TrialPanorama/Dataset huggingface dataset:
Please select the outcome measures that correspond to the clinical trial below.
Title: Comparing Smoking Treatment Programs for Lighter Smokers
Brief Summary: The purpose of this study was to compare two different types of Food and Drug Administration (FDA) approved smoking cessation medications (nicotine patch or bupropion) used in conjunction with two levels of counseling. It was hypothesized that the higher level of counseling would have the highest rates of treatment completion and highest rates of abstinence.


Options:
A: Percent Treatment Sessions Attended (52 weeks)
B: Change from baseline prevalence of tobacco use at one week and at 2 years [Questionnaire] (One week and Two years after the completion of the intervention)
C: Primary result is percent not using NRT and not smoking at 12 weeks (point prevalence last 7 days) verified by self-declaration combined with a CO < 8 ppm and a p-cotinine < 15 ng/ml (12 weeks +/- 1 week)
D: Cigarette use (8 weeks)

Answer: A
Please select the outcome measures that correspond to the clinical trial below.
Title: Future Revascularization Evaluation in Patients With Diabetes Mellitus: Optimal Management of Multivessel Disease (FREEDOM)
Brief Summary: The purpose of this study is to compare 5-year mortality rates in diabetic individuals with multivessel coronary artery disease (CAD) who undergo either coronary artery bypass grafting (CABG) surgery or percutaneous coronary stenting.


Options:
A: M1/M2 polarization balance (day 5)
B: Safety and tolerability in patients with T2DM and severe renal insufficiency over 24 weeks of treatment (24 weeks)
C: Time From Randomisation to First Occurrence of Cardiovascular Death, Non-fatal Myocardial Infarction, or Non-fatal Stroke (a Composite Cardiovascular Outcome) (from randomisation (visit 3; month 0) to last contact (visit 16; up to month 60+30 days))
D: 5-year Composite Endpoint of All-cause Mortality, Non-fatal Myocardial Infarction, and Stroke (Measured at Year 5)

Answer: D
Please select the outcome measures that correspond to the clinical trial below.
Title: A Multicenter, Randomized, Double-Blind Study to Evaluate the Safety and Efficacy of the Addition of MK0431 to Patients With Type 2 Diabetes Mellitus Who Have Inadequate Glycemic Control on Pioglitazone Therapy
Brief Summary: The purpose of this study is to determine the safety and efficacy of an investigational drug in patients with type 2 diabetes mellitus.


Options:
A: Change from baseline in HbA1c at 52 weeks
B: Change From Baseline in HbA1c (Hemoglobin A1C) at Week 24 (Baseline and week 24)
C: Change from baseline in HbA1c after 24 weeks
D: Change from baseline in HbA1c at 24 weeks

Answer: B
Please select the outcome measures that correspond to the clinical trial below.
Title: Citalopram Treatment in Children With Autism Spectrum Disorders and High Levels of Repetitive Behavior
Brief Summary: This study will determine the efficacy and safety of citalopram compared to placebo in the treatment of children with autism.


Options:
A: Change in Mullen Scales of Early Learning - Expressive Language Raw Score (From baseline visit to six-month visit); Change in Mullen Scales of Early Learning - Combined Age Equivalent Score (From baseline visit to six-month visit)
B: Clinical Global Improvement (Week 12)
C: N/A
D: Change From Baseline in Parent Rated Social Responsiveness Scale, 2nd Edition (SRS-2) T-Score After Treatment. (Baseline; Week 4)

Answer: B
Please select the outcome measures that correspond to the clinical trial below.
Title: Citalopram Treatment in Children With Autism Spectrum Disorders and High Levels of Repetitive Behavior
Brief Summary: This study will determine the efficacy and safety of citalopram compared to placebo in the treatment of children with autism.


Options:
A: Core autistic symptoms (ATEC) (Once every 4 weeks during the first three mounth); Side effects and adverse events questionnaire (Once every 4 weeks during the first phase(12 weeks))
B: Aberrant Behavior Checklist- 2nd Edition (ABC-2): Irritability subscale raw score (Baseline to Week 12)
C: Change in Clinical Global Impressions (CGI) Global Improvement (Change from Baseline at 8 Weeks); Change in Clinical Global Impressions (CGI) Global Improvement (Change from Open-Label Baseline at 8 Weeks); Change in Lethargy Subscale of the Aberrant Behavior Checklist (ABC) (Change from Baseline at 8 Weeks.); Change in Lethargy Subscale of the Aberrant Behavior Checklist (ABC) (Change from Open-Label Baseline at 8 Weeks)
D: Clinical Global Improvement (Week 12)

Answer: D
Please select the outcome measures that correspond to the clinical trial below.
Title: Citalopram Treatment in Children With Autism Spectrum Disorders and High Levels of Repetitive Behavior
Brief Summary: This study will determine the efficacy and safety of citalopram compared to placebo in the treatment of children with autism.


Options:
A: ADHD Rating Scale (ADHDRS)-Home Version Total Score (Randomized Phase) (8 weeks)
B: Aberrant Behavior Checklist Hyperactivity Subscale (Week 8)
C: Clinical Global Improvement (Week 12)
D: N/A

Answer: C
Please select the outcome measures that correspond to the clinical trial below.
Title: Randomized, Double-Blind, Placebo-Controlled, Parallel Group Evaluation of the Efficacy and Tolerability of Two Different Doses of ELMIRON for the Treatment of Interstitial Cystitis
Brief Summary: The purpose of this study is to evaluate the safety and effectiveness of pentosan polysulfate sodium 100 mg once a day, pentosan polysulfate sodium 100 mg three times a day, and placebo for 24 weeks for the relief of bladder pain or discomfort associated with interstitial cystitis.


Options:
A: Global Response Assessment (GRA) (12 Weeks)
B: Count of Participants With Patient Global Impression of Improvement (PG-I) Score = 1 or 2 (12 weeks)
C: Number of Responders Defined as Having at Least a 30% Reduction in the O'Leary-Sant Interstitial Cystitis Symptom Index (ICSI) From Baseline to Study Endpoint (Baseline to Week 24)
D: Number consenting to join study out of eligible patients approached (6 months); Number of times therapists adhered to prescribed therapeutic protocol (12 weeks)

Answer: C
Please select the outcome measures that correspond to the clinical trial below.
Title: Phase II Trial of Doxorubicin, Vinblastine, and Gemcitabine (AVG) Chemotherapy for Non-Bulky Stage I and II Hodgkin's Lymphoma
Brief Summary: RATIONALE: Drugs used in chemotherapy, such as doxorubicin, vinblastine, and gemcitabine, work in different ways to stop cancer cells from dividing so they stop growing or die. Combining more than one drug may kill more cancer cells.

PURPOSE: This phase II trial is studying how well combination chemotherapy works in treating patients with newly diagnosed stage I or stage II Hodgkin's lymphoma.


Options:
A: Progression-free Survival by Independent Review (Up to approximately 4 years)
B: Progression-free survival
C: Response (24 weeks)
D: Progression free survival (5 years)

Answer: C
Please select the outcome measures that correspond to the clinical trial below.
Title: Phase II Trial of Doxorubicin, Vinblastine, and Gemcitabine (AVG) Chemotherapy for Non-Bulky Stage I and II Hodgkin's Lymphoma
Brief Summary: RATIONALE: Drugs used in chemotherapy, such as doxorubicin, vinblastine, and gemcitabine, work in different ways to stop cancer cells from dividing so they stop growing or die. Combining more than one drug may kill more cancer cells.

PURPOSE: This phase II trial is studying how well combination chemotherapy works in treating patients with newly diagnosed stage I or stage II Hodgkin's lymphoma.


Options:
A: To evaluate if patients resistant to the initial treatment for residual PET-positive masses after the first two courses of ABVD (PET-2 positive), can be salvaged by early shift to high-dose chemotherapy supported by stem cell rescue. (4 years)
B: Response (24 weeks)
C: Progression-free survival
D: 3-year progression-free survival (3 years)

Answer: B
Please select the outcome measures that correspond to the clinical trial below.
Title: A Multicenter, Randomized, Double-Blind Study to Evaluate the Safety and Efficacy of MK0431 Monotherapy in Patients With Type 2 Diabetes Mellitus Who Have Inadequate Glycemic Control
Brief Summary: The purpose of this clinical study is to determine the safety and efficacy of an investigational drug in patients with type 2 diabetes mellitus.


Options:
A: Change from baseline in HbA1c after 24 weeks
B: Change from baseline in HbA1c at 24 weeks
C: Change From Baseline in A1C at Week 24 (Weeks 0-24)
D: Change from baseline in HbA1c at 24 weeks

Answer: C
Please select the outcome measures that correspond to the clinical trial below.
Title: A Phase II/III, Randomized, Double-Blind, Parallel-Group, Placebo-Controlled, Multicenter Study to Evaluate the Safety and Efficacy of Rituximab in Adults With Primary Progressive Multiple Sclerosis
Brief Summary: This is a Phase II/III, randomized, double-blind, parallel group, placebo controlled, multicenter study to evaluate the safety and efficacy of rituximab in adults with PPMS. The study will enroll approximately 435 subjects at up to 60 sites in the United States and Canada.


Options:
A: Time to Confirmed Disease Progression (CDP) (96 weeks (from Screening to Week 96, and at least 12 weeks after initial progression)); Percentage of Participants With CDP (96 weeks (from Screening to Week 96, and at least 12 weeks after initial progression))
B: Small effect of an intervention (immediate after completion of study); Moderate effect of an intervention (immediate after completion of study); Large effect of an intervention (immediate after completion of study)
C: Percent Brain Volume Change (PBVC) From Baseline to Week 48 Using a Repeated Measures ANCOVA Model (Baseline (at least 14 days but not more than 6 weeks prior to Day 1), Weeks 24, 48 and including early termination visits); Percent Brain Volume Change (PBVC) From Baseline to Weeks 24 and 48 (Baseline (at least 14 days but not more than 6 weeks prior to Day 1), Weeks 24, 48)
D: 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)

Answer: A
Please select the outcome measures that correspond to the clinical trial below.
Title: A Phase II/III, Randomized, Double-Blind, Parallel-Group, Placebo-Controlled, Multicenter Study to Evaluate the Safety and Efficacy of Rituximab in Adults With Primary Progressive Multiple Sclerosis
Brief Summary: This is a Phase II/III, randomized, double-blind, parallel group, placebo controlled, multicenter study to evaluate the safety and efficacy of rituximab in adults with PPMS. The study will enroll approximately 435 subjects at up to 60 sites in the United States and Canada.


Options:
A: Number of participants with adverse events (One year after completed treatment)
B: Time to Confirmed Disease Progression (CDP) (96 weeks (from Screening to Week 96, and at least 12 weeks after initial progression)); Percentage of Participants With CDP (96 weeks (from Screening to Week 96, and at least 12 weeks after initial progression))
C: To investigate the efficacy of rituximab compared with placebo, as measured by MRI scans of the brain for the total number of lesions observed, and to evaluate the safety and tolerability of rituximab in subjects with RRMS.
D: Analysis of Changes in CSF CXCL13 Induced by Active Treatment (Rituximab) Measured 3 Months After 1st Drug Administration (3 months); Analysis of Changes in CSF BAFF Induced by Active Treatment (Rituximab) Measured 3 Months After 1st Drug Administration (3 months)

Answer: B
Please select the outcome measures that correspond to the clinical trial below.
Title: A Phase II/III, Randomized, Double-Blind, Parallel-Group, Placebo-Controlled, Multicenter Study to Evaluate the Safety and Efficacy of Rituximab in Adults With Primary Progressive Multiple Sclerosis
Brief Summary: This is a Phase II/III, randomized, double-blind, parallel group, placebo controlled, multicenter study to evaluate the safety and efficacy of rituximab in adults with PPMS. The study will enroll approximately 435 subjects at up to 60 sites in the United States and Canada.


Options:
A: Change From Baseline in Prebronchodilator Clinic-Measured, Percent-Predicted Forced Expiratory Volume in 1 Second (Baseline and Week 24); Number of Severe Asthma Exacerbations Per Patient From Baseline Through 6 Months (Baseline to Week 24)
B: Time to Confirmed Disease Progression (CDP) (96 weeks (from Screening to Week 96, and at least 12 weeks after initial progression)); Percentage of Participants With CDP (96 weeks (from Screening to Week 96, and at least 12 weeks after initial progression))
C: Visual analogue scale pain score, Oswestry disability index, medication intake (7 months)
D: Number of Participants Meeting the American College of Rheumatology 20 (ACR 20) Response at Week 16 (Week 16)

Answer: B
Please select the outcome measures that correspond to the clinical trial below.
Title: A Phase II/III, Randomized, Double-Blind, Parallel-Group, Placebo-Controlled, Multicenter Study to Evaluate the Safety and Efficacy of Rituximab in Adults With Primary Progressive Multiple Sclerosis
Brief Summary: This is a Phase II/III, randomized, double-blind, parallel group, placebo controlled, multicenter study to evaluate the safety and efficacy of rituximab in adults with PPMS. The study will enroll approximately 435 subjects at up to 60 sites in the United States and Canada.


Options:
A: Number of Patients Free of Gadolinium-enhanced T1-Weighted Magnetic Resonance Imaging (MRI) Lesions at Both Month 3 and Month 6 (Month 3 and Month 6)
B: Percent Brain Volume Change (PBVC) From Baseline to Week 48 Using a Repeated Measures ANCOVA Model (Baseline (at least 14 days but not more than 6 weeks prior to Day 1), Weeks 24, 48 and including early termination visits); Percent Brain Volume Change (PBVC) From Baseline to Weeks 24 and 48 (Baseline (at least 14 days but not more than 6 weeks prior to Day 1), Weeks 24, 48)
C: 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)
D: Time to Confirmed Disease Progression (CDP) (96 weeks (from Screening to Week 96, and at least 12 weeks after initial progression)); Percentage of Participants With CDP (96 weeks (from Screening to Week 96, and at least 12 weeks after initial progression))

Answer: D
Please select the outcome measures that correspond to the clinical trial below.
Title: A Prospective, Randomized, Open-label Study Evaluating the Viral Kinetics and Pharmacokinetics of Pegasys® Plus Copegus® and PEG-Intron® Plus Rebetol® in Interferon-naïve Patients With Chronic Hepatitis C.
Brief Summary: This study will examine the viral kinetics and pharmacokinetics of Pegasys plus ribavirin and PEG-Intron plus ribavirin in interferon-naive patients with CHC. The anticipated time on study treatment is 3-12 months, and the target sample size is 100-500 individuals.


Options:
A: SVR, defined as undetectable serum HCV RNA (24 weeks after discontinuation of treatment)
B: Sustained Virologic Response (SVR) Rate (Assessed at the end of a 24-week post-treatment follow-up)
C: Progression of Liver Disease as Indicated by Death, Hepatic Decompensation, Hepatocellular Carcinoma, or for Patients With Noncirrhotic Fibrosis at Baseline, an Increase in the Ishak Hepatic Fibrosis Score of 2 or More Points (1400 days (3.85 years) post randomization); Increase in Ishak Fibrosis Score by 2 Points or More at 2 or 4 Year Biopsies (1400 days (3.85 years) post randomization); Death From Any Cause (1400 days (3.85 years) post randomization); Development of Hepatocellular Carcinoma (HCC) (1400 days (3.85 years) post randomization); Child-Turcotte-Pugh (CTP) Score of 7 or Higher at Two Consecutive Study Visits (1400 days (3.85 years) post randomization); Variceal Hemorrhage (1400 days (3.85 years) post randomization); Ascites (1400 days (3.85 years) post randomization); Spontaneous Bacterial Peritonitis (1400 days (3.85 years) post randomization); Hepatic Encephalopathy (1400 days (3.85 years) post randomization)
D: Change From Baseline in Viral Load (log10 Reduction) at Week 12 (From Baseline to Week 12)

Answer: D
Please select the outcome measures that correspond to the clinical trial below.
Title: Maintaining Abstinence in Chronic Cigarette Smokers
Brief Summary: The purpose of this study is to evaluate the extended pharmacological and psychological treatment for chronic cigarette smokers.


Options:
A: Smoking Behavior (2)
B: Primary result is percent not using NRT and not smoking at 12 weeks (point prevalence last 7 days) verified by self-declaration combined with a CO < 8 ppm and a p-cotinine < 15 ng/ml (12 weeks +/- 1 week)
C: Smoking Abstinence (3 months); Smoking Abstinence (6 months); Smoking Abstinence (12 months)
D: Number of Participants With Reported 7-day Point Prevalence Abstinence at Week 12 (12 weeks following treatment initiation); Number of Participants With Reported 7-day Point Prevalence Abstinence at Week 24 (24 weeks following treatment initiation); Number of Participants With Reported 7-day Point Prevalence Abstinence at Week 52 (52 weeks following treatment initiation); Number of Participants With Reported 7-day Point Prevalence Abstinence at Follow-up Week 64 (64 weeks following treatment initiation); Number of Participants With Reported 7-day Point Prevalence Abstinence at Follow-up Week 104 (104 weeks following treatment initiation)

Answer: A
Please select the outcome measures that correspond to the clinical trial below.
Title: Maintaining Abstinence in Chronic Cigarette Smokers
Brief Summary: The purpose of this study is to evaluate the extended pharmacological and psychological treatment for chronic cigarette smokers.


Options:
A: Number of Subjects With a 4 Week Continuous Quit Rate (CQR) From Smokeless Tobacco (Weeks 9 through 12)
B: To Determine the Safety of Varenicline in PLWH Who Smoke (3 months)
C: Smoking Behavior (2)
D: Days to Relapse (4 weeks)

Answer: C
Please select the outcome measures that correspond to the clinical trial below.
Title: Maintaining Abstinence in Chronic Cigarette Smokers
Brief Summary: The purpose of this study is to evaluate the extended pharmacological and psychological treatment for chronic cigarette smokers.


Options:
A: Smoking Behavior (2)
B: Emotional Reactivity By Pharmacotherapy (Baseline to 1 month); Emotional Reactivity By Pharmacotherapy Moderated by DRD2 A1 Allele (Baseline to 1 month)
C: Number of Participants With 4-week Continuous Abstinence (Weeks 9 through 12)
D: Long term abstinence (one year)

Answer: A
Please select the outcome measures that correspond to the clinical trial below.
Title: Maintaining Abstinence in Chronic Cigarette Smokers
Brief Summary: The purpose of this study is to evaluate the extended pharmacological and psychological treatment for chronic cigarette smokers.


Options:
A: Continuous abstinence Weeks 13 -24.
B: Smoking Behavior (2)
C: 52-Week Point-Prevalence Abstinence (Assessed 52 weeks after quit date)
D: Number of Participants With Reported 7-day Point Prevalence Abstinence at Week 12 (12 weeks following treatment initiation); Number of Participants With Reported 7-day Point Prevalence Abstinence at Week 24 (24 weeks following treatment initiation); Number of Participants With Reported 7-day Point Prevalence Abstinence at Week 52 (52 weeks following treatment initiation); Number of Participants With Reported 7-day Point Prevalence Abstinence at Follow-up Week 64 (64 weeks following treatment initiation); Number of Participants With Reported 7-day Point Prevalence Abstinence at Follow-up Week 104 (104 weeks following treatment initiation)

Answer: B
Please select the outcome measures that correspond to the clinical trial below.
Title: Maintaining Abstinence in Chronic Cigarette Smokers
Brief Summary: The purpose of this study is to evaluate the extended pharmacological and psychological treatment for chronic cigarette smokers.


Options:
A: Varenicline Adherence as Measured by Pill Count (Weeks 0-1, 1-2, 2-3, 4-6, 7-9, 10-12)
B: Smoking Behavior (2)
C: Will bupropion reduce relapse to smoking compared to placebo (52 weeks and 76 weeks)
D: Number of Subjects With Four Week Continuous Quit Rate (CQR) (Week 9 through Week 12)

Answer: B
Please select the outcome measures that correspond to the clinical trial below.
Title: Effects of Arzoxifene on Vertebral Fracture Incidence and on Invasive Breast Cancer Incidence in Postmenopausal Women With Osteoporosis or With Low Bone Density.
Brief Summary: The purpose of this trial is to study:

* Effects of arzoxifene on bone fractures and bone mass.
* Effects of arzoxifene on getting breast cancer.
* Effects of arzoxifene on certain types of cardiovascular events, such as heart attack and stroke.
* Effects of arzoxifene that changes the amount of certain substances in the blood that are related to osteoporosis and cardiovascular health.
* Effects of arzoxifene on the uterus.
* The safety of arzoxifene and any side effects.


Options:
A: Effects of arzoxifene on bone fractures and bone mass (5 years); Effects of arzoxifene on getting breast cancer (5 years); The safety of arzoxifene and any side effects (5 years)
B: Incidence of hip fxs; Incidence of new vertebral fxs
C: The primary efficacy parameter was reduction in incident new vertebral fractures assessed by spinal radiographs (anterior-posterior and lateral) (3 years)
D: fractures (4 years)

Answer: A
Please select the outcome measures that correspond to the clinical trial below.
Title: Efficacy and Safety of Olanzapine in Patients With Borderline Personality Disorder: A Randomized Double-Blind Comparison With Placebo
Brief Summary: The purpose of the protocol is to evaluate the efficacy and safety of olanzapine compared with placebo in patients with Borderline Personality Disorder (BPD).


Options:
A: To assess the efficacy of olanzapine therapy (5.0-10.0 mg/day) compared with placebo in patients with BPD,as defined by DSM-IV-TR criteria,; in improving overall symptomatology as measured by the last observation carried forward (LOCF) mean change from baseline to endpoint in the ZAN-BPD total score for up to 12 weeks of double-blind treatment.
B: Clinical Global Impression (CGI) (Day 0); Suicide Intent Scale (Day 0); Montgomery-Asberg depression rating scale (Day 0)
C: Beck scale for suicidal ideation (six months)
D: The number of contacts with mental health services appropriate to the patient's needs. (3 months)

Answer: A
Please select the outcome measures that correspond to the clinical trial below.
Title: Efficacy and Safety of Olanzapine in Patients With Borderline Personality Disorder: A Randomized Double-Blind Comparison With Placebo
Brief Summary: The purpose of the protocol is to evaluate the efficacy and safety of olanzapine compared with placebo in patients with Borderline Personality Disorder (BPD).


Options:
A: CGI scale for use in borderline personality disorder (CGI-BPD) (12 weeks)
B: To assess the efficacy of olanzapine therapy (5.0-10.0 mg/day) compared with placebo in patients with BPD,as defined by DSM-IV-TR criteria,; in improving overall symptomatology as measured by the last observation carried forward (LOCF) mean change from baseline to endpoint in the ZAN-BPD total score for up to 12 weeks of double-blind treatment.
C: Suicidal behaviour (3 and 6 months); Suicidal behaviour (3 and 6 months)
D: EPs during BART (Baseline (Day 0), Day 5, Day 12 and Day 30 post-tDCS)

Answer: B