TrialPanorama/Dataset huggingface dataset:
Please select the outcome measures that correspond to the clinical trial below.
Title: A 12-Week, Double-Blind, Randomized, Placebo-Controlled, Multicenter Study With Follow-Up Evaluating The Safety And Efficacy Of Varenicline Tartrate (CP-526,555-18) 1 Mg Bid For Smoking Cessation (Protocol A3051080)
Brief Summary: The primary objective of this protocol is to evaluate 12 weeks of treatment of varenicline compared to placebo for smoking cessation. Abstinence from cigarette smoking and other tobacco products (e.g., pipe, cigars, chew, snuff.) use during non-treatment follow-up period will also be evaluated.


Options:
A: Continuous abstinence (Russell Standard) (Six months post quit date)
B: Continuous Nicotine Abstinence (8 weeks)
C: 4-week continuous quit rate (CQR) at Weeks 4-7 and 9-12 .
D: Number of Participants With 4-week Continuous Abstinence (Weeks 9 through 12)

Answer: D
Please select the outcome measures that correspond to the clinical trial below.
Title: A 12-Week, Double-Blind, Randomized, Placebo-Controlled, Multicenter Study With Follow-Up Evaluating The Safety And Efficacy Of Varenicline Tartrate (CP-526,555-18) 1 Mg Bid For Smoking Cessation (Protocol A3051080)
Brief Summary: The primary objective of this protocol is to evaluate 12 weeks of treatment of varenicline compared to placebo for smoking cessation. Abstinence from cigarette smoking and other tobacco products (e.g., pipe, cigars, chew, snuff.) use during non-treatment follow-up period will also be evaluated.


Options:
A: Point prevalence of smoking cessation (those who have quitted smoking and have not smoked in the past week prior to the assessment date). (52 weeks after starting the treatment)
B: Complete Switching From Combustible Cigarettes to JUUL e-cigarette as measured by Exhaled carbon monoxide (CO) (After 8 weeks); Complete Switching From Combustible Cigarettes to JUUL e-cigarette as measured by change in Total urinary 4-(methylnitrosamino)-1-(3-pyridyl)-1-butanol (NNAL) (Baseline, Week 8, Week 12); Complete Switching From Combustible Cigarettes to JUUL e-cigarette as measured by change in self-report of daily cigarette and e-cigarette use (Daily from Week 2 to Week 12)
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: Number of Participants With 4-week Continuous Abstinence (Weeks 9 through 12)

Answer: D
Please select the outcome measures that correspond to the clinical trial below.
Title: A 12-Week, Double-Blind, Randomized, Placebo-Controlled, Multicenter Study With Follow-Up Evaluating The Safety And Efficacy Of Varenicline Tartrate (CP-526,555-18) 1 Mg Bid For Smoking Cessation (Protocol A3051080)
Brief Summary: The primary objective of this protocol is to evaluate 12 weeks of treatment of varenicline compared to placebo for smoking cessation. Abstinence from cigarette smoking and other tobacco products (e.g., pipe, cigars, chew, snuff.) use during non-treatment follow-up period will also be evaluated.


Options:
A: 4-week continuous quit rate (CQR) for Weeks 9-12
B: To compare 12 weeks of treatment with varenicline 1 mg BID to placebo for smoking cessation, and to evaluate continuous abstinence from smoking for 12 weeks after the treatment period.
C: Number of Participants With 4-week Continuous Abstinence (Weeks 9 through 12)
D: Biochemically Verified 7-day Point Prevalence Abstinence (End of Treatment (week 24))

Answer: C
Please select the outcome measures that correspond to the clinical trial below.
Title: A 12-Week, Double-Blind, Randomized, Placebo-Controlled, Multicenter Study With Follow-Up Evaluating The Safety And Efficacy Of Varenicline Tartrate (CP-526,555-18) 1 Mg Bid For Smoking Cessation (Protocol A3051080)
Brief Summary: The primary objective of this protocol is to evaluate 12 weeks of treatment of varenicline compared to placebo for smoking cessation. Abstinence from cigarette smoking and other tobacco products (e.g., pipe, cigars, chew, snuff.) use during non-treatment follow-up period will also be evaluated.


Options:
A: 4-week continuous quit rate (CQR) for Weeks 9-12
B: Number of Participants With 4-week Continuous Abstinence (Weeks 9 through 12)
C: Point prevalence of smoking cessation (those who have quitted smoking and have not smoked in the past week prior to the assessment date). (52 weeks after starting the treatment)
D: Continuous Abstinence Rate (CAR) From Week 9 Through Week 12 (Week 9 through Week 12)

Answer: B
Please select the outcome measures that correspond to the clinical trial below.
Title: A 12-Week, Double-Blind, Randomized, Placebo-Controlled, Multicenter Study With Follow-Up Evaluating The Safety And Efficacy Of Varenicline Tartrate (CP-526,555-18) 1 Mg Bid For Smoking Cessation (Protocol A3051080)
Brief Summary: The primary objective of this protocol is to evaluate 12 weeks of treatment of varenicline compared to placebo for smoking cessation. Abstinence from cigarette smoking and other tobacco products (e.g., pipe, cigars, chew, snuff.) use during non-treatment follow-up period will also be evaluated.


Options:
A: Summarization of safety data in smokers treated with either varenicline or placebo.
B: 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)
C: Prolonged Smoking Abstinence Rates at 12 Weeks in Cigarettes Smokers. (3 months); Point Prevalence Abstinence at 3 Months. (3 months)
D: Number of Participants With 4-week Continuous Abstinence (Weeks 9 through 12)

Answer: D
Please select the outcome measures that correspond to the clinical trial below.
Title: A 12-Week, Double-Blind, Randomized, Placebo-Controlled, Multicenter Study With Follow-Up Evaluating The Safety And Efficacy Of Varenicline Tartrate (CP-526,555-18) 1 Mg Bid For Smoking Cessation (Protocol A3051080)
Brief Summary: The primary objective of this protocol is to evaluate 12 weeks of treatment of varenicline compared to placebo for smoking cessation. Abstinence from cigarette smoking and other tobacco products (e.g., pipe, cigars, chew, snuff.) use during non-treatment follow-up period will also be evaluated.


Options:
A: Number of Participants With 4-week Continuous Abstinence (Weeks 9 through 12)
B: Continuous Nicotine Abstinence (8 weeks)
C: N/A
D: Quit Rate (4 months)

Answer: A
Please select the outcome measures that correspond to the clinical trial below.
Title: A 12-Week, Double-Blind, Randomized, Placebo-Controlled, Multicenter Study With Follow-Up Evaluating The Safety And Efficacy Of Varenicline Tartrate (CP-526,555-18) 1 Mg Bid For Smoking Cessation (Protocol A3051080)
Brief Summary: The primary objective of this protocol is to evaluate 12 weeks of treatment of varenicline compared to placebo for smoking cessation. Abstinence from cigarette smoking and other tobacco products (e.g., pipe, cigars, chew, snuff.) use during non-treatment follow-up period will also be evaluated.


Options:
A: Point prevalence abstinence
B: Number of Participants With 4-week Continuous Abstinence (Weeks 9 through 12)
C: The primary outcome is self-reported consecutive quit at 3 and 12 months following intervention. (3 and 12 month); Secondary outcomes are reduction in use, number of quit attempts at 3 and 12 months, and increases in readiness to quit. (3 and 12 months)
D: 4 week continuous quit rate (CQR) at Weeks 9-12 and Weeks 4-7

Answer: B
Please select the outcome measures that correspond to the clinical trial below.
Title: A 12-Week, Double-Blind, Randomized, Placebo-Controlled, Multicenter Study With Follow-Up Evaluating The Safety And Efficacy Of Varenicline Tartrate (CP-526,555-18) 1 Mg Bid For Smoking Cessation (Protocol A3051080)
Brief Summary: The primary objective of this protocol is to evaluate 12 weeks of treatment of varenicline compared to placebo for smoking cessation. Abstinence from cigarette smoking and other tobacco products (e.g., pipe, cigars, chew, snuff.) use during non-treatment follow-up period will also be evaluated.


Options:
A: Smoking cessation (point prevalence, both self reported as biochemical verified) (12 months)
B: Number of Participants With 4-week Continuous Abstinence (Weeks 9 through 12)
C: 4 week Continuous Quit Rate ( 4 week CQR ) for weeks 9 -12
D: Continuous Nicotine Abstinence (8 weeks)

Answer: B
Please select the outcome measures that correspond to the clinical trial below.
Title: Discontinuation of Antipsychotics and Antidepressants Among Patients With Dementia and BPSD Living in Nursing Homes - a 24 Weeks Double Blind RCT.
Brief Summary: The aim of this study is to discontinue antipsychotics and antidepressants, and to study its effect on Behavioural- and Psychological Symptoms in Dementia (BPSD).


Options:
A: Documented Decisions to Forgo Hospitalization (by six months)
B: Change From Baseline in the Mini-Mental State Examination (MMSE) Score (Baseline, Month 24); The Number of Deaths Reported in Participants (Up to 2 years)
C: Changes in Neuropsychiatric Inventory (24 weeks); Changes in Cornell's Depression Scale (24 weeks); Changes in UPDRS subscale (24 weeks)
D: Relapse by Study Week 32 (0-16 weeks in Phase B (16-32 weeks in study))

Answer: C
Please select the outcome measures that correspond to the clinical trial below.
Title: Discontinuation of Antipsychotics and Antidepressants Among Patients With Dementia and BPSD Living in Nursing Homes - a 24 Weeks Double Blind RCT.
Brief Summary: The aim of this study is to discontinue antipsychotics and antidepressants, and to study its effect on Behavioural- and Psychological Symptoms in Dementia (BPSD).


Options:
A: Changes in Neuropsychiatric Inventory (24 weeks); Changes in Cornell's Depression Scale (24 weeks); Changes in UPDRS subscale (24 weeks)
B: Number of patients who fully discontinued their antidepressant medication after 6 months. (6 months)
C: N/A
D: Number of Participants in Remission According to the Longitudinal Interval Follow-up Evaluation (LIFE) and the Hamilton Rating Scale for Depression (HRSD) (Through month 18 of treatment); Number of Participants in Recovery According to the LIFE and HRSD (Through 36 months of treatment); Number of Participants in Recurrence According to the LIFE and HRSD (Measured up to Month 36 from recovery)

Answer: A
Please select the outcome measures that correspond to the clinical trial below.
Title: Discontinuation of Antipsychotics and Antidepressants Among Patients With Dementia and BPSD Living in Nursing Homes - a 24 Weeks Double Blind RCT.
Brief Summary: The aim of this study is to discontinue antipsychotics and antidepressants, and to study its effect on Behavioural- and Psychological Symptoms in Dementia (BPSD).


Options:
A: Changes in Neuropsychiatric Inventory (24 weeks); Changes in Cornell's Depression Scale (24 weeks); Changes in UPDRS subscale (24 weeks)
B: Change From Baseline in the Mini-Mental State Examination (MMSE) Score (Baseline, Month 24); The Number of Deaths Reported in Participants (Up to 2 years)
C: Change in scores from baseline to week 26 on measuring cognition Severe Impairment Battery test and the Minimum Data Set Activities of Daily Living test.
D: Decisional Conflict Scale (3 months)

Answer: A
Please select the outcome measures that correspond to the clinical trial below.
Title: Enhancing Fitness in Older Overweight Vets With Impaired Fasting Glucose
Brief Summary: This study targets older adults (ages 60 and over) who are overweight (body mass index 25-40) with impaired fasting glucose (100 - 125). We propose a three-year, randomized controlled clinical trial (n=300) to determine the effect of a one-year physical activity counseling intervention on glucose metabolism and secondary outcomes compared to usual care.


Options:
A: To assess the numbers of patients who receive thrombolytics and the time to treatment in patients evaluated by telemedicine (90 days)
B: Fasting Insulin (Baseline); 3 Month Fasting Insulin (3 month); 12 Month Fasting Insulin (12 months); Fasting Glucose (Baseline); 3 Month Fasting Glucose (3 months); 12 Month Fasting Glucose (12 Months)
C: Mean # Participants Who Had Hospitalizations or ED Visits Compared to Usual Care in a High Risk Group of Adults ≥ 60 Years of Age With Mixed Chronic Disease. (12 months)
D: Duration and Intensity of Physical Activity (1 month, 3 months and 12 months after discharge)

Answer: B
Please select the outcome measures that correspond to the clinical trial below.
Title: Enhancing Fitness in Older Overweight Vets With Impaired Fasting Glucose
Brief Summary: This study targets older adults (ages 60 and over) who are overweight (body mass index 25-40) with impaired fasting glucose (100 - 125). We propose a three-year, randomized controlled clinical trial (n=300) to determine the effect of a one-year physical activity counseling intervention on glucose metabolism and secondary outcomes compared to usual care.


Options:
A: Change in body mass index (BMI) (Measured at Year 2)
B: To test for differences in rates of screening between the early intervention and delayed groups, the chi-square test will be used for each outcome. (End of project, 12/2011)
C: Composite measure of psychological quality of life, composite index of all cause mortality and COPD-related hospitalization. (4 years)
D: Fasting Insulin (Baseline); 3 Month Fasting Insulin (3 month); 12 Month Fasting Insulin (12 months); Fasting Glucose (Baseline); 3 Month Fasting Glucose (3 months); 12 Month Fasting Glucose (12 Months)

Answer: D
Please select the outcome measures that correspond to the clinical trial below.
Title: Age-Related Eye Disease Study (AREDS) and AREDS2 Follow-Up
Brief Summary: This study is a 5-year extension of the AREDS protocol, in which investigators followed the natural course of age-related macular degeneration (AMD) and cataracts. Participants in the former AREDS protocol are eligible for this study.

Participants have a complete eye examination once a year and are contacted at least once a year between visits to check on their status. The eye examination includes measurement of visual acuity (vision chart test) and examination of the inside of the eye after the pupils have been dilated with eye drops. Photographs of the inside of the eye may be taken using a special camera that flashes a bright light in the eye. A blood sample may be obtained to test for cholesterol level and genes related to inflammation....


Options:
A: Major fatal and non fatal ischemic cardiovascular events; Cancer any kind except for basal cell skin carcinoma
B: Outcomes assessed will be based on the ongoing ocular examination and historical data that will be obtained at each visit. The visual acuity data and the photographic documentation of the two diseases will be of particular importance. (5 years)
C: Plasma selenoprotein P levels at 0, 4, 8, 12, 16, 20, 24, 32, and 40 weeks (40 weeks)
D: 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)

Answer: B
Please select the outcome measures that correspond to the clinical trial below.
Title: Closing the Post Fracture Care Gap in Manitoba
Brief Summary: The objective of this study is to evaluate a post-fracture intervention for improving osteoporosis care in older men and women who have suffered a fracture that may indicate the presence of osteoporosis. Although osteoporosis can be identified with a bone mineral density (BMD) test, most individuals with osteoporosis are not diagnosed until they fracture. Post-fracture care often "falls between the cracks" when there is a breakdown in communication between hospital and community, or between specialists and primary care physicians. Often physicians and patients fail to make the connection between an acute fracture and osteoporosis, or the value of secondary prevention strategies. If untreated, there is an extremely high rate of additional fractures after a first osteoporotic fracture. It follows that improving BMD testing and/or treatment in appropriately identified individuals is a necessary step in optimizing post-fracture patient care. Over the next three years we will be testing and optimizing a notification procedure to physicians and/or patients relying upon fracture events reported to the provincial health service (Manitoba Health).


Options:
A: Rates of BMD testing and/or osteoporosis pharmacotherapy in the year post-fracture using the population-based provincial administrative health data repository. (3 years (Phase 1 analysis at 1 year))
B: Increased use of proven efficacious osteoporosis treatment within six months of study enrollment, defined as: hormone therapy, a bisphosphonate, raloxifene, or calcitonin.
C: The proportion of patients starting bisphosphonate treatment within 6 months of fracture (6 months)
D: Bone mineral density (BMD) testing rates

Answer: A
Please select the outcome measures that correspond to the clinical trial below.
Title: Phase 2/3 Study of Rituximab for Graves' Ophthalmopathy
Brief Summary: This study is being done to investigate the effects (good and bad) of Rituximab for the treatment of an autoimmune eye disease called Graves' ophthalmopathy. This disease has proven to be difficult to treat. Rituximab is a monoclonal antibody that depletes a line of cells involved in the autoimmune response. The study hypotheses is that rituximab is effective in the treatment of patients with moderate to severe active Graves' ophthalmopathy.


Options:
A: Change in Clinical Activity Score (CAS) (baseline, 6 months after the first infusion)
B: Responder Status at Week 24 (Week 24)
C: Drug efficacy will be established as a decrease in CAS (clinical activity score) by 2 or more points in a scale of 10. (It will be measured before treatment (week -4 / 0), after treatment (week 16) and after the end of the follow-up (week 40).)
D: Percentage of Participants Who Were Proptosis Responders at Week 24 (Week 24)

Answer: A
Please select the outcome measures that correspond to the clinical trial below.
Title: A Randomised, Double-blind, Placebo Controlled, Multi-centre Phase II Study of Atacicept in Anti-TNFα-naïve Patients With Moderate to Severely Active Rheumatoid Arthritis and an Inadequate Response to Methotrexate
Brief Summary: The primary objective of this study is to evaluate the efficacy of atacicept compared to placebo in the treatment of signs and symptoms in a subject population with active rheumatoid arthritis (RA), inadequate response to methotrexate (MTX) and no previous exposure to anti-tumor necrosis factor alpha (anti-TNFalpha) therapy.


Options:
A: Percentage of Participants Achieving American College of Rheumatology 20 Response Based on C-reactive Protein (ACR20-CRP) at Week 26 (Week 26)
B: Percentage of Participants With American College of Rheumatology-ACR20 Response (Baseline, Week 24); Change From Baseline in Modified Total Sharp-Genant Score at Week 52 (Baseline, Week 52); Change in Physical Function as Measured by the Area Under the Curve (AUC) for the Change From Baseline in the Health Assessment Questionnaire (HAQ) Disability Index at Week 52 (Baseline to Week 52); Change From Baseline in the Modified Total Sharp-Genant Score at Week 104 (Baseline, Week 104); Change in Physical Function as Measured by the Area Under the Curve for the Change From Baseline in the Health Assessment Questionnaire- Disability Index (HAQ-DI) at Week 104 (Baseline to Week 104)
C: Percentage of Participants With an American College of Rheumatology (ACR) 20 Response at Day 169 in Short Term Period (Day 169); Percentage of Participants With Sustained American College of Rheumatology (ACR) Response at Day 533 in Long Term Period - All Randomized and Treated Participants During the Long Term Period (Day 533); Mean Change From Baseline in HAQ-DI Score at Day 533 in Long Term Period (Baseline to Day 533); Percentage of Participants With Health Assessment Questionnaire (HAQ) Response at Day 533 in Long Term Period (Day 533); Mean Change in DAS28-CRP From Baseline at Day 533 in Long Term Period (Baseline to Day 533)
D: Percentage of patients with ACR 20 response (Week 24)

Answer: A
Please select the outcome measures that correspond to the clinical trial below.
Title: Efficacy of Varenicline in Ambivalent Smokers
Brief Summary: The purpose of this study is to test whether Varenicline can help ambivalent smokers (those who are interested in quitting at some point in the future but have no current plans to quit) to reduce their smoking and eventually quit.


Options:
A: Number of Participants With a Quit Attempt (6 months)
B: Primary efficacy and Safety endpoint: (within 12 month from enrollment)
C: 4 week Continuous Quit Rate ( 4 week CQR ) for Weeks 9 -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: A
Please select the outcome measures that correspond to the clinical trial below.
Title: Efficacy of Varenicline in Ambivalent Smokers
Brief Summary: The purpose of this study is to test whether Varenicline can help ambivalent smokers (those who are interested in quitting at some point in the future but have no current plans to quit) to reduce their smoking and eventually quit.


Options:
A: Smoking Abstinence (3 months); Smoking Abstinence (6 months); Smoking Abstinence (12 months)
B: Four-week Continuous Abstinence From Cigarette Smoking (Study week 8 thru week 11)
C: Number of Participants With a Quit Attempt (6 months)
D: Smoking Abstinence - Serum/Urine Measurements (Week 12); Smoking Abstinence - Number of Cigarettes Smoked (Week 12); Smoking Abstinence - Exhaled Carbon Monoxide (Week 12)

Answer: C
Please select the outcome measures that correspond to the clinical trial below.
Title: Efficacy of Varenicline in Ambivalent Smokers
Brief Summary: The purpose of this study is to test whether Varenicline can help ambivalent smokers (those who are interested in quitting at some point in the future but have no current plans to quit) to reduce their smoking and eventually quit.


Options:
A: Days of abstinence following the programmed lapse (7 days)
B: Weight Gain in Treatment Completers (baseline and 12 weeks)
C: Percent Compliance With Chantix (Months 1, 2, 3)
D: Number of Participants With a Quit Attempt (6 months)

Answer: D