TrialPanorama/Dataset huggingface dataset:
Please select the outcome measures that correspond to the clinical trial below.
Title: Postoperative Atelectasis in Pediatric Patients With Prone Position : Effect of Repetitive Alveolar Recruitment by Lung Ultrasound
Brief Summary: This study evaluates the incidence of postoperative atelectasis after general anesthesia with prone position using lung ultrasound in children age \< 3 years.


Options:
A: 28-day mortality from all causes (28 days)
B: Incidence of pre-extubation atelectasis (postoperative 10 minutes)
C: Work of breathing (60 min)
D: Area under ROC curve of the variation in continuous cardiac output during Trendelenburg position, to detect preload dependence (1 minute after Trendelenburg position onset.)

Answer: B
Please select the outcome measures that correspond to the clinical trial below.
Title: A Focused Suicide Prevention Strategy for Youth Presenting to the Emergency Department With Suicide Related Behaviour: A Randomized Controlled Trial
Brief Summary: This study evaluates whether a Family-centered suicide prevention strategy, when added to usual care (F-SPS + UC), is more effective than enhanced usual care (EUC) in reducing suicide-related behaviors in 128 youth at high-risk of suicide. Half of the participants will be randomized to receive F-SPS + UC and half will receive EUC.


Options:
A: Change in suicidal ideation severity as measured by the Suicidal Ideation Questionnaire - Jr (Screening, 6 weeks, 24 weeks)
B: The Zanarini Rating Scale for Borderline Personality Disorder (Weeks 0, 2, 4, 6, 8, 10, 12); Borderline Evaluation of Severity over Time (BEST) (Weeks 0,2,4,6,8,10,12)
C: Non-suicidal self-harm (6 months); Suicidal ideation (6 months); suicide attempts (6 months)
D: Self-stigma related to suicide attempt (2 weeks)

Answer: A
Please select the outcome measures that correspond to the clinical trial below.
Title: A Focused Suicide Prevention Strategy for Youth Presenting to the Emergency Department With Suicide Related Behaviour: A Randomized Controlled Trial
Brief Summary: This study evaluates whether a Family-centered suicide prevention strategy, when added to usual care (F-SPS + UC), is more effective than enhanced usual care (EUC) in reducing suicide-related behaviors in 128 youth at high-risk of suicide. Half of the participants will be randomized to receive F-SPS + UC and half will receive EUC.


Options:
A: Patient Satisfaction Questionnaire ((baseline) Assessment taking place immediately after completion of intervention)
B: Occurrence of suicidal event assessed by Columbia-Suicide Severity Rating Scale (C-SSRS) (6 months)
C: Number of suicidal behaviours (12 months)
D: Change in suicidal ideation severity as measured by the Suicidal Ideation Questionnaire - Jr (Screening, 6 weeks, 24 weeks)

Answer: D
Please select the outcome measures that correspond to the clinical trial below.
Title: A Focused Suicide Prevention Strategy for Youth Presenting to the Emergency Department With Suicide Related Behaviour: A Randomized Controlled Trial
Brief Summary: This study evaluates whether a Family-centered suicide prevention strategy, when added to usual care (F-SPS + UC), is more effective than enhanced usual care (EUC) in reducing suicide-related behaviors in 128 youth at high-risk of suicide. Half of the participants will be randomized to receive F-SPS + UC and half will receive EUC.


Options:
A: Suicide repetition (or death by suicide) (12 months)
B: Change in suicidal ideation severity as measured by the Suicidal Ideation Questionnaire - Jr (Screening, 6 weeks, 24 weeks)
C: Beck scale for suicidal ideation (six months)
D: PTSD Symptom Scale - Interview (Pre-treatment, 4-, 8-, 12-, and 15-months); Suicide Attempt Self-Injury Interview (Pre-treatment, 4-, 8-, 12-, and 15-months)

Answer: B
Please select the outcome measures that correspond to the clinical trial below.
Title: The BEACON Study: Protocol for Cluster RCT of a Service to Deliver Smartphone-Assisted Problem-Solving Therapy Compared to Usual Care in Men Who Present With Intentional Self-Harm to the ED in Ontario (Protocol A)
Brief Summary: This study evaluates the effectiveness of a smartphone-assisted problem-solving therapy (PST) service across Emergency Departments in Ontario. A total of 25 Emergency Departments have been randomized to either usual care or the smartphone-assisted PST service intervention. The main cluster randomized controlled trial will use data collected from the Institute of Clinical Evaluative Sciences (ICES) to assess the impact of this service on suicides and re-presentations to hospital for self-harm as well as other health service use one-year post study launch.


Options:
A: Changes in Stages of Change Questionnaire, which measures motivation (3 months); Changes in Reasons for Living Inventory (3 months); Changes in State Hope Scale (3 months); Changes in Interpersonal Needs Questionnaire, which measures constructs of thwarted belongingness and perceived burdensomeness. (3 months); Changes in Beck Scale for Suicide Ideation (3 months); Suicide Attempt Self-Injury Count (3 months)
B: Change From Baseline in ZANarini Rating Scale for Borderline Personality Disorder (ZAN-BPD) Total Score at Week 10 (The change from baseline at Week 10 in the total ZAN-BPD score was calculated using the MMRM model which is a longitudinal analyses and it incorporates ZAN-BPD measurements from baseline, Weeks 1, 2, 4, 6, 8 and Week 10.)
C: Reduction of dissociative symptoms (End of 3rd week treatment of naltrexon)
D: Change in Number of Deaths by Suicide and/or Re-Presentations to Any Emergency Department (ED) in Ontario for Self-Harm - Data from the Institute for Clinical Evaluative Sciences (ICES) (Baseline; 12 Months.)

Answer: D
Please select the outcome measures that correspond to the clinical trial below.
Title: The BEACON Study: Protocol for Cluster RCT of a Service to Deliver Smartphone-Assisted Problem-Solving Therapy Compared to Usual Care in Men Who Present With Intentional Self-Harm to the ED in Ontario (Protocol A)
Brief Summary: This study evaluates the effectiveness of a smartphone-assisted problem-solving therapy (PST) service across Emergency Departments in Ontario. A total of 25 Emergency Departments have been randomized to either usual care or the smartphone-assisted PST service intervention. The main cluster randomized controlled trial will use data collected from the Institute of Clinical Evaluative Sciences (ICES) to assess the impact of this service on suicides and re-presentations to hospital for self-harm as well as other health service use one-year post study launch.


Options:
A: Change in self-injury attentional bias as measured by a Dot Probe Paradigm (The Dot Probe Paradigm will be administered immediately preceding the mindfulness or control conditions and immediately following the mindfulness or control conditions)
B: Time to Suicide Attempt (Up to 18 months)
C: Number of days with hospital admission (Change between the period from 12 month retrospectively to Baseline and the period from baseline to 12 months prospectively)
D: Change in Number of Deaths by Suicide and/or Re-Presentations to Any Emergency Department (ED) in Ontario for Self-Harm - Data from the Institute for Clinical Evaluative Sciences (ICES) (Baseline; 12 Months.)

Answer: D
Please select the outcome measures that correspond to the clinical trial below.
Title: The BEACON Study: Protocol for Cluster RCT of a Service to Deliver Smartphone-Assisted Problem-Solving Therapy Compared to Usual Care in Men Who Present With Intentional Self-Harm to the ED in Ontario (Protocol A)
Brief Summary: This study evaluates the effectiveness of a smartphone-assisted problem-solving therapy (PST) service across Emergency Departments in Ontario. A total of 25 Emergency Departments have been randomized to either usual care or the smartphone-assisted PST service intervention. The main cluster randomized controlled trial will use data collected from the Institute of Clinical Evaluative Sciences (ICES) to assess the impact of this service on suicides and re-presentations to hospital for self-harm as well as other health service use one-year post study launch.


Options:
A: Rate of suicide attempts (Annual)
B: Frequency of non-suicidal self-injurious thoughts and behaviors (Daily (up to 126 days))
C: Suicide ideation (12 month)
D: Change in Number of Deaths by Suicide and/or Re-Presentations to Any Emergency Department (ED) in Ontario for Self-Harm - Data from the Institute for Clinical Evaluative Sciences (ICES) (Baseline; 12 Months.)

Answer: D
Please select the outcome measures that correspond to the clinical trial below.
Title: Innovative Pulmonary Rehabilitation Telehealth Program for Improving COPD Patient Outcomes
Brief Summary: Researchers want to learn more about telehealth pulmonary rehabilitation programs that help people with Chronic obstructive pulmonary disease (COPD) improve physical activity and quality of life.


Options:
A: Improvement tolerance capacity (4 months and 6 months)
B: Measure of physical activity (Change from Baseline to Week 12)
C: COPD Assessment Test, CAT, to assess symtoms of COPD (Assess change from baseline to 10 weeks, 6 month and 12 month follow-up)
D: Patient's perception of the variability of symptoms due to severe stable state COPD throughout the day, the week and the year (Once)

Answer: B
Please select the outcome measures that correspond to the clinical trial below.
Title: Innovative Pulmonary Rehabilitation Telehealth Program for Improving COPD Patient Outcomes
Brief Summary: Researchers want to learn more about telehealth pulmonary rehabilitation programs that help people with Chronic obstructive pulmonary disease (COPD) improve physical activity and quality of life.


Options:
A: Measure of physical activity (Change from Baseline to Week 12)
B: Change in level of objectively measured physical activity (7 Days at baseline, 7 days at 3- and 12- months after baseline)
C: Hospital Readmission (12 months)
D: Self-Reported Respiratory-Specific Quality of Life (four months from randomization); Self-Reported Respiratory-Specific Quality of Life (twelve months from randomization)

Answer: A
Please select the outcome measures that correspond to the clinical trial below.
Title: The Outcome of Respiratory Muscle Training in Stroke Patients: A Prospective Study
Brief Summary: Stroke survivors commonly have respiratory muscle weakness, swallowing disturbance, general weakness, reduced the daily living activities and short of motivation for rehabilitation. Respiratory muscle training (RMT) has been reported to improve the pulmonary function, respiratory muscle strength, exercise capacity, sensation of dyspnea and quality of life in several diseases, but rare in stroke patients. Reviewing previous reports, the protocol, intensity and duration of respiratory muscle training is still variable.

Purpose: To investigate the feasibility and efficacy of respiratory muscle training on cardio-pulmonary function, swallowing function, cough function and reduction of incidence of pneumonia in post-stroke patients.

Methods: A prospective, single blinded, randomized study. Consecutive patients with diagnosis of stroke will be proved by magnetic resonance image or computerized tomography. Stroke patients, aged 35-80 years old, with inspiratory muscle weakness or swallowing disturbance will be enrolled and randomly divided into control group (usual rehabilitation alone) and experimental group \[inspiratory muscle training (IMT) group for patients with inspiratory muscle weakness and expiratory muscle strengthening training (EMT) for patients with swallowing disturbance\]. Each patients will receive usual rehabilitation.

The investigator expect that RMT will be practical for the restoration of respiratory muscle, swallowing function, cough function and voice quality, thereby reduction of the incidence of pneumonia.


Options:
A: Recruitment (Through study completion, an average of 1.5 months.); Retention (Through study completion, an average of 1.5 months.); Participation (Through study completion, an average of 1.5 months.); Adherence (Through study completion, an average of 1.5 months.); Acceptability and enjoyment (Through study completion, an average of 1.5 months.); Safety and Adverse events (Through study completion, an average of 1.5 months.); Device development or modifications (Through study completion, an average of 1.5 months.); Fatigue (Through study completion, an average of 1.5 months.); Patient Global Impression of Change (Through study completion, an average of 1.5 months.)
B: Change in Anterior Trunk Displacement (Baseline, 1 hour (after completing 1st feedback condition) and 2 hours (after completing 2nd feedback condition))
C: MIP (maximal inspiratory pressure) (At the beginning and the end of program respectively, up to 6 weeks.); MEP (maximal expiratory pressure) (At the beginning and the end of program respectively, up to 6 weeks.)
D: Change in the Function In Sitting Test (FIST) from baseline to after 10-12 treatment sessions (baseline, immediately after 10-12 treatments); Change in the Function In Sitting Test (FIST) from baseline to 1 month after second assessment (baseline,1 month after second assessment)

Answer: C
Please select the outcome measures that correspond to the clinical trial below.
Title: Mechanical Bowel Preparation and Oral Antibiotics Before Rectal Cancer Surgery: a Multi Center Double-Blinded Randomized Controlled Trial (PREPACOL2 Study)
Brief Summary: This study aims to demonstrate that a preoperative combination of mechanical bowel preparation and oral antibiotics, before elective laparoscopic rectal cancer surgery, is associated with a reduction of postoperative surgical site infection rate, as compared to mechanical bowel preparation alone Our hypothesis is that a preoperative colonic preparation including a combination of mechanical bowel preparation and oral antibiotics before elective laparoscopic rectal cancer surgery is associated with a reduced rate of 30-day postoperative surgical site infection, as compared to mechanical bowel preparation alone


Options:
A: The primary endpoint of the study was anastomotic failure.
B: Surgical Site Infections (30 days (exact 30 days after the Operation date))
C: Surgical site infection incidence (30 days after surgery)
D: Postoperative 30-day surgical site infection (SSI). (30 days)

Answer: D
Please select the outcome measures that correspond to the clinical trial below.
Title: Restrictive vs. Liberal Oxygen Therapy for Trauma Patients. PILOT: The TRAUMOX Trial
Brief Summary: The objective of this trial is to investigate whether treatment with oxygen in the early phases after a trauma plays a role in recovery.


Options:
A: Neuron-specific enolase (NSE) serum concentration (48 hour after cardiac arrest)
B: Surgical wound infection (14 days after surgery)
C: Composite Primary Outcomes (30 days)
D: Ventilator-free Days (VFDs) to Study Day 28 (28 days)

Answer: C
Please select the outcome measures that correspond to the clinical trial below.
Title: Drinkers' Intervention to Prevent Tuberculosis (DIPT Study)
Brief Summary: There is an urgent global need to decrease the high mortality of tuberculosis (TB) in persons with HIV as TB is the leading cause of death among persons with HIV worldwide. The DIPT (Drinkers' Intervention to Prevent TB) study is a randomized, 2x2 factorial trial among HIV/TB co-infected adults in Uganda with heavy alcohol use (n=680 persons, 340 each U01). The goal of the study is to determine whether economic incentive interventions can promote both reduced alcohol use and isoniazid (INH) pill taking among HIV/TB co-infected adult heavy drinkers, during isoniazid preventive therapy (IPT: a six-month course of INH) at HIV clinics in southwestern Uganda. Participants will be randomized to one of four arms: Arm 1: no incentives (control); Arm 2: economic incentives for decreasing alcohol use only; Arm 3: economic incentives for IPT adherence only; Arm 4: economic incentives for decreasing alcohol use and for IPT adherence (rewarded independently).


Options:
A: Number of Participants With and Without Non-hazardous Drinking, as Determined by Self-report and the Biomarker Phosphatidylethanol, at 3- and 6-months. (Both 3 months and 6 months (composite measure)); Number of Participants With >90% Isoniazid (INH) Adherence During Prescribed Course of INH (6 months)
B: Alcohol use and STI/HIV infection (up to 12 months)
C: Percentage of Women Who Test Ethyl Glucuronide (EtG) Negative (3-, 6-, and 9-month post-baseline)
D: Baby's health status (6 days after birth; 6 months after birth; 12 months after birth)

Answer: A
Please select the outcome measures that correspond to the clinical trial below.
Title: An International Phase 3, Randomized, Double-Blind, Placebo- and Active (Tolterodine)-Controlled Multicenter Study to Evaluate the Safety and Efficacy of Vibegron in Patients With Symptoms of Overactive Bladder
Brief Summary: This study is designed to evaluate the safety, tolerability, and efficacy of vibegron administered once daily in patients with OAB.


Options:
A: improvement of symptom domain means decreased frequency to less than 8 micturitions per 24 hours, no urgency noted per 24 hrs and less that 3 wakening at bedtime for micturation. (12 weeks)
B: Number of Micturations Per 24 Hour Period (12 weeks)
C: Change From Baseline (CFB) at Week 12 in the Average Number of Micturitions Per 24 Hours in All Overactive Bladder (OAB) Participants (Baseline (BL); Week 12); CFB at Week 12 in the Average Number of Urge Urinary Incontinence (UUI) Episodes Per 24 Hours in OAB Wet Participants (Baseline; Week 12)
D: The main outcome will be the change in bladder wall thickness, as measured by intra-vaginal ultrasound from baseline to week 12.

Answer: C
Please select the outcome measures that correspond to the clinical trial below.
Title: Evaluating an eHealth Breastfeeding Resource for Mothers, Fathers, Partners and Co-parents
Brief Summary: This trial will evaluate an eHealth breastfeeding co-parenting resource designed for mothers and their co-parents. Couples will be randomized to study groups and the intervention group will receive information about this resource or the control group will receive usual care. The primary outcomes will be exclusive breastfeeding at 4 and 24 weeks postpartum.


Options:
A: Infant Feeding Questionnaire (4 weeks)
B: Exclusive breastfeeding (EBF) among children 0-6 months of age (4 years after baseline); Child anthropometry (height, weight) among children 24-48 months of age (4 years after baseline); Complementary feeding among children 6-23.9 months of age (4 years after baseline); Anemia among children 6-23.9 months (4 years after baseline)
C: Proportion of women who exclusively breastfeed to 6 months (The outcome will be measured when the infant is 6-7 months old.)
D: proportion of patients with breastfeeding completed at 6 months (6 months)

Answer: A
Please select the outcome measures that correspond to the clinical trial below.
Title: Physical Activity Across the Curriculum (PAAC 3):Teacher vs. Remotely Delivered Classroom Physical Activity Breaks
Brief Summary: The study is designed to compare two methods of delivering short (\~10 min) physical activity breaks that will occur during the regular school day for 3 years. Schools will be randomized to deliver physical activity breaks led by either the regular classroom teacher or by a remote instructor through a video in the classroom. Both delivery methods will promote a variety of whole body movements using large muscle groups. The schools will not be able to choose which group (regular teacher or remote instructor) they will be part of.


Options:
A: pedometer-derived step count (baseline and every 3 months)
B: Change in minutes spent in moderate to vigorous physical activity in after school programs from baseline to end of intervention (7 months) and 1 year after end of intervention. (Baseline, end of intervention (7 months), 1 year after intervention)
C: Method of student transportation to school (Immediately pre- and post-intervention)
D: Moderate-to-vigorous physical activity (MVPA) time during activity breaks (Year 3)

Answer: D
Please select the outcome measures that correspond to the clinical trial below.
Title: Randomized Placebo-controlled Treatment of Impulsivity in Adults With Probiotics
Brief Summary: A multicentre randomized double-blind placebo controlled parallel design (10 weeks) study investigating probiotic supplementation in highly impulsive adults (18-65 yrs; N=180). The probiotic studied is Synbiotic2000Forte that contain three well-studied anti-inflammatory lactic acid bacteria (LABs) and four fermentable fibers: Pediococcus pentosaceus 5-33:3, Lactobacillus paracasei subsp paracasei 19, and Lactobacillus plantarum 2362 in combination with the following four fermentable fibres: betaglucan, inulin, pectin and resistant starch. With this study we aim to detect, whether treatment with probiotics is effective in adults with high levels of impulsivity, compulsivity, and aggression.


Options:
A: Change in the self-rating of affective reactivity (ARI-S) (Assessed at Baseline, at week 5, week 10 and week 11.); Clinical Global Impression - Improvement (CGI-I) total score of 1 or 2 (much improved, very much improved). (assessed at weeks 5, 10, and 11.)
B: Repeated fatal or non fatal suicidal act (one year)
C: Reduced Self-harm (3 months)
D: Repetition of self-harm (Three months); Change scores on the Suicide Behaviors Questionnaire from baseline (Baseline and three months)

Answer: A
Please select the outcome measures that correspond to the clinical trial below.
Title: Randomized Placebo-controlled Treatment of Impulsivity in Adults With Probiotics
Brief Summary: A multicentre randomized double-blind placebo controlled parallel design (10 weeks) study investigating probiotic supplementation in highly impulsive adults (18-65 yrs; N=180). The probiotic studied is Synbiotic2000Forte that contain three well-studied anti-inflammatory lactic acid bacteria (LABs) and four fermentable fibers: Pediococcus pentosaceus 5-33:3, Lactobacillus paracasei subsp paracasei 19, and Lactobacillus plantarum 2362 in combination with the following four fermentable fibres: betaglucan, inulin, pectin and resistant starch. With this study we aim to detect, whether treatment with probiotics is effective in adults with high levels of impulsivity, compulsivity, and aggression.


Options:
A: Change in the self-rating of affective reactivity (ARI-S) (Assessed at Baseline, at week 5, week 10 and week 11.); Clinical Global Impression - Improvement (CGI-I) total score of 1 or 2 (much improved, very much improved). (assessed at weeks 5, 10, and 11.)
B: Suicidal behavior and ideation (Weeks 4, 12, and 24)
C: Parasuicidal behaviour (intermittent)
D: Affective symptoms measured with the Hamilton Depression Scale (Ham-D) and the Young Mania Rating Scale (YMRS). (weeks: 0, 2, 4, 6, 8, 10, 12); Impulsivity and aggressivity measured with the Time Paradigsm and the the Point Subtraction Aggression Paradigm. (0, 6, 12)

Answer: A
Please select the outcome measures that correspond to the clinical trial below.
Title: Recombinant Factor VIIa (rFVIIa) for Acute Hemorrhagic Stroke Administered At Earliest Time (FASTEST) Trial
Brief Summary: The objective of the rFVIIa for Acute Hemorrhagic Stroke Administered at Earliest Time (FASTEST) Trial is to establish the first treatment for acute spontaneous intracerebral hemorrhage (ICH) within a time window and subgroup of patients that is most likely to benefit. The central hypothesis is that rFVIIa, administered within 120 minutes from stroke onset with an identified subgroup of patients most likely to benefit, will improve outcomes at 180 days as measured by the Modified Rankin Score (mRS) and decrease ongoing bleeding as compared to standard therapy.


Options:
A: INR ≤ 1.2 within 3 hours after start of drug infusion (3 hours)
B: Modified Rankin Scale (mRS) (180 days)
C: ICH growth by 24±3 hours as defined by either 33% or 6 ml increase from baseline, adjusted for baseline ICH volume. (24+/-3 hours)
D: Hematoma expansion (up to 27 hours)

Answer: B