TrialPanorama/Dataset huggingface dataset:
Please select the outcome measures that correspond to the clinical trial below.
Title: A Randomised Controlled Trial of a Fixed-dose Combination Polypill Medication (the Red Heart Pill) and Usual Care in Those at High Risk of Cardiovascular Disease.
Brief Summary: People with established cardiovascular disease need secondary prevention that addresses multiple risk factors. Complexity \& cost confer particularly difficult barriers to uptake of treatment; recovery from a stroke or heart attack typically necessitates multiple drugs for cholesterol, blood pressure and platelet function. A low-cost, fixed-dose, once-daily combination polypill, the Red Heart Pill, has been formulated by Dr Reddy's Laboratories. UMPIRE will evaluate whether provision of this polypill compared with usual medications improves adherence and clinical outcomes among high-risk patients in Europe and India. The results will be used to develop recommendations for equitable access.


Options:
A: Adherence to medication; self-reported current use of antiplatelet, statin and combination (≥ 2) blood pressure lowering therapy (End of trial follow-up); Change in blood pressure (End of trial follow-up); Change in LDL cholesterol (End of trial follow-up)
B: Drug adherence in patients (daily proportion of patients taking one tablet of the prescribed hypertensive therapy as prescribed)
C: Percentage Changed in Adherence Score (Baseline compared to the mean of the combined 3, 6, 9, and 12 month scores); Number of Symptom-free Days (Baseline compared to the mean of the combined 3, 6, 9, and 12 month scores)
D: Change in proportion of pills taken compared to baseline (0-2months) at 8months; Between-group comparison of medication persistence at 14months

Answer: A
Please select the outcome measures that correspond to the clinical trial below.
Title: A Randomised Controlled Trial of a Fixed-dose Combination Polypill Medication (the Red Heart Pill) and Usual Care in Those at High Risk of Cardiovascular Disease.
Brief Summary: People with established cardiovascular disease need secondary prevention that addresses multiple risk factors. Complexity \& cost confer particularly difficult barriers to uptake of treatment; recovery from a stroke or heart attack typically necessitates multiple drugs for cholesterol, blood pressure and platelet function. A low-cost, fixed-dose, once-daily combination polypill, the Red Heart Pill, has been formulated by Dr Reddy's Laboratories. UMPIRE will evaluate whether provision of this polypill compared with usual medications improves adherence and clinical outcomes among high-risk patients in Europe and India. The results will be used to develop recommendations for equitable access.


Options:
A: Adherence to medication; self-reported current use of antiplatelet, statin and combination (≥ 2) blood pressure lowering therapy (End of trial follow-up); Change in blood pressure (End of trial follow-up); Change in LDL cholesterol (End of trial follow-up)
B: Any stroke at 90 days; Stroke severity
C: Telephone Modified Rankin Scale (Centralised, Blinded Assessment) (90 days)
D: Two (2) year incidence of stroke or Hard TIA (2 years); All cause mortality for the first 30 days of follow up/discharge, whichever is longer (30 days); Neurological mortality from 31 days of follow up (F/U) or longer (31 days)

Answer: A
Please select the outcome measures that correspond to the clinical trial below.
Title: A Randomised Controlled Trial of a Fixed-dose Combination Polypill Medication (the Red Heart Pill) and Usual Care in Those at High Risk of Cardiovascular Disease.
Brief Summary: People with established cardiovascular disease need secondary prevention that addresses multiple risk factors. Complexity \& cost confer particularly difficult barriers to uptake of treatment; recovery from a stroke or heart attack typically necessitates multiple drugs for cholesterol, blood pressure and platelet function. A low-cost, fixed-dose, once-daily combination polypill, the Red Heart Pill, has been formulated by Dr Reddy's Laboratories. UMPIRE will evaluate whether provision of this polypill compared with usual medications improves adherence and clinical outcomes among high-risk patients in Europe and India. The results will be used to develop recommendations for equitable access.


Options:
A: Change From Baseline in Mean Seated Trough Cuff Systolic Blood Pressure (SBP) to Week 7 (Baseline and Week 7)
B: Adherence to medication; self-reported current use of antiplatelet, statin and combination (≥ 2) blood pressure lowering therapy (End of trial follow-up); Change in blood pressure (End of trial follow-up); Change in LDL cholesterol (End of trial follow-up)
C: 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.]))
D: To evaluate the effectiveness of amlodipine/atorvastatin therapy by assessing percentage of subjects who reach target BP and LDL-C targets as defined by their governing guidelines.

Answer: B
Please select the outcome measures that correspond to the clinical trial below.
Title: A Randomised Controlled Trial Comparing TVT, Pelvicol and Autologous Fascial Slings for the Treatment of Stress Urinary Incontinence in Women
Brief Summary: The purpose of this trial was to discover which type of operation for stress urinary incontinence in women offered better results: autologous slings, TVT or Pelvicol slings.


Options:
A: Primary outcome (Observational)
B: 24 Month Cumulative Success Rate Computed From Kaplan Meier Time-to-event Analysis (Reported as Percent Success). (Two years); 24 Month Cumulative Stress Specific Success Rates Computed From Kaplan Meier Time-to-event Analysis (Reported as % Success) (Two years)
C: Objective Treatment Success at 12 Months (12 months); Subjective Treatment Success at 12 Months (12 months)
D: success rate at improving symptom of stress urinary incontinence (1 year)

Answer: D
Please select the outcome measures that correspond to the clinical trial below.
Title: A PHASE 3B MULTICENTER, DOUBLE-BLIND, RANDOMIZED WITHDRAWAL EFFICACY AND SAFETY STUDY OF PREGABALIN IN THE TREATMENT OF PATIENTS WITH INADEQUATELY TREATED PAINFUL DIABETIC PERIPHERAL NEUROPATHY
Brief Summary: Patients will be switched from their current medication for painful diabetic peripheral neuropathy to evaluate the safety and efficacy of pregabalin as compared to placebo. All patients will receive pregabalin, and half of patients will receive placebo at some point during the study.


Options:
A: Change From Single-Blind Baseline in Mean Pain Score at Week 19 During Double-Blind Phase (SB Baseline, Week 19 (DB Phase))
B: Whether there is a reduction in subjective pain as assessed by the Brief Pain Inventory. (December 2008)
C: Daily Evening Patient Reported Pain Intensity Scores (Baseline and 6 Weeks)
D: Mean pain score

Answer: A
Please select the outcome measures that correspond to the clinical trial below.
Title: Chiropractic and Exercise Management of Spinal Dysfunction in Seniors
Brief Summary: This study will compare the effectiveness of chiropractic and exercise treatment in the short- and long-term, when managing chronic neck and back disability in seniors over the age of 65 years.


Options:
A: Patient-rated neck and back disability (9 months)
B: N/A
C: Neck Disability Index (4 weeks, 6 months)
D: Neck Pain (Up to 10 months)

Answer: A
Please select the outcome measures that correspond to the clinical trial below.
Title: Meditation and Exercise for Prevention of Acute Respiratory Infection
Brief Summary: The overarching goal of this project is to determine whether mind-body practices such as meditation or exercise can reduce the public health burden of acute respiratory infection. A major secondary goal is to determine whether mindfulness meditation or moderately strenuous exercise can enhance immune processes such as antibody response to influenza vaccination (flu shots). Finally, we want to investigate the influence of stress, optimism, anxiety and positive and negative emotion on immunity and resistance to respiratory infection.


Options:
A: To determine whether standardized rehabilitation therapy will decrease hospital length of stay. (5 years)
B: Severity-weighted Total Days of ARI Illness (8 months)
C: Severity-adjusted total days of acute respiratory infection (ARI) illness, as self-reported on the Wisconsin Upper Respiratory Symptom Survey (WURSS-24). Incidence (number) of cold flu episodes and total unadjusted days of illness will also be reported. (2009-2010 cold season)
D: Major Mobility Disability, Defined as Incapacity to Walk 400 Meters (Median 2.7 years/Average 2.6 years)

Answer: C
Please select the outcome measures that correspond to the clinical trial below.
Title: Nurse Managed Upper Body Strength Training in COPD
Brief Summary: This is a four month exercise training program for people with chronic obstructive pulmonary disease (COPD)with a 12 month follow-up.


Options:
A: Change From Baseline in Inspiratory Capacity (IC) at Isotime (baseline, six weeks of treatment)
B: Changes in objectively measured physical activity (2 weeks before pulmonary rehabilitation (T0), 6 weeks after pulmonary rehabilitation (T3) and 6 months after pulmonary rehabilitation (T4))
C: Health related quality of life measured by the Chronic Respiratory Questionnaire
D: Upper body strength (before training, after training, 6 months post training, 12 months post training); Dyspnea (before training, after training, 6 months post training, 12 months post training); Functional performance (before training, after training, 6 months post training, 12 months post training)

Answer: D
Please select the outcome measures that correspond to the clinical trial below.
Title: Sequenced Atypical Antipsychotics Therapy With Intensive or Basic Psychosocial Intervention for First-episode Schizophrenia: An Effectiveness Study
Brief Summary: Schizophrenia is not a curable but a treatable disease by antipsychotics. Kinds of atypical antipsychotics are widely used since 1990s' in China. Although their efficacy for acute phase are all better than typicals, individulized regimen of them for first-episode schizophrenia and their effectiveness in real naturalistic clinical settings still remain unclear. And those patients also need more comprehensive intervention such as psychosocial programs to improve their function. This protocol is to conduct a study in several sites of China to investigate the effectiveness of comprehensive intervention combining sequenced atypical antipsychotic therapy and intensive psychosocial intervention for first-episode schizophrenic patients. In addition, this protocol also aims at collecting such information as molecular genetics, neurochemical test, neucognitive performance and neuroimaging for outcome analysis.


Options:
A: the time the patients remain stable (1 year)
B: Reduction in the agitation score (90 minutes)
C: Evaluate the efficacy of adding Aripiprazole to atypical antipsychotic treatment via Positive and Negative Symptoms Scale (PANSS) score at endpoint ((Week 16) or at time of discontinuation)
D: Time to Relapse of Psychotic Symptoms During 6 Weeks (6 Weeks)

Answer: A
Please select the outcome measures that correspond to the clinical trial below.
Title: Sequenced Atypical Antipsychotics Therapy With Intensive or Basic Psychosocial Intervention for First-episode Schizophrenia: An Effectiveness Study
Brief Summary: Schizophrenia is not a curable but a treatable disease by antipsychotics. Kinds of atypical antipsychotics are widely used since 1990s' in China. Although their efficacy for acute phase are all better than typicals, individulized regimen of them for first-episode schizophrenia and their effectiveness in real naturalistic clinical settings still remain unclear. And those patients also need more comprehensive intervention such as psychosocial programs to improve their function. This protocol is to conduct a study in several sites of China to investigate the effectiveness of comprehensive intervention combining sequenced atypical antipsychotic therapy and intensive psychosocial intervention for first-episode schizophrenic patients. In addition, this protocol also aims at collecting such information as molecular genetics, neurochemical test, neucognitive performance and neuroimaging for outcome analysis.


Options:
A: Brief Psychotic Rating Scale (BPRS): Measure of efficacy will be changes in BPRS total and subscale scores from baseline to 8th week endpoint. Follow-up evaluation will be made every 6th month till 1 year after 8th week end point. (one year); Schedule for Assessment of Negative Symptoms (SANS): Measure of efficacy will be changes in SANS total and subscale scores from baseline to 8th week endpoint. Follow-up evaluation will be made at 6 month and 12 month after 8th week end point. (one year); Serum Prolactin Level (one year); Body Mass Index & Abdominal Circumference (one year); Lipid Panel with LDL Cholesterol (one year); FBS-PP & HbA1c (one year)
B: For 100 subjects with incomplete response to adequate treatment with clozapine, the primary objective is to determine if risperidone augmentation of clozapine is superior to augmentation with placebo, using the outcome measure of total PANSS score
C: Withdrawal from allocated treatment within 3 months.
D: the time the patients remain stable (1 year)

Answer: D
Please select the outcome measures that correspond to the clinical trial below.
Title: Randomized Trial of Intensive Physical Therapy for Patients With Acute Respiratory Failure
Brief Summary: Acute respiratory failure is a heterogeneous disorder that results in more than 300,000 Americans requiring admission to an intensive care unit for invasive mechanical ventilatory support each year. Though acute respiratory failure is a pulmonary disorder, patients who survive their hospitalization are not limited by respiratory symptoms after discharge. Rather persistent neuromuscular weakness is the primary disorder that adversely alters their quality of life and ability to function on a daily basis. In this application the investigators plan to conduct a randomized clinical trial called the Do It Now study (Diagnosis and Treatment of Neuromuscular Weakness) to determine the effectiveness of an intensive physical therapy program for patients recovering from acute respiratory failure. This trial will establish the efficacy of the physical therapy programs that is currently performed for patients with acute respiratory failure in a non-evidence based manner across the United States.


Options:
A: Muscle mass (lean mass) (Change from baseline in muscle mass at 3 month after discharge)
B: The Primary Outcome Variable for This Study Will be the Short Form of the Continuous Scale Physical Functional Performance Test (CS-PFP) Called the PFP-10 (1 month)
C: Glittre test (up to 9 months)
D: Recover basal functional capacity (During hospital stay, from admission (first evaluation) until hospital discharge (second evaluation, and 3-months postdischarge (last evaluation).)

Answer: B
Please select the outcome measures that correspond to the clinical trial below.
Title: Randomized Trial of Intensive Physical Therapy for Patients With Acute Respiratory Failure
Brief Summary: Acute respiratory failure is a heterogeneous disorder that results in more than 300,000 Americans requiring admission to an intensive care unit for invasive mechanical ventilatory support each year. Though acute respiratory failure is a pulmonary disorder, patients who survive their hospitalization are not limited by respiratory symptoms after discharge. Rather persistent neuromuscular weakness is the primary disorder that adversely alters their quality of life and ability to function on a daily basis. In this application the investigators plan to conduct a randomized clinical trial called the Do It Now study (Diagnosis and Treatment of Neuromuscular Weakness) to determine the effectiveness of an intensive physical therapy program for patients recovering from acute respiratory failure. This trial will establish the efficacy of the physical therapy programs that is currently performed for patients with acute respiratory failure in a non-evidence based manner across the United States.


Options:
A: The Primary Outcome Variable for This Study Will be the Short Form of the Continuous Scale Physical Functional Performance Test (CS-PFP) Called the PFP-10 (1 month)
B: Hospital mortality (during hospitalization)
C: Number of patients returning to independent functional status: defined as ability to perform 6 activities of daily living (ADL's)(bathing, dressing, eating, grooming, transfer from bed to chair, toileting) and independent ambulation (Hospital Discharge)
D: Time receiving mechanical ventilation, total intensive care and hospital length of stay.

Answer: A
Please select the outcome measures that correspond to the clinical trial below.
Title: Multicomponent Intervention to Decrease COPD-related Hospitalizations
Brief Summary: The investigators' proposed study is a randomized controlled trial that will prospectively examine the effect of a multicomponent intervention on the rate of hospitalizations, daily physical activity, self efficacy and health status in patients who have COPD and have been hospitalized because of a COPD exacerbation.

In the study, a convenience sample of patients recently hospitalized for a COPD exacerbation, who meet the selection criteria and agree to participate will be randomized to receive one of the following at the time of hospital discharge: (1) the current standard of care plus a multicomponent intervention (counselor + pulmonary rehabilitation) or (2) the current standard of care without the intervention.

This study plans to test the following hypotheses: (1) The primary outcome of the study to be the composite endpoint of death or COPD hospitalization (2) Time to first rehospitalization will be shorter in the intervention group than the control group (3) At follow-up, the physical activity level measured in terms of the average number of steps and active energy expenditure will be higher in the intervention group than in the control group.


Options:
A: change in St. George's Respiratory Questionnaire (SGRQ) (14 weeks after intervention)
B: Physical activity (Change between baseline (T0) and directly after the intervention, after 4-6 months from baseline (T1)); Physical activity (Change between T1 and T2: 3 months follow up)
C: 6-Minute Walking Distance (Baseline and 8 weeks follow-up)
D: To determine the impact of the intervention initiated after hospital discharge from a COPD exacerbation on the rate of COPD related re-hospitalizations in the intervention versus the control group . (12 months); To determine the impact of the intervention initiated after hospital discharge from a COPD exacerbation on the rate of the composite outcome, COPD related hospitalizations or death in the intervention versus the control group. (12 months)

Answer: D
Please select the outcome measures that correspond to the clinical trial below.
Title: Multicomponent Intervention to Decrease COPD-related Hospitalizations
Brief Summary: The investigators' proposed study is a randomized controlled trial that will prospectively examine the effect of a multicomponent intervention on the rate of hospitalizations, daily physical activity, self efficacy and health status in patients who have COPD and have been hospitalized because of a COPD exacerbation.

In the study, a convenience sample of patients recently hospitalized for a COPD exacerbation, who meet the selection criteria and agree to participate will be randomized to receive one of the following at the time of hospital discharge: (1) the current standard of care plus a multicomponent intervention (counselor + pulmonary rehabilitation) or (2) the current standard of care without the intervention.

This study plans to test the following hypotheses: (1) The primary outcome of the study to be the composite endpoint of death or COPD hospitalization (2) Time to first rehospitalization will be shorter in the intervention group than the control group (3) At follow-up, the physical activity level measured in terms of the average number of steps and active energy expenditure will be higher in the intervention group than in the control group.


Options:
A: Self-Reported Respiratory-Specific Quality of Life (four months from randomization); Self-Reported Respiratory-Specific Quality of Life (twelve months from randomization)
B: To determine the impact of the intervention initiated after hospital discharge from a COPD exacerbation on the rate of COPD related re-hospitalizations in the intervention versus the control group . (12 months); To determine the impact of the intervention initiated after hospital discharge from a COPD exacerbation on the rate of the composite outcome, COPD related hospitalizations or death in the intervention versus the control group. (12 months)
C: Dyspnea with ADL (3, 6, and 12 months); Exercise and functional performance (3, 6, and 12 months); Exercise adherence (3, 6, and 12 months); Acute COPD exacerbations (3, 6, and 12 months)
D: Change from baseline at 12 month in Annual systematic chronic disease follow up consultations (Month 4, 3, 2 before baseline and month 13,14,15 after baseline (after intervention))

Answer: B
Please select the outcome measures that correspond to the clinical trial below.
Title: Multicomponent Intervention to Decrease COPD-related Hospitalizations
Brief Summary: The investigators' proposed study is a randomized controlled trial that will prospectively examine the effect of a multicomponent intervention on the rate of hospitalizations, daily physical activity, self efficacy and health status in patients who have COPD and have been hospitalized because of a COPD exacerbation.

In the study, a convenience sample of patients recently hospitalized for a COPD exacerbation, who meet the selection criteria and agree to participate will be randomized to receive one of the following at the time of hospital discharge: (1) the current standard of care plus a multicomponent intervention (counselor + pulmonary rehabilitation) or (2) the current standard of care without the intervention.

This study plans to test the following hypotheses: (1) The primary outcome of the study to be the composite endpoint of death or COPD hospitalization (2) Time to first rehospitalization will be shorter in the intervention group than the control group (3) At follow-up, the physical activity level measured in terms of the average number of steps and active energy expenditure will be higher in the intervention group than in the control group.


Options:
A: Relational Coordination (For average period of 3 months)
B: Combined number of hospitalizations and emergency department presentations (Two years)
C: Disease-specific health related quality of life assessed with the Chronic Respiratory Questionnaire (CRQ-SR) (At baseline, after one year follow-up, and after two years follow-up)
D: To determine the impact of the intervention initiated after hospital discharge from a COPD exacerbation on the rate of COPD related re-hospitalizations in the intervention versus the control group . (12 months); To determine the impact of the intervention initiated after hospital discharge from a COPD exacerbation on the rate of the composite outcome, COPD related hospitalizations or death in the intervention versus the control group. (12 months)

Answer: D