TrialPanorama/Dataset huggingface dataset:
Please select the outcome measures that correspond to the clinical trial below.
Title: Improving Older Adults' Decision Making for Obstructive Sleep Apnea Treatment (Phase 3)
Brief Summary: This study evaluates the feasibility of conducting a randomized controlled trial that tests a patient decision aid for obstructive sleep apnea in older adults with newly-diagnosed obstructive sleep apnea treated in an outpatient sleep clinic. Half of the participants will use a patient decision aid, while the other half will receive general information about sleep.


Options:
A: Recruitment rates (Through study completion, an average of 1 year); Enrollment rates (Through study completion, an average of 1 year)
B: Change in Hamilton Depression Rating Scale-17 Score (Baseline, Week 24 post-intervention)
C: SCL-20 depression (baseline, 3, 6 12, 18 month follow-ups)
D: Quality of Decision Making (Immediately following each patient's index visit and before they leave the clinic on that day, typically within 10 minutes of completing the clinical encounter.); Knowledge Transfer (Immediately following each patient's index visit and before they leave the clinic on that day, typically within 10 minutes of completing the clinical encounter.)

Answer: A
Please select the outcome measures that correspond to the clinical trial below.
Title: Nasal High Frequency Oscillation Ventilation(NHFOV) vs. Nasal Continuous Positive Airway Pressure(NCPAP) as Post-extubation Respiratory Support in Preterm Infants With Respiratory Distress Syndrome:a Randomized Controlled Trial
Brief Summary: In very preterm infants with severe respiratory distress syndrome(RDS), invasive ventilation(IV) , besides nasal continuous positive airway pressure (NCPAP) and early/selective pulmonary surfactant administration, is one key cornerstone to reduce neonatal mortality. However, IV is related to increased risks of bronchopulmonary dysplasia (BPD) and abnormal developmental outcomes in the survival.Weaning from IV is therefore a key procedure to reducing these risks above, and if extubation does not success, repeated intubation and/or prolonged duration of IV will result in increased medical burden and intubation-associated complications and death. How to minimize the need for endotracheal ventilation and subsequent complications constitutes a challenge for neonatologists.


Options:
A: Difference in time (min) required to normalize the respiratory distress (modified Silverman score = 0, no need for oxygen, RF < 50 bpm and SaO2 > 92%) between the two ventilatory modes (Within the first 6 hours after birth)
B: Number of Participants Who Required Intubation (during the first 7 days after birth)
C: intubation rate (3 days); total time of hospitalization (100 days); bronchopulmonary dysplasia(BPD) (at 28 days after birth or 36 weeks'gestational age or at discharge)
D: Duration of Invasive Mechanical Ventilation (up to 8 weeks); Ventilator-free Days (up to 8 weeks); Number of Babies With Reintubation (up to 8 weeks)

Answer: C
Please select the outcome measures that correspond to the clinical trial below.
Title: Lifespan Integration After Sexual Trauma, a Randomized Treatment Study
Brief Summary: A new psychological trauma treatment method is tested on a population (n 100) of adult women who have been sexually traumatized at one specific time 0-5 years before they enter the study.


Options:
A: Posttraumatic Stress Disorder Symptom Scale- Interview Version (PSS-I) (12 weeks); Timeline Followback Heavy Episodic Drinking Episodes (12 weeks)
B: Change in Percent Drinking Days on The Time Line Follow-Back (Participants will report on drinking during the 30 days prior to initiation of the study, and every day until study completion completion of study visits, approximately six weeks.); Change in number of standard drinks per drinking day on The Time Line Follow-Back (Participants will report on drinking during the 30 days prior to initiation of the study, and ever day until completion of study visits, approximately six weeks.); Change in Posttraumatic Stress Disorder Symptoms on The Posttraumatic Stress Disorder Checklist for Diagnostic and Statistical Manual of Mental Disorders (PCL-5) (Baseline and after completion of study visits, approximately six weeks.); Change in Posttraumatic Stress Disorder Symptoms on The Clinician-Administered Posttraumatic Stress Disorder Scale for the Diagnostic and Statistical Manual of Mental Disorders (Baseline and after completion of study visits, approximately six weeks.)
C: Change of Points on Impact of event scale before and after Lifespan Integration treatment after a sexual trauma (3 weeks)
D: Change in Pittsburgh Sleep Quality Index total score (Pre-Treatment; Post-Treatment 1 (5 weeks after pre-treatment); Post-Treatment 2 (20 weeks after pre-treatment); 3-month FU; 6-month FU; 12-month FU); Change in Modified PTSD Symptom Scale - Self Report total score (Pre-Treatment; Post-Treatment 1 (5 weeks after pre-treatment); Post-Treatment 2 (20 weeks after pre-treatment); 3-month FU; 6-month FU; 12-month FU)

Answer: C
Please select the outcome measures that correspond to the clinical trial below.
Title: Blood Pressure and Oxygenation Targets in Post-resuscitation Care, a Randomized Clinical Trial
Brief Summary: This study compares two blood pressure targets and two oxygenation targets in the post-resuscitation care of comatose out-of-hospital cardiac arrets patients. Using a novel method the blood pressure-intervention is double-blinded. The oxygenation-intervention is open-label. As a subordinate study, the patients will be randomized 1:1 to active fever-control with an automated feedback temperature control-device for 36 or 72 hours following return of spontaneous circulation.


Options:
A: All-cause mortality or severe anoxic brain injury (3 months after OHCA.)
B: 1-year all-cause mortality (1 year)
C: Mortality in ICU (30 days)
D: oxygen saturation ≥90% (baseline)

Answer: A
Please select the outcome measures that correspond to the clinical trial below.
Title: A Phase 3, Randomized, Open-Label Study of Nivolumab Combined With Cabozantinib Versus Sunitinib in Participants With Previously Untreated Advanced or Metastatic Renal Cell Carcinoma
Brief Summary: The purpose of this study is to determine whether Nivolumab Combined with Cabozantinib is safe and effective compared to Sunitinib in previously untreated advanced or metastatic renal cell carcinoma


Options:
A: Progression Free Survival (PFS) (From randomization date to date of first documented tumor progression or death, whichever occurs first (Up to 31 months))
B: Time to progression (7-11 months expected)
C: Progression-free Survival (PFS) (Assessed every 2 cycles for the first 12 cycles, then every 3 cycles until treatment discontinuation, then every 8 weeks until disease progression or up to 5 years)
D: Progression-free Survival (PFS) (From randomization until the earliest date of disease progression or date of death from any cause, assessed up to approximately 39 months)

Answer: A
Please select the outcome measures that correspond to the clinical trial below.
Title: A Phase 3, Randomized, Open-Label Study of Nivolumab Combined With Cabozantinib Versus Sunitinib in Participants With Previously Untreated Advanced or Metastatic Renal Cell Carcinoma
Brief Summary: The purpose of this study is to determine whether Nivolumab Combined with Cabozantinib is safe and effective compared to Sunitinib in previously untreated advanced or metastatic renal cell carcinoma


Options:
A: Investigator-assessed Objective Response Rate(ORR) in Intermediate/Poor Risk Participants Per IRRC Using RECIST v1.1 (From first dose until date of documented disease progression or subsequent therapy, whichever occurs first (assessed up to June 2017, approximately 31 months)); Overall Survival (OS) in Intermediate/Poor-Risk Participants With Previously Untreated Metastatic Renal Cell Carcinoma (mRCC) (From the date of randomization to the date of death (assessed up to June 2017, approximately 31 months)); Progression-Free Survival (PFS) in Intermediate/Poor-Risk Participants With Previously Untreated Metastatic Renal Cell Carcinoma (mRCC) (From date of first dose to date of documented disease progression or death due to any cause, whichever occurs first (assessed up to June 2017, approximately 31 months))
B: Progression Free Survival (PFS) (From randomization date to date of first documented tumor progression or death, whichever occurs first (Up to 31 months))
C: Objective Response Rate (ORR) - Percentage of Participants With Objective Response (Baseline up to disease progression, death, or withdrawal; performed at baseline and repeated every 8 weeks for 24 weeks, then every 12 weeks.)
D: Progression Free Survival (2 3/4 years)

Answer: B
Please select the outcome measures that correspond to the clinical trial below.
Title: Mindfulness Training to Improve Mental Health, Stress and Performance In Physicians
Brief Summary: Background:

Burnout and overwhelming stress are growing issues among surgeons and are associated with mental illness, attrition and diminished patient care. Among surgical trainees, burnout and distress are alarmingly prevalent but high inherent mindfulness has been shown to decrease the risk of depression, suicidal ideation, burnout and overwhelming stress by more than 75%. In other high-stress populations formal mindfulness training has been shown to improve mental health and buffer overwhelming stress and yet this approach has not been tried in surgery.

The aim of this study is to evaluate feasibility and acceptability of modified mindfulness-based stress reduction (MBSR) training among PGY-1 surgery residents and to obtain initial evidence of efficacy in regard to well-being and performance.

Design: A pilot randomized clinical trial of modified MBSR versus an active control.

Setting: Residency training program, tertiary academic medical center.

Participants: PGY-1 surgery residents.

Intervention:

Weekly two-hour modified MBSR classes (compared to an active control) and 20 minutes of suggested daily home practice over an eight-week period.

Main Outcomes and Measures:

Primary outcome is feasibility, assessed along six domains (demand, implementation, practicality, acceptability, adaptation and integration), using focus groups, interviews, surveys, attendance, daily practice time and subjective self-report of experience.

Secondary outcomes include perceived stress, mindfulness and executive function (specifically working memory capacity), followed by psychosocial well-being (burnout, depression, resilience), performance (motor skills testing) and functional brain scans focused on areas associated with reappraisal as a surrogate for emotional control.

This study seeks to demonstrate the feasibility of mindfulness training in surgery PGY-1s while simultaneously providing preliminary quantitative data on the effects of mindfulness training in a randomized, controlled setting. Data will inform modifications to the MBSR curriculum that enhance feasibility and inform sample size calculations for subsequent, adequately-powered RCTs which will likely need to be multi-center trials.

Results could potentially impact formal medical training, the mental health of providers at every level, and the overall quality of patient care.


Options:
A: Change in Stress (baseline, 8wks (post-intervention),12-month follow-up)
B: Change from Baseline 'Maslach Burnout Inventory- General Survey (MBI-GS)' at immediate after intervention [T2] and 4 weeks follow-up [T3]. (It will be assessed at baseline [T1], immediately after intervention [T2], and four weeks post intervention [T3].)
C: Differences in Burnout as measured by the Maslach Burnout Inventory Score (MBI). (At the time of enrollment and at 1 month, 3 months, 6 months after enrollment)
D: Perceived Stress Scale (PSS) (Week-1(baseline), Week-5 (post-intervention), Week-13 (follow-up))

Answer: A
Please select the outcome measures that correspond to the clinical trial below.
Title: Mindfulness Training to Improve Mental Health, Stress and Performance In Physicians
Brief Summary: Background:

Burnout and overwhelming stress are growing issues among surgeons and are associated with mental illness, attrition and diminished patient care. Among surgical trainees, burnout and distress are alarmingly prevalent but high inherent mindfulness has been shown to decrease the risk of depression, suicidal ideation, burnout and overwhelming stress by more than 75%. In other high-stress populations formal mindfulness training has been shown to improve mental health and buffer overwhelming stress and yet this approach has not been tried in surgery.

The aim of this study is to evaluate feasibility and acceptability of modified mindfulness-based stress reduction (MBSR) training among PGY-1 surgery residents and to obtain initial evidence of efficacy in regard to well-being and performance.

Design: A pilot randomized clinical trial of modified MBSR versus an active control.

Setting: Residency training program, tertiary academic medical center.

Participants: PGY-1 surgery residents.

Intervention:

Weekly two-hour modified MBSR classes (compared to an active control) and 20 minutes of suggested daily home practice over an eight-week period.

Main Outcomes and Measures:

Primary outcome is feasibility, assessed along six domains (demand, implementation, practicality, acceptability, adaptation and integration), using focus groups, interviews, surveys, attendance, daily practice time and subjective self-report of experience.

Secondary outcomes include perceived stress, mindfulness and executive function (specifically working memory capacity), followed by psychosocial well-being (burnout, depression, resilience), performance (motor skills testing) and functional brain scans focused on areas associated with reappraisal as a surrogate for emotional control.

This study seeks to demonstrate the feasibility of mindfulness training in surgery PGY-1s while simultaneously providing preliminary quantitative data on the effects of mindfulness training in a randomized, controlled setting. Data will inform modifications to the MBSR curriculum that enhance feasibility and inform sample size calculations for subsequent, adequately-powered RCTs which will likely need to be multi-center trials.

Results could potentially impact formal medical training, the mental health of providers at every level, and the overall quality of patient care.


Options:
A: 7-day point prevalence by self report (at 6 months)
B: Point prevalence abstinence at 6 months (6 months after beginning treatment)
C: Change in Stress (baseline, 8wks (post-intervention),12-month follow-up)
D: Self-report of not having smoked for the past 7 days (At 6th month after the initial intervention)

Answer: C
Please select the outcome measures that correspond to the clinical trial below.
Title: Mindfulness Training to Improve Mental Health, Stress and Performance In Physicians
Brief Summary: Background:

Burnout and overwhelming stress are growing issues among surgeons and are associated with mental illness, attrition and diminished patient care. Among surgical trainees, burnout and distress are alarmingly prevalent but high inherent mindfulness has been shown to decrease the risk of depression, suicidal ideation, burnout and overwhelming stress by more than 75%. In other high-stress populations formal mindfulness training has been shown to improve mental health and buffer overwhelming stress and yet this approach has not been tried in surgery.

The aim of this study is to evaluate feasibility and acceptability of modified mindfulness-based stress reduction (MBSR) training among PGY-1 surgery residents and to obtain initial evidence of efficacy in regard to well-being and performance.

Design: A pilot randomized clinical trial of modified MBSR versus an active control.

Setting: Residency training program, tertiary academic medical center.

Participants: PGY-1 surgery residents.

Intervention:

Weekly two-hour modified MBSR classes (compared to an active control) and 20 minutes of suggested daily home practice over an eight-week period.

Main Outcomes and Measures:

Primary outcome is feasibility, assessed along six domains (demand, implementation, practicality, acceptability, adaptation and integration), using focus groups, interviews, surveys, attendance, daily practice time and subjective self-report of experience.

Secondary outcomes include perceived stress, mindfulness and executive function (specifically working memory capacity), followed by psychosocial well-being (burnout, depression, resilience), performance (motor skills testing) and functional brain scans focused on areas associated with reappraisal as a surrogate for emotional control.

This study seeks to demonstrate the feasibility of mindfulness training in surgery PGY-1s while simultaneously providing preliminary quantitative data on the effects of mindfulness training in a randomized, controlled setting. Data will inform modifications to the MBSR curriculum that enhance feasibility and inform sample size calculations for subsequent, adequately-powered RCTs which will likely need to be multi-center trials.

Results could potentially impact formal medical training, the mental health of providers at every level, and the overall quality of patient care.


Options:
A: Change in Stress (baseline, 8wks (post-intervention),12-month follow-up)
B: Stress Mindset Measure - General (SMM-G) (Change from Baseline SMM-G score at 6-months post CAR Training)
C: Rate of participant recruitment (1 year); Rate of retention (1 year); Completeness of data entry (1 year); Cost of interventions (1 year); Unexpected costs (1 year)
D: Perceived Stress (3 months post-intervention)

Answer: A
Please select the outcome measures that correspond to the clinical trial below.
Title: Mindfulness Training to Improve Mental Health, Stress and Performance In Physicians
Brief Summary: Background:

Burnout and overwhelming stress are growing issues among surgeons and are associated with mental illness, attrition and diminished patient care. Among surgical trainees, burnout and distress are alarmingly prevalent but high inherent mindfulness has been shown to decrease the risk of depression, suicidal ideation, burnout and overwhelming stress by more than 75%. In other high-stress populations formal mindfulness training has been shown to improve mental health and buffer overwhelming stress and yet this approach has not been tried in surgery.

The aim of this study is to evaluate feasibility and acceptability of modified mindfulness-based stress reduction (MBSR) training among PGY-1 surgery residents and to obtain initial evidence of efficacy in regard to well-being and performance.

Design: A pilot randomized clinical trial of modified MBSR versus an active control.

Setting: Residency training program, tertiary academic medical center.

Participants: PGY-1 surgery residents.

Intervention:

Weekly two-hour modified MBSR classes (compared to an active control) and 20 minutes of suggested daily home practice over an eight-week period.

Main Outcomes and Measures:

Primary outcome is feasibility, assessed along six domains (demand, implementation, practicality, acceptability, adaptation and integration), using focus groups, interviews, surveys, attendance, daily practice time and subjective self-report of experience.

Secondary outcomes include perceived stress, mindfulness and executive function (specifically working memory capacity), followed by psychosocial well-being (burnout, depression, resilience), performance (motor skills testing) and functional brain scans focused on areas associated with reappraisal as a surrogate for emotional control.

This study seeks to demonstrate the feasibility of mindfulness training in surgery PGY-1s while simultaneously providing preliminary quantitative data on the effects of mindfulness training in a randomized, controlled setting. Data will inform modifications to the MBSR curriculum that enhance feasibility and inform sample size calculations for subsequent, adequately-powered RCTs which will likely need to be multi-center trials.

Results could potentially impact formal medical training, the mental health of providers at every level, and the overall quality of patient care.


Options:
A: Perceived Stress Scale (PSS) (Week-1(baseline), Week-5 (post-intervention), Week-13 (follow-up))
B: Changes in PTSD symptoms(PCL) (Pre-treatment(baseline), after first deployment, 10 days after combat, 4 months after combat); Probable PTSD diagnosis(CAPS) (Four months after combat)
C: Change in Stress (baseline, 8wks (post-intervention),12-month follow-up)
D: NICU health professional resilience (10 days, 1 month, 6 months, 12 months)

Answer: C
Please select the outcome measures that correspond to the clinical trial below.
Title: Urinary Retention Rates After Immediate Removal of Foley Catheter Versus Backfill Void Trial Following Total Laparoscopic Hysterectomy: A Randomized Controlled Trial
Brief Summary: Acute urinary retention is a complication of hysterectomies that can result in bladder over-distension and long term bladder dysfunction. The incidence of acute urinary retention after total laparoscopic hysterectomy (TLH) has been reported to be anywhere between 4% and 34%. Studies have varied in the method of post-operative bladder challenge and the modality of hysterectomy included. Moreover, most of the published studies are retrospective chart reviews or prospective observational studies, with a lack of randomized controlled trials. Risk factors for urinary retention include type of anesthesia used, how the hysterectomy is performed, use of post-operative narcotics, pre-operative urinary retention, and possibly aggressive bladder dissection. With the increased trend towards same-day discharge following TLH, urinary retention may cause unnecessary patient distress and a worsened post-operative course. Standardization of post-hysterectomy bladder challenge and identification of risk factors for urinary retention may aid in preventing urinary retention or acute bladder dysfunction. The primary objective is to compare the rate of void trial failure after TLH with the backfill technique versus the autofill technique.


Options:
A: Number of Participants With Void Trial Failure Rate (post-operative day, about 4 hours post-surgery)
B: Post-operative urinary retention requiring re-catheterisation (14 days following urethral catheter removal)
C: Re-insertion rate of urinary catheter after removal (after removal of urinary catheter)
D: Hospital stay (4 weeks)

Answer: A
Please select the outcome measures that correspond to the clinical trial below.
Title: Renal Effects of Remote Ischemic Preconditioning in Patients After Total Arch Replacement
Brief Summary: The purpose of this study is to test the hypothesis that remote ischemic preconditioning prevents acute kidney injury and improves clinical outcomes in patients undergoing total arch replacement.


Options:
A: Peak post-operative troponin (ng/L) (At 6-12, 24, 48, 72h)
B: Serum troponin levels (3 days)
C: occurrence of a pulmonary complication (Before the 48 hours after the beginning surgery); occurrence of a kidney complication (During the 8 days after surgery); occurrence of a pulmonary complication (During the 8 days after surgery); occurrence of a pulmonary complication (During the 48 hours after initial extubation)
D: Incidence of AKI within the 7 days after the surgery (Within 7 days after the surgery)

Answer: D