TrialPanorama/Dataset huggingface dataset:
Please select the outcome measures that correspond to the clinical trial below.
Title: Smoking-Cessation and Stimulant Treatment (S-CAST): Evaluation of the Impact of Concurrent Outpatient Smoking-Cessation and Stimulant Treatment on Stimulant-Dependence Outcomes
Brief Summary: The primary objective of this study is to evaluate the impact of substance-abuse treatment as usual plus smoking-cessation treatment (TAU+SCT), relative to substance-abuse treatment as usual (TAU), on drug-abuse outcomes. Specifically, this study will evaluate whether concurrent smoking-cessation treatment improves, worsens, or has no effect on stimulant-use outcomes in smokers who are in outpatient substance-abuse treatment for cocaine or methamphetamine dependence.


Options:
A: Smoking abstinence: Self reported abstinence (6 or more months without smoking) confirmed by an expired air carbon monoxide concentration of 6 parts per millions or less (12 months after initiation of study)
B: Stimulant-free Weeks Assessed by Self-report and Twice-weekly Urine Drug Screens (Week 16)
C: N/A
D: Results in Abstinence Rates (1 Year)

Answer: B
Please select the outcome measures that correspond to the clinical trial below.
Title: Impact of a Decision Aid on Patient Participation in Decision Making and Resource Use in Low Risk Chest Pain Patients: A Randomized Trial
Brief Summary: We are doing a study to assess the impact of including patients in making decision regarding their own medical care in the emergency department. We will randomly assign them to either receive a decision aid or usual care. In doing this, we aim to increase patient satisfaction and safely decrease medical cost.


Options:
A: Quality of Decision Making (Immediately following each patient's index visit and before they leave the clinic on that day, typically within 10 minutes of completing the clinical encounter.); Knowledge Transfer (Immediately following each patient's index visit and before they leave the clinic on that day, typically within 10 minutes of completing the clinical encounter.)
B: preferences (at time of interview)
C: Patient knowledge (Immediately after patient visit)
D: Feasibility of subject recruitment; feasibility of delivery of the CHD intervention and surveys in a busy practice setting; feasibility of measuring study outcomes (Measured at the end of the study period (approximately 2 years))

Answer: C
Please select the outcome measures that correspond to the clinical trial below.
Title: Impact of a Decision Aid on Patient Participation in Decision Making and Resource Use in Low Risk Chest Pain Patients: A Randomized Trial
Brief Summary: We are doing a study to assess the impact of including patients in making decision regarding their own medical care in the emergency department. We will randomly assign them to either receive a decision aid or usual care. In doing this, we aim to increase patient satisfaction and safely decrease medical cost.


Options:
A: Decision Self Efficacy (post intervention)
B: Men's understanding that prostate cancer screening requires a decision (baseline, post intervention, post clinical visit); Men's knowledge about prostate cancer and prostate cancer screening (baseline, post intervention, post clinical visit); Men's participation in the decision about prostate cancer screening with their clinician at their preferred level (baseline, post intervention, post clinical visit)
C: Patient knowledge (Immediately after patient visit)
D: Glycaemic control measured by HbA1c (12 months)

Answer: C
Please select the outcome measures that correspond to the clinical trial below.
Title: Alcohol Pharmacotherapy for HIV+ Prisoners With Alcohol Dependence and Problem Drinking
Brief Summary: This is a randomized controlled trial of injectable intramuscular naltrexone (XR-NTX) versus intramuscular placebo among HIV-infected prisoners meeting Diagnostic and Statistical Manual of Mental Disorders, Fourth Edition (DSM-IV) criteria for alcohol dependence or problem drinking, who are transitioning to the community and seeking treatment to prevent relapse to alcohol use. We hypothesize that extended release naltrexone (XR-NTX) will result in improved HIV outcomes (lower log10 HIV-1RNA levels and higher CD4 count) as well as improved alcohol treatment outcomes, and reduced drug/sex HIV related risk behaviors and decreased rates of reincarceration.


Options:
A: Primary Outcome Measure (3 years)
B: N/A
C: Percentage of Those Maintain or Improve to HIV RNA-1 Viral Load Less Then 400 Copies/mL (Baseline to month 6 post release)
D: Recurrence of intimate partner violence (18 months); Health-specific quality of life (18 months); Harms of screening and/or usual care (18 months)

Answer: C
Please select the outcome measures that correspond to the clinical trial below.
Title: Early Continuous High Volume Veno-venous Hemofiltration vs. Standard Care for Post-cardiac Surgery Shock Requiring High Doses Catecholamines. The HEROICS Study: HEmofiltration to Rescue Severe shOck followIng Cardiac Surgery
Brief Summary: This study seeks to determine if early continuous High Volume Veno-venous Hemofiltration (HVHF) reduces 30-day all cause mortality in post-cardiac surgery patients developing shock requiring high doses catecholamines.


Options:
A: Progression free survival (90 days)
B: 60-day All-cause Mortality (60 days)
C: All-cause Mortality. (90 days following study randomization.)
D: Death from all causes at 30 days after randomisation (30 days)

Answer: D
Please select the outcome measures that correspond to the clinical trial below.
Title: Early Continuous High Volume Veno-venous Hemofiltration vs. Standard Care for Post-cardiac Surgery Shock Requiring High Doses Catecholamines. The HEROICS Study: HEmofiltration to Rescue Severe shOck followIng Cardiac Surgery
Brief Summary: This study seeks to determine if early continuous High Volume Veno-venous Hemofiltration (HVHF) reduces 30-day all cause mortality in post-cardiac surgery patients developing shock requiring high doses catecholamines.


Options:
A: all-cause mortality. (28-day)
B: Death from all causes at 30 days after randomisation (30 days)
C: 60-day All-cause Mortality (60 days)
D: Death from all causes at 90 days after randomisation. (Within 90 days after randomisation)

Answer: B
Please select the outcome measures that correspond to the clinical trial below.
Title: Early Continuous High Volume Veno-venous Hemofiltration vs. Standard Care for Post-cardiac Surgery Shock Requiring High Doses Catecholamines. The HEROICS Study: HEmofiltration to Rescue Severe shOck followIng Cardiac Surgery
Brief Summary: This study seeks to determine if early continuous High Volume Veno-venous Hemofiltration (HVHF) reduces 30-day all cause mortality in post-cardiac surgery patients developing shock requiring high doses catecholamines.


Options:
A: Death from all causes at 30 days after randomisation (30 days)
B: all-cause mortality. (28-day)
C: Death from all causes at 90 days after randomisation. (Within 90 days after randomisation)
D: 60-day All-cause Mortality (60 days)

Answer: A
Please select the outcome measures that correspond to the clinical trial below.
Title: Early Continuous High Volume Veno-venous Hemofiltration vs. Standard Care for Post-cardiac Surgery Shock Requiring High Doses Catecholamines. The HEROICS Study: HEmofiltration to Rescue Severe shOck followIng Cardiac Surgery
Brief Summary: This study seeks to determine if early continuous High Volume Veno-venous Hemofiltration (HVHF) reduces 30-day all cause mortality in post-cardiac surgery patients developing shock requiring high doses catecholamines.


Options:
A: Accumulation of anti-Xa activity in plasma and removal of anti-Xa activity by filtration. (24 hours)
B: Death (90 days)
C: Death from all causes at 30 days after randomisation (30 days)
D: Death from all causes at 90 days after randomisation. (Within 90 days after randomisation)

Answer: C
Please select the outcome measures that correspond to the clinical trial below.
Title: Collaborative Behavioral e-Care to Decrease Cardiovascular Risk (e-Compare)
Brief Summary: The e-Care for Heart Wellness study will look at ways to reduce a person's chances of getting heart disease. We are asking about 100 Group Health members whose electronic medical record shows they have uncontrolled high blood pressure to be in the study. Having high blood pressure increases your future risk of heart attacks and strokes.

There are many things you can do to help keep your heart healthy. Examples include lowering blood pressure and cholesterol, eating healthier, and being more active. Our goal is to test whether getting care and supportive emails from a dietician helps people do things like this to lower their chances of having a heart attack or a stroke.

For some people, this study will involve both research and clinical care. About half the people in the study will receive care related to heart disease prevention from a dietician. It's a standard clinical practice for dieticians to help people reduce their risk of heart attacks and strokes. What's different about this study is using emails from a dietician to help people take steps to improve their heart health.


Options:
A: N/A
B: percentage of participants with increase of the adequacy of lipid-lowering prescription (up to 24 months)
C: Greater reduction in CHD risk in case group vs. control (6 months)
D: Adherence to the decision to use or not to use statins

Answer: A
Please select the outcome measures that correspond to the clinical trial below.
Title: Phase I Dose-Finding Trial of Letrozole in Postmenopausal Women at High Risk for Breast Cancer
Brief Summary: This randomized phase I trial studies the side effects and the best dose of letrozole in preventing breast cancer in healthy postmenopausal women at high risk for breast cancer. Chemoprevention is the use of drugs to keep breast cancer from forming or coming back. The use of letrozole may keep cancer from forming in healthy postmenopausal women at high risk for breast cancer.


Options:
A: Number of Participants With Major Cardiovascular Events (a Combined Endpoint of Nonfatal Myocardial Infarction, Nonfatal Stroke, and Total Cardiovascular Death) (Average follow-up 10.1 years); Number of Participants With Cancer, Excluding Nonmelanoma Skin Cancer (Average follow-up 10.1 years)
B: Percentage of serum estradiol suppression in postmenopausal women at high risk for breast cancer (Baseline to week 30)
C: The primary efficacy parameter was reduction in incident new vertebral fractures assessed by spinal radiographs (anterior-posterior and lateral) (3 years)
D: N/A

Answer: B
Please select the outcome measures that correspond to the clinical trial below.
Title: A Phase 4 12-week, Double-Blind, Placebo-Controlled, Multicenter Study Evaluating The Safety And Efficacy Of Varenicline Tartrate (CP-526,555) 1mg BID For Smoking Cessation In Subjects With Depression
Brief Summary: Patients with depression tend to have a higher prevalence of smoking as well as increased severity of nicotine dependence. Phase 2 and Phase 3 varenicline clinical trials that demonstrated its efficacy and tolerability have not included subjects with depression. This smoking cessation study focuses on the depressed population and will assess the efficacy and safety of varenicline.


Options:
A: Biochemically-confirmed 7-Day Point-Prevalence Abstinence at 26 Weeks (Assessed 26 weeks after the target quit day.)
B: Percentage of Participants With a Four-Week Continuous Quit Rate (CQR) (Week 9 through Week 12)
C: Number of Participants With Smoking Abstinence at Month 6 (Month 6)
D: 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

Answer: B
Please select the outcome measures that correspond to the clinical trial below.
Title: A Phase 4 12-week, Double-Blind, Placebo-Controlled, Multicenter Study Evaluating The Safety And Efficacy Of Varenicline Tartrate (CP-526,555) 1mg BID For Smoking Cessation In Subjects With Depression
Brief Summary: Patients with depression tend to have a higher prevalence of smoking as well as increased severity of nicotine dependence. Phase 2 and Phase 3 varenicline clinical trials that demonstrated its efficacy and tolerability have not included subjects with depression. This smoking cessation study focuses on the depressed population and will assess the efficacy and safety of varenicline.


Options:
A: Pharmacokinetic parameters: Population mean estimate for apparent plasma clearance (CL/F), central volume of distribution (V2/F) and steady-state volume of distribution (Vss/F).
B: Percentage of Participants With a Four-Week Continuous Quit Rate (CQR) (Week 9 through Week 12)
C: Prolonged Smoking Abstinence at End of 12 Weeks of Varenicline Treatment (12 weeks)
D: Proportion of participants with verified continuous smoking abstinence (Six months post-quit date)

Answer: B
Please select the outcome measures that correspond to the clinical trial below.
Title: A Phase 4 12-week, Double-Blind, Placebo-Controlled, Multicenter Study Evaluating The Safety And Efficacy Of Varenicline Tartrate (CP-526,555) 1mg BID For Smoking Cessation In Subjects With Depression
Brief Summary: Patients with depression tend to have a higher prevalence of smoking as well as increased severity of nicotine dependence. Phase 2 and Phase 3 varenicline clinical trials that demonstrated its efficacy and tolerability have not included subjects with depression. This smoking cessation study focuses on the depressed population and will assess the efficacy and safety of varenicline.


Options:
A: Percentage of Participants With a Four-Week Continuous Quit Rate (CQR) (Week 9 through Week 12)
B: to assess the continuous abstinence from tobacco smoking at every visit during the last four weeks of treatment through direct inquiry of patients; exhaled carbon monoxide testing; and plasma cotinine measurements
C: biologically verified smoking cessation or reduction (8 weeks and delivery)
D: Rating of urges to smoke 1-week after the target quit (1 week)

Answer: A
Please select the outcome measures that correspond to the clinical trial below.
Title: A Phase 4 12-week, Double-Blind, Placebo-Controlled, Multicenter Study Evaluating The Safety And Efficacy Of Varenicline Tartrate (CP-526,555) 1mg BID For Smoking Cessation In Subjects With Depression
Brief Summary: Patients with depression tend to have a higher prevalence of smoking as well as increased severity of nicotine dependence. Phase 2 and Phase 3 varenicline clinical trials that demonstrated its efficacy and tolerability have not included subjects with depression. This smoking cessation study focuses on the depressed population and will assess the efficacy and safety of varenicline.


Options:
A: Biochemically confirmed 7-day point-prevalence abstinence at 6-month (6-month follow-up)
B: Percentage of Participants With a Four-Week Continuous Quit Rate (CQR) (Week 9 through Week 12)
C: Emotional Reactivity By Pharmacotherapy (Baseline to 1 month); Emotional Reactivity By Pharmacotherapy Moderated by DRD2 A1 Allele (Baseline to 1 month)
D: Rate of 7-day Point Prevalence Abstinence at the End of the Relapse Prevention Phase (Study Week 53) in the Extended Duration Pharmacotherapy Group vs. the Placebo Group (76 weeks)

Answer: B
Please select the outcome measures that correspond to the clinical trial below.
Title: A Phase 4 12-week, Double-Blind, Placebo-Controlled, Multicenter Study Evaluating The Safety And Efficacy Of Varenicline Tartrate (CP-526,555) 1mg BID For Smoking Cessation In Subjects With Depression
Brief Summary: Patients with depression tend to have a higher prevalence of smoking as well as increased severity of nicotine dependence. Phase 2 and Phase 3 varenicline clinical trials that demonstrated its efficacy and tolerability have not included subjects with depression. This smoking cessation study focuses on the depressed population and will assess the efficacy and safety of varenicline.


Options:
A: 7 Day Point Prevalence Abstinence From All Forms of Tobacco (4 weeks after beginning study)
B: Number of Participants Completing Continuous Four-week Abstinence From Smoking Between the 8-week and 11-week Post Quit Day Visits (Period between 8-week and 11-week visits post target Quit Day)
C: Percentage of Participants With a Four-Week Continuous Quit Rate (CQR) (Week 9 through Week 12)
D: Expired-air Carbon Monoxide Confirmed Smoking Abstinence (52 weeks)

Answer: C
Please select the outcome measures that correspond to the clinical trial below.
Title: A Phase 4 12-week, Double-Blind, Placebo-Controlled, Multicenter Study Evaluating The Safety And Efficacy Of Varenicline Tartrate (CP-526,555) 1mg BID For Smoking Cessation In Subjects With Depression
Brief Summary: Patients with depression tend to have a higher prevalence of smoking as well as increased severity of nicotine dependence. Phase 2 and Phase 3 varenicline clinical trials that demonstrated its efficacy and tolerability have not included subjects with depression. This smoking cessation study focuses on the depressed population and will assess the efficacy and safety of varenicline.


Options:
A: Four-week Continuous Abstinence From Cigarette Smoking (Study week 8 thru week 11)
B: Occurrence of Neuropsychiatric (NPS) Adverse Events (AE) - the Primary Study Endpoint (Treatment emergent is first dose date to last dose date (up to 12 weeks) plus 30 days.); Estimated NPS AE Rate (%), by Cohort (Treatment emergent is first dose date to last dose date (up to 12 weeks) plus 30 days.)
C: 4 week continuous quit rate ( 4 week CQR ) for weeks 9 -12
D: Percentage of Participants With a Four-Week Continuous Quit Rate (CQR) (Week 9 through Week 12)

Answer: D
Please select the outcome measures that correspond to the clinical trial below.
Title: A Phase 4 12-week, Double-Blind, Placebo-Controlled, Multicenter Study Evaluating The Safety And Efficacy Of Varenicline Tartrate (CP-526,555) 1mg BID For Smoking Cessation In Subjects With Depression
Brief Summary: Patients with depression tend to have a higher prevalence of smoking as well as increased severity of nicotine dependence. Phase 2 and Phase 3 varenicline clinical trials that demonstrated its efficacy and tolerability have not included subjects with depression. This smoking cessation study focuses on the depressed population and will assess the efficacy and safety of varenicline.


Options:
A: Percentage of Participants With a Four-Week Continuous Quit Rate (CQR) (Week 9 through Week 12)
B: Self-Reported 7-Day Point-Prevalence Abstinence (Assessed at 52 weeks after target quit day)
C: 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)
D: Long term abstinence (one year)

Answer: A
Please select the outcome measures that correspond to the clinical trial below.
Title: A Phase 4 12-week, Double-Blind, Placebo-Controlled, Multicenter Study Evaluating The Safety And Efficacy Of Varenicline Tartrate (CP-526,555) 1mg BID For Smoking Cessation In Subjects With Depression
Brief Summary: Patients with depression tend to have a higher prevalence of smoking as well as increased severity of nicotine dependence. Phase 2 and Phase 3 varenicline clinical trials that demonstrated its efficacy and tolerability have not included subjects with depression. This smoking cessation study focuses on the depressed population and will assess the efficacy and safety of varenicline.


Options:
A: 4-week continuous quit rate (CQR) for Weeks 9-12
B: Percentage of Participants With a Four-Week Continuous Quit Rate (CQR) (Week 9 through Week 12)
C: Biochemically Confirmed 7-day Point Prevalence Abstinence From Tobacco (12 weeks following start of medication)
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: B
Please select the outcome measures that correspond to the clinical trial below.
Title: A Phase 4 12-week, Double-Blind, Placebo-Controlled, Multicenter Study Evaluating The Safety And Efficacy Of Varenicline Tartrate (CP-526,555) 1mg BID For Smoking Cessation In Subjects With Depression
Brief Summary: Patients with depression tend to have a higher prevalence of smoking as well as increased severity of nicotine dependence. Phase 2 and Phase 3 varenicline clinical trials that demonstrated its efficacy and tolerability have not included subjects with depression. This smoking cessation study focuses on the depressed population and will assess the efficacy and safety of varenicline.


Options:
A: Time to Occurrence of Major Adverse Cardiovascular Event (MACE) During Treatment Period (up to Date of Last Dose of Study Drug) in Study NCT01456936. (Baseline to last dose of study drug in parent study NCT01456936 (up to 12 weeks).)
B: Percentage of Participants With a Four-Week Continuous Quit Rate (CQR) (Week 9 through Week 12)
C: Continuous Abstinence Rate (CAR) From Week 9 Through Week 12 (Week 9 through Week 12)
D: Smoking Abstinence (12 months)

Answer: B
Please select the outcome measures that correspond to the clinical trial below.
Title: A Phase II, Open Label, Non Randomised, Non Comparative, Multicentre Study to Assess the Efficacy and Safety of Olaparib Given Orally Twice Daily in Patients With Advanced Cancers Who Have a Confirmed Genetic BRCA 1 and/or BRCA2 Mutation
Brief Summary: To assess the efficacy of oral olaparib in patients with advanced cancer who have a confirmed genetic BRCA1 and/or BRCA2 mutation, by assessment of tumour response


Options:
A: Tumour Response Rate (Tumour assessments carried out at baseline ie 28 days before first study drug dose and then every 8 weeks up to 6 months after starting study treatment, then every 12 weeks until objective disease progression, assessed maximum up to 29 months)
B: Progression free survival (PFS) (To assess from the time of randomization until the date of objective disease progression or death (by any cause in the absence of progression) or approximately up to 2.5 years.)
C: Progression Free Survival (PFS) (Tumour assessment was to be assessed at screening, every 8 weeks during the study and at the withdrawal visit, up to 56 weeks. (Data cut-off for primary analysis of PFS: 15 September 2009))
D: Confirmed Objective Tumour Response (According to Response Evaluation Criteria In Solid Tumors (RECIST) (Baseline, every 8 also at study termination or initiation of confounding anti-cancer therapy.)

Answer: A