TrialPanorama/Dataset huggingface dataset:
Please select the outcome measures that correspond to the clinical trial below.
Title: Evaluating Safety and Efficacy of MMF, Daclizumab and Corticosteroids as Mainstay Immunosuppression in Combination With Low-Dose CsA, Tac or Sir in Comparison to Current Standard Immunosuppression (MMF, CsA and Corticosteroids) in Renal Tx
Brief Summary: To determine the renal function, as expressed by the glomerular filtration rate at 12 months, in renal transplant recipients receiving mycophenolate mofetil, daclizumab, and corticosteroids as mainstay immunosuppression in combination with low-dose cyclosporine, tacrolimus, or sirolimus, and compare it to that of renal transplant recipients receiving standard immunosuppression with mycophenolate mofetil, normal dose cyclosporine and corticosteroids.


Options:
A: Reduced Exposure Cyclosporine in Renal Transplant Recipients (12 months after the time of kidney transplantation)
B: renal function as measured by serum creatinine at 6 months post-transplant
C: GFR calculated from the serum creatinine with the Cockcroft-Gault formula at 12 months posttransplantation
D: Primary endpoint: progression of subclinical cardiovascular disease as assessed by intima media thickness (IMT), pulse wave velocity (PWV) and left ventricular hypertrophy (LVH) (3 years)

Answer: C
Please select the outcome measures that correspond to the clinical trial below.
Title: Evaluating Safety and Efficacy of MMF, Daclizumab and Corticosteroids as Mainstay Immunosuppression in Combination With Low-Dose CsA, Tac or Sir in Comparison to Current Standard Immunosuppression (MMF, CsA and Corticosteroids) in Renal Tx
Brief Summary: To determine the renal function, as expressed by the glomerular filtration rate at 12 months, in renal transplant recipients receiving mycophenolate mofetil, daclizumab, and corticosteroids as mainstay immunosuppression in combination with low-dose cyclosporine, tacrolimus, or sirolimus, and compare it to that of renal transplant recipients receiving standard immunosuppression with mycophenolate mofetil, normal dose cyclosporine and corticosteroids.


Options:
A: renal function as measured by serum creatinine at 6 months post-transplant
B: Time to first BPAR episode or treatment failure (6 months)
C: GFR calculated from the serum creatinine with the Cockcroft-Gault formula at 12 months posttransplantation
D: Freedom from acute rejection, kidney transplant loss, delayed kidney transplant function and death at 6 months after transplant. (6 months)

Answer: C
Please select the outcome measures that correspond to the clinical trial below.
Title: A Randomized, Double-Blind, Placebo-Controlled, Parallel-Group, Multi-Center Trial of Pregabalin Versus Placebo in the Treatment of Neuropathic Pain Associated With HIV Neuropathy.
Brief Summary: Study to determine if pregabalin is more effective than placebo in treating subjects with nerve pain associated with HIV neuropathy.


Options:
A: Average Diabetic Peripheral Neuropathy (DPN) Pain Based on a Numeric Rating Scale (NRS) Over the Last 7 Days of Each Treatment Period (Week 6 of Each Treatment Period) (End of Period (includes both Visits 5 and 9))
B: Mean Pain Score at Endpoint as Measured by Daily Pain Rating Scale (DPRS) (Up to Week 12)
C: Duration Adjusted Average Change (DAAC) of Mean Pain Score (Baseline, Week 16)
D: Change From Baseline for Numerical Rating Scale (NRS) Pain Scores at Endpoint-LOCF (Last Observation Carried Forward) Relative to Baseline (Baseline, Week 14)

Answer: D
Please select the outcome measures that correspond to the clinical trial below.
Title: The Effect Of Eplerenone Versus Placebo On Cardiovascular Mortality And Heart Failure Hospitalization In Subjects With NYHA Class II Chronic Systolic Heart Failure
Brief Summary: In an earlier study, eplerenone was shown to improve survival in patients who had heart failure immediately following a heart attack. However, it is not known how patients with established mild-to-moderate heart failure (NYHA Class II), who have the additional risk of sudden death, will respond if treated with eplerenone. In this trial, eplerenone plus standard heart failure medicines is being compared to placebo plus standard heart failure medicines in terms of an additional ability to prolong life and prevent re-hospitalizations for worsening heart failure in these patients.

The Data Safety Monitoring Committee (DSMC) observed during its conduct of the protocol-specified second interim analysis on the 6th of May, 2010 that the efficacy of eplerenone had met the pre-specified stopping rules in the protocol. As a result of the discussion between the DSMC and the Executive Steering Committee (ESC), the ESC recommended that EMPHASIS-HF should be terminated, Based on the convincing efficacy and the consideration that it would be unethical not to offer this treatment to patients, the ESC recommended that all the patients in the trial should be transferred to open-label eplerenone. The Open Label Extension eplerenone arm will last for 12 months. Eplerenone is not currently approved for the indication studied in this patient population.

On May 26, 2010, further enrollment into EMPHASIS-HF was stopped. The amendment is considered to be the most appropriate way to ensure that all the subjects who participated in the double-blind phase of the EMPHASIS-HF trial can be offered treatment with eplerenone


Options:
A: Number of Participants With First Occurrence of Cardiovascular (CV) Mortality or Hospitalization Due to Heart Failure (HF) (Adjudicated): Up to Cut-off Date (Baseline (30 March 2006) up to 50 months (cut-off date: 25 May 2010)); Number of Participants With First Occurrence of Cardiovascular (CV) Mortality or Hospitalization Due to Heart Failure (HF) (Adjudicated) (Baseline (30 March 2006) up to 59.5 months (complete DB phase: 18 March 2011))
B: Primary Composite Endpoint (From the date of randomisation to the date of the first occurrence of the first event, up to 3 years.)
C: Change in VO2max measured by CPEX (After 2 weeks of intervention)
D: N/A

Answer: A
Please select the outcome measures that correspond to the clinical trial below.
Title: The Effect Of Eplerenone Versus Placebo On Cardiovascular Mortality And Heart Failure Hospitalization In Subjects With NYHA Class II Chronic Systolic Heart Failure
Brief Summary: In an earlier study, eplerenone was shown to improve survival in patients who had heart failure immediately following a heart attack. However, it is not known how patients with established mild-to-moderate heart failure (NYHA Class II), who have the additional risk of sudden death, will respond if treated with eplerenone. In this trial, eplerenone plus standard heart failure medicines is being compared to placebo plus standard heart failure medicines in terms of an additional ability to prolong life and prevent re-hospitalizations for worsening heart failure in these patients.

The Data Safety Monitoring Committee (DSMC) observed during its conduct of the protocol-specified second interim analysis on the 6th of May, 2010 that the efficacy of eplerenone had met the pre-specified stopping rules in the protocol. As a result of the discussion between the DSMC and the Executive Steering Committee (ESC), the ESC recommended that EMPHASIS-HF should be terminated, Based on the convincing efficacy and the consideration that it would be unethical not to offer this treatment to patients, the ESC recommended that all the patients in the trial should be transferred to open-label eplerenone. The Open Label Extension eplerenone arm will last for 12 months. Eplerenone is not currently approved for the indication studied in this patient population.

On May 26, 2010, further enrollment into EMPHASIS-HF was stopped. The amendment is considered to be the most appropriate way to ensure that all the subjects who participated in the double-blind phase of the EMPHASIS-HF trial can be offered treatment with eplerenone


Options:
A: Number of Participants With First Occurrence of Cardiovascular (CV) Mortality or Hospitalization Due to Heart Failure (HF) (Adjudicated): Up to Cut-off Date (Baseline (30 March 2006) up to 50 months (cut-off date: 25 May 2010)); Number of Participants With First Occurrence of Cardiovascular (CV) Mortality or Hospitalization Due to Heart Failure (HF) (Adjudicated) (Baseline (30 March 2006) up to 59.5 months (complete DB phase: 18 March 2011))
B: 96 Hour Change in NT-proBNP (Randomization to 96 hours)
C: Change in 24 hour urine albumin to creatinine ratio after 12 months of treatment
D: Change of of Systolic Blood Pressure (4 months); Change of Diastolic Blood Pressure (4 months)

Answer: A
Please select the outcome measures that correspond to the clinical trial below.
Title: N/A
Brief Summary: The purpose of this study is to investigate whether fish oil supplements may reduce the frequency and duration of paroxysmal atrial fibrillation episodes.

Atrial fibrillation is a heart condition which effects a large percentage of the population .

Atrial fibrillation is a condition frequently experienced by people who have had pacemakers inserted .

Certain Pacemakers have sophisticated monitoring features that are able to recognise episodes of atrial fibrillation.

Fish oil supplements may be of benefit to patients with heart problems.Recent evidence suggests that fish oils may be beneficial to patients with rhythm disturbances.

By interrogating pacemakers this study will investigate the effect of fish oil supplements on the frequency and duration of episodes of atrial fibrillation.


Options:
A: Changes from baseline in global cognitive composite score (2 years); Changes from baseline in macular degeneration (2 years)
B: Rate of Change on the ADAS-Cog 11. (Baseline, 6, 12, 18 months); Rate of Change on CDR-SOB (18 months)
C: cardiovascular deaths and hospitalization for cardiovascular causes (5 years)
D: Atrial tachycardia and atrial fibrillation burden (18 months)

Answer: D
Please select the outcome measures that correspond to the clinical trial below.
Title: N/A
Brief Summary: The purpose of this study is to investigate whether fish oil supplements may reduce the frequency and duration of paroxysmal atrial fibrillation episodes.

Atrial fibrillation is a heart condition which effects a large percentage of the population .

Atrial fibrillation is a condition frequently experienced by people who have had pacemakers inserted .

Certain Pacemakers have sophisticated monitoring features that are able to recognise episodes of atrial fibrillation.

Fish oil supplements may be of benefit to patients with heart problems.Recent evidence suggests that fish oils may be beneficial to patients with rhythm disturbances.

By interrogating pacemakers this study will investigate the effect of fish oil supplements on the frequency and duration of episodes of atrial fibrillation.


Options:
A: Death, all-cause (Up to 7 years)
B: Atrial tachycardia and atrial fibrillation burden (18 months)
C: Percentage of Liver Fat (Baseline and 18 months); Liver Fibrosis Score (Baseline and 18 months); NAFLD Fibrosis Score (Baseline and 18 months)
D: COPD exacerbations in the past year over the course of the study (at baseline (before randomization), 1-year, 2-year, 3-year,4-year, 5-year); Airflow obstruction/change in pulmonary function (pre-randomization and after 2 years follow-up); Pneumonia in the past year over the course of the study (at baseline (before randomization), 1-year, 2-year, 3-year,4-year, 5-year)

Answer: B
Please select the outcome measures that correspond to the clinical trial below.
Title: N/A
Brief Summary: The purpose of this study is to investigate whether fish oil supplements may reduce the frequency and duration of paroxysmal atrial fibrillation episodes.

Atrial fibrillation is a heart condition which effects a large percentage of the population .

Atrial fibrillation is a condition frequently experienced by people who have had pacemakers inserted .

Certain Pacemakers have sophisticated monitoring features that are able to recognise episodes of atrial fibrillation.

Fish oil supplements may be of benefit to patients with heart problems.Recent evidence suggests that fish oils may be beneficial to patients with rhythm disturbances.

By interrogating pacemakers this study will investigate the effect of fish oil supplements on the frequency and duration of episodes of atrial fibrillation.


Options:
A: Transition to psychotic disorder (12 Months)
B: Variables of atherosclerosis progression: IMT, Pulse Wave Propagation Time, Circulating biomarkers (1997-2010)
C: Atrial tachycardia and atrial fibrillation burden (18 months)
D: Major coronary events (sudden cardiac death, fatal and nonfatal myocardial infarction, unstable angina pectoris including hospitalization for ischemic episodes,events of angioplasty/ stenting or coronary artery bypass grafting)

Answer: C
Please select the outcome measures that correspond to the clinical trial below.
Title: N/A
Brief Summary: The purpose of this study is to investigate whether fish oil supplements may reduce the frequency and duration of paroxysmal atrial fibrillation episodes.

Atrial fibrillation is a heart condition which effects a large percentage of the population .

Atrial fibrillation is a condition frequently experienced by people who have had pacemakers inserted .

Certain Pacemakers have sophisticated monitoring features that are able to recognise episodes of atrial fibrillation.

Fish oil supplements may be of benefit to patients with heart problems.Recent evidence suggests that fish oils may be beneficial to patients with rhythm disturbances.

By interrogating pacemakers this study will investigate the effect of fish oil supplements on the frequency and duration of episodes of atrial fibrillation.


Options:
A: Atrial tachycardia and atrial fibrillation burden (18 months)
B: Change in Liver Fat (baseline and 12 months); Change in Enhanced Liver Fibrosis Score (ELF) (baseline and 12 months); Change in NAFLD Fibrosis Score (baseline and 12 months); Change in Bifidobacterium Spp. (baseline and 12 months)
C: Major coronary events (sudden cardiac death, fatal and nonfatal myocardial infarction, unstable angina pectoris including hospitalization for ischemic episodes,events of angioplasty/ stenting or coronary artery bypass grafting)
D: Changes from baseline in global cognitive composite score (2 years); Changes from baseline in macular degeneration (2 years)

Answer: A
Please select the outcome measures that correspond to the clinical trial below.
Title: N/A
Brief Summary: The purpose of this study is to investigate whether fish oil supplements may reduce the frequency and duration of paroxysmal atrial fibrillation episodes.

Atrial fibrillation is a heart condition which effects a large percentage of the population .

Atrial fibrillation is a condition frequently experienced by people who have had pacemakers inserted .

Certain Pacemakers have sophisticated monitoring features that are able to recognise episodes of atrial fibrillation.

Fish oil supplements may be of benefit to patients with heart problems.Recent evidence suggests that fish oils may be beneficial to patients with rhythm disturbances.

By interrogating pacemakers this study will investigate the effect of fish oil supplements on the frequency and duration of episodes of atrial fibrillation.


Options:
A: Development of Advanced AMD in People at Moderate to High Risk for Progression. (5 years of follow-up)
B: Atrial tachycardia and atrial fibrillation burden (18 months)
C: Histological Response Defined by Change From Baseline in Standardized Scoring of Liver Biopsies (12 months); Alanine Transaminase (ALT) Levels (3 month endpoint); Alanine Transaminase (ALT) Levels (6 months)
D: Percentage of Liver Fat (Baseline and 18 months); Liver Fibrosis Score (Baseline and 18 months); NAFLD Fibrosis Score (Baseline and 18 months)

Answer: B
Please select the outcome measures that correspond to the clinical trial below.
Title: Double Blind Placebo Controlled Dose Ranging Study of the Efficacy and Safety of SSR149744C 300 or 600 mg for the Conversion of Atrial Fibrillation / Flutter
Brief Summary: Double blind study to assess versus placebo the efficacy of SSR149744C for the conversion of atrial fibrillation/flutter to sinus rhythm at the time of the planned electrical cardioversion.


Options:
A: All-cause mortality or worsening heart failure requiring unplanned hospitalization (7 years)
B: First Hospitalization for Cardiovascular Reason or Death From Any Cause (minimum follow-up duration: 1 year ; maximum: 2.5 years)
C: The primary endpoint of the study is the time from randomisation to first documented AF/AFL recurrence
D: The primary efficacy endpoint is the rate of conversion to sinus rhythm documented by ECG just before the planned electrical cardioversion on D3 i.e. after 48 hours following the first study drug administration.

Answer: D
Please select the outcome measures that correspond to the clinical trial below.
Title: VERTOS II. Percutaneous Vertebroplasty Versus Conservative Therapy in Patients With Osteoporotic Vertebral Fractures
Brief Summary: Percutaneous vertebroplasty is a new procedure for treating painful osteoporotic compression fractures of the spine. Five-thousand out of 12.000 patients (16.000 vertebral fractures/year in the Netherlands) present with sudden, severe back pain in the region of the fracture.Until recently, bed rest, analgesia and physical support were the only treatment options. After decades of performing PV, no large RCT with mid-term follow-up has been published.

Design:

This will be a multicenter (6 centers), prospective, randomised, intervention study. Eligible patients will be randomised for percutaneous vertebroplasty or conservative therapy.

Study population:

Age: 50 and older, vertebral fracture, level: thoracic vertebral body 5 (Th 5) or lower, osteopenia (T-score \&lt; -1 SD), back pain for no more than 6 weeks and edema in the vertebrae on MR imaging

Statistical analyses All analyses will be performed on an 'intention to treat' principle. The planned number of subjects will be 200 in total, 100 in each intervention arm.

Economic evaluation:

Cost-effectiveness will be assessed. The costs of the procedure and the medical treatment, and of visits to medical specialists, GP's and physical therapists will be compared.

Time schedule:

The total study will take 36 months

Recruitment of patients (200) has been completed. In May 2009 the 1 year follow-up will be finished.


Options:
A: Back-specific Functional Status Using Roland-Morris Disability Questionnaire (RDQ) Scale at 1 Month (1 month after procedure); Patient's Rating of Average Pain at 1 Month (1 month)
B: Back specific functional status(Roland) (12 mo); Pain (12 mo)
C: pain relief (12 months)
D: To compare the cost-effectivity in the two groups (1 month, 1 year); VAS score in time (1 month, 1 year)

Answer: D
Please select the outcome measures that correspond to the clinical trial below.
Title: VERTOS II. Percutaneous Vertebroplasty Versus Conservative Therapy in Patients With Osteoporotic Vertebral Fractures
Brief Summary: Percutaneous vertebroplasty is a new procedure for treating painful osteoporotic compression fractures of the spine. Five-thousand out of 12.000 patients (16.000 vertebral fractures/year in the Netherlands) present with sudden, severe back pain in the region of the fracture.Until recently, bed rest, analgesia and physical support were the only treatment options. After decades of performing PV, no large RCT with mid-term follow-up has been published.

Design:

This will be a multicenter (6 centers), prospective, randomised, intervention study. Eligible patients will be randomised for percutaneous vertebroplasty or conservative therapy.

Study population:

Age: 50 and older, vertebral fracture, level: thoracic vertebral body 5 (Th 5) or lower, osteopenia (T-score \&lt; -1 SD), back pain for no more than 6 weeks and edema in the vertebrae on MR imaging

Statistical analyses All analyses will be performed on an 'intention to treat' principle. The planned number of subjects will be 200 in total, 100 in each intervention arm.

Economic evaluation:

Cost-effectiveness will be assessed. The costs of the procedure and the medical treatment, and of visits to medical specialists, GP's and physical therapists will be compared.

Time schedule:

The total study will take 36 months

Recruitment of patients (200) has been completed. In May 2009 the 1 year follow-up will be finished.


Options:
A: To compare the cost-effectivity in the two groups (1 month, 1 year); VAS score in time (1 month, 1 year)
B: pain relief (12 months)
C: Patient rated pain intensity (two weeks)
D: Impact into quality of life with the Qualeffo-41 test (Baseline, 2 weeks, 2 months, 6 months and 1 year)

Answer: A
Please select the outcome measures that correspond to the clinical trial below.
Title: Cardiovascular Magnetic Resonance Evaluation of the Effects of Niaspan on Regression of Atherosclerosis and Restoration of Endothelial Function
Brief Summary: AIM 1 will test the hypothesis that elevation of high-density lipoprotein (HDL) through treatment with Niaspan will accelerate the regression of atherosclerotic plaque in patients with established atherosclerosis. The investigators will therefore study patients with atherosclerosis in the aorta and carotid artery. Plaque quantification will be with magnetic resonance imaging (MRI).

AIM 2 will assess the ability of Niaspan to improve endothelial function in patients with coronary artery disease and type II diabetes mellitus, who typically have low high-density lipoprotein cholesterol (HDL-C), and high risk of cardiovascular events.


Options:
A: Regression of artheriosclerotic plaque measured using functional magnetic resonance imaging.
B: change in percent atheroma volume at 12 months intravascular ultrasonography (12 months)
C: N/A
D: Coadministered MK0524B will be more efficacious in reducing LDL-C concentrations compared to MK0524A.

Answer: A
Please select the outcome measures that correspond to the clinical trial below.
Title: RCT of a Telecommunications System in Sleep Apnea
Brief Summary: This study is investigating the effects of a telecommunications system designed to improve patient adherence with prescribed positive airway pressure (CPAP).


Options:
A: CPAP adherence in minutes used per night (after 3 months)
B: proportion of patients using Continuous Positive Airway Pressure for more than 3 hours per night in the 2 groups (CPAP use was evaluated for 4 months)
C: Objective CPAP Use (12 months)
D: A composite of the CV endpoints of CV death, non-fatal acute myocardial infarction, non-fatal stroke, hospital admission for heart failure, and new hospitalisation for unstable angina or transient ischaemic attack. (Reviewed 6-monthly; average patient follow up, 4.5 years)

Answer: C
Please select the outcome measures that correspond to the clinical trial below.
Title: RCT of a Telecommunications System in Sleep Apnea
Brief Summary: This study is investigating the effects of a telecommunications system designed to improve patient adherence with prescribed positive airway pressure (CPAP).


Options:
A: Objective CPAP Use (12 months)
B: colorectal cancer screening (one year)
C: The incidence and frequency of COPD exacerbations in each of the intervention groups (December 2008 to March 2009 inclusive); Electronic diary symptoms using the EXACT instrument (Daily recording)
D: The study hypothesis is that the goal systems intervention will out perform the social cognitive intervention and that both of these interventions will outperform the control group for fruit and vegetable consumption. (July 2006-July 2009)

Answer: A