TrialPanorama/Dataset huggingface dataset:
Please select the outcome measures that correspond to the clinical trial below.
Title: A Phase III Randomised, Double-blind, Placebo-controlled, Parallel-group Trial to Evaluate Efficacy and Safety of Tiotropium Inhalation Solution Delivered Via Respimat® Inhaler (2.5 and 5 µg Once Daily) Compared With Placebo and Salmeterol HFA MDI (50 µg Twice Daily) Over 24 Weeks in Moderate Persistent Asthma
Brief Summary: The aim of this trial is to evaluate the efficacy and safety of 2.5 and 5 mcg tiotropium over a 24-week treatment period as compared to placebo and salmeterol (50 mcg twice daily). Tiotropium inhalation solution delivered by the Respimat® inhaler will be examined on top of maintenance treatment with inhaled corticosteroid controller medication in patients with moderate persistent asthma. Efficacy and safety will be assessed by measuring effects on lung function, effects on asthma exacerbations, effects on quality of life, effects on asthma control, effects on health care resource utilisation, and number of adverse events.


Options:
A: Number of Patients With Drug-related Adverse Events (after the first dose of trial medication and within 30 days after the last dose of trial medication, up to 409)
B: Change Between Week 14 and Week 0 in the Morning (AM) Peak Expiratory Flow (PEF) (AM PEF was measured daily during each of the three 14-week treatment periods. The primary analysis constructed the change between week 14 and week 0.)
C: Peak Forced Expiratory Volume in 1 Second (FEV1) Response Within 3 Hours Post Dosing (0-3h) After a Treatment Period of 24 Weeks. (Baseline and 24 weeks); Trough FEV1 Response Determined After a Treatment Period of 24 Weeks. (Baseline and 24 weeks); Time to First Severe Asthma Exacerbation During the 48-week Treatment of the Pooled Data From the Two Twin Trials 205.416 (NCT00772538) and the Present 205.417 (NCT00776984). (48 weeks)
D: Peak FEV1 Within 3 Hours Post-dose Response (24 weeks); Trough FEV1 Response (24 weeks); The Responder Rate as Assessed by the ACQ From the Two Twin Trials 205.418 (NCT01172808) and the Present 205.419 (NCT01172821) (24 weeks)

Answer: D
Please select the outcome measures that correspond to the clinical trial below.
Title: The BASIC Trial. Morbid Obesity in Children and Adolescents: a Prospective Randomised Trial of Conservative Treatment Versus Surgery
Brief Summary: Rationale:

In the Western world overweight and obesity is an increasing problem both in adults and in children. In youth, it is associated with early death and a number of co-morbidities including metabolic and endocrine changes, increased inflammatory status, cardiovascular abnormalities, nonalcoholic fatty liver disease, and impaired quality of life.

The standard treatment for morbid obesity in children is by combined life style interventions. However, the medium and long term effects of dietetic interventions, behaviour therapy and medication is relatively poor. In adults bariatric surgery shows good results with up to 30% weight reduction in 3 years. The preliminary results in youth are similar, but surgery in this age group is relatively uncommon. In the Netherlands surgery in this age group is only allowed in clinical trials, until the benefits and risks have been established. (National Health Authorities)

Objective:

To determine if surgery gives a superior weight and body mass index (BMI) reduction than combined life style interventions in adolescents with morbid obesity and to assess its effect on obesity associated co-morbidity.

Study design:

Prospective randomised interventional study.

Study population:

Morbidly obese children, aged 14 - 16 years, with sex and age adjusted BMI \>40 kg/m2 or \>35 kg/m2 with co-morbidity.

Intervention:

Bariatric surgery by laparoscopic adjustable gastric band (LAGB) or combined life style interventions

Main study parameters/endpoints:

Primary endpoints: weight loss, loss of excess weight, loss of excess BMI. Secondary endpoints: Body composition, pubertal development, metabolic and endocrine changes, inflammatory status, cardiovascular abnormalities, non-alcoholic steatohepatitis, brain development, quality of life, and behaviour changes. The potential complications of surgery are monitored.


Options:
A: Weight (6 months); Weight (12 months); Weight (24 months); Weight (36 months)
B: growth disorders (18 years); obesity (18 years)
C: BMIZ-score evolution in 2 years. (2 years)
D: Glycemic Control (At one year)

Answer: A
Please select the outcome measures that correspond to the clinical trial below.
Title: The Efficacy of a Brief Motivational Enhancement Education Programme on Continuous Positive Airway Pressure Adherence in Obstructive Sleep Apnea: A Randomised Controlled Trial
Brief Summary: The purpose of this study is to examine whether an education programme would enhance continuous positive airway pressure (CPAP) adherence.


Options:
A: Home Arterial Blood Pressure (Home arterial Blood Pressure is assessed at week 1); Home Arterial Blood Pressure (Home arterial Blood Pressure is assessed at week 16)
B: CPAP usage (12-week)
C: Effect of intensive intervention on CPAP adherence (24 months)
D: objective sleep pattern (90 days)

Answer: B
Please select the outcome measures that correspond to the clinical trial below.
Title: Renal Artery Stenosis in Coronary Artery Disease: Medical Therapy Versus Medical Therapy Plus Renal Artery Stenting in Preventing Cardiac and Renal Outcomes. The Rationale and Study Design of a Prospective,Randomized Trial: the RASCAD Study
Brief Summary: The Stenting of Renal Artery Stenosis in Coronary Artery Disease (RASCAD) study is a randomized controlled trial designed to evaluate the effect of renal artery stenting+medical therapy versus medical therapy alone on left ventricular mass progression and cardiovascular morbidity and mortality in patients affected by coronary artery disease and renal artery stenosis.


Options:
A: Left Ventricular Mass (LVMI, g/m2) changes (1 year)
B: late lumen loss measured by quantitative coronary angiography (9 months)
C: incidence of contrast-induced nephropathy (within 48 hours after using a contrast agent)
D: Renal composite endpoints [Time to first occurrence of one of the following events:] (2-4 year)

Answer: A
Please select the outcome measures that correspond to the clinical trial below.
Title: Effect of Amiodarone on the Procedure Outcome in Long-standing Persistent Atrial Fibrillation Undergoing Pulmonary Vein Antral Isolation
Brief Summary: This prospective randomized study aims to investigate the effect of continuous versus interrupted use of Amiodarone on the procedure outcome in long-standing persistent (LSP) atrial fibrillation patients undergoing pulmonary vein antral isolation (PVAI).


Options:
A: Recurrence of atrial arrhythmia (1 year)
B: Time to first recurrence of electrocardiographically documented, symptomatic AF or atrial flutter/tachycardia between 3 and 12 months post ablation in the absence of antiarrhythmic drug therapy. (Between 3 and 12 months post ablation)
C: Recurrence of Atrial Fibrillation (One year)
D: Number of Participants With Composite of Total Mortality, Disabling Stroke, Serious Bleeding, or Cardiac Arrest in Patients Warranting Therapy for AF. (From date of enrollment until time-to-first event over a median follow-up of 48.5 months.)

Answer: A
Please select the outcome measures that correspond to the clinical trial below.
Title: Processed Residual Pump Blood in Cardiac Surgery: The PRBC Trial
Brief Summary: The study is an randomized controlled trial (RCT) of 198 coronary artery bypass graft (CABG) patients, exploring whether ultrafiltration of residual blood in the cardiopulmonary bypass circuit reduces transfusion and bleeding.


Options:
A: the proportion of patients transfused with homologous red blood cells (RBC) (At 30 days post-operatively)
B: In-hospital death (In-hospital); Recurrent myocardial infarction (MI) (In-hospital); New or worsening heart failure (In-hospital)
C: Mean Post-operative hemoglobin (longitudinal outcome) (Day 0 - 15)
D: Mortality at the 45th day (45 days)

Answer: A
Please select the outcome measures that correspond to the clinical trial below.
Title: Clinical and Biomarker Assessment of Efficacy of Cognitive Remediation in Patients With Schizophrenia or Schizoaffective Disorder Stabilized on Lurasidone
Brief Summary: The investigators hypothesize that cognitive remediation will be superior to the active control group on the change from baseline to study end point of cognitive remediation phase on both co-primary outcome measures (standardized composite MATRICS score and Cognitive Assessment Interview).


Options:
A: Cognitive Function Measured by MCCB Composite Score (4-6 month period); Cognitive Function as Measured by the University of California, San Diego, Performance-Based Skills Assessment-Brief (UPSA-B) Scale (4-6 month period)
B: Feasibility of a multisite trial using cognitive remediation (Measured at post-treatment)
C: Cognitive performance as measured by a neuropsychological battery (Measured at Weeks 8, 14, and 8 and Month 6 follow-up)
D: Cognitive performance, as measured by a neuropsychological battery (Measured at baseline, Weeks 8 and Month 6, 12, 18, and 24 follow-up)

Answer: A
Please select the outcome measures that correspond to the clinical trial below.
Title: Delivery, Uptake and Acceptability of HPV Vaccination in Tanzanian Girls
Brief Summary: The aims of this study are:

1. To determine feasibility of a school-based human papillomavirus (HPV) vaccination programme in Tanzania.
2. To measure the uptake and acceptability of two different vaccination strategies in rural and urban schools.
3. To examine the characteristics of accepters/refusers of vaccination and to identify reasons for acceptance, refusal or non-completion.
4. To measure the cost of implementing a school-based HPV vaccination programme in Tanzania.


Options:
A: Change in Vaccination Rate: HPV vaccine initiation among 11-12 year olds (Baseline and 5 months follow-up)
B: Vaccine coverage by delivery strategy (Month 12); Vaccine coverage (dose 2) by delivery strategy (Month 5); Vaccine coverage (dose 1) by delivery strategy (Month 3)
C: Intention to use condom if new partner (Change from Baseline Intention at 3 months); Intention to use condom if new partner (Change from Baseline Intention at 12 months); Intention to use condom if new partner (Change from Baseline Intention at 24 months); Attitude to prevention about HPV (Change from Baseline Attitude at 3 months); Attitude to prevention about HPV (Change from Baseline Attitude at 12 months); Attitude to prevention about HPV (Change from Baseline Attitude at 24 months)
D: The percentage of adolescents who initiate the HPV vaccine series (1 year)

Answer: B
Please select the outcome measures that correspond to the clinical trial below.
Title: A Randomized, Assessor-blind, Controlled Trial of Electroacupuncture Combined With Antidepressants in Treating Patients With Post-stroke Depression
Brief Summary: This is a randomized, assessor-blind, placebo controlled study in post stroke depression patients. Subjects receiving antidepressant drug would be assigned to either active or placebo scalp electro-acupuncture treatment, on the hypothesis that acupuncture intervention combined with antidepressants could produce greater therapeutic effects than antidepressants alone.


Options:
A: N/A
B: Pre-post treatment change in anxiety as assessed with the Hospital Anxiety and Depression scale (HAD) (Baseline and after eight weeks of treatment completion)
C: Antidepressant Response, Defined as a Hamilton Depression Rating Scale Score Relative Decrease of 50 % or More and a Final Score < 10 (Change from Baseline to Post-Intervention Endpoint)
D: HAMD-17, GDS , BI and CGI (28-day (course of treatment))

Answer: D
Please select the outcome measures that correspond to the clinical trial below.
Title: Drug Eluting Versus Conventional Balloon Angioplasty for the Treatment of Failing Dialysis Access. A Prospective Randomized Single-Center Trial.
Brief Summary: The aim of the study is to compare the feasibility and the effectiveness, by means of immediate and long-term results, of drug eluting balloon (DEB) versus conventional balloon angioplasty for the treatment of failing dialysis access.


Options:
A: Percent of Participants With Treatment Area Primary Patency (TAPP) (6 month follow-up)
B: Technical success (1 minute after the final balloon angioplasty); Primary patency (1 year)
C: N/A
D: N/A

Answer: B
Please select the outcome measures that correspond to the clinical trial below.
Title: Drug Eluting Versus Conventional Balloon Angioplasty for the Treatment of Failing Dialysis Access. A Prospective Randomized Single-Center Trial.
Brief Summary: The aim of the study is to compare the feasibility and the effectiveness, by means of immediate and long-term results, of drug eluting balloon (DEB) versus conventional balloon angioplasty for the treatment of failing dialysis access.


Options:
A: Incidence of PTE after thrombectomy of native and prosthetic AVFs. (The presence of PTE will be evaluated within 24 hours after treatment.); PTE resolution rate 1 month after thrombectomy of native and prosthetic AVFs. (The resolution of PTE will be evaluated 1-month after the treatment)
B: Primary patency of arterial-venous graft (time from initial thrombectomy to next graft intervention either: angioplasty, thrombectomy or surgical revision) (time from initial thrombectomy to next graft intervention)
C: Target Lesion Primary Patency at 6 Months (6 months); Target Lesion Primary Patency at 12 Months (12 Months); Target Lesion Primary Patency at 24 Months (24 Months); Freedom From Major Device, Procedure and Treatment Site-related Adverse Adverse Events Through 30 Days Post-procedure (30 days)
D: Technical success (1 minute after the final balloon angioplasty); Primary patency (1 year)

Answer: D
Please select the outcome measures that correspond to the clinical trial below.
Title: The ELOPE Study: Prospective Evaluation of Long-term Outcomes After Pulmonary Embolism
Brief Summary: The purpose of this study is to evaluate the long-term impact of Pulmonary Embolism (PE) on heart and lung function, quality of life, ability to work, symptoms of breathlessness and functional status of patients one year after their initial diagnosis and treatment for PE


Options:
A: at 3 months, combined criteria including recurrent PE confirmed by objective tests and fatal PE confirmed by autopsy and death which can not be attribuated to a documented cause and for which PE/DVT can't be ruled out (3 months)
B: Exercise Limitation (1 month); Exercise Limitation (12 months)
C: Number of Patients With Cardiogenic Shock or Respiratory Failure From Pulmonary Embolism and Number of Patietnts With Major Hemorrhage (1,2,3,4, and 5 days); Number With Functional Cardiopulmonary Limitations Assessed With a Composite Measurement (Six Minute Walk Distance, Right Ventricular Function and Quality of Life Score on the SF-36) (90 days); Number With Recurrent Venous Thromboembolism and/or Severe Post-phlebitic Syndrome (90 days)
D: Reduction of RV/LV Ratio (24 hours); Major Bleeding and Intracranial Bleeding at 30 Days. (30 days)

Answer: B
Please select the outcome measures that correspond to the clinical trial below.
Title: Development of a Methamphetamine Early Intervention
Brief Summary: Methamphetamine abuse has a strong and consistent epidemiologic association with high-risk sexual behavior and both prevalent and incident HIV in men who have sex with men (MSM), and some authorities have advocated methamphetamine treatment as an HIV prevention strategy. However, methamphetamine interventions have not been evaluated in controlled trials, nor have they been implemented and assessed outside of substance abuse treatment programs. This application proposes preliminary investigations to adapt a methamphetamine treatment intervention previously associated with decreased sexual-risk taking among MSM for use as an early intervention among MSM in Seattle, Washington. Sixty methamphetamine-using MSM will be enrolled in a randomized controlled trial of contingency management (CM) versus no intervention. CM participants will have their urine tested for methamphetamine 3 times weekly for 12 weeks, and will receive vouchers of escalating value when their urines test negative; vouchers will be withheld when participants' urines test positive for methamphetamine or participants miss urine testing visits. All participants will undergo urine methamphetamine testing and audio-computer assisted self-interviews on sexual behavior and substance use at baseline and at 6 week intervals for 6 months. Participants will be tested for HIV, syphilis, rectal gonorrhea and chlamydial infection, and pharyngeal gonorrhea at baseline and at 3 and 6 month follow-up. The study will determine how often MSM will initiate and complete the early intervention, and will longitudinally measure unsafe sexual behaviors among intervention and control participants. Study results will determine the feasibility of instituting and studying CM as an early intervention; define whether the intervention is sufficiently promising to justify a larger, definitive randomized controlled trial; and will provide estimates for defining the number of participants such a trial would require.


Options:
A: Percentage of Monthly Urine Samples That Are Negative for Cocaine (1 year)
B: Addiction Severity Index Alcohol Composite (Baseline, end of treatment (month 3), 3-month post-treatment follow-up); Addiction Severity Index Drug Composite (Baseline, end of treatment (3 months), and 3-month post-treatment followup); Brief Addiction Monitor (Baseline, end of treatment (month 3), 3-month post-treatment follow-up)
C: abused drug abstinence measured by observed urine specimen testing weeks 1-52, and bimonthly months 13-18
D: Non-concordant unprotected anal intercourse (Baseline, 6, 12, 18, 24 weeks)

Answer: D
Please select the outcome measures that correspond to the clinical trial below.
Title: Development of a Methamphetamine Early Intervention
Brief Summary: Methamphetamine abuse has a strong and consistent epidemiologic association with high-risk sexual behavior and both prevalent and incident HIV in men who have sex with men (MSM), and some authorities have advocated methamphetamine treatment as an HIV prevention strategy. However, methamphetamine interventions have not been evaluated in controlled trials, nor have they been implemented and assessed outside of substance abuse treatment programs. This application proposes preliminary investigations to adapt a methamphetamine treatment intervention previously associated with decreased sexual-risk taking among MSM for use as an early intervention among MSM in Seattle, Washington. Sixty methamphetamine-using MSM will be enrolled in a randomized controlled trial of contingency management (CM) versus no intervention. CM participants will have their urine tested for methamphetamine 3 times weekly for 12 weeks, and will receive vouchers of escalating value when their urines test negative; vouchers will be withheld when participants' urines test positive for methamphetamine or participants miss urine testing visits. All participants will undergo urine methamphetamine testing and audio-computer assisted self-interviews on sexual behavior and substance use at baseline and at 6 week intervals for 6 months. Participants will be tested for HIV, syphilis, rectal gonorrhea and chlamydial infection, and pharyngeal gonorrhea at baseline and at 3 and 6 month follow-up. The study will determine how often MSM will initiate and complete the early intervention, and will longitudinally measure unsafe sexual behaviors among intervention and control participants. Study results will determine the feasibility of instituting and studying CM as an early intervention; define whether the intervention is sufficiently promising to justify a larger, definitive randomized controlled trial; and will provide estimates for defining the number of participants such a trial would require.


Options:
A: Non-concordant unprotected anal intercourse (Baseline, 6, 12, 18, 24 weeks)
B: longest continuous period of cocaine abstinence (Week 8)
C: Stimulant drug use as measured by urine analysis (Treatment phase: 12 weeks (3 measurements a week), Follow Up Phase: 3 months (1 measuresment a month))
D: reduction in drug use (8 weeks)

Answer: A
Please select the outcome measures that correspond to the clinical trial below.
Title: A Pilot Study Of A Randomized Trial Comparing Two Different Time Frames For Copper T380A Intrauterine Contraception Insertion; Immediately Postpartum Compared To 4-6 Weeks Postpartum In Lilongwe, Malawi
Brief Summary: The purpose of this non-blinded randomized clinical trial is to pilot the design of a randomized clinical trial to be conducted in Malawi to investigate immediate postpartum insertion of the Copper T380 intrauterine contraceptive device (CuT380A-IUCD) compared to placement at the 6-week postpartum visit.

The investigators hypothesize that it will be feasible to enroll 140 women into this study, and that women will find the 10 minute to 48 hour time frame for IUCD placement acceptable.


Options:
A: Expulsion rate (6 months); The percentage of females seeking contraception (6 months)
B: Time (6 months)
C: Use of the LNG-IUS for Contraception (12 months after cesarean delivery)
D: IUD Usage Rate at 6 Months (6 months after delivery)

Answer: B
Please select the outcome measures that correspond to the clinical trial below.
Title: A Pilot Study Of A Randomized Trial Comparing Two Different Time Frames For Copper T380A Intrauterine Contraception Insertion; Immediately Postpartum Compared To 4-6 Weeks Postpartum In Lilongwe, Malawi
Brief Summary: The purpose of this non-blinded randomized clinical trial is to pilot the design of a randomized clinical trial to be conducted in Malawi to investigate immediate postpartum insertion of the Copper T380 intrauterine contraceptive device (CuT380A-IUCD) compared to placement at the 6-week postpartum visit.

The investigators hypothesize that it will be feasible to enroll 140 women into this study, and that women will find the 10 minute to 48 hour time frame for IUCD placement acceptable.


Options:
A: Continuation Rates of the LNG-IUS when placed postpartum at three time periods (at 6 months)
B: Time (6 months)
C: IUD Usage Rate at 6 Months (6 months after delivery)
D: 6 month IUD usage rates (6 months)

Answer: B
Please select the outcome measures that correspond to the clinical trial below.
Title: Effects of Breathing Retraining on Pulmonary Function, Exercise Capacity, Quality of Life and Cardiac Autonomic Function in Patients With COPD
Brief Summary: Conventional pulmonary rehabilitation programs improve exercise tolerance, peripheral muscle strength, and health related quality of live but not pulmonary function in patients with chronic obstructive pulmonary disease (COPD). The role of breathing retraining techniques in the rehabilitation of patients with COPD remains unclear. The hypothesis to be tested in this study is that pulmonary function, cardio-pulmonary exercise capacity, health related quality of life and cardiac autonomic modulation of patients with COPD who undergo pulmonary rehabilitation plus breathing retraining will be better than that of patients undergoing a conventional pulmonary rehabilitation.


Options:
A: thoracoabdominal motion (2 years)
B: Visual Analogue Scale (VAS) - distress due to breathlessness (End of intervention (8 weeks after baseline))
C: Exercise endurance (12 weeks)
D: cardiopulmonary exercise capacity

Answer: D