TrialPanorama/Dataset huggingface dataset:
Please select the outcome measures that correspond to the clinical trial below.
Title: Maintenance Treatment for Prevention of Smoking Relapse
Brief Summary: The purpose of this study is to determine the efficacy and cost-effectiveness of long-term pharmacotherapy (using Zyban and/or nicotine replacement) for reducing the relapse rate associated with stopping smoking.


Options:
A: 7-day Point Prevalence of Smoking, Biochemically (Exhaled CO) Confirmed (6 months post quit date)
B: Seven-day point prevalence and treatment or treatment strategy (At week 6); Main effects of varenicline and nicotine patch + lozenge on smokers who remain on these medications throughout the trial as documented in questionnaires (Up to 12 weeks); Probability of response at week 12 conditional on response at week 6 and continuation of treatment (At 12 weeks); Probability of response at week 12 conditional on non-response at week 6 and continuation of treatment (At 12 weeks); Probability of response at week 12 conditional on non-response at week 6 and augmentation of treatment (At 12 weeks); Probability of response at week 12 conditional on non-response at week 6 and treatment switching (At 12 weeks); Probability that treatment continuation, switching, or augmentation confers benefit conditional upon failing to quit after the initial treatment with nicotine patch + lozenge for six weeks (12 weeks); Probability that treatment continuation, switching, or augmentation confers benefit conditional upon failing to quit after initial treatment with varenicline for six weeks (12 weeks)
C: Survival abstinence rate with maintenance treatment (48 weeks after start of treatment)
D: 7 day point prevalence of cigarette abstinence; measured at Week 13 and on a weekly basis (Weekly, and 13 weeks after beginning study medication (Week 13).)

Answer: C
Please select the outcome measures that correspond to the clinical trial below.
Title: Maintenance Treatment for Prevention of Smoking Relapse
Brief Summary: The purpose of this study is to determine the efficacy and cost-effectiveness of long-term pharmacotherapy (using Zyban and/or nicotine replacement) for reducing the relapse rate associated with stopping smoking.


Options:
A: Survival abstinence rate with maintenance treatment (48 weeks after start of treatment)
B: Number of Responders With Carbon Monoxide (CO) Confirmed 4-week Continuous Quit Rate (CQR) for Last 4 Weeks of Treatment (Trtmt) (weeks 9 through 12)
C: Percentage of Participants With Carbon Monoxide (CO) Confirmed 10-Week Continuous Abstinence (CA) From Smoking (Week 15 - 24)
D: Change in Smoking Behavior (Change in cigarettes per day from Week 2 to Week 5)

Answer: A
Please select the outcome measures that correspond to the clinical trial below.
Title: Maintenance Treatment for Prevention of Smoking Relapse
Brief Summary: The purpose of this study is to determine the efficacy and cost-effectiveness of long-term pharmacotherapy (using Zyban and/or nicotine replacement) for reducing the relapse rate associated with stopping smoking.


Options:
A: Survival abstinence rate with maintenance treatment (48 weeks after start of treatment)
B: To compare 12 weeks of treatment with varenicline 1 mg BID to placebo for smoking cessation, and to evaluate continuous abstinence from smoking for 12 weeks after the treatment period.
C: Will bupropion reduce relapse to smoking compared to placebo (52 weeks and 76 weeks)
D: Smoking Behavior (2)

Answer: A
Please select the outcome measures that correspond to the clinical trial below.
Title: Maintenance Treatment for Prevention of Smoking Relapse
Brief Summary: The purpose of this study is to determine the efficacy and cost-effectiveness of long-term pharmacotherapy (using Zyban and/or nicotine replacement) for reducing the relapse rate associated with stopping smoking.


Options:
A: Survival abstinence rate with maintenance treatment (48 weeks after start of treatment)
B: Cotinine Level (Baseline, 4 weeks, 8 weeks); Change From Baseline in Cognitive Performance (basline and 8 weeks (or end of study iif patient ended participation before the 8-weeks))
C: 7-day smoking abstinence (7 days); 6-month smoking abstinence (6 months); cost-effectiveness (6 months)
D: Four-week Continuous Abstinence From Cigarette Smoking (Study week 8 thru week 11)

Answer: A
Please select the outcome measures that correspond to the clinical trial below.
Title: Maintenance Treatment for Prevention of Smoking Relapse
Brief Summary: The purpose of this study is to determine the efficacy and cost-effectiveness of long-term pharmacotherapy (using Zyban and/or nicotine replacement) for reducing the relapse rate associated with stopping smoking.


Options:
A: Emotional Reactivity By Pharmacotherapy (Baseline to 1 month); Emotional Reactivity By Pharmacotherapy Moderated by DRD2 A1 Allele (Baseline to 1 month)
B: Survival abstinence rate with maintenance treatment (48 weeks after start of treatment)
C: The primary outcome is prolonged abstinence at 7.5 months following intervention. (7.5 months)
D: The four-week continuous quit rate over the last four weeks of treatment (Last 4 weeks of therapy)

Answer: B
Please select the outcome measures that correspond to the clinical trial below.
Title: Clinical Research Network in Nonalcoholic Steatohepatitis: Pioglitazone vs. Vitamin E vs. Placebo for the Treatment of Non-Diabetic Patients With Nonalcoholic Steatohepatitis (PIVENS)
Brief Summary: The purpose of this study is to determine if therapy with pioglitazone or vitamin E will lead to an improvement in liver histology in non-diabetic adult patients with non-alcoholic steatohepatitis (NASH).


Options:
A: Regression of white matter lesion load in terms of numbers and size in the brain (1 to 2 years)
B: Number of Participants With Improvement in Non-alcoholic Fatty Liver Disease (NAFLD) Activity Defined by Change in Standardized Scoring of Liver Biopsies at Baseline and After 96 Weeks of Treatment. (baseline and 96 weeks)
C: Change in Liver Fat (baseline and 12 months); Change in Enhanced Liver Fibrosis Score (ELF) (baseline and 12 months); Change in NAFLD Fibrosis Score (baseline and 12 months); Change in Bifidobacterium Spp. (baseline and 12 months)
D: Biomarkers related to oxidative stress (Twelve weeks)

Answer: B
Please select the outcome measures that correspond to the clinical trial below.
Title: Clinical Research Network in Nonalcoholic Steatohepatitis: Pioglitazone vs. Vitamin E vs. Placebo for the Treatment of Non-Diabetic Patients With Nonalcoholic Steatohepatitis (PIVENS)
Brief Summary: The purpose of this study is to determine if therapy with pioglitazone or vitamin E will lead to an improvement in liver histology in non-diabetic adult patients with non-alcoholic steatohepatitis (NASH).


Options:
A: Change in Liver Fat as Measured by MRI-PDFF (Baseline, 24 weeks)
B: Percentage of Responders With Disappearance of Steatohepatitis Without Worsening of Fibrosis (ie, Participants no Longer Meeting the Criteria for Steatohepatitis) (Baseline (Visit 2; Week 0) to Visit 8 (Week 52))
C: Insulin Resistance and Glucose Homeostasis (baseline and 6 weeks)
D: Number of Participants With Improvement in Non-alcoholic Fatty Liver Disease (NAFLD) Activity Defined by Change in Standardized Scoring of Liver Biopsies at Baseline and After 96 Weeks of Treatment. (baseline and 96 weeks)

Answer: D
Please select the outcome measures that correspond to the clinical trial below.
Title: Clinical Research Network in Nonalcoholic Steatohepatitis: Treatment of Nonalcoholic Fatty Liver Disease in Children (TONIC)
Brief Summary: The purpose of this study is to determine if therapeutic modification of insulin resistance or oxidative stress leads to improvement in serum or histologic indicators of liver injury or quality of life.


Options:
A: Number of Participants With Improvement in Non-alcoholic Fatty Liver Disease (NAFLD) Activity Defined by Change in Standardized Scoring of Liver Biopsies at Baseline and After 96 Weeks of Treatment. (baseline and 96 weeks)
B: Histological change (9 months)
C: Geometric Mean Ratio (Week 12/Baseline) of % Liver Fat as Assessed by MRI (Epanova Versus Placebo) (Baseline and 12 weeks)
D: Number of Participants With Sustained Reduction in Alanine Aminotransferase (ALT) to Either 50% of Baseline Value or < 40 IU/L (baseline and 96 weeks)

Answer: D
Please select the outcome measures that correspond to the clinical trial below.
Title: Clinical Research Network in Nonalcoholic Steatohepatitis: Treatment of Nonalcoholic Fatty Liver Disease in Children (TONIC)
Brief Summary: The purpose of this study is to determine if therapeutic modification of insulin resistance or oxidative stress leads to improvement in serum or histologic indicators of liver injury or quality of life.


Options:
A: Number of Participants With Sustained Reduction in Alanine Aminotransferase (ALT) to Either 50% of Baseline Value or < 40 IU/L (baseline and 96 weeks)
B: Major Cardiovascular Events (5 years)
C: Liver Histological improvement (48 weeks)
D: Number of Participants With Improvement in Non-alcoholic Fatty Liver Disease (NAFLD) Activity Defined by Change in Standardized Scoring of Liver Biopsies at Baseline and After 96 Weeks of Treatment. (baseline and 96 weeks)

Answer: A
Please select the outcome measures that correspond to the clinical trial below.
Title: A Phase II-III Prospective, Randomized, Double-Blind, Placebo-Controlled Efficacy and Safety Study of Oxypurinol Added to Standard Therapy in Patients With NYHA Class III-IV Congestive Heart Failure
Brief Summary: The OPT-CHF (OxyPurinol Therapy for CHF) study is designed to demonstrate the efficacy and safety of oral oxypurinol vs. placebo in a randomized, double-blind, twenty-four week trial in 400 patients in up to 50 centers. Measures of clinical efficacy (NYHA class and Patient Global Assessment) as well as clinical outcomes (e.g., death, worsening heart failure, and hospitalization) will be assessed as a composite endpoint in this trial.


Options:
A: Plasma Uric Acid (PUA) Responder (Months 3 and 6)
B: Percentage of Subjects Whose Serum Urate Level is <6.0 Milligrams Per Deciliter (mg/dL) at the Final Visit. (Last Visit on treatment (up to 6 months))
C: Uric Acid (mg/dL) (Week 13, Week 25, Week 53, Week 101)
D: N/A

Answer: D
Please select the outcome measures that correspond to the clinical trial below.
Title: Phase III Trial Comparing Dexamethasone (DEX) to the Combination of DEX + CC-5013 in Patients With Previously Untreated Multiple Myeloma
Brief Summary: RATIONALE: Drugs used in chemotherapy such as dexamethasone use different ways to stop cancer cells from dividing so they stop growing or die. Lenalidomide may stop the growth of multiple myeloma by stopping blood flow to the tumor. It is not yet known whether dexamethasone is more effective with or without lenalidomide in treating multiple myeloma.

PURPOSE: This randomized phase III trial is studying dexamethasone and lenalidomide to see how well they work compared to dexamethasone alone in treating patients with previously untreated stage I, stage II, or stage III multiple myeloma.


Options:
A: The primary objective is to analyze and compare the efficacy, the response rate, the CR and the response rate duration of both induction treatments and both maintenance treatments (5 years)
B: Progression Free Survival (PFS) (From randomization until disease progression. Median follow-up time was 43 months.)
C: Percentage of Participants Who Achieved Complete Response (CR) - European Group for Blood and Marrow Transplantation (EBMT) Criteria (Up to disease progression, approximately 3 years)
D: Progression-Free Survival (From date of initial registration to date of progression/relapse of disease or death from any cause, whichever came first, up to 5 years)

Answer: D
Please select the outcome measures that correspond to the clinical trial below.
Title: Randomized Intergroup Trial of First Line Treatment for Patients With Diffuse Large B-Cell Non-Hodgkin's Lymphoma With a CHOP-Like Chemotherapy Regimen With or Without the Anti-CD20 Antibody Rituximab
Brief Summary: RATIONALE: Drugs used in chemotherapy use different ways to stop cancer cells from dividing so they stop growing or die. Monoclonal antibodies such as rituximab can locate cancer cells and either kill them or deliver cancer-killing substances to them without harming normal cells. It is not yet known whether combination chemotherapy is more effective with or without rituximab in treating patients with non-Hodgkin's lymphoma.

PURPOSE: This randomized phase III trial is studying four different combination chemotherapy regimens and rituximab to see how well they work compared to four different combination chemotherapy regimens alone in treating patients with non-Hodgkin's lymphoma.


Options:
A: Treatment-related adverse events (AEs) as assessed by CTCAE v4.03 (Up to 730 days after the final JCAR017 infusion); Dose-limiting toxicities of JCAR017 (28 days after first (single-dose schedule) or second (2-dose schedule) JCAR017 infusion); Objective response rate (ORR) (24 months)
B: Time to treatment failure (TTF) at 3 years (3 years)
C: Phase I - Identification of the dose limiting toxicity (DLT) (4 weeks after CAR T cell infusion); Phase II - Efficacy (4 weeks after CAR T cell infusion)
D: Overall response rate (12 weeks); Overall Survival (6 months,1 year, 2 years); Progression-free Survival (12 weeks,6 months,1 year, 2 years); Event-free Survival (12 weeks,6 months,1 year, 2 years)

Answer: B
Please select the outcome measures that correspond to the clinical trial below.
Title: Randomized Intergroup Trial of First Line Treatment for Patients With Diffuse Large B-Cell Non-Hodgkin's Lymphoma With a CHOP-Like Chemotherapy Regimen With or Without the Anti-CD20 Antibody Rituximab
Brief Summary: RATIONALE: Drugs used in chemotherapy use different ways to stop cancer cells from dividing so they stop growing or die. Monoclonal antibodies such as rituximab can locate cancer cells and either kill them or deliver cancer-killing substances to them without harming normal cells. It is not yet known whether combination chemotherapy is more effective with or without rituximab in treating patients with non-Hodgkin's lymphoma.

PURPOSE: This randomized phase III trial is studying four different combination chemotherapy regimens and rituximab to see how well they work compared to four different combination chemotherapy regimens alone in treating patients with non-Hodgkin's lymphoma.


Options:
A: Achievement of 75% or greater improvement from baseline in the Psoriasis Area and Severity Index (PASI) after 12 weeks of double-blind treatment.
B: Number of Responders With a Reduction of Signs and Symptoms of Ankylosing Spondylitis (AS) as Measured With ASAS International Working Group Response Criteria (ASAS 20). (Week 12); Mean Change in the Modified Stoke Ankylosing Spondylitis Spine Score (mSASSS) Compared Against a Historical Control Group (Outcomes in Ankylosing Spondylitis International Study [OASIS]) Using the ANCOVA Model Adjusting for Baseline mSASSS Score (Week 104)
C: Time to treatment failure (TTF) at 3 years (3 years)
D: American College of Rheumatology (ACR)-20 responder rate at Week 24 (24 weeks)

Answer: C
Please select the outcome measures that correspond to the clinical trial below.
Title: An International Randomized Study Evaluating the Efficacy and Safety of Fondaparinux Versus Control Therapy in a Broad Range of Patients With ST Segment Elevation Acute Myocardial Infarction.
Brief Summary: This is a randomized, double blindcontrolled, parallel group, multi-center, multinational study of fondaparinux vs. control in patients with STEMI (ST segment myocardial infarction) randomized within 24 hours of the onset of symptoms.


Options:
A: Number of Subjects Reaching the Composite Endpoint of Cardiovascular (CV) Death, Nonfatal Myocardial Infarction (MI), or Nonfatal Stroke (Randomization up to 15 months)
B: Percentage of Participants With Symptomatic Recurrent Venous Thromboembolism [VTE] (i.e. the Composite of Recurrent Deep Vein Thrombosis [DVT] or Fatal or Non-fatal Pulmonary Embolism [PE]) Until the Intended End of Study Treatment (6- or 12-month study treatment period)
C: Death or recurrent myocardial infarction (up to day 30); Severe hemorrhage (up to Day 9)
D: death, myocardial infarction or refractory (up to and including Day 9); major bleeding (Up to Day 9)

Answer: C
Please select the outcome measures that correspond to the clinical trial below.
Title: A Randomized, Double-Blind, Controlled Dose Finding Study of NGX-4010 for the Treatment of Painful HIV-Associated Distal Symmetrical Polyneuropathy
Brief Summary: The purpose of the study is to determine if an investigational drug, NGX-4010 (high-concentration capsaicin patch), is effective in treating painful HIV-associated neuropathy.


Options:
A: Percent change from baseline in "average pain for the past 24 hours" Numeric Pain Rating Scale (NPRS) score (i.e., average of scores during Weeks 2 to 8, compared to baseline) in the active group compared to the control group
B: Percent change from baseline in "average pain for the past 24 hours" Numeric Pain Rating Scale (NPRS) score (i.e., average of scores during Weeks 2 to 12, compared to baseline)
C: Endpoint mean pain score derived from the subject's daily pain diary (Endpoint); Patient Global Assessment (Patient Global Impression of Change) at Termination Visit (Weeks 5 and 13); Change from baseline in functioning (score created from the Short Form-36 [SF-36] Social and Physical Functioning, Fibromyalgia Impact Questionnaire [FIQ]-Total Score, and Sheehan Disability Scale [SDS] Total Score) at Termination Visit (Baseline and Weeks 5, 9, and 13)
D: Percent change from baseline in the "average pain for the past 24 hours" Numeric Pain Rating Scale (NPRS) score (i.e., average of scores during Weeks 2-12, compared to baseline)

Answer: D
Please select the outcome measures that correspond to the clinical trial below.
Title: Randomized Clinical Trial of the Burch Modified Tanagho and Autologous Fascia Sling Procedures for Women With Predominantly Stress Urinary Incontinence
Brief Summary: The primary aim of this clinical trial is to compare the treatment success for two surgical procedures that are frequently used and have similar cure rates, yet have not been compared directly to each other in a large, rigorously conducted randomized trial. The secondary aims of the trial are to compare other outcomes for the two surgical procedures, including quality of life, sexual function, satisfaction with treatment outcomes, complications, and need for other treatment(s)after surgery. Follow-up will be a minimum of two years and up to four years.


Options:
A: 24 Month Cumulative Success Rate Computed From Kaplan Meier Time-to-event Analysis (Reported as Percent Success). (Two years); 24 Month Cumulative Stress Specific Success Rates Computed From Kaplan Meier Time-to-event Analysis (Reported as % Success) (Two years)
B: Change from baseline in average number of urinations per patient per day at Week 12
C: Number of micturitions in a 24 hour bladder diary and number of urge urinary incontinence episodes by subjects' reports per week. (Phase I, II, and III)
D: Evaluation of subjective cure (At the end of 3 months of supervised treatment)

Answer: A
Please select the outcome measures that correspond to the clinical trial below.
Title: Randomized Clinical Trial of the Burch Modified Tanagho and Autologous Fascia Sling Procedures for Women With Predominantly Stress Urinary Incontinence
Brief Summary: The primary aim of this clinical trial is to compare the treatment success for two surgical procedures that are frequently used and have similar cure rates, yet have not been compared directly to each other in a large, rigorously conducted randomized trial. The secondary aims of the trial are to compare other outcomes for the two surgical procedures, including quality of life, sexual function, satisfaction with treatment outcomes, complications, and need for other treatment(s)after surgery. Follow-up will be a minimum of two years and up to four years.


Options:
A: A change in number of cured patients (Up to 1 year)
B: 24 Month Cumulative Success Rate Computed From Kaplan Meier Time-to-event Analysis (Reported as Percent Success). (Two years); 24 Month Cumulative Stress Specific Success Rates Computed From Kaplan Meier Time-to-event Analysis (Reported as % Success) (Two years)
C: To assess the effects of maternal obesity on the concentrations and adequacy of antimicrobial activity of prophylactically administered antibiotics within tissues (subcutaneous adipose and myometrial) at the time of cesarean delivery. (6 weeks)
D: Urinary Tract Infections (three weeks post-operative)

Answer: B
Please select the outcome measures that correspond to the clinical trial below.
Title: Randomized Clinical Trial of the Burch Modified Tanagho and Autologous Fascia Sling Procedures for Women With Predominantly Stress Urinary Incontinence
Brief Summary: The primary aim of this clinical trial is to compare the treatment success for two surgical procedures that are frequently used and have similar cure rates, yet have not been compared directly to each other in a large, rigorously conducted randomized trial. The secondary aims of the trial are to compare other outcomes for the two surgical procedures, including quality of life, sexual function, satisfaction with treatment outcomes, complications, and need for other treatment(s)after surgery. Follow-up will be a minimum of two years and up to four years.


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

Answer: C
Please select the outcome measures that correspond to the clinical trial below.
Title: Folic Acid for Vascular Outcome Reduction In Transplantation (FAVORIT)
Brief Summary: The purpose of this randomized clinical trial is to determine if lowering homocysteine levels in renal transplant recipients with a multivitamin will reduce the occurrence of cardiovascular disease outcomes.


Options:
A: The composite of cardiovascular death, myocardial infarction (MI) and stroke
B: Cardiovascular disease; Cancer
C: N/A
D: Recurrent or de Novo Arteriosclerotic Cardiovascular Disease (CVD) Defined as the Occurrence of Non-fatal or Fatal Arteriosclerotic Outcomes Including Coronary Heart, Cerebrovascular, and Peripheral Vascular Disease Events (Up to 6 years (mean 4 years))

Answer: D
Please select the outcome measures that correspond to the clinical trial below.
Title: Combination Nicotine Replacement for Alcoholic Smokers
Brief Summary: The overall objective of the study is to develop recommendations for treatment programs to help alcoholic smokers to stop smoking. A sample of 175 alcohol dependent cigarette smokers will be recruited from the community and treated in a 6-month outpatient alcohol and tobacco treatment program. The 175 patients will be divided into two groups. One group will receive an active nicotine patch and active nicotine gum. The other group will receive an active nicotine patch and placebo nicotine gum. Followup assessments will be conducted for 1-year from the beginning of treatment.


Options:
A: 6 Month Smoking Abstinence (6 months after smoking quit date); 12 Month Smoking Abstinence (12 months after smoking quit date)
B: The primary outcome measure for alcohol use will be the number of drinks/week at the end of the treatment phase, relative to baseline and during-treatment data. (8 weeks)
C: Proportion of Cocaine Positive Urine Tests Per Week (Weekly Measures over 12 weeks)
D: Smoking Abstinence (12 weeks); Smoking Abstinence (2 weeks)

Answer: A