TrialPanorama/Dataset huggingface dataset:
Please select the outcome measures that correspond to the clinical trial below.
Title: A Phase III Randomized, Open-Label, Multi-Center, Global Study of MEDI4736 in Combination With Tremelimumab Therapy or MEDI4736 Monotherapy Versus Standard of Care Platinum-Based Chemotherapy in First Line Treatment of Patients With Advanced or Metastatic Non Small-Cell Lung Cancer (NSCLC)(MYSTIC).
Brief Summary: This is a randomized, open-label, multi-center, global, Phase III study to determine the efficacy and safety of MEDI4736 + tremelimumab combination therapy and MEDI4736 monotherapy versus platinum-based SoC chemotherapy in the first-line treatment of patients with epidermal growth factor receptor (EGFR) and anaplastic lymphoma kinase (ALK) wild-type locally advanced or metastatic NSCLC


Options:
A: Overall Survival (OS) (Through pre-specified database cutoff date of 30 Sep 2015 (Up to approximately 24 months)); Progression-free Survival (PFS) by Response Evaluation Criteria in Solid Tumors Version 1.1 (RECIST 1.1) (Through pre-specified database cutoff date of 30 Sep 2015 (Up to approximately 24 months)); Percentage of Participants Experiencing Adverse Events (AEs) (Through pre-specified database cutoff date of 30 Sep 2015 (Up to approximately 24 months)); Percentage of Participants Discontinuing Study Drug Due to AEs (Through pre-specified database cutoff date of 30 Sep 2015 (Up to approximately 24 months))
B: Investigator-assessed Objective Progression-free Survival (PFS) (Date of randomization to the date of measured PD or date of death from any cause (up to 19.3 months))
C: Objective Response Rate (ORR) by PD-L1 Positive and Negative Levels - Part 1 (From first dose to database lock (Up to 18 months)); Number of Participants With Dose Limiting Toxicities (DLTs) - Part 2 (9 weeks after first dose); Number of Participants With Adverse Events (AEs) - Part 2 (Deaths are from first dose to database lock (Up to 24 months). AEs and SAEs are from first dose to 30 days post last dose); Number of Participants With Laboratory Abnormalities in Hepatic Tests - Part 2 (From first dose to 30 days post last dose); Number of Participants With Laboratory Abnormalities in Thyroid Tests - Part 2 (From first dose to 30 days post last dose)
D: Overall Survival (OS); PD-L1 (TC >=25%) Analysis Set Population, Durvalumab Monotherapy Vs SoC Chemotherapy and Durvalumab + Tremelimumab Vs SoC Chemotherapy (From baseline (Day 1, Week 0) until death due to any cause, assessed up to the data cut-off date (a maximum of approximately 3 years).); Progression-Free Survival (PFS); PD-L1 (TC >=25%) Analysis Set Population, Durvalumab + Tremelimumab Vs SoC Chemotherapy (Tumour scans performed at baseline then every 6 weeks up to 48 weeks relative to the date of randomization, then every 8 weeks thereafter until confirmed disease progression. Assessed up to the data cut-off date (a maximum of approximately 3 years).)

Answer: D
Please select the outcome measures that correspond to the clinical trial below.
Title: Precision Dosing Versus Conventional Dosing of Infliximab Maintenance Therapy: a Randomized Controlled Multicenter Study in Patients With IBD in Clinical Remission
Brief Summary: Infliximab (IFX) is highly effective in inducing and maintaining remission in patients with inflammatory bowel disease (IBD). However, a large proportion of patients will eventually lose response to IFX. Therefore, strategies to improve the outcome of maintenance treatment with IFX are required. Retrospective analyses suggest that adjusting IFX treatment in order to achieve IFX trough levels (TL) above a well-defined therapeutic threshold will improve the outcome of IFX treatment.


Options:
A: Occurrence of disease worsening (52 weeks)
B: Sustained clinical remission for the precision dosing group vs. the conventional IFX maintenance dosing group (52 weeks)
C: Percentage of Participants With Clinical Recurrence (CR) of Crohn's Disease (CD) Prior to or at Week 76 (Baseline up to Week 76)
D: Proportion of patients in remission at the end of the 24 month followup period. Remission is defined as a HBS< or = 4 without use of steroids for the treatment of CD. the primary analysis will be performed at the level of the practice. (24 months)

Answer: B
Please select the outcome measures that correspond to the clinical trial below.
Title: A Randomized Double-blind, Placebo-controlled Cross-over Study of Inhaled Alginate Oligosaccharide (OligoG) for 28 Days in Subjects With Cystic Fibrosis Using Aztreonam Due to Chronic Colonization With Burkholderia Spp.
Brief Summary: The purpose of the study is to assess the efficacy of Alginate oligosaccharide (OligoG) dry powder for inhalation in cystic fibrosis (CF) patients with a Burkholderia spp. infection.


Options:
A: Changes in Burkholderia spp. density in expectorated sputum and/or induced sputum. (28 days, i.e. at start and end of treatment)
B: Absolute Change in Percent Predicted Forced Expiratory Volume in 1 Second (ppFEV1) (From Baseline at Week 4)
C: Glycemic control (serum hemoglobin A1c) (3 month after start of trial)
D: Time to Need for Inhaled or Intravenous (IV) Antipseudomonal Antibiotics (Day 0 to Day 84 (end of study))

Answer: A
Please select the outcome measures that correspond to the clinical trial below.
Title: Pre-surgery Physiotherapy for Patients With Specific Low Back Pain , RCT
Brief Summary: The aim is to study if pre-surgery physiotherapy improves function, pain and health in patients with specific low back pain scheduled for surgery. Patients are followed over a two year period. A secondary aim is to study what factors predict short and long term outcomes.


Options:
A: Oswestry Disability Index (ODI) (Change in ODI from baseline to after intervention (after 3 months) and 3 months, 1 and 2 years post-surgery)
B: 6 minute walk test (6MWT) (up to 8 weeks after surgery)
C: six minute walk test (baseline, preop, 4 weeks, 8weeks postop)
D: Anaerobic threshold prior to liver resection (4 weeks)

Answer: A
Please select the outcome measures that correspond to the clinical trial below.
Title: Pre-surgery Physiotherapy for Patients With Specific Low Back Pain , RCT
Brief Summary: The aim is to study if pre-surgery physiotherapy improves function, pain and health in patients with specific low back pain scheduled for surgery. Patients are followed over a two year period. A secondary aim is to study what factors predict short and long term outcomes.


Options:
A: Recovery measured as physical recovery measured in questionnaire (4-6 weeks)
B: Oxygen consumption (VO2) (4 weeks (before surgery))
C: Oswestry Disability Index (ODI) (Change in ODI from baseline to after intervention (after 3 months) and 3 months, 1 and 2 years post-surgery)
D: Maintain or improve physical fitness (anaerobic threshold measured by CPET)after treatment with neoadjuvant chemoradiotherapy in colorectal cancer patients. (3 years)

Answer: C
Please select the outcome measures that correspond to the clinical trial below.
Title: Electronic Warning System to Improve Stroke Prevention in Atrial Fibrillation - A Quality Improvement Initiative at the University Hospital Bern
Brief Summary: The aim of this randomized controlled study is to evaluate whether a newly designed electronic warning system will increase the initiation rate of adequate stroke preventive measures in patients with atrial fibrillation.


Options:
A: Rate of initiation of adequate measures to prevent stroke (oral anticoagulant prescription) by physician in charge (End of hospital stay (expected average duration of 1 week))
B: Change in CD4 count (Throughout study)
C: referral to a nephrologist (12 months)
D: Mortality (at 90 days)

Answer: A
Please select the outcome measures that correspond to the clinical trial below.
Title: Effect of Counseling During Pulmonary Rehabilitation on Self-determined Motivation Towards Physical Activity in Patients With Chronic Obstructive Pulmonary Disease
Brief Summary: The purpose of this study is to investigate if a physical activity counseling program during pulmonary rehabilitation increases the physical activity level in daily life in patients with Chronic Obstructive Pulmonary Disease.


Options:
A: Walking time in daily life and the amount of time spent in moderate intense activities
B: The primary endpoint will be change from baseline in the dyspnoea domain of the Chronic Respiratory Questionnaire (CRQ). (14 Months)
C: number of steps per day (6 months)
D: Composite measure of psychological quality of life, composite index of all cause mortality and COPD-related hospitalization. (4 years)

Answer: C
Please select the outcome measures that correspond to the clinical trial below.
Title: Effect of Counseling During Pulmonary Rehabilitation on Self-determined Motivation Towards Physical Activity in Patients With Chronic Obstructive Pulmonary Disease
Brief Summary: The purpose of this study is to investigate if a physical activity counseling program during pulmonary rehabilitation increases the physical activity level in daily life in patients with Chronic Obstructive Pulmonary Disease.


Options:
A: Asthma composite score (During first year of follow-up); COPD composite score (During first year of follow-up); Asthma-or-COPD diagnosis rate (During first year of follow-up)
B: change from baseline in Modified Medical Research Council dyspnea score (12 weeks); change from baseline in COPD Assessment Test(CAT) score (12 weeks); change from baseline in real distance walked for 6 minutes (12 weeks)
C: The number of ED presentations (1 year after randomization.)
D: number of steps per day (6 months)

Answer: D
Please select the outcome measures that correspond to the clinical trial below.
Title: Dancing for Better Aging: Evaluating the Impact of a Dance/Movement Therapy Program for Older Adults Through an Empirical Research Approach
Brief Summary: The aim of this study is to empirically evaluate the impact of a Dance/Movement Therapy program adapted to older adults. Participants over 60 years old are enrolled in one of three groups: Dance/Movement Therapy, Aerobic Exercise or Waiting List (control group) for 12 weeks. The training groups occur 3 times a week for 1 hour each session. Physical condition, cognitive function, general health and lifestyle, and stress hormones are assessed at baseline, after 12 weeks and after 28 weeks.


Options:
A: Motor Imitation Scale (Change from pre to post program (baseline and 12-weeks)); Actions & Gestures (Change from pre to post program (baseline and 12-weeks)); Parenting Stress Index, 4th edition Short Form (Change from pre to post program (baseline and 12-weeks)); Parenting Efficacy/Quality (Change from pre to post program (baseline and 12-weeks))
B: The Arabic Language test (Baseline,Change from Baseline at the end of 12 Months Music Therapy .)
C: Z-score change on Cognitive Functioning (0, 12 and 28 weeks)
D: Changes of Childhood Autism Rating Scale-2 (Pre-test 2 weeks before Day 1); Changes of Childhood Autism Rating Scale-2 (2 weeks after intervention); Changes of Childhood Autism Rating Scale-2 (4 months after intervention); Changes of Social Responsiveness Scale second edition (Pre-test 2 weeks before Day 1); Changes of Social Responsiveness Scale second edition (2 weeks after intervention); Changes of Social Responsiveness Scale second edition (4 months after intervention); In-session social behavior (Day 1); In-session social behavior (Last intervention session, approximately 12 weeks after Day 1.)

Answer: C
Please select the outcome measures that correspond to the clinical trial below.
Title: Safety of Transcranial Direct Current Stimulation in the Subacute Phase After Stroke
Brief Summary: Stroke is the second cause of death worldwide and represented the first cause of death in Brazil between 2006 and 2010. Most patients survive, and there is a need to develop cost-effective rehabilitation strategies to decrease the burden of disability from stroke.

This study addresses this important issue, by evaluating, in the early phase post-stroke, effects of motor conventional physical therapy associated or not with transcranial direct current stimulation (tDCS).


Options:
A: Jebsen Taylor Hand Function Test (2 weeks); Cortical Excitability (1 hour); Cortical Oscillations - EEG (15 minutes)
B: Safety of the intervention as assessed by frequency of adverse events (2 weeks)
C: Disability (three months)
D: Fugl-Meyer Assessment Upper Extremity (6 weeks)

Answer: B
Please select the outcome measures that correspond to the clinical trial below.
Title: Safety of Transcranial Direct Current Stimulation in the Subacute Phase After Stroke
Brief Summary: Stroke is the second cause of death worldwide and represented the first cause of death in Brazil between 2006 and 2010. Most patients survive, and there is a need to develop cost-effective rehabilitation strategies to decrease the burden of disability from stroke.

This study addresses this important issue, by evaluating, in the early phase post-stroke, effects of motor conventional physical therapy associated or not with transcranial direct current stimulation (tDCS).


Options:
A: Motor learning improvement with tDCS (Improvement on motor learning were recorded from baseline to 4 weeks after the intervention)
B: Wolf Motor Function test (immediately before and immediately after treatment); Fugl-Meyer Assessment (immediately before and immediately after treatment)
C: Safety of the intervention as assessed by frequency of adverse events (2 weeks)
D: Jebsen Taylor test (5-15-30 days)

Answer: C
Please select the outcome measures that correspond to the clinical trial below.
Title: Esmolol Reduces Anesthetic Requirements Thereby Facilitating Early Extubation; a Prospective Controlled Study in Patients Undergoing Intracranial Surgery
Brief Summary: Anesthesia techniques that minimize anesthetic requirements and their effects may be beneficial. Esmolol, a short acting hyperselective β-adrenergic blocker is effective in blunting adrenergic response to several perioperative stimuli and so it might interfere in the effect of the anesthetic drugs on the brain. This study was designed to investigate the effect of esmolol on the consumption of propofol and sevoflurane in patients undergoing craniotomy.


Options:
A: systolic arterial pressure fluctuation (intraoperative)
B: electroencephalographic (BIS) and functional cognitive recovery (24h)
C: The incidence of explicit recall of events during the surgical and anesthetic periods. (Three years)
D: The incidence of explicit recall of events during the surgical and anesthetic periods. (30 days)

Answer: A
Please select the outcome measures that correspond to the clinical trial below.
Title: Comparative Efficacy of 4 Oral Analgesics for the Initial Management of Acute Musculoskeletal Extremity Pain
Brief Summary: The purpose of this study is to perform a randomized, double blind 4-arm clinical trial of the comparative efficacy of 4 oral analgesics in the initial management of acute musculoskeletal extremity pain presenting to the ED.


Options:
A: analgesic efficacy both at rest and with movement (72 hours)
B: Pain Intensity - Percentage of Children Who Achieved VAS < 30 mm (60 minutes post-analgesia)
C: Between Group Difference in Change in Numerical Rating Scale (NRS) Pain Scores (2 hours)
D: Decrement of the pain on VAS (Baseline and 60 minutes)

Answer: C
Please select the outcome measures that correspond to the clinical trial below.
Title: A Randomised Controlled Trial of a Pedometer Based Phased Intervention to Encourage Physical Activity in Schools: A Feasibility Study.
Brief Summary: A school based pedometer competition among Year 9 pupils (12 - 14 years old) to promote physical activity (PA).


Options:
A: Change from baseline in physical activity as assessed by Actigraph accelerometer (Baseline, 6 months and 1 year)
B: Body height and weight (Sept 2006- May 2009); Healthy Start Knowledge Quiz (Sept 2006- May 2009); 24-hour diet observation and recall (Sept 2006- May 2009); Physical activity (Sept 2006- May 2009); Television viewing (child outcomes, measured immediately after the study and at a 1-year follow-up visit) (Sept 2006- May 2009); Score on short Acculturation Scale (parent outcome, measured immediately after the study and at a 1-year follow-up visit) (Sept 2006- May 2009); Nutrition and exercise knowledge (Sept 2006- May 2009); Self-efficacy for eating and exercise behaviors (Sept 2006- May 2009); Score on Nutrition Attitudes Scale (Sept 2006- May 2009); Support and role modeling for healthy eating (teacher outcomes, measured immediately after the study and at a 1-year follow-up visit) (Sept 2006- May 2009)
C: Physical activity opportunities delivered (minutes/week); School environment scores; Height (cm); Weight (kg); Body mass index (kg/m^2); Physical fitness (Fitnessgram (C)); Children's leisure time physical activity (PAQ-C); Children's dietary intake; Physical activity interventions planned
D: Blood pressure (6 months)

Answer: A
Please select the outcome measures that correspond to the clinical trial below.
Title: Strengthening Physician Communication About HPV Vaccines
Brief Summary: The purpose of this study is to determine if a multimodal Human Papillomavirus (HPV) immunization program carried out in pediatric and family medicine practices would be more effective in improving adolescent patients' HPV immunization rates than the usual care provided to adolescents in pediatric and family medicine practices.


Options:
A: 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)
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: The percentage of adolescents who initiate the HPV vaccine series (1 year)
D: Receipt of Adolescent Immunization at End of Study Period (Tdap, Menactra, HPV) (15 months)

Answer: C
Please select the outcome measures that correspond to the clinical trial below.
Title: Xenogenous Collagen Matrix Graft Associated or Not With Enamel Matrix Derivative Proteins in the Treatment of Gingival Recession Class I and II of Miller: Randomized Controlled Clinical Study
Brief Summary: The purpose of this study is to evaluate the reduction of gingival recession of single Miller Class I and II defects treated by coronally advanced flap with subepithelial porcine collagen matrix graft and / or enamel matrix proteins.


Options:
A: Recession Reduction (6 months)
B: Percentage of Defect Coverage (6 months)
C: Percentage of root coverage (6 months)
D: percentage of root coverage (6 month)

Answer: A
Please select the outcome measures that correspond to the clinical trial below.
Title: A Phase 3, Randomized, Double-blind, Placebo-controlled Study to Evaluate the Efficacy and Safety of AMG 334 in Migraine Prevention
Brief Summary: The primary objective of the study was to evaluate the effect of erenumab compared to placebo on the change from baseline in monthly migraine days.


Options:
A: Change in Frequency of Headache Days (Baseline, Week 24)
B: Change From Baseline in the Monthly Average Number of Headache Days of At Least Moderate Severity During the 12-Week Period After the First Dose of Study Drug (Baseline (Days -28 to Day -1), Treatment (Days 1 - Week 12)); Participants With Treatment-Emergent Adverse Events (TEAEs) (Day 1 to Week 12)
C: Change From Baseline in Mean Monthly Migraine Days to the Last 3 Months of the Double-blind Treatment Period (4-week baseline phase and the last 3 months (months 4, 5, and 6) of the 24-week double-blind treatment phase)
D: Change in Frequency of Headache Episodes (Baseline, Week 24)

Answer: C
Please select the outcome measures that correspond to the clinical trial below.
Title: Mindfulness-Based Therapy for Interstitial Cystitis/Bladder Pain Syndrome
Brief Summary: Interstitial cystitis/bladder pain syndrome (IC/BPS) is a poorly understood disease with unreliable treatments. Although it is not known what causes it for certain, we do know that life stressors may make the disease worse or cause flares. Mindfulness Based Stress Reduction (MBSR) is an 8 week class focused on meditation and other techniques that the investigators think may be helpful to people with IC/BPS. This trial will assign participants to an MBSR class or usual care for their IC/BPS to see if the MBSR class would be helpful for their disease.


Options:
A: Proportion of responders moderately or markedly improved on a 7-point global response assessment (GRA) scale (12 Weeks)
B: Number of Responders Defined as Having at Least a 30% Reduction in the O'Leary-Sant Interstitial Cystitis Symptom Index (ICSI) From Baseline to Study Endpoint (Baseline to Week 24)
C: Global Response Assessment (GRA) (Within 2 weeks of 8-week class ending)
D: Symptom Interpretation Questionnaire (SIQ) (Change from baseline symptom attribution at 6-weeks); Brief Pain Inventory (BPI) (Change from baseline pain at 6-weeks)

Answer: C