TrialPanorama/Dataset huggingface dataset:
Please select the outcome measures that correspond to the clinical trial below.
Title: Alberta Clinical Trial in Optimizing Hypertension: The RxAction Study
Brief Summary: The purpose of this study is to evaluate the effect of enhanced pharmacist care (patient identification, assessment, education, prescribing/titration of antihypertensive medications and close follow-up) on systolic blood pressure (BP) reduction in patients with poorly controlled hypertension in the community setting.


Options:
A: Comparison of difference in change in systolic BP between enhanced care and usual care (24 weeks)
B: Complete abortion (14 days)
C: Cumulative Treatment Failure Rate of Participants on First Line Antiretroviral Therapy Monitored by Primary Health Care Nurses (Investigative Arm)is Not Inferior to the Cumulative Treatment Failure Rate of Participants Monitored by Doctors (Control Arm). (96 weeks)
D: Blood pressure control (Measured by zero blood pressure measurements at baseline and 2, 4, 6, 8, and 9 months)

Answer: A
Please select the outcome measures that correspond to the clinical trial below.
Title: The Toronto Prehospital Hypertonic Resuscitation Head Injury and Multi Organ Dysfunction Trial
Brief Summary: This clinical trial will evaluate the ease of conducting a randomized trial on patients with severe head injury who are cared for by paramedics in the out of hospital setting. The trial will compare two different kinds of fluids that are commonly used to elevate blood pressure and minimize the impact of the brain injury. The two solutions are a salt solution of different concentrations. One is a normal saline solution similar to the consistency of human blood and the other is a higher concentration mixed with a sugar that helps to keep the solution in the blood stream longer. This study is conducted without patient consent at the time of the study enrolment. The study will report on whether this trial is feasible in the out of hospital setting before launching into a larger definitive trial.


Options:
A: Amount of Study Drug Required to Achieve Initial Hemodynamic Stabilization (until hemodynamic stabilization (up to 48 hours))
B: baseline survival rates for the treatment and control group to aid in the design of a definitive multicentre trial (survival at 48 hours, hospital discharge, 30 days and 4 months); randomization compliance rate (duration of enrolment); ease of protocol implementation in the out-of-hospital setting (duration of study); adverse event rate of hypertonic saline dextran infusion (duration of study)
C: Adult respiratory distress syndrome symptoms (measured 28 days post-injury)
D: Mortality (28 day); Morbidity (mean sepsis-related organ failure assessment [SOFA] score during intensive care unit length of stay [ICU LOS])

Answer: B
Please select the outcome measures that correspond to the clinical trial below.
Title: Action Plan to Enhance Self-management and Early Detection of Exacerbations in COPD Patients; A Multicenter RCT (ACZiE)
Brief Summary: The purpose of this randomized controlled trial is to evaluate the hypothesis that the 'written' action plan, a self-management tool developed by the project group, enhances early detection and prompt action measures and consequently isbeneficial in exacerbation outcome (i.e., health status recovery time).


Options:
A: Hospitalization or Emergency Department Visit for COPD (1 yr); Hospitalization or ED Visit for COPD (Mean Cumulative Frequency) (1 yr)
B: Identifying new patient subtypes and endpoints for COPD (3 years)
C: Number of hospital admissions for exacerbations of COPD
D: CCQ-recovery time in the event of an exacerbation(Health status recovery time) (6-months)

Answer: D
Please select the outcome measures that correspond to the clinical trial below.
Title: Action Plan to Enhance Self-management and Early Detection of Exacerbations in COPD Patients; A Multicenter RCT (ACZiE)
Brief Summary: The purpose of this randomized controlled trial is to evaluate the hypothesis that the 'written' action plan, a self-management tool developed by the project group, enhances early detection and prompt action measures and consequently isbeneficial in exacerbation outcome (i.e., health status recovery time).


Options:
A: Change from baseline of functional capacity and quality of life after Home-based rehab (After two months of treatment)
B: Health related quality of life (12 month follow-up); Incremental cost-effectiveness ratio (ICER) (12 month follow-up)
C: CCQ-recovery time in the event of an exacerbation(Health status recovery time) (6-months)
D: Difference in COPD admission rates and death over one year between patients treated with supported self-management, in addition to usual care, and those treated with usual care alone? (1 year)

Answer: C
Please select the outcome measures that correspond to the clinical trial below.
Title: Action Plan to Enhance Self-management and Early Detection of Exacerbations in COPD Patients; A Multicenter RCT (ACZiE)
Brief Summary: The purpose of this randomized controlled trial is to evaluate the hypothesis that the 'written' action plan, a self-management tool developed by the project group, enhances early detection and prompt action measures and consequently isbeneficial in exacerbation outcome (i.e., health status recovery time).


Options:
A: CCQ-recovery time in the event of an exacerbation(Health status recovery time) (6-months)
B: Change in level of objectively measured physical activity (7 Days at baseline, 7 days at 3- and 12- months after baseline)
C: change from baseline in Modified Medical Research Council dyspnea score (12 weeks); change from baseline in COPD Assessment Test(CAT) score (12 weeks); change from baseline in real distance walked for 6 minutes (12 weeks)
D: change in asthma control between baseline and six months as measured by ACQ.24 The ACQ measures clinical goals of asthma management on a scale: 0 (good control) to 6, is responsive to change,24 with a intra-individual minimum important difference (6 months)

Answer: A
Please select the outcome measures that correspond to the clinical trial below.
Title: A Randomized, Double-blind, Multi-center Phase III Study Comparing Everolimus (RAD001) Plus Best Supportive Care Versus Placebo Plus Best Supportive Care in Patients With Advanced Gastric Cancer After Progression on 1 or 2 Prior Systemic Chemotherapy
Brief Summary: This study is designed to assess the safety and efficacy of RAD001 monotherapy in patients with advanced gastric cancer which has progressed after one or two lines of prior chemotherapy.


Options:
A: Overall Survival (OS) (2.5 years)
B: overall survival (median)
C: Overall survival (OS) rate (1 year)
D: Overall Survival (OS) (Randomization up to 28 months post-randomization)

Answer: A
Please select the outcome measures that correspond to the clinical trial below.
Title: A Randomized, Double-blind, Multi-center Phase III Study Comparing Everolimus (RAD001) Plus Best Supportive Care Versus Placebo Plus Best Supportive Care in Patients With Advanced Gastric Cancer After Progression on 1 or 2 Prior Systemic Chemotherapy
Brief Summary: This study is designed to assess the safety and efficacy of RAD001 monotherapy in patients with advanced gastric cancer which has progressed after one or two lines of prior chemotherapy.


Options:
A: Progression-Free Survival (PFS) (Randomization to measured PD or date of death from any cause (up to Month 25.0))
B: Progression Free Survival (PFS) (22 months)
C: Overall Survival (OS) (2.5 years)
D: Progression Free Survival (PFS) (5 years)

Answer: C
Please select the outcome measures that correspond to the clinical trial below.
Title: A Randomized, Double-blind, Multi-center Phase III Study Comparing Everolimus (RAD001) Plus Best Supportive Care Versus Placebo Plus Best Supportive Care in Patients With Advanced Gastric Cancer After Progression on 1 or 2 Prior Systemic Chemotherapy
Brief Summary: This study is designed to assess the safety and efficacy of RAD001 monotherapy in patients with advanced gastric cancer which has progressed after one or two lines of prior chemotherapy.


Options:
A: Overall Survival (OS) - Percentage of Participants With an Event (Baseline (BL), Days 1, 8, 15, 22, 43, 64, 85, 106, 127, and every 21 days until the end of study, 1 year after the cut-off date for the 2nd interim efficacy analysis); Overall Survival - Time to Event (BL, Days 1, 8, 15, 22, 43, 64, 85, 106, 127, and every 21 days until the end of study, 1 year after the cut-off date for the 2nd interim efficacy analysis)
B: Overall survival (Early termination)
C: Overall Survival (OS) (2.5 years)
D: Progression free survival (PFS), as measured by RECIST per local review (Subjects coming off study will be contacted by telephone or at routine clinic visits approximately every 3 months until 36 months from date the last subject is randomized into the study.)

Answer: C
Please select the outcome measures that correspond to the clinical trial below.
Title: A Randomized, Double-blind, Multi-center Phase III Study Comparing Everolimus (RAD001) Plus Best Supportive Care Versus Placebo Plus Best Supportive Care in Patients With Advanced Gastric Cancer After Progression on 1 or 2 Prior Systemic Chemotherapy
Brief Summary: This study is designed to assess the safety and efficacy of RAD001 monotherapy in patients with advanced gastric cancer which has progressed after one or two lines of prior chemotherapy.


Options:
A: Overall Survival (OS) (2.5 years)
B: Overall Survival (OS) (From the date of randomization to the data cut-off date (maximum duration: up to approximately 46 months))
C: Objective Response Rate ( ORR ) (60 months)
D: Overall survival (Up to study completion (estimated time frame: 30 months), every 2 weeks in principle)

Answer: A
Please select the outcome measures that correspond to the clinical trial below.
Title: Randomized Trial of Vitamin D Supplementation in Winter-related, Childhood Atopic Dermatitis
Brief Summary: The goal of this clinical trial is to investigate the therapeutic role of vitamin D supplementation in a subset of patients with atopic dermatitis (AD): children with disease onset or worsening in the winter. The investigators hypothesis is that (1) vitamin D supplementation in patients with either wintertime onset or exacerbation of AD will improve Eczema Area and Severity Index (EASI) scores, and (2) vitamin D supplementation will improve the Investigator's Global Assessment.


Options:
A: Number of children dying during the study period; Average weight gain in each of the treatment groups
B: Serum vitamin D levels (6 months); Tuberculin Skin Test conversion (6 monhs)
C: Change in Z score for weight and improvement in X ray film (6 months)
D: EASI score (1 month); Investigator Global Assessment (IGA) (1 month)

Answer: D
Please select the outcome measures that correspond to the clinical trial below.
Title: Randomized Trial of Vitamin D Supplementation in Winter-related, Childhood Atopic Dermatitis
Brief Summary: The goal of this clinical trial is to investigate the therapeutic role of vitamin D supplementation in a subset of patients with atopic dermatitis (AD): children with disease onset or worsening in the winter. The investigators hypothesis is that (1) vitamin D supplementation in patients with either wintertime onset or exacerbation of AD will improve Eczema Area and Severity Index (EASI) scores, and (2) vitamin D supplementation will improve the Investigator's Global Assessment.


Options:
A: Equivalency of isoforms (3 months)
B: Serum concentration of 25(OH) D at 36 weeks postmenstrual age. (36 weeks); Prevalence of vitamin D deficiency at 36 weeks postmenstrual age. (36 weeks)
C: Mean Annual Rate of Respiratory Events (Up to 2 years)
D: EASI score (1 month); Investigator Global Assessment (IGA) (1 month)

Answer: D
Please select the outcome measures that correspond to the clinical trial below.
Title: A Phase II, Double-blind, Randomized, Multi-center, Adaptive Dose-ranging, Placebo-controlled, Parallel-group Study Evaluating Safety, Tolerability and Efficacy on MRI Lesion Parameters and Determining the Dose Response Curve of BAF312 Given Orally Once Daily in Patients With Relapsing-remitting Multiple Sclerosis.
Brief Summary: The purpose of this study was to determine the dose-response curve for the MRI-based efficacy of BAF312 compared with placebo in patients with Relapsing-Remitting Multiple Sclerosis (RRMS), and to characterize its safety and tolerability for the selection of an optimal dose in a later phase III study.

Study Design Rationale An adaptive design was chosen to characterize the dose response curve of BAF312. In a first period of study ("Period 1"), three doses of BAF312 and placebo were tested for MRI efficacy. Based on an interim analysis (IA) after 3 months of treatment, two additional active doses for period 2 wereselected , thus allowing to optimize the overall determination of the dose response curve with 5 data points of active treatment, and placebo. The doses were kept blinded. The use of Modeling and Simulation allowed to establish the full range and dynamics of the dose-response curve in silico, and hence the definition of the optimal dose for later phase III studies.

The choice of placebo as treatment control was essential to obtain information on the specific compared to non-specific effects of active treatment and provides the best way of evaluating the efficacy and of assessing the true safety and tolerability profile of BAF312. Short-term placebo exposure (6 (Period 1) or 3 (Period 2) months, respectively) was unlikely to lead to longer term differences in outcomes \[Polman, 2008\]. The use of an adaptive design strategy contributed to a significant reduction of placebo exposure, both in terms of the number of patients and duration, as compared to conventional trial models.

Patients having completed the study within the protocol might be eligible for the Extension Phase study where they receive long-term BAF312 treatment (a separate protocol).


Options:
A: Dose Responsiveness of BAF312 Based on the Number of Combined Unique Active MRI Lesions (CUAL) (3 months of treatment)
B: Proportion of Participants who are overall disease activity-free at Months 12 and 24 (Baseline and Months 12 and 24); Proportion of participants who are clinical disease activity-free at Months 36 and 48 (Baseline and Months 36 and 48)
C: Kaplan-Meier Estimate of the Risk of 3-month Confirmed Disability Progression Based on Composite Endpoint (up to 36 months after the last patient was randomized)
D: Annualized Relapse Rate (ARR) at 1 Year (1 Year)

Answer: A
Please select the outcome measures that correspond to the clinical trial below.
Title: Effects of Strength Training and Walking Training on Physical Fitness of Patients With Intermittent Claudication
Brief Summary: Background: Muscle atrophy and reduced leg strength are related to exercise intolerance in patients with intermittent claudication (IC), suggesting that strength training (ST) could improve exercise performance in these patients.

Objective: Analyze the effects of ST in walking capacity in patients with IC comparing with walking training (WT) effects.

Intervention: Patients were randomized into ST and WT. Both groups trained twice a week, for 12 weeks, at the same rate of perceived exertion. ST consisted of 3 sets of 10 repetitions of whole body exercises. WT consisted of 15 two-minute bouts of walking intercalated with 2 minutes of resting.

Measurements: Walking capacity, peak VO2, walking economy, ankle brachial index, ischemic window and knee extension strength


Options:
A: Change in the walking distance to onset of leg pain, and the change in walking distance to maximal leg pain (3 months)
B: MWD change score (Measured at 6 months); MWD change score (Measured at 6 months); MWD change score (Measured at 6 months)
C: Total Walking Distance (12 weeks)
D: Change in the walking distance to onset of leg pain, and the change in walking distance to maximal leg pain. (6 months)

Answer: C
Please select the outcome measures that correspond to the clinical trial below.
Title: Effects of Strength Training and Walking Training on Physical Fitness of Patients With Intermittent Claudication
Brief Summary: Background: Muscle atrophy and reduced leg strength are related to exercise intolerance in patients with intermittent claudication (IC), suggesting that strength training (ST) could improve exercise performance in these patients.

Objective: Analyze the effects of ST in walking capacity in patients with IC comparing with walking training (WT) effects.

Intervention: Patients were randomized into ST and WT. Both groups trained twice a week, for 12 weeks, at the same rate of perceived exertion. ST consisted of 3 sets of 10 repetitions of whole body exercises. WT consisted of 15 two-minute bouts of walking intercalated with 2 minutes of resting.

Measurements: Walking capacity, peak VO2, walking economy, ankle brachial index, ischemic window and knee extension strength


Options:
A: Change in the walking distance to onset of leg pain, and the change in walking distance to maximal leg pain (3 months)
B: Six-minute walk distance (Measured at baseline and follow-up study visits); Summary performance score (Measured at baseline and follow-up study visits)
C: Treadmill walking distances - Intermittent claudication distance(ICD),maximum walking distance(MWD) (Pretreatment, 1, 3, 6, 12, 36, & 60 months post treatment); Ankle brachial pressure indices(ABPI) measured at rest and post exercise (Pretreatment, 1, 3, 6, 12, 36, & 60 months post treatment)
D: Total Walking Distance (12 weeks)

Answer: D
Please select the outcome measures that correspond to the clinical trial below.
Title: AVANDIA CV Outcomes Study: Thiazolidinedione Intervention With Vitamin D Evaluation (TIDE) A Multicenter Randomized Double-Blind Placebo-Controlled Trial of a Thiazolidinedione or Placebo and of Vitamin D or Placebo In People With Type 2 Diabetes at Risk For Cardiovascular Disease
Brief Summary: This study will answer two separate questions.

The first question is to test the cardiovascular effects of long-term treatment with rosiglitazone or pioglitazone when used as part of standard of care compared to similar standard of care without rosiglitazone or pioglitazone in patients with type 2 diabetes who have a history of or are at risk for cardiovascular disease.

The second question will compare the effects of long-term supplementation of vitamin D on death and cancer


Options:
A: rate of falls compared between treatment arms
B: 25-hydroxyvitamin D3 (25-OHD) (Baseline, 4 weeks and 3 months); Parathyroid Hormone (PTH) (Baseline); Calcium (Baseline, 4 weeks); Phosphate (Baseline); Alkaline Phosphatase (Baseline); Hemoglobin (Baseline); Creatinine (Baseline)
C: fractures (3 year follow-up)
D: Number of Participants With the Indicated Components of the Composite Cardiovascular Outcome for Thiazolidinedione (TZD) (From Randomization at Visit 3 up to the Final Visit (average of 162 days)); Number of Participants With the Indicated Components of the Composite Outcome for Vitamin D (From Randomization at Visit 3 to Final Visit (up to 162 days))

Answer: D
Please select the outcome measures that correspond to the clinical trial below.
Title: AVANDIA CV Outcomes Study: Thiazolidinedione Intervention With Vitamin D Evaluation (TIDE) A Multicenter Randomized Double-Blind Placebo-Controlled Trial of a Thiazolidinedione or Placebo and of Vitamin D or Placebo In People With Type 2 Diabetes at Risk For Cardiovascular Disease
Brief Summary: This study will answer two separate questions.

The first question is to test the cardiovascular effects of long-term treatment with rosiglitazone or pioglitazone when used as part of standard of care compared to similar standard of care without rosiglitazone or pioglitazone in patients with type 2 diabetes who have a history of or are at risk for cardiovascular disease.

The second question will compare the effects of long-term supplementation of vitamin D on death and cancer


Options:
A: Time to the Composite of All Cause Mortality, Non-Fatal Myocardial Infarction, Stroke, Acute Coronary Syndrome, Major Leg Amputation, Cardiac Intervention, Bypass Surgery or Leg Revascularization. (At First Occurrence)
B: Effect on cardiovascular death, non-fatal myocardial infarction and non-fatal stroke (Throughout study, approximately 4.5 years)
C: Number of Participants With the Indicated Components of the Composite Cardiovascular Outcome for Thiazolidinedione (TZD) (From Randomization at Visit 3 up to the Final Visit (average of 162 days)); Number of Participants With the Indicated Components of the Composite Outcome for Vitamin D (From Randomization at Visit 3 to Final Visit (up to 162 days))
D: Recurrent Fatal or Non-fatal Stroke, or Fatal or Non-fatal Myocardial Infarction (Up to 5 years)

Answer: C
Please select the outcome measures that correspond to the clinical trial below.
Title: A Randomized Controlled Trial Comparing Buprenorphine and Methadone for Opioid Dependent Chronic Pain Patients
Brief Summary: The purpose of this study is to determine if buprenorphine or methadone is better for the treatment of chronic pain among patients who have become addicted to prescription narcotics.


Options:
A: Self-reported frequency of illicit opioid use (6 months); Percentage of opioid-negative urine specimens (6 months); Maximum number of weeks abstinent from illicit opioids (6 months)
B: CDF of the percent of urine samples negative for opioids in Probuphine and Placebo groups from weeks 1-24 (1-24 weeks); CDF of the percent of urine samples negative for opioids from weeks 1-24 with imputation based on illicit drug use self-report data for Probuphine and placebo groups (1-24 weeks)
C: Number of Participants Retained in Treatment (6 months)
D: Analgesia (6 months)

Answer: C
Please select the outcome measures that correspond to the clinical trial below.
Title: A Randomized Controlled Trial Comparing Buprenorphine and Methadone for Opioid Dependent Chronic Pain Patients
Brief Summary: The purpose of this study is to determine if buprenorphine or methadone is better for the treatment of chronic pain among patients who have become addicted to prescription narcotics.


Options:
A: Retention to substance abuse treatment (12 months)
B: The cumulative distribution function (CDF) of the percent of urine samples negative for illicit opioids (weeks 1-16)
C: Number of Participants Retained in Treatment (6 months)
D: Child's Head Circumference Measurement (Measured at Birth) (birth); Child's Length of Hospital Stay (delivery until hospital discharge (min=2 days, max=79 days)); Number of Children Requiring Treatment for Neonatal Abstinence Signs (NAS) (From birth until hospital discharge (min=4 days, max=10, depending on site)); Child's Peak Daily Total NAS Score (minimum twice daily from birth until NAS no longer measured (min=10 days)); Total Amount of Morphine Sulfate That a Neonate Receives to Treat NAS (Start of NAS treatment until discontinuation of NAS treatment (min=0 days, max=76 days))

Answer: C