TrialPanorama/Dataset huggingface dataset:
Please select the outcome measures that correspond to the clinical trial below.
Title: Atorvastatin Compared With Simvastatin In The Prevention of CHD Morbidity And Mortality In Patients With CHD
Brief Summary: To investigate whether a long-term strategy to lower LDL cholesterol with atorvastatin as much as possible will improve prognosis in CHD patients compared with a strategy reflecting current best clinical practice with simvastatin.


Options:
A: Change from baseline in circulating markers of inflammation after 4 weeks and after 52 weeks
B: Time to of a major coronary event: 1) non-fatal acute myocardial infarction 2) coronary death 3) resuscitated cardiac arrest
C: plaque volume (one year)
D: Reduction of LDL-C following 12 weeks of treatment

Answer: B
Please select the outcome measures that correspond to the clinical trial below.
Title: A Multi-Centre, Multinational, Long-Term Extension Study, to Assess the Safety and Toleration of Subject Optimised Treatment Regimens of Oral Sildenafil Citrate for Pulmonary Arterial Hypertension in Subjects Who Have Completed Study A1481140.
Brief Summary: Open label extension study to the pivotal efficacy study to assess the safety of sildenafil citrate in patients with pulmonary arterial hypertension


Options:
A: Describe tolerability of transition from sildenafil to tadalafil for treatment of pulmonary arterial hypertension (PAH). (12/2011)
B: Safety; Standard safety data; Efficacy; 6-Minute Walk Test; BORG Dyspnoea Score; WHO Functional Class; Quality of Life SF-36 and EQ-5D
C: Time to First Confirmed Morbidity or Mortality Event up to the End of Treatment (Kaplan-Meier Estimate of Patients Without a Morbidity or Mortality Event) (Up to end of treatment (data presented up to month 36))
D: Change in 6-minute Walk Test (0 - 6 months)

Answer: B
Please select the outcome measures that correspond to the clinical trial below.
Title: A Randomized, Double-Blind, Placebo Controlled, Dose Ranging, Parallel Group Study of Oral Sildenafil in the Treatment of Children, Aged 1-17 Years, With Pulmonary Arterial Hypertension.
Brief Summary: This is a clinical research study designed to evaluate sildenafil for the treatment of Pulmonary Arterial Hypertension in children, aged 1 to 17 years. The purpose of the study is to assess the efficacy, safety, and pharmacokinetics of 16 weeks of chronic treatment with oral sildenafil given in three different doses, compared to placebo (inactive treatment). Efficacy will be measured by exercise and hemodynamics. Patients who complete this trial may be eligible to take part in an extension study, in which all patients will receive active treatment of sildenafil.


Options:
A: Mean Pulmonary Artery Pressure Measured by Right Heart Catheterization (baseline and 12 weeks)
B: Pulmonary Artery Systolic Pressure (PASP)
C: Percent Change From Baseline in Peak Volume of Oxygen (VO2) Consumed : Intent To Treat Population (Baseline, Week 16); Percent Change From Baseline in Peak Volume of Oxygen (VO2) Consumed : Per Protocol Population (Baseline, Week 16)
D: Peak 6-minute Walk Distance (12 weeks)

Answer: C
Please select the outcome measures that correspond to the clinical trial below.
Title: Prone-Supine Study II: The Effect of Prone Positioning for Patients Affected by Acute Respiratory Distress Syndrome
Brief Summary: The purpose of this study is to determine whether prone positioning is effective in improving survival in patients affected by acute respiratory distress syndrome (ARDS).


Options:
A: Survival to days 28 and 60 post-randomization, and to Hospital Discharge (28 days to more than 60 days post-randomization)
B: Physiological variables (i.e. ventilation pressures and oxygenation) during the first 7-10 days following randomization (8-10 days post-randomization); Survival to days 28 and 60 post-randomization and to Hospital Discharge (28 days to more than 60 days post-randomization)
C: 28-day mortality from all causes (28 days)
D: Mortality (at 28 days)

Answer: D
Please select the outcome measures that correspond to the clinical trial below.
Title: Prone-Supine Study II: The Effect of Prone Positioning for Patients Affected by Acute Respiratory Distress Syndrome
Brief Summary: The purpose of this study is to determine whether prone positioning is effective in improving survival in patients affected by acute respiratory distress syndrome (ARDS).


Options:
A: Development of ARDS (28 days)
B: Reduction of the mortality rate of ARDS patients at d90 (36 months)
C: 28-day mortality from all causes (28 days)
D: Mortality (at 28 days)

Answer: D
Please select the outcome measures that correspond to the clinical trial below.
Title: Effectiveness and Cost-effectiveness of the Diabetes Integrated Care Breakthrough Collaborative to Improve Diabetes Care, Its Health Outcomes and Economic Costs
Brief Summary: The study tests whether implementing professional evidence-based guidelines and best practices for diabetes care -through participation of multidisciplinary teams in a Breakthrough collaborative- results in an improvement of diabetes care, its health outcomes and economic costs. Determinants of success are studied. Data on diabetes will also be used to better understand Breakthrough as an implementation or improvement method.


Options:
A: Processes of clinical care for diabetes; Cardiovascular risk as determined by UKPDS Risk; Metabolic outcomes (HgbA1c); Metabolic outcomes (LDL Cholesterol); Metabolic Outcomes (Systolic Blood Pressure)
B: At set time points the following will be measured: Recovery from depression Patient quality of life 1 year before and after: Clinic depression treatment utilization and costs
C: Brief Pain Inventory (Pain) (1 year)
D: HbA1c (baseline, after 12 months and after 24 months)

Answer: D
Please select the outcome measures that correspond to the clinical trial below.
Title: N/A
Brief Summary: Aim-to conduct a randomized clinical intervention study to compare three diets (low-fat, low-carbohydrate and Mediterranean diet) for weight loss


Options:
A: weight loss
B: Hemoglobin A1c (22 weeks)
C: Dietary intake (6 month)
D: Composite of the First Occurrence of Cardiovascular (CV) Death, Nonfatal Myocardial Infarction (MI) or Nonfatal Stroke (from randomization until study cut-off date (median duration of follow-up: 6.2 years)); Composite of the First Occurrence of Cardiovascular (CV) Death, Nonfatal Myocardial Infarction (MI), Nonfatal Stroke, Revascularization Procedure or Hospitalization for Heart Failure (HF) (from randomization until study cut-off date (median duration of follow-up: 6.2 years))

Answer: A
Please select the outcome measures that correspond to the clinical trial below.
Title: N/A
Brief Summary: Aim-to conduct a randomized clinical intervention study to compare three diets (low-fat, low-carbohydrate and Mediterranean diet) for weight loss


Options:
A: Body mass index (BMI); Glycated Haemoglobin (HbA1c); Triglycerides; Dietary intake as measured by 3-day weighed diet records; All measures to be compared at end of study (6 months)
B: Combined apparition of hard cardiovascular events (myocardial infarction, revascularization, ischemic stroke, documented peripheral artery disease or cardiovascular death) after a median follow-up of 7 years. (Seven Years)
C: weight loss
D: Number of participants with allergic disease (Up to 13 years); Weight gain (Up to 13 years); Number of patients with chronic inflammatory disease (Up to 13 years)

Answer: C
Please select the outcome measures that correspond to the clinical trial below.
Title: N/A
Brief Summary: Aim-to conduct a randomized clinical intervention study to compare three diets (low-fat, low-carbohydrate and Mediterranean diet) for weight loss


Options:
A: Number of participants with allergic disease (Up to 13 years); Weight gain (Up to 13 years); Number of patients with chronic inflammatory disease (Up to 13 years)
B: Breast Cancer Recurrence (Lifetime)
C: weight loss
D: Hemoglobin A1c (22 weeks)

Answer: C
Please select the outcome measures that correspond to the clinical trial below.
Title: N/A
Brief Summary: Aim-to conduct a randomized clinical intervention study to compare three diets (low-fat, low-carbohydrate and Mediterranean diet) for weight loss


Options:
A: Weigtreduction; Increase in maximum oxygen uptake; Change in foodintake; Change in self-reported activity
B: Cesarean Section (At delivery); Preeclampsia/Pregnancy Induced Hypertension (Delivery); Gestational Diabetes Mellitus (Delivery); Large for Gestational Age (Delivery); Neonatal Intensive Care Unit (Within 1 month postpartum); Gestational Weight Gain (Gestational week 35)
C: weight loss
D: The primary outcome being measured is the level of activity monitored by the activity monitor. Control and Intervention subjects will be encouraged to wear the activity monitor on a daily basis for the 12 week course of the study. (12 weeks)

Answer: C
Please select the outcome measures that correspond to the clinical trial below.
Title: N/A
Brief Summary: Aim-to conduct a randomized clinical intervention study to compare three diets (low-fat, low-carbohydrate and Mediterranean diet) for weight loss


Options:
A: weight loss
B: Changes in body weight; Weight loss maintenance efficacy (>5% and >10%); Body composition (whole body DEXA-scanning); Drop-out rate; Glucose metabolism (Oral Glucose Tolerance Test); Endothelium function (flow-mediated vasodilatation, FMD)
C: N/A
D: body weight (prior to and after 4, 8, and 12 months of dieting)

Answer: A
Please select the outcome measures that correspond to the clinical trial below.
Title: N/A
Brief Summary: Aim-to conduct a randomized clinical intervention study to compare three diets (low-fat, low-carbohydrate and Mediterranean diet) for weight loss


Options:
A: Breast Cancer Recurrence (Lifetime)
B: Hemoglobin A1c (22 weeks)
C: weight loss
D: Body weight reduction (Month 6)

Answer: C
Please select the outcome measures that correspond to the clinical trial below.
Title: N/A
Brief Summary: Aim-to conduct a randomized clinical intervention study to compare three diets (low-fat, low-carbohydrate and Mediterranean diet) for weight loss


Options:
A: weight loss
B: area under the curve for glucose (AUC Glucose0-120) at the oral glucose tolerance test at baseline, 3 months and 6 months; area under the curve for insulin (AUC Insulin0-120) at the oral glucose tolerance test at baseline, 3 months and 6 months; HbA1C at baseline, 3 months and 6 months; weight at baseline, 3 months and 6 months; waist circumference at baseline, 3 months and 6 months
C: change in adiposity as measured by dual energy x-ray absorptiometry (DEXA).
D: Changes in adipose tissue (Baseline and 3 months and 6 months)

Answer: A
Please select the outcome measures that correspond to the clinical trial below.
Title: N/A
Brief Summary: Aim-to conduct a randomized clinical intervention study to compare three diets (low-fat, low-carbohydrate and Mediterranean diet) for weight loss


Options:
A: weight loss
B: Measured glomerular filtration rate (renal function) using the iohexol clearance method in patients with stages 3-4 chronic kidney disease (0, 6, 12 months)
C: Change in Proteinuria (12 weeks minus baseline); Change in Proteinuria (52 weeks minus baseline)
D: Time-to-first event of the composite endpoint (Approximately 24 months)

Answer: A
Please select the outcome measures that correspond to the clinical trial below.
Title: A Phase III, 12-Month, Randomized, Double-Blind Study to Evaluate the Efficacy and Safety of Two Doses of J867 Versus Placebo in Subjects With Uterine Leiomyomata.
Brief Summary: The objective of this study is to determine the safety and effectiveness of asoprisnil in symptomatic women with abnormal uterine bleeding associated with uterine fibroids.


Options:
A: Percentage of Subjects With Reduction of Uterine Bleeding at Week 13 Visit Defined as Pictorial Blood-loss Assessment Chart (PBAC) Score < 75 at End-of-treatment Visit (Week 13 Visit) (3 months); Co-primary Safety Endpoint: Serum Estradiol Levels at End of Treatment Visit (Week 13 Visit) for PGL4001 Compared With GnRHagonist (Week 13 visit); Co-primary Safety Endpoint: % of Subjects Reporting Moderate or Severe Hot Flushes as Adverse Events Throughout the Treatment Period for PGL4001 Compared With GnRH-agonist (Up to week 17)
B: percentage of subjects in amennorrhoea at the end of each PGL4001 treatment course received (From baseline to end of each PGL4001 treatment (3months treatment))
C: The percent of subjects who demonstrate a clinically meaningful improvement in bleeding and do not have surgical/invasive intervention. (Month 12 or Final Visit)
D: The percent of subjects who demonstrate a clinically meaningful improvement in bleeding and who do not require surgical/invasive intervention. (Month 12 or Final Visit)

Answer: D
Please select the outcome measures that correspond to the clinical trial below.
Title: Orlistat (Xenical) in the Treatment of Overweight Patients With Nonalcoholic Steatohepatitis (NASH)
Brief Summary: The purpose of this study is to determine if orlistat (Xenical) therapy in overweight patients with NASH leads to enhanced weight loss over time, with subsequent improvement in the underlying necroinflammatory and fibrotic changes that are typical of NASH.


Options:
A: Liver Histological improvement (48 weeks)
B: The primary endpoint is weight loss leading to improvement in the global necroinflammatory and fibrosis scores on liver biopsies. A change of one point in the necroinflammatory grade or fibrosis stage will be considered statistically significant.
C: Major Cardiovascular Events (5 years)
D: Number of Participants With Improvement in Non-alcoholic Fatty Liver Disease (NAFLD) Activity Defined by Change in Standardized Scoring of Liver Biopsies at Baseline and After 96 Weeks of Treatment. (baseline and 96 weeks)

Answer: B
Please select the outcome measures that correspond to the clinical trial below.
Title: A Phase 2, Randomized, Double-Blind, Parallel Group Study to Evaluate the Safety and Efficacy of Asoprisnil (J867) in Patients With Uterine Leiomyomata.
Brief Summary: This study was designed to determine the safety and effectiveness of 3 asoprisnil doses compared to placebo, taken for 12 weeks by women with uterine fibroids.


Options:
A: Percent change from baseline in uterine volume and volume of the largest fibroid. (Treatment weeks 4, 8, 12 and Post-treatment months 3 and 6.); Duration of amenorrhea (Day 1 to 1st post treatment menses)
B: Mean Change From Baseline to the Last 28 Days of Treatment in Menstrual Blood Loss (MBL) (Baseline (last menstrual cycle during the screening period) and the last 28 days of treatment (approximately days 61 to 90))
C: Shrinkage of Fibroids - Size of Fibroids (3 months (baseline to end of treatment))
D: Percentage of Participants With a Menstrual Blood Loss (MBL) Volume of < 80 mL at the Final Month and a ≥ 50% Reduction in MBL Volume From Baseline to the Final Month (Baseline, Final Month (last 28 days of treatment))

Answer: A
Please select the outcome measures that correspond to the clinical trial below.
Title: A Phase 2, Randomized, Double-Blind, Parallel Group Study to Evaluate the Safety and Efficacy of Asoprisnil (J867) in Patients With Uterine Leiomyomata.
Brief Summary: This study was designed to determine the safety and effectiveness of 3 asoprisnil doses compared to placebo, taken for 12 weeks by women with uterine fibroids.


Options:
A: Volume of the uterine leiomyomata with 2,5mg vs 5 mg daily of mifepristone after 3 months of treatment (3 months)
B: Efficacy endpoints (From baseline to end of PGL4001 treatment (3months treatment) and to approximately 2 weeks after double blind treatment with progestin/placebo.); Number and proportion of subjects experiencing open label treatment-emergent adverse events (From baseline to end of PGL4001 treatment (3months treatment))
C: Uterine Volume (6 months)
D: Percent change from baseline in uterine volume and volume of the largest fibroid. (Treatment weeks 4, 8, 12 and Post-treatment months 3 and 6.); Duration of amenorrhea (Day 1 to 1st post treatment menses)

Answer: D
Please select the outcome measures that correspond to the clinical trial below.
Title: A Phase III Multi-national, Multi-centre, Open Label, Safety Study to Assess the Safety of Chronic Therapy With the Humanised Anti-TNF PEG Conjugate CDP870 400 mg sc, (Dosed 4-weekly), in the Treatment of Patients With Active Crohn's Disease Who Have Previously Completed Studies CDP870-031 or CDP870-032
Brief Summary: An open-label follow-on safety study of CDP870 (400 mg every 4 weeks) in patients with Crohn's Disease who have completed a 26-week blinded study (CDP870-031 \[NCT00152490\] or CDP870-032 \[NCT00152425\]).


Options:
A: In the population with CRP ≥ 10 mg/L at baseline; Clinical response at week 6; Clinical response at week 6 and week 26
B: Percentage of Subjects in Clinical Remission at Week 6 (Week 6)
C: Mean Change From Baseline in CDEIS (Crohn's Disease Endoscopic Index of Severity) Score at Week 10 Using Local Non-blinded Assessments (Baseline, Week 10); Mean Change From Baseline in CDEIS (Crohn's Disease Endoscopic Index of Severity) Score at Week 10 Using Central Blinded Assessments (Baseline, Week 10)
D: Percentage of Subjects With at Least One Adverse Event (AE) During the Duration of the Study CDP870-033 (up to 84 Months) (Up to 84 months from Study Entry (Week 0) to the Study End (Week 364) and the Safety Follow-up (Week 374)); Percentage of Subjects With at Least One Serious Adverse Event (SAE) During the Duration of This Study CDP870-033 (up to 84 Months) (Up to 84 months from Study Entry (Week 0) to the Study End (Week 364) and the Safety Follow-up (Week 374))

Answer: D
Please select the outcome measures that correspond to the clinical trial below.
Title: A Phase III Multi-center, Double-blind, Placebo-controlled, Parallel Group 24-Week Study to Assess the Efficacy and Safety of Two Dose Regimens of Liquid Certolizumab Pegol as Additional Medication to Methotrexate in the Treatment of Signs and Symptoms of Rheumatoid Arthritis and in Prevention of Joint Damage in Patients With Active Rheumatoid Arthritis Who Have an Incomplete Response to Methotrexate.
Brief Summary: A 24 week study in which patients are given study medication and assessed for signs and symptoms of rheumatoid arthritis. X-rays are performed to assess the progress of joint damage during the study.


Options:
A: American college of Rheumatolofy (ACR)-20 responder rate at Week 24
B: Percentage of Subjects With at Least One Adverse Event (AE) From First Certolizumab Pegol (CZP) Dose up to Approximately 7 Years (From first dose of CZP to the end of the open-label study (approximately 7 years)); Percentage of Subjects With at Least One Serious Adverse Event (SAE) From First Certolizumab Pegol (CZP) Dose up to Approximately 7 Years (From first dose of CZP to the end of the open-label study (approximately 7 years)); Percentage of Subjects Who Withdrew Due to an Adverse Event (AE) During the Study (From Entry Visit (Week 0) to the end of the study (approximately 6.5 years))
C: Compare efficacy of two dose regimens of certolizumab pegol in combination with MTX to MTX alone in patients with RA measured by the ACR20 at week 24.
D: Change From Baseline in Modified Total Sharp Score (mTSS) at Week 52 (Baseline and Week 52)

Answer: C
Please select the outcome measures that correspond to the clinical trial below.
Title: A Phase III Multi-center, Open-label, Follow-up Study, to Assess the Safety and Efficacy of Liquid Certolizumab Pegol as Additional Medication to Methotrexate, in the Treatment of Signs and Symptoms and in the Prevention of Joint Damage in Patients With Active Rheumatoid Arthritis Who Participated in Study CDP870-050
Brief Summary: An open ended study in which patients who completed the preceding double-blind study NCT00160602 are given Certolizumab Pegol and assessed for signs and symptoms of Rheumatoid Arthritis.


Options:
A: Change in Synovitis Measured by Outcome Measures in Rheumatoid Arthritis Clinical Trials (OMERACT) Rheumatoid Arthritis Magnetic Resonance Image Scoring System (RAMRIS) Score at Week 16 Compared to Baseline for Certolizumab Pegol Arm (From Baseline to Week 16); Change in Synovitis Measured by Outcome Measures in Rheumatoid Arthritis Clinical Trials (OMERACT) Rheumatoid Arthritis Magnetic Resonance Image Scoring System (RAMRIS) Score at Week 8 Compared to Baseline for Certolizumab Pegol Arm (From Baseline to Week 8); Change in Synovitis Measured by Outcome Measures in Rheumatoid Arthritis Clinical Trials (OMERACT) Rheumatoid Arthritis Magnetic Resonance Image Scoring System (RAMRIS) Score at Week 4 Compared to Baseline for Certolizumab Pegol Arm (From Baseline to Week 4); Change in Synovitis Measured by Outcome Measures in Rheumatoid Arthritis Clinical Trials (OMERACT) Rheumatoid Arthritis Magnetic Resonance Image Scoring System (RAMRIS) Score at Week 2 Compared to Baseline for Certolizumab Pegol Arm (From Baseline to Week 2); Change in Synovitis Measured by Outcome Measures in Rheumatoid Arthritis Clinical Trials (OMERACT) Rheumatoid Arthritis Magnetic Resonance Image Scoring System (RAMRIS) Score at Week 1 Compared to Baseline for Certolizumab Pegol Arm (From Baseline to Week 1)
B: American College of Rheumatology 20% (ACR20) Response at Week 12 (Baseline, Week 12)
C: Compare efficacy of two dose regimens of certolizumab pegol in combination with MTX to MTX alone in patients with RA measured by the ACR20 at week 24.
D: Percentage of Subjects With at Least One Adverse Event (AE) From First Certolizumab Pegol (CZP) Dose up to Approximately 6.8 Years (From first dose of CZP to the end of the open-label study (approximately 6.8 years)); Percentage of Subjects With at Least One Serious Adverse Event (SAE) From First Certolizumab Pegol (CZP) Dose up to Approximately 6.8 Years (From first dose of CZP to the end of the open-label study (approximately 6.8 years)); Percentage of Subjects Who Withdrew Due to an Adverse Event (AE) During the Study (From Entry Visit (Week 0) to the end of the study (approximately 6.3 years))

Answer: D
Please select the outcome measures that correspond to the clinical trial below.
Title: ESPRIT: European/Australasian Stroke Prevention in Reversible Ischaemia Trial
Brief Summary: The objective of ESPRIT was to compare the efficacy and safety of mild anticoagulation or a combination treatment of aspirin and dipyridamole with the efficacy and safety of treatment with aspirin alone after cerebral ischemia of arterial origin.


Options:
A: The combined event of death from all vascular causes, nonfatal stroke, nonfatal myocardial infarction or major bleeding complication, whichever happens first during follow-up
B: Adherence to medication; self-reported current use of antiplatelet, statin and combination (≥ 2) blood pressure lowering therapy (End of trial follow-up); Change in blood pressure (End of trial follow-up); Change in LDL cholesterol (End of trial follow-up)
C: Number of Participants With Composite of Stroke/MI/Death (From randomization up to 97 days)
D: Two (2) year incidence of stroke or Hard TIA (2 years); All cause mortality for the first 30 days of follow up/discharge, whichever is longer (30 days); Neurological mortality from 31 days of follow up (F/U) or longer (31 days)

Answer: A