TrialPanorama/Dataset huggingface dataset:
Please select the outcome measures that correspond to the clinical trial below.
Title: The Effects on Depression of Internet-administered Behavioural Activation and Physical Exercise With Treatment Rationale and Relapse Prevention: Study Protocol for a Randomised Controlled Trial
Brief Summary: The purpose of this study is to compare an internet-based behavioral activation program with a physical activation program, as treatments for mild to moderate depression. The added effect of rationale and motivational interviewing will also be studied, as well as the effects of relapse prevention program.


Options:
A: Patient Health Questionnaire (PHQ-9)- Change from baseline (Two weeks pre treatment, two weeks post treatment, six months and 12 months post treatment); Beck Depression Inventory (BDI)- Change from baseline (Two weeks pre treatment, two weeks post treatment, six months and 12 months post treatment)
B: Recruitment and retention rates, data completion, and resource utilization. (Baseline, Week 18)
C: Change from baseline in Patient Health Questionnaire (PHQ-9) (Weekly during treatment period of 12 weeks); Change from baseline in Patient Health Questionnaire (PHQ-9) (24 hours); Change from baseline in Patient Health Questionnaire (PHQ-9) (12 months); Change from baseline in Patient Health Questionnaire (PHQ-9) (24 months); Change from baseline in Patient Health Questionnaire (PHQ-9) (Monthly, 0-24 months)
D: Patient Health Questionnaire (PHQ-9)- Change from baseline (Two weeks pre treatment, two weeks post treatment, six months and 12 months post treatment); Beck Depression Inventory (BDI)- Change from baseline (Two weeks pre treatment, two weeks post treatment, six months and 12 months post treatment)

Answer: C
Please select the outcome measures that correspond to the clinical trial below.
Title: The Brazilian Cardioprotective Nutritional Program to Reduce Events and Risk Factors in Secondary Prevention for Cardiovascular Disease
Brief Summary: There are no studies exploring the benefits of a diet composed of typical Brazilian food in the secondary prevention of cardiovascular diseases. Randomized studies show that the Mediterranean diet is beneficial for patients with established cardiovascular disease or in risk for CVD development. Indeed, nutritional composition of the Mediterranean Diet is one of main references for dietary guidelines for treatment and prevention of CVD in Brazil and the world. However, in many countries, such as Brazil, most foods of the Mediterranean diet are not widely available, may be expensive or are not part of population eating habits. So, the prescription of the Mediterranean diet intervention for cardiovascular disease to the Brazilian population may not be feasible, leading to a low adherence. In this context, patients with established CVD have a low compliance to nutritional prescription. The BALANCE Program, considers 3 concepts: a) A dietary prescription guided by nutritional content recommendations from the Brazilian national guidelines; b) A nutritional education program based on fun, playful strategies and suggestions of affordable foods; and c) Intensive follow-up through one-on-one visits, group sessions, and phone calls. This is the first proposal to use these concepts concurrently with the objective to increase adherence of secondary prevention patients to the diet proposed by the guidelines. Therefore, The primary outcome is a composite of death (any cause), cardiac arrest, acute myocardial infarction, stroke, myocardial revascularization, amputation for peripheral arterial disease, or hospitalization for unstable angina.


Options:
A: Blood pressure (4 months)
B: Changes in Mediterranean diet scale (6, 12, and 24 months)
C: Composity of Major Cardiovascular Events (up to 48 month)
D: Change in body weight (kg) (26 weeks)

Answer: C
Please select the outcome measures that correspond to the clinical trial below.
Title: Efficacy and Safety of Liraglutide Versus Placebo as add-on to Existing Diabetes Medication in Subjects With Type 2 Diabetes and Moderate Renal Impairment. A 26-week Double-blind Placebo-controlled, Randomised, Multicentre, Multi-national, Parallel-group Trial
Brief Summary: This trial is conducted in Europe and the United States of America (USA). The aim of this trial is to investigate the efficacy and safety of liraglutide in subjects with type 2 diabetes and moderate renal impairment.

The trial medication will be add-on to the subject's stable pre-trial OAD and/or insulin regimen.


Options:
A: Major macrovascular events -a composite of non-fatal myocardial infarction, non-fatal stroke and death from any cardiovascular cause (based on investigator diagnosis) (2014); Death from any cause (2014)
B: Estimated Mean From the Statistical Model and Standard Deviation From Observed Data For Change From Baseline to Week 26 in HbA1c (%) (Glycosylated Haemoglobin) (Week 0, Week 26)
C: Number of Participants With Progression of Diabetic Retinopathy of at Least 3 Stages on the Early Treatment Diabetic Retinopathy Study (ETDRS) Scale, or Development of Proliferative Diabetic Retinopathy Necessitating Photocoagulation Therapy or Vitrectomy (Measured at Year 4)
D: Renal function: estimated glomerular filtration rate (Week 60)

Answer: B
Please select the outcome measures that correspond to the clinical trial below.
Title: Efficacy and Safety of Liraglutide Versus Placebo as add-on to Existing Diabetes Medication in Subjects With Type 2 Diabetes and Moderate Renal Impairment. A 26-week Double-blind Placebo-controlled, Randomised, Multicentre, Multi-national, Parallel-group Trial
Brief Summary: This trial is conducted in Europe and the United States of America (USA). The aim of this trial is to investigate the efficacy and safety of liraglutide in subjects with type 2 diabetes and moderate renal impairment.

The trial medication will be add-on to the subject's stable pre-trial OAD and/or insulin regimen.


Options:
A: Number of Participants Who Experienced an Event For Time, From Randomization to First Occurrence of Cardiovascular Death, Non-fatal Myocardial Infarction, or Non-fatal Stroke (a Composite Cardiovascular Outcome) (From randomization to first occurrence or death from any cause or study completion (Median Follow-Up of 5.4 Years))
B: To evaluate the effect of vildagliptin on left ventricular function in patients with T2DM and CHF (NYHA class I-III) by showing that vildagliptin is at least not inferior to placebo with respect to change in left ventricular ejection fraction (LVEF). (52 weeks)
C: Beta-cell function (after 12 weeks of intervention); LVEF (after 12 weeks of intervention)
D: Estimated Mean From the Statistical Model and Standard Deviation From Observed Data For Change From Baseline to Week 26 in HbA1c (%) (Glycosylated Haemoglobin) (Week 0, Week 26)

Answer: D
Please select the outcome measures that correspond to the clinical trial below.
Title: N-3 Polyunsaturated Fatty Acids in the Prevention and Treatment for IFN-induced Depression
Brief Summary: The first part is a double-blind placebo-controlled trial to identify the effects of omega-3 polyunsaturated fatty acids (PUFAs) in prevention of IFN-induced depression. The second part is a double-blind trial to identify the antidepressant effects of omega-3 PUFAs in patients with IFN-induced depression.


Options:
A: Serum Fasting Blood Sugar(FBS) (Change from baseline at 10 weeks)
B: Percentage of Participants with major depressive episode (for Study 1); Changes in Hamilton Depression Rating Scale (HDRS) (for Study 2) (Weeks 0 to 24)
C: Hamilton Depression Rating Scale 17 (HDRS-17) Scores (Baseline, Weeks 1, 2, 4, 6, 8, 10 and 12)
D: Changes from Baseline Hamilton Depression Rating Scale (HDRS) at 12 weeks (Week 12); Remission rate (Week 12); Response rate (Week 12)

Answer: B
Please select the outcome measures that correspond to the clinical trial below.
Title: Symptom Management Program for Hemodialysis Patients
Brief Summary: Self-management intervention may decrease symptom burden and improve functioning over time.


Options:
A: a composite of mortality with the change over 12 months in left ventricular mass (12 months); a composite of mortality with the change over 12 months in the SF-36 RAND physical health composite. (12 months)
B: Proportion of participants screened as eligible who enroll (34 months); Proportion of participants who enrolled who completed the 8 week-trial (34 months); Tolerability of Meditation Intervention on a 10-point Likert scale (8 weeks)
C: Decrease symptom burden (8 weeks)
D: Occurrence of clinically relevant calcium disturbances (patients are followed for 8 weeks); Occurrence of clinically relevant acid-base disturbances (patients are followed for 8 weeks)

Answer: C
Please select the outcome measures that correspond to the clinical trial below.
Title: Symptom Management Program for Hemodialysis Patients
Brief Summary: Self-management intervention may decrease symptom burden and improve functioning over time.


Options:
A: Change From Baseline in the Weekly Mean of the Daily 24-hour Worst Itching Intensity NRS Score During Week 8 (Baseline, Week 8)
B: Decrease symptom burden (8 weeks)
C: improvement in pruritus (6 mo)
D: Investigator Global Assessment (Disease severity assessed at baseline and 4 weeks, week 4 reported)

Answer: B
Please select the outcome measures that correspond to the clinical trial below.
Title: Parent Training to Address Pediatric Functional Abdominal Pain
Brief Summary: Functional abdominal pain (FAP) is a common complaint of childhood, associated with considerable health care costs, disruption of normal activity, emotional distress, and long-term health effects. The study will test a treatment approach which, if successful, would substantially change the treatment for FAP and potentially for a wide range of childhood medical problems where parental responses to symptoms contribute to these adverse effects. The study would also provide a model which would be much more accessible than traditional face-to-face therapies to a broader range of families in need than are currently served.


Options:
A: N/A
B: Juvenile Arthritis Quality of Life Questionnaire (JAQQ) (Baseline (prior to randomization) and 3 months after intervention)
C: Adherence (beginning at baseline - week 20)
D: Abdominal Pain Index (Baseline, 1 week post treatment session 3, 3 months post treatment session 3, 6 months post treatment session 3, 12 months post treatment session 3)

Answer: D
Please select the outcome measures that correspond to the clinical trial below.
Title: Parent Training to Address Pediatric Functional Abdominal Pain
Brief Summary: Functional abdominal pain (FAP) is a common complaint of childhood, associated with considerable health care costs, disruption of normal activity, emotional distress, and long-term health effects. The study will test a treatment approach which, if successful, would substantially change the treatment for FAP and potentially for a wide range of childhood medical problems where parental responses to symptoms contribute to these adverse effects. The study would also provide a model which would be much more accessible than traditional face-to-face therapies to a broader range of families in need than are currently served.


Options:
A: Adherence (beginning at baseline - week 20)
B: Headache diaries assess headache frequency. (Completed one month prior to first visit, then weekly up to Week 20, then one month prior to Month 3, 6, 9, and 12 Follow-Up Visits.)
C: Change in FDI (Functional Disability Inventory) Scores at End of Study (Baseline and 6 months (end of study))
D: Abdominal Pain Index (Baseline, 1 week post treatment session 3, 3 months post treatment session 3, 6 months post treatment session 3, 12 months post treatment session 3)

Answer: D
Please select the outcome measures that correspond to the clinical trial below.
Title: Parent Training to Address Pediatric Functional Abdominal Pain
Brief Summary: Functional abdominal pain (FAP) is a common complaint of childhood, associated with considerable health care costs, disruption of normal activity, emotional distress, and long-term health effects. The study will test a treatment approach which, if successful, would substantially change the treatment for FAP and potentially for a wide range of childhood medical problems where parental responses to symptoms contribute to these adverse effects. The study would also provide a model which would be much more accessible than traditional face-to-face therapies to a broader range of families in need than are currently served.


Options:
A: Metabolic Control: Hemoglobin A1c (HbA1c) (2 years)
B: Parent Report Measures (4 years)
C: Abdominal Pain Index (Baseline, 1 week post treatment session 3, 3 months post treatment session 3, 6 months post treatment session 3, 12 months post treatment session 3)
D: Change in baseline of Diabetes Knowledge (Baseline and 14 weeks)

Answer: C
Please select the outcome measures that correspond to the clinical trial below.
Title: Effect Evaluation of a Theory and Evidence Based Programme for Establishing Effective Breastfeeding After Short Time Hospitalization Post Partum
Brief Summary: The purpose of this study is to evaluate if the developed theory and evidence based programme has a positive effect on mother's breastfeeding self efficacy, establishing an effective breastfeeding and breastfeeding duration after short time hospitalization.


Options:
A: skin to skin contact (within first 28 days after birth); careseeking for newborn (within first 28 days after birth)
B: Initiation of LARC by time of standard postpartum visit (4-8 weeks postpartum)
C: Parents breastfeeding self efficacy (7 days post partum)
D: Use of unplanned maternal and child healthcare services (inpatient, Emergency Department (ED), urgent/acute care, primary care, and mental health) in the first 14 days after delivery (3 years)

Answer: C
Please select the outcome measures that correspond to the clinical trial below.
Title: Effect Evaluation of a Theory and Evidence Based Programme for Establishing Effective Breastfeeding After Short Time Hospitalization Post Partum
Brief Summary: The purpose of this study is to evaluate if the developed theory and evidence based programme has a positive effect on mother's breastfeeding self efficacy, establishing an effective breastfeeding and breastfeeding duration after short time hospitalization.


Options:
A: Parents breastfeeding self efficacy (7 days post partum)
B: Initiation of LARC by time of standard postpartum visit (4-8 weeks postpartum)
C: Number of Participants With Combined Common Mental Disorders (CMDs, i.e. Anxiety and Depression). (6 weeks postpartum)
D: Change in receipt of primary care services - self report (2-months and 6-months Postpartum (baseline and 4-months from baseline data collection)); Change in receipt of primary care services - EMR review (2-months and 6-months Postpartum (baseline and 4-months from baseline data collection))

Answer: A
Please select the outcome measures that correspond to the clinical trial below.
Title: A Randomized Controlled Clinical Trial of Bupropion SR and Individual Smoking Cessation Counseling
Brief Summary: The purpose of this study was to determine if bupropion plus counseling was more effective than bupropion alone or counseling alone in helping smokers quit smoking.


Options:
A: 7-day Point Prevalence Abstinence From Smoking at 6 Months (6 months)
B: Smoking Cessation at 7 days (7-day point prevalence abstinence); Continuous Smoking Abstinence at 6 weeks (6 weeks)
C: Change of ExpiredCO Level From Baseline (Weekly for 12 weeks); Level of Nicotine Dependence by Treatment Assignment (Weekly for 12 weeks)
D: To examine the effects of varenicline treatment used concomitantly with antipsychotic medications, on cognitive dysfunction in people with schizophrenia. (8 weeks)

Answer: A
Please select the outcome measures that correspond to the clinical trial below.
Title: A Randomized Controlled Clinical Trial of Bupropion SR and Individual Smoking Cessation Counseling
Brief Summary: The purpose of this study was to determine if bupropion plus counseling was more effective than bupropion alone or counseling alone in helping smokers quit smoking.


Options:
A: Smoking Status (at week 48)
B: Percent Treatment Sessions Attended (52 weeks)
C: Cigarette use (8 weeks)
D: 7-day Point Prevalence Abstinence From Smoking at 6 Months (6 months)

Answer: D
Please select the outcome measures that correspond to the clinical trial below.
Title: A Randomized Controlled Clinical Trial of Bupropion SR and Individual Smoking Cessation Counseling
Brief Summary: The purpose of this study was to determine if bupropion plus counseling was more effective than bupropion alone or counseling alone in helping smokers quit smoking.


Options:
A: Seven-day point prevalence smoking abstinence at end of trial (abstinence based on self-reported smoking abstinence verified by CO levels < 10 ppm) (9 weeks)
B: Percentage of Participants With Carbon Monoxide (CO) Confirmed 10-Week Continuous Abstinence (CA) From Smoking (Week 15 - 24)
C: Prolonged Smoking Abstinence at End of 12 Weeks of Varenicline Treatment (12 weeks)
D: 7-day Point Prevalence Abstinence From Smoking at 6 Months (6 months)

Answer: D
Please select the outcome measures that correspond to the clinical trial below.
Title: A Randomized Controlled Clinical Trial of Bupropion SR and Individual Smoking Cessation Counseling
Brief Summary: The purpose of this study was to determine if bupropion plus counseling was more effective than bupropion alone or counseling alone in helping smokers quit smoking.


Options:
A: 7-day Point Prevalence Abstinence From Smoking at 6 Months (6 months)
B: Percentage of Participants With 4-week Continuous Abstinence (CA) (Week 9 through Week 12)
C: Seven-day point prevalence and treatment or treatment strategy (At week 6); Main effects of varenicline and nicotine patch + lozenge on smokers who remain on these medications throughout the trial as documented in questionnaires (Up to 12 weeks); Probability of response at week 12 conditional on response at week 6 and continuation of treatment (At 12 weeks); Probability of response at week 12 conditional on non-response at week 6 and continuation of treatment (At 12 weeks); Probability of response at week 12 conditional on non-response at week 6 and augmentation of treatment (At 12 weeks); Probability of response at week 12 conditional on non-response at week 6 and treatment switching (At 12 weeks); Probability that treatment continuation, switching, or augmentation confers benefit conditional upon failing to quit after the initial treatment with nicotine patch + lozenge for six weeks (12 weeks); Probability that treatment continuation, switching, or augmentation confers benefit conditional upon failing to quit after initial treatment with varenicline for six weeks (12 weeks)
D: 52-Week Point-Prevalence Abstinence (Assessed 52 weeks after quit date)

Answer: A
Please select the outcome measures that correspond to the clinical trial below.
Title: A Randomized Controlled Clinical Trial of Bupropion SR and Individual Smoking Cessation Counseling
Brief Summary: The purpose of this study was to determine if bupropion plus counseling was more effective than bupropion alone or counseling alone in helping smokers quit smoking.


Options:
A: 7-day Point Prevalence Abstinence From Smoking at 6 Months (6 months)
B: Expired-air Carbon Monoxide Confirmed Smoking Abstinence (52 weeks)
C: Number of Subjects With a 4 Week Continuous Quit Rate (CQR) From Smokeless Tobacco (Weeks 9 through 12)
D: Smoking Cessation at 7 days (7-day point prevalence abstinence); Continuous Smoking Abstinence at 6 weeks (6 weeks)

Answer: A
Please select the outcome measures that correspond to the clinical trial below.
Title: Efficacy of Bupropion Alone and in Combination With Nicotine Gum
Brief Summary: Focus of this study was to determine if bupropion was more effective for smoking cessation when used alone or combined with nicotine gum.


Options:
A: 7-day point prevalence abstinence measured at 6 months (6 months)
B: Change in sputum eosinophile-% from >1% to normal or neutrophile-% from >61% to normal, from baseline (week 0) to week 12. (Time frame for primary outcome: 0-12 weeks (total study duration 24 weeks))
C: Number of Responders With Carbon Monoxide (CO) Confirmed 4-week Continuous Quit Rate (CQR) for Last 4 Weeks of Treatment (Trtmt) (weeks 9 through 12)
D: Tobacco use abstinence (26 week)

Answer: A
Please select the outcome measures that correspond to the clinical trial below.
Title: Efficacy of Bupropion Alone and in Combination With Nicotine Gum
Brief Summary: Focus of this study was to determine if bupropion was more effective for smoking cessation when used alone or combined with nicotine gum.


Options:
A: Prevention in relapse (Up to 6 months)
B: 7-day point prevalence of abstinence, 9-12 week continuous abstinence, 9-26 week continuous abstinence (9-12 weeks; 9-26)
C: Comparison of Prolonged Abstinence (up to12 weeks post-quit)
D: 7-day point prevalence abstinence measured at 6 months (6 months)

Answer: D
Please select the outcome measures that correspond to the clinical trial below.
Title: Efficacy of Bupropion Alone and in Combination With Nicotine Gum
Brief Summary: Focus of this study was to determine if bupropion was more effective for smoking cessation when used alone or combined with nicotine gum.


Options:
A: Biochemically verified 7 day point prevalence abstinence from smoking.
B: N/A
C: Number of Participants Completing Continuous Four-week Abstinence From Smoking Between the 8-week and 11-week Post Quit Day Visits (Period between 8-week and 11-week visits post target Quit Day)
D: 7-day point prevalence abstinence measured at 6 months (6 months)

Answer: D
Please select the outcome measures that correspond to the clinical trial below.
Title: Efficacy of Bupropion Alone and in Combination With Nicotine Gum
Brief Summary: Focus of this study was to determine if bupropion was more effective for smoking cessation when used alone or combined with nicotine gum.


Options:
A: Self-Reported 7-Day Point-Prevalence Abstinence (Assessed at 52 weeks after target quit day)
B: Biochemically Verified 7-day Point Prevalence Abstinence (End of Treatment (week 24))
C: 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))
D: 7-day point prevalence abstinence measured at 6 months (6 months)

Answer: D
Please select the outcome measures that correspond to the clinical trial below.
Title: Efficacy of Bupropion Alone and in Combination With Nicotine Gum
Brief Summary: Focus of this study was to determine if bupropion was more effective for smoking cessation when used alone or combined with nicotine gum.


Options:
A: Percent Treatment Sessions Attended (52 weeks)
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: 7-day point prevalence abstinence measured at 6 months (6 months)

Answer: D