TrialPanorama/Dataset huggingface dataset:
Please select the outcome measures that correspond to the clinical trial below.
Title: An International, Seven-week, Double-blind, Placebo-controlled, Two Parallel Group Study to Assess the Efficacy of Dianicline 40 mg Bid as an Aid to Smoking Cessation in Cigarette Smokers
Brief Summary: The primary study objective is to demonstrate the efficacy of dianicline as an aid to smoking cessation in cigarette smokers. The main secondary objectives are to assess the: craving for cigarettes, nicotine withdrawal symptoms, and safety of dianicline.


Options:
A: 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)
B: Sustained 50% Reduction in the Number of Cig/Day at Week-24 From Baseline (Reducers) (number of cigarettes/day as assessed at week 24)
C: Number of Subjects With a 4 Week Continuous Quit Rate (CQR) From Smokeless Tobacco (Weeks 9 through 12)
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: D
Please select the outcome measures that correspond to the clinical trial below.
Title: An International, Seven-week, Double-blind, Placebo-controlled, Two Parallel Group Study to Assess the Efficacy of Dianicline 40 mg Bid as an Aid to Smoking Cessation in Cigarette Smokers
Brief Summary: The primary study objective is to demonstrate the efficacy of dianicline as an aid to smoking cessation in cigarette smokers. The main secondary objectives are to assess the: craving for cigarettes, nicotine withdrawal symptoms, and safety of dianicline.


Options:
A: Rating of urges to smoke one week after the target quit date assessed by Mood and Physical Symptoms Scale (1 week)
B: 7 Day Point Prevalence of Cigarette Abstinence (6-month follow up); 7 Day Point Prevalence of Cigarette Abstinence (Week 8)
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: 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)

Answer: C
Please select the outcome measures that correspond to the clinical trial below.
Title: An International, Seven-week, Double-blind, Placebo-controlled, Two Parallel Group Study to Assess the Efficacy of Dianicline 40 mg Bid as an Aid to Smoking Cessation in Cigarette Smokers
Brief Summary: The primary study objective is to demonstrate the efficacy of dianicline as an aid to smoking cessation in cigarette smokers. The main secondary objectives are to assess the: craving for cigarettes, nicotine withdrawal symptoms, and safety of dianicline.


Options:
A: The primary efficacy outcome is smoking abstinence for any continuous 4-week period (4-week CQR) during the study treatment phase.
B: 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
C: 4 week Continuous Quit Rate ( 4 week CQR ) for weeks 9 -12
D: 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.

Answer: B
Please select the outcome measures that correspond to the clinical trial below.
Title: An International, Seven-week, Double-blind, Placebo-controlled, Two Parallel Group Study to Assess the Efficacy of Dianicline 40 mg Bid as an Aid to Smoking Cessation in Cigarette Smokers
Brief Summary: The primary study objective is to demonstrate the efficacy of dianicline as an aid to smoking cessation in cigarette smokers. The main secondary objectives are to assess the: craving for cigarettes, nicotine withdrawal symptoms, and safety of dianicline.


Options:
A: Days to Relapse (4 weeks)
B: Success rates and safety at week 24 in the varenicline vs placebo. Success rates will be defined as the Continuous Quit Rate since last visit. Maintain abstinence during this period of time with end-expiratory exhaled CO measurements ≤ 10 ppm. (week 24)
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: Percentage of Participants With Carbon Monoxide (CO) Confirmed 10-Week Continuous Abstinence (CA) From Smoking (Week 15 - 24)

Answer: C
Please select the outcome measures that correspond to the clinical trial below.
Title: An International, Seven-week, Double-blind, Placebo-controlled, Two Parallel Group Study to Assess the Efficacy of Dianicline 40 mg Bid as an Aid to Smoking Cessation in Cigarette Smokers
Brief Summary: The primary study objective is to demonstrate the efficacy of dianicline as an aid to smoking cessation in cigarette smokers. The main secondary objectives are to assess the: craving for cigarettes, nicotine withdrawal symptoms, and safety of dianicline.


Options:
A: Smoking Cessation at 7 days (7-day point prevalence abstinence); Continuous Smoking Abstinence at 6 weeks (6 weeks)
B: The primary outcome will be the biochemically confirmed (exhaled CO < 10 ppm) self-reported continuous abstinence for weeks 12 to 26. (26 weeks)
C: Number of Subjects With Four Week Continuous Quit Rate (CQR) (Week 9 through Week 12)
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: D
Please select the outcome measures that correspond to the clinical trial below.
Title: An International, Seven-week, Double-blind, Placebo-controlled, Two Parallel Group Study to Assess the Efficacy of Dianicline 40 mg Bid as an Aid to Smoking Cessation in Cigarette Smokers
Brief Summary: The primary study objective is to demonstrate the efficacy of dianicline as an aid to smoking cessation in cigarette smokers. The main secondary objectives are to assess the: craving for cigarettes, nicotine withdrawal symptoms, and safety of dianicline.


Options:
A: Proportion of Cocaine Positive Urine Tests Per Week (Weekly Measures over 12 weeks)
B: 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
C: A Serious Quit Attempt in Which the Participant Intends to Permanently Stop Smoking (From study enrollment through six month follow-up); A 24 Hour Serious Quit Attempt in Which the Participant Intends to Permanently Stop Smoking (From study enrollment through six month follow-up)
D: tobacco abstinence (6 months)

Answer: B
Please select the outcome measures that correspond to the clinical trial below.
Title: An International, Seven-week, Double-blind, Placebo-controlled, Two Parallel Group Study to Assess the Efficacy of Dianicline 40 mg Bid as an Aid to Smoking Cessation in Cigarette Smokers
Brief Summary: The primary study objective is to demonstrate the efficacy of dianicline as an aid to smoking cessation in cigarette smokers. The main secondary objectives are to assess the: craving for cigarettes, nicotine withdrawal symptoms, and safety of dianicline.


Options:
A: Quit Rate (4 months)
B: Percent Compliance With Chantix (Months 1, 2, 3)
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: 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))

Answer: C
Please select the outcome measures that correspond to the clinical trial below.
Title: An International, Seven-week, Double-blind, Placebo-controlled, Two Parallel Group Study to Assess the Efficacy of Dianicline 40 mg Bid as an Aid to Smoking Cessation in Cigarette Smokers
Brief Summary: The primary study objective is to demonstrate the efficacy of dianicline as an aid to smoking cessation in cigarette smokers. The main secondary objectives are to assess the: craving for cigarettes, nicotine withdrawal symptoms, and safety of dianicline.


Options:
A: Primary efficacy and Safety endpoint: (within 12 month from enrollment)
B: Comparison of Prolonged Abstinence (up to12 weeks post-quit)
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: Participants Abstinent From Cigarettes (Two years)

Answer: C
Please select the outcome measures that correspond to the clinical trial below.
Title: Wiser Choices for Patients With Type II Diabetes: Diabetes Medication Choice
Brief Summary: The purpose of this study is to examine how different ways of sharing information about diabetes medication treatment options with patients can affect their choices and health.


Options:
A: Blood Pressure, Health-Related Quality of Life(Medical outcome Study Short Form-36) (Baseling, 12month, 24month)
B: Medication adherence assessment method (one month)
C: Understanding (Directly proceeding the clinical encounter); Decisional Conflict (Directly proceeding the clinical visit); Treatment Action, adherence (Directly proceeding the clinical encounter, 6 months after the clinical encounter)
D: Geriatric Depression Scale (12 months); Physical Performance Test (PPT) (12 months); SF-36 Health Survey (12 months); Mental Mental Status Exam (MMSE) (12 months); Hospitalization (12 month enrollment period); Hospital Days (12 Month Enrollment Period); Emergency Department Visits (12 month Enrollment Period); Medicare Costs (12 Month Enrollment Period)

Answer: C
Please select the outcome measures that correspond to the clinical trial below.
Title: Wiser Choices for Patients With Type II Diabetes: Diabetes Medication Choice
Brief Summary: The purpose of this study is to examine how different ways of sharing information about diabetes medication treatment options with patients can affect their choices and health.


Options:
A: Discussion with provider about CHD risk reduction; Stated plans for CHD risk reduction
B: Understanding (Directly proceeding the clinical encounter); Decisional Conflict (Directly proceeding the clinical visit); Treatment Action, adherence (Directly proceeding the clinical encounter, 6 months after the clinical encounter)
C: Receipt of colorectal cancer screening (24 weeks)
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: Wiser Choices for Patients With Type II Diabetes: Diabetes Medication Choice
Brief Summary: The purpose of this study is to examine how different ways of sharing information about diabetes medication treatment options with patients can affect their choices and health.


Options:
A: Discussion with provider about CHD risk reduction; Stated plans for CHD risk reduction
B: Understanding (Directly proceeding the clinical encounter); Decisional Conflict (Directly proceeding the clinical visit); Treatment Action, adherence (Directly proceeding the clinical encounter, 6 months after the clinical encounter)
C: Readmission and death rate at 6 months' follow up.
D: Adherence; Self-efficacy; Quality of life

Answer: B
Please select the outcome measures that correspond to the clinical trial below.
Title: Wiser Choices for Patients With Type II Diabetes: Diabetes Medication Choice
Brief Summary: The purpose of this study is to examine how different ways of sharing information about diabetes medication treatment options with patients can affect their choices and health.


Options:
A: N/A
B: Medication adherence (At Month 12)
C: Understanding (Directly proceeding the clinical encounter); Decisional Conflict (Directly proceeding the clinical visit); Treatment Action, adherence (Directly proceeding the clinical encounter, 6 months after the clinical encounter)
D: Pill count (18 months)

Answer: C
Please select the outcome measures that correspond to the clinical trial below.
Title: Wiser Choices for Patients With Type II Diabetes: Diabetes Medication Choice
Brief Summary: The purpose of this study is to examine how different ways of sharing information about diabetes medication treatment options with patients can affect their choices and health.


Options:
A: Mean Patient-centered Communication in Advanced Cancer Score (3 years)
B: Patient's satisfaction and confidence with the information given. (Within two weeks after receiving the information and after 3 months.)
C: Decision Self Efficacy (post intervention)
D: Understanding (Directly proceeding the clinical encounter); Decisional Conflict (Directly proceeding the clinical visit); Treatment Action, adherence (Directly proceeding the clinical encounter, 6 months after the clinical encounter)

Answer: D
Please select the outcome measures that correspond to the clinical trial below.
Title: A Prescription for Enhancing Resident Quality of Life
Brief Summary: Many persons with dementia exhibit behaviors that caregivers find difficult to manage. The purpose of this study is to test the effectiveness of individualized recreational activities for reducing agitation and passivity in persons with dementia.


Options:
A: Agitation (During activity intervention, random times outside of activity intervention (during the intervention period), and one week post intervention period); Passivity (During activity intervention, random times outside of activity intervention (during the intervention period), and one week post intervention period)
B: Composite: Proportion of patients with any risk factor as defined in secondary outcome measures to 9, who have received any high risk prescriptions of anti-inflammatory drugs or antiplatelets as defined in secondary outcome measures 1 to 9 (8 weeks)
C: Agitation Behavior Mapping Instrument (ABMI) (10 days of intervention vs. 10 days of baseline)
D: Engagement between the 1st minute - 10th minute of each session (through study completion for 8 weeks); Engagement between the 25th minute - 35th minute of each session (through study completion for 8 weeks); Engagement between the 50th minute - 60th minute of each session (through study completion for 8 weeks); Affect between the 1st minute - 10th minute of each session (through study completion for 8 weeks); Affect between the 25th minute - 35th minute of each session (through study completion for 8 weeks); Affect between the 50th minute - 60th minute of each session (through study completion for 8 weeks)

Answer: A
Please select the outcome measures that correspond to the clinical trial below.
Title: A Prescription for Enhancing Resident Quality of Life
Brief Summary: Many persons with dementia exhibit behaviors that caregivers find difficult to manage. The purpose of this study is to test the effectiveness of individualized recreational activities for reducing agitation and passivity in persons with dementia.


Options:
A: Number of Participants With a Decline of 6 Points on the Hopkins Verbal Learning Test-Revised (HVLT-R) (24 months)
B: Minutes of exercise per week (Change from baseline in number of minutes of exercise each week during treatment phase of study, weeks 7-12); Restricted Activity Days (Baseline); Restricted Activity Days (Change from Baseline to Pre-Treatment (6 weeks)); Restricted Activity Days (Change from Baseline to Post- Treatment 1 (13 weeks)); Restricted Activity Days (Change from Baseline to Post-Treatment 2 (30 weeks)); Restricted Days of Activity (Change from Baseline to 13 Month Follow-Up); Independence/Residential Status (Change from Baseline to 13 Month Follow-Up)
C: Agitation (During activity intervention, random times outside of activity intervention (during the intervention period), and one week post intervention period); Passivity (During activity intervention, random times outside of activity intervention (during the intervention period), and one week post intervention period)
D: Montgomery Asberg Depression Scale (MADRS) (12 week outcome); WHO Disability Assessment Schedule (WHODAS)-II (12-week outcome)

Answer: C
Please select the outcome measures that correspond to the clinical trial below.
Title: A Prescription for Enhancing Resident Quality of Life
Brief Summary: Many persons with dementia exhibit behaviors that caregivers find difficult to manage. The purpose of this study is to test the effectiveness of individualized recreational activities for reducing agitation and passivity in persons with dementia.


Options:
A: Neuropsychiatric Inventory (At baseline in the 2 weeks prior to the music therapy intervention, then at weeks 11-12, weeks 21-22 and as a follow-up at week 27-28.)
B: Agitation (During activity intervention, random times outside of activity intervention (during the intervention period), and one week post intervention period); Passivity (During activity intervention, random times outside of activity intervention (during the intervention period), and one week post intervention period)
C: Composite: Proportion of patients with any risk factor as defined in secondary outcome measures to 9, who have received any high risk prescriptions of anti-inflammatory drugs or antiplatelets as defined in secondary outcome measures 1 to 9 (8 weeks)
D: Agitation Behavior Mapping Instrument (ABMI) (10 days of intervention vs. 10 days of baseline)

Answer: B
Please select the outcome measures that correspond to the clinical trial below.
Title: A Prescription for Enhancing Resident Quality of Life
Brief Summary: Many persons with dementia exhibit behaviors that caregivers find difficult to manage. The purpose of this study is to test the effectiveness of individualized recreational activities for reducing agitation and passivity in persons with dementia.


Options:
A: Agitation (During activity intervention, random times outside of activity intervention (during the intervention period), and one week post intervention period); Passivity (During activity intervention, random times outside of activity intervention (during the intervention period), and one week post intervention period)
B: quality of life: RAND, GDS (pre and post treatment); caregiver: sense of competence (SCQ), burden of the problems in the Revised Memory and Behavioral Problems (RMBP) (pre- and post intervention)
C: Hamilton Rating Scale for Depression (Measured at screening, weeks 1 through 12, and week 36)
D: Number of Participants With a Decline of 6 Points on the Hopkins Verbal Learning Test-Revised (HVLT-R) (24 months)

Answer: A
Please select the outcome measures that correspond to the clinical trial below.
Title: Improving Drug Use for Elderly Heart Failure Patients
Brief Summary: The aims of this randomized, clinical trial are to develop and test a multileveled pharmacy-based program to improve the care of patients with heart failure. Risk factors for deterioration of heart failure will be determined including poor adherence to medication.


Options:
A: Medication adherence; Exacerbation of heart failure; Health-related quality of life
B: Time to the first occurrence of hospital readmission, emergency department visit, or death. (0-35 days)
C: HbA1c (12month); Blood pressure (12 month); Lipid profile (12 months); quality of life (12month)
D: Medication possession ratio (MPR), gaps and persistence in medicines use (Seven months after recruitment)

Answer: A
Please select the outcome measures that correspond to the clinical trial below.
Title: Improving Drug Use for Elderly Heart Failure Patients
Brief Summary: The aims of this randomized, clinical trial are to develop and test a multileveled pharmacy-based program to improve the care of patients with heart failure. Risk factors for deterioration of heart failure will be determined including poor adherence to medication.


Options:
A: The difference in change in estimated cardiovascular risk between advanced care and usual care groups (3 months)
B: Medication adherence; Exacerbation of heart failure; Health-related quality of life
C: To Reduce the Use of Health Care Services by Quantifying the Number of Hospitalizations (1 year); To Reduce the Use of Health Care Services by Quantifying the Number of Emergency Service Consultations (1 year); To Reduce the Use of Health Care Services by Quantifying the Number of Unscheduled Outpatient Visits (1 year)
D: BP at 6 months (6 months)

Answer: B
Please select the outcome measures that correspond to the clinical trial below.
Title: Improving Drug Use for Elderly Heart Failure Patients
Brief Summary: The aims of this randomized, clinical trial are to develop and test a multileveled pharmacy-based program to improve the care of patients with heart failure. Risk factors for deterioration of heart failure will be determined including poor adherence to medication.


Options:
A: death, myocardial infarction or refractory (up to and including Day 9); major bleeding (Up to Day 9)
B: Medication adherence; Exacerbation of heart failure; Health-related quality of life
C: 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%)
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: B