TrialPanorama/Dataset huggingface dataset:
Please select the outcome measures that correspond to the clinical trial below.
Title: Randomized Study of Soy Protein and Effexor on Vasomotor Symptoms of Men With Prostate Cancer
Brief Summary: RATIONALE: Soy protein/isoflavones and venlafaxine may help relieve hot flashes in patients receiving hormone therapy for prostate cancer. It is not yet known whether soy protein/isoflavones are more effective than venlafaxine when given together or with a placebo in treating hot flashes.

PURPOSE: This randomized phase III trial is studying soy protein/isoflavones and venlafaxine to compare how well they work when given together or with a placebo in treating hot flashes in patients receiving hormone therapy for prostate cancer.


Options:
A: serial dexamethasone/CRH tests (week 0, 1, and 5)
B: depressive symptoms (3 to 28 days)
C: Hot Flash Symptom Severity Score (12 weeks)
D: HADS Anxiety (2-4 weeks prior to drug administration); HADS Anxiety (1 day prior to drug administration 1); HADS Anxiety (1 day post drug administration 1); HADS Anxiety (6 weeks post drug administration 1); HADS Anxiety (1 day prior to drug administration 2); HADS Anxiety (6 weeks post drug administration 2); HADS Anxiety (26 weeks post drug administration 2); State-Trait Anxiety Inventory (STAI) State (2-4 weeks prior to drug administration/ Baseline); STAI State (1 day prior to drug administration 1); STAI State (1 day post drug administration 1); HADS Depression (2-4 weeks prior to drug administration/ Baseline); STAI State (6 weeks post drug administration 1); STAI State (1 day prior to drug administration 2); STAI State (1 day post drug administration 2); STAI State (6 weeks post drug administration 2); STAI State (26 weeks post drug administration 2); STAI Trait (2-4 weeks prior to drug administration/ Baseline); STAI Trait (1 day prior to drug administration 1); STAI Trait (1 day post drug administration 1); STAI Trait (6 weeks post drug administration 1); STAI Trait (1 day prior to drug administration 2); STAI Trait (1 day post drug administration 2); STAI Trait (6 weeks prior to drug administration 2); STAI Trait (6 weeks post drug administration 2); HADS Depression (1 day prior to drug administration 1); HADS Depression (1 day post drug administration 1); HADS Depression (6 weeks post drug administration 1); HADS Anxiety (1 day post drug administration 2); HADS Depression (1 day post drug administration 2); HADS Depression (6 weeks post drug administration 2); HADS Depression (26 weeks post drug administration 2)

Answer: C
Please select the outcome measures that correspond to the clinical trial below.
Title: Randomized Study of Soy Protein and Effexor on Vasomotor Symptoms of Men With Prostate Cancer
Brief Summary: RATIONALE: Soy protein/isoflavones and venlafaxine may help relieve hot flashes in patients receiving hormone therapy for prostate cancer. It is not yet known whether soy protein/isoflavones are more effective than venlafaxine when given together or with a placebo in treating hot flashes.

PURPOSE: This randomized phase III trial is studying soy protein/isoflavones and venlafaxine to compare how well they work when given together or with a placebo in treating hot flashes in patients receiving hormone therapy for prostate cancer.


Options:
A: serial dexamethasone/CRH tests (week 0, 1, and 5)
B: Cycle 1 Sensory Neuropathy Score (Items 31-36, 39, 40 and 48) of the European Organization for Research and Treatment of Cancer (EORTC) Quality of Life Questionnaire (QLQ)-CIPN20 (Up to 2 weeks)
C: Overall Response Rate (ORR) (6 weeks)
D: Hot Flash Symptom Severity Score (12 weeks)

Answer: D
Please select the outcome measures that correspond to the clinical trial below.
Title: A Double-Blind, Placebo-Controlled Study of N-Acetyl Cysteine in Trichotillomania
Brief Summary: This is a 12-week, double-blind study of N-Acetyl Cysteine in the treatment of trichotillomania


Options:
A: Clinicial administered Massachusetts General Hospital Hair Pulling Scale for trichotillomania (First 6 weeks of treatment)
B: Massachusetts General Hospital Hairpulling Scale (Baseline and final visit after 12 weeks)
C: Massachusetts General Hospital Hair Pulling Scale (MGH-HPS) (Week 12)
D: National Institute of Mental Health Trichotillomania Symptom Severity Scale (This is the final score, measured at week 8 (final visit).)

Answer: B
Please select the outcome measures that correspond to the clinical trial below.
Title: Impact of Azithromycin and Clarithromycin Therapy on Pharyngeal Carriage of Macrolide-Resistant Streptococci Among Healthy Volunteers: A Randomised, Double-Blind, Placebo-Controlled Trial
Brief Summary: Resistance to antibiotics is a major public-health problem and studies linking antibiotic use and resistance have shown an association not a causal effect. Utilizing the newer macrolides, azithromycin and clarithromycin that are commonly prescribed for respiratory infections, we investigated the direct impact of antibiotic exposure on resistance at the individual level.


Options:
A: Proportion of patients reporting a decision for "immediate antibiotics." (After index consultation)
B: Antibiotic use; Length of stay in hospital
C: the antibiotic prescribing rate (within the first 2 weeks after first consultation)
D: Changes in proportions of macrolide-resistant streptococcal (MRS) carriage in the oropharynx

Answer: D
Please select the outcome measures that correspond to the clinical trial below.
Title: Impact of Azithromycin and Clarithromycin Therapy on Pharyngeal Carriage of Macrolide-Resistant Streptococci Among Healthy Volunteers: A Randomised, Double-Blind, Placebo-Controlled Trial
Brief Summary: Resistance to antibiotics is a major public-health problem and studies linking antibiotic use and resistance have shown an association not a causal effect. Utilizing the newer macrolides, azithromycin and clarithromycin that are commonly prescribed for respiratory infections, we investigated the direct impact of antibiotic exposure on resistance at the individual level.


Options:
A: Peak expiratory flow rate. (12 weeks)
B: Progression to Clinically Significant Lower Respiratory Tract Symptoms (14 days after initiation of APRIL therapy); OCELOT: Pediatric Respiratory Assessment Measure (36-72 hours after initiation of OCELOT therapy)
C: Changes in proportions of macrolide-resistant streptococcal (MRS) carriage in the oropharynx
D: To measure and compare reduction in the concentration of lower airway bacteria in patients with COPD between three different antibiotic regimes and placebo (Week 14 post treatment)

Answer: C
Please select the outcome measures that correspond to the clinical trial below.
Title: Impact of Azithromycin and Clarithromycin Therapy on Pharyngeal Carriage of Macrolide-Resistant Streptococci Among Healthy Volunteers: A Randomised, Double-Blind, Placebo-Controlled Trial
Brief Summary: Resistance to antibiotics is a major public-health problem and studies linking antibiotic use and resistance have shown an association not a causal effect. Utilizing the newer macrolides, azithromycin and clarithromycin that are commonly prescribed for respiratory infections, we investigated the direct impact of antibiotic exposure on resistance at the individual level.


Options:
A: Proportion of Participants With Severe Asthma Exacerbations (from baseline to week 26)
B: Changes in proportions of macrolide-resistant streptococcal (MRS) carriage in the oropharynx
C: Re-hospitalization or Death (6 months)
D: Comparison of number of participants with very good partial response or better response after three courses of VCD combined with clarithromycin or placebo (10 weeks)

Answer: B
Please select the outcome measures that correspond to the clinical trial below.
Title: Improving Systems for Colorectal Cancer Screening
Brief Summary: RATIONALE: Screening may help doctors find colorectal cancer sooner, when it may be easier to treat. Computerized and mailed reminders may help increase the rate of colorectal cancer screening in adults with an average risk for colorectal cancer.

PURPOSE: This randomized clinical trial is studying how well computerized and mailed reminders work in increasing the rate of colorectal cancer screening in adults with an average risk for colorectal cancer.


Options:
A: Change in screening and assessment of childhood obesity at the point of care, including BMI, blood pressure, and laboratory screening, and provision of nutrition and physical activity counseling (Baseline and 1 Year)
B: Western Ontario and McMasters Universities Osteoarthritis Index (WOMAC) (12-months)
C: Rate of colorectal cancer screening
D: Number of patients reported to the Ontario Ministry of Transportation (When participants have completed 500 patient assessments (expected to take approximately 12 months))

Answer: C
Please select the outcome measures that correspond to the clinical trial below.
Title: NT-BNP Guided Care in Addition to Multidisciplinary Care in Patients With Chronic Heart Failure A Three-Arm, Prospective, Randomised Study
Brief Summary: HF is associated with repeated hospitalisations and poor prognosis.The aim of this study is to investigate whether BNP-guided care (BGC) in addition to multidisciplinary management(MM) improves outcome compared to HNC alone or usual care (UC) for decompensated HF patients after discharge.

Patients hospitalised with cardiac decompensation in 9 Viennese hospitals are randomised to BGC, MM alone, or UC. MM includes 2 consultations of a heart failure (HF) specialist 10 days and 2 months after discharge for recommending medical optimisation and care by a specialised HF nurse including 4 home visits and telephone contact. In addition, BGC includes intensified increase of medical treatment during repeated follow-up visits in a HF clinic in patients with an Nt-BNP level above 2200pg/ml at discharge.


Options:
A: Heart failure rehospitalisation rate;; combined endpoint death or heart failure rehospitalisation;
B: Number of Participants With First Occurrence of Any Component of the Composite of Major Adverse Cardiovascular Events (Cardiovascular [CV] Death, Non-fatal Myocardial Infarction [MI] or Non-fatal Stroke) During the Time Period for Follow-up of CV Events (From randomization until the End-of-Treatment visit or the last date on which endpoints were able to be assessed (up to 4.25 years/average of 3.51 years))
C: Difference in total number of days alive and outside the hospital between the NT-proBNP guided and the clinical guided group. (minimum of one year)
D: CV Death or Heart Failure Hospitalization (24 Months)

Answer: A
Please select the outcome measures that correspond to the clinical trial below.
Title: NT-BNP Guided Care in Addition to Multidisciplinary Care in Patients With Chronic Heart Failure A Three-Arm, Prospective, Randomised Study
Brief Summary: HF is associated with repeated hospitalisations and poor prognosis.The aim of this study is to investigate whether BNP-guided care (BGC) in addition to multidisciplinary management(MM) improves outcome compared to HNC alone or usual care (UC) for decompensated HF patients after discharge.

Patients hospitalised with cardiac decompensation in 9 Viennese hospitals are randomised to BGC, MM alone, or UC. MM includes 2 consultations of a heart failure (HF) specialist 10 days and 2 months after discharge for recommending medical optimisation and care by a specialised HF nurse including 4 home visits and telephone contact. In addition, BGC includes intensified increase of medical treatment during repeated follow-up visits in a HF clinic in patients with an Nt-BNP level above 2200pg/ml at discharge.


Options:
A: Prevalence and severity of LVD (5 year)
B: Effect of Standard of Care therapy versus Standard of Care plus NT-proBNP targeted therapy on total cardiovascular events (One year)
C: Difference in total number of days alive and outside the hospital between the NT-proBNP guided and the clinical guided group. (minimum of one year)
D: Heart failure rehospitalisation rate;; combined endpoint death or heart failure rehospitalisation;

Answer: D
Please select the outcome measures that correspond to the clinical trial below.
Title: A Multicenter, Double-Blind, Randomized Conversion to Monotherapy Comparison of Two Doses of Lamotrigine for the Treatment of Partial Seizures
Brief Summary: This study is being conducted to determine the effectiveness of a lower monotherapy dose of lamotrigine than that currently approved.


Options:
A: Rate of seizure-free patients (in the first 6 weeks of the trial)
B: Assessment and comparative analysis of initial and follow-up Neuropsychological evaluation in both treated groups. (Levetiracetam and Carbamazepine) (52 weeks)
C: Percentage of Participants Who Experienced Seizure Freedom for 26-weeks During the Maintenance Phase (Week 31 through Week 109)
D: The Percentage of Participants in the 300 mg/Day Dose Group Who Prematurely Discontinued the Study Between Study Visit 5 (Approximately Week 7) and Visit 9 (End of the Treatment Phase) (From Study Visit 5 through Visit 9 of the Treatment Phase (approximately Week 7 through Week 23))

Answer: D
Please select the outcome measures that correspond to the clinical trial below.
Title: A Multicenter, Double-Blind, Randomized Conversion to Monotherapy Comparison of Two Doses of Lamotrigine for the Treatment of Partial Seizures
Brief Summary: This study is being conducted to determine the effectiveness of a lower monotherapy dose of lamotrigine than that currently approved.


Options:
A: 58-week Retention Rate Measured by the Number of Drop Outs Due to Adverse Events or Seizures From Day 1 of Treatment (58 weeks)
B: The Percentage of Participants in the 300 mg/Day Dose Group Who Prematurely Discontinued the Study Between Study Visit 5 (Approximately Week 7) and Visit 9 (End of the Treatment Phase) (From Study Visit 5 through Visit 9 of the Treatment Phase (approximately Week 7 through Week 23))
C: The Cumulative Exit Rate at 112 Days After the Beginning of the Previous Antiepileptic Drug (AED) Tapering Phase (112 days)
D: N/A

Answer: B
Please select the outcome measures that correspond to the clinical trial below.
Title: A Multicenter, Double-Blind, Randomized Conversion to Monotherapy Comparison of Two Doses of Lamotrigine for the Treatment of Partial Seizures
Brief Summary: This study is being conducted to determine the effectiveness of a lower monotherapy dose of lamotrigine than that currently approved.


Options:
A: 58-week Retention Rate Measured by the Number of Drop Outs Due to Adverse Events or Seizures From Day 1 of Treatment (58 weeks)
B: The Percentage of Participants in the 300 mg/Day Dose Group Who Prematurely Discontinued the Study Between Study Visit 5 (Approximately Week 7) and Visit 9 (End of the Treatment Phase) (From Study Visit 5 through Visit 9 of the Treatment Phase (approximately Week 7 through Week 23))
C: Proportion of Subjects in the Full Analysis Set (FAS) Remaining Seizure Free for 6 Consecutive Months (26 Consecutive Weeks) of Treatment Following Stabilization at the Last Evaluated Dose for Each Subject (6 consecutive months (26 consecutive weeks) of treatment following stabilization at the last evaluated dose for each subject); Proportion of Subjects in the Per Protocol Set (PPS) Remaining Seizure Free for 6 Consecutive Months (26 Consecutive Weeks) of Treatment Following Stabilization at the Last Evaluated Dose for Each Subject (6 consecutive months (26 consecutive weeks) of treatment); Number of Subjects With at Least One Treatment-emergent Adverse Event (AE) During the Treatment Phase (up to 113 Weeks) (Duration of the Treatment Phase (up to 113 weeks)); Number of Subjects Who Withdraw From the Study Due to a Treatment-emergent Adverse Event (AE) During the Treatment Phase (up to 113 Weeks) (Duration of the Treatment Phase (up to 113 weeks)); Number of Subjects With at Least One Treatment-emergent Serious Adverse Event (SAE) During the Treatment Phase (up to 113 Weeks) (Duration of the Treatment Phase (up to 113 weeks))
D: Percentage of Participants Who Experienced Seizure Freedom for 26-weeks During the Maintenance Phase (Week 31 through Week 109)

Answer: B
Please select the outcome measures that correspond to the clinical trial below.
Title: 24-month Double-blind, Randomized, Multicenter, Placebo-controlled, Parallel-group Study Comparing the Efficacy and Safety of 0.5 mg and 1.25 mg Fingolimod (FTY720) Administered Orally Once Daily Versus Placebo in Patients With Relapsing-remitting Multiple Sclerosis With Optional Extension Phase
Brief Summary: This study assessed the safety, tolerability and efficacy of two doses of oral fingolimod compared to placebo on efficacy parameters in patients with relapsing-remitting multiple sclerosis (RRMS).


Options:
A: Core Treatment Period: Annualized Relapse Rate (ARR): Poisson Regression Estimate (Core treatment period between 48 - 152 weeks depending on time of enrollment)
B: Number of Participants Experiencing Treatment Emergent Adverse Events (TEAEs) and Serious Adverse Events (SAEs) (From first dose to two weeks after last dose of study drug (Up to 98 weeks)); Number of Participants With Potentially Clinically Significant Vital Sign Abnormalities (From first dose to two weeks after last dose of study drug (Up to 98 weeks)); Number of Participants With Potentially Clinically Significant 12-Lead Electrocardiogram (ECG) Abnormalities (From first dose to two weeks after last dose of study drug (Up to 98 weeks)); Number of Participants With Columbia Suicide Severity Rating Scale (C-SSRS) Score at Any Post-Baseline Visit (Up to 98 weeks); Number of Participants With Potentially Clinically Significant Laboratory Abnormalities (From first dose to two weeks after last dose of study drug (Up to 98 weeks))
C: Annualized Relapse Rate (ARR) in Participants With Relapsing Multiple Sclerosis (MS) at 96 Weeks (Week 96)
D: Aggregate Annualized Relapse Rate (ARR) Estimate up to Month 24 (24 months)

Answer: D
Please select the outcome measures that correspond to the clinical trial below.
Title: 24-month Double-blind, Randomized, Multicenter, Placebo-controlled, Parallel-group Study Comparing the Efficacy and Safety of 0.5 mg and 1.25 mg Fingolimod (FTY720) Administered Orally Once Daily Versus Placebo in Patients With Relapsing-remitting Multiple Sclerosis With Optional Extension Phase
Brief Summary: This study assessed the safety, tolerability and efficacy of two doses of oral fingolimod compared to placebo on efficacy parameters in patients with relapsing-remitting multiple sclerosis (RRMS).


Options:
A: 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)
B: Aggregate Annualized Relapse Rate (ARR) Estimate up to Month 24 (24 months)
C: Change from baseline in Pulmonary function tests (particularly Forced Expiratory Volume at 1 sec (FEV1) at Day 10 (10 days); Safety of FTY720 (10 days)
D: Estimated Annualized Aggregate Relapse Rate (ARR) (Baseline to end of study (Month 24))

Answer: B
Please select the outcome measures that correspond to the clinical trial below.
Title: 24-month Double-blind, Randomized, Multicenter, Placebo-controlled, Parallel-group Study Comparing the Efficacy and Safety of 0.5 mg and 1.25 mg Fingolimod (FTY720) Administered Orally Once Daily Versus Placebo in Patients With Relapsing-remitting Multiple Sclerosis With Optional Extension Phase
Brief Summary: This study assessed the safety, tolerability and efficacy of two doses of oral fingolimod compared to placebo on efficacy parameters in patients with relapsing-remitting multiple sclerosis (RRMS).


Options:
A: Annualized Relapse Rate [ARR]: Poisson Regression Estimates (108 weeks)
B: Aggregate Annualized Relapse Rate (ARR) Estimate up to Month 24 (24 months)
C: Mean Number of Time Constant 1 (T1) Gadolinium (Gd)-Enhancing Lesions Per Participant Per Scan (Weeks 12 to 36)
D: Hazard ratio for relapses (During the first and during the second 52 weeks)

Answer: B
Please select the outcome measures that correspond to the clinical trial below.
Title: 24-month Double-blind, Randomized, Multicenter, Placebo-controlled, Parallel-group Study Comparing the Efficacy and Safety of 0.5 mg and 1.25 mg Fingolimod (FTY720) Administered Orally Once Daily Versus Placebo in Patients With Relapsing-remitting Multiple Sclerosis With Optional Extension Phase
Brief Summary: This study assessed the safety, tolerability and efficacy of two doses of oral fingolimod compared to placebo on efficacy parameters in patients with relapsing-remitting multiple sclerosis (RRMS).


Options:
A: Delay to disability deterioration as assessed by the Expanded Disability Status Scale (EDSS: 0.5 or 1 point increase, depending on baseline score) (every 4 weeks for one year, then every 8 weeks for one year)
B: Part A: Number of Participants With Adverse Events (AEs) (Baseline (Week 0) to Week 24); Part B: Rate of Development of New Active Lesions Over 24 Weeks (Baseline (Week 0) to Week 24)
C: Annualized Relapse Rate (ARR) in Participants With Relapsing Multiple Sclerosis (MS) at 96 Weeks (Week 96)
D: Aggregate Annualized Relapse Rate (ARR) Estimate up to Month 24 (24 months)

Answer: D
Please select the outcome measures that correspond to the clinical trial below.
Title: Adapting Tools to Implement Stroke Risk Management to Veterans
Brief Summary: The purpose of this study is to develop and evaluate the local adaptation of existing stroke prevention tools into practice. A stroke prevention program is a collection of materials including written materials like pamphlets and brochures, videotapes and training guides for stroke survivors and evidence based guidelines for the doctors that provide care for them. Other tools that may be used in a stroke prevention program include devices that help patients monitor medical symptoms at home like home blood pressure machines or blood sugar monitors and messaging devices that allow reporting symptoms from home to a health care provider.

We hypothesized Veterans with stroke who receive the Veteran Stroke Prevention Program would engage in better medication compliance and stroke specific quality of life compared to those who did not receive the program.


Options:
A: Stroke Specific Health Related Quality of Life (6 months for (SSQoL) and 3 months for Perceived Energy Subdomain); Self-Efficacy to Manage Stroke Symptoms (6 months)
B: Barthel Index (Change from Baseline to 2, 4, 12 and 22 weeks)
C: Blood Pressure (6 months post enrollment into trial); LDL Cholesterol (6 months post enrollment into trial); Use of Anti-thrombotic Medication (6 months post enrollment into trial)
D: Surveillance methodologies will measure arrival times of acute strokes from stroke symptoms onset to ER among participants for the length of the study, as well as increase in stroke knowledge at one month and one year post stroke event. (at one month and one year post stroke event)

Answer: A