TrialPanorama/Dataset huggingface dataset:
Please select the outcome measures that correspond to the clinical trial below.
Title: A Multicenter, Double-Blind, Randomized Study to Establish the Clinical Benefit and Safety of Vytorin (Ezetimibe/Simvastatin Tablet) vs Simvastatin Monotherapy in High-Risk Subjects Presenting With Acute Coronary Syndrome (IMProved Reduction of Outcomes: Vytorin Efficacy International Trial - IMPROVE IT)
Brief Summary: This is a randomized, active-control, double-blind study of subjects with stabilized high-risk acute coronary syndrome (ACS). The primary objective is to evaluate the clinical benefit of Ezetimibe/Simvastatin Combination 10/40 (single tablet, under the brand VYTORIN in the United States) compared with Simvastatin 40 mg. As per the original protocol, if low-density lipoprotein cholesterol (LDL-C) response was inadequate, the dose of simvastatin in the VYTORIN arm or simvastatin arm, could be increased to 80 mg (Note: per June 2011 protocol amendment, criteria for continued use of 80 mg simvastatin were modified and new increases of simvastatin dose to 80 mg were stopped). Clinical benefit will be defined as the reduction in the risk of the occurrence of the composite endpoint of cardiovascular (CV) death, major coronary events, and stroke.


Options:
A: Compare the effects of simvastatin + ezetimibe with those of simvastatin alone, on thrombogenic mechanisms, in patients with diabetes mellitus type 2. (6 weeks, 14-18 weeks, 22-24 weeks)
B: Urinary Protein/Creatinine Ratio at Week 52 [LOCF] (Assessed at baseline and Week 52 (LOCF))
C: Time from randomization to the occurrence of a primary clinical endpoint; i.e. major coronary event or CABG or other coronary revascularization procedure; or unstable angina or resuscitated cardiac arrest or stroke.
D: Time to First Occurrence of Cardiovascular Death, Major Coronary Event, or Non-fatal Stroke (Kaplan-Meier Estimate of Percentage of Participants Experiencing a Qualifying Event) (Up to approximately 9 years)

Answer: D
Please select the outcome measures that correspond to the clinical trial below.
Title: A Multicenter, Double-Blind, Randomized Study to Establish the Clinical Benefit and Safety of Vytorin (Ezetimibe/Simvastatin Tablet) vs Simvastatin Monotherapy in High-Risk Subjects Presenting With Acute Coronary Syndrome (IMProved Reduction of Outcomes: Vytorin Efficacy International Trial - IMPROVE IT)
Brief Summary: This is a randomized, active-control, double-blind study of subjects with stabilized high-risk acute coronary syndrome (ACS). The primary objective is to evaluate the clinical benefit of Ezetimibe/Simvastatin Combination 10/40 (single tablet, under the brand VYTORIN in the United States) compared with Simvastatin 40 mg. As per the original protocol, if low-density lipoprotein cholesterol (LDL-C) response was inadequate, the dose of simvastatin in the VYTORIN arm or simvastatin arm, could be increased to 80 mg (Note: per June 2011 protocol amendment, criteria for continued use of 80 mg simvastatin were modified and new increases of simvastatin dose to 80 mg were stopped). Clinical benefit will be defined as the reduction in the risk of the occurrence of the composite endpoint of cardiovascular (CV) death, major coronary events, and stroke.


Options:
A: Event Rate Per 100 Participant-years for First Occurrence of Major Cardiovascular (CV) Event (From baseline until the date of first adjudicated and confirmed occurrence of major CV event (maximum duration: up to 3.4 years))
B: Percent Change From Baseline in Calculated LDL-C at Week 24 - Intent-to-Treat (ITT) Analysis (From Baseline to Week 52)
C: Percent Change From Baseline in Calculated LDL-C at Week 24 - Intent-to-Treat (ITT) Analysis (From Baseline to Week 24)
D: Time to First Occurrence of Cardiovascular Death, Major Coronary Event, or Non-fatal Stroke (Kaplan-Meier Estimate of Percentage of Participants Experiencing a Qualifying Event) (Up to approximately 9 years)

Answer: D
Please select the outcome measures that correspond to the clinical trial below.
Title: A Multicenter, Double-Blind, Randomized Study to Establish the Clinical Benefit and Safety of Vytorin (Ezetimibe/Simvastatin Tablet) vs Simvastatin Monotherapy in High-Risk Subjects Presenting With Acute Coronary Syndrome (IMProved Reduction of Outcomes: Vytorin Efficacy International Trial - IMPROVE IT)
Brief Summary: This is a randomized, active-control, double-blind study of subjects with stabilized high-risk acute coronary syndrome (ACS). The primary objective is to evaluate the clinical benefit of Ezetimibe/Simvastatin Combination 10/40 (single tablet, under the brand VYTORIN in the United States) compared with Simvastatin 40 mg. As per the original protocol, if low-density lipoprotein cholesterol (LDL-C) response was inadequate, the dose of simvastatin in the VYTORIN arm or simvastatin arm, could be increased to 80 mg (Note: per June 2011 protocol amendment, criteria for continued use of 80 mg simvastatin were modified and new increases of simvastatin dose to 80 mg were stopped). Clinical benefit will be defined as the reduction in the risk of the occurrence of the composite endpoint of cardiovascular (CV) death, major coronary events, and stroke.


Options:
A: Percent Change From Baseline in Calculated LDL-C at Week 24 - Intent-to-treat (ITT) Analysis (From Baseline to Week 52)
B: Percent Change From Baseline in Low-density Lipoprotein Cholesterol (LDL-C) (baseline to 6 weeks)
C: Time to First Occurrence of Cardiovascular Death, Major Coronary Event, or Non-fatal Stroke (Kaplan-Meier Estimate of Percentage of Participants Experiencing a Qualifying Event) (Up to approximately 9 years)
D: The primary endpoint is the change in carotid intima-media thickness between groups after 14 months (14 months)

Answer: C
Please select the outcome measures that correspond to the clinical trial below.
Title: A Multicenter, Double-Blind, Randomized Study to Establish the Clinical Benefit and Safety of Vytorin (Ezetimibe/Simvastatin Tablet) vs Simvastatin Monotherapy in High-Risk Subjects Presenting With Acute Coronary Syndrome (IMProved Reduction of Outcomes: Vytorin Efficacy International Trial - IMPROVE IT)
Brief Summary: This is a randomized, active-control, double-blind study of subjects with stabilized high-risk acute coronary syndrome (ACS). The primary objective is to evaluate the clinical benefit of Ezetimibe/Simvastatin Combination 10/40 (single tablet, under the brand VYTORIN in the United States) compared with Simvastatin 40 mg. As per the original protocol, if low-density lipoprotein cholesterol (LDL-C) response was inadequate, the dose of simvastatin in the VYTORIN arm or simvastatin arm, could be increased to 80 mg (Note: per June 2011 protocol amendment, criteria for continued use of 80 mg simvastatin were modified and new increases of simvastatin dose to 80 mg were stopped). Clinical benefit will be defined as the reduction in the risk of the occurrence of the composite endpoint of cardiovascular (CV) death, major coronary events, and stroke.


Options:
A: Percentage of Participants Who Experienced Adverse Events (AEs) (Up to 10 weeks after last study drug administration (maximum of 86 weeks))
B: The primary endpoint in the study is to assess the incidence and severity of treatment-emergent adverse events in hyperlipidemic patients treated with REGN727 or placebo receiving stable doses of atorvastatin. (visit 4 (day 1) to visit 16 (day 148))
C: Percent Change From Baseline in Calculated LDL-C at Week 24 - Intent-to-treat (ITT) Analysis (From Baseline to Week 24)
D: Time to First Occurrence of Cardiovascular Death, Major Coronary Event, or Non-fatal Stroke (Kaplan-Meier Estimate of Percentage of Participants Experiencing a Qualifying Event) (Up to approximately 9 years)

Answer: D
Please select the outcome measures that correspond to the clinical trial below.
Title: A Multicenter, Double-Blind, Randomized Study to Establish the Clinical Benefit and Safety of Vytorin (Ezetimibe/Simvastatin Tablet) vs Simvastatin Monotherapy in High-Risk Subjects Presenting With Acute Coronary Syndrome (IMProved Reduction of Outcomes: Vytorin Efficacy International Trial - IMPROVE IT)
Brief Summary: This is a randomized, active-control, double-blind study of subjects with stabilized high-risk acute coronary syndrome (ACS). The primary objective is to evaluate the clinical benefit of Ezetimibe/Simvastatin Combination 10/40 (single tablet, under the brand VYTORIN in the United States) compared with Simvastatin 40 mg. As per the original protocol, if low-density lipoprotein cholesterol (LDL-C) response was inadequate, the dose of simvastatin in the VYTORIN arm or simvastatin arm, could be increased to 80 mg (Note: per June 2011 protocol amendment, criteria for continued use of 80 mg simvastatin were modified and new increases of simvastatin dose to 80 mg were stopped). Clinical benefit will be defined as the reduction in the risk of the occurrence of the composite endpoint of cardiovascular (CV) death, major coronary events, and stroke.


Options:
A: Time to First Occurrence of Cardiovascular Death, Major Coronary Event, or Non-fatal Stroke (Kaplan-Meier Estimate of Percentage of Participants Experiencing a Qualifying Event) (Up to approximately 9 years)
B: Composite End Point of CHD Death, Nonfatal MI, Ischemic Stroke, Hospitalization for Non-ST Segment Elevation Acute Coronary Syndrome (ACS), or Symptom-driven Coronary or Cerebral Revascularization (Time to first event measured from date of randomization through last follow-up visit (common termination) for an average of 36 months follow-up, maximum 66 months.)
C: Coadministered MK0524B will be more efficacious in reducing LDL-C concentrations compared to MK0524A.
D: change in percent atheroma volume at 12 months intravascular ultrasonography (12 months)

Answer: A
Please select the outcome measures that correspond to the clinical trial below.
Title: Randomized Controlled Single Blind Trial of Autologous Bone Marrow Mononuclear Cells Under Electromechanical Guidance for Therapeutic Angiogenesis
Brief Summary: This is a phase 1, single-blind trial to evaluate using autologous bone marrow mononuclear stem cells in ischemic cardiomyopathy patients. The patients must have a Left Ventricular Ejection Fraction (LVEF) of less than or equal to 45%. Once the patient meets all inclusion criteria, and no exclusion criteria are found, the subject is consented for the study, and extensive baseline testing is performed at St Luke's Hospital in Houston. Once all baseline testing criteria is met, the patient has their own bone marrow harvested and later that day the subject is taken to a cardiac catheterization lab where left ventricular electromechanical mapping using NOGA software (NOGA mapping) is performed and the processed stem cells are injected under electromechanical guidance into the affected areas of the left ventricle. The patient is usually discharged home the next day and returns for follow up visits at weeks 1, 2, 4, 6, 8, 12, months 6 and 12 and for phone call follow-up at months 4, 5, 7, 8, 9, 10, 11. Patients undergo extensive testing at most of these follow-up visits, including repeat cardiac catheterization with NOGA mapping at month 6 after stem cell injection.


Options:
A: Change in Maximal Oxygen Consumption (VO2max) (Measured at Baseline and Month 6); Change in Left Ventricular End Systolic Volume (LVESV)as Assessed Via Echo (Measured at Baseline and Month 6); Change in Reversible Defect Size (Measured at Baseline and Month 6)
B: Safety of Autologous-bone-marrow Injections (up to 2 weeks post-procedure, 3 months and 6 months)
C: Efficacy between groups post-index procedure (39 weeks post-index)
D: Improvements in left ventricular function (6 and 12 months)

Answer: B
Please select the outcome measures that correspond to the clinical trial below.
Title: A Randomized Multicenter Trial Comparing Mycophenolate Mofetil and Azathioprine as Remission-maintaining Treatment for Proliferative Lupus Glomerulonephritis. The MAINTAIN Nephritis Trial.
Brief Summary: The purpose of the study is to determine whether mycophenolate mofetil is superior to azathioprine to prevent flares of lupus nephritis.


Options:
A: remission rate (month 6)
B: Efficacy and Safety (6 months)
C: Time to renal flare (5 years)
D: N/A

Answer: C
Please select the outcome measures that correspond to the clinical trial below.
Title: A Multicenter Trial of Academic Hospitalists
Brief Summary: Care of hospitalized patients by "hospitalists" -- often defined as physicians who dedicate at least 25% of their practice to inpatient care -- is a recent, growing, and controversial trend in health care delivery in the United States. But despite the growth of interest in hospitalists, there have been few scientific evaluations of the concept. The comprehensive aim of this research study is to measure and analyze the effects of hospitalists on patient outcomes, costs and medical education on the general medical services of a group of academic centers.


Options:
A: ADEs (Measured 30 and 90 days after hospital discharge); Medication appropriateness (Measured 30 and 90 days after hospital discharge by the Hanlon et al. Medication Appropriateness Index); Complications related to medications, including the number of hospital readmissions, unscheduled visits to emergency departments or urgent care facilities, and physician visits related to a medication problem or ADE (Measured 30 and 90 days after hospital discharge); Cost-effectiveness of the minimal or enhanced treatment compared to usual care (Measured 30 and 90 days after hospital discharge)
B: Health-related quality of life (6 months)
C: the effects of hospitalists on patient outcomes, costs, and medical education on the general medicine services (30 days after discharge)
D: Effects on hospital visits (1 year)

Answer: C
Please select the outcome measures that correspond to the clinical trial below.
Title: Psychological Intervention for Persons at Risk of Psychosis in the Early Initial Prodromal State
Brief Summary: The purpose of this randomized controlled trial is to develop a cognitive behavioral therapy (CBT) for persons with at risk mental states in the early initial prodromal state and to evaluate CBT in comparison to supportive counselling (SC).It is hypothesized that CBT is more effective than SC on transition to subthreshold psychosis, psychosis and schizophrenia as well as on prodromal symptoms and social adjustment.


Options:
A: Change in subthreshold psychotic (positive and negative) symptoms (Change from pretreatment (assessed for the 3 months prior to randomization) to 12 month reassessment)
B: transition to subthreshold psychosis (and psychosis or schizophrenia)
C: Cognitive performance (20 weeks)
D: Change in total PANSS (Positive and Negative Syndrome Scale for Schizophrenia) from baseline to the 8-week endpoint

Answer: B
Please select the outcome measures that correspond to the clinical trial below.
Title: Psychological Intervention for Persons at Risk of Psychosis in the Early Initial Prodromal State
Brief Summary: The purpose of this randomized controlled trial is to develop a cognitive behavioral therapy (CBT) for persons with at risk mental states in the early initial prodromal state and to evaluate CBT in comparison to supportive counselling (SC).It is hypothesized that CBT is more effective than SC on transition to subthreshold psychosis, psychosis and schizophrenia as well as on prodromal symptoms and social adjustment.


Options:
A: Perceived burden of care (Chinese version of the 25-item Family Burden Interview Schedule) (6 months (for Phases 1 and 2) after completion of intervention); Perceived burden of care (Chinese version of the 25-item Family Burden Interview Schedule) (12 months (for Phases 1 and 2) after completion of intervention); Perceived burden of care (Chinese version of the 25-item Family Burden Interview Schedule) (24 months (for Phase 2 only) after completion of intervention); Coping style (42-item Revised Ways of Coping Checklist) (6 months (for Phases 1 and 2) after completion of intervention); Coping style (42-item Revised Ways of Coping Checklist) (12 months (for Phases 1 and 2) after completion of intervention); Coping style (42-item Revised Ways of Coping Checklist) (24 months (for Phase 2 only) after completion of intervention)
B: Scale of Prodromal Symptoms Total Score (Baseline); Change in Scale of Prodromal Symptoms Total Score (Change from Baseline at 8 Weeks)
C: transition to subthreshold psychosis (and psychosis or schizophrenia)
D: Mean Heinrichs-Carpenter Quality of Life Scale Scores Over Time (Baseline, Month 6, month 12, month 18 and month 24)

Answer: C
Please select the outcome measures that correspond to the clinical trial below.
Title: A Patient-Centered Approach to Advance Care Planning of Patients With End Stage Heart Failure and Renal Disease
Brief Summary: Based on theories regarding decision-making and patient education the investigators have developed Patient-Centered Advance Care Planning (PC-ACP). This intervention is designed to improve patient and surrogate knowledge of ACP, increase the congruence between patient and surrogate in treatment decisions, decrease the patient's and surrogate's conflict in making such decisions, and increase the consistency between patient preferences and the actual care they receive. The ACP intervention is conducted with the patient in the presence of the surrogate.


Options:
A: Number of Control and Intervention Participants on Skin Self-examination Performance at Follow-up 1 Month After Intervention (1 month)
B: Health literacy levels (Measured at Week 6 and Months 6, 12, 18, and 24); Blood pressure control (Measured at Week 6 and Months 6, 12, 18, and 24); Reduction in blood pressure (Measured at Month 24)
C: efficacy of PC-ACP
D: Hemoglobin A1C (6 months)

Answer: C
Please select the outcome measures that correspond to the clinical trial below.
Title: A Patient-Centered Approach to Advance Care Planning of Patients With End Stage Heart Failure and Renal Disease
Brief Summary: Based on theories regarding decision-making and patient education the investigators have developed Patient-Centered Advance Care Planning (PC-ACP). This intervention is designed to improve patient and surrogate knowledge of ACP, increase the congruence between patient and surrogate in treatment decisions, decrease the patient's and surrogate's conflict in making such decisions, and increase the consistency between patient preferences and the actual care they receive. The ACP intervention is conducted with the patient in the presence of the surrogate.


Options:
A: Function Assessment of Chronic Illness Therapy-General (FACT-G) (6 months)
B: Change in Kansas City Cardiomyopathy Questionnaire (KCCQ) (Baseline, 6 months); Change in Functional Assessment of Chronic Illness Therapy - Palliative Care Scale (FACIT-Pal) (Baseline, 6 months)
C: quality of communication (1 month after intervention completed)
D: efficacy of PC-ACP

Answer: D
Please select the outcome measures that correspond to the clinical trial below.
Title: A Patient-Centered Approach to Advance Care Planning of Patients With End Stage Heart Failure and Renal Disease
Brief Summary: Based on theories regarding decision-making and patient education the investigators have developed Patient-Centered Advance Care Planning (PC-ACP). This intervention is designed to improve patient and surrogate knowledge of ACP, increase the congruence between patient and surrogate in treatment decisions, decrease the patient's and surrogate's conflict in making such decisions, and increase the consistency between patient preferences and the actual care they receive. The ACP intervention is conducted with the patient in the presence of the surrogate.


Options:
A: The primary outcome for this study is the proportion of enrolled patients with live donor kidney transplants. (one year)
B: Medication Adherence Change from Baseline to 6 Months (6 months); Medication Adherence Change from 6 Months to 12 Months (12 months); Medication Adherence Change from Baseline to 12 Months (12)
C: efficacy of PC-ACP
D: Change in blood pressure measurement at baseline and at one year follow-up (Baseline and one year follow-up)

Answer: C
Please select the outcome measures that correspond to the clinical trial below.
Title: A Team Model of Hypertension Care in African Americans
Brief Summary: This Team Education and Adherence Monitoring (TEAM) trial will evaluate the cost-effectiveness of a pharmacy-based intervention in a randomized controlled trial involving 597 treated hypertensive African American patients in five Wisconsin cities. The study involves 28 community pharmacies (14 intervention, 14 control) owned by two pharmacy corporations. Intervention pharmacists and pharmacy technicians implemented a 6-month blood pressure (BP) monitoring program that involved working together as a team with patients and their physicians to achieve improved medication adherence, healthy lifestyles, drug therapy, and hypertension control.


Options:
A: Quality of life. (12 months)
B: Proportion of patients achieving hypertension control (6 months after enrollment); change in systolic and diastolic blood pressure (6 months after enrollment)
C: Comparison of difference in change in systolic BP between enhanced care and usual care (24 weeks)
D: Adherence to Antidepressant Medication (At 3 and 6 months)

Answer: B
Please select the outcome measures that correspond to the clinical trial below.
Title: A Team Model of Hypertension Care in African Americans
Brief Summary: This Team Education and Adherence Monitoring (TEAM) trial will evaluate the cost-effectiveness of a pharmacy-based intervention in a randomized controlled trial involving 597 treated hypertensive African American patients in five Wisconsin cities. The study involves 28 community pharmacies (14 intervention, 14 control) owned by two pharmacy corporations. Intervention pharmacists and pharmacy technicians implemented a 6-month blood pressure (BP) monitoring program that involved working together as a team with patients and their physicians to achieve improved medication adherence, healthy lifestyles, drug therapy, and hypertension control.


Options:
A: Patient-reported Adherence to Triple Therapy (Aspirin/Antiplatelet; Beta Blocker; and Statin) at 6 Months (6 months)
B: Comparison of percentage of patients with persistence to >=10/12 administrations of Bonviva in feedback and no feedback group (12 months)
C: Proportion of patients achieving hypertension control (6 months after enrollment); change in systolic and diastolic blood pressure (6 months after enrollment)
D: Patient Adherence to Inhaled Corticosteroids (ICS) (1 year)

Answer: C