TrialPanorama/Dataset huggingface dataset:
Please select the outcome measures that correspond to the clinical trial below.
Title: A Phase II Double-Blind, Placebo-Controlled Study of Two Doses of EPA-E in Patients With NASH
Brief Summary: This is a controlled study to determine the effectiveness and safety of ethyl icosapentate (EPA-E) in the treatment of adult patients with non-alcoholic steatohepatitis (NASH).


Options:
A: Rate of Change on the ADAS-Cog 11. (Baseline, 6, 12, 18 months); Rate of Change on CDR-SOB (18 months)
B: Histological Response Defined by Change From Baseline in Standardized Scoring of Liver Biopsies (12 months); Alanine Transaminase (ALT) Levels (3 month endpoint); Alanine Transaminase (ALT) Levels (6 months)
C: Weight loss (1 year)
D: 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)

Answer: B
Please select the outcome measures that correspond to the clinical trial below.
Title: A Phase II Double-Blind, Placebo-Controlled Study of Two Doses of EPA-E in Patients With NASH
Brief Summary: This is a controlled study to determine the effectiveness and safety of ethyl icosapentate (EPA-E) in the treatment of adult patients with non-alcoholic steatohepatitis (NASH).


Options:
A: Histological Response Defined by Change From Baseline in Standardized Scoring of Liver Biopsies (12 months); Alanine Transaminase (ALT) Levels (3 month endpoint); Alanine Transaminase (ALT) Levels (6 months)
B: Sudden cardiac death (12 months)
C: N/A
D: Changes from baseline in global cognitive composite score (2 years); Changes from baseline in macular degeneration (2 years)

Answer: A
Please select the outcome measures that correspond to the clinical trial below.
Title: MIPARC - Multilevel Intervention for Physical Activity in Retirement Communities
Brief Summary: The purpose of this study was to assess whether a 6-month multilevel physical activity intervention can significantly increase physical activity levels in sedentary adults, 65 and older, living in Continuing Care Retirement Communities (CCRCs).

Sedentary residents (N=307) in 11 CCRCs received the multilevel MIPARC intervention or a control health education program for 6 months. A group randomized control design was employed with site as the unit of randomization. The intervention was delivered through group sessions, phone calls, printed materials, tailored signage and mapping and targeted peer led advocacy efforts.


Options:
A: Daily Minutes of Physical Activity (Baseline); Daily Minutes of Physical Activity (6 months); Minutes of Light to Moderate Physical Activity (12 months)
B: REACH Session Feedback (6 weeks)
C: Self reported physical activity (after 3 month); Self reported physical activity (After 6 month)
D: Change in Hours of Sitting Time (12 weeks)

Answer: A
Please select the outcome measures that correspond to the clinical trial below.
Title: Restoration of Bowel Function After Laparoscopic Colorectal Surgery: Effect of Intravenous Lidocaine
Brief Summary: Patients receiving perioperative intravenous lidocaine, post operative restoration of bowel movement will be faster and decrease pain intensity, opioid consumption and side effects, length of hospital stay; probably as a result of a significant opioid sparing and attenuated inflammatory response.


Options:
A: Restoration of bowel function (72 hours after an operation)
B: Quality of Recovery 40 Score (24 hours post surgery)
C: opiate consumption (hospital discharge/ days 0-7)
D: Quality of recovery 40(QoR-40) score (24hours after operation day)

Answer: A
Please select the outcome measures that correspond to the clinical trial below.
Title: Carvedilol Post-intervention Long-term Administration in Large-scale Randomized Controlled Trial
Brief Summary: The purpose of this study is to evaluate whether beta-blocker therapy improves 6-year clinical outcomes in patients with ST-segment elevation acute myocardial infarction and preserved left ventricular ejection fraction after primary percutaneous coronary intervention.


Options:
A: Occurrence of myocardial infarction,stroke or cardiovascular death.
B: Adjusted Mean Monthly Percent of Days Covered With B-blocker Following Intervention Date (9 months)
C: major cardiovascular events (defined as cardiovascular death, nonfatal myocardial infarction, or nonfatal cardiac arrest) (30 days)
D: All cause mortality (6-year); Composite of death, myocardial infarction, acute coronary syndrome, heart failure hospitalization (6-year)

Answer: D
Please select the outcome measures that correspond to the clinical trial below.
Title: Carvedilol Post-intervention Long-term Administration in Large-scale Randomized Controlled Trial
Brief Summary: The purpose of this study is to evaluate whether beta-blocker therapy improves 6-year clinical outcomes in patients with ST-segment elevation acute myocardial infarction and preserved left ventricular ejection fraction after primary percutaneous coronary intervention.


Options:
A: Infarct size evaluated primarily by area of delayed enhancement on cardiac magnetic resonance imaging. (5-7 days after reperfusion)
B: All cause mortality (6-year); Composite of death, myocardial infarction, acute coronary syndrome, heart failure hospitalization (6-year)
C: Death and the composite outcome of death, non-fatal reinfarction or stroke
D: All causes mortality at each follow-up period (6 months, each year)

Answer: B
Please select the outcome measures that correspond to the clinical trial below.
Title: N/A
Brief Summary: The assessment intends to investigate the efficacy of psychosocial counseling for the treatment of help seeking individuals with psychosocial problems in Mazar-e-Sharif, Afghanistan. Treatment was administered by local counselors who had received specific education and training


Options:
A: HSCL 25 (Symptoms were assessed at baseline); HSCL 25 (3-month follow-up); HSCL 25 (Assessment at 12-month-follow-up)
B: Change in scores on the Oxford Measure of Psychosocial Adjustment & World Health Organization Disability Assessment Schedule, 2.0 (WHODAS 2.0) (Administered at 4 timepoints: (1) baseline; (2) within 15 days of YRI completion; (3) 6 months post-YRI; (4) 12 months post-YRI)
C: Clinician-Administered PTSD Scale (CAPS) (After 14 weeks of treatment)
D: Change in post-traumatic stress symptoms measured by UCLA-PTSD-RI (Post-intervention and 3 month)

Answer: A
Please select the outcome measures that correspond to the clinical trial below.
Title: N/A
Brief Summary: The assessment intends to investigate the efficacy of psychosocial counseling for the treatment of help seeking individuals with psychosocial problems in Mazar-e-Sharif, Afghanistan. Treatment was administered by local counselors who had received specific education and training


Options:
A: Harvard Trauma Questionnaire (Baseline, 12 weeks, 3 months)
B: Change in stigmatizing attitudes, as measured by the Social Distance questionnaire (Baseline, post-training (immediately after 10-day training curriculum), +4 months, + 16 months)
C: General psychological distress - General Health Questionnaire (20-weeks after baseline)
D: HSCL 25 (Symptoms were assessed at baseline); HSCL 25 (3-month follow-up); HSCL 25 (Assessment at 12-month-follow-up)

Answer: D
Please select the outcome measures that correspond to the clinical trial below.
Title: Assessment of the Effectiveness of a Program of Preparation to Pregnancy and Delivery
Brief Summary: Introduction: randomized studies on programs implemented during pre-natal care that offer information and physical activities preparing pregnant women for delivery are scarce in the scientific literature. Objective: to evaluate the effectively of the Program for Preparation of Pregnant Women for Delivery on the prevention of physical and psychological difficulties and problems during pregnancy and delivery in nulliparous women participating in the program. Subjects and methods: a randomized clinical single blind trial will be conducted with 192 pregnant nulliparous women allocated to participate or not of the program activities. The women allocated to the study group will participate of physical and educational activities at each pre-natal consultation and will receive orientation on the exercises they will perform at their home. Participants of the non-interventional group will follow the habitual routine care at the service. Participants will be selected among nulliparous low risk pregnant women aged between 16 and 40 years old after the 20th week of gestation. Data analysis: will be performing by intention to treat. For the continues variables the t-Student or Wilcoxon test will be performing; for the categorical variables the tests x² or Fisher, and the risk estimate will be estimated using a Relative Risk with 95% CI. ANOVA will be use for measures between the groups and along time, and correlation tests for anxiety and physical activity with gestational and perinatal variables.


Options:
A: Primary outcomes are overall weight gain during pregnancy and proportion of participants exceeding weight gain above IOM recommendations. (week 36-38 of pregnancy)
B: To assess the well being of the women trought the proportion of women with back pain and stress urinary incontinence (The outcome will be that the pregnant women will be interview at an average of up to 30 days after delivery)
C: Urinary incontinence score assessed with ICIQ-SF questionnaire (one year post partum)
D: UI reduction (12 months)

Answer: B
Please select the outcome measures that correspond to the clinical trial below.
Title: Assessment of the Effectiveness of a Program of Preparation to Pregnancy and Delivery
Brief Summary: Introduction: randomized studies on programs implemented during pre-natal care that offer information and physical activities preparing pregnant women for delivery are scarce in the scientific literature. Objective: to evaluate the effectively of the Program for Preparation of Pregnant Women for Delivery on the prevention of physical and psychological difficulties and problems during pregnancy and delivery in nulliparous women participating in the program. Subjects and methods: a randomized clinical single blind trial will be conducted with 192 pregnant nulliparous women allocated to participate or not of the program activities. The women allocated to the study group will participate of physical and educational activities at each pre-natal consultation and will receive orientation on the exercises they will perform at their home. Participants of the non-interventional group will follow the habitual routine care at the service. Participants will be selected among nulliparous low risk pregnant women aged between 16 and 40 years old after the 20th week of gestation. Data analysis: will be performing by intention to treat. For the continues variables the t-Student or Wilcoxon test will be performing; for the categorical variables the tests x² or Fisher, and the risk estimate will be estimated using a Relative Risk with 95% CI. ANOVA will be use for measures between the groups and along time, and correlation tests for anxiety and physical activity with gestational and perinatal variables.


Options:
A: Weight gain during pregnancy (From 14 weeks pregnancy to delivery)
B: To assess the well being of the women trought the proportion of women with back pain and stress urinary incontinence (The outcome will be that the pregnant women will be interview at an average of up to 30 days after delivery)
C: Pain Visual Analog Scale (VAS) (10 weeks); confirmatory low back pain test (10 weeks); Confirmatory pelvic pain test (10 weeks)
D: Reported pain intensity on visual analogue scale

Answer: B
Please select the outcome measures that correspond to the clinical trial below.
Title: Assessment of the Effectiveness of a Program of Preparation to Pregnancy and Delivery
Brief Summary: Introduction: randomized studies on programs implemented during pre-natal care that offer information and physical activities preparing pregnant women for delivery are scarce in the scientific literature. Objective: to evaluate the effectively of the Program for Preparation of Pregnant Women for Delivery on the prevention of physical and psychological difficulties and problems during pregnancy and delivery in nulliparous women participating in the program. Subjects and methods: a randomized clinical single blind trial will be conducted with 192 pregnant nulliparous women allocated to participate or not of the program activities. The women allocated to the study group will participate of physical and educational activities at each pre-natal consultation and will receive orientation on the exercises they will perform at their home. Participants of the non-interventional group will follow the habitual routine care at the service. Participants will be selected among nulliparous low risk pregnant women aged between 16 and 40 years old after the 20th week of gestation. Data analysis: will be performing by intention to treat. For the continues variables the t-Student or Wilcoxon test will be performing; for the categorical variables the tests x² or Fisher, and the risk estimate will be estimated using a Relative Risk with 95% CI. ANOVA will be use for measures between the groups and along time, and correlation tests for anxiety and physical activity with gestational and perinatal variables.


Options:
A: UI reduction (12 months)
B: To assess the well being of the women trought the proportion of women with back pain and stress urinary incontinence (The outcome will be that the pregnant women will be interview at an average of up to 30 days after delivery)
C: First Occurrence of a Severe Cardiovascular Event (up to 11 years)
D: Urinary incontinence score assessed with ICIQ-SF questionnaire (one year post partum)

Answer: B
Please select the outcome measures that correspond to the clinical trial below.
Title: Assessment of the Effectiveness of a Program of Preparation to Pregnancy and Delivery
Brief Summary: Introduction: randomized studies on programs implemented during pre-natal care that offer information and physical activities preparing pregnant women for delivery are scarce in the scientific literature. Objective: to evaluate the effectively of the Program for Preparation of Pregnant Women for Delivery on the prevention of physical and psychological difficulties and problems during pregnancy and delivery in nulliparous women participating in the program. Subjects and methods: a randomized clinical single blind trial will be conducted with 192 pregnant nulliparous women allocated to participate or not of the program activities. The women allocated to the study group will participate of physical and educational activities at each pre-natal consultation and will receive orientation on the exercises they will perform at their home. Participants of the non-interventional group will follow the habitual routine care at the service. Participants will be selected among nulliparous low risk pregnant women aged between 16 and 40 years old after the 20th week of gestation. Data analysis: will be performing by intention to treat. For the continues variables the t-Student or Wilcoxon test will be performing; for the categorical variables the tests x² or Fisher, and the risk estimate will be estimated using a Relative Risk with 95% CI. ANOVA will be use for measures between the groups and along time, and correlation tests for anxiety and physical activity with gestational and perinatal variables.


Options:
A: To assess the well being of the women trought the proportion of women with back pain and stress urinary incontinence (The outcome will be that the pregnant women will be interview at an average of up to 30 days after delivery)
B: Weight gain during pregnancy (From 14 weeks pregnancy to delivery)
C: Urinary incontinence score assessed with ICIQ-SF questionnaire (one year post partum)
D: Change from baseline in ICIQ-Urinary Incontinence Short Form Questionnaire (Week 10-14 gestation (baseline), week 36-39 (after intervention))

Answer: A
Please select the outcome measures that correspond to the clinical trial below.
Title: Educore Project: A Clinical Trial, Randomised by Clusters, to Assess the Effect of a Visual Learning Method on Blood Pressure Control in the Primary Health Care Setting
Brief Summary: Background: High blood pressure (HBP) is a major risk factor for cardiovascular disease (CVD). European hypertension and cardiology societies as well as expert committees on CVD prevention recommend stratifying cardiovascular risk (CVR) using the SCORE method, the modification of lifestyles to prevent CVD, and achieving good control over risk factors. The EDUCORE (Education and Coronary Risk Evaluation) project aims to determine whether the use of a CVR visual learning method - the EDUCORE method - is more effective than normal clinical practice in improving the control of blood pressure within one year in patients with poorly controlled hypertension but no background of CVD.

Design \& Method: Cluster randomized controlled clinical trial. Location: 22 primary health care centres in Madrid. Participants: patients diagnosed as hypertensive (systolic \>140 mmHg and/or diastolic \>90 mmHg) at least a year before, uncontrolled. Age: 40-65 year-old patients who consent to take part. Sampling: randomized cluster assignment. Random allocation unit: health care centre. Analysis unit: patient who match criteria. Size: 736 patients (368 each arm. Measurements: Outcome variables: systolic and diastolic blood pressure (mmHg). Cardiovascular risk level: SCORE. Measure of Adherence to treatment (Morisky-Green questionnaire. Health related quality of life questionnaire MINICHAL. Smoking habits. Total Cholesterol. Other variables: Gender. Age. Educational level. Physical activity in metabolic equivalent (MET). Body mass index. Drug consume (cardiovascular line). Treatment changes and nature of the change. Intervention: EDUCORE group (direct exhibition of their cardiovascular risk with SCORE, visual images and documentation to the patients); Control Group: standard practice care.


Options:
A: Percentage (%) change from baseline to week 24 in serum LDL-C levels. (24 weeks from Baseline)
B: Main outcome variable: control of blood pressure (Baseline and 1 year)
C: Incidence of CHD and other lifestyle related diseases after ten years (2012)
D: percentage of participants with increase of the adequacy of lipid-lowering prescription (up to 24 months)

Answer: B
Please select the outcome measures that correspond to the clinical trial below.
Title: Reducing Pediatric Obesity Through After-school Programs
Brief Summary: This study will assess the impact of a national, community-based after-school program promoting physical activity (America SCORES) on obesity, fitness and important cardiovascular risk factors among minority children. The investigators central hypothesis is that established community-based programs, such as America SCORES, can reduce obesity and cardiovascular risk among participants. The 1-year study followed 158 children from 6 public schools, 3 of which were randomized to have SCORES and 3 to "usual care" after-school program. Primary outcomes are change in body mass index (BMI), physical activity (measured by accelerometer), and fitness (aerobic capacity assessed with the 20-meter shuttle test). Cardiovascular outcomes include blood pressure, body composition (assessed using bioelectrical impedance) and waist circumference. The investigators will also measure academic outcomes.


Options:
A: Academic performance (October 2014 - June 2015 (8 months))
B: Change in BMI z-score (Baseline (0 months) and 9 months)
C: Math Skills, as measured by a 45-minute standardized math test specifically designed for this age group by the developer of the Danish national tests (MG) (Hoegrefe Forlag). (Change from Baseline Math Skills at 9 months)
D: Weight in Kilograms (Baseline, 12 weeks); Weight z Score (Baseline, 12 weeks); BMI Calculated as "Weight (kg) / Height (m^2)" (Baseline, 12 weeks); BMI z Score (Baseline, 12 weeks); Body Fat Percentage as Determined by Siri Formula From Skinfold Thicknesses (Baseline, 12 weeks)

Answer: B
Please select the outcome measures that correspond to the clinical trial below.
Title: Reducing Pediatric Obesity Through After-school Programs
Brief Summary: This study will assess the impact of a national, community-based after-school program promoting physical activity (America SCORES) on obesity, fitness and important cardiovascular risk factors among minority children. The investigators central hypothesis is that established community-based programs, such as America SCORES, can reduce obesity and cardiovascular risk among participants. The 1-year study followed 158 children from 6 public schools, 3 of which were randomized to have SCORES and 3 to "usual care" after-school program. Primary outcomes are change in body mass index (BMI), physical activity (measured by accelerometer), and fitness (aerobic capacity assessed with the 20-meter shuttle test). Cardiovascular outcomes include blood pressure, body composition (assessed using bioelectrical impedance) and waist circumference. The investigators will also measure academic outcomes.


Options:
A: Body Mass Index Z-Score (Fall 2005, Spring 2006, Fall 2006, Spring 2007, Fall 2007, Spring 2008)
B: Body mass index (Baseline, 3 and 6 months)
C: Change in BMI z-score (Baseline (0 months) and 9 months)
D: Change from baseline in nutrition and physical activity goals met (aggregate score) (Measured pre/post about 6 months apart)

Answer: C
Please select the outcome measures that correspond to the clinical trial below.
Title: Reducing Pediatric Obesity Through After-school Programs
Brief Summary: This study will assess the impact of a national, community-based after-school program promoting physical activity (America SCORES) on obesity, fitness and important cardiovascular risk factors among minority children. The investigators central hypothesis is that established community-based programs, such as America SCORES, can reduce obesity and cardiovascular risk among participants. The 1-year study followed 158 children from 6 public schools, 3 of which were randomized to have SCORES and 3 to "usual care" after-school program. Primary outcomes are change in body mass index (BMI), physical activity (measured by accelerometer), and fitness (aerobic capacity assessed with the 20-meter shuttle test). Cardiovascular outcomes include blood pressure, body composition (assessed using bioelectrical impedance) and waist circumference. The investigators will also measure academic outcomes.


Options:
A: BMI and aerobic fitness (1 schoolyear)
B: Change in BMI z-score (Baseline (0 months) and 9 months)
C: Number of months of breast feeding (6 and 12 months)
D: Anthropometric measurements (1.3 years); Anthropometric measurements (5 years); Anthropometric measurements (10 years)

Answer: B
Please select the outcome measures that correspond to the clinical trial below.
Title: Reducing Pediatric Obesity Through After-school Programs
Brief Summary: This study will assess the impact of a national, community-based after-school program promoting physical activity (America SCORES) on obesity, fitness and important cardiovascular risk factors among minority children. The investigators central hypothesis is that established community-based programs, such as America SCORES, can reduce obesity and cardiovascular risk among participants. The 1-year study followed 158 children from 6 public schools, 3 of which were randomized to have SCORES and 3 to "usual care" after-school program. Primary outcomes are change in body mass index (BMI), physical activity (measured by accelerometer), and fitness (aerobic capacity assessed with the 20-meter shuttle test). Cardiovascular outcomes include blood pressure, body composition (assessed using bioelectrical impedance) and waist circumference. The investigators will also measure academic outcomes.


Options:
A: change in physical activity (4 months)
B: Physical Activity (Accelerometer) (0, 6, 12, 18, 24 months)
C: Self-Reported physical activity (Baseline, 3 months, and 6 months)
D: Change in BMI z-score (Baseline (0 months) and 9 months)

Answer: D