TrialPanorama/Dataset huggingface dataset:
Please select the outcome measures that correspond to the clinical trial below.
Title: A Phase III, Randomized, Double-Blind, Placebo-Controlled, Parallel-Arm, Multi-Center Study Measuring the Efficacy and Safety of PRC-063 in Adolescent ADHD Patients
Brief Summary: The purpose of this randomized, placebo-controlled, double-blind, parallel group study is to evaluate the clinical efficacy and safety of PRC-063 in adolescents with ADHD.


Options:
A: Change in ADHD and ODD symptoms (Every week for six weeks); Change in attention, motor activity and executive functioning (The neuropsychological tests are administered once on each type of medication during the six week trial); Change in side-effects (Once every week through the six week trial)
B: Change from Baseline in Clinician-administered ADHD-5-Rating Scale (Baseline week 2, weeks 3-6)
C: ADHD Severity (baseline and 20 weeks); Substance Use (20 weeks)
D: Change From Baseline in Attention Deficit Hyperactivity Disorder Rating Scale-fourth Edition (ADHD-RS-IV) Total Score at up to 7 Weeks (Baseline and up to 7 weeks)

Answer: B
Please select the outcome measures that correspond to the clinical trial below.
Title: Evaluating a Novel Working Memory Training Program to Decrease Symptoms of PTSD
Brief Summary: The study is designed to evaluate the effect of a novel computer training program on PTSD.


Options:
A: Impact of Events Scale-Revised 'IESR' (Change from Baseline PTSD symptomology at up to 5 months); The Psychology Experiment Building Language 'PEBL' Test (Change from Baseline neuropsychological functioning at up to 5 months); Generalized Anxiety Disorder 7 (GAD-7) Scale (Change from Baseline anxiety levels at up to 5 months); Patient Health Questionnaire 9 (PHQ-9) Scale (Change from Baseline depression levels at up to 5 months); Weekly Problems Rating Scale (Change from Baseline emotional and behavioural functioning at up to 5 months); Rosenberg Self-Esteem Scale 'RSES' (Change from Baseline levels of self-worth at up to 5 months); The Valued Living Questionnaire 'VLQ' (Change from Baseline quality of life issues at up to 5 months)
B: Change in Clinician Administered PTSD Scale; Re-experiencing (Baseline, Week 4)
C: Alcohol Use Interview (Past month); Alcohol Use Self-Report (Past month); Posttraumatic Stress Disorder Severity (PTSD) Interview (Past two weeks); Posttraumatic Stress Disorder Severity (PTSD) Self-Report (Past two weeks)
D: Posttraumatic Stress Disorder Symptom Scale- Interview Version (PSS-I) (12 weeks); Timeline Followback Heavy Episodic Drinking Episodes (12 weeks)

Answer: B
Please select the outcome measures that correspond to the clinical trial below.
Title: A Phase 3 Efficacy and Safety Study of Ataluren (PTC124®) in Patients With Nonsense Mutation Cystic Fibrosis
Brief Summary: This is a Phase 3, international, multicenter, randomized, double-blind, placebo-controlled, efficacy and safety study of ataluren in patients with nonsense mutation cystic fibrosis (nmCF) not receiving chronic inhaled aminoglycosides.


Options:
A: Absolute Change From Baseline in Percent-predicted Forced Expiratory Volume in One Second (ppFEV1) at Week 48 (From Baseline to Week 48)
B: Safety as Determined by Adverse Events (AEs) (Start of study drug through the Follow-up Visit (Up to Day 56)); Change in Sweat Chloride From Baseline Through Study Day 28 for Group 1-5b (Baseline through Day 28); Change in Sweat Chloride From Baseline Through Study Day 28 for Group 6 (Baseline through Day 28); Change in Sweat Chloride From Baseline Through Study Day 28 for Group 7 (Baseline through Day 28)
C: Absolute Change in Percent Predicted Forced Expiratory Volume in 1 Second (ppFEV1) (From Baseline at Week 4)
D: Change of Sweat Chloride Content From Baseline (Baseline, at day 14 and day 28 in study part 1)

Answer: A
Please select the outcome measures that correspond to the clinical trial below.
Title: A Phase 3 Efficacy and Safety Study of Ataluren (PTC124®) in Patients With Nonsense Mutation Cystic Fibrosis
Brief Summary: This is a Phase 3, international, multicenter, randomized, double-blind, placebo-controlled, efficacy and safety study of ataluren in patients with nonsense mutation cystic fibrosis (nmCF) not receiving chronic inhaled aminoglycosides.


Options:
A: Absolute Change From Baseline in Percent Predicted Forced Expiratory Volume in 1 Second (FEV1) at Week 24 (Baseline, Week 16 and 24)
B: Safety and Tolerability Based on Adverse Events (AEs) (Up to 14 days after last dose (last dose = Day 28))
C: Absolute Change From Baseline in Percent-predicted Forced Expiratory Volume in One Second (ppFEV1) at Week 48 (From Baseline to Week 48)
D: N/A

Answer: C
Please select the outcome measures that correspond to the clinical trial below.
Title: Improving Consent and Survey Procedures for Young MSM in Web-based HIV Prevention
Brief Summary: A two-part study to test the efficacy of alternative consent procedures and the efficacy of alternative methods to improve survey completion.


Options:
A: Antihypertensive medication adherence (8 weeks during the study)
B: Knowledge of Consent Information (At baseline (time zero))
C: Response rate (up to 10 weeks after receiving the questionnaire)
D: Overall response rate (Up to 3 months (from February 3 2017 to maxium Maj 5 2017))

Answer: B
Please select the outcome measures that correspond to the clinical trial below.
Title: A 12-Week, Double-Blind, Placebo-Controlled, Efficacy and Safety Study of Fluticasone Propionate Multidose Dry Powder Inhaler Compared With Fluticasone/Salmeterol Multidose Dry Powder Inhaler in Adolescent and Adult Patients With Persistent Asthma Symptomatic Despite Low-dose or or Mid-dose Inhaled Corticosteroid Therapy
Brief Summary: The primary objective of this study was to evaluate the efficacy of fluticasone propionate multidose dry powder inhaler (Fp MDPI) and fluticasone propionate/salmeterol xinafoate multidose dry powder inhaler (FS MDPI) when administered over 12 weeks in patients 12 years of age and older with persistent asthma.

Study drug and placebo was supplied in Teva multidose dry powder inhaler (MDPI) devices and provided for participants to use at home. Participants performed spirometry at every visit. Each participant was given a diary at each visit for use until the next visit. Rescue medication (albuterol/salbutamol) was dispensed at each visit, if needed, as determined by the investigational center personnel.


Options:
A: Change in Mean Weekly Morning Peak Expiratory Flow From Baseline to the End of the Trial (baseline and after 16 weeks of treatment)
B: Number of Participants Experiencing an Event in the Composite Endpoint (Asthma-related Death, Asthma-related Intubation or Asthma-related Hospitalization) (Up to 27 weeks); Number of Participants Experiencing an Event Included in the Definition of Asthma Exacerbation (Up to 26 weeks)
C: Standardized Baseline-Adjusted Forced Expiratory Volume in 1 Second (FEV1) Area Under the Effect Curve From Time Zero to 12 Hours Postdose (FEV1 AUEC0-12h) at Week 12 (Day 1 (predose, baseline), Week 12 and was performed at the following times relative to the administration of study drug (±5 minutes): 15 and 30 minutes and 1, 2, 3, 4, 6, 8, 10, and 12 hours); Change From Baseline in Morning Trough Forced Expiratory Volume in 1 Second (FEV1) at Week 12 (Day 1 (predose, baseline), Week 12)
D: Treatment Failure (16 weeks)

Answer: C
Please select the outcome measures that correspond to the clinical trial below.
Title: Sustained Aeration of Infant Lungs Trial
Brief Summary: This study is a 2-arm randomized, controlled, multi-center clinical trial to determine which of two strategies at birth are best to optimally aerate the lung of preterm infants. Specifically we will determine in 600 infants of 23-26 weeks gestational age (GA) requiring respiratory support at birth which of two lung opening strategies - either a standard PEEP/CPAP of 5-7 cm H2O in the delivery room (DR), as compared to early lung recruitment using Sustained Inflation (SI) in the DR, will result in a lower rate of the combined endpoint of death or bronchopulmonary dysplasia (BPD) at 36 weeks gestational age.

Hypotheses:

1. Early lung recruitment with SI superimposed upon standard PEEP/CPAP in the DR will reduce the need for mechanical ventilation in the first seven days of life, and reduce need for surfactant use; and
2. A policy of DR SI on standard PEEP/CPAP recruitment will confer better outcomes at 36 weeks post-menstrual age (PMA) than standard PEEP/CPAP


Options:
A: Time Needed to Achieve Return of Spontaneous Circulation (within the first 10 minutes after birth)
B: Return of Spontaneous Circulation (up to 60 Minutes of chest compression)
C: Combined Outcome of Death or Bronchopulmonary Dysplasia (36 weeks)
D: Difference in bronchopulmonary dysplasia (36 weeks corrected gestational age)

Answer: C
Please select the outcome measures that correspond to the clinical trial below.
Title: Enhancing Housing First Programs With a Social Network Substance Use Intervention
Brief Summary: Housing First programs are promising approaches to transitioning substance using chronically homeless adults to affordable housing. However, Housing First programs need to provide support to residents to adjust to their changing social environments. The proposed project fulfills a critical gap by developing an electronic tool for a social network intervention using motivational interviewing techniques as well as results of a pilot test of the tool. The hypothesis to be tested is that Housing First residents who are given the intervention will be significantly more motivated to change their drinking, drug use, sexual risk behaviors, and social networks compared to controls receiving usual care.


Options:
A: Change in Treatment Session Attendance from Baseline (0, 3, 6, 9, 12 months)
B: Self-reported frequency of distributive sharing of injection and non-injection drug equipment (i.e., lending, giving or selling used needles, syringes or paraphernalia to others)
C: Readiness to change alcohol and other drug use (Baseline and 13-14 weeks (post intervention)); Readiness to change risky sexual behavior (Baseline and 13-14 weeks (post intervention)); Self efficacy to change alcohol and other drug use (Baseline and 13-14 weeks (post intervention)); Self efficacy to change risky sexual behavior (Baseline and 13-14 weeks (post intervention)); Self-efficacy to change social networks (Baseline and 13-14 weeks (post intervention)); Perceived Social Network support and approval/disapproval of alcohol, drug use, and risky sex. (Baseline and 13-14 weeks (after intervention))
D: Compare the NCMIT and SCMT programs among homeless young gay and bisexual stimulant using men with respect to completion of a HBV vaccination series administered in three doses over a four-month period. (5 years)

Answer: C
Please select the outcome measures that correspond to the clinical trial below.
Title: Multicentre Randomised Controlled Trial of Minimally-invasive Surfactant Therapy in Preterm Infants 25-28 Weeks Gestation on Continuous Positive Airways Pressure
Brief Summary: Trial question: Does administration of exogenous surfactant using a minimally-invasive technique improve outcome in preterm infants 25-28 weeks gestation treated with continuous positive airway pressure (CPAP)? Trial hypothesis: That early surfactant administration via a minimally-invasive technique to preterm infants on CPAP will result in a lesser duration of mechanical respiratory support, and a higher incidence of survival without bronchopulmonary dysplasia. Trial design: Multicentre, randomised, masked, controlled trial in inborn preterm infants 25-28 weeks gestation, aged less than 6 hours, requiring CPAP because of respiratory distress, with an FiO2 of \>=0.3 and CPAP pressure 5-8. Infants randomised to surfactant treatment receive 200 mg/kg of poractant alfa (Curosurf) administered under direct laryngoscopy using a surfactant instillation catheter, followed by reinstitution of CPAP. Controls continue on CPAP. The intervention is masked from the clinical team. Care thereafter is as per usual in both groups, other than the requirement to adhere to intubation criteria. The primary outcome is incidence of death or BPD. Secondary outcomes include incidence of death, major neonatal morbidities (BPD, intraventricular haemorrhage, periventricular leukomalacia, retinopathy of prematurity, necrotising enterocolitis), pneumothorax and patent ductus arteriosus; need for intubation and surfactant therapy; durations of mechanical respiratory support, intubation, CPAP, intubation and CPAP, high flow nasal cannula (HFNC), oxygen therapy, intensive care stay and hospitalisation; hospitalisation cost; applicability and safety of the MIST procedure; and outcome at 2 years. The sample size is 303/group, allowing detection of a 33% difference in the primary outcome with 90% power. The trial commenced at Royal Hobart Hospital December 2011 and Royal Women's Hospital during 2012, and will ultimately be conducted over 5 years in multiple centres internationally.


Options:
A: Death or physiological bronchopulmonary dysplasia (36 weeks post menstrual age)
B: Death or Chronic Lung Disease (at 36 weeks postmenstrual age); Death (36 weeks adjusted age)
C: Survival Without Bronchopulmonary Dysplasia (BPD) (36 weeks); Survival Without Severe Retinopathy of Prematurity (ROP) (Threshold Disease or the Need for Surgery) (55 weeks)
D: Efficacy of nasal intermittent mandatory ventilation (IMV) and nasal continuous positive airway pressure (CPAP) in early rescue surfactant treatment in preterm infants (3 months)

Answer: A
Please select the outcome measures that correspond to the clinical trial below.
Title: Efficacy and Cost-Effectiveness of a Super Simplified System for the Management of Patients With Sleep Apneas in Primary Healthcare.
Brief Summary: Primary objectives: To determine the efficacy and cost-effectiveness of a management program for patients with obstructive sleep apnea syndrome (OSAS) carried out in primary or specialist healthcare. In the primary arm, the diagnosis and therapeutic decision will be made by means of a domiciliary nasal pressure (DNP) channel and oximetry while the specialist healthcare arm will use polysomnography (PSG) in a hospital. Patients with an intermediate-high suspicion of OSAS will be included, taking as primary variables the Epworth scale, for efficacy, and the Epworth scale and EuroQol 5D, for cost-effectiveness.

Secondary objectives: efficacy of the two SAHS management programs according to the following secondary variables: a) quality-of-life tests: FOSQ questionnaire, SF36 and analogical wellbeing scale, b) adherence to and compliance with the treatment.


Options:
A: A composite of the CV endpoints of CV death, non-fatal acute myocardial infarction, non-fatal stroke, hospital admission for heart failure, and new hospitalisation for unstable angina or transient ischaemic attack. (Reviewed 6-monthly; average patient follow up, 4.5 years)
B: Efficacy of the extra- and intra-hospital programs using DNP or PSG, taking as primary variable the Epworth scale. (Before and after 6 months of follow-up)
C: Hopkins Verbal Learning Test-Revised (HVLT-R) (Change from baseline at 6 months and 1 year); Digit Symbol Subtest (DS) (Change from baseline at 6 months and 1 year); Mini Mental State Evaluation Exam (MMSE) (Change from baseline at 6 months and 1 year); Stroop Color and Word Test (SCW) (Change from baseline at 6 months and 1 year); The Psychomotor Vigilance Task (PVT) (Change from baseline at 6 months and 1 year); Epworth Sleepiness Scale [ESS] (Change from baseline at 6 months and 1 year)
D: Objective CPAP Use (12 months)

Answer: B
Please select the outcome measures that correspond to the clinical trial below.
Title: A Randomized Crossover Mucociliary Clearance Study of Aerosolized 7% NaCl Solution Administered Overnight by the tPAD Device to Subjects With Cystic Fibrosis
Brief Summary: The primary objective of this study is to determine whether a single overnight, eight-hour administration of a 7% NaCl solution delivered by the Parion Sciences transnasal Pulmonary Aerosol Delivery (tPAD) device has a significant effect on mucociliary clearance in subjects with cystic fibrosis, as compared to no treatment. This study will be conducted at the University of Pittsburgh Medical Center.


Options:
A: Percent Mucociliary Clearance at 60 Minutes (60 minutes)
B: Comparison of the judgement on global pleasure of the inhalation between the two treatment groups (The outcome measure was assessed at day 1, day 7, day 14, day 21, and day 28 of the four-weeks treatment period. For each time-point we operated a comparison between the two groups.); Comparison of the symptom cough between the two treatment groups (The outcome measure was assessed at day 1, day 7, day 14, day 21, and day 28 of the four-weeks treatment period. For each time-point we operated a comparison between the two groups.); Comparison of the sensation of saltiness between the two treatment groups (The outcome measure was assessed at day 1, day 7, day 14, day 21, and day 28 of the four-weeks treatment period. For each time-point we operated a comparison between the two groups.); Comparison of the sensation of throat irritation between the two treatment groups (The outcome measure was assessed at day 1, day 7, day 14, day 21, and day 28 of the four-weeks treatment period. For each time-point we operated a comparison between the two groups.)
C: Lung Clearance Index (90 minutes post treatment)
D: mucociliary clearance (6 hours)

Answer: D
Please select the outcome measures that correspond to the clinical trial below.
Title: A Phase 2 Open-Label Study of the Efficacy and Safety of ABT-199 (GDC-0199) in Chronic Lymphocytic Leukemia Subjects With Relapse or Refractory to B-Cell Receptor Signaling Pathway Inhibitor Therapy
Brief Summary: This was an open-label, non-randomized, multicenter, Phase 2 study evaluating the efficacy and safety of ABT-199 in 127 participants with relapsed or refractory chronic lymphocytic leukemia (CLL) after B-cell receptor signaling pathway inhibitors (BCR PI) treatment.


Options:
A: Overall Response Rate (ORR) (At Wk 5, Day 1; Wk 8, Day 1; Wk 12, Day 1; Wk 16, Day 1; Wk 20, Day 1; Wk 24, Day 1; Wk 36, Day 1; every 12 wks after Wk 36; Final Visit; estimated median time on follow-up was 1694 d for ibrutinib failure cohort and 1942 d for idelalisib failure cohort)
B: Arm A: Percentage of Complete Responses (7 months); Arm B: Treatment-free Survival at 18 Months (18 months)
C: Progression-free Survival (PFS) as Assessed by Independent Review Committee (IRC) (From the randomization date up to 60 months post the randomization date.)
D: Overall Response Rate (ORR) (From 3 cycles (90 days) up to 6 cycles (approximately 180 days))

Answer: A
Please select the outcome measures that correspond to the clinical trial below.
Title: Plasticity-based, Adaptive, Computerized Cognitive Remediation Treatment (PACR) for Adults With Multiple Sclerosis (MS)
Brief Summary: Cognitive impairment remains a major disability for individuals with multiple sclerosis (MS). The primary objective of this study is to evaluate the efficacy for treating MS-associated cognitive deficits using a unique computer-based plasticity-based and adaptive cognitive remediation treatment (PACR) compared to a computer-based control. This novel cognitive remediation approach has led to striking improvements in cognitive functioning in other disorders (schizophrenia, traumatic brain injury, aging, and dementia) but has never been applied to individuals with MS. The investigators will enroll 136 MS participants who will be randomized in a 2:1 pattern to complete either the treatment or control condition for 60 hours across a 12-week treatment period. Both the treatment and control conditions will be accessed remotely by the subjects from a study-provided laptop computer. Study outcomes will include program compliance, performance on study tasks and neuropsychological measures, quality of life and functional status. Given the success of this program with other disorders and strong preliminary data from our feasibility study, the investigators believe PACR is an exciting untapped opportunity to improve cognition in individuals with MS.


Options:
A: Neurotrophic Factor BDNF (3-weeks)
B: Efficacy of cognitive rehabilitation on quality of life at short term. (10 weeks); Efficacy of cognitive rehabilitation on quality of life at long term. (34 weeks)
C: Neuropsychological Assessment (Baseline assessment, and Week 3)
D: A composite derived from a standardized battery of neuropsychological tests (12weeks)

Answer: D
Please select the outcome measures that correspond to the clinical trial below.
Title: The Effect of Arabinoxylan-oligosaccharides (AXOS) on Intestinal Generation of Microbial Metabolites in Chronic Kidney Disease
Brief Summary: Chronic kidney disease is associated with the accumulation of various metabolites, i.e., uremic retention solutes. Evidence is mounting that the colonic microbiota contributes substantially to these uremic retention solutes. Indoxyl sulfate and p-cresyl sulfate are among the most extensively studied gut microbial metabolites, and are associated with cardiovascular disease, overall mortality and chronic kidney disease progression. The most important regulator of colonic bacterial metabolism is nutrient availability and especially the ratio of available fermentable carbohydrate to nitrogen, which can be modified by intake of so-called prebiotics (non-digestible food ingredients). Arabinoxylan oligosaccharides (AXOS) are a recently developed group of prebiotics, and already demonstrated a decreasing effect on intestinal generation of p-cresol in healthy individuals. Whether prebiotics in general, and AXOS more specifically, can influence intestinal generation of microbial metabolites in predialysis patients has not been studied to date. An interventional study with AXOS will therefore be initiated to test the hypothesis that AXOS can decrease intestinal generation and serum concentrations of microbial metabolites in patients with CKD not yet on dialysis.


Options:
A: Change from baseline of the microbial gut populations (5 months); Change from baseline of the microbial inflammatory uremic toxins (5 months); Change from baseline of the markers of cardiovascular diseases (5 months); Change from baseline of the markers of intestinal barrier permeability (5 months)
B: Change in blood uremic toxin, indoxyl sulphate, between treatments (between endpoints of each experimental period (week 8 to week 18)); Change in blood uremic toxin, p-cresyl sulphate, between treatments (between endpoints of each experimental period (week 8 to week 18))
C: Serum levels of p-cresol and indole derivatives (After 4 weeks of intervention)
D: Change in gut microbiota profile measured by denaturing gradient gel electrophoresis after supplementation of resistance starch treatment (Change from Baseline microbiota gut at 6 weeks); Change in cytokines plasma levels measured by ELISA after supplementation of resistance starch (Change from Baseline inflammation at 6 weeks)

Answer: C