TrialPanorama/Dataset huggingface dataset:
Please select the outcome measures that correspond to the clinical trial below.
Title: Treatment of Periodontal Disease in Patients With Acute Myocardial Infarction: Randomized Controlled Trial
Brief Summary: The main objective of this study is to evaluate the effect of treatment periodontal endothelium-dependent artery of the arm in patients with acute myocardial infarction with ST-segment elevation undergoing primary coronary intervention.


Options:
A: Brachial Artery Flow-mediated Dilation (Baseline; 24 hours post periodontal therapy; 12 weeks post periodontal therapy)
B: Changes in C reactive protein (Baseline, 3, 6 and 12 months); Changes in flow-mediated dilation (Baseline, 1, 3 and 6 months)
C: Intake of nutrients; Serum lipid and lipoprotein concentrations; Growth and development; Smoking; Physical activity level and fitness; Intima-media thickness of arteries and rate of NO-induced vasodilatation
D: The difference in dilation measured by brachial artery blood flow (6 months)

Answer: D
Please select the outcome measures that correspond to the clinical trial below.
Title: Hybrid Controlled Trial to Implement Collaborative Care in General Mental Health
Brief Summary: This randomized program evaluation is undertaken in conjunction with the Department of Veterans Affairs (VA) Office of Mental Health Operations (OMHO) and the Quality Enhancement Research Initiative. It is designed to answer two related questions: (1) Can an evidence-based implementation strategy using the Center for Disease Control (CDC)'s Replicating Effective Programs plus External Facilitation (REP-F) enhance the adoption of team-based care in VA General Mental Health (GMH) Clinics, and (2) Does the establishment of such teams via implementation enhance Veterans' health status, satisfaction, and perceptions of care? The model for team-based care is the evidence-based Collaborative Chronic Care Model (CCM).

In conjunction with a nation-wide roll-out of the VA's Behavioral Health Interdisciplinary Program team (BHIP) initiative, the investigators have structured a randomized, controlled program evaluation to answer these questions. Specifically, using a stepped wedge design the investigators will randomize 9 VAMCs that have requested support in establishing a BHIP to 1 of 3 waves of REP-F support: immediate implementation support vs. 4-month vs. 8-month wait with dissemination of CCM materials (3 sites per wave). Fidelity and health outcome measures will be collected in a repeated measures design at 6-month intervals, and analyzed with general linear modeling.


Options:
A: Quality of primary medical care (Measured over 2 years)
B: SCL-20 depression (baseline, 3, 6 12, 18 month follow-ups)
C: Veterans RAND-12 Mental Component Score (VR-12 MCS) (one year)
D: Occurrence of Discussion About Goals of Care at Target Visit (2 weeks after target visit)

Answer: C
Please select the outcome measures that correspond to the clinical trial below.
Title: Hybrid Controlled Trial to Implement Collaborative Care in General Mental Health
Brief Summary: This randomized program evaluation is undertaken in conjunction with the Department of Veterans Affairs (VA) Office of Mental Health Operations (OMHO) and the Quality Enhancement Research Initiative. It is designed to answer two related questions: (1) Can an evidence-based implementation strategy using the Center for Disease Control (CDC)'s Replicating Effective Programs plus External Facilitation (REP-F) enhance the adoption of team-based care in VA General Mental Health (GMH) Clinics, and (2) Does the establishment of such teams via implementation enhance Veterans' health status, satisfaction, and perceptions of care? The model for team-based care is the evidence-based Collaborative Chronic Care Model (CCM).

In conjunction with a nation-wide roll-out of the VA's Behavioral Health Interdisciplinary Program team (BHIP) initiative, the investigators have structured a randomized, controlled program evaluation to answer these questions. Specifically, using a stepped wedge design the investigators will randomize 9 VAMCs that have requested support in establishing a BHIP to 1 of 3 waves of REP-F support: immediate implementation support vs. 4-month vs. 8-month wait with dissemination of CCM materials (3 sites per wave). Fidelity and health outcome measures will be collected in a repeated measures design at 6-month intervals, and analyzed with general linear modeling.


Options:
A: Veterans RAND-12 Mental Component Score (VR-12 MCS) (one year)
B: The Work Behavior Inventory (Ten months)
C: Severity of depression symptoms
D: Generic Mental Health-Related Quality of Life (Measured 8 months post-CABG)

Answer: A
Please select the outcome measures that correspond to the clinical trial below.
Title: Smokerface: A Photoaging Mobile App Promoting Poster Campaign for Preventing Smoking in Secondary Schools: Randomized Controlled Trial
Brief Summary: The purpose of this study is to determine whether photoaging mobile app promoting poster campaigns are effective to reduce smoking prevalence among adolescents in Germany. This is measured via questionnaire.


Options:
A: Number of Participants With Changes in Help Seeking Scores (Baseline and 1-month post intervention)
B: Standardized Tobacco Susceptibility as assessed by 12 likert scale items drawn primarily from the global youth tobacco survey (within 24 hours of receiving presentation)
C: The change in smoking prevalence between baseline and 24 months of follow-up between the two groups measured via questionnaires. (24 months post intervention)
D: Number of Participants With Self-reported 30-day Point Prevalence Abstinence (ITT) (7 months post enrollment)

Answer: C
Please select the outcome measures that correspond to the clinical trial below.
Title: Smokerface: A Photoaging Mobile App Promoting Poster Campaign for Preventing Smoking in Secondary Schools: Randomized Controlled Trial
Brief Summary: The purpose of this study is to determine whether photoaging mobile app promoting poster campaigns are effective to reduce smoking prevalence among adolescents in Germany. This is measured via questionnaire.


Options:
A: The change in smoking prevalence between baseline and 24 months of follow-up between the two groups measured via questionnaires. (24 months post intervention)
B: Abstinence from smoking in the past 30 days at 6 months and 1 year
C: Pharmacokinetic parameters: Population mean estimate for apparent plasma clearance (CL/F), central volume of distribution (V2/F) and steady-state volume of distribution (Vss/F).
D: Conners' Global Index - Parent Version (CGI-P) (Once weekly during the medication trial); Conner's Global Index - Teacher Version (CGI-T) (Once weekly during the medication trial)

Answer: A
Please select the outcome measures that correspond to the clinical trial below.
Title: Smokerface: A Photoaging Mobile App Promoting Poster Campaign for Preventing Smoking in Secondary Schools: Randomized Controlled Trial
Brief Summary: The purpose of this study is to determine whether photoaging mobile app promoting poster campaigns are effective to reduce smoking prevalence among adolescents in Germany. This is measured via questionnaire.


Options:
A: Smoking cessation (Change in smoking status from baseline at 6 months)
B: The change in smoking prevalence between baseline and 24 months of follow-up between the two groups measured via questionnaires. (24 months post intervention)
C: Longest duration of abstinence (Week 24)
D: smoking abstinence (12 months); smoking abstinence (12 months); smoking abstinence (12 months)

Answer: B
Please select the outcome measures that correspond to the clinical trial below.
Title: A Phase 3, Rollover Study to Evaluate the Safety and Efficacy of Long-term Treatment With Lumacaftor in Combination With Ivacaftor in Subjects Aged 6 Years and Older With Cystic Fibrosis, Homozygous for the F508del-CFTR Mutation
Brief Summary: Study 110 is a Phase 3, multicenter study in subjects aged 6 years and older with cystic fibrosis (CF) who are homozygous for the F508del-CF transmembrane conductance regulator (CFTR) mutation and who participated in Study 109 (NCT02514473) or Study 011B (NCT01897233). Study 110 is designed to evaluate the safety and efficacy of long term treatment of lumacaftor in combination with ivacaftor.


Options:
A: Treatment Period 1 (Treatment Cohorts): Safety and Tolerability as Assessed by Number of Participants With Treatment-Emergent Adverse Events (AEs) and Serious Adverse Events (SAEs) (Day 1 up to Week 100)
B: Absolute Change in Lung Clearance Index 2.5 (LCI2.5) Through Week 8 (From baseline through Week 8)
C: Cohort 1: Safety and Tolerability Based on Adverse Events (AEs) (Cohort 1: Day 1 up to 28 days after last dose (Last dose = Day 21)); Cohort 2 and 3: Safety and Tolerability Based on Adverse Events (AEs) (Cohort 2 and 3: Day 1 up to 28 days after last dose (Last dose = Day 56)); Cohort 4: Safety and Tolerability Assessed by Number of Participants With AEs and SAEs (Cohort 4: Day 1 up to 28 days after last dose (Last dose = Day 56)); Cohort 1: Absolute Change From Day 14 in Sweat Chloride at Day 21 (Cohort 1: Day 14, Day 21); Cohort 2 And 3: Absolute Change From Day 28 in Sweat Chloride at Day 56 (Cohort 2 and 3: Day 28, Day 56); Cohort 4: Absolute Change From Baseline in Percent Predicted Forced Expiratory Volume in 1 Second (ppFEV1) at Day 56 (Cohort 4: Baseline, Day 56)
D: Absolute Change From Baseline (Day 1) in Percent Predicted Forced Expiratory Volume in 1 Second (ppFEV1) Through Week 24 (Day 1, Through Week 24)

Answer: A
Please select the outcome measures that correspond to the clinical trial below.
Title: High-flow Nasal Cannula Oxygen Versus Conventional Oxygen Therapy After Pulmonary Lobectomy
Brief Summary: The primary objective of this study is to evaluate the effect of early application of nasal high flow oxygen therapy after pulmonary lobectomy on the incidence of postoperative hypoxemia


Options:
A: Post-extubation respiratory failure and Reintubation rate (3 months)
B: Arterial partial pressure of carbon dioxide (PaCO2) (2 hours after randomization)
C: Failure of the ventilation system (One week)
D: Number of patients with hypoxemia (defined as a PaO2/FiO2 ratio <300) after pulmonary lobectomy in patients with lung cancer (during the first 96 hours after surgery)

Answer: D
Please select the outcome measures that correspond to the clinical trial below.
Title: High-flow Nasal Cannula Oxygen Versus Conventional Oxygen Therapy After Pulmonary Lobectomy
Brief Summary: The primary objective of this study is to evaluate the effect of early application of nasal high flow oxygen therapy after pulmonary lobectomy on the incidence of postoperative hypoxemia


Options:
A: The decrease of diaphragmatic workload (thickening fraction of the diaphragm) (30 minutes)
B: Number of patients with hypoxemia (defined as a PaO2/FiO2 ratio <300) after pulmonary lobectomy in patients with lung cancer (during the first 96 hours after surgery)
C: Inspiratory muscle effort : oesophageal pressure (Poes) and the oesophageal pressure time product (PTPoes) (Every 30 minutes for 90 minutes)
D: Oxygenation (PaO2/FiO2 ratio) (Up to 48 hours after extubation)

Answer: B
Please select the outcome measures that correspond to the clinical trial below.
Title: Randomized Clinical Study of Extra-Corporal Life Support in Cardiogenic Shock Complicating Acute Myocardial Infarction
Brief Summary: This study compares standard treatment plus Extra-Corporal Life Support (ECLS) versus standard treatment alone in patients with cardiogenic shock due to myocardial infarction.


Options:
A: Survival (Approximately 25 days)
B: Ventilator free days within 28 days after enrollment (28 days)
C: Left ventricular ejection fraction (LVEF) on day 30 (30 days)
D: Feasibility of telephone interview (At completion of telephone interview, expected average of 6 months)

Answer: C
Please select the outcome measures that correspond to the clinical trial below.
Title: Randomized Clinical Study of Extra-Corporal Life Support in Cardiogenic Shock Complicating Acute Myocardial Infarction
Brief Summary: This study compares standard treatment plus Extra-Corporal Life Support (ECLS) versus standard treatment alone in patients with cardiogenic shock due to myocardial infarction.


Options:
A: Left ventricular ejection fraction (LVEF) on day 30 (30 days)
B: Survival at 60 days (60 days)
C: 30-day survival rate with favorable neurological status (30 days)
D: Responder Analysis - Peak Oxygen Uptake (Peak VO2) (Baseline to 6 months); Responder Analysis - Six (6) Minute Walk (6MW) Distance (Baseline to 6 months); Responder Analysis - Minnesota Living With Heart Failure (MLWHF) Quality of Life Overall Score (baseline to 6 months); Number of Participant Deaths (12 months)

Answer: A
Please select the outcome measures that correspond to the clinical trial below.
Title: Optimizing Sedentary Behavior Interventions to Affect Acute Physiological
Brief Summary: An emerging body of epidemiological evidence suggests that various forms of sedentary behavior, including TV viewing, occupational sitting, and total daily sitting, may be associated with all-cause and cardiovascular mortality, overweight and obesity, type 2 diabetes, depression and psychological well-being. Importantly, many of these associations were independent of participation in moderate to vigorous intensity physical activity. We propose a pilot study to assess the feasibility, acceptability and preliminary efficacy of two interventions targeting sedentary behavior. Since it is currently unknown what component of sedentary behavior exposure presents the greatest risk to health, we propose separate interventions to reduce overall sedentary time and to promote breaks in sedentary time.


Options:
A: Study uptake rates (as % of those approached who are randomised, recruitment rates (N/mth) (Assessed post-study-endpoint (up to month 18)); Intervention adherence to goals (Assessed post-study-endpoint (up to month 18)); Percentage of participants whose surgery is scheduled up to 2 weeks prior to the end of the intervention (Assessed post-study-endpoint (up to month 18)); Percentage of participants whose surgery is scheduled up to three weeks after the end of the intervention (Assessed post-study-endpoint (up to month 18)); Percentage of participants whose surgery is cancelled or delayed for too long (Assessed post-study-endpoint (up to month 18)); Retention rates (% of participants randomised who provide data at follow-up) (Assessed post-study-endpoint (up to month 18)); Acceptability of intervention for participants (Pre-surgery (visit 4, up to week 10), post-surgery (visit 5, up to week 18)); Practicality of intervention for participants (Pre-surgery (visit 4, up to week 10), post-surgery (visit 5, up to week 18)); Participant satisfaction with the study (Pre-surgery (visit 4, up to week 10), post-surgery (visit 5, up to week 18)); Patient perception of the safety of the study as assessed by questionnaire (Pre-surgery (visit 4, up to week 10), post-surgery (visit 5, up to week 18))
B: Change in Fruit/Vegetable Serving Intake (3, 6, and 9 months); Change in Saturated Fat (% of daily calories from fat) Intake (3, 6, and 9-months); Change in Sedentary Leisure Screen Time (minutes/week) (3, 6, and 9-months); Change in Physical Activity (minutes/week) (3, 6, and 9-months); Change in Dietary Intake (3 and 9-months); Healthy Diet and Activity Improvement (3, 6, and 9 months)
C: Acceptability and feasibility (3 weeks)
D: Daily Minutes of Physical Activity (Baseline); Daily Minutes of Physical Activity (6 months); Minutes of Light to Moderate Physical Activity (12 months)

Answer: C
Please select the outcome measures that correspond to the clinical trial below.
Title: Optimizing Sedentary Behavior Interventions to Affect Acute Physiological
Brief Summary: An emerging body of epidemiological evidence suggests that various forms of sedentary behavior, including TV viewing, occupational sitting, and total daily sitting, may be associated with all-cause and cardiovascular mortality, overweight and obesity, type 2 diabetes, depression and psychological well-being. Importantly, many of these associations were independent of participation in moderate to vigorous intensity physical activity. We propose a pilot study to assess the feasibility, acceptability and preliminary efficacy of two interventions targeting sedentary behavior. Since it is currently unknown what component of sedentary behavior exposure presents the greatest risk to health, we propose separate interventions to reduce overall sedentary time and to promote breaks in sedentary time.


Options:
A: Change in objective measure of degree of physical activity (baseline, 12 weeks, 6 months)
B: Acceptability and feasibility (3 weeks)
C: change in physical activity (4 months)
D: 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)

Answer: B
Please select the outcome measures that correspond to the clinical trial below.
Title: Optimizing Sedentary Behavior Interventions to Affect Acute Physiological
Brief Summary: An emerging body of epidemiological evidence suggests that various forms of sedentary behavior, including TV viewing, occupational sitting, and total daily sitting, may be associated with all-cause and cardiovascular mortality, overweight and obesity, type 2 diabetes, depression and psychological well-being. Importantly, many of these associations were independent of participation in moderate to vigorous intensity physical activity. We propose a pilot study to assess the feasibility, acceptability and preliminary efficacy of two interventions targeting sedentary behavior. Since it is currently unknown what component of sedentary behavior exposure presents the greatest risk to health, we propose separate interventions to reduce overall sedentary time and to promote breaks in sedentary time.


Options:
A: 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)
B: Step Watch - Physical Activity Minutes (12 weeks between baseline and post-intervention follow up)
C: 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)
D: Acceptability and feasibility (3 weeks)

Answer: D
Please select the outcome measures that correspond to the clinical trial below.
Title: The Anti-inflammatory Effect of Prophylactic Macrolides on Children With Chronic Lung Disease: a Double Blinded RCT
Brief Summary: The purpose of this study is to determine if the prophylactic use of azithromycin will reduce the total number of days when unscheduled treatment is given outside of the home in a clinic, urgent care, emergency room or hospital setting between the respiratory illness season months (October 1-March 31) and subsequent 2 month follow-up (April and May)


Options:
A: Duration of diarrhea in days (up to 10 days)
B: Number of Unscheduled Face-to-face Physician Visits (Clinic Visits, ER Visits, and Hospitalizations) (5 to 8 months)
C: Forced Expiratory Volume in one second z score (FEV1) (12 months)
D: Does prolonged antibiotic treatment with AZM reduce the number of bacterial exacerbations in patients with bronchiectasis? (1 year); Does treatment with AZM increase lung function parameters (Δ FEV1, Δ FVC )? (1 year)

Answer: B
Please select the outcome measures that correspond to the clinical trial below.
Title: A Randomized, Double-blind, Placebo-controlled, Parallel-group, Multicenter, Event-driven Phase 3 Study to Investigate Efficacy and Safety of Finerenone on the Reduction of Cardiovascular Morbidity and Mortality in Subjects With Type 2 Diabetes Mellitus and the Clinical Diagnosis of Diabetic Kidney Disease in Addition to Standard of Care.
Brief Summary: The purpose of this study was to evaluate whether oral finerenone (study drug), in addition to standard daily therapy, is effective and safe in treating patients with type 2 diabetes mellitus and diabetic kidney disease, when compared to a placebo.


Options:
A: Proteinuria reduction (bi-monthly)
B: Pulse wave velocity (24 weeks); Pulse Wave velocity (12 weeks); Pulse wave velocity (baseline)
C: Change in 24 hour urine albumin to creatinine ratio after 12 months of treatment
D: The First Occurrence of the Composite Endpoint of Cardiovascular Death, Non-fatal Myocardial Infarction, Non Fatal Stroke, or Hospitalization for Heart Failure. (From randomization up until the first occurrence of the CV composite endpoint, or censoring at the end of the study, with an average study duration of 41 months.)

Answer: D
Please select the outcome measures that correspond to the clinical trial below.
Title: HIV Point-of-Care Tests in Babies Study (BABY) - Operational Evaluation of HIV Point-of-Care Tests for Very Early Infant HIV Diagnostics in Infants Born to HIV Infected Mothers in Mbeya, Tanzania
Brief Summary: HIV Point-of-Care tests in Babies Study (BABY) - Operational evaluation of HIV Point-of-Care tests for very early infant HIV diagnostics in infants born to HIV infected mothers in Mbeya, Tanzania.


Options:
A: Proportion of infants tested at birth (0-4 weeks); Proportion of infants tested at 6-weeks (4-12 weeks postpartum)
B: Specificity of PoC HIV test (Participants are planned to be followed for the duration of 6 weeks, i.e. the time point of the current Standard of Care EID); Sensitivity of PoC HIV test (Participants are planned to be followed for the duration of 6 weeks, i.e. the time point of the current Standard of Care EID)
C: Accessibility and availability (Three months)
D: The proportion of HIV-positive infants initiating antiretroviral therapy within 60 days of sample collection (up to 6 months); the proportion of HIV-positive infants who initiated antiretroviral therapy that were retained in care at 90 days of follow-up. (3 months after treatment initiation)

Answer: B
Please select the outcome measures that correspond to the clinical trial below.
Title: Antiproteinuric Effects of Liraglutide Treatment in Patients With Type 2 Diabetes and Albuminuria: A Randomised, Placebo-Controlled Trial
Brief Summary: The purpose of the study is to determine the effect of Liraglutide on albuminuria in type 2 diabetes.


Options:
A: Change in albuminuria (24 weeks)
B: N/A
C: HbA1c Change From Baseline in Patients With Mild or Moderate Renal Impairment (Baseline and 24 weeks); HbA1c Change From Baseline in Patients With Mild Renal Impairment (Baseline and 24 weeks); HbA1c Change From Baseline in Patients With Moderate Renal Impairment (Baseline and 24 weeks)
D: Absolute Change From Baseline to Week 24 in Glycosylated Haemoglobin A1c (HbA1c) (Baseline , Week 24)

Answer: A