TrialPanorama/Dataset huggingface dataset:
Please select the outcome measures that correspond to the clinical trial below.
Title: A Randomized Controlled Trial of Aliskiren in the Prevention of Major Cardiovascular Events in Elderly People
Brief Summary: This study was planned to provide new information regarding the role of aliskiren (with or without additional therapy with a diuretic or a Calcium channel blockers (CCB)) in elderly individuals (≥ 65 years) with systolic blood pressure (SBP) 130 to 159 mmHg, in preventing major cardiovascular (CV) events and on global measures of physical, executive and cognitive function.


Options:
A: Change from baseline in diastolic blood pressure after 26 weeks
B: Change from baseline in mean sitting diastolic blood pressure after 8 weeks
C: Change from baseline in diastolic blood pressure after week 8
D: Number of Participants With Composite Cardiovascular Endpoints in Aliskiren Based Regimen Versus Non-Aliskiren Based Regimen (End of study (209 days (median))); Number of Participants With Composite Cardiovascular Endpoints in Aliskiren+Amlodipine/HCTZ Group Versus All Placebo Group (End of study (209 days (median)))

Answer: D
Please select the outcome measures that correspond to the clinical trial below.
Title: A Randomized, Double-Blind, Placebo-Controlled, Sequential Ascending, Repeated-Dose Study of the Safety and Pharmacokinetics of Subcutaneous REGN668 in Patients With Moderate-to-Severe Extrinsic Atopic Dermatitis
Brief Summary: The purpose of this study is to assess the Safety and Tolerability of REGN668 (how the body reacts to the drug) compared to placebo (an inert substance) in patients with moderate-to-severe extrinsic Atopic Dermatitis.


Options:
A: Percent Change in Eczema Area and Severity Index Score (EASI) From Baseline to Week 16 (Baseline to Week 16)
B: Percentage of Participants With Investigator's Global Assessment (IGA) Score of "0" or "1" and Reduction From Baseline of ≥2 Points at Week 16 (Baseline to Week 16)
C: The primary endpoint in the study is the incidence of treatment-emergent adverse events (TEAEs) in patients treated with REGN668 or Placebo from baseline through week 12. (12 weeks)
D: Absolute Change From Baseline in Eczema Area and Severity Index (EASI) Total Score at Week 12 (Baseline (Day 1) and Week 12); Percentage of Participants Achieving Investigator's Global Assessment (IGA) Response of 0 (Clear) or 1 (Almost Clear) and at Least a 2-Grade Reduction From Baseline at Week 12 (Week 12)

Answer: C
Please select the outcome measures that correspond to the clinical trial below.
Title: A 40-week, Randomized, Double-blind, Placebo-controlled, Multicenter Efficacy and Safety Study of Methylphenidate HCl Extended Release in the Treatment of Adult Patients With Childhood-onset ADHD
Brief Summary: This study will evaluate efficacy and safety of methylphenidate hydrochloride extended release compared to placebo in adult patients with childhood-onset attention deficit/hyperactivity disorder (ADHD).


Options:
A: The change from Baseline in the Adult ADHD Investigator Symptom Rating Scale (AISRS) total score as assessed by the Investigator at the Final Visit/2 Week Efficacy Assessment Visit
B: Change from baseline in the sum of the inattention and hyperactivity/impulsivity subscale scores of the investigator-rated Conners' Adult ADHD Rating Scale at the end of the double-blind phase (5 weeks) compared with placebo.
C: Change in ADHD-Rating Scale 5 (ADHD-RS-5) Total Score From Baseline to Month 2 Among Patients Treated With Adhansia XR (Baseline to Month-2)
D: Change From Baseline of Period 1 (Baseline 1) to End of Period 1 on Attention-Deficit/Hyperactivity Disorder Rating Scale (DSM-IV ADHD RS) Total Score by Treatment (Baseline 1 to End of Period 1 (Week 9)); Change From Baseline Period 1 (Baseline 1) to End of Period 1 on Sheehan Disability Scale (SDS) Total Score by Treatment (Baseline 1 to End of Period 1 (Week 9)); Percentage of Participants With Treatment Failures During Period 3 (Baseline Period 1 (Baseline 1) and Baseline Period 3 (Baseline 2) to End of Week 40)

Answer: D
Please select the outcome measures that correspond to the clinical trial below.
Title: N/A
Brief Summary: Due to the increasing demand for colonoscopy in clinical practice, great interest has recently renewed for unsedated colonoscopy. Both Carbon dioxide Insufflation (CO2) and Warm Water Infusion (WWI) have been advocated to improve patient tolerance for colonoscopy as compared to standard Air Insufflation (AI). This study is aimed at evaluating the performance of the above techniques versus AI in unsedated patients.


Options:
A: number of patients undergoing complete unsedated colonoscopy (6 months)
B: Colonoscopy Success With Minimal Sedation (At the time of the procedure)
C: Proportion of Patients Without Pain (up to 12 months)
D: Increments of medications used for sedation (duration of procedure)

Answer: A
Please select the outcome measures that correspond to the clinical trial below.
Title: China Rural Health Initiative: High Cardiovascular Risk Management and Salt Reduction in Rural Villages in China -- Two Parallel Large Cluster Randomized Controlled Trials
Brief Summary: Cardiovascular disease is the leading cause of death in China. At the village level, strategies for the control of cardiovascular disease are mostly absent. National clinical guidelines for the management of hypertension and cardiovascular disease are rarely disseminated to, or implemented by, the village primary care providers. Salt reduction has greater potential in rural China than almost anywhere else in the world. Very high levels of salt consumption, very little use of processed food and most dietary salt deriving from home cooking makes the removal of salt from the diet easier, cheaper and more worthwhile than in almost any other setting. The two large-scale cluster-randomized controlled trials proposed here will precisely and reliably define the effect of two highly plausible intervention strategies on important clinical outcomes. The evidence provided by the project will form the basis for policy setting that has the potential to greatly reduce the occurrence of vascular disease in rural China and take an important step towards balancing the rural urban divide in health and healthcare.


Options:
A: Systolic Blood Pressure (three months)
B: Stroke (5 years)
C: Mean systematic blood pressure level (October 2010 - December 2012); 24 hour urinary sodium (October -December 2012)
D: The modified Rankin scale (mRs) (6 months); The National Institute of Health Stroke Scale (NIHSS) (6 months); The Barthel index (BI) (6 months); The "good neurological performance" (6 months)

Answer: C
Please select the outcome measures that correspond to the clinical trial below.
Title: China Rural Health Initiative: High Cardiovascular Risk Management and Salt Reduction in Rural Villages in China -- Two Parallel Large Cluster Randomized Controlled Trials
Brief Summary: Cardiovascular disease is the leading cause of death in China. At the village level, strategies for the control of cardiovascular disease are mostly absent. National clinical guidelines for the management of hypertension and cardiovascular disease are rarely disseminated to, or implemented by, the village primary care providers. Salt reduction has greater potential in rural China than almost anywhere else in the world. Very high levels of salt consumption, very little use of processed food and most dietary salt deriving from home cooking makes the removal of salt from the diet easier, cheaper and more worthwhile than in almost any other setting. The two large-scale cluster-randomized controlled trials proposed here will precisely and reliably define the effect of two highly plausible intervention strategies on important clinical outcomes. The evidence provided by the project will form the basis for policy setting that has the potential to greatly reduce the occurrence of vascular disease in rural China and take an important step towards balancing the rural urban divide in health and healthcare.


Options:
A: Mean systematic blood pressure level (October 2010 - December 2012); 24 hour urinary sodium (October -December 2012)
B: Dietary sodium intake as assessed from 3-day recalls. (baseline and 4 months); Dietary sodium effluent and urine concentration. (baseline and 4 months); Morning blood pressure. (baseline and 4 months); Morning post dialysis weight. (baseline and 4 months); Feasibility and acceptability of PDA-based dietary monitoring. (4 months)
C: 24 hour blood pressure (Two weeks after start of each intervention)
D: Office systolic and diastolic BP readings (9 months)

Answer: A
Please select the outcome measures that correspond to the clinical trial below.
Title: China Rural Health Initiative: High Cardiovascular Risk Management and Salt Reduction in Rural Villages in China -- Two Parallel Large Cluster Randomized Controlled Trials
Brief Summary: Cardiovascular disease is the leading cause of death in China. At the village level, strategies for the control of cardiovascular disease are mostly absent. National clinical guidelines for the management of hypertension and cardiovascular disease are rarely disseminated to, or implemented by, the village primary care providers. Salt reduction has greater potential in rural China than almost anywhere else in the world. Very high levels of salt consumption, very little use of processed food and most dietary salt deriving from home cooking makes the removal of salt from the diet easier, cheaper and more worthwhile than in almost any other setting. The two large-scale cluster-randomized controlled trials proposed here will precisely and reliably define the effect of two highly plausible intervention strategies on important clinical outcomes. The evidence provided by the project will form the basis for policy setting that has the potential to greatly reduce the occurrence of vascular disease in rural China and take an important step towards balancing the rural urban divide in health and healthcare.


Options:
A: Reduction in blood pressure (Six months)
B: 24-hourly urinary sodium excretion (up to 9 months)
C: 24 hour blood pressure (Two weeks after start of each intervention)
D: Mean systematic blood pressure level (October 2010 - December 2012); 24 hour urinary sodium (October -December 2012)

Answer: D
Please select the outcome measures that correspond to the clinical trial below.
Title: The Impact of Dietary Cocoa Flavanols on Cardio-pulmonary Exercise Capacity in Human.
Brief Summary: The purpose of this study is to characterize the potential improvement of cocoa flavanols on exercise capacity in highly trained cyclist. A placebo-controlled double-blinded randomized control study will be performed in 13 highly trained cyclist (crossover design). Participants will perform a baseline exercise testing on an ergometer. They will receive either a flavanol-poor or flavanol rich cocoa drink twice daily for one week before a second and third exercise testing is performed. The order of drinks is randomized and balanced (high-flavanol--\>low-flavanol drink or low-flavanol drink--\>high-flavanol drink)


Options:
A: Cardiopulmonary exercise capacity (time to complete time trail, lactate anaerobic threshold, cardio-pulmonary exercise capacity (7 days)
B: The primary outcome measure is postoperative neurocognitive dysfunction. (Preoperative, 1 week and 3 months after surgery)
C: Peak CK-MB within 24 hours after surgery (24 hours)
D: Mitochondrial respiration (1 hour)

Answer: A
Please select the outcome measures that correspond to the clinical trial below.
Title: Nordic Randomized Phase III Trial of Two Different Durations of Adjuvant Therapy With Intermediate-dose Interferon Alfa-2b in Patients With High-risk Melanoma
Brief Summary: The aim of this study is to evaluate the effect of giving adjuvant treatment with intermediate doses of interferon-alpha2b to patients operated for high risk melanoma. Patients are randomly assigned to either observation only or interferon treatment for 2 different durations. The outcome with respect to overall survival, relapse-free survival, side effects and quality of life is analysed.


Options:
A: Overall Survival (From randomization (initiated January 2010) to December 30 2010. Median follow-up time in the vemurafenib group was 3.75 months (range 0.3 to 10.8) and in the dacarbazine group was 2.33 months (range <0.1 to 10.3).); Progression-free Survival (From randomization (initiated January 2010) to December 30 2010.)
B: To determine whether wide excision of the primary with intraoperative lymphatic mapping (LM) followed by selective lymphadenectomy will effectively prolong overall survival compared to wide excision of the primary melanoma alone. (10 years)
C: Overall survival (Evaluated at regular intervals: every 3 months for 2 years, every 6 months up to 5 years and yearly up to 10 years following randomization. Actual median follow-up is 72.4 months)
D: Overall Survival (OS) (Time-to-Death) Difference Between MDX-010 in Combination With gp 100 Melanoma Peptide Vaccine Versus gp 100 Melanoma Peptide Vaccine Alone (From randomization until the end of the study, which was defined as the time at which 481 deaths were observed (264 weeks))

Answer: C
Please select the outcome measures that correspond to the clinical trial below.
Title: The Effect of a Perioperative Smoking Cessation Program on Rates of Smoking Cessation/Reduction and Perioperative Complications: a Randomized Clinical Trial.
Brief Summary: The purpose of this study is to determine whether a perioperative smoking cessation program, implemented at least 3 weeks prior to elective surgery, is effective in increasing rates of smoking cessation or reduction. Intraoperative and immediate postoperative complications will also be compared.


Options:
A: Self-reported, Prolonged Abstinence From Smoking Between a Quit Date and 6 Months Afterwards. (6 months from participant's quit date)
B: Results in Abstinence Rates (1 Year)
C: smoking cessation (date of surgery)
D: Stimulant-free Weeks Assessed by Self-report and Twice-weekly Urine Drug Screens (Week 16)

Answer: C
Please select the outcome measures that correspond to the clinical trial below.
Title: A Randomized, Unblinded, Single Research Site, Comparator Study of Raisins Versus Alternative Snacks on Cardiovascular Risk Factors In Generally Healthy Subjects
Brief Summary: This trial compared the effects of raisin intake on cardiovascular risk factors compared to common, commercially available, alternative snacks. These cardiovascular risk factors include glucose, blood pressure, lipid levels, body weight, and waist circumference.


Options:
A: Dietary intake (6 month)
B: Percent Change in Postprandial Glucose Levels (12 weeks); Percent Change in Fasting Glucose Levels (12 weeks); Percent Change in Body Weight (12 weeks)
C: Lipid Analysis (June 2012); Body Weight Analysis (November 2011); Glycemic Control Analysis (June 2012); Blood Pressure (BP) Analysis (January 2012); Uric Acid Analysis (February 2012); "Catalytic" Fructose Across Cardiometabolic Endpoints Analysis (January 2012); Non-Alcoholic Fatty Liver (NAFL) Analysis (June 2012)
D: Weight change (0, 3, 6 months)

Answer: B
Please select the outcome measures that correspond to the clinical trial below.
Title: Continuum of Care, From the Emergency Ward to Living at Home - Implementation and Evaluation of an Intervention for Frail Elderly People
Brief Summary: The present study "Continuum of care for frail elderly people" form part of the research programme "Support for frail elderly persons - from prevention to palliation" (www.vardalinstitutet.net) which comprises research into three interventions. The program comprises interventions addressing frail elderly people in different phases of the disablement process, from elderly people who are beginning to develop frailty to very frail elderly people receiving palliative care.

The intervention "Continuum of care for frail elderly people" addresses elderly people who are frail and that have a great risk of high health care consumption. The hypothesis is that an intervention program for frail elderly people can reduce the number of visits to the emergency department, increase the life satisfaction and maintain the functional ability. The intervention, including an early geriatric assessment at the emergency department, early family support, a case manager in the community with a multi-professional team and active follow-up by the case manager, contributes to early recognition of the elderly people's need of information, care and rehabilitation and of informal caregivers' need of information. It enhances the transfer of information and integrates the care between different caregivers and different care levels, thereby better recognize frail elderly people's needs. Specifically, this study is expected to show that the intervention has a positive effect on the frail elderly person's functional ability, life satisfaction, satisfaction with health and social care, and health care consumption.


Options:
A: Hospitalizations: rates of first hospitalization, number and reason (Three years)
B: Functional status; health status; hospitalization and nursing home placement
C: Health Care Consumption (1 year); Dependence in Activities of Daily Living (1 year); Satisfaction With Health and Social Care (1 year)
D: Health related quality of life (quality adjusted life years [QALYs]) (baseline, 6 months, 12 months)

Answer: C
Please select the outcome measures that correspond to the clinical trial below.
Title: Continuum of Care, From the Emergency Ward to Living at Home - Implementation and Evaluation of an Intervention for Frail Elderly People
Brief Summary: The present study "Continuum of care for frail elderly people" form part of the research programme "Support for frail elderly persons - from prevention to palliation" (www.vardalinstitutet.net) which comprises research into three interventions. The program comprises interventions addressing frail elderly people in different phases of the disablement process, from elderly people who are beginning to develop frailty to very frail elderly people receiving palliative care.

The intervention "Continuum of care for frail elderly people" addresses elderly people who are frail and that have a great risk of high health care consumption. The hypothesis is that an intervention program for frail elderly people can reduce the number of visits to the emergency department, increase the life satisfaction and maintain the functional ability. The intervention, including an early geriatric assessment at the emergency department, early family support, a case manager in the community with a multi-professional team and active follow-up by the case manager, contributes to early recognition of the elderly people's need of information, care and rehabilitation and of informal caregivers' need of information. It enhances the transfer of information and integrates the care between different caregivers and different care levels, thereby better recognize frail elderly people's needs. Specifically, this study is expected to show that the intervention has a positive effect on the frail elderly person's functional ability, life satisfaction, satisfaction with health and social care, and health care consumption.


Options:
A: Depressive Symptoms (CES-D Score) (Baseline, 12 month FU)
B: Change in Patient Health Questionnaire-9 items (PHQ-9) score (Baseline, 3-month, 6-month, 9-month, 12-month)
C: Health Care Consumption (1 year); Dependence in Activities of Daily Living (1 year); Satisfaction With Health and Social Care (1 year)
D: This research study may lead to a potentially useful treatment for diabetes management when depression is present. (6 weeks); HbA1c (3-,6-, and 9-months); Depression (3-, 6- and 9-months)

Answer: C
Please select the outcome measures that correspond to the clinical trial below.
Title: Continuum of Care, From the Emergency Ward to Living at Home - Implementation and Evaluation of an Intervention for Frail Elderly People
Brief Summary: The present study "Continuum of care for frail elderly people" form part of the research programme "Support for frail elderly persons - from prevention to palliation" (www.vardalinstitutet.net) which comprises research into three interventions. The program comprises interventions addressing frail elderly people in different phases of the disablement process, from elderly people who are beginning to develop frailty to very frail elderly people receiving palliative care.

The intervention "Continuum of care for frail elderly people" addresses elderly people who are frail and that have a great risk of high health care consumption. The hypothesis is that an intervention program for frail elderly people can reduce the number of visits to the emergency department, increase the life satisfaction and maintain the functional ability. The intervention, including an early geriatric assessment at the emergency department, early family support, a case manager in the community with a multi-professional team and active follow-up by the case manager, contributes to early recognition of the elderly people's need of information, care and rehabilitation and of informal caregivers' need of information. It enhances the transfer of information and integrates the care between different caregivers and different care levels, thereby better recognize frail elderly people's needs. Specifically, this study is expected to show that the intervention has a positive effect on the frail elderly person's functional ability, life satisfaction, satisfaction with health and social care, and health care consumption.


Options:
A: Hospital readmission (30 days)
B: Depressive Symptoms (CES-D Score) (Baseline, 12 month FU)
C: Combined Effect of Intervention on SCL-20, Systolic Blood Pressure, LDL and HbA1c (Baseline to 12 months); Symptom Checklist-20 Score at Baseline, 6 Months and 12 Months (Measured at Baseline, 6 Months, 12 months); Systolic Blood Pressure at Baseline, 6 Months and 12 Months (Measured at Baseline, 6 Months, 12 months); LDL Cholesterol at Baseline and 12 Months (Measured at Baseline and 12 months); Glycated Hemoglobin (HbA1c) at Baseline, 6 Months and 12 Months (Measured at Baseline, 6 months and 12 months)
D: Health Care Consumption (1 year); Dependence in Activities of Daily Living (1 year); Satisfaction With Health and Social Care (1 year)

Answer: D