TrialPanorama/Dataset huggingface dataset:
Please select the outcome measures that correspond to the clinical trial below.
Title: Biventricular Versus Right Ventricular Pacing in Heart Failure Patients With Atrioventricular Block (BLOCK HF)
Brief Summary: Heart failure is a progressive disease that decreases the pumping action of the heart. This may cause a backup of fluid in the heart and may result in heart beat changes. When there are changes in the heartbeat, sometimes a pacemaker is used to control the rate and rhythm of the heartbeat. In this trial, the researchers will test if pacing both the left and right lower half of the heart (ventricles) will:

* decrease the number of hospital and clinic visits due to heart failure symptoms
* extend life
* delay heart failure symptoms as compared to those who are paced in only one ventricle (the right ventricle)


Options:
A: Time to first ICD shock following LVAD implant (Within 12 months following LVAD implant)
B: All cause mortality (5 years)
C: Mortality, Heart Failure-related Urgent Care Visits, or Significant Increase in Left Ventricular End Systolic Volume Index (LVESVI) (Participants were followed for the duration of the study, an average of 39.8 months post-randomization.)
D: Percentage of Patients Worsened for Clinical Composite Response (12 Months)

Answer: C
Please select the outcome measures that correspond to the clinical trial below.
Title: N/A
Brief Summary: Anorexia and cachexia are devastating complications in late-stage cancer patients and is strongly associated with mortality in these patients. Activation of Ghrelin receptors have been demonstrated to stimulate appetite. RC-1291 HCl, by virtue of its ghrelin like activity and Growth Hormone releasing effects may have a dual role in the reversal of cancer induced anorexia and cachexia. This placebo controlled study will evaluate the safety and efficacy of RC-1291 HCl in cancer patients with anorexia and cachexia.


Options:
A: Change in Lean Body Mass (Change in Lean Body Mass from Baseline Over 12 Weeks); Change in Handgrip Strength (Change in Handgrip Strength of the Non-Dominant Hand from Baseline Over 12 Weeks)
B: Body Weight; Lean Body Mass; Functional Performance
C: Change in Lean Body Mass (Change in Lean Body Mass from Baseline Over 12 Weeks); Change in Handgrip Strength (Change in Handgrip Strength of the Non-Dominant Hand from Baseline Over 12 Weeks)
D: Body weight; Lean body mass; Functional performance

Answer: D
Please select the outcome measures that correspond to the clinical trial below.
Title: The Effect of Pentoxifylline on Nonalcoholic Steatohepatitis (NASH)
Brief Summary: The purpose of this study is to explore the potential benefit of the medication, pentoxifylline, for the treatment of NASH.


Options:
A: The Number of Participants With a 30% Reduction in Alanine Aminotransferase (ALT) Treated With Pentoxifylline (PTX) or Placebo for 12 Months. (baseline and 12 months)
B: Liver Histological improvement (48 weeks)
C: 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)
D: Percentage of Responders With Disappearance of Steatohepatitis Without Worsening of Fibrosis (ie, Participants no Longer Meeting the Criteria for Steatohepatitis) (Baseline (Visit 2; Week 0) to Visit 8 (Week 52))

Answer: A
Please select the outcome measures that correspond to the clinical trial below.
Title: Effects of Exercise on Multiple Risk Factors and Health Costs in Community Living Elderly Women. The Senior Fitness and Prevention Study (SEFIP)
Brief Summary: The purpose of this study is to determine whether exercise training may impact relevant risk factors and health costs of community living women older 65 years.


Options:
A: Change in gait variability (6 months)
B: Incidence of serious fall-related injuries and of all injurious falls including those leading to more moderate injuries (2 years)
C: Fall incidence, which is measured by monthly fall registration cards
D: health costs after 18 months (baseline 18 month control); falls after 18 months (daily records, analysis after 18 months); Bone parameters after 6, 12 and 18 months (baseline, 6, 12, 18 month-control)

Answer: D
Please select the outcome measures that correspond to the clinical trial below.
Title: Effects of Exercise on Multiple Risk Factors and Health Costs in Community Living Elderly Women. The Senior Fitness and Prevention Study (SEFIP)
Brief Summary: The purpose of this study is to determine whether exercise training may impact relevant risk factors and health costs of community living women older 65 years.


Options:
A: Number of falls and injurious falls in 12 months
B: Balance (Baseline=june; Endline=september); Muscle strength (Baseline=june; Endline=september); Motivation (Baseline=june; Endline=september)
C: Improvement in formal balance score (4 weeks and 12 weeks following the exercise intervention)
D: health costs after 18 months (baseline 18 month control); falls after 18 months (daily records, analysis after 18 months); Bone parameters after 6, 12 and 18 months (baseline, 6, 12, 18 month-control)

Answer: D
Please select the outcome measures that correspond to the clinical trial below.
Title: A Phase 2, Multicenter, Randomized, Double-blind, Placebo-controlled Trial of CNTO 1275, a Fully Human Anti-IL-12 Monoclonal Antibody, Administered Subcutaneously, in Subjects With Active Psoriatic Arthritis
Brief Summary: The purpose of this study is to evaluate the effectiveness and safety of CNTO 1275 (ustekinumab) in patients with psoriatic arthritis.


Options:
A: Percentage of Participants Achieving 90% Improvement in Psoriasis Area and Severity Index (PASI) Score (PASI90) at Week 16 (Part A) (Week 16); Percentage of Participants Achieving Static Physician Global Assessment (sPGA) Score of Clear or Almost Clear at Week 16 (Part A) (Week 16); Percentage of Participants Who Were Re-Randomized to Receive Either Adalimumab or Risankizumab in Part B Achieving PASI90 at Week 44 (Part B) (Week 44)
B: Number of Participants With an American College of Rheumatology (ACR) 20 Response at Week 12 (Week 0 to Week 12)
C: Achievement of ≥90% Reduction From Baseline PASI Score (PASI90) at Week 12 (Baseline and Week 12)
D: Change in Vascular Inflammation (Baseline - Week 12); Change in Cardiometabolic Biomarkers: Total Cholesterol (Baseline - Week 12); Change in Cardiometabolic Biomarkers: Cholesterol Efflux (Baseline - Week 12); Change in Cardiometabolic Biomarkers: Low Density Lipoprotein Particle Total (Baseline - Week 12); Change in Cardiometabolic Biomarkers: High Density Lipoprotein Particle Total (Baseline - Week 12); Change in Cardiometabolic Biomarkers: Log Insulin (Baseline - Week 12); Change in Cardiometabolic Biomarkers: Log Adiponectin (Baseline - Week 12); Change in Cardiometabolic Biomarkers: Log Leptin (Baseline - Week 12); Change in Cardiometabolic Biomarkers: Log C-reactive Protein (Baseline - Week 12); Change in Cardiometabolic Biomarkers: Log Tumor Necrosis Factor-alpha (Baseline - Week 12); Change in Cardiometabolic Biomarkers: Log Interleukin 6 (Baseline - Week 12); Change in Cardiometabolic Biomarkers: GlycA (Baseline - Week 12)

Answer: B
Please select the outcome measures that correspond to the clinical trial below.
Title: A Phase 2, Multicenter, Randomized, Double-blind, Placebo-controlled Trial of CNTO 1275, a Fully Human Anti-IL-12 Monoclonal Antibody, Administered Subcutaneously, in Subjects With Active Psoriatic Arthritis
Brief Summary: The purpose of this study is to evaluate the effectiveness and safety of CNTO 1275 (ustekinumab) in patients with psoriatic arthritis.


Options:
A: Pharmacokinetics (PK): Maximum Serum Concentration (Cmax) by Drug Delivery Device (Day 2, Day 4, Day 7, Day 10 and Day 14 (prior to Ixekizumab administration)); PK: Area Under the Concentration Time Curve From Time Zero to Last Measured Concentration Value (AUC 0-[Tlast]) by Drug Delivery Device (Day 2, Day 4, Day 7, Day 10 and Day 14 (prior to Ixekizumab administration))
B: Percent improvement from baseline in Psoriasis Area and Severity Index (PASI) at Week 12 (12 weeks)
C: Number of Participants With an American College of Rheumatology (ACR) 20 Response at Week 12 (Week 0 to Week 12)
D: The changes in the target (atherosclerotic plaque) to background (blood) ratio (TBR) from the carotid artery and ascending aorta in patients randomized to adalimumab as compared to patients randomized to standard non-systemic therapy. (Day -10 to -1, Day 105)

Answer: C
Please select the outcome measures that correspond to the clinical trial below.
Title: A Phase 2, Multicenter, Randomized, Double-blind, Placebo-controlled Trial of CNTO 1275, a Fully Human Anti-IL-12 Monoclonal Antibody, Administered Subcutaneously, in Subjects With Active Psoriatic Arthritis
Brief Summary: The purpose of this study is to evaluate the effectiveness and safety of CNTO 1275 (ustekinumab) in patients with psoriatic arthritis.


Options:
A: Number of Participants With an American College of Rheumatology (ACR) 20 Response at Week 12 (Week 0 to Week 12)
B: Number of Participants With Psoriasis Area and Severity Index (PASI) Score of 75 Percent or Above at Week 12 (Week 0 to Week 12)
C: Proportion of subjects who achieve a PASI 75 response relative to baseline at Week 24 (Week 24); The proportion of subjects who achieve a PGA score of 0 or 1 at Week 24 (Week 24); Proportion of subjects who achieve a PASI 75 response relative to baseline at Week 52 (Week 52); The proportion of subjects who achieve a PGA score of 0 or 1 at Week 52 (Week 52)
D: Percentage of Participants With Corticosteriod-free Clinical Remission (Week 26)

Answer: A
Please select the outcome measures that correspond to the clinical trial below.
Title: A Phase 2, Multicenter, Randomized, Double-blind, Placebo-controlled Trial of CNTO 1275, a Fully Human Anti-IL-12 Monoclonal Antibody, Administered Subcutaneously, in Subjects With Active Psoriatic Arthritis
Brief Summary: The purpose of this study is to evaluate the effectiveness and safety of CNTO 1275 (ustekinumab) in patients with psoriatic arthritis.


Options:
A: Percentage of Participants With Active Psoriatic Arthritis (PsA) Achieving an American College of Rheumatology Response 20 (ACR20) at Week 16 (Week 16)
B: The Efficacy of Three Induction Regimens of AIN457 Administered Subcutaneously in Patients With Moderate to Severe Chronic Plaque-type Psoriasis With Respect to PASI 75 Achievement After 12 Weeks of Treatment, Compared to Placebo. (13 weeks)
C: Number of Participants With an American College of Rheumatology (ACR) 20 Response at Week 12 (Week 0 to Week 12)
D: N/A

Answer: C
Please select the outcome measures that correspond to the clinical trial below.
Title: A Phase 2, Multicenter, Randomized, Double-blind, Placebo-controlled Trial of CNTO 1275, a Fully Human Anti-IL-12 Monoclonal Antibody, Administered Subcutaneously, in Subjects With Active Psoriatic Arthritis
Brief Summary: The purpose of this study is to evaluate the effectiveness and safety of CNTO 1275 (ustekinumab) in patients with psoriatic arthritis.


Options:
A: Achievement of ≥90% Reduction From Baseline PASI Score (PASI90) at Week 12 (Baseline and Week 12)
B: Change in Vascular Inflammation (Baseline - Week 12); Change in Cardiometabolic Biomarkers: Total Cholesterol (Baseline - Week 12); Change in Cardiometabolic Biomarkers: Cholesterol Efflux (Baseline - Week 12); Change in Cardiometabolic Biomarkers: Low Density Lipoprotein Particle Total (Baseline - Week 12); Change in Cardiometabolic Biomarkers: High Density Lipoprotein Particle Total (Baseline - Week 12); Change in Cardiometabolic Biomarkers: Log Insulin (Baseline - Week 12); Change in Cardiometabolic Biomarkers: Log Adiponectin (Baseline - Week 12); Change in Cardiometabolic Biomarkers: Log Leptin (Baseline - Week 12); Change in Cardiometabolic Biomarkers: Log C-reactive Protein (Baseline - Week 12); Change in Cardiometabolic Biomarkers: Log Tumor Necrosis Factor-alpha (Baseline - Week 12); Change in Cardiometabolic Biomarkers: Log Interleukin 6 (Baseline - Week 12); Change in Cardiometabolic Biomarkers: GlycA (Baseline - Week 12)
C: Number of Subjects With Physician's Global Assessment of Psoriasis (PGA) of Clear or Almost Clear at Week 16 (Week 16)
D: Number of Participants With an American College of Rheumatology (ACR) 20 Response at Week 12 (Week 0 to Week 12)

Answer: D
Please select the outcome measures that correspond to the clinical trial below.
Title: A Phase 2, Multicenter, Randomized, Double-blind, Placebo-controlled Trial of CNTO 1275, a Fully Human Anti-IL-12 Monoclonal Antibody, Administered Subcutaneously, in Subjects With Active Psoriatic Arthritis
Brief Summary: The purpose of this study is to evaluate the effectiveness and safety of CNTO 1275 (ustekinumab) in patients with psoriatic arthritis.


Options:
A: Participants With Psoriasis Area and Severity Index (PASI) 75 Response After 12 Weeks of Treatment (12 weeks); Participants With IGA Mod 2011 0 or 1 After 12 Weeks of Treatment (12 weeks)
B: Number of Participants With an American College of Rheumatology (ACR) 20 Response at Week 12 (Week 0 to Week 12)
C: The changes in the target (atherosclerotic plaque) to background (blood) ratio (TBR) from the carotid artery and ascending aorta in patients randomized to adalimumab as compared to patients randomized to standard non-systemic therapy. (Day -10 to -1, Day 105)
D: Percentage of Participants With a Psoriasis Area and Severity Index 90 (PASI90) Response at Week 16 (Week 16); Percentage of Participants With an Investigator's Global Assessment (IGA) Response (Clear or Almost Clear With at Least 2-Category Improvement Relative to Baseline) at Week 16 (Week 16)

Answer: B
Please select the outcome measures that correspond to the clinical trial below.
Title: A Phase 3, Multicenter, Randomized, Double-blind, Placebo Controlled Trial Evaluating the Efficacy and Safety of Ustekinumab (CNTO 1275) in the Treatment of Subjects With Moderate to Severe Plaque-type Psoriasis
Brief Summary: The primary purpose of this study is to evaluate the effectiveness and safety of ustekinumab (CNTO 1275) in the treatment of patients with moderate to severe plaque psoriasis.


Options:
A: Psoriasis Area-and-severity Index (PASI) 75% Improvement From Baseline at Week 12. (Week 12)
B: Group 2a and Group 2b: Percentage of Participants Who Achieved an Absolute Psoriasis Area and Severity Index (PASI) Score Less Than (<) 3 at Week 68 (Week 68)
C: Percentage of Participants With a Psoriasis Area and Severity Index 100 (PASI100) Response at Week 16 (Week 16)
D: Percentage of Participants Achieving a 90% or Higher Improvement From Baseline in Psoriasis Area and Severity Index (PASI) Score at Week 12 (Week 12)

Answer: A
Please select the outcome measures that correspond to the clinical trial below.
Title: A Phase 3, Multicenter, Randomized, Double-blind, Placebo Controlled Trial Evaluating the Efficacy and Safety of Ustekinumab (CNTO 1275) in the Treatment of Subjects With Moderate to Severe Plaque-type Psoriasis
Brief Summary: The primary purpose of this study is to evaluate the effectiveness and safety of ustekinumab (CNTO 1275) in the treatment of patients with moderate to severe plaque psoriasis.


Options:
A: Proportion of subjects with clinical response relative to Baseline PASI score (Week 12, Week 40 and Week 60)
B: Number of Participants With an American College of Rheumatology (ACR) 20 Response at Week 12 (Week 0 to Week 12)
C: Number of Participants Attaining a 90 Percent Reduction in PASI From Baseline (PASI 90) - ITT (112 and 140 days)
D: Psoriasis Area-and-severity Index (PASI) 75% Improvement From Baseline at Week 12. (Week 12)

Answer: D
Please select the outcome measures that correspond to the clinical trial below.
Title: A Phase 3, Multicenter, Randomized, Double-blind, Placebo Controlled Trial Evaluating the Efficacy and Safety of Ustekinumab (CNTO 1275) in the Treatment of Subjects With Moderate to Severe Plaque-type Psoriasis
Brief Summary: The primary purpose of this study is to evaluate the effectiveness and safety of ustekinumab (CNTO 1275) in the treatment of patients with moderate to severe plaque psoriasis.


Options:
A: Psoriasis Area-and-severity Index (PASI) 75% Improvement From Baseline at Week 12. (Week 12)
B: Change in PASI score from baseline in the two groups (12 weeks)
C: Percentage of Participants With Active Psoriatic Arthritis (PsA) Achieving an American College of Rheumatology Response 20 (ACR20) at Week 16 (Week 16)
D: N/A

Answer: A
Please select the outcome measures that correspond to the clinical trial below.
Title: A Phase 3, Multicenter, Randomized, Double-blind, Placebo Controlled Trial Evaluating the Efficacy and Safety of Ustekinumab (CNTO 1275) in the Treatment of Subjects With Moderate to Severe Plaque-type Psoriasis
Brief Summary: The primary purpose of this study is to evaluate the effectiveness and safety of ustekinumab (CNTO 1275) in the treatment of patients with moderate to severe plaque psoriasis.


Options:
A: Psoriasis Area-and-severity Index (PASI) 75% Improvement From Baseline at Week 12. (Week 12)
B: Change in Vascular Inflammation (Baseline - Week 12); Change in Cardiometabolic Biomarkers: Total Cholesterol (Baseline - Week 12); Change in Cardiometabolic Biomarkers: Cholesterol Efflux (Baseline - Week 12); Change in Cardiometabolic Biomarkers: Low Density Lipoprotein Particle Total (Baseline - Week 12); Change in Cardiometabolic Biomarkers: High Density Lipoprotein Particle Total (Baseline - Week 12); Change in Cardiometabolic Biomarkers: Log Insulin (Baseline - Week 12); Change in Cardiometabolic Biomarkers: Log Adiponectin (Baseline - Week 12); Change in Cardiometabolic Biomarkers: Log Leptin (Baseline - Week 12); Change in Cardiometabolic Biomarkers: Log C-reactive Protein (Baseline - Week 12); Change in Cardiometabolic Biomarkers: Log Tumor Necrosis Factor-alpha (Baseline - Week 12); Change in Cardiometabolic Biomarkers: Log Interleukin 6 (Baseline - Week 12); Change in Cardiometabolic Biomarkers: GlycA (Baseline - Week 12)
C: Percentage of Participants With Active Psoriatic Arthritis (PsA) Achieving an American College of Rheumatology Response 20 (ACR20) at Week 16 (Week 16)
D: Change from baseline in the target (atherosclerotic plaque) to background (blood) ratio (TBR) from the ascending aorta at Week 16 for patients randomized to adalimumab as compared to patients randomized to placebo (Baseline, Week 16 and Week 52 or 68)

Answer: A
Please select the outcome measures that correspond to the clinical trial below.
Title: A Phase 3, Multicenter, Randomized, Double-blind, Placebo Controlled Trial Evaluating the Efficacy and Safety of Ustekinumab (CNTO 1275) in the Treatment of Subjects With Moderate to Severe Plaque-type Psoriasis
Brief Summary: The primary purpose of this study is to evaluate the effectiveness and safety of ustekinumab (CNTO 1275) in the treatment of patients with moderate to severe plaque psoriasis.


Options:
A: The Efficacy of Three Induction Regimens of AIN457 Administered Subcutaneously in Patients With Moderate to Severe Chronic Plaque-type Psoriasis With Respect to PASI 75 Achievement After 12 Weeks of Treatment, Compared to Placebo. (13 weeks)
B: Number of Participants Achieving a Greater Than or Equal to 75 Percentage Improvement From Baseline in Psoriasis Area and Severity Index (PASI 75) Score at Week 12 (Baseline and Week 12)
C: Percentage of Participants With an sPGA Score of 0 (Clear) or 1 (Almost Clear) at Week 12 (Week 12); Percentage of Participants With an sPGA Score of 0 (Clear) or 1 (Almost Clear) at Week 12 by Anti-adalimumab Antibody Status (Week 12)
D: Psoriasis Area-and-severity Index (PASI) 75% Improvement From Baseline at Week 12. (Week 12)

Answer: D
Please select the outcome measures that correspond to the clinical trial below.
Title: A Multicentre, Randomised, Double-blind, Parallel Group, Placebo-controlled Study to Investigate the Long-term Effects of Salmeterol/Fluticasone Propionate (Seretide tm) 50/500mcg BD, Salmeterol 50mcg BD and Fluticasone Propionate 500mcg BD, All Delivered Via the Diskus tm/Accuhaler tm Inhaler, on Mortality and Morbidity of Subjects With Chronic Obstructive Pulmonary Disease (COPD) Over 3 Years of Treatment
Brief Summary: The purpose of this study is to see if fluticasone 500mcg/salmeterol 50mcg can improve the survival of subjects with COPD and also assess the long term safety profile of this drug.


Options:
A: Pre-bronchodilator Forced Expiratory Volume in First Second (FEV1) (Change from baseline over 52 weeks of treatment); COPD Exacerbation Rate (Moderate or Severe) (52 weeks treatment period)
B: All cause mortality at 3 years
C: The frequency of patients experiencing at least one moderate or severe exacerbation during the treatment period.; Change in FEV1 from baseline during the treatment period.
D: Number of CD8+ Inflammatory Cells in Bronchial Biopsy Tissue. (16 weeks); Change in Number of CD8+ Inflammatory Cells in Bronchial Biopsy Tissue (Baseline to 16 weeks)

Answer: B
Please select the outcome measures that correspond to the clinical trial below.
Title: A Multicentre, Randomised, Double-blind, Parallel Group, Placebo-controlled Study to Investigate the Long-term Effects of Salmeterol/Fluticasone Propionate (Seretide tm) 50/500mcg BD, Salmeterol 50mcg BD and Fluticasone Propionate 500mcg BD, All Delivered Via the Diskus tm/Accuhaler tm Inhaler, on Mortality and Morbidity of Subjects With Chronic Obstructive Pulmonary Disease (COPD) Over 3 Years of Treatment
Brief Summary: The purpose of this study is to see if fluticasone 500mcg/salmeterol 50mcg can improve the survival of subjects with COPD and also assess the long term safety profile of this drug.


Options:
A: All cause mortality at 3 years
B: Safety of Treatment With NVA237 in Patients With Moderate to Severe Chronic Obstructive Pulmonary Disease (COPD) (28 days)
C: Trough Forced Expiratory Volume in One Second (FEV1) Following 26 Weeks of Treatment to Demonstrate the Non-inferiority of QVA149 110/50 μg o.d. to Fluticasone/Salmeterol 500/50 μg b.i.d (26 weeks)
D: Forced Expiratory Volume in One Second (FEV1) Area Under Curve 0-3 Hour (h) (AUC 0-3h) Response at Day 85 (12 Weeks) (1 hour (h) and 10 minutes (min) prior to dose on the first day of randomized treatment (baseline) to -10 min, 5 min, 15 min, 30 min, 1 h, 2 h, and 3 h relative to dose on Day 85); Trough FEV1 Response at Day 85 (12 Weeks) (1 h and 10 min prior to dose on the first day of randomized treatment (baseline) and -1 h and - 10 mins prior to study drug at Day 85.)

Answer: A
Please select the outcome measures that correspond to the clinical trial below.
Title: A Multicentre, Randomised, Double-blind, Parallel Group, Placebo-controlled Study to Investigate the Long-term Effects of Salmeterol/Fluticasone Propionate (Seretide tm) 50/500mcg BD, Salmeterol 50mcg BD and Fluticasone Propionate 500mcg BD, All Delivered Via the Diskus tm/Accuhaler tm Inhaler, on Mortality and Morbidity of Subjects With Chronic Obstructive Pulmonary Disease (COPD) Over 3 Years of Treatment
Brief Summary: The purpose of this study is to see if fluticasone 500mcg/salmeterol 50mcg can improve the survival of subjects with COPD and also assess the long term safety profile of this drug.


Options:
A: All cause mortality at 3 years
B: lung oxygenation (over a period of 6-8 hours, from the time of induction of general anesthesia until time of patients discharge from the PACU.)
C: Identifying new patient subtypes and endpoints for COPD (3 years)
D: Measurements of forced vital capacity (FVC), forced expiratory volume (FEV1), functional residual capacity (FRC),maximal respiratory pressures,maximal oxygen consumption and maximal work load. (Immediatly after the end of IV infusion)

Answer: A