TrialPanorama/Dataset huggingface dataset:
Please select the outcome measures that correspond to the clinical trial below.
Title: A Pilot Study of Positively Smoke Free on the Web (PSFW) for HIV-infected Smokers
Brief Summary: The purpose of this study is to evaluate the first web-based cessation program developed expressly for people living with HIV who smoke tobacco. Main study goals are (1) to evaluate the website's feasibility (i.e., recruitment, adherence, retention, and satisfaction) and (2) to complete a prospective, randomized controlled trial comparing the efficacy of the online program to standard care with a primary outcome of 3 month point-prevalence abstinence.


Options:
A: 24-hour Point-prevalence tobacco abstinence (3 months)
B: Point Prevalence Abstinence (5 month follow-up)
C: Smoking abstinence as measured by 7-day point prevalence abstinence at 12 months following treatment (12 months)
D: Physician performance on refering patients that smoke cigarettes to the web intervention (pre-intervention, 6 months, 12 months and 24 months); Of the smokers who are referred to the web intervention, the number who go to the site (preintervention, 6 months, 12 months, 24 months); Point prevalence smoking cessation (6 months)

Answer: A
Please select the outcome measures that correspond to the clinical trial below.
Title: A Pilot Study of Positively Smoke Free on the Web (PSFW) for HIV-infected Smokers
Brief Summary: The purpose of this study is to evaluate the first web-based cessation program developed expressly for people living with HIV who smoke tobacco. Main study goals are (1) to evaluate the website's feasibility (i.e., recruitment, adherence, retention, and satisfaction) and (2) to complete a prospective, randomized controlled trial comparing the efficacy of the online program to standard care with a primary outcome of 3 month point-prevalence abstinence.


Options:
A: smoking cessation (6-months)
B: End-of-intervention Varenicline Adherence (4 Weeks)
C: 24-hour Point-prevalence tobacco abstinence (3 months)
D: Effectiveness of counseling intervention vs. control intervention on smoking cessation rates of participants enrolled in study (4 yrs)

Answer: C
Please select the outcome measures that correspond to the clinical trial below.
Title: Evaluation of the "Housing First Program" in Homeless Patients With Severe Mental Disorders in France: a Multicentric Randomized Controlled Study
Brief Summary: As mental health care shifted from state psychiatric hospitals to the community in France and western countries, the mental health system became inevitably involved in housing as it strove to meet the broader psychosocial needs of consumers. Simultaneously, as many consumers found themselves unable to find stable living in the community and struggling with addictions, they became a significant subgroup within a larger homeless population, which has received increasing policy attention over the past three decades. There are two distinct service models for adults who have severe mental illness and are homeless: the residential continuum model and the Housing First model.


Options:
A: N/A
B: Participants Who Had Undetectable HIV-1 RNA Levels at Less Than 400 Copies/mL at Six Month (6 months)
C: Treatment Progress (6 months)
D: healthcare utilisation (3 YEARS)

Answer: D
Please select the outcome measures that correspond to the clinical trial below.
Title: Renal Denervation in Patients With Resistant Hypertension
Brief Summary: The DENER-HTN study is a, multicenter, prospective, open, randomized, controlled study of the effectiveness and costs of renal denervation in addition to standardized medical treatment compared to medical treatment alone in subjects with resistant hypertension. Bilateral renal denervation will be performed using the Symplicity Catheter - a percutaneous system that delivers radiofrequency (RF) energy through the luminal surface of the renal artery.


Options:
A: Mean diurnal systolic blood pressure assessed by ABPM (Baseline to 6 months); Cost-effectiveness evaluation (1 year)
B: Anti-arrhythmic Drug (AAD)-Free Single-procedure Freedom From Atrial Fibrillation Recurrence (up to 12 months)
C: Number of Participants With Major Adverse Events (MAE) Defined as a Composite of Events. (From baseline to 1 month post-procedure (6 months for new renal artery stenosis)); Baseline Adjusted Change (Using Analysis of Covariance) in Systolic Blood Pressure as Measured by 24-hour Ambulatory Blood Pressure Monitoring (From baseline to 3 months post-procedure)
D: Change in Systolic Blood Pressure From Baseline to 6 Months on 24-h Ambulatory Measurement (Follow-up Minus Baseline Measurement) (The primary endpoint has been assessed 6 months after randomization.); Change in Glomerular Filtration Rate (This endpoint has been assessed 6 months after randomization.)

Answer: A
Please select the outcome measures that correspond to the clinical trial below.
Title: Renal Denervation in Patients With Resistant Hypertension
Brief Summary: The DENER-HTN study is a, multicenter, prospective, open, randomized, controlled study of the effectiveness and costs of renal denervation in addition to standardized medical treatment compared to medical treatment alone in subjects with resistant hypertension. Bilateral renal denervation will be performed using the Symplicity Catheter - a percutaneous system that delivers radiofrequency (RF) energy through the luminal surface of the renal artery.


Options:
A: Change in systolic blood pressure (ABPM mean value) (6 months)
B: Change in atrial fibrillation burden (from Baseline and 12 months)
C: Safety - complications associated with delivery and/or use of the Ardian Catheter, adverse renal events, electrolyte disturbances, hemodynamic events. (Through 3 years)
D: Mean diurnal systolic blood pressure assessed by ABPM (Baseline to 6 months); Cost-effectiveness evaluation (1 year)

Answer: D
Please select the outcome measures that correspond to the clinical trial below.
Title: Effect of Breakfast Omission on Postprandial Glycemia After Lunch and Dinner in T2D
Brief Summary: The investigators will explore the effect of omission of breakfast on postprandial hyperglycemia and insulin and intact GLP-1 response after subsequent meals in type 2 diabetic patients


Options:
A: Adipose tissue dynamics (12 weeks)
B: Change in Total Body Fat, kg (Baseline, 12 week, 64 weeks)
C: Change from baseline shear wave elastography (SWE) at 8 weeks (Change from baseline at 8-week); Change from baseline liver steatosis at 8 weeks (Change from baseline at 8-week); Concentration of high-density lipoprotein (HDL) (Change from baseline at 8-week); Concentration of low-density lipoprotein (LDL) (Change from baseline at 8-week); Concentration of triglycerides (TG) (Change from baseline at 8-week); Concentration of total cholesterol (TC) (Change from baseline at 8-week); Concentration of fasting blood sugar (FBS) (Change from baseline at 8-week); Concentration of alanine aminotransferase (ALT) (Change from baseline at 8-week); Concentration of aspartate aminotransferase (AST) (Change from baseline at 8-week)
D: Postprandial Glucose Response (12 weeks)

Answer: D
Please select the outcome measures that correspond to the clinical trial below.
Title: Randomised, Double-blind, Parallel-group, Active-comparator (Venlafaxine Extended Release), Fixed-dose Study of [Vortioxetine] Lu AA21004 in Major Depressive Disorder in Asian Countries
Brief Summary: This study will be conducted with the aim of investigating the efficacy, safety and tolerability of 10 mg/day Vortioxetine in Asian patients compared to an approved active comparator (venlafaxine extended release 150 mg/day).


Options:
A: Change From Baseline in MADRS Total Score at Week 8 (Baseline and Week 8)
B: Change From Baseline in MADRS Total Score After 6 Weeks of Treatment (Baseline and Week 6)
C: Change From Baseline to Week 8 in DSST (Number of Correct Symbols) and RAVLT (Acquisition and Delayed Recall) Using the Composite Z-score Defined as the Weighted Sum of the Individual Patient Z-scores (Baseline and Week 8)
D: Change From Baseline in Montgomery-Åsberg Depression Rating Scale (MADRS) Total Score (Baseline and Week 8)

Answer: A
Please select the outcome measures that correspond to the clinical trial below.
Title: Study of Community Based Dual Task and Aerobic Exercise Intervention on Cognition and Mobility in Older Adults Without Dementia
Brief Summary: The investigators proposed research will establish whether combining aerobic exercise with cognitive challenges is feasible and effective in community dwelling older adults with early signs of cognitive impairment.


Options:
A: Global cognitive functioning (26 weeks)
B: STROOP-Negative Priming (Change from Baseline Stroop-Negative Priming task at 15 weeks and 30 weeks); ODDBALL (Change from Baseline oddball task at 15 weeks and 30 weeks); N-BACK (Change from Baseline N-back task at 15 weeks and 30 weeks); CORSI BLOCK (Participants with non-action video-game training, change from baseline Corsi block task at 15 weeks and 30 weeks)
C: Activity Compliance (Compliance with programmed activities will be assessed at the end of participation which is expected to be at 24 weeks)
D: Change in cognitive function summary score (12 weeks)

Answer: A
Please select the outcome measures that correspond to the clinical trial below.
Title: Study of Community Based Dual Task and Aerobic Exercise Intervention on Cognition and Mobility in Older Adults Without Dementia
Brief Summary: The investigators proposed research will establish whether combining aerobic exercise with cognitive challenges is feasible and effective in community dwelling older adults with early signs of cognitive impairment.


Options:
A: Change in Global Cognition Assessed Using the ADASCog(13 and Plus Modalities). (baseline and at 20 weeks (after interventions finalised))
B: Change scores of Montreal Cognitive Assessment (MoCA) (baseline, posttest (an expected average of 3 months), follow-up (up to 9 months)); Change scores of Stroop test (baseline, posttest (an expected average of 3 months), follow-up (up to 9 months)); Change scores of Dual-task test (baseline, posttest (an expected average of 3 months), follow-up (up to 9 months)); Change scores of Timed up and go (TUG) test (baseline, posttest (an expected average of 3 months), follow-up (up to 9 months))
C: Useful Field of View Test (12 months)
D: Global cognitive functioning (26 weeks)

Answer: D
Please select the outcome measures that correspond to the clinical trial below.
Title: Study of Community Based Dual Task and Aerobic Exercise Intervention on Cognition and Mobility in Older Adults Without Dementia
Brief Summary: The investigators proposed research will establish whether combining aerobic exercise with cognitive challenges is feasible and effective in community dwelling older adults with early signs of cognitive impairment.


Options:
A: Activity Compliance (Compliance with programmed activities will be assessed at the end of participation which is expected to be at 24 weeks)
B: Change in Global Cognition Assessed Using the ADASCog(13 and Plus Modalities). (baseline and at 20 weeks (after interventions finalised))
C: cognition: MMSE, ADAS-cog. (month 0, 6, 12)
D: Global cognitive functioning (26 weeks)

Answer: D
Please select the outcome measures that correspond to the clinical trial below.
Title: Study of Community Based Dual Task and Aerobic Exercise Intervention on Cognition and Mobility in Older Adults Without Dementia
Brief Summary: The investigators proposed research will establish whether combining aerobic exercise with cognitive challenges is feasible and effective in community dwelling older adults with early signs of cognitive impairment.


Options:
A: Reduction of frailty (12 months); Frailty score (continuous variable) (12 months); Measures of frailty components (BMI, fast gait speed test, knee extension, exhaustion score and time spent on physical activities per day). (12 months)
B: Change in cognitive function summary score (12 weeks)
C: Change scores of Montreal Cognitive Assessment (MoCA) (baseline, posttest (an expected average of 3 months), follow-up (up to 9 months)); Change scores of Stroop test (baseline, posttest (an expected average of 3 months), follow-up (up to 9 months)); Change scores of Dual-task test (baseline, posttest (an expected average of 3 months), follow-up (up to 9 months)); Change scores of Timed up and go (TUG) test (baseline, posttest (an expected average of 3 months), follow-up (up to 9 months))
D: Global cognitive functioning (26 weeks)

Answer: D
Please select the outcome measures that correspond to the clinical trial below.
Title: Behavioral Activation Therapy for Rural Veterans With Diabetes and Depression
Brief Summary: This clinical trial will compare the effectiveness of the Healthy Outcomes through Patient Empowerment (HOPE) intervention to enhanced usual care (EUC) for diabetes and depression at 6 and 12 month follow-up. The proposed study is a randomized controlled trial enrolling 242 largely rural Veterans with uncontrolled diabetes and clinically-significant depressive symptoms. Both groups will receive screening, education, and notification of clinical findings along with follow-up in usual primary care. HOPE participants will also receive behavioral coaching telephone sessions over a six month period. Patients in the control group will be screened, and providers will be notified of high risk patients' status and need for intervention. Both groups will receive only usual primary care during the subsequent 6 month maintenance period. Study measurements using self-report questionnaires will also be collected at baseline, 6 and 12 months follow-up. The investigators will also conduct chart reviews to evaluate usual care blood tests for diabetes control. Changes in measurements from baseline will be compared between groups. This intervention will reach Veterans in rural setting where community-based primary care is needed, especially care that blends treatment strategies for physical and emotional health.


Options:
A: Change in Hemoglobin A1C (Hemoglobin A1C levels will be measured at baseline, 6-, and 12- months.); Change in Patient Health Questionnaires-9 During Intervention (PHQ-9 will be assessed at baseline, 6-, and 12- months.)
B: Hospital readmission (30 days)
C: Work limitations (One year); Work engagement (One year)
D: The primary outcome is defined by the number of patients free from clinically relevant adverse treatment events and/or drug interactions in each treatment arm at end of study. (6 months)

Answer: A
Please select the outcome measures that correspond to the clinical trial below.
Title: Behavioral Activation Therapy for Rural Veterans With Diabetes and Depression
Brief Summary: This clinical trial will compare the effectiveness of the Healthy Outcomes through Patient Empowerment (HOPE) intervention to enhanced usual care (EUC) for diabetes and depression at 6 and 12 month follow-up. The proposed study is a randomized controlled trial enrolling 242 largely rural Veterans with uncontrolled diabetes and clinically-significant depressive symptoms. Both groups will receive screening, education, and notification of clinical findings along with follow-up in usual primary care. HOPE participants will also receive behavioral coaching telephone sessions over a six month period. Patients in the control group will be screened, and providers will be notified of high risk patients' status and need for intervention. Both groups will receive only usual primary care during the subsequent 6 month maintenance period. Study measurements using self-report questionnaires will also be collected at baseline, 6 and 12 months follow-up. The investigators will also conduct chart reviews to evaluate usual care blood tests for diabetes control. Changes in measurements from baseline will be compared between groups. This intervention will reach Veterans in rural setting where community-based primary care is needed, especially care that blends treatment strategies for physical and emotional health.


Options:
A: Change in Patient Health Questionnaire-9 items (PHQ-9) score (Baseline, 3-month, 6-month, 9-month, 12-month)
B: Health Care Consumption (1 year); Dependence in Activities of Daily Living (1 year); Satisfaction With Health and Social Care (1 year)
C: The primary outcome is defined by the number of patients free from clinically relevant adverse treatment events and/or drug interactions in each treatment arm at end of study. (6 months)
D: Change in Hemoglobin A1C (Hemoglobin A1C levels will be measured at baseline, 6-, and 12- months.); Change in Patient Health Questionnaires-9 During Intervention (PHQ-9 will be assessed at baseline, 6-, and 12- months.)

Answer: D
Please select the outcome measures that correspond to the clinical trial below.
Title: A Phase III, Long-term, Randomized, Double-blind, Extension Study of the Efficacy, Safety, and Tolerability of Two Fixed Dose Combinations of Aclidinium Bromide/Formoterol Fumarate, Aclidinium Bromide, Formoterol Fumarate and Placebo for 28- Weeks Treatment in Patients With Moderate to Severe, Stable Chronic Obstructive Pulmonary Disease (COPD)
Brief Summary: The purpose of this Phase III study is to evaluate the long-term safety and tolerability of two fixed-dose combinations of inhaled aclidinium bromide/formoterol fumarate, aclidinium bromide, formoterol fumarate and placebo in patients with moderate to severe Chronic Obstructive Pulmonary Disease (COPD). Long-term efficacy, pharmacoeconomic and health-related quality of life assessments will also be evaluated. This extension study will include a 28 week treatment period, followed by a four week follow up visit. All patients will remain in the same treatment group as for the lead-in study and continue on one of the four treatment arms or placebo.


Options:
A: Change From Baseline in Trough Functional Residual Capacity (FRC) After 4 Weeks of Treatment (Baseline and Week 4)
B: Percentage of Patients to Experience Any Treatment-emergent Adverse Event (Baseline of lead-in study to follow-up call 14±3 days after last dose of investigational product (up to Week 52))
C: Peak Forced Expiratory Volume in One Second (FEV1) at Week 24 (At Week 24)
D: Percentage of Patients to Experience at Least One Treatment-emergent Adverse Event (TEAE) (Up to study Week 56 ± 3 days)

Answer: B
Please select the outcome measures that correspond to the clinical trial below.
Title: A Phase III, Long-term, Randomized, Double-blind, Extension Study of the Efficacy, Safety, and Tolerability of Two Fixed Dose Combinations of Aclidinium Bromide/Formoterol Fumarate, Aclidinium Bromide, Formoterol Fumarate and Placebo for 28- Weeks Treatment in Patients With Moderate to Severe, Stable Chronic Obstructive Pulmonary Disease (COPD)
Brief Summary: The purpose of this Phase III study is to evaluate the long-term safety and tolerability of two fixed-dose combinations of inhaled aclidinium bromide/formoterol fumarate, aclidinium bromide, formoterol fumarate and placebo in patients with moderate to severe Chronic Obstructive Pulmonary Disease (COPD). Long-term efficacy, pharmacoeconomic and health-related quality of life assessments will also be evaluated. This extension study will include a 28 week treatment period, followed by a four week follow up visit. All patients will remain in the same treatment group as for the lead-in study and continue on one of the four treatment arms or placebo.


Options:
A: Percentage of Patients to Experience Any Treatment-emergent Adverse Event (Baseline of lead-in study to follow-up call 14±3 days after last dose of investigational product (up to Week 52))
B: Number of Participants With Adverse Events, Serious Adverse Events or Death (52 weeks + Follow-up (Up to Day 394))
C: Safety of Treatment With NVA237 in Patients With Moderate to Severe Chronic Obstructive Pulmonary Disease (COPD) (28 days)
D: Change From Baseline (BL) in 0 to 24 Hour Weighted Mean Forced Expiratory Volume Over 1 Second (FEV1) at Day 84 (Baseline and Day 84)

Answer: A
Please select the outcome measures that correspond to the clinical trial below.
Title: A Placebo-controlled Trial of Roflumilast (Daliresp) on Markers of Inflammation in Chronic Obstructive Pulmonary Disease (COPD)
Brief Summary: The purpose of the study is to propose that roflumilast is associated with meaningful reductions in biomarkers of pulmonary inflammation and sputum neutrophilia, including confirmation of previously described results, and correlate these findings with improvement in pulmonary function, sputum scores, and quality of life in stable moderate to severe COPD. The investigators aim to demonstrate this regardless of concomitant medication use, including inhaled corticosteroids. Additionally, the investigators hope to provide a mechanistic pathway by which these effects occur.


Options:
A: Induced Sputum Proline-glycine-proline (PGP) Levels at Baseline (baseline); Mean Induced Sputum Proline-glycine-proline (PGP) Levels at 1 Month After Randomization. (1 month after baseline); Mean Induced Sputum Proline-glycine-proline (PGP) Levels at 3 Months After Randomization (3 months after baseline)
B: Rate of Moderate or Severe COPD Exacerbations Per Patient Per Year (52 weeks)
C: Number of participants with adverse events (AEs) and serious adverse events (SAEs) (Up to follow up (approximately 56 days)); Change from Baseline (Day 0 [pre-bronchodilator]) in 12-lead electrocardiogram (ECG) findings (Baseline (Day 0 [pre-bronchodilator]) and up to Day 28 (Visit 6b)); Change from Baseline (Day 0 [pre-bronchodilator]) in 12-lead electrocardiogram (ECG) findings-ventricular rate (Baseline (Day 0 [pre-bronchodilator]) and up to Day 28 (Visit 6b)); Number of participants with abnormal (potential clinical importance [PCI]) systolic blood pressure (SBP), diastolic blood pressure (DBP) and heart rate (HR) (Up to Day 27 (Visit 6a)); Number of participants with abnormal (PCI) clinical chemistry (Up to Day 42 (follow up visit)); Number of participants with abnormal (PCI) hematology (Up to Day 42 (follow up visit)); Number of participants with abnormal urinalysis (Up to Day 56 (Visit follow up)); Change from Baseline (Day 0) in lung function parameters: forced expiratory volume in one second (FEV1) and forced vital capacity (FVC) (Baseline (Day 0) and up to Day 27 (Visit 6a)); Number of participants with abnormal Holter interpretations (Up to Day 27 (Visit 6a)); Number of participants who withdrawn for exacerbations of chronic obstructive pulmonary disease (COPD) (Up to Day 27 (Visit 6a))
D: Pre-bronchodilator Forced Expiratory Volume in First Second (FEV1) (Change from baseline over 24 weeks of treatment)

Answer: A
Please select the outcome measures that correspond to the clinical trial below.
Title: A Placebo-controlled Trial of Roflumilast (Daliresp) on Markers of Inflammation in Chronic Obstructive Pulmonary Disease (COPD)
Brief Summary: The purpose of the study is to propose that roflumilast is associated with meaningful reductions in biomarkers of pulmonary inflammation and sputum neutrophilia, including confirmation of previously described results, and correlate these findings with improvement in pulmonary function, sputum scores, and quality of life in stable moderate to severe COPD. The investigators aim to demonstrate this regardless of concomitant medication use, including inhaled corticosteroids. Additionally, the investigators hope to provide a mechanistic pathway by which these effects occur.


Options:
A: change in FEV1 from baseline during the treatment period; number of COPD exacerbations.
B: Induced Sputum Proline-glycine-proline (PGP) Levels at Baseline (baseline); Mean Induced Sputum Proline-glycine-proline (PGP) Levels at 1 Month After Randomization. (1 month after baseline); Mean Induced Sputum Proline-glycine-proline (PGP) Levels at 3 Months After Randomization (3 months after baseline)
C: Pre-bronchodilator Forced Expiratory Volume in First Second (FEV1) (Change from baseline over 52 weeks of treatment); COPD Exacerbation Rate (Moderate or Severe) (52 weeks treatment period)
D: Pre-bronchodilator Forced Expiratory Volume in First Second (FEV1) (Change from baseline over 52 weeks of treatment); COPD Exacerbation Rate (Moderate or Severe) (52 weeks treatment period)

Answer: B