TrialPanorama/Dataset huggingface dataset:
Please select the outcome measures that correspond to the clinical trial below.
Title: A Randomized, Placebo-controlled, Double-masked Clinical Trial of Buspirone in the Treatment of 2- 6 Year Old Children With Autistic Disorder
Brief Summary: The purpose of this study is to evaluate the effects of twice-daily oral buspirone on core features of autism in autistic children aged 2-6 years as measured by the change from baseline in the Autism Diagnostic Observation Schedule (ADOS) Composite Total scores compared to placebo at 6 months.


Options:
A: To evaluate the effects of twice-daily oral buspirone on core features of autism in autistic children 2-6 years measuring the change from baseline in ADOS (Autism Diagnostic Observation Schedule) Composite Total scores compared to placebo at 6 months. (Baseline 1, Week 24)
B: Core autistic symptoms (ATEC) (Once every 4 weeks during the first three mounth); Side effects and adverse events questionnaire (Once every 4 weeks during the first phase(12 weeks))
C: Clinical Global Impression-Improvement Scale (CGI-I) (Baseline to 12 weeks)
D: Clinical Global Impression - Severity (Week 12); Clinical Global Impression - Improvement (Week 12)

Answer: A
Please select the outcome measures that correspond to the clinical trial below.
Title: Supplemental Postoperative Oxygen and the Risk of Surgical Wound Infection in a Vascular Surgery Population: A Randomized Controlled Trial
Brief Summary: The purpose of this study was to test the hypothesis that supplemental postoperative oxygen reduces the risk of surgical wound infection in patients following lower limb vascular surgery.


Options:
A: The primary endpoint is hospital length of stay (LOS), defined from the start of surgery until actual hospital discharge. Patients transferred to another hospital will be tracked until final discharge to home (or other final destination). LOS is likely
B: The Primary Endpoint is a Composite of Death and Cardiovascular Events (Clinical and Silent MI, Cardiac Failure, Cardiac Arrest, Pulmonary Embolism, and Stroke) Measured at 30 Days After Surgery. (30 days post op)
C: surgical wound infection (30 days)
D: Surgical site infection (2 weeks)

Answer: C
Please select the outcome measures that correspond to the clinical trial below.
Title: A 12-week Randomized, Double-blind, Multicenter Pilot Study to Evaluate the Effect of Etanercept 100 mg and 50 mg Weekly in Subjects With Ankylosing Spondylitis
Brief Summary: The purpose of this study was to evaluate efficacy and safety of etanercept 100 mg (50 mg twice a week) compared with 50 mg once a week in adult subjects with ankylosing spondylitis (AS) and previous failure to usual practice therapies in Spain.


Options:
A: The primary endpoint of this study was the proportion of subjects who achieved an ASAS 20 response at week 24.
B: ASAS 40 at week 12
C: Number of Patients Achieving Assessment in Ankylosing Spondylitis (ASAS) 20. (12 weeks)
D: Number of Patients Achieving Assessment in Ankylosing Spondylitis (ASAS 20) (16 weeks)

Answer: C
Please select the outcome measures that correspond to the clinical trial below.
Title: A Phase 2a, Randomized, Double-blind, Placebo-Controlled, Parallel-Arm, Multicenter Study to Evaluate the Efficacy and Safety of CAT-354, a Recombinant Human Monoclonal Antibody Directed Against Interleukin-13 (IL-13), on Asthma Control in Adults With Uncontrolled, Moderate-to-severe, Persistent Asthma
Brief Summary: This is a Phase 2a, randomized, double-blind, placebo-controlled, parallel-arm study to evaluate the efficacy and safety of 3 subcutaneous (SC) treatment regimens of CAT-354 in adult subjects with uncontrolled, moderate-to-severe, persistent asthma.


Options:
A: Mean Change From Baseline (BL) in St. George's Respiratory Questionnaire (SGRQ) Score at Week 24 (Baseline and Week 24)
B: Change From Baseline in the Mean Asthma Control Questionnaire (ACQ) Score at Day 92 (Day 1 and 92)
C: To understand the mechanisms driving eosinophilia and disease pathogenesis in patients with a wide range of eosinophilic disorders (Ongoing assessment)
D: Change From Baseline in Basophils, Full Analysis Set, Excluding MELTEMI Patients (Week 56); Change From Baseline in Basophils, Full Analysis Set, Adolescents Only (SIROCCO/CALIMA) (Week 108); Change From Baseline in Leukocytes, Full Analysis Set, Excluding MELTEMI Patients (Week 56); Change From Baseline in Leukocytes, Full Analysis Set, Adolescents Only (SIROCCO/CALIMA) (Week 108); Change From Baseline in Lymphocytes, Full Analysis Set, Excluding MELTEMI Patients (Week 56); Change From Baseline in Lymphocytes, Full Analysis Set, Adolescents Only (SIROCCO/CALIMA) (Week 108); Change From Baseline in Neutrophils, Full Analysis Set, Excluding MELTEMI Patients (Week 56); Change From Baseline in Neutrophils, Full Analysis Set, Adolescents Only (SIROCCO/CALIMA) (Week 108); Change From Baseline in Eosinophils, Full Analysis Set, Excluding MELTEMI Patients (Week 56); Change From Baseline in Eosinophils, Full Analysis Set, Adolescents Only (SIROCCO/CALIMA) (Week 108); Change From Baseline in Alanine Aminotransferase (ALT), Full Analysis Set, Excluding MELTEMI Patients (Week 56); Change From Baseline in ALT, Full Analysis Set, Adolescents Only (SIROCCO/CALIMA) (Week 108); Change From Baseline in Aspartate Aminotransferase (AST), Full Analysis Set, Excluding MELTEMI Patients (Week 56); Change From Baseline in AST, Full Analysis Set, Adolescents Only (SIROCCO/CALIMA) (Week 108); Change From Baseline in Bilirubin, Full Analysis Set, Excluding MELTEMI Patients (Week 56); Change From Baseline in Bilirubin, Full Analysis Set, Adolescents Only (SIROCCO/CALIMA) (Week 108)

Answer: B
Please select the outcome measures that correspond to the clinical trial below.
Title: A Phase 2a, Randomized, Double-blind, Placebo-Controlled, Parallel-Arm, Multicenter Study to Evaluate the Efficacy and Safety of CAT-354, a Recombinant Human Monoclonal Antibody Directed Against Interleukin-13 (IL-13), on Asthma Control in Adults With Uncontrolled, Moderate-to-severe, Persistent Asthma
Brief Summary: This is a Phase 2a, randomized, double-blind, placebo-controlled, parallel-arm study to evaluate the efficacy and safety of 3 subcutaneous (SC) treatment regimens of CAT-354 in adult subjects with uncontrolled, moderate-to-severe, persistent asthma.


Options:
A: Rate of asthma exacerbations during the 52-week placebo-controlled period (weeks 0-52)
B: Change From Baseline in the Mean Asthma Control Questionnaire (ACQ) Score at Day 92 (Day 1 and 92)
C: Change From Baseline in the Expression of FcεRI Receptors of Blood Basophils (Baseline and 16 weeks); Change From Baseline in the Expression of FcεRI Receptors of Dendritic Cells (Baseline and 16 weeks)
D: Number of Participants With Adverse Events (AEs) Including Both Systemic (i.e. Allergic/Immunoglobulin (Ig)E-mediated and Non-allergic) and Local Site Reactions (From Baseline visit until the follow-up visit (approximately [approx.] week 60 [12 weeks post-last dose]))

Answer: B
Please select the outcome measures that correspond to the clinical trial below.
Title: A Phase 2a, Randomized, Double-blind, Placebo-Controlled, Parallel-Arm, Multicenter Study to Evaluate the Efficacy and Safety of CAT-354, a Recombinant Human Monoclonal Antibody Directed Against Interleukin-13 (IL-13), on Asthma Control in Adults With Uncontrolled, Moderate-to-severe, Persistent Asthma
Brief Summary: This is a Phase 2a, randomized, double-blind, placebo-controlled, parallel-arm study to evaluate the efficacy and safety of 3 subcutaneous (SC) treatment regimens of CAT-354 in adult subjects with uncontrolled, moderate-to-severe, persistent asthma.


Options:
A: Rate of Clinically Significant Asthma Exacerbations Per Patient in the 24-week Fixed-dose Steroid Treatment Period (Baseline to end of the fixed-dose steroid treatment period (Week 24)); Percentage of Participants With at Least 1 Adverse Event (Baseline to end of the study (Week 68))
B: Integrated Asthma Quality of Life Questionnaire (AQLQ) Score (Change From Baseline) (Baseline, 12 Months)
C: Change From Baseline in the Mean Asthma Control Questionnaire (ACQ) Score at Day 92 (Day 1 and 92)
D: Change in forced expiratory volume in 1 second (FEV1) (From baseline to Week 12)

Answer: C
Please select the outcome measures that correspond to the clinical trial below.
Title: N/A
Brief Summary: The EVOLVO study is designed to compare the remote defibrillator management to the current standard of care, to assess its ability to treat and triage patients more effectively.


Options:
A: The rate of cardiac or device related clinic visits (16 months)
B: Lowering of blood pressure from hypertension to prehypertension in 50% of study subjects (6 months)
C: Home Monitoring Effectiveness (12 months); Percent of Participants Experiencing Death, Incidence of Stroke, or Event Requiring Surgical Intervention. (12 months)
D: Dyspnea; Exercise adherence and performance; Pulmonary exacerbations

Answer: A
Please select the outcome measures that correspond to the clinical trial below.
Title: Comparison of Three Modalities of Continuous Positive Pressure Airway Treatment for Obstructive Sleep Apnea Syndrome
Brief Summary: The purpose of this study is to compare the treatment adherence and effects in three modalities of Continuous Positive Airway Pressure Treatment for Obstructive Sleep Apnea.


Options:
A: proportion of participants compliant (at least four hours of use per night for all nights) in the Auto Bilevel group compared to the CPAP group after 90 days of treatment during the investigation. (90 days)
B: subjective sleepiness and other OSAS symptoms (3 months, 1 year, 2 years); quality of life (3 months, 1 year, 2 years); percentage of withdrawal and cross-over to other CPAP mode (3 months, 1 year, 2 years); objective vigilance (3 months, 1 year, 2 years); blood pressure (3 months, 1 year, 2 years); cost/utility ratios (3 months, 1 year, 2 years)
C: To compare the compliance of auto-CPAP and fixed CPAP in terms of CPAP usage hours.; To compare the clinical efficacy of auto-CPAP and fixed CPAP in terms of pressure level to abolish OSA, Epworth sleepiness scale and quality of life questionnaire.; To compare patient acceptance of the different type of treatment.
D: objective CPAP adherence (objective adherence are downloaded and reported by the memory card located in the CPAP device.) (3 months)

Answer: D
Please select the outcome measures that correspond to the clinical trial below.
Title: Early Blood Pressure Management in Extremely Preterm Infants Feasibility Pilot Study
Brief Summary: This trial tests the feasibility of enrolling 60 extremely preterm infants in a randomized, double-blinded study of blood pressure management within 12 months. Eligible infants will receive an infusion drug (dopamine or a dextrose placebo) and a syringe drug (hydrocortisone or a normal saline placebo).

Enrolled infants will be randomized to receive one of the following drug pairs:

* dopamine and hydrocortisone
* dopamine and normal saline
* dextrose and hydrocortisone
* dextrose and normal saline.

In addition to the intervention above, the NRN is conducting a 6-month time-limited prospective observational study of all infants born at an NRN center between 23 and 26 weeks gestational age. All clinical decisions made for these babies will be at the discretion of the attending neonatologist/infant care team according to standard practice at each institution. Data on blood pressure management in the first 24 postnatal hours collected for each infant.


Options:
A: Enrollment and completion of 60 infants (1 year)
B: dichotomous variable: survival without BPD at 36 weeks PMA. (add 8 to12)
C: Total Cerebral Volume as Measured by Volumetric Brain MRI (38 weeks postmenstrual age (PMA))
D: Survival Without Moderate/Severe Physiologic Bronchopulmonary Dysplasia (BPD) (From day of randomization to 36 weeks post menstrual age); Survival Without Moderate/Severe Neurodevelopmental Impairment (NDI) (From day of randomization to 22-26 months corrected age)

Answer: A
Please select the outcome measures that correspond to the clinical trial below.
Title: A Randomized, Open-label, Multi-center Phase III Study of Erlotinib Versus Gemcitabine/Carboplatin in Chemo-naive Stage IIIB/IV Non-Small Cell Lung Cancer Patients With EGFR Exon 19 or 21 Mutation (Optimal)
Brief Summary: Epidermal growth factor receptor tyrosine kinase inhibitors (EGFR TKIs) such as erlotinib have proved effective in second or third line therapy for advanced non-small cell lung cancer(NSCLC).It is well tolerated without the side effects usually associated with chemotherapy. The mutations in EGFR exons 19 or 21 have been reported to be associated with efficacy of EGFR TKIs.Based on the encouraging preliminary results from the Spanish lung cancer group' prospective study reported that the efficacy of Tarceva as first line treatment for metastatic NSCLC patients with EGFR mutation would delay disease progression,prolong overall survival and be well tolerated, medium Progression-free survival(PFS) was around 12 months and OS reach 24 months，our study is designed to compare PFS between the patients with mutant EGFR treated by gemcitabine/carboplatin and those by erlotinib in the first-line setting. We assumed 11 months of PFS on Tarceva arm versus 6 months on chemotherapy arm with a=0.025(alpha-spend for an interim analysis), 80% power and 12 months enrolment period, 12 months FU duration to calculate the sample size. The sample size is 69 pairs. Considering about 10% drop-out rate, the final sample size is 152 patients.So, chemo-naive staged IIIb/IV patients with EGFR mutations in exon 19 or 21 will be enrolled into this open-label, randomized,multicenter phase III study.


Options:
A: Median Progression Free Survival (PFS) in Months (Tumour assessments as per RECIST were performed at baseline and then every 42 days ± 7 days from randomization until data cut off (14th April 2008).)
B: Median Progression Free Survival (PFS) Time (Randomization until PD or death (assessed at baseline and every 8 weeks thereafter until PD, death or end of study [up to approximately 1.5 years]))
C: Progression-Free Survival (PFS) Time (Tumour assessments were performed at Screening, Week 6, Week 12, Week 18 and then every 12-18 weeks until disease progression)
D: Progression free survival (12 months)

Answer: D
Please select the outcome measures that correspond to the clinical trial below.
Title: A Randomized, Open-label, Multi-center Phase III Study of Erlotinib Versus Gemcitabine/Carboplatin in Chemo-naive Stage IIIB/IV Non-Small Cell Lung Cancer Patients With EGFR Exon 19 or 21 Mutation (Optimal)
Brief Summary: Epidermal growth factor receptor tyrosine kinase inhibitors (EGFR TKIs) such as erlotinib have proved effective in second or third line therapy for advanced non-small cell lung cancer(NSCLC).It is well tolerated without the side effects usually associated with chemotherapy. The mutations in EGFR exons 19 or 21 have been reported to be associated with efficacy of EGFR TKIs.Based on the encouraging preliminary results from the Spanish lung cancer group' prospective study reported that the efficacy of Tarceva as first line treatment for metastatic NSCLC patients with EGFR mutation would delay disease progression,prolong overall survival and be well tolerated, medium Progression-free survival(PFS) was around 12 months and OS reach 24 months，our study is designed to compare PFS between the patients with mutant EGFR treated by gemcitabine/carboplatin and those by erlotinib in the first-line setting. We assumed 11 months of PFS on Tarceva arm versus 6 months on chemotherapy arm with a=0.025(alpha-spend for an interim analysis), 80% power and 12 months enrolment period, 12 months FU duration to calculate the sample size. The sample size is 69 pairs. Considering about 10% drop-out rate, the final sample size is 152 patients.So, chemo-naive staged IIIb/IV patients with EGFR mutations in exon 19 or 21 will be enrolled into this open-label, randomized,multicenter phase III study.


Options:
A: Progression free survival (12 months)
B: Overall Survival (OS) Time (Time from randomization to death or last day known to be alive, reported between day of first participant randomized, that is, Sep 2008 until cut-off date, (19 Nov 2012))
C: Overall Survival (During treatment and every three months from end of treatment through end of study or approximately up to 5 years.)
D: Overall Survival (OS) (From randomization to date of death or last follow-up. Analysis occurs after all 390 deaths have been reported.); Progression-free Survival (PFS) (From randomization to date of progression, death, or last follow-up for progression-free survival. Analysis occurs after all 390 deaths have been reported.)

Answer: A
Please select the outcome measures that correspond to the clinical trial below.
Title: A Phase 2a Study of BMS-790052 in Combination With Peginterferon Alfa-2a (Pegasys®) and Ribavirin (Copegus®) in Treatment Naive Subjects With Chronic Hepatitis C Virus Genotype 1
Brief Summary: The purpose of this study is to identify 1 or more doses of daclatasvir, which when used in combination with pegylated interferon alpha and ribavirin, are safe and demonstrate sufficient anti-hepatitis C virus activity.


Options:
A: Part 1: Rapid Virological Response (RVR) (4 weeks); Part 2: Sustained Virological Response (SVR) (From drug administration until 12 weeks after end of treatment, up to 52 weeks); Part 3 and 4: Sustained Virological Response (SVR) (From drug administration until 12 weeks after end of treatment, up to 36 weeks)
B: Percentage of Participants With Extended Rapid Virologic Response (eRVR) at Weeks 4 and 12 (A Weeks 4 and 12)
C: The Percentage of Participants Achieving a Sustained Virologic Response 12 Weeks After the Planned End of Treatment (SVR12) (Week 36 or Week 60)
D: Sustained Virological Response 12 Weeks Post-treatment (SVR12) (12 weeks post treatment, up to 60 weeks)

Answer: B
Please select the outcome measures that correspond to the clinical trial below.
Title: Study of the Benefits of Lower Limb Electrostimulation Training on Muscular Parameters and Minute Ventilation During Exercise in Severe and Deconditioned COPD Patients.
Brief Summary: This study was designed to test the following hypothesis:

The benefit of electrostimulation training will be greater than sham stimulation training in term of muscle strength and mass (muscle hypertrophy), exercise tolerance, reduction of ventilation during exercise and quality of life in COPD patients


Options:
A: number of steps per day (6 months)
B: Change in the strength of the quadriceps over the 6-week electrostimulation program. (6 to 8 weeks)
C: Changes in objectively measured physical activity (2 weeks before pulmonary rehabilitation (T0), 6 weeks after pulmonary rehabilitation (T3) and 6 months after pulmonary rehabilitation (T4))
D: Quality of Life: Chronic Respiratory Questionaire (8 weeks from the start of the intervention); Daily Physical Activity measured by Actigraph (8 weeks from the start of the intervention)

Answer: B
Please select the outcome measures that correspond to the clinical trial below.
Title: Study of the Benefits of Lower Limb Electrostimulation Training on Muscular Parameters and Minute Ventilation During Exercise in Severe and Deconditioned COPD Patients.
Brief Summary: This study was designed to test the following hypothesis:

The benefit of electrostimulation training will be greater than sham stimulation training in term of muscle strength and mass (muscle hypertrophy), exercise tolerance, reduction of ventilation during exercise and quality of life in COPD patients


Options:
A: Change in the strength of the quadriceps over the 6-week electrostimulation program. (6 to 8 weeks)
B: Lower Extremity Strength, at Hospital Discharge, of 3 Bilateral Muscle Groups (Pretibial, Triceps Surae, and Quadriceps) Measured Via MMT Using a Composite Medical Research Council (MRC) Score (At hospital discharge)
C: Change From Baseline in Isometric Quadriceps Muscle Torque 3.5 Weeks Post-operatively (Baseline through 3.5 weeks)
D: Diagnosis of CIPNM (June 2009)

Answer: A
Please select the outcome measures that correspond to the clinical trial below.
Title: Study of the Benefits of Lower Limb Electrostimulation Training on Muscular Parameters and Minute Ventilation During Exercise in Severe and Deconditioned COPD Patients.
Brief Summary: This study was designed to test the following hypothesis:

The benefit of electrostimulation training will be greater than sham stimulation training in term of muscle strength and mass (muscle hypertrophy), exercise tolerance, reduction of ventilation during exercise and quality of life in COPD patients


Options:
A: Change in SGRQ (12 months)
B: Chronic Respiratory Disease Questionnaire (CRQ) (12 weeks)
C: Re-hospitalization (90 days)
D: Change in the strength of the quadriceps over the 6-week electrostimulation program. (6 to 8 weeks)

Answer: D
Please select the outcome measures that correspond to the clinical trial below.
Title: Study of the Benefits of Lower Limb Electrostimulation Training on Muscular Parameters and Minute Ventilation During Exercise in Severe and Deconditioned COPD Patients.
Brief Summary: This study was designed to test the following hypothesis:

The benefit of electrostimulation training will be greater than sham stimulation training in term of muscle strength and mass (muscle hypertrophy), exercise tolerance, reduction of ventilation during exercise and quality of life in COPD patients


Options:
A: oxygen uptake (VO2) (during 30 minutes exercise)
B: Tolerance to ES = Change in ES intensity between session 2 and 3 (delta intensity) (1 week)
C: Incremental shuttle walk test (10 weeks)
D: Change in the strength of the quadriceps over the 6-week electrostimulation program. (6 to 8 weeks)

Answer: D
Please select the outcome measures that correspond to the clinical trial below.
Title: Efficacy and Safety of Ethanol Lock Solution in Prevention of Catheter Related Bloodstream Infection for Patients Suffering Acute Renal Failure, and Hospitalized in Intensive Care Unit. A Multi-Center, Randomized, Versus Placebo, Double Blinded Clinical Trial.
Brief Summary: The primary objective of the study is to demonstrate the efficacy of 60% ethanol lock solution in preventing major catheter related infections in critically ill patients.


Options:
A: The number of major catheter-related infections (CRI) defined as either catheter-related clinical sepsis without bloodstream infection or catheter-related bloodstream infection (CRBSI), during the ICU stay (after renal replacement therapy session)
B: Number of Participants With Microbiological Response at Test-of-Cure (TOC) Visit (Short term follow-up (STFU) visit for TOC (2 to 3 weeks after the last dose of study medication))
C: Positive Blood Cultures (PBCs) Per 1,000 Central Venous Catheter (CVC)-Days (Up to 12 months)
D: Success Rate (90 days)

Answer: A
Please select the outcome measures that correspond to the clinical trial below.
Title: Perioperative Supplemental Oxygen and the Risk of Surgical Site Infection
Brief Summary: This is a study to see whether increasing the oxygen concentration during and after a cesarean section decreases the infection rate.


Options:
A: The Primary Endpoint is a Composite of Death and Cardiovascular Events (Clinical and Silent MI, Cardiac Failure, Cardiac Arrest, Pulmonary Embolism, and Stroke) Measured at 30 Days After Surgery. (30 days post op)
B: Frequency of patients with the composite outcome measure of either a subsequent, new or recurrent, cancer registration or a new histological specimen showing any neoplasm (36-60 months after randomization)
C: %/type Surgical wound infections rated per infection classifications of NNIS/CDC (with in 30 days post-op)
D: Surgical site infection (2 weeks)

Answer: D