TrialPanorama/Dataset huggingface dataset:
Please select the outcome measures that correspond to the clinical trial below.
Title: Varenicline Versus Nicotine Replacement for Methadone-Maintained Smokers
Brief Summary: RATIONALE: Varenicline, the nicotine patch, and nicotine gum help people stop smoking. It is not yet known whether varenicline is more effective than the nicotine patch given together with nicotine gum in helping smokers quit smoking.

PURPOSE: This randomized clinical trial is studying varenicline to see how well it works compared with the nicotine patch given together with nicotine gum in helping smokers in a methadone treatment program stop smoking.


Options:
A: Percent days abstinent of tobacco, alcohol and drugs (Past 90 days)
B: Four-week Continuous Abstinence From Cigarette Smoking (Study week 8 thru week 11)
C: Self- Reported 7-day Abstinence (6 Months); Carbon Monoxide (CO)-Confirmed 7-day Abstinence (6-Months); Rates of Smoking Cessation Continuous From First Quit Day to 6 Months (6-Months); Self-reported 7-day Abstinence (12 Months); CO-confirmed 7-day Abstinence (12 Months)
D: Self-reported continuous abstinence of smoking and exhaled carbon monoxide levels less than 10 ppm as measured and recorded by the research nurse at weeks 12 and 52. (1 year)

Answer: C
Please select the outcome measures that correspond to the clinical trial below.
Title: Varenicline Versus Nicotine Replacement for Methadone-Maintained Smokers
Brief Summary: RATIONALE: Varenicline, the nicotine patch, and nicotine gum help people stop smoking. It is not yet known whether varenicline is more effective than the nicotine patch given together with nicotine gum in helping smokers quit smoking.

PURPOSE: This randomized clinical trial is studying varenicline to see how well it works compared with the nicotine patch given together with nicotine gum in helping smokers in a methadone treatment program stop smoking.


Options:
A: 4 week Continuous Quit Rate ( 4 week CQR ) for Weeks 9 -12.
B: 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)
C: To assess the continuous abstinence from tobacco smoking at every visit during the last 4 weeks of treatment period, i.e. from week 4 to week 7, through direct inquiry of patients, exhaled carbon monoxide (CO) testing, and plasma cotinine measurements
D: Self- Reported 7-day Abstinence (6 Months); Carbon Monoxide (CO)-Confirmed 7-day Abstinence (6-Months); Rates of Smoking Cessation Continuous From First Quit Day to 6 Months (6-Months); Self-reported 7-day Abstinence (12 Months); CO-confirmed 7-day Abstinence (12 Months)

Answer: D
Please select the outcome measures that correspond to the clinical trial below.
Title: The SASA! Study: a Cluster Randomised Controlled Trial of a Community Mobilisation Intervention to Prevention Violence Against Women and Reduce HIV/AIDS Risk in Kampala, Uganda
Brief Summary: The SASA! Study is a cluster randomized trial of a community mobilization intervention for the prevention of HIV and gender based violence. The study is being conducted in Kampala, Uganda.


Options:
A: Past year experience of physical violence by an intimate partner (among women partnered in past year) (4 years after intervention implementation); Past year experience of sexual violence by an intimate partner (among women partnered in the past year) (4 years after intervention implementation); Acceptability of violence against women (4 years after intervention implementation); Acceptability of a woman refusing sex (4 years after intervention implementation); Community response to women experiencing physical and/or sexual IPV in past year (among women reporting physical/sexual IPV in past year) (4 years after intervention implementation); Past year concurrent sexual partner (among men partnered in past year) (4 years after intervention implementation)
B: Change in partner violence victimization (summary score) (baseline to 12 months); Change in reproductive coercion (summary score) (baseline to12 months)
C: Effectiveness of brief intervention for decreasing problem drinking and partner violence (Weekly for 3 months; then 6 and 12 months)
D: Reducing children's exposure to Intimate Partner Violence (Baseline (entry into the study), birth of the infant, and 3, 6, 12 and 24 months after the infant's birth.); Patterns of Intimate Partner Violence (Baseline (entry into the study), birth of the infant, and 3, 6, 12 and 24 months after the infant's birth.); Reducing Intimate Partner Violence (Baseline (entry into the study), birth of the infant, and 3, 6, 12 and 24 months after the infant's birth.)

Answer: A
Please select the outcome measures that correspond to the clinical trial below.
Title: The SASA! Study: a Cluster Randomised Controlled Trial of a Community Mobilisation Intervention to Prevention Violence Against Women and Reduce HIV/AIDS Risk in Kampala, Uganda
Brief Summary: The SASA! Study is a cluster randomized trial of a community mobilization intervention for the prevention of HIV and gender based violence. The study is being conducted in Kampala, Uganda.


Options:
A: Intimate partner violence (One year)
B: Past year experience of physical violence by an intimate partner (among women partnered in past year) (4 years after intervention implementation); Past year experience of sexual violence by an intimate partner (among women partnered in the past year) (4 years after intervention implementation); Acceptability of violence against women (4 years after intervention implementation); Acceptability of a woman refusing sex (4 years after intervention implementation); Community response to women experiencing physical and/or sexual IPV in past year (among women reporting physical/sexual IPV in past year) (4 years after intervention implementation); Past year concurrent sexual partner (among men partnered in past year) (4 years after intervention implementation)
C: condom use (4.5 months)
D: Severity of Violence Against Women (6 months); Women's Experience with Battering (6 months); Safety Behavior Checklist (6 months); Decisional Conflict Scale (6 months)

Answer: B
Please select the outcome measures that correspond to the clinical trial below.
Title: Short-term Atorvastatin's Effect on Acute Kidney Injury Following Cardiac Surgery
Brief Summary: Aim1a: Statin naive patient's scheduled for cardiac surgery will be randomized to 80mg atorvastatin or placebo on the day prior to surgery and then 40mg daily thereafter until hospital discharge to test the hypothesis that short-term atorvastatin use decreases:

1. acute kidney injury following cardiac surgery.
2. postoperative delirium following cardiac surgery.

Aim1b: Patients using statins preoperatively will be randomized to atorvastatin 80mg or placebo on day of surgery and 40mg or placebo on postop day 1 with resumption of preoperative statin therapy on postop day 2 to test the hypothesis that short-term atorvastatin use decreases:

1. acute kidney injury following cardiac surgery.
2. postoperative delirium following cardiac surgery.

Endpoints include glomerular filtration, urine and plasma markers of renal dysfunction, markers of oxidative stress, mitochondrial function, systemic inflammatory markers, delirium, dialysis, stroke, myocardial infarction, time to extubation, ICU length of stay, and death.


Options:
A: the development of postoperative in-hospital atrial fibrillation confirmed by 12-lead ECG (in-hospital period)
B: Vascular Nitric oxide bioavailability (Arm A + B) (At the start and at the end of 2-week treatment period (arm A) and at the start and at the end of 3-day treatment period (arm B))
C: Number of Participants With Acute Kidney Injury (postoperative day 2); Number of Participants With Delirium (while in ICU (about 2 days))
D: An absolute increase in SCr >=0.5mg/dL（>=44.2μmmol/L）or a >= 25% increase in SCr from baseline to 72h after the procedure (72 h)

Answer: C
Please select the outcome measures that correspond to the clinical trial below.
Title: Short-term Atorvastatin's Effect on Acute Kidney Injury Following Cardiac Surgery
Brief Summary: Aim1a: Statin naive patient's scheduled for cardiac surgery will be randomized to 80mg atorvastatin or placebo on the day prior to surgery and then 40mg daily thereafter until hospital discharge to test the hypothesis that short-term atorvastatin use decreases:

1. acute kidney injury following cardiac surgery.
2. postoperative delirium following cardiac surgery.

Aim1b: Patients using statins preoperatively will be randomized to atorvastatin 80mg or placebo on day of surgery and 40mg or placebo on postop day 1 with resumption of preoperative statin therapy on postop day 2 to test the hypothesis that short-term atorvastatin use decreases:

1. acute kidney injury following cardiac surgery.
2. postoperative delirium following cardiac surgery.

Endpoints include glomerular filtration, urine and plasma markers of renal dysfunction, markers of oxidative stress, mitochondrial function, systemic inflammatory markers, delirium, dialysis, stroke, myocardial infarction, time to extubation, ICU length of stay, and death.


Options:
A: Number of Participants With Acute Kidney Injury (postoperative day 2); Number of Participants With Delirium (while in ICU (about 2 days))
B: to evaluate whether 2 years of treatment with 40 mg rosuvastatin results in regression of coronary artery atheroma burden via the total atheroma volume in the most diseased segment or the percent atheroma volume, as measured by IVUS
C: Post operative atrial fibrillation detected on continuous ECG monitoring. (Monitoring will commence soon after surgery and will be continued until the end of post operative day 5); Myocardial injury assessed by Troponin release (Serial blood samples for Troponin assay will be collected at 6, 24, 48 and 120 hours after surgery)
D: The primary objective of this study is to determine whether rosuvastatin reduces the combined endpoint of cardiovascular death or non-fatal myocardial infarction (MI) or non-fatal stroke (time to first event).

Answer: A
Please select the outcome measures that correspond to the clinical trial below.
Title: Open Label Trial Concerning the Effectiveness of Trazodone in the Treatment of Fibromyalgia (Phase I) and Its Augmentation With Pregabalin in Trazodone Partial Responders (Phase II)
Brief Summary: The study has a double purpose: a first phase intends to assess the effectiveness and tolerability of trazodone, an antidepressant with sedative and sleep-promoting properties, in the treatment of fibromyalgia; a second phase intends to evaluate if the addition of pregabalin to patients who have shown a partial response to trazodone additionally improves fibromyalgia symptomatology.


Options:
A: To evaluate the efficacy of pregabalin for pain relief by comparing the mean pain score between treatment groups and placebo.
B: Mean decrease, from baseline to endpoint, in the Fibromyalgia Impact Questionnaire (Baseline, 6, 12, 18 and 24 weeks)
C: N/A
D: Change from Baseline in pain on Fibromyalgia Impact Questionnaire (FIQ) at week 6 (Baseline, week 6); Change from Baseline in Pain Pressure Threshold (PPT) at week 6 (Baseline, week 6); Change from Baseline Brain-derived neurotrophic factor at week 6 (Baseline, week 6)

Answer: B
Please select the outcome measures that correspond to the clinical trial below.
Title: A Double-Blind, Randomized Phase II Study Evaluating the Efficacy and Safety of Sorafenib Compared to Placebo in Ovarian Epithelial Cancer or Primary Peritoneal Cancer Patients Who Have Achieved a Complete Clinical Response After Standard Platinum/Taxane Containing Chemotherapy
Brief Summary: Comparison of Nexavar with a placebo as maintenance therapy for patients with advanced Ovarian or primary Peritoneal cancers in complete remission following surgery and one regimen of chemotherapy.


Options:
A: Percentage of Participants With Disease Progression or Death (Data Cutoff 14 November 2011) (Screening Visit, Every 8 weeks (or 9 weeks if receiving topotecan) until progression reported between day of first participant randomized (29 October 2009) until cutoff date of 14 November 2011); Progression Free Survival (PFS; Data Cutoff 14 November 2011) (Screening Visit, Every 8 weeks (or 9 weeks if receiving topotecan) until progression reported between day of first participant randomized (29 October 2009) until cutoff date of 14 November 2011)
B: PFS Based on Investigator Assessment According to Modified Response Evaluation Criteria in Solid Tumors, Version 1.1 (mRECIST), and Additional Clinical Criteria. (First drug administration to date of disease progression or death whichever occurs first , upto 29 months); PFS Based on Investigator Assessment According to Modified Response Evaluation Criteria in Solid Tumors, Version 1.1 (mRECIST), and Additional Clinical Criteria (Follow up Analysis). (First drug administration to date of disease progression or death whichever occurs first until final Data Base Lock (DBL) 26September16, upto 62 months)
C: Progression-Free Survival (PFS) Comparison (2 Years)
D: Progression-free Survival (PFS), Based on Radiological or Pathologic Assessment (From randomization of the first patient until 32.5 months later, assessed every 8 weeks)

Answer: D
Please select the outcome measures that correspond to the clinical trial below.
Title: A Double-Blind, Randomized Phase II Study Evaluating the Efficacy and Safety of Sorafenib Compared to Placebo in Ovarian Epithelial Cancer or Primary Peritoneal Cancer Patients Who Have Achieved a Complete Clinical Response After Standard Platinum/Taxane Containing Chemotherapy
Brief Summary: Comparison of Nexavar with a placebo as maintenance therapy for patients with advanced Ovarian or primary Peritoneal cancers in complete remission following surgery and one regimen of chemotherapy.


Options:
A: progression free survival (12 months)
B: - Progression free survival (PFS) in patients who have failed one, but no more than two, prior treatments
C: Disease Control Rate (DCR) at Week 24 According to Response Evaluation Criteria In Solid Tumours (RECIST) Version 1.1 (Week 24)
D: Progression-free Survival (PFS), Based on Radiological or Pathologic Assessment (From randomization of the first patient until 32.5 months later, assessed every 8 weeks)

Answer: D
Please select the outcome measures that correspond to the clinical trial below.
Title: A Double-Blind, Randomized Phase II Study Evaluating the Efficacy and Safety of Sorafenib Compared to Placebo in Ovarian Epithelial Cancer or Primary Peritoneal Cancer Patients Who Have Achieved a Complete Clinical Response After Standard Platinum/Taxane Containing Chemotherapy
Brief Summary: Comparison of Nexavar with a placebo as maintenance therapy for patients with advanced Ovarian or primary Peritoneal cancers in complete remission following surgery and one regimen of chemotherapy.


Options:
A: Progression free survival (PFS) (4 months)
B: Progression-free Survival (PFS) Differences Between Ixabepilone Alone and Ixabepilone + Bevacizumab (Up to 37 months)
C: Progression Free Survival (PFS) - in non-tBRCA HRD positive patients (Approximately 4 years); Progression Free Survival (PFS) - in all non-tBRCA patients (Approximately 4 years)
D: Progression-free Survival (PFS), Based on Radiological or Pathologic Assessment (From randomization of the first patient until 32.5 months later, assessed every 8 weeks)

Answer: D
Please select the outcome measures that correspond to the clinical trial below.
Title: A Multicenter, Double-blind, Randomized, Placebo-controlled, Parallel-group Trial to Assess the Efficacy, Pharmacokinetics, and Safety of CDP870 Without Coadministration of MTX in Japanese Active RA Patients in Whom MTX Cannot be Administrated.
Brief Summary: The objectives of this study are to verify the superiority in efficacy (American College of Rheumatology 20%: ACR20) and investigate the pharmacokinetics and safety of CDP870 versus placebo without coadministration of MTX in active RA patients in whom MTX cannot be administrated.


Options:
A: Clinical Disease Activity Index (CDAI) Remission (≤2.8) at Both Week 20 and Week 24 (Week 20 and Week 24)
B: Percentage of ACR20 (American College of Rheumatology 20% Improvement) Responders at Week 34 in Patients Randomized at Week 18 (Baseline, Week 34)
C: American College of Rheumatology 20% (ACR20) Response at Week 12 (Baseline, Week 12)
D: American college of Rheumatolofy (ACR)-20 responder rate at Week 24

Answer: C
Please select the outcome measures that correspond to the clinical trial below.
Title: A Multicenter, Double-blind, Randomized, Placebo-controlled, Parallel-group Trial to Assess the Efficacy, Pharmacokinetics, and Safety of CDP870 Without Coadministration of MTX in Japanese Active RA Patients in Whom MTX Cannot be Administrated.
Brief Summary: The objectives of this study are to verify the superiority in efficacy (American College of Rheumatology 20%: ACR20) and investigate the pharmacokinetics and safety of CDP870 versus placebo without coadministration of MTX in active RA patients in whom MTX cannot be administrated.


Options:
A: American College of Rheumatology 20% (ACR20) Response at Week 12 (Baseline, Week 12)
B: Double-blind Period: Mean Synovitis Scores at Baseline As Measured by the Rheumatoid Arthritis Clinical Trials 6 (OMERACT 6) Rheumatoid Arthritis Magnetic Resonance Imaging Score (RAMRIS) (At baseline); Double-blind Period: Mean Change From Baseline in OMERACT 6 Wrist Synovitis Score: Planned Analysis Using Non-Parametric ANCOVA (Baseline to Day 113); Double-blind Period: Mean Change From Baseline in OMERACT 6 Wrist Synovitis Score: Post Hoc Sensitivity Analysis Using Parametric ANCOVA Analysis (Baseline to Day 113)
C: Change From Baseline in Modified Total Sharp X-Ray Score at Week 26 (Baseline, Week 26)
D: American College of Rheumatology 20% (ACR20) Response at Week 12 (Baseline, Week 12)

Answer: A
Please select the outcome measures that correspond to the clinical trial below.
Title: A Multicenter, Double-blind, Randomized, Placebo-controlled, Parallel-group Trial to Assess the Efficacy, Pharmacokinetics, and Safety of CDP870 Without Coadministration of MTX in Japanese Active RA Patients in Whom MTX Cannot be Administrated.
Brief Summary: The objectives of this study are to verify the superiority in efficacy (American College of Rheumatology 20%: ACR20) and investigate the pharmacokinetics and safety of CDP870 versus placebo without coadministration of MTX in active RA patients in whom MTX cannot be administrated.


Options:
A: Double-blind Period: Number of Participants Achieving American College of Rheumatology (ACR) 20 Response at Day 169 (Day 169); Anti-TNF Failure Sub-Study Double Blind Period : Number of Participants With Positive Anti-abatacept or Anti-Cytotoxic T Lymphocyte Antigen 4-T Cell (CTLA4-T) Response in Anti-TNF Failure Population (Days 85, and 169 and postvisits on Days 28, 56, and 85)
B: American College of Rheumatology 20% (ACR20) Response at Week 12 (Baseline, Week 12)
C: Percentage of Participants Achieving American College of Rheumatology 50 (ACR50) Response at Week 24 (Week 24)
D: Percentage of Participants Achieving American College of Rheumatology 20% (ACR20) Response at Week 6 (Week 6)

Answer: B
Please select the outcome measures that correspond to the clinical trial below.
Title: A Multicenter, Double-blind, Randomized, Placebo-controlled, Parallel-group Trial to Assess the Efficacy, Pharmacokinetics, and Safety of CDP870 Without Coadministration of MTX in Japanese Active RA Patients in Whom MTX Cannot be Administrated.
Brief Summary: The objectives of this study are to verify the superiority in efficacy (American College of Rheumatology 20%: ACR20) and investigate the pharmacokinetics and safety of CDP870 versus placebo without coadministration of MTX in active RA patients in whom MTX cannot be administrated.


Options:
A: Double-blind Withdrawal (DBW) Period; Percentage of Participants With Positive Anti-Abatacept or Anti-Cytotoxic T-Lymphocyte Antigen 4 (CTLA4) Antibody Responses by Enzyme-Linked Immunosorbent Assay (ELISA) at Day 169 (Day 169); Re-introduction (RI) Period; Percentage of Participants With Positive Anti-Abatacept or Anti-CTLA4 Antibody Responses by ELISA at Day 253, by DBW Period Groups (Day 253 (short term))
B: American College of Rheumatology 20% (ACR20) Response at Week 12 (Baseline, Week 12)
C: Percentage of Patients With an American College of Rheumatology 20 (ACR20) Response at Week 24 (Baseline to Week 24)
D: Percentage of Participants Achieving American College of Rheumatology 20% (ACR20) Response at Month 6 (Month 6); Change From Baseline in the Health Assessment Questionnaire-Disability Index (HAQ-DI) at Month 3 (Baseline, Month 3); Percentage of Participants With Disease Activity Score Using 28-Joint Count and Erythrocyte Sedimentation Rate (4 Variables) (DAS28-4 [ESR]) Less Than 2.6 at Month 6 (Month 6)

Answer: B
Please select the outcome measures that correspond to the clinical trial below.
Title: A Multicenter, Double-blind, Randomized, Placebo-controlled, Parallel-group Trial to Assess the Efficacy, Pharmacokinetics, and Safety of CDP870 Without Coadministration of MTX in Japanese Active RA Patients in Whom MTX Cannot be Administrated.
Brief Summary: The objectives of this study are to verify the superiority in efficacy (American College of Rheumatology 20%: ACR20) and investigate the pharmacokinetics and safety of CDP870 versus placebo without coadministration of MTX in active RA patients in whom MTX cannot be administrated.


Options:
A: American College of Rheumatology 20% (ACR20) Response at Week 12 (Baseline, Week 12)
B: Number of Subjects Experiencing Any Adverse Event (throughout entire study (61 +/- 28.9 weeks on average)); Number of Subjects Experiencing Serious Adverse Event (throughout entire study (61 +/- 28.9 weeks on average)); Number of Subjects Experiencing Any Infection (throughout entire study (61 +/- 28.9 weeks on average))
C: Percentage of Participants Achieving 28 Joint Disease Activity Score (DAS28) Less Than or Equal to (≤) 3.2 at Week 88 (Week 88)
D: Baseline change in disease activity, assessed as the Disease Activity Score (DAS28) and erythrocyte sedimentation rate, or DAS28-(4)-ESR (Day 85); Incidence and severity of adverse events and clinical laboratory abnormalities as a measure of safety and tolerability of MLTA3698A (Length of study (through Day 85))

Answer: A