TrialPanorama/Dataset huggingface dataset:
Please select the outcome measures that correspond to the clinical trial below.
Title: A Phase 4, Multi-National, Randomized, Double-Blind, Placebo-Controlled Study To Evaluate The Efficacy And Safety Of Varenicline Compared To Placebo For Smoking Cessation Through Reduction
Brief Summary: This study will determine whether varenicline is safe and helps people to quit smoking through reduction when they are not willing/able to make an abrupt quit attempt.


Options:
A: 7-day point prevalence of abstinence, 9-12 week continuous abstinence, 9-26 week continuous abstinence (9-12 weeks; 9-26)
B: 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))
C: Percentage of Participants With Carbon Monoxide (CO) Confirmed 10-Week Continuous Abstinence (CA) From Smoking (Week 15 - 24)
D: Proportion of Daily Cigarettes Smoked in the 4 Hours After Receiving Methadone Dose (7 weeks)

Answer: C
Please select the outcome measures that correspond to the clinical trial below.
Title: A Phase 4, Multi-National, Randomized, Double-Blind, Placebo-Controlled Study To Evaluate The Efficacy And Safety Of Varenicline Compared To Placebo For Smoking Cessation Through Reduction
Brief Summary: This study will determine whether varenicline is safe and helps people to quit smoking through reduction when they are not willing/able to make an abrupt quit attempt.


Options:
A: Percentage of Participants With Carbon Monoxide (CO) Confirmed 10-Week Continuous Abstinence (CA) From Smoking (Week 15 - 24)
B: 7 day point prevalence of cigarette abstinence (End of trial (week 10))
C: 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).)
D: 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

Answer: A
Please select the outcome measures that correspond to the clinical trial below.
Title: A Phase III Multi-Center, Randomized, Double-Blind, Placebo-Controlled, Parallel Group Trial of 14 Day Treatment With Esomeprazole 20 mg Once Daily in Subjects With Frequent Heartburn
Brief Summary: This study will investigate the efficacy of esomeprazole 20 mg once a day in the treatment of frequent heartburn


Options:
A: The Number of Patients With Complete Resolution of Heartburn by Week 4 (week 4 of treatment); The Number of Patients Achieving Complete Resolution of Regurgitation Symptoms at Week 4 (4 weeks); The Number of Patients Achieving Satisfactory Resolution of Heartburn by Week 4 (4 weeks); The Number of Patients Achieving Satisfactory Resolution of Regurgitation Symptoms by Week 4 (4 weeks)
B: Mean Change From Baseline to Month 12 for Hemoglobin Values (Baseline and Month 12); Mean Change From Baseline to Month 12 for Hematocrit Values (Baseline and Month 12); Mean Change From Baseline to Month 12 for Red Blood Cell Count Values (Baseline and Month 12); Mean Change From Baseline to Month 12 for Mean Corpuscular Hemoglobin Concentration Values (Baseline and Month 12); Mean Change From Baseline to Month 12 for Platelet Count Values (Baseline and Month 12); Mean Change From Baseline to Month 12 for White Blood Cell Count Values (Baseline and Month 12); Mean Change From Baseline to Month 12 for Blood Urea Nitrogen Values (Baseline and Month 12); Mean Change From Baseline to Month 12 for Creatinine Values (Baseline and Month 12); Mean Change From Baseline to Month 12 for Calcium Values (Baseline and Month 12); Mean Change From Baseline to Month 12 for Inorganic Phosphorus Values (Baseline and Month 12); Mean Change From Baseline to Month 12 for Total Bilirubin Values (Baseline and Month 12); Mean Change From Baseline to Month 12 for Alkaline Phosphatase Values (Baseline and Month 12); Mean Change From Baseline to Month 12 for Aspartate Aminotransferase Values (Baseline and Month 12); Mean Change From Baseline to Month 12 for Alanine Aminotransferase Values (Baseline and Month 12); Mean Change From Baseline to Month 12 for Serum Gastrin Levels (Baseline and Month 12); Mean Change From Baseline to Month 12 for Systolic Blood Pressure (Baseline and Month 12); Mean Change From Baseline to Month 12 for Diastolic Blood Pressure (Baseline and Month 12); Mean Change From Baseline to Month 12 for Pulse Rate (Baseline and Month 12); Changes From Baseline to Final Visit in Antrum Biopsy Results (Baseline and Final Visit (up to 12 months)); Changes From Baseline to Final Visit in Fundus Biopsy Results (Baseline and Final Visit (up to 12 months))
C: Failure of patient perceived symptom control despite treatment with project medication (12 months)
D: Percentage of Heartburn Free 24 Hour Days During 14 Days of Randomized Treatment (From randomisation to day 14); Percentage of Heartburn Free 24 Hour Days During 14 Days of Randomized Treatment (From randomization to day 14)

Answer: D
Please select the outcome measures that correspond to the clinical trial below.
Title: A Phase III Multi-Center, Randomized, Double-Blind, Placebo-Controlled, Parallel Group Trial of 14 Day Treatment With Esomeprazole 20 mg Once Daily in Subjects With Frequent Heartburn
Brief Summary: This study will investigate the efficacy of esomeprazole 20 mg once a day in the treatment of frequent heartburn


Options:
A: Proportion of Participants Who Remain Well Controlled After Switching From Their Current Twice-daily Proton Pump Inhibitor Therapy to Dexlansoprazole MR. (Week 3 through Week 6)
B: Difference between the proportion of patients who discontinued on-demand esomeprazole treatment versus continuous esomeprazole treatment due to unsatisfactory treatment as determined by the investigator in consultation with the patient (6 months)
C: Percentage of Heartburn Free 24 Hour Days During 14 Days of Randomized Treatment (From randomisation to day 14)
D: The Rates of Complete Symptom Relief (at the 20 weeks after the end of initial treatment.)

Answer: C
Please select the outcome measures that correspond to the clinical trial below.
Title: Comparative Efficacy of Two Psychosocial Strategies of Intervention (Neurocognitive vs Psychoeducative) as add-on Therapy Versus Treatment as Usual in Bipolar Disorder
Brief Summary: Bipolar disorder is a severe, chronic and recurrent illness, that affects nearly the 5% of the population. Recent research point at the relevance and persistence of cognitive dysfunctions in bipolar patients even beyond the acute phases, although cognitive impairment has been classically associated with schizophrenia and not bipolar disorder. Current findings suggest that some intervention is needed in order to improve not only affective symptoms but also cognitive dysfunctions, so that patients could benefit from cognitive remediation techniques to improve cognitive impairment and the functional outcome. There is no previous research on the efficacy of cognitive remediation programs on bipolar disorder.


Options:
A: Obtain Competitive Employment (1 calendar year)
B: Functional Assessment Short Test (FAST) (Baseline); Functional Assessment Short Test (FAST) (6 months); Functional Assessment Short Test (FAST) (12 months)
C: AMOUNT OF EMPLOYMENT (24 months)
D: sucessful employment for one day in the open labour market

Answer: B
Please select the outcome measures that correspond to the clinical trial below.
Title: Pilot Study to Test the Efficacy of a Worksite Intervention for Reducing Daily Sedentary Time and Improving Risk Factors for Cardiometabolic Disease Among Sedentary, Overweight, Full-time Working Adults
Brief Summary: The primary aim of this pilot study is to test the efficacy of a worksite intervention for reducing daily sedentary time and improving risk factors for cardiometabolic disease (e.g., measures of adiposity, anthropometrics, cardiorespiratory fitness) among sedentary, overweight, full-time working adults as compared to a waitlist control. A secondary aim will be to test pedal time at work as a measure of compliance with the intervention.


Options:
A: Step Watch - Physical Activity Minutes (12 weeks between baseline and post-intervention follow up)
B: Changes in daily sitting time in hours and minutes (Baseline, 4 months, 10 months and 22 months)
C: Change in Body Mass Index (BMI) (Baseline to 24 Months)
D: Change from control week and intervention week in total energy expenditure (TEE) (week 1 and week 2); Resting energy expenditure (REE) (Baseline (day 0)); Change from control week and intervention week in physical activity energy expenditure (PAEE) (week 1 and week 2); Change from control week and intervention week in daily time spent in sedentary (SB) (week 1 and week 2); Change from control week and intervention week in light (LIPA), moderate and vigorous (MVPA) intensity activities (week 1 and week 2); Change from control week and intervention week in number of breaks in sedentary time (BST) (week 1 and week 2); Change from control week and intervention week in time spent sitting (TSS) (week 1 and week 2); Change from control week and intervention week in time spent standing (TSst) (week 1 and week 2); Change from control week and intervention week in time spent walking (TSW) (week 1 and week 2); Change from control week and intervention week in number of steps (week 1 and week 2)

Answer: A
Please select the outcome measures that correspond to the clinical trial below.
Title: Pilot Study to Test the Efficacy of a Worksite Intervention for Reducing Daily Sedentary Time and Improving Risk Factors for Cardiometabolic Disease Among Sedentary, Overweight, Full-time Working Adults
Brief Summary: The primary aim of this pilot study is to test the efficacy of a worksite intervention for reducing daily sedentary time and improving risk factors for cardiometabolic disease (e.g., measures of adiposity, anthropometrics, cardiorespiratory fitness) among sedentary, overweight, full-time working adults as compared to a waitlist control. A secondary aim will be to test pedal time at work as a measure of compliance with the intervention.


Options:
A: Step Watch - Physical Activity Minutes (12 weeks between baseline and post-intervention follow up)
B: Aerobic Fitness; Resting Blood Pressure; Body Fatness; Blood Lipids; C-reactive Protein
C: Body Weight (4 months); Body Weight (7 Months)
D: Primary outcome measure was step count (6-weeks)

Answer: A
Please select the outcome measures that correspond to the clinical trial below.
Title: Pilot Study to Test the Efficacy of a Worksite Intervention for Reducing Daily Sedentary Time and Improving Risk Factors for Cardiometabolic Disease Among Sedentary, Overweight, Full-time Working Adults
Brief Summary: The primary aim of this pilot study is to test the efficacy of a worksite intervention for reducing daily sedentary time and improving risk factors for cardiometabolic disease (e.g., measures of adiposity, anthropometrics, cardiorespiratory fitness) among sedentary, overweight, full-time working adults as compared to a waitlist control. A secondary aim will be to test pedal time at work as a measure of compliance with the intervention.


Options:
A: Change from baseline occupational sitting time (minutes/day) at post-intervention (19 weeks) and two months follow-up. (Baseline,19 weeks, two months follow-up); Change from baseline step counts (steps/day) at post-intervention (19 weeks) and two months follow-up (Baseline,19 weeks, two months follow-up)
B: Change from baseline in physical activity and sedentariness at 12 months (Baseline, 12 months)
C: Step Watch - Physical Activity Minutes (12 weeks between baseline and post-intervention follow up)
D: Acceptability and feasibility (3 weeks)

Answer: C
Please select the outcome measures that correspond to the clinical trial below.
Title: Pilot Study to Test the Efficacy of a Worksite Intervention for Reducing Daily Sedentary Time and Improving Risk Factors for Cardiometabolic Disease Among Sedentary, Overweight, Full-time Working Adults
Brief Summary: The primary aim of this pilot study is to test the efficacy of a worksite intervention for reducing daily sedentary time and improving risk factors for cardiometabolic disease (e.g., measures of adiposity, anthropometrics, cardiorespiratory fitness) among sedentary, overweight, full-time working adults as compared to a waitlist control. A secondary aim will be to test pedal time at work as a measure of compliance with the intervention.


Options:
A: change in physical activity (4 months)
B: Incidence of CHD and other lifestyle related diseases after ten years (2012)
C: Step Watch - Physical Activity Minutes (12 weeks between baseline and post-intervention follow up)
D: Change from baseline in physical activity and sedentariness at 12 months (Baseline, 12 months)

Answer: C
Please select the outcome measures that correspond to the clinical trial below.
Title: Pilot Study to Test the Efficacy of a Worksite Intervention for Reducing Daily Sedentary Time and Improving Risk Factors for Cardiometabolic Disease Among Sedentary, Overweight, Full-time Working Adults
Brief Summary: The primary aim of this pilot study is to test the efficacy of a worksite intervention for reducing daily sedentary time and improving risk factors for cardiometabolic disease (e.g., measures of adiposity, anthropometrics, cardiorespiratory fitness) among sedentary, overweight, full-time working adults as compared to a waitlist control. A secondary aim will be to test pedal time at work as a measure of compliance with the intervention.


Options:
A: Mean Change in Light-intensity Physical Activity at Work From Baseline to 12 Months (1 year); Mean Change in Sitting Time at Work From Baseline to 12 Months (1 year)
B: Change from baseline in experienced community of practice at 6 and 12 months. Post intervention maintenance from 12 to 24 months. (Baseline, 6 months, 12 months, 24 months); Change from baseline in well-being at 6 and 12 months. Post intervention maintenance from 12 to 24 months. (Baseline, 6 months, 12 months, 24 months); Change from baseline in dietary behaviors at 6 and 12 months. Post intervention maintenance from 12 to 24 months. (Baseline, 6 months, 12 months, 24 months); Change from baseline in exercise behaviors at 6 and 12 months. Post intervention maintenance from 12 to 24 months. (Baseline, 6 months, 12 months, 24 months); Change from baseline in safety behavior counts at 6 and 12 months, Post intervention maintenance from 12 to 24 months. (Baseline, 6 months, 12 months, 24 months); Change from baseline safety behavior consistency at 6 and 12 months, Post intervention maintenance from 12 to 24 months. (Baseline, 6 months, 12 months, 24 months)
C: Need for Recovery (up to 4 months); Fatigue (up to 4 months)
D: Step Watch - Physical Activity Minutes (12 weeks between baseline and post-intervention follow up)

Answer: D
Please select the outcome measures that correspond to the clinical trial below.
Title: Pilot Study to Test the Efficacy of a Worksite Intervention for Reducing Daily Sedentary Time and Improving Risk Factors for Cardiometabolic Disease Among Sedentary, Overweight, Full-time Working Adults
Brief Summary: The primary aim of this pilot study is to test the efficacy of a worksite intervention for reducing daily sedentary time and improving risk factors for cardiometabolic disease (e.g., measures of adiposity, anthropometrics, cardiorespiratory fitness) among sedentary, overweight, full-time working adults as compared to a waitlist control. A secondary aim will be to test pedal time at work as a measure of compliance with the intervention.


Options:
A: Change in objective measure of degree of physical activity (baseline, 12 weeks, 6 months)
B: Step Watch - Physical Activity Minutes (12 weeks between baseline and post-intervention follow up)
C: non-exercise activity (Measured constantly during the entire control period and measured constantly during the entire intervention period and the two periods were compared to determine change in non-exercise activity)
D: Incidence of CHD and other lifestyle related diseases after ten years (2012)

Answer: B
Please select the outcome measures that correspond to the clinical trial below.
Title: A 6-month, Open-label, Multi-center, Flexible Dose Extension Study To The B2061032 Study To Evaluate The Safety, Tolerability And Efficacy Of Desvenlafaxine Succinate Sustained Release (Dvs Sr) Tablets In The Treatment Of Children And Adolescent Outpatients With Major Depressive Disorder
Brief Summary: This is a 6-month, open-label, flexible-dose study evaluating Desvenlafaxine Succinate Sustained-Release (DVS SR) in the Treatment of Child and Adolescent Outpatients with Major Depressive Disorder (MDD).


Options:
A: Percentage of Participants With a Treatment-emergent Adverse Event (TEAE) (From Week 8 (B2061032)/Day 1 (B2061030) to Week 26 of B2061030); Percentage of Participants With a Treatment-emergent Adverse Event (TEAE) (Combination Group) (From Week 8 (B2061032)/Day 1 (B2061030) to Week 26 of B2061030)
B: Change From Baseline in the Children's Depression Rating Scale Revised (CDRS-R) Total Score at Week 8 (Baseline, Week 8)
C: Change From Baseline in Children's Depression Rating Scale-Revised (CDRS-R) Total Score at Week 10 Endpoint (Baseline, Week 10)
D: The primary objective is to compare the antidepressant efficacy, safety, and tolerability of DVS-SR in subjects receiving daily doses of 50 mg or 100 mg of DVS SR versus subjects receiving placebo.

Answer: A
Please select the outcome measures that correspond to the clinical trial below.
Title: A 6 Month, Open Label, Multi Center, Flexible Dose Extension Study To The B2061014 Study To Evaluate The Safety, Tolerability And Efficacy Of Desvenlafaxine Succinate Sustained Release (Dvs Sr) Tablets In The Treatment Of Children And Adolescent Outpatients With Major Depressive Disorder
Brief Summary: This is a 6-month, open-label, flexible-dose study evaluating desvenlafaxine succinate sustained release (DVS SR) in the treatment of child and adolescent outpatients with major depressive disorder (MDD).


Options:
A: Percentage of Participants Experiencing a Treatment Emergent Adverse Event (Week 9 (B2061014)/Day 1 (B2061031) to Week 26 of the B2061031 Study)
B: Change in Children's Depression Rating Scale - Revised (CDRS-R) Total Score (Baseline to end of week 8)
C: The primary objective is to compare the antidepressant efficacy, safety, and tolerability of DVS-SR in subjects receiving daily doses of 50 mg or 100 mg of DVS SR versus subjects receiving placebo.
D: Change From Baseline in Children's Depression Rating Scale-Revised (CDRS-R) Total Score at Week 10 Endpoint (Baseline, Week 10)

Answer: A
Please select the outcome measures that correspond to the clinical trial below.
Title: A Multicenter, Randomized, Double-blind, Placebo-controlled, Parallel-group Study To Evaluate The Efficacy, Safety And Tolerability Of Desvenlafaxine Succinate Sustained-release (Dvs Sr) In The Treatment Of Children And Adolescent Outpatients With Major Depressive Disorder
Brief Summary: This is a double-blind study evaluating Desvenlafaxine Succinate Sustained-Release (DVS SR) versus placebo in the Treatment of Children and Adolescent Outpatients with Major Depressive Disorder (MDD).


Options:
A: Alcohol Use Behaviors (Average number of drinks as recorded on the Timeline Follow-Back (subject-reported) measure daily over the 12-week acute phase.); Depressive Symptoms (Average score as measured by participant's report on the Beck Depression Inventory (BDI).)
B: Change From Baseline to Week 8 in the Children's Depression Rating Scale, Revised (CDRS-R) Total Score (n=102, 104, 106) (Baseline and Week 8)
C: Change in Children's Depression Rating Scale - Revised (CDRS-R) Total Score (Baseline to end of week 8)
D: Measured throughout the study: Relapse; Time to relapse

Answer: B
Please select the outcome measures that correspond to the clinical trial below.
Title: A Multicenter, Randomized, Open-Label, Dose Ranging Study to Evaluate the Efficacy and Safety of Patiromer in the Treatment of Hyperkalemia in Patients With Hypertension and Diabetic Nephropathy Receiving Angiotensin-converting Enzyme Inhibitor (ACEI) and/or Angiotensin II Receptor Blocker (ARB) Drugs, With or Without Spironolactone
Brief Summary: This study determined the optimal starting dose of patiromer in treating hyperkalemia in participants with hypertension and diabetic nephropathy who were already receiving ACEI and/or ARB drugs, with or without spironolactone. This study also evaluated the efficacy and safety of patiromer and the long term use of patiromer.


Options:
A: Least Squares Mean Change in Serum Potassium From Baseline to Week 4 or Time of First Titration for Each Individual Starting Dose Group (Baseline to Week 4 or First Titration which could occur at any scheduled study visit after patiromer initiation.)
B: Mean Serum Potassium Between Maintenance Phase Study Days 8 to 29, Inclusive (MP-ITT Population). (22 Days; Maintenance Phase Days 8 - 29, inclusive.)
C: Exponential Rate of Change in Serum Potassium (S-K) Levels During the Initial 48 Hours of Study Drug Treatment. (Through 48 hours acute phase); Exponential Rate of Change in S-K Levels in the Subacute Phase. (Through 12 days subacute phase (Day 3 through Day 15))
D: Change in Serum Potassium From Part A Baseline to Part A Week 4 (Part A Baseline to Part A Week 4); Change in Serum Potassium From Part B Baseline (Part B Baseline to Part B Week 4 or first local laboratory serum potassium < 3.8 mEq/L or ≥ 5.5 mEq/L)

Answer: A
Please select the outcome measures that correspond to the clinical trial below.
Title: A Multicenter, Randomized, Open-Label, Dose Ranging Study to Evaluate the Efficacy and Safety of Patiromer in the Treatment of Hyperkalemia in Patients With Hypertension and Diabetic Nephropathy Receiving Angiotensin-converting Enzyme Inhibitor (ACEI) and/or Angiotensin II Receptor Blocker (ARB) Drugs, With or Without Spironolactone
Brief Summary: This study determined the optimal starting dose of patiromer in treating hyperkalemia in participants with hypertension and diabetic nephropathy who were already receiving ACEI and/or ARB drugs, with or without spironolactone. This study also evaluated the efficacy and safety of patiromer and the long term use of patiromer.


Options:
A: Least Squares Mean Change in Serum Potassium From Baseline to Week 4 or Time of First Titration for Each Individual Starting Dose Group (Baseline to Week 4 or First Titration which could occur at any scheduled study visit after patiromer initiation.)
B: Change From Baseline in Serum Potassium to the End of the 28-day Treatment Period. (Baseline and Day 28)
C: Exponential Rate of Change in Serum Potassium (S-K) Levels During the Initial 48 Hours of Study Drug Treatment. (Through 48 hours acute phase); Exponential Rate of Change in S-K Levels in the Subacute Phase. (Through 12 days subacute phase (Day 3 through Day 15))
D: Number of episodes of serum K ≥ 5.5 mEq/L (4 weeks)

Answer: A
Please select the outcome measures that correspond to the clinical trial below.
Title: Development and Evaluation of an Intervention for Intimate Partner Violence in the Context of Nurse Home Visits
Brief Summary: The purpose of this study is to determine whether the Intimate Partner Violence (IPV) intervention in the context of Nurse-Family Partnership (NFP) program improves women's quality of life and reduces violence relative to the NFP alone using a cluster randomized controlled trial. Our hypothesis is that an IPV intervention can be designed that is acceptable to participants in the NFP, feasible to implement, and that this intervention will improve quality of life for women and reduce exposure to violence.


Options:
A: Change from baseline in WHO Quality of Life-BREF at 6, 12, 18, and 24 months (Baseline, 3-, 6-,12-, 18-, and 24-month postpartum)
B: Effectiveness of brief intervention for decreasing problem drinking and partner violence (Weekly for 3 months; then 6 and 12 months)
C: Discussion of family psychosocial problem; Referral of family psychosocial problem; Contacting community resources
D: Intimate partner violence (One year)

Answer: A