TrialPanorama/Dataset huggingface dataset:
Please select the outcome measures that correspond to the clinical trial below.
Title: A Phase 3 Randomized Safety and Efficacy Trial of HP802-247 in the Treatment of Chronic Venous Leg Ulcers (EU)
Brief Summary: This study is being done to find out if an investigational product called HP802-247 can help people with venous leg ulcers. Investigational means that HP802-247 has not been approved by the U.S. Food and Drug Administration (FDA).

This research is being done to compare the efficacy of HP802-247 plus compression therapy against Vehicle plus compression therapy in achieving complete wound closure over the 12-week treatment period. Vehicle looks the same as HP802-247 but contains no cells.

At least 440 subjects will participate. The study is going to be conducted in approximately 5 countries at approximately 50 sites across the European Union.


Options:
A: Compare the Treatment Groups for the Proportion of Subjects With Complete Wound Closure Over the 12-Week Treatment Period From Baseline (12 Weeks)
B: Complete wound closure rate at week 8 of treatment (week 9)
C: Proportion of patients with complete healing of reference ulcer (24 weeks)
D: Compare the Treatment Groups for the Number of Subjects With Complete Wound Closure Over the 12-Week Treatment Period From Baseline (Weekly, over 12 Weeks or until wound closure, which ever occurred first)

Answer: D
Please select the outcome measures that correspond to the clinical trial below.
Title: Improving Physical Activity in Patients With Severe Chronic Obstructive Pulmonary Disease With Urban Walking Circuits
Brief Summary: The aim of this study was to assess the effectiveness of the implementation of walking urban circuits in increasing the level of physical activity and exercise capacity in severe chronic obstructive pulmonary disease (COPD) patients after being enrolled in a pulmonary rehabilitation program.


Options:
A: walked in meters in the six minute walking test (6MWT) (Unlike walking meters of baseline and one year)
B: Change From Baseline in Lung Function as Measured by the Forced Expiratory Volume in 1 Second (FEV1) Area Under the Curve From 0-3h (AUC0-3h) (baseline, week 24)
C: 6-Minute Walking Distance (Baseline and 8 weeks follow-up)
D: Change From Baseline in Endurance Time (Seconds) (Week 3)

Answer: A
Please select the outcome measures that correspond to the clinical trial below.
Title: Improving Physical Activity in Patients With Severe Chronic Obstructive Pulmonary Disease With Urban Walking Circuits
Brief Summary: The aim of this study was to assess the effectiveness of the implementation of walking urban circuits in increasing the level of physical activity and exercise capacity in severe chronic obstructive pulmonary disease (COPD) patients after being enrolled in a pulmonary rehabilitation program.


Options:
A: walked in meters in the six minute walking test (6MWT) (Unlike walking meters of baseline and one year)
B: Change in physical activity levels (1 week before, 1 week after, 3 and 6 months after the PR program)
C: Effectiveness of an Tele Respiratory Rehabiltation program (TeleRehab) in the maintenance of benefits after an intensive respiratory rehabilitation program evaluated through the 6 m Walking test and health quality questionnaires after 12 months (One Year)
D: Steps per day as mean over one week from baseline until the treatment end (Every day for 6 months)

Answer: A
Please select the outcome measures that correspond to the clinical trial below.
Title: A Randomized, Double-Blind, Placebo-Controlled, Dose-Ranging Study to Evaluate Dupilumab in Patients With Moderate to Severe Uncontrolled Asthma
Brief Summary: Primary Objective:

To evaluate the efficacy of different doses and regimens of dupilumab in participants with moderate to severe uncontrolled asthma.

Secondary Objective:

To evaluate different doses and regimens of dupilumab in participants with moderate to severe uncontrolled asthma, with regard to:

* Safety and tolerability
* Dupilumab systemic exposure and anti-drug antibodies


Options:
A: Change in Nasal Polyp Score (Week 5 and Week 25)
B: Change From Baseline at Week 24 in Nasal Congestion/Obstruction Symptom Severity Score (Baseline, Week 24); Change From Baseline at Week 24 in Nasal Polyp Score (Baseline, Week 24)
C: Mucosal thickness on CT scan (after 6 months of treatment)
D: Absolute Change From Baseline in Forced Expiratory Volume in 1 Second (FEV1) at Week 12: High Eosinophils -Intent to Treat (HEos-ITT) Population (Baseline, Week 12); Absolute Change From Baseline in FEV1 at Week 12: ITT Population (Baseline, Week 12)

Answer: D
Please select the outcome measures that correspond to the clinical trial below.
Title: A Randomized, Double-Blind, Placebo-Controlled, Dose-Ranging Study to Evaluate Dupilumab in Patients With Moderate to Severe Uncontrolled Asthma
Brief Summary: Primary Objective:

To evaluate the efficacy of different doses and regimens of dupilumab in participants with moderate to severe uncontrolled asthma.

Secondary Objective:

To evaluate different doses and regimens of dupilumab in participants with moderate to severe uncontrolled asthma, with regard to:

* Safety and tolerability
* Dupilumab systemic exposure and anti-drug antibodies


Options:
A: Mucosal thickness on CT scan (after 6 months of treatment)
B: Absolute Change From Baseline in Forced Expiratory Volume in 1 Second (FEV1) at Week 12: High Eosinophils -Intent to Treat (HEos-ITT) Population (Baseline, Week 12); Absolute Change From Baseline in FEV1 at Week 12: ITT Population (Baseline, Week 12)
C: Annualized Rate of Severe Exacerbation Events During The 52-Week Treatment Period: Intent-to-Treat (ITT) Population (Baseline to Week 52); Absolute Change From Baseline in Pre-Bronchodilator Forced Expiratory Volume in 1 Second (FEV1) at Week 12: ITT Population (Baseline, Week 12)
D: Frequency of Clinical Asthma Exacerbations (CAEs) During 12 Months of Treatment (Day 1 to Month 12); Frequency of Each of the Two Criteria for Clinical Asthma Exacerbations (CAEs) (Day 1 to Month 12)

Answer: B
Please select the outcome measures that correspond to the clinical trial below.
Title: A Randomized, Double Blind, Chronic Dosing, Placebo-Controlled, Parallel Group, Multi Center Study to Assess the Efficacy and Safety of PT003, PT005, and PT001 in Subjects With Moderate to Very Severe COPD, Compared With Placebo and Spiriva® Handihaler® (Tiotropium Bromide 18 µg Open-Label) as an Active Control
Brief Summary: The overall objective of this study is to assess the efficacy and safety of treatment with PT003 (GFF MDI), PT005 (FF MDI), PT001 (GP MDI), and open-label tiotropium bromide inhalation powder compared with each other and Placebo MDI over 24 weeks in subjects with moderate to very severe COPD.


Options:
A: Trough Forced Expiratory Volume in 1 Second (FEV1) After 12 Weeks of Treatment (Week 12)
B: Trough Forced Expiratory Volume at 1 Second (FEV1) (12 weeks)
C: Change From Baseline in 24-hour Weighted-mean Serial FEV1 on Treatment Day 84 (Baseline and Day 84)
D: Change From Baseline in Morning Pre-dose Trough FEV1 at Week 24 (Baseline and at Week 24)

Answer: D
Please select the outcome measures that correspond to the clinical trial below.
Title: A Randomized, Double Blind, Chronic Dosing, Placebo-Controlled, Parallel Group, Multi Center Study to Assess the Efficacy and Safety of PT003, PT005, and PT001 in Subjects With Moderate to Very Severe COPD, Compared With Placebo and Spiriva® Handihaler® (Tiotropium Bromide 18 µg Open-Label) as an Active Control
Brief Summary: The overall objective of this study is to assess the efficacy and safety of treatment with PT003 (GFF MDI), PT005 (FF MDI), PT001 (GP MDI), and open-label tiotropium bromide inhalation powder compared with each other and Placebo MDI over 24 weeks in subjects with moderate to very severe COPD.


Options:
A: Forced Expiratory Volume in One Second (FEV1) Area Under the Curve (AUC) (0-3h) Response on Day 169 (1 hour (h) and 10 minutes (min) prior to dose to on the first day of randomized treatment and on Day 169 and 5 min, 15 min, 30 min, 1 h, 2 h, 3 h post-dose on Day 169); Trough FEV1 Response on Day 170 (1 h and 10 min prior to dose on the first day of randomized treatment (baseline) and at 23 h and at 23 h 50 min after inhalation of study medication on Day 170); Saint George's Respiratory Questionnaire (SGRQ) Total Score on Day 169 From the Two Twin Trials, Present 1237.6 (NCT01431287) and 1237.5 (NCT01431274). (Day 169)
B: Change From Baseline in Morning -Pre-dose Trough FEV1 Over 52 Weeks (Baseline and Weeks 2 to 52)
C: Adjusted Mean Endurance Time During Constant Work Rate Cycle Ergometry (CWRCE) After 12 Weeks (12 weeks)
D: Change From Baseline in Morning Pre-dose Trough FEV1 at Week 24 (Baseline and at Week 24)

Answer: D
Please select the outcome measures that correspond to the clinical trial below.
Title: A Randomized, Double-Blind (Test Products and Placebo), Chronic Dosing (24 Weeks), Placebo-Controlled, Parallel Group, Multi-Center Study to Assess the Efficacy and Safety of PT003, PT005, and PT001 in Subjects With Moderate to Very Severe COPD, Compared With Placebo
Brief Summary: This is a multicenter, randomized, double-blind, parallel group, chronic-dosing (24 weeks), placebo-controlled study to assess the efficacy and safety of Glycopyrrolate (GP and Formoterol Fumarate (FF) combination metered-dose inhaler (MDI) (GFF; PT003), GP MDI (PT001), and FF MDI (PT005) compared with Placebo MDI in subjects with moderate to very severe COPD.


Options:
A: Mean Area Under the Time Curve From 0 to 12 Hours (AUC(0-12 Hours)) of Change From Baseline to Week 13 in Forced Expiratory Volume (Liters) in 1 Second (FEV1) (Baseline to Endpoint (13 weeks)); Mean Change From Baseline to Week 13 Endpoint in AM Predose FEV1 (Baseline to Endpoint (13 weeks))
B: Change From Baseline in Trough Forced Expiratory Volume in One Second (FEV1) on Day 85 (Baseline (BL) and Day 85)
C: First Occurrence of (Moderate or Severe) COPD Exacerbation (52 weeks)
D: Change From Baseline in Morning Pre-dose Trough FEV1 (At Week 24)

Answer: D
Please select the outcome measures that correspond to the clinical trial below.
Title: A Randomized, Double-Blind (Test Products and Placebo), Chronic Dosing (24 Weeks), Placebo-Controlled, Parallel Group, Multi-Center Study to Assess the Efficacy and Safety of PT003, PT005, and PT001 in Subjects With Moderate to Very Severe COPD, Compared With Placebo
Brief Summary: This is a multicenter, randomized, double-blind, parallel group, chronic-dosing (24 weeks), placebo-controlled study to assess the efficacy and safety of Glycopyrrolate (GP and Formoterol Fumarate (FF) combination metered-dose inhaler (MDI) (GFF; PT003), GP MDI (PT001), and FF MDI (PT005) compared with Placebo MDI in subjects with moderate to very severe COPD.


Options:
A: Change From Baseline in Morning Pre-dose Trough FEV1 (At Week 24)
B: Change From Baseline in Trough Forced Expiratory Volume in 1 Second (FEV1) at Day 7 (Baseline, Day 7)
C: Forced Expiratory Volume in 1 Second Area Under the Curve (FEV1 AUC) 0-12 (Week 26)
D: Percentage of Patients to Experience at Least One Treatment-emergent Adverse Event (TEAE) (Up to study Week 56 ± 3 days)

Answer: A
Please select the outcome measures that correspond to the clinical trial below.
Title: A Comparative Study of Three Airway Clearance Techniques With Different Autonomy Degrees in Non Cystic Fibrosis Bronchiectasis: Randomized Cross-over Trial.
Brief Summary: Study design: a randomized, crossover trial. Each patient performed three different airway clearance techniques (Autogenic drainage, slow expiratory with glottis opened in lateral posture \[ELTGOL\], temporary- positive expiratory pressure \[T-PEP\] with not similar autonomy degree in a randomized order. Each technique were applied in 3 sessions during one week at alternate days (Monday /Wednesday/Friday or Tuesday/Thursday/Saturday). The time spent in each bronchial session was 40 minutes. Seven days were the wash-out time period between the different techniques.


Options:
A: Health related quality of life (St George's Respiratory Questionnaire) (3 months)
B: The primary endpoint of this study is improvement in exercise tolerance from an incremental walk test. (8 weeks)
C: 24 hour sputum volume and assessment of cough severity (Leicester Cough Questionnaire) (3 months)
D: Weight of sputum expectorated during each airway clearance therapy session (40 minutes); Weight of sputum expectorated 24 hours post each bronchial session (24 hours)

Answer: D
Please select the outcome measures that correspond to the clinical trial below.
Title: A Multicenter, Controlled, Open-label Extension (OLE) Study to Assess the Long-term Safety and Efficacy of AMG 145
Brief Summary: This study will contribute to the evaluation of long-term safety, tolerability and efficacy of evolocumab (AMG 145) in adults with hyperlipidemia and adults with mixed dyslipidemia.


Options:
A: Number of Participants With Adverse Events (48 weeks in the SOC-controlled period and up to 2 years in the All-IP period)
B: Change From Baseline in Low-density Lipoprotein Cholesterol (LDL-C) at Week 12 (Baseline, Week 12)
C: Percent Change From Baseline in Calculated LDL-C at Week 24 - Intent-to-Treat (ITT) Analysis (From Baseline to Week 52)
D: Percent Change From Baseline in Calculated LDL-C at Week 24 - Intent-to-treat (ITT) Analysis (From Baseline to Week 24)

Answer: A
Please select the outcome measures that correspond to the clinical trial below.
Title: A Hospital-based Intervention Using Motivational Interviewing and Interactive Voice Response to Reduce Readmissions in Congestive Heart Failure and Chronic Obstructive Pulmonary Disease Patients: A Randomized Controlled Trial
Brief Summary: The primary purpose of this study is to determine the effectiveness of a hospital-based intervention, using motivational interviewing and interactive voice response (IVR), to reduce hospital readmissions within 90 days of enrollment compared to usual care, for patients with heart failure and chronic obstructive pulmonary disease.


Options:
A: Hospital readmission rate (all cause) (90 days)
B: Number of patients hospitalized due to COPD worsening (180 days)
C: NIHSS Stroke Scale, relapse rate (360 days)
D: Time to composite all-cause readmissions/emergency department (ED) visits/death at 3 months (Within 3 months of hospital discharge); Time to composite all-cause readmissions/emergency department (ED) visits/death at 30 days (Within 30 days of hospital discharge)

Answer: A
Please select the outcome measures that correspond to the clinical trial below.
Title: A Hospital-based Intervention Using Motivational Interviewing and Interactive Voice Response to Reduce Readmissions in Congestive Heart Failure and Chronic Obstructive Pulmonary Disease Patients: A Randomized Controlled Trial
Brief Summary: The primary purpose of this study is to determine the effectiveness of a hospital-based intervention, using motivational interviewing and interactive voice response (IVR), to reduce hospital readmissions within 90 days of enrollment compared to usual care, for patients with heart failure and chronic obstructive pulmonary disease.


Options:
A: The number of ED presentations (1 year after randomization.)
B: Hospital readmission rate (all cause) (90 days)
C: Change in level of objectively measured physical activity (7 Days at baseline, 7 days at 3- and 12- months after baseline)
D: Re-hospitalization (90 days)

Answer: B
Please select the outcome measures that correspond to the clinical trial below.
Title: A Hospital-based Intervention Using Motivational Interviewing and Interactive Voice Response to Reduce Readmissions in Congestive Heart Failure and Chronic Obstructive Pulmonary Disease Patients: A Randomized Controlled Trial
Brief Summary: The primary purpose of this study is to determine the effectiveness of a hospital-based intervention, using motivational interviewing and interactive voice response (IVR), to reduce hospital readmissions within 90 days of enrollment compared to usual care, for patients with heart failure and chronic obstructive pulmonary disease.


Options:
A: Total Number of Rehospitalizations (Emergency Department Visits Plus Hospital Admissions) in the 30 Days After Discharge. (30 days after discharge)
B: Hospital readmission rate (all cause) (90 days)
C: Effects on hospital visits (1 year)
D: 30-day hospital readmissions (30-days); Emergency Department use (30-days post-discharge)

Answer: B
Please select the outcome measures that correspond to the clinical trial below.
Title: The Role of Clinical Pharmacist's Intervention in Management of Clinically Relevant Drug-drug Interactions in Patients With Chronic Heart Failure
Brief Summary: Drug-drug interactions (DDIs) are common in patients with chronic heart failure (CHF) and their incidence increases with the number of drugs that the patients are prescribed for treatment of their condition. Data bases often detect DDIs that are of high clinical relevance. The investigators have performed this study in order to detect clinically significant DDIs and to diminish their occurrence by sending notification about DDIs to attending physician.


Options:
A: To assess the difference in frequency and severity of clinically significant DDIs in control arm and interventional arm between admission and discharge (90 days)
B: To test for differences in rates of screening between the early intervention and delayed groups, the chi-square test will be used for each outcome. (End of project, 12/2011)
C: Urinary catheter day (participants will be followed for the duration of hospital stay, an expected average of 3 weeks)
D: Bone mineral density (BMD) testing rates

Answer: A
Please select the outcome measures that correspond to the clinical trial below.
Title: The Role of Clinical Pharmacist's Intervention in Management of Clinically Relevant Drug-drug Interactions in Patients With Chronic Heart Failure
Brief Summary: Drug-drug interactions (DDIs) are common in patients with chronic heart failure (CHF) and their incidence increases with the number of drugs that the patients are prescribed for treatment of their condition. Data bases often detect DDIs that are of high clinical relevance. The investigators have performed this study in order to detect clinically significant DDIs and to diminish their occurrence by sending notification about DDIs to attending physician.


Options:
A: Medicines adherence (Change in adherence from 6 weeks to 10 weeks and 26 weeks); Cost effectiveness (6 months); Operation of the NMS (1 year from first recruited patient)
B: Change in proportion of pills taken compared to baseline (0-2months) at 8months; Between-group comparison of medication persistence at 14months
C: Comparison of difference in change in systolic BP between enhanced care and usual care (24 weeks)
D: To assess the difference in frequency and severity of clinically significant DDIs in control arm and interventional arm between admission and discharge (90 days)

Answer: D
Please select the outcome measures that correspond to the clinical trial below.
Title: Pasos Saludables: A Pilot Intervention to Prevent Obesity and Diabetes Among Latino Farm Workers
Brief Summary: This is a study to assess the effectiveness of a culturally appropriate behavioral intervention to reduce obesity levels and ultimately the risk of developing diabetes type II in immigrant Latino farm workers. Workers enrolled in a 2:1 ratio by random allocation into an intervention or control arm of the study. The intervention participants received weekly classes for 10 weeks with education on diabetes, diet and physical activity and practical exercises. Both control and intervention were measured for weight, waist circumference, fasting blood glucose and interviewed before and after the study intervention. The main hypothesis was that intervention, but not control participants, would experience reduction in body measurements after the intervention.


Options:
A: Change in BMI (Before intervention and after (12-14 weeks after first assessment))
B: Systolic Blood Pressure (SBP) (one year)
C: Beck Depression Inventory- II (Assessed at every session and at the 1-month follow-up)
D: New Advance Care Planning Documentation in the Medical Record at 15 Months (15 months after study enrollment)

Answer: A
Please select the outcome measures that correspond to the clinical trial below.
Title: Pasos Saludables: A Pilot Intervention to Prevent Obesity and Diabetes Among Latino Farm Workers
Brief Summary: This is a study to assess the effectiveness of a culturally appropriate behavioral intervention to reduce obesity levels and ultimately the risk of developing diabetes type II in immigrant Latino farm workers. Workers enrolled in a 2:1 ratio by random allocation into an intervention or control arm of the study. The intervention participants received weekly classes for 10 weeks with education on diabetes, diet and physical activity and practical exercises. Both control and intervention were measured for weight, waist circumference, fasting blood glucose and interviewed before and after the study intervention. The main hypothesis was that intervention, but not control participants, would experience reduction in body measurements after the intervention.


Options:
A: Change in Body Mass Index (BMI) (Baseline to 24 months)
B: Weight Loss (1 year)
C: Change in BMI (Before intervention and after (12-14 weeks after first assessment))
D: Quit Rate (30-day Follow-Up); Quit Rate (6-Month Follow-Up)

Answer: C
Please select the outcome measures that correspond to the clinical trial below.
Title: A Randomized, Controlled Trial of L-arginine and Spironolactone in Dialysis-dependant End Stage Renal Disease
Brief Summary: Cardiovascular disease is the primary cause of death in patients with end stage renal disease (ESRD). New research suggests that the high risk of death may be partly due to high levels of fibrosis and a loss of small blood vessels in the heart of patients with dialysis-dependent ESRD. This study is designed to compare the effects of two different drugs, spironolactone and L-arginine, with placebo on structure and function of the heart in individuals with dialysis-dependent ESRD.


Options:
A: The time to onset of the first incident :non-fatal MI or acute coronary syndrome or hospitalization for heart failure or nonfatal stroke or cardiovascular (CV) death (25 months)
B: Change in coronary Flow Reserve (PET) (Between baseline and 9 months); Change in left ventricular diastolic function (Between baseline and 9 months)
C: Left Ventricular Mass Index (9 months)
D: Reduction of Left Ventricular Hypertrophy (12 months)

Answer: B
Please select the outcome measures that correspond to the clinical trial below.
Title: The Effect of Body Mass Index on Etonogestrel Levels in Women Using the Single-rod Contraceptive Implant
Brief Summary: Two-thirds of young women in the United States are overweight or obese. This excess weight may affect how their body metabolizes drugs such as different birth control methods. There is a not a lot of research about how excess weight could affect the hormone levels of the contraceptive implant. Methods like the implant contain only progesterone, which is a hormone that does not increase a woman's risk of blood clot. These methods would be preferred for overweight and obese women because excess weight also increases a woman's risk of blood clot.

The investigators propose a study comparing blood hormone levels of women using the implant for at least twelve months and in all weight categories. The investigators hope to show that all women, regardless of weight, will have hormone levels high enough to prevent pregnancy.


Options:
A: Pregnancy (AG200-15: 6 months; Lessina: 6 months; AG200-15: 1 year)
B: LNG Steady State at Baseline and Then Post-randomization (baseline (2 months) and post-randomization (4 months))
C: Serum Etonogestrel Level (Up to 12 months)
D: Venous Thromboembolism (VTE); Hazard Ratio for DRSP-24 Day vs. Non-DRSP OCs (Within 60 months); Arterial Thromboembolism (ATE), Hazard Ratio for DRSP-24 Day vs. Non-DRSP OCs (Within 60 months)

Answer: C