TrialPanorama/Dataset huggingface dataset:
Please select the outcome measures that correspond to the clinical trial below.
Title: RENEWING HEALTH - Large Scale Pilot in Veneto Region: Life-long Monitoring in COPD
Brief Summary: The purpose of this study is to evaluate whether the introduction of large-scale telemonitoring of patients with COPD produces benefits in terms of improved health-related quality of life and reduced access to hospital facilities. In addition, the trial evaluates the economic and organisational impact of the new services, and examine their acceptability by patients and health professionals.


Options:
A: Hospital Readmission (12 months)
B: Health-Related quality of life (12 months)
C: Number of hospital admissions for exacerbations of COPD
D: Improvement tolerance capacity (4 months and 6 months)

Answer: B
Please select the outcome measures that correspond to the clinical trial below.
Title: RENEWING HEALTH - Large Scale Pilot in Veneto Region: Life-long Monitoring in COPD
Brief Summary: The purpose of this study is to evaluate whether the introduction of large-scale telemonitoring of patients with COPD produces benefits in terms of improved health-related quality of life and reduced access to hospital facilities. In addition, the trial evaluates the economic and organisational impact of the new services, and examine their acceptability by patients and health professionals.


Options:
A: Number of hospital admissions for exacerbations of COPD
B: Physical activity (Change between baseline (T0) and directly after the intervention, after 4-6 months from baseline (T1)); Physical activity (Change between T1 and T2: 3 months follow up)
C: Health-Related quality of life (12 months)
D: The combined number of hospital admissions and ED visits for a COPD exacerbation (6-month follow-up period)

Answer: C
Please select the outcome measures that correspond to the clinical trial below.
Title: RENEWING HEALTH - Large Scale Pilot in Veneto Region: Life-long Monitoring in COPD
Brief Summary: The purpose of this study is to evaluate whether the introduction of large-scale telemonitoring of patients with COPD produces benefits in terms of improved health-related quality of life and reduced access to hospital facilities. In addition, the trial evaluates the economic and organisational impact of the new services, and examine their acceptability by patients and health professionals.


Options:
A: Identifying new patient subtypes and endpoints for COPD (3 years)
B: Adherence to Pulmonary Rehabilitation (baseline to 3 months)
C: COPD Assessment Test (CAT) (1 Year)
D: Health-Related quality of life (12 months)

Answer: D
Please select the outcome measures that correspond to the clinical trial below.
Title: Decision Aid to Technologically Enhance Shared Decision Making
Brief Summary: Physicians face a challenge in promoting colorectal cancer screening (CRCS) in the face of multiple competing demands. A decision aid (DA) that clarifies patient preferences and improves decision quality could aid shared decision making (SDM) and be effective at increasing CRCS rates. However, exactly how such DA improves SDM is not clear. This 4-year R01 study funded by the National Cancer Institute seeks to provide detailed understanding of how an interactive DA affects patient-physician communication and SDM, and ultimately CRCS adherence.


Options:
A: Number of Participants Reporting Preferred Screening Type as Reported by Chart Audits (6 months following intervention a chart audit will be conducted to determine if CRCS was completed.)
B: The primary outcome measure was total medical costs (capped at $200,000 per individual per year) and pharmacy costs.
C: Medication start/stop, knowledge, and patient involvement. (Baseline and at 6 months)
D: Participant-reported most important attribute from survey (1 day)

Answer: A
Please select the outcome measures that correspond to the clinical trial below.
Title: A Multicenter, Randomized, Double-Blind, Placebo-Controlled Study to Evaluate the Safety and Efficacy of Pulmaquin® in the Management of Chronic Lung Infections With Pseudomonas Aeruginosa in Subjects With Non-Cystic Fibrosis Bronchiectasis, Including 28 Day Open-Label Extension and Pharmacokinetic Substudy (ORBIT-3)
Brief Summary: This study (ARD-3150-1201, ORBIT-3) will evaluate the safety and efficacy of inhaled Pulmaquin (ciprofloxacin dispersion for inhalation) compared to inhaled placebo in subjects who have a confirmed diagnosis of non-cystic fibrosis (non-CF) bronchiectasis with a history of pulmonary exacerbations and chronic P. aeruginosa infections.


Options:
A: Time to first exacerbation (One Year)
B: Change in QOL-B Respiratory Symptoms Score at Day 28 (Baseline to Day 28)
C: Time to first pulmonary exacerbation (from baseline) (48 weeks)
D: Change in QOL-B Respiratory Symptoms Score at Day 28 (Baseline to Day 28)

Answer: A
Please select the outcome measures that correspond to the clinical trial below.
Title: The Women In Steady Exercise Research (WISER) Survivor Trial & Cost of Illness and Cost Effectiveness of Alternative Management Strategies
Brief Summary: WISER Survivor is a one year weight loss and exercise study for sedentary breast cancer survivors who are overweight or obese with breast cancer related lymphedema. There will be four groups in this trial: exercise only, weight loss only, exercise and weight-loss combined, and a control group. The primary purpose of this study is to test the effects of these interventions on clinical lymphedema outcomes. Secondary outcomes include weight loss, breast cancer related biomarkers, and quality of life. To the extent that funding will be available, participants will be followed long term to examine effects on recurrence and mortality.


Options:
A: Percent interlimb difference, change over 12 months. (Baseline and 12 months)
B: Stimulated ln (TNF-a) (Immediately post-treatment and 3 months post-treatment); Stimulated ln (IL-6) (Immediately post-treatment and 3 months post-treatment); Stimulated ln (IL-1b) (Immediately post-treatment and 3 months post-treatment); MFSI-SF Fatigue (Immediately post-treatment and 3 months post-treatment); Vitality, SF-36 (Immediately post-treatment and 3 months post-treatment); CES-D (Immediately post-treatment and 3 months post-treatment)
C: Assessment of arthralgia scores and patients' compliance within the first year of anastrozole treatment, stratified by upfront and switch therapy as well as assessment of the relationship between compliance and arthralgia scores. (12 months)
D: Bone mass-lumbar spine and hip (DEXA) (baseline, 12 months)

Answer: A
Please select the outcome measures that correspond to the clinical trial below.
Title: The Women In Steady Exercise Research (WISER) Survivor Trial & Cost of Illness and Cost Effectiveness of Alternative Management Strategies
Brief Summary: WISER Survivor is a one year weight loss and exercise study for sedentary breast cancer survivors who are overweight or obese with breast cancer related lymphedema. There will be four groups in this trial: exercise only, weight loss only, exercise and weight-loss combined, and a control group. The primary purpose of this study is to test the effects of these interventions on clinical lymphedema outcomes. Secondary outcomes include weight loss, breast cancer related biomarkers, and quality of life. To the extent that funding will be available, participants will be followed long term to examine effects on recurrence and mortality.


Options:
A: Physical function as assessed by Short-Form Health Survey (SF-36) with physical function subscale and late effects lower body subscales at baseline and years 1 and 2 following study completion (one year)
B: Percent interlimb difference, change over 12 months. (Baseline and 12 months)
C: Invasive disease-free survival (Up to 10 years)
D: Change in weight (6 months); change in weight (12 months)

Answer: B
Please select the outcome measures that correspond to the clinical trial below.
Title: N/A
Brief Summary: The investigators hypothesize that a three-month aerobic exercise training program will positively affect the lipid profile, insulin sensitivity , cytokine profile, the cardiovascular parameters and muscle strength in SLE patients.


Options:
A: Peak oxygen uptake (VO2peak) (12-weeks)
B: Endothelial function and endothelial progenitor cells (EPCs) number (16 weeks)
C: Change in physiological measures (At baseline and after 10 weeks of HIIT)
D: Lipid profile - Plasma levels of total cholesterol (mg/dl), VLDL-chol (mg/dl) HDL-chol (mg/dl), LDL-chol (mg/dl), triglycerides (mg/dl), Apolipoprotein AI and AII (mg/dl) and Apolipoprotein B (mg/dl) (3 months); Insulin sensitivity as measured by the Hyperinsulinemic-Euglycemic Clamp (3 months); Cytokine response - Plasma levels of TNF-α (pg/ml), IL-6 (pg/ml), IFN-type I (pg/ml), IL-10 (pg/ml)and IL-1ra (pg/ml) (3 months)

Answer: D
Please select the outcome measures that correspond to the clinical trial below.
Title: Interventions to Enhance Medication Persistence and Compliance in Patients With Overactive Bladder : 6-month, Randomized, Open-label, Multi-center Trial
Brief Summary: Study Objectives: To explore the effectiveness of adjunctive intervention to enhance the medication compliance and persistence in patients with Overactive Bladder (OAB), thereby to improve treatment outcomes

Study Hypothesis: Health Education Intervention (HEI) can enhance the medication compliance and persistence, thereby can improve the treatment outcomes in conjunction with pharmacological therapy in OAB patients

Study Design: 6-month, randomized, open-label, multi-center trial at 13 university hospitals


Options:
A: 24-hour Voiding Frequency (post-treatment (week 8))
B: Difference in the % of patients maintaining persistence between no intervention and HEI group (6 months)
C: Change in International Consultation on Incontinence Questionnaire - Urinary Incontinence Short Form (ICIQ-UI SF) (baseline to 12 weeks)
D: Urogenital Distress Inventory (UDI-6) (baseline to 6 or 8 weeks); Incontinence Impact Questionnaire (IIQ-7) (baseline to 6 or 8 weeks)

Answer: B
Please select the outcome measures that correspond to the clinical trial below.
Title: Interventions to Enhance Medication Persistence and Compliance in Patients With Overactive Bladder : 6-month, Randomized, Open-label, Multi-center Trial
Brief Summary: Study Objectives: To explore the effectiveness of adjunctive intervention to enhance the medication compliance and persistence in patients with Overactive Bladder (OAB), thereby to improve treatment outcomes

Study Hypothesis: Health Education Intervention (HEI) can enhance the medication compliance and persistence, thereby can improve the treatment outcomes in conjunction with pharmacological therapy in OAB patients

Study Design: 6-month, randomized, open-label, multi-center trial at 13 university hospitals


Options:
A: Difference in the % of patients maintaining persistence between no intervention and HEI group (6 months)
B: Urinary incontinence rates measured by scores on the Australian Female PelvicFloor questionnaire (16 weeks)
C: urgencyepisodes (after 2 month (end of study)); urgeincontinence (after 2 month (studyend)); VAS score from ICI_OAB_Q (after 2 month (studyend))
D: Change from baseline in ICIQ-Urinary Incontinence Short Form Questionnaire (Week 10-14 gestation (baseline), week 36-39 (after intervention))

Answer: A
Please select the outcome measures that correspond to the clinical trial below.
Title: Effectiveness of Home-Based Therapy for Symptomatic Convergence Insufficiency
Brief Summary: The purpose of this study is to determine the effectiveness of home-based computer therapy for symptomatic convergence insufficiency (CI) compared to traditional home-based near target push-ups and placebo treatment.


Options:
A: Treatment Group Comparison of the Percentage of Participants Classified as an Overall Success at 12 Weeks - HB-C Versus HB-PU (12 weeks after randomization (baseline)); Treatment Group Comparison of the Percentage of Participants Classified as an Overall Success at 12 Weeks - HB-C Versus HB-P (12-weeks after randomization (baseline))
B: The primary outcome measure is the score on the Convergence Insufficiency Symptom Survey
C: Symptom score on the Convergence Insufficiency Symptom Survey
D: symptomatic convergence insufficiency (one month)

Answer: A
Please select the outcome measures that correspond to the clinical trial below.
Title: Promoting Healthy Lifestyles Using Mobile Phones
Brief Summary: The purpose of this research is to test programs to increase physical activity and reduce sedentary behavior using motivational messages over a cell phone.


Options:
A: Low Back Pain Disability (6 months); Usual Low Back Pain (6 months)
B: Time spent being physically active (2 months); Time spent sitting (2 months); Changes in food consumption (2 months)
C: Average daily sedentary minutes (4 weeks)
D: Change in objective physical activity (PA) (Baseline, 5 weeks, 3 months, 1 year); Change in objective sedentary behaviour (Baseline, 5 weeks, 3 months, 1 year); Change in self-reported physical activity (PA) (Baseline, 5 weeks, 3 months, 1 year); Change in self-reported sedentary behaviour (Baseline, 5 weeks, 3 months, 1 year)

Answer: B
Please select the outcome measures that correspond to the clinical trial below.
Title: Promoting Healthy Lifestyles Using Mobile Phones
Brief Summary: The purpose of this research is to test programs to increase physical activity and reduce sedentary behavior using motivational messages over a cell phone.


Options:
A: Daily Minutes of Physical Activity (Baseline); Daily Minutes of Physical Activity (6 months); Minutes of Light to Moderate Physical Activity (12 months)
B: Self reported physical activity (after 3 month); Self reported physical activity (After 6 month)
C: Number of myPAtHS exercise sessions. (12 weeks & 24 weeks); Time spent doing the myPAtHS exercise programme. (12 weeks & 24 weeks)
D: Time spent being physically active (2 months); Time spent sitting (2 months); Changes in food consumption (2 months)

Answer: D
Please select the outcome measures that correspond to the clinical trial below.
Title: Smoking Cessation Via Text Messaging: Feasibility Testing of SMS USA
Brief Summary: The investigators developed a text messaging-based smoking cessation program called SMS (Stop My Smoking) USA. It was tailored for the unique needs and smoking habits of young adults. The investigators hypothesized that those in the SMS USA intervention would be significantly more likely to be quit at 6-months compared to the attention-matched control group.


Options:
A: Continuous Abstinence at 3-months Assessed in Accordance With the NIH Behavior Change Consortium's Recommendations (3-months post-quit)
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: Biologically-verified 7-day Point Prevalence Smoking Abstinence (End of treatment (week 6))
D: 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).

Answer: A
Please select the outcome measures that correspond to the clinical trial below.
Title: Randomized, Open-label, Parallel-group, Active-controlled Study of Rivaroxaban in Patients With Acute Symptomatic Pulmonary Embolism, With or Without Symptomatic Deep Vein Thrombosis
Brief Summary: The objective of this study is to evaluate the efficacy, safety, pharmacokinetics (PK) and pharmacodynamics (PD) of rivaroxaban in the treatment of pulmonary embolism (PE) and the prevention of the occurrence and the recurrence of deep vein thrombosis (DVT) or PE in Japanese patients with acute symptomatic PE with or without symptomatic DVT.


Options:
A: Number of participants with newly onset of symptomatic venous thromboembolism (VTE) (Up to 12 months); Number of clinically relevant bleedings (Up to 2 days after last dose)
B: Percentage of Participants With Symptomatic Recurrent Venous Thromboembolism [VTE] (i.e. the Composite of Recurrent Deep Vein Thrombosis [DVT] or Fatal or Non-fatal Pulmonary Embolism [PE]) Until the Intended End of Study Treatment (6- or 12-month study treatment period)
C: Incidence of Post-thrombotic Syndrome (PTS) (During 2-year follow up)
D: Number of Participants With Recurrent Symptomatic Venous Thromboembolism (VTE) and Deaths Related to VTE (For statistical analysis 1: from randomisation to end of post treatment period (ptp), planned to be up to day 224. For statistical analysis 2: from randomisation to 6 months (up to day 180))

Answer: A
Please select the outcome measures that correspond to the clinical trial below.
Title: Randomized, Open-label, Parallel-group, Active-controlled Study of Rivaroxaban in Patients With Acute Symptomatic Pulmonary Embolism, With or Without Symptomatic Deep Vein Thrombosis
Brief Summary: The objective of this study is to evaluate the efficacy, safety, pharmacokinetics (PK) and pharmacodynamics (PD) of rivaroxaban in the treatment of pulmonary embolism (PE) and the prevention of the occurrence and the recurrence of deep vein thrombosis (DVT) or PE in Japanese patients with acute symptomatic PE with or without symptomatic DVT.


Options:
A: Symptomatic DVT (3 months); Symptomatic PE (3 months); Unsuspected PE and DVT (3 months); Worsening of pulmonary vascular or venous obstruction (3 months)
B: Number of participants with newly onset of symptomatic venous thromboembolism (VTE) (Up to 12 months); Number of clinically relevant bleedings (Up to 2 days after last dose)
C: 6 Month Bleeding Rate (Up to 6 months)
D: Incidence Rates of All Symptomatic Recurrent Venous Thromboembolism During the Main Treatment Period (During the main study treatment period (i.e., 3 months, except for children with central venous catheter venous thromboembolism (CVC-VTE) aged <2 years for whom it was 1 month)); Incidence Rates of All Symptomatic Recurrent Venous Thromboembolism During the Main Treatment Period (During the main study treatment period (i.e., 3 months, except for children with CVC-VTE aged <2 years for whom it was 1 month)); Incidence Rates of All Symptomatic Recurrent Venous Thromboembolism During Extended Treatment Period (During extended treatment period: up to month 12.); Number of Subjects With the Composite of All Symptomatic Recurrent Venous Thromboembolism During the 30 Days Post-study Treatment Period (i.e. >2 and ≤ 30 Days After Stop of Study Medication) (More than 2 and up to 30 days after stop of study medication); Incidence Rates of the Composite of Treatment Emergent Overt Major Bleeding and Clinically Relevant Non-major (CRNM) Bleeding During Main Treatment Period (During the main study treatment period (i.e., 3 months, except for children with CVC-VTE aged <2 years for whom it was 1 month)); Incidence Rates of the Composite of Treatment Emergent Overt Major Bleeding and Clinically Relevant Non-major (CRNM) Bleeding During Extended Treatment Period (During extended treatment period: up to month 12.)

Answer: B
Please select the outcome measures that correspond to the clinical trial below.
Title: Randomized, Open-label (Double Blind Among Rivaroxaban Groups in the Initial 3 Weeks), Parallel-group, Active-controlled Study of Rivaroxaban in Patients With Acute Symptomatic Deep Vein Thrombosis Without Symptomatic Pulmonary Embolism
Brief Summary: The objective of this study is to evaluate the efficacy, safety, pharmacokinetics (PK) and pharmacodynamics (PD) of two different dosages of rivaroxaban in the treatment of deep vein thrombosis (DVT) and the prevention of the occurrence and the recurrence of DVT or pulmonary embolism (PE) in Japanese patients with acute symptomatic DVT without symptomatic PE.


Options:
A: Incidence of Post-thrombotic Syndrome (PTS) (During 2-year follow up)
B: Incidence of Adjudicated Composite of Symptomatic, Recurrent Venous Thromboembolism (VTE) or VTE-Related Death During 6 Months of Treatment (Day 1 to Week 24 + 2 Days or 355 days (Discontinued Early))
C: Symptomatic DVT (3 months); Symptomatic PE (3 months); Unsuspected PE and DVT (3 months); Worsening of pulmonary vascular or venous obstruction (3 months)
D: Number of participants with newly onset of symptomatic venous thromboembolism (VTE) (Up to 12 months); Number of clinically relevant bleedings (Up to 2 days after last dose)

Answer: D
Please select the outcome measures that correspond to the clinical trial below.
Title: Randomized, Open-label (Double Blind Among Rivaroxaban Groups in the Initial 3 Weeks), Parallel-group, Active-controlled Study of Rivaroxaban in Patients With Acute Symptomatic Deep Vein Thrombosis Without Symptomatic Pulmonary Embolism
Brief Summary: The objective of this study is to evaluate the efficacy, safety, pharmacokinetics (PK) and pharmacodynamics (PD) of two different dosages of rivaroxaban in the treatment of deep vein thrombosis (DVT) and the prevention of the occurrence and the recurrence of DVT or pulmonary embolism (PE) in Japanese patients with acute symptomatic DVT without symptomatic PE.


Options:
A: Number of participants with newly onset of symptomatic venous thromboembolism (VTE) (Up to 12 months); Number of clinically relevant bleedings (Up to 2 days after last dose)
B: Number of Participants With Recurrent Symptomatic Venous Thromboembolism (VTE) and Deaths Related to VTE (For statistical analysis 1: from randomisation to end of post treatment period (ptp), planned to be up to day 224. For statistical analysis 2: from randomisation to 6 months (up to day 180))
C: Percentage of Participants With Symptomatic Recurrent Venous Thromboembolism [VTE] (i.e. the Composite of Recurrent Deep Vein Thrombosis [DVT] or Fatal or Non-fatal Pulmonary Embolism [PE]) Until the Intended End of Study Treatment (3-, 6-, or 12-month study treatment period)
D: Symptomatic Recurrent VTE, i.e., the Composite of DVT, Non-fatal PE, and Fatal PE (12 months from time of randomization)

Answer: A
Please select the outcome measures that correspond to the clinical trial below.
Title: A Double-Blind, Randomized, Placebo-controlled, Multicenter Study to Evaluate Long-Term Tolerability and Durable Efficacy of AMG 145 (Evolocumab) on LDL-C in Hyperlipidemic Subjects
Brief Summary: To evaluate the efficacy, safety, and tolerability of 52 weeks of subcutaneous (SC) evolocumab (AMG 145) compared with placebo when added to assigned background lipid-lowering therapy.


Options:
A: Percent Change From Baseline in LDL-C at Week 52 (Baseline and Week 52)
B: Percent Change From Baseline in Calculated LDL-C at Week 24 - Intent-to-Treat (ITT) Analysis (From Baseline to Week 24)
C: The primary endpoint in the study is to assess the incidence and severity of treatment-emergent adverse events in hyperlipidemic patients treated with REGN727 or placebo receiving stable doses of atorvastatin. (visit 4 (day 1) to visit 16 (day 148))
D: Event Rate Per 100 Participant-years for First Occurrence of Major Cardiovascular (CV) Event (From baseline until the date of first adjudicated and confirmed occurrence of major CV event (maximum duration: up to 3.4 years))

Answer: A
Please select the outcome measures that correspond to the clinical trial below.
Title: A Double-Blind, Randomized, Placebo-controlled, Multicenter Study to Evaluate Long-Term Tolerability and Durable Efficacy of AMG 145 (Evolocumab) on LDL-C in Hyperlipidemic Subjects
Brief Summary: To evaluate the efficacy, safety, and tolerability of 52 weeks of subcutaneous (SC) evolocumab (AMG 145) compared with placebo when added to assigned background lipid-lowering therapy.


Options:
A: Effect of Intensive Lipid Modification Medication Therapy on Progression of Atherosclerosis and Restenosis of Femoral Arteries Measured Using High Resolution Magnetic Resonance Imaging (MRI) to Examine the Femoral Artery for Progression of Atherosclerosis (Measured at baseline and 24 Months)
B: Absolute change from baseline to follow-up in percent atheroma volume (PAV) in the target lesion (before randomization & 9-12 months after randomization)
C: Percent Change From Baseline in LDL-C at Week 52 (Baseline and Week 52)
D: Percent Change From Baseline to 3 Months in Low-Density Lipoprotein Cholesterol (LDL-C) (Baseline, 3 Months)

Answer: C