TrialPanorama/Dataset huggingface dataset:
Please select the outcome measures that correspond to the clinical trial below.
Title: AML2003 - Randomized Comparison Between Standard-Therapy and Intensified Therapy for Adult Acute Myeloid Leukemia Patients <= 60 Years. A Prospective, Randomized, Multi-center Therapy-Optimizing-Study.
Brief Summary: AML2003 is a prospective randomized trial, to investigate the value of early allogeneic stem cell transplantation in aplasia after induction therapy for high risk patients with acute myeloid leukemia.


Options:
A: Event-free and absolute survival from the date of diagnosis concerning objective 1 and from the date of randomisation concerning objective 2 (5 years); Concerning objective 3: Disease-free survival from the date of randomisation (5 years)
B: relapse-free survival (two years)
C: overall survival; relapse-free survival
D: Event free survival (after 5 years)

Answer: C
Please select the outcome measures that correspond to the clinical trial below.
Title: Comparison of Medical Therapy, Pacing and Defibrillation in Heart Failure
Brief Summary: The purpose of this study is to determine whether combined mortality and hospitalization in heart failure patients receiving optimal pharmacologic therapy can be reduced by combining optimal pharmacologic therapy and 1) biventricular pacing therapy alone or 2) biventricular pacing with defibrillation.


Options:
A: N/A
B: Time to first ICD shock following LVAD implant (Within 12 months following LVAD implant)
C: To Evaluate Over the Aggregate IMPROVE-HF Practice Sites the Relative Changes in 7 Performance Measures at 24 Months Compared With Baseline and Determine the Number of Performance Measures That Achieved a Relative 20% or Greater Positive Change. (24 Month)
D: Combination of all-cause mortality and first hospitalization (time to first event), where all-cause mortality is defined as death from all causes.

Answer: D
Please select the outcome measures that correspond to the clinical trial below.
Title: Randomised Controlled Trial of Low Dose Steroid +Aspirin +Heparin Versus Aspirin+Heparin Amongst Pregnant Women With APS
Brief Summary: Does the addition of steroids during the first trimester to the standard aspirin + heparin treatment reduce the miscarriage rates in women with antiphospholipid antibodies and recurrent first trimester miscarriage in those who had an unsuccessful pregnancy with aspirin + heparin?


Options:
A: ongoing intact pregnancy at 24 weeks of gestation (at 24 weeks of gestation)
B: Live Birth (after delivery)
C: Number of Successful Pregnancies Defined as an Ongoing Pregnancy Over 20 Weeks Gestation, Per Number of Index Pregnancies (20 weeks gestation)
D: Successful pregnancy outcome

Answer: D
Please select the outcome measures that correspond to the clinical trial below.
Title: Randomised Controlled Trial of Low Dose Steroid +Aspirin +Heparin Versus Aspirin+Heparin Amongst Pregnant Women With APS
Brief Summary: Does the addition of steroids during the first trimester to the standard aspirin + heparin treatment reduce the miscarriage rates in women with antiphospholipid antibodies and recurrent first trimester miscarriage in those who had an unsuccessful pregnancy with aspirin + heparin?


Options:
A: Successful pregnancy outcome
B: placental syndrome or thromboembolic event (9 months)
C: Fetal loss (From 12 weeks to 42 weeks gestational age)
D: Number of steps (48 hours)

Answer: A
Please select the outcome measures that correspond to the clinical trial below.
Title: Randomised Controlled Trial of Low Dose Steroid +Aspirin +Heparin Versus Aspirin+Heparin Amongst Pregnant Women With APS
Brief Summary: Does the addition of steroids during the first trimester to the standard aspirin + heparin treatment reduce the miscarriage rates in women with antiphospholipid antibodies and recurrent first trimester miscarriage in those who had an unsuccessful pregnancy with aspirin + heparin?


Options:
A: To investigate whether treatment with LMW heparin plus ASA results in an increased rate of livebirths compared to treatment with ASA alone. (Duration of pregnancy)
B: Pregnancy outcome: livebirths (>37 weeks of gestation), premature livebirths (> 24, but <37 weeks of gestation) (gestational weeks >37 and gestational weeks > 24, but <37)
C: pregnancy loss (during first 20 weeks of gregnancy)
D: Successful pregnancy outcome

Answer: D
Please select the outcome measures that correspond to the clinical trial below.
Title: Randomised Controlled Trial of Low Dose Steroid +Aspirin +Heparin Versus Aspirin+Heparin Amongst Pregnant Women With APS
Brief Summary: Does the addition of steroids during the first trimester to the standard aspirin + heparin treatment reduce the miscarriage rates in women with antiphospholipid antibodies and recurrent first trimester miscarriage in those who had an unsuccessful pregnancy with aspirin + heparin?


Options:
A: pregnancy loss (during first 20 weeks of gregnancy)
B: Successful pregnancy outcome
C: Live Birth Rate = (Number of Live Births / Total Number of Pregnancies) (pregnancy > 24weeks gestation)
D: To investigate whether treatment with LMW heparin plus ASA results in an increased rate of livebirths compared to treatment with ASA alone. (Duration of pregnancy)

Answer: B
Please select the outcome measures that correspond to the clinical trial below.
Title: Atrasentan and Zometa for Men With Androgen Independent Prostate Cancer Metastatic to Bone: A Randomized Pilot Study
Brief Summary: The main purpose of this study is to look at the effects (good or bad) that Atrasentan given alone and Atrasentan given with Zometa has on levels of bone formation and bone destruction in men with prostate cancer that has spread to the bones.


Options:
A: uNTx (Corrected by Creatinine) < 50 Nmol/mmol at Week 13 (13 weeks)
B: To compare the effects of Atrasentan monotherapy with combination therapy using Atrasentan and Zometa on bone specific alkaline phosphatase.
C: Overall survival (1:Not applicable)
D: Time to First Skeletal Related Event (Up to 10 years)

Answer: B
Please select the outcome measures that correspond to the clinical trial below.
Title: A Double-Blind Comparison of Concerta and Placebo in Adults With Attention Deficit Hyperactivity Disorder
Brief Summary: This is a double-blind, placebo-controlled study using daily doses of up to 1.3 mg/kg/day of Concerta in the treatment of adults with the DSM-IV diagnosis of attention deficit hyperactivity disorder (ADHD) (childhood onset). We hypothesize ADHD symptomatology in adults with DSM-IV ADHD will be responsive to Concerta treatment and Concerta-associated response of ADHD symptomatology in adults will be sustained over time.


Options:
A: Monitoring adverse events, blood pressure, pulse, and weight throughout the study; ECG at Screening, Baseline, 1 week after upward dose titration, Months 3, 6, 9, 12 or Early Termination; Laboratory tests Screening, Month 6, Month 12 or Early Termination
B: Adult ADHD symptoms (Conners Adult ADHD Rating Scale); Impairment ratings (CGI); Side Effects (Pittsburgh Side Effect Scale)
C: Symptom reduction using ADHD-Clinical Global Impression and ADHD Symptom Checklist Severity scale administered at each visit. (34 weeks)
D: The change from Baseline in the Adult ADHD Investigator Symptom Rating Scale (AISRS) total score as assessed by the Investigator at the Final Visit/2 Week Efficacy Assessment Visit

Answer: C
Please select the outcome measures that correspond to the clinical trial below.
Title: Prevention of Cigarette Smoking in ADHD Youth With Concerta
Brief Summary: This study will consist of a six-week open-label treatment period with an extended duration methylphenidate (OROS MPH) followed by subsequent monthly visits for 24 months in a large sample of youths aged 12-17 who meet Diagnostic and Statistical Manual of Mental Disorders, Fourth Edition (DSM-IV) criteria for ADHD.

The researchers hypothesize that OROS MPH treatment will be associated with low rates of cigarette smoking in ADHD youth.


Options:
A: The change from survey day 1 to first visit in Clinical Global Impression score (3 weeks)
B: Psychopathology: improvement on PANSS positive scale (PANSS 'Positive and Negative Syndrome Scale') (12 weeks)
C: Cigarette Smoking (24 months)
D: Korean Version of the Attention-Deficit/Hyperactivity Disorder (ADHD) Rating Scale (K-ARS) Score (Week 12); Clinical Global Impression - Severity (CGI-S) Score (Week 12); Clinical Global Impression - Improvement (CGI-I) Score (Week 12); Learning Skill Test (LST) Total Score (Week 12)

Answer: C
Please select the outcome measures that correspond to the clinical trial below.
Title: Safety and Efficacy of Sustained-Release (SR) Bupropion for Smokers Hospitalized Smokers With Acute Coronary Heart Disease
Brief Summary: The purpose of the study is to test the efficacy and safety of bupropion SR for smokers hospitalized with acute cardiovascular disease.


Options:
A: Cotinine-validated 7-day point prevalence tobacco abstinence at 1 year follow-up; Cotinine-validated 7-day point prevalence tobacco abstinence at 3 month follow-up (end of treatment)
B: The Fagerstrom Test for Nicotine Dependence, expired CO level, and urine cotinine will be used to determine if bupropion SR, when used as an adjunct to antipsychotic medication, is superior to placebo for helping patients with schizophrenia improve their (Expired CO weekly, Fagerstrom baseline and end of study, Urine cotinine baseline, week 2 and week 8); Neuropsychological testing will be used to determine the effects of smoking cessation on patient's attention and memory function. (Beginning and end of study)
C: Tobacco use abstinence (26 week)
D: Percentage of Participants With Carbon Monoxide (CO) Confirmed 10-Week Continuous Abstinence (CA) From Smoking (Week 15 - 24)

Answer: A
Please select the outcome measures that correspond to the clinical trial below.
Title: Safety and Efficacy of Sustained-Release (SR) Bupropion for Smokers Hospitalized Smokers With Acute Coronary Heart Disease
Brief Summary: The purpose of the study is to test the efficacy and safety of bupropion SR for smokers hospitalized with acute cardiovascular disease.


Options:
A: 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
B: Cotinine-validated 7-day point prevalence tobacco abstinence at 1 year follow-up; Cotinine-validated 7-day point prevalence tobacco abstinence at 3 month follow-up (end of treatment)
C: Percent Compliance With Chantix (Months 1, 2, 3)
D: Number of Participants With 4-week Continuous Abstinence (Weeks 9 through 12)

Answer: B
Please select the outcome measures that correspond to the clinical trial below.
Title: Safety and Efficacy of Sustained-Release (SR) Bupropion for Smokers Hospitalized Smokers With Acute Coronary Heart Disease
Brief Summary: The purpose of the study is to test the efficacy and safety of bupropion SR for smokers hospitalized with acute cardiovascular disease.


Options:
A: N/A
B: 7-day Point Prevalence of Smoking, Biochemically (Exhaled CO) Confirmed (6 months post quit date)
C: Cotinine-validated 7-day point prevalence tobacco abstinence at 1 year follow-up; Cotinine-validated 7-day point prevalence tobacco abstinence at 3 month follow-up (end of treatment)
D: Efficacy: Smoking abstinence rate (1 year); Efficiency: Incremental Cost-Effectiveness Ratio (1 year)

Answer: C
Please select the outcome measures that correspond to the clinical trial below.
Title: Safety and Efficacy of Sustained-Release (SR) Bupropion for Smokers Hospitalized Smokers With Acute Coronary Heart Disease
Brief Summary: The purpose of the study is to test the efficacy and safety of bupropion SR for smokers hospitalized with acute cardiovascular disease.


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: Cotinine-validated 7-day point prevalence tobacco abstinence at 1 year follow-up; Cotinine-validated 7-day point prevalence tobacco abstinence at 3 month follow-up (end of treatment)
C: Smoking cessation (point prevalence, both self reported as biochemical verified) (12 months)
D: 7 Day Point Prevalence of Cigarette Abstinence (6-month follow up); 7 Day Point Prevalence of Cigarette Abstinence (Week 8)

Answer: B
Please select the outcome measures that correspond to the clinical trial below.
Title: Safety and Efficacy of Sustained-Release (SR) Bupropion for Smokers Hospitalized Smokers With Acute Coronary Heart Disease
Brief Summary: The purpose of the study is to test the efficacy and safety of bupropion SR for smokers hospitalized with acute cardiovascular disease.


Options:
A: 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)
B: Cotinine-validated 7-day point prevalence tobacco abstinence at 1 year follow-up; Cotinine-validated 7-day point prevalence tobacco abstinence at 3 month follow-up (end of treatment)
C: effectiveness (2 years)
D: 7-day Prevalence of Abstinence From Cigarette Smoking at 12 Weeks (12 weeks); 7 Day Prevalence of Abstinence From Cigarette Smoking at 24 Weeks (24 weeks)

Answer: B
Please select the outcome measures that correspond to the clinical trial below.
Title: Safety and Efficacy of Sustained-Release (SR) Bupropion for Smokers Hospitalized Smokers With Acute Coronary Heart Disease
Brief Summary: The purpose of the study is to test the efficacy and safety of bupropion SR for smokers hospitalized with acute cardiovascular disease.


Options:
A: Safety: All-cause mortality (6 weeks); Safety: Readmission for any of CHF, unstable angina, arrhythmia, re-infarction, revascularization, stroke, or major bleeding requiring transfusion (6 weeks); Feasibility: Proportion of patients in the intervention group discharged within 72 hours ("feasible" if >= 70%); Feasibility: Proportion of patients in the intervention group who saw nurse practitioner within 3 days of discharge ("feasible" if >= 80%); Feasibility: Proportion of patients in the intervention group who saw nurse practitioner within 5 days of discharge ("feasible" if >= 90%)
B: Cotinine-validated 7-day point prevalence tobacco abstinence at 1 year follow-up; Cotinine-validated 7-day point prevalence tobacco abstinence at 3 month follow-up (end of treatment)
C: Combination of cardiac death, non-fatal myocardial infarction, and symptom-driven revascularization
D: proportion of participants who reported using any tobacco dependence treatment during the 3-month study period (3 months)

Answer: B
Please select the outcome measures that correspond to the clinical trial below.
Title: Safety and Efficacy of Sustained-Release (SR) Bupropion for Smokers Hospitalized Smokers With Acute Coronary Heart Disease
Brief Summary: The purpose of the study is to test the efficacy and safety of bupropion SR for smokers hospitalized with acute cardiovascular disease.


Options:
A: Number of Participants With Adverse Events (AEs) and Serious Adverse Events (SAEs) (Baseline up to 30 days after last dose of study treatment or up to Week 16); Number of Participants With Psychiatric Adverse Events (Baseline up to Week 24); Change From Baseline to Week 12 in Positive and Negative Syndrome Scale (PANSS): Total Score (Baseline to Week 12); Change From Baseline to Week 24 in Positive and Negative Syndrome Scale (PANSS): Total Score (Baseline to Week 24); Change From Baseline to Week 12 in Positive and Negative Syndrome Scale (PANSS): Positive Symptoms Score (Baseline to Week 12); Change From Baseline to Week 24 in Positive and Negative Syndrome Scale (PANSS): Positive Symptoms Score (Baseline to Week 24); Change From Baseline to Week 12 in Positive and Negative Syndrome Scale (PANSS): Negative Symptoms Score (Baseline to Week 12); Change From Baseline to Week 24 in Positive and Negative Syndrome Scale (PANSS): Negative Symptoms Score (Baseline to Week 24); Change From Baseline to Week 12 in Simpson Angus Rating Scale (SARS) (Baseline to Week 12); Change From Baseline to Week 24 in Simpson Angus Rating Scale (SARS) (Baseline to Week 24); Number of Participants With Suicidal Behavior and / or Ideation ("Yes" Response) on the Columbia Suicide Severity Rating Scale (C-SSRS) During the Treatment Phase (Week 1 to Week 12 (Treatment phase)); Number of Participants With Suicidal Behavior or Suicical Ideation ("Yes" Response ) on the Columbia Suicide-Severity Rating Scale (C-SSRS) During the Post Treatment Phase (Week 13 to Week 24 (Post treatment phase)); Number of Participants With Shift From Baseline to Week 12 in Clinical Global Impressions Scale-Severity (CGI-S) Score (Baseline (Bsl) to Week 12); Number of Participants With Shift From Baseline to Week 24 in Clinical Global Impressions Scale-Severity (CGI-S) Score (Baseline to Week 24); Number of Participants With Clinical Global Impression of Improvement Scale (CGI-I) Score at Week 1 (Baseline, Week 1); Number of Participants With Clinical Global Impression of Improvement Scale (CGI-I) Score at Week 12 (Baseline, Week 12); Number of Participants With Clinical Global Impression of Improvement Scale (CGI-I) Score at Week 24 (Baseline, Week 24)
B: Comparison of Prolonged Abstinence (up to12 weeks post-quit)
C: Cotinine-validated 7-day point prevalence tobacco abstinence at 1 year follow-up; Cotinine-validated 7-day point prevalence tobacco abstinence at 3 month follow-up (end of treatment)
D: 7-day point prevalence of abstinence, 9-12 week continuous abstinence, 9-26 week continuous abstinence (9-12 weeks; 9-26)

Answer: C
Please select the outcome measures that correspond to the clinical trial below.
Title: Safety and Efficacy of Sustained-Release (SR) Bupropion for Smokers Hospitalized Smokers With Acute Coronary Heart Disease
Brief Summary: The purpose of the study is to test the efficacy and safety of bupropion SR for smokers hospitalized with acute cardiovascular disease.


Options:
A: Cotinine-validated 7-day point prevalence tobacco abstinence at 1 year follow-up; Cotinine-validated 7-day point prevalence tobacco abstinence at 3 month follow-up (end of treatment)
B: Four-week Continuous Abstinence From Cigarette Smoking (Study week 8 thru week 11)
C: Pocket depth in peridontitis (Change from baseline at 12 months); Per-implant marginal bone loss (Change from baseline at 12 months); Size reduction of oral mucosal diseases (Change from baseline at 12 months)
D: Smoking status at 6 months after enrollment (6 months)

Answer: A
Please select the outcome measures that correspond to the clinical trial below.
Title: Safety and Efficacy of Sustained-Release (SR) Bupropion for Smokers Hospitalized Smokers With Acute Coronary Heart Disease
Brief Summary: The purpose of the study is to test the efficacy and safety of bupropion SR for smokers hospitalized with acute cardiovascular disease.


Options:
A: Rating of Urges to Smoke 24 Hours and One Week After the Target Quit Date Assessed by Mood and Physical Symptoms Scale (24 hours and 7 days after quit date (week 4))
B: Number of Participants Not Smoking in the Previous 7 Days, Confirmed by Expired Carbon Monoxide Reading < 10 Parts Per Million at Week 52 (7-day point prevalence)
C: Percent Compliance With Chantix (Months 1, 2, 3)
D: Cotinine-validated 7-day point prevalence tobacco abstinence at 1 year follow-up; Cotinine-validated 7-day point prevalence tobacco abstinence at 3 month follow-up (end of treatment)

Answer: D
Please select the outcome measures that correspond to the clinical trial below.
Title: Safety and Efficacy of Sustained-Release (SR) Bupropion for Smokers Hospitalized Smokers With Acute Coronary Heart Disease
Brief Summary: The purpose of the study is to test the efficacy and safety of bupropion SR for smokers hospitalized with acute cardiovascular disease.


Options:
A: Participants Abstinent From Cigarettes (Two years)
B: Cotinine-validated 7-day point prevalence tobacco abstinence at 1 year follow-up; Cotinine-validated 7-day point prevalence tobacco abstinence at 3 month follow-up (end of treatment)
C: Biochemically verified 7 day point prevalence abstinence from smoking.
D: Number of Participants With Salivary Cotinine-verified Smoking Abstinence at 6 Months (6 months)

Answer: B
Please select the outcome measures that correspond to the clinical trial below.
Title: N/A
Brief Summary: The principal objective is to test whether offering pregnant smokers a proactive telephone counseling program throughout pregnancy and for 2 months postpartum increases the rate of smoking cessation at end of pregnancy and 3 months postpartum, compared to a "best practice" control condition.


Options:
A: Biochemically-validated 7-day point prevalence tobacco abstinence at end of pregnancy
B: Percentage of Participants With 30-day Abstinence (6-months post enrollment)
C: Quit Rate (30-day Follow-Up); Quit Rate (6-Month Follow-Up)
D: Results in Abstinence Rates (1 Year)

Answer: A
Please select the outcome measures that correspond to the clinical trial below.
Title: N/A
Brief Summary: The principal objective is to test whether offering pregnant smokers a proactive telephone counseling program throughout pregnancy and for 2 months postpartum increases the rate of smoking cessation at end of pregnancy and 3 months postpartum, compared to a "best practice" control condition.


Options:
A: Participants' Smoking Status (around the 32nd week of gestation.); The Effectiveness of the Interventions According the Levels of Urine Cotinine Before and After Intervention. (At the baseline and at the 32nd week of gestation)
B: Biochemically-validated 7-day point prevalence tobacco abstinence at end of pregnancy
C: Biochemically validated quit rates (6 weeks after treatment, end of pregnancy)
D: Cotinine validated quit rates.

Answer: B
Please select the outcome measures that correspond to the clinical trial below.
Title: N/A
Brief Summary: The principal objective is to test whether offering pregnant smokers a proactive telephone counseling program throughout pregnancy and for 2 months postpartum increases the rate of smoking cessation at end of pregnancy and 3 months postpartum, compared to a "best practice" control condition.


Options:
A: Postpartum weight retention (no more than 1.5 years)
B: To assess the ability of direct communication and education to patients using modern technology (cellular text messaging) to enhance vaccine uptake. (at participant post-partum visit)
C: Breastfeeding at 3 months and at 6 months (3 months and six months)
D: Biochemically-validated 7-day point prevalence tobacco abstinence at end of pregnancy

Answer: D
Please select the outcome measures that correspond to the clinical trial below.
Title: N/A
Brief Summary: The principal objective is to test whether offering pregnant smokers a proactive telephone counseling program throughout pregnancy and for 2 months postpartum increases the rate of smoking cessation at end of pregnancy and 3 months postpartum, compared to a "best practice" control condition.


Options:
A: Smoking cessation (14 months post baseline)
B: smoking cessation (6-months)
C: Biochemically-validated 7-day point prevalence tobacco abstinence at end of pregnancy
D: 7-day point prevalence abstinence from smoking (6 months after enrollment)

Answer: C