TrialPanorama/Dataset huggingface dataset:
Please select the outcome measures that correspond to the clinical trial below.
Title: A Double-blind Randomized, Placebo-Controlled, Single-Center Study to Assess the Impact of Statins on the Autonomic Nervous System and Cardiac Structure/Function in Non-Ischemic Heart Failure
Brief Summary: The goal of the investigators' study is to further understand the potentially beneficial effects of statin therapy in patients with heart failure. It is hypothesized that statins will 1) increase the heart's pumping ability 2) improve functioning of the sympathetic nervous system and 3) decrease immune activation in heart failure.


Options:
A: Androgen secretion (0, 3, 6 months); Glucose metabolism (0, (3), 6 months)
B: Effects on HDL-C and Triglycerides after 12 weeks; Safety after 12 weeks
C: The primary endpoint in the study is the incidence of treatment-emergent adverse events in subjects treated with REGN727 or placebo, reported from the administration of study drug on day 1 to the completion of the study on day 106. (106 days)
D: LVEF (Left Ventricular Ejection Fraction) (baseline and three months); Muscle Sympathetic Nerve Activity (by Sympathetic Microneurography) (Baseline and three months)

Answer: D
Please select the outcome measures that correspond to the clinical trial below.
Title: An Open Label, Randomized Study to Compare Antiretroviral Therapy (ART) Initiation When CD4 is Between 15% to 24% to ART Initiation When CD4 Falls Below 15% in Children With HIV Infection and Moderate Immune Suppression
Brief Summary: The purpose of this study is to determine when HIV infected children should begin taking anti-HIV medications in order to improve both patient quality of life and survival.


Options:
A: AIDS-free survival (Week 144)
B: Time to Failure of First Line Therapy or Death (From date of randomization up to failure of first-line therapy or death from any cause, whichever came first, assessed up to 4.8 years); Number of Participants Who Experienced Immunological Failure Defined as Failure of CD4% to Reach 20% or CD4% Falls Below 20% on Two Occasions, Within 4 Weeks, at Any Time After the First 24 Weeks of Therapy (Initial Therapy or Restart) (This outcome was assessed from the date of randomization to immunological failure. Immunological failure was assessed in the entire study duration of 4.8 years.); Number of Participants Who Experienced Regimen-limiting ART Drug Toxicity (Regimen limiting drug toxicity was monitored from randomization up to the entire study duration of 4.8 years.); Number of Participants Who Experienced Clinical Failure (Defined as Development of Severe CDC Stage B or Stage C Disease.) on Therapy. (Clinical failure on therapy was assessed at each visit for the entire study duration of 4.8 years.); Number of Participants Who Experienced Virological Failure Defined as Confirmed HIV-1 RNA Value of at Least 10,000 Copies Per/ml Recorded on Two Consecutive Separate Occasions After 24 Weeks of Treatment (Initial Therapy or Restart) (Virological failure was assessed from randomization through the entire study duration of 4.8 years.)
C: Virologic suppression at 6 months after randomization
D: Percent of Participants With Treatment Failure, Defined as a Confirmed Virologic Failure or Permanent Discontinuation of the Randomized NNRTI or PI Component of Study Treatment (Earlier of 24 weeks or date of DSMB decision to unblind Cohort results (Coh I: April 20, 2009; Coh II: October 27, 2010))

Answer: A
Please select the outcome measures that correspond to the clinical trial below.
Title: Prevention of Asthma in Infants/Young Children - PAC
Brief Summary: The purpose of this study is to investigate the ability of budesonide, given during episodes of troublesome lung symptoms to reduce further symptoms in infants and young children at risk of developing asthma


Options:
A: symptom free days; days with no use of bronchodilator; days with no use of bronchodilator and no symptoms; number of treated episodes; number of treatment with add-on medication
B: The proportion of upper respiratory tract infections (URTIs) in each group requiring treatment with systemic corticosteroids as confirmed by review of medical records and pharmacy records of prescriptions dispensed.
C: Pulmonary Function as Measured by Normalized FEV1 Over a 4-6 Year Period (At the end of treatment, 4-6 years from baseline assessment)
D: Rate of Exacerbations Requiring Systemic Corticosteroids (Measured during the 12-month follow-up period)

Answer: A
Please select the outcome measures that correspond to the clinical trial below.
Title: A Prospective Randomized Multicenter Study Comparing the Safety and Efficacy of Renal Artery Stenting With/Without Distal Protection Device (AngioGuard) and With/Without the Use of a Platelet Aggregator Inhibitor (Abciximab-Reopro) (RESIST)
Brief Summary: This study is designed to demonstrate the safety and efficacy of using a protective device/drug to prevent renal injury during renal artery stenting and to assess whether the preventative effects are measurable and if there is a differential treatment effect for either device alone or in combination.


Options:
A: Changes in renal function in diabetic patients treated with aspirin (1 year)
B: Kaplan-Meier Estimate of the Percentage of Participants Who Experienced Cardiovascular (CV) Death, Myocardial Infarction (MI), Stroke, or Urgent Coronary Revascularization (UCR) Within 3 Years From Randomization (up to 3 years)
C: Glomerular Filtration Rate; Adverse Events
D: Occurrence of myocardial infarction,stroke or cardiovascular death.

Answer: C
Please select the outcome measures that correspond to the clinical trial below.
Title: Evaluation of the Effect of Position Change During the Withdrawal Phase of Colonoscopy on Adenoma Detection Rate
Brief Summary: The hypothesis to be tested is that position changes during the withdrawal phase of colonoscopy leads to a higher adenoma (polyp) detection rate because of better distension of the colon. Since adenomas are precancerous lesions the enhanced adenoma detection will increase the success of colorectal cancer screening programmes. This study will provide evidence for the value of position changes and encourage endoscopist to adopt position change as a routine in their practice.

May 2007: protocol amendment to include additional prospective analysis using High Definition TV (HDTV).


Options:
A: Detection Rates for Adenomas and for Total Polyps (Acute - subjects were followed for the duration of the procedures, an average of 40 minutes.)
B: polyp detection rate (1 year)
C: adenoma detection rate for position 1 compared to position 2
D: Correlation of adenoma detection rate with case volume of endoscopists (18 months)

Answer: C
Please select the outcome measures that correspond to the clinical trial below.
Title: A Phase II, Double-blind, Randomized, Placebo-controlled Study to Assess the Efficacy and Safety of Lanthanum Carbonate for the Reduction of Serum Phosphorus in Subjects With Stage 3 and 4 Chronic Kidney Disease Who Have Elevated Serum Phosphorus Levels
Brief Summary: Chronic kidney disease (CKD) can result in a loss of ability to filter and excrete phosphate. The body's attempt to adjust to an increased level of phosphate in the blood can result in elevated levels of hormones and minerals resulting in serious clinical consequences. This study is being conducted to evaluate the safety and efficacy of lanthanum carbonate in lowering high levels of phosphorus in the blood in subjects with CKD Stages 3 and 4 compared to placebo.


Options:
A: Change in Transferrin Saturation (TSAT) From Baseline to End of Treatment (12 Weeks); Change in Serum Phosphorus Levels From Baseline to End of Treatment (12 Weeks)
B: Serum phosphorus levels at 8 weeks. (8 weeks)
C: Composite end-point of Ca, P, Ca*P within K/DOQI recommendation (12 months)
D: Change in Serum Phosphorus From Baseline to End of Treatment (Baseline and day 28)

Answer: B
Please select the outcome measures that correspond to the clinical trial below.
Title: Maternal Problem-Solving in Childhood Cancer
Brief Summary: The purpose of this study is to help mothers of children with cancer to cope more effectively by increasing their problem-solving skills.


Options:
A: The primary aim of the study is to evaluate the effectiveness of problem-solving training provided to mothers of children with newly diagnosed cancer in decreasing negative affectivity; e.g. depression, anxiety, and increasing satisfaction with resource utilization
B: Perceived Stress Scale (At the end of five days retreat); Self-compassion (At the end of five days retreat)
C: Change in Maslach Burnout Inventory score (6 month); Change in Physician Job Satisfaction Scale score (6 month); change in Empowerment at Work Scale score (6 month); change in Utrecht Work Engagement score (6 months)
D: The Anxiety Disorder Scale (A week); The Grief Inventory (A week); The Coping Mechanisms Scale (A week); The Psychiatric Morbidity Scale (A week); The Physical Symptoms Scale (A week); The Insomnia Scale (A week); The Binge Eating Scale (A week); The Burnout Inventory (A week); Alcohol use (A week); Drug use (A week)

Answer: A
Please select the outcome measures that correspond to the clinical trial below.
Title: Maternal Problem-Solving in Childhood Cancer
Brief Summary: The purpose of this study is to help mothers of children with cancer to cope more effectively by increasing their problem-solving skills.


Options:
A: The primary aim of the study is to evaluate the effectiveness of problem-solving training provided to mothers of children with newly diagnosed cancer in decreasing negative affectivity; e.g. depression, anxiety, and increasing satisfaction with resource utilization
B: Remission From Major Depressive Episode in Intent to Treat Sample (Up to 12 Weeks); Remission From Major Depressive Episode Among Participants Who Completed the Intervention (Measured at Weeks 10 and 12)
C: Functioning Assessment Scale Test (FAST) (up to three years)
D: Change from baseline Perceived Stress Scale (PSS) score at 4, 8 weeks (Baseline and after 4, 8 weeks later)

Answer: A
Please select the outcome measures that correspond to the clinical trial below.
Title: Maternal Problem-Solving in Childhood Cancer
Brief Summary: The purpose of this study is to help mothers of children with cancer to cope more effectively by increasing their problem-solving skills.


Options:
A: Change from baseline in CDRS at 3 months (Month 0, Month 3)
B: Parent Report Measures (5 years)
C: The primary aim of the study is to evaluate the effectiveness of problem-solving training provided to mothers of children with newly diagnosed cancer in decreasing negative affectivity; e.g. depression, anxiety, and increasing satisfaction with resource utilization
D: Parent Report Measures (4 years)

Answer: C
Please select the outcome measures that correspond to the clinical trial below.
Title: Maternal Problem-Solving in Childhood Cancer
Brief Summary: The purpose of this study is to help mothers of children with cancer to cope more effectively by increasing their problem-solving skills.


Options:
A: The primary aim of the study is to evaluate the effectiveness of problem-solving training provided to mothers of children with newly diagnosed cancer in decreasing negative affectivity; e.g. depression, anxiety, and increasing satisfaction with resource utilization
B: glycemic control (1/2006-3/2009); treatment adherence (1/2006-3/2009)
C: Metabolic Control: Hemoglobin A1c (HbA1c) (2 years)
D: ER visits (18 months)

Answer: A
Please select the outcome measures that correspond to the clinical trial below.
Title: Sibutramine Cardiovascular Morbidity/Mortality Outcomes Study in Overweight or Obese Subjects at Risk of a Cardiovascular Event
Brief Summary: The purpose of the study was to determine the long-term effect of sibutramine treatment on cardiovascular outcomes in overweight and obese patients at risk of a cardiovascular event.


Options:
A: Change From Baseline in Apnoea-hypopnoea Index (AHI) (Week 0, Week 32)
B: Change in Weight (kg) (52 weeks post-randomization); Proportion Maintaining >= 5% Loss of Initial Weight (52 weeks post-randomization)
C: First occurrence of any of myocardial infarction, stroke or cardiovascular (CV) death (From randomization up to common study end date (33-50 months))
D: Risk of Experiencing a Primary Outcome Event (POE) (i.e., Nonfatal Myocardial Infarction [MI], Nonfatal Stroke, Resuscitated Cardiac Arrest, Cardiovascular [CV] Death) (From randomization up to 6 years)

Answer: D
Please select the outcome measures that correspond to the clinical trial below.
Title: Sibutramine Cardiovascular Morbidity/Mortality Outcomes Study in Overweight or Obese Subjects at Risk of a Cardiovascular Event
Brief Summary: The purpose of the study was to determine the long-term effect of sibutramine treatment on cardiovascular outcomes in overweight and obese patients at risk of a cardiovascular event.


Options:
A: Compare the percent loss of total body fat to the percent loss of visceral fat with leptin alone, caffeine and ephedrine and the combination of leptin,caffeine and ephedrine. (28 weeks)
B: Body weight (24 weeks)
C: The primary outcome measure that will be used to test the study hypothesis is change in Body Mass Index (BMI). The mean change from baseline in individual BMIs between the two groups will be compared at two time-points; at week 52 and week 100.
D: Risk of Experiencing a Primary Outcome Event (POE) (i.e., Nonfatal Myocardial Infarction [MI], Nonfatal Stroke, Resuscitated Cardiac Arrest, Cardiovascular [CV] Death) (From randomization up to 6 years)

Answer: D
Please select the outcome measures that correspond to the clinical trial below.
Title: A Two-Phase Study for Primary and Secondary Prevention of Diabetic Nephropathy by Combined ACE Inhibition and Calcium Channel Blockade (BENEDICT)
Brief Summary: The BENEDICT study is conducted to examine the effects of an ACE inhibitor, calcium channel blockade, a combination of these, and placebo, in the prevention of micro- and macro-albuminuria in Type 2 diabetic patients.


Options:
A: Phase A: microalbuminuria; Phase B: progression from microalbuminuria to macroalbuminuria. (3 years)
B: ONTARGET. Composite Endpoint of Cardiovascular Death, Non-fatal Myocardial Infarction, Non-fatal Stroke and Hospitalization for Congestive Heart Failure (56 months); ONTARGET. 3-fold Composite Endpoint of Doubling of Serum Creatinine, Progression to End Stage Renal Disease (ESRD) and All-cause Mortality in Diabetic Nephropathy Patients (56 months); TRANSCEND. Composite Endpoint of Cardiovascular Death, Non-fatal Myocardial Infarction, Non-fatal Stroke and Hospitalization for Congestive Heart Failure (56 months)
C: The rate of decline of glomerular filtration rate (GFR).GFR is measured at baseline,and at 6,12,18,24,30 and 36 months after randomization
D: Time-to-event Analysis of Percentage of Patients With a Composite Cardiovascular (CV) Morbidity or Mortality Event (For each patient, baseline to time of first CV morbidity or mortality event (or last exposure if no event occurred). (Median duration of exposure was 33.4 months. [25th to 75th percentiles: 21 to 41 months.]))

Answer: A
Please select the outcome measures that correspond to the clinical trial below.
Title: A Two-Phase Study for Primary and Secondary Prevention of Diabetic Nephropathy by Combined ACE Inhibition and Calcium Channel Blockade (BENEDICT)
Brief Summary: The BENEDICT study is conducted to examine the effects of an ACE inhibitor, calcium channel blockade, a combination of these, and placebo, in the prevention of micro- and macro-albuminuria in Type 2 diabetic patients.


Options:
A: Phase A: microalbuminuria; Phase B: progression from microalbuminuria to macroalbuminuria. (3 years)
B: Overall Mean Change From Baseline in Mean Sitting Systolic Blood Pressure (msSBP) Over 8, 16 and 24 Weeks (Baseline, 8 weeks, 16 weeks, and 24 weeks); Change From Baseline in Mean Sitting Systolic Blood Pressure (msSBP) at Week 24 (Baseline to 24 weeks)
C: The rate of decline of glomerular filtration rate (GFR).GFR is measured at baseline,and at 6,12,18,24,30 and 36 months after randomization
D: ONTARGET. Composite Endpoint of Cardiovascular Death, Non-fatal Myocardial Infarction, Non-fatal Stroke and Hospitalization for Congestive Heart Failure (56 months); ONTARGET. 3-fold Composite Endpoint of Doubling of Serum Creatinine, Progression to End Stage Renal Disease (ESRD) and All-cause Mortality in Diabetic Nephropathy Patients (56 months); TRANSCEND. Composite Endpoint of Cardiovascular Death, Non-fatal Myocardial Infarction, Non-fatal Stroke and Hospitalization for Congestive Heart Failure (56 months)

Answer: A
Please select the outcome measures that correspond to the clinical trial below.
Title: A Two-Phase Study for Primary and Secondary Prevention of Diabetic Nephropathy by Combined ACE Inhibition and Calcium Channel Blockade (BENEDICT)
Brief Summary: The BENEDICT study is conducted to examine the effects of an ACE inhibitor, calcium channel blockade, a combination of these, and placebo, in the prevention of micro- and macro-albuminuria in Type 2 diabetic patients.


Options:
A: Number of Participants With a 2-step or Greater Increase in Early Treatment Diabetic Retinopathy Study (ETDRS) Severity Scale. (From baseline to end of study, i.e. 5 years, with visits after a half year, one year and thereafter one visit per year.)
B: Phase A: microalbuminuria; Phase B: progression from microalbuminuria to macroalbuminuria. (3 years)
C: Composite of non-fatal stroke, non-fatal myocardial infarction or death from any cardiovascular cause (July 2001 - December 2007); Composite of new or substantially worsening nephropathy or microvascular eye disease. (July 2001 - December 2007)
D: ONTARGET. Composite Endpoint of Cardiovascular Death, Non-fatal Myocardial Infarction, Non-fatal Stroke and Hospitalization for Congestive Heart Failure (56 months); ONTARGET. 3-fold Composite Endpoint of Doubling of Serum Creatinine, Progression to End Stage Renal Disease (ESRD) and All-cause Mortality in Diabetic Nephropathy Patients (56 months); TRANSCEND. Composite Endpoint of Cardiovascular Death, Non-fatal Myocardial Infarction, Non-fatal Stroke and Hospitalization for Congestive Heart Failure (56 months)

Answer: B
Please select the outcome measures that correspond to the clinical trial below.
Title: Treatment and Prevention of Pericarditis With Colchicine. A Multicenter Double Blind Randomized Trial. The CORP 2 Trial: COlchicine for Recurrent Pericarditis.
Brief Summary: The purpose of the study is to determine whether colchicine is safe and effective in treatment and prevention of recurrent pericarditis after failure of conventional treatment.


Options:
A: Post-pericardiotomy syndrome, post-operative effusions, post-operative atrial fibrillation incidence (3 months)
B: Recurrence rate at 18 months
C: Recurrence rate at 18 months (18 m onths)
D: Iranian Behcet's Disease Dynamic Activity Measurement (IBDDAM) (8 months)

Answer: C
Please select the outcome measures that correspond to the clinical trial below.
Title: Adalimumab in Early Axial Spondyloarthritis (Without Radiological Sacroiliitis): Placebo Controlled Phase Over 3 Months Followed by a 9 Months Open Extension Phase
Brief Summary: Reduction of signs and symptoms in patients with moderate to severely early axial spondyloarthritis (without radiological sacroiliitis) who have had an inadequate response to or do not tolerate NSAID therapy.

Study Objectives:Efficacy -To assess whether patients with moderate to severely active early axial spondyloarthritis (without radiological sacroiliitis) will show response when adalimumab is added to the pre-existing or in case of intolerance to NSAID therapy. Response will be measured at week 12 by change of efficacy parameters compared to baseline.Safety - To demonstrate the safety of adalimumab in study patients with moderate to severely active early axial spondyloarthritis (without radiological sacroiliitis) in patients who have had an inadequate response to or do not tolerate NSAID therapy.


Options:
A: The objective of this study is to evaluate the therapeutic response including radiographic changes and safety of etanercept alone, methotrexate (MTX) alone, and the combination of etanercept and MTX in patients with rheumatoid arthritis (RA)
B: ASAS 40 at week 12
C: Percentage of patients with ACR 20 response (Week 24)
D: Percentage of Participants With an American College of Rheumatology 20 (ACR20) Response (Baseline to the end of the retreatment period (up to 7 years, 6 months))

Answer: B
Please select the outcome measures that correspond to the clinical trial below.
Title: Adalimumab in Early Axial Spondyloarthritis (Without Radiological Sacroiliitis): Placebo Controlled Phase Over 3 Months Followed by a 9 Months Open Extension Phase
Brief Summary: Reduction of signs and symptoms in patients with moderate to severely early axial spondyloarthritis (without radiological sacroiliitis) who have had an inadequate response to or do not tolerate NSAID therapy.

Study Objectives:Efficacy -To assess whether patients with moderate to severely active early axial spondyloarthritis (without radiological sacroiliitis) will show response when adalimumab is added to the pre-existing or in case of intolerance to NSAID therapy. Response will be measured at week 12 by change of efficacy parameters compared to baseline.Safety - To demonstrate the safety of adalimumab in study patients with moderate to severely active early axial spondyloarthritis (without radiological sacroiliitis) in patients who have had an inadequate response to or do not tolerate NSAID therapy.


Options:
A: Number of Patients Achieving Assessment in Ankylosing Spondylitis (ASAS 20) (16 weeks)
B: The primary endpoint of this study was the proportion of subjects who achieved an ASAS 20 response at week 24.
C: The primary end point was the proportion of patients with a 20% improvement response according to the ASAS criteria, at week 54.
D: ASAS 40 at week 12

Answer: D
Please select the outcome measures that correspond to the clinical trial below.
Title: Plasma Transfusion in Liver Transplantation : a Randomized, Double Blind, Multicenter Trial of Methylene Blue, Solvent/Detergent and Quarantined Plasma.
Brief Summary: The aim of the study is to compare the clinical efficacy of three types of plasma secured on the viral level either by quarantine or by chemical treatment in patients undergoing liver transplantation.


Options:
A: 24-hour Mortality (First 24 hours after ED admission); 30-day Mortality (First 30 days after ED admission); Coagulation as Indicated by Number of Participants With Reported Venous Thrombolic Events (VTE) (From time of ED admission, for up to 72 hours)
B: Bleeding within 24 hours after cvc application; other complications within the first 24 hours
C: Procedure-related relevant bleeding, occurring within 24 hours after the procedure. (24 hours after the procedure)
D: Volume of transfused plasma during surgery (5 years)

Answer: D