TrialPanorama/Dataset huggingface dataset:
Please select the outcome measures that correspond to the clinical trial below.
Title: The Effects of a Strength and Neuromuscular Exercise Programme for the Lower Extremity on Knee Load, Pain and Function in Obese Children and Adolescents: a Randomised, Single-blinded Controlled Trial
Brief Summary: Childhood obesity is one of the most critical and accelerating health challenges throughout the world. It is a major risk factor for developing varus/valgus misalignments of the knee joint. The combination of misalignment at the knee and excess body mass may result in increased joint stress and damage to articular cartilage. A training programme, which aims at developing a more neutral alignment of the trunk and lower limbs during movement tasks may be able to reduce knee loading during locomotion. Despite the large number of guidelines for muscle strength training and neuromuscular exercises that exists, most are not specifically designed to target the obese children and adolescent demographic.

The purpose of this study is to evaluate a training programme which combines strength and neuromuscular exercises specifically designed to the needs and limitations of obese children and adolescents and analyse the effects of the training programme from a biomechanical and clinical point of view.


Options:
A: PATIENT-RATED LOW BACK PAIN (3 and 12 months)
B: Number of recurrences during the follow-up period. (2 1/2 year)
C: Pain Diary - Average Daily Pain (Baseline,12 weeks, and 26 weeks); Pain Diary - Average Daily Activity Limitations (Baseline,12 weeks, and 26 weeks); Adaptive Coping - Coping Attempts (Baseline,12 weeks, and 26 weeks)
D: Overall peak external frontal knee moment and impulse (Baseline and 12 weeks)

Answer: D
Please select the outcome measures that correspond to the clinical trial below.
Title: Long-term High-flow Nasal Cannula Therapy in Patients With Stable COPD: a Prospective, Randomized Crossover Study
Brief Summary: This is a prospective, randomized crossover study for evaluation of the efficacy and safety of long-term nocturnal high-flow nasal cannula therapy with the myAIRVO2® in stable COPD patients with stage 2-4 of the Global Initiative for Chronic Obstructive Lung Disease (GOLD) and hypercapnia who require home oxygen therapy (HOT). The total duration of subject participation will be 52 weeks, consisting of 12-week treatment period and 40-week continuation period. Subjects who satisfy all inclusion and exclusion criteria will be randomly assigned to one of two treatment arms, Arm A (week 1-6: the myAIRVO2® therapy plus HOT, week 7-12: HOT only) or Arm B (week 1-6: HOT only, week 7-12: the myAIRVO2® therapy plus HOT). All subjects will receive nocturnal high-flow nasal cannula therapy with the myAIRVO2®, in addition to their current HOT. After treatment period, the willing subjects can continue the myAIRVO2® therapy plus HOT for week 13-52 regardless of treatment arm assignment. The end of the study is defined as the treatment period or continuation period end date of the last participant, whichever is later. Subjects will primarily be assessed by the St. George's Respiratory Questionnaire for COPD Patients (SGRQ-C) at week 0, 6, 12, 24 and 52.


Options:
A: Change From Baseline in Peak Inspiratory Capacity (IC) Comparison Between QVA149 and Placebo (Baseline, day 22, baseline day 36, day 57); Change From Baseline in the Comparison of QVA149 Versus Placebo With Respect to Average Physical Activity Level (Baseline, day 22, baseline day 36, day 57)
B: Exercise Duration Time Assessed by Constant-load Cycle Ergometry at the End of Each Treatment Period (End of each 3 week treatment period (last day of Weeks 3 and 9))
C: Dyspnea (Chronic Respiratory Questionnaire (CRQ) domain) (Change from baseline to 12 months)
D: Changes from baseline in the St. George's Respiratory Questionnaire for COPD patients (SGRQ-C) total score at week 6 and 12 (Week 0, 6 and 12)

Answer: D
Please select the outcome measures that correspond to the clinical trial below.
Title: A Randomized, Double-blind, Placebo-controlled, Multicenter Parallel Group Phase 3 Study Measuring the Effect of Rosuvastatin 20 mg on Carotid Intima-Media Thickness in Chinese Subjects
Brief Summary: The purpose of this study is to evaluate the effects of of rosuvastatin 20 mg compared to placebo for treating Chinese patients with subclinical atherosclerosis.


Options:
A: N/A
B: N/A
C: Change in intima media thickness as measured by carotid ultrasound
D: Annualized Rate of Change in Mean of the Maximum (MeanMax) CIMT Measurements From Each of the 12 Carotid Artery Sites Based on All Scans Performed During the 104-Week Study Period (From baseline (pre-randomization Week -2 and Week -4) to end-of-study (Week 104).)

Answer: D
Please select the outcome measures that correspond to the clinical trial below.
Title: A Randomized, Double-blind, Placebo-controlled, Multicenter Parallel Group Phase 3 Study Measuring the Effect of Rosuvastatin 20 mg on Carotid Intima-Media Thickness in Chinese Subjects
Brief Summary: The purpose of this study is to evaluate the effects of of rosuvastatin 20 mg compared to placebo for treating Chinese patients with subclinical atherosclerosis.


Options:
A: N/A
B: absolute changes in carotid intima-media thickness from baseline to final visit (12 months)
C: Annualized Rate of Change in Mean of the Maximum (MeanMax) CIMT Measurements From Each of the 12 Carotid Artery Sites Based on All Scans Performed During the 104-Week Study Period (From baseline (pre-randomization Week -2 and Week -4) to end-of-study (Week 104).)
D: Changes in carotid wall volume as measured by MRI scan (At 40 weeks and 104 weeks)

Answer: C
Please select the outcome measures that correspond to the clinical trial below.
Title: A Randomized, Double-blind, Placebo-controlled, Multicenter Parallel Group Phase 3 Study Measuring the Effect of Rosuvastatin 20 mg on Carotid Intima-Media Thickness in Chinese Subjects
Brief Summary: The purpose of this study is to evaluate the effects of of rosuvastatin 20 mg compared to placebo for treating Chinese patients with subclinical atherosclerosis.


Options:
A: Bleeding (28 days); Thrombosis (28 days); Mortality (28 days)
B: 21 Day Organ Support (Respiratory or Vasopressor) Free Days (21 days from study enrollment)
C: N/A
D: Annualized Rate of Change in Mean of the Maximum (MeanMax) CIMT Measurements From Each of the 12 Carotid Artery Sites Based on All Scans Performed During the 104-Week Study Period (From baseline (pre-randomization Week -2 and Week -4) to end-of-study (Week 104).)

Answer: D
Please select the outcome measures that correspond to the clinical trial below.
Title: Dexmedetomidine and IV Acetaminophen for the Prevention of Postoperative Delirium Following Cardiac Surgery in Adult Patients 60 Years of Age and Older
Brief Summary: Investigators will assess the incidence and duration of postoperative delirium in patients ≥60 years old undergoing coronary artery bypass grafting (CABG), with/without valve surgery (aortic and/or mitral) based on different regimens for postoperative sedation and analgesia. Patients will receive either intravenous (IV) dexmedetomidine and IV acetaminophen or standard postoperative management using IV propofol with morphine or hydromorphone. The Confusion Assessment Method (CAM) will be used to assess delirium in these patients. Investigators also seek to compare postoperative (48 hours) analgesic requirements in patients with or without IV acetaminophen. Investigators will finally assess postoperative cognition in post-surgical patients up to one year post-discharge using a cognitive assessment scale.


Options:
A: Incidence of Delirium (Participants will be followed for the duration of the hospital stay, an average of 5 days)
B: Composite endpoint of postoperative SIRS and at least one major organ dysfunction (day-7)
C: 90-day mortality (90 day)
D: mortality (1 year)

Answer: A
Please select the outcome measures that correspond to the clinical trial below.
Title: Isotonic Solutions and Major Adverse Renal Events Trial in Non-Medical Intensive Care Units
Brief Summary: The administration of intravenous fluids is ubiquitous in the care of the critically ill. Commonly available isotonic crystalloid solutions contain a broad spectrum electrolyte compositions including a range chloride concentrations. Recent studies have associated solutions with supraphysiologic chloride content with hyperchloremia, metabolic acidosis and renal vasoconstriction, acute kidney injury and renal replacement therapy, and increased mortality but no large, randomized-controlled trials have been conducted. SMART-SURG will be a large, cluster-randomized, multiple-crossover trial enrolling critically ill patients from the non-medical ICUs at Vanderbilt University from October 2015 until April 2017. The primary endpoint will be the incidence of Major Adverse Kidney Events in 30 days after enrollment (MAKE30 is the composite of death, new renal replacement, or persistent renal dysfunction at discharge).


Options:
A: Mortality (90 days)
B: Major Adverse Kidney Event Within 30 Days (30 days after enrollment censored at hospital discharge)
C: Major Adverse Kidney Event Within 30 Days (30 days after enrollment censored at hospital discharge)
D: Type of resuscitation fluid in ICU (24-hour study day)

Answer: C
Please select the outcome measures that correspond to the clinical trial below.
Title: Enhancing Physical Activity and Weight Reduction Through Smartcare and Financial Incentives: A Pilot Randomized Controlled Trial
Brief Summary: The investigators are planning to conduct a pilot RCT of young obese population to evaluate the effect of smartcare with or without financial incentives for 12 weeks. Participants will be randomly assigned to a three-arm of control, smartcare, and smartcare plus financial incentives group.


Options:
A: Change from Baseline (Baseline, at 8 weeks, at 6 months)
B: the amount of weight loss (kg) (12 weeks)
C: Change in body weight as assessed by digital scale (6 months)
D: Change in physical activity from baseline to 8-months (three assessment periods: baseline, 4-months, and 8-months); Feasibility and acceptability of the Smartphone delivered physical activity program (4-months)

Answer: B
Please select the outcome measures that correspond to the clinical trial below.
Title: Vitamin D Status in the First 9 Months of Life
Brief Summary: In this study the investigators wanted to assess vitamin D status and possible consequences of low plasma 25-hydroxyvitamin D levels in a population of healthy mothers and their infants, in the community of Aarhus, Denmark.


Options:
A: The number of days of detectable milk vitamin D concentrations (28 days)
B: The prevalence of challenge-proven food allergy at 12 months of age (At 12 months of age); The occurrence of definite food allergy or tolerance at 6 years of age (At 6 years of age)
C: Serum 25-hydroxyvitamin D concentration (Maternal: during 3rd trimester; Neonatal (cord blood))
D: Prevalence in plasma 25OHD and parathyroid hormone at birth (at birth (baseline))

Answer: D
Please select the outcome measures that correspond to the clinical trial below.
Title: Adverse Metabolic Effects of Dietary Sugar: Ad Libitum vs Energy-balanced Diets
Brief Summary: It is not known whether consumption of excessive amounts of sugar can increase risk factors for cardiovascular disease or diabetes in the absence of increased food (caloric) intake and weight gain, nor whether the negative effects of sugar consumption are made worse when accompanied by weight gain. This study will investigate the effects of excess sugar when consumed with an energy-balanced diet that prevents weight gain, and the effects of excess sugar when consumed with a diet that can cause weight gain. The results will determine whether excess sugar consumption and excess caloric intake that lead to weight gain have independent and additive effects on risk factors for cardiovascular disease or diabetes, and will have the potential to influence dietary guidelines and public health policy.


Options:
A: Feasibility measured by recruitment and retention rates (1 year in a 9 year study)
B: Matsuda Insulin Sensitivity Index (MISI) (6 weeks)
C: Change of de novo lipogenesis: palmitate tracer-to-tracee ratios by gas chromatography-mass spectrometry. (22 hours at Baseline and 4-week Intervention)
D: Gut microbiome composition measured by 16S rRNA gene sequencing (Week 0 and week 4 of each intervention); 75g OGTT derived plasma glucose iAUC (Week 0 and week 4 of each intervention)

Answer: C
Please select the outcome measures that correspond to the clinical trial below.
Title: Dexmedetomidine Versus Propofol for Prolonged Sedation in Critically Ill Trauma and Surgical Patients
Brief Summary: The purpose of this study is to assess the efficacy of dexmedetomidine versus propofol for prolonged sedation in trauma and surgical patients.


Options:
A: delirium (during admission at the critical care)
B: time to successful extubation (This will be the length of time that the patient remains on continuous infusions of sedation and/or analgesia in the ICU. At 60 days, all study interventions will terminate, but patients will be followed for outcomes.)
C: Duration of Mechanical Ventilation (ICU stay)
D: All cause mortality (28-day)

Answer: C
Please select the outcome measures that correspond to the clinical trial below.
Title: Ultrasound Guided Radial Artery Cathetrization, A Novel Technique.
Brief Summary: Comparing an novel technique ( oblique view) during ultrasound guided radial artery catheterization versus Transverse and longitudinal views


Options:
A: Only one attempt at arterial puncture was necessary (yes/no) (Day 0 - end of procedure)
B: success rate of radial artery cathertrization (postoperate 72 hours)
C: Successful rate without extra vascular damage (Through study completion, an average of 1 year.)
D: Is only one puncture attempt necessary to attain the radial artery? yes/no (maximum two hours)

Answer: B
Please select the outcome measures that correspond to the clinical trial below.
Title: Ultrasound Guided Radial Artery Cathetrization, A Novel Technique.
Brief Summary: Comparing an novel technique ( oblique view) during ultrasound guided radial artery catheterization versus Transverse and longitudinal views


Options:
A: First Pass Success When Attempting Arterial Catheterization. (Immediate, upon study entry)
B: Time Needed to Correctly Insert the Arterial or Midline Catheter. (Immediately following intervention (within 2 hours))
C: Incidence of the composite of vascular access complications and bleeding (BARC 2, 3, or 5) (Evaluations will occur up to 30 days)
D: success rate of radial artery cathertrization (postoperate 72 hours)

Answer: D
Please select the outcome measures that correspond to the clinical trial below.
Title: Ultrasound Guided Radial Artery Cathetrization, A Novel Technique.
Brief Summary: Comparing an novel technique ( oblique view) during ultrasound guided radial artery catheterization versus Transverse and longitudinal views


Options:
A: Is only one puncture attempt necessary to attain the radial artery? yes/no (maximum two hours)
B: The proportion of patients who only needs one puncture attempt in order to successfully extract enough blood to make an arterial blood gas analysis (up to 1 hour after arterial puncture)
C: success rate of radial artery cathertrization (postoperate 72 hours)
D: Success rate of arterial or femoral catheter placement (1 day)

Answer: C
Please select the outcome measures that correspond to the clinical trial below.
Title: Synergistic Effects of Aerobic Exercise and Cognitive Training on Cognition, Physiological Markers, Daily Function and Quality of Life in Stroke Patients With Cognitive Decline
Brief Summary: The purpose of this study is to determine the treatment effects of sequential combination of aerobic exercise and cognitive training on cognitive function, physiological markers, daily function, physical function, social participation and quality of life in stroke patients with cognitive decline. The investigators hypothesized that: (1) sequential training protocol can improve outcome measures compared to single mode of training; (2) these treatment effects will retain at 6-month follow-up.


Options:
A: Stroke Self-efficacy questionnaire (Measured at baseline, 3 and 9 months post discharged from rehabilitation hospital)
B: Change in Reintegration to Normal Living Index score (Baseline, average of 14 weeks, and 6 months)
C: Change scores of Montreal Cognitive Assessment (MoCA) (Baseline, posttest (an expected average of 3 months), follow-up (up to 9 months)); Change scores of Wechsler Memory Scale - Third Edition (WMS-III) (Baseline, posttest (an expected average of 3 months), follow-up (up to 9 months)); Change scores of Wechsler Adult Intelligence Scale - Third Edition (WAIS-III) (Baseline, posttest (an expected average of 3 months), follow-up (up to 9 months)); Change scores of Useful Field of View (UFOV) (Baseline, posttest (an expected average of 3 months), follow-up (up to 9 months)); Change scores of Stroop Color-Word test (Baseline, posttest (an expected average of 3 months), follow-up (up to 9 months)); Change scores of Dual-task test (Baseline, posttest (an expected average of 3 months), follow-up (up to 9 months))
D: Change scores of Montreal Cognitive Assessment (MoCA) (Baseline, posttest (an expected average of 3 months), follow-up (up to 9 months)); Change scores of Wechsler Memory Scale - Third Edition (WMS-III) (Baseline, posttest (an expected average of 3 months), follow-up (up to 9 months)); Change scores of Wechsler Adult Intelligence Scale - Third Edition (WAIS-III) (Baseline, posttest (an expected average of 3 months), follow-up (up to 9 months)); Change scores of Useful Field of View (UFOV) (Baseline, posttest (an expected average of 3 months), follow-up (up to 9 months)); Change scores of Stroop Color-Word test (Baseline, posttest (an expected average of 3 months), follow-up (up to 9 months)); Change scores of Dual-task test (Baseline, posttest (an expected average of 3 months), follow-up (up to 9 months))

Answer: C
Please select the outcome measures that correspond to the clinical trial below.
Title: Synergistic Effects of Aerobic Exercise and Cognitive Training on Cognition, Physiological Markers, Daily Function and Quality of Life in Stroke Patients With Cognitive Decline
Brief Summary: The purpose of this study is to determine the treatment effects of sequential combination of aerobic exercise and cognitive training on cognitive function, physiological markers, daily function, physical function, social participation and quality of life in stroke patients with cognitive decline. The investigators hypothesized that: (1) sequential training protocol can improve outcome measures compared to single mode of training; (2) these treatment effects will retain at 6-month follow-up.


Options:
A: Change scores of Montreal Cognitive Assessment (MoCA) (Baseline, posttest (an expected average of 3 months), follow-up (up to 9 months)); Change scores of Wechsler Memory Scale - Third Edition (WMS-III) (Baseline, posttest (an expected average of 3 months), follow-up (up to 9 months)); Change scores of Wechsler Adult Intelligence Scale - Third Edition (WAIS-III) (Baseline, posttest (an expected average of 3 months), follow-up (up to 9 months)); Change scores of Useful Field of View (UFOV) (Baseline, posttest (an expected average of 3 months), follow-up (up to 9 months)); Change scores of Stroop Color-Word test (Baseline, posttest (an expected average of 3 months), follow-up (up to 9 months)); Change scores of Dual-task test (Baseline, posttest (an expected average of 3 months), follow-up (up to 9 months))
B: Evolution of the motor control deficiency assessed by the Fugl Meyer (FM) scale modified by LINDMARK (between day 0 and month 3)
C: Change from baseline in Physical activity levels - multisensor monitor (At baseline, 12 weeks post-intervention, and at 4-week follow-up); Change from baseline in Physical activity levels - Human Activity Profile (At baseline, 12 weeks post-intervention, and at 4-week follow-up); Change from baseline in sedentary behavior - multisensor monitor (At baseline, 12 weeks post-intervention, and at 4-week follow-up)
D: Adherence (8 weeks)

Answer: A
Please select the outcome measures that correspond to the clinical trial below.
Title: iPhone App Compared to Standard RR-measurement - iPARR Trial
Brief Summary: In this Trial we compare a new application (App) running on an iPhone (Apple inc., Model 4S) to determine systolic blood pressure (RR) and compare it to conventional oscillometric measurements using an Omron HBP-1300-E Pro device. We will include 1000 participants and perform seven repetitive blood pressure measurements (3 iPhone, 4 Omron) in each person. Primary parameter will be the absolute difference (Delta) between the correlating blood pressure measurements in mmHg.


Options:
A: Systolic/diastolic blood pressure (mmHg) (Three years)
B: Mean systematic blood pressure level (October 2010 - December 2012); 24 hour urinary sodium (October -December 2012)
C: Absolute difference between systolic blood pressure values determined with an oscillometric cuff device and an iPhone 4s (Delta mmHg) (1 day)
D: Change in Baseline Mean Systolic Blood Pressure (mmHg) at 6 months ((Baseline compared to 6 months after start of intervention))

Answer: C
Please select the outcome measures that correspond to the clinical trial below.
Title: The Effect of Integrating Child and Adolescent Mental Health Into Primary Health Care and Traditional Healers' Practice: a Randomized Controlled Trial in Eastern Uganda
Brief Summary: This randomized controlled trial will compare the effect of a CAMH integration package on yield of CAMH cases compared to non-CAMH integrated sites. It will be conducted among nurses, midwives and clinical officers who provide PHC services to children and adolescents in 42 health centers; and eligible traditional healers.


Options:
A: Severity of mental health symptoms (previous 4 weeks)
B: Proportion of clinics which recorded at least one non-epilepsy CAMH diagnosis in the intervention compared to the control group. (3 months)
C: Recovery from Common Mental Disorder (defined by ICD10) (6 months)
D: Change in stigmatizing attitudes, as measured by the Social Distance questionnaire (Baseline, post-training (immediately after 10-day training curriculum), +4 months, + 16 months)

Answer: B
Please select the outcome measures that correspond to the clinical trial below.
Title: Nicotinic Cholinergic Modulation as a Novel Treatment Strategy for Aggression Associated With Autism
Brief Summary: Some individuals with autism spectrum disorders (ASD) also demonstrate irritability or aggression, which can interfere with functioning. The purpose of this pilot study is to test whether transdermal nicotine is effective for irritability and/or aggression in adults with ASD using a double-blind, placebo-controlled clinical trial. Subjects will participate in three visits. At the first visit, subjects are screened for eligibility and enrolled. Baseline measures include rating scales and a frustrative computerized task. They will then wear seven days of transdermal nicotine or placebo. Visit two is on day seven and the study measures are repeated, vital signs and side effects monitored. Subjects will return for a third and final visit on day 21 to repeat the study measures performed during visit two.


Options:
A: Change From Baseline in Aberrant Behavior Checklist Irritability Subscale (ABC-I) (Baseline and 7 days.)
B: Change From Baseline in Social Communication Deficits as Measured by Social Responsiveness Scale 2 (SRS-2) (Baseline, Week 12); Percentage of Participants with Suicidality, as Measured by the Columbia-Suicide Severity Rating Scale (C-SSRS) (Baseline up to Week 12); Percentage of Participants With Adverse Events (From Baseline up to Week 18)
C: Mean Change (Week 8 - Baseline) in the Autistic Behavior Checklist (ABC) Irritability Subscale Score (Week 8)
D: Change From Baseline in Vineland™-II Adaptive Behavior Scale Two Domain Composite (2DC) Score at Week 24 for Balovaptan (R05285119) 10 mg Equivalent Compared to Placebo (Baseline, Week 24)

Answer: A