TrialPanorama/Dataset huggingface dataset:
Please select the outcome measures that correspond to the clinical trial below.
Title: A Phase 3, Randomized, Double-blind, Placebo-controlled Study to Investigate the Efficacy, Safety and Tolerability of TMC435 Versus Placebo as Part of a Treatment Regimen Including Peginterferon α-2a (Pegasys®) and Ribavirin (Copegus®) or Peginterferon α-2b (PegIntron®) and Ribavirin (Rebetol®) in Treatment-naïve, Genotype 1, Hepatitis C-infected Subjects
Brief Summary: The purpose of this study is to investigate the effectiveness and safety of TMC435 compared with placebo in participants who are infected with genotype 1 hepatitis C virus who have never received treatment before. Participants will also receive peginterferon alfa-2a or peginterferon alfa-2b and ribavirin as part of their treatment.


Options:
A: Percentage of Participants With Sustained Virologic Response at Post Treatment Week 12 (SVR12) (Follow-up Week 12)
B: Percentage of Participants With Sustained Virologic Response 12 Weeks After Discontinuation of Therapy (SVR12) (Posttreatment Week 12); Adverse Events Leading to Permanent Discontinuation of Study Drug(s) (Up to 24 weeks)
C: Percentage of Participants With Virologic Response at Week 12 (End of treatment (EOT) (up to Week 48))
D: The Percentage of Participants Achieving a Sustained Virologic Response 12 Weeks After the Planned End of Treatment (SVR12) (Week 36 or Week 60)

Answer: D
Please select the outcome measures that correspond to the clinical trial below.
Title: A Phase 3, Randomized, Double-blind, Placebo-controlled Study to Investigate the Efficacy, Safety and Tolerability of TMC435 Versus Placebo as Part of a Treatment Regimen Including Peginterferon α-2a (Pegasys®) and Ribavirin (Copegus®) or Peginterferon α-2b (PegIntron®) and Ribavirin (Rebetol®) in Treatment-naïve, Genotype 1, Hepatitis C-infected Subjects
Brief Summary: The purpose of this study is to investigate the effectiveness and safety of TMC435 compared with placebo in participants who are infected with genotype 1 hepatitis C virus who have never received treatment before. Participants will also receive peginterferon alfa-2a or peginterferon alfa-2b and ribavirin as part of their treatment.


Options:
A: Proportion of Participants With Sustained Virologic Response 12 (SVR-12) (12 weeks post-therapy)
B: The Percentage of Participants Achieving a Sustained Virologic Response 12 Weeks After the Planned End of Treatment (SVR12) (Week 36 or Week 60)
C: Sustained Virological Response (SVR12) (60 weeks)
D: Percentage of Participants Achieving Sustained Virologic Response (SVR)12 (Posttreatment Week 12); Number of Participants Experiencing Adverse Events Leading to Permanent Discontinuation of Study Drug (Baseline to Week 12)

Answer: B
Please select the outcome measures that correspond to the clinical trial below.
Title: Blacks and Exacerbations on LABA vs. Tiotropium (BELT)
Brief Summary: We are doing this study to learn how genes affect the way that people, specifically Black people, respond to treatment for asthma. Recent studies suggest that people respond differently to some asthma medications (eg Serevent, Foradil). Some people feel better when they use these inhalers, but others may not, and some people get worse. It seems that this difference shows up more often in Blacks than in Whites, which is why we are looking for Black subjects for this study. In all people, this difference seems to depend on their genes or DNA. This study is comparing the use of long acting asthma medications (Serevent, Foradil) to Tiotropium (Spiriva) for the treatment of asthma. Spiriva is used to treat chronic obstructive pulmonary disease (COPD). This study will help to see if this medication is also useful for treating asthma and whether it works better for some people than the current asthma medications.


Options:
A: Time to Asthma Exacerbation (Mean Number of Exacerbations/Person-year) (evaluated monthly (on average) via questionnaire for 12 months)
B: Change in Mean Weekly Morning Peak Expiratory Flow From Baseline to the End of the Trial (baseline and after 16 weeks of treatment)
C: Peak Forced Expiratory Volume in 1 Second (FEV1) Response Within 3 Hours Post Dosing (0-3h) After a Treatment Period of 24 Weeks. (Baseline and 24 weeks); Trough FEV1 Response Determined After a Treatment Period of 24 Weeks. (Baseline and 24 weeks); Time to First Severe Asthma Exacerbation During the 48-week Treatment of the Pooled Data From the Two Twin Trials 205.416 (NCT00772538) and the Present 205.417 (NCT00776984). (48 weeks)
D: Time to All-Cause Mortality (Up to 3 years); Time to First COPD Exacerbation (Up to 3 years)

Answer: A
Please select the outcome measures that correspond to the clinical trial below.
Title: Blacks and Exacerbations on LABA vs. Tiotropium (BELT)
Brief Summary: We are doing this study to learn how genes affect the way that people, specifically Black people, respond to treatment for asthma. Recent studies suggest that people respond differently to some asthma medications (eg Serevent, Foradil). Some people feel better when they use these inhalers, but others may not, and some people get worse. It seems that this difference shows up more often in Blacks than in Whites, which is why we are looking for Black subjects for this study. In all people, this difference seems to depend on their genes or DNA. This study is comparing the use of long acting asthma medications (Serevent, Foradil) to Tiotropium (Spiriva) for the treatment of asthma. Spiriva is used to treat chronic obstructive pulmonary disease (COPD). This study will help to see if this medication is also useful for treating asthma and whether it works better for some people than the current asthma medications.


Options:
A: Time-to-First Serious Asthma Outcomes (SAO): Number of First SAO in the MF/F vs MF Arms (26 weeks, or 7 days after the last treatment dose, whichever occurred later)
B: Time to Asthma Exacerbation (Mean Number of Exacerbations/Person-year) (evaluated monthly (on average) via questionnaire for 12 months)
C: Peak FEV1 Within 3 Hours Post-dose Response (24 weeks); Trough FEV1 Response (24 weeks); The Responder Rate as Assessed by the ACQ From the Two Twin Trials 205.418 (NCT01172808) and the Present 205.419 (NCT01172821) (24 weeks)
D: 12 hour serial FEV1 measurements and withdrawals due to asthma exacerbation (FEV1: before start of tretment and at 2 and 12 weeks after start of treatment. Withdrawals: throughout the treatment period)

Answer: B
Please select the outcome measures that correspond to the clinical trial below.
Title: Blacks and Exacerbations on LABA vs. Tiotropium (BELT)
Brief Summary: We are doing this study to learn how genes affect the way that people, specifically Black people, respond to treatment for asthma. Recent studies suggest that people respond differently to some asthma medications (eg Serevent, Foradil). Some people feel better when they use these inhalers, but others may not, and some people get worse. It seems that this difference shows up more often in Blacks than in Whites, which is why we are looking for Black subjects for this study. In all people, this difference seems to depend on their genes or DNA. This study is comparing the use of long acting asthma medications (Serevent, Foradil) to Tiotropium (Spiriva) for the treatment of asthma. Spiriva is used to treat chronic obstructive pulmonary disease (COPD). This study will help to see if this medication is also useful for treating asthma and whether it works better for some people than the current asthma medications.


Options:
A: Time to Asthma Exacerbation (Mean Number of Exacerbations/Person-year) (evaluated monthly (on average) via questionnaire for 12 months)
B: FEV1 peak0-3 Change From Baseline (Baseline and 24 weeks)
C: Number of Participants With Any Non-serious Adverse Event (AE) and Any Serious Adverse Event (SAE) (From the start of investigational product to the last dose of treatment (up to Week 52/Withdrawal [WD]))
D: Change From Baseline in Weighted-mean 24 Hour Serial FEV1 on Day 168/Week 24 (Baseline and Day 168/Week 24)

Answer: A
Please select the outcome measures that correspond to the clinical trial below.
Title: Phase III Trial Exploring the Combination of Bevacizumab and Lomustine in Patients With First Recurrence of a Glioblastoma
Brief Summary: RATIONALE: Monoclonal antibodies, such as bevacizumab, can block tumor growth in different ways. Some block the ability of tumor cells to grow and spread. Others find tumor cells and help kill them or carry tumor-killing substances to them. Drugs used in chemotherapy, such as lomustine, work in different ways to stop the growth of tumor cells, either by killing the cells or by stopping them from dividing. It is not yet known which regimen of bevacizumab given together with lomustine is most effective in treating patients with glioblastoma multiforme in first recurrence.

PURPOSE: The primary objective of this study is to investigate whether the addition of bevacizumab to lomustine improves overall survival (OS) in patients with recurrent glioblastoma compared to treatment with lomustine alone.


Options:
A: Progression free survival (PFS) at 12 months (1 year)
B: Overall Survival (Time to event)
C: Groups 1 and 2: Progression-free survival rate (6 months post-Day 1); Group 2C: Objective Response Rate (Every 8 weeks from Day 1 through progression or initiation of other anti-cancer therapy)
D: Overall survival (From the date of randomization to 18 months or to the date of death from any cause)

Answer: B
Please select the outcome measures that correspond to the clinical trial below.
Title: Phase III Trial Exploring the Combination of Bevacizumab and Lomustine in Patients With First Recurrence of a Glioblastoma
Brief Summary: RATIONALE: Monoclonal antibodies, such as bevacizumab, can block tumor growth in different ways. Some block the ability of tumor cells to grow and spread. Others find tumor cells and help kill them or carry tumor-killing substances to them. Drugs used in chemotherapy, such as lomustine, work in different ways to stop the growth of tumor cells, either by killing the cells or by stopping them from dividing. It is not yet known which regimen of bevacizumab given together with lomustine is most effective in treating patients with glioblastoma multiforme in first recurrence.

PURPOSE: The primary objective of this study is to investigate whether the addition of bevacizumab to lomustine improves overall survival (OS) in patients with recurrent glioblastoma compared to treatment with lomustine alone.


Options:
A: Overall Survival (OS) (From randomization to date of death or last follow-up. Analysis occurs after all 390 deaths have been reported.); Progression-free Survival (PFS) (From randomization to date of progression, death, or last follow-up for progression-free survival. Analysis occurs after all 390 deaths have been reported.)
B: Overall Survival (Time to event)
C: N/A
D: Overall Survival (OS) Time (Time from randomization to death or last day known to be alive, reported between day of first participant randomized, that is, Sep 2008 until cut-off date, (19 Nov 2012))

Answer: B
Please select the outcome measures that correspond to the clinical trial below.
Title: Double-blind, Placebo-controlled Cross-over Study to Investigate the Effects of the Phosphodiesterase 5-inhibitor Vardenafil on Periphery Blood Flow and Clinical Symptoms of Patients With Raynaud's Syndrome
Brief Summary: The purpose of this study is to determine whether vardenafil is effective in improving clinical symptoms and peripheral blood flow in patients with primary and secondary Raynaud phenomenon.


Options:
A: The primary outcome variables will be frequency and duration of Raynaud's attacks, evolution of trophic digital lesions (6 weeeks and 12 weeks)
B: Change in the Raynaud's Condition Score (daily for 18 weeks)
C: Mean change in the Raynaud's Condition Score (RCS) during treatment, as compared to placebo. (7 days)
D: RP Attacks Per Day (baselin and 4 weeks)

Answer: B
Please select the outcome measures that correspond to the clinical trial below.
Title: A Multicenter, Randomized, Double-blind, Placebo-controlled, Parallel-group Study to Evaluate Prevention of Relapse in Patients With Schizophrenia Receiving Either Flexible Dose Iloperidone or Placebo in Long-term Use (up to 26 Weeks) Followed by up to 52 Weeks of Open-label Extension
Brief Summary: The purpose of this study is to determine whether Iloperidone is effective in the prevention of relapse in patients with schizophrenia


Options:
A: The primary efficacy criteria for this study is the time from randomization to the first recurrence event during the double-blind recurrence prevention period (After 68 relapse events)
B: Time to Relapse or Impending Relapse (Up to 26 weeks post-randomization)
C: Change From Baseline to Week 6 in the PANSS Total Score (Baseline to Week 6)
D: Double-blind: Percentage of Participants Who Experienced Relapse (Day 1 up to Month 15 of double blind relapse prevention period)

Answer: B
Please select the outcome measures that correspond to the clinical trial below.
Title: A Multicenter, Randomized, Double-blind, Placebo-controlled, Parallel-group Study to Evaluate Prevention of Relapse in Patients With Schizophrenia Receiving Either Flexible Dose Iloperidone or Placebo in Long-term Use (up to 26 Weeks) Followed by up to 52 Weeks of Open-label Extension
Brief Summary: The purpose of this study is to determine whether Iloperidone is effective in the prevention of relapse in patients with schizophrenia


Options:
A: The change in the total score of the Positive and Negative Syndrome Scale (PANSS) from the beginning to the end of the double-blind treatment period or to the last post-randomization assessment.
B: Clinical Utility Index (CUI) (Baseline through Week 6)
C: Composite MATRICS Consensus Cognitive Battery Score (4 weeks)
D: Time to Relapse or Impending Relapse (Up to 26 weeks post-randomization)

Answer: D
Please select the outcome measures that correspond to the clinical trial below.
Title: Testing Delivery Channels of Brief Motivational Alcohol Intervention Among General Hospital Inpatients With Risky Drinking: Personal Counseling Versus Computer-generated Feedback Letters
Brief Summary: The aim of this study is to investigate whether motivation-tailored alcohol interventions are more effective when delivered by person or by computer-generated feedback letters. A sample of 920 general hospital inpatients with risky drinking will be recruited through a computerized screening procedure. Patients with more severe alcohol problems will be excluded from the study. Participants will be allocated by time frame randomization to one of three study arms: (1) personal counseling based on Motivational Interviewing, (2) computer-expert system intervention that generates individualized feedback-letters, and (3) control group (treatment-as-usual). The interventions differ in their channel of delivery, but not regarding their content. Both intervention groups receive interventions at three time points: directly after the baseline-assessment at the general hospital, and 1 and 3 months later by mail and phone, respectively. Outcome will be assessed six, 12, 18 and 24 months after baseline.


Options:
A: N/A
B: Child Distress - unrelieved symptoms (20 weeks); Trends of PedsQL Total Scores (20 weeks); Trends of MSAS total scores (20 weeks); Trends of MSAS physical scores (20 weeks); Trends of MSAS psychological scores (20 weeks); Trends of PedsQL Physical Subscale Scores (20 weeks); Trends of PedsQL Emotional Subscale Scores (20 weeks)
C: UWQOL v4 QoL (Post-Treatment 1 Year Review Clinic)
D: Risky drinking (6, 12, 18, 24 months)

Answer: D
Please select the outcome measures that correspond to the clinical trial below.
Title: Efficacy of a Intervention to Reduce Medication Errors and Therapeutic Failure in Patients Over 65 Years Polypharmacy
Brief Summary: The purpose of this study is to demonstrate that an intervention based on the motivational interview directed to patients with polypharmacy to improve the Therapeutic Adherence and to reduce the errors of Medication in major measure that the habitual intervention.


Options:
A: medication errors in the patients (Baseline, 1, 3 and 6 months)
B: Change in Glycemic Control (HbA1c) (6 months (baseline to 6 months))
C: Patients with confirmed DRA after discharge from the index hospitalisation (12 months)
D: Change from Baseline in self-management adherence at 3 and 6 months (3 and 6 months following intervention)

Answer: A
Please select the outcome measures that correspond to the clinical trial below.
Title: Efficacy of a Intervention to Reduce Medication Errors and Therapeutic Failure in Patients Over 65 Years Polypharmacy
Brief Summary: The purpose of this study is to demonstrate that an intervention based on the motivational interview directed to patients with polypharmacy to improve the Therapeutic Adherence and to reduce the errors of Medication in major measure that the habitual intervention.


Options:
A: Failure to persist with medication regimen (6 months)
B: Medication adherence (One month after patients receive intervention materials)
C: Composite measure of proportion of patients at risk of an adverse event from specified prescribing. (Change in proportion of patients prescribed a high risk drug between baseline and 12 months after the intervention)
D: medication errors in the patients (Baseline, 1, 3 and 6 months)

Answer: D
Please select the outcome measures that correspond to the clinical trial below.
Title: Pentoxifylline Treatment in Acute Pancreatitis; A Double-Blind Placebo-Controlled Randomized Trial
Brief Summary: The purpose of this study is to determine the effects (good and bad) of giving a drug called pentoxifylline to patients with acute pancreatitis, to see if it can improve blood tests associated with inflammation (tissue damage). Pentoxifylline is approved by the US Food and Drug Administration (FDA) for treatment of circulation problems, but its use in this study is investigational, which means that the FDA has not approved it for the treatment of pancreatitis. However, the FDA has allowed the use of pentoxifylline in this research study.


Options:
A: The primary safety endpoint was the number of bleedings, and the primary efficacy endpoint was the change in SOFA between the start of the drug (day 0) and day 5. (0-60 days)
B: Change in C-Reactive Protein (CRP) (baseline, Day 1, Day 3); Change in Tumor Necrosis Factor (TNF)-Alpha (baseline, Day 1, Day 3); Change in Interleukin (IL) IL-6 (baseline, Day 1, Day 3); Changes in Interleukin (IL) IL-8 (baseline, Day 1, Day 3)
C: Post-ERCP Pancreatitis (5 days)
D: Reduction of the CRP by 20% from the control group (Day 7 post infusion)

Answer: B
Please select the outcome measures that correspond to the clinical trial below.
Title: PROMIS - Prostate MRI Imaging Study - Evaluation of Multi-Parametric Magnetic Resonance Imaging in the Diagnosis and Characterization of Prostate Cancer
Brief Summary: RATIONALE: Diagnostic procedures, such as magnetic resonance imaging (MRI), may help find prostate cancer and learn the extent of disease.

PURPOSE: This clinical trial is studying the safety of MRI and to see how well it works in diagnosing prostate cancer.


Options:
A: Safety of multiparametric magnetic resonance imaging (MP-MRI); Recruitment; Proportion of men who could safely avoid biopsy as determined by specificity and negative predictive values; Proportion of men correctly identified by MP-MRI to have clinically significant prostate cancer as determined by sensitivity and positive predictive values
B: Diagnostic accuracy of multiparametric MRI in prostate cancer diagnosis (3 months)
C: Detection of "clinically significant cancer" (using definition A, i.e. Gleason ≥7 cancers) in at least one core of SB or TB. (Between 1 and 4 months after the enrollment)
D: Feasibility of using electromagnetic devices in different cohorts. (Day 1)

Answer: A
Please select the outcome measures that correspond to the clinical trial below.
Title: Lunch in the Bag: Packing More Fruit, Vegetables, Grain in Preschool Sack Lunches
Brief Summary: Lunch is in the Bag is an intervention designed to increase fruits, vegetables, and whole grains in sack lunches prepared for preschool children. Lunch is in the Bag includes 5 weeks of parent handouts, classroom activities related to topics in the handouts, parent and child activities to reinforce behavioral constructs, and a one week booster 22 weeks later.

The primary study hypothesis is that Lunch is in the Bag will increase fruit, vegetables, and whole grains in sack lunches. Additional hypotheses are that lunches at child care centers where the program is used will have higher dietary quality than centers without the program and that children at the centers where the program is used will have a smaller increase in body mass index than children at centers with the program.

The study will also look at the child's home environment and the childcare center. Hypotheses for this research question include

1. Children at centers with Lunch is in the Bag will have greater frequency of eating fruits, vegetables, and whole grains at home than those at centers without the program.
2. Compared to parents at centers without the program, parents of children at centers with Lunch is in the Bag will have

   1. Greater knowledge, expected benefits, support, intentions, and belief in their ability for packing fruit, vegetables, and whole grain in their child's sack lunch daily.
   2. Availability of fruit, vegetable, and whole grain in the home pantry.
   3. Number of lunches with temperature in the safe range at time of service.


Options:
A: Very low food security among children according to the U.S. Household Food Security Survey Module, 30-day reference period (Between 30 and 120 days after SEBTC benefits were issued)
B: Vegetable Intake in Preschool Children (1 year 11 months)
C: Change in fruit, vegetable, whole grain in the lunch sack from baseline to 6 weeks, 22 weeks, and 28 weeks (Baseline, 6 weeks, 22 weeks, 28 weeks)
D: Satisfaction and Exit Survey Composite Scale Score -- ONLY CAREGIVERS COMPLETED THIS MEASURE (6 weeks)

Answer: C