chemoembolization within 30 days prior to commencement of the study~No condition, including the presence of laboratory abnormalities, which places the subject at unacceptable risk if he/she were to participate in the study or confounds the ability to interpret data from the study~No use of any other experimental drug or therapy within 28 days of baseline~No known hypersensitivity to thalidomide~Patients who developed erythema nodosum if characterized by a desquamating rash while taking thalidomide or similar drugs will be excluded~No prior use of lenalidomide~No concurrent use of other anti-cancer agents or treatments~No known positivity for HIV or infectious hepatitis, type B-8/9 or C~No active infection not controlled effectively with antimicrobial or antiviral therapy
|
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 Dose Limiting Toxicities as a Measure of Safety of the combination of lenalidomide and sorafenib. | | 2 years |
|
Angiogenesis Modulating Agents, Physiological Effects of Drugs, Angiogenesis Inhibitors, Lenalidomide, Sorafenib, Immunologic Factors, Growth Substances, Growth Inhibitors, Antineoplastic Agents, Protein Kinase Inhibitors, Enzyme Inhibitors, Molecular Mechanisms of Pharmacological Action
|
| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Open Label, Single Arm<br>Dose escalation of lenalidomide in combination with sorafenib at standard doses in patients with advanced, unresectable hepatocellular carcinoma. | Drug: Lenalidomide<br>* Escalating doses starting at 15 mg by mouth per day.<br>Drug: Sorafenib<br>* Fixed dose of 400 mg by mouth twice a day.<br>|
|
Lenalidomide in Combination With a Fixed Dose of Sorafenib for the Treatment of Hepatocellular Carcinoma
Study Overview
=================
Brief Summary
-----------------
The purpose of this study is to evaluate the combination of Revlimid® (lenalidomide) and Nexavar® (sorafenib) for the treatment of hepatocellular carcinoma that can't be cured with surgery.
Official Title
-----------------
A Phase I Open-label Dose-escalation Study With Lenalidomide in Combination With a Fixed Dose of Sorafenib for the Treatment of Hepatocellular Carcinoma
Conditions
-----------------
Hepatocellular Carcinoma
Intervention / Treatment
-----------------
* Drug: Lenalidomide
* Drug: Sorafenib
Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Clinical or pathological diagnosis of unresectable hepatocellular carcinoma (HCC) based on radiologic criteria, elevated alpha fetoprotein and/or tissue biopsy All previous cancer therapy, including radiation, hormonal therapy and surgery, must have been discontinued at least 28 days prior to treatment in this study Child-Pugh Liver Function Class A/B9 Eastern Cooperative Oncology Group (ECOG) performance status of </= 2 at study entry Laboratory test results within protocol-specific ranges Disease free of prior malignancies for >/= 5 years with exception of currently treated basal cell, squamous cell carcinoma of the skin, or carcinoma in situ of the cervix or breast. All study participants must be registered into the mandatory RevAssist® program, and be willing and able to comply with the requirements of RevAssist® (Revlimid is only available under a restricted distribution program called RevAssist.) Females of childbearing potential must have two negative pregnancy tests before starting lenalidomide and must agree to use two methods of birth control and submit to pregnancy tests throughout the study. Able to take aspirin daily as prophylactic anticoagulation Age >18 years at the time of signing the informed consent form Life expectancy of at least 30 days Exclusion Criteria: No serious medical condition, laboratory abnormality, or psychiatric illness (including no evidence of hepatic encephalopathy) that would prevent the subject from signing the informed consent form No pregnant or breast feeding females. (Lactating females must agree not to breast feed while taking lenalidomide) No patients who have undergone surgical resection or received chemotherapy, percutaneous ethanol injection, radiation therapy or chemoembolization within 30 days prior to commencement of the study No condition, including the presence of laboratory abnormalities, which places the subject at unacceptable risk if he/she were to participate in the study or confounds the ability to interpret data from the study No use of any other experimental drug or therapy within 28 days of baseline No known hypersensitivity to thalidomide Patients who developed erythema nodosum if characterized by a desquamating rash while taking thalidomide or similar drugs will be excluded No prior use of lenalidomide No concurrent use of other anti-cancer agents or treatments No known positivity for HIV or infectious hepatitis, type B-8/9 or C No active infection not controlled effectively with antimicrobial or antiviral therapy
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: Open Label, Single Arm<br>Dose escalation of lenalidomide in combination with sorafenib at standard doses in patients with advanced, unresectable hepatocellular carcinoma. | Drug: Lenalidomide<br>* Escalating doses starting at 15 mg by mouth per day.<br>Drug: Sorafenib<br>* Fixed dose of 400 mg by mouth twice a day.<br>|
What is the study measuring?
-----------------
Primary Outcome Measures
| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Number of Participants with Dose Limiting Toxicities as a Measure of Safety of the combination of lenalidomide and sorafenib. | | 2 years |
|
|||
NCT00836940
|
A Clinical Study of GRC 8200 in Type 2 Diabetes Mellitus
|
The study is aimed at evaluating efficacy and safety of GRC 8200 in type 2 diabetes mellitus patients.~The study involves six weeks of wash out period and two weeks run in period for patients currently on mono-therapy and a two week run in period only for drug naïve patients.~This is a placebo controlled study. One of the five treatment arms is placebo. The duration of treatment is 12 weeks.
|
A 12-week Randomized, Double-blind, Parallel Group, Placebo-controlled Study to Evaluate Safety, Tolerability, and Efficacy of GRC 8200, a New Oral DPP -IV Inhibitor, in Patients With Type 2 Diabetes Mellitus.
|
Type 2 Diabetes Mellitus
|
* Drug: GRC 8200
|
Inclusion Criteria:~Male or female patients ≥30 years of age~At screening, females of non-childbearing potential or females of childbearing potential with adequate contraception~Has an established clinical diagnosis of type 2 diabetes mellitus for at least 3 months prior to the screening period~Is being treated for diabetes either with diet and exercise alone, or on monotherapy with any of the antidiabetic drugs~Has an HbA1c value at screening between 6.5% and 10%~Exclusion Criteria:~Has type 1 diabetes~Is a female who is lactating or is pregnant~Has a history of acute metabolic diabetic complications~Has clinically significant disease other than type 2 diabetes mellitus
|
30 Years
| null |
All
|
No
|
Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple
|
| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change from baseline in HbA1c compared with placebo at the end of 12 week treatment period | | 12 weeks |
|
| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change in HbA1c from baseline at the end of 4 and 8 weeks of treatment | | 4 and 8 weeks |
| Fasting plasma glucose and fasting serum insulin | | 12 weeks |
| Plasma glucose 2 hours post glucose challenge (OGTT) | | 12 weeks |
| HOMA-IR | | 12 weeks |
| HOMA-B | | 12 weeks |
| Change in serum lipids | | 12 weeks |
| Body weight | | 12 weeks |
| Waist circumference | | 12 weeks |
|
Type 2 diabetes mellitus, GRC 8200
|
Diabetes Mellitus, Diabetes Mellitus, Type 2, Glucose Metabolism Disorders, Metabolic Diseases, Endocrine System Diseases
|
| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Placebo Comparator: 1<br> | Drug: GRC 8200<br>* Capsules, 25 to 100mg, once/ twice a day, 12 weeks<br>|
| Experimental: 2<br>GRC 8200-25mg OD | Drug: GRC 8200<br>* Capsules, 25 to 100mg, once/ twice a day, 12 weeks<br>|
| Experimental: 3<br>GRC 8200-50mg OD | Drug: GRC 8200<br>* Capsules, 25 to 100mg, once/ twice a day, 12 weeks<br>|
| Experimental: 4<br>GRC 8200-50mg BD | Drug: GRC 8200<br>* Capsules, 25 to 100mg, once/ twice a day, 12 weeks<br>|
| Experimental: 5<br>GRC 8200-100mg OD | Drug: GRC 8200<br>* Capsules, 25 to 100mg, once/ twice a day, 12 weeks<br>|
|
A Clinical Study of GRC 8200 in Type 2 Diabetes Mellitus
Study Overview
=================
Brief Summary
-----------------
The study is aimed at evaluating efficacy and safety of GRC 8200 in type 2 diabetes mellitus patients. The study involves six weeks of wash out period and two weeks run in period for patients currently on mono-therapy and a two week run in period only for drug naïve patients. This is a placebo controlled study. One of the five treatment arms is placebo. The duration of treatment is 12 weeks.
Official Title
-----------------
A 12-week Randomized, Double-blind, Parallel Group, Placebo-controlled Study to Evaluate Safety, Tolerability, and Efficacy of GRC 8200, a New Oral DPP -IV Inhibitor, in Patients With Type 2 Diabetes Mellitus.
Conditions
-----------------
Type 2 Diabetes Mellitus
Intervention / Treatment
-----------------
* Drug: GRC 8200
Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Male or female patients ≥30 years of age At screening, females of non-childbearing potential or females of childbearing potential with adequate contraception Has an established clinical diagnosis of type 2 diabetes mellitus for at least 3 months prior to the screening period Is being treated for diabetes either with diet and exercise alone, or on monotherapy with any of the antidiabetic drugs Has an HbA1c value at screening between 6.5% and 10% Exclusion Criteria: Has type 1 diabetes Is a female who is lactating or is pregnant Has a history of acute metabolic diabetic complications Has clinically significant disease other than type 2 diabetes mellitus
Ages Eligible for Study
-----------------
Minimum Age: 30 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 |
| --- | --- |
| Placebo Comparator: 1<br> | Drug: GRC 8200<br>* Capsules, 25 to 100mg, once/ twice a day, 12 weeks<br>|
| Experimental: 2<br>GRC 8200-25mg OD | Drug: GRC 8200<br>* Capsules, 25 to 100mg, once/ twice a day, 12 weeks<br>|
| Experimental: 3<br>GRC 8200-50mg OD | Drug: GRC 8200<br>* Capsules, 25 to 100mg, once/ twice a day, 12 weeks<br>|
| Experimental: 4<br>GRC 8200-50mg BD | Drug: GRC 8200<br>* Capsules, 25 to 100mg, once/ twice a day, 12 weeks<br>|
| Experimental: 5<br>GRC 8200-100mg OD | Drug: GRC 8200<br>* Capsules, 25 to 100mg, once/ twice a day, 12 weeks<br>|
What is the study measuring?
-----------------
Primary Outcome Measures
| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change from baseline in HbA1c compared with placebo at the end of 12 week treatment period | | 12 weeks |
Secondary Outcome Measures
| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change in HbA1c from baseline at the end of 4 and 8 weeks of treatment | | 4 and 8 weeks |
| Fasting plasma glucose and fasting serum insulin | | 12 weeks |
| Plasma glucose 2 hours post glucose challenge (OGTT) | | 12 weeks |
| HOMA-IR | | 12 weeks |
| HOMA-B | | 12 weeks |
| Change in serum lipids | | 12 weeks |
| Body weight | | 12 weeks |
| Waist circumference | | 12 weeks |
Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Type 2 diabetes mellitus, GRC 8200
|
|
NCT02097888
|
Influence of Erythropoietin on Bone Marrow Microenvironment
|
This will be a prospective observational study. The investigators will compare Erythropoietin (Epo) levels, erythropoiesis, and regulators of erythropoiesis, bone imaging and bone metabolism in healthy volunteers living at different altitudes.
|
Influence of Erythropoietin on Bone Marrow Microenvironment: A Pilot Study
|
Healthy Men and Non- Pregnant Women
|
Inclusion Criteria:~healthy men and non-pregnant women, ages ≥18-40 years and ≥ 60 years living in the predefined area~Exclusion Criteria:~Known bone pathology including osteoporosis, known haematological disease, known renal disease, heart insufficiency, pulmonal disease~pregnancy
|
18 Years
| null |
All
|
Accepts Healthy Volunteers
|
| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Difference of EPO level between control groups | | up to 4 years |
|
Influence of Erythropoietin on Bone Marrow Microenvironment
Study Overview
=================
Brief Summary
-----------------
This will be a prospective observational study. The investigators will compare Erythropoietin (Epo) levels, erythropoiesis, and regulators of erythropoiesis, bone imaging and bone metabolism in healthy volunteers living at different altitudes.
Official Title
-----------------
Influence of Erythropoietin on Bone Marrow Microenvironment: A Pilot Study
Conditions
-----------------
Healthy Men and Non- Pregnant Women
Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: healthy men and non-pregnant women, ages ≥18-40 years and ≥ 60 years living in the predefined area Exclusion Criteria: Known bone pathology including osteoporosis, known haematological disease, known renal disease, heart insufficiency, pulmonal disease pregnancy
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?
-----------------
What is the study measuring?
-----------------
Primary Outcome Measures
| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Difference of EPO level between control groups | | up to 4 years |
|
|||||||
NCT03367780
|
Dose-Effect Relation of Salivary Gland Irradiation
|
Optimization of radiotherapy to reduce xerostomia is difficult, because many gland locations cannot be seen with current imaging modalities and biological dose-effect are currently insufficiently understood. PSMA PET is a new diagnostic instrument which can visualize the presence of vital acinar cells in salivary gland locations throughout the head and neck, with a sensitive and quantitative signal. A reduction of PSMA accumulation in salivary glands is thought to correlate with loss of vital acinar cells. The PET images can be correlated with radiotherapy dose distributions in gland-based or voxel-based evaluations. This makes PSMA PET a suitable instrument to derive the radiobiological dose-effect relations that are required to develop better and gland-specific dose constraints for radiotherapy. The results of this study can contribute to lower toxicity and better quality of life in patients treated with high-dose radiotherapy in the head and neck.
|
Primary objective of this prospective observational study is to determine the gland-based dose-effect relation between conventionally fractionated radiotherapy (RT) and long-term loss of acinar cells, per salivary gland type. The study population consists of a maximum of 20 patients with HNSCC referred for high-dose (CC)RT. There is no therapeutic intervention. Diagnostic intervention is PSMA PET/CT.
|
Determining the Dose-Effect Relation of Salivary Gland Irradiation and Cell Loss With PSMA PET
|
HNSCC
|
* Device: PSMA PET/CT-scan
|
Inclusion Criteria:~HNSCC of the head-neck area, cTx-4 N0-3 M0~Accepted for EBRT in a conventionally fractionated schedule of 6-7 weeks.~Exclusion Criteria:~Age <18y~Pregnancy or lactation~Participation in conflicting studies, e.g. with non-standard treatment and/or imaging~Inability to provide informed consent
|
18 Years
| null |
All
|
No
|
| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| the mean received radiation dose to salivary glands (Dmean), and the total uptake of PSMA in salivary glands (SUVtotal) and its relative reduction after radiotherapy (ΔSUVtotal-6). | Dmean and ΔSUVtotal-6 are correlated to determine the dose-effect relation. | 6 months |
|
| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| ΔSUV | | 1 month |
| the clinical evaluation of a dry mouth | according to the C30+HN35 QoL | before treatment, once during 7 weeks of treatment and follow up 6 months after |
| the clinical evaluation of a dry mouth | Groningen questionnaires | before treatment, once a week during 7 weeks of treatment and follow up 6 months after |
| voxel-based ΔSUV | | 7 weeks of treatment, follow-up 1 and 6 months |
| Voxel-based received radiation dose | | 7 weeks of treatment, 1 and 6 months |
|
Head-neck tumours, Radiotherapy, Salivary gland toxicity, PSMA PET/CT
|
| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| RT with curative intent for HNSCC<br>several schemes for radical (chemo)radiotherapy, administered in 30-35 fractions over 6-7 weeks | Device: PSMA PET/CT-scan<br>* PSMA PET is a new diagnostic instrument which can visualize the presence of vital acinar cells in salivary gland locations throughout the head and neck, with a sensitive and quantitative signal.<br>|
|
Dose-Effect Relation of Salivary Gland Irradiation
Study Overview
=================
Brief Summary
-----------------
Optimization of radiotherapy to reduce xerostomia is difficult, because many gland locations cannot be seen with current imaging modalities and biological dose-effect are currently insufficiently understood. PSMA PET is a new diagnostic instrument which can visualize the presence of vital acinar cells in salivary gland locations throughout the head and neck, with a sensitive and quantitative signal. A reduction of PSMA accumulation in salivary glands is thought to correlate with loss of vital acinar cells. The PET images can be correlated with radiotherapy dose distributions in gland-based or voxel-based evaluations. This makes PSMA PET a suitable instrument to derive the radiobiological dose-effect relations that are required to develop better and gland-specific dose constraints for radiotherapy. The results of this study can contribute to lower toxicity and better quality of life in patients treated with high-dose radiotherapy in the head and neck.
Detailed Description
-----------------
Primary objective of this prospective observational study is to determine the gland-based dose-effect relation between conventionally fractionated radiotherapy (RT) and long-term loss of acinar cells, per salivary gland type. The study population consists of a maximum of 20 patients with HNSCC referred for high-dose (CC)RT. There is no therapeutic intervention. Diagnostic intervention is PSMA PET/CT.
Official Title
-----------------
Determining the Dose-Effect Relation of Salivary Gland Irradiation and Cell Loss With PSMA PET
Conditions
-----------------
HNSCC
Intervention / Treatment
-----------------
* Device: PSMA PET/CT-scan
Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: HNSCC of the head-neck area, cTx-4 N0-3 M0 Accepted for EBRT in a conventionally fractionated schedule of 6-7 weeks. Exclusion Criteria: Age <18y Pregnancy or lactation Participation in conflicting studies, e.g. with non-standard treatment and/or imaging Inability to provide informed 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?
-----------------
Arms and Interventions
| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| RT with curative intent for HNSCC<br>several schemes for radical (chemo)radiotherapy, administered in 30-35 fractions over 6-7 weeks | Device: PSMA PET/CT-scan<br>* PSMA PET is a new diagnostic instrument which can visualize the presence of vital acinar cells in salivary gland locations throughout the head and neck, with a sensitive and quantitative signal.<br>|
What is the study measuring?
-----------------
Primary Outcome Measures
| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| the mean received radiation dose to salivary glands (Dmean), and the total uptake of PSMA in salivary glands (SUVtotal) and its relative reduction after radiotherapy (ΔSUVtotal-6). | Dmean and ΔSUVtotal-6 are correlated to determine the dose-effect relation. | 6 months |
Secondary Outcome Measures
| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| ΔSUV | | 1 month |
| the clinical evaluation of a dry mouth | according to the C30+HN35 QoL | before treatment, once during 7 weeks of treatment and follow up 6 months after |
| the clinical evaluation of a dry mouth | Groningen questionnaires | before treatment, once a week during 7 weeks of treatment and follow up 6 months after |
| voxel-based ΔSUV | | 7 weeks of treatment, follow-up 1 and 6 months |
| Voxel-based received radiation dose | | 7 weeks of treatment, 1 and 6 months |
Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Head-neck tumours, Radiotherapy, Salivary gland toxicity, PSMA PET/CT
|
||
NCT03563365
|
The Functional and Emotional Benefits of Replenix Power of Three With Resveratrol
|
A Randomized, Investigator Blinded, Single Site, Three Arm Clinical Study to Assess the Functional and Emotional Benefits of Replenix Power of Three Cream with Resveratrol , Replenix Power of Three Cream with Resveratrol with Adapalene and Benzoyl Peroxide Gel, 0.1%/2.5%, and Adapalene and Benzoyl Peroxide Gel, 0.1%/2.5%, utilized to treat subjects with Facial Acne Vulgaris
|
Acne vulgaris is a common skin problem which can be challenging to treat. Enhancing the efficacy and tolerability of treatment regimens can enhance compliance and outcomes thereby potentially decreasing the morbidities associated with acne vulgaris.~The present study is designed to assess the ability of Power of 3 with resveratrol to improve efficacy and tolerability of an existing combination acne medication.
|
A Randomized, Investigator Blinded, Single Site, Three Arm Clinical Study to Assess the Functional and Emotional Benefits of Replenix Power of Three Cream With Resveratrol , Replenix Power of Three Cream With Resveratrol With Adapalene and Benzoyl Peroxide Gel, 0.1%/2.5%, and Adapalene and Benzoyl Peroxide Gel, 0.1%/2.5%, Utilized to Treat Subjects With Facial Acne Vulgaris
|
Acne Vulgaris
|
* Other: Replenix Power of 3 Cream with resveratrol
* Drug: Adapalene and Benzoyl peroxide gel, 0.1%/2.5%
|
Inclusion Criteria:~Healthy male or non pregnant female aged ≥ 12 and ≤ 40 years with a clinical diagnosis of Acne vulgaris~On the face, ≥ 20 non-inflammatory lesions (i.e., open and closed comedones) AND < 75 inflammatory lesions (i.e., papules and pustules) AND ≤ 1 nodulocystic lesions (i.e., nodules and cysts).~Investigator's Global Assessment (IGA) of acne severity grade 2 or 3~Subject must be able to follow study instructions and likely to complete all required visits, as assessed by the Investigator.~Subject/Guardian must sign an IRB-approved Informed Consent/Assent/Assent Form including photography consent, and the Authorization for Use and release of Health and Research Study Information (HIPAA) form prior to any study-related procedures being performed~Exclusion Criteria:~Presence of any skin condition that would interfere with the diagnosis or assessment of acne vulgaris (e.g., on the face: rosacea, dermatitis, psoriasis, squamous cell carcinoma, eczema, acneform eruptions caused by medications, steroid acne, steroid folliculitis, or bacterial folliculitis).~Subjects who have acne conglobata, acne fulminans and secondary acne (e.g.:~chloracne and drug induced acne).~Excessive facial hair (e.g. beards, sideburns, moustaches, etc.) that would interfere with diagnosis or assessment of acne vulgaris. Well trimmed moustaches are allowed.~History of hypersensitivity or allergy to benzoyl peroxide or adapalene and or any of the study product ingredients.~Subjects who have a severe or intense irritation on the face.~Use within 6 months prior to baseline (Randomization) of oral retinoids (e.g. Accutane®) or therapeutic vitamin A supplements of greater than 10,000 units/day (multivitamins are allowed).~Use for less than 3 months prior to baseline (Randomization) of estrogens or oral contraceptives; use of such therapy is allowed if it will remain constant throughout the study.~Use on the face within 1 month prior to baseline (Randomization) or during the study of: 1) cryodestruction or chemodestruction, 2) dermabrasion, 3) photodynamic therapy, 4) acne surgery, 5) intralesional steroids, or 6) x-ray therapy.~Use within 1 month prior to baseline (Randomization) of: 1) spironolactone, 2) systemic steroids, 3) systemic antibiotics, 4) systemic treatment for acne vulgaris (other than oralretinoids, which require a 6-month washout), or 5) systemic anti- inflammatory agents.~Use within 2 weeks prior to baseline (Randomization) of: 1) topical steroids, 2) topical retinoids, 3) topical acne treatments including over-the-counter preparations, 4) topical anti-inflammatory agents, 5) medicated cleansers or 6) topical antibiotics.~Subjects who have had general anesthesia for any reason and patients who have received neuromuscular blocking agents within 14 days prior to study entry (Randomization).~Concomitant use of facial product containing glycolic or other acids, masks, washes or soaps containing benzoyl peroxide or salicylic acid, non mild cleansers or moisturizers containing retinol, salicylic or α- or β-hydroxy acids.~Concomitant use of mega-doses of certain vitamins (such as vitamin D and vitamin B12), haloperidol, halogens such as iodide and bromide, lithium, hydantoin and phenobarbital.~Facial procedures (chemical or laser peel, microdermabrasion, etc.) within the past 2 weeks or during the study.~Concomitant use of tanning booths or sunbathing.~A significant medical history of or are currently immunocompromised~Have any systemic or dermatologic disease that may affect the evaluation of study results.~Have a history of regional enteritis, ulcerative colitis, pseudomembranous colitis or antibiotic-associated colitis.~Subjects with clinically significant unstable medical disorders, life-threatening disease, or current malignancies.
|
12 Years
|
40 Years
|
All
|
Accepts Healthy Volunteers
|
Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Factorial Assignment
Masking: Single
|
| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Investigator Global Assessment (IGA) | To assess the change in Acne Vulgaris on a scale of 1 to 4, where 1 represents clear skin and 4 represents severe acne, at each scheduled visit with the use of Replenix Power of three with Resveratrol. | Screening, Baseline, Week 2, Week 4, Week 8, Week 12 |
| Subject Global Assessment (SGA) | To assess the change in Acne Vulgaris on a scale of 1 to 5, where 1 represents a worsening of acne and 5 represents clearing of acne, at each scheduled visit as compared to baseline with the use of Replenix Power of three with Resveratrol. | Screening, Baseline, Week 2, Week 4, Week 8, Week 12 |
| Subject Overall Assessment of Tone and Texture (SOATT) | To assess the change on skin tone and texture on a scale of 1 to 7, where 1 represents worse tone and texture and 7 represents better tone and texture, at each scheduled visit with use of Replenix Power of three with Resveratrol. | Screening, Baseline, Week 2, Week 4, Week 8, Week 12 |
| Investigator Overall Assessment of Tone and Texture (IOATT) | To assess the change on skin tone and texture on a scale of 1 to 7, where 1 represents worse tone and texture and 7 represents better tone and texture, at each scheduled visit with use of Replenix Power of three with Resveratrol. | Screening, Baseline, Week 2, Week 4, Week 8, Week 12 |
| Subject Assessment of Skin Dysesthesia (SDA) | To assess the change in Dysesthesia on a scale of 1 to 7, where 1 represents no dysesthesia and 7 represents severe dysesthesia, at each scheduled visit with use of Replenix Power of three with Resveratrol. | Screening, Baseline, Week 2, Week 4, Week 8, Week 12 |
| Subject Quality of Life (SQOL) | To assess the change in Subject Quality of Life on a scale of 1 to 7, where 1 represents better quality of life and 7 represents worse quality of life, at Screening, Baseline and week 12 with use of Replenix Power of three with Resveratrol. | Screening, Baseline, Week 12 |
| Local Tolerability Assessment | To assess the change in Local Tolerability on a scale of 0 to 3, where 0 represents no tolerability issues and 3 represents severe tolerability issues, at each scheduled visit with use of Replenix Power of three with Resveratrol. | Screening, Baseline, Week 2, Week 4, Week 8, Week 12 |
|
Adapalene, Benzoyl Peroxide, Resveratrol, Antioxidants, Molecular Mechanisms of Pharmacological Action, Protective Agents, Physiological Effects of Drugs, Enzyme Inhibitors, Platelet Aggregation Inhibitors, Dermatologic Agents, Anti-Inflammatory Agents, Non-Steroidal, Analgesics, Non-Narcotic, Analgesics, Sensory System Agents, Peripheral Nervous System Agents, Anti-Inflammatory Agents, Antirheumatic Agents
|
| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Replenix<br>Replenix power of 3 cream with Resveratrol applied twice daily | Other: Replenix Power of 3 Cream with resveratrol<br>* Cosmetic product containing Green Tea Polyphenols, Resveratrol, Caffeine USP, Bisabolol Cucumber extract, Chamomile extract, Rosemary extract, Squalane, Soy Phospholipids<br>|
| Experimental: Replenix and Adapalene and Benzoyl Peroxide gel<br>Replenix power of 3 cream with Resveratrol applied twice daily and Adapalene and Benzoyl Peroxide Gel, 0.1%/2.5% applied once daily | Other: Replenix Power of 3 Cream with resveratrol<br>* Cosmetic product containing Green Tea Polyphenols, Resveratrol, Caffeine USP, Bisabolol Cucumber extract, Chamomile extract, Rosemary extract, Squalane, Soy Phospholipids<br>Drug: Adapalene and Benzoyl peroxide gel, 0.1%/2.5%<br>* FDA approved topical agent for the treatment of acne<br>|
| Active Comparator: Adapalene and Benzoyl Peroxide gel<br>Adapalene and Benzoyl Peroxide Gel, 0.1%/2.5% applied once daily | Drug: Adapalene and Benzoyl peroxide gel, 0.1%/2.5%<br>* FDA approved topical agent for the treatment of acne<br>|
|
The Functional and Emotional Benefits of Replenix Power of Three With Resveratrol
Study Overview
=================
Brief Summary
-----------------
A Randomized, Investigator Blinded, Single Site, Three Arm Clinical Study to Assess the Functional and Emotional Benefits of Replenix Power of Three Cream with Resveratrol , Replenix Power of Three Cream with Resveratrol with Adapalene and Benzoyl Peroxide Gel, 0.1%/2.5%, and Adapalene and Benzoyl Peroxide Gel, 0.1%/2.5%, utilized to treat subjects with Facial Acne Vulgaris
Detailed Description
-----------------
Acne vulgaris is a common skin problem which can be challenging to treat. Enhancing the efficacy and tolerability of treatment regimens can enhance compliance and outcomes thereby potentially decreasing the morbidities associated with acne vulgaris. The present study is designed to assess the ability of Power of 3 with resveratrol to improve efficacy and tolerability of an existing combination acne medication.
Official Title
-----------------
A Randomized, Investigator Blinded, Single Site, Three Arm Clinical Study to Assess the Functional and Emotional Benefits of Replenix Power of Three Cream With Resveratrol , Replenix Power of Three Cream With Resveratrol With Adapalene and Benzoyl Peroxide Gel, 0.1%/2.5%, and Adapalene and Benzoyl Peroxide Gel, 0.1%/2.5%, Utilized to Treat Subjects With Facial Acne Vulgaris
Conditions
-----------------
Acne Vulgaris
Intervention / Treatment
-----------------
* Other: Replenix Power of 3 Cream with resveratrol
* Drug: Adapalene and Benzoyl peroxide gel, 0.1%/2.5%
Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Healthy male or non pregnant female aged ≥ 12 and ≤ 40 years with a clinical diagnosis of Acne vulgaris On the face, ≥ 20 non-inflammatory lesions (i.e., open and closed comedones) AND < 75 inflammatory lesions (i.e., papules and pustules) AND ≤ 1 nodulocystic lesions (i.e., nodules and cysts). Investigator's Global Assessment (IGA) of acne severity grade 2 or 3 Subject must be able to follow study instructions and likely to complete all required visits, as assessed by the Investigator. Subject/Guardian must sign an IRB-approved Informed Consent/Assent/Assent Form including photography consent, and the Authorization for Use and release of Health and Research Study Information (HIPAA) form prior to any study-related procedures being performed Exclusion Criteria: Presence of any skin condition that would interfere with the diagnosis or assessment of acne vulgaris (e.g., on the face: rosacea, dermatitis, psoriasis, squamous cell carcinoma, eczema, acneform eruptions caused by medications, steroid acne, steroid folliculitis, or bacterial folliculitis). Subjects who have acne conglobata, acne fulminans and secondary acne (e.g.: chloracne and drug induced acne). Excessive facial hair (e.g. beards, sideburns, moustaches, etc.) that would interfere with diagnosis or assessment of acne vulgaris. Well trimmed moustaches are allowed. History of hypersensitivity or allergy to benzoyl peroxide or adapalene and or any of the study product ingredients. Subjects who have a severe or intense irritation on the face. Use within 6 months prior to baseline (Randomization) of oral retinoids (e.g. Accutane®) or therapeutic vitamin A supplements of greater than 10,000 units/day (multivitamins are allowed). Use for less than 3 months prior to baseline (Randomization) of estrogens or oral contraceptives; use of such therapy is allowed if it will remain constant throughout the study. Use on the face within 1 month prior to baseline (Randomization) or during the study of: 1) cryodestruction or chemodestruction, 2) dermabrasion, 3) photodynamic therapy, 4) acne surgery, 5) intralesional steroids, or 6) x-ray therapy. Use within 1 month prior to baseline (Randomization) of: 1) spironolactone, 2) systemic steroids, 3) systemic antibiotics, 4) systemic treatment for acne vulgaris (other than oralretinoids, which require a 6-month washout), or 5) systemic anti- inflammatory agents. Use within 2 weeks prior to baseline (Randomization) of: 1) topical steroids, 2) topical retinoids, 3) topical acne treatments including over-the-counter preparations, 4) topical anti-inflammatory agents, 5) medicated cleansers or 6) topical antibiotics. Subjects who have had general anesthesia for any reason and patients who have received neuromuscular blocking agents within 14 days prior to study entry (Randomization). Concomitant use of facial product containing glycolic or other acids, masks, washes or soaps containing benzoyl peroxide or salicylic acid, non mild cleansers or moisturizers containing retinol, salicylic or α- or β-hydroxy acids. Concomitant use of mega-doses of certain vitamins (such as vitamin D and vitamin B12), haloperidol, halogens such as iodide and bromide, lithium, hydantoin and phenobarbital. Facial procedures (chemical or laser peel, microdermabrasion, etc.) within the past 2 weeks or during the study. Concomitant use of tanning booths or sunbathing. A significant medical history of or are currently immunocompromised Have any systemic or dermatologic disease that may affect the evaluation of study results. Have a history of regional enteritis, ulcerative colitis, pseudomembranous colitis or antibiotic-associated colitis. Subjects with clinically significant unstable medical disorders, life-threatening disease, or current malignancies.
Ages Eligible for Study
-----------------
Minimum Age: 12 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: Treatment
Allocation: Randomized
Intervention Model: Factorial Assignment
Masking: Single
Arms and Interventions
| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Replenix<br>Replenix power of 3 cream with Resveratrol applied twice daily | Other: Replenix Power of 3 Cream with resveratrol<br>* Cosmetic product containing Green Tea Polyphenols, Resveratrol, Caffeine USP, Bisabolol Cucumber extract, Chamomile extract, Rosemary extract, Squalane, Soy Phospholipids<br>|
| Experimental: Replenix and Adapalene and Benzoyl Peroxide gel<br>Replenix power of 3 cream with Resveratrol applied twice daily and Adapalene and Benzoyl Peroxide Gel, 0.1%/2.5% applied once daily | Other: Replenix Power of 3 Cream with resveratrol<br>* Cosmetic product containing Green Tea Polyphenols, Resveratrol, Caffeine USP, Bisabolol Cucumber extract, Chamomile extract, Rosemary extract, Squalane, Soy Phospholipids<br>Drug: Adapalene and Benzoyl peroxide gel, 0.1%/2.5%<br>* FDA approved topical agent for the treatment of acne<br>|
| Active Comparator: Adapalene and Benzoyl Peroxide gel<br>Adapalene and Benzoyl Peroxide Gel, 0.1%/2.5% applied once daily | Drug: Adapalene and Benzoyl peroxide gel, 0.1%/2.5%<br>* FDA approved topical agent for the treatment of acne<br>|
What is the study measuring?
-----------------
Primary Outcome Measures
| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Investigator Global Assessment (IGA) | To assess the change in Acne Vulgaris on a scale of 1 to 4, where 1 represents clear skin and 4 represents severe acne, at each scheduled visit with the use of Replenix Power of three with Resveratrol. | Screening, Baseline, Week 2, Week 4, Week 8, Week 12 |
| Subject Global Assessment (SGA) | To assess the change in Acne Vulgaris on a scale of 1 to 5, where 1 represents a worsening of acne and 5 represents clearing of acne, at each scheduled visit as compared to baseline with the use of Replenix Power of three with Resveratrol. | Screening, Baseline, Week 2, Week 4, Week 8, Week 12 |
| Subject Overall Assessment of Tone and Texture (SOATT) | To assess the change on skin tone and texture on a scale of 1 to 7, where 1 represents worse tone and texture and 7 represents better tone and texture, at each scheduled visit with use of Replenix Power of three with Resveratrol. | Screening, Baseline, Week 2, Week 4, Week 8, Week 12 |
| Investigator Overall Assessment of Tone and Texture (IOATT) | To assess the change on skin tone and texture on a scale of 1 to 7, where 1 represents worse tone and texture and 7 represents better tone and texture, at each scheduled visit with use of Replenix Power of three with Resveratrol. | Screening, Baseline, Week 2, Week 4, Week 8, Week 12 |
| Subject Assessment of Skin Dysesthesia (SDA) | To assess the change in Dysesthesia on a scale of 1 to 7, where 1 represents no dysesthesia and 7 represents severe dysesthesia, at each scheduled visit with use of Replenix Power of three with Resveratrol. | Screening, Baseline, Week 2, Week 4, Week 8, Week 12 |
| Subject Quality of Life (SQOL) | To assess the change in Subject Quality of Life on a scale of 1 to 7, where 1 represents better quality of life and 7 represents worse quality of life, at Screening, Baseline and week 12 with use of Replenix Power of three with Resveratrol. | Screening, Baseline, Week 12 |
| Local Tolerability Assessment | To assess the change in Local Tolerability on a scale of 0 to 3, where 0 represents no tolerability issues and 3 represents severe tolerability issues, at each scheduled visit with use of Replenix Power of three with Resveratrol. | Screening, Baseline, Week 2, Week 4, Week 8, Week 12 |
|
||
NCT05107817
|
Aquatic Exercise and Reactive Balance
|
The present clinical trial aims to identify if skills acquired during aquatic exercise are more effectively transferred to a reactive balance task than land exercise. This study is designed as a double-blinded, randomized controlled clinical trial. Forty-four older adults aged 60 years or above who meet the eligibility criteria will be recruited and randomized into an aquatic exercise group or land exercise group. Each group will participate in the same balance training exercise during a single session that includes a ball throwing and catching task. A modified lean-and-release test will be implemented on land immediately before, after, and one week after the training session. The outcomes will include reaction time, rapid response accuracy, and mini-BESTest scores obtained from stepping and grasping reactions.
|
During the modified lean-and-release test, there are two possible settings: 1) the leg block is placed in front of both legs, and a safety handle is uncovered; or 2) the leg block is removed, and the safety handle is covered. The leg block and handle cover will be controlled via computer-triggered, servo motors. The testing session will be comprised of three blocks: 1) REACH (grasping a safety handle using their right hand while maintaining both feet fixed), 2) STEP (stepping forward using any leg), and 3) RANDOM (random variations of STEP and REACH).
|
Catching and Throwing Exercises to Improve Reactive Balance: A Randomized Controlled Trial Protocol for the Comparison of Aquatic and Dry-land Training Environments
|
Aging, Aged, Accidental Falls, Postural Balance, Exercise, Exercise Therapy
|
* Other: Exercise intervention
|
Inclusion Criteria:~Ability to stand using a double-leg stance for one minute of time~Ability to walk independently~Normal or corrected to normal vision~Normal or corrected to normal hearing based on a qualitative assessment~Exclusion Criteria:~Any neurological or musculoskeletal disorders that may inhibit the participation in the training and testing protocols~A concussion within the past one year before the participation~Any cognitive deficiencies (e.g., memory, concentration, or attention disorder)~One or more 'yes' answered on the Physical Activity Readiness Questionnaire (PAR-Q)~Fear of water
|
65 Years
| null |
All
|
Accepts Healthy Volunteers
|
Primary Purpose: Prevention
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double
|
| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Reaction time measures (REACH) | Hand contact time during REACH following the cable release will be calculated. | Immediately before the intervention. Duration of each assessment will be 15 minutes. |
| Reaction time measures (STEP1) | Foot-off time during STEP following the cable release will be calculated. | Immediately before the intervention. Duration of each assessment will be 15 minutes. |
| Reaction time measures (STEP2) | Foot contact time during STEP following the cable release will be calculated. | Immediately before the intervention. Duration of each assessment will be 15 minutes. |
| Rapid response accuracy | For the RANDOM block, response accuracy, defined as the percentage of accurate responses, will be calculated. To represent a composite measure of accuracy and speed of response, rapid response accuracy will be calculated using the ratio of response accuracy to the reaction time (%/ms). Foot-off and hand contact data will be used for the calculation. | Immediately before the intervention. Duration of each assessment will be 15 minutes. |
| Mini-Balance Evaluation Systems Test | During the REACH, STEP, and RANDOM blocks, the quality of the compensatory reactions will be scored using the Reactive Postural Control section of the Mini-Balance Evaluation Systems Test. The scores will be ranged from 0 (worst) to 2 (best). | Immediately before the intervention. Duration of each assessment will be 15 minutes. |
| Reaction time measures (REACH) | Hand contact time during REACH following the cable release will be calculated. | Immediately after the intervention. Duration of each assessment will be 15 minutes. |
| Reaction time measures (STEP1) | Foot-off time during STEP following the cable release will be calculated. | Immediately after the intervention. Duration of each assessment will be 15 minutes. |
| Reaction time measures (STEP2) | Foot contact time during STEP following the cable release will be calculated. | Immediately after the intervention. Duration of each assessment will be 15 minutes. |
| Rapid response accuracy | For the RANDOM block, response accuracy, defined as the percentage of accurate responses, will be calculated. To represent a composite measure of accuracy and speed of response, rapid response accuracy will be calculated using the ratio of response accuracy to the reaction time (%/ms). Foot-off and hand contact data will be used for the calculation. | Immediately after the intervention. Duration of each assessment will be 15 minutes. |
| Mini-Balance Evaluation Systems Test | During the REACH, STEP, and RANDOM blocks, the quality of the compensatory reactions will be scored using the Reactive Postural Control section of the Mini-Balance Evaluation Systems Test. The scores will be ranged from 0 (worst) to 2 (best). | Immediately after the intervention. Duration of each assessment will be 15 minutes. |
| Reaction time measures (REACH) | Hand contact time during REACH following the cable release will be calculated. | One week after the intervention. Duration of each assessment will be 15 minutes. |
| Reaction time measures (STEP1) | Foot-off time during STEP following the cable release will be calculated. | One week after the intervention. Duration of each assessment will be 15 minutes. |
| Reaction time measures (STEP2) | Foot contact time during STEP following the cable release will be calculated. | One week after the intervention. Duration of each assessment will be 15 minutes. |
| Rapid response accuracy | For the RANDOM block, response accuracy, defined as the percentage of accurate responses, will be calculated. To represent a composite measure of accuracy and speed of response, rapid response accuracy will be calculated using the ratio of response accuracy to the reaction time (%/ms). Foot-off and hand contact data will be used for the calculation. | One week after the intervention. Duration of each assessment will be 15 minutes. |
| Mini-Balance Evaluation Systems Test | During the REACH, STEP, and RANDOM blocks, the quality of the compensatory reactions will be scored using the Reactive Postural Control section of the Mini-Balance Evaluation Systems Test. The scores will be ranged from 0 (worst) to 2 (best). | One week after the intervention. Duration of each assessment will be 15 minutes. |
|
Reactive balance, Aquatic exercise, Aquatic therapy, Fall prevention
|
| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Aquatic Exercise group<br>Participants will engage in a single session of training consisting of 120 repetitions of a ball throwing and catching task in water. | Other: Exercise intervention<br>* A ball catching and throwing exercise.<br>|
| Active Comparator: Land Exercise group<br>Participants will engage in a single session of training consisting of 120 repetitions of a ball throwing and catching task on dry land. | Other: Exercise intervention<br>* A ball catching and throwing exercise.<br>|
|
Aquatic Exercise and Reactive Balance
Study Overview
=================
Brief Summary
-----------------
The present clinical trial aims to identify if skills acquired during aquatic exercise are more effectively transferred to a reactive balance task than land exercise. This study is designed as a double-blinded, randomized controlled clinical trial. Forty-four older adults aged 60 years or above who meet the eligibility criteria will be recruited and randomized into an aquatic exercise group or land exercise group. Each group will participate in the same balance training exercise during a single session that includes a ball throwing and catching task. A modified lean-and-release test will be implemented on land immediately before, after, and one week after the training session. The outcomes will include reaction time, rapid response accuracy, and mini-BESTest scores obtained from stepping and grasping reactions.
Detailed Description
-----------------
During the modified lean-and-release test, there are two possible settings: 1) the leg block is placed in front of both legs, and a safety handle is uncovered; or 2) the leg block is removed, and the safety handle is covered. The leg block and handle cover will be controlled via computer-triggered, servo motors. The testing session will be comprised of three blocks: 1) REACH (grasping a safety handle using their right hand while maintaining both feet fixed), 2) STEP (stepping forward using any leg), and 3) RANDOM (random variations of STEP and REACH).
Official Title
-----------------
Catching and Throwing Exercises to Improve Reactive Balance: A Randomized Controlled Trial Protocol for the Comparison of Aquatic and Dry-land Training Environments
Conditions
-----------------
Aging, Aged, Accidental Falls, Postural Balance, Exercise, Exercise Therapy
Intervention / Treatment
-----------------
* Other: Exercise intervention
Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Ability to stand using a double-leg stance for one minute of time Ability to walk independently Normal or corrected to normal vision Normal or corrected to normal hearing based on a qualitative assessment Exclusion Criteria: Any neurological or musculoskeletal disorders that may inhibit the participation in the training and testing protocols A concussion within the past one year before the participation Any cognitive deficiencies (e.g., memory, concentration, or attention disorder) One or more 'yes' answered on the Physical Activity Readiness Questionnaire (PAR-Q) Fear of water
Ages Eligible for Study
-----------------
Minimum Age: 65 Years
Sexes Eligible for Study
-----------------
All
Accepts Healthy Volunteers
-----------------
Accepts Healthy Volunteers
Study Plan
=================
How is the study designed?
-----------------
Design Details
Primary Purpose: Prevention
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double
Arms and Interventions
| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Aquatic Exercise group<br>Participants will engage in a single session of training consisting of 120 repetitions of a ball throwing and catching task in water. | Other: Exercise intervention<br>* A ball catching and throwing exercise.<br>|
| Active Comparator: Land Exercise group<br>Participants will engage in a single session of training consisting of 120 repetitions of a ball throwing and catching task on dry land. | Other: Exercise intervention<br>* A ball catching and throwing exercise.<br>|
What is the study measuring?
-----------------
Primary Outcome Measures
| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Reaction time measures (REACH) | Hand contact time during REACH following the cable release will be calculated. | Immediately before the intervention. Duration of each assessment will be 15 minutes. |
| Reaction time measures (STEP1) | Foot-off time during STEP following the cable release will be calculated. | Immediately before the intervention. Duration of each assessment will be 15 minutes. |
| Reaction time measures (STEP2) | Foot contact time during STEP following the cable release will be calculated. | Immediately before the intervention. Duration of each assessment will be 15 minutes. |
| Rapid response accuracy | For the RANDOM block, response accuracy, defined as the percentage of accurate responses, will be calculated. To represent a composite measure of accuracy and speed of response, rapid response accuracy will be calculated using the ratio of response accuracy to the reaction time (%/ms). Foot-off and hand contact data will be used for the calculation. | Immediately before the intervention. Duration of each assessment will be 15 minutes. |
| Mini-Balance Evaluation Systems Test | During the REACH, STEP, and RANDOM blocks, the quality of the compensatory reactions will be scored using the Reactive Postural Control section of the Mini-Balance Evaluation Systems Test. The scores will be ranged from 0 (worst) to 2 (best). | Immediately before the intervention. Duration of each assessment will be 15 minutes. |
| Reaction time measures (REACH) | Hand contact time during REACH following the cable release will be calculated. | Immediately after the intervention. Duration of each assessment will be 15 minutes. |
| Reaction time measures (STEP1) | Foot-off time during STEP following the cable release will be calculated. | Immediately after the intervention. Duration of each assessment will be 15 minutes. |
| Reaction time measures (STEP2) | Foot contact time during STEP following the cable release will be calculated. | Immediately after the intervention. Duration of each assessment will be 15 minutes. |
| Rapid response accuracy | For the RANDOM block, response accuracy, defined as the percentage of accurate responses, will be calculated. To represent a composite measure of accuracy and speed of response, rapid response accuracy will be calculated using the ratio of response accuracy to the reaction time (%/ms). Foot-off and hand contact data will be used for the calculation. | Immediately after the intervention. Duration of each assessment will be 15 minutes. |
| Mini-Balance Evaluation Systems Test | During the REACH, STEP, and RANDOM blocks, the quality of the compensatory reactions will be scored using the Reactive Postural Control section of the Mini-Balance Evaluation Systems Test. The scores will be ranged from 0 (worst) to 2 (best). | Immediately after the intervention. Duration of each assessment will be 15 minutes. |
| Reaction time measures (REACH) | Hand contact time during REACH following the cable release will be calculated. | One week after the intervention. Duration of each assessment will be 15 minutes. |
| Reaction time measures (STEP1) | Foot-off time during STEP following the cable release will be calculated. | One week after the intervention. Duration of each assessment will be 15 minutes. |
| Reaction time measures (STEP2) | Foot contact time during STEP following the cable release will be calculated. | One week after the intervention. Duration of each assessment will be 15 minutes. |
| Rapid response accuracy | For the RANDOM block, response accuracy, defined as the percentage of accurate responses, will be calculated. To represent a composite measure of accuracy and speed of response, rapid response accuracy will be calculated using the ratio of response accuracy to the reaction time (%/ms). Foot-off and hand contact data will be used for the calculation. | One week after the intervention. Duration of each assessment will be 15 minutes. |
| Mini-Balance Evaluation Systems Test | During the REACH, STEP, and RANDOM blocks, the quality of the compensatory reactions will be scored using the Reactive Postural Control section of the Mini-Balance Evaluation Systems Test. The scores will be ranged from 0 (worst) to 2 (best). | One week after the intervention. Duration of each assessment will be 15 minutes. |
Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Reactive balance, Aquatic exercise, Aquatic therapy, Fall prevention
|
||
NCT00001849
|
New Imaging Techniques in the Evaluation of Patients With Ectopic Cushing Syndrome
|
Cushing Syndrome is an endocrine disorder causing an over production of the hormone cortisol. Cortisol is produced in the adrenal gland as a response to the production of corticotropin (ACTH) in the pituitary gland.~Between 10% and 20% of patients with hypercortisolism (Cushing Syndrome) have ectopic production of the hormone ACTH. Meaning, the hormone is not being released from the normal site, the pituitary gland. In many cases the ectopic ACTH is being produced by a tumor of the lung, thymus, or pancreas. However, in approximately 50% of these patients the source of the ACTH cannot be found even with the use of extensive imaging studies such as computed tomography (CT) scans, magnetic resonance imaging (MRI), and nuclear scans (111-indium pentetreotide). The ability of these tests to locate the source of the hormone production is dependent on the changes of anatomy and / or the dose and adequate uptake of the radioactive agent. The inability to detect the source of ectopic ACTH production often results in unnecessary pituitary surgery or irradiation.~Unlike the previously described tests, positron emission tomography (PET scan) has the ability to detect pathologic tissue based on physiologic and biochemical processes within the abnormal tissue.~This study will test whether fluorine-18-fluorodeoxyglucose (FDG), fluorine-18-dihydroxyphenylalanine (F-DOPA) or use of a higher dose of 111-indium pentetreotide can be used to successfully localize the source of ectopic ACTH production.
|
Between 10 percent and 20 percent of patients with hypercortisolism (Cushing syndrome) have ectopic production of adrenocorticotropin hormone (ACTH) that causes cortisol excess. In approximately 50 percent of these patients, the source of ACTH cannot be found despite very detailed and extensive examination including imaging studies such as computed tomography scanning, magnetic resonance imaging, and octreotide scan (octreoscan) using the conventional low dose of indium-111 pentetreotide. The sensitivity and specificity of these imaging studies depends on anatomic alterations and/or the dose and adequate uptake of radiopharmaceutical. In contrast, positron emission tomography (PET) has the ability to detect pathologic tissue based on physiologic and biochemical processes within the abnormal tissue. This protocol tests whether fluorine-18 dihydroxyphenylalanine (F-DOPA) or use of a higher dose of indium-111 pentetreotide (Octreoscan) can be used to localize successfully the source of ectopic ACTH production. In addition the study examines whether administration of the glucocorticoid antagonist mifepristone can improved the sensitivity of the standard dose Octreoscan. Eligible patients participating in this arm of the study will have a second standard dose scan. Others will receive a higher dose octreoscan instead.
|
New Imaging Modalities in the Evaluation of Patients With Ectopic Cushing's Syndrome
|
Cushing Syndrome, Endocrine Disease
|
* Drug: Pentetreotide
* Drug: 18F-DOPA
* Device: CT scan
* Device: MRI
* Drug: 18-FDG
|
INCLUSION CRITERIA:~All eligible patients are invited to participate in this protocol. Patients are adults with possible ectopic Cushing syndrome. Since both men and women are affected with ectopic Cushing syndrome, both sexes are studied. All ethnic and racial groups are at risk and will be included. Patients must be willing to return to the National Institutes of Health (NIH) Clinical Center for follow-up studies.~EXCLUSION CRITERIA:~Pregnant or lactating women. A pregnancy test is performed in women of childbearing potential (up to age 55) unless they have a history of hysterectomy.~Children (age less than18) are excluded. Because ectopic ACTH secretion is rare in this age group, the likelihood of benefit is less and does not balance the risk of radiation.~Patients taking medications that alter CYP3A4 activity will not be eligible for the mifepristone study, since this P450 system metabolizes mifepristone. Such participants would receive a clinical high dose (18 mCi) octreoscan (H-OCT) instead, if the standard 6 mCi octreoscan (L-OCT) was negative. Patients with hypokalemia (K < 3.5 milliequivalent (mEq)/L) despite medical therapy with replacement or mineralocorticoid antagonists will also be excluded from the mifepristone studies.~The presence of:~severe active infection.~clinically significantly impaired cardiovascular (e.g., history of abnormally low ejection fraction, the presence of moderate pulmonary fluid overload or leg edema, and blood pressure over 190/100), abnormal coagulation (partial thromboplastin time or prothrombin time elevated by 30 percent above the normal values), hematopoietic (hematocrit less than 30 percent, hemoglobin below 10 g/dl, white count below 3000 K/microliter (UL), and platelets below 100,000 K/mm(3)), hepatic (liver enzymes elevated by 3-fold above normal values) or renal function (plasma creatinine level over 2.0).~impaired mental capacity or markedly abnormal psychiatric evaluation that precludes informed consent.~body weight over 136 kg, which is the limit for the tables used in the scanning areas.~combined blood withdrawal, during the six weeks preceding the study, of greater than 450 ml.~known allergy to 111-indium pentetreotide or other somatostatin analogues.~strong evidence for Cushing disease. This includes those with positive inferior petrosal sinus sampling or a lesion on pituitary MRI.
|
18 Years
|
90 Years
|
All
|
No
|
Primary Purpose: Diagnostic
Intervention Model: Single Group Assignment
Interventional Model Description: Comparison of results in patients receiving similar imaging scans
Masking: None (Open Label)
|
| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Sensitivity of Imaging Modalities for the Detection of ACTH-secreting Non-pituitary Tumor in Patients | The percentage of patients in whom imaging correctly identified an ACTH-secreting non-pituitary tumor within six months of resection or in which imaging identified a recurrence at a site of previous resection. | six months or less |
| Sensitivity of Imaging Modalities for the Detection of ACTH-secreting Non-pituitary Tumor in Specific Lesions | The percentage of lesions for which imaging correctly identified an ACTH-secreting non-pituitary tumor within six months of resection or for which imaging identified a recurrence at a site of previous resection. | six months or less |
|
PET, fluorine -18(18F)-DOPA, Pentetreotide, ACTH, Octreotide, Cushing's Syndrome, Ectopic Cushing Syndrome
|
Edetic Acid, Pentetic Acid, Molecular Mechanisms of Pharmacological Action, Physiological Effects of Drugs, Antidotes, Protective Agents, Chelating Agents, Sequestering Agents, Iron Chelating Agents, Anticoagulants, Calcium Chelating Agents
|
| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Patients with Cushing Syndrome<br>Patients receive various types of radiologic or nuclear medicine scans to identify tumor | Drug: Pentetreotide<br>* Binds primarily to the somatostatin receptors subtypes (sst) 2 and 5. A high dose (18mCi) was used if the conventional dose (6mCi) was negative and scheduling was available. High doses limited to 3 over the course of the study.<br>* Other names: [111In-diethylenetriaminepentaacetic acid-D-Phe]-pentetreotide;Drug: 18F-DOPA<br>* 18F-DOPA is a radiolabeled amino acid used as a radiotracer in positron emission tomography (PET). Limited to 3 doses over the course of the study.<br>* Other names: 56494;Device: CT scan<br>* CT scan of chest, abdomen, neck and /or pelvis<br>* Other names: computed tomography scan;Device: MRI<br>* MRI scan of head/pituitary, chest, abdomen, neck and /or pelvis<br>* Other names: magnetic resonance imaging scan;Drug: 18-FDG<br>* FDG PET scan of body<br>* Other names: 18-fluorine fluorodeoxyglucose PET scan;|
|
New Imaging Techniques in the Evaluation of Patients With Ectopic Cushing Syndrome
Study Overview
=================
Brief Summary
-----------------
Cushing Syndrome is an endocrine disorder causing an over production of the hormone cortisol. Cortisol is produced in the adrenal gland as a response to the production of corticotropin (ACTH) in the pituitary gland. Between 10% and 20% of patients with hypercortisolism (Cushing Syndrome) have ectopic production of the hormone ACTH. Meaning, the hormone is not being released from the normal site, the pituitary gland. In many cases the ectopic ACTH is being produced by a tumor of the lung, thymus, or pancreas. However, in approximately 50% of these patients the source of the ACTH cannot be found even with the use of extensive imaging studies such as computed tomography (CT) scans, magnetic resonance imaging (MRI), and nuclear scans (111-indium pentetreotide). The ability of these tests to locate the source of the hormone production is dependent on the changes of anatomy and / or the dose and adequate uptake of the radioactive agent. The inability to detect the source of ectopic ACTH production often results in unnecessary pituitary surgery or irradiation. Unlike the previously described tests, positron emission tomography (PET scan) has the ability to detect pathologic tissue based on physiologic and biochemical processes within the abnormal tissue. This study will test whether fluorine-18-fluorodeoxyglucose (FDG), fluorine-18-dihydroxyphenylalanine (F-DOPA) or use of a higher dose of 111-indium pentetreotide can be used to successfully localize the source of ectopic ACTH production.
Detailed Description
-----------------
Between 10 percent and 20 percent of patients with hypercortisolism (Cushing syndrome) have ectopic production of adrenocorticotropin hormone (ACTH) that causes cortisol excess. In approximately 50 percent of these patients, the source of ACTH cannot be found despite very detailed and extensive examination including imaging studies such as computed tomography scanning, magnetic resonance imaging, and octreotide scan (octreoscan) using the conventional low dose of indium-111 pentetreotide. The sensitivity and specificity of these imaging studies depends on anatomic alterations and/or the dose and adequate uptake of radiopharmaceutical. In contrast, positron emission tomography (PET) has the ability to detect pathologic tissue based on physiologic and biochemical processes within the abnormal tissue. This protocol tests whether fluorine-18 dihydroxyphenylalanine (F-DOPA) or use of a higher dose of indium-111 pentetreotide (Octreoscan) can be used to localize successfully the source of ectopic ACTH production. In addition the study examines whether administration of the glucocorticoid antagonist mifepristone can improved the sensitivity of the standard dose Octreoscan. Eligible patients participating in this arm of the study will have a second standard dose scan. Others will receive a higher dose octreoscan instead.
Official Title
-----------------
New Imaging Modalities in the Evaluation of Patients With Ectopic Cushing's Syndrome
Conditions
-----------------
Cushing Syndrome, Endocrine Disease
Intervention / Treatment
-----------------
* Drug: Pentetreotide
* Drug: 18F-DOPA
* Device: CT scan
* Device: MRI
* Drug: 18-FDG
Participation Criteria
=================
Eligibility Criteria
-----------------
INCLUSION CRITERIA: All eligible patients are invited to participate in this protocol. Patients are adults with possible ectopic Cushing syndrome. Since both men and women are affected with ectopic Cushing syndrome, both sexes are studied. All ethnic and racial groups are at risk and will be included. Patients must be willing to return to the National Institutes of Health (NIH) Clinical Center for follow-up studies. EXCLUSION CRITERIA: Pregnant or lactating women. A pregnancy test is performed in women of childbearing potential (up to age 55) unless they have a history of hysterectomy. Children (age less than18) are excluded. Because ectopic ACTH secretion is rare in this age group, the likelihood of benefit is less and does not balance the risk of radiation. Patients taking medications that alter CYP3A4 activity will not be eligible for the mifepristone study, since this P450 system metabolizes mifepristone. Such participants would receive a clinical high dose (18 mCi) octreoscan (H-OCT) instead, if the standard 6 mCi octreoscan (L-OCT) was negative. Patients with hypokalemia (K < 3.5 milliequivalent (mEq)/L) despite medical therapy with replacement or mineralocorticoid antagonists will also be excluded from the mifepristone studies. The presence of: severe active infection. clinically significantly impaired cardiovascular (e.g., history of abnormally low ejection fraction, the presence of moderate pulmonary fluid overload or leg edema, and blood pressure over 190/100), abnormal coagulation (partial thromboplastin time or prothrombin time elevated by 30 percent above the normal values), hematopoietic (hematocrit less than 30 percent, hemoglobin below 10 g/dl, white count below 3000 K/microliter (UL), and platelets below 100,000 K/mm(3)), hepatic (liver enzymes elevated by 3-fold above normal values) or renal function (plasma creatinine level over 2.0). impaired mental capacity or markedly abnormal psychiatric evaluation that precludes informed consent. body weight over 136 kg, which is the limit for the tables used in the scanning areas. combined blood withdrawal, during the six weeks preceding the study, of greater than 450 ml. known allergy to 111-indium pentetreotide or other somatostatin analogues. strong evidence for Cushing disease. This includes those with positive inferior petrosal sinus sampling or a lesion on pituitary MRI.
Ages Eligible for Study
-----------------
Minimum Age: 18 Years
Maximum Age: 90 Years
Sexes Eligible for Study
-----------------
All
Accepts Healthy Volunteers
-----------------
No
Study Plan
=================
How is the study designed?
-----------------
Design Details
Primary Purpose: Diagnostic
Intervention Model: Single Group Assignment
Interventional Model Description: Comparison of results in patients receiving similar imaging scans
Masking: None (Open Label)
Arms and Interventions
| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Patients with Cushing Syndrome<br>Patients receive various types of radiologic or nuclear medicine scans to identify tumor | Drug: Pentetreotide<br>* Binds primarily to the somatostatin receptors subtypes (sst) 2 and 5. A high dose (18mCi) was used if the conventional dose (6mCi) was negative and scheduling was available. High doses limited to 3 over the course of the study.<br>* Other names: [111In-diethylenetriaminepentaacetic acid-D-Phe]-pentetreotide;Drug: 18F-DOPA<br>* 18F-DOPA is a radiolabeled amino acid used as a radiotracer in positron emission tomography (PET). Limited to 3 doses over the course of the study.<br>* Other names: 56494;Device: CT scan<br>* CT scan of chest, abdomen, neck and /or pelvis<br>* Other names: computed tomography scan;Device: MRI<br>* MRI scan of head/pituitary, chest, abdomen, neck and /or pelvis<br>* Other names: magnetic resonance imaging scan;Drug: 18-FDG<br>* FDG PET scan of body<br>* Other names: 18-fluorine fluorodeoxyglucose PET scan;|
What is the study measuring?
-----------------
Primary Outcome Measures
| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Sensitivity of Imaging Modalities for the Detection of ACTH-secreting Non-pituitary Tumor in Patients | The percentage of patients in whom imaging correctly identified an ACTH-secreting non-pituitary tumor within six months of resection or in which imaging identified a recurrence at a site of previous resection. | six months or less |
| Sensitivity of Imaging Modalities for the Detection of ACTH-secreting Non-pituitary Tumor in Specific Lesions | The percentage of lesions for which imaging correctly identified an ACTH-secreting non-pituitary tumor within six months of resection or for which imaging identified a recurrence at a site of previous resection. | six months or less |
Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
PET, fluorine -18(18F)-DOPA, Pentetreotide, ACTH, Octreotide, Cushing's Syndrome, Ectopic Cushing Syndrome
|
|
NCT04634500
|
The Efficacy and Safety of DWP16001 in Combination With Metformin in Patients With Type 2 Diabetes.
|
Therapeutic Confirmatory Study to Evaluate the Efficacy and Safety of DWP16001 in Combination with Metformin in Patients With Type 2 Diabetes Mellitus who Have Inadequate Glycemic Control on Metformin Alone.
|
A Multi-center, Randomized, Double-Blind, Active-controlled, Phase 3, Therapeutic Confirmatory Study to Evaluate the Efficacy and Safety of DWP16001 in Combination with Metformin in Patients With Type 2 Diabetes Mellitus who Have Inadequate Glycemic Control on Metformin Alone.
|
Therapeutic Confirmatory Study to Evaluate the Efficacy and Safety of DWP16001 in Combination With Metformin in Patients With Type 2 Diabetes Mellitus Who Have Inadequate Glycemic Control on Metformin Alone
|
T2DM (Type 2 Diabetes Mellitus)
|
* Drug: Dapagliflozin
|
Inclusion Criteria:~Subjects with T2DM aged 19 to 80 years~Subjects who have received metformin alone at a fixed dose for the last 8 weeks and has 7% ≤ HbA1c ≤ 10.5%~Subjects with BMI of 20-45 kg/m2~Subjects who voluntarily decided to participate and provided written consent after being told of the objectives, method, and effects of this study~Exclusion Criteria:~Subjects with current or history of hypersensitivity to the IP of this study, metformin or drugs of the same class and their components (e.g., history of hypersensitivity to biguanide or SGLT2 inhibitors)~Diabetic ketoacidosis, diabetic coma or precoma within the past year~Urinary tract infections or genital infections within~Uncontrolled hypertension (SBP > 180 mmHg or DBP > 110 mmHg)~eGFR < 60 mL/min/1.73 m2~Severe heart failure (NYHA class III/IV)
|
19 Years
|
80 Years
|
All
|
No
|
Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double
|
| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change from baseline in HbA1c | | at 24 weeks |
|
Dapagliflozin, Sodium-Glucose Transporter 2 Inhibitors, Molecular Mechanisms of Pharmacological Action, Hypoglycemic Agents, Physiological Effects of Drugs
|
| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Study group<br>DWP16001 A mg, Dapagliflozin placebo | Drug: Dapagliflozin<br>* Dapagliflozin Tablet<br>* Other names: DWP16001;|
| Active Comparator: Control group<br>DWP16001 A mg placebo, Dapagliflozin | Drug: Dapagliflozin<br>* Dapagliflozin Tablet<br>* Other names: DWP16001;|
|
The Efficacy and Safety of DWP16001 in Combination With Metformin in Patients With Type 2 Diabetes.
Study Overview
=================
Brief Summary
-----------------
Therapeutic Confirmatory Study to Evaluate the Efficacy and Safety of DWP16001 in Combination with Metformin in Patients With Type 2 Diabetes Mellitus who Have Inadequate Glycemic Control on Metformin Alone.
Detailed Description
-----------------
A Multi-center, Randomized, Double-Blind, Active-controlled, Phase 3, Therapeutic Confirmatory Study to Evaluate the Efficacy and Safety of DWP16001 in Combination with Metformin in Patients With Type 2 Diabetes Mellitus who Have Inadequate Glycemic Control on Metformin Alone.
Official Title
-----------------
Therapeutic Confirmatory Study to Evaluate the Efficacy and Safety of DWP16001 in Combination With Metformin in Patients With Type 2 Diabetes Mellitus Who Have Inadequate Glycemic Control on Metformin Alone
Conditions
-----------------
T2DM (Type 2 Diabetes Mellitus)
Intervention / Treatment
-----------------
* Drug: Dapagliflozin
Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Subjects with T2DM aged 19 to 80 years Subjects who have received metformin alone at a fixed dose for the last 8 weeks and has 7% ≤ HbA1c ≤ 10.5% Subjects with BMI of 20-45 kg/m2 Subjects who voluntarily decided to participate and provided written consent after being told of the objectives, method, and effects of this study Exclusion Criteria: Subjects with current or history of hypersensitivity to the IP of this study, metformin or drugs of the same class and their components (e.g., history of hypersensitivity to biguanide or SGLT2 inhibitors) Diabetic ketoacidosis, diabetic coma or precoma within the past year Urinary tract infections or genital infections within Uncontrolled hypertension (SBP > 180 mmHg or DBP > 110 mmHg) eGFR < 60 mL/min/1.73 m2 Severe heart failure (NYHA class III/IV)
Ages Eligible for Study
-----------------
Minimum Age: 19 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: Study group<br>DWP16001 A mg, Dapagliflozin placebo | Drug: Dapagliflozin<br>* Dapagliflozin Tablet<br>* Other names: DWP16001;|
| Active Comparator: Control group<br>DWP16001 A mg placebo, Dapagliflozin | Drug: Dapagliflozin<br>* Dapagliflozin Tablet<br>* Other names: DWP16001;|
What is the study measuring?
-----------------
Primary Outcome Measures
| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change from baseline in HbA1c | | at 24 weeks |
|
||
NCT02997722
|
The Effect of Ketamine on the Length of Hospital Stay of Patients Hospitalized With Suicidal Ideation.
|
This study will evaluate the effect of ketamine on the treatment of patients hospitalized with suicidal thoughts. Half of the patients will receive one dose of ketamine in the vein. The other half will receive a placebo. Because we think that ketamine will improve depression and suicidal thoughts, we expect that patients who receive ketamine will require less time in the hospital than patients who receive placebo.
|
Patients admitted to UMMC's psychiatry inpatient unit with suicidal thoughts will be given the opportunity to participate in the study. Those patients who consent to participate, after being informed about the study and its risks, will be randomized to receive an IV infusion of either saline or ketamine 0.5 mg/kg. The infusion will be given within 24 hours of arriving on the psychiatry inpatient unit. We will record the dates and times that the patient was admitted to and discharged from the psychiatric inpatient unit. At completion of the study, we will compare the average length of stay, defined as date and time of discharge minus date of time of admission, of the group that received ketamine to the average length of stay of the group that received placebo.
|
Ketamine: Its Effects on Suicidal Ideations and Inpatient Hospital Length of Stay
|
Suicidal Ideation
|
* Drug: Ketamine
* Drug: Normal Saline
|
Inclusion Criteria:~Men and women between the ages of 18 and 64~Patients admitted to the University of Mississippi Medical Center inpatient psychiatry service with suicidal ideations~Exclusion Criteria:~Lifetime history of schizophrenia or other primary psychotic disorder~Current psychotic or manic symptoms~Substance use disorder within one month of admission~Positive urine toxicology at admission~Any lifetime abuse of ketamine or phencyclidine~Systolic BP >180 mmHg or diastolic BP >110 mmHg~Any patient who has eaten food within 8 hours prior to receiving the ketamine infusion or who has drank clear liquids within 2 hours prior to receiving the infusion~Known central nervous system (CNS) mass~CNS abnormalities~Hydrocephalus~Glaucoma~Acute globe injury~Porphyria~Untreated thyroid disease~Known coronary artery disease with poor functional capacity~Pregnancy~Currently breast-feeding
|
18 Years
|
64 Years
|
All
|
No
|
Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple
|
| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Inpatient Hospital Length of Stay | We defined length of hospital stay as the difference between 1) the date and time that the patient was admitted to the psychiatry inpatient unit and 2) the date and time that the patient was discharged from the psychiatry inpatient. | The dates and times of each patients' admission to and discharge from the inpatient unit (i.e., the data necessary to calculate length of stay) were collected by chart review performed approximately 6 months after enrollment in the study. |
|
ketamine, suicidal ideation, length of stay
|
Anesthetics, General, Ketamine, Analgesics, Sensory System Agents, Peripheral Nervous System Agents, Physiological Effects of Drugs, Anesthetics, Dissociative, Anesthetics, Intravenous, Anesthetics, Central Nervous System Depressants, Excitatory Amino Acid Antagonists, Excitatory Amino Acid Agents, Neurotransmitter Agents, Molecular Mechanisms of Pharmacological Action
|
| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Ketamine infusion<br>Assignment to this arm involves receiving a single IV infusion of ketamine 0.5 mg/kg given over 45 minutes. | Drug: Ketamine<br>* IV infusion of ketamine 0.5 mg/kg administered over 45 minutes.<br>|
| Placebo Comparator: Normal Saline infusion<br>Assignment to this arm involves receiving an IV infusion of normal saline over the course of 45 minutes. | Drug: Normal Saline<br>* IV infusion of 100 ml of normal saline over 45 minutes.<br>|
|
The Effect of Ketamine on the Length of Hospital Stay of Patients Hospitalized With Suicidal Ideation.
Study Overview
=================
Brief Summary
-----------------
This study will evaluate the effect of ketamine on the treatment of patients hospitalized with suicidal thoughts. Half of the patients will receive one dose of ketamine in the vein. The other half will receive a placebo. Because we think that ketamine will improve depression and suicidal thoughts, we expect that patients who receive ketamine will require less time in the hospital than patients who receive placebo.
Detailed Description
-----------------
Patients admitted to UMMC's psychiatry inpatient unit with suicidal thoughts will be given the opportunity to participate in the study. Those patients who consent to participate, after being informed about the study and its risks, will be randomized to receive an IV infusion of either saline or ketamine 0.5 mg/kg. The infusion will be given within 24 hours of arriving on the psychiatry inpatient unit. We will record the dates and times that the patient was admitted to and discharged from the psychiatric inpatient unit. At completion of the study, we will compare the average length of stay, defined as date and time of discharge minus date of time of admission, of the group that received ketamine to the average length of stay of the group that received placebo.
Official Title
-----------------
Ketamine: Its Effects on Suicidal Ideations and Inpatient Hospital Length of Stay
Conditions
-----------------
Suicidal Ideation
Intervention / Treatment
-----------------
* Drug: Ketamine
* Drug: Normal Saline
Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Men and women between the ages of 18 and 64 Patients admitted to the University of Mississippi Medical Center inpatient psychiatry service with suicidal ideations Exclusion Criteria: Lifetime history of schizophrenia or other primary psychotic disorder Current psychotic or manic symptoms Substance use disorder within one month of admission Positive urine toxicology at admission Any lifetime abuse of ketamine or phencyclidine Systolic BP >180 mmHg or diastolic BP >110 mmHg Any patient who has eaten food within 8 hours prior to receiving the ketamine infusion or who has drank clear liquids within 2 hours prior to receiving the infusion Known central nervous system (CNS) mass CNS abnormalities Hydrocephalus Glaucoma Acute globe injury Porphyria Untreated thyroid disease Known coronary artery disease with poor functional capacity Pregnancy Currently breast-feeding
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: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple
Arms and Interventions
| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Ketamine infusion<br>Assignment to this arm involves receiving a single IV infusion of ketamine 0.5 mg/kg given over 45 minutes. | Drug: Ketamine<br>* IV infusion of ketamine 0.5 mg/kg administered over 45 minutes.<br>|
| Placebo Comparator: Normal Saline infusion<br>Assignment to this arm involves receiving an IV infusion of normal saline over the course of 45 minutes. | Drug: Normal Saline<br>* IV infusion of 100 ml of normal saline over 45 minutes.<br>|
What is the study measuring?
-----------------
Primary Outcome Measures
| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Inpatient Hospital Length of Stay | We defined length of hospital stay as the difference between 1) the date and time that the patient was admitted to the psychiatry inpatient unit and 2) the date and time that the patient was discharged from the psychiatry inpatient. | The dates and times of each patients' admission to and discharge from the inpatient unit (i.e., the data necessary to calculate length of stay) were collected by chart review performed approximately 6 months after enrollment in the study. |
Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
ketamine, suicidal ideation, length of stay
|
|
NCT03373799
|
Effectiveness of Video-Based Rehabilitation Program on Pain, Functionality and Quality of Life in the Treatment of Rotator Cuff Tears
|
The aim of this study was to investigate the efficacy of the video-based rehabilitation program on pain, functionality and quality of life in the conservative treatment of partial tears of the rotator cuff whether it was as successful as the physiotherapist-supervised rehabilitation program.
|
In our study a common exercise program, which can be used in conservative treatment of a partial rotator cuff tear, is applied with two different methods; a video-based rehabilitation program and physiotherapist-supervised rehabilitation program. Video-based rehabilitation program was developed to investigate whether this program is effective on pain, functionality and quality of life and as successful as a physiotherapist-supervised rehabilitation program.
|
Effectiveness of Video-Based Rehabilitation Program on Pain, Functionality and Quality of Life in the Treatment of Rotator Cuff Tears
|
Rotator Cuff Tear, Pain, Shoulder
|
* Other: Video-Based Rehabilitation Program
* Other: Physiotherapist-Supervised Rehabilitation Program
|
Inclusion Criteria:~Forty years of age or older patients that had been diagnosed for a partial rotator cuff tear that was unrelated to trauma by a specialist orthopedist with MRI and physical examination and no other shoulder problems on the diagnosed shoulder were included into this study.~Exclusion Criteria:~Patients that had been diagnosed for a full-thickness or massive rotator cuff tear, operated previously, had frozen shoulder or glenohumeral instability~Younger than 40-year-old, and athletic patients with acute tear symptom were excluded from this study.
|
40 Years
|
60 Years
|
All
|
No
|
Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single
|
| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Shoulder Range of Motion (ROM) | The shoulder flexion, abduction, internal and external rotation ROM were evaluated with goniometer while the patient was in supine position. | Shoulder range of motion evaluation was performed first time at baseline and second time after 6 weeks rehabilitation program. After treatment change was assessed. |
|
| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Visual Analogue Scale (VAS) | The levels of pain felt at rest / activity / night were measured using visual analogue scale (VAS). | Evaluation was performed before treatment and after 6 weeks rehabilitation program. Patients were asked to evaluate their pain status with a 10-point scale and high scores are positively correlated with pain. |
| ASES (The American Shoulder and Elbow Surgeons Standardized Shoulder Assessment) Form | ASES is an assessment form prepared by shoulder and elbow surgeons with objective and subjective sections. The total score is at least 0 and at most 100, and the high scores are positively correlated with the normal function. | Evaluation was performed before treatment and after 6 weeks rehabilitation program. |
| Disabilities of the Arm, Shoulder and Hand (DASH) Questionnaire | DASH questionnaire inquires about the activities of a person in daily life, the degree of participation in recreational activities, the symptom and psychosocial state that affects their pain, emotional state and sleep quality. The total score is at least 0 and at most 100, and the high scores are positively correlated with the increased functional impairment. | Evaluation was performed before treatment and after 6 weeks rehabilitation program. |
| Short Form 12 (SF-12) | SF-12 was used to assess physical and mental health-related quality of life. The total score is at least 0 and at most 100, and the high scores are positively correlated with high quality of life. | Evaluation was performed before treatment and after 6 weeks rehabilitation program. |
| Global Rating of Change (GRC) Scale | Global Rating of Change (GRC) scale was used to assess the overall satisfaction levels of the patients. Patients were asked to evaluate their post-treatment status with a 5-point likert scale and high scores are positively correlated with satisfaction. | Evaluation was performed after 6 weeks rehabilitation program. |
|
rotator cuff, physiotherapy, video-based rehabilitation, exercise
|
Pain, Shoulder Pain, Rotator Cuff Injuries, Rupture, Wounds and Injuries, Shoulder Injuries, Tendon Injuries, Arthralgia, Joint Diseases, Musculoskeletal Diseases, Neurologic Manifestations
|
| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Group 1<br>Video-Based Rehabilitation Group | Other: Video-Based Rehabilitation Program<br>* In both groups, a program consisting of exercises used in conservative treatment of rotator cuff tears was performed. A video record was made by the physiotherapist to a patient where each exercise was described in detail and the patient correctly performed the exercises according to the verbal and visual commands of the physiotherapist. This video record watched by the patients who come to the clinic and patients were asked to do the exercises in the video. Patients did the exercises under control of the physiotherapist in the clinic.<br>|
| Active Comparator: Group 2<br>Physiotherapist-Supervised Rehabilitation Group | Other: Physiotherapist-Supervised Rehabilitation Program<br>* In both groups, a program consisting of exercises used in conservative treatment of rotator cuff tears was performed. Program was carried out by teaching the same exercises individually by the physiotherapist.<br>|
|
Effectiveness of Video-Based Rehabilitation Program on Pain, Functionality and Quality of Life in the Treatment of Rotator Cuff Tears
Study Overview
=================
Brief Summary
-----------------
The aim of this study was to investigate the efficacy of the video-based rehabilitation program on pain, functionality and quality of life in the conservative treatment of partial tears of the rotator cuff whether it was as successful as the physiotherapist-supervised rehabilitation program.
Detailed Description
-----------------
In our study a common exercise program, which can be used in conservative treatment of a partial rotator cuff tear, is applied with two different methods; a video-based rehabilitation program and physiotherapist-supervised rehabilitation program. Video-based rehabilitation program was developed to investigate whether this program is effective on pain, functionality and quality of life and as successful as a physiotherapist-supervised rehabilitation program.
Official Title
-----------------
Effectiveness of Video-Based Rehabilitation Program on Pain, Functionality and Quality of Life in the Treatment of Rotator Cuff Tears
Conditions
-----------------
Rotator Cuff Tear, Pain, Shoulder
Intervention / Treatment
-----------------
* Other: Video-Based Rehabilitation Program
* Other: Physiotherapist-Supervised Rehabilitation Program
Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Forty years of age or older patients that had been diagnosed for a partial rotator cuff tear that was unrelated to trauma by a specialist orthopedist with MRI and physical examination and no other shoulder problems on the diagnosed shoulder were included into this study. Exclusion Criteria: Patients that had been diagnosed for a full-thickness or massive rotator cuff tear, operated previously, had frozen shoulder or glenohumeral instability Younger than 40-year-old, and athletic patients with acute tear symptom were excluded from this study.
Ages Eligible for Study
-----------------
Minimum Age: 40 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: Single
Arms and Interventions
| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Group 1<br>Video-Based Rehabilitation Group | Other: Video-Based Rehabilitation Program<br>* In both groups, a program consisting of exercises used in conservative treatment of rotator cuff tears was performed. A video record was made by the physiotherapist to a patient where each exercise was described in detail and the patient correctly performed the exercises according to the verbal and visual commands of the physiotherapist. This video record watched by the patients who come to the clinic and patients were asked to do the exercises in the video. Patients did the exercises under control of the physiotherapist in the clinic.<br>|
| Active Comparator: Group 2<br>Physiotherapist-Supervised Rehabilitation Group | Other: Physiotherapist-Supervised Rehabilitation Program<br>* In both groups, a program consisting of exercises used in conservative treatment of rotator cuff tears was performed. Program was carried out by teaching the same exercises individually by the physiotherapist.<br>|
What is the study measuring?
-----------------
Primary Outcome Measures
| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Shoulder Range of Motion (ROM) | The shoulder flexion, abduction, internal and external rotation ROM were evaluated with goniometer while the patient was in supine position. | Shoulder range of motion evaluation was performed first time at baseline and second time after 6 weeks rehabilitation program. After treatment change was assessed. |
Secondary Outcome Measures
| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Visual Analogue Scale (VAS) | The levels of pain felt at rest / activity / night were measured using visual analogue scale (VAS). | Evaluation was performed before treatment and after 6 weeks rehabilitation program. Patients were asked to evaluate their pain status with a 10-point scale and high scores are positively correlated with pain. |
| ASES (The American Shoulder and Elbow Surgeons Standardized Shoulder Assessment) Form | ASES is an assessment form prepared by shoulder and elbow surgeons with objective and subjective sections. The total score is at least 0 and at most 100, and the high scores are positively correlated with the normal function. | Evaluation was performed before treatment and after 6 weeks rehabilitation program. |
| Disabilities of the Arm, Shoulder and Hand (DASH) Questionnaire | DASH questionnaire inquires about the activities of a person in daily life, the degree of participation in recreational activities, the symptom and psychosocial state that affects their pain, emotional state and sleep quality. The total score is at least 0 and at most 100, and the high scores are positively correlated with the increased functional impairment. | Evaluation was performed before treatment and after 6 weeks rehabilitation program. |
| Short Form 12 (SF-12) | SF-12 was used to assess physical and mental health-related quality of life. The total score is at least 0 and at most 100, and the high scores are positively correlated with high quality of life. | Evaluation was performed before treatment and after 6 weeks rehabilitation program. |
| Global Rating of Change (GRC) Scale | Global Rating of Change (GRC) scale was used to assess the overall satisfaction levels of the patients. Patients were asked to evaluate their post-treatment status with a 5-point likert scale and high scores are positively correlated with satisfaction. | Evaluation was performed after 6 weeks rehabilitation program. |
Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
rotator cuff, physiotherapy, video-based rehabilitation, exercise
|
NCT03904316
|
Use of Biodesign® Otologic Graft in Tympanoplasty
|
This is a prospective, randomized trial to evaluate tympanoplasty outcomes using Biodesign SIS graft compared to autologous temporalis fascia, the most commonly used graft for repair of tympanic membrane.
|
Patients 18 years or older will undergo primary tympanoplasty without mastoidectomy. The patients will be randomized into groups receiving Biodesign versus autograft temporalis fascia for repair.
|
Use of Biodesign® Otologic Graft in Tympanoplasty: A Prospective, Randomized Trial
|
Tympanic Membrane Perforation
|
* Biological: Biodesign Otologic graft
* Other: Autologous temporalis fascia
|
Inclusion Criteria:~Patients undergoing primary tympanoplasty without mastoidectomy.~Exclusion Criteria:~Patients with a known biologic sensitivity or a cultural objection to use of porcine materials.
|
18 Years
| null |
All
|
No
|
Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
|
| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Assessment of graft take after tympanoplasty | Microscopically evaluate tympanic membrane for perforation closure | 1 month postoperatively by the surgeon |
| Assessment of graft take after tympanoplasty | Microscopically evaluate tympanic membrane for perforation closure | 2 months postoperatively by the surgeon |
| Assessment of graft take after tympanoplasty | Microscopically evaluate tympanic membrane for perforation closure | 3 months postoperatively by the surgeon |
| Assessment of graft take after tympanoplasty | Microscopically evaluate tympanic membrane for perforation closure | 6 months postoperatively by the surgeon |
|
| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Measurement of Hearing Parameters | Test the pure tone conduction (average of 500, 1000 and 2000 Hz). | Measure hearing parameters preoperatively |
| Measurement of Hearing Parameters | Test the Air Bone Gap starting at 1000 Hz then 2000, 4000, 8000, 250 and 500 for air-conduction thresholds. Then test non-masked bone-conduction thresholds at the same frequencies. | Measure hearing parameters preoperatively. |
| Measurement of Hearing Parameters | Test Word Recognition for 50-2 syllables words | Measure hearing parameters preoperatively |
| Measurement of Hearing Parameters | Test the pure tone conduction (average of 500, 1000 and 2000 Hz). | Measure hearing parameters 3 months postoperatively |
| Measurement of Hearing Parameters | Determine the air bond gap by measuring the difference between the air conduction and gone conduction testing. The air bone gap is the difference between the 2 readings and must be present at 3 consecutive frequencies. | Measure hearing parameters 3 months postoperatively |
| Measurement of Hearing Parameters | The word recognition testing evaluates the patient's ability to repeat phonetically balanced words appropriate for his/her hearing level. | Measure hearing parameters 3 months postoperatively |
| Measurement of Hearing Parameters | Test the pure tone conduction (average of 500, 1000 and 2000 Hz). | Measure hearing parameters 6 months postoperatively |
| Measurement of Hearing Parameters | Determine the air bond gap by measuring the difference between the air conduction and gone conduction testing. The air bone gap is the difference between the 2 readings and must be present at 3 consecutive frequencies. | Measure hearing parameters 6 months postoperatively |
| Measurement of Hearing Parameters | The word recognition testing evaluates the patient's ability to repeat phonetically balanced words appropriate for his/her hearing level. | Measure hearing parameters 6 months postoperatively |
|
Tympanic Membrane Perforation, Ear Diseases, Otorhinolaryngologic Diseases, Wounds and Injuries
|
| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Biodesign graft tympanic membrane repair<br>Patient's perforated tympanic membrane will be repaired with an acellular matrix derived from porcine small intestine submucosa, Biodesign Otologic graft | Biological: Biodesign Otologic graft<br>* Acellular matrix derived from porcine small intestine submucosa<br>|
| Active Comparator: Autograft tympanic membrane repair<br>Patient's perforated tympanic membrane will be repaired with autologous temporalis fascia. | Other: Autologous temporalis fascia<br>* An autologous graft for tympanic membrane repair<br>|
|
Use of Biodesign® Otologic Graft in Tympanoplasty
Study Overview
=================
Brief Summary
-----------------
This is a prospective, randomized trial to evaluate tympanoplasty outcomes using Biodesign SIS graft compared to autologous temporalis fascia, the most commonly used graft for repair of tympanic membrane.
Detailed Description
-----------------
Patients 18 years or older will undergo primary tympanoplasty without mastoidectomy. The patients will be randomized into groups receiving Biodesign versus autograft temporalis fascia for repair.
Official Title
-----------------
Use of Biodesign® Otologic Graft in Tympanoplasty: A Prospective, Randomized Trial
Conditions
-----------------
Tympanic Membrane Perforation
Intervention / Treatment
-----------------
* Biological: Biodesign Otologic graft
* Other: Autologous temporalis fascia
Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Patients undergoing primary tympanoplasty without mastoidectomy. Exclusion Criteria: Patients with a known biologic sensitivity or a cultural objection to use of porcine materials.
Ages Eligible for Study
-----------------
Minimum Age: 18 Years
Sexes Eligible for Study
-----------------
All
Accepts Healthy Volunteers
-----------------
No
Study Plan
=================
How is the study designed?
-----------------
Design Details
Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Arms and Interventions
| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Biodesign graft tympanic membrane repair<br>Patient's perforated tympanic membrane will be repaired with an acellular matrix derived from porcine small intestine submucosa, Biodesign Otologic graft | Biological: Biodesign Otologic graft<br>* Acellular matrix derived from porcine small intestine submucosa<br>|
| Active Comparator: Autograft tympanic membrane repair<br>Patient's perforated tympanic membrane will be repaired with autologous temporalis fascia. | Other: Autologous temporalis fascia<br>* An autologous graft for tympanic membrane repair<br>|
What is the study measuring?
-----------------
Primary Outcome Measures
| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Assessment of graft take after tympanoplasty | Microscopically evaluate tympanic membrane for perforation closure | 1 month postoperatively by the surgeon |
| Assessment of graft take after tympanoplasty | Microscopically evaluate tympanic membrane for perforation closure | 2 months postoperatively by the surgeon |
| Assessment of graft take after tympanoplasty | Microscopically evaluate tympanic membrane for perforation closure | 3 months postoperatively by the surgeon |
| Assessment of graft take after tympanoplasty | Microscopically evaluate tympanic membrane for perforation closure | 6 months postoperatively by the surgeon |
Secondary Outcome Measures
| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Measurement of Hearing Parameters | Test the pure tone conduction (average of 500, 1000 and 2000 Hz). | Measure hearing parameters preoperatively |
| Measurement of Hearing Parameters | Test the Air Bone Gap starting at 1000 Hz then 2000, 4000, 8000, 250 and 500 for air-conduction thresholds. Then test non-masked bone-conduction thresholds at the same frequencies. | Measure hearing parameters preoperatively. |
| Measurement of Hearing Parameters | Test Word Recognition for 50-2 syllables words | Measure hearing parameters preoperatively |
| Measurement of Hearing Parameters | Test the pure tone conduction (average of 500, 1000 and 2000 Hz). | Measure hearing parameters 3 months postoperatively |
| Measurement of Hearing Parameters | Determine the air bond gap by measuring the difference between the air conduction and gone conduction testing. The air bone gap is the difference between the 2 readings and must be present at 3 consecutive frequencies. | Measure hearing parameters 3 months postoperatively |
| Measurement of Hearing Parameters | The word recognition testing evaluates the patient's ability to repeat phonetically balanced words appropriate for his/her hearing level. | Measure hearing parameters 3 months postoperatively |
| Measurement of Hearing Parameters | Test the pure tone conduction (average of 500, 1000 and 2000 Hz). | Measure hearing parameters 6 months postoperatively |
| Measurement of Hearing Parameters | Determine the air bond gap by measuring the difference between the air conduction and gone conduction testing. The air bone gap is the difference between the 2 readings and must be present at 3 consecutive frequencies. | Measure hearing parameters 6 months postoperatively |
| Measurement of Hearing Parameters | The word recognition testing evaluates the patient's ability to repeat phonetically balanced words appropriate for his/her hearing level. | Measure hearing parameters 6 months postoperatively |
|
|
NCT03617315
|
Crosslinked Hyaluronic Acid With Liposomes and Crocin in Dry Eye
|
A total of 50 eyes were analyzed (25 patients). The subjects selected were over 18 years of age. No gender distinction was made in the choice of subjects. All subjects were carriers of silicone hydrogel contact lenses. The antecedents of the eye diseases not identified, neither the previous eye surgeries nor the systemic or ocular medication. All patients read, understood and signed an informed consent form of the study.
|
A study was performed using the contralateral eye, the study groups were randomized. The choice of eye for each tear was random and established as an artificial tear A and artificial tear B. The patients were not previously warned about the type of artificial tear they were going to use or the difference that existed between them, therefore, they were unaware of the benefits that such tears could offer them. The examiner did know what tear was applied to each eye.~As for the lubricants used; Tear A (Aquoral Forte®, ESTEVE®, Farmigea, Pisa, Italy) was a combination of 0.4% unridged hyaluronic acid and 0.2% Galacto-xyloglucan. The galacto-xyloglucan is extracted from the tamarind seed. It consists of 30 single doses, each with 0.5 ml and have a daily use closure, that is, it can not be used once 12 hours have passed since the dose was opened. This lubricant lacks preservatives.~On the other hand, tear B (Aquoral Lipo® [Spain] / Lumixa® [Italy], ESTEVE®, Farmigea, Pisa, Italy) is a combination of three components; cross-linked hyaluronic acid (CXL) at 0.15%, crocin and liposomes. It is an ophthalmic lubricant and antioxidant solution. Its package is 10 ml multidose, so it can be used for a long time. It is composed of liposomes, sodium salt of crosslinked hyaluronic acid 0.15%, ethylenediaminetetraacetic acid (EDTA) disodium salt and crocin. Although this tear comes in a multi-dose container, it does not contain a preservative due to the dispenser that does not let microorganisms from outside. Contact lenses can be used while both lubricants are applied. In this regard, the study patients used their silicone hydrogel contact lenses monthly during the study.~All patients in the study had a period of one month without using any type of artificial tear or eye drops. Once this time or study was over, the patients were explained how artificial tears should be instilled. The visits were carried out blindly by research optometrists. Who did not know how the distribution of artificial tears in patients had been. The artificial tears were administered 3 times a day for 6 weeks and the subjects belonging to the study underwent a clinical examination in the period prior to treatment and 45 days after the treatment, once the treatment with artificial tears. He was repeated the tests of the beginning, nevertheless, the meibografía was not realized, since the use of artificial tears was not going to cause the growth of the glands of Meibomio
|
Crosslinked Hyaluronic Acid With Liposomes and Crocin in the Treatment of Dry Eye Disease Due to Moderate Meibomian Glands Dysfunction
|
Dry Eye, Meibomian Gland Dysfunction, Dry Eye Syndromes
|
* Drug: Hylauronic Acid
|
Inclusion Criteria:~Ocular Surface Disease Index over 15~Dysfunction of the meibomian gland~User contact lenses silicone hydrogel~User of digital screens for a long timeç~Exclusion Criteria:~Previous eye surgeries~Previous eye pathologies~User of artificial tears~User of ophthalmic gels
|
18 Years
|
30 Years
|
All
|
Accepts Healthy Volunteers
|
Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Interventional Model Description: Contralateral Eye Study
Masking: Double
|
| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Schirmer Test | Measurement of the tear volume. Scale between 0 and 30 milimeters (mm) Higger is better | 6 weeks |
| Break Up Time Test | Lacrimal rupture time of the lipid layer. Scale between 0 and 25 seconds (s) Higger is better | 6 weeks |
| Ocular Surface Disease Index | Dry Eye Score from Questionnaire. Scale between 0 and 50 points. Higger is worse | 6 weeks |
|
Crosslinked Hyaluronic Acid, Meibomian Gland Disfunction, Lubricants, Contact Lens, Dry Eye
|
Dry Eye Syndromes, Keratoconjunctivitis Sicca, Meibomian Gland Dysfunction, Lacrimal Apparatus Diseases, Eye Diseases, Keratoconjunctivitis, Conjunctivitis, Conjunctival Diseases, Keratitis, Corneal Diseases, Eyelid Diseases
|
| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Hyaluronic Acid<br>One drop application of Hyaluronic acid + Galact-Xyloglucan with a dosage of 3 times a day for 45 days | Drug: Hylauronic Acid<br>* Schirmer Test, BUT test and OSDI test. Previous and After treatment<br>* Other names: HA+GX;|
| Experimental: CrossLinked Hyalurnic Acid<br>One drop application of Crosslinked Hylauronic Acid + Liposomes with a dosage of 3 times a day for 45 days | Drug: Hylauronic Acid<br>* Schirmer Test, BUT test and OSDI test. Previous and After treatment<br>* Other names: HA+GX;|
|
Crosslinked Hyaluronic Acid With Liposomes and Crocin in Dry Eye
Study Overview
=================
Brief Summary
-----------------
A total of 50 eyes were analyzed (25 patients). The subjects selected were over 18 years of age. No gender distinction was made in the choice of subjects. All subjects were carriers of silicone hydrogel contact lenses. The antecedents of the eye diseases not identified, neither the previous eye surgeries nor the systemic or ocular medication. All patients read, understood and signed an informed consent form of the study.
Detailed Description
-----------------
A study was performed using the contralateral eye, the study groups were randomized. The choice of eye for each tear was random and established as an artificial tear A and artificial tear B. The patients were not previously warned about the type of artificial tear they were going to use or the difference that existed between them, therefore, they were unaware of the benefits that such tears could offer them. The examiner did know what tear was applied to each eye. As for the lubricants used; Tear A (Aquoral Forte®, ESTEVE®, Farmigea, Pisa, Italy) was a combination of 0.4% unridged hyaluronic acid and 0.2% Galacto-xyloglucan. The galacto-xyloglucan is extracted from the tamarind seed. It consists of 30 single doses, each with 0.5 ml and have a daily use closure, that is, it can not be used once 12 hours have passed since the dose was opened. This lubricant lacks preservatives. On the other hand, tear B (Aquoral Lipo® [Spain] / Lumixa® [Italy], ESTEVE®, Farmigea, Pisa, Italy) is a combination of three components; cross-linked hyaluronic acid (CXL) at 0.15%, crocin and liposomes. It is an ophthalmic lubricant and antioxidant solution. Its package is 10 ml multidose, so it can be used for a long time. It is composed of liposomes, sodium salt of crosslinked hyaluronic acid 0.15%, ethylenediaminetetraacetic acid (EDTA) disodium salt and crocin. Although this tear comes in a multi-dose container, it does not contain a preservative due to the dispenser that does not let microorganisms from outside. Contact lenses can be used while both lubricants are applied. In this regard, the study patients used their silicone hydrogel contact lenses monthly during the study. All patients in the study had a period of one month without using any type of artificial tear or eye drops. Once this time or study was over, the patients were explained how artificial tears should be instilled. The visits were carried out blindly by research optometrists. Who did not know how the distribution of artificial tears in patients had been. The artificial tears were administered 3 times a day for 6 weeks and the subjects belonging to the study underwent a clinical examination in the period prior to treatment and 45 days after the treatment, once the treatment with artificial tears. He was repeated the tests of the beginning, nevertheless, the meibografía was not realized, since the use of artificial tears was not going to cause the growth of the glands of Meibomio
Official Title
-----------------
Crosslinked Hyaluronic Acid With Liposomes and Crocin in the Treatment of Dry Eye Disease Due to Moderate Meibomian Glands Dysfunction
Conditions
-----------------
Dry Eye, Meibomian Gland Dysfunction, Dry Eye Syndromes
Intervention / Treatment
-----------------
* Drug: Hylauronic Acid
Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Ocular Surface Disease Index over 15 Dysfunction of the meibomian gland User contact lenses silicone hydrogel User of digital screens for a long timeç Exclusion Criteria: Previous eye surgeries Previous eye pathologies User of artificial tears User of ophthalmic gels
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: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Interventional Model Description: Contralateral Eye Study
Masking: Double
Arms and Interventions
| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Hyaluronic Acid<br>One drop application of Hyaluronic acid + Galact-Xyloglucan with a dosage of 3 times a day for 45 days | Drug: Hylauronic Acid<br>* Schirmer Test, BUT test and OSDI test. Previous and After treatment<br>* Other names: HA+GX;|
| Experimental: CrossLinked Hyalurnic Acid<br>One drop application of Crosslinked Hylauronic Acid + Liposomes with a dosage of 3 times a day for 45 days | Drug: Hylauronic Acid<br>* Schirmer Test, BUT test and OSDI test. Previous and After treatment<br>* Other names: HA+GX;|
What is the study measuring?
-----------------
Primary Outcome Measures
| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Schirmer Test | Measurement of the tear volume. Scale between 0 and 30 milimeters (mm) Higger is better | 6 weeks |
| Break Up Time Test | Lacrimal rupture time of the lipid layer. Scale between 0 and 25 seconds (s) Higger is better | 6 weeks |
| Ocular Surface Disease Index | Dry Eye Score from Questionnaire. Scale between 0 and 50 points. Higger is worse | 6 weeks |
Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Crosslinked Hyaluronic Acid, Meibomian Gland Disfunction, Lubricants, Contact Lens, Dry Eye
|
|
NCT00307086
|
Bortezomib Followed by High-Dose Melphalan and Bortezomib as Conditioning Regimen for Tandem Stem Cell Transplants
|
The primary objectives of this study are to:~To determine the maximum tolerated dose (MTD) of bortezomib in combination with high-dose melphalan as a conditioning regimen.~To determine the safety, tolerability, and response rates of bortezomib given in combination with high-dose melphalan, as a conditioning regimen, for tandem transplants in patients with primary refractory multiple myeloma or plasma cell leukemia.~The secondary objectives of this study are to:~To determine gene expression profiles (pharmacogenomics) and perform RTPCR for Fanconi anemia pathway genes, prior to and after treatment with bortezomib, in patients with primary refractory multiple myeloma and plasma cell leukemia and correlate profiles with responses to treatment.~To determine the time to disease progression and overall survival in patients with primary refractory multiple myeloma and plasma cell leukemia treated with bortezomib followed by tandem autologous transplantation~To determine the response rates of 2 cycles of bortezomib in patients with primary refractory multiple myeloma or plasma cell leukemia
|
Patients with primary refractory multiple myeloma or plasma cell leukemia either newly diagnosed or previously treated will receive 2-cycles of standard dose bortezomib followed by high-dose melphalan and bortezomib as a conditioning regimen prior to a tandem autologous peripheral blood stem cell transplantation (PBSCT). Following treatment with two cycles of standard dose bortezomib, sequential cohorts of patients will be given escalating bortezomib doses combined with standard and constant conditioning regimen doses of melphalan. Once the MTD of bortezomib is reached, that dose will be administered in combination with melphalan as conditioning prior to PBSCT.
|
An Evaluation of Bortezomib (VelcadeR ) Followed by High-Dose Melphalan and Bortezomib (VelcadeR) as Conditioning Regimen for Tandem Peripheral Blood Stem Cell Transplants in Patients With Primary Refractory Multiple Myeloma and Plasma Cell Leukemia
|
Multiple Myeloma, Plasma Cell Leukemia
|
* Drug: Bortezomib
* Drug: Melphalan
* Procedure: PBSCT
|
Inclusion Criteria:~Voluntary written informed consent before performance of any study-related procedure not part of normal medical care, with the understanding that consent may be withdrawn by the subject at any time without prejudice to future medical care.~Female is either post-menopausal or surgically sterilized or willing to use an acceptable method of birth control (i.e., a hormonal contraceptive, intra-uterine device, diaphragm with spermicide, condom with spermicide, or abstinence) for the duration of the study.~Male agrees to use an acceptable method for contraception for the duration of the study.~Multiple Myeloma Criteria:~Patients with primary refractory disease (those failing to achieve at least a partial response, as defined by the Bladé multiple myeloma response criteria, after first-line (induction) therapy). A partial response will be defined as the following: ≥50% reduction in the level of the serum monoclonal paraprotein, maintained for a minimum of 6 weeks, Reduction in 24-hour urinary light chain excretion either by ≥ 90% or to < 200 mg, maintained for a minimum of 6 weeks. For patients with non-secretory myeloma only, ≥ 50% reduction in plasma cells in a bone marrow aspirate and biopsy, maintained for a minimum of 6 weeks, ≥ 50% reduction in the size of soft tissue plasmacytomas (by radiography or physical examination). No increase in the size or number of lytic bone lesions (development of a compression fracture does not exclude response).~Patients with plasma cell leukemia, either newly diagnosed or previously treated.~Patients greater than or equal to 18 years of age are eligible.~Patients must have a histologically confirmed diagnosis by a pathologic review at the H. Lee Moffitt Cancer Center and Research Institute.~Patients must have undergone a complete psychosocial evaluation and have been considered capable of compliance.~Exclusion Criteria:~Patient has a platelet count of <30× 10^9/L within 14 days before enrollment.~Patient has an absolute neutrophil count of <1.0 × 10^9/L within 14 days before enrollment.~Patient has a serum creatinine of greater than 2.0 mg/dL OR a creatinine clearance of less than 40 ml/minute within 14 days before enrollment. Creatinine clearance can be measured or calculated.~Has >Grade 2 peripheral neuropathy within 14 days before enrollment.~Myocardial infarction within 6 months prior to enrollment or has New York Hospital Association (NYHA) Class III or IV heart failure (see section 8.4), uncontrolled angina, severe uncontrolled ventricular arrhythmias, or electrocardiographic evidence of acute ischemia or active conduction system abnormalities. Prior to study entry, any ECG abnormality at screening has to be documented by the investigator as not medically relevant.~Patient has hypersensitivity to bortezomib, boron or mannitol.~Female is pregnant or breast-feeding. Confirmation that the subject is not pregnant must be established by a negative serum β-human chorionic gonadotropin (β-hCG) pregnancy test result obtained during screening. Pregnancy testing is not required for postmenopausal or surgically sterilized women.~Patient has received other investigational drugs with 14 days before enrollment~Serious medical or psychiatric illness likely to interfere with participation in this clinical study.~Patients with a DLCO less than 50% (adjusted) of normal or with symptomatic obstructive or restrictive lung disease are ineligible.~Patients with renal dysfunction secondary to multiple myeloma may be enrolled at the discretion of the principal investigator. However, patients on hemodialysis or peritoneal dialysis are ineligible.~Patients with a total bilirubin greater than 2.0 mg/dL and SGOT or SGPT greater than two and a half times normal (unless due to primary malignancy), or a history of severe hepatic dysfunction are ineligible.~Patients with active infections are ineligible.~Patients who are HIV positive are ineligible.~Patients with active leptomeningeal involvement are ineligible. Patients with a history of previous CSF tumor involvement without symptoms or signs are eligible provided the CSF is now free of disease on lumbar puncture, and MRI of the brain shows no tumor involvement. Patients with severe symptomatic central nervous system (CNS) disease of any etiology are ineligible.~Patients with uncontrolled insulin-dependent diabetes mellitus or uncompensated major thyroid or adrenal dysfunction are ineligible.~Patients with an Eastern Cooperative Oncology Group (ECOG) performance status of ≥ 2 are ineligible.~Patients with an ECOG performance status of 2 to 3, secondary to bone pain, may be enrolled at the discretion of the institutional investigator(s).
|
18 Years
| null |
All
|
No
|
Primary Purpose: Treatment
Intervention Model: Single Group Assignment
Masking: None (Open Label)
|
| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Overall Survival (OS) | Median overall survival after first peripheral blood stem cell transplant (PBSCT). | 40 months post transplant |
|
Bortezomib, Melphalan, Antineoplastic Agents, Antineoplastic Agents, Alkylating, Alkylating Agents, Molecular Mechanisms of Pharmacological Action, Myeloablative Agonists, Immunosuppressive Agents, Immunologic Factors, Physiological Effects of Drugs
|
| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Other: Autologous PBSCT<br>bortezomib in combination with high-dose melphalan as a conditioning regimen for autologous peripheral blood stem cell transplant (PBSCT) | Drug: Bortezomib<br>* the maximum tolerated dose (MTD) of bortezomib in combination with high-dose melphalan as a conditioning regimen for autologous stem cell transplant<br>* Other names: Velcade;Drug: Melphalan<br>* Day -4 melphalan 100 mg/m2 intravenously over 30 minutes, Day -3 melphalan 100 mg/m2 intravenously over 30 minutes<br>* Other names: Alkeran(R);Procedure: PBSCT<br>* PBSCT #1 Day 0 PBSCT #2 Day 0 (approx 90 days =/- 15 days after PBSCT #1)<br>* Other names: peripheral blood stem cell transplant (PBSCT);|
|
Bortezomib Followed by High-Dose Melphalan and Bortezomib as Conditioning Regimen for Tandem Stem Cell Transplants
Study Overview
=================
Brief Summary
-----------------
The primary objectives of this study are to: To determine the maximum tolerated dose (MTD) of bortezomib in combination with high-dose melphalan as a conditioning regimen. To determine the safety, tolerability, and response rates of bortezomib given in combination with high-dose melphalan, as a conditioning regimen, for tandem transplants in patients with primary refractory multiple myeloma or plasma cell leukemia. The secondary objectives of this study are to: To determine gene expression profiles (pharmacogenomics) and perform RTPCR for Fanconi anemia pathway genes, prior to and after treatment with bortezomib, in patients with primary refractory multiple myeloma and plasma cell leukemia and correlate profiles with responses to treatment. To determine the time to disease progression and overall survival in patients with primary refractory multiple myeloma and plasma cell leukemia treated with bortezomib followed by tandem autologous transplantation To determine the response rates of 2 cycles of bortezomib in patients with primary refractory multiple myeloma or plasma cell leukemia
Detailed Description
-----------------
Patients with primary refractory multiple myeloma or plasma cell leukemia either newly diagnosed or previously treated will receive 2-cycles of standard dose bortezomib followed by high-dose melphalan and bortezomib as a conditioning regimen prior to a tandem autologous peripheral blood stem cell transplantation (PBSCT). Following treatment with two cycles of standard dose bortezomib, sequential cohorts of patients will be given escalating bortezomib doses combined with standard and constant conditioning regimen doses of melphalan. Once the MTD of bortezomib is reached, that dose will be administered in combination with melphalan as conditioning prior to PBSCT.
Official Title
-----------------
An Evaluation of Bortezomib (VelcadeR ) Followed by High-Dose Melphalan and Bortezomib (VelcadeR) as Conditioning Regimen for Tandem Peripheral Blood Stem Cell Transplants in Patients With Primary Refractory Multiple Myeloma and Plasma Cell Leukemia
Conditions
-----------------
Multiple Myeloma, Plasma Cell Leukemia
Intervention / Treatment
-----------------
* Drug: Bortezomib
* Drug: Melphalan
* Procedure: PBSCT
Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Voluntary written informed consent before performance of any study-related procedure not part of normal medical care, with the understanding that consent may be withdrawn by the subject at any time without prejudice to future medical care. Female is either post-menopausal or surgically sterilized or willing to use an acceptable method of birth control (i.e., a hormonal contraceptive, intra-uterine device, diaphragm with spermicide, condom with spermicide, or abstinence) for the duration of the study. Male agrees to use an acceptable method for contraception for the duration of the study. Multiple Myeloma Criteria: Patients with primary refractory disease (those failing to achieve at least a partial response, as defined by the Bladé multiple myeloma response criteria, after first-line (induction) therapy). A partial response will be defined as the following: ≥50% reduction in the level of the serum monoclonal paraprotein, maintained for a minimum of 6 weeks, Reduction in 24-hour urinary light chain excretion either by ≥ 90% or to < 200 mg, maintained for a minimum of 6 weeks. For patients with non-secretory myeloma only, ≥ 50% reduction in plasma cells in a bone marrow aspirate and biopsy, maintained for a minimum of 6 weeks, ≥ 50% reduction in the size of soft tissue plasmacytomas (by radiography or physical examination). No increase in the size or number of lytic bone lesions (development of a compression fracture does not exclude response). Patients with plasma cell leukemia, either newly diagnosed or previously treated. Patients greater than or equal to 18 years of age are eligible. Patients must have a histologically confirmed diagnosis by a pathologic review at the H. Lee Moffitt Cancer Center and Research Institute. Patients must have undergone a complete psychosocial evaluation and have been considered capable of compliance. Exclusion Criteria: Patient has a platelet count of <30× 10^9/L within 14 days before enrollment. Patient has an absolute neutrophil count of <1.0 × 10^9/L within 14 days before enrollment. Patient has a serum creatinine of greater than 2.0 mg/dL OR a creatinine clearance of less than 40 ml/minute within 14 days before enrollment. Creatinine clearance can be measured or calculated. Has >Grade 2 peripheral neuropathy within 14 days before enrollment. Myocardial infarction within 6 months prior to enrollment or has New York Hospital Association (NYHA) Class III or IV heart failure (see section 8.4), uncontrolled angina, severe uncontrolled ventricular arrhythmias, or electrocardiographic evidence of acute ischemia or active conduction system abnormalities. Prior to study entry, any ECG abnormality at screening has to be documented by the investigator as not medically relevant. Patient has hypersensitivity to bortezomib, boron or mannitol. Female is pregnant or breast-feeding. Confirmation that the subject is not pregnant must be established by a negative serum β-human chorionic gonadotropin (β-hCG) pregnancy test result obtained during screening. Pregnancy testing is not required for postmenopausal or surgically sterilized women. Patient has received other investigational drugs with 14 days before enrollment Serious medical or psychiatric illness likely to interfere with participation in this clinical study. Patients with a DLCO less than 50% (adjusted) of normal or with symptomatic obstructive or restrictive lung disease are ineligible. Patients with renal dysfunction secondary to multiple myeloma may be enrolled at the discretion of the principal investigator. However, patients on hemodialysis or peritoneal dialysis are ineligible. Patients with a total bilirubin greater than 2.0 mg/dL and SGOT or SGPT greater than two and a half times normal (unless due to primary malignancy), or a history of severe hepatic dysfunction are ineligible. Patients with active infections are ineligible. Patients who are HIV positive are ineligible. Patients with active leptomeningeal involvement are ineligible. Patients with a history of previous CSF tumor involvement without symptoms or signs are eligible provided the CSF is now free of disease on lumbar puncture, and MRI of the brain shows no tumor involvement. Patients with severe symptomatic central nervous system (CNS) disease of any etiology are ineligible. Patients with uncontrolled insulin-dependent diabetes mellitus or uncompensated major thyroid or adrenal dysfunction are ineligible. Patients with an Eastern Cooperative Oncology Group (ECOG) performance status of ≥ 2 are ineligible. Patients with an ECOG performance status of 2 to 3, secondary to bone pain, may be enrolled at the discretion of the institutional investigator(s).
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: Autologous PBSCT<br>bortezomib in combination with high-dose melphalan as a conditioning regimen for autologous peripheral blood stem cell transplant (PBSCT) | Drug: Bortezomib<br>* the maximum tolerated dose (MTD) of bortezomib in combination with high-dose melphalan as a conditioning regimen for autologous stem cell transplant<br>* Other names: Velcade;Drug: Melphalan<br>* Day -4 melphalan 100 mg/m2 intravenously over 30 minutes, Day -3 melphalan 100 mg/m2 intravenously over 30 minutes<br>* Other names: Alkeran(R);Procedure: PBSCT<br>* PBSCT #1 Day 0 PBSCT #2 Day 0 (approx 90 days =/- 15 days after PBSCT #1)<br>* Other names: peripheral blood stem cell transplant (PBSCT);|
What is the study measuring?
-----------------
Primary Outcome Measures
| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Overall Survival (OS) | Median overall survival after first peripheral blood stem cell transplant (PBSCT). | 40 months post transplant |
|
||
NCT03120403
|
Safety and Efficacy of Intrathecal Morphine in Children
|
Postoperative pain in pediatrics can usually be well controlled with a combination of analgesics including acetaminophen ( paracetamol) ,NSIADS, opioids , and local/regional anesthesia.The use of epidural and subarachnoid morphine for analgesia in adults has grown almost as quickly as Morton's discovery of anesthesia in 1846. The application of these techniques to the pediatric patients has evolved much more slowly,although significant progress is being made by many investigators.
|
Advantage of intrathecal morphine as that extremely small doses of opioids are required when administrated intrathecally because they have direct access to spinal cord opioid receptors. Drug administered epidurally or caudally are required in much higher doses because they must first diffuse into the CSF before they reach spinal opioid receptors. As a result, the duration of action of intrathecal morphine is greater than that of single shot peridural techniques.~To investigate the safety and efficacy of intrathecal morphine in post operative pain relief in pediatric patients undergoing major abdominal cancer surgeries using different doses of intrathecal morphine (2 μg/kg , 5 μg/kg ,10μg/kg).
|
Safety and Efficacy of Intrathecal Morphine in Children Undergoing Major Abdominal Surgeries, Dose-finding Clinical Study
|
Abdominal Cancer
|
* Procedure: intrathecal morphine
|
Inclusion Criteria:~pediatric patients aged 3-12 years , weighting between 10-30 kg , and of American Society of Anesthesiologists (ASA) physical status I and II scheduled for major abdominal surgeries , expected to last more than 90 minutes under general anesthesia combined with intratehcal morphine.~Exclusion Criteria:~Children with sacral bone abnormalities ,spina bifida , coagulopathy , mental delay or retardation , known allergy to the study drugs , and local infection at the site of injection will be excluded from the study.
|
3 Years
|
12 Years
| null |
No
|
Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Interventional Model Description: intratehcal injection of drug( morphine).
Masking: Double
|
| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| The face , Legs , Activity, Crying , and Consolability (FLACC) score | The face , Legs , Activity, Crying , and Consolability (FLACC) pain score with its 0- 10 score range will be used to assess pain | 24 hours (every 4 hours ) |
|
Analgesics, Morphine, Analgesics, Opioid, Narcotics, Central Nervous System Depressants, Physiological Effects of Drugs, Sensory System Agents, Peripheral Nervous System Agents
|
| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: intrathecal morphine 2 μg/kg<br>After G A and securing the tube in place , the patients will be placed in the lateral decubtious position and a single dose of intrathecal morphine will be performed using a 25 gauge needle (Brown ®,Germany) and free flow of CSF technique.children will receive intrathecal morphine 2 μg/kg in 2 ml volume normal saline. | Procedure: intrathecal morphine<br> <br> |
| Active Comparator: intrathecal morphine 5 μg/kg<br>After G A and securing the tube in place , the patients will be placed in the lateral decubtious position and a single dose of intrathecal morphine will be performed using a 25 gauge needle (Brown ®,Germany) and free flow of CSF technique. children will receive intrathecal morphine 5 μg/kg in 2 ml volume normal saline. | Procedure: intrathecal morphine<br> <br> |
| Active Comparator: intrathecal morphine 10 μg/kg<br>After G A and securing the tube in place , the patients will be placed in the lateral decubtious position and a single dose of intrathecal morphine will be performed using a 25 gauge needle (Brown ®,Germany) and free flow of CSF technique.children will receive intrathecal morphine 10 μg/kg in 2 ml volume normal saline. | Procedure: intrathecal morphine<br> <br> |
|
Safety and Efficacy of Intrathecal Morphine in Children
Study Overview
=================
Brief Summary
-----------------
Postoperative pain in pediatrics can usually be well controlled with a combination of analgesics including acetaminophen ( paracetamol) ,NSIADS, opioids , and local/regional anesthesia.The use of epidural and subarachnoid morphine for analgesia in adults has grown almost as quickly as Morton's discovery of anesthesia in 1846. The application of these techniques to the pediatric patients has evolved much more slowly,although significant progress is being made by many investigators.
Detailed Description
-----------------
Advantage of intrathecal morphine as that extremely small doses of opioids are required when administrated intrathecally because they have direct access to spinal cord opioid receptors. Drug administered epidurally or caudally are required in much higher doses because they must first diffuse into the CSF before they reach spinal opioid receptors. As a result, the duration of action of intrathecal morphine is greater than that of single shot peridural techniques. To investigate the safety and efficacy of intrathecal morphine in post operative pain relief in pediatric patients undergoing major abdominal cancer surgeries using different doses of intrathecal morphine (2 μg/kg , 5 μg/kg ,10μg/kg).
Official Title
-----------------
Safety and Efficacy of Intrathecal Morphine in Children Undergoing Major Abdominal Surgeries, Dose-finding Clinical Study
Conditions
-----------------
Abdominal Cancer
Intervention / Treatment
-----------------
* Procedure: intrathecal morphine
Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: pediatric patients aged 3-12 years , weighting between 10-30 kg , and of American Society of Anesthesiologists (ASA) physical status I and II scheduled for major abdominal surgeries , expected to last more than 90 minutes under general anesthesia combined with intratehcal morphine. Exclusion Criteria: Children with sacral bone abnormalities ,spina bifida , coagulopathy , mental delay or retardation , known allergy to the study drugs , and local infection at the site of injection will be excluded from the study.
Ages Eligible for Study
-----------------
Minimum Age: 3 Years
Maximum Age: 12 Years
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: intratehcal injection of drug( morphine).
Masking: Double
Arms and Interventions
| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: intrathecal morphine 2 μg/kg<br>After G A and securing the tube in place , the patients will be placed in the lateral decubtious position and a single dose of intrathecal morphine will be performed using a 25 gauge needle (Brown ®,Germany) and free flow of CSF technique.children will receive intrathecal morphine 2 μg/kg in 2 ml volume normal saline. | Procedure: intrathecal morphine<br> <br> |
| Active Comparator: intrathecal morphine 5 μg/kg<br>After G A and securing the tube in place , the patients will be placed in the lateral decubtious position and a single dose of intrathecal morphine will be performed using a 25 gauge needle (Brown ®,Germany) and free flow of CSF technique. children will receive intrathecal morphine 5 μg/kg in 2 ml volume normal saline. | Procedure: intrathecal morphine<br> <br> |
| Active Comparator: intrathecal morphine 10 μg/kg<br>After G A and securing the tube in place , the patients will be placed in the lateral decubtious position and a single dose of intrathecal morphine will be performed using a 25 gauge needle (Brown ®,Germany) and free flow of CSF technique.children will receive intrathecal morphine 10 μg/kg in 2 ml volume normal saline. | Procedure: intrathecal morphine<br> <br> |
What is the study measuring?
-----------------
Primary Outcome Measures
| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| The face , Legs , Activity, Crying , and Consolability (FLACC) score | The face , Legs , Activity, Crying , and Consolability (FLACC) pain score with its 0- 10 score range will be used to assess pain | 24 hours (every 4 hours ) |
|
||
NCT03031834
|
Efficacy of Administration of ACE-Inhibition on Autonomic and Peripheral Neuropathy in Patients With Diabetes Mellitus
|
Patients with diabetes mellitus and definite autonomic and peripheral neuropathy were randomized to receive quinapril or no treatment for 2 years.
|
Efficacy of Administration of Angiotensin Converting Enzyme Inhibition on Autonomic and Peripheral Neuropathy in Patients With Diabetes Mellitus
|
Diabetic Autonomic Neuropathy
|
* Drug: Quinapril
|
Inclusion Criteria:~Diabetes mellitus with both autonomic and peripheral neuropathy~Exclusion Criteria:~Hypertension, coronary heart disease
| null | null |
All
| null |
| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Changes in R-R variation during deep breathing | | 2 years |
| Changes in response to Valsalva maneuver | | 2 years |
| Changes in 30:15 ratio | | 2 years |
| Changes in blood pressure response to standing | | 2 years |
|
Quinapril, Angiotensin-Converting Enzyme Inhibitors, Protease Inhibitors, Enzyme Inhibitors, Molecular Mechanisms of Pharmacological Action, Antihypertensive Agents
|
| Intervention/Treatment |
| --- |
|Drug: Quinapril|nan|
|
Efficacy of Administration of ACE-Inhibition on Autonomic and Peripheral Neuropathy in Patients With Diabetes Mellitus
Study Overview
=================
Brief Summary
-----------------
Patients with diabetes mellitus and definite autonomic and peripheral neuropathy were randomized to receive quinapril or no treatment for 2 years.
Official Title
-----------------
Efficacy of Administration of Angiotensin Converting Enzyme Inhibition on Autonomic and Peripheral Neuropathy in Patients With Diabetes Mellitus
Conditions
-----------------
Diabetic Autonomic Neuropathy
Intervention / Treatment
-----------------
* Drug: Quinapril
Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Diabetes mellitus with both autonomic and peripheral neuropathy Exclusion Criteria: Hypertension, coronary heart disease
Sexes Eligible for Study
-----------------
All
Study Plan
=================
How is the study designed?
-----------------
Arms and Interventions
| Intervention/Treatment |
| --- |
|Drug: Quinapril|nan|
What is the study measuring?
-----------------
Primary Outcome Measures
| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Changes in R-R variation during deep breathing | | 2 years |
| Changes in response to Valsalva maneuver | | 2 years |
| Changes in 30:15 ratio | | 2 years |
| Changes in blood pressure response to standing | | 2 years |
|
||||
NCT00078494
|
Peptide Vaccine to Prevent Recurrence of Nasopharyngeal Cancer
|
This study will examine the effectiveness and side effects of an experimental vaccine to prevent recurrence of nasopharyngeal cancer. The likelihood of this cancer returning is higher in patients whose original lesion was large, whose cancer had spread to the adjacent lymph nodes, or who had surgery for metastatic disease (cancer that spread beyond the primary site). Nasopharyngeal tumors are caused by a common virus called Epstein-Barr virus, which produces a protein called LMP-2. Vaccination with specific pieces, or peptides, of the LMP-2 protein may boost the immune system's fight against the cancer. The vaccine injections are mixed with an oil-based substance called Montanide ISA-51, which is intended to increase the immune response to the peptide.~Patients 18 years of age and older whose nasopharyngeal cancer has been controlled by standard treatment with surgery, chemotherapy, or radiation therapy and who are currently free of disease may be eligible for this study. Candidates are screened with a physical examination and blood and urine tests. x-rays and other imaging studies are also done in patients who have not had these tests recently. All candidates are tested for HLA tissue type. Only patients with type HLA-A*1101 or HLA-A*2402 - the types on which the two vaccines in this study are based - receive vaccine therapy; others are offered standard medical treatment and observation.~Participants are randomly assigned to receive injections of one of two different vaccines (LMP-2:340-349 or LMP-2:419-427) to determine which peptide may offer the best immunity. Each treatment course consists of weekly immunizations for 8 consecutive weeks. The injections are given under the skin of the thigh. After every other treatment course (about every 3 months), patients undergo a series of x-rays and scans to look for tumor. The immunizations are given at the NIH Clinical Center. Patients are monitored for 1 hour after each injection and have blood tests and a physical examination to look for treatment side effects. Immunizations may continue for up to 12 months as long as the cancer does not return.~Patients are followed with blood tests every 12 weeks to monitor body functions. They also undergo leukapheresis-a procedure to collect white blood cells-before starting treatment and about 3 to 4 weeks after the fourth vaccine to evaluate how the vaccines affect the action of the immune system cells. For this procedure, blood is drawn through a needle in the arm, similar to donating blood. The blood is processed by a machine that separates and removes the lymphocytes (white blood cells), and the rest of the blood is returned through a needle in the other arm. Patients not receiving the vaccine also undergo leukapheresis to assess their natural response to LMP-2. Some patients may have a biopsy-surgical removal of a small piece of tissue under local anesthetic-of normal skin and tumor or lymph node tissue to examine the vaccine's effects on the tumor immune cells.~Patients who show no evidence of immunization against the LMP-2 protein after two courses of vaccine treatment are subsequently be followed with observation alone. Those who do respond to the vaccine are offered two additional courses of treatment to strengthen the response or to be followed by observation alone. Patients whose disease recurs after completing the first two treatment courses are taken off the study and referred back to their local physician or to another study, if an appropriate one is available.
|
HLA-A*1101 and HLA-A*2402 positive patients with locally controlled anaplastic nasopharyngeal carcinoma at risk for loco-regional or distant recurrence will receive immunization with peptides representing HLA-restricted T cell epitopes of the Epstein-Barr virus encoded latent membrane protein-2 (LMP-2) emulsified in Montanide ISA-51. Patients will be allocated to treatment according to their HLA phenotype. The immunologic potential of the vaccine will be followed by enumerating the frequency of vaccines-specific CD8+ T cells in the peripheral blood using tetrameric HLA/peptide complexes. This study is designed to evaluate the immunologic effectiveness of peptide immunization in adjuvant settings in the context of anaplastic NPC.
|
Phase I/II Trial of Latent Membrane Protein (LMP) - 2 Immunization for the Assessment of the Natural History and the Immunization-Induced Immunological Response in Patients at High Risk for Recurrence of Anaplastic Nasopharyngeal Cancer
|
Nasopharyngeal Neoplasms
|
* Drug: EBV-LMP-2
|
INCLUSION CRITERIA:~HLA-A*1101 and HLA-A*2402 patients, greater than 18 years of age, with advanced local disease (T3-T4N0-1M0), nodal disease (T1-T2N2-3M0) and loco-regional disease (T3-T4N2-3M0) at onset but presently controlled by standard therapy (combination of chemotherapy and radiotherapy) or with completely resected metastatic disease, 3 months after the completion of their primary treatment will be considered.~All subjects will be judged disease free based on physical examination, ENT endoscopy, CT scan of abdomen, chest, neck and nasal sinuses and MRI of the head. All subjects must have received standard surgical, chemotherapy and radiation therapy appropriate for their stage of disease.~Currently, standard treatment for locally advanced NPC in the U.S. consists of concomitant cisplatin with radiation followed by 3 courses of cisplatin and 5-fluorouracil. This, or comparable standard therapies will be considered part of standard therapy and patients will be considered for accrual three or more months after its completion. Patients must demonstrate evidence of local control with no histological or radiological evidence of recurrent disease three months after the end of standard therapy and be, otherwise, clinically disease free at the time of protocol entry as documented by radiological studies within 6 weeks of patient entry. Physical and histological evidence of disease recurrence at the time of patients' screening and during follow up will be performed under the supervision of Dr. Carter Van Waes during an out patient evaluation. Similar enrollment criteria will be used with patients who do not bear HLA-A*1101 or HLA-A*2402. However, these patients will be followed by observation only.~Pathologic confirmation of nasopharyngeal carcinoma by the NCI Laboratory of Pathology (NPC).~serum creatinine of 2.0 mg/dl or less,~Total bilirubin 1.6 mg/dl or less, except for patients with Gilbert's Syndrome who must have a total bilirubin less than 3.0 mg/dl.~WBC 3000/mm(3) or greater,~platelet count 90,000 mm(3) or greater,~serum AST/ALT less than three times normal,~ECOG performance status of 0 or 1.~Patients of both genders must be willing to practice effective birth control during this trial because the potential for teratogenic effects are unknown.~Patients may have had prior adjuvant treatment or may have had treatment for metastatic disease and are now with no evidence of disease, including chemotherapy or biotherapy, as long as 1 month has elapsed since prior systemic therapy.~EXCLUSION CRITERIA:~Patients will be excluded:~Who are undergoing or have undergone in the past 3 weeks any systemic therapy except surgery for their cancer, and must have recovered from any adverse effects of treatment prior to entry, other than those that do not have clinical implications, e.g. alopecia. In the case a patient has received surgical intervention; at least one month should pass before enrollment in the study. All toxicity from previous therapy must have resolved to less than or equal to Grade 1 by NCI-CTC v 3.0 before enrollment.~Who have active systemic infections, autoimmune disease or any known immunodeficiency disease.~d. Who require systemic steroid therapy.~e. Who are pregnant (because of possible side effects on the fetus) or breastfeeding (because of unknown effects on the developing child).~f. Who are known to be positive for hepatitis BsAG or HIV antibody (because of possible immune effects of these conditions). Patients who may screen or have history positive for hepatitis C may be enrolled if their transaminases levels are within the limits specified in inclusion criteria.~g. Who have any form of active primary or secondary immunodeficiency or who have not recovered immune competence after chemotherapy or radiation therapy. (The experimental treatment being evaluated in this protocol depends on an intact immune system. Patients who have decreased immune competence may be less responsive to the experimental treatment and more susceptible to its toxicities.) Active or secondary immunodeficiency will be judged based on the patient past medical history and normality of circulating T and B cell counts (Normal range 650-2, 108 and 49 to 424 respectively, Department of Laboratory Medicine, CC). In the similar fashion recovery from chemotherapy and radiation therapy will be evaluated. Previous experience in patients with melanoma or renal cell carcinoma who underwent chemotherapy of local radiation demonstrated that they immune response to common T cell epitopes such as Flu or Cytomegalovirus are rapidly restored within the first month from such treatment (unpublished observation).~h. Who have known hypersensitivity to any of the agents used in this study.
| null | null |
All
|
No
|
Primary Purpose: Treatment
|
| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
|
NPC, Immunization, Vaccine, Nasopharyngeal Cancer, Immunotherapy, Cancer
|
Nasopharyngeal Neoplasms, Nasopharyngeal Carcinoma, Recurrence, Disease Attributes, Pathologic Processes, Pharyngeal Neoplasms, Otorhinolaryngologic Neoplasms, Head and Neck Neoplasms, Neoplasms by Site, Neoplasms, Nasopharyngeal Diseases, Pharyngeal Diseases, Stomatognathic Diseases, Otorhinolaryngologic Diseases, Carcinoma, Neoplasms, Glandular and Epithelial, Neoplasms by Histologic Type
|
| Intervention/Treatment |
| --- |
|Drug: EBV-LMP-2|nan|
|
Peptide Vaccine to Prevent Recurrence of Nasopharyngeal Cancer
Study Overview
=================
Brief Summary
-----------------
This study will examine the effectiveness and side effects of an experimental vaccine to prevent recurrence of nasopharyngeal cancer. The likelihood of this cancer returning is higher in patients whose original lesion was large, whose cancer had spread to the adjacent lymph nodes, or who had surgery for metastatic disease (cancer that spread beyond the primary site). Nasopharyngeal tumors are caused by a common virus called Epstein-Barr virus, which produces a protein called LMP-2. Vaccination with specific pieces, or peptides, of the LMP-2 protein may boost the immune system's fight against the cancer. The vaccine injections are mixed with an oil-based substance called Montanide ISA-51, which is intended to increase the immune response to the peptide. Patients 18 years of age and older whose nasopharyngeal cancer has been controlled by standard treatment with surgery, chemotherapy, or radiation therapy and who are currently free of disease may be eligible for this study. Candidates are screened with a physical examination and blood and urine tests. x-rays and other imaging studies are also done in patients who have not had these tests recently. All candidates are tested for HLA tissue type. Only patients with type HLA-A*1101 or HLA-A*2402 - the types on which the two vaccines in this study are based - receive vaccine therapy; others are offered standard medical treatment and observation. Participants are randomly assigned to receive injections of one of two different vaccines (LMP-2:340-349 or LMP-2:419-427) to determine which peptide may offer the best immunity. Each treatment course consists of weekly immunizations for 8 consecutive weeks. The injections are given under the skin of the thigh. After every other treatment course (about every 3 months), patients undergo a series of x-rays and scans to look for tumor. The immunizations are given at the NIH Clinical Center. Patients are monitored for 1 hour after each injection and have blood tests and a physical examination to look for treatment side effects. Immunizations may continue for up to 12 months as long as the cancer does not return. Patients are followed with blood tests every 12 weeks to monitor body functions. They also undergo leukapheresis-a procedure to collect white blood cells-before starting treatment and about 3 to 4 weeks after the fourth vaccine to evaluate how the vaccines affect the action of the immune system cells. For this procedure, blood is drawn through a needle in the arm, similar to donating blood. The blood is processed by a machine that separates and removes the lymphocytes (white blood cells), and the rest of the blood is returned through a needle in the other arm. Patients not receiving the vaccine also undergo leukapheresis to assess their natural response to LMP-2. Some patients may have a biopsy-surgical removal of a small piece of tissue under local anesthetic-of normal skin and tumor or lymph node tissue to examine the vaccine's effects on the tumor immune cells. Patients who show no evidence of immunization against the LMP-2 protein after two courses of vaccine treatment are subsequently be followed with observation alone. Those who do respond to the vaccine are offered two additional courses of treatment to strengthen the response or to be followed by observation alone. Patients whose disease recurs after completing the first two treatment courses are taken off the study and referred back to their local physician or to another study, if an appropriate one is available.
Detailed Description
-----------------
HLA-A*1101 and HLA-A*2402 positive patients with locally controlled anaplastic nasopharyngeal carcinoma at risk for loco-regional or distant recurrence will receive immunization with peptides representing HLA-restricted T cell epitopes of the Epstein-Barr virus encoded latent membrane protein-2 (LMP-2) emulsified in Montanide ISA-51. Patients will be allocated to treatment according to their HLA phenotype. The immunologic potential of the vaccine will be followed by enumerating the frequency of vaccines-specific CD8+ T cells in the peripheral blood using tetrameric HLA/peptide complexes. This study is designed to evaluate the immunologic effectiveness of peptide immunization in adjuvant settings in the context of anaplastic NPC.
Official Title
-----------------
Phase I/II Trial of Latent Membrane Protein (LMP) - 2 Immunization for the Assessment of the Natural History and the Immunization-Induced Immunological Response in Patients at High Risk for Recurrence of Anaplastic Nasopharyngeal Cancer
Conditions
-----------------
Nasopharyngeal Neoplasms
Intervention / Treatment
-----------------
* Drug: EBV-LMP-2
Participation Criteria
=================
Eligibility Criteria
-----------------
INCLUSION CRITERIA: HLA-A*1101 and HLA-A*2402 patients, greater than 18 years of age, with advanced local disease (T3-T4N0-1M0), nodal disease (T1-T2N2-3M0) and loco-regional disease (T3-T4N2-3M0) at onset but presently controlled by standard therapy (combination of chemotherapy and radiotherapy) or with completely resected metastatic disease, 3 months after the completion of their primary treatment will be considered. All subjects will be judged disease free based on physical examination, ENT endoscopy, CT scan of abdomen, chest, neck and nasal sinuses and MRI of the head. All subjects must have received standard surgical, chemotherapy and radiation therapy appropriate for their stage of disease. Currently, standard treatment for locally advanced NPC in the U.S. consists of concomitant cisplatin with radiation followed by 3 courses of cisplatin and 5-fluorouracil. This, or comparable standard therapies will be considered part of standard therapy and patients will be considered for accrual three or more months after its completion. Patients must demonstrate evidence of local control with no histological or radiological evidence of recurrent disease three months after the end of standard therapy and be, otherwise, clinically disease free at the time of protocol entry as documented by radiological studies within 6 weeks of patient entry. Physical and histological evidence of disease recurrence at the time of patients' screening and during follow up will be performed under the supervision of Dr. Carter Van Waes during an out patient evaluation. Similar enrollment criteria will be used with patients who do not bear HLA-A*1101 or HLA-A*2402. However, these patients will be followed by observation only. Pathologic confirmation of nasopharyngeal carcinoma by the NCI Laboratory of Pathology (NPC). serum creatinine of 2.0 mg/dl or less, Total bilirubin 1.6 mg/dl or less, except for patients with Gilbert's Syndrome who must have a total bilirubin less than 3.0 mg/dl. WBC 3000/mm(3) or greater, platelet count 90,000 mm(3) or greater, serum AST/ALT less than three times normal, ECOG performance status of 0 or 1. Patients of both genders must be willing to practice effective birth control during this trial because the potential for teratogenic effects are unknown. Patients may have had prior adjuvant treatment or may have had treatment for metastatic disease and are now with no evidence of disease, including chemotherapy or biotherapy, as long as 1 month has elapsed since prior systemic therapy. EXCLUSION CRITERIA: Patients will be excluded: Who are undergoing or have undergone in the past 3 weeks any systemic therapy except surgery for their cancer, and must have recovered from any adverse effects of treatment prior to entry, other than those that do not have clinical implications, e.g. alopecia. In the case a patient has received surgical intervention; at least one month should pass before enrollment in the study. All toxicity from previous therapy must have resolved to less than or equal to Grade 1 by NCI-CTC v 3.0 before enrollment. Who have active systemic infections, autoimmune disease or any known immunodeficiency disease. d. Who require systemic steroid therapy. e. Who are pregnant (because of possible side effects on the fetus) or breastfeeding (because of unknown effects on the developing child). f. Who are known to be positive for hepatitis BsAG or HIV antibody (because of possible immune effects of these conditions). Patients who may screen or have history positive for hepatitis C may be enrolled if their transaminases levels are within the limits specified in inclusion criteria. g. Who have any form of active primary or secondary immunodeficiency or who have not recovered immune competence after chemotherapy or radiation therapy. (The experimental treatment being evaluated in this protocol depends on an intact immune system. Patients who have decreased immune competence may be less responsive to the experimental treatment and more susceptible to its toxicities.) Active or secondary immunodeficiency will be judged based on the patient past medical history and normality of circulating T and B cell counts (Normal range 650-2, 108 and 49 to 424 respectively, Department of Laboratory Medicine, CC). In the similar fashion recovery from chemotherapy and radiation therapy will be evaluated. Previous experience in patients with melanoma or renal cell carcinoma who underwent chemotherapy of local radiation demonstrated that they immune response to common T cell epitopes such as Flu or Cytomegalovirus are rapidly restored within the first month from such treatment (unpublished observation). h. Who have known hypersensitivity to any of the agents used in this study.
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: EBV-LMP-2|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
-----------------
NPC, Immunization, Vaccine, Nasopharyngeal Cancer, Immunotherapy, Cancer
|
|
NCT03059875
|
Place of Comprehensive Geriatric Assessment in Patients ≥ 75 Years Care, With Breast Cancer, After Screening With FOG (Oncology Geriatric Filter)
|
The risk of diagnosis of cancer increases with age, especially breast cancer in elderly women. Elderly population is heterogeneous, regarding physiological reserves, comorbidities, disability and geriatric conditions. Comprehensive geriatric assessment (CGA) is a multidimensional approach to determine geriatric profile, in helping the therapeutic strategy. In-patients with diagnosis of cancer are screened with the FOG (oncology geriatric filter), to identify vulnerable subjects who may benefit from CGA. This scale of ten questions includes geriatric domains such as functional status, nutrition, mood, cognitive abilities and comorbidities. In elderly patients with breast cancer considered as fit (FOG=0), CGA is not necessary before adjuvant treatment. In vulnerable patients (FOG ≤ 1 and < 3), CGA is held in routine to discuss the adjuvant therapy feasibility. Patients with FOG ≥ 4 underwent CGA if palliative care is considered.~Patients in the intermediate group (FOG 1-3) are randomized to determine time of CGA, before or after surgery.~The aims of this study are to assess the outcomes regarding the time of CGA, in elderly female patients with breast cancer management, and to define the optimal place of CGA in care pathway.
|
Place of Comprehensive Geriatric Assessment (CGA) in Patients ≥ 75 Years Care, With Breast Cancer, After Screening With FOG (Oncology Geriatric Filter): Comparison Between CGA Before Surgery (Strategy A) vs. After Surgery (Strategy B)
|
Surgery, 75 Years Old and More, Female Breast Cancer
|
* Behavioral: Medical consultation for a Standardized Geriatric Evaluation
|
Inclusion Criteria:~First breast cancer localized, indication of surgery~Onco-geriatric filter (FOG) >= 1 ou < 4~Exclusion Criteria:~Male, less of 75 years old~Contraindication of surgery~Breast cancer with metastasis~Onco-geriatric filter (FOG) = 0 or 4
|
75 Years
| null |
Female
|
No
|
Primary Purpose: Prevention
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
|
| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Compare Comprehensive Geriatric Assessment before the surgery and Comprehensive Geriatric Assessment after the surgery | | 5 years |
|
| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Quality of life of patients | Questionnary EORTC QLQ - BR33 | 5 years |
| Patient satisfaction with their management | Questionnary REPERES 60 - Consumer Satisfaction Survey | 5 years |
| Compare proportions of patients who received adjuvant chemotherapy and / or radiation standard | | 5 years |
| Compare time to take care of Comprehensive Geriatric Assessment before the surgery and Comprehensive Geriatric Assessment after the surgery | | 5 years |
| Compare the proportions of patients receiving adjuvant therapy, including complete hormone therapy | | 5 years |
|
Breastcancer, Standardized Geriatric Evaluation, Onco-Geriatric Filter
|
Breast Neoplasms, Neoplasms by Site, Neoplasms, Breast Diseases, Skin Diseases
|
| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Other: Strategy A<br>Comprehensive Geriatric Assessment before the surgery of breast | Behavioral: Medical consultation for a Standardized Geriatric Evaluation<br> <br> |
| Other: Strategy B<br>Comprehensive Geriatric Assessment after the surgery of breast | Behavioral: Medical consultation for a Standardized Geriatric Evaluation<br> <br> |
|
Place of Comprehensive Geriatric Assessment in Patients ≥ 75 Years Care, With Breast Cancer, After Screening With FOG (Oncology Geriatric Filter)
Study Overview
=================
Brief Summary
-----------------
The risk of diagnosis of cancer increases with age, especially breast cancer in elderly women. Elderly population is heterogeneous, regarding physiological reserves, comorbidities, disability and geriatric conditions. Comprehensive geriatric assessment (CGA) is a multidimensional approach to determine geriatric profile, in helping the therapeutic strategy. In-patients with diagnosis of cancer are screened with the FOG (oncology geriatric filter), to identify vulnerable subjects who may benefit from CGA. This scale of ten questions includes geriatric domains such as functional status, nutrition, mood, cognitive abilities and comorbidities. In elderly patients with breast cancer considered as fit (FOG=0), CGA is not necessary before adjuvant treatment. In vulnerable patients (FOG ≤ 1 and < 3), CGA is held in routine to discuss the adjuvant therapy feasibility. Patients with FOG ≥ 4 underwent CGA if palliative care is considered. Patients in the intermediate group (FOG 1-3) are randomized to determine time of CGA, before or after surgery. The aims of this study are to assess the outcomes regarding the time of CGA, in elderly female patients with breast cancer management, and to define the optimal place of CGA in care pathway.
Official Title
-----------------
Place of Comprehensive Geriatric Assessment (CGA) in Patients ≥ 75 Years Care, With Breast Cancer, After Screening With FOG (Oncology Geriatric Filter): Comparison Between CGA Before Surgery (Strategy A) vs. After Surgery (Strategy B)
Conditions
-----------------
Surgery, 75 Years Old and More, Female Breast Cancer
Intervention / Treatment
-----------------
* Behavioral: Medical consultation for a Standardized Geriatric Evaluation
Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: First breast cancer localized, indication of surgery Onco-geriatric filter (FOG) >= 1 ou < 4 Exclusion Criteria: Male, less of 75 years old Contraindication of surgery Breast cancer with metastasis Onco-geriatric filter (FOG) = 0 or 4
Ages Eligible for Study
-----------------
Minimum Age: 75 Years
Sexes Eligible for Study
-----------------
Female
Accepts Healthy Volunteers
-----------------
No
Study Plan
=================
How is the study designed?
-----------------
Design Details
Primary Purpose: Prevention
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Arms and Interventions
| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Other: Strategy A<br>Comprehensive Geriatric Assessment before the surgery of breast | Behavioral: Medical consultation for a Standardized Geriatric Evaluation<br> <br> |
| Other: Strategy B<br>Comprehensive Geriatric Assessment after the surgery of breast | Behavioral: Medical consultation for a Standardized Geriatric Evaluation<br> <br> |
What is the study measuring?
-----------------
Primary Outcome Measures
| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Compare Comprehensive Geriatric Assessment before the surgery and Comprehensive Geriatric Assessment after the surgery | | 5 years |
Secondary Outcome Measures
| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Quality of life of patients | Questionnary EORTC QLQ - BR33 | 5 years |
| Patient satisfaction with their management | Questionnary REPERES 60 - Consumer Satisfaction Survey | 5 years |
| Compare proportions of patients who received adjuvant chemotherapy and / or radiation standard | | 5 years |
| Compare time to take care of Comprehensive Geriatric Assessment before the surgery and Comprehensive Geriatric Assessment after the surgery | | 5 years |
| Compare the proportions of patients receiving adjuvant therapy, including complete hormone therapy | | 5 years |
Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Breastcancer, Standardized Geriatric Evaluation, Onco-Geriatric Filter
|
|
NCT01564875
|
Efficacy and Safety of Simvast Controlled Release (CR) and Zocor in Chronic Kidney Disease(CKD) Stage 3, 4 and 5 Patients With Hyperlipidemia
|
Study design~Multicenter, double-dummy, double-blinded, randomized, Phase 4 study~Patients will be randomized to either a study group or a control group in a 1:1 ratio, and will be orally administered the assigned drugs~Study Objective~-The study is designed to demonstrate that efficacy and safety of morning dosing of Simvast Controlled Release (CR) Tab is not inferior to evening dosing of Zocor Tab in patients with stage 3,4,5 chronic kidney disease with hyperlipidemia~Primary objective~-to assess the percent change of LDL-C at Week 8 from baseline in Chronic Kidney Disease(CKD) stage 3,4,5 with hyperlipidemia subjects.
|
The secondary objectives of the study are as follows:~to assess the change and percent change of TC, HDL-C, TG from baseline.~to assess the accomplishment rate of therapeutic goals based on the therapeutic guidance for hyperlipidemia of the Korean Society of Lipidology and Atherosclerosis.
|
Efficacy and Safety of Morning Intake of Simvast Controlled Release (CR) Tablet Versus Evening Intake of Zocor Tablet in Chronic Kidney Disease Stage(CKD)3, 4 and 5 Patients With Hyperlipidemia: A Randomized, Double-blind, Multicenter Phase 4 Trial (HM-SIM4)
|
Chronic Kidney Disease, Hyperlipidemia
|
* Drug: Simvast CR
* Drug: Zocor
|
Inclusion criteria:~Patient with age of 20 to 75 (inclusive)~Patients with fasting serum lipid panels meeting the followings:~At Visit 1 screening 100mg/dL ≤ LDL-C < 220 mg/dL Triglyceride < 400mg/dL However, if the patient has been treated with antihyperlipidemics for 4 consecutive weeks or longer at the time of screening, it should be 100mg/ dL ≤ LDL-C < 160 mg/dL.~At Visit 2 screening 100mg/dL ≤ LDL-C < 220 mg/dL Triglyceride < 400mg/dL~Patients with CKD stage 3 to 5.~Subjects considered requiring medication by the principal investigator based on the therapeutic -guidance for hyperlipidemia of the Korean Society of Lipidology and Atherosclerosis.~Patients who understand the study procedures and signed the informed consent form.~Exclusion criteria:~Patients with a hypersensitivity to HMG-CoA reductase inhibitor or any of its ingredients.~Patients who consume more than 14 units of alcohol a week, who are considered to have a history of drug overdose within 12 months of screening by the investigator, or who abuse other drugs.~Patients with the following history:~Active gallbladder disease within 12 months of screening (patients who had cholecystectomy are eligible for the study).~Pancreatitis or liver disease (AST or ALT > 2 times the upper limit of the normal range at Visits 1 and 2).~Patients with uncontrolled diabetes mellitus (HbA1c ≥ 9.0 %).~Patients with hypotension (systolic blood pressure< 90mmHg or diastolic blood pressure<50mmHg).~Patients with uncontrolled hypertension: mean systolic blood pressure (SBP)> 160mmHg or mean diastolic blood pressure (DBP) > 100mmHg at Visit 2.~Patients with myocardial infarction or who had coronary artery bypass or angioplasty within 6 months before screening.~Patients who had stroke, transient ischemic attack (TIA), or deep vein thrombosis (DVT) within 6 months of screening.~Patients who had been treated for carotid artery disease, peripheral artery disease, or abdominal aortic aneurysm.~Patients with serious heart disease (patients with NYHA class (Attachment 4) III or IV congestive heart failure, unstable angina pectoris, or acute myocardial infarction).~Patients who were diagnosed with malignancy within 5 years or who have active tumors.~Patients with fibromyalgia, myopathy, rhadomyolysis, or sudden muscle pain, or patients who experienced adverse events during the previous treatment with statins.~Patients with mental illnesses considered by the investigator serious enough to adversely affect the patients' participation in the study.~Patients with uncontrolled primary hypothyroidism.~Patients with active peptic ulcer disease.~Patients with gastrointestinal conditions that may restrict drug absorptions, such as chronic diarrhea, inflammatory colic disease, partial ileal bypass, gastrorrhaphy, or gastric banding.~Screening CPK level > 3 times the upper limit of the normal range.~Patients on immunosuppressives after kidney transplantation.~Patients who need to be on immunosuppressives for other reasons.~Patients who have participated in another clinical trial within the last 4 weeks of screening (except those who participated in clinical trials including observational studies that do not involve interventions such as medication).~Pregnant women, lactating women, or women of childbearing potential who do not use appropriate contraceptives.~Patients currently on dialysis.~Other patients considered ineligible by the principal investigator and investigators.
|
20 Years
|
75 Years
|
All
|
No
|
Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Triple
|
| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Percent change of LDL-C | Percent change of LDL-C at Week 8 from baseline | 8 weeks |
|
| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change and percent change of TC, HDL-C, TG | Change and percent change of TC, HDL-C, TG from baseline. | 8 weeks |
| Accomplishment rate of therapeutic goals | -Accomplishment rate of therapeutic goals based on the therapeutic guidance for hyperlipidemia of the Korean Society of Lipidology and Atherosclerosis. | 8 weeks |
|
Simvast CR, Zocor
|
Kidney Diseases, Renal Insufficiency, Chronic, Hyperlipidemias, Hyperlipoproteinemias, Urologic Diseases, Female Urogenital Diseases, Female Urogenital Diseases and Pregnancy Complications, Urogenital Diseases, Male Urogenital Diseases, Renal Insufficiency, Chronic Disease, Disease Attributes, Pathologic Processes, Dyslipidemias, Lipid Metabolism Disorders, Metabolic Diseases
|
| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Simvast CR<br>Simvast CR Tab 20mg, 1 tablet once daily to be administered between 6 and 9 a.m.~Placebo with the same appearance and formulation as that of Zocor Tab, 1 tablet once daily to be administered between 6 and 9 p.m. | Drug: Simvast CR<br>* Simvast CR Tab 20mg, 1 tablet once daily to be administered between 6 and 9 a.m.<br>|
| Active Comparator: Zocor<br>Placebo with the same appearance and formulation as that of Simvast CR Tab, 1 tablet once daily to be administered between 6 and 9 a.m.~Zocor Tab 20mg, 1 tablet once daily to be administered between 6 and 9 p.m. | Drug: Zocor<br>* Zocor Tab 20mg, 1 tablet once daily to be administered between 6 and 9 p.m.<br>|
|
Efficacy and Safety of Simvast Controlled Release (CR) and Zocor in Chronic Kidney Disease(CKD) Stage 3, 4 and 5 Patients With Hyperlipidemia
Study Overview
=================
Brief Summary
-----------------
Study design Multicenter, double-dummy, double-blinded, randomized, Phase 4 study Patients will be randomized to either a study group or a control group in a 1:1 ratio, and will be orally administered the assigned drugs Study Objective -The study is designed to demonstrate that efficacy and safety of morning dosing of Simvast Controlled Release (CR) Tab is not inferior to evening dosing of Zocor Tab in patients with stage 3,4,5 chronic kidney disease with hyperlipidemia Primary objective -to assess the percent change of LDL-C at Week 8 from baseline in Chronic Kidney Disease(CKD) stage 3,4,5 with hyperlipidemia subjects.
Detailed Description
-----------------
The secondary objectives of the study are as follows: to assess the change and percent change of TC, HDL-C, TG from baseline. to assess the accomplishment rate of therapeutic goals based on the therapeutic guidance for hyperlipidemia of the Korean Society of Lipidology and Atherosclerosis.
Official Title
-----------------
Efficacy and Safety of Morning Intake of Simvast Controlled Release (CR) Tablet Versus Evening Intake of Zocor Tablet in Chronic Kidney Disease Stage(CKD)3, 4 and 5 Patients With Hyperlipidemia: A Randomized, Double-blind, Multicenter Phase 4 Trial (HM-SIM4)
Conditions
-----------------
Chronic Kidney Disease, Hyperlipidemia
Intervention / Treatment
-----------------
* Drug: Simvast CR
* Drug: Zocor
Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion criteria: Patient with age of 20 to 75 (inclusive) Patients with fasting serum lipid panels meeting the followings: At Visit 1 screening 100mg/dL ≤ LDL-C < 220 mg/dL Triglyceride < 400mg/dL However, if the patient has been treated with antihyperlipidemics for 4 consecutive weeks or longer at the time of screening, it should be 100mg/ dL ≤ LDL-C < 160 mg/dL. At Visit 2 screening 100mg/dL ≤ LDL-C < 220 mg/dL Triglyceride < 400mg/dL Patients with CKD stage 3 to 5. Subjects considered requiring medication by the principal investigator based on the therapeutic -guidance for hyperlipidemia of the Korean Society of Lipidology and Atherosclerosis. Patients who understand the study procedures and signed the informed consent form. Exclusion criteria: Patients with a hypersensitivity to HMG-CoA reductase inhibitor or any of its ingredients. Patients who consume more than 14 units of alcohol a week, who are considered to have a history of drug overdose within 12 months of screening by the investigator, or who abuse other drugs. Patients with the following history: Active gallbladder disease within 12 months of screening (patients who had cholecystectomy are eligible for the study). Pancreatitis or liver disease (AST or ALT > 2 times the upper limit of the normal range at Visits 1 and 2). Patients with uncontrolled diabetes mellitus (HbA1c ≥ 9.0 %). Patients with hypotension (systolic blood pressure< 90mmHg or diastolic blood pressure<50mmHg). Patients with uncontrolled hypertension: mean systolic blood pressure (SBP)> 160mmHg or mean diastolic blood pressure (DBP) > 100mmHg at Visit 2. Patients with myocardial infarction or who had coronary artery bypass or angioplasty within 6 months before screening. Patients who had stroke, transient ischemic attack (TIA), or deep vein thrombosis (DVT) within 6 months of screening. Patients who had been treated for carotid artery disease, peripheral artery disease, or abdominal aortic aneurysm. Patients with serious heart disease (patients with NYHA class (Attachment 4) III or IV congestive heart failure, unstable angina pectoris, or acute myocardial infarction). Patients who were diagnosed with malignancy within 5 years or who have active tumors. Patients with fibromyalgia, myopathy, rhadomyolysis, or sudden muscle pain, or patients who experienced adverse events during the previous treatment with statins. Patients with mental illnesses considered by the investigator serious enough to adversely affect the patients' participation in the study. Patients with uncontrolled primary hypothyroidism. Patients with active peptic ulcer disease. Patients with gastrointestinal conditions that may restrict drug absorptions, such as chronic diarrhea, inflammatory colic disease, partial ileal bypass, gastrorrhaphy, or gastric banding. Screening CPK level > 3 times the upper limit of the normal range. Patients on immunosuppressives after kidney transplantation. Patients who need to be on immunosuppressives for other reasons. Patients who have participated in another clinical trial within the last 4 weeks of screening (except those who participated in clinical trials including observational studies that do not involve interventions such as medication). Pregnant women, lactating women, or women of childbearing potential who do not use appropriate contraceptives. Patients currently on dialysis. Other patients considered ineligible by the principal investigator and investigators.
Ages Eligible for Study
-----------------
Minimum Age: 20 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: Triple
Arms and Interventions
| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Simvast CR<br>Simvast CR Tab 20mg, 1 tablet once daily to be administered between 6 and 9 a.m. Placebo with the same appearance and formulation as that of Zocor Tab, 1 tablet once daily to be administered between 6 and 9 p.m. | Drug: Simvast CR<br>* Simvast CR Tab 20mg, 1 tablet once daily to be administered between 6 and 9 a.m.<br>|
| Active Comparator: Zocor<br>Placebo with the same appearance and formulation as that of Simvast CR Tab, 1 tablet once daily to be administered between 6 and 9 a.m. Zocor Tab 20mg, 1 tablet once daily to be administered between 6 and 9 p.m. | Drug: Zocor<br>* Zocor Tab 20mg, 1 tablet once daily to be administered between 6 and 9 p.m.<br>|
What is the study measuring?
-----------------
Primary Outcome Measures
| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Percent change of LDL-C | Percent change of LDL-C at Week 8 from baseline | 8 weeks |
Secondary Outcome Measures
| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change and percent change of TC, HDL-C, TG | Change and percent change of TC, HDL-C, TG from baseline. | 8 weeks |
| Accomplishment rate of therapeutic goals | -Accomplishment rate of therapeutic goals based on the therapeutic guidance for hyperlipidemia of the Korean Society of Lipidology and Atherosclerosis. | 8 weeks |
Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Simvast CR, Zocor
|
NCT01069601
|
H1N1sw Vaccine in Adult Transplant Recipients
|
The trial investigates the efficacy of the adjuvanted H1N1 influenza vaccine Focetria(R) in immunocompromised adults who have undergone solid organ or bone marrow transplantation. It is expected that when administered twice the vaccine fulfills all serological efficacy criteria required for the elderly population age 60 years and older.
|
A Phase II Study to Evaluate the Immunogenicity, Safety and Tolerability of a H1N1 Influenza Vaccine in Immunocompromised Adults Who Have Undergone Solid Organ Transplantation or Bone Marrow Transplantation and in Age-Matched Healthy Volunteers
|
Immunocompromised
|
* Biological: Focetria (2x H1N1 vaccine with MF59 adjuvants)
|
Inclusion Criteria:~Adult subjects 18-60 years of age who have undergone prior renal, cardiac, liver, lung, or bone marrow transplantation for any reason, more than 3 months prior to enrolment~Patients able to visit the outpatient clinic with a life expectancy of at least one year~Patients who receive any immunosuppressive treatment currently taken to prevent organ rejection~Exclusion Criteria:~Individuals who received any vaccine within 30 days prior to study entry~Individuals who received a H1N1 vaccination less than 6 months prior to the study~Influenza diagnosed by a physician within 4 months prior to the study start~Pregnant or lactating females~History of an anaphylactic (i.e. life-threatening) reaction to any of the components of the vaccines, including egg and chicken proteins, ovalbumin, kanamycin and neomycin sulphate, formaldehyde and cetyltrimethylammonium bromide (CTAB)
|
18 Years
|
60 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 |
| --- | --- | --- |
| The adjuvanted H1N1 influenza vaccine, when administered twice in transplanted patients, fulfils all serological efficacy criteria as required for the elderly population (aged 60 and older) according to the respective European guidance documents. | | 42 days |
|
| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| The adjuvanted H1N1 influenza vaccine in transplanted patients, when administered twice, is at least as effective as the adjuvanted H1N1 influenza vaccine in the healthy volunteers after only one administration. | | 42 days |
|
solid organ transplantation, bone marrow transplantation, adults, adults with solid organ transplantation, adults with bone marrow transplantation
|
| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: transplanted adults<br>male and female adults who have previously undergone solid organ transplantation or allogeneic or autologous BMT | Biological: Focetria (2x H1N1 vaccine with MF59 adjuvants)<br>* 7,5µg H1N1sw monovalent vaccine with MF59 adjuvants; two doses 3 weeks apart<br>* Other names: Focetria(R);|
|
H1N1sw Vaccine in Adult Transplant Recipients
Study Overview
=================
Brief Summary
-----------------
The trial investigates the efficacy of the adjuvanted H1N1 influenza vaccine Focetria(R) in immunocompromised adults who have undergone solid organ or bone marrow transplantation. It is expected that when administered twice the vaccine fulfills all serological efficacy criteria required for the elderly population age 60 years and older.
Official Title
-----------------
A Phase II Study to Evaluate the Immunogenicity, Safety and Tolerability of a H1N1 Influenza Vaccine in Immunocompromised Adults Who Have Undergone Solid Organ Transplantation or Bone Marrow Transplantation and in Age-Matched Healthy Volunteers
Conditions
-----------------
Immunocompromised
Intervention / Treatment
-----------------
* Biological: Focetria (2x H1N1 vaccine with MF59 adjuvants)
Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Adult subjects 18-60 years of age who have undergone prior renal, cardiac, liver, lung, or bone marrow transplantation for any reason, more than 3 months prior to enrolment Patients able to visit the outpatient clinic with a life expectancy of at least one year Patients who receive any immunosuppressive treatment currently taken to prevent organ rejection Exclusion Criteria: Individuals who received any vaccine within 30 days prior to study entry Individuals who received a H1N1 vaccination less than 6 months prior to the study Influenza diagnosed by a physician within 4 months prior to the study start Pregnant or lactating females History of an anaphylactic (i.e. life-threatening) reaction to any of the components of the vaccines, including egg and chicken proteins, ovalbumin, kanamycin and neomycin sulphate, formaldehyde and cetyltrimethylammonium bromide (CTAB)
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: Prevention
Allocation: Non-Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Arms and Interventions
| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: transplanted adults<br>male and female adults who have previously undergone solid organ transplantation or allogeneic or autologous BMT | Biological: Focetria (2x H1N1 vaccine with MF59 adjuvants)<br>* 7,5µg H1N1sw monovalent vaccine with MF59 adjuvants; two doses 3 weeks apart<br>* Other names: Focetria(R);|
What is the study measuring?
-----------------
Primary Outcome Measures
| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| The adjuvanted H1N1 influenza vaccine, when administered twice in transplanted patients, fulfils all serological efficacy criteria as required for the elderly population (aged 60 and older) according to the respective European guidance documents. | | 42 days |
Secondary Outcome Measures
| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| The adjuvanted H1N1 influenza vaccine in transplanted patients, when administered twice, is at least as effective as the adjuvanted H1N1 influenza vaccine in the healthy volunteers after only one administration. | | 42 days |
Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
solid organ transplantation, bone marrow transplantation, adults, adults with solid organ transplantation, adults with bone marrow transplantation
|
||
NCT00411931
|
A Pharmacokinetics Study of MultiHance in Pediatric Patients
|
Compare relative exposure in the younger age group in order to supplement the PK profile already determined in older children and adults
|
A Clinical Investigation of the Pharmacokinetics and Safety of MultiHance in Patients From 2-5 Years of Age Undergoing A Clinical Indicated MRI of the CNS
|
Central Nervous System Pathology
|
* Drug: Multihance
|
Inclusion Criteria:~Male or female between 2 and 5 years of age~Obtained informed consent from patient's parent or guardian~Obtain assent when applicable according to local law~Known or suspected disease of the central nervous system (brain or spine)~Referred for MRI of the brain or spine requiring an injection of an MR contrast agent~Exclusion Criteria:~Contraindications to MR examination~Undergoing MRI in an emergency situation~Known allergy to one or more ingredients in the contrast agent or history of hypersensitivity to gadolinium or metals~Sickle cell anemia~Likely to undergo an invasive examination within 72 hours after administration of the investigational product
|
2 Years
|
5 Years
|
All
|
No
|
Primary Purpose: Diagnostic
Allocation: Non-Randomized
Intervention Model: Single Group Assignment
Masking: None (Open Label)
|
| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Assess the blood PK of Multihance in patients from 2 to 5 years of age | | up to 24 hours post dose |
|
| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Evaluate the safety of Multihance in patients from 2 to 5 years of age | | through 72 hours post dose |
|
| Intervention/Treatment |
| --- |
|Drug: Multihance|0.5M administered as a single injection|
|
A Pharmacokinetics Study of MultiHance in Pediatric Patients
Study Overview
=================
Brief Summary
-----------------
Compare relative exposure in the younger age group in order to supplement the PK profile already determined in older children and adults
Official Title
-----------------
A Clinical Investigation of the Pharmacokinetics and Safety of MultiHance in Patients From 2-5 Years of Age Undergoing A Clinical Indicated MRI of the CNS
Conditions
-----------------
Central Nervous System Pathology
Intervention / Treatment
-----------------
* Drug: Multihance
Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Male or female between 2 and 5 years of age Obtained informed consent from patient's parent or guardian Obtain assent when applicable according to local law Known or suspected disease of the central nervous system (brain or spine) Referred for MRI of the brain or spine requiring an injection of an MR contrast agent Exclusion Criteria: Contraindications to MR examination Undergoing MRI in an emergency situation Known allergy to one or more ingredients in the contrast agent or history of hypersensitivity to gadolinium or metals Sickle cell anemia Likely to undergo an invasive examination within 72 hours after administration of the investigational product
Ages Eligible for Study
-----------------
Minimum Age: 2 Years
Maximum Age: 5 Years
Sexes Eligible for Study
-----------------
All
Accepts Healthy Volunteers
-----------------
No
Study Plan
=================
How is the study designed?
-----------------
Design Details
Primary Purpose: Diagnostic
Allocation: Non-Randomized
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Arms and Interventions
| Intervention/Treatment |
| --- |
|Drug: Multihance|0.5M administered as a single injection|
What is the study measuring?
-----------------
Primary Outcome Measures
| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Assess the blood PK of Multihance in patients from 2 to 5 years of age | | up to 24 hours post dose |
Secondary Outcome Measures
| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Evaluate the safety of Multihance in patients from 2 to 5 years of age | | through 72 hours post dose |
|
|||
NCT00146432
|
Immunoadsorption of LPS, C5a and IL-6 in Severe Sepsis and Septic Shock (ISASS-1)
|
The purpose of this study is to determine whether immunoadsorption of LPS, Il-6 and C5a reduces systemic hyperinflammation, improves immune function and improves organ function in patients with severe sepsis and septic shock
|
Prospective, Controlled Pilot Trial: Treatment of Patients in Severe Sepsis and Septic Shock With Immunoadsorption of LPS, IL-6, C5a
|
Septicemia
|
* Procedure: Immunoadsorption of LPS, IL-6 and C5a
|
Inclusion Criteria:~Diagnosis of severe sepsis or septic shock (ACCP/SCCM)~Presence of 4 SIRS criteria/indicators~Suspected or proven infection (refer also to: 1.)~Age 18-80~APACHE II score > 18~At least one acute organ dysfunction (renal/pulmonary/hemodynamics/cerebral)~Exclusion Criteria:~Suspected or proven pregnancy~Absolute contraindication for anticoagulation (active bleeding)~Absolute IgA-deficiency~History of anaphylactic reaction to egg-albumin~Participants in other clinical trials (<12 wks. prior to study inclusion)
|
18 Years
|
80 Years
|
All
| null |
Primary Purpose: Treatment
Allocation: Non-Randomized
Intervention Model: Factorial Assignment
Masking: None (Open Label)
|
| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
|
Sepsis, Infections, Systemic Inflammatory Response Syndrome, Inflammation, Pathologic Processes
|
| Intervention/Treatment |
| --- |
|Procedure: Immunoadsorption of LPS, IL-6 and C5a|nan|
|
Immunoadsorption of LPS, C5a and IL-6 in Severe Sepsis and Septic Shock (ISASS-1)
Study Overview
=================
Brief Summary
-----------------
The purpose of this study is to determine whether immunoadsorption of LPS, Il-6 and C5a reduces systemic hyperinflammation, improves immune function and improves organ function in patients with severe sepsis and septic shock
Official Title
-----------------
Prospective, Controlled Pilot Trial: Treatment of Patients in Severe Sepsis and Septic Shock With Immunoadsorption of LPS, IL-6, C5a
Conditions
-----------------
Septicemia
Intervention / Treatment
-----------------
* Procedure: Immunoadsorption of LPS, IL-6 and C5a
Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Diagnosis of severe sepsis or septic shock (ACCP/SCCM) Presence of 4 SIRS criteria/indicators Suspected or proven infection (refer also to: 1.) Age 18-80 APACHE II score > 18 At least one acute organ dysfunction (renal/pulmonary/hemodynamics/cerebral) Exclusion Criteria: Suspected or proven pregnancy Absolute contraindication for anticoagulation (active bleeding) Absolute IgA-deficiency History of anaphylactic reaction to egg-albumin Participants in other clinical trials (<12 wks. prior to study inclusion)
Ages Eligible for Study
-----------------
Minimum Age: 18 Years
Maximum Age: 80 Years
Sexes Eligible for Study
-----------------
All
Study Plan
=================
How is the study designed?
-----------------
Design Details
Primary Purpose: Treatment
Allocation: Non-Randomized
Intervention Model: Factorial Assignment
Masking: None (Open Label)
Arms and Interventions
| Intervention/Treatment |
| --- |
|Procedure: Immunoadsorption of LPS, IL-6 and C5a|nan|
What is the study measuring?
-----------------
Primary Outcome Measures
| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
|
|||
NCT03982563
|
Computerized Single-Session Interventions for Indian Adolescents
|
The overall aim of this project is to understand if single-session interventions are acceptable, culturally appropriate, and effective for Indian adolescents. The investigators will be examining the effects of three interventions on the well-being and mental health of adolescents. The investigators hypothesize that at least one of the three interventions will yield statistically significant improvements in wellbeing and mental health relative to a study skills control condition.
|
Evaluating the Acceptability and Efficacy of Computerized Single-Session Interventions for Indian Adolescents
|
Well-being, Depression, Anxiety
|
* Behavioral: Growth Mindset
* Behavioral: Gratitude
* Behavioral: Behavioral Activation
* Behavioral: Study Skills
|
Inclusion Criteria:~Attending a participating secondary school~Age 12 to 18~Literate in English~Exclusion Criteria:~Unable to provide informed consent
|
12 Years
|
18 Years
|
All
|
Accepts Healthy Volunteers
|
Primary Purpose: Prevention
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Triple
|
| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change in The Warwick-Edinburgh Mental Wellbeing Scale | Well-being questionnaire. Total score ranges from 14 to 70. Higher values indicate a better outcome. | Baseline, 4 week follow-up, 12 week follow-up |
| Intervention Appropriateness Measure | Questionnaire measuring the appropriateness of an intervention. Appropriateness refers to the perceived fit or relevance of an intervention. The total score ranges from 4 to 20. Higher scores indicate a better outcome. | Immediately post-intervention (i.e., 0 weeks) |
|
| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Patient Health Questionnaire-9 | Depression Questionnaire. The total score ranges from 0 to 27. Lower scores indicate a better outcome. | Baseline, 4 week follow-up, 12 week follow-up |
| Generalized Anxiety Disorder Screener-7 | Anxiety Questionnaire. The total score ranges from 0 to 21. Lower scores indicate a better outcome. | Baseline, 4 week follow-up, 12 week follow-up |
| The EPOCH Measure of Adolescent Well-being | Questionnaire with five subscales measuring engagement, perseverance, optimism, connectedness, and happiness. Each subscale score ranges from 4 to 20. Higher scores indicate a better outcome. The happiness and optimism subscales will be used as secondary outcomes for this trial. A total score is not computed. | Baseline, 4 week follow-up, 12 week follow-up |
| Acceptability of Intervention Measure | Questionnaire measuring the acceptability of an intervention. Acceptability refers to the perception that a given treatment is agreeable or satisfactory. The total score ranges from 4 to 20. Higher scores indicate a better outcome. | Immediately post-intervention (i.e., 0 weeks) |
| Feasibility of Intervention Measure | Questionnaire measuring the feasibility of an intervention. Feasibility refers to the degree to which a treatment can be successfully implemented in a given setting. The total score ranges from 4 to 20. Higher scores indicate a better outcome. | Immediately post-intervention (i.e., 0 weeks) |
| Perceived Stress Scale-4 | Questionnaire measuring perceived stress. The total score ranges from 0 to 16. Lower scores indicate a better outcome. | Baseline, 4 week follow-up, 12 week follow-up |
|
Depression, Behavioral Symptoms
|
| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Growth Mindset<br> | Behavioral: Growth Mindset<br>* Reading and writing activities designed to instill the belief that people can change.<br>|
| Experimental: Gratitude<br> | Behavioral: Gratitude<br>* Reading and writing activities designed to practice noticing and appreciating good things in life.<br>|
| Experimental: Behavioral Activation<br> | Behavioral: Behavioral Activation<br>* Reading and writing activities designed to identify and schedule positive activities.<br>|
| Sham Comparator: Study Skills<br> | Behavioral: Study Skills<br>* Reading and writing activities designed to learn evidence-based study strategies.<br>|
|
Computerized Single-Session Interventions for Indian Adolescents
Study Overview
=================
Brief Summary
-----------------
The overall aim of this project is to understand if single-session interventions are acceptable, culturally appropriate, and effective for Indian adolescents. The investigators will be examining the effects of three interventions on the well-being and mental health of adolescents. The investigators hypothesize that at least one of the three interventions will yield statistically significant improvements in wellbeing and mental health relative to a study skills control condition.
Official Title
-----------------
Evaluating the Acceptability and Efficacy of Computerized Single-Session Interventions for Indian Adolescents
Conditions
-----------------
Well-being, Depression, Anxiety
Intervention / Treatment
-----------------
* Behavioral: Growth Mindset
* Behavioral: Gratitude
* Behavioral: Behavioral Activation
* Behavioral: Study Skills
Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Attending a participating secondary school Age 12 to 18 Literate in English Exclusion Criteria: Unable to provide informed consent
Ages Eligible for Study
-----------------
Minimum Age: 12 Years
Maximum Age: 18 Years
Sexes Eligible for Study
-----------------
All
Accepts Healthy Volunteers
-----------------
Accepts Healthy Volunteers
Study Plan
=================
How is the study designed?
-----------------
Design Details
Primary Purpose: Prevention
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Triple
Arms and Interventions
| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Growth Mindset<br> | Behavioral: Growth Mindset<br>* Reading and writing activities designed to instill the belief that people can change.<br>|
| Experimental: Gratitude<br> | Behavioral: Gratitude<br>* Reading and writing activities designed to practice noticing and appreciating good things in life.<br>|
| Experimental: Behavioral Activation<br> | Behavioral: Behavioral Activation<br>* Reading and writing activities designed to identify and schedule positive activities.<br>|
| Sham Comparator: Study Skills<br> | Behavioral: Study Skills<br>* Reading and writing activities designed to learn evidence-based study strategies.<br>|
What is the study measuring?
-----------------
Primary Outcome Measures
| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change in The Warwick-Edinburgh Mental Wellbeing Scale | Well-being questionnaire. Total score ranges from 14 to 70. Higher values indicate a better outcome. | Baseline, 4 week follow-up, 12 week follow-up |
| Intervention Appropriateness Measure | Questionnaire measuring the appropriateness of an intervention. Appropriateness refers to the perceived fit or relevance of an intervention. The total score ranges from 4 to 20. Higher scores indicate a better outcome. | Immediately post-intervention (i.e., 0 weeks) |
Secondary Outcome Measures
| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Patient Health Questionnaire-9 | Depression Questionnaire. The total score ranges from 0 to 27. Lower scores indicate a better outcome. | Baseline, 4 week follow-up, 12 week follow-up |
| Generalized Anxiety Disorder Screener-7 | Anxiety Questionnaire. The total score ranges from 0 to 21. Lower scores indicate a better outcome. | Baseline, 4 week follow-up, 12 week follow-up |
| The EPOCH Measure of Adolescent Well-being | Questionnaire with five subscales measuring engagement, perseverance, optimism, connectedness, and happiness. Each subscale score ranges from 4 to 20. Higher scores indicate a better outcome. The happiness and optimism subscales will be used as secondary outcomes for this trial. A total score is not computed. | Baseline, 4 week follow-up, 12 week follow-up |
| Acceptability of Intervention Measure | Questionnaire measuring the acceptability of an intervention. Acceptability refers to the perception that a given treatment is agreeable or satisfactory. The total score ranges from 4 to 20. Higher scores indicate a better outcome. | Immediately post-intervention (i.e., 0 weeks) |
| Feasibility of Intervention Measure | Questionnaire measuring the feasibility of an intervention. Feasibility refers to the degree to which a treatment can be successfully implemented in a given setting. The total score ranges from 4 to 20. Higher scores indicate a better outcome. | Immediately post-intervention (i.e., 0 weeks) |
| Perceived Stress Scale-4 | Questionnaire measuring perceived stress. The total score ranges from 0 to 16. Lower scores indicate a better outcome. | Baseline, 4 week follow-up, 12 week follow-up |
|
||
NCT01236196
|
Telephone Cognitive Behavior Therapy for OEF Veterans With Pain
|
We conducted a randomized clinical trial comparing telephone-delivered cognitive behavior therapy and pain education control. We enrolled 41 OEF/OIF/OND veterans with chronic pain and randomizing them into one of two treatment conditions. The study sample was recruited from primary care clinics at the San Francisco VA Medical Center and affiliated VA community-based outpatient clinics (CBOCs) in downtown San Francisco, Clearlake, Eureka, San Bruno, Santa Rosa, and Ukiah. Recruitment targeted OEF/OIF/OND veterans with pain disorders that involved muscle strain and inflammation, trauma to nerves, and/or central nervous system dysfunction. Both interventions were delivered by telephone and consisted of 12 sessions scheduled over a 20-week period. Pain management outcomes were measured at 10 weeks (mid-treatment), 20 weeks (post-treatment), 32 weeks (3-month follow-up), and 46 weeks (6-month follow-up). The sample size was chosen to provide greater than 80% power at a two-tailed alpha of 0.05. The study hypothesis, assessment methodology, and intervention procedures were based on the cognitive-behavioral model of chronic pain.
|
In the VHA, over 50% of OEF/OIF/OND veterans who are seen in primary care settings report disabling pain symptoms. Although cognitive behavior therapy (CBT) is now commonly employed within interdisciplinary pain management programs, access to these interventions is often limited due to the distance from clinical care and disabling impact of pain. In addition, the dropout rate in studies of face-to-face CBT for chronic pain further detracts from its impact in pain management. A telephone-delivered version of CBT for chronic pain overcomes these barriers to access.~Primary Aim: to investigate the effectiveness of telephone CBT in the management of chronic pain with OEF/OIF/OND veterans enrolled in VA primary care clinics.~Secondary Aim: to determine moderator and mediating factors by which telephone CBT facilitates pain management and successful adjustment of OEF/OIF/OND veterans to chronic pain.~Major hypothesis:~Hypothesis 1: Patients who receive telephone CBT will show significantly greater improvements in coping skills, reduced emotional distress, and increased quality of life compared with those who participate in telephone pain education (EDU).~Hypothesis 2: The dropout rate for both of the telephone interventions in this study will be significantly lower than the attrition rate found in previous studies of face-to-face CBT for chronic pain.~Secondary hypothesis:~Hypothesis 3: An increase in use of coping skills will be positively associated with treatment outcome measures reflecting improved adjustment to chronic pain.~Hypothesis 4: A decrease in catastrophizing will be positively associated with treatment outcome measures reflecting improved adjustment to chronic pain.~To accomplish these aims, we conducted a randomized clinical trial comparing telephone-delivered cognitive behavior therapy and pain education control. A total of 42 OEF/OIF/OND veterans with chronic pain were enrolled in the study and randomized into one of two treatment conditions. The study sample was recruited from primary care clinics at the San Francisco VA Medical Center and affiliated VA community-based outpatient clinics (CBOCs) in downtown San Francisco, Eureka, San Bruno, Santa Rosa, and Ukiah. Recruitment targeted OEF/OIF/OND veterans with pain disorders that involved muscle strain and inflammation, trauma to nerves, and/or central nervous system dysfunction. Both interventions were delivered by telephone and consisted of 12 sessions scheduled over a 20-week period. Pain management outcomes were measured at 10 weeks (mid-treatment), 20 weeks (post-treatment), 32 weeks (3-month follow-up), and 46 weeks (6-month follow-up). The sample size was chosen to provide greater than 80% power at a two-tailed alpha of 0.05. The study hypothesis, assessment methodology, and intervention procedures were based on the cognitive-behavioral model of chronic pain.
|
Telephone Cognitive Behavior Therapy for OEF Veterans With Pain
|
Chronic Pain
|
* Behavioral: Telephone cognitive behavior therapy
* Behavioral: Telephone pain education
|
Inclusion Criteria:~To be eligible to participate in this study, potential subjects must have:~access to a telephone~documented pain for at least the past year~a pain disorder involving muscle strain and inflammation, trauma to nerves, or central nervous system dysfunction~pain condition must be stable~must have no clear indication for specific medical/surgical intervention.~Exclusion Criteria:~Patients were excluded who were:~acutely psychotic~cognitively impaired~showed significant suicidal risk (history of multiple suicide attempts or actively suicidal)~currently abusing alcohol or other drugs, including prescribed opioid pain medications~patients were also excluded who had an unstable medical condition and clear indication for specific medical/surgical intervention in the near future.
|
18 Years
|
50 Years
|
All
|
No
|
Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
|
| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Level of Functioning | Physical health (quality of life), reported on the SF-12, range 0-100, higher scores reflect better quality of life and higher level of functioning | Baseline, 46 weeks |
| Depressive Symptoms | Depressive symptoms, measured on Beck Depression Inventory-II (total score with range from 0 to 63) | Baseline, 46 weeks |
| Pain Behavior | Pain behavior measured as total score on Pain Behavior Checklist (range 0-6), higher score indicating more pain behavior | Baseline, 46 weeks |
| Pain Intensity | Pain Intensity Rating, ranging from 0-6, higher score indicates greater pain intensity | Baseline, 46 weeks |
|
pain, chronic pain, cognitive therapy, telehealth
|
Chronic Pain, Pain, Neurologic Manifestations
|
| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Arm 1 - Telephone CBT<br>telephone cognitive behavior therapy for pain management | Behavioral: Telephone cognitive behavior therapy<br>* Cognitive behavior therapy aimed at teaching pain coping skills was conducted by telephone (12 sessions over a 6-month period).<br>|
| Active Comparator: Arm 2 - telephone education<br>telephone pain education | Behavioral: Telephone pain education<br>* Participants received information on the management of chronic pain during 12 telephone sessions conducted over a 6-month period).<br>|
|
Telephone Cognitive Behavior Therapy for OEF Veterans With Pain
Study Overview
=================
Brief Summary
-----------------
We conducted a randomized clinical trial comparing telephone-delivered cognitive behavior therapy and pain education control. We enrolled 41 OEF/OIF/OND veterans with chronic pain and randomizing them into one of two treatment conditions. The study sample was recruited from primary care clinics at the San Francisco VA Medical Center and affiliated VA community-based outpatient clinics (CBOCs) in downtown San Francisco, Clearlake, Eureka, San Bruno, Santa Rosa, and Ukiah. Recruitment targeted OEF/OIF/OND veterans with pain disorders that involved muscle strain and inflammation, trauma to nerves, and/or central nervous system dysfunction. Both interventions were delivered by telephone and consisted of 12 sessions scheduled over a 20-week period. Pain management outcomes were measured at 10 weeks (mid-treatment), 20 weeks (post-treatment), 32 weeks (3-month follow-up), and 46 weeks (6-month follow-up). The sample size was chosen to provide greater than 80% power at a two-tailed alpha of 0.05. The study hypothesis, assessment methodology, and intervention procedures were based on the cognitive-behavioral model of chronic pain.
Detailed Description
-----------------
In the VHA, over 50% of OEF/OIF/OND veterans who are seen in primary care settings report disabling pain symptoms. Although cognitive behavior therapy (CBT) is now commonly employed within interdisciplinary pain management programs, access to these interventions is often limited due to the distance from clinical care and disabling impact of pain. In addition, the dropout rate in studies of face-to-face CBT for chronic pain further detracts from its impact in pain management. A telephone-delivered version of CBT for chronic pain overcomes these barriers to access. Primary Aim: to investigate the effectiveness of telephone CBT in the management of chronic pain with OEF/OIF/OND veterans enrolled in VA primary care clinics. Secondary Aim: to determine moderator and mediating factors by which telephone CBT facilitates pain management and successful adjustment of OEF/OIF/OND veterans to chronic pain. Major hypothesis: Hypothesis 1: Patients who receive telephone CBT will show significantly greater improvements in coping skills, reduced emotional distress, and increased quality of life compared with those who participate in telephone pain education (EDU). Hypothesis 2: The dropout rate for both of the telephone interventions in this study will be significantly lower than the attrition rate found in previous studies of face-to-face CBT for chronic pain. Secondary hypothesis: Hypothesis 3: An increase in use of coping skills will be positively associated with treatment outcome measures reflecting improved adjustment to chronic pain. Hypothesis 4: A decrease in catastrophizing will be positively associated with treatment outcome measures reflecting improved adjustment to chronic pain. To accomplish these aims, we conducted a randomized clinical trial comparing telephone-delivered cognitive behavior therapy and pain education control. A total of 42 OEF/OIF/OND veterans with chronic pain were enrolled in the study and randomized into one of two treatment conditions. The study sample was recruited from primary care clinics at the San Francisco VA Medical Center and affiliated VA community-based outpatient clinics (CBOCs) in downtown San Francisco, Eureka, San Bruno, Santa Rosa, and Ukiah. Recruitment targeted OEF/OIF/OND veterans with pain disorders that involved muscle strain and inflammation, trauma to nerves, and/or central nervous system dysfunction. Both interventions were delivered by telephone and consisted of 12 sessions scheduled over a 20-week period. Pain management outcomes were measured at 10 weeks (mid-treatment), 20 weeks (post-treatment), 32 weeks (3-month follow-up), and 46 weeks (6-month follow-up). The sample size was chosen to provide greater than 80% power at a two-tailed alpha of 0.05. The study hypothesis, assessment methodology, and intervention procedures were based on the cognitive-behavioral model of chronic pain.
Official Title
-----------------
Telephone Cognitive Behavior Therapy for OEF Veterans With Pain
Conditions
-----------------
Chronic Pain
Intervention / Treatment
-----------------
* Behavioral: Telephone cognitive behavior therapy
* Behavioral: Telephone pain education
Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: To be eligible to participate in this study, potential subjects must have: access to a telephone documented pain for at least the past year a pain disorder involving muscle strain and inflammation, trauma to nerves, or central nervous system dysfunction pain condition must be stable must have no clear indication for specific medical/surgical intervention. Exclusion Criteria: Patients were excluded who were: acutely psychotic cognitively impaired showed significant suicidal risk (history of multiple suicide attempts or actively suicidal) currently abusing alcohol or other drugs, including prescribed opioid pain medications patients were also excluded who had an unstable medical condition and clear indication for specific medical/surgical intervention in the near future.
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: None (Open Label)
Arms and Interventions
| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Arm 1 - Telephone CBT<br>telephone cognitive behavior therapy for pain management | Behavioral: Telephone cognitive behavior therapy<br>* Cognitive behavior therapy aimed at teaching pain coping skills was conducted by telephone (12 sessions over a 6-month period).<br>|
| Active Comparator: Arm 2 - telephone education<br>telephone pain education | Behavioral: Telephone pain education<br>* Participants received information on the management of chronic pain during 12 telephone sessions conducted over a 6-month period).<br>|
What is the study measuring?
-----------------
Primary Outcome Measures
| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Level of Functioning | Physical health (quality of life), reported on the SF-12, range 0-100, higher scores reflect better quality of life and higher level of functioning | Baseline, 46 weeks |
| Depressive Symptoms | Depressive symptoms, measured on Beck Depression Inventory-II (total score with range from 0 to 63) | Baseline, 46 weeks |
| Pain Behavior | Pain behavior measured as total score on Pain Behavior Checklist (range 0-6), higher score indicating more pain behavior | Baseline, 46 weeks |
| Pain Intensity | Pain Intensity Rating, ranging from 0-6, higher score indicates greater pain intensity | Baseline, 46 weeks |
Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
pain, chronic pain, cognitive therapy, telehealth
|
|
NCT00096642
|
Cognitive Behavioral Therapy for Early-Onset Depression
|
Depression is a debilitating illness affecting large numbers of young people. In this study, children and adolescents ages 10 to 17 meeting criteria for clinical depression will participate in a 15-session group therapy (cognitive behavioral therapy or CBT) that teaches strategies for overcoming depressed mood. For half the participants, their parents will also participate in a parent group. By studying the role of parental involvement, we hope to develop more effective treatments for depressed children and teens in the future.
|
Depression is a debilitating illness affecting large numbers of young people. Psychotherapy approaches have shown some promise in teens, but few studies have examined these interventions when offered in a group format. The role of parents in treatment outcome has also received little attention.~In this study, children and adolescents ages 10 to 17 meeting criteria for clinical depression will participate in a 15-session group therapy (cognitive behavioral therapy or CBT) that teaches strategies for overcoming depressed mood. For half the participants, their parents will also participate in a parent group to help them better manage their depressed children and teens. We will randomly assign children to CBT with or without parental involvement. We hope to show that involving parents results in additional improvements in the children. We will also study factors that predict which children do best in treatment, and maintenance of gains at 6 month and 1 year follow-up. These findings will allow us to provide more effective treatments to depressed children and teens in the future.
|
Comprehensive Treatment for Depressed Youth: An Outcome Evaluation Study
|
Major Depressive Disorder, Dysthymic Disorder
|
* Behavioral: Cognitive Behavioral Therapy
|
Inclusion Criteria:~Children and adolescents meeting DSM-IV criteria for either Major Depression or Dysthymic Disorder.~Exclusion Criteria:~Psychotic,~Actively suicidal,~IQ less than 80,~Unable to speak English
|
10 Years
|
17 Years
|
All
|
No
|
Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single
|
| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Diagnosis on structured interview | | pre and post-intervention |
| Children's Depression Inventory score | | pre- and post-intervention |
|
| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Multidimensional Anxiety Scale for Children | | pre- and post-intervention |
| Children's Global Assessment Scale | | pre- and post-intervention |
| Brief Family Assessment Measure | | pre- and post-intervention |
| Perceived Competence Scale for Children | | pre- and post-intervention |
|
depression, cognitive behavioral therapy, group therapy, parenting, children and adolescents
|
Depressive Disorder, Depressive Disorder, Major, Dysthymic Disorder, Mood Disorders, Mental Disorders
|
| Intervention/Treatment |
| --- |
|Behavioral: Cognitive Behavioral Therapy|Cognitive behaviour versus standard care|
|
Cognitive Behavioral Therapy for Early-Onset Depression
Study Overview
=================
Brief Summary
-----------------
Depression is a debilitating illness affecting large numbers of young people. In this study, children and adolescents ages 10 to 17 meeting criteria for clinical depression will participate in a 15-session group therapy (cognitive behavioral therapy or CBT) that teaches strategies for overcoming depressed mood. For half the participants, their parents will also participate in a parent group. By studying the role of parental involvement, we hope to develop more effective treatments for depressed children and teens in the future.
Detailed Description
-----------------
Depression is a debilitating illness affecting large numbers of young people. Psychotherapy approaches have shown some promise in teens, but few studies have examined these interventions when offered in a group format. The role of parents in treatment outcome has also received little attention. In this study, children and adolescents ages 10 to 17 meeting criteria for clinical depression will participate in a 15-session group therapy (cognitive behavioral therapy or CBT) that teaches strategies for overcoming depressed mood. For half the participants, their parents will also participate in a parent group to help them better manage their depressed children and teens. We will randomly assign children to CBT with or without parental involvement. We hope to show that involving parents results in additional improvements in the children. We will also study factors that predict which children do best in treatment, and maintenance of gains at 6 month and 1 year follow-up. These findings will allow us to provide more effective treatments to depressed children and teens in the future.
Official Title
-----------------
Comprehensive Treatment for Depressed Youth: An Outcome Evaluation Study
Conditions
-----------------
Major Depressive Disorder, Dysthymic Disorder
Intervention / Treatment
-----------------
* Behavioral: Cognitive Behavioral Therapy
Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Children and adolescents meeting DSM-IV criteria for either Major Depression or Dysthymic Disorder. Exclusion Criteria: Psychotic, Actively suicidal, IQ less than 80, Unable to speak English
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: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single
Arms and Interventions
| Intervention/Treatment |
| --- |
|Behavioral: Cognitive Behavioral Therapy|Cognitive behaviour versus standard care|
What is the study measuring?
-----------------
Primary Outcome Measures
| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Diagnosis on structured interview | | pre and post-intervention |
| Children's Depression Inventory score | | pre- and post-intervention |
Secondary Outcome Measures
| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Multidimensional Anxiety Scale for Children | | pre- and post-intervention |
| Children's Global Assessment Scale | | pre- and post-intervention |
| Brief Family Assessment Measure | | pre- and post-intervention |
| Perceived Competence Scale for Children | | pre- and post-intervention |
Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
depression, cognitive behavioral therapy, group therapy, parenting, children and adolescents
|
NCT02534077
|
Intravenous Fat Emulsion Comprised of Fish Oil in the Treatment of Parenteral Nutrition Induced Liver Injury in Infants
|
To provide a mechanism for critically ill infants with parenteral nutrition (PN) associated cholestasis to receive Omegaven for compassionate use situations for which there are no satisfactory alternative treatments.
|
Compassionate Use of an Intravenous Fat Emulsion Comprised of Fish Oil in the Treatment of Parenteral Nutrition Induced Liver Injury in Infants
|
Total Parenteral Nutrition-induced Cholestasis
|
* Drug: Omegaven
* Drug: Omegaven
* Drug: Omegaven
|
Inclusion Criteria:~Critically ill infants with either a known anatomic short gut (greater than 50% of the bowel removed) or known severe dysmotility of the gut reflecting non-functional gut similar to anatomic short gut will be offered Omegaven® when their direct bilirubin reaches 2 mg/dL. Infants who do not meet the above criteria for anatomic or dysfunctional short gut will be allowed to receive Omegaven® when their direct bilirubin reaches 4 mg/dL. The qualifying measurements of 2 mg/dL or 4 mg/dL direct bilirubin must be consecutive and obtained at least 24 hours apart.~Be expected to require intravenous nutrition for at least an additional 28 days~Patient must have documented failure of or ineligibility for the following therapies to prevent progression of PNALD:~Reduction of Intralipid® to 1 g/kg/day~Limiting trace minerals including copper and manganese~Initiation and use of Ursodiol~Cycling of parenteral nutrition~Advancement of enteral feedings~Parental informed consent must be signed.~Exclusion Criteria:~Have a congenitally lethal condition (e.g. Trisomy 13).~Have clinically severe bleeding not able to be managed with routine measures.~Have evidence of a viral hepatitis or primary liver disease as the primary etiology of their cholestasis.~Have other health problems such that survival is extremely unlikely even if the infant's cholestasis improves.~Has culture positive sepsis
|
14 Days
|
2 Years
|
All
|
No
|
Primary Purpose: Treatment
Intervention Model: Single Group Assignment
Masking: None (Open Label)
|
| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Death associated with liver disease | Those patients with death only associated with liver diseasepre-treatment period and the expected rate of growth. | Maximum 2 years |
|
| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Liver transplantation | | Maximum 2 years |
| Growth over time as determined by weight in grams. | | Maximum 2 years |
| Growth over time as measured by length in cm. | | Maximum 2 years |
| Growth over time as measured by head circumference in cm. | | Maximum 2 years |
| Development of essential fatty acid (EFA) deficiency as measured by triene:tetraene ratio in those with prolonged NPO status. | | Maximum 2 years |
| Hyperlipidemia as measured by triglyceride level | | Maximum 2 years |
|
omegaven, cholestasis, parenteral nutrition associated liver disease
|
Cholestasis, Bile Duct Diseases, Biliary Tract Diseases, Digestive System Diseases
|
| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: 1<br>Drug: Omegaven | Drug: Omegaven<br>* Therapy with Omegaven will be provided at a dose of 1 gm/kg/day (by continuous infusion). Omegaven will be infused intravenously through either a central or peripheral catheter in conjunction with parenteral nutrition.<br>* Other names: omega-3 enriched fat emulsion;Drug: Omegaven<br>* Treatment will be given for as long as the child needs any TPN AND has a conjugated bilirubin greater than 2 mg/dL for a maximum of 2 years.<br>Drug: Omegaven<br>* If the bilirubin is less than 2 mg/dL but the child still requires TPN, then the Omegaven will be continued until the infant no longer requires TPN.<br>|
|
Intravenous Fat Emulsion Comprised of Fish Oil in the Treatment of Parenteral Nutrition Induced Liver Injury in Infants
Study Overview
=================
Brief Summary
-----------------
To provide a mechanism for critically ill infants with parenteral nutrition (PN) associated cholestasis to receive Omegaven for compassionate use situations for which there are no satisfactory alternative treatments.
Official Title
-----------------
Compassionate Use of an Intravenous Fat Emulsion Comprised of Fish Oil in the Treatment of Parenteral Nutrition Induced Liver Injury in Infants
Conditions
-----------------
Total Parenteral Nutrition-induced Cholestasis
Intervention / Treatment
-----------------
* Drug: Omegaven
* Drug: Omegaven
* Drug: Omegaven
Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Critically ill infants with either a known anatomic short gut (greater than 50% of the bowel removed) or known severe dysmotility of the gut reflecting non-functional gut similar to anatomic short gut will be offered Omegaven® when their direct bilirubin reaches 2 mg/dL. Infants who do not meet the above criteria for anatomic or dysfunctional short gut will be allowed to receive Omegaven® when their direct bilirubin reaches 4 mg/dL. The qualifying measurements of 2 mg/dL or 4 mg/dL direct bilirubin must be consecutive and obtained at least 24 hours apart. Be expected to require intravenous nutrition for at least an additional 28 days Patient must have documented failure of or ineligibility for the following therapies to prevent progression of PNALD: Reduction of Intralipid® to 1 g/kg/day Limiting trace minerals including copper and manganese Initiation and use of Ursodiol Cycling of parenteral nutrition Advancement of enteral feedings Parental informed consent must be signed. Exclusion Criteria: Have a congenitally lethal condition (e.g. Trisomy 13). Have clinically severe bleeding not able to be managed with routine measures. Have evidence of a viral hepatitis or primary liver disease as the primary etiology of their cholestasis. Have other health problems such that survival is extremely unlikely even if the infant's cholestasis improves. Has culture positive sepsis
Ages Eligible for Study
-----------------
Minimum Age: 14 Days
Maximum Age: 2 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: 1<br>Drug: Omegaven | Drug: Omegaven<br>* Therapy with Omegaven will be provided at a dose of 1 gm/kg/day (by continuous infusion). Omegaven will be infused intravenously through either a central or peripheral catheter in conjunction with parenteral nutrition.<br>* Other names: omega-3 enriched fat emulsion;Drug: Omegaven<br>* Treatment will be given for as long as the child needs any TPN AND has a conjugated bilirubin greater than 2 mg/dL for a maximum of 2 years.<br>Drug: Omegaven<br>* If the bilirubin is less than 2 mg/dL but the child still requires TPN, then the Omegaven will be continued until the infant no longer requires TPN.<br>|
What is the study measuring?
-----------------
Primary Outcome Measures
| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Death associated with liver disease | Those patients with death only associated with liver diseasepre-treatment period and the expected rate of growth. | Maximum 2 years |
Secondary Outcome Measures
| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Liver transplantation | | Maximum 2 years |
| Growth over time as determined by weight in grams. | | Maximum 2 years |
| Growth over time as measured by length in cm. | | Maximum 2 years |
| Growth over time as measured by head circumference in cm. | | Maximum 2 years |
| Development of essential fatty acid (EFA) deficiency as measured by triene:tetraene ratio in those with prolonged NPO status. | | Maximum 2 years |
| Hyperlipidemia as measured by triglyceride level | | Maximum 2 years |
Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
omegaven, cholestasis, parenteral nutrition associated liver disease
|
|
NCT03731806
|
Capsule Endoscopy in Newly Diagnosed Patients of Celiac Disease
|
Celiac Disease is an autoimmune disorder that affects approximately 1% of the world's population 1. The diagnosis of CD requires clinical, histopathological and serological factors 2. Since upper gastrointestinal endoscopy allows only visualization of the small bowel up to the second part of duodenum therefore this study was designed to determine involvement of different segments of small bowel using endoscopic scale by Bonatto MW et al 3 in newly diagnosed patients of celiac disease.
|
This cross sectional observational study will take place in Medical Unit-II Ruth KM Pfau Civil Hospital Karachi, Pakistan. All newly diagnosed patients of celiac disease between the ages of 8 & 60 years and patients who are currently not on gluten free diet will be included.~Patients having intestinal obstruction, strictures, fistulae, dysphagia, pregnant females will be excluded. Patients having cardiac pacemakers or other implanted electromedical devices and those who are unable to swallow the capsule will also be excluded.~All patients meeting inclusion criteria will be included. Informed consent will be taken from ethics committee. Patients will be provided proper brief information of procedure and confidentiality of the patients will be ensured. Patients will be advised to start clear liquid diet for 24 hours before the procedure. They will be advised to drink Movcol powder 10 sachet in 500ml of water within 20 mins, 12 hours before the procedure. They will be kept nil orally for 08 hours before the procedure. Syrup Infacol (simethicone) 15ml diluted in 50 ml of water will be given 30 mins before the procedure. Patients will be asked to swallow the capsule with 200 ml of water. Patients will be allowed to take food 4 after ingestion of capsule. All patients will be provided with capsule retrieval kit from stool. Patients will be explained to pass any stool after ingestion of capsule till it passed in stool or up to 7 days whichever is earlier. Capsule retrieved will be brought back to investigators for data retrieval from capsule. Reporting will be done by person trained to interpret capsule endoscopy. This will include presence of any pathology, its severity, approximate length and segment of small intestine involved and quality of bowel preparation.~Categorical data will be presented as frequency and percentage, e.g., gender, findings of capsule endoscopy like, bowel preparation, mosaic pattern,ulcers, erythema, telangiectasia etc. Quantitative data will be presented as mean with standard deviation, e.g., age. Involvement of different segments of small intestine (duodenum, jejunum and Ileum) will be documented. Categorical data will be compared on gender by Chi-square test and quantitative data will be analyzed by student's t-test. Significance level will be set at ≤0.05.
|
Extent of Small Bowel Involvement on Capsule Endoscopy in Newly Diagnosed Patients of Celiac Disease
|
Celiac Disease
|
Inclusion Criteria:~All newly diagnosed patients of celiac disease between the ages of 8 & 60 years.~Patients who are currently not on gluten free diet.~Exclusion Criteria:~Patients having intestinal obstruction, strictures, fistulae, dysphagia will be excluded.~Pregnant females will be excluded.~Patients having cardiac pacemakers or other implanted electromedical devices.~Unable to swallow capsule.
|
8 Years
|
60 Years
|
All
| null |
| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Grading of Celiac Disease on Capsule Endoscopy using Bonatto Classification | Bonatto Endoscopic Classification of Celiac~0 = Normal~I = Mostly regular villi, some foci, no mosaic pattern~II = Agglutinated but visible villi, mosaic pattern~III = Mosaic pattern, absence of villi | 8 hours |
|
celiac disease, capsule endoscopy
|
Celiac Disease, Malabsorption Syndromes, Intestinal Diseases, Gastrointestinal Diseases, Digestive System Diseases, Metabolic Diseases
|
Capsule Endoscopy in Newly Diagnosed Patients of Celiac Disease
Study Overview
=================
Brief Summary
-----------------
Celiac Disease is an autoimmune disorder that affects approximately 1% of the world's population 1. The diagnosis of CD requires clinical, histopathological and serological factors 2. Since upper gastrointestinal endoscopy allows only visualization of the small bowel up to the second part of duodenum therefore this study was designed to determine involvement of different segments of small bowel using endoscopic scale by Bonatto MW et al 3 in newly diagnosed patients of celiac disease.
Detailed Description
-----------------
This cross sectional observational study will take place in Medical Unit-II Ruth KM Pfau Civil Hospital Karachi, Pakistan. All newly diagnosed patients of celiac disease between the ages of 8 & 60 years and patients who are currently not on gluten free diet will be included. Patients having intestinal obstruction, strictures, fistulae, dysphagia, pregnant females will be excluded. Patients having cardiac pacemakers or other implanted electromedical devices and those who are unable to swallow the capsule will also be excluded. All patients meeting inclusion criteria will be included. Informed consent will be taken from ethics committee. Patients will be provided proper brief information of procedure and confidentiality of the patients will be ensured. Patients will be advised to start clear liquid diet for 24 hours before the procedure. They will be advised to drink Movcol powder 10 sachet in 500ml of water within 20 mins, 12 hours before the procedure. They will be kept nil orally for 08 hours before the procedure. Syrup Infacol (simethicone) 15ml diluted in 50 ml of water will be given 30 mins before the procedure. Patients will be asked to swallow the capsule with 200 ml of water. Patients will be allowed to take food 4 after ingestion of capsule. All patients will be provided with capsule retrieval kit from stool. Patients will be explained to pass any stool after ingestion of capsule till it passed in stool or up to 7 days whichever is earlier. Capsule retrieved will be brought back to investigators for data retrieval from capsule. Reporting will be done by person trained to interpret capsule endoscopy. This will include presence of any pathology, its severity, approximate length and segment of small intestine involved and quality of bowel preparation. Categorical data will be presented as frequency and percentage, e.g., gender, findings of capsule endoscopy like, bowel preparation, mosaic pattern,ulcers, erythema, telangiectasia etc. Quantitative data will be presented as mean with standard deviation, e.g., age. Involvement of different segments of small intestine (duodenum, jejunum and Ileum) will be documented. Categorical data will be compared on gender by Chi-square test and quantitative data will be analyzed by student's t-test. Significance level will be set at ≤0.05.
Official Title
-----------------
Extent of Small Bowel Involvement on Capsule Endoscopy in Newly Diagnosed Patients of Celiac Disease
Conditions
-----------------
Celiac Disease
Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: All newly diagnosed patients of celiac disease between the ages of 8 & 60 years. Patients who are currently not on gluten free diet. Exclusion Criteria: Patients having intestinal obstruction, strictures, fistulae, dysphagia will be excluded. Pregnant females will be excluded. Patients having cardiac pacemakers or other implanted electromedical devices. Unable to swallow capsule.
Ages Eligible for Study
-----------------
Minimum Age: 8 Years
Maximum Age: 60 Years
Sexes Eligible for Study
-----------------
All
Study Plan
=================
How is the study designed?
-----------------
What is the study measuring?
-----------------
Primary Outcome Measures
| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Grading of Celiac Disease on Capsule Endoscopy using Bonatto Classification | Bonatto Endoscopic Classification of Celiac 0 = Normal I = Mostly regular villi, some foci, no mosaic pattern II = Agglutinated but visible villi, mosaic pattern III = Mosaic pattern, absence of villi | 8 hours |
Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
celiac disease, capsule endoscopy
|
||||
NCT03258190
|
Lime Powder Regimen (LPR) for Prevention of Renal Stone Recurrence
|
Lime powder regimen (LPR) is a lime-derived composition enriches with citrate/citric acid and potassium. LPR was invented to treat the renal stone patients with high risk of stone recurrence after stone removal. LPR should have equal or higher efficacy and lower adverse effect than current standard medicine.
|
Lime powder regimen (LPR) is a mixture of lime-derive component with adjuvants containing high concentration of citrate, and moderate amount of potassium, magnesium and antioxidants. LPR was tested and verified to be very less toxic in cell culture and animal models. The clinical trial phase II showed that LPR reduced urinary metabolic abnormalities that enhance stone formation, such as hypocitraturia, hypokaliuria and acidified urine. Adverse effect of LPR was very low.
|
Lime Powder Regimen Supplement Alleviates Urinary Metabolic Abnormalities to Prevent Urolithiasis Recurrence.
|
Urolithiasis
|
* Drug: Lime Powder Regimen
|
Inclusion Criteria:~Renal stone patients who were identified and stone was removed by surgical method.~Exclusion Criteria:~Chronic kidney disease, chronic liver disease, history of coronary artery disease, or person who takes any medication that alters urinary metabolic profiles
|
18 Years
|
65 Years
|
All
|
No
|
Primary Purpose: Prevention
Allocation: Randomized
Intervention Model: Parallel Assignment
Interventional Model Description: Randomized control trial
Masking: Single
|
| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Renal stone recurrence | The stone recurrence after surgical removal of stone that can be detected by CT scan | 6 months |
|
Citrate, Urolithiasis, Recurrence, Antioxidants, Lime Powder Regimen
|
Recurrence, Urogenital Diseases, Urolithiasis, Urinary Calculi, Disease Attributes, Pathologic Processes, Urologic Diseases, Female Urogenital Diseases, Female Urogenital Diseases and Pregnancy Complications, Male Urogenital Diseases, Calculi, Pathological Conditions, Anatomical
|
| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Lime Powder Regimen<br>Participants were asked to take LPR twice a day for 6 months | Drug: Lime Powder Regimen<br>* LPR and placebo were randomly given to subjects for 6 months<br>* Other names: LPR supplement;|
| Placebo Comparator: Placebo<br>Participants were asked to take Placebo twice a day for 6 months | Drug: Lime Powder Regimen<br>* LPR and placebo were randomly given to subjects for 6 months<br>* Other names: LPR supplement;|
|
Lime Powder Regimen (LPR) for Prevention of Renal Stone Recurrence
Study Overview
=================
Brief Summary
-----------------
Lime powder regimen (LPR) is a lime-derived composition enriches with citrate/citric acid and potassium. LPR was invented to treat the renal stone patients with high risk of stone recurrence after stone removal. LPR should have equal or higher efficacy and lower adverse effect than current standard medicine.
Detailed Description
-----------------
Lime powder regimen (LPR) is a mixture of lime-derive component with adjuvants containing high concentration of citrate, and moderate amount of potassium, magnesium and antioxidants. LPR was tested and verified to be very less toxic in cell culture and animal models. The clinical trial phase II showed that LPR reduced urinary metabolic abnormalities that enhance stone formation, such as hypocitraturia, hypokaliuria and acidified urine. Adverse effect of LPR was very low.
Official Title
-----------------
Lime Powder Regimen Supplement Alleviates Urinary Metabolic Abnormalities to Prevent Urolithiasis Recurrence.
Conditions
-----------------
Urolithiasis
Intervention / Treatment
-----------------
* Drug: Lime Powder Regimen
Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Renal stone patients who were identified and stone was removed by surgical method. Exclusion Criteria: Chronic kidney disease, chronic liver disease, history of coronary artery disease, or person who takes any medication that alters urinary metabolic profiles
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: Prevention
Allocation: Randomized
Intervention Model: Parallel Assignment
Interventional Model Description: Randomized control trial
Masking: Single
Arms and Interventions
| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Lime Powder Regimen<br>Participants were asked to take LPR twice a day for 6 months | Drug: Lime Powder Regimen<br>* LPR and placebo were randomly given to subjects for 6 months<br>* Other names: LPR supplement;|
| Placebo Comparator: Placebo<br>Participants were asked to take Placebo twice a day for 6 months | Drug: Lime Powder Regimen<br>* LPR and placebo were randomly given to subjects for 6 months<br>* Other names: LPR supplement;|
What is the study measuring?
-----------------
Primary Outcome Measures
| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Renal stone recurrence | The stone recurrence after surgical removal of stone that can be detected by CT scan | 6 months |
Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Citrate, Urolithiasis, Recurrence, Antioxidants, Lime Powder Regimen
|
|
NCT00200538
|
Efficacy and Tolerability of Memantine in Frontotemporal Dementia (FTD) Patients
|
The purpose of this trial is to assess the efficacy and tolerability of memantine (anti-excitotoxic, neuroprotective treatment currently used in Alzheimer's disease [AD]) in frontotemporal dementia patients after a one-year treatment.
|
Background: Frontotemporal dementia (FTD) is the first cause of dementia in the presenium (onset before the age of 65 years). Characterized by behavioral disorders, it is often more incapacitating than Alzheimer's disease (AD), and leads to death within 7 years on average (9-10 years for AD). It affects young individuals (on average, 20 years younger than in AD), who are often still active. Management of these patients is therefore burdensome and complex. As opposed to AD, however, no treatment is currently available. Few therapeutic trials have actually been conducted on this disorder. Many reasons may account for this:~recent availability of reliable diagnostic criteria (the Lund and Manchester groups' consensus statement in 1994; revised in 1998),~the very small number of cases as opposed to AD-the number of cases was estimated at approximately 3,500 vs 600,000, for AD, in France in 2004-, FTD therefore falls into the category of rare diseases (i.e., less than 30,000 cases),~the scarcity of valuable physiopathological hypotheses.~Besides a non-specific serotoninergic dysfunction, no significant anomalies related to particular neuromediators have apparently been found (as opposed to AD, which is characterized by a cholinergic deficit). In 1998, the discovery of mutations in the Tau gene in certain kindreds showing a dominant autosomal transmission of FTD, oriented research efforts toward the tau protein and provided new perspectives. Many studies have suggested the role of excitotoxicity. Abnormal aggregation of the tau protein has been observed in the brains of a majority of FTD patients (familial and sporadic form). Excitotoxicity may be responsible for promoting this abnormal aggregation through modification of the expression and phosphorylation state of the tau protein. The hypothesis of this study is that an anti-excitotoxic neuroprotective treatment may slow the pathogenic process and therefore be an effective treatment for this pathology.~Goals: To assess the efficacy and tolerability of memantine (anti-excitotoxic, neuroprotective treatment currently used in AD) in FTD patients after a one-year treatment.~Type of study: National, multicenter, randomized, double-blind, parallel group, placebo-controlled, phase II therapeutic trial.~Study design: Sixty four (64) patients, aged 45 to 75 years, will be enrolled in the study for a period of 12 months (clinical inclusion criteria are defined based on the Lund and Manchester group consensus statement [revised version 1998]), and followed up for 1 year in a controlled study. At the time of inclusion, the Mini Mental Status Examination (MMSE) score should be at least 19 (below 18, a neuropsychological examination is impossible). Patients will either take memantine, or a placebo (randomization ratio of 1:1) twice a day (i.e., 20 mg of memantine per day in the memantine arm). The primary efficacy variable will be a global assessment tool, the CIBIC-Plus (Clinician's Interview-Based Impression of Change Plus Caregiver Input). Secondary efficacy variables will include behavioral scales [the NeuroPsychiatric Inventory (NPI), the Frontal Behavior Inventory (FBI)], cognitive scales [the Mattis Dementia Rating Scale (MDRS), the MMSE], activities of daily living (Disability Assessment for Dementia, DAD), time spent by the caregiver of the patient (Resource Utilization in Dementia, RUD), and caregiver burden scale (Zarit Burden Inventory), and tolerability of the drug. The main analysis will be carried out on an intention-to-treat basis in all randomized patients having undergone at least one evaluation after inclusion (the Last Observation Carried Forward LOCF value, will be attributed to missing values). This analysis will be carried out at the end of the double-blind study (main judgement criterion)~Expected results and perspectives: The main expected result is the confirmation of the efficacy of memantine as a treatment for FTD, which would set a precedent in the treatment of this disease. Such a result could also lead the way to the development of treatments for other related neurodegenerative disorders (tauopathies) such as the other frontotemporal lobar degenerations (semantic dementia, progressive non-fluent aphasia), progressive supranuclear palsy, or corticobasal degeneration. Finally, the standardized follow-up of a 64 patient cohort in this study will provide important information on the natural history of a rare and poorly-known disease.
|
Double-blind, Parallel Group, Placebo-controlled Trial of the Efficacy and Tolerability of Memantine (20 mg) in Frontotemporal Dementia (FTD) Patients
|
Dementia
|
* Drug: memantine
|
Inclusion Criteria:~Patients with FTD based on the criteria defined by the Lund and Manchester groups' consensus statement (revised in 1998), whose disease has been progressing during the last year.~MMSE score of 19 or higher~Men and women aged 45 to 75 years~Without speech, visuospatial, or episodic memory impairments~Exclusion Criteria:~Age > 76 years~Illiterate or misunderstanding patients~Patients with cancer, heart disease, lung disease, kidney disease (creatinine > 200 mg/dL), or epilepsy
|
45 Years
|
75 Years
|
All
|
No
|
Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double
|
| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
|
frontotemporal dementia, Mémantine, Patients with frontotemporal dementia
|
Memantine, Antiparkinson Agents, Anti-Dyskinesia Agents, Dopamine Agents, Neurotransmitter Agents, Molecular Mechanisms of Pharmacological Action, Physiological Effects of Drugs, Excitatory Amino Acid Antagonists, Excitatory Amino Acid Agents
|
| Intervention/Treatment |
| --- |
|Drug: memantine|nan|
|
Efficacy and Tolerability of Memantine in Frontotemporal Dementia (FTD) Patients
Study Overview
=================
Brief Summary
-----------------
The purpose of this trial is to assess the efficacy and tolerability of memantine (anti-excitotoxic, neuroprotective treatment currently used in Alzheimer's disease [AD]) in frontotemporal dementia patients after a one-year treatment.
Detailed Description
-----------------
Background: Frontotemporal dementia (FTD) is the first cause of dementia in the presenium (onset before the age of 65 years). Characterized by behavioral disorders, it is often more incapacitating than Alzheimer's disease (AD), and leads to death within 7 years on average (9-10 years for AD). It affects young individuals (on average, 20 years younger than in AD), who are often still active. Management of these patients is therefore burdensome and complex. As opposed to AD, however, no treatment is currently available. Few therapeutic trials have actually been conducted on this disorder. Many reasons may account for this: recent availability of reliable diagnostic criteria (the Lund and Manchester groups' consensus statement in 1994; revised in 1998), the very small number of cases as opposed to AD-the number of cases was estimated at approximately 3,500 vs 600,000, for AD, in France in 2004-, FTD therefore falls into the category of rare diseases (i.e., less than 30,000 cases), the scarcity of valuable physiopathological hypotheses. Besides a non-specific serotoninergic dysfunction, no significant anomalies related to particular neuromediators have apparently been found (as opposed to AD, which is characterized by a cholinergic deficit). In 1998, the discovery of mutations in the Tau gene in certain kindreds showing a dominant autosomal transmission of FTD, oriented research efforts toward the tau protein and provided new perspectives. Many studies have suggested the role of excitotoxicity. Abnormal aggregation of the tau protein has been observed in the brains of a majority of FTD patients (familial and sporadic form). Excitotoxicity may be responsible for promoting this abnormal aggregation through modification of the expression and phosphorylation state of the tau protein. The hypothesis of this study is that an anti-excitotoxic neuroprotective treatment may slow the pathogenic process and therefore be an effective treatment for this pathology. Goals: To assess the efficacy and tolerability of memantine (anti-excitotoxic, neuroprotective treatment currently used in AD) in FTD patients after a one-year treatment. Type of study: National, multicenter, randomized, double-blind, parallel group, placebo-controlled, phase II therapeutic trial. Study design: Sixty four (64) patients, aged 45 to 75 years, will be enrolled in the study for a period of 12 months (clinical inclusion criteria are defined based on the Lund and Manchester group consensus statement [revised version 1998]), and followed up for 1 year in a controlled study. At the time of inclusion, the Mini Mental Status Examination (MMSE) score should be at least 19 (below 18, a neuropsychological examination is impossible). Patients will either take memantine, or a placebo (randomization ratio of 1:1) twice a day (i.e., 20 mg of memantine per day in the memantine arm). The primary efficacy variable will be a global assessment tool, the CIBIC-Plus (Clinician's Interview-Based Impression of Change Plus Caregiver Input). Secondary efficacy variables will include behavioral scales [the NeuroPsychiatric Inventory (NPI), the Frontal Behavior Inventory (FBI)], cognitive scales [the Mattis Dementia Rating Scale (MDRS), the MMSE], activities of daily living (Disability Assessment for Dementia, DAD), time spent by the caregiver of the patient (Resource Utilization in Dementia, RUD), and caregiver burden scale (Zarit Burden Inventory), and tolerability of the drug. The main analysis will be carried out on an intention-to-treat basis in all randomized patients having undergone at least one evaluation after inclusion (the Last Observation Carried Forward LOCF value, will be attributed to missing values). This analysis will be carried out at the end of the double-blind study (main judgement criterion) Expected results and perspectives: The main expected result is the confirmation of the efficacy of memantine as a treatment for FTD, which would set a precedent in the treatment of this disease. Such a result could also lead the way to the development of treatments for other related neurodegenerative disorders (tauopathies) such as the other frontotemporal lobar degenerations (semantic dementia, progressive non-fluent aphasia), progressive supranuclear palsy, or corticobasal degeneration. Finally, the standardized follow-up of a 64 patient cohort in this study will provide important information on the natural history of a rare and poorly-known disease.
Official Title
-----------------
Double-blind, Parallel Group, Placebo-controlled Trial of the Efficacy and Tolerability of Memantine (20 mg) in Frontotemporal Dementia (FTD) Patients
Conditions
-----------------
Dementia
Intervention / Treatment
-----------------
* Drug: memantine
Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Patients with FTD based on the criteria defined by the Lund and Manchester groups' consensus statement (revised in 1998), whose disease has been progressing during the last year. MMSE score of 19 or higher Men and women aged 45 to 75 years Without speech, visuospatial, or episodic memory impairments Exclusion Criteria: Age > 76 years Illiterate or misunderstanding patients Patients with cancer, heart disease, lung disease, kidney disease (creatinine > 200 mg/dL), or epilepsy
Ages Eligible for Study
-----------------
Minimum Age: 45 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
| Intervention/Treatment |
| --- |
|Drug: memantine|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
-----------------
frontotemporal dementia, Mémantine, Patients with frontotemporal dementia
|
|
NCT03020459
|
Internal Limiting Membrane Peeling-reposition to Treat Idiopathic Macular Holes
|
To compare the morphologic and functional outcomes of internal limiting membrane peeling-reposition versus peeling in idiopathic macular holes
|
This randomized clinical trial will be performed at a single center. Eligible patients with idiopathic macular holes will be equally randomized to internal limiting membrane (ILM) peeling-reposition group or ILM peeling group through computer-aided random allocation.~A standard 3-port pars plana vitrectomy was performed by a single surgeon using the Constellation 23 gauge vitrectomy system (Alcon Laboratories Inc, Fort Worth, Texas, USA).After posterior vitreous detachment was achieved, peeling of the ILM was performed by an end gripping forceps with the assistance of Brilliant Blue G. In ILM peeling-reposition group, the peeled ILM flap is flatten back to peeled area with assistance of perfluoro-n-octane. In ILM peeling group, a round shape with 2.5 to 3.5 disc diameter of ILM is peeled. This is followed by a complete fluid-gas exchange. Patients are encouraged to maintain a face-down position for two weeks postoperatively in two groups.~Postoperative measurements of BCVA and spectral domain optical coherence tomography(SD-OCT) are conducted at 1,3 and 6-month follow-up visits by independent masked observers. Macular light sensitivity and fixation stability are determined with microperimetry at 1,3, and 6 months of follow-up. Mf-ERG, M-score chart and VFQ-25 chart are performed 1,3, and 6 months of follow-up.~Comparison of BCVA, anatomical closure were primarily performed between the two groups. Then, the morphologic changes of inner retina and the functional parameters measured from microperimetry, Mf-ERG, M-score chart, VFQ-25 chart were analyzed.
|
Comparing the Surgical Outcomes of Internal Limiting Membrane Peeling-reposition Versus Peeling in Idiopathic Macular Holes: A Randomized Controlled Trial
|
Macular Hole, Surgery
|
* Procedure: peeling-reposition
* Procedure: peeling
* Drug: Brilliant Blue G
* Other: postoperative posture
* Device: Constellation 23-gauge vitrectomy system
|
Inclusion Criteria:~The patients are diagnosed as macular hole by optical coherence tomography.~Age ranges from 50 to 80 years.~The patients have indication for surgery.~Exclusion Criteria:~Traumatic macular hole.~Combined with serious epiretinal membrane.~Combined with diabetic retinopathy, hypertensive retinopathy.~Combined with other ocular diseases, such as keratitis，uveitis，retinal vasculitis.~- 6.0 diopters or more of spherical equivalent, 26mm or more of axial length.~History of intraocular surgery.~Presence of staphyloma.~Other ocular diseases that could influence macular microstructure or visual function~Exit criteria:~For reposition group, the patients will exit the research if the peeled ILM cannot reposition successfully.~Due to adverse events, especially severe adverse events, the researchers consider withdrawal of patients based on concerns of safety and ethics;~Drop out;~The patients voluntarily withdraw the informed consent;~Serious violation of the study protocol due to the subjects or investigators' reasons;~Other reasons that the researchers believe for quitting the study.
|
50 Years
|
80 Years
|
All
|
No
|
Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double
|
| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Best corrected visual acuity(BCVA) | Change from baseline BCVA at 6 months after operation, examined with snellen chart. | Pre-operation and 6 months after operation |
|
| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Close rate of macular holes | Observed from optical coherence tomography | 1 month after operation |
|
macular holes
|
Retinal Perforations, Retinal Diseases, Eye Diseases
|
| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: peeling-reposition<br>After dying with Brilliant Blue G (Brilliant Blue; Gender, Germany) with the help of Constellation 23-gauge vitrectomy system (Alcon Laboratories Inc, Fort Worth, TX), the intervention of peeling-reposition was used to peel and unfold the ILM. And the postoperative posture would be prone position in two weeks for all patients after the operation. | Procedure: peeling-reposition<br>* After dying with Brilliant Blue G (BBG, Brilliant Blue; Gender, Germany), a horizontal ILM strip is peeled off in inferior quadrant of macular area. Then the ILM was peeled from inferior to superior area continuously. The ILM roll was unfolded with assistance of perfluoro-n-octane (PFO). Finally, the position of the fixed ILM flap is adjusted under PFO bubble using flute needle or forceps.This was followed by a complete fluid-gas exchange using 14% perfluoropropane gas.Patients are introduced to maintain facedown position for two weeks postoperatively.<br>Drug: Brilliant Blue G<br>* We intravitreal injected 0.1ml of Brilliant Blue G (Brilliant Blue; Gender, Germany) to dye ILM before ILM peeling.<br>* Other names: BBG;Other: postoperative posture<br>* Patients of both two groups need to keep prone position for two weeks after the operation.<br>Device: Constellation 23-gauge vitrectomy system<br>* All surgical procedures are operated on the Constellation 23-gauge vitrectomy system (Alcon Laboratories Inc, Fort Worth, TX).<br>|
| Active Comparator: peeling<br>After dying with Brilliant Blue G (Brilliant Blue; Gender, Germany) with the help of Constellation 23-gauge vitrectomy system, the intervention of peeling was used to grasped ILM with end-gripping forceps. And the postoperative posture would be prone position in two weeks for all patients after the operation. | Procedure: peeling<br>* After dying with Brilliant Blue G (Brilliant Blue; Gender, Germany), a horizontal ILM strip is peeled off in inferior quadrant of macular area. Then, the strand of ILM was peeled off radially from the foveal center to vascular arcade. In result, a round -shaped with 2.5-3.5 disc diameter ILM -peeled area was created.This was followed by a complete fluid-gas exchange using 14% perfluoropropane gas. Patients are encourage to maintain facedown position for two weeks postoperatively.<br>Drug: Brilliant Blue G<br>* We intravitreal injected 0.1ml of Brilliant Blue G (Brilliant Blue; Gender, Germany) to dye ILM before ILM peeling.<br>* Other names: BBG;Other: postoperative posture<br>* Patients of both two groups need to keep prone position for two weeks after the operation.<br>Device: Constellation 23-gauge vitrectomy system<br>* All surgical procedures are operated on the Constellation 23-gauge vitrectomy system (Alcon Laboratories Inc, Fort Worth, TX).<br>|
|
Internal Limiting Membrane Peeling-reposition to Treat Idiopathic Macular Holes
Study Overview
=================
Brief Summary
-----------------
To compare the morphologic and functional outcomes of internal limiting membrane peeling-reposition versus peeling in idiopathic macular holes
Detailed Description
-----------------
This randomized clinical trial will be performed at a single center. Eligible patients with idiopathic macular holes will be equally randomized to internal limiting membrane (ILM) peeling-reposition group or ILM peeling group through computer-aided random allocation. A standard 3-port pars plana vitrectomy was performed by a single surgeon using the Constellation 23 gauge vitrectomy system (Alcon Laboratories Inc, Fort Worth, Texas, USA).After posterior vitreous detachment was achieved, peeling of the ILM was performed by an end gripping forceps with the assistance of Brilliant Blue G. In ILM peeling-reposition group, the peeled ILM flap is flatten back to peeled area with assistance of perfluoro-n-octane. In ILM peeling group, a round shape with 2.5 to 3.5 disc diameter of ILM is peeled. This is followed by a complete fluid-gas exchange. Patients are encouraged to maintain a face-down position for two weeks postoperatively in two groups. Postoperative measurements of BCVA and spectral domain optical coherence tomography(SD-OCT) are conducted at 1,3 and 6-month follow-up visits by independent masked observers. Macular light sensitivity and fixation stability are determined with microperimetry at 1,3, and 6 months of follow-up. Mf-ERG, M-score chart and VFQ-25 chart are performed 1,3, and 6 months of follow-up. Comparison of BCVA, anatomical closure were primarily performed between the two groups. Then, the morphologic changes of inner retina and the functional parameters measured from microperimetry, Mf-ERG, M-score chart, VFQ-25 chart were analyzed.
Official Title
-----------------
Comparing the Surgical Outcomes of Internal Limiting Membrane Peeling-reposition Versus Peeling in Idiopathic Macular Holes: A Randomized Controlled Trial
Conditions
-----------------
Macular Hole, Surgery
Intervention / Treatment
-----------------
* Procedure: peeling-reposition
* Procedure: peeling
* Drug: Brilliant Blue G
* Other: postoperative posture
* Device: Constellation 23-gauge vitrectomy system
Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: The patients are diagnosed as macular hole by optical coherence tomography. Age ranges from 50 to 80 years. The patients have indication for surgery. Exclusion Criteria: Traumatic macular hole. Combined with serious epiretinal membrane. Combined with diabetic retinopathy, hypertensive retinopathy. Combined with other ocular diseases, such as keratitis，uveitis，retinal vasculitis. - 6.0 diopters or more of spherical equivalent, 26mm or more of axial length. History of intraocular surgery. Presence of staphyloma. Other ocular diseases that could influence macular microstructure or visual function Exit criteria: For reposition group, the patients will exit the research if the peeled ILM cannot reposition successfully. Due to adverse events, especially severe adverse events, the researchers consider withdrawal of patients based on concerns of safety and ethics; Drop out; The patients voluntarily withdraw the informed consent; Serious violation of the study protocol due to the subjects or investigators' reasons; Other reasons that the researchers believe for quitting the study.
Ages Eligible for Study
-----------------
Minimum Age: 50 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: peeling-reposition<br>After dying with Brilliant Blue G (Brilliant Blue; Gender, Germany) with the help of Constellation 23-gauge vitrectomy system (Alcon Laboratories Inc, Fort Worth, TX), the intervention of peeling-reposition was used to peel and unfold the ILM. And the postoperative posture would be prone position in two weeks for all patients after the operation. | Procedure: peeling-reposition<br>* After dying with Brilliant Blue G (BBG, Brilliant Blue; Gender, Germany), a horizontal ILM strip is peeled off in inferior quadrant of macular area. Then the ILM was peeled from inferior to superior area continuously. The ILM roll was unfolded with assistance of perfluoro-n-octane (PFO). Finally, the position of the fixed ILM flap is adjusted under PFO bubble using flute needle or forceps.This was followed by a complete fluid-gas exchange using 14% perfluoropropane gas.Patients are introduced to maintain facedown position for two weeks postoperatively.<br>Drug: Brilliant Blue G<br>* We intravitreal injected 0.1ml of Brilliant Blue G (Brilliant Blue; Gender, Germany) to dye ILM before ILM peeling.<br>* Other names: BBG;Other: postoperative posture<br>* Patients of both two groups need to keep prone position for two weeks after the operation.<br>Device: Constellation 23-gauge vitrectomy system<br>* All surgical procedures are operated on the Constellation 23-gauge vitrectomy system (Alcon Laboratories Inc, Fort Worth, TX).<br>|
| Active Comparator: peeling<br>After dying with Brilliant Blue G (Brilliant Blue; Gender, Germany) with the help of Constellation 23-gauge vitrectomy system, the intervention of peeling was used to grasped ILM with end-gripping forceps. And the postoperative posture would be prone position in two weeks for all patients after the operation. | Procedure: peeling<br>* After dying with Brilliant Blue G (Brilliant Blue; Gender, Germany), a horizontal ILM strip is peeled off in inferior quadrant of macular area. Then, the strand of ILM was peeled off radially from the foveal center to vascular arcade. In result, a round -shaped with 2.5-3.5 disc diameter ILM -peeled area was created.This was followed by a complete fluid-gas exchange using 14% perfluoropropane gas. Patients are encourage to maintain facedown position for two weeks postoperatively.<br>Drug: Brilliant Blue G<br>* We intravitreal injected 0.1ml of Brilliant Blue G (Brilliant Blue; Gender, Germany) to dye ILM before ILM peeling.<br>* Other names: BBG;Other: postoperative posture<br>* Patients of both two groups need to keep prone position for two weeks after the operation.<br>Device: Constellation 23-gauge vitrectomy system<br>* All surgical procedures are operated on the Constellation 23-gauge vitrectomy system (Alcon Laboratories Inc, Fort Worth, TX).<br>|
What is the study measuring?
-----------------
Primary Outcome Measures
| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Best corrected visual acuity(BCVA) | Change from baseline BCVA at 6 months after operation, examined with snellen chart. | Pre-operation and 6 months after operation |
Secondary Outcome Measures
| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Close rate of macular holes | Observed from optical coherence tomography | 1 month after operation |
Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
macular holes
|
NCT02372955
|
Mechanistic Study of the Systolic Blood Pressure Lowering Effect of Dapagliflozin in Type 2 Diabetes
|
Dapagliflozin has been shown to lower clinic systolic and diastolic blood pressure in patients with type 2 diabetes mellitus. The exact mechanism(s) by which dapagliflozin lowers clinic SBP is unknown. The primary objective of the study is to determine the effect of dapagliflozin , 10 mg daily, on parameters of arterial stiffness: aPWV, augmentation index (AI), 24-hour blood pressure patterns, SBP, and pulse pressure. Urinary sodium excretion, and Intravascular volume status will be recorded. The study will involve 21 subjects for a duration of 16 weeks.
|
Dapagliflozin has been shown to lower clinic systolic and diastolic blood pressure in patients with type 2 diabetes mellitus. In particular, the reduction in SBP is impressive. The effect on circadian patterns of blood pressure measured by ambulatory blood pressure monitoring has not been established. The exact mechanism(s) by which dapagliflozin lowers clinic SBP is not clear although there has been speculation that it is due to a decrease in intravascular volume secondary to the osmotic diuresis produced by the drug. However, SBP is dependent on both pulse volume and vascular stiffness (impedance to ejection).~Dapagliflozin may have a favorable effect on vascular stiffness by a reduction in blood glucose resulting in decreased proximal arterial collagen cross-linking due to non-enzymatic glycosylation of proteins.~Dapagliflozin may also have a favorable effect on vascular stiffness by increasing urinary sodium excretion. Dapagliflozin is a sodium/glucose co-transporter inhibitor and the effects on sodium excretion are not clear. Increased sodium intake is associated with an increase in vascular stiffness.~An increase in vascular stiffness has been correlated with increased cardiovascular morbidity and mortality. Thus, it is important to know if dapagliflozin has an effect on vascular stiffness.~The current gold standard for vascular stiffness is aortic pulse wave velocity (aPWV). Other measures of vascular stiffness include: systolic blood pressure, pulse pressure and augmentation index. Also, measurement of calculated central blood pressure provides information that may not be apparent from measurement of brachial blood pressure.~Measures of intravascular volume status include: body weight, jugular venous pressure, orthostatic changes in blood pressure and heart rate.~It is important to recognize that some oral anti-diabetic drugs, e.g. sulfonylurea's are associated with an increase in systemic arterial blood pressure.~Hypothesis~That treatment of type 2 diabetes mellitus with dapagliflozin will result in a decrease in arterial stiffness~Primary Objectives~The primary objective of the study is to determine the effect of dapagliflozin (Appendix A), 10 mg daily, on parameters of arterial stiffness: aPWV, augmentation index (AI), 24-hour blood pressure patterns, SBP, and pulse pressure.~Key Questions~What effect will dapagliflozin have on measures of arterial stiffness?~What effect will dapagliflozin have on central blood pressure?~Will dapagliflozin lower BP over the 24-hour period and will the pattern of BP change?~Will dapagliflozin increase sodium excretion for 16 weeks?~What will be the effect of dapagliflozin on intravascular volume status at 16 weeks?~Secondary Objectives~Urinary sodium excretion~Intravascular volume status: jugular venous pressure, body weight, orthostatic change in BP and pulse rate~Treatment~All patients will receive a background treatment with metformin. After randomization (2:1) patients will receive dapagliflozin, 10 mg daily or glimpiride (Appendix B), 4 mg daily. The treatment period will last ;16 weeks.~For high risk subjects, dapagliflozin therapy will begin with 5 mg with up-titration at 2 weeks. High risk subjects are those prone to volume depletion and are identified by signs of hypovolemia, e.g. low venous pressure, and a low arteriasl blood pressure.~Subjects will also be closely monitored for the development of hypoglycemia. This risk will be minimized by not enrolling subjects taking insulin. Subjects will be made aware of the signs of hypotlycemia, e.g. sweating and palpitation, and will be instructed to treat with ingestion of sugar, particularly fructose in orange juice.
|
Mechanistic Study of the Systolic Blood Pressure Lowering Effect of Dapagliflozin in Type 2 Diabetes
|
Diabetes Mellitus Type 2
|
* Drug: dapagliflozin
* Drug: glimpiride
|
Inclusion Criteria:~Type 2 diabetes mellitus~Metformin treatment~Exclusion Criteria:~• Type 1 diabetes mellitus~Hgb A1c > 9~Advanced diabetic complications, e.g. diabetic renal disease (eGFR < 60 cc/min), heavy proteinuria, diabetic retinopathy, autonomic neuropathy~Pregnancy or unwilling to practice contraception.~Uncontrolled hypertension (SBP > 150 mm Hg; DBP > 100 mm Hg)~Chronic substance abusers~Carcinoma of the urinary bladder~Subjects deemed at risk for dehydration
|
21 Years
| null |
All
|
No
|
Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double
|
| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| systolic blood pressure by ambulatory blood pressure monitoring (ABPM) | | 16 weeks |
| arterial stiffness | arterial stiffness will be assessed by measuring aortic pulse wave velocity (aPWV) and augmentation index | 16 weeks |
|
| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| urinary sodium excretion | | 16 weeks |
| composite intravascular volume status | jugular venous pressure, body weight, orthostatic change in BP and pulse rate | 16 weeks |
|
Hypoglycemic Agents, Dapagliflozin, Sodium-Glucose Transporter 2 Inhibitors, Molecular Mechanisms of Pharmacological Action, Physiological Effects of Drugs
|
| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: dapagliflozin 10 mg daily<br>dapagliflozin, 10 mg daily for 16 weeks | Drug: dapagliflozin<br>* subjects will be randomly assigned to receive dapagliflozin 10 mg daily<br>* Other names: Farxiga;|
| Active Comparator: glimpiride<br>glimpiride 4 mg daily for 16 weeks | Drug: glimpiride<br>* subjects will be randomly assigned to receive glimpiride 4 mg daily<br>* Other names: Amaryl;|
|
Mechanistic Study of the Systolic Blood Pressure Lowering Effect of Dapagliflozin in Type 2 Diabetes
Study Overview
=================
Brief Summary
-----------------
Dapagliflozin has been shown to lower clinic systolic and diastolic blood pressure in patients with type 2 diabetes mellitus. The exact mechanism(s) by which dapagliflozin lowers clinic SBP is unknown. The primary objective of the study is to determine the effect of dapagliflozin , 10 mg daily, on parameters of arterial stiffness: aPWV, augmentation index (AI), 24-hour blood pressure patterns, SBP, and pulse pressure. Urinary sodium excretion, and Intravascular volume status will be recorded. The study will involve 21 subjects for a duration of 16 weeks.
Detailed Description
-----------------
Dapagliflozin has been shown to lower clinic systolic and diastolic blood pressure in patients with type 2 diabetes mellitus. In particular, the reduction in SBP is impressive. The effect on circadian patterns of blood pressure measured by ambulatory blood pressure monitoring has not been established. The exact mechanism(s) by which dapagliflozin lowers clinic SBP is not clear although there has been speculation that it is due to a decrease in intravascular volume secondary to the osmotic diuresis produced by the drug. However, SBP is dependent on both pulse volume and vascular stiffness (impedance to ejection). Dapagliflozin may have a favorable effect on vascular stiffness by a reduction in blood glucose resulting in decreased proximal arterial collagen cross-linking due to non-enzymatic glycosylation of proteins. Dapagliflozin may also have a favorable effect on vascular stiffness by increasing urinary sodium excretion. Dapagliflozin is a sodium/glucose co-transporter inhibitor and the effects on sodium excretion are not clear. Increased sodium intake is associated with an increase in vascular stiffness. An increase in vascular stiffness has been correlated with increased cardiovascular morbidity and mortality. Thus, it is important to know if dapagliflozin has an effect on vascular stiffness. The current gold standard for vascular stiffness is aortic pulse wave velocity (aPWV). Other measures of vascular stiffness include: systolic blood pressure, pulse pressure and augmentation index. Also, measurement of calculated central blood pressure provides information that may not be apparent from measurement of brachial blood pressure. Measures of intravascular volume status include: body weight, jugular venous pressure, orthostatic changes in blood pressure and heart rate. It is important to recognize that some oral anti-diabetic drugs, e.g. sulfonylurea's are associated with an increase in systemic arterial blood pressure. Hypothesis That treatment of type 2 diabetes mellitus with dapagliflozin will result in a decrease in arterial stiffness Primary Objectives The primary objective of the study is to determine the effect of dapagliflozin (Appendix A), 10 mg daily, on parameters of arterial stiffness: aPWV, augmentation index (AI), 24-hour blood pressure patterns, SBP, and pulse pressure. Key Questions What effect will dapagliflozin have on measures of arterial stiffness? What effect will dapagliflozin have on central blood pressure? Will dapagliflozin lower BP over the 24-hour period and will the pattern of BP change? Will dapagliflozin increase sodium excretion for 16 weeks? What will be the effect of dapagliflozin on intravascular volume status at 16 weeks? Secondary Objectives Urinary sodium excretion Intravascular volume status: jugular venous pressure, body weight, orthostatic change in BP and pulse rate Treatment All patients will receive a background treatment with metformin. After randomization (2:1) patients will receive dapagliflozin, 10 mg daily or glimpiride (Appendix B), 4 mg daily. The treatment period will last ;16 weeks. For high risk subjects, dapagliflozin therapy will begin with 5 mg with up-titration at 2 weeks. High risk subjects are those prone to volume depletion and are identified by signs of hypovolemia, e.g. low venous pressure, and a low arteriasl blood pressure. Subjects will also be closely monitored for the development of hypoglycemia. This risk will be minimized by not enrolling subjects taking insulin. Subjects will be made aware of the signs of hypotlycemia, e.g. sweating and palpitation, and will be instructed to treat with ingestion of sugar, particularly fructose in orange juice.
Official Title
-----------------
Mechanistic Study of the Systolic Blood Pressure Lowering Effect of Dapagliflozin in Type 2 Diabetes
Conditions
-----------------
Diabetes Mellitus Type 2
Intervention / Treatment
-----------------
* Drug: dapagliflozin
* Drug: glimpiride
Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Type 2 diabetes mellitus Metformin treatment Exclusion Criteria: • Type 1 diabetes mellitus Hgb A1c > 9 Advanced diabetic complications, e.g. diabetic renal disease (eGFR < 60 cc/min), heavy proteinuria, diabetic retinopathy, autonomic neuropathy Pregnancy or unwilling to practice contraception. Uncontrolled hypertension (SBP > 150 mm Hg; DBP > 100 mm Hg) Chronic substance abusers Carcinoma of the urinary bladder Subjects deemed at risk for dehydration
Ages Eligible for Study
-----------------
Minimum Age: 21 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: dapagliflozin 10 mg daily<br>dapagliflozin, 10 mg daily for 16 weeks | Drug: dapagliflozin<br>* subjects will be randomly assigned to receive dapagliflozin 10 mg daily<br>* Other names: Farxiga;|
| Active Comparator: glimpiride<br>glimpiride 4 mg daily for 16 weeks | Drug: glimpiride<br>* subjects will be randomly assigned to receive glimpiride 4 mg daily<br>* Other names: Amaryl;|
What is the study measuring?
-----------------
Primary Outcome Measures
| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| systolic blood pressure by ambulatory blood pressure monitoring (ABPM) | | 16 weeks |
| arterial stiffness | arterial stiffness will be assessed by measuring aortic pulse wave velocity (aPWV) and augmentation index | 16 weeks |
Secondary Outcome Measures
| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| urinary sodium excretion | | 16 weeks |
| composite intravascular volume status | jugular venous pressure, body weight, orthostatic change in BP and pulse rate | 16 weeks |
|
|
NCT05436119
|
Select Nutrient and Gene Variant Analysis in a Targeted Diet and Lifestyle Intervention Reduces Preterm Birth
|
Preterm birth (PTB) rates in the US are among the highest in wealthy nations across the globe, and they are particularly high in our most socio-economically disadvantaged populations. PTB increases lifelong morbidity and mortality at significant economic cost. In addition to neonates born too early, small for gestational infants predict the greatest risk for chronic disease in the neonate (F1 generation) through adulthood. Single lifestyle, nutrient, or medical interventions intended to reduce PTB have produced mixed results, but combined micronutrient interventions appear more successful. The investigators experienced a reduced preterm birth rate and combined preeclampsia, gestational diabetes and small for gestational age rate in a 50% Medicaid population by providing targeted micro/macronutrient, genomic and lifestyle evaluation with personalized intervention in a trimester-by-trimester group educational setting (1). The model requires validation in more diverse populations.~This study will be applied in a 100% Medicaid population with greater ethnic diversity. Participation will be voluntary, offered to all pregnant participants enrolling at 18 weeks gestation or earlier with the comparator group being those participants who decline the intervention. The study population will receive targeted biomarker evaluation including serum 25-OH D, zinc and carnitine levels, dried blood spot omega 3 fatty acids and select gene variant analysis. Virtual group nutrition and lifestyle education visits conducted by the nutritionist cluster participants in the same trimester allowing for personalization of the nutrition and lifestyle plan based on the data collected and adapted to the specific needs of the trimester. Each study participant will receive individualized nutrient supplementation and probiotic supplementation. Anticipated performance improvement endpoints are significant reduction of preterm birth and combined incidence of preeclampsia, gestational diabetes, small for gestational age, neonatal morbidities and related health care expenses. The investigators will explore gene variants' role in directing nutrition, lifestyle and toxic exposure interventions and in predicting adverse maternal and neonatal outcomes.
|
Hypothesis:~• Diet and lifestyle education with diet and lifestyle modification will significantly decrease the incidence of preterm birth (PTB).~Secondary Hypothesis:~• Diet and lifestyle education and modification refined by limited genomics and nutrient biomarkers will significantly decrease the incidence of preeclampsia (preE), gestational diabetes mellitus (GDM), small for gestational age (SGA) and large for gestational age (LGA) neonates, and neonatal hospitalizations within the first 2 weeks of life.~Exploratory Hypotheses:~A gene variant pattern will emerge that predicts PTB.~A gene variant pattern will emerge that predicts preE, GDM, SGA, and LGA.~Goals:~Ascertain PTB rates for both intervention and non-intervention groups.~Ascertain preE, GDM, SGA, LGA, and neonatal hospitalization rates for both groups.~Correlate diet and lifestyle education and modification refined by limited genomics and micronutrient biomarkers with reduced primary and secondary outcomes.~Reduce related net healthcare costs.~Methods:~• Prospective longitudinal observational cohort with nested case-control study.~Relevance:~Determine whether diet and lifestyle education and modification refined by trimester and by limited genomics and micronutrient biomarkers applied to a 100% Medicaid population is associated with reduced rates of PTB, preE, GDM, SGA, LGA, and neonatal hospitalizations.~Determine whether the reduction in pregnancy and neonatal morbidities is associated with a reduction in related net health care costs.~Explore predictive capability of limited genomics panel in a 100% Medicaid population.
|
Select Nutrient and Gene Variant Analysis in a Targeted Diet and Lifestyle Intervention Reduces Preterm Birth (SNGLI-PTB)
|
Premature Birth, Pre-Eclampsia, Small for Gestational Age Infant
|
* Dietary Supplement: GrowBaby
|
Inclusion Criteria:~pregnant~gestational age < 19 weeks at time of enrollment~Health care coverage through Molina Health of Nevada MCO~Residing in the state of Nevada~Signed consent~Exclusion Criteria:~Not pregnant~Gestational age > 19 weeks at time of enrollment~Health care coverage not through Molina~Living outside the state of Nevada~No signed consent or unable to give informed consent
| null | null |
Female
| null |
| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Preterm Birth < 37 weeks EGA | Evaluating the percentage of preterm birth in each group, further divided by delivery < 28 weeks, 28 to <= 32 weeks, 32 to <= 36 weeks, and 36 to <= 37 weeks. | At conclusion of pregnancy |
|
| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Preeclampsia | Evaluating the percentage of preeclampsia, condition defined by ACOG standards | At conclusion of pregnancy |
| Gestational diabetes mellitus(GDM) | Evaluating the percentage of GDM in each group, condition defined by ACOG standards | At conclusion of pregnancy |
| Small for gestational age infant (SGA) | Evaluating the percentage of SGA in each group, condition defined by APP standards. | At conclusion of pregnancy |
| Large for gestational age infant (LGA) | Evaluating the percentage of LGA in each group, condition defined by APP standards. | At conclusion of pregnancy |
| Neonatal hospitalization within 2 weeks of delivery | Evaluating the percentage of neonatal hospitalization within 2 weeks of delivery in each group | 8 weeks postpartum |
|
Nutrition, Lifestyle, Probiotics, Gene variants, Medicaid
|
Premature Birth, Eclampsia, Pre-Eclampsia, Obstetric Labor, Premature, Obstetric Labor Complications, Pregnancy Complications, Female Urogenital Diseases and Pregnancy Complications, Urogenital Diseases, Hypertension, Pregnancy-Induced
|
| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| GrowBaby<br>All pregnant women presenting at < 19 weeks EGA for prenatal care covered by Molina Health of Nevada MCO will be offered the GrowBaby group nutrition and lifestyle program. Primary and secondary outcomes of those who opt out of the program will be compared to those who opt in. Additionally, all women who develop primary or secondary outcomes in the GrowBaby arm will be compared to those who do not develop primary or secondary outcomes (nested case-control). Outcomes will be compared locally, regionally and nationally within the Medicaid population, as well. | Dietary Supplement: GrowBaby<br>* Virtual group educational visits will cluster women in the same trimester of pregnancy teaching trimester-specific diet and lifestyle modification, further customized to the individual using limited micronutrient and gene variant analysis. Each woman will receive base multi-nutrient and probiotic supplementation with customization if identified needs cannot be met with diet and lifestyle modification alone.<br>* Other names: Behavioral;|
|
Select Nutrient and Gene Variant Analysis in a Targeted Diet and Lifestyle Intervention Reduces Preterm Birth
Study Overview
=================
Brief Summary
-----------------
Preterm birth (PTB) rates in the US are among the highest in wealthy nations across the globe, and they are particularly high in our most socio-economically disadvantaged populations. PTB increases lifelong morbidity and mortality at significant economic cost. In addition to neonates born too early, small for gestational infants predict the greatest risk for chronic disease in the neonate (F1 generation) through adulthood. Single lifestyle, nutrient, or medical interventions intended to reduce PTB have produced mixed results, but combined micronutrient interventions appear more successful. The investigators experienced a reduced preterm birth rate and combined preeclampsia, gestational diabetes and small for gestational age rate in a 50% Medicaid population by providing targeted micro/macronutrient, genomic and lifestyle evaluation with personalized intervention in a trimester-by-trimester group educational setting (1). The model requires validation in more diverse populations. This study will be applied in a 100% Medicaid population with greater ethnic diversity. Participation will be voluntary, offered to all pregnant participants enrolling at 18 weeks gestation or earlier with the comparator group being those participants who decline the intervention. The study population will receive targeted biomarker evaluation including serum 25-OH D, zinc and carnitine levels, dried blood spot omega 3 fatty acids and select gene variant analysis. Virtual group nutrition and lifestyle education visits conducted by the nutritionist cluster participants in the same trimester allowing for personalization of the nutrition and lifestyle plan based on the data collected and adapted to the specific needs of the trimester. Each study participant will receive individualized nutrient supplementation and probiotic supplementation. Anticipated performance improvement endpoints are significant reduction of preterm birth and combined incidence of preeclampsia, gestational diabetes, small for gestational age, neonatal morbidities and related health care expenses. The investigators will explore gene variants' role in directing nutrition, lifestyle and toxic exposure interventions and in predicting adverse maternal and neonatal outcomes.
Detailed Description
-----------------
Hypothesis: • Diet and lifestyle education with diet and lifestyle modification will significantly decrease the incidence of preterm birth (PTB). Secondary Hypothesis: • Diet and lifestyle education and modification refined by limited genomics and nutrient biomarkers will significantly decrease the incidence of preeclampsia (preE), gestational diabetes mellitus (GDM), small for gestational age (SGA) and large for gestational age (LGA) neonates, and neonatal hospitalizations within the first 2 weeks of life. Exploratory Hypotheses: A gene variant pattern will emerge that predicts PTB. A gene variant pattern will emerge that predicts preE, GDM, SGA, and LGA. Goals: Ascertain PTB rates for both intervention and non-intervention groups. Ascertain preE, GDM, SGA, LGA, and neonatal hospitalization rates for both groups. Correlate diet and lifestyle education and modification refined by limited genomics and micronutrient biomarkers with reduced primary and secondary outcomes. Reduce related net healthcare costs. Methods: • Prospective longitudinal observational cohort with nested case-control study. Relevance: Determine whether diet and lifestyle education and modification refined by trimester and by limited genomics and micronutrient biomarkers applied to a 100% Medicaid population is associated with reduced rates of PTB, preE, GDM, SGA, LGA, and neonatal hospitalizations. Determine whether the reduction in pregnancy and neonatal morbidities is associated with a reduction in related net health care costs. Explore predictive capability of limited genomics panel in a 100% Medicaid population.
Official Title
-----------------
Select Nutrient and Gene Variant Analysis in a Targeted Diet and Lifestyle Intervention Reduces Preterm Birth (SNGLI-PTB)
Conditions
-----------------
Premature Birth, Pre-Eclampsia, Small for Gestational Age Infant
Intervention / Treatment
-----------------
* Dietary Supplement: GrowBaby
Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: pregnant gestational age < 19 weeks at time of enrollment Health care coverage through Molina Health of Nevada MCO Residing in the state of Nevada Signed consent Exclusion Criteria: Not pregnant Gestational age > 19 weeks at time of enrollment Health care coverage not through Molina Living outside the state of Nevada No signed consent or unable to give informed consent
Sexes Eligible for Study
-----------------
Female
Study Plan
=================
How is the study designed?
-----------------
Arms and Interventions
| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| GrowBaby<br>All pregnant women presenting at < 19 weeks EGA for prenatal care covered by Molina Health of Nevada MCO will be offered the GrowBaby group nutrition and lifestyle program. Primary and secondary outcomes of those who opt out of the program will be compared to those who opt in. Additionally, all women who develop primary or secondary outcomes in the GrowBaby arm will be compared to those who do not develop primary or secondary outcomes (nested case-control). Outcomes will be compared locally, regionally and nationally within the Medicaid population, as well. | Dietary Supplement: GrowBaby<br>* Virtual group educational visits will cluster women in the same trimester of pregnancy teaching trimester-specific diet and lifestyle modification, further customized to the individual using limited micronutrient and gene variant analysis. Each woman will receive base multi-nutrient and probiotic supplementation with customization if identified needs cannot be met with diet and lifestyle modification alone.<br>* Other names: Behavioral;|
What is the study measuring?
-----------------
Primary Outcome Measures
| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Preterm Birth < 37 weeks EGA | Evaluating the percentage of preterm birth in each group, further divided by delivery < 28 weeks, 28 to <= 32 weeks, 32 to <= 36 weeks, and 36 to <= 37 weeks. | At conclusion of pregnancy |
Secondary Outcome Measures
| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Preeclampsia | Evaluating the percentage of preeclampsia, condition defined by ACOG standards | At conclusion of pregnancy |
| Gestational diabetes mellitus(GDM) | Evaluating the percentage of GDM in each group, condition defined by ACOG standards | At conclusion of pregnancy |
| Small for gestational age infant (SGA) | Evaluating the percentage of SGA in each group, condition defined by APP standards. | At conclusion of pregnancy |
| Large for gestational age infant (LGA) | Evaluating the percentage of LGA in each group, condition defined by APP standards. | At conclusion of pregnancy |
| Neonatal hospitalization within 2 weeks of delivery | Evaluating the percentage of neonatal hospitalization within 2 weeks of delivery in each group | 8 weeks postpartum |
Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Nutrition, Lifestyle, Probiotics, Gene variants, Medicaid
|
|
NCT04552015
|
Microneedles for Diagnosis of LTBI
|
This study will evaluate new technique, microneedle, to detect latent tuberculosis (TB) in healthy volunteers
|
The cross-sectional study to investigate the effect of microneedle formulations and lengths of Tuberculin PPD microneedles on the delayed-type hypersensitivity response in healthy volunteers.
|
Pilot Study for Development of Microneedles for Diagnosis of Latent Tuberculosis Infection
|
Latent Tuberculosis
|
* Diagnostic Test: TST vs PPD microneedle test
|
Inclusion Criteria:~Sex : Male and Female~Age : 20-60 years~TB contacts or those at risk of TB e.g. health-care workers~HIV-negative healthy individuals~Exclusion Criteria:~Presence of an acute infection, as determined by investigators~Receiving immunosuppression drugs e.g. steroids~Having autoimmune diseases e.g. SLE (Systemic Lupus Erythematous)~Being pregnant or breastfeeding
|
20 Years
|
60 Years
|
All
|
Accepts Healthy Volunteers
|
Primary Purpose: Diagnostic
Intervention Model: Single Group Assignment
Masking: None (Open Label)
|
| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| size of induration at 48 hours post-PPD injection | Monitoring the response of delayed-type hypersensitivity on the skin by comparing TST to microneedle tests | 48 hours |
|
Tuberculosis, Latent Tuberculosis, Mycobacterium Infections, Actinomycetales Infections, Gram-Positive Bacterial Infections, Bacterial Infections, Bacterial Infections and Mycoses, Infections, Latent Infection
|
| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Other: volunteers<br>two different types of diagnostic tools (TST vs microneedle) will be used to screen for latent TB infection | Diagnostic Test: TST vs PPD microneedle test<br>* TST vs First patch: 800 um in length, PPD1 formulation; Second patch: 1,500 um in length, PPD1 formulation; Third patch: 800 um in length, PPD2 formulation; and Fourth patch: 1,500 um in length, PPD2 formulation<br>|
|
Microneedles for Diagnosis of LTBI
Study Overview
=================
Brief Summary
-----------------
This study will evaluate new technique, microneedle, to detect latent tuberculosis (TB) in healthy volunteers
Detailed Description
-----------------
The cross-sectional study to investigate the effect of microneedle formulations and lengths of Tuberculin PPD microneedles on the delayed-type hypersensitivity response in healthy volunteers.
Official Title
-----------------
Pilot Study for Development of Microneedles for Diagnosis of Latent Tuberculosis Infection
Conditions
-----------------
Latent Tuberculosis
Intervention / Treatment
-----------------
* Diagnostic Test: TST vs PPD microneedle test
Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Sex : Male and Female Age : 20-60 years TB contacts or those at risk of TB e.g. health-care workers HIV-negative healthy individuals Exclusion Criteria: Presence of an acute infection, as determined by investigators Receiving immunosuppression drugs e.g. steroids Having autoimmune diseases e.g. SLE (Systemic Lupus Erythematous) Being pregnant or breastfeeding
Ages Eligible for Study
-----------------
Minimum Age: 20 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: Diagnostic
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Arms and Interventions
| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Other: volunteers<br>two different types of diagnostic tools (TST vs microneedle) will be used to screen for latent TB infection | Diagnostic Test: TST vs PPD microneedle test<br>* TST vs First patch: 800 um in length, PPD1 formulation; Second patch: 1,500 um in length, PPD1 formulation; Third patch: 800 um in length, PPD2 formulation; and Fourth patch: 1,500 um in length, PPD2 formulation<br>|
What is the study measuring?
-----------------
Primary Outcome Measures
| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| size of induration at 48 hours post-PPD injection | Monitoring the response of delayed-type hypersensitivity on the skin by comparing TST to microneedle tests | 48 hours |
|
||
NCT04925401
|
Evaluation of Knowledge About Fever After Consultation in the Pediatric Emergency Department
|
The purpose of this study is to evaluate the effect of an information brochure on parent / legal guardians' knowledge of what to do about their child's febrile episode after a pediatric emergency department visit.~Single-center randomized controlled trial.
|
Fever is a common symptom of viral or bacterial infection in pediatrics. Previous studies using both qualitative and quantitative methods have established that intervention with parents/legal guardians on fever management decreases their worry and anxiety related to their child's occurrence of a febrile episode, limits unwise use of antipyretic medication (Walsh, 2006; Walsh, 2008; Peetom, 2017), but also reduces the use of emergency room or telephone medical consultations (Peetom, 2017).~The majority of visits for febrile conditions in children over 3 months of age are avoidable and do not require emergency and/or hospital care. Mistaken beliefs and lack of knowledge about what to do in the event of a febrile episode lead parents to consult a hospital emergency room for their child, which can have an impact on emergency room overcrowding.~The proportion of emergency room visits for febrile conditions assessed by the Intake and Referral Nurse (IOR) as not requiring urgent care raises questions about parents'/legal guardians' knowledge of fever, its monitoring, and what to do during a febrile episode.~The aim of our study is to evaluate parents' knowledge of fever and the appropriate course of action during a febrile episode in a pediatric emergency department of a Parisian university hospital by comparing standard management practices with the knowledge provided by an information brochure.
|
Evaluation of Knowledge About Fever After Consultation in the Pediatric Emergency Department: Standard Consultation Versus Standard Consultation With Distribution of an Information Leaflet About Fever in Pre-consultation
|
Febrile Illness, Fever, Stress
|
* Behavioral: The Information brochure will be created on the basis of information given by the French pediatric network Courlygone and the French National Authority for Health.
|
Inclusion Criteria:~Be of legal age~Be the parent/legal guardian of a child aged between 3 months and 15 years,~A child with a fever > 38°celsus on arrival at the emergency room (measured by electronic thermometer rectally for children under 2 years of age or axillary/oral for children over 2 years of age),~Severity of care rating by the IOA grade 4 (non-emergency care)~Parent affiliated to a social security system or entitled to it~Parent under AME French social security system~Parent informed and having signed the consent~Exclusion Criteria~Parent/legal guardian who does not speak or read French,~Child with a pathology that does not allow for rectal temperature taking~Parent/legal guardian with a visual impairment that prevents reading the information note and/or the information brochure.~Parent / legal guardian under guardianship
|
18 Years
| null |
All
|
No
|
Primary Purpose: Prevention
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single
|
| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Number of participants with correct answer to question about management of a paediatric febrile episode. | Number of correct answers to question n°7 (what to do during a febrile episode) of the questionnaire | 1 day |
|
| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Number of participants with correct answer to question n°1 about knowledge about paediatric febrile episode | Answer to question n°1, 2, 3, 4, 5, 6, 8, 9 & 10. Number of participants with correct answers, between the two arms | 1 day |
| Number of participants with correct answer to question n°2 about knowledge's about paediatric febrile episode | Answer to question n° 2. Number of participants with correct answers, between the two arms. Factors associated with a high number of correct responses: age of child, age of legal guardian, socio-professional category, child's place in sibling group, child's medical follow-up. | 1 day |
| Number of participants with correct answer to question n°3 about knowledge's about paediatric febrile episode | Answer to question n° 3. Number of participants with correct answers, between the two arms. | 1 day |
| Number of participants with correct answer to question n°4 about knowledge's about paediatric febrile episode | Answer to question n° 4. Number of participants with correct answers, between the two arms. | 1 day |
| Number of participants with correct answer to question n°5 about knowledge's about paediatric febrile episode | Answer to question n° 5. Number of participants with correct answers, between the two arms. | 1 day |
| Number of participants with correct answer to question n°6 about knowledge's about paediatric febrile episode | Answer to question n° 6. Number of participants with correct answers, between the two arms. | 1 day |
| Number of participants with correct answer to question n°8 about knowledge's about paediatric febrile episode | Answer to question n° 8. Number of participants with correct answers, between the two arms. | 1 day |
| Number of participants with correct answer to question n°9 about knowledge's about paediatric febrile episode | Answer to question n° 9. Number of participants with correct answers, between the two arms. | 1 day |
| Number of participants with correct answer to question n°10 about knowledge's about paediatric febrile episode | Answer to question n° 10. Number of participants with correct answers, between the two arms. | 1 day |
|
Febrile episode, pediatric, pediatric emergency department, therapeutic education
|
Emergencies, Fever, Disease Attributes, Pathologic Processes, Body Temperature Changes
|
| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Information brochure Arm<br>The experimental group will receive an information brochure on fever in children and how to deal with a febrile episode and usual medical management. | Behavioral: The Information brochure will be created on the basis of information given by the French pediatric network Courlygone and the French National Authority for Health.<br>* An information brochure on fever in children and how to deal with a paediatric febrile episode and usual medical management.<br>|
| No Intervention: Habitual care<br>The control group will receive the usual medical management | |
|
Evaluation of Knowledge About Fever After Consultation in the Pediatric Emergency Department
Study Overview
=================
Brief Summary
-----------------
The purpose of this study is to evaluate the effect of an information brochure on parent / legal guardians' knowledge of what to do about their child's febrile episode after a pediatric emergency department visit. Single-center randomized controlled trial.
Detailed Description
-----------------
Fever is a common symptom of viral or bacterial infection in pediatrics. Previous studies using both qualitative and quantitative methods have established that intervention with parents/legal guardians on fever management decreases their worry and anxiety related to their child's occurrence of a febrile episode, limits unwise use of antipyretic medication (Walsh, 2006; Walsh, 2008; Peetom, 2017), but also reduces the use of emergency room or telephone medical consultations (Peetom, 2017). The majority of visits for febrile conditions in children over 3 months of age are avoidable and do not require emergency and/or hospital care. Mistaken beliefs and lack of knowledge about what to do in the event of a febrile episode lead parents to consult a hospital emergency room for their child, which can have an impact on emergency room overcrowding. The proportion of emergency room visits for febrile conditions assessed by the Intake and Referral Nurse (IOR) as not requiring urgent care raises questions about parents'/legal guardians' knowledge of fever, its monitoring, and what to do during a febrile episode. The aim of our study is to evaluate parents' knowledge of fever and the appropriate course of action during a febrile episode in a pediatric emergency department of a Parisian university hospital by comparing standard management practices with the knowledge provided by an information brochure.
Official Title
-----------------
Evaluation of Knowledge About Fever After Consultation in the Pediatric Emergency Department: Standard Consultation Versus Standard Consultation With Distribution of an Information Leaflet About Fever in Pre-consultation
Conditions
-----------------
Febrile Illness, Fever, Stress
Intervention / Treatment
-----------------
* Behavioral: The Information brochure will be created on the basis of information given by the French pediatric network Courlygone and the French National Authority for Health.
Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Be of legal age Be the parent/legal guardian of a child aged between 3 months and 15 years, A child with a fever > 38°celsus on arrival at the emergency room (measured by electronic thermometer rectally for children under 2 years of age or axillary/oral for children over 2 years of age), Severity of care rating by the IOA grade 4 (non-emergency care) Parent affiliated to a social security system or entitled to it Parent under AME French social security system Parent informed and having signed the consent Exclusion Criteria Parent/legal guardian who does not speak or read French, Child with a pathology that does not allow for rectal temperature taking Parent/legal guardian with a visual impairment that prevents reading the information note and/or the information brochure. Parent / legal guardian under guardianship
Ages Eligible for Study
-----------------
Minimum Age: 18 Years
Sexes Eligible for Study
-----------------
All
Accepts Healthy Volunteers
-----------------
No
Study Plan
=================
How is the study designed?
-----------------
Design Details
Primary Purpose: Prevention
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single
Arms and Interventions
| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Information brochure Arm<br>The experimental group will receive an information brochure on fever in children and how to deal with a febrile episode and usual medical management. | Behavioral: The Information brochure will be created on the basis of information given by the French pediatric network Courlygone and the French National Authority for Health.<br>* An information brochure on fever in children and how to deal with a paediatric febrile episode and usual medical management.<br>|
| No Intervention: Habitual care<br>The control group will receive the usual medical management | |
What is the study measuring?
-----------------
Primary Outcome Measures
| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Number of participants with correct answer to question about management of a paediatric febrile episode. | Number of correct answers to question n°7 (what to do during a febrile episode) of the questionnaire | 1 day |
Secondary Outcome Measures
| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Number of participants with correct answer to question n°1 about knowledge about paediatric febrile episode | Answer to question n°1, 2, 3, 4, 5, 6, 8, 9 & 10. Number of participants with correct answers, between the two arms | 1 day |
| Number of participants with correct answer to question n°2 about knowledge's about paediatric febrile episode | Answer to question n° 2. Number of participants with correct answers, between the two arms. Factors associated with a high number of correct responses: age of child, age of legal guardian, socio-professional category, child's place in sibling group, child's medical follow-up. | 1 day |
| Number of participants with correct answer to question n°3 about knowledge's about paediatric febrile episode | Answer to question n° 3. Number of participants with correct answers, between the two arms. | 1 day |
| Number of participants with correct answer to question n°4 about knowledge's about paediatric febrile episode | Answer to question n° 4. Number of participants with correct answers, between the two arms. | 1 day |
| Number of participants with correct answer to question n°5 about knowledge's about paediatric febrile episode | Answer to question n° 5. Number of participants with correct answers, between the two arms. | 1 day |
| Number of participants with correct answer to question n°6 about knowledge's about paediatric febrile episode | Answer to question n° 6. Number of participants with correct answers, between the two arms. | 1 day |
| Number of participants with correct answer to question n°8 about knowledge's about paediatric febrile episode | Answer to question n° 8. Number of participants with correct answers, between the two arms. | 1 day |
| Number of participants with correct answer to question n°9 about knowledge's about paediatric febrile episode | Answer to question n° 9. Number of participants with correct answers, between the two arms. | 1 day |
| Number of participants with correct answer to question n°10 about knowledge's about paediatric febrile episode | Answer to question n° 10. Number of participants with correct answers, between the two arms. | 1 day |
Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Febrile episode, pediatric, pediatric emergency department, therapeutic education
|
NCT00002454
|
Papilloma Virus Vaccine Therapy in Treating Young Patients With Recurrent Papilloma of the Larynx
|
RATIONALE: Vaccines made from papilloma virus cells may make the body build an immune response to and kill papilloma cells.~PURPOSE: Phase II trial to study the effectiveness of papilloma virus vaccine in treating young patients with recurrent papilloma of the larynx.
|
OBJECTIVES: I. Determine the immune response in patients with juvenile papilloma of the larynx treated with autogenous vaccine derived from each patient's own tumor.~OUTLINE: Patients receive autogenous papilloma vaccine intradermally and subcutaneously weekly for 20 weeks.~PROJECTED ACCRUAL: Not specified
|
Phase II Study of Immunotherapy With Autogenous Papilloma Vaccine in Patients With Recurrent Juvenile Papilloma of the Larynx
|
Precancerous Condition
|
* Biological: autologous tumor cell vaccine
|
DISEASE CHARACTERISTICS: Diagnosis of severe recurrent juvenile papilloma of the larynx requiring surgery at least 4 times per year Condition must have existed for more than 1 year~PATIENT CHARACTERISTICS: Age: 1 and over Performance status: Not specified Life expectancy: Not specified Hematopoietic: Not specified Hepatic: Not specified Renal: Not specified~PRIOR CONCURRENT THERAPY: See Disease Characteristics
|
1 Year
| null |
All
|
No
|
Primary Purpose: Treatment
|
| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
|
lung papilloma
|
Papilloma, Precancerous Conditions, Neoplasms, Squamous Cell, Neoplasms, Glandular and Epithelial, Neoplasms by Histologic Type, Neoplasms
|
| Intervention/Treatment |
| --- |
|Biological: autologous tumor cell vaccine|nan|
|
Papilloma Virus Vaccine Therapy in Treating Young Patients With Recurrent Papilloma of the Larynx
Study Overview
=================
Brief Summary
-----------------
RATIONALE: Vaccines made from papilloma virus cells may make the body build an immune response to and kill papilloma cells. PURPOSE: Phase II trial to study the effectiveness of papilloma virus vaccine in treating young patients with recurrent papilloma of the larynx.
Detailed Description
-----------------
OBJECTIVES: I. Determine the immune response in patients with juvenile papilloma of the larynx treated with autogenous vaccine derived from each patient's own tumor. OUTLINE: Patients receive autogenous papilloma vaccine intradermally and subcutaneously weekly for 20 weeks. PROJECTED ACCRUAL: Not specified
Official Title
-----------------
Phase II Study of Immunotherapy With Autogenous Papilloma Vaccine in Patients With Recurrent Juvenile Papilloma of the Larynx
Conditions
-----------------
Precancerous Condition
Intervention / Treatment
-----------------
* Biological: autologous tumor cell vaccine
Participation Criteria
=================
Eligibility Criteria
-----------------
DISEASE CHARACTERISTICS: Diagnosis of severe recurrent juvenile papilloma of the larynx requiring surgery at least 4 times per year Condition must have existed for more than 1 year PATIENT CHARACTERISTICS: Age: 1 and over Performance status: Not specified Life expectancy: Not specified Hematopoietic: Not specified Hepatic: Not specified Renal: Not specified PRIOR CONCURRENT THERAPY: See Disease Characteristics
Ages Eligible for Study
-----------------
Minimum Age: 1 Year
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 |
| --- |
|Biological: autologous tumor cell vaccine|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
-----------------
lung papilloma
|
|
NCT04560673
|
Duloxetine and Neurofeedback Training for the Treatment of Chemotherapy Induced Peripheral Neuropathy
|
This phase II trial investigates how well duloxetine and neurofeedback training work in treating patients with chemotherapy induced peripheral neuropathy. Duloxetine is a type of serotonin and norepinephrine reuptake inhibitor that increases the amount of certain chemicals in the brain that help relieve depression and peripheral neuropathy. Neurofeedback training is a type of therapy that uses an electroencephalograph (EEG) and a computer software program to measure brain wave activity and may help teach patients with peripheral neuropathy (nerve damage) how to change their own brain waves to lower their feelings of neuropathy and help improve their overall quality of life. Giving duloxetine and neurofeedback training may work better in treating peripheral neuropathy caused by chemotherapy compared to duloxetine or neurofeedback training alone.
|
PRIMARY OBJECTIVE:~I. Determine if the combination of duloxetine (DL) and neurofeedback (NFB) is superior to DL or NFB alone in treating chemotherapy induced peripheral neuropathy (CIPN).~SECONDARY OBJECTIVES:~I. Determine the optimal number of neurofeedback sessions needed to result in long-term relief of CIPN in a large cohort of cancer survivors and across socioeconomic groups.~II. Examine baseline brain signatures as a predictor of response to neurofeedback (NFB) and to duloxetine and determine who will require more sessions of NFB to achieve relief of symptoms.~III. Examine if the combination of DL + NFB (than those getting DL or NFB alone) or a larger number of NFB sessions results in better improvements in cancer-related symptoms, physical functioning, and quality of life (QOL).~OUTLINE: Patients are randomized to 1 of 3 groups.~GROUP I: Patients receive neurofeedback training over 1 hour each 3-5 times weekly for up to 5 weeks. Patients also receive duloxetine orally (PO) once daily (QD) for 5 weeks in the absence of unacceptable toxicity.~GROUP II: Patients receive neurofeedback training session over 1 hour 3-5 times weekly for up to 5 weeks.~GROUP III: Patients receive duloxetine PO QD for 5 weeks in the absence of unacceptable toxicity.~After completion of study, patients are followed up at 6 and 12 months.
|
Optimizing Neurofeedback to Treat Chemotherapy Induced Peripheral Neuropathy
|
Chemotherapy-Induced Peripheral Neuropathy, Hematopoietic and Lymphoid Cell Neoplasm, Malignant Solid Neoplasm
|
* Drug: Duloxetine
* Behavioral: Neurofeedback
* Other: Quality-of-Life Assessment
* Other: Questionnaire Administration
|
Inclusion Criteria:~Patients must have the ability to understand and read English, sign a written informed consent, and be willing to follow protocol requirements~Eastern Cooperative Oncology Group (ECOG) performance status of 0-2~Pain score >= 4 on a 0-10 numeric pain scale and/or grade 1-4 neuropathic pain according to the National Cancer Institute's 4 point grading scale~Neuropathic symptoms must be related to chemotherapy (in the opinion of the treating physician)~Patients must have had neuropathic symptoms for a minimum of 3 months~No plans to change pain medication regimen during the course of the study~Off active chemotherapy treatment for minimum of 3 months~Hormonal (e.g., tamoxifen or Arimidex, etc.) and targeted (Tarceva and Avastin, etc.) therapies allowed as long as they will be continued during the course of the study~Willing to come to one of the participating cancer centers for the therapy sessions; or willing to participate in the therapy sessions at their homes and live within a 45 minute drive of the main campuses; or can participate in the therapy sessions from MD Anderson regional care centers~If participants agree to the Remote Training Option, participants should be willing to receive equipment at their homes and to return the equipment to MDA in case of malfunction or completion of the study~If participants agree to the Remote Training Option, participants should be willing to download necessary software to their home computer~If participants agree to the Remote Training Option, participants should be willing to allow research staff remote access to their computer to run the neurofeedback program~Exclusion Criteria:~Patients who are taking any antipsychotic medications~Patients with active central nervous system (CNS) disease, such as clinically-evident metastases or leptomeningeal disease, dementia, or encephalopathy~Patients who have ever been diagnosed with bipolar disorder or schizophrenia~Patients with known, previously diagnosed peripheral neuropathy from causes other than chemotherapy~Patients who have a history of head injury or who have known seizure activity~Patients for whom any contraindications of DL are known~Patients with suicidal ideation~Patients who are already taking duloxetine for peripheral neuropathy
|
18 Years
| null |
All
|
No
|
Primary Purpose: Supportive Care
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
|
| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change in Pain Quality Assessment Scale (PQAS) unpleasantness score | The primary analysis will be a linear model comparing the mean difference in the change of the unpleasantness subscale of the (PQAS)Pain Quality Assessment Scale from baseline to the end of treatment (5 weeks) between the combination arm, the duloxetine (DL), and the neurofeedback (NFB) arm while adjusting for the stratification factor. Pain Quality Assessment Scale (0-10) 0-No pain-10 Most Intense Pain Imaginable. | Baseline 5 up to week 10 |
|
| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change in PQAS unpleasantness score | Will use analysis of covariance (ANCOVA) to evaluate whether chemotherapy induced peripheral neuropathy (CIPN) differs across the three subgroups with 0, 10 or 15 additional sessions of NFB, among the participants from the NFB + DL group who report at least 1-point clinical improvement in CIPN at week 5. The analysis will adjust for the baseline outcome (at week 5), time with CIPN symptoms (minimization factor), and other covariates such as age, sex, cancer stage, time since diagnosis, and cancer type, as appropriate. Pain Quality Assessment Scale (0-10) 0-No pain-10 Most Intense Pain Imaginable. | Baseline 5 up to week 10 |
| Baseline brain signatures as predictors of response to NFB and to DL | Will perform ANCOVA with the change of the unpleasantness subscale from baseline to week 5 (i.e., end of the first 15 sessions of NFB) as the outcome, intervention (NFB, DL or combo), the brain signature (one at a time) and its interaction with intervention as the independent variables of interest. Pain Quality Assessment Scale (0-10) 0-No pain-10 Most Intense Pain Imaginable. | Up to week 5 |
| Evaluation of patients who will require more sessions of NFB to achieve relief of symptoms | Linear mixed model (LMM) analyses will be performed using data measured at end of treatment, months 6 and 12 only on patients who report clinical improvement at week 5. | Up to 12 months post-treatment |
| Change in cancer-related symptoms | ANCOVA and LMM analyses will be performed to evaluate the effect of the number of additional NFB sessions on cancer-related symptoms. | Baseline up to 12 months post-treatment |
| Change in physical functioning | ANCOVA and LMM analyses will be performed to evaluate the effect of the number of additional NFB sessions on physical functioning. | Baseline up to 12 months post-treatment |
| Change in quality of life | ANCOVA and LMM analyses will be performed to evaluate the effect of the number of additional NFB sessions on quality of life. | Baseline up to 12 months post-treatment |
|
Duloxetine Hydrochloride, Serotonin and Noradrenaline Reuptake Inhibitors, Neurotransmitter Uptake Inhibitors, Membrane Transport Modulators, Molecular Mechanisms of Pharmacological Action, Neurotransmitter Agents, Physiological Effects of Drugs, Analgesics, Sensory System Agents, Peripheral Nervous System Agents, Antidepressive Agents, Psychotropic Drugs, Dopamine Agents
|
| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Group I (neurofeedback training, duloxetine)<br>Patients receive neurofeedback training over 1 hour 3-5 times weekly for up to 5 weeks. Patients also receive duloxetine PO QD for 5 weeks in the absence of unacceptable toxicity. | Drug: Duloxetine<br>* Given PO<br>Behavioral: Neurofeedback<br>* Receive neurofeedback training<br>* Other names: EEG biofeedback;Other: Quality-of-Life Assessment<br>* Ancillary studies<br>* Other names: Quality of Life Assessment;Other: Questionnaire Administration<br>* Ancillary studies<br>|
| Experimental: Group II (neurofeedback training)<br>Patients receive neurofeedback training over 1 hour 3-5 times weekly for up to 5 weeks. | Behavioral: Neurofeedback<br>* Receive neurofeedback training<br>* Other names: EEG biofeedback;Other: Quality-of-Life Assessment<br>* Ancillary studies<br>* Other names: Quality of Life Assessment;Other: Questionnaire Administration<br>* Ancillary studies<br>|
| Experimental: Group III (duloxetine)<br>Patients receive duloxetine PO QD for 5 weeks in the absence of unacceptable toxicity. | Drug: Duloxetine<br>* Given PO<br>Other: Quality-of-Life Assessment<br>* Ancillary studies<br>* Other names: Quality of Life Assessment;Other: Questionnaire Administration<br>* Ancillary studies<br>|
|
Duloxetine and Neurofeedback Training for the Treatment of Chemotherapy Induced Peripheral Neuropathy
Study Overview
=================
Brief Summary
-----------------
This phase II trial investigates how well duloxetine and neurofeedback training work in treating patients with chemotherapy induced peripheral neuropathy. Duloxetine is a type of serotonin and norepinephrine reuptake inhibitor that increases the amount of certain chemicals in the brain that help relieve depression and peripheral neuropathy. Neurofeedback training is a type of therapy that uses an electroencephalograph (EEG) and a computer software program to measure brain wave activity and may help teach patients with peripheral neuropathy (nerve damage) how to change their own brain waves to lower their feelings of neuropathy and help improve their overall quality of life. Giving duloxetine and neurofeedback training may work better in treating peripheral neuropathy caused by chemotherapy compared to duloxetine or neurofeedback training alone.
Detailed Description
-----------------
PRIMARY OBJECTIVE: I. Determine if the combination of duloxetine (DL) and neurofeedback (NFB) is superior to DL or NFB alone in treating chemotherapy induced peripheral neuropathy (CIPN). SECONDARY OBJECTIVES: I. Determine the optimal number of neurofeedback sessions needed to result in long-term relief of CIPN in a large cohort of cancer survivors and across socioeconomic groups. II. Examine baseline brain signatures as a predictor of response to neurofeedback (NFB) and to duloxetine and determine who will require more sessions of NFB to achieve relief of symptoms. III. Examine if the combination of DL + NFB (than those getting DL or NFB alone) or a larger number of NFB sessions results in better improvements in cancer-related symptoms, physical functioning, and quality of life (QOL). OUTLINE: Patients are randomized to 1 of 3 groups. GROUP I: Patients receive neurofeedback training over 1 hour each 3-5 times weekly for up to 5 weeks. Patients also receive duloxetine orally (PO) once daily (QD) for 5 weeks in the absence of unacceptable toxicity. GROUP II: Patients receive neurofeedback training session over 1 hour 3-5 times weekly for up to 5 weeks. GROUP III: Patients receive duloxetine PO QD for 5 weeks in the absence of unacceptable toxicity. After completion of study, patients are followed up at 6 and 12 months.
Official Title
-----------------
Optimizing Neurofeedback to Treat Chemotherapy Induced Peripheral Neuropathy
Conditions
-----------------
Chemotherapy-Induced Peripheral Neuropathy, Hematopoietic and Lymphoid Cell Neoplasm, Malignant Solid Neoplasm
Intervention / Treatment
-----------------
* Drug: Duloxetine
* Behavioral: Neurofeedback
* Other: Quality-of-Life Assessment
* Other: Questionnaire Administration
Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Patients must have the ability to understand and read English, sign a written informed consent, and be willing to follow protocol requirements Eastern Cooperative Oncology Group (ECOG) performance status of 0-2 Pain score >= 4 on a 0-10 numeric pain scale and/or grade 1-4 neuropathic pain according to the National Cancer Institute's 4 point grading scale Neuropathic symptoms must be related to chemotherapy (in the opinion of the treating physician) Patients must have had neuropathic symptoms for a minimum of 3 months No plans to change pain medication regimen during the course of the study Off active chemotherapy treatment for minimum of 3 months Hormonal (e.g., tamoxifen or Arimidex, etc.) and targeted (Tarceva and Avastin, etc.) therapies allowed as long as they will be continued during the course of the study Willing to come to one of the participating cancer centers for the therapy sessions; or willing to participate in the therapy sessions at their homes and live within a 45 minute drive of the main campuses; or can participate in the therapy sessions from MD Anderson regional care centers If participants agree to the Remote Training Option, participants should be willing to receive equipment at their homes and to return the equipment to MDA in case of malfunction or completion of the study If participants agree to the Remote Training Option, participants should be willing to download necessary software to their home computer If participants agree to the Remote Training Option, participants should be willing to allow research staff remote access to their computer to run the neurofeedback program Exclusion Criteria: Patients who are taking any antipsychotic medications Patients with active central nervous system (CNS) disease, such as clinically-evident metastases or leptomeningeal disease, dementia, or encephalopathy Patients who have ever been diagnosed with bipolar disorder or schizophrenia Patients with known, previously diagnosed peripheral neuropathy from causes other than chemotherapy Patients who have a history of head injury or who have known seizure activity Patients for whom any contraindications of DL are known Patients with suicidal ideation Patients who are already taking duloxetine for peripheral neuropathy
Ages Eligible for Study
-----------------
Minimum Age: 18 Years
Sexes Eligible for Study
-----------------
All
Accepts Healthy Volunteers
-----------------
No
Study Plan
=================
How is the study designed?
-----------------
Design Details
Primary Purpose: Supportive Care
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Arms and Interventions
| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Group I (neurofeedback training, duloxetine)<br>Patients receive neurofeedback training over 1 hour 3-5 times weekly for up to 5 weeks. Patients also receive duloxetine PO QD for 5 weeks in the absence of unacceptable toxicity. | Drug: Duloxetine<br>* Given PO<br>Behavioral: Neurofeedback<br>* Receive neurofeedback training<br>* Other names: EEG biofeedback;Other: Quality-of-Life Assessment<br>* Ancillary studies<br>* Other names: Quality of Life Assessment;Other: Questionnaire Administration<br>* Ancillary studies<br>|
| Experimental: Group II (neurofeedback training)<br>Patients receive neurofeedback training over 1 hour 3-5 times weekly for up to 5 weeks. | Behavioral: Neurofeedback<br>* Receive neurofeedback training<br>* Other names: EEG biofeedback;Other: Quality-of-Life Assessment<br>* Ancillary studies<br>* Other names: Quality of Life Assessment;Other: Questionnaire Administration<br>* Ancillary studies<br>|
| Experimental: Group III (duloxetine)<br>Patients receive duloxetine PO QD for 5 weeks in the absence of unacceptable toxicity. | Drug: Duloxetine<br>* Given PO<br>Other: Quality-of-Life Assessment<br>* Ancillary studies<br>* Other names: Quality of Life Assessment;Other: Questionnaire Administration<br>* Ancillary studies<br>|
What is the study measuring?
-----------------
Primary Outcome Measures
| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change in Pain Quality Assessment Scale (PQAS) unpleasantness score | The primary analysis will be a linear model comparing the mean difference in the change of the unpleasantness subscale of the (PQAS)Pain Quality Assessment Scale from baseline to the end of treatment (5 weeks) between the combination arm, the duloxetine (DL), and the neurofeedback (NFB) arm while adjusting for the stratification factor. Pain Quality Assessment Scale (0-10) 0-No pain-10 Most Intense Pain Imaginable. | Baseline 5 up to week 10 |
Secondary Outcome Measures
| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change in PQAS unpleasantness score | Will use analysis of covariance (ANCOVA) to evaluate whether chemotherapy induced peripheral neuropathy (CIPN) differs across the three subgroups with 0, 10 or 15 additional sessions of NFB, among the participants from the NFB + DL group who report at least 1-point clinical improvement in CIPN at week 5. The analysis will adjust for the baseline outcome (at week 5), time with CIPN symptoms (minimization factor), and other covariates such as age, sex, cancer stage, time since diagnosis, and cancer type, as appropriate. Pain Quality Assessment Scale (0-10) 0-No pain-10 Most Intense Pain Imaginable. | Baseline 5 up to week 10 |
| Baseline brain signatures as predictors of response to NFB and to DL | Will perform ANCOVA with the change of the unpleasantness subscale from baseline to week 5 (i.e., end of the first 15 sessions of NFB) as the outcome, intervention (NFB, DL or combo), the brain signature (one at a time) and its interaction with intervention as the independent variables of interest. Pain Quality Assessment Scale (0-10) 0-No pain-10 Most Intense Pain Imaginable. | Up to week 5 |
| Evaluation of patients who will require more sessions of NFB to achieve relief of symptoms | Linear mixed model (LMM) analyses will be performed using data measured at end of treatment, months 6 and 12 only on patients who report clinical improvement at week 5. | Up to 12 months post-treatment |
| Change in cancer-related symptoms | ANCOVA and LMM analyses will be performed to evaluate the effect of the number of additional NFB sessions on cancer-related symptoms. | Baseline up to 12 months post-treatment |
| Change in physical functioning | ANCOVA and LMM analyses will be performed to evaluate the effect of the number of additional NFB sessions on physical functioning. | Baseline up to 12 months post-treatment |
| Change in quality of life | ANCOVA and LMM analyses will be performed to evaluate the effect of the number of additional NFB sessions on quality of life. | Baseline up to 12 months post-treatment |
|
|
NCT04509479
|
National Tunisian Registry of Valvulopathies (NATURE-VALVE)
|
The National Tunisian Registry of Valvulopathies is an observational, prospective and multicenter study aiming to assess the epidemiological, clinical and therapeutic profile of valve disease in tunisian departments of cardiology. Cardiologists from both sectors (public and private) are participating in the study, with 37 investigational centers. Data will be captured electronically by DACIMA Clinical Suite, according to FDA 21 CFR part 11 (Food and Drug Administration 21 Code of Federal Regulations part 11), HIPAA (Health Insurance Portability and Accountability Act) & ICH (International Conference on Harmonisation) requirements.
|
National Tunisian Registry of Valvulopathies (NATURE-VALVE)
|
Valvular Stenosis, Valvular Heart Disease, Valvular Insufficiency
|
* Procedure: Valve replacement
|
Inclusion Criteria:~Patients originated from Tunisia~Signed informed consent~Patients with at least one of the following conditions :~moderate to severe native mitral and / or aortic and / or tricuspid native valve disease~and / or a history of a previous percutaneous or surgical valve intervention~and / or a history of infectious endocarditis~Exclusion Criteria:~Congenital valve diseases not including bicuspid aortic valve~Isolated pulmonary valvulopathies
|
18 Years
| null |
All
|
No
|
| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Valvulopathies incidence | Number of subjects with valvular disease (mitral or aortic or tricuspid) and willing to participate at the study | at inclusion |
|
| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Major adverse cardiovascular events (MACE) | Number of patients with Major adverse cardiovascular events (MACE), including nonfatal stroke, nonfatal myocardial infarction, and cardiovascular death. | at 6 months of follow-up |
|
Valvular, Heart, Aortic, Mitral, Tricuspid
|
Heart Diseases, Heart Valve Diseases, Cardiovascular Diseases
|
| Intervention/Treatment |
| --- |
|Procedure: Valve replacement|Description of valve replacements|
|
National Tunisian Registry of Valvulopathies (NATURE-VALVE)
Study Overview
=================
Brief Summary
-----------------
The National Tunisian Registry of Valvulopathies is an observational, prospective and multicenter study aiming to assess the epidemiological, clinical and therapeutic profile of valve disease in tunisian departments of cardiology. Cardiologists from both sectors (public and private) are participating in the study, with 37 investigational centers. Data will be captured electronically by DACIMA Clinical Suite, according to FDA 21 CFR part 11 (Food and Drug Administration 21 Code of Federal Regulations part 11), HIPAA (Health Insurance Portability and Accountability Act) & ICH (International Conference on Harmonisation) requirements.
Official Title
-----------------
National Tunisian Registry of Valvulopathies (NATURE-VALVE)
Conditions
-----------------
Valvular Stenosis, Valvular Heart Disease, Valvular Insufficiency
Intervention / Treatment
-----------------
* Procedure: Valve replacement
Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Patients originated from Tunisia Signed informed consent Patients with at least one of the following conditions : moderate to severe native mitral and / or aortic and / or tricuspid native valve disease and / or a history of a previous percutaneous or surgical valve intervention and / or a history of infectious endocarditis Exclusion Criteria: Congenital valve diseases not including bicuspid aortic valve Isolated pulmonary valvulopathies
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 |
| --- |
|Procedure: Valve replacement|Description of valve replacements|
What is the study measuring?
-----------------
Primary Outcome Measures
| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Valvulopathies incidence | Number of subjects with valvular disease (mitral or aortic or tricuspid) and willing to participate at the study | at inclusion |
Secondary Outcome Measures
| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Major adverse cardiovascular events (MACE) | Number of patients with Major adverse cardiovascular events (MACE), including nonfatal stroke, nonfatal myocardial infarction, and cardiovascular death. | at 6 months of follow-up |
Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Valvular, Heart, Aortic, Mitral, Tricuspid
|
||
NCT04343209
|
Ammonia N-13 Myocardial Blood Flow Absolute Quantification by PET in Patients With Known or Suspected CAD (Ammonia MAP)
|
This study is being conducted to provide access to and collect test data for an established nuclear medicine diagnostic imaging test called Positron Emission Tomography (PET), using a specific radioactive drug called Ammonia N-13 (Ammonia), referred to simply as an Ammonia PET scan, which is used to visualize the blood flow through the blood vessels and into the heart muscle in order to identify areas of restricted blood flow within the heart. The scanner used in this study may be a stand-alone PET scanner or a PET/CT scanner, which combines the PET scanner and a Computed Tomography (CT) scanner into a single device. Unless otherwise stated in this consent form, the term PET will be used to refer to both stand-alone PET and PET/CT scanners. While physicians have used the Ammonia PET test for many years to visualize (image) the blood flow into the heart muscle (perfusion), it is now possible to also measure the flow of blood into the heart muscle. Research studies have demonstrated clinical value in reviewing the measured blood flow values in addition to reviewing the perfusion images of blood flow into the heart muscle. Therefore, this study will establish a database of a large number of Ammonia PET measured blood flow values to serve as a future reference.
|
This is a prospective, multicenter database that will be populated by sites utilizing N-13 Ammonia and sponsored by Ionetix. Each site with access to N-13 produced under an investigational new drug (IND) application will be eligible to participate. Once the site is activated, the site will enroll patients into the database that are scheduled for clinically indicated PET-MPI with N-13 (as determined by their treating physicians). PET-MPI perfusion, MBF, percent ischemia, pharmacologic stress agent, and gated left ventricular ejection fraction/function values will be collected when available, in an anonymous fashion and uploaded into the database. All patient health identifiers (PHI) will be removed prior to upload. No procedures additional to those clinically indicated will be performed for the purposes of this study.
|
Ammonia N-13 Myocardial Blood Flow Absolute Quantification by Positron Emission Tomography in Patients With Known or Suspected Coronary Artery Disease (Ammonia MAP)
|
Arteriosclerosis, Myocardial Ischemia, Coronary Disease, Coronary Artery Disease, Heart Diseases, Cardiovascular Diseases, Arterial Occlusive Diseases, Vascular Diseases
|
* Diagnostic Test: Myocardial Perfusion Imaging Study
* Drug: AMMONIA N-13 37.5 mCi in 1 mL INTRAVENOUS INJECTION [Ammonia N 13]
|
Inclusion Criteria:~Adults ≥18 able to give informed consent.~Clinical indication for PET-MPI as determined by the subject's treating physician~Exclusion Criteria:~Any clinical contraindication for pharmacologic stress testing per ASNC/SNMMI/ACC myocardial perfusion imaging guidelines when stress perfusion imaging is required clinically.~Inability or unwilling to give informed consent~Pregnant subjects
|
18 Years
| null |
All
|
No
|
| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Establish the N-13 measured MBF (ml/g/min) value range | Non-invasive measurements of myocardial blood flow (MBF) in milliliter/minute/gram using PET/CT or PET scanner will be compared to invasive cardiac angiography values (current gold standard). MBF values are obtained using image-derived time activity curves from the left ventricular blood and myocardial tissue regions. These values represent radiotracer exchange between the blood and the tissue over time. The rate of radiotracer uptake into the myocardial tissue provides an estimate of MBF. Processing software will then use the time-activity curves to calculate MBF at rest and at stress. | an estimated average of 2 hours |
|
MBF, Ammonia N-13, Positron Emission Tomography, Myocardial Blood Flow, Myocardial Perfusion, Ammonia N 13 Injection, USP, Coronary Artery Disease
|
Cardiovascular Diseases, Coronary Artery Disease, Myocardial Ischemia, Coronary Disease, Heart Diseases, Vascular Diseases, Arteriosclerosis, Arterial Occlusive Diseases, Ischemia, Pathologic Processes
|
| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Individuals with confirmed or suspected cardiovascular disease<br>Individuals in this group will undergo myocardial perfusion imaging, utilizing Ammonia N-13 PET imaging agent. Each individual will receive two intravenous injections of Ammonia N-13 in accordance with site imaging protocol. | Diagnostic Test: Myocardial Perfusion Imaging Study<br>* Evaluation of myocardial perfusion via PET imaging agent<br>Drug: AMMONIA N-13 37.5 mCi in 1 mL INTRAVENOUS INJECTION [Ammonia N 13]<br>* Cardiac PET imaging agent<br>|
|
Ammonia N-13 Myocardial Blood Flow Absolute Quantification by PET in Patients With Known or Suspected CAD (Ammonia MAP)
Study Overview
=================
Brief Summary
-----------------
This study is being conducted to provide access to and collect test data for an established nuclear medicine diagnostic imaging test called Positron Emission Tomography (PET), using a specific radioactive drug called Ammonia N-13 (Ammonia), referred to simply as an Ammonia PET scan, which is used to visualize the blood flow through the blood vessels and into the heart muscle in order to identify areas of restricted blood flow within the heart. The scanner used in this study may be a stand-alone PET scanner or a PET/CT scanner, which combines the PET scanner and a Computed Tomography (CT) scanner into a single device. Unless otherwise stated in this consent form, the term PET will be used to refer to both stand-alone PET and PET/CT scanners. While physicians have used the Ammonia PET test for many years to visualize (image) the blood flow into the heart muscle (perfusion), it is now possible to also measure the flow of blood into the heart muscle. Research studies have demonstrated clinical value in reviewing the measured blood flow values in addition to reviewing the perfusion images of blood flow into the heart muscle. Therefore, this study will establish a database of a large number of Ammonia PET measured blood flow values to serve as a future reference.
Detailed Description
-----------------
This is a prospective, multicenter database that will be populated by sites utilizing N-13 Ammonia and sponsored by Ionetix. Each site with access to N-13 produced under an investigational new drug (IND) application will be eligible to participate. Once the site is activated, the site will enroll patients into the database that are scheduled for clinically indicated PET-MPI with N-13 (as determined by their treating physicians). PET-MPI perfusion, MBF, percent ischemia, pharmacologic stress agent, and gated left ventricular ejection fraction/function values will be collected when available, in an anonymous fashion and uploaded into the database. All patient health identifiers (PHI) will be removed prior to upload. No procedures additional to those clinically indicated will be performed for the purposes of this study.
Official Title
-----------------
Ammonia N-13 Myocardial Blood Flow Absolute Quantification by Positron Emission Tomography in Patients With Known or Suspected Coronary Artery Disease (Ammonia MAP)
Conditions
-----------------
Arteriosclerosis, Myocardial Ischemia, Coronary Disease, Coronary Artery Disease, Heart Diseases, Cardiovascular Diseases, Arterial Occlusive Diseases, Vascular Diseases
Intervention / Treatment
-----------------
* Diagnostic Test: Myocardial Perfusion Imaging Study
* Drug: AMMONIA N-13 37.5 mCi in 1 mL INTRAVENOUS INJECTION [Ammonia N 13]
Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Adults ≥18 able to give informed consent. Clinical indication for PET-MPI as determined by the subject's treating physician Exclusion Criteria: Any clinical contraindication for pharmacologic stress testing per ASNC/SNMMI/ACC myocardial perfusion imaging guidelines when stress perfusion imaging is required clinically. Inability or unwilling to give informed consent Pregnant subjects
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 |
| --- | --- |
| Individuals with confirmed or suspected cardiovascular disease<br>Individuals in this group will undergo myocardial perfusion imaging, utilizing Ammonia N-13 PET imaging agent. Each individual will receive two intravenous injections of Ammonia N-13 in accordance with site imaging protocol. | Diagnostic Test: Myocardial Perfusion Imaging Study<br>* Evaluation of myocardial perfusion via PET imaging agent<br>Drug: AMMONIA N-13 37.5 mCi in 1 mL INTRAVENOUS INJECTION [Ammonia N 13]<br>* Cardiac PET imaging agent<br>|
What is the study measuring?
-----------------
Primary Outcome Measures
| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Establish the N-13 measured MBF (ml/g/min) value range | Non-invasive measurements of myocardial blood flow (MBF) in milliliter/minute/gram using PET/CT or PET scanner will be compared to invasive cardiac angiography values (current gold standard). MBF values are obtained using image-derived time activity curves from the left ventricular blood and myocardial tissue regions. These values represent radiotracer exchange between the blood and the tissue over time. The rate of radiotracer uptake into the myocardial tissue provides an estimate of MBF. Processing software will then use the time-activity curves to calculate MBF at rest and at stress. | an estimated average of 2 hours |
Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
MBF, Ammonia N-13, Positron Emission Tomography, Myocardial Blood Flow, Myocardial Perfusion, Ammonia N 13 Injection, USP, Coronary Artery Disease
|
||
NCT01720368
|
OPERA Database - Crohn's Protocol
|
The investigators believe that patients with Crohn's disease are able to report details of their own medical history accurately and record changes in clinical status effectively over time. Using an internet-based database the investigators will ask patients to report their own disease history, and the investigators will compare their reports to the medical record.
|
IBD-OPERA Database IBD OPERA Database: Inflammatory Bowel Disease - Outcomes, Preferences, Education, Resource Utilization, Assessment Database - Crohn's Protocol
|
Inflammatory Bowel Disease, Crohn's Disease
|
Inclusion Criteria:~Adults (over 18 years of age) with physician diagnosed Crohn's disease~A current or past prescription of anti-TNF~Access to medical record for validation of clinical information~Exclusion Criteria:~Unwilling or unable to provide informed consent for study participation~Unable to access or use the internet~Ulcerative colitis or IBD-U~Illiterate or does not possess minimum level of literacy required to complete questionnaire
|
18 Years
| null |
All
|
No
|
| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Validity of patient self reporting | The validity of patient self report on details of their Crohn's disease compared to chart review. Validity is defined as a match between patient self report and medical records. | 12 months |
|
IBD, Crohn's
|
Crohn Disease, Intestinal Diseases, Inflammatory Bowel Diseases, Gastroenteritis, Gastrointestinal Diseases, Digestive System Diseases
|
| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| 1st Group of 50 patients<br> | |
| 2nd Group of 50 patients<br> | |
|
OPERA Database - Crohn's Protocol
Study Overview
=================
Brief Summary
-----------------
The investigators believe that patients with Crohn's disease are able to report details of their own medical history accurately and record changes in clinical status effectively over time. Using an internet-based database the investigators will ask patients to report their own disease history, and the investigators will compare their reports to the medical record.
Official Title
-----------------
IBD-OPERA Database IBD OPERA Database: Inflammatory Bowel Disease - Outcomes, Preferences, Education, Resource Utilization, Assessment Database - Crohn's Protocol
Conditions
-----------------
Inflammatory Bowel Disease, Crohn's Disease
Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Adults (over 18 years of age) with physician diagnosed Crohn's disease A current or past prescription of anti-TNF Access to medical record for validation of clinical information Exclusion Criteria: Unwilling or unable to provide informed consent for study participation Unable to access or use the internet Ulcerative colitis or IBD-U Illiterate or does not possess minimum level of literacy required to complete questionnaire
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 |
| --- | --- |
| 1st Group of 50 patients<br> | |
| 2nd Group of 50 patients<br> | |
What is the study measuring?
-----------------
Primary Outcome Measures
| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Validity of patient self reporting | The validity of patient self report on details of their Crohn's disease compared to chart review. Validity is defined as a match between patient self report and medical records. | 12 months |
Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
IBD, Crohn's
|
||||
NCT04584216
|
Effects and Safety of Steam Eye Mask With Acupoints Stimulation
|
To evaluate the effects and safety of the steam eye mask with acupoints stimulation by the moist heat of approximately 40 degree C for 20 minutes and massage acupoints on eyebrows for eye fatigue, dry eye symptoms and symptom-induced decline of Quality of life (QoL) in VDT users.
|
A prospective study is conducted to evaluate the effect of the steam eye mask with acupoints stimulation on eye fatigue and dry eye symptoms in VDT users. The effects and safety of the single therapy by the moist heat of approximately 40 degree C for 20 minutes with eyebrows acupoints massage for the first 3 minutes are evaluated in the single application study, and the effects and safety of the repeated therapy by the moist heat applied and massage acupoints on eyebrows once per working day for two weeks are evaluated in the repeated application study.
|
Evaluation of the Effects and Safety by the Steam Eye Mask With Acupoints Stimulation for VDT User
|
Dry Eye Symptom, Eye Fatigue
|
* Other: Steam Eye Mask with acupoints stimulation
* Other: Steam Eye Mask
|
Inclusion Criteria:~Males or females aged from 20 to 69 years old (both inclusive).~Participants who use VDTs, including laptops, electronic tablets, readers and smartphones for 6 hours or more a day.~Participants who respond to the 16 symptoms of visual symptoms related to computer use in the working population for the total score over 6 based on a computer vision syndrome questionnaire.~Participants who respond to more than 1 of 12 typical dry eye symptoms by constantly or often based on a dry eye questionnaire.~Participants are able and willing to comply with all protocol requirements and procedures.~Participants who must be capable of providing informed consent document, with one's signature.~Exclusion Criteria:~Participants with eye diseases that could affect the ocular surface (e.g. Ocular inflammation, infectious conjunctivitis, allergic diseases, autoimmune diseases and collagen diseases).~Participants who have been treated by physicians because of eye diseases and do not recover from that disease yet at the moment of joining to this study, or participants who need to be treated by physicians because of eye disease.~Participants with the excessive meibomian lipid secretion (seborrheic MGD).~Participants with trauma, swelling and eczema at the skin around eyes.~Participants with allergic reaction for heating, abnormality of the heat or depression of the heat.~Participants who are deemed inappropriate to participate in this study by physicians.
|
20 Years
|
69 Years
|
All
|
Accepts Healthy Volunteers
|
Primary Purpose: Other
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
|
| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Assessment of symptoms and mood state (Visual Analog Scale, VAS) evaluated by participants. | The severity of symptoms and mood state are evaluated using a VAS by each participant. A VAS is a horizontal line, 100mm in length, anchored by word descriptors at each end. Participants mark on the line the point that they feel their perception of their current state. The VAS score is determined by measuring the length from the left hand end of the line to the point that they mark. The five symptoms to be evaluated are: tiredness of eyes, dryness of eyes, grittiness of eyes, blurred vision, and ocular discomfort. Each symptom is relieved as the VAS score decreases. The mood states to be evaluated are: relaxation and comfort. Each mood state is enhanced as the VAS score increases. | 14 days |
|
| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| The computer visual syndrome questionnaire (CVS-Q) evaluated by participants. | The computer vision syndrome questionnaire (CVS-Q) is applied to evaluate the visual health of workers exposed to the computer screen. This questionnaire consists of sixteen items with the response options of the severity (frequency and intensity) of each particular symptom and the overall symptom severity (CVS score). The score of each ocular discomfort is calculated by the frequency multiplies the intensity. The frequency for each symptom is answered by the subject as never, occasionally, and often/always which are coded as 0, 1, and 2, respectively. The intensity is defined for two options as 1 for moderate and 2 for intense, respectively. Moreover, the score obtained for each item will then be coded as 1 while the multiplied score is 1 or 2; and 2 while the multiplied score is 4. The results can be compared between different individuals or in the same individual at different times and circumstances. The higher score a subject gained, the worsen ocular condition he/she experienced. | 19 days |
| Dry eye questionnaire evaluated by participants. | The dry eye questionnaire will be used for evaluate the dry eye symptom of each participant. This questionnaire consists of 12 typical dry-eye-related symptoms, include 1. Ocular fatigue, 2. Discharge, 3. Foreign body sensation, 4. Heavy sensation, 5. Dry sensation, 6. Uncomfortable sensation, 7. Excess tearing, 8. Blurred vision, 9. Itching, 10. Sensitivity to bright light, 11. Redness, 12. Pain. Each symptom will be evaluated from never, sometimes, often, and Constantly. | 19 days |
| The quality of life (Dry-Eye-Related Quality of Life Score, DEQS) evaluated by participants. | The Dry-Eye-Related Quality of Life Score can assess various aspects of Quality of Life including its mental aspect. This questionnaire consists of 15 items related to dry eye symptoms(0 to 4, 0 as never, the less score as mild) and influence(1-4, the less score as rare) on daily life, and the overall degree of Quality of Life Score impairment is calculated as a summary score. The subject also grades the overall for the past week, including subject's eye symptoms and how they have affected subject's daily life, it will be graded from 1 to 6, the lower score means the subject is in better condition. DEQS score is decreased as Quality of Life Score is improved. | 14 days |
| Measurement of Tear Meniscus Height (TMH) using Oculus Keratograph 5M by an examiner. | Tear Meniscus Height is observed with Oculus Keratograph 5M. | 14 days |
| Tear film breakup time (TBUT) evaluated by an examiner. | Tear film breakup time is the parameter of tear film stability, defined as the time to initial breakup of the tear film after a blink. | 14 days |
| Schirmer test evaluated by an examiner. | Schirmer test is an estimation of tear flow reflex by insertion of a filter paper into the conjunctival sac. This test is performed with the participants' eyes closed in 5 minutes. | 19 days |
| Meibomian gland expression evaluated by an examiner. | Meibomian gland expression can be performed as an indicator of meibomian gland function, meibum expressibility and quality. The secretion expressed from the glands is observed with a physical force applied to the outer surface of the eyelid to determine whether a specific meibomian gland is functional and capable of providing secretion. | 19 days |
| Visual acuity (VA) evaluated by an examiner. | The normal visual acuity is measured for both eyes separately using a Snellen chart. | 14 days |
| Intraocular pressure (IOP) evaluated by an examiner. | The intraocular pressure is measured for both eyes separately using the tonometer. | 14 days |
| Ocular surface/eyelids findings diagnosed by an examiner. | An ophthalmologist observes the cornea, conjunctiva, and eyelids for each participant and confirms whether there are any inflammation and hyperemia on the ocular surface or any other abnormalities on the ocular surface and eyelids before and after the application of IP.~The slit lamp is applied to evaluate the following 6 items for both eyes including 1. Lid Margin Irregularity, 2. Lid Margin Vascularity, 3. Meibomian Orifice Plugging, 4. Mucocutaneous J Retroplacement, 5. Surface Finding Cornea, and 6. Surface Finding Conjunctiva. And the clinical judgments of normal or abnormal among these items will then assess by the investigators. | 19 days |
| Diary reported by a participant. | Participants are asked to record the time, date, place and adverse events, if there is, in a daily questionnaire after every use of IP. If there is any report of adverse events, an ophthalmologist determines the severity and the relationship of the adverse events to using IP. | 14 days |
| Adverse events | All adverse events will be record, and the incidence rates will be calculated. | 19 days |
| Staining of ocular surface evaluated by an examiner | Ocular surface damage is assessed by staining cornea and conjunctiva. The liquid of fluorescein is instilled by the micropipette to stain the ocular surface. The staining of ocular surface is graded on a scale of 0 to 3 on the cornea and both areas of the conjunctiva, and then summed (Total range in 0-9 points) for each eye, according to the van Bijsterveld system. | 14 days |
|
Steam Eye Mask, Acupoints Stimulation, Dry Eye Symptom, Eye Fatigue, Visual Display Terminal, Moist Heat, Massage
|
Asthenopia, Dry Eye Syndromes, Fatigue, Lacrimal Apparatus Diseases, Eye Diseases
|
| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Steam Eye Mask With Acupoints Stimulation<br>The Steam Eye Mask with acupoints stimulation (SEM with acupoints stimulation), is an eye mask which contains iron (Fe) and generates the heat with the steam (the moist heat) by the oxidative reaction of the iron with oxygen in air.~Also, on the eyebrow have the acupoints made by nonwoven fabric can use hands to massage.~The temperature of the moist heat is approximately 40 degree C and the moist heat lasts for around 20 minutes and use hands to massage the acupoints on the eyebrows for the first 3 minutes. | Other: Steam Eye Mask with acupoints stimulation<br>* A participant needs to use SEM with acupoints stimulation once a day for 10 days and use hands to massage the acupoints on the eyebrows for the first 3 minutes, total application time at least for 20 minutes.<br>* Other names: SEM with acupoints stimulation;|
| Active Comparator: Steam Eye Mask<br>The Steam Eye Mask (SEM), is an eye mask which contains iron (Fe) and generates the heat with the steam (the moist heat) by the oxidative reaction of the iron with oxygen in air.~The temperature of the moist heat is approximately 40 degree C and the moist heat lasts for around 20 minutes. | Other: Steam Eye Mask<br>* A participant needs to use SEM once a day for 10 days, total application time at least for 20 minutes.<br>* Other names: SEM;|
|
Effects and Safety of Steam Eye Mask With Acupoints Stimulation
Study Overview
=================
Brief Summary
-----------------
To evaluate the effects and safety of the steam eye mask with acupoints stimulation by the moist heat of approximately 40 degree C for 20 minutes and massage acupoints on eyebrows for eye fatigue, dry eye symptoms and symptom-induced decline of Quality of life (QoL) in VDT users.
Detailed Description
-----------------
A prospective study is conducted to evaluate the effect of the steam eye mask with acupoints stimulation on eye fatigue and dry eye symptoms in VDT users. The effects and safety of the single therapy by the moist heat of approximately 40 degree C for 20 minutes with eyebrows acupoints massage for the first 3 minutes are evaluated in the single application study, and the effects and safety of the repeated therapy by the moist heat applied and massage acupoints on eyebrows once per working day for two weeks are evaluated in the repeated application study.
Official Title
-----------------
Evaluation of the Effects and Safety by the Steam Eye Mask With Acupoints Stimulation for VDT User
Conditions
-----------------
Dry Eye Symptom, Eye Fatigue
Intervention / Treatment
-----------------
* Other: Steam Eye Mask with acupoints stimulation
* Other: Steam Eye Mask
Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Males or females aged from 20 to 69 years old (both inclusive). Participants who use VDTs, including laptops, electronic tablets, readers and smartphones for 6 hours or more a day. Participants who respond to the 16 symptoms of visual symptoms related to computer use in the working population for the total score over 6 based on a computer vision syndrome questionnaire. Participants who respond to more than 1 of 12 typical dry eye symptoms by constantly or often based on a dry eye questionnaire. Participants are able and willing to comply with all protocol requirements and procedures. Participants who must be capable of providing informed consent document, with one's signature. Exclusion Criteria: Participants with eye diseases that could affect the ocular surface (e.g. Ocular inflammation, infectious conjunctivitis, allergic diseases, autoimmune diseases and collagen diseases). Participants who have been treated by physicians because of eye diseases and do not recover from that disease yet at the moment of joining to this study, or participants who need to be treated by physicians because of eye disease. Participants with the excessive meibomian lipid secretion (seborrheic MGD). Participants with trauma, swelling and eczema at the skin around eyes. Participants with allergic reaction for heating, abnormality of the heat or depression of the heat. Participants who are deemed inappropriate to participate in this study by physicians.
Ages Eligible for Study
-----------------
Minimum Age: 20 Years
Maximum Age: 69 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: None (Open Label)
Arms and Interventions
| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Steam Eye Mask With Acupoints Stimulation<br>The Steam Eye Mask with acupoints stimulation (SEM with acupoints stimulation), is an eye mask which contains iron (Fe) and generates the heat with the steam (the moist heat) by the oxidative reaction of the iron with oxygen in air. Also, on the eyebrow have the acupoints made by nonwoven fabric can use hands to massage. The temperature of the moist heat is approximately 40 degree C and the moist heat lasts for around 20 minutes and use hands to massage the acupoints on the eyebrows for the first 3 minutes. | Other: Steam Eye Mask with acupoints stimulation<br>* A participant needs to use SEM with acupoints stimulation once a day for 10 days and use hands to massage the acupoints on the eyebrows for the first 3 minutes, total application time at least for 20 minutes.<br>* Other names: SEM with acupoints stimulation;|
| Active Comparator: Steam Eye Mask<br>The Steam Eye Mask (SEM), is an eye mask which contains iron (Fe) and generates the heat with the steam (the moist heat) by the oxidative reaction of the iron with oxygen in air. The temperature of the moist heat is approximately 40 degree C and the moist heat lasts for around 20 minutes. | Other: Steam Eye Mask<br>* A participant needs to use SEM once a day for 10 days, total application time at least for 20 minutes.<br>* Other names: SEM;|
What is the study measuring?
-----------------
Primary Outcome Measures
| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Assessment of symptoms and mood state (Visual Analog Scale, VAS) evaluated by participants. | The severity of symptoms and mood state are evaluated using a VAS by each participant. A VAS is a horizontal line, 100mm in length, anchored by word descriptors at each end. Participants mark on the line the point that they feel their perception of their current state. The VAS score is determined by measuring the length from the left hand end of the line to the point that they mark. The five symptoms to be evaluated are: tiredness of eyes, dryness of eyes, grittiness of eyes, blurred vision, and ocular discomfort. Each symptom is relieved as the VAS score decreases. The mood states to be evaluated are: relaxation and comfort. Each mood state is enhanced as the VAS score increases. | 14 days |
Secondary Outcome Measures
| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| The computer visual syndrome questionnaire (CVS-Q) evaluated by participants. | The computer vision syndrome questionnaire (CVS-Q) is applied to evaluate the visual health of workers exposed to the computer screen. This questionnaire consists of sixteen items with the response options of the severity (frequency and intensity) of each particular symptom and the overall symptom severity (CVS score). The score of each ocular discomfort is calculated by the frequency multiplies the intensity. The frequency for each symptom is answered by the subject as never, occasionally, and often/always which are coded as 0, 1, and 2, respectively. The intensity is defined for two options as 1 for moderate and 2 for intense, respectively. Moreover, the score obtained for each item will then be coded as 1 while the multiplied score is 1 or 2; and 2 while the multiplied score is 4. The results can be compared between different individuals or in the same individual at different times and circumstances. The higher score a subject gained, the worsen ocular condition he/she experienced. | 19 days |
| Dry eye questionnaire evaluated by participants. | The dry eye questionnaire will be used for evaluate the dry eye symptom of each participant. This questionnaire consists of 12 typical dry-eye-related symptoms, include 1. Ocular fatigue, 2. Discharge, 3. Foreign body sensation, 4. Heavy sensation, 5. Dry sensation, 6. Uncomfortable sensation, 7. Excess tearing, 8. Blurred vision, 9. Itching, 10. Sensitivity to bright light, 11. Redness, 12. Pain. Each symptom will be evaluated from never, sometimes, often, and Constantly. | 19 days |
| The quality of life (Dry-Eye-Related Quality of Life Score, DEQS) evaluated by participants. | The Dry-Eye-Related Quality of Life Score can assess various aspects of Quality of Life including its mental aspect. This questionnaire consists of 15 items related to dry eye symptoms(0 to 4, 0 as never, the less score as mild) and influence(1-4, the less score as rare) on daily life, and the overall degree of Quality of Life Score impairment is calculated as a summary score. The subject also grades the overall for the past week, including subject's eye symptoms and how they have affected subject's daily life, it will be graded from 1 to 6, the lower score means the subject is in better condition. DEQS score is decreased as Quality of Life Score is improved. | 14 days |
| Measurement of Tear Meniscus Height (TMH) using Oculus Keratograph 5M by an examiner. | Tear Meniscus Height is observed with Oculus Keratograph 5M. | 14 days |
| Tear film breakup time (TBUT) evaluated by an examiner. | Tear film breakup time is the parameter of tear film stability, defined as the time to initial breakup of the tear film after a blink. | 14 days |
| Schirmer test evaluated by an examiner. | Schirmer test is an estimation of tear flow reflex by insertion of a filter paper into the conjunctival sac. This test is performed with the participants' eyes closed in 5 minutes. | 19 days |
| Meibomian gland expression evaluated by an examiner. | Meibomian gland expression can be performed as an indicator of meibomian gland function, meibum expressibility and quality. The secretion expressed from the glands is observed with a physical force applied to the outer surface of the eyelid to determine whether a specific meibomian gland is functional and capable of providing secretion. | 19 days |
| Visual acuity (VA) evaluated by an examiner. | The normal visual acuity is measured for both eyes separately using a Snellen chart. | 14 days |
| Intraocular pressure (IOP) evaluated by an examiner. | The intraocular pressure is measured for both eyes separately using the tonometer. | 14 days |
| Ocular surface/eyelids findings diagnosed by an examiner. | An ophthalmologist observes the cornea, conjunctiva, and eyelids for each participant and confirms whether there are any inflammation and hyperemia on the ocular surface or any other abnormalities on the ocular surface and eyelids before and after the application of IP. The slit lamp is applied to evaluate the following 6 items for both eyes including 1. Lid Margin Irregularity, 2. Lid Margin Vascularity, 3. Meibomian Orifice Plugging, 4. Mucocutaneous J Retroplacement, 5. Surface Finding Cornea, and 6. Surface Finding Conjunctiva. And the clinical judgments of normal or abnormal among these items will then assess by the investigators. | 19 days |
| Diary reported by a participant. | Participants are asked to record the time, date, place and adverse events, if there is, in a daily questionnaire after every use of IP. If there is any report of adverse events, an ophthalmologist determines the severity and the relationship of the adverse events to using IP. | 14 days |
| Adverse events | All adverse events will be record, and the incidence rates will be calculated. | 19 days |
| Staining of ocular surface evaluated by an examiner | Ocular surface damage is assessed by staining cornea and conjunctiva. The liquid of fluorescein is instilled by the micropipette to stain the ocular surface. The staining of ocular surface is graded on a scale of 0 to 3 on the cornea and both areas of the conjunctiva, and then summed (Total range in 0-9 points) for each eye, according to the van Bijsterveld system. | 14 days |
Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Steam Eye Mask, Acupoints Stimulation, Dry Eye Symptom, Eye Fatigue, Visual Display Terminal, Moist Heat, Massage
|
NCT04839419
|
Obesity-hypoventilation in Metabolic Syndrom Patients
|
The purpose of the study is to determined the prevalence of obesity-hypoventilation syndrome in patients with metabolic syndrom.
|
After being informed about the study and potential risks, patient agreed to participate and undergo :~a functional respiratory exploration, an arterial blood gas analyze, and a polygraphy coupled with a capnography during the same night.
|
Prevalence of Obesity-hypoventilation Syndrome in Patients With Metabolic Syndrome.
|
Metabolic Syndrome, Obesity Hypoventilation Syndrome, Capnography
|
Inclusion Criteria:~BMI>30 kg/m2~no treatment with CPAP nor NIV~Exclusion Criteria:~obstructive respiratory disease~non-treated cardiac dysfunction
|
18 Years
| null |
All
|
Accepts Healthy Volunteers
|
| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Capnia | Arterial pression in CO2 and transcutaneous pression in CO2 | Up to one mont after inclusion |
| Arterial pression in CO2 | PaCO2 | At the inclusion |
|
| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| BMI | body mass index | At the inclusion |
| Arterial pression in oxygen | PaO2 | At the inclusion |
| somnolence | EPWORTH questionnaire; Minimum = 0; Maximum = 24, Higher score means a worth outcome | At the inclusion |
| Physical activity level | Ricci&Gagnon questionnaire, Minimum = 9; Maximum = 45, Higher score means a worth outcome | At the inclusion |
| Arterial blood bicarbonates | HCO3- | At the inclusion |
| Arterial blood gases | pH | At the inclusion |
| Hemoglobin | Hb | At the inclusion |
| obstructive sleep apnea items | Apnea-hypopnea index | Up to one mont after inclusion |
| Night Oxygen saturation | SpO2 | Up to one mont after inclusion |
|
Hypoventilation, Obesity Hypoventilation Syndrome, Obesity, Metabolic Syndrome, Syndrome, Disease, Pathologic Processes, Overweight, Overnutrition, Nutrition Disorders, Body Weight, Insulin Resistance, Hyperinsulinism, Glucose Metabolism Disorders, Metabolic Diseases, Respiratory Insufficiency, Respiration Disorders, Respiratory Tract Diseases, Signs and Symptoms, Respiratory, Sleep Apnea, Obstructive, Sleep Apnea Syndromes, Apnea, Sleep Disorders, Intrinsic, Dyssomnias, Sleep Wake Disorders, Nervous System Diseases
|
Obesity-hypoventilation in Metabolic Syndrom Patients
Study Overview
=================
Brief Summary
-----------------
The purpose of the study is to determined the prevalence of obesity-hypoventilation syndrome in patients with metabolic syndrom.
Detailed Description
-----------------
After being informed about the study and potential risks, patient agreed to participate and undergo : a functional respiratory exploration, an arterial blood gas analyze, and a polygraphy coupled with a capnography during the same night.
Official Title
-----------------
Prevalence of Obesity-hypoventilation Syndrome in Patients With Metabolic Syndrome.
Conditions
-----------------
Metabolic Syndrome, Obesity Hypoventilation Syndrome, Capnography
Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: BMI>30 kg/m2 no treatment with CPAP nor NIV Exclusion Criteria: obstructive respiratory disease non-treated cardiac dysfunction
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?
-----------------
What is the study measuring?
-----------------
Primary Outcome Measures
| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Capnia | Arterial pression in CO2 and transcutaneous pression in CO2 | Up to one mont after inclusion |
| Arterial pression in CO2 | PaCO2 | At the inclusion |
Secondary Outcome Measures
| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| BMI | body mass index | At the inclusion |
| Arterial pression in oxygen | PaO2 | At the inclusion |
| somnolence | EPWORTH questionnaire; Minimum = 0; Maximum = 24, Higher score means a worth outcome | At the inclusion |
| Physical activity level | Ricci&Gagnon questionnaire, Minimum = 9; Maximum = 45, Higher score means a worth outcome | At the inclusion |
| Arterial blood bicarbonates | HCO3- | At the inclusion |
| Arterial blood gases | pH | At the inclusion |
| Hemoglobin | Hb | At the inclusion |
| obstructive sleep apnea items | Apnea-hypopnea index | Up to one mont after inclusion |
| Night Oxygen saturation | SpO2 | Up to one mont after inclusion |
|
||||
NCT00759252
|
Perceptions Regarding Investigational Screening for Memory Problems in Primary Care
|
The purpose of this study is to conduct a cross-sectional survey of primary care patients to better understand their perceptions of the risks and benefits of a screen and subsequent diagnostic confirmation of dementia.
|
The Health Belief Model was used to explore the public's acceptance or enthusiasm for early recognition of dementia. Based on this model, prior research and clinical experiences, and a systematic literature review, the PRISM-PC instrument was developed. The PRISM-PC items seek to capture both the patient's acceptance of dementia screening and the patient's perception of potential harms and benefits of such screening. The instrument includes questions regarding screening by performance-based questionnaires, blood tests, or brain imaging.~The PRISM-PC instrument includes 50 items that are organized into 8 sets of questions that cover the following areas:~A) Prior experience with AD (5 items) B) Acceptance of screening for AD (6 items) C) Acceptance of screening for other conditions (2 items) D) Benefits of screening for AD (9 items) E) Stigma of screening for AD (10 items) F) Impact of screening for AD on independence (6 items) G) Suffering of screening for AD (4 items) H) Demographics (7 items) Excluding section A and H (prior experience with AD and demographics), each item of the six other sections is rated on a 5-point Likert scale (strongly agree, agree, don't know, disagree, and strongly disagree).~Based on the previous PRISM-PC pilot study (a survey response rate of 80%) and the Dementia screening and diagnosis study (screening acceptance rate of 90%, positive dementia screening rate of 20% among participants aged 70 and older, and dementia diagnostic acceptance rate of 50%), a total of 1,500 volunteers will be approached. A random selection of 200 participants will be re-administered the questionnaire within one week to test the short-term temporal stability of their responses (test-retest).
|
Perceptions Regarding Investigational Screening for Memory Problems in Primary Care: The PRISM-PC Study
|
Dementia
|
Inclusion Criteria:~Aged 65 and older~At least one office visit to their primary care physician within the last year~No chart-based diagnosis of dementia or memory problem~Willing to sign a consent form to participate in the study~Exclusion Criteria:~Does not speak English~Too hearing-impaired to hear the informed consent statement or the survey~Severe mental illness based on the patient's electronic medical charts
|
65 Years
| null |
All
|
Accepts Healthy Volunteers
|
| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Primary care patients' perceptions of the risks and benefits of early identification of dementia | | Measurement will continue through the duration of the study |
|
| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Evaluation of the association between primary care patients' acceptance for early identification of dementia and their perceptions of the risks and benefits of such identification after adjusting for potential confounders such as demographics | | Measurement will continue through the duration of the study |
|
diagnosis of dementia, perceptions of risk, dementia screening
|
Dementia, Brain Diseases, Central Nervous System Diseases, Nervous System Diseases, Neurocognitive Disorders, Mental Disorders
|
Perceptions Regarding Investigational Screening for Memory Problems in Primary Care
Study Overview
=================
Brief Summary
-----------------
The purpose of this study is to conduct a cross-sectional survey of primary care patients to better understand their perceptions of the risks and benefits of a screen and subsequent diagnostic confirmation of dementia.
Detailed Description
-----------------
The Health Belief Model was used to explore the public's acceptance or enthusiasm for early recognition of dementia. Based on this model, prior research and clinical experiences, and a systematic literature review, the PRISM-PC instrument was developed. The PRISM-PC items seek to capture both the patient's acceptance of dementia screening and the patient's perception of potential harms and benefits of such screening. The instrument includes questions regarding screening by performance-based questionnaires, blood tests, or brain imaging. The PRISM-PC instrument includes 50 items that are organized into 8 sets of questions that cover the following areas: A) Prior experience with AD (5 items) B) Acceptance of screening for AD (6 items) C) Acceptance of screening for other conditions (2 items) D) Benefits of screening for AD (9 items) E) Stigma of screening for AD (10 items) F) Impact of screening for AD on independence (6 items) G) Suffering of screening for AD (4 items) H) Demographics (7 items) Excluding section A and H (prior experience with AD and demographics), each item of the six other sections is rated on a 5-point Likert scale (strongly agree, agree, don't know, disagree, and strongly disagree). Based on the previous PRISM-PC pilot study (a survey response rate of 80%) and the Dementia screening and diagnosis study (screening acceptance rate of 90%, positive dementia screening rate of 20% among participants aged 70 and older, and dementia diagnostic acceptance rate of 50%), a total of 1,500 volunteers will be approached. A random selection of 200 participants will be re-administered the questionnaire within one week to test the short-term temporal stability of their responses (test-retest).
Official Title
-----------------
Perceptions Regarding Investigational Screening for Memory Problems in Primary Care: The PRISM-PC Study
Conditions
-----------------
Dementia
Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Aged 65 and older At least one office visit to their primary care physician within the last year No chart-based diagnosis of dementia or memory problem Willing to sign a consent form to participate in the study Exclusion Criteria: Does not speak English Too hearing-impaired to hear the informed consent statement or the survey Severe mental illness based on the patient's electronic medical charts
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?
-----------------
What is the study measuring?
-----------------
Primary Outcome Measures
| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Primary care patients' perceptions of the risks and benefits of early identification of dementia | | Measurement will continue through the duration of the study |
Secondary Outcome Measures
| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Evaluation of the association between primary care patients' acceptance for early identification of dementia and their perceptions of the risks and benefits of such identification after adjusting for potential confounders such as demographics | | Measurement will continue through the duration of the study |
Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
diagnosis of dementia, perceptions of risk, dementia screening
|
|||
NCT03553485
|
Effects of VNS on RT-induced Inflammation and Prognosis of Patients With NSCLC
|
Lung cancer (LC) remains a leading cause of death among cancers worldwide. Though radiotherapy is one of the most frequently used treatments, it increases side-effects (pain, fatigue) and inflammation, possibly leading to further tumorigenesis of surviving cancer cells. The purpose of this study is to test the effects of transcutaneous auricular VNS vagal nerve stimulation (taVNS), known to reduce inflammation, on radiotherapy-induced inflammation and other side-effects in LC patients undergoing radiotherapy.~In this feasibility study 12 patients with NSCLC stage III (A/B) receiving radiotherapy will be enrolled. Our primary endpoint is the effect of vagus nerve stimulation (VNS) on inflammatory levels (such as CRP and cytokines), immunological factors (neutrophils, monocytes, lymphocytes) and the tumor marker CEA. Our secondary endpoint is the psychological well-being and quality of life of the patients during their radiotherapy treatment.
|
Effects of Transcutaneous Auricular Vagal Nerve Stimulation on Radiotherapy-induced Inflammation and Prognosis of Patients With Lung Cancer
|
Lung Cancer, Non-small Cell
|
* Device: Transcutaneous vagus nerve stimulation
* Device: Sham
* Radiation: Radiotherapy
|
Inclusion Criteria:~Patients >18 years old~Patients with non-small cell lung cancer stage III (A or B)~Patients receiving radiotherapy or chemoradiotherapy~Patients with an HRV < 70 msec~Exclusion Criteria:~Patients with an active implantable medical device, such as a pacemaker, hearing aid implant or any other implanted electronic device~Patients with an implanted or wearable defibrillator.~Patients with myocardial disease~Patients with arrhythmias~Patients with an implanted metallic or electronic device in their head.~Pregnant or breastfeeding women
|
18 Years
| null |
All
|
No
|
Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Triple
|
| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Cancer prognosis: tumor marker | CEA (µg/mL) | 7 weeks |
| Cancer prognosis: inflammatory level | CRP (mg/mL) | 7 weeks |
| Cancer prognosis: inflammatory level | cytokines: IL1, IL2, IL6 and IL8 (pg/mL) | 7 weeks |
| Cancer prognosis: immunological factors | neutrophil count (x10³/mm³) | 7 weeks |
|
| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Health related Quality of Life | To assess the psychological well-being and quality of life of the patients during their radiotherapy treatment the EORTC QLQ-C30 questionnaire will be used. | 7 weeks |
|
Neoplasms, Lung Neoplasms, Carcinoma, Non-Small-Cell Lung, Inflammation, Respiratory Tract Neoplasms, Thoracic Neoplasms, Neoplasms by Site, Lung Diseases, Respiratory Tract Diseases, Pathologic Processes, Carcinoma, Bronchogenic, Bronchial Neoplasms
|
| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: taVNS<br>Treatment will be carried out twice a day (once before the RT session and 8h later) during 7 weeks. Each treatment takes 30 minutes. | Device: Transcutaneous vagus nerve stimulation<br>* The transcutaneous auricular vagus nerve stimulator Parasym consists of a stimulation unit and a dedicated ear electrode. The stimulation unit, having approximately the size of a common mobile phone, sends out the electrical impulses. It is connected with the ear electrode, which patients wear like an earphone. The patient can regulate and adapt the intensity of the stimulation (current intensity) according to his/her individual sensitivity, which can vary from day to day or even over the period of the therapy.<br>Radiation: Radiotherapy<br>* Standard treatment for included patients<br>|
| Sham Comparator: Control<br>Treatment will be carried out twice a day (once before the RT session and 8h later) during 7 weeks. Each treatment takes 30 minutes. | Device: Sham<br>* Sham Earclip electrodes are electrodes that appear identical to functioning electrodes, however do not deliver any stimulation due to removed wiring.<br>Radiation: Radiotherapy<br>* Standard treatment for included patients<br>|
|
Effects of VNS on RT-induced Inflammation and Prognosis of Patients With NSCLC
Study Overview
=================
Brief Summary
-----------------
Lung cancer (LC) remains a leading cause of death among cancers worldwide. Though radiotherapy is one of the most frequently used treatments, it increases side-effects (pain, fatigue) and inflammation, possibly leading to further tumorigenesis of surviving cancer cells. The purpose of this study is to test the effects of transcutaneous auricular VNS vagal nerve stimulation (taVNS), known to reduce inflammation, on radiotherapy-induced inflammation and other side-effects in LC patients undergoing radiotherapy. In this feasibility study 12 patients with NSCLC stage III (A/B) receiving radiotherapy will be enrolled. Our primary endpoint is the effect of vagus nerve stimulation (VNS) on inflammatory levels (such as CRP and cytokines), immunological factors (neutrophils, monocytes, lymphocytes) and the tumor marker CEA. Our secondary endpoint is the psychological well-being and quality of life of the patients during their radiotherapy treatment.
Official Title
-----------------
Effects of Transcutaneous Auricular Vagal Nerve Stimulation on Radiotherapy-induced Inflammation and Prognosis of Patients With Lung Cancer
Conditions
-----------------
Lung Cancer, Non-small Cell
Intervention / Treatment
-----------------
* Device: Transcutaneous vagus nerve stimulation
* Device: Sham
* Radiation: Radiotherapy
Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Patients >18 years old Patients with non-small cell lung cancer stage III (A or B) Patients receiving radiotherapy or chemoradiotherapy Patients with an HRV < 70 msec Exclusion Criteria: Patients with an active implantable medical device, such as a pacemaker, hearing aid implant or any other implanted electronic device Patients with an implanted or wearable defibrillator. Patients with myocardial disease Patients with arrhythmias Patients with an implanted metallic or electronic device in their head. Pregnant or breastfeeding 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
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Triple
Arms and Interventions
| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: taVNS<br>Treatment will be carried out twice a day (once before the RT session and 8h later) during 7 weeks. Each treatment takes 30 minutes. | Device: Transcutaneous vagus nerve stimulation<br>* The transcutaneous auricular vagus nerve stimulator Parasym consists of a stimulation unit and a dedicated ear electrode. The stimulation unit, having approximately the size of a common mobile phone, sends out the electrical impulses. It is connected with the ear electrode, which patients wear like an earphone. The patient can regulate and adapt the intensity of the stimulation (current intensity) according to his/her individual sensitivity, which can vary from day to day or even over the period of the therapy.<br>Radiation: Radiotherapy<br>* Standard treatment for included patients<br>|
| Sham Comparator: Control<br>Treatment will be carried out twice a day (once before the RT session and 8h later) during 7 weeks. Each treatment takes 30 minutes. | Device: Sham<br>* Sham Earclip electrodes are electrodes that appear identical to functioning electrodes, however do not deliver any stimulation due to removed wiring.<br>Radiation: Radiotherapy<br>* Standard treatment for included patients<br>|
What is the study measuring?
-----------------
Primary Outcome Measures
| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Cancer prognosis: tumor marker | CEA (µg/mL) | 7 weeks |
| Cancer prognosis: inflammatory level | CRP (mg/mL) | 7 weeks |
| Cancer prognosis: inflammatory level | cytokines: IL1, IL2, IL6 and IL8 (pg/mL) | 7 weeks |
| Cancer prognosis: immunological factors | neutrophil count (x10³/mm³) | 7 weeks |
Secondary Outcome Measures
| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Health related Quality of Life | To assess the psychological well-being and quality of life of the patients during their radiotherapy treatment the EORTC QLQ-C30 questionnaire will be used. | 7 weeks |
|
||
NCT03603691
|
Study to Evaluate the Reliability and Validity of the Modified Manual Muscle Test for Persons With MS
|
Many patients with multiple sclerosis (MS) are treated with physiotherapy. Muscle weakness is a common symptom. It can be evaluated with a variety of muscle function tests. In MS patients, testing muscle function can be confounded by many factors, such as spasticity and ataxia, which are not considered by the existing tests and may cause biased test results. Steinlin Egli described a Modified Manual Muscle Test (MMMT) that considers spasticity and may provide a more reliable and valid muscle function test for MS patients.~The investigators aim to evaluate the inter- and intra-rater reliability of the Modified Manual Muscle Test in MS and evaluate the validity of the Modified MMT according to the criteria of the 6 level British Medical Research Council (BMRC) manual muscle test and the microFET2 handhold dynamometer.
|
Background In Switzerland, many patients with multiple sclerosis (MS) are treated with physiotherapy. Muscle weakness is a common symptom. Particularly in progressive disease courses, motor dysfunction is a major contributor to the reduced mobility and quality of life. Therefore, improving the motor dysfunction is an important goal for therapy and is evaluated with a variety of muscle function tests. The 6 level British Medical Research Council (BMRC) manual muscle test is the most widely used test in MS and is a part of the Neurostatus-Expanded Disability Status Scale (EDSS) assessment, which has been adopted as the standard in most of the pivotal trials that have led to the approval of the current MS treatments. In MS patients, testing muscle function can be confounded by many factors, such as spasticity and ataxia, which are not considered by the existing tests and may cause biased test results. Steinlin Egli described a Modified Manual Muscle Test (MMMT) that considers spasticity and may provide a more reliable and valid muscle function test for MS patients.~Aim of the study is to evaluate the inter- and intra-rater reliability of the Modified Manual Muscle Test in MS and evaluate the validity of the Modified MMT according to the criteria of the Neurostatus BMRC manual muscle test and the microFET2 handhold dynamometer.~Methods This is a single-centre, prospective cross-sectional study with a test-retest design. The Neurostatus BMRC manual muscle test and the microFET2 hand held dynamometer are used as the criteria. The primary endpoint is the ordinal MMMT level. The intra-class correlation coefficient (ICC) of the ranked MMMT levels will be estimated. The investigator aims to show that the MMMT results are clinically relevant with a high level of ICC.~The secondary endpoints include the Neurostatus BMRC levels, the muscle strength as measured by the microFET2 dynamometer and fatigue using a numeric rating scale (NRS). Subgroup analyses will determine whether the MMMT is less sensitive to the influence of spasticity than the Neurostatus BMRC.~28 patients with MS will be tested in 2 days. In each day, six examiners will test seven patients in the morning and seven patients in the afternoon. Three MS-therapists from the Specialized Group Physiotherapy in MS and three neurologists from the Department of Neurology at the University Hospital Basel will be tester. All examiners will be blinded to the results of the other examiners. All test persons will be blinded to their test results. First, the patient will rate his fatigue using the NRS. Muscle function will be tested with the microFET2 and spasticity will be assessed using the modified Tardieu Scale. Then, the first round of manual testing will be executed. After each test, there will be a break that is long enough for the patients to recuperate. The order of the examiners will be randomized. The retest round will proceed in a different order. Finally, spasticity will be tested again using the modified Tardieu Scale, and the patients will rate their fatigue.~Statistical Analysis The study data will be analysed using the internet-based program R. The descriptive statistics will describe the sample characteristics. The inter-rater reliability will be estimated by the ICC of the MMMT ranks. The ICC will be estimated by a two-way random-effects ANOVA and reported with 95% CI. If the lower limit of the CI is larger than the pre-specified clinically relevant ICC margin, the MMMT will be considered a reliable tool for evaluating muscle strength in MS patients.~The inter-rater reliability the Neurostatus BMRC will be estimated similarly by the ICC. The ICC of both tests will be compared. The test-retest reliability of the MMMT and Neurostatus BMRC will be estimated using two-way random-effects ANOVA and will be reported by ICC estimates. The influence of potential fatigue will be analysed by plotting the test and retest results against the NRS and investigating the associations and interactions using a linear mixed effects model. The pairwise correlations of the MMMT and the Neurostatus BMRC with the microFET2 will be graphically analysed (scatterplots and/or boxplots), and Spearman's ρ will be calculated. The primary and secondary analyses will be repeated for subgroups with high and low spasticity patients to compare the sensitivity of the MMMT and Neurostatus BMRC to spasticity.~Expected results: The investigators expect the MMMT for MS to be a reliable and valid manual muscle function test that can be used in the evaluation of the long-term treatment of MS patients with physical therapy.
|
A Single-centre, Prospective, Cross-sectional Study to Evaluate the Reliability and Validity of the Modified Manual Muscle Test for Persons With Multiple Sclerosis) (MS)
|
Multiple Sclerosis
|
* Diagnostic Test: Modified Manual Muscle Test
* Diagnostic Test: BMRC manual muscle test
* Diagnostic Test: MicroFET2 handhold dynamometer
* Diagnostic Test: Modified Tardieu Scale
* Diagnostic Test: Fatigue Scale for Motor and Cognitive Functions
* Diagnostic Test: numeric rating scale Fatigue
|
Inclusion Criteria~diagnosed with MS according to the McDonald criteria~EDSS between 0 and 6.5~older than 18 years of age.~Exclusion Criteria:~An acute episode of MS within 3 months prior to the testing,~grave cognitive changes~distinct fatigue~a history of current back, neck or elbow pain
|
18 Years
| null |
All
|
No
|
Primary Purpose: Diagnostic
Allocation: Randomized
Intervention Model: Crossover Assignment
Interventional Model Description: Prospective, cross-sectional and test-retest
Masking: Single
|
| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Inter-rater reliability Modified Manual Muscle Test | The primary endpoint is the MMMT level. The ordinal levels (2+, 3-, 3, 4-, 4, 4+ and 5) will be transformed to ranks (1-7), and the intra-class correlation coefficient (ICC) of the ranked MMMT levels will be estimated. The aim is to show that the MMMT results are at a clinically relevant - thus high - level of ICC (that is a pre-specified, clinically relevant level the ICC margin).~The null hypothesis is that the lower limit of the 95% confidence interval (CI) of the ICC is smaller than or equal to the ICC margin. The alternative hypothesis is that the lower limit of the 95% CI of the ICC is larger than the ICC margin.~If the lower limit of the CI is larger than the ICC margin, the MMMT will be considered a reliable tool for evaluating muscle strength in MS patients. | Baseline |
|
| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Intra-rater reliability Modified Manual Muscle Test | The intra-rater reliability will be evaluated by comparing the test results of two tests (test-retest), which will be executed by the same tester. The two tests will be executed on the same day within 4 hours. The intra-class correlation coefficient of the ranked MMMT levels (analogue to the primary endpoint) will be used to describe the intra-rater reliability of the MMMT. | Baseline- Baseline plus 4 hours |
| Validity of the Modified Manual Muscle Test | The inter-rater reliability of the BMRC will be measured by the ICC. The ICC of the BMRC will be estimated and analysed as previously described for the primary analysis. The ICCs of the MMMT and the BMRC will be compared descriptively.~The test-retest reliability of the MMMT and the BMRC will be estimated for each rater separately using a two-way random-effects ANOVA, including the patient and test type (test/retest) as random effects. The ICC estimates will be reported with the 95% CI and compared descriptively between the raters using the same test and between the tests (MMMT vs BMRC).~The pairwise correlations of the MMMT and the BMRC with the muscle strength as assessed by the microFET2 will be investigated graphically (scatterplots and/or boxplots). Furthermore, Spearman's rank correlation coefficient will be presented with the corresponding 95% CI and p-values. | Baseline- Baseline plus 4 hours |
| Modified Tardieu Scale level | The BMRC has 6 levels, which makes the scale robust and reliable but insensitive to change. In addition, the BMRC does not consider spasticity. The MMMT has 12 levels, which makes it more sensitive, but it also might mean that the scale is less reliable. Because the MMMT considers spasticity, we expect that this compensates for the possible loss of reliability. It is assumed that the MMMT is less sensitive to spasticity than the BMRC. Thus, for patients with a different level of spasticity measured by the Modified Tardieu Scale, both the inter-rater and the test-retest reliability of the MMMT are expected to be equal to those of the BMRC.~The primary and secondary analyses will thus be repeated for the subgroups of high-spasticity and low-spasticity patients separately (assuming that a reasonable number of patients per subgroup and endpoint are available). | Baseline- Baseline plus 4 hours |
|
Multiple Sclerosis, Sclerosis, Pathologic Processes, Demyelinating Autoimmune Diseases, CNS, Autoimmune Diseases of the Nervous System, Nervous System Diseases, Demyelinating Diseases, Autoimmune Diseases, Immune System Diseases
|
| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: Modified Manual Muscle Test<br>The MMMT will be tested in a test-retest design | Diagnostic Test: Modified Manual Muscle Test<br>* Manual Muscle Testing Grading System from 0=No visible or palpable contraction to 5= full range of movement against gravity, maximal resistance<br>Diagnostic Test: BMRC manual muscle test<br>* muscle scale grades muscle power on a scale of 0 to 5 in relation to the maximum expected for that muscle<br>Diagnostic Test: MicroFET2 handhold dynamometer<br>* MicroFET 2 Handheld Dynamometer is a force evaluation testing device to evaluate the strength of various muscle groups<br>Diagnostic Test: Modified Tardieu Scale<br>* Modified Tardieu Scale is to measure if there is spasticity present in a person's muscle and its response to movement<br>Diagnostic Test: Fatigue Scale for Motor and Cognitive Functions<br>* Measures cognitive and motor fatigue for people with MS<br>Diagnostic Test: numeric rating scale Fatigue<br>* visual analog scale that uses a scalar numbering system to objectify a patient's fatigue (0 = no fatigue; 10 = most extreme fatigue)<br>|
| Active Comparator: Neurostatus BMRC<br>The Neurostatus BMRC measures Strength and will be used in a test-retest design | Diagnostic Test: Modified Manual Muscle Test<br>* Manual Muscle Testing Grading System from 0=No visible or palpable contraction to 5= full range of movement against gravity, maximal resistance<br>Diagnostic Test: BMRC manual muscle test<br>* muscle scale grades muscle power on a scale of 0 to 5 in relation to the maximum expected for that muscle<br>Diagnostic Test: MicroFET2 handhold dynamometer<br>* MicroFET 2 Handheld Dynamometer is a force evaluation testing device to evaluate the strength of various muscle groups<br>Diagnostic Test: Modified Tardieu Scale<br>* Modified Tardieu Scale is to measure if there is spasticity present in a person's muscle and its response to movement<br>Diagnostic Test: Fatigue Scale for Motor and Cognitive Functions<br>* Measures cognitive and motor fatigue for people with MS<br>Diagnostic Test: numeric rating scale Fatigue<br>* visual analog scale that uses a scalar numbering system to objectify a patient's fatigue (0 = no fatigue; 10 = most extreme fatigue)<br>|
| Active Comparator: MicroFET2<br>The MicroFET2 is a hand held dynamometer to measure strength | Diagnostic Test: Modified Manual Muscle Test<br>* Manual Muscle Testing Grading System from 0=No visible or palpable contraction to 5= full range of movement against gravity, maximal resistance<br>Diagnostic Test: BMRC manual muscle test<br>* muscle scale grades muscle power on a scale of 0 to 5 in relation to the maximum expected for that muscle<br>Diagnostic Test: MicroFET2 handhold dynamometer<br>* MicroFET 2 Handheld Dynamometer is a force evaluation testing device to evaluate the strength of various muscle groups<br>Diagnostic Test: Modified Tardieu Scale<br>* Modified Tardieu Scale is to measure if there is spasticity present in a person's muscle and its response to movement<br>Diagnostic Test: Fatigue Scale for Motor and Cognitive Functions<br>* Measures cognitive and motor fatigue for people with MS<br>Diagnostic Test: numeric rating scale Fatigue<br>* visual analog scale that uses a scalar numbering system to objectify a patient's fatigue (0 = no fatigue; 10 = most extreme fatigue)<br>|
|
Study to Evaluate the Reliability and Validity of the Modified Manual Muscle Test for Persons With MS
Study Overview
=================
Brief Summary
-----------------
Many patients with multiple sclerosis (MS) are treated with physiotherapy. Muscle weakness is a common symptom. It can be evaluated with a variety of muscle function tests. In MS patients, testing muscle function can be confounded by many factors, such as spasticity and ataxia, which are not considered by the existing tests and may cause biased test results. Steinlin Egli described a Modified Manual Muscle Test (MMMT) that considers spasticity and may provide a more reliable and valid muscle function test for MS patients. The investigators aim to evaluate the inter- and intra-rater reliability of the Modified Manual Muscle Test in MS and evaluate the validity of the Modified MMT according to the criteria of the 6 level British Medical Research Council (BMRC) manual muscle test and the microFET2 handhold dynamometer.
Detailed Description
-----------------
Background In Switzerland, many patients with multiple sclerosis (MS) are treated with physiotherapy. Muscle weakness is a common symptom. Particularly in progressive disease courses, motor dysfunction is a major contributor to the reduced mobility and quality of life. Therefore, improving the motor dysfunction is an important goal for therapy and is evaluated with a variety of muscle function tests. The 6 level British Medical Research Council (BMRC) manual muscle test is the most widely used test in MS and is a part of the Neurostatus-Expanded Disability Status Scale (EDSS) assessment, which has been adopted as the standard in most of the pivotal trials that have led to the approval of the current MS treatments. In MS patients, testing muscle function can be confounded by many factors, such as spasticity and ataxia, which are not considered by the existing tests and may cause biased test results. Steinlin Egli described a Modified Manual Muscle Test (MMMT) that considers spasticity and may provide a more reliable and valid muscle function test for MS patients. Aim of the study is to evaluate the inter- and intra-rater reliability of the Modified Manual Muscle Test in MS and evaluate the validity of the Modified MMT according to the criteria of the Neurostatus BMRC manual muscle test and the microFET2 handhold dynamometer. Methods This is a single-centre, prospective cross-sectional study with a test-retest design. The Neurostatus BMRC manual muscle test and the microFET2 hand held dynamometer are used as the criteria. The primary endpoint is the ordinal MMMT level. The intra-class correlation coefficient (ICC) of the ranked MMMT levels will be estimated. The investigator aims to show that the MMMT results are clinically relevant with a high level of ICC. The secondary endpoints include the Neurostatus BMRC levels, the muscle strength as measured by the microFET2 dynamometer and fatigue using a numeric rating scale (NRS). Subgroup analyses will determine whether the MMMT is less sensitive to the influence of spasticity than the Neurostatus BMRC. 28 patients with MS will be tested in 2 days. In each day, six examiners will test seven patients in the morning and seven patients in the afternoon. Three MS-therapists from the Specialized Group Physiotherapy in MS and three neurologists from the Department of Neurology at the University Hospital Basel will be tester. All examiners will be blinded to the results of the other examiners. All test persons will be blinded to their test results. First, the patient will rate his fatigue using the NRS. Muscle function will be tested with the microFET2 and spasticity will be assessed using the modified Tardieu Scale. Then, the first round of manual testing will be executed. After each test, there will be a break that is long enough for the patients to recuperate. The order of the examiners will be randomized. The retest round will proceed in a different order. Finally, spasticity will be tested again using the modified Tardieu Scale, and the patients will rate their fatigue. Statistical Analysis The study data will be analysed using the internet-based program R. The descriptive statistics will describe the sample characteristics. The inter-rater reliability will be estimated by the ICC of the MMMT ranks. The ICC will be estimated by a two-way random-effects ANOVA and reported with 95% CI. If the lower limit of the CI is larger than the pre-specified clinically relevant ICC margin, the MMMT will be considered a reliable tool for evaluating muscle strength in MS patients. The inter-rater reliability the Neurostatus BMRC will be estimated similarly by the ICC. The ICC of both tests will be compared. The test-retest reliability of the MMMT and Neurostatus BMRC will be estimated using two-way random-effects ANOVA and will be reported by ICC estimates. The influence of potential fatigue will be analysed by plotting the test and retest results against the NRS and investigating the associations and interactions using a linear mixed effects model. The pairwise correlations of the MMMT and the Neurostatus BMRC with the microFET2 will be graphically analysed (scatterplots and/or boxplots), and Spearman's ρ will be calculated. The primary and secondary analyses will be repeated for subgroups with high and low spasticity patients to compare the sensitivity of the MMMT and Neurostatus BMRC to spasticity. Expected results: The investigators expect the MMMT for MS to be a reliable and valid manual muscle function test that can be used in the evaluation of the long-term treatment of MS patients with physical therapy.
Official Title
-----------------
A Single-centre, Prospective, Cross-sectional Study to Evaluate the Reliability and Validity of the Modified Manual Muscle Test for Persons With Multiple Sclerosis) (MS)
Conditions
-----------------
Multiple Sclerosis
Intervention / Treatment
-----------------
* Diagnostic Test: Modified Manual Muscle Test
* Diagnostic Test: BMRC manual muscle test
* Diagnostic Test: MicroFET2 handhold dynamometer
* Diagnostic Test: Modified Tardieu Scale
* Diagnostic Test: Fatigue Scale for Motor and Cognitive Functions
* Diagnostic Test: numeric rating scale Fatigue
Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria diagnosed with MS according to the McDonald criteria EDSS between 0 and 6.5 older than 18 years of age. Exclusion Criteria: An acute episode of MS within 3 months prior to the testing, grave cognitive changes distinct fatigue a history of current back, neck or elbow pain
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
Allocation: Randomized
Intervention Model: Crossover Assignment
Interventional Model Description: Prospective, cross-sectional and test-retest
Masking: Single
Arms and Interventions
| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: Modified Manual Muscle Test<br>The MMMT will be tested in a test-retest design | Diagnostic Test: Modified Manual Muscle Test<br>* Manual Muscle Testing Grading System from 0=No visible or palpable contraction to 5= full range of movement against gravity, maximal resistance<br>Diagnostic Test: BMRC manual muscle test<br>* muscle scale grades muscle power on a scale of 0 to 5 in relation to the maximum expected for that muscle<br>Diagnostic Test: MicroFET2 handhold dynamometer<br>* MicroFET 2 Handheld Dynamometer is a force evaluation testing device to evaluate the strength of various muscle groups<br>Diagnostic Test: Modified Tardieu Scale<br>* Modified Tardieu Scale is to measure if there is spasticity present in a person's muscle and its response to movement<br>Diagnostic Test: Fatigue Scale for Motor and Cognitive Functions<br>* Measures cognitive and motor fatigue for people with MS<br>Diagnostic Test: numeric rating scale Fatigue<br>* visual analog scale that uses a scalar numbering system to objectify a patient's fatigue (0 = no fatigue; 10 = most extreme fatigue)<br>|
| Active Comparator: Neurostatus BMRC<br>The Neurostatus BMRC measures Strength and will be used in a test-retest design | Diagnostic Test: Modified Manual Muscle Test<br>* Manual Muscle Testing Grading System from 0=No visible or palpable contraction to 5= full range of movement against gravity, maximal resistance<br>Diagnostic Test: BMRC manual muscle test<br>* muscle scale grades muscle power on a scale of 0 to 5 in relation to the maximum expected for that muscle<br>Diagnostic Test: MicroFET2 handhold dynamometer<br>* MicroFET 2 Handheld Dynamometer is a force evaluation testing device to evaluate the strength of various muscle groups<br>Diagnostic Test: Modified Tardieu Scale<br>* Modified Tardieu Scale is to measure if there is spasticity present in a person's muscle and its response to movement<br>Diagnostic Test: Fatigue Scale for Motor and Cognitive Functions<br>* Measures cognitive and motor fatigue for people with MS<br>Diagnostic Test: numeric rating scale Fatigue<br>* visual analog scale that uses a scalar numbering system to objectify a patient's fatigue (0 = no fatigue; 10 = most extreme fatigue)<br>|
| Active Comparator: MicroFET2<br>The MicroFET2 is a hand held dynamometer to measure strength | Diagnostic Test: Modified Manual Muscle Test<br>* Manual Muscle Testing Grading System from 0=No visible or palpable contraction to 5= full range of movement against gravity, maximal resistance<br>Diagnostic Test: BMRC manual muscle test<br>* muscle scale grades muscle power on a scale of 0 to 5 in relation to the maximum expected for that muscle<br>Diagnostic Test: MicroFET2 handhold dynamometer<br>* MicroFET 2 Handheld Dynamometer is a force evaluation testing device to evaluate the strength of various muscle groups<br>Diagnostic Test: Modified Tardieu Scale<br>* Modified Tardieu Scale is to measure if there is spasticity present in a person's muscle and its response to movement<br>Diagnostic Test: Fatigue Scale for Motor and Cognitive Functions<br>* Measures cognitive and motor fatigue for people with MS<br>Diagnostic Test: numeric rating scale Fatigue<br>* visual analog scale that uses a scalar numbering system to objectify a patient's fatigue (0 = no fatigue; 10 = most extreme fatigue)<br>|
What is the study measuring?
-----------------
Primary Outcome Measures
| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Inter-rater reliability Modified Manual Muscle Test | The primary endpoint is the MMMT level. The ordinal levels (2+, 3-, 3, 4-, 4, 4+ and 5) will be transformed to ranks (1-7), and the intra-class correlation coefficient (ICC) of the ranked MMMT levels will be estimated. The aim is to show that the MMMT results are at a clinically relevant - thus high - level of ICC (that is a pre-specified, clinically relevant level the ICC margin). The null hypothesis is that the lower limit of the 95% confidence interval (CI) of the ICC is smaller than or equal to the ICC margin. The alternative hypothesis is that the lower limit of the 95% CI of the ICC is larger than the ICC margin. If the lower limit of the CI is larger than the ICC margin, the MMMT will be considered a reliable tool for evaluating muscle strength in MS patients. | Baseline |
Secondary Outcome Measures
| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Intra-rater reliability Modified Manual Muscle Test | The intra-rater reliability will be evaluated by comparing the test results of two tests (test-retest), which will be executed by the same tester. The two tests will be executed on the same day within 4 hours. The intra-class correlation coefficient of the ranked MMMT levels (analogue to the primary endpoint) will be used to describe the intra-rater reliability of the MMMT. | Baseline- Baseline plus 4 hours |
| Validity of the Modified Manual Muscle Test | The inter-rater reliability of the BMRC will be measured by the ICC. The ICC of the BMRC will be estimated and analysed as previously described for the primary analysis. The ICCs of the MMMT and the BMRC will be compared descriptively. The test-retest reliability of the MMMT and the BMRC will be estimated for each rater separately using a two-way random-effects ANOVA, including the patient and test type (test/retest) as random effects. The ICC estimates will be reported with the 95% CI and compared descriptively between the raters using the same test and between the tests (MMMT vs BMRC). The pairwise correlations of the MMMT and the BMRC with the muscle strength as assessed by the microFET2 will be investigated graphically (scatterplots and/or boxplots). Furthermore, Spearman's rank correlation coefficient will be presented with the corresponding 95% CI and p-values. | Baseline- Baseline plus 4 hours |
| Modified Tardieu Scale level | The BMRC has 6 levels, which makes the scale robust and reliable but insensitive to change. In addition, the BMRC does not consider spasticity. The MMMT has 12 levels, which makes it more sensitive, but it also might mean that the scale is less reliable. Because the MMMT considers spasticity, we expect that this compensates for the possible loss of reliability. It is assumed that the MMMT is less sensitive to spasticity than the BMRC. Thus, for patients with a different level of spasticity measured by the Modified Tardieu Scale, both the inter-rater and the test-retest reliability of the MMMT are expected to be equal to those of the BMRC. The primary and secondary analyses will thus be repeated for the subgroups of high-spasticity and low-spasticity patients separately (assuming that a reasonable number of patients per subgroup and endpoint are available). | Baseline- Baseline plus 4 hours |
|
|
NCT01919606
|
EXPAREL Administered Into the TAP for Analgesia in Subjects Undergoing Open Total Abdominal Hysterectomy
|
The primary objective of this study is to determine the optimal of two different volumes of EXPAREL 266 mg when administered via infiltration into the transversus abdominis plane (TAP) for prolonged postoperative analgesia in subjects undergoing open total abdominal hysterectomy.
|
This is a prospective, open-label, non-randomized study with two treatment groups differing only in the volume of EXPAREL infiltrated into the TAP. All subjects will undergo an open total abdominal hysterectomy. The dose of EXPAREL for the TAPs will be the same for all 20 subjects, 133 mg on the right side of the abdomen and 133 mg on the left side of the abdomen.
|
Evaluation of the Safety and Efficacy of EXPAREL(R) (Bupivacaine Liposome Injectable Suspension) When Administered Into the Transversus Abdominis Plane (TAP) for Prolonged Postoperative Analgesia in Subjects Undergoing Open Total Abdominal Hysterectomy
|
Postoperative Pain
|
* Drug: EXPAREL
|
Inclusion Criteria:~Females, 18-75 years of age inclusive.~American Society of Anesthesiologist (ASA) physical status 1-3.~Undergoing open total abdominal hysterectomy (i.e., laparoscopic procedures are not sufficient) without any concurrent surgical procedure(s).~Physically and mentally able to participate in the study and complete all study assessments.~Able to give fully informed consent to participate in this study after demonstrating a good understanding of the risks and benefits of the TAP.~Exclusion Criteria:~Demonstrated hypersensitivity or idiosyncratic reactions to amide-type local anesthetics.~Any subject whose anatomy, or surgical procedure, in the opinion of the Investigator, might preclude the potential successful performance of a TAP.~Any subject who in the opinion of the Investigator might be harmed or be a poor candidate for participation in the study.~Any subject, who in the opinion of the Investigator, is on chronic pain medicine.~Subjects who have received any investigational drug within 30 days prior to study drug administration, or planned administration of another investigational product or procedure during their participation in this study.
|
18 Years
|
75 Years
|
Female
|
No
|
Primary Purpose: Treatment
Allocation: Non-Randomized
Intervention Model: Single Group Assignment
Masking: None (Open Label)
|
| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Duration of Analgesia | | End of surgery to time of subject's first postsurgical opioid administration (through 72 hours) |
|
| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Incidence of Adverse Events | | 10 days post surgery plus or minus 3 days |
|
hysterectomy, analgesia
|
Bupivacaine, Anesthetics, Local, Anesthetics, Central Nervous System Depressants, Physiological Effects of Drugs, Sensory System Agents, Peripheral Nervous System Agents
|
| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: EXPAREL Group 1<br>EXPAREL 266 mg diluted with saline to a volume of 40 mL | Drug: EXPAREL<br>* Single-dose EXPAREL diluted with 20 mL or 40 mL saline to a volume of 40 mL or 60 mL, respectively.<br>* Other names: Bupivacaine liposome injectable suspension;|
| Experimental: EXPAREL Group 2<br>EXPAREL 266 mg diluted with saline to a volume of 60 mL | Drug: EXPAREL<br>* Single-dose EXPAREL diluted with 20 mL or 40 mL saline to a volume of 40 mL or 60 mL, respectively.<br>* Other names: Bupivacaine liposome injectable suspension;|
|
EXPAREL Administered Into the TAP for Analgesia in Subjects Undergoing Open Total Abdominal Hysterectomy
Study Overview
=================
Brief Summary
-----------------
The primary objective of this study is to determine the optimal of two different volumes of EXPAREL 266 mg when administered via infiltration into the transversus abdominis plane (TAP) for prolonged postoperative analgesia in subjects undergoing open total abdominal hysterectomy.
Detailed Description
-----------------
This is a prospective, open-label, non-randomized study with two treatment groups differing only in the volume of EXPAREL infiltrated into the TAP. All subjects will undergo an open total abdominal hysterectomy. The dose of EXPAREL for the TAPs will be the same for all 20 subjects, 133 mg on the right side of the abdomen and 133 mg on the left side of the abdomen.
Official Title
-----------------
Evaluation of the Safety and Efficacy of EXPAREL(R) (Bupivacaine Liposome Injectable Suspension) When Administered Into the Transversus Abdominis Plane (TAP) for Prolonged Postoperative Analgesia in Subjects Undergoing Open Total Abdominal Hysterectomy
Conditions
-----------------
Postoperative Pain
Intervention / Treatment
-----------------
* Drug: EXPAREL
Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Females, 18-75 years of age inclusive. American Society of Anesthesiologist (ASA) physical status 1-3. Undergoing open total abdominal hysterectomy (i.e., laparoscopic procedures are not sufficient) without any concurrent surgical procedure(s). Physically and mentally able to participate in the study and complete all study assessments. Able to give fully informed consent to participate in this study after demonstrating a good understanding of the risks and benefits of the TAP. Exclusion Criteria: Demonstrated hypersensitivity or idiosyncratic reactions to amide-type local anesthetics. Any subject whose anatomy, or surgical procedure, in the opinion of the Investigator, might preclude the potential successful performance of a TAP. Any subject who in the opinion of the Investigator might be harmed or be a poor candidate for participation in the study. Any subject, who in the opinion of the Investigator, is on chronic pain medicine. Subjects who have received any investigational drug within 30 days prior to study drug administration, or planned administration of another investigational product or procedure during their participation in this study.
Ages Eligible for Study
-----------------
Minimum Age: 18 Years
Maximum Age: 75 Years
Sexes Eligible for Study
-----------------
Female
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: EXPAREL Group 1<br>EXPAREL 266 mg diluted with saline to a volume of 40 mL | Drug: EXPAREL<br>* Single-dose EXPAREL diluted with 20 mL or 40 mL saline to a volume of 40 mL or 60 mL, respectively.<br>* Other names: Bupivacaine liposome injectable suspension;|
| Experimental: EXPAREL Group 2<br>EXPAREL 266 mg diluted with saline to a volume of 60 mL | Drug: EXPAREL<br>* Single-dose EXPAREL diluted with 20 mL or 40 mL saline to a volume of 40 mL or 60 mL, respectively.<br>* Other names: Bupivacaine liposome injectable suspension;|
What is the study measuring?
-----------------
Primary Outcome Measures
| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Duration of Analgesia | | End of surgery to time of subject's first postsurgical opioid administration (through 72 hours) |
Secondary Outcome Measures
| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Incidence of Adverse Events | | 10 days post surgery plus or minus 3 days |
Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
hysterectomy, analgesia
|
NCT03472755
|
Comparison of Direct Anterior and Posterior Surgical Approaches in Regards to the Patient' Physical Characteristics
|
Recent increased interest in tissue-sparing and minimally invasive arthroplasty has given rise to a sharp increase in the utilization of direct anterior total hip arthroplasty.
|
Purpose: The direct anterior approach to the hip has been suggested to have several advantages compared to previously classical approaches. However, no studies focused on the effects of these different surgeries on patients' perception recovery and walking efficiency according the initial physical fitness. Therefore, the purpose of this study is to compare the effects of surgical procedures on perceptual walking skills and efficiency according to the patients' physical fitness.~Abstract : Some earlier studies report differences between surgery types in self- reported mobility, functional recovery and residual hip pain. The direct anterior approach to the hip has been suggested to have several advantages compared to previously popular approaches through its use of an intra-muscular and intra-nervous interval between the tensor fasciae latae and sartorius muscles. However, patients' physical fitness, postural response and perceptual walking skill relation was not taking account. 80 patients will be tested, one before and at various times after hip surgery. In randomized conditions, our patients will be divided in two groups, according the surgery approaches and their physical fitness. All patients performed a Performance-Oriented Mobility Assessment Walking test with and without step and the PMA, Harris, Oxford 12 and Womac scores will be evaluated before, 3 weeks, 6 weeks, 3 months and 1 year after the surgery. During the Performance-Oriented Mobility Assessment Walking test, self-reported walking capacity, rating of exertion perception and walking parameters will be measured.
|
Subjective Walking Capacity : Comparison of Direct Anterior and Posterior Surgical Approaches in Regards to the Patient' Physical Characteristics (MOPHEM)
|
Hip Arthropathy
|
* Other: The posterolateral approach
* Other: Direct anterior technique
|
Inclusion Criteria:~Age > 50 years~Body mass index < 35~Scheduled hip arthroplasty surgery~Exclusion Criteria:~No health coverage~Age > 85 years~Body mass index ≥ 35~Cognitive impairment (score Mini Mental Statue < 24)~Any other osteo-articular diseases than the operated hip, any muscular or neurological diseases that could penalize the walk
|
50 Years
|
85 Years
|
All
|
No
|
Primary Purpose: Supportive Care
Allocation: Randomized
Intervention Model: Parallel Assignment
Interventional Model Description: Patients provided written informed consent to participate in this study, as approved by the local ethics committee. Prior to surgery, patients were informed about the benefits and risk of the conventional posterolateral and direct anterior approaches. Then they performed postural test and a Performance-Oriented Mobility Assessment Walking test with and without step. After randomization, patients were operated according the conventional posterolateral or direct anterior techniques.
Masking: None (Open Label)
|
| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| hip's range of motion. | | 1 year |
|
hip arthroplasty, surgeries, physical fitness, perception, energetic cost, autonomy
|
Joint Diseases, Musculoskeletal Diseases
|
| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Other: The posterolateral approach<br>The posterolateral approach was used for implantation among patients in lateral position. This approach goes through the gluteus maximus, the piriformis and superior gemeli muscles are detached and later reattached to bone | Other: The posterolateral approach<br>* The posterolateral approach was used for implantation among patients in lateral position. This approach goes through the gluteus maximus, the piriformis and superior gemeli muscles are detached and later reattached to bone<br>|
| Other: Direct anterior techniques.<br>. In the direct anterior technique, patients were fixed in a supine position, a small entry incision was made in the vessel free interval between the tensor fasciae latae and the sartorius muscles and the prosthesis socket were put in place. Via a second dorsal incision, after releasing the external rotators, the prosthesis stem and ball were implanted and the two parts of the prosthesis were attached. | Other: Direct anterior technique<br>* patients were fixed in a supine position, a small entry incision was made in the vessel free interval between the tensor fasciae latae and the sartorius muscles and the prosthesis socket were put in place. Via a second dorsal incision, after releasing the external rotators, the prosthesis stem and ball were implanted and the two parts of the prosthesis were attached<br>|
|
Comparison of Direct Anterior and Posterior Surgical Approaches in Regards to the Patient' Physical Characteristics
Study Overview
=================
Brief Summary
-----------------
Recent increased interest in tissue-sparing and minimally invasive arthroplasty has given rise to a sharp increase in the utilization of direct anterior total hip arthroplasty.
Detailed Description
-----------------
Purpose: The direct anterior approach to the hip has been suggested to have several advantages compared to previously classical approaches. However, no studies focused on the effects of these different surgeries on patients' perception recovery and walking efficiency according the initial physical fitness. Therefore, the purpose of this study is to compare the effects of surgical procedures on perceptual walking skills and efficiency according to the patients' physical fitness. Abstract : Some earlier studies report differences between surgery types in self- reported mobility, functional recovery and residual hip pain. The direct anterior approach to the hip has been suggested to have several advantages compared to previously popular approaches through its use of an intra-muscular and intra-nervous interval between the tensor fasciae latae and sartorius muscles. However, patients' physical fitness, postural response and perceptual walking skill relation was not taking account. 80 patients will be tested, one before and at various times after hip surgery. In randomized conditions, our patients will be divided in two groups, according the surgery approaches and their physical fitness. All patients performed a Performance-Oriented Mobility Assessment Walking test with and without step and the PMA, Harris, Oxford 12 and Womac scores will be evaluated before, 3 weeks, 6 weeks, 3 months and 1 year after the surgery. During the Performance-Oriented Mobility Assessment Walking test, self-reported walking capacity, rating of exertion perception and walking parameters will be measured.
Official Title
-----------------
Subjective Walking Capacity : Comparison of Direct Anterior and Posterior Surgical Approaches in Regards to the Patient' Physical Characteristics (MOPHEM)
Conditions
-----------------
Hip Arthropathy
Intervention / Treatment
-----------------
* Other: The posterolateral approach
* Other: Direct anterior technique
Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Age > 50 years Body mass index < 35 Scheduled hip arthroplasty surgery Exclusion Criteria: No health coverage Age > 85 years Body mass index ≥ 35 Cognitive impairment (score Mini Mental Statue < 24) Any other osteo-articular diseases than the operated hip, any muscular or neurological diseases that could penalize the walk
Ages Eligible for Study
-----------------
Minimum Age: 50 Years
Maximum Age: 85 Years
Sexes Eligible for Study
-----------------
All
Accepts Healthy Volunteers
-----------------
No
Study Plan
=================
How is the study designed?
-----------------
Design Details
Primary Purpose: Supportive Care
Allocation: Randomized
Intervention Model: Parallel Assignment
Interventional Model Description: Patients provided written informed consent to participate in this study, as approved by the local ethics committee. Prior to surgery, patients were informed about the benefits and risk of the conventional posterolateral and direct anterior approaches. Then they performed postural test and a Performance-Oriented Mobility Assessment Walking test with and without step. After randomization, patients were operated according the conventional posterolateral or direct anterior techniques.
Masking: None (Open Label)
Arms and Interventions
| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Other: The posterolateral approach<br>The posterolateral approach was used for implantation among patients in lateral position. This approach goes through the gluteus maximus, the piriformis and superior gemeli muscles are detached and later reattached to bone | Other: The posterolateral approach<br>* The posterolateral approach was used for implantation among patients in lateral position. This approach goes through the gluteus maximus, the piriformis and superior gemeli muscles are detached and later reattached to bone<br>|
| Other: Direct anterior techniques.<br>. In the direct anterior technique, patients were fixed in a supine position, a small entry incision was made in the vessel free interval between the tensor fasciae latae and the sartorius muscles and the prosthesis socket were put in place. Via a second dorsal incision, after releasing the external rotators, the prosthesis stem and ball were implanted and the two parts of the prosthesis were attached. | Other: Direct anterior technique<br>* patients were fixed in a supine position, a small entry incision was made in the vessel free interval between the tensor fasciae latae and the sartorius muscles and the prosthesis socket were put in place. Via a second dorsal incision, after releasing the external rotators, the prosthesis stem and ball were implanted and the two parts of the prosthesis were attached<br>|
What is the study measuring?
-----------------
Primary Outcome Measures
| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| hip's range of motion. | | 1 year |
Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
hip arthroplasty, surgeries, physical fitness, perception, energetic cost, autonomy
|
|
NCT02972073
|
Investigation of Trunk Neuromuscular Control in Patients With Non-specific Low Back Pain
|
The purposes of this study include 1) determine clinical utility of clinical observation of aberrant movement patterns during functional trunk and pelvic movements in asymptomatic individuals and patients with non-specific low back pain, 2) characterize trunk neuromuscular control in asymptomatic individuals and patients with non-specific low back pain, and 3) determine the appropriate physical therapy intervention that addresses trunk neuromuscular control deficits in patients with non-specific low back pain.
|
This study will use a sample of convenience between the ages of 21 - 65. Patients with non-specific low back pain (NSLBP) will be recruited by advertisement in 2 Mahidol university physical therapy clinics and participating clinics and hospitals. Asymptomatic participants will be also recruited by flyers posted in 2 Mahidol university physical therapy clinics.~Based upon power analysis for change in kinematic pattern in patients with NSLBP after an 8-week core stabilization exercise program, a total required sample size is 29 patients with NSLBP to detect a medium effect size (Cohen's d) of .48 at level (α) of .05 and power (1-β) of .80. Fifteen percent drop-out rate is used as a conservative sample size calculation. Therefore, 34 patients with NSLBP (29 X 15% drop-out) and 34 age-, sex-, and BMI-matched asymptomatic participants will be included for each independent intervention study (core stabilization exercise approach, movement system impairment approach, neuromuscular activation using suspension, and kinematic linkage imbalance approach). Each intervention will be separately collected and analyzed. The total of 272 participants will be recruited to fulfill this study project (4 independent intervention studies). However, sample size for asymptomatic participants can be decreased if participant from one intervention study is matched with patients with NSLBP in other intervention studies.~Patients with NSLBP who are interested in participation will undergo a screening process using inclusion-exclusion criteria checklist and receive brief information regarding the study. If they meet all inclusion criteria, the consent process and biomechanical testing will be scheduled. On date of consent and biomechanical testing, both asymptomatic participants and participants with NSLBP will be provided a consent form. To ensure they understand the study, they will be simply asked regarding the study (i.e. objectives, benefits, etc.) before signing the consent form. After the participants provide a written informed consent, they will undergo a standardized physical therapy examination performed by an experienced physical therapist (PT-A). For patients with NSLBP, they will also complete 3 clinical outcome measures including 1) numeric pain rating scale (Thai version), 2) Oswestry disability index (Thai version), and 3) general health status questionnaire (Thai version). This pre-biomechanical data collection process will last approximately 60 minutes.~For biomechanical testing, body landmarks will be identified and marked with a skin pen for 4 motion sensors and 16 pairs of surface electromyography (EMG) electrodes in lower back and abdominal areas. Any hair in the area around the sensors and electrodes will be shaved. Before placing surface EMG electrodes, the skin will be lightly abraded using abrasive paper and cleaned using cotton with alcohol to lower the skin impedance. Electrodes will be aligned parallel to the muscle fibers. This process will take approximately 30 minutes. Then, participants will proceed to the biomechanical testing which includes 1) trunk muscle strength test, 2) functional trunk and pelvic movement tests, and 3) core control tasks.~Trunk muscle strength test Strength test Participants will wear a climbing harness connecting with a tension load cell and sit in a testing apparatus in a neutral trunk position with pelvic securely locked. This apparatus intends to reduce compensation from lower extremities during sub-maximal (15% of body weight) and maximal voluntary isometric contractions. Participants will be instructed to use their trunk gradually pulling the load cell (isometric contraction in neutral trunk position) for 10 seconds in forward, backward, and 2 side bending directions. Participants will be given 2 practice trials in each direction to adjust the force and reduce a learning effect. Visual feedback of force to sub-maximal target will be provided. Two trials of sub-maximal voluntary isometric contractions will be collected in each direction. Only 1 trial of maximal voluntary isometric contraction will be collected to avoid muscle fatigue (in both asymptomatic participants and patients with NSLBP) and pain exacerbation (in patients with NSLBP). The intention of collecting maximal contraction data is to use for EMG standardization. Participants will rest in between each trial to minimize fatigue. Pain and rating perceived exertion (RPE) will be monitored and recorded at the end of trunk strength test. This protocol will take approximately 15 minutes.~Functional trunk and pelvic movement tests Participants will stand on a drawing paper with feet shoulder width apart in front of the motion transmitter. The foot print will be drawn using a marker. This foot print will be used for post-test positioning. The participants will stand in a natural stance facing away from the transmitter with arms down by sides. Participants will be instructed to stand up straight and maintain that position for digitization. After the completion of digitization, participants will be instructed to perform functional movements including 1) active forward bend and return to upright position, 2) right and left straight leg raise tests, 3) right and left hip abduction with knee flexion tests, 4) quadruped backward rock test, 5) prone with right and left knee flexion tests, 6) prone with right and left hip internal/external rotation tests, and 7) prone with right and left hip extension tests. Participants will perform 2 trials of 3 consecutive repetitions of each functional movement tests. Two physical therapists (PT-B and PT-C), who are blinded to the group membership, will simultaneously observe and independently rate aberrant movement patterns during biomechanical data collection. This protocol will take approximately 30 minutes.~Core control tasks Participants will sit on an unstable chair with feet supported. The chair is mounted on a half ball that makes the chair unstable and tilt. Participants will be instructed to balance the chair without tipping the chair in any direction. The participants will maintain upright seated balance with crossing both arms in front of their chest. The participants will have an opportunity to get familiar with the balance testing protocol prior to the data collection to minimize the learning effect. This core control tasks aim to investigate the performances that represent static and dynamic stabilities of the trunk. For static stability, the participants will perform 3 trials of 60-second seated balance tests with their eyes open, and 3 trials of 60-second seated balance tests with their eyes closed. The participants will be given a 1-minute rest period between trials to avoid muscle fatigue. For dynamic stability, the participants will be instructed to perform a dynamic stability using lumbar spine (without trunk leaning to tilt an unstable chair as far as they can) in 8 different directions (forward, backward, right, left, right diagonal, and left diagonal). The participants will be given 1 practice trial to reduce possibility of learning effect, and 3 real trials with 1-minute rest period between trials. Pain and RPE will be recorded at the completion of core control task. This protocol will take approximately 30 minutes.~Patients with NSLBP will be assigned to one of different physical therapy interventions according to participating clinics and hospitals, while asymptomatic participants will be encouraged to maintain usual daily activities and avoid participating in activities that involve trunk muscle exercise. After completion of an 8-week physical therapy intervention, both asymptomatic participants and patients with NSLBP will undergo the standardized physical therapy examination and biomechanical data collection again. For patients with NSLBP, they will also complete clinical outcome measures for post physical therapy intervention.~Physical therapy intervention Patients with NSLBP will be treated with a standard physical therapy intervention based upon different treatment concepts. In general, these interventions include strengthening exercise, endurance exercise, stretching exercise, patient education, patient ergonomics, and home exercise program. There is no reported adverse effect of those physical therapy interventions. Therefore, those physical therapy interventions are safe for treating patients with NSLBP. Each patient will be treated 1-2 times per week for 60 minutes each session for 8 weeks by experienced physical therapists. Patients will be given a home exercise log for exercise compliance.~All Statistical analyses will be performed using statistical package for the social science (SPSS) software (IBM SPSS Statistics for Windows, Version 21.0., New York, USA).~Study objective 1 is to determine inter-rater reliability and diagnostic accuracy of clinical observation of aberrant movement patterns during functional trunk and pelvic movements in patients with NSLBP. Agreement on the presence/absence of aberrant movement patterns between physical therapists (PT-B and PT-C) will be determined using separate kappa statistics. Diagnostic accuracy will be determined using accuracy statistics which include sensitivity, specificity, and likelihood ratio. Significance level will be held at .05 for all analysis. Confidence intervals will also be calculated.~Study objective 2 is to characterize neuromuscular control in asymptomatic participants and patients with NSLBP during functional activities. Each variable will be analyzed separately. Descriptive statistics (i.e. mean and standard deviation) will be performed and statistical assumptions (i.e. normal distribution, homogeneity of variance, etc.) related to specific statistical tests will be performed. Statistical transformation will be performed if appropriate. Then, statistical test (i.e. independent t-test, Mann-Whitney U-test, etc.) that appropriate to the data will be performed to determine the difference between asymptomatic participants and patients with NSLBP. Significance level will be held at .05 for all analyses. Post-hoc power analysis will also be performed to determine statistical power and effect size.~Study objective 3 is to determine the appropriate physical therapy intervention that addresses neuromuscular control deficits in patients with NSLBP. First, the effects of each physical therapy intervention on trunk neuromuscular control and clinical outcomes will be determined. Prior to utilization of statistical tests, descriptive statistics will be performed and statistical assumptions will be tested. Transformation will be performed if the data are not normally distributed. Appropriate statistical tests will be performed to determine the effects of each physical therapy intervention on neuromuscular control and clinical outcome. Significance level will be held at .05 for all analyses. Post-hoc power analysis will be performed. In addition, this study objective will determine the ability of physical therapy intervention on matched- and unmatched-intervention patients based upon each intervention criteria. Each patient with NSLBP will be classified based upon clinical criteria of each physical therapy intervention. Pre-post difference for matched and unmatched groups will be compared using appropriate statistical tests. Significance level will be held at .05 for all analyses. Post-hoc power analysis will also be performed.
|
Investigation of Trunk Neuromuscular Control in Patients With Non-specific Low Back Pain
|
Low Back Pain
|
* Other: Exercise intervention
|
Inclusion Criteria for patients with non-specific low back pain:~Between the ages of 21 and 65~Current episode of back pain less than 3 months which they seek medical intervention~Numeric pain rating scale (NPRS) greater than 5 on an 11-point scale (0 = no pain, 10 = worst pain ever)~Oswestry disability score (Thai version) greater than 50%~No medical or professional health care intervention including physical therapy for low back pain in last 6 months~Inclusion Criteria for healthy individual:~Between the ages of 21 and 65~No episode of back pain for 3 months prior to the participation~No regular exercise routine that is composed of core stabilization exercise.~Exclusion Criteria for both groups:~Clinical signs of systemic disease~Definitive neurologic signs including weakness or numbness in the lower extremity~Previous spinal surgery~Diagnosed osteoporosis, severe spinal stenosis, and/or inflammatory joint disease~Pregnancy~Any lower extremity condition that would potentially alter trunk movement in standing~Vestibular dysfunction~Extreme psychosocial involvement~Body mass index (BMI) greater than 30 kg/m2~Active treatment of another medical illness that would preclude participation in any aspect of the study
|
21 Years
|
65 Years
|
All
|
Accepts Healthy Volunteers
|
Primary Purpose: Treatment
Allocation: Non-Randomized
Intervention Model: Parallel Assignment
Masking: Single
|
| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Electromyography (EMG) muscle activity | Muscle activity recorded by surface-electromyography (EMG) during functional movements will be used to determine muscle activation pattern changes at 8 weeks after exercise intervention. | Change from baseline muscle activity at 8 weeks after exercise intervention. |
| Kinematic pattern of movement | Patterns of functional movement will be captured using electromagnetic tracking system and used to determine changes in kinematic pattern of movement at 8 weeks after exercise the exercise intervention. | Change from baseline movement pattern at 8 weeks after exercise intervention. |
|
| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Numeric pain rating scale | Pain assessed by a numeric pain rating scale will be used to determine change in pain at 8 weeks after exercise intervention. | Change in pain from baseline at 8 weeks after exercise intervention |
| Oswestry disability index | Disability level measured by Oswestry disability index will be used to determine change in disability level at 8 weeks after exercise intervention. | Change from baseline disability level at 8 weeks after exercise intervention |
| Short-form general heath status (SF-36) questionnaire | General health status assessed by short-form general health status questionnaire (SF-36) will be used to change in general health status at 8 weeks after exercise intervention. | Change from baseline general health status at 8 weeks after exercise intervention |
|
Low back pain, Neuromuscular control
|
Pain, Back Pain, Low Back Pain, Neurologic Manifestations
|
| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Exercise intervention<br>There are 4 different exercise interventions (4 independent intervention studies) based on different concepts in this entire project. Interventions include:~core stabilization exercise~movement system impairment approach~neuromuscular activation using suspension~kinematic linkage imbalance | Other: Exercise intervention<br>* Physical therapist will provide exercise for patients with low back pain for 60 minutes per day, 2-3 days per week for the total of 8 weeks.<br>|
| No Intervention: Healthy control<br>This healthy control group will be informed to maintain usual daily activities and avoid participating in activities that involve trunk muscle exercise | |
|
Investigation of Trunk Neuromuscular Control in Patients With Non-specific Low Back Pain
Study Overview
=================
Brief Summary
-----------------
The purposes of this study include 1) determine clinical utility of clinical observation of aberrant movement patterns during functional trunk and pelvic movements in asymptomatic individuals and patients with non-specific low back pain, 2) characterize trunk neuromuscular control in asymptomatic individuals and patients with non-specific low back pain, and 3) determine the appropriate physical therapy intervention that addresses trunk neuromuscular control deficits in patients with non-specific low back pain.
Detailed Description
-----------------
This study will use a sample of convenience between the ages of 21 - 65. Patients with non-specific low back pain (NSLBP) will be recruited by advertisement in 2 Mahidol university physical therapy clinics and participating clinics and hospitals. Asymptomatic participants will be also recruited by flyers posted in 2 Mahidol university physical therapy clinics. Based upon power analysis for change in kinematic pattern in patients with NSLBP after an 8-week core stabilization exercise program, a total required sample size is 29 patients with NSLBP to detect a medium effect size (Cohen's d) of .48 at level (α) of .05 and power (1-β) of .80. Fifteen percent drop-out rate is used as a conservative sample size calculation. Therefore, 34 patients with NSLBP (29 X 15% drop-out) and 34 age-, sex-, and BMI-matched asymptomatic participants will be included for each independent intervention study (core stabilization exercise approach, movement system impairment approach, neuromuscular activation using suspension, and kinematic linkage imbalance approach). Each intervention will be separately collected and analyzed. The total of 272 participants will be recruited to fulfill this study project (4 independent intervention studies). However, sample size for asymptomatic participants can be decreased if participant from one intervention study is matched with patients with NSLBP in other intervention studies. Patients with NSLBP who are interested in participation will undergo a screening process using inclusion-exclusion criteria checklist and receive brief information regarding the study. If they meet all inclusion criteria, the consent process and biomechanical testing will be scheduled. On date of consent and biomechanical testing, both asymptomatic participants and participants with NSLBP will be provided a consent form. To ensure they understand the study, they will be simply asked regarding the study (i.e. objectives, benefits, etc.) before signing the consent form. After the participants provide a written informed consent, they will undergo a standardized physical therapy examination performed by an experienced physical therapist (PT-A). For patients with NSLBP, they will also complete 3 clinical outcome measures including 1) numeric pain rating scale (Thai version), 2) Oswestry disability index (Thai version), and 3) general health status questionnaire (Thai version). This pre-biomechanical data collection process will last approximately 60 minutes. For biomechanical testing, body landmarks will be identified and marked with a skin pen for 4 motion sensors and 16 pairs of surface electromyography (EMG) electrodes in lower back and abdominal areas. Any hair in the area around the sensors and electrodes will be shaved. Before placing surface EMG electrodes, the skin will be lightly abraded using abrasive paper and cleaned using cotton with alcohol to lower the skin impedance. Electrodes will be aligned parallel to the muscle fibers. This process will take approximately 30 minutes. Then, participants will proceed to the biomechanical testing which includes 1) trunk muscle strength test, 2) functional trunk and pelvic movement tests, and 3) core control tasks. Trunk muscle strength test Strength test Participants will wear a climbing harness connecting with a tension load cell and sit in a testing apparatus in a neutral trunk position with pelvic securely locked. This apparatus intends to reduce compensation from lower extremities during sub-maximal (15% of body weight) and maximal voluntary isometric contractions. Participants will be instructed to use their trunk gradually pulling the load cell (isometric contraction in neutral trunk position) for 10 seconds in forward, backward, and 2 side bending directions. Participants will be given 2 practice trials in each direction to adjust the force and reduce a learning effect. Visual feedback of force to sub-maximal target will be provided. Two trials of sub-maximal voluntary isometric contractions will be collected in each direction. Only 1 trial of maximal voluntary isometric contraction will be collected to avoid muscle fatigue (in both asymptomatic participants and patients with NSLBP) and pain exacerbation (in patients with NSLBP). The intention of collecting maximal contraction data is to use for EMG standardization. Participants will rest in between each trial to minimize fatigue. Pain and rating perceived exertion (RPE) will be monitored and recorded at the end of trunk strength test. This protocol will take approximately 15 minutes. Functional trunk and pelvic movement tests Participants will stand on a drawing paper with feet shoulder width apart in front of the motion transmitter. The foot print will be drawn using a marker. This foot print will be used for post-test positioning. The participants will stand in a natural stance facing away from the transmitter with arms down by sides. Participants will be instructed to stand up straight and maintain that position for digitization. After the completion of digitization, participants will be instructed to perform functional movements including 1) active forward bend and return to upright position, 2) right and left straight leg raise tests, 3) right and left hip abduction with knee flexion tests, 4) quadruped backward rock test, 5) prone with right and left knee flexion tests, 6) prone with right and left hip internal/external rotation tests, and 7) prone with right and left hip extension tests. Participants will perform 2 trials of 3 consecutive repetitions of each functional movement tests. Two physical therapists (PT-B and PT-C), who are blinded to the group membership, will simultaneously observe and independently rate aberrant movement patterns during biomechanical data collection. This protocol will take approximately 30 minutes. Core control tasks Participants will sit on an unstable chair with feet supported. The chair is mounted on a half ball that makes the chair unstable and tilt. Participants will be instructed to balance the chair without tipping the chair in any direction. The participants will maintain upright seated balance with crossing both arms in front of their chest. The participants will have an opportunity to get familiar with the balance testing protocol prior to the data collection to minimize the learning effect. This core control tasks aim to investigate the performances that represent static and dynamic stabilities of the trunk. For static stability, the participants will perform 3 trials of 60-second seated balance tests with their eyes open, and 3 trials of 60-second seated balance tests with their eyes closed. The participants will be given a 1-minute rest period between trials to avoid muscle fatigue. For dynamic stability, the participants will be instructed to perform a dynamic stability using lumbar spine (without trunk leaning to tilt an unstable chair as far as they can) in 8 different directions (forward, backward, right, left, right diagonal, and left diagonal). The participants will be given 1 practice trial to reduce possibility of learning effect, and 3 real trials with 1-minute rest period between trials. Pain and RPE will be recorded at the completion of core control task. This protocol will take approximately 30 minutes. Patients with NSLBP will be assigned to one of different physical therapy interventions according to participating clinics and hospitals, while asymptomatic participants will be encouraged to maintain usual daily activities and avoid participating in activities that involve trunk muscle exercise. After completion of an 8-week physical therapy intervention, both asymptomatic participants and patients with NSLBP will undergo the standardized physical therapy examination and biomechanical data collection again. For patients with NSLBP, they will also complete clinical outcome measures for post physical therapy intervention. Physical therapy intervention Patients with NSLBP will be treated with a standard physical therapy intervention based upon different treatment concepts. In general, these interventions include strengthening exercise, endurance exercise, stretching exercise, patient education, patient ergonomics, and home exercise program. There is no reported adverse effect of those physical therapy interventions. Therefore, those physical therapy interventions are safe for treating patients with NSLBP. Each patient will be treated 1-2 times per week for 60 minutes each session for 8 weeks by experienced physical therapists. Patients will be given a home exercise log for exercise compliance. All Statistical analyses will be performed using statistical package for the social science (SPSS) software (IBM SPSS Statistics for Windows, Version 21.0., New York, USA). Study objective 1 is to determine inter-rater reliability and diagnostic accuracy of clinical observation of aberrant movement patterns during functional trunk and pelvic movements in patients with NSLBP. Agreement on the presence/absence of aberrant movement patterns between physical therapists (PT-B and PT-C) will be determined using separate kappa statistics. Diagnostic accuracy will be determined using accuracy statistics which include sensitivity, specificity, and likelihood ratio. Significance level will be held at .05 for all analysis. Confidence intervals will also be calculated. Study objective 2 is to characterize neuromuscular control in asymptomatic participants and patients with NSLBP during functional activities. Each variable will be analyzed separately. Descriptive statistics (i.e. mean and standard deviation) will be performed and statistical assumptions (i.e. normal distribution, homogeneity of variance, etc.) related to specific statistical tests will be performed. Statistical transformation will be performed if appropriate. Then, statistical test (i.e. independent t-test, Mann-Whitney U-test, etc.) that appropriate to the data will be performed to determine the difference between asymptomatic participants and patients with NSLBP. Significance level will be held at .05 for all analyses. Post-hoc power analysis will also be performed to determine statistical power and effect size. Study objective 3 is to determine the appropriate physical therapy intervention that addresses neuromuscular control deficits in patients with NSLBP. First, the effects of each physical therapy intervention on trunk neuromuscular control and clinical outcomes will be determined. Prior to utilization of statistical tests, descriptive statistics will be performed and statistical assumptions will be tested. Transformation will be performed if the data are not normally distributed. Appropriate statistical tests will be performed to determine the effects of each physical therapy intervention on neuromuscular control and clinical outcome. Significance level will be held at .05 for all analyses. Post-hoc power analysis will be performed. In addition, this study objective will determine the ability of physical therapy intervention on matched- and unmatched-intervention patients based upon each intervention criteria. Each patient with NSLBP will be classified based upon clinical criteria of each physical therapy intervention. Pre-post difference for matched and unmatched groups will be compared using appropriate statistical tests. Significance level will be held at .05 for all analyses. Post-hoc power analysis will also be performed.
Official Title
-----------------
Investigation of Trunk Neuromuscular Control in Patients With Non-specific Low Back Pain
Conditions
-----------------
Low Back Pain
Intervention / Treatment
-----------------
* Other: Exercise intervention
Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria for patients with non-specific low back pain: Between the ages of 21 and 65 Current episode of back pain less than 3 months which they seek medical intervention Numeric pain rating scale (NPRS) greater than 5 on an 11-point scale (0 = no pain, 10 = worst pain ever) Oswestry disability score (Thai version) greater than 50% No medical or professional health care intervention including physical therapy for low back pain in last 6 months Inclusion Criteria for healthy individual: Between the ages of 21 and 65 No episode of back pain for 3 months prior to the participation No regular exercise routine that is composed of core stabilization exercise. Exclusion Criteria for both groups: Clinical signs of systemic disease Definitive neurologic signs including weakness or numbness in the lower extremity Previous spinal surgery Diagnosed osteoporosis, severe spinal stenosis, and/or inflammatory joint disease Pregnancy Any lower extremity condition that would potentially alter trunk movement in standing Vestibular dysfunction Extreme psychosocial involvement Body mass index (BMI) greater than 30 kg/m2 Active treatment of another medical illness that would preclude participation in any aspect of the study
Ages Eligible for Study
-----------------
Minimum Age: 21 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: Treatment
Allocation: Non-Randomized
Intervention Model: Parallel Assignment
Masking: Single
Arms and Interventions
| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Exercise intervention<br>There are 4 different exercise interventions (4 independent intervention studies) based on different concepts in this entire project. Interventions include: core stabilization exercise movement system impairment approach neuromuscular activation using suspension kinematic linkage imbalance | Other: Exercise intervention<br>* Physical therapist will provide exercise for patients with low back pain for 60 minutes per day, 2-3 days per week for the total of 8 weeks.<br>|
| No Intervention: Healthy control<br>This healthy control group will be informed to maintain usual daily activities and avoid participating in activities that involve trunk muscle exercise | |
What is the study measuring?
-----------------
Primary Outcome Measures
| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Electromyography (EMG) muscle activity | Muscle activity recorded by surface-electromyography (EMG) during functional movements will be used to determine muscle activation pattern changes at 8 weeks after exercise intervention. | Change from baseline muscle activity at 8 weeks after exercise intervention. |
| Kinematic pattern of movement | Patterns of functional movement will be captured using electromagnetic tracking system and used to determine changes in kinematic pattern of movement at 8 weeks after exercise the exercise intervention. | Change from baseline movement pattern at 8 weeks after exercise intervention. |
Secondary Outcome Measures
| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Numeric pain rating scale | Pain assessed by a numeric pain rating scale will be used to determine change in pain at 8 weeks after exercise intervention. | Change in pain from baseline at 8 weeks after exercise intervention |
| Oswestry disability index | Disability level measured by Oswestry disability index will be used to determine change in disability level at 8 weeks after exercise intervention. | Change from baseline disability level at 8 weeks after exercise intervention |
| Short-form general heath status (SF-36) questionnaire | General health status assessed by short-form general health status questionnaire (SF-36) will be used to change in general health status at 8 weeks after exercise intervention. | Change from baseline general health status at 8 weeks after exercise intervention |
Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Low back pain, Neuromuscular control
|
NCT02041286
|
Evaluation of an Karajishi Contour Investigational Blood Glucose Monitoring System
|
The purpose of this study is to determine if subjects who have diabetes can operate the Investigational Blood Glucose Monitoring System (BGMS) without training and obtain valid glucose results.
|
User Performance of the Karajishi Contour Blood Glucose Monitoring System
|
Diabetes
|
* Device: Karajishi Contour Investigational BG Monitoring System
|
Inclusion Criteria:~Males and females, 18 years of age and older~People with type 1 or type 2 diabetes~Able to speak, read, and understand English~Willing to complete all study procedures~Exclusion Criteria:~Hemophilia or any other bleeding disorder~Pregnancy~Physical, visual, or neurological impairments that would make the person unable to perform testing with the BGM~Previously participated in a BG monitor study using the Karajishi BGMS (or used a Bayer Contour meter)~Working for a medical laboratory, hospital, or other clinical setting that involves training on and clinical use of blood glucose monitors~Working for a competitive medical device company, or having an immediate family member who works for such a company~A condition which, in the opinion of the investigator or designee, would put the person or study conduct at risk
|
18 Years
| null |
All
|
No
|
Primary Purpose: Supportive Care
Intervention Model: Single Group Assignment
Masking: None (Open Label)
|
| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Number of Self-Test Fingerstick Blood Glucose (BG) Results Within +/- 15 mg/dL (<100 mg/dL) and Within +/- 15% (>=100 mg/dL) of Laboratory Glucose Method | Subjects with diabetes self-test fingerstick blood use an investigational Blood Glucose Monitoring System (BGMS) with no training. BGMS results are compared with subject capillary plasma BG results obtained with a Yellow Springs Instrument (YSI) Analyzer. YSI Analyzer BG results are used to calculate the number of BGMS results within +/-15 mg/dL (<100 mg/dL YSI capillary plasma) and +/-15% (>=100 mg/dL YSI capillary plasma). | 1 hour |
|
| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Number of Venous Blood Glucose (BG) Results Within +/- 15 mg/dL (<100 mg/dL) and Within +/- 15% (>=100 mg/dL) of Laboratory Glucose Method | Study staff test subject venous blood using an investigational Blood Glucose Monitoring System (BGMS). Venous BGMS results are compared with subject venous plasma BG results obtained with a Yellow Springs Instrument (YSI) Analyzer. YSI Analyzer venous plasma BG results are used to calculate the number of BGMS results within +/-15 mg/dL (<100 mg/dL YSI venous plasma) and +/-15% (>=100 mg/dL YSI venous plasma). | 1 hour |
| Number of Blood Glucose (BG) Results From Alternative Site Testing (AST) Palm Blood Within +/- 15 mg/dL (<100 mg/dL) and Within +/- 15% (>=100 mg/dL) of Laboratory Glucose Method | Subjects with diabetes self-test Alternative Site (AST) palm blood using an investigational Blood Glucose Monitoring System (BGMS) with no training. BGMS AST palm results are compared with subject capillary plasma BG results obtained with a Yellow Springs Instrument (YSI) Analyzer. YSI Analyzer BG results are used to calculate the number of BGMS results within +/-15 mg/dL (<100 mg/dL YSI capillary plasma) and +/-15% (>=100 mg/dL YSI capillary plasma). | 1 hour |
| Number of Subject Fingerstick Blood Glucose (BG) Results Within +/- 15 mg/dL (<100 mg/dL) and Within +/- 15% (>=100 mg/dL) of Laboratory Glucose Method When Obtained and Tested by Study Staff | Study staff obtain and test subject fingerstick blood using an investigational Blood Glucose Monitoring System (BGMS). BGMS results are compared with subject capillary plasma BG results obtained with a Yellow Springs Instrument (YSI) Analyzer. YSI capillary plasma results are used to calculate the number of BGMS results within +/-15 mg/dL (<100 mg/dL YSI capillary plasma) and +/-15% (>=100 mg/dL YSI capillary plasma). | 1 hour |
| Number of Subject Responses That Strongly Agree or Agree or Are Neutral With Questionnaire Statements | Staff will obtain subject responses using short questionnaires to provide feedback on instructions for use and the basic operation of the BGMS. Subjects may respond Strongly Agree; Agree; Neutral; Disagree; or Strongly Disagree. | 1 hour |
|
| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Intended Users of the Monitoring System<br>Subjects with diabetes use the Karajishi Contour Investigational BG Monitoring System with no training. The criteria for the intended use population:~At least 60% of subjects will be younger than age 65~At least 10% of subjects will have type 1 diabetes | Device: Karajishi Contour Investigational BG Monitoring System<br>* Subjects with diabetes perform self Blood Glucose (BG) tests with capillary fingerstick and palm blood using the Karajishi Contour Investigational BG Monitoring System with no training. All BG results are compared to reference method results obtained from subject capillary plasma. Also, study staff test subject venous blood and BG results are compared to reference method results obtained from subject venous plasma.<br>|
|
Evaluation of an Karajishi Contour Investigational Blood Glucose Monitoring System
Study Overview
=================
Brief Summary
-----------------
The purpose of this study is to determine if subjects who have diabetes can operate the Investigational Blood Glucose Monitoring System (BGMS) without training and obtain valid glucose results.
Official Title
-----------------
User Performance of the Karajishi Contour Blood Glucose Monitoring System
Conditions
-----------------
Diabetes
Intervention / Treatment
-----------------
* Device: Karajishi Contour Investigational BG Monitoring System
Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Males and females, 18 years of age and older People with type 1 or type 2 diabetes Able to speak, read, and understand English Willing to complete all study procedures Exclusion Criteria: Hemophilia or any other bleeding disorder Pregnancy Physical, visual, or neurological impairments that would make the person unable to perform testing with the BGM Previously participated in a BG monitor study using the Karajishi BGMS (or used a Bayer Contour meter) Working for a medical laboratory, hospital, or other clinical setting that involves training on and clinical use of blood glucose monitors Working for a competitive medical device company, or having an immediate family member who works for such a company A condition which, in the opinion of the investigator or designee, would put the person or study conduct at risk
Ages Eligible for Study
-----------------
Minimum Age: 18 Years
Sexes Eligible for Study
-----------------
All
Accepts Healthy Volunteers
-----------------
No
Study Plan
=================
How is the study designed?
-----------------
Design Details
Primary Purpose: Supportive Care
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Arms and Interventions
| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Intended Users of the Monitoring System<br>Subjects with diabetes use the Karajishi Contour Investigational BG Monitoring System with no training. The criteria for the intended use population: At least 60% of subjects will be younger than age 65 At least 10% of subjects will have type 1 diabetes | Device: Karajishi Contour Investigational BG Monitoring System<br>* Subjects with diabetes perform self Blood Glucose (BG) tests with capillary fingerstick and palm blood using the Karajishi Contour Investigational BG Monitoring System with no training. All BG results are compared to reference method results obtained from subject capillary plasma. Also, study staff test subject venous blood and BG results are compared to reference method results obtained from subject venous plasma.<br>|
What is the study measuring?
-----------------
Primary Outcome Measures
| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Number of Self-Test Fingerstick Blood Glucose (BG) Results Within +/- 15 mg/dL (<100 mg/dL) and Within +/- 15% (>=100 mg/dL) of Laboratory Glucose Method | Subjects with diabetes self-test fingerstick blood use an investigational Blood Glucose Monitoring System (BGMS) with no training. BGMS results are compared with subject capillary plasma BG results obtained with a Yellow Springs Instrument (YSI) Analyzer. YSI Analyzer BG results are used to calculate the number of BGMS results within +/-15 mg/dL (<100 mg/dL YSI capillary plasma) and +/-15% (>=100 mg/dL YSI capillary plasma). | 1 hour |
Secondary Outcome Measures
| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Number of Venous Blood Glucose (BG) Results Within +/- 15 mg/dL (<100 mg/dL) and Within +/- 15% (>=100 mg/dL) of Laboratory Glucose Method | Study staff test subject venous blood using an investigational Blood Glucose Monitoring System (BGMS). Venous BGMS results are compared with subject venous plasma BG results obtained with a Yellow Springs Instrument (YSI) Analyzer. YSI Analyzer venous plasma BG results are used to calculate the number of BGMS results within +/-15 mg/dL (<100 mg/dL YSI venous plasma) and +/-15% (>=100 mg/dL YSI venous plasma). | 1 hour |
| Number of Blood Glucose (BG) Results From Alternative Site Testing (AST) Palm Blood Within +/- 15 mg/dL (<100 mg/dL) and Within +/- 15% (>=100 mg/dL) of Laboratory Glucose Method | Subjects with diabetes self-test Alternative Site (AST) palm blood using an investigational Blood Glucose Monitoring System (BGMS) with no training. BGMS AST palm results are compared with subject capillary plasma BG results obtained with a Yellow Springs Instrument (YSI) Analyzer. YSI Analyzer BG results are used to calculate the number of BGMS results within +/-15 mg/dL (<100 mg/dL YSI capillary plasma) and +/-15% (>=100 mg/dL YSI capillary plasma). | 1 hour |
| Number of Subject Fingerstick Blood Glucose (BG) Results Within +/- 15 mg/dL (<100 mg/dL) and Within +/- 15% (>=100 mg/dL) of Laboratory Glucose Method When Obtained and Tested by Study Staff | Study staff obtain and test subject fingerstick blood using an investigational Blood Glucose Monitoring System (BGMS). BGMS results are compared with subject capillary plasma BG results obtained with a Yellow Springs Instrument (YSI) Analyzer. YSI capillary plasma results are used to calculate the number of BGMS results within +/-15 mg/dL (<100 mg/dL YSI capillary plasma) and +/-15% (>=100 mg/dL YSI capillary plasma). | 1 hour |
| Number of Subject Responses That Strongly Agree or Agree or Are Neutral With Questionnaire Statements | Staff will obtain subject responses using short questionnaires to provide feedback on instructions for use and the basic operation of the BGMS. Subjects may respond Strongly Agree; Agree; Neutral; Disagree; or Strongly Disagree. | 1 hour |
|
|||
NCT05269225
|
Organic Diet in Pregnancy and Risk Markers of Health Effects (The OrgDiet Project)
|
The OrgDiet project is a two-armed (1:1), open, intention-to-treat randomized controlled trial. The aim is to examine effects of consumption of organic foods (intervention group) vs. conventional foods (control group) during pregnancy in both mother and child. About 100 participants will be included and the participants will be followed until the children are two years old. Both groups will also be recommended to eat according to the dietary guidelines of the Directory of Health in Norway.
|
Organic Diet in Pregnancy and Risk Markers of Health Effects
|
Nutrition
|
* Other: Organic diet
* Other: Conventional diet
|
Inclusion Criteria:~Nulli- or multipara pregnant in first trimester~Exclusion Criteria:~Consuming an organic diet regularly~Using medication regularly that might interfere with study adherence or - outcomes~Diagnosed with a chronic disorder or cancer~Having a food allergy or intolerance
| null | null |
Female
|
Accepts Healthy Volunteers
|
Primary Purpose: Prevention
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
|
| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Maternal urinary excretion level of dialkylphosphates | The difference in maternal urinary excretion level of these pesticides at the end of intervention (gestational week 37) between the intervention group and the control group, measured at baseline (gestational week 12-14), and at several occasions until 2 years after the birth of the baby. | 2.5 years |
|
| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Blood concentration of cholesterol | The difference in blood concentration of cholesterol at the end of intervention (gestational week 37) between the intervention group and the control group, measured at baseline (gestational week 12-14), and at several occasions until 2 years after the birth of the baby. | 2.5 years |
| Abundance and species-types of gut microbiota (e.g. staphylococci and enterobacter) sampled from stool samples | The difference in microbiota species-types and abundance (using 16S rRNA amplicon sequencing) in stool samples between the intervention group and the control group, measured at baseline (gestational week 12-14), and at several occasions until 2 years after the birth of the baby. | 2.5 years |
| DNA methylation patterns in leucocytes as a marker of altered epigenetic programming | DNA methylation will be investigated on DNA isolated from leukocytes. Degree of DNA methylation will be analyzed at a genome-wide scale using Illumina Infinium EPIC bead chip array (or similar methods, depending on the cost-benefit consideration at the time). The DNA methylation data will be normalized, and presented as beta-values ranging from 0-1. The outcome measure in the study is intra-individual DNA methylation changes during the study-period, measured as changes in the beta-value, between the intervention group and the control group, measured at baseline (gestational week 12-14), and at several occasions until 2 years after the birth of the baby. | 2.5 years |
| Child body weight | The difference in child body weight (kg) between the intervention group and the control group, measured at baseline (birth), and at several occasions until 2 years after the birth of the baby. | 2 years |
| Child urinary excretion level of dialkylphosphates | The difference in child urinary excretion level of dialkylphosphates between the intervention group and the control group, measured at several occasions until 2 years after the birth of the baby. | 2 years |
| Blood concentration HbA1c | The difference in blood concentration of HbA1c at the end of intervention (gestational week 37) between the intervention group and the control group, measured at baseline (gestational week 12-14), and at several occasions until 2 years after the birth of the baby. | 2.5 years |
| Blood concentration CRP | The difference in blood concentration of CRP at the end of intervention (gestational week 37) between the intervention group and the control group, measured at baseline (gestational week 12-14), and at several occasions until 2 years after the birth of the baby. | 2.5 years |
| Child body length | The difference in child body length (cm) between the intervention group and the control group, measured at baseline (birth), and at several occasions until 2 years after the birth of the baby. | 2 years |
|
| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Organic diet<br>Consuming organic food from the start of 2nd trimester and until gestational week 37. | Other: Organic diet<br>* Organically produced foods.<br>|
| Placebo Comparator: Conventional diet<br>Consuming conventional food throughout the whole pregnancy. | Other: Conventional diet<br>* Conventionally produced foods.<br>* Other names: Control;|
|
Organic Diet in Pregnancy and Risk Markers of Health Effects (The OrgDiet Project)
Study Overview
=================
Brief Summary
-----------------
The OrgDiet project is a two-armed (1:1), open, intention-to-treat randomized controlled trial. The aim is to examine effects of consumption of organic foods (intervention group) vs. conventional foods (control group) during pregnancy in both mother and child. About 100 participants will be included and the participants will be followed until the children are two years old. Both groups will also be recommended to eat according to the dietary guidelines of the Directory of Health in Norway.
Official Title
-----------------
Organic Diet in Pregnancy and Risk Markers of Health Effects
Conditions
-----------------
Nutrition
Intervention / Treatment
-----------------
* Other: Organic diet
* Other: Conventional diet
Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Nulli- or multipara pregnant in first trimester Exclusion Criteria: Consuming an organic diet regularly Using medication regularly that might interfere with study adherence or - outcomes Diagnosed with a chronic disorder or cancer Having a food allergy or intolerance
Sexes Eligible for Study
-----------------
Female
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: Organic diet<br>Consuming organic food from the start of 2nd trimester and until gestational week 37. | Other: Organic diet<br>* Organically produced foods.<br>|
| Placebo Comparator: Conventional diet<br>Consuming conventional food throughout the whole pregnancy. | Other: Conventional diet<br>* Conventionally produced foods.<br>* Other names: Control;|
What is the study measuring?
-----------------
Primary Outcome Measures
| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Maternal urinary excretion level of dialkylphosphates | The difference in maternal urinary excretion level of these pesticides at the end of intervention (gestational week 37) between the intervention group and the control group, measured at baseline (gestational week 12-14), and at several occasions until 2 years after the birth of the baby. | 2.5 years |
Secondary Outcome Measures
| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Blood concentration of cholesterol | The difference in blood concentration of cholesterol at the end of intervention (gestational week 37) between the intervention group and the control group, measured at baseline (gestational week 12-14), and at several occasions until 2 years after the birth of the baby. | 2.5 years |
| Abundance and species-types of gut microbiota (e.g. staphylococci and enterobacter) sampled from stool samples | The difference in microbiota species-types and abundance (using 16S rRNA amplicon sequencing) in stool samples between the intervention group and the control group, measured at baseline (gestational week 12-14), and at several occasions until 2 years after the birth of the baby. | 2.5 years |
| DNA methylation patterns in leucocytes as a marker of altered epigenetic programming | DNA methylation will be investigated on DNA isolated from leukocytes. Degree of DNA methylation will be analyzed at a genome-wide scale using Illumina Infinium EPIC bead chip array (or similar methods, depending on the cost-benefit consideration at the time). The DNA methylation data will be normalized, and presented as beta-values ranging from 0-1. The outcome measure in the study is intra-individual DNA methylation changes during the study-period, measured as changes in the beta-value, between the intervention group and the control group, measured at baseline (gestational week 12-14), and at several occasions until 2 years after the birth of the baby. | 2.5 years |
| Child body weight | The difference in child body weight (kg) between the intervention group and the control group, measured at baseline (birth), and at several occasions until 2 years after the birth of the baby. | 2 years |
| Child urinary excretion level of dialkylphosphates | The difference in child urinary excretion level of dialkylphosphates between the intervention group and the control group, measured at several occasions until 2 years after the birth of the baby. | 2 years |
| Blood concentration HbA1c | The difference in blood concentration of HbA1c at the end of intervention (gestational week 37) between the intervention group and the control group, measured at baseline (gestational week 12-14), and at several occasions until 2 years after the birth of the baby. | 2.5 years |
| Blood concentration CRP | The difference in blood concentration of CRP at the end of intervention (gestational week 37) between the intervention group and the control group, measured at baseline (gestational week 12-14), and at several occasions until 2 years after the birth of the baby. | 2.5 years |
| Child body length | The difference in child body length (cm) between the intervention group and the control group, measured at baseline (birth), and at several occasions until 2 years after the birth of the baby. | 2 years |
|
|||
NCT01869634
|
Mechanisms of Immune Reconstitution & Reduced Immune Activation Following Darunavir-based ART
|
Potent HIV suppression with Darunavir-based antiretroviral therapy (ART) will lead to repopulation of gastrointestinal-associated lymphoid tissue (GALT) cluster of differentiation (CD)4+ T-cell populations, normalization of systemic immune activation, and improved HIV-associated cardiovascular disease (CVD) risk.
|
Rationale Infection with HIV causes significant morbidity and mortality, even among individuals who are virologically suppressed with combination anti-retroviral therapy (ART). ART is effective in prolonging life and enabling individuals who are HIV positive to live near-normal life spans. However, these individuals are increasingly developing a number of chronic diseases of aging, such as atherosclerotic cardiovascular disease (ASCVD). The proposed studies will examine the role of highly active antiretroviral therapy in restoring the mucosal immunity and the systemic effect on immune activation, bacterial translocation, and change in HIV-associated cardiovascular disease risk.
|
Mechanisms of Immune Reconstitution & Reduced Immune Activation Following Darunavir-based ART
|
Human Immunodeficiency Virus Infection
|
* Drug: darunavir with ritonavir and fixed-dose viread+emtricitabine daily
|
Inclusion Criteria:~Willing to sign consent form~Naïve to ART (remote ART use >5 years will be considered on a case by case basis)~No known GI or cardiovascular disease~Between the ages of 18 and 60~No active opportunistic infections or therapy for acute OI within 30 days of entry. Subjects can be on secondary prophylaxis with a history of AIDS defining illness.~All women of childbearing potential (WCBP) must have a negative urine pregnancy test before any of the invasive or radiation exposure study procedures.~Normal population should be free of chronic metabolic conditions such as diabetes, hypercholesterolemia, or coronary artery disease~There are no CD4+ T-cell count or HIV plasma viral load restrictions.~Exclusion Criteria:~Abnormal coagulation parameters (PT>1.2 upper limit of normal (ULN))~Thrombocytopenia (platelet count <50.000 within 6 weeks)~Contra-indications to upper endoscopy or conscious sedation~Anemia (>grade 1 [appendix 1])~Aspirin, ibuprofen, warfarin or other agents that interfere with the coagulation cascade are prohibited within 1 week of endoscopy.~Renal insufficiency (serum Creatinine >1.2 ULN)~History of chronic proteinuria that could impact viread use.~Allergy to contrast used for CT angiography~Requirement to take medications that are contraindicated with study ART regimen.
|
21 Years
| null |
All
|
Accepts Healthy Volunteers
|
Primary Purpose: Treatment
Allocation: Non-Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
|
| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Number of CD4+ T-cells in the Lamina Propria/mm2 Before and After 12 Months of Therapy Compared to Age-matched Control Volunteers Without HIV | CD4+ T-cells in the lamina propria/mm2 before and after 12 months of therapy compared to age-matched control volunteers without HIV. | Baseline, 12 months |
|
| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change in Percentage of Total Artery Diameter | computerized axial tomography angiography of the coronary arteries (CT-angio) before and after 12-months of Darunavir therapy | Baseline, 12 months |
|
HIV, cardiovascular risk, systemic immune activation
|
Ritonavir, Darunavir, Emtricitabine, HIV Protease Inhibitors, Viral Protease Inhibitors, Protease Inhibitors, Enzyme Inhibitors, Molecular Mechanisms of Pharmacological Action, Anti-HIV Agents, Anti-Retroviral Agents, Antiviral Agents, Anti-Infective Agents, Cytochrome P-450 CYP3A Inhibitors, Cytochrome P-450 Enzyme Inhibitors, Reverse Transcriptase Inhibitors, Nucleic Acid Synthesis Inhibitors
|
| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: HIV positive naive to ART<br>HIV subjects will receive open-label darunavir 800 mg in combination with ritonavir 100 mg tablets and fixed-dose combination viread + emtricitabine (Truvada®) to be taken once daily without regard to food. Subjects will undergo upper endoscopy, CT cardiac angiogram, intimal-medial thickening, and peripheral blood collection before and after 12 months of ART. | Drug: darunavir with ritonavir and fixed-dose viread+emtricitabine daily<br> <br> * Other names: darunavir (Prezista®) 800 mg with ritonavir 100 mg and Truvada® to be taken once daily;|
| No Intervention: normal control volunteers<br>HIV negative age-matched controls will undergo the same interventions and procedures without receiving ART at study entry and after 12 months. | |
|
Mechanisms of Immune Reconstitution & Reduced Immune Activation Following Darunavir-based ART
Study Overview
=================
Brief Summary
-----------------
Potent HIV suppression with Darunavir-based antiretroviral therapy (ART) will lead to repopulation of gastrointestinal-associated lymphoid tissue (GALT) cluster of differentiation (CD)4+ T-cell populations, normalization of systemic immune activation, and improved HIV-associated cardiovascular disease (CVD) risk.
Detailed Description
-----------------
Rationale Infection with HIV causes significant morbidity and mortality, even among individuals who are virologically suppressed with combination anti-retroviral therapy (ART). ART is effective in prolonging life and enabling individuals who are HIV positive to live near-normal life spans. However, these individuals are increasingly developing a number of chronic diseases of aging, such as atherosclerotic cardiovascular disease (ASCVD). The proposed studies will examine the role of highly active antiretroviral therapy in restoring the mucosal immunity and the systemic effect on immune activation, bacterial translocation, and change in HIV-associated cardiovascular disease risk.
Official Title
-----------------
Mechanisms of Immune Reconstitution & Reduced Immune Activation Following Darunavir-based ART
Conditions
-----------------
Human Immunodeficiency Virus Infection
Intervention / Treatment
-----------------
* Drug: darunavir with ritonavir and fixed-dose viread+emtricitabine daily
Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Willing to sign consent form Naïve to ART (remote ART use >5 years will be considered on a case by case basis) No known GI or cardiovascular disease Between the ages of 18 and 60 No active opportunistic infections or therapy for acute OI within 30 days of entry. Subjects can be on secondary prophylaxis with a history of AIDS defining illness. All women of childbearing potential (WCBP) must have a negative urine pregnancy test before any of the invasive or radiation exposure study procedures. Normal population should be free of chronic metabolic conditions such as diabetes, hypercholesterolemia, or coronary artery disease There are no CD4+ T-cell count or HIV plasma viral load restrictions. Exclusion Criteria: Abnormal coagulation parameters (PT>1.2 upper limit of normal (ULN)) Thrombocytopenia (platelet count <50.000 within 6 weeks) Contra-indications to upper endoscopy or conscious sedation Anemia (>grade 1 [appendix 1]) Aspirin, ibuprofen, warfarin or other agents that interfere with the coagulation cascade are prohibited within 1 week of endoscopy. Renal insufficiency (serum Creatinine >1.2 ULN) History of chronic proteinuria that could impact viread use. Allergy to contrast used for CT angiography Requirement to take medications that are contraindicated with study ART regimen.
Ages Eligible for Study
-----------------
Minimum Age: 21 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: Non-Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Arms and Interventions
| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: HIV positive naive to ART<br>HIV subjects will receive open-label darunavir 800 mg in combination with ritonavir 100 mg tablets and fixed-dose combination viread + emtricitabine (Truvada®) to be taken once daily without regard to food. Subjects will undergo upper endoscopy, CT cardiac angiogram, intimal-medial thickening, and peripheral blood collection before and after 12 months of ART. | Drug: darunavir with ritonavir and fixed-dose viread+emtricitabine daily<br> <br> * Other names: darunavir (Prezista®) 800 mg with ritonavir 100 mg and Truvada® to be taken once daily;|
| No Intervention: normal control volunteers<br>HIV negative age-matched controls will undergo the same interventions and procedures without receiving ART at study entry and after 12 months. | |
What is the study measuring?
-----------------
Primary Outcome Measures
| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Number of CD4+ T-cells in the Lamina Propria/mm2 Before and After 12 Months of Therapy Compared to Age-matched Control Volunteers Without HIV | CD4+ T-cells in the lamina propria/mm2 before and after 12 months of therapy compared to age-matched control volunteers without HIV. | Baseline, 12 months |
Secondary Outcome Measures
| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change in Percentage of Total Artery Diameter | computerized axial tomography angiography of the coronary arteries (CT-angio) before and after 12-months of Darunavir therapy | Baseline, 12 months |
Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
HIV, cardiovascular risk, systemic immune activation
|
NCT00534911
|
Reducing Depressive Symptoms in Physically Ill Youth
|
Children and adolescents with inflammatory bowel disease (IBD) have high rates of depressive symptoms and more trouble with daily functioning than those without physical illness. The proposed study will investigate if cognitive behavioral therapy (CBT) is better than supportive therapy (SNDT) in reducing emotional distress and improving functioning in youth ages 9-17 with Crohn's disease or Ulcerative Colitis and depression. This study will also assess the effect of CBT on IBD-related factors such as disease severity, medication adherence, and physical-health related quality of life.~Hypothesis~- Individuals who receive CBT will show more improvement than individuals who receive SNDT.
|
Children and adolescents with inflammatory bowel disease (IBD) have high rates of depressive symptoms and more trouble with daily functioning than those without physical illness. Furthermore, the medications used to treat IBR, such as steroids, may induce depression. The proposed study will investigate if cognitive behavioral therapy (CBT) is better than supportive therapy (SNDT) in reducing emotional distress and improving functioning in youth ages 9-17 with Crohn's disease and depression. This study will also be the first to assess the effect of CBT on IBD-related factors such as disease severity, medication adherence, and physical-health related quality of life.~Participants will be carefully evaluated for depression and those who have clinically significant depression will be randomly assigned to either CBT designed for youth with IBD or supportive therapy sessions. Youth in the CBT group will learn new ways of thinking and acting to reduce symptoms of depression focused on the reconstruction of negative or hopeless physical illness narratives. Parents in the CBT group will participate in three family sessions designed to improve family understanding and communication about the physical illness and about risks for developing depression. Children in the supportive therapy condition will receive social support and information about IBD and depression similar to what they would likely receive from social workers in their pediatric medical clinic. Because emotional difficulties such as the experience of depressive symptoms have been linked with the severity and course of IBD symptoms, this information may enable parents to better help their child cope with his/her physical illness. In addition, participants in both groups may experience reduced depression and improved quality of life.~It is predicted that those in the CBT group will benefit by learning effective strategies for coping with IBD and depression, enhancing their social skills, and improving family communication skills while those in the supportive therapy group will benefit by receiving social support and useful information. The proposed study will help determine which psychosocial approach is of greater benefit for depressed youth with IBD and provide a model for integrating behavioral treatment to decrease both emotional and IBD-related suffering into the comprehensive medical care for IBD in the pediatric population.~Aim 1(primary) Are there differences between the two types of therapy in terms of improving depression.~Aim 2 (secondary) Are there differences between the two types of therapy in terms of improving IBD activity, quality of life, and medication adherence? Aim 3) (secondary) Are there differences between the two types of therapy in terms of improving sleep and pain? Aim 4) (exploratory) Are anxiety, steroid use, and gender moderators of treatment outcome.
|
Reducing Depressive Symptoms in Physically Ill Youth
|
Inflammatory Bowel Disease, Depression
|
* Behavioral: Cognitive Behavioral Therapy
* Behavioral: Supportive Non-directive Therapy (SNDT)
|
Inclusion Criteria:~Step 1:~ages 9 to 17 inclusive~capable of completing CDI~meeting diagnostic criteria for CD (the date of diagnosis = date of the first diagnostic test confirming CD)~absence of mental retardation by history~having at least one appointment at the GI clinic (this will include patients followed in these clinics as well as those seeking consultation)~Step 2:~CDI or CDI-P greater than or equal to 10 at Step 1.~ages between 9-17 inclusive~having CD~Exclusion Criteria:~history or current episode of bipolar disorder, eating disorder, or psychotic disorder by DSM-IV criteria~mental retardation by history~antidepressant medications within one month of assessment~suicidality with plan or of severity requiring immediate psychiatric hospitalization or significant act involving intentional self-harm (e.g., cutting or overdose, resulting in medical attention)~unacceptable risk for dangerousness to others as indicated by homicidal (or other violent) ideation, intent or plan or action, or use of illegal weapons~current pregnancy by history~substance abuse by history within one month of enrollment other than nicotine dependence~current treatment with CBT or failure of previous CBT trial for depression judged adequate by at least 12 treatment sessions over a period of less than 1 year conducted by an appropriately trained mental health provider using a manual~if currently receiving other psychotherapy modalities willingness to suspend treatment for 12-week acute treatment phase of study
|
9 Years
|
17 Years
|
All
|
No
|
Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
|
| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change from baseline in CDRS at 3 months | Change in Child Depression Rating Scale (CDRS) score from month 0 assessment to three month assessment. | Month 0, Month 3 |
|
| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change from baseline in KSADS diagnosis at 3 months | Remission of depressive episode as measured by Kiddie Schedule for Affective Disorders and Schizophrenia (KSADS) from month 0 assessment to 3 month assessment. | Month 0, Month 3 |
|
Depression, Physical Illness, Inflammatory Bowel Disease, Cognitive Behavioral Therapy
|
Intestinal Diseases, Inflammatory Bowel Diseases, Depression, Behavioral Symptoms, Gastrointestinal Diseases, Digestive System Diseases, Gastroenteritis
|
| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Cognitive Behavioral Therapy<br>Primary & Secondary Control Enhancement Training (PASCET) | Behavioral: Cognitive Behavioral Therapy<br>* Participants will receive 12 weeks of CBT designed for youth with IBD. During sessions, participants will learn new ways of thinking (e.g., reconstruction of personal physical illness narratives, coping strategies, social skills) and behaving (e.g., positive activities, family communication, sleep hygiene, relaxation) to improve emotional and physical outcomes. Parent sessions will be provided at the beginning, middle, and end of the treatment to improve family understanding and communication about the physical illness and about risks of developing depression. There will also be 6-month booster sessions during follow-up.~Other Name: Primary and secondary coping enhancement training (PASCET)<br>|
| Active Comparator: Supportive Non-Directive Therapy (SNDT)<br>Supportive Non-Directive Therapy | Behavioral: Supportive Non-directive Therapy (SNDT)<br>* SNDT is a 12-week non-directive therapeutic intervention. Participants will receive social support and quality information about the warning signs and risk factors for depression. Parent sessions will be provided at the beginning, middle, and end of the treatment to improve family understanding and communication about the physical illness and about risks of developing depression. There will also be 6-month booster sessions during follow-up.<br>|
|
Reducing Depressive Symptoms in Physically Ill Youth
Study Overview
=================
Brief Summary
-----------------
Children and adolescents with inflammatory bowel disease (IBD) have high rates of depressive symptoms and more trouble with daily functioning than those without physical illness. The proposed study will investigate if cognitive behavioral therapy (CBT) is better than supportive therapy (SNDT) in reducing emotional distress and improving functioning in youth ages 9-17 with Crohn's disease or Ulcerative Colitis and depression. This study will also assess the effect of CBT on IBD-related factors such as disease severity, medication adherence, and physical-health related quality of life. Hypothesis - Individuals who receive CBT will show more improvement than individuals who receive SNDT.
Detailed Description
-----------------
Children and adolescents with inflammatory bowel disease (IBD) have high rates of depressive symptoms and more trouble with daily functioning than those without physical illness. Furthermore, the medications used to treat IBR, such as steroids, may induce depression. The proposed study will investigate if cognitive behavioral therapy (CBT) is better than supportive therapy (SNDT) in reducing emotional distress and improving functioning in youth ages 9-17 with Crohn's disease and depression. This study will also be the first to assess the effect of CBT on IBD-related factors such as disease severity, medication adherence, and physical-health related quality of life. Participants will be carefully evaluated for depression and those who have clinically significant depression will be randomly assigned to either CBT designed for youth with IBD or supportive therapy sessions. Youth in the CBT group will learn new ways of thinking and acting to reduce symptoms of depression focused on the reconstruction of negative or hopeless physical illness narratives. Parents in the CBT group will participate in three family sessions designed to improve family understanding and communication about the physical illness and about risks for developing depression. Children in the supportive therapy condition will receive social support and information about IBD and depression similar to what they would likely receive from social workers in their pediatric medical clinic. Because emotional difficulties such as the experience of depressive symptoms have been linked with the severity and course of IBD symptoms, this information may enable parents to better help their child cope with his/her physical illness. In addition, participants in both groups may experience reduced depression and improved quality of life. It is predicted that those in the CBT group will benefit by learning effective strategies for coping with IBD and depression, enhancing their social skills, and improving family communication skills while those in the supportive therapy group will benefit by receiving social support and useful information. The proposed study will help determine which psychosocial approach is of greater benefit for depressed youth with IBD and provide a model for integrating behavioral treatment to decrease both emotional and IBD-related suffering into the comprehensive medical care for IBD in the pediatric population. Aim 1(primary) Are there differences between the two types of therapy in terms of improving depression. Aim 2 (secondary) Are there differences between the two types of therapy in terms of improving IBD activity, quality of life, and medication adherence? Aim 3) (secondary) Are there differences between the two types of therapy in terms of improving sleep and pain? Aim 4) (exploratory) Are anxiety, steroid use, and gender moderators of treatment outcome.
Official Title
-----------------
Reducing Depressive Symptoms in Physically Ill Youth
Conditions
-----------------
Inflammatory Bowel Disease, Depression
Intervention / Treatment
-----------------
* Behavioral: Cognitive Behavioral Therapy
* Behavioral: Supportive Non-directive Therapy (SNDT)
Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Step 1: ages 9 to 17 inclusive capable of completing CDI meeting diagnostic criteria for CD (the date of diagnosis = date of the first diagnostic test confirming CD) absence of mental retardation by history having at least one appointment at the GI clinic (this will include patients followed in these clinics as well as those seeking consultation) Step 2: CDI or CDI-P greater than or equal to 10 at Step 1. ages between 9-17 inclusive having CD Exclusion Criteria: history or current episode of bipolar disorder, eating disorder, or psychotic disorder by DSM-IV criteria mental retardation by history antidepressant medications within one month of assessment suicidality with plan or of severity requiring immediate psychiatric hospitalization or significant act involving intentional self-harm (e.g., cutting or overdose, resulting in medical attention) unacceptable risk for dangerousness to others as indicated by homicidal (or other violent) ideation, intent or plan or action, or use of illegal weapons current pregnancy by history substance abuse by history within one month of enrollment other than nicotine dependence current treatment with CBT or failure of previous CBT trial for depression judged adequate by at least 12 treatment sessions over a period of less than 1 year conducted by an appropriately trained mental health provider using a manual if currently receiving other psychotherapy modalities willingness to suspend treatment for 12-week acute treatment phase of study
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: None (Open Label)
Arms and Interventions
| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Cognitive Behavioral Therapy<br>Primary & Secondary Control Enhancement Training (PASCET) | Behavioral: Cognitive Behavioral Therapy<br>* Participants will receive 12 weeks of CBT designed for youth with IBD. During sessions, participants will learn new ways of thinking (e.g., reconstruction of personal physical illness narratives, coping strategies, social skills) and behaving (e.g., positive activities, family communication, sleep hygiene, relaxation) to improve emotional and physical outcomes. Parent sessions will be provided at the beginning, middle, and end of the treatment to improve family understanding and communication about the physical illness and about risks of developing depression. There will also be 6-month booster sessions during follow-up. Other Name: Primary and secondary coping enhancement training (PASCET)<br>|
| Active Comparator: Supportive Non-Directive Therapy (SNDT)<br>Supportive Non-Directive Therapy | Behavioral: Supportive Non-directive Therapy (SNDT)<br>* SNDT is a 12-week non-directive therapeutic intervention. Participants will receive social support and quality information about the warning signs and risk factors for depression. Parent sessions will be provided at the beginning, middle, and end of the treatment to improve family understanding and communication about the physical illness and about risks of developing depression. There will also be 6-month booster sessions during follow-up.<br>|
What is the study measuring?
-----------------
Primary Outcome Measures
| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change from baseline in CDRS at 3 months | Change in Child Depression Rating Scale (CDRS) score from month 0 assessment to three month assessment. | Month 0, Month 3 |
Secondary Outcome Measures
| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change from baseline in KSADS diagnosis at 3 months | Remission of depressive episode as measured by Kiddie Schedule for Affective Disorders and Schizophrenia (KSADS) from month 0 assessment to 3 month assessment. | Month 0, Month 3 |
Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Depression, Physical Illness, Inflammatory Bowel Disease, Cognitive Behavioral Therapy
|
NCT01327339
|
REQUIP RLS Post Marketing Surveillance
|
post-marketing surveillance to monitor safety and efficacy of ropinirole during using of treatment for RLS
|
This study is a post-marketing surveillance to monitor safety and efficacy of ropinirole during using of treatment for RLS(restless leg syndrome) and identify SAEs, adverse drug reactions, and unexpected AEs not described as precautions or warnings and to identify prognostic factors that have an effect on the AEs and to assess effectiveness of ropinirole in real clinical practices after marketing. The subjects are patients prescribed for ropinirole by the investigators at the sites based on prescription information in normal clinical practices.
|
An Open-label, Multi-centre, Observational, Post-marketing Surveillance to Monitor the Safety of REQUIP(Ropinirole) Administered in Korean Restless Leg Syndrome Patients According to the Prescribing Information
|
Restless Legs Syndrome
|
* Drug: Ropinirole
|
Inclusion Criteria:~Subjects diagnosed with RLS by the investigator~Subjects who the investigator believes that they can and will comply with the requirements of the protocol~To be contactable over the phone~To follow the administration regimen.~A male or female aged 18 years and more at the time of the first prescription.~Subjects with no experience of RLS treatment using ropinirole~Exclusion Criteria:~Considering the nature of this non-interventional PMS study, there is no strict exclusion criteria set up. GSK Korea encourage the doctors participating this study to enrol the subjects prescribed with Ropinirole following the locally approved Prescribing Information (Appendix ) The following criteria should be checked at the time of study entry.~Subjects with hypersensitivity to ropinirole and any excipients~Female who is during the period of the pregnancy or who are lactating
| null | null |
All
|
No
|
| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Number of Participants With Any Adverse Event | An adverse event is any untoward medical occurrence in a participant, temporally associated with the use of a medicinal product, whether or not considered related to the medicinal product. | one month |
|
| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Number of Participants With Any Serious Adverse Event | A serious adverse event is defined as any untoward medical occurrence that, at any dose, results in death, is life threatening , requires hospitalization or results in prolongation of existing hospitalization, results in disability/incapacity, or is a congenital anomaly/birth defect. For a list of all serious adverse events occurring during the course of the study, see the table entitled Serious Adverse Events in the Adverse Event section of the results record. | one month |
| Number of Participants With the Indicated Unexpected Adverse Events | An adverse event is any untoward medical occurrence in a participant, temporally associated with the use of a medicinal product, whether or not considered related to the medicinal product. Unexpected adverse events include those not listed in the approved product information and not described as precautions or warnings. | one month |
|
Ropinirole, Antiparkinson Agents, Anti-Dyskinesia Agents, Dopamine Agonists, Dopamine Agents, Neurotransmitter Agents, Molecular Mechanisms of Pharmacological Action, Physiological Effects of Drugs
|
| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Subjects eligible for REQUIP prescription<br>Male and female subjects who were considered appropriate to be prescribed REQUIP according to the prescribing information will be included in this study. | Drug: Ropinirole<br>* Basically there is no treatment allocation. Subjects who would be administered of ropinirole at their physician's direction will be enrolled. Dosage regimen will be recommended according to the prescribing information. Subjects will be enrolled consecutively.<br>|
|
REQUIP RLS Post Marketing Surveillance
Study Overview
=================
Brief Summary
-----------------
post-marketing surveillance to monitor safety and efficacy of ropinirole during using of treatment for RLS
Detailed Description
-----------------
This study is a post-marketing surveillance to monitor safety and efficacy of ropinirole during using of treatment for RLS(restless leg syndrome) and identify SAEs, adverse drug reactions, and unexpected AEs not described as precautions or warnings and to identify prognostic factors that have an effect on the AEs and to assess effectiveness of ropinirole in real clinical practices after marketing. The subjects are patients prescribed for ropinirole by the investigators at the sites based on prescription information in normal clinical practices.
Official Title
-----------------
An Open-label, Multi-centre, Observational, Post-marketing Surveillance to Monitor the Safety of REQUIP(Ropinirole) Administered in Korean Restless Leg Syndrome Patients According to the Prescribing Information
Conditions
-----------------
Restless Legs Syndrome
Intervention / Treatment
-----------------
* Drug: Ropinirole
Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Subjects diagnosed with RLS by the investigator Subjects who the investigator believes that they can and will comply with the requirements of the protocol To be contactable over the phone To follow the administration regimen. A male or female aged 18 years and more at the time of the first prescription. Subjects with no experience of RLS treatment using ropinirole Exclusion Criteria: Considering the nature of this non-interventional PMS study, there is no strict exclusion criteria set up. GSK Korea encourage the doctors participating this study to enrol the subjects prescribed with Ropinirole following the locally approved Prescribing Information (Appendix ) The following criteria should be checked at the time of study entry. Subjects with hypersensitivity to ropinirole and any excipients Female who is during the period of the pregnancy or who are lactating
Sexes Eligible for Study
-----------------
All
Accepts Healthy Volunteers
-----------------
No
Study Plan
=================
How is the study designed?
-----------------
Arms and Interventions
| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Subjects eligible for REQUIP prescription<br>Male and female subjects who were considered appropriate to be prescribed REQUIP according to the prescribing information will be included in this study. | Drug: Ropinirole<br>* Basically there is no treatment allocation. Subjects who would be administered of ropinirole at their physician's direction will be enrolled. Dosage regimen will be recommended according to the prescribing information. Subjects will be enrolled consecutively.<br>|
What is the study measuring?
-----------------
Primary Outcome Measures
| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Number of Participants With Any Adverse Event | An adverse event is any untoward medical occurrence in a participant, temporally associated with the use of a medicinal product, whether or not considered related to the medicinal product. | one month |
Secondary Outcome Measures
| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Number of Participants With Any Serious Adverse Event | A serious adverse event is defined as any untoward medical occurrence that, at any dose, results in death, is life threatening , requires hospitalization or results in prolongation of existing hospitalization, results in disability/incapacity, or is a congenital anomaly/birth defect. For a list of all serious adverse events occurring during the course of the study, see the table entitled Serious Adverse Events in the Adverse Event section of the results record. | one month |
| Number of Participants With the Indicated Unexpected Adverse Events | An adverse event is any untoward medical occurrence in a participant, temporally associated with the use of a medicinal product, whether or not considered related to the medicinal product. Unexpected adverse events include those not listed in the approved product information and not described as precautions or warnings. | one month |
|
||
NCT02228590
|
A Study to Examine APL-130277 in Patients With Parkinson's Disease
|
The primary objective of this study is to evaluate the efficacy, tolerability and safety of single treatments of APL-130277 in 16 patients with Parkinson's Disease (PD)
|
A Phase 2 Study to Examine the Safety, Tolerability and Efficacy of APL-130277 in Patients With Parkinson's Disease
|
Parkinson's Disease
|
* Drug: APL-130277
|
Inclusion Criteria:~Male or female ≥18 years of age.~Clinical diagnosis of Idiopathic PD~Receiving stable doses of L-dopa +/- other adjunctive PD therapy for at least 4 weeks before study participation.~At least one OFF episode per day and a total daily OFF time of > 2 hours duration.~Experience predictable OFF episodes in the morning on awakening prior to receiving morning dose of levodopa.~Stage I to III on the Hoehn and Yahr scale in the ON state.~If female and of childbearing potential, must agree to use one of the following methods of birth control:~Willing and able to comply with scheduled visits, treatment plan, laboratory tests, and other study-related procedures to complete the study.~Able to understand the consent form, and to provide written informed consent.~Exclusion Criteria:~Atypical or secondary parkinsonism~Changes in L-dopa or other PD drug dosing regimens 4 weeks before the screening visit.~Past treatment with any form of apomorphine within 30 days of Dosing Day 1 (patients who stopped apomorphine for reasons other than lack of efficacy OR tolerability issues may be considered for the trial).~Female who is pregnant or lactating.~Contraindications to APOKYN or hypersensitive to apomorphine hydrochloride or any of the ingredients of APOKYN (notably sodium metabisulfite), or Tigan®.~Participation in any other clinical trial within 14 days of the screening visit.~Receipt of any investigational (i.e., unapproved) medication within 30 days of the screening visit.~Currently taking, or likely to need to take at any time during the course of the study~Currently taking dopamine antagonists or depleting drugs excluding anticholinergics and/or antihistamines with anticholinergic effects.~Drug or alcohol dependency in the past 6 months.~Clinically significant orthostatic hypotension.~Malignant melanoma or a history of previously treated malignant melanoma within 5 years.~Clinically significant medical surgical or laboratory abnormality in the judgment of the investigator.~Psychiatric disorder, including but not limited to dementia or any disorder that, in the opinion of the Investigator requires ongoing treatment that would make study participation unsafe or make treatment compliance difficult.~Dementia that precludes providing informed consent.~Potential for lack of compliance and follow-up in the judgment of the investigator.~Any other condition, current therapy, or prior therapy (within 30 days of the screening visit), which, in the opinion of the Investigator, would make the subject unsuitable for the study.~Previous neurosurgery for PD.~Donation of blood or plasma in the 30 days prior to dosing.~Presence of cankers or mouth sores.
|
18 Years
|
80 Years
|
All
|
No
|
Primary Purpose: Treatment
Intervention Model: Single Group Assignment
Masking: None (Open Label)
|
| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| The Percentage of Patients With Resolution of an 'OFF' Episode to an 'ON' State Following Administration of APL-130277 | Clinical confirmation of an 'OFF' state was assessed prior to dosing and confirmation of 'OFF' or 'ON' was assessed after dosing at Visits 3 - 5 by the Investigator. The first full 'ON' dose was defined as the earliest dose in which a patient achieved a full 'ON' state as assessed by the Investigator. The percentage of patients who achieved their first full 'ON' is presented for each timepoint, regardless of the dose received, and for the study overall (i.e. all post-dose timepoints). | At 15, 30, 45, 60 and 90 minutes after dosing at Visits 3 - 5. |
| Time to 'ON' State From Time of Dosing of APL-130277 | Clinical confirmation of 'OFF' or 'ON' was assessed after dosing at Visits 3 - 5 by the Investigator. The time to the full 'ON' state from the time of dosing in minutes was calculated from timings noted by the Investigator and recorded in the electronic case report form (eCRF). The mean time taken for a patient to reach their first full 'ON' state following administration of APL-130277 is presented for patients who turned 'ON' for the study overall. | At 15, 30, 45, 60 and 90 minutes after dosing at Visits 3 - 5. |
| Duration of 'ON' Response From Time of Dosing of APL-130277 | Clinical confirmation of 'OFF' or 'ON' was assessed after dosing at Visits 3 - 5 by the Investigator. The duration of the 'ON' response was defined as the length of time in which a patient was confirmed 'ON' within a dose, and was calculated from the time noted by the Investigator and recorded in the eCRF. The mean duration of the first full 'ON' response following administration of APL-130277 is presented for patients who turned 'ON' for the study overall. | At 15, 30, 45, 60 and 90 minutes after dosing at Visits 3 - 5. |
| Percentage of Patients Who Completed the Trial and Experienced an 'ON' Episode | Clinical confirmation of 'OFF' or 'ON' was assessed after dosing at Visits 3 - 5 by the Investigator. For the overall study, the percentage of patients who completed the trial, and who experienced an 'ON' episode is presented. | At 15, 30, 45, 60 and 90 minutes after dosing at Visits 3 - 5. |
| Pharmacokinetic (PK) Evaluation: Maximum Observed Plasma Concentration (Cmax) | The mean Cmax values are presented for each dosage administered at Visits 3, 4, and 5 for which data was available.~Plasma concentrations of the active substance of APL-130277, apomorphine, were analysed using a validated liquid chromatography-tandem mass spectrometry (LC-MS/MS) assay, with a lower limit of quantification of 0.020 nanograms per millilitre (ng/mL). | Just prior to dosing and at 10, 20, 30, 45, 60 and 90 minutes after each dose at Visits 3 - 5. |
| PK Evaluation: Time of Maximum Observed Plasma Concentration (Tmax) | The median Tmax values are presented for each dosage administered at Visits 3, 4, and 5 for which data was available.~Plasma concentrations of the active substance of APL-130277, apomorphine, were analysed using a validated LC-MS/MS assay, with a lower limit of quantification of 0.020 ng/mL. | Just prior to dosing and at 10, 20, 30, 45, 60 and 90 minutes after each dose at Visits 3 - 5. |
| PK Evaluation: Time to Last Analytically Quantifiable Concentration (Tlast) | The mean Tlast values are presented for each dosage administered at Visits 3, 4, and 5 for which data was available.~Plasma concentrations of the active substance of APL-130277, apomorphine, were analysed using a validated LC-MS/MS assay, with a lower limit of quantification of 0.020 ng/mL. | Just prior to dosing and at 10, 20, 30, 45, 60 and 90 minutes after each dose at Visits 3 - 5. |
| PK Evaluation: Area Under the Plasma Concentration Time Curve, From Time 0 to 90 Minutes (AUC0-90) | The mean AUC0-90 values are presented for each dosage administered at Visits 3, 4, and 5 for which data was available.~Plasma concentrations of the active substance of APL-130277, apomorphine, were analysed using a validated LC-MS/MS assay, with a lower limit of quantification of 0.020 ng/mL. | Just prior to dosing and at 10, 20, 30, 45, 60 and 90 minutes after each dose at Visits 3 - 5. |
| PK Evaluation: Area Under the Plasma Concentration Time Curve, From Time 0 to the Last Measurable Non-zero Concentration (AUClast) | The mean AUClast values are presented for each dosage administered at Visits 3, 4, and 5 for which data was available.~Plasma concentrations of the active substance of APL-130277, apomorphine, were analysed using a validated LC-MS/MS assay, with a lower limit of quantification of 0.020 ng/mL. The AUClast was calculated by a combination of linear and logarithmic trapezoidal methods (linear up/log down method). | Just prior to dosing and at 10, 20, 30, 45, 60 and 90 minutes after each dose at Visits 3 - 5. |
|
| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Percentage Change in MDS-UPDRS Section III Score From Pre-dose Assessment | The Motor Function section (Section III) of the Movement Disorder Society Unified Parkinson's Disease Rating Scale (MDS-UPDRS) included 33 scores based on 18-items, each anchored with 5 responses: 0 = normal, 1 = slight, 2 = mild, 3 = moderate, and 4 = severe. The scale range was from 0 to 132, with a lower score indicating better motor function and a higher score indicating more severe motor symptoms. The percent change in the MDS-UPDRS Section III score from pre-dose to the first full ON dose or last dose for non-responders is presented. A negative change from baseline indicates an improvement. | At 15, 30, 45, 60 and 90 minutes after dosing at Visits 3 - 5. |
|
Parkinson's Disease
|
Apomorphine, Emetics, Physiological Effects of Drugs, Autonomic Agents, Peripheral Nervous System Agents, Gastrointestinal Agents, Dopamine Agonists, Dopamine Agents, Neurotransmitter Agents, Molecular Mechanisms of Pharmacological Action
|
| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Other: APL-130277<br>open label baseline comparison | Drug: APL-130277<br>* Apomorphine Hydrochloride, Sublingual Thin Film<br>* Other names: Apomorphine Hydrochloride, Sublingual Thin Film;|
|
A Study to Examine APL-130277 in Patients With Parkinson's Disease
Study Overview
=================
Brief Summary
-----------------
The primary objective of this study is to evaluate the efficacy, tolerability and safety of single treatments of APL-130277 in 16 patients with Parkinson's Disease (PD)
Official Title
-----------------
A Phase 2 Study to Examine the Safety, Tolerability and Efficacy of APL-130277 in Patients With Parkinson's Disease
Conditions
-----------------
Parkinson's Disease
Intervention / Treatment
-----------------
* Drug: APL-130277
Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Male or female ≥18 years of age. Clinical diagnosis of Idiopathic PD Receiving stable doses of L-dopa +/- other adjunctive PD therapy for at least 4 weeks before study participation. At least one OFF episode per day and a total daily OFF time of > 2 hours duration. Experience predictable OFF episodes in the morning on awakening prior to receiving morning dose of levodopa. Stage I to III on the Hoehn and Yahr scale in the ON state. If female and of childbearing potential, must agree to use one of the following methods of birth control: Willing and able to comply with scheduled visits, treatment plan, laboratory tests, and other study-related procedures to complete the study. Able to understand the consent form, and to provide written informed consent. Exclusion Criteria: Atypical or secondary parkinsonism Changes in L-dopa or other PD drug dosing regimens 4 weeks before the screening visit. Past treatment with any form of apomorphine within 30 days of Dosing Day 1 (patients who stopped apomorphine for reasons other than lack of efficacy OR tolerability issues may be considered for the trial). Female who is pregnant or lactating. Contraindications to APOKYN or hypersensitive to apomorphine hydrochloride or any of the ingredients of APOKYN (notably sodium metabisulfite), or Tigan®. Participation in any other clinical trial within 14 days of the screening visit. Receipt of any investigational (i.e., unapproved) medication within 30 days of the screening visit. Currently taking, or likely to need to take at any time during the course of the study Currently taking dopamine antagonists or depleting drugs excluding anticholinergics and/or antihistamines with anticholinergic effects. Drug or alcohol dependency in the past 6 months. Clinically significant orthostatic hypotension. Malignant melanoma or a history of previously treated malignant melanoma within 5 years. Clinically significant medical surgical or laboratory abnormality in the judgment of the investigator. Psychiatric disorder, including but not limited to dementia or any disorder that, in the opinion of the Investigator requires ongoing treatment that would make study participation unsafe or make treatment compliance difficult. Dementia that precludes providing informed consent. Potential for lack of compliance and follow-up in the judgment of the investigator. Any other condition, current therapy, or prior therapy (within 30 days of the screening visit), which, in the opinion of the Investigator, would make the subject unsuitable for the study. Previous neurosurgery for PD. Donation of blood or plasma in the 30 days prior to dosing. Presence of cankers or mouth sores.
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
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Arms and Interventions
| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Other: APL-130277<br>open label baseline comparison | Drug: APL-130277<br>* Apomorphine Hydrochloride, Sublingual Thin Film<br>* Other names: Apomorphine Hydrochloride, Sublingual Thin Film;|
What is the study measuring?
-----------------
Primary Outcome Measures
| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| The Percentage of Patients With Resolution of an 'OFF' Episode to an 'ON' State Following Administration of APL-130277 | Clinical confirmation of an 'OFF' state was assessed prior to dosing and confirmation of 'OFF' or 'ON' was assessed after dosing at Visits 3 - 5 by the Investigator. The first full 'ON' dose was defined as the earliest dose in which a patient achieved a full 'ON' state as assessed by the Investigator. The percentage of patients who achieved their first full 'ON' is presented for each timepoint, regardless of the dose received, and for the study overall (i.e. all post-dose timepoints). | At 15, 30, 45, 60 and 90 minutes after dosing at Visits 3 - 5. |
| Time to 'ON' State From Time of Dosing of APL-130277 | Clinical confirmation of 'OFF' or 'ON' was assessed after dosing at Visits 3 - 5 by the Investigator. The time to the full 'ON' state from the time of dosing in minutes was calculated from timings noted by the Investigator and recorded in the electronic case report form (eCRF). The mean time taken for a patient to reach their first full 'ON' state following administration of APL-130277 is presented for patients who turned 'ON' for the study overall. | At 15, 30, 45, 60 and 90 minutes after dosing at Visits 3 - 5. |
| Duration of 'ON' Response From Time of Dosing of APL-130277 | Clinical confirmation of 'OFF' or 'ON' was assessed after dosing at Visits 3 - 5 by the Investigator. The duration of the 'ON' response was defined as the length of time in which a patient was confirmed 'ON' within a dose, and was calculated from the time noted by the Investigator and recorded in the eCRF. The mean duration of the first full 'ON' response following administration of APL-130277 is presented for patients who turned 'ON' for the study overall. | At 15, 30, 45, 60 and 90 minutes after dosing at Visits 3 - 5. |
| Percentage of Patients Who Completed the Trial and Experienced an 'ON' Episode | Clinical confirmation of 'OFF' or 'ON' was assessed after dosing at Visits 3 - 5 by the Investigator. For the overall study, the percentage of patients who completed the trial, and who experienced an 'ON' episode is presented. | At 15, 30, 45, 60 and 90 minutes after dosing at Visits 3 - 5. |
| Pharmacokinetic (PK) Evaluation: Maximum Observed Plasma Concentration (Cmax) | The mean Cmax values are presented for each dosage administered at Visits 3, 4, and 5 for which data was available. Plasma concentrations of the active substance of APL-130277, apomorphine, were analysed using a validated liquid chromatography-tandem mass spectrometry (LC-MS/MS) assay, with a lower limit of quantification of 0.020 nanograms per millilitre (ng/mL). | Just prior to dosing and at 10, 20, 30, 45, 60 and 90 minutes after each dose at Visits 3 - 5. |
| PK Evaluation: Time of Maximum Observed Plasma Concentration (Tmax) | The median Tmax values are presented for each dosage administered at Visits 3, 4, and 5 for which data was available. Plasma concentrations of the active substance of APL-130277, apomorphine, were analysed using a validated LC-MS/MS assay, with a lower limit of quantification of 0.020 ng/mL. | Just prior to dosing and at 10, 20, 30, 45, 60 and 90 minutes after each dose at Visits 3 - 5. |
| PK Evaluation: Time to Last Analytically Quantifiable Concentration (Tlast) | The mean Tlast values are presented for each dosage administered at Visits 3, 4, and 5 for which data was available. Plasma concentrations of the active substance of APL-130277, apomorphine, were analysed using a validated LC-MS/MS assay, with a lower limit of quantification of 0.020 ng/mL. | Just prior to dosing and at 10, 20, 30, 45, 60 and 90 minutes after each dose at Visits 3 - 5. |
| PK Evaluation: Area Under the Plasma Concentration Time Curve, From Time 0 to 90 Minutes (AUC0-90) | The mean AUC0-90 values are presented for each dosage administered at Visits 3, 4, and 5 for which data was available. Plasma concentrations of the active substance of APL-130277, apomorphine, were analysed using a validated LC-MS/MS assay, with a lower limit of quantification of 0.020 ng/mL. | Just prior to dosing and at 10, 20, 30, 45, 60 and 90 minutes after each dose at Visits 3 - 5. |
| PK Evaluation: Area Under the Plasma Concentration Time Curve, From Time 0 to the Last Measurable Non-zero Concentration (AUClast) | The mean AUClast values are presented for each dosage administered at Visits 3, 4, and 5 for which data was available. Plasma concentrations of the active substance of APL-130277, apomorphine, were analysed using a validated LC-MS/MS assay, with a lower limit of quantification of 0.020 ng/mL. The AUClast was calculated by a combination of linear and logarithmic trapezoidal methods (linear up/log down method). | Just prior to dosing and at 10, 20, 30, 45, 60 and 90 minutes after each dose at Visits 3 - 5. |
Secondary Outcome Measures
| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Percentage Change in MDS-UPDRS Section III Score From Pre-dose Assessment | The Motor Function section (Section III) of the Movement Disorder Society Unified Parkinson's Disease Rating Scale (MDS-UPDRS) included 33 scores based on 18-items, each anchored with 5 responses: 0 = normal, 1 = slight, 2 = mild, 3 = moderate, and 4 = severe. The scale range was from 0 to 132, with a lower score indicating better motor function and a higher score indicating more severe motor symptoms. The percent change in the MDS-UPDRS Section III score from pre-dose to the first full ON dose or last dose for non-responders is presented. A negative change from baseline indicates an improvement. | At 15, 30, 45, 60 and 90 minutes after dosing at Visits 3 - 5. |
Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Parkinson's Disease
|
|
NCT01705379
|
Safety of One Dose of Meningococcal ACWY Conjugate Vaccine in Subjects 2 Years of Age and Older
|
A multicenter, single arm, postmarketing surveillance study. This study is a postlicensure requirement of the Philippine Food and Drug Administration (FDA) to provide continued safety evaluation of MenACWY-CRM in Philippine individuals 2 years of age and older, receiving MenACWY-CRM vaccination according to routine clinical practice and prescribing information.
|
A Multicenter, Single Arm, Post Marketing Surveillance Study to Monitor the Safety of Novartis Meningococcal ACWY Conjugate Vaccine (MenACWY-CRM) Administered According to the Prescribing Information to Healthy Subjects 2 Years of Age and Older in the Philippines
|
Meningococcal Disease
|
* Biological: Novartis Meningococcal ACWY Conjugate Vaccine
|
Inclusion Criteria:~Individuals eligible for enrolment in this study are those:~who are of any gender, from the age of 2 and older, and to whom/whose parents or legally acceptable representatives the nature of the study has been described and the subject/subject's parent/legally acceptable representative has provided written informed consent.~who the investigator believes that the subject and/or his or her parent/legal representative can and will comply with the requirements of the protocol.~who are in good health as determined by clinical judgment of the investigator.~Exclusion Criteria:~Individuals not eligible to be enrolled in the study are those:~who are unwilling or unable to give written informed consent or assent to participate in the study.~who are perceived to be unreliable or unavailable for the duration of the study period.~who have previously been immunized with a meningococcal vaccine or vaccine containing meningococcal antigen(s) (licensed or investigational).~who have received any investigational or non-registered product (drug or vaccine) within 30 days prior to enrolment or who expect to receive an investigational drug or vaccine prior to the completion of the study.~who have received or who are planning to receive any vaccines (other than routine childhood vaccines) within 30 days before and after administration of study vaccine.~(Exception: Influenza vaccine may be administered up to 15 days prior to study vaccination and at least 15 days after study vaccination)~who have behavioral or cognitive impairment or psychiatric disease that, in the opinion of the investigator, may interfere with the subject's ability to participate in the study.~who are pregnant or breast feeding (female subjects of appropriate age) or who plan to become pregnant during the course of the study.~who have any serious acute, chronic or progressive disease (e.g., any history of neoplasm, cancer, diabetes, cardiac disease, autoimmune disease, HIV infection or AIDS, or blood dyscrasias, with signs of cardiac or renal failure or severe malnutrition), who have epilepsy or any progressive neurological disease or history of Guillain-Barre syndrome.~who have a history of any anaphylaxis, serious vaccine reactions, or allergy to any vaccine components.~who are known to have a bleeding diathesis, or any condition that may be associated with a prolonged bleeding time.~who are included in study personnel or close family members of personnel conducting this study.
|
2 Years
| null |
All
|
Accepts Healthy Volunteers
|
| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| All adverse events | | Day 29 |
| All serious adverse events | | Day 29 |
|
Neisseria meningitidis, conjugate vaccine, phase IV clinical trial
|
Lactitol, Cathartics, Gastrointestinal Agents
|
| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| MenACWY-CRM<br>2 years of age and older | Biological: Novartis Meningococcal ACWY Conjugate Vaccine<br>* Immunization<br>|
|
Safety of One Dose of Meningococcal ACWY Conjugate Vaccine in Subjects 2 Years of Age and Older
Study Overview
=================
Brief Summary
-----------------
A multicenter, single arm, postmarketing surveillance study. This study is a postlicensure requirement of the Philippine Food and Drug Administration (FDA) to provide continued safety evaluation of MenACWY-CRM in Philippine individuals 2 years of age and older, receiving MenACWY-CRM vaccination according to routine clinical practice and prescribing information.
Official Title
-----------------
A Multicenter, Single Arm, Post Marketing Surveillance Study to Monitor the Safety of Novartis Meningococcal ACWY Conjugate Vaccine (MenACWY-CRM) Administered According to the Prescribing Information to Healthy Subjects 2 Years of Age and Older in the Philippines
Conditions
-----------------
Meningococcal Disease
Intervention / Treatment
-----------------
* Biological: Novartis Meningococcal ACWY Conjugate Vaccine
Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Individuals eligible for enrolment in this study are those: who are of any gender, from the age of 2 and older, and to whom/whose parents or legally acceptable representatives the nature of the study has been described and the subject/subject's parent/legally acceptable representative has provided written informed consent. who the investigator believes that the subject and/or his or her parent/legal representative can and will comply with the requirements of the protocol. who are in good health as determined by clinical judgment of the investigator. Exclusion Criteria: Individuals not eligible to be enrolled in the study are those: who are unwilling or unable to give written informed consent or assent to participate in the study. who are perceived to be unreliable or unavailable for the duration of the study period. who have previously been immunized with a meningococcal vaccine or vaccine containing meningococcal antigen(s) (licensed or investigational). who have received any investigational or non-registered product (drug or vaccine) within 30 days prior to enrolment or who expect to receive an investigational drug or vaccine prior to the completion of the study. who have received or who are planning to receive any vaccines (other than routine childhood vaccines) within 30 days before and after administration of study vaccine. (Exception: Influenza vaccine may be administered up to 15 days prior to study vaccination and at least 15 days after study vaccination) who have behavioral or cognitive impairment or psychiatric disease that, in the opinion of the investigator, may interfere with the subject's ability to participate in the study. who are pregnant or breast feeding (female subjects of appropriate age) or who plan to become pregnant during the course of the study. who have any serious acute, chronic or progressive disease (e.g., any history of neoplasm, cancer, diabetes, cardiac disease, autoimmune disease, HIV infection or AIDS, or blood dyscrasias, with signs of cardiac or renal failure or severe malnutrition), who have epilepsy or any progressive neurological disease or history of Guillain-Barre syndrome. who have a history of any anaphylaxis, serious vaccine reactions, or allergy to any vaccine components. who are known to have a bleeding diathesis, or any condition that may be associated with a prolonged bleeding time. who are included in study personnel or close family members of personnel conducting this study.
Ages Eligible for Study
-----------------
Minimum Age: 2 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 |
| --- | --- |
| MenACWY-CRM<br>2 years of age and older | Biological: Novartis Meningococcal ACWY Conjugate Vaccine<br>* Immunization<br>|
What is the study measuring?
-----------------
Primary Outcome Measures
| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| All adverse events | | Day 29 |
| All serious adverse events | | Day 29 |
Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Neisseria meningitidis, conjugate vaccine, phase IV clinical trial
|
|||
NCT01275638
|
The Effect of Moderate-Dose Steroid Therapy in Sepsis
|
Despite the new developments in sepsis treatment, mortality rate is still high. Discussions on steroid treatment in sepsis are going on. In this study, we aimed to investigate the effects of moderate dosage steroid treatment and endocrinologic changes occurring in sepsis on prognosis in patients with sepsis.
|
This prospective, randomized, single-centre, double-blind, placebo-controlled trial was conducted between April 2005 and May 2008 in the department of Medical ICU and the Department of Infectious Diseases of Erciyes University Medical School. The study was approved by our Institutional Review Board and informed consent was obtained from the patients' relatives. The study did not alter therapy, and each patient's clinical care was determined by their own physician.
|
The Effect of Moderate-Dose Steroid Therapy in Sepsis: A Placebo-Controlled, Randomized Study
|
Sepsis
|
* Drug: Prednisolone
|
Inclusion Criteria:~Patients over 17 years old and diagnosed with sepsis were included in the study consecutively~Exclusion Criteria:~Already known pre-existing adrenal disease or adrenalectomy, known malignancies, tuberculosis that might have involved the adrenal gland, and administration of steroids within the 3 months before the admission. In addition, patients with burns, hemorrhagic shock or those who had suffered myocardial infarction were not included.
|
17 Years
| null |
All
|
No
|
Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple
|
| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| All-cause mortality | | 28-day |
|
| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Adverse Events | | 28 days |
|
cortisol, prednisolone, adrenal insufficiency, sepsis
|
Prednisolone, Methylprednisolone Acetate, Methylprednisolone, Methylprednisolone Hemisuccinate, Prednisolone acetate, Prednisolone hemisuccinate, Prednisolone phosphate, Anti-Inflammatory Agents, Glucocorticoids, Hormones, Hormones, Hormone Substitutes, and Hormone Antagonists, Physiological Effects of Drugs, Antineoplastic Agents, Hormonal, Antineoplastic Agents, Antiemetics, Autonomic Agents, Peripheral Nervous System Agents, Gastrointestinal Agents, Neuroprotective Agents, Protective Agents
|
| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Placebo Comparator: Prednisolone (20 mg/day) for 10 days.<br> | Drug: Prednisolone<br>* Soon after the presumptive diagnosis of severe sepsis, initial laboratory specimens were obtained within 2 hours, and the patients were randomized to treatment with prednisolone or placebo groups. The treatment groups were determined by a computer-generated randomization procedure (in a 1:1 ratio). The steroid group received prednisolone at a moderate-dose (20 mg/day). Prednisolone was given intravenously at 06.00 (10 mg) 14.00 (5 mg) and 22.00 (5 mg) for 10 days. The standard therapy group received a placebo infusion containing physiological saline solution in an identical manner. Patients and their primary physicians were blinded as to which therapy was administered.<br>* Other names: prednizolone;|
|
The Effect of Moderate-Dose Steroid Therapy in Sepsis
Study Overview
=================
Brief Summary
-----------------
Despite the new developments in sepsis treatment, mortality rate is still high. Discussions on steroid treatment in sepsis are going on. In this study, we aimed to investigate the effects of moderate dosage steroid treatment and endocrinologic changes occurring in sepsis on prognosis in patients with sepsis.
Detailed Description
-----------------
This prospective, randomized, single-centre, double-blind, placebo-controlled trial was conducted between April 2005 and May 2008 in the department of Medical ICU and the Department of Infectious Diseases of Erciyes University Medical School. The study was approved by our Institutional Review Board and informed consent was obtained from the patients' relatives. The study did not alter therapy, and each patient's clinical care was determined by their own physician.
Official Title
-----------------
The Effect of Moderate-Dose Steroid Therapy in Sepsis: A Placebo-Controlled, Randomized Study
Conditions
-----------------
Sepsis
Intervention / Treatment
-----------------
* Drug: Prednisolone
Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Patients over 17 years old and diagnosed with sepsis were included in the study consecutively Exclusion Criteria: Already known pre-existing adrenal disease or adrenalectomy, known malignancies, tuberculosis that might have involved the adrenal gland, and administration of steroids within the 3 months before the admission. In addition, patients with burns, hemorrhagic shock or those who had suffered myocardial infarction were not included.
Ages Eligible for Study
-----------------
Minimum 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: Quadruple
Arms and Interventions
| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Placebo Comparator: Prednisolone (20 mg/day) for 10 days.<br> | Drug: Prednisolone<br>* Soon after the presumptive diagnosis of severe sepsis, initial laboratory specimens were obtained within 2 hours, and the patients were randomized to treatment with prednisolone or placebo groups. The treatment groups were determined by a computer-generated randomization procedure (in a 1:1 ratio). The steroid group received prednisolone at a moderate-dose (20 mg/day). Prednisolone was given intravenously at 06.00 (10 mg) 14.00 (5 mg) and 22.00 (5 mg) for 10 days. The standard therapy group received a placebo infusion containing physiological saline solution in an identical manner. Patients and their primary physicians were blinded as to which therapy was administered.<br>* Other names: prednizolone;|
What is the study measuring?
-----------------
Primary Outcome Measures
| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| All-cause mortality | | 28-day |
Secondary Outcome Measures
| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Adverse Events | | 28 days |
Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
cortisol, prednisolone, adrenal insufficiency, sepsis
|
NCT02972294
|
HiFIT Study : Hip Fracture: Iron and Tranexamic Acid
|
Fractures of the upper end of the femur, called commonly Hip fractures are very common, with an incidence of approximately 1.6 million cases per year worldwide. This high incidence is anticipated to grow rapidly in the next decades, driven by population aging. Anemia is very frequent on admission for hip fracture, concerning up to 45% of the patients, with a mean hemoglobin level of 12.5±0.2 g/dl. This high prevalence of anemia together with blood losses, secondary to the fracture itself and surgery are responsible for a high rate of blood transfusion (approximately 40-50% of the patients). However, both anemia and blood transfusion are associated with poor outcome, including increased mortality, length of stay, infection rate etc. In addition, blood is a scarce and expensive resource and its use should be limited as much as possible. There is therefore a need to treat this anemia and/or to prevent the decrease in hemoglobin. For this purpose, intravenous iron has been proposed. Some non-randomized, mainly retrospective, studies have shown that perioperative intravenous iron was able to reduce blood transfusion (i.e. the number of patients transfused and the number of units per patient). Another way to reduce blood transfusion would be to reduce perioperative bleeding. Tranexamic acid has proven to be efficient for this purpose both in trauma patients and in elective surgery patients.The interest for perioperative blood management has recently increased thanks to better recognition of the adverse effects of blood transfusion, better understanding of iron metabolism, new intravenous iron drugs and a renewed interest in former medications (i.e. tranexamic acid). HiFIT study therefore propose a 2X2 factorial design for this study in order to answer questions vis-à-vis the interest of iron and tranexamic acid to reduce blood transfusion in hip fracture patients.
|
Fractures of the upper end of the femur, called commonly Hip fracturesare very common, with an incidence of approximately 1.6 million cases per year worldwide. This high incidence is anticipated to grow rapidly in the next decades, driven by population aging. Anemia is very frequent on admission for hip fracture, concerning up to 45% of the patients, with a mean hemoglobin level of 12.5±0.2 g/dl. This high prevalence of anemia together with blood losses, secondary to the fracture itself and surgery are responsible for a high rate of blood transfusion (approximately 40-50% of the patients). However, both anemia and blood transfusion are associated with poor outcome, including increased mortality, length of stay, infection rate etc. In addition, blood is a scarce and expensive resource and its use should be limited as much as possible. There is therefore a need to treat this anemia and/or to prevent the decrease in hemoglobin. For this purpose, intravenous iron has been proposed. Some non-randomized, mainly retrospective, studies have shown that perioperative intravenous iron was able to reduce blood transfusion (i.e. the number of patients transfused and the number of units per patient). Indeed, a pooled analysis of 5 studies including 1,361 patients suggests that intravenous iron could reduce perioperative transfusion in hip fracture patients. However, there is no definitive data. Another way to reduce blood transfusion would be to reduce perioperative bleeding. Tranexamic acid has proven to be efficient for this purpose both in trauma patients and in elective surgery patients. However, there are only two randomized studies investigating the interest of tranexamic acid in hip fractures, and they are not conclusive probably owing to a lack of power. In addition, use of intravenous tranexamic acid could be limited in this population of frail patients and topical use of tranexamic acid, notably to prevent the intraoperative bleeding, appear to be an accurate and sure alternative.~Although hip fracture is a very frequent pathology, with a high burden of care, few data are available that focus on the management of perioperative anemia in this context. The interest for perioperative blood management has recently increased thanks to better recognition of the adverse effects of blood transfusion, better understanding of iron metabolism, new intravenous iron drugs and a renewed interest in former medications (i.e. tranexamic acid). hiFIT study therefore propose a 2X2 factorial design for this study in order to answer questions vis-à-vis the interest of iron and tranexamic acid to reduce blood transfusion in hip fracture patients.
|
HiFIT Study: Interest of Intravenous Iron and Tranexamic Acid to Reduce Transfusion in Hip Fracture Patients
|
Hip Fractures Pathologic, Anemia
|
* Drug: Iron Isomaltoside 1000
* Drug: Tranexamic Acid
* Drug: Placebos iron isomaltoside 1000
* Drug: Placebos tranexamic acid
|
Inclusion Criteria:~Age ≥ 18 years,~Osteoporotic Fractures of the upper end of the femur requiring surgical repair.~Preoperative hemoglobin between 9.5 and 13 g/dl.~Patient or relative signed informed consent or inclusion thanks to urgent inclusion procedure~Exclusion Criteria:~Bone marrow disease or ongoing treatment (such as chemotherapy), which could interfere with bone marrow erythropoiesis,~Known allergy or counter-indication to iron and/or to tranexamic acid,~Uncontrolled arterial hypertension,~Recent iron infusion (within one week),~Blood transfusion within one week before inclusion or preoperative blood transfusion already scheduled,~Any patient who cannot be transfused or has refused consent for a blood transfusion,~Bedridden or very dependent patient (equivalent to GIR 1 or 2 class).~Non-affiliation to French health care coverage,~Adult patient protected under the law (guardianship),~Pregnancy.
|
18 Years
| null |
All
|
No
|
Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Factorial Assignment
Masking: Triple
|
| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Proportion of patients who received a blood transfusion during their hospital stay following surgery | Proportion of patients who received a blood transfusion during their hospital stay following surgery | From the day of surgery until hospital discharge (or until day 30 if patient is still hospitalized). |
|
| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Proportion of patients who received a blood transfusion after surgery | Proportion of patients who received a blood transfusion during the month following surgery (including fresh frozen plasma and platelets) | From the day of surgery until Day 3, Day 7 and Day 30 post surgery. |
| Number of packed red blood cell units transfused per patient, as well as number of fresh frozen plasma and platelets units | Number of packed red blood cell units transfused per patient, as well as number of fresh frozen plasma and platelets units | Till postoperative Day3, first week posteratively,and till hospital discharge (or one month if patients still hospitalised) |
| Hemoglobin concentration | Hemoglobin concentration | At inclusion and on days 3, 7 (or hospital discharge if it happens first) and 30. |
| Proportion of patients with anemia (hemoglobin <12 g/dL in women and <13 g/dL in men) | Proportion of patients with anemia (hemoglobin <12 g/dL in women and <13 g/dL in men) | At inclusion and on days 3, 7, hospital discharge (if it happens before Day 30) and 30. |
| Reticulocytes count | Reticulocytes count | On days 3, 7 (or hospital discharge if it happens first) and 30 post surgery |
| Perioperative blood loss (estimated according to a formula based on hematocrit variation). | Perioperative blood loss (estimated according to a formula based on hematocrit variation): (HtD0 - HtD3)*TBV + number of RPBC transfused unit x 200 ml. Ht = Haematocrit, TBV = total blood volume (70 mL/kg in men and 65 mL/kg in women) | During surgery |
| Post operative Iron deficiency rate | Proportion of patients with Iron deficiency (defined as a ferritin < 100 ng/ml or < 300 ng/ml together with transferrin saturation <20%), measurement of ferritin and transferrin saturation | On Day 7 (or hospital discharge if it happens first) and Day 30. |
| Number of hospitalization days | Number of hospitalization days | On Day 30 and Day 90 following surgery. |
| Proportion of patients at home | Proportion of patients returned at home (or at their previous place of living) | On Day 30 and Day 90. |
| Proportion of patients able to walk a distance of ten feet without assistance | Proportion of patients able to walk a distance of ten feet without assistance | On Day 30 and Day 90 |
| Variation of quality of life | Variation of EQ-5D score | From inclusion to Day 30 and Day 90 |
| Variation of perceived quality of life | Variation of perceived quality of life with a single overall item from PQOL scale | From inclusion to Day 7 (or hospital discharge if it happens first) and Day 90. |
| Variation of IADL test | Variation of IADL test | From inclusion to Day 90. |
| Death rate from all causes | Death rate from all causes | From inclusion to Day 90 |
| Rate of adverse events including the following clinical complications: Vascular events, Heart failure; Renal failure; Infectious complications; Anaphylactic reaction; Transfusion-related complications | Rate of adverse events including the following clinical complications: Vascular events, Heart failure; Renal failure; Infectious complications; Anaphylactic reaction; Transfusion-related complications | From inclusion to Day 90 |
|
iron isomaltoside, tranexamic acid
|
Iron, Tranexamic Acid, Iron isomaltoside 1000, Ferric Compounds, Trace Elements, Micronutrients, Physiological Effects of Drugs, Antifibrinolytic Agents, Fibrin Modulating Agents, Molecular Mechanisms of Pharmacological Action, Hemostatics, Coagulants, Hematinics
|
| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: TXA + IIM<br>The patients randomized to this arm will have iron isomaltoside 1000 and tranexamic acid | Drug: Iron Isomaltoside 1000<br>* Iron Isomaltoside 1000 will be use. Blinding procedure will be put in place for the administration of the treatment<br>* Other names: monofer;Drug: Tranexamic Acid<br>* Tranexamic acid will be use.<br>* Other names: exacyl;|
| Experimental: Placebo TXA + IIM<br>The patients randomized to this arm will have iron isomaltoside 1000 and Placebos tranexamic acid | Drug: Iron Isomaltoside 1000<br>* Iron Isomaltoside 1000 will be use. Blinding procedure will be put in place for the administration of the treatment<br>* Other names: monofer;Drug: Placebos tranexamic acid<br>* placebo of tranexamic acid correspond to a saline solution.<br>* Other names: saline serum;|
| Experimental: TXA + Placebo IIM<br>The patients randomized to this arm will have Placebos iron isomaltoside 1000 and tranexamic acid | Drug: Tranexamic Acid<br>* Tranexamic acid will be use.<br>* Other names: exacyl;Drug: Placebos iron isomaltoside 1000<br>* placebo of Iron Isomaltoside 1000 correspond to a saline solution. Blinding procedure will be put in place for the administration of this treatment<br>* Other names: saline serum;|
| Experimental: Placebo TXA + Placebo IIM<br>The patients randomized to this arm will have Placebos iron isomaltoside 1000 and Placebos tranexamic acid | Drug: Placebos iron isomaltoside 1000<br>* placebo of Iron Isomaltoside 1000 correspond to a saline solution. Blinding procedure will be put in place for the administration of this treatment<br>* Other names: saline serum;Drug: Placebos tranexamic acid<br>* placebo of tranexamic acid correspond to a saline solution.<br>* Other names: saline serum;|
|
HiFIT Study : Hip Fracture: Iron and Tranexamic Acid
Study Overview
=================
Brief Summary
-----------------
Fractures of the upper end of the femur, called commonly Hip fractures are very common, with an incidence of approximately 1.6 million cases per year worldwide. This high incidence is anticipated to grow rapidly in the next decades, driven by population aging. Anemia is very frequent on admission for hip fracture, concerning up to 45% of the patients, with a mean hemoglobin level of 12.5±0.2 g/dl. This high prevalence of anemia together with blood losses, secondary to the fracture itself and surgery are responsible for a high rate of blood transfusion (approximately 40-50% of the patients). However, both anemia and blood transfusion are associated with poor outcome, including increased mortality, length of stay, infection rate etc. In addition, blood is a scarce and expensive resource and its use should be limited as much as possible. There is therefore a need to treat this anemia and/or to prevent the decrease in hemoglobin. For this purpose, intravenous iron has been proposed. Some non-randomized, mainly retrospective, studies have shown that perioperative intravenous iron was able to reduce blood transfusion (i.e. the number of patients transfused and the number of units per patient). Another way to reduce blood transfusion would be to reduce perioperative bleeding. Tranexamic acid has proven to be efficient for this purpose both in trauma patients and in elective surgery patients.The interest for perioperative blood management has recently increased thanks to better recognition of the adverse effects of blood transfusion, better understanding of iron metabolism, new intravenous iron drugs and a renewed interest in former medications (i.e. tranexamic acid). HiFIT study therefore propose a 2X2 factorial design for this study in order to answer questions vis-à-vis the interest of iron and tranexamic acid to reduce blood transfusion in hip fracture patients.
Detailed Description
-----------------
Fractures of the upper end of the femur, called commonly Hip fracturesare very common, with an incidence of approximately 1.6 million cases per year worldwide. This high incidence is anticipated to grow rapidly in the next decades, driven by population aging. Anemia is very frequent on admission for hip fracture, concerning up to 45% of the patients, with a mean hemoglobin level of 12.5±0.2 g/dl. This high prevalence of anemia together with blood losses, secondary to the fracture itself and surgery are responsible for a high rate of blood transfusion (approximately 40-50% of the patients). However, both anemia and blood transfusion are associated with poor outcome, including increased mortality, length of stay, infection rate etc. In addition, blood is a scarce and expensive resource and its use should be limited as much as possible. There is therefore a need to treat this anemia and/or to prevent the decrease in hemoglobin. For this purpose, intravenous iron has been proposed. Some non-randomized, mainly retrospective, studies have shown that perioperative intravenous iron was able to reduce blood transfusion (i.e. the number of patients transfused and the number of units per patient). Indeed, a pooled analysis of 5 studies including 1,361 patients suggests that intravenous iron could reduce perioperative transfusion in hip fracture patients. However, there is no definitive data. Another way to reduce blood transfusion would be to reduce perioperative bleeding. Tranexamic acid has proven to be efficient for this purpose both in trauma patients and in elective surgery patients. However, there are only two randomized studies investigating the interest of tranexamic acid in hip fractures, and they are not conclusive probably owing to a lack of power. In addition, use of intravenous tranexamic acid could be limited in this population of frail patients and topical use of tranexamic acid, notably to prevent the intraoperative bleeding, appear to be an accurate and sure alternative. Although hip fracture is a very frequent pathology, with a high burden of care, few data are available that focus on the management of perioperative anemia in this context. The interest for perioperative blood management has recently increased thanks to better recognition of the adverse effects of blood transfusion, better understanding of iron metabolism, new intravenous iron drugs and a renewed interest in former medications (i.e. tranexamic acid). hiFIT study therefore propose a 2X2 factorial design for this study in order to answer questions vis-à-vis the interest of iron and tranexamic acid to reduce blood transfusion in hip fracture patients.
Official Title
-----------------
HiFIT Study: Interest of Intravenous Iron and Tranexamic Acid to Reduce Transfusion in Hip Fracture Patients
Conditions
-----------------
Hip Fractures Pathologic, Anemia
Intervention / Treatment
-----------------
* Drug: Iron Isomaltoside 1000
* Drug: Tranexamic Acid
* Drug: Placebos iron isomaltoside 1000
* Drug: Placebos tranexamic acid
Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Age ≥ 18 years, Osteoporotic Fractures of the upper end of the femur requiring surgical repair. Preoperative hemoglobin between 9.5 and 13 g/dl. Patient or relative signed informed consent or inclusion thanks to urgent inclusion procedure Exclusion Criteria: Bone marrow disease or ongoing treatment (such as chemotherapy), which could interfere with bone marrow erythropoiesis, Known allergy or counter-indication to iron and/or to tranexamic acid, Uncontrolled arterial hypertension, Recent iron infusion (within one week), Blood transfusion within one week before inclusion or preoperative blood transfusion already scheduled, Any patient who cannot be transfused or has refused consent for a blood transfusion, Bedridden or very dependent patient (equivalent to GIR 1 or 2 class). Non-affiliation to French health care coverage, Adult patient protected under the law (guardianship), Pregnancy.
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: Factorial Assignment
Masking: Triple
Arms and Interventions
| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: TXA + IIM<br>The patients randomized to this arm will have iron isomaltoside 1000 and tranexamic acid | Drug: Iron Isomaltoside 1000<br>* Iron Isomaltoside 1000 will be use. Blinding procedure will be put in place for the administration of the treatment<br>* Other names: monofer;Drug: Tranexamic Acid<br>* Tranexamic acid will be use.<br>* Other names: exacyl;|
| Experimental: Placebo TXA + IIM<br>The patients randomized to this arm will have iron isomaltoside 1000 and Placebos tranexamic acid | Drug: Iron Isomaltoside 1000<br>* Iron Isomaltoside 1000 will be use. Blinding procedure will be put in place for the administration of the treatment<br>* Other names: monofer;Drug: Placebos tranexamic acid<br>* placebo of tranexamic acid correspond to a saline solution.<br>* Other names: saline serum;|
| Experimental: TXA + Placebo IIM<br>The patients randomized to this arm will have Placebos iron isomaltoside 1000 and tranexamic acid | Drug: Tranexamic Acid<br>* Tranexamic acid will be use.<br>* Other names: exacyl;Drug: Placebos iron isomaltoside 1000<br>* placebo of Iron Isomaltoside 1000 correspond to a saline solution. Blinding procedure will be put in place for the administration of this treatment<br>* Other names: saline serum;|
| Experimental: Placebo TXA + Placebo IIM<br>The patients randomized to this arm will have Placebos iron isomaltoside 1000 and Placebos tranexamic acid | Drug: Placebos iron isomaltoside 1000<br>* placebo of Iron Isomaltoside 1000 correspond to a saline solution. Blinding procedure will be put in place for the administration of this treatment<br>* Other names: saline serum;Drug: Placebos tranexamic acid<br>* placebo of tranexamic acid correspond to a saline solution.<br>* Other names: saline serum;|
What is the study measuring?
-----------------
Primary Outcome Measures
| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Proportion of patients who received a blood transfusion during their hospital stay following surgery | Proportion of patients who received a blood transfusion during their hospital stay following surgery | From the day of surgery until hospital discharge (or until day 30 if patient is still hospitalized). |
Secondary Outcome Measures
| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Proportion of patients who received a blood transfusion after surgery | Proportion of patients who received a blood transfusion during the month following surgery (including fresh frozen plasma and platelets) | From the day of surgery until Day 3, Day 7 and Day 30 post surgery. |
| Number of packed red blood cell units transfused per patient, as well as number of fresh frozen plasma and platelets units | Number of packed red blood cell units transfused per patient, as well as number of fresh frozen plasma and platelets units | Till postoperative Day3, first week posteratively,and till hospital discharge (or one month if patients still hospitalised) |
| Hemoglobin concentration | Hemoglobin concentration | At inclusion and on days 3, 7 (or hospital discharge if it happens first) and 30. |
| Proportion of patients with anemia (hemoglobin <12 g/dL in women and <13 g/dL in men) | Proportion of patients with anemia (hemoglobin <12 g/dL in women and <13 g/dL in men) | At inclusion and on days 3, 7, hospital discharge (if it happens before Day 30) and 30. |
| Reticulocytes count | Reticulocytes count | On days 3, 7 (or hospital discharge if it happens first) and 30 post surgery |
| Perioperative blood loss (estimated according to a formula based on hematocrit variation). | Perioperative blood loss (estimated according to a formula based on hematocrit variation): (HtD0 - HtD3)*TBV + number of RPBC transfused unit x 200 ml. Ht = Haematocrit, TBV = total blood volume (70 mL/kg in men and 65 mL/kg in women) | During surgery |
| Post operative Iron deficiency rate | Proportion of patients with Iron deficiency (defined as a ferritin < 100 ng/ml or < 300 ng/ml together with transferrin saturation <20%), measurement of ferritin and transferrin saturation | On Day 7 (or hospital discharge if it happens first) and Day 30. |
| Number of hospitalization days | Number of hospitalization days | On Day 30 and Day 90 following surgery. |
| Proportion of patients at home | Proportion of patients returned at home (or at their previous place of living) | On Day 30 and Day 90. |
| Proportion of patients able to walk a distance of ten feet without assistance | Proportion of patients able to walk a distance of ten feet without assistance | On Day 30 and Day 90 |
| Variation of quality of life | Variation of EQ-5D score | From inclusion to Day 30 and Day 90 |
| Variation of perceived quality of life | Variation of perceived quality of life with a single overall item from PQOL scale | From inclusion to Day 7 (or hospital discharge if it happens first) and Day 90. |
| Variation of IADL test | Variation of IADL test | From inclusion to Day 90. |
| Death rate from all causes | Death rate from all causes | From inclusion to Day 90 |
| Rate of adverse events including the following clinical complications: Vascular events, Heart failure; Renal failure; Infectious complications; Anaphylactic reaction; Transfusion-related complications | Rate of adverse events including the following clinical complications: Vascular events, Heart failure; Renal failure; Infectious complications; Anaphylactic reaction; Transfusion-related complications | From inclusion to Day 90 |
Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
iron isomaltoside, tranexamic acid
|
NCT02511353
|
Efficacy and Safety of High-dose Ivermectin for Reducing Malaria Transmission: A Dose Finding Study
|
In western Kenya the prevalence of malaria in <5 year olds has fallen from 70% in 1997 to 40% in 2008, where it has now stagnated. Innovative approaches are needed to continue towards elimination. Ivermectin is a broad spectrum antiparasitic endectocide widely used for the control of onchocerciasis and lymphatic filariasis at a dose of 150-200 mcg/kg. Ivermectin at this dose has a potent, but short-lived effect for 6-11 days on mosquito survival, egg-laying, and parasite sporogony. Higher doses are needed to prolong its mosquitocidal effects. Previous studies have shown ivermectin is very well tolerated and safe even up to 2,000 mcg/kg. This dose finding study will evaluate the transmission blocking effect of high-dose ivermectin to define the optimal dose for future use of ivermectin in combination with artemisinin-based combination therapy (ACT) for mass drug administration (MDA). It explores a research question of global relevance. A prolonged transmission blocking effect of ivermectin could have substantial consequences for malaria control in the next decades. The results are expected to inform national malaria control programs in malaria endemic countries, to inform WHO guidelines, and to contribute to the regulatory process.
|
Efficacy and Safety of High-dose Ivermectin for Reducing Malaria Transmission: A Dose Finding Study (IVERMAL)
|
Malaria
|
* Drug: ivermectin
* Drug: placebo
* Drug: dihydroartemisinin-piperaquine
|
Inclusion Criteria:~Symptomatic, uncomplicated Plasmodium falciparum infection~Positive malaria microscopy or malaria RDT (pLDH)~Age: 18-50 years~Provide written informed consent~Agree to be able to travel to clinic on days: 1, 2, 7, 10, 14, 21, and 28~Exclusion Criteria:~Signs or symptoms of severe malaria~Unable to provide written informed consent~For women: pregnancy or lactation~Hypersensitivity to ivermectin or DP~QTc >460 ms on ECG~Body Mass Index (BMI) below 16 or above 32 kg/m2~Haemoglobin concentration below 9 g/dL~Taken ivermectin in the last month~Taken dihydroartemisinin-piperaquine in the last 12 weeks~Loa loa as assessed by travel history to Angola, Cameroon, Chad, Central African Republic, Congo, DR Congo, Equatorial Guinea, Ethiopia, Gabon, Nigeria and Sudan~History and/or symptoms indicating chronic illness~Current use of tuberculosis or anti-retroviral medication~Previously enrolled in the same study
|
18 Years
|
50 Years
|
All
|
No
|
Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple
|
| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Mosquito survival | | Survival of mosquitoes at 14 days after feeding on blood taking from study participants who started the 3-day ivermectin and DP regimen 7 days earlier. |
|
| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Mosquito survival | | Survival of mosquitoes at each day up to day 21 or 28 after each feeding experiments performed at 0, 2 day+4h, 10, 14, 21, 28 days after start of treatment. |
| Number of patients with malaria clinical and parasitological treatment response | | Up to day 28. |
| Area under the plasma concentration versus time curve (AUC) of ivermectin | | Up to day 28. |
| Area under the plasma concentration versus time curve (AUC) of piperaquine | Dihydroartemisinin-piperaquine is a combination drug. As dihydroartemisinin has a very short elimination time, only the AUC for the longer acting piperaquine component will be determined. | Up to day 28. |
| Peak plasma Concentration (Cmax) of ivermectin | | Up to day 28. |
| Peak plasma Concentration (Cmax) of piperaquine | Dihydroartemisinin-piperaquine is a combination drug. As dihydroartemisinin has a very short elimination time, only the Cmax for the longer acting piperaquine component will be determined. | Up to day 28. |
| Tolerability as assessed by adverse events reported in a general toxicity questionnaire | | Up to day 28. |
| CNS adverse events | | Up to day 28. |
| Serious adverse events | | Up to day 28. |
| Haemoglobin concentrations | | Up to day 28. |
| QTc interval | | At 52 hours. |
| Mydriasis quantitated by pupillometry | | Up to day 28. |
|
plasmodium, malaria, dihydroartemisinin-piperaquine, ivermectin
|
Ivermectin, Piperaquine, Artenimol, Antiparasitic Agents, Anti-Infective Agents, Antimalarials, Antiprotozoal Agents
|
| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Placebo Comparator: placebo<br>Standard 3-day course of dihydroartemisinin-piperaquine, plus once a day for 3 days: placebo 600 mcg/kg/day. | Drug: placebo<br>* Placebo for ivermectin.<br>Drug: dihydroartemisinin-piperaquine<br> <br> |
| Experimental: ivermectin 300 mcg/kg<br>Standard 3-day course of dihydroartemisinin-piperaquine, plus once a day for 3 days: ivermectin 300 mcg/kg/day and placebo 300 mcg/kg/day. | Drug: ivermectin<br> <br> Drug: placebo<br>* Placebo for ivermectin.<br>Drug: dihydroartemisinin-piperaquine<br> <br> |
| Experimental: ivermectin 600 mcg/kg<br>Standard 3-day course of dihydroartemisinin-piperaquine, plus once a day for 3 days: ivermectin 600 mcg/kg/day. | Drug: ivermectin<br> <br> Drug: dihydroartemisinin-piperaquine<br> <br> |
|
Efficacy and Safety of High-dose Ivermectin for Reducing Malaria Transmission: A Dose Finding Study
Study Overview
=================
Brief Summary
-----------------
In western Kenya the prevalence of malaria in <5 year olds has fallen from 70% in 1997 to 40% in 2008, where it has now stagnated. Innovative approaches are needed to continue towards elimination. Ivermectin is a broad spectrum antiparasitic endectocide widely used for the control of onchocerciasis and lymphatic filariasis at a dose of 150-200 mcg/kg. Ivermectin at this dose has a potent, but short-lived effect for 6-11 days on mosquito survival, egg-laying, and parasite sporogony. Higher doses are needed to prolong its mosquitocidal effects. Previous studies have shown ivermectin is very well tolerated and safe even up to 2,000 mcg/kg. This dose finding study will evaluate the transmission blocking effect of high-dose ivermectin to define the optimal dose for future use of ivermectin in combination with artemisinin-based combination therapy (ACT) for mass drug administration (MDA). It explores a research question of global relevance. A prolonged transmission blocking effect of ivermectin could have substantial consequences for malaria control in the next decades. The results are expected to inform national malaria control programs in malaria endemic countries, to inform WHO guidelines, and to contribute to the regulatory process.
Official Title
-----------------
Efficacy and Safety of High-dose Ivermectin for Reducing Malaria Transmission: A Dose Finding Study (IVERMAL)
Conditions
-----------------
Malaria
Intervention / Treatment
-----------------
* Drug: ivermectin
* Drug: placebo
* Drug: dihydroartemisinin-piperaquine
Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Symptomatic, uncomplicated Plasmodium falciparum infection Positive malaria microscopy or malaria RDT (pLDH) Age: 18-50 years Provide written informed consent Agree to be able to travel to clinic on days: 1, 2, 7, 10, 14, 21, and 28 Exclusion Criteria: Signs or symptoms of severe malaria Unable to provide written informed consent For women: pregnancy or lactation Hypersensitivity to ivermectin or DP QTc >460 ms on ECG Body Mass Index (BMI) below 16 or above 32 kg/m2 Haemoglobin concentration below 9 g/dL Taken ivermectin in the last month Taken dihydroartemisinin-piperaquine in the last 12 weeks Loa loa as assessed by travel history to Angola, Cameroon, Chad, Central African Republic, Congo, DR Congo, Equatorial Guinea, Ethiopia, Gabon, Nigeria and Sudan History and/or symptoms indicating chronic illness Current use of tuberculosis or anti-retroviral medication Previously enrolled in the same study
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: Quadruple
Arms and Interventions
| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Placebo Comparator: placebo<br>Standard 3-day course of dihydroartemisinin-piperaquine, plus once a day for 3 days: placebo 600 mcg/kg/day. | Drug: placebo<br>* Placebo for ivermectin.<br>Drug: dihydroartemisinin-piperaquine<br> <br> |
| Experimental: ivermectin 300 mcg/kg<br>Standard 3-day course of dihydroartemisinin-piperaquine, plus once a day for 3 days: ivermectin 300 mcg/kg/day and placebo 300 mcg/kg/day. | Drug: ivermectin<br> <br> Drug: placebo<br>* Placebo for ivermectin.<br>Drug: dihydroartemisinin-piperaquine<br> <br> |
| Experimental: ivermectin 600 mcg/kg<br>Standard 3-day course of dihydroartemisinin-piperaquine, plus once a day for 3 days: ivermectin 600 mcg/kg/day. | Drug: ivermectin<br> <br> Drug: dihydroartemisinin-piperaquine<br> <br> |
What is the study measuring?
-----------------
Primary Outcome Measures
| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Mosquito survival | | Survival of mosquitoes at 14 days after feeding on blood taking from study participants who started the 3-day ivermectin and DP regimen 7 days earlier. |
Secondary Outcome Measures
| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Mosquito survival | | Survival of mosquitoes at each day up to day 21 or 28 after each feeding experiments performed at 0, 2 day+4h, 10, 14, 21, 28 days after start of treatment. |
| Number of patients with malaria clinical and parasitological treatment response | | Up to day 28. |
| Area under the plasma concentration versus time curve (AUC) of ivermectin | | Up to day 28. |
| Area under the plasma concentration versus time curve (AUC) of piperaquine | Dihydroartemisinin-piperaquine is a combination drug. As dihydroartemisinin has a very short elimination time, only the AUC for the longer acting piperaquine component will be determined. | Up to day 28. |
| Peak plasma Concentration (Cmax) of ivermectin | | Up to day 28. |
| Peak plasma Concentration (Cmax) of piperaquine | Dihydroartemisinin-piperaquine is a combination drug. As dihydroartemisinin has a very short elimination time, only the Cmax for the longer acting piperaquine component will be determined. | Up to day 28. |
| Tolerability as assessed by adverse events reported in a general toxicity questionnaire | | Up to day 28. |
| CNS adverse events | | Up to day 28. |
| Serious adverse events | | Up to day 28. |
| Haemoglobin concentrations | | Up to day 28. |
| QTc interval | | At 52 hours. |
| Mydriasis quantitated by pupillometry | | Up to day 28. |
Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
plasmodium, malaria, dihydroartemisinin-piperaquine, ivermectin
|
|
NCT01986465
|
Effectiveness of Steroid Injection in Treating Patients With Lateral Epicondylitis
|
The aim of this study is to evaluate the effectiveness of steroid injection and immobilization versus no immobilization in treating patients with lateral epicondylitis.
|
Comparing the Effectiveness of Steroid Injection Versus Placebo and Immobilization Versus no Immobilization in Treating Patients With Lateral Epicondylitis
|
Lateral Epicondylitis
|
* Drug: Depomedrol
* Drug: Placebo
|
Inclusion Criteria:~age 18 to 65 years~confirmed lateral epicondylitis~had not received any treatment prior to enrolment~Exclusion Criteria:~symptoms lasting less than 6 weeks~history of acute trauma, fracture, and/or surgery within 12 months~patients who had received corticosteroid injection, physiotherapy, splint or casting during the past 6 months~bilateral involvement and history of cervical disk herniation, radiculopathy or abnormal electrophysiologic study
|
18 Years
|
65 Years
|
All
|
No
|
Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple
|
| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Function | The trial subjects are evaluated using the Oxford Elbow Scale (OES). They are asked to come to the trial office at 2 weeks, 4 weeks and 24 weeks for follow-up evaluation by administration of OES. | Within the first 24 weeks after therapy |
| Pain | The trial subjects are evaluated using the Oxford Elbow Scale (OES). They are asked to come to the trial office at 2 weeks, 4 weeks and 24 weeks for follow-up evaluation by administration of OES. | Within the first 24 weeks after therapy |
| Social-psychological | The trial subjects are evaluated using the Oxford Elbow Scale (OES). They are asked to come to the trial office at 2 weeks, 4 weeks and 24 weeks for follow-up evaluation by administration of OES. | Within the first 24 weeks after therapy |
|
lateral epicondylitis, treatment, steroid, immobilization
|
Methylprednisolone Acetate, Methylprednisolone, Methylprednisolone Hemisuccinate, Prednisolone, Prednisolone acetate, Prednisolone hemisuccinate, Prednisolone phosphate, Anti-Inflammatory Agents, Antiemetics, Autonomic Agents, Peripheral Nervous System Agents, Physiological Effects of Drugs, Gastrointestinal Agents, Glucocorticoids, Hormones, Hormones, Hormone Substitutes, and Hormone Antagonists, Neuroprotective Agents, Protective Agents, Antineoplastic Agents, Hormonal, Antineoplastic Agents
|
| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Depomedrol<br>The trial pharmacist prepares a series of similar vials containing either 4 mg of Depomedrol or Normal Saline and coded them either 1, 2, 3 or 4, the group assignments are not decoded until the end of the trial when the final analysis is due to take place. Patients take their envelopes to the trial pharmacist who give them a coded vial which they take to the orthopaedic surgeon who make the injection. After the injection the trial clerk take the patients to a technician who give patients in groups 1 and 3 long arm splints. | Drug: Depomedrol<br> <br> |
| Placebo Comparator: Placebo<br>The trial pharmacist prepares a series of similar vials containing either 4 mg of Depomedrol or Normal Saline and coded them either 1, 2, 3 or 4, the group assignments are not decoded until the end of the trial when the final analysis is due to take place. Patients take their envelopes to the trial pharmacist who give them a coded vial which they take to the orthopaedic surgeon who make the injection. After the injection the trial clerk take the patients to a technician who give patients in groups 1 and 3 long arm splints. | Drug: Placebo<br> <br> |
|
Effectiveness of Steroid Injection in Treating Patients With Lateral Epicondylitis
Study Overview
=================
Brief Summary
-----------------
The aim of this study is to evaluate the effectiveness of steroid injection and immobilization versus no immobilization in treating patients with lateral epicondylitis.
Official Title
-----------------
Comparing the Effectiveness of Steroid Injection Versus Placebo and Immobilization Versus no Immobilization in Treating Patients With Lateral Epicondylitis
Conditions
-----------------
Lateral Epicondylitis
Intervention / Treatment
-----------------
* Drug: Depomedrol
* Drug: Placebo
Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: age 18 to 65 years confirmed lateral epicondylitis had not received any treatment prior to enrolment Exclusion Criteria: symptoms lasting less than 6 weeks history of acute trauma, fracture, and/or surgery within 12 months patients who had received corticosteroid injection, physiotherapy, splint or casting during the past 6 months bilateral involvement and history of cervical disk herniation, radiculopathy or abnormal electrophysiologic study
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: Depomedrol<br>The trial pharmacist prepares a series of similar vials containing either 4 mg of Depomedrol or Normal Saline and coded them either 1, 2, 3 or 4, the group assignments are not decoded until the end of the trial when the final analysis is due to take place. Patients take their envelopes to the trial pharmacist who give them a coded vial which they take to the orthopaedic surgeon who make the injection. After the injection the trial clerk take the patients to a technician who give patients in groups 1 and 3 long arm splints. | Drug: Depomedrol<br> <br> |
| Placebo Comparator: Placebo<br>The trial pharmacist prepares a series of similar vials containing either 4 mg of Depomedrol or Normal Saline and coded them either 1, 2, 3 or 4, the group assignments are not decoded until the end of the trial when the final analysis is due to take place. Patients take their envelopes to the trial pharmacist who give them a coded vial which they take to the orthopaedic surgeon who make the injection. After the injection the trial clerk take the patients to a technician who give patients in groups 1 and 3 long arm splints. | Drug: Placebo<br> <br> |
What is the study measuring?
-----------------
Primary Outcome Measures
| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Function | The trial subjects are evaluated using the Oxford Elbow Scale (OES). They are asked to come to the trial office at 2 weeks, 4 weeks and 24 weeks for follow-up evaluation by administration of OES. | Within the first 24 weeks after therapy |
| Pain | The trial subjects are evaluated using the Oxford Elbow Scale (OES). They are asked to come to the trial office at 2 weeks, 4 weeks and 24 weeks for follow-up evaluation by administration of OES. | Within the first 24 weeks after therapy |
| Social-psychological | The trial subjects are evaluated using the Oxford Elbow Scale (OES). They are asked to come to the trial office at 2 weeks, 4 weeks and 24 weeks for follow-up evaluation by administration of OES. | Within the first 24 weeks after therapy |
Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
lateral epicondylitis, treatment, steroid, immobilization
|
||
NCT02259933
|
Safety, Tolerability and Pharmacokinetics of KUC 7483 CL Tablets in Healthy Male Volunteers
|
Study to investigate safety, tolerability and pharmacokinetics of KUC 7483 CL after repeated dosing
|
A Double-blind (at Each Dose Level), Randomised, Placebo Controlled Study to Evaluate Safety, Tolerability and Pharmacokinetics of Increasing Repeated Oral Doses of KUC 7483 CL Tablets (Dosage: 40, 120, 180 mg b.i.d.) Over 7 Days in Healthy Male Volunteers
|
Healthy
|
* Drug: KUC 7483 CL
* Drug: Placebo
|
Inclusion Criteria:~Healthy males according to the following criteria:~Based upon a complete medical history, including the physical examination, vital signs (BP, PR), 12-lead ECG, clinical laboratory tests~No finding deviating from normal and of clinical relevance~No evidence of a clinically relevant concomitant disease~Age ≥21 and Age ≤60 years~BMI ≥18.5 and BMI ≤29.9 kg/m2 (Body Mass Index)~Signed and dated written informed consent prior to admission to the study in accordance with Good Clinical Practice and the local legislation~Exclusion Criteria:~Gastrointestinal, hepatic, renal, respiratory, cardiovascular, metabolic, immunological or hormonal disorders~Diseases of the central nervous system (such as epilepsy) or psychiatric disorders or neurological disorders~History of relevant orthostatic hypotension, fainting spells or blackouts~Chronic or relevant acute infections~History of allergy/hypersensitivity (including drug allergy) which is deemed relevant to the trial as judged by the investigator~Intake of drugs with a long half-life (> 24 hours) within at least one month or less than 10 half-lives of the respective drug prior to administration or during the trial~Use of drugs which might reasonably influence the results of the trial based on the knowledge at the time of protocol preparation within 10 days prior to administration or during the trial~Participation in another trial with an investigational drug within two months prior to administration or during the trial~Smoker (> 10 cigarettes or > 3 cigars of > 3 pipes/day)~Inability to refrain from smoking on trial days~Alcohol abuse (more than 60 g/day)~Drug abuse~Blood donation (more than 100 mL within four weeks prior to administration or during the trial)~Excessive physical activities (within one week prior to administration or during the trial)~Any laboratory value outside the reference range of clinical relevance
|
21 Years
|
60 Years
|
Male
|
Accepts Healthy Volunteers
|
Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double
|
| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Number of subjects with abnormal findings in physical examination | | up to 8 days after last drug administration |
| Number of subjects with clinically significant changes in 12-lead ECG (electrocardiogram) | | up to 8 days after last drug administration |
| Number of subjects with clinically significant changes in vital signs | Blood Pressure, Pulse Rate, body temperature, orthostatic testing | up to 8 days after last drug administration |
| Number of subjects with clinically significant changes in laboratory tests | | up to 8 days after last drug administration |
| Changes in salivary secretion | | pre-dose and 2, 4 and 8 hours after drug administration on days 1 and 7 |
| Changes in residual urine volume | | pre-dose and 2, 4 and 8 hours after drug administration on days 1 and 7 |
| Number of subjects with adverse events | | up to 8 days after last drug administration |
| Assessment of tolerability by investigator on a 5-point scale | | within 8 days after last drug administration |
| Number of subjects with clinically significant changes in special laboratory parameters | Tropanin I, Insulin, C-Peptide, Glucagon, free fatty acids and faecal occult blood testing, Potassium, Lactate and cAMP | up to day 8 |
|
| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Maximum measured concentration of the analyte in plasma (Cmax) | | up to day 9 |
| Time from dosing to the maximum concentration of the analyte in plasma (Tmax) | | up to day 9 |
| Area under the concentration-time curve of the analyte in plasma (AUC) | | up to day 9 |
| Terminal rate constant of the analyte constant in plasma (λz) | | up to day 9 |
| Terminal half-life of the analyte in plasma (t1/2) | | up to day 9 |
| Mean residence time of the analyte in the body after oral administration (MRTpo) | | up to day 9 |
| Apparent clearance of the analyte in the plasma after extravascular administration (CL/F) | | up to day 9 |
| Apparent volume of distribution during the terminal phase λz following an extravascular dose (Vz/F) | | up to day 9 |
| Amount of the analyte that is eliminated in urine from the time point t1 until time point t2 (Aet1-t2) | | up to day 9 |
| Fraction of administered drug excreted in urine from the time point t1 until time point t2 (fet1-t2) | | up to day 9 |
| Renal clearance of the analyte determined from the time point t1 until time point t2 (CLR,t1-t2) | | up to day 9 |
| Minimum concentration of the analyte in plasma at steady state (Cmin,ss ) | | up to day 9 |
| Accumulation ratio (RA) | | up to day 9 |
| Linearity index (LI) | | up to day 9 |
|
| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: KUC 7483 CL<br>increasing repeated oral doses | Drug: KUC 7483 CL<br> <br> |
| Placebo Comparator: Placebo<br> | Drug: Placebo<br> <br> |
|
Safety, Tolerability and Pharmacokinetics of KUC 7483 CL Tablets in Healthy Male Volunteers
Study Overview
=================
Brief Summary
-----------------
Study to investigate safety, tolerability and pharmacokinetics of KUC 7483 CL after repeated dosing
Official Title
-----------------
A Double-blind (at Each Dose Level), Randomised, Placebo Controlled Study to Evaluate Safety, Tolerability and Pharmacokinetics of Increasing Repeated Oral Doses of KUC 7483 CL Tablets (Dosage: 40, 120, 180 mg b.i.d.) Over 7 Days in Healthy Male Volunteers
Conditions
-----------------
Healthy
Intervention / Treatment
-----------------
* Drug: KUC 7483 CL
* Drug: Placebo
Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Healthy males according to the following criteria: Based upon a complete medical history, including the physical examination, vital signs (BP, PR), 12-lead ECG, clinical laboratory tests No finding deviating from normal and of clinical relevance No evidence of a clinically relevant concomitant disease Age ≥21 and Age ≤60 years BMI ≥18.5 and BMI ≤29.9 kg/m2 (Body Mass Index) Signed and dated written informed consent prior to admission to the study in accordance with Good Clinical Practice and the local legislation Exclusion Criteria: Gastrointestinal, hepatic, renal, respiratory, cardiovascular, metabolic, immunological or hormonal disorders Diseases of the central nervous system (such as epilepsy) or psychiatric disorders or neurological disorders History of relevant orthostatic hypotension, fainting spells or blackouts Chronic or relevant acute infections History of allergy/hypersensitivity (including drug allergy) which is deemed relevant to the trial as judged by the investigator Intake of drugs with a long half-life (> 24 hours) within at least one month or less than 10 half-lives of the respective drug prior to administration or during the trial Use of drugs which might reasonably influence the results of the trial based on the knowledge at the time of protocol preparation within 10 days prior to administration or during the trial Participation in another trial with an investigational drug within two months prior to administration or during the trial Smoker (> 10 cigarettes or > 3 cigars of > 3 pipes/day) Inability to refrain from smoking on trial days Alcohol abuse (more than 60 g/day) Drug abuse Blood donation (more than 100 mL within four weeks prior to administration or during the trial) Excessive physical activities (within one week prior to administration or during the trial) Any laboratory value outside the reference range of clinical relevance
Ages Eligible for Study
-----------------
Minimum Age: 21 Years
Maximum Age: 60 Years
Sexes Eligible for Study
-----------------
Male
Accepts Healthy Volunteers
-----------------
Accepts Healthy Volunteers
Study Plan
=================
How is the study designed?
-----------------
Design Details
Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double
Arms and Interventions
| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: KUC 7483 CL<br>increasing repeated oral doses | Drug: KUC 7483 CL<br> <br> |
| Placebo Comparator: Placebo<br> | Drug: Placebo<br> <br> |
What is the study measuring?
-----------------
Primary Outcome Measures
| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Number of subjects with abnormal findings in physical examination | | up to 8 days after last drug administration |
| Number of subjects with clinically significant changes in 12-lead ECG (electrocardiogram) | | up to 8 days after last drug administration |
| Number of subjects with clinically significant changes in vital signs | Blood Pressure, Pulse Rate, body temperature, orthostatic testing | up to 8 days after last drug administration |
| Number of subjects with clinically significant changes in laboratory tests | | up to 8 days after last drug administration |
| Changes in salivary secretion | | pre-dose and 2, 4 and 8 hours after drug administration on days 1 and 7 |
| Changes in residual urine volume | | pre-dose and 2, 4 and 8 hours after drug administration on days 1 and 7 |
| Number of subjects with adverse events | | up to 8 days after last drug administration |
| Assessment of tolerability by investigator on a 5-point scale | | within 8 days after last drug administration |
| Number of subjects with clinically significant changes in special laboratory parameters | Tropanin I, Insulin, C-Peptide, Glucagon, free fatty acids and faecal occult blood testing, Potassium, Lactate and cAMP | up to day 8 |
Secondary Outcome Measures
| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Maximum measured concentration of the analyte in plasma (Cmax) | | up to day 9 |
| Time from dosing to the maximum concentration of the analyte in plasma (Tmax) | | up to day 9 |
| Area under the concentration-time curve of the analyte in plasma (AUC) | | up to day 9 |
| Terminal rate constant of the analyte constant in plasma (λz) | | up to day 9 |
| Terminal half-life of the analyte in plasma (t1/2) | | up to day 9 |
| Mean residence time of the analyte in the body after oral administration (MRTpo) | | up to day 9 |
| Apparent clearance of the analyte in the plasma after extravascular administration (CL/F) | | up to day 9 |
| Apparent volume of distribution during the terminal phase λz following an extravascular dose (Vz/F) | | up to day 9 |
| Amount of the analyte that is eliminated in urine from the time point t1 until time point t2 (Aet1-t2) | | up to day 9 |
| Fraction of administered drug excreted in urine from the time point t1 until time point t2 (fet1-t2) | | up to day 9 |
| Renal clearance of the analyte determined from the time point t1 until time point t2 (CLR,t1-t2) | | up to day 9 |
| Minimum concentration of the analyte in plasma at steady state (Cmin,ss ) | | up to day 9 |
| Accumulation ratio (RA) | | up to day 9 |
| Linearity index (LI) | | up to day 9 |
|
|||
NCT03526380
|
The OPT-IN Project
|
Prescription opioid overdose represents a public health crisis. A number of efforts have been implemented to address opioid prescribing and opioid risk mitigation strategies for prescribers, but relatively few efforts have sought to address this problem directly with individuals who use opioids. This gap likely fails to fully address the inherent reinforcing nature of the medications that make it challenging to reduce use.~The specific aim of this study is to pilot test a toolkit that pairs an intervention with the distribution of naloxone. External facilitation (supervision check-ins) will aid translation to delivery by non-research staff. Firstly, data will be collected from participants over time as a control group, prior to training site staff. Next, non-research staff will be trained on the intervention. Staff at the site will use the online toolkit developed in the beginning of this project to deliver the interventions and naloxone to their clients/patients as part of usual care. After staff at the site(s) are trained, additional data will be collected from participants during the intervention period and after 3-months.
|
Based on feedback from non-research site staff, the OPT-IN Project implementation package was tailored for optimal delivery in the site setting. The translation strategy will be evaluated using the RE-AIM framework, which includes Reach (e.g., number of individuals receiving intervention), Effectiveness (e.g., patient/client outcomes), Adoption (e.g., numbers trained), Implementation (e.g., fidelity of intervention delivery) and Maintenance (e.g., sustained in routine practice over time) with mixed qualitative and quantitative methods with intervention recipients.
|
Translation of Opiate Overdose Prevention Strategies
|
Opioid-Related Disorders
|
* Behavioral: Behavioral: the OPT-IN Intervention
|
Inclusion Criteria:~Speaks English Fluently~Receiving services at one of the investigator's partner sites~History of opioid use~Exclusion Criteria:~Medically unstable~Prisoners~Inability to speak and understand English~Inability to give informed, voluntary, written consent for any reason
|
18 Years
| null |
All
|
No
|
Primary Purpose: Health Services Research
Allocation: Non-Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
|
| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Overdose Risk Behaviors (ORB) | The ORB measures change over time for prescription opioid use, specific to type of opioid use, combination with other substances, route, and if they use alone. This scale is a total sum of 9 items assessing participant's self-report of engaging in behavior that increases risk for overdose. Higher scores indicate greater risk for overdose. The range for this measure is 0 to 32 in one assessment. | 3 months post-baseline |
|
Drug overdose, Substance-Related Disorders, Chemically-Induced Disorders, Risk Reduction Behavior, Harm Reduction
|
Opioid-Related Disorders, Narcotic-Related Disorders, Substance-Related Disorders, Chemically-Induced Disorders, Mental Disorders
|
| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Treatment<br>Participants receive the OPT-IN Brief Intervention. | Behavioral: Behavioral: the OPT-IN Intervention<br>* A private one-on-one brief motivational interviewing intervention administered by non-research staff at community organizations. This will take up to 30 minutes to complete. The goal of the intervention is to improve opioid safety and reduce related overdoses among those who has a history of misusing opioids (prescription and illicit). The session will use techniques to change behavior in a respectful, non-confrontational, and non-judgmental manner. This intervention will also seek to empower participants by providing content on bystander response as well as peer outreach, which emphasizes ways to discuss overdose risk with others at risk for overdose.<br>|
| No Intervention: Control<br>Participants will only complete the baseline and follow-up surveys. | |
|
The OPT-IN Project
Study Overview
=================
Brief Summary
-----------------
Prescription opioid overdose represents a public health crisis. A number of efforts have been implemented to address opioid prescribing and opioid risk mitigation strategies for prescribers, but relatively few efforts have sought to address this problem directly with individuals who use opioids. This gap likely fails to fully address the inherent reinforcing nature of the medications that make it challenging to reduce use. The specific aim of this study is to pilot test a toolkit that pairs an intervention with the distribution of naloxone. External facilitation (supervision check-ins) will aid translation to delivery by non-research staff. Firstly, data will be collected from participants over time as a control group, prior to training site staff. Next, non-research staff will be trained on the intervention. Staff at the site will use the online toolkit developed in the beginning of this project to deliver the interventions and naloxone to their clients/patients as part of usual care. After staff at the site(s) are trained, additional data will be collected from participants during the intervention period and after 3-months.
Detailed Description
-----------------
Based on feedback from non-research site staff, the OPT-IN Project implementation package was tailored for optimal delivery in the site setting. The translation strategy will be evaluated using the RE-AIM framework, which includes Reach (e.g., number of individuals receiving intervention), Effectiveness (e.g., patient/client outcomes), Adoption (e.g., numbers trained), Implementation (e.g., fidelity of intervention delivery) and Maintenance (e.g., sustained in routine practice over time) with mixed qualitative and quantitative methods with intervention recipients.
Official Title
-----------------
Translation of Opiate Overdose Prevention Strategies
Conditions
-----------------
Opioid-Related Disorders
Intervention / Treatment
-----------------
* Behavioral: Behavioral: the OPT-IN Intervention
Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Speaks English Fluently Receiving services at one of the investigator's partner sites History of opioid use Exclusion Criteria: Medically unstable Prisoners Inability to speak and understand English Inability to give informed, voluntary, written consent for any reason
Ages Eligible for Study
-----------------
Minimum Age: 18 Years
Sexes Eligible for Study
-----------------
All
Accepts Healthy Volunteers
-----------------
No
Study Plan
=================
How is the study designed?
-----------------
Design Details
Primary Purpose: Health Services Research
Allocation: Non-Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Arms and Interventions
| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Treatment<br>Participants receive the OPT-IN Brief Intervention. | Behavioral: Behavioral: the OPT-IN Intervention<br>* A private one-on-one brief motivational interviewing intervention administered by non-research staff at community organizations. This will take up to 30 minutes to complete. The goal of the intervention is to improve opioid safety and reduce related overdoses among those who has a history of misusing opioids (prescription and illicit). The session will use techniques to change behavior in a respectful, non-confrontational, and non-judgmental manner. This intervention will also seek to empower participants by providing content on bystander response as well as peer outreach, which emphasizes ways to discuss overdose risk with others at risk for overdose.<br>|
| No Intervention: Control<br>Participants will only complete the baseline and follow-up surveys. | |
What is the study measuring?
-----------------
Primary Outcome Measures
| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Overdose Risk Behaviors (ORB) | The ORB measures change over time for prescription opioid use, specific to type of opioid use, combination with other substances, route, and if they use alone. This scale is a total sum of 9 items assessing participant's self-report of engaging in behavior that increases risk for overdose. Higher scores indicate greater risk for overdose. The range for this measure is 0 to 32 in one assessment. | 3 months post-baseline |
Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Drug overdose, Substance-Related Disorders, Chemically-Induced Disorders, Risk Reduction Behavior, Harm Reduction
|
|
NCT01221961
|
Masimo Radical-7 Monitor a Useful Adjuvant During Major Spine Surgery
|
This is a study designed to compare the agreement of hemoglobin (Hb) measurements, documented at specific time points (the time a blood sample was obtained by the standard clinical care after physician/nurse orders it and, during that same time, the Hb value recorded by the Masimo Radical-7 monitor); recorded several times throughout patient's major spine surgery procedure (depending on how many times the physician/nurse orders the Hb value to be tested), between the standard clinical practice {intermittent measure of Hb [Cedar Sinai Medical Center (CSMC) Lab and outside lab) and Masimo radical-7 device (continuous, non-invasive Hb level measurements)*.
|
*See whether or not the hemoglobin values recorded at the same time matches between the standard clinical practice (CSMC Lab and outside Lab) and the Masimo device
|
A Study to Determine the Agreement Between Masimo Monitor and Standard of Care
|
Major Spine Surgery Procedure
|
* Device: Masimo Radical-7
|
Inclusion Criteria:~Patients scheduled to undergo multiple level spine surgery procedures~18 - 80 years of age~American Society of Anesthesiologists (ASA) Class I - III adults of either sex~Pregnant women~Exclusion Criteria:~Patients with a perfusion index less than 1 or low confidence reading~Patients with nail polish and /or a nail deformity on a finger that would used for sensor placement~Patient undergoing cardio-pulmonary bypass
|
18 Years
|
80 Years
|
All
|
No
|
| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Hemoglobin value | During the time surgery last. | 0-8 hours |
|
| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Blood transfusion | During the time surgery last. | 0-8 hours |
|
Major spine surgery, Hemoglobin, Blood transfusion
|
| Intervention/Treatment |
| --- |
|Device: Masimo Radical-7|The Masimo device will be placed on one finger of the patient. To see whether or not the hemoglobin values recorded at the same time matches between the standard clinical practice (CSMC Lab and outside Lab) and the Masimo device|
|
Masimo Radical-7 Monitor a Useful Adjuvant During Major Spine Surgery
Study Overview
=================
Brief Summary
-----------------
This is a study designed to compare the agreement of hemoglobin (Hb) measurements, documented at specific time points (the time a blood sample was obtained by the standard clinical care after physician/nurse orders it and, during that same time, the Hb value recorded by the Masimo Radical-7 monitor); recorded several times throughout patient's major spine surgery procedure (depending on how many times the physician/nurse orders the Hb value to be tested), between the standard clinical practice {intermittent measure of Hb [Cedar Sinai Medical Center (CSMC) Lab and outside lab) and Masimo radical-7 device (continuous, non-invasive Hb level measurements)*.
Detailed Description
-----------------
*See whether or not the hemoglobin values recorded at the same time matches between the standard clinical practice (CSMC Lab and outside Lab) and the Masimo device
Official Title
-----------------
A Study to Determine the Agreement Between Masimo Monitor and Standard of Care
Conditions
-----------------
Major Spine Surgery Procedure
Intervention / Treatment
-----------------
* Device: Masimo Radical-7
Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Patients scheduled to undergo multiple level spine surgery procedures 18 - 80 years of age American Society of Anesthesiologists (ASA) Class I - III adults of either sex Pregnant women Exclusion Criteria: Patients with a perfusion index less than 1 or low confidence reading Patients with nail polish and /or a nail deformity on a finger that would used for sensor placement Patient undergoing cardio-pulmonary bypass
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?
-----------------
Arms and Interventions
| Intervention/Treatment |
| --- |
|Device: Masimo Radical-7|The Masimo device will be placed on one finger of the patient. To see whether or not the hemoglobin values recorded at the same time matches between the standard clinical practice (CSMC Lab and outside Lab) and the Masimo device|
What is the study measuring?
-----------------
Primary Outcome Measures
| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Hemoglobin value | During the time surgery last. | 0-8 hours |
Secondary Outcome Measures
| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Blood transfusion | During the time surgery last. | 0-8 hours |
Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Major spine surgery, Hemoglobin, Blood transfusion
|
||
NCT03760900
|
Safety of Autologous Cord Blood Cells for Preterm Infants.
|
To assess the safety of autologous volume- and red blood cell (RBC)-reduced non-cryopreserved umbilical cord blood (UCB) cell infusion to preterm infants.
|
Preterm birth complications are one of the leading causes of death among children under 5 years of age. Despite advances in medical care, many survivors face a lifetime of disability, including mental and physical retardation, and chronic lung disease. More recently, both allogenic and autogenic cord blood cells have been applied in the treatment of neonatal conditions such as hypoxic-ischemic encephalopathy (HIE) and bronchopulmonary dysplasia (BPD).~Objective-To assess the safety of autologous volume- and red blood cell (RBC)-reduced non-cryopreserved umbilical cord blood (UCB) cell infusion to preterm infants.~Method- This study was a phase I, open-label, single-arm, single center trial to evaluate the safety of autologous, volume- and RBC-reduced non-cyropreserved UCB cell (5×107cells/kg) infusion for preterm infants <37 weeks gestational age. UCB cell characteristics, pre- and post- infusion vital signs, laboratory investigations were recorded. Clinical data including mortality rates and preterm complications were recorded.~Results-After processing, (22.67±4.05) ml UCB cells in volume, (2.67±2.00)×108 cells in number, with (22.67±4.05)×106 CD34+, and (3.72±3.25)×105colony forming cells (CFU-GM), (99.7±0.17%) vitality were infused to 15 preterm infants within 8 hours after birth. No adverse effects were noticed during treatment. All fifteen patients who received UCB infusion survived. The duration of hospitalization ranged from 4 to 65 (30±23.6) days. Regarding preterm complications, no BPD, necrotizing enterocolitis (NEC), retinopathy of prematurity (ROP) were observed. There were 1/15 (7%) infant with intraventricular hemorrhage (IVH), and 5/15 (33.3%) infants with ventilation-associated pneumonia, 10/15(66.67%) with anemia respectively.~Conclusions-Collection, preparation and infusion of fresh autologous UCB cells to preterm infants is feasible and safe. Adequately powered randomized controlled studies are needed.
|
Safety of Autologous Cord Blood Cells for Preterm Infants.
|
Safety Issues, Effect of Drugs, Neonatal Death
|
* Combination Product: Autologous Umbilical Cord Blood Stem Cells Therapy
|
Inborn Infants admitted to the Neonatal Intensive Care Unit (NICU) of Guang Dong Women and Children's Hospital were eligible if they were: 1. Preterm: <37 weeks gestation 2. Without congenital abnormalities; 3. Without maternal chorioamnionitis 4. had available UCB. 5.the mother was negative for hepatitis B (HBsAg and/or HBeAg) and C virus (anti-HCV), syphilis, HIV (anti-HIV-1 and -2) and IgM against cytomegalovirus, rubella, toxoplasma and herpes simplex virus.
| null |
37 Weeks
|
All
|
No
|
Primary Purpose: Prevention
Intervention Model: Single Group Assignment
Masking: None (Open Label)
|
| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Short-term safety of autologous umbilical cord blood stem cell infusion for preterm infants | vital signs~blood gas analysis~blood routine~liver and kidney function before and after infusion will be compared | during infusion |
| Short-term safety of autologous umbilical cord blood stem cell infusion for preterm infants | vital signs~blood gas analysis~blood routine~liver and kidney function before and after infusion will be compared | 6 hours after infusion |
| Long-term safety(2-3 years follow-up after discharge) of autologous umbilical cord blood stem cell infusion for preterm infants | 1. The growth and development curve will be drawn and compared | 2years |
|
Autologous Umbilical Cord Blood Stem Cells, Safety, Effect, neonates, Mechanism
|
Perinatal Death, Pregnancy Complications, Female Urogenital Diseases and Pregnancy Complications, Urogenital Diseases, Death, Pathologic Processes
|
| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: infusion group<br>Autologous Umbilical Cord Blood Stem Cells Therapy | Combination Product: Autologous Umbilical Cord Blood Stem Cells Therapy<br>* Autologous Umbilical Cord Blood Stem Cells Therapy,the dose is 5×107cells/kg, within 24 hours after birth<br>|
|
Safety of Autologous Cord Blood Cells for Preterm Infants.
Study Overview
=================
Brief Summary
-----------------
To assess the safety of autologous volume- and red blood cell (RBC)-reduced non-cryopreserved umbilical cord blood (UCB) cell infusion to preterm infants.
Detailed Description
-----------------
Preterm birth complications are one of the leading causes of death among children under 5 years of age. Despite advances in medical care, many survivors face a lifetime of disability, including mental and physical retardation, and chronic lung disease. More recently, both allogenic and autogenic cord blood cells have been applied in the treatment of neonatal conditions such as hypoxic-ischemic encephalopathy (HIE) and bronchopulmonary dysplasia (BPD). Objective-To assess the safety of autologous volume- and red blood cell (RBC)-reduced non-cryopreserved umbilical cord blood (UCB) cell infusion to preterm infants. Method- This study was a phase I, open-label, single-arm, single center trial to evaluate the safety of autologous, volume- and RBC-reduced non-cyropreserved UCB cell (5×107cells/kg) infusion for preterm infants <37 weeks gestational age. UCB cell characteristics, pre- and post- infusion vital signs, laboratory investigations were recorded. Clinical data including mortality rates and preterm complications were recorded. Results-After processing, (22.67±4.05) ml UCB cells in volume, (2.67±2.00)×108 cells in number, with (22.67±4.05)×106 CD34+, and (3.72±3.25)×105colony forming cells (CFU-GM), (99.7±0.17%) vitality were infused to 15 preterm infants within 8 hours after birth. No adverse effects were noticed during treatment. All fifteen patients who received UCB infusion survived. The duration of hospitalization ranged from 4 to 65 (30±23.6) days. Regarding preterm complications, no BPD, necrotizing enterocolitis (NEC), retinopathy of prematurity (ROP) were observed. There were 1/15 (7%) infant with intraventricular hemorrhage (IVH), and 5/15 (33.3%) infants with ventilation-associated pneumonia, 10/15(66.67%) with anemia respectively. Conclusions-Collection, preparation and infusion of fresh autologous UCB cells to preterm infants is feasible and safe. Adequately powered randomized controlled studies are needed.
Official Title
-----------------
Safety of Autologous Cord Blood Cells for Preterm Infants.
Conditions
-----------------
Safety Issues, Effect of Drugs, Neonatal Death
Intervention / Treatment
-----------------
* Combination Product: Autologous Umbilical Cord Blood Stem Cells Therapy
Participation Criteria
=================
Eligibility Criteria
-----------------
Inborn Infants admitted to the Neonatal Intensive Care Unit (NICU) of Guang Dong Women and Children's Hospital were eligible if they were: 1. Preterm: <37 weeks gestation 2. Without congenital abnormalities; 3. Without maternal chorioamnionitis 4. had available UCB. 5.the mother was negative for hepatitis B (HBsAg and/or HBeAg) and C virus (anti-HCV), syphilis, HIV (anti-HIV-1 and -2) and IgM against cytomegalovirus, rubella, toxoplasma and herpes simplex virus.
Ages Eligible for Study
-----------------
Maximum Age: 37 Weeks
Sexes Eligible for Study
-----------------
All
Accepts Healthy Volunteers
-----------------
No
Study Plan
=================
How is the study designed?
-----------------
Design Details
Primary Purpose: Prevention
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Arms and Interventions
| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: infusion group<br>Autologous Umbilical Cord Blood Stem Cells Therapy | Combination Product: Autologous Umbilical Cord Blood Stem Cells Therapy<br>* Autologous Umbilical Cord Blood Stem Cells Therapy,the dose is 5×107cells/kg, within 24 hours after birth<br>|
What is the study measuring?
-----------------
Primary Outcome Measures
| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Short-term safety of autologous umbilical cord blood stem cell infusion for preterm infants | vital signs blood gas analysis blood routine liver and kidney function before and after infusion will be compared | during infusion |
| Short-term safety of autologous umbilical cord blood stem cell infusion for preterm infants | vital signs blood gas analysis blood routine liver and kidney function before and after infusion will be compared | 6 hours after infusion |
| Long-term safety(2-3 years follow-up after discharge) of autologous umbilical cord blood stem cell infusion for preterm infants | 1. The growth and development curve will be drawn and compared | 2years |
Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Autologous Umbilical Cord Blood Stem Cells, Safety, Effect, neonates, Mechanism
|
|
NCT00044655
|
Switching Medication to Treat Schizophrenia
|
This study will evaluate the effectiveness of switching medications in decreasing schizophrenia symptoms in individuals who are currently taking an antipsychotic medication for the treatment of schizophrenia.
|
Over the past several years, new, atypical antipsychotic medications have become available to treat schizophrenia with little information to guide prescribing for relatively stable outpatients.~Participants will be randomly assigned to either continue taking their current medications for schizophrenia, or to switch to a new medication. Participants assigned to switch to a new medication will begin receiving either olanzapine (Zyprexa), risperidone (Risperdal), ziprasidone (Geodon), quetiapine (Seroquel), or aripiprazole (Abilify), depending on what they are currently taking. Participants currently taking a single oral medication will switch to olanzapine, risperidone, ziprasidone, quetiapine, or aripiprazole. Participants currently taking a single conventional injectable will begin taking long-acting injectable risperidone (Risperdal Consta). Participants currently taking two antipsychotic medications will begin taking only one of the medications they are currently using. Participants will stay on their assigned treatment for 6 months, after which time the participant's prescribing psychiatrist will advise the participant on which medication should be used. Study participants are interviewed at study start and at follow-up visits for 1 year.
|
Effectiveness of Switching Antipsychotic Medications
|
Schizophrenia
|
* Drug: Risperidone
* Drug: Olanzapine
* Drug: Ziprasidone
* Drug: Quetiapine
* Drug: Aripiprazole
|
Inclusion criteria:~SCID diagnosis of schizophrenia or schizoaffective disorder~Partially remitted outpatients, defined as persons who have received clear symptomatic benefit from antipsychotic medication but remain symptomatic (due to lack of efficacy or inability to tolerate an efficacious dose) or suffer significant side effects~Treatment with antipsychotic medications for at least 2 months~Received at least 1 outpatient mental health service every 3 months for the past 6 months~Exclusion criteria:~Severe symptoms or side effects that indicate the necessity for a medication change~Currently taking 3 or more antipsychotic medications for ongoing daily administration (PRN medications and mood stabilizers are allowable)~Treatment with clozapine~One or more nights spent in a psychiatric hospitalization within the past 3 months~Received services from a crisis intervention program within the past 3 months~Require placement in a skilled nursing facility as a result of a physical condition or disability~Criminal charges pending (once charges clear, the person will be considered)~Pregnant or breast feeding~Contraindication to any of the medications to which the patient might be assigned
|
18 Years
| null |
All
|
No
|
Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single
|
| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Number Who Discontinued Medication Within First 6 Study Months | | Measured at Six Months |
|
| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Psychiatric Symptoms, Hospitalization, and Medication Side Effects | | Measured at Year 1 |
|
Olanzapine, Antiemetics, Autonomic Agents, Peripheral Nervous System Agents, Gastrointestinal Agents, Selective Serotonin Reuptake Inhibitors, Neurotransmitter Uptake Inhibitors, Membrane Transport Modulators, Antidepressive Agents, Dopamine Agonists, Serotonin 5-HT1 Receptor Agonists, Risperidone, Aripiprazole, Quetiapine Fumarate, Ziprasidone, Serotonin Antagonists, Serotonin Agents, Neurotransmitter Agents, Molecular Mechanisms of Pharmacological Action, Physiological Effects of Drugs, Antipsychotic Agents, Tranquilizing Agents, Central Nervous System Depressants, Psychotropic Drugs, Dopamine Antagonists, Dopamine Agents, Serotonin Receptor Agonists, Serotonin 5-HT2 Receptor Antagonists, Dopamine D2 Receptor Antagonists
|
| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: Stay on baseline medication prescribed<br>Participants will continue taking medication prescribed at study entry: 1) either long-acting injectable haloperidol or fluphenazine, OR 2) two antipsychotic medications which might include a combination of any of the following: risperidone, olanzapine, ziprasidone, quetiapine, aripiprazole, or conventional (typical) antipsychotic medications. | Drug: Risperidone<br>* As prescribed by routine prescriber (not dictated by study protocol)<br>* Other names: Risperdal, Risperdal Consta;Drug: Olanzapine<br>* As prescribed by routine prescriber (not dictated by study protocol)<br>* Other names: Zyprexa;Drug: Ziprasidone<br>* As prescribed by routine prescriber (not dictated by study protocol)<br>* Other names: Geodon;Drug: Quetiapine<br>* As prescribed by routine prescriber (not dictated by study protocol)<br>* Other names: Seroquel;Drug: Aripiprazole<br>* As prescribed by routine prescriber (not dictated by study protocol)<br>* Other names: Abilify;|
| Active Comparator: Switch per study protocol<br>Participants will change medications from medication prescribed at study entry, either: 1) long-acting injectable risperidone, OR 2) one of the two antipsychotic medications prescribed at baseline which may include any of the following: risperidone, olanzapine, ziprasidone, quetiapine, aripiprazole, or conventional (typical) antipsychotic medications. | Drug: Risperidone<br>* As prescribed by routine prescriber (not dictated by study protocol)<br>* Other names: Risperdal, Risperdal Consta;Drug: Olanzapine<br>* As prescribed by routine prescriber (not dictated by study protocol)<br>* Other names: Zyprexa;Drug: Ziprasidone<br>* As prescribed by routine prescriber (not dictated by study protocol)<br>* Other names: Geodon;Drug: Quetiapine<br>* As prescribed by routine prescriber (not dictated by study protocol)<br>* Other names: Seroquel;Drug: Aripiprazole<br>* As prescribed by routine prescriber (not dictated by study protocol)<br>* Other names: Abilify;|
|
Switching Medication to Treat Schizophrenia
Study Overview
=================
Brief Summary
-----------------
This study will evaluate the effectiveness of switching medications in decreasing schizophrenia symptoms in individuals who are currently taking an antipsychotic medication for the treatment of schizophrenia.
Detailed Description
-----------------
Over the past several years, new, atypical antipsychotic medications have become available to treat schizophrenia with little information to guide prescribing for relatively stable outpatients. Participants will be randomly assigned to either continue taking their current medications for schizophrenia, or to switch to a new medication. Participants assigned to switch to a new medication will begin receiving either olanzapine (Zyprexa), risperidone (Risperdal), ziprasidone (Geodon), quetiapine (Seroquel), or aripiprazole (Abilify), depending on what they are currently taking. Participants currently taking a single oral medication will switch to olanzapine, risperidone, ziprasidone, quetiapine, or aripiprazole. Participants currently taking a single conventional injectable will begin taking long-acting injectable risperidone (Risperdal Consta). Participants currently taking two antipsychotic medications will begin taking only one of the medications they are currently using. Participants will stay on their assigned treatment for 6 months, after which time the participant's prescribing psychiatrist will advise the participant on which medication should be used. Study participants are interviewed at study start and at follow-up visits for 1 year.
Official Title
-----------------
Effectiveness of Switching Antipsychotic Medications
Conditions
-----------------
Schizophrenia
Intervention / Treatment
-----------------
* Drug: Risperidone
* Drug: Olanzapine
* Drug: Ziprasidone
* Drug: Quetiapine
* Drug: Aripiprazole
Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion criteria: SCID diagnosis of schizophrenia or schizoaffective disorder Partially remitted outpatients, defined as persons who have received clear symptomatic benefit from antipsychotic medication but remain symptomatic (due to lack of efficacy or inability to tolerate an efficacious dose) or suffer significant side effects Treatment with antipsychotic medications for at least 2 months Received at least 1 outpatient mental health service every 3 months for the past 6 months Exclusion criteria: Severe symptoms or side effects that indicate the necessity for a medication change Currently taking 3 or more antipsychotic medications for ongoing daily administration (PRN medications and mood stabilizers are allowable) Treatment with clozapine One or more nights spent in a psychiatric hospitalization within the past 3 months Received services from a crisis intervention program within the past 3 months Require placement in a skilled nursing facility as a result of a physical condition or disability Criminal charges pending (once charges clear, the person will be considered) Pregnant or breast feeding Contraindication to any of the medications to which the patient might be assigned
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: Single
Arms and Interventions
| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: Stay on baseline medication prescribed<br>Participants will continue taking medication prescribed at study entry: 1) either long-acting injectable haloperidol or fluphenazine, OR 2) two antipsychotic medications which might include a combination of any of the following: risperidone, olanzapine, ziprasidone, quetiapine, aripiprazole, or conventional (typical) antipsychotic medications. | Drug: Risperidone<br>* As prescribed by routine prescriber (not dictated by study protocol)<br>* Other names: Risperdal, Risperdal Consta;Drug: Olanzapine<br>* As prescribed by routine prescriber (not dictated by study protocol)<br>* Other names: Zyprexa;Drug: Ziprasidone<br>* As prescribed by routine prescriber (not dictated by study protocol)<br>* Other names: Geodon;Drug: Quetiapine<br>* As prescribed by routine prescriber (not dictated by study protocol)<br>* Other names: Seroquel;Drug: Aripiprazole<br>* As prescribed by routine prescriber (not dictated by study protocol)<br>* Other names: Abilify;|
| Active Comparator: Switch per study protocol<br>Participants will change medications from medication prescribed at study entry, either: 1) long-acting injectable risperidone, OR 2) one of the two antipsychotic medications prescribed at baseline which may include any of the following: risperidone, olanzapine, ziprasidone, quetiapine, aripiprazole, or conventional (typical) antipsychotic medications. | Drug: Risperidone<br>* As prescribed by routine prescriber (not dictated by study protocol)<br>* Other names: Risperdal, Risperdal Consta;Drug: Olanzapine<br>* As prescribed by routine prescriber (not dictated by study protocol)<br>* Other names: Zyprexa;Drug: Ziprasidone<br>* As prescribed by routine prescriber (not dictated by study protocol)<br>* Other names: Geodon;Drug: Quetiapine<br>* As prescribed by routine prescriber (not dictated by study protocol)<br>* Other names: Seroquel;Drug: Aripiprazole<br>* As prescribed by routine prescriber (not dictated by study protocol)<br>* Other names: Abilify;|
What is the study measuring?
-----------------
Primary Outcome Measures
| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Number Who Discontinued Medication Within First 6 Study Months | | Measured at Six Months |
Secondary Outcome Measures
| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Psychiatric Symptoms, Hospitalization, and Medication Side Effects | | Measured at Year 1 |
|
|
NCT04595188
|
Sulphur Amino Acid Requirements in Adults >60 Years
|
This study aims to determine the requirements for the sulphur amino acids in adults over the age of 60 years:~the total sulphur amino acid requirement as methionine only. Methionine is an essential amino acid.~the minimum methionine requirement as methionine in the presence of excess dietary cysteine.~It is known that protein and amino acid metabolism may be altered with age and methionine and cysteine, in particular, may be important in the diet of older adults.~Up to 7 different levels of methionine intake as methionine only (no dietary cysteine) and up to 7 different levels of methionine intake in the presence of excess dietary cysteine will be tested in each subject in random order. Each level of intake will involve a 3-day maintenance diet, with measures being collected on the third.
|
The sulphur amino acids (SAA) are methionine and cysteine. Methionine is essential and must be obtained from the diet whereas cysteine is considered non-essential and is synthesized from methionine. They have many other important roles that are secondary to their role in protein building. For example, they are needed to make the antioxidant glutathione (GSH), which protects the body's cells from damage. However, protein and GSH metabolism have been shown to change with age and hence, the SAA requirements may also be changed. Despite this, current SAA requirements are based on studies conducted in young adults. Thus, there is a need to determine the SAA requirements directly in older adults.~The purpose of the study is to apply the minimally invasive indicator amino acid oxidation (IAAO) protocol to determine the SAA requirements in healthy adults over 60 years of age. The requirements will be determined as (1) the total sulphur amino acid requirement as methionine only and (2) the minimum methionine requirement by providing methionine in the presence of excess dietary cysteine.~A pre-study assessment will be conducted to assess health status using: medical history and a physical exam; and a blood draw (10mL) for fasting blood glucose and hemoglobin A1c to test for diabetes, vitamin B and folate concentrations, and urea and creatinine to test renal function.~In order to determine the requirements, each participant will be studied at up to 7 varying intakes levels of methionine in random order. Each intake level will be studied over 3-days: two adaptation days (day 1 and 2) and one study day (day 3). On the adaptation days, participants will be provided with a milkshake diet providing all the protein and nutrients they need. Participants will consume 4 meals/day in their usual home environment. On the 3rd day participants will come to the Clinical Research Centre at SickKids where they will be given hourly meals and breath and urine samples at specified times.A blood sample will also be collected for analysis of serum insulin, glucose and secondary parameters (i.e. concentrations of amino acids, glutathione, homocysteine and CRP). The mean (estimate average requirement) total sulphur amino acid requirement and minimum methionine requirement will be calculated with breakpoint analysis using a two-phase linear regression crossover analysis.
|
The Sulphur Amino Acid Requirements in Healthy Adults Over 60 Years
|
Healthy
|
* Other: Sulphur amino acids
|
Inclusion Criteria:~Consent provided~Aged 60 to 90 years old~In good general health as evidenced by medical history, physical health and blood draw~Fasting blood glucose, hemoglobin A1c (HbA1c), urea, creatinine, vitamin-B6, vitamin- B12 and folate levels within normal ranges for age.~Willingness to participate in the study.~BMI <30 kg/m2.~Exclusion Criteria:~Presence of chronic disease and/or acute illness known to affect protein/amino acid metabolism (e.g. HIV, diabetes, cancer, liver or kidney disease, acute cold or flu)~Taking medications known to affect protein/AA metabolism (e.g. steroids)~Inability to tolerate the diet (i.e. allergy)~Significant weight loss during the past month or consumption of weight reducing diets.~Significant caffeine consumption (>2 cups per day)~Significant consumption of alcohol (>1 drink per day i.e. 1 beer or ½ glass of wine).~Unwilling to have blood drawn from a venous access, or using a ventilated hood indirect calorimeter for the purposes of the study.
|
60 Years
|
90 Years
|
All
|
Accepts Healthy Volunteers
|
Primary Purpose: Other
Intervention Model: Single Group Assignment
Masking: None (Open Label)
|
| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Determination of total sulphur amino acid requirements in adults >60 years of age | methionine requirement the presence of zero cysteine | up to 24 months |
|
| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Determination of minimum sulphur amino acid requirements in adults >60 years of age | methionine requirement in the presence of excess cysteine | up to 24 months |
|
elderly, amino acid requirement, methionine, cysteine, dietary requirement, sulphur amino acids
|
| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Sulphur amino acids in Adults > 60<br>Total sulphur amino acid, as methionine only: all subjects will receive up to 7 methionine test levels, without dietary cysteine, assigned in random order.~Minimum methionine, with excess dietary cysteine: all subjects will receive up to 7 methionine test levels, in the presence of excess and constant dietary cysteine, assigned in random order. | Other: Sulphur amino acids<br>* For the total sulphur amino acid requirement, there are 7 different methionine test levels (without dietary cysteine) ranging from 5 to 40 mg of methionine per kilogram body weight per day.~For the minimum methionine requirement, there are 7 different methionine test levels (with excess dietary cysteine).<br>|
|
Sulphur Amino Acid Requirements in Adults >60 Years
Study Overview
=================
Brief Summary
-----------------
This study aims to determine the requirements for the sulphur amino acids in adults over the age of 60 years: the total sulphur amino acid requirement as methionine only. Methionine is an essential amino acid. the minimum methionine requirement as methionine in the presence of excess dietary cysteine. It is known that protein and amino acid metabolism may be altered with age and methionine and cysteine, in particular, may be important in the diet of older adults. Up to 7 different levels of methionine intake as methionine only (no dietary cysteine) and up to 7 different levels of methionine intake in the presence of excess dietary cysteine will be tested in each subject in random order. Each level of intake will involve a 3-day maintenance diet, with measures being collected on the third.
Detailed Description
-----------------
The sulphur amino acids (SAA) are methionine and cysteine. Methionine is essential and must be obtained from the diet whereas cysteine is considered non-essential and is synthesized from methionine. They have many other important roles that are secondary to their role in protein building. For example, they are needed to make the antioxidant glutathione (GSH), which protects the body's cells from damage. However, protein and GSH metabolism have been shown to change with age and hence, the SAA requirements may also be changed. Despite this, current SAA requirements are based on studies conducted in young adults. Thus, there is a need to determine the SAA requirements directly in older adults. The purpose of the study is to apply the minimally invasive indicator amino acid oxidation (IAAO) protocol to determine the SAA requirements in healthy adults over 60 years of age. The requirements will be determined as (1) the total sulphur amino acid requirement as methionine only and (2) the minimum methionine requirement by providing methionine in the presence of excess dietary cysteine. A pre-study assessment will be conducted to assess health status using: medical history and a physical exam; and a blood draw (10mL) for fasting blood glucose and hemoglobin A1c to test for diabetes, vitamin B and folate concentrations, and urea and creatinine to test renal function. In order to determine the requirements, each participant will be studied at up to 7 varying intakes levels of methionine in random order. Each intake level will be studied over 3-days: two adaptation days (day 1 and 2) and one study day (day 3). On the adaptation days, participants will be provided with a milkshake diet providing all the protein and nutrients they need. Participants will consume 4 meals/day in their usual home environment. On the 3rd day participants will come to the Clinical Research Centre at SickKids where they will be given hourly meals and breath and urine samples at specified times.A blood sample will also be collected for analysis of serum insulin, glucose and secondary parameters (i.e. concentrations of amino acids, glutathione, homocysteine and CRP). The mean (estimate average requirement) total sulphur amino acid requirement and minimum methionine requirement will be calculated with breakpoint analysis using a two-phase linear regression crossover analysis.
Official Title
-----------------
The Sulphur Amino Acid Requirements in Healthy Adults Over 60 Years
Conditions
-----------------
Healthy
Intervention / Treatment
-----------------
* Other: Sulphur amino acids
Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Consent provided Aged 60 to 90 years old In good general health as evidenced by medical history, physical health and blood draw Fasting blood glucose, hemoglobin A1c (HbA1c), urea, creatinine, vitamin-B6, vitamin- B12 and folate levels within normal ranges for age. Willingness to participate in the study. BMI <30 kg/m2. Exclusion Criteria: Presence of chronic disease and/or acute illness known to affect protein/amino acid metabolism (e.g. HIV, diabetes, cancer, liver or kidney disease, acute cold or flu) Taking medications known to affect protein/AA metabolism (e.g. steroids) Inability to tolerate the diet (i.e. allergy) Significant weight loss during the past month or consumption of weight reducing diets. Significant caffeine consumption (>2 cups per day) Significant consumption of alcohol (>1 drink per day i.e. 1 beer or ½ glass of wine). Unwilling to have blood drawn from a venous access, or using a ventilated hood indirect calorimeter for the purposes of the study.
Ages Eligible for Study
-----------------
Minimum Age: 60 Years
Maximum Age: 90 Years
Sexes Eligible for Study
-----------------
All
Accepts Healthy Volunteers
-----------------
Accepts Healthy Volunteers
Study Plan
=================
How is the study designed?
-----------------
Design Details
Primary Purpose: Other
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Arms and Interventions
| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Sulphur amino acids in Adults > 60<br>Total sulphur amino acid, as methionine only: all subjects will receive up to 7 methionine test levels, without dietary cysteine, assigned in random order. Minimum methionine, with excess dietary cysteine: all subjects will receive up to 7 methionine test levels, in the presence of excess and constant dietary cysteine, assigned in random order. | Other: Sulphur amino acids<br>* For the total sulphur amino acid requirement, there are 7 different methionine test levels (without dietary cysteine) ranging from 5 to 40 mg of methionine per kilogram body weight per day. For the minimum methionine requirement, there are 7 different methionine test levels (with excess dietary cysteine).<br>|
What is the study measuring?
-----------------
Primary Outcome Measures
| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Determination of total sulphur amino acid requirements in adults >60 years of age | methionine requirement the presence of zero cysteine | up to 24 months |
Secondary Outcome Measures
| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Determination of minimum sulphur amino acid requirements in adults >60 years of age | methionine requirement in the presence of excess cysteine | up to 24 months |
Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
elderly, amino acid requirement, methionine, cysteine, dietary requirement, sulphur amino acids
|
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