TrialPanorama/Dataset huggingface dataset:
Please select the outcome measures that correspond to the clinical trial below.
Title: Assessment of the Efficacy of Omega-3 Fatty Acids Supplementation, Multi-domain Intervention or Their Combination on the Change of Cognitive Functions in Frail Elderly Subjects
Brief Summary: Epidemiological and fundamental research carried out in recent years has highlighted the role played by omega-3 fatty acids in the process of cognitive decline that accompanies advancing age and Alzheimer's disease. In addition, it has been recognized for some years, following several convergent studies on the prevention of cognitive decline, that nutrition, physical exercise, cognitive training and social activities play a significant role in the maintenance of cognitive faculties. At present, there are a number of epidemiological arguments in favour of a protective role of each of these factors taken in isolation. It can be postulated that a multi-domain intervention may potentiate the protective role of omega-3 fatty acids.

The main objective of this study is to assess the efficacy of isolated supplementation with omega-3 fatty acid, an isolated multi-domain intervention (nutrition, physical exercise, cognitive stimulation, social activities), or their combination on the change of cognitive functions in frail elderly subjects aged of 70 years and older over 3 years.

Secondary objectives:

* To assess the efficacy of each treatment strategy on the change of functional capacities and the prevention of dependency,
* To study the long-term safety and tolerability of V0137,
* To study compliance and adhesion to the multi-domain intervention programme,

Ancillary studies :

To assess the impact of an intervention program on brain metabolism in FDG PET (MAPT-NI : : impact of multidomain intervention on brain metabolism (FDG-PET))

* To evaluate the impact of preventive strategies (Omega-3 treatment and multidomain intervention ) of MAPT study on brain atrophy (MRI),
* To evaluate the presence and density of ß-amyloid in MAPT subjects using AV45 PET scans (MAPT AV45),
* To determine if sleep disorders at early stage of Alzheimer 's disease could be predictive of cognitive decline and used as diagnosis tools (Mapt SLEEP)
* To evaluate the impact of omega-3 fatty acids on the body composition measured by DXA scans (MAPT-DXA)


Options:
A: Number of Participants With All-cause Mortality, Cardiovascular Mortality, Stroke, and Myocardial Infarctions (1 year)
B: Major coronary events (sudden cardiac death, fatal and nonfatal myocardial infarction, unstable angina pectoris including hospitalization for ischemic episodes,events of angioplasty/ stenting or coronary artery bypass grafting)
C: Combined total mortality, first event of non-fatal myocardial infarction, stroke, revascularization or hospital admission for new or worsened heart failure. (24months)
D: Change in cognitive function at 36 months determined by a composite score (sum of Z-score of 4 tests: FCRST test (free recall + total recall) score, MMSE orientation score, Wais-R score (Digit Substitution Symbol test), and the Category Naming Test score (Baseline, 6, 12, 24, 36 months)

Answer: D
Please select the outcome measures that correspond to the clinical trial below.
Title: Assessment of the Efficacy of Omega-3 Fatty Acids Supplementation, Multi-domain Intervention or Their Combination on the Change of Cognitive Functions in Frail Elderly Subjects
Brief Summary: Epidemiological and fundamental research carried out in recent years has highlighted the role played by omega-3 fatty acids in the process of cognitive decline that accompanies advancing age and Alzheimer's disease. In addition, it has been recognized for some years, following several convergent studies on the prevention of cognitive decline, that nutrition, physical exercise, cognitive training and social activities play a significant role in the maintenance of cognitive faculties. At present, there are a number of epidemiological arguments in favour of a protective role of each of these factors taken in isolation. It can be postulated that a multi-domain intervention may potentiate the protective role of omega-3 fatty acids.

The main objective of this study is to assess the efficacy of isolated supplementation with omega-3 fatty acid, an isolated multi-domain intervention (nutrition, physical exercise, cognitive stimulation, social activities), or their combination on the change of cognitive functions in frail elderly subjects aged of 70 years and older over 3 years.

Secondary objectives:

* To assess the efficacy of each treatment strategy on the change of functional capacities and the prevention of dependency,
* To study the long-term safety and tolerability of V0137,
* To study compliance and adhesion to the multi-domain intervention programme,

Ancillary studies :

To assess the impact of an intervention program on brain metabolism in FDG PET (MAPT-NI : : impact of multidomain intervention on brain metabolism (FDG-PET))

* To evaluate the impact of preventive strategies (Omega-3 treatment and multidomain intervention ) of MAPT study on brain atrophy (MRI),
* To evaluate the presence and density of ß-amyloid in MAPT subjects using AV45 PET scans (MAPT AV45),
* To determine if sleep disorders at early stage of Alzheimer 's disease could be predictive of cognitive decline and used as diagnosis tools (Mapt SLEEP)
* To evaluate the impact of omega-3 fatty acids on the body composition measured by DXA scans (MAPT-DXA)


Options:
A: The Primary endpoint will be improvement in a composite score of histological injury as measured by the NASH Activity Score (NAS). (approximately 12 months from enrollment)
B: time to clinical relapse (52 weeks)
C: Change in cognitive function at 36 months determined by a composite score (sum of Z-score of 4 tests: FCRST test (free recall + total recall) score, MMSE orientation score, Wais-R score (Digit Substitution Symbol test), and the Category Naming Test score (Baseline, 6, 12, 24, 36 months)
D: All-cause mortality (from enrollment to 1252 deaths in R2 arm); All cause mortality or hospitalizations for any reason (from enrollment to 1252 deaths)

Answer: C
Please select the outcome measures that correspond to the clinical trial below.
Title: Assessment of the Efficacy of Omega-3 Fatty Acids Supplementation, Multi-domain Intervention or Their Combination on the Change of Cognitive Functions in Frail Elderly Subjects
Brief Summary: Epidemiological and fundamental research carried out in recent years has highlighted the role played by omega-3 fatty acids in the process of cognitive decline that accompanies advancing age and Alzheimer's disease. In addition, it has been recognized for some years, following several convergent studies on the prevention of cognitive decline, that nutrition, physical exercise, cognitive training and social activities play a significant role in the maintenance of cognitive faculties. At present, there are a number of epidemiological arguments in favour of a protective role of each of these factors taken in isolation. It can be postulated that a multi-domain intervention may potentiate the protective role of omega-3 fatty acids.

The main objective of this study is to assess the efficacy of isolated supplementation with omega-3 fatty acid, an isolated multi-domain intervention (nutrition, physical exercise, cognitive stimulation, social activities), or their combination on the change of cognitive functions in frail elderly subjects aged of 70 years and older over 3 years.

Secondary objectives:

* To assess the efficacy of each treatment strategy on the change of functional capacities and the prevention of dependency,
* To study the long-term safety and tolerability of V0137,
* To study compliance and adhesion to the multi-domain intervention programme,

Ancillary studies :

To assess the impact of an intervention program on brain metabolism in FDG PET (MAPT-NI : : impact of multidomain intervention on brain metabolism (FDG-PET))

* To evaluate the impact of preventive strategies (Omega-3 treatment and multidomain intervention ) of MAPT study on brain atrophy (MRI),
* To evaluate the presence and density of ß-amyloid in MAPT subjects using AV45 PET scans (MAPT AV45),
* To determine if sleep disorders at early stage of Alzheimer 's disease could be predictive of cognitive decline and used as diagnosis tools (Mapt SLEEP)
* To evaluate the impact of omega-3 fatty acids on the body composition measured by DXA scans (MAPT-DXA)


Options:
A: Number of Participants With All-cause Mortality, Cardiovascular Mortality, Stroke, and Myocardial Infarctions (1 year)
B: Change in cognitive function at 36 months determined by a composite score (sum of Z-score of 4 tests: FCRST test (free recall + total recall) score, MMSE orientation score, Wais-R score (Digit Substitution Symbol test), and the Category Naming Test score (Baseline, 6, 12, 24, 36 months)
C: cardiovascular deaths and hospitalization for cardiovascular causes (5 years)
D: All-cause mortality (from enrollment to 1252 deaths in R2 arm); All cause mortality or hospitalizations for any reason (from enrollment to 1252 deaths)

Answer: B
Please select the outcome measures that correspond to the clinical trial below.
Title: Assessment of the Efficacy of Omega-3 Fatty Acids Supplementation, Multi-domain Intervention or Their Combination on the Change of Cognitive Functions in Frail Elderly Subjects
Brief Summary: Epidemiological and fundamental research carried out in recent years has highlighted the role played by omega-3 fatty acids in the process of cognitive decline that accompanies advancing age and Alzheimer's disease. In addition, it has been recognized for some years, following several convergent studies on the prevention of cognitive decline, that nutrition, physical exercise, cognitive training and social activities play a significant role in the maintenance of cognitive faculties. At present, there are a number of epidemiological arguments in favour of a protective role of each of these factors taken in isolation. It can be postulated that a multi-domain intervention may potentiate the protective role of omega-3 fatty acids.

The main objective of this study is to assess the efficacy of isolated supplementation with omega-3 fatty acid, an isolated multi-domain intervention (nutrition, physical exercise, cognitive stimulation, social activities), or their combination on the change of cognitive functions in frail elderly subjects aged of 70 years and older over 3 years.

Secondary objectives:

* To assess the efficacy of each treatment strategy on the change of functional capacities and the prevention of dependency,
* To study the long-term safety and tolerability of V0137,
* To study compliance and adhesion to the multi-domain intervention programme,

Ancillary studies :

To assess the impact of an intervention program on brain metabolism in FDG PET (MAPT-NI : : impact of multidomain intervention on brain metabolism (FDG-PET))

* To evaluate the impact of preventive strategies (Omega-3 treatment and multidomain intervention ) of MAPT study on brain atrophy (MRI),
* To evaluate the presence and density of ß-amyloid in MAPT subjects using AV45 PET scans (MAPT AV45),
* To determine if sleep disorders at early stage of Alzheimer 's disease could be predictive of cognitive decline and used as diagnosis tools (Mapt SLEEP)
* To evaluate the impact of omega-3 fatty acids on the body composition measured by DXA scans (MAPT-DXA)


Options:
A: All-cause mortality (from enrollment to 1252 deaths in R2 arm); All cause mortality or hospitalizations for any reason (from enrollment to 1252 deaths)
B: time to clinical relapse (52 weeks)
C: Percentage of Liver Fat (Baseline and 18 months); Liver Fibrosis Score (Baseline and 18 months); NAFLD Fibrosis Score (Baseline and 18 months)
D: Change in cognitive function at 36 months determined by a composite score (sum of Z-score of 4 tests: FCRST test (free recall + total recall) score, MMSE orientation score, Wais-R score (Digit Substitution Symbol test), and the Category Naming Test score (Baseline, 6, 12, 24, 36 months)

Answer: D
Please select the outcome measures that correspond to the clinical trial below.
Title: Promoting Colon Cancer Screening Among African Americans
Brief Summary: RATIONALE: An interactive computer program may be more effective than a brochure in increasing colorectal cancer screening among African Americans.

PURPOSE: This randomized clinical trial is studying an interactive computer program to see how well it works compared with a brochure in increasing colorectal cancer screening among African Americans.


Options:
A: Bone mineral density (BMD) testing rates
B: Resolution or improvement in screened chronic condition; Improved communication with primary care doctor; Improved patient satisfaction; Improved physician satisfaction
C: Self-reported colorectal cancer (CRC) screening adherence with medical record verification of screening test completion (6 and 15 months post-intervention)
D: The proportion of subjects who fail to attend at least one outpatient adult endocrinology visit during the second year after transition to adult diabetes care. (30 months)

Answer: C
Please select the outcome measures that correspond to the clinical trial below.
Title: Randomized Comparison of β-D-Glucan Surveillance With Preemptive Anidulafungin Versus Standard Care for the Management of Invasive Candidiasis in Surgical Intensive Care Unit Patients
Brief Summary: This is a single center, prospective, open label assessment of β-D-glucan surveillance with preemptive anidulafungin therapy versus standard care for the prevention of invasive candidiasis in at-risk surgical intensive care unit (SICU) patients. Subjects will be stratified by APACHE II score and randomized in 3:1 fashion to either biweekly surveillance using the β-D-glucan assay or standard care. Subjects in the active monitoring arm will receive intravenous anidulafungin should the β-D-glucan exceed 60 pg/mL on a single determination. Subjects in the standard care arm will have biweekly blood draws for β-D-glucan, but the specimens will be batched and tested retrospectively. Antifungal use in the standard care arm is at the discretion of the treating physicians. The primary study end-points are the feasibility of a preemptive antifungal strategy in a SICU setting, β-D-glucan test characteristics, and the safety and tolerability of preemptive anidulafungin. Risks associated with study participation include the risks associated with blood draws, study drug related side effects, and the potential for loss of confidentiality.


Options:
A: Overall Recruitment Rate (32 months)
B: Clinical Utility of Biweekly β-D-glucan (BDG) Testing in At-risk Intensive Care Unit (ICU) Patients. (Participants were followed until ICU discharge, an average of 17 days); Safety and Tolerability of Preemptive Anidulafungin (weekly until ICU discharge)
C: Proven and Probable Invasive Candidiasis Based on Modified Mycoses Study Group/European Organization for Research and Treatment of Cancer (MSG/EORTC) Criteria. (Within 7 days after end of therapy)
D: course of the colonization index over time. (AT 15 day from ICU admission)

Answer: B
Please select the outcome measures that correspond to the clinical trial below.
Title: French Registry of Acute Coronary Syndrome With or Without ST Elevation
Brief Summary: The Fast-MI registry was designed to evaluate the "real world" management of patients with acute myocardial infarction (MI), and to assess their in-hospital, medium and long-term outcomes


Options:
A: All causes mortality at each follow-up period (6 months, each year)
B: Infarct size evaluated primarily by area of delayed enhancement on cardiac magnetic resonance imaging. (5-7 days after reperfusion)
C: major cardiovascular events (defined as cardiovascular death, nonfatal myocardial infarction, or nonfatal cardiac arrest) (30 days)
D: Death and the composite outcome of death, non-fatal reinfarction or stroke

Answer: A
Please select the outcome measures that correspond to the clinical trial below.
Title: A Randomized, Double-Blind, Parallel-Group Trial Comparing Bicalutamide (Casodex) 150mg Once Daily With Placebo in Patients With Non-metastatic Prostate Cancer
Brief Summary: The purpose of this trial is to study the effect of adjuvant or immediate hormonal therapy, versus placebo, in subjects who have either undergone a primary therapy (principally radical prostatectomy or radiotherapy) or who were otherwise to be managed by watchful waiting.


Options:
A: Time to clinical progression (Throughout study period); Overall patient survival (Throughout study period)
B: Survival (Throughout study period); Time to clinical progression (Throughout study period)
C: Time to clinical progression (Throughout study period); Tolerability in terms of adverse events and laboratory parameters (Throughout study period)
D: Quality of life (using Rand 36-Item Health Survey SF-36) (3 monthly for 1 year)

Answer: C
Please select the outcome measures that correspond to the clinical trial below.
Title: A Randomized, Double-Blind, Parallel-Group Trial Comparing Bicalutamide (Casodex) 150mg Once Daily With Placebo in Patients With Non-metastatic Prostate Cancer
Brief Summary: The purpose of this trial is to study the effect of adjuvant or immediate hormonal therapy, versus placebo, in subjects who have either undergone a primary therapy (principally radical prostatectomy or radiotherapy) or who were otherwise to be managed by watchful waiting.


Options:
A: Time to clinical progression (Throughout study period); Tolerability in terms of adverse events and laboratory parameters (Throughout study period)
B: To determine if the 2 year freedom from PSA failure is increased in patients receiving total androgen suppression and radiation therapy compared to those patients receiving radiation therapy alone. (Years)
C: Death from any cause at 8 years
D: Survival (Throughout study period); Time to clinical progression (Throughout study period)

Answer: A
Please select the outcome measures that correspond to the clinical trial below.
Title: Flexible Dosed Duloxetine Versus Placebo in the Treatment of Fibromyalgia
Brief Summary: The purpose of this study is to confirm the efficacy and safety of duloxetine 60-120 mg once daily in comparison to placebo on symptom improvement in patients meeting criteria for fibromyalgia aged 18 and older. Patients will be randomized to duloxetine or placebo, however, all patients will receive duloxetine at some point in the study.


Options:
A: Mean Change From Baseline at 12-Week Endpoint in the Weekly Mean of Pain Severity Score (Baseline, 12 weeks)
B: Change of item 5 score in Brief Pain Inventory Short Form (BPI-SF) scale (Baseline - Day 56)
C: Intent-toTreat Analysis of Descriptor Differential Scale (DDS) of Pain Intensity (12 weeks after baseline (or last observation carried forward))
D: Patient's Global Impressions of Improvement (PGI-I) at Week 12 (12 weeks)

Answer: D
Please select the outcome measures that correspond to the clinical trial below.
Title: Flexible Dosed Duloxetine Versus Placebo in the Treatment of Fibromyalgia
Brief Summary: The purpose of this study is to confirm the efficacy and safety of duloxetine 60-120 mg once daily in comparison to placebo on symptom improvement in patients meeting criteria for fibromyalgia aged 18 and older. Patients will be randomized to duloxetine or placebo, however, all patients will receive duloxetine at some point in the study.


Options:
A: Composite Syndrome Responder Status (At the end of the three-month stable dose treatment phase); Composite Pain Responder Status (At the end of three-month stable dose treatment phase)
B: Number of Awakenings After Sleep Onset (NAASO) (4-Week maintenance treatment with milnacipran and placebo); Sleep Efficiency (SE) (4-Week maintenance treatment with milnacipran and placebo); Wake After Sleep Onset (WASO) (4-Week maintenance treatment with milnacipran and placebo)
C: Composite responder analysis based on pain and patient global status, with or without physical function.
D: Patient's Global Impressions of Improvement (PGI-I) at Week 12 (12 weeks)

Answer: D
Please select the outcome measures that correspond to the clinical trial below.
Title: Flexible Dosed Duloxetine Versus Placebo in the Treatment of Fibromyalgia
Brief Summary: The purpose of this study is to confirm the efficacy and safety of duloxetine 60-120 mg once daily in comparison to placebo on symptom improvement in patients meeting criteria for fibromyalgia aged 18 and older. Patients will be randomized to duloxetine or placebo, however, all patients will receive duloxetine at some point in the study.


Options:
A: Patient's Global Impressions of Improvement (PGI-I) at Week 12 (12 weeks)
B: Compare efficacy of Duloxetine versus placebo on somatic complaints of pain in patients meeting criteria for major depressive disorder.
C: Change From Week 8 to Week 16 Endpoint in 24 Hour Average Pain Item Score on the Brief Pain Inventory (BPI) Modified Short Form (Week 8, Week 16)
D: Assess efficacy of duloxetine versus placebo on the treatment of pain in patients with fibromyalgia syndrome

Answer: A
Please select the outcome measures that correspond to the clinical trial below.
Title: Diffusion of Clinical Pathways for the Implementation of Effective and Appropriate Care
Brief Summary: The purposes of this study are to determine whether clinical pathways: 1)improve the quality of the care provided to patients affected by stroke in terms of clinical outcomes, efficiency continuity of care and patients' satisfaction; 2) facilitate the use of evidence based medicine in clinical practice.


Options:
A: Mortality (30 days after hospital admission)
B: percentage of all-or-none measure of evidence-based performance measures in acute ischemic stroke patients without contraindications (participants will be followed for the duration of hospital stay, an expected average of 2 weeks); a composite measure score of performance measures (participants will be followed for the duration of hospital stay, an expected average of 2 weeks)
C: functional gain as measured by motor FIM score (One year post team training intervention)
D: Six minute walk test (walking ability) (1-3 months); Functional Independence Measure (1-3 months); Functional Ambulation Category (1-3 months)

Answer: A
Please select the outcome measures that correspond to the clinical trial below.
Title: Diffusion of Clinical Pathways for the Implementation of Effective and Appropriate Care
Brief Summary: The purposes of this study are to determine whether clinical pathways: 1)improve the quality of the care provided to patients affected by stroke in terms of clinical outcomes, efficiency continuity of care and patients' satisfaction; 2) facilitate the use of evidence based medicine in clinical practice.


Options:
A: Mortality (30 days after hospital admission)
B: percentage of all-or-none measure of evidence-based performance measures in acute ischemic stroke patients without contraindications (participants will be followed for the duration of hospital stay, an expected average of 2 weeks); a composite measure score of performance measures (participants will be followed for the duration of hospital stay, an expected average of 2 weeks)
C: Mortality, dependence, psychoscial outcome; Mortality, dependence and psychosocial outcome (6 months endpoint)
D: Six minute walk test (walking ability) (1-3 months); Functional Independence Measure (1-3 months); Functional Ambulation Category (1-3 months)

Answer: A