TrialPanorama/Dataset huggingface dataset:
Please select the outcome measures that correspond to the clinical trial below.
Title: Group Learning Achieves Decreased Incidents of Lower Urinary Symptoms
Brief Summary: This three-site randomized controlled trial compares the effectiveness and cost-effectiveness of a group-administered behavioral treatment program to no treatment. Women with stress, urgency, or mixed urinary incontinence will be recruited and screened centrally, evaluated clinically at each of three study sites, and random assigned to one of two treatment arms: 1. Group behavioral treatment or 2. No treatment. Group treatment modalities have the potential to reach a larger population of older women with urinary incontinence, not only in the traditional medical settings, but also in community settings. The investigators hypothesize that group behavioral treatment will be more effective than no treatment. The investigators hypothesize that the group treatment will be cost-effective compared to no treatment.


Options:
A: Group Behavioral Treatment Effectiveness as Shown by Changes From Baseline to 3 Months in Urinary Incontinence Severity. (Baseline and 3 months)
B: UI incidence/severity (12 months - 3 years post-index birth)
C: To assess the well being of the women trought the proportion of women with back pain and stress urinary incontinence (The outcome will be that the pregnant women will be interview at an average of up to 30 days after delivery)
D: Change from baseline in mean frequency of micturitions per 24 hours (4, 8 weeks in treatment, 12th and 24th weeks of follow-up)

Answer: A
Please select the outcome measures that correspond to the clinical trial below.
Title: The Fluid Translation of Research Into Practice Study (Fluid-TRIPS): An International Cross-Sectional Survey of Fluid Resuscitation Practice
Brief Summary: Translating reliable evidence on fluid resuscitation of intensive care patients into clinical practice - Improving patient outcomes and containing public health costs


Options:
A: Change From Baseline of Venous Serum Bicarbonate at 4 Hours From Start of Intravenous (IV) (Day 1 (4 Hours after start of IV))
B: Mortality (90 days)
C: Type of resuscitation fluid in ICU (24-hour study day)
D: Quality of Recovery-40 Score at 24 Hours (24 hours after ED visit)

Answer: C
Please select the outcome measures that correspond to the clinical trial below.
Title: THrombolysis for Acute Wake-up and Unclear-onset Strokes With Alteplase at 0.6 mg/kg Trial (THAWS)
Brief Summary: The purpose of this study is to clarify efficacy and safety of MRI-based intravenous thrombolysis with alteplase for patients with acute wake-up ischemic stroke and those having acute ischemic stroke with unknown time of symptom onset.


Options:
A: Efficacy (90 day after stroke); Safety (90 day after stroke)
B: Utility-weighted 90-day Modified Rankin Score (90 days post randomization)
C: Weighted Modified Rankin Scale (mRS) Score, Lead Co-Primary Efficacy Outcome (90 days); Functional Independence (mRS 0-2), Nested Co-Primary Efficacy Outcome (90 days); Stroke-related Mortality, Primary Safety Outcome (90 days)
D: Modified Rankin Scale 0-1 (90 days after stroke onset)

Answer: D
Please select the outcome measures that correspond to the clinical trial below.
Title: Trial of a Positive Psychology Intervention to Reduce Suicide Risk in Patients With Major Depression
Brief Summary: In this study, the investigators will perform an exploratory randomized trial of Positive Psychology (PP). The trial will consist of 50 participants and will compare the impact of a phone-based PP intervention vs. an attentional control condition, in Major Depressive Disorder (MDD) patients who are hospitalized for SI or following a suicide attempt. This is a 12 week trial with 6 weeks of intervention and two blinded follow-up assessments at 6 and 12 weeks.

Specific Aim #1: To assess the feasibility and acceptability of the phone-based PP intervention in this high-risk population.

Hypotheses: The intervention will be feasible (with most patients completing at least 4/6 PP and with follow-up data from at least 80% of subjects). The ratings of ease and subjective helpfulness of the exercise and other mental states as measured before and after each PP exercise will be more than 6 out of 10 and higher than the same ratings obtained from subjects in the control condition.

Specific Aim #2: To examine the impact of the six-session PP intervention on positive psychological well-being.

Hypothesis: Compared to control subjects, subjects randomized to PP will have greater scores on scales of optimism (measured via the Life Orientation Test-Revised \[LOT-R\]), gratitude (Gratitude Questionnaire-6 \[GQ-6\]), and positive affect (Positive Affect Negative Affect Schedule \[PANAS\]) at 6 and 12 weeks.

Specific Aim #3 (primary aim): To assess the impact of the PP intervention on key suicide risk factors.

Hypothesis: PP subjects will have greater scores on scales of hopelessness (Beck Hopelessness Scale \[BHS\]; primary study outcome measure), suicidal ideation (SI) (Concise Health Risk Tracking scale \[CHRT\]), and depression (Quick Inventory of Depressive Symptomatology-Self Report \[QIDS-SR\]) at 6 and 12 weeks.

We will also measure impact on readmission and suicide attempts to assess these key outcomes.


Options:
A: Changes in score of Affective Lability Scale (Baseline and then weekly for 12 weeks); Changes in the score of the Affective Lability Item of the Zanarini Rating Scale for Borderline Personality Disorder (Baseline and then weekly for 12 weeks)
B: Estimated Percentage of Participants Making Suicide Attempt During 24-month Follow-up (24 months)
C: Suicide attempts (measured by the Columbia Suicide Severity Rating Scale) (6-months); Suicidal ideation (measured by the Beck Suicide Scale (BSS)) (6-months)
D: Change in BHS Scores (Baseline, 6 weeks, and 12 weeks)

Answer: D
Please select the outcome measures that correspond to the clinical trial below.
Title: Trial of a Positive Psychology Intervention to Reduce Suicide Risk in Patients With Major Depression
Brief Summary: In this study, the investigators will perform an exploratory randomized trial of Positive Psychology (PP). The trial will consist of 50 participants and will compare the impact of a phone-based PP intervention vs. an attentional control condition, in Major Depressive Disorder (MDD) patients who are hospitalized for SI or following a suicide attempt. This is a 12 week trial with 6 weeks of intervention and two blinded follow-up assessments at 6 and 12 weeks.

Specific Aim #1: To assess the feasibility and acceptability of the phone-based PP intervention in this high-risk population.

Hypotheses: The intervention will be feasible (with most patients completing at least 4/6 PP and with follow-up data from at least 80% of subjects). The ratings of ease and subjective helpfulness of the exercise and other mental states as measured before and after each PP exercise will be more than 6 out of 10 and higher than the same ratings obtained from subjects in the control condition.

Specific Aim #2: To examine the impact of the six-session PP intervention on positive psychological well-being.

Hypothesis: Compared to control subjects, subjects randomized to PP will have greater scores on scales of optimism (measured via the Life Orientation Test-Revised \[LOT-R\]), gratitude (Gratitude Questionnaire-6 \[GQ-6\]), and positive affect (Positive Affect Negative Affect Schedule \[PANAS\]) at 6 and 12 weeks.

Specific Aim #3 (primary aim): To assess the impact of the PP intervention on key suicide risk factors.

Hypothesis: PP subjects will have greater scores on scales of hopelessness (Beck Hopelessness Scale \[BHS\]; primary study outcome measure), suicidal ideation (SI) (Concise Health Risk Tracking scale \[CHRT\]), and depression (Quick Inventory of Depressive Symptomatology-Self Report \[QIDS-SR\]) at 6 and 12 weeks.

We will also measure impact on readmission and suicide attempts to assess these key outcomes.


Options:
A: Columbia Suicide Severity Rating Scale (CSSRS) Suicide Ideation (Baseline, 4 months post baseline, 12 months post baseline)
B: Completion of follow-up (End of treatment at 12 weeks); The fraction of eligible participants who consent to inclusion and randomization (End of treatment at 12 weeks); Compliance (End of treatment at 12 weeks); Non-suicidal self-injury as explorative primary clinical outcome (End of treatment at 12 weeks)
C: Suicide re-attempt rate reduction using the Columbia Suicide Severity Rating Scale (C-SSRS) (At 2 years after the intervention)
D: Change in BHS Scores (Baseline, 6 weeks, and 12 weeks)

Answer: D
Please select the outcome measures that correspond to the clinical trial below.
Title: Trial of a Positive Psychology Intervention to Reduce Suicide Risk in Patients With Major Depression
Brief Summary: In this study, the investigators will perform an exploratory randomized trial of Positive Psychology (PP). The trial will consist of 50 participants and will compare the impact of a phone-based PP intervention vs. an attentional control condition, in Major Depressive Disorder (MDD) patients who are hospitalized for SI or following a suicide attempt. This is a 12 week trial with 6 weeks of intervention and two blinded follow-up assessments at 6 and 12 weeks.

Specific Aim #1: To assess the feasibility and acceptability of the phone-based PP intervention in this high-risk population.

Hypotheses: The intervention will be feasible (with most patients completing at least 4/6 PP and with follow-up data from at least 80% of subjects). The ratings of ease and subjective helpfulness of the exercise and other mental states as measured before and after each PP exercise will be more than 6 out of 10 and higher than the same ratings obtained from subjects in the control condition.

Specific Aim #2: To examine the impact of the six-session PP intervention on positive psychological well-being.

Hypothesis: Compared to control subjects, subjects randomized to PP will have greater scores on scales of optimism (measured via the Life Orientation Test-Revised \[LOT-R\]), gratitude (Gratitude Questionnaire-6 \[GQ-6\]), and positive affect (Positive Affect Negative Affect Schedule \[PANAS\]) at 6 and 12 weeks.

Specific Aim #3 (primary aim): To assess the impact of the PP intervention on key suicide risk factors.

Hypothesis: PP subjects will have greater scores on scales of hopelessness (Beck Hopelessness Scale \[BHS\]; primary study outcome measure), suicidal ideation (SI) (Concise Health Risk Tracking scale \[CHRT\]), and depression (Quick Inventory of Depressive Symptomatology-Self Report \[QIDS-SR\]) at 6 and 12 weeks.

We will also measure impact on readmission and suicide attempts to assess these key outcomes.


Options:
A: Suicidal behaviour (2-year follow-up); Suicidal behaviour (1-year follow-up)
B: Change in BHS Scores (Baseline, 6 weeks, and 12 weeks)
C: Beck Depression Inventory (V2) (Baseline to 6 months)
D: Suicidal Attempts (Months 1, 3, 6, 12, 18, and 24)

Answer: B
Please select the outcome measures that correspond to the clinical trial below.
Title: Transcutaneous Auricular Vagus Nerve Stimulation as a Complementary Treatment for Pediatric Epilepsy
Brief Summary: The purpose of this study is to determine whether transcutaneous auricular vagus nerve stimulation as a complementary therapy is effective in the treatment of pediatric epilepsy.


Options:
A: Estimate the Effect Size Associated With Objective Measures and Patient Self-reports of Clinical Outcomes Including Seizure Frequency, Seizure Severity, Seizure Duration, Seizure Intensity, and Post-ictal Duration. (Up to 18 Month Visit-End of Study)
B: Summary of Seizures Reported by Investigators and Triple Review (Epilepsy Monitoring Unit Stay); Observed Sensitivity Based on Heart Rate Increase Associated With Seizures by Randomized SDA Setting (Epilepsy Monitoring Unit (EMU) Stay); Modeled Sensitivity Based on Heart Rate Increase Associated With Seizures by SDA Setting Post-Processed Through Bench-top Device Simulant (Epilepsy Monitoring Unit (EMU) Stay); Potential False Positives Based on Heart Rate Increase Associated With Seizures by Randomized SDA Setting (Epilepsy Monitoring Unit (EMU) Stay)
C: Changes in seizure frequency (12 weeks of stimulation)
D: frequency of epileptic seizures (Change from baseline at 8, 16, 24 weeks respectively in frequency of epileptic seizures)

Answer: D
Please select the outcome measures that correspond to the clinical trial below.
Title: The Study of Heart Rate Variability in Patients With Fibromyalgia - Effects of Strengthening Exercises
Brief Summary: Abstract Objective: Autonomic dysfunction is an important mechanism that could explain many symptoms observed in fibromyalgia (FM). Exercise is an effective treatment, with benefits potentially mediated through changes in autonomic modulation. Strengthening is one of the less studied exercises in FM, and the acute and chronic effects of strengthening on the autonomic system remain unknown. The objective of this study is to assess the effects of strengthening exercises (STRE) on autonomic modulation, pain perception and the quality of life (QOL) of FM patients. Methods: Sedentary women with FM (ACR 1990) will be randomly selected to STRE or flexibility (FLEX) exercises in a blind controlled trial. The intensity of STRE will be set at 45% of the estimated load of 1 Repetition Maximum (RM) in 12 different exercises. The primary outcomes will be pain measured using the Visual Analog Scale (VAS) and the Heart Rate Variability (HRV) analysis. Other outcomes will be assess: fitness measured by treadmill test, the sit and reach test (Wells and Dillon's Bench), handgrip dynamometry; and quality of life by the Fibromyalgia Impact Questionnaire (FIQ), the Beck and Idate Trait-State Inventory (IDATE), a short-form health survey (SF-36). Statistical analyses and ethical procedures: The visual analog scale (VAS) for pain will be the primary measure used to determine sample size. Statistical significance will be set at 5% and power of 80%. These led to at least 58 participants to be randomized. The main hypothesis is that strengthening exercise is a better treatment than flexibility exercise to improve pain, HRV and quality of life. In all measures tested we will consider the null hypothesis (H0) as being the point of equality between groups tested and H1 the point of difference. Bilateral tests were carried out adopting a 5% level of significance. The normality of the results will be tested using the Shapiro-Wilk test. Student's "t"-test for paired samples will be used to perform intra-group comparisons at different times, when the data were normally distributed, and the nonparametric equivalent of Student's t-test (Wilcoxon test) will be used when the data show an asymmetrical distribution. To compare the data between the STRE and FLEX groups, ANOVA for repeated measures will be used, followed by post-hoc Bonferroni's test.


Options:
A: Six-minute Walk Test (15 weeks); Change of Pain Level From Baseline. (15 weeks)
B: pain (4 weeks)
C: The primary outcome measure will be the change in mean daily pain diary score from baseline (average pain score over 7 days pre-treatment) to the final week of Qigong treatment. (7 days)
D: Pain (10 sessions, in 5 weeks, 2 times a week)

Answer: B
Please select the outcome measures that correspond to the clinical trial below.
Title: The Study of Heart Rate Variability in Patients With Fibromyalgia - Effects of Strengthening Exercises
Brief Summary: Abstract Objective: Autonomic dysfunction is an important mechanism that could explain many symptoms observed in fibromyalgia (FM). Exercise is an effective treatment, with benefits potentially mediated through changes in autonomic modulation. Strengthening is one of the less studied exercises in FM, and the acute and chronic effects of strengthening on the autonomic system remain unknown. The objective of this study is to assess the effects of strengthening exercises (STRE) on autonomic modulation, pain perception and the quality of life (QOL) of FM patients. Methods: Sedentary women with FM (ACR 1990) will be randomly selected to STRE or flexibility (FLEX) exercises in a blind controlled trial. The intensity of STRE will be set at 45% of the estimated load of 1 Repetition Maximum (RM) in 12 different exercises. The primary outcomes will be pain measured using the Visual Analog Scale (VAS) and the Heart Rate Variability (HRV) analysis. Other outcomes will be assess: fitness measured by treadmill test, the sit and reach test (Wells and Dillon's Bench), handgrip dynamometry; and quality of life by the Fibromyalgia Impact Questionnaire (FIQ), the Beck and Idate Trait-State Inventory (IDATE), a short-form health survey (SF-36). Statistical analyses and ethical procedures: The visual analog scale (VAS) for pain will be the primary measure used to determine sample size. Statistical significance will be set at 5% and power of 80%. These led to at least 58 participants to be randomized. The main hypothesis is that strengthening exercise is a better treatment than flexibility exercise to improve pain, HRV and quality of life. In all measures tested we will consider the null hypothesis (H0) as being the point of equality between groups tested and H1 the point of difference. Bilateral tests were carried out adopting a 5% level of significance. The normality of the results will be tested using the Shapiro-Wilk test. Student's "t"-test for paired samples will be used to perform intra-group comparisons at different times, when the data were normally distributed, and the nonparametric equivalent of Student's t-test (Wilcoxon test) will be used when the data show an asymmetrical distribution. To compare the data between the STRE and FLEX groups, ANOVA for repeated measures will be used, followed by post-hoc Bonferroni's test.


Options:
A: Visual Analog Scale for Pain (baseline, after 16 weeks and after 32 weeks)
B: pain (4 weeks)
C: Six-minute Walk Test (15 weeks); Change of Pain Level From Baseline. (15 weeks)
D: Fibromyalgia Impact Questionnaire (Assessed following 12 week intervention)

Answer: B
Please select the outcome measures that correspond to the clinical trial below.
Title: Ancillary Effects of Dexmedetomidine Sedation After Cardiac Surgery
Brief Summary: Ancillary Effects of Dexmedetomidine Sedation After Cardiac Surgery


Options:
A: Incidence of Delirium (Participants will be followed for the duration of the hospital stay, an average of 5 days)
B: Number of Patients With Atrial Arrhythmia (From the end of surgery to postoperative day 5); Number of Patients With Delirium (From the end of surgery to postoperative day 5)
C: N/A
D: Total Number of Days in Hospital (Within 60 days of randomization)

Answer: B
Please select the outcome measures that correspond to the clinical trial below.
Title: Monitoring and Evaluation of an MNCH Mentoring Intervention in Two Districts of Karnataka
Brief Summary: Our hypothesis is that an on-site mentoring program for staff at primary health care centers in northern Karnataka, will improve the quality of maternal, neonatal and child health care, and improve clinical outcomes.


Options:
A: Difference in differences: change in use of oxytocin for prevention of postpartum hemorrhage (Baseline, Midline (6 months), Endline (12 months))
B: Changes in provider knowledge and performance from baseline on intrapartum, postpartum and newborn care (12-24 months)
C: Episiotomies; Oxytocin use in third stage of labor
D: Percentage of participants with AMI, coronary artery bypass graft, PCI or IVD, and who had documentation of used of aspirin or another antithrombotic during the measurement period. (Quarterly for 4 years); Percentage of participants with diagnosis of hypertension and whose blood pressure was adequately controlled (<140/90 mmHg) during the measurement period. (Quarterly for 4 years); Percentage of participants considered at high risk of cardiovascular events who were prescribed or were on a statin therapy during the measurement period. (Quarterly for 4 years); Percentage of participants who were screened for tobacco use and received cessation counseling intervention if identified as a tobacco user. (Quarterly for 4 years)

Answer: B
Please select the outcome measures that correspond to the clinical trial below.
Title: Improving High School Breakfast Environments
Brief Summary: The goals of this intervention study are to implement best practice strategies to expand and promote the school breakfast program and test the impact upon student participation rates among a) all 10th and 11th grade students and among a randomly selected cohort of 800 students b) total diet and body mass index and percent body fat inin 16 rural Minnesota school districts.

School-wide Primary Aim: Improve participation in the school breakfast program among high school students. Hypothesis: School-wide school breakfast program participation will be higher in the intervention versus comparison group.


Options:
A: Improved dietary quality (Baseline- 24 months); Increased physical activity (Baseline- 24 months)
B: Change From Baseline in Percent Students Eating the School Breakfast Per School (Change from baseline (SY1) in average school year school-level breakfast participation at the end of one school year (SY2).)
C: Percent Body Fat (Baseline and One year)
D: Number of students obtaining lunch per day by National School Lunch Program (NSLP) eligibility (5 months); Number of fruits and vegetables served per day (5 months)

Answer: B
Please select the outcome measures that correspond to the clinical trial below.
Title: Three Arm, Prospective, Single-blind, Randomized Study Comparing Ranibizumab Plus Green Diode Laser Versus Ranibizumab Plus Pattern Scan Laser (Pascal) Versus Ranibizumab (Monotherapy) for Proliferative Diabetic Retinopathy.
Brief Summary: Objectives:

Primary objective:

To evaluate the effects on retinal morphophysiology of full scatter single target panretinal photocoagulation (PRP) versus full scatter multiple target panretinal photocoagulation (both combined with intravitreous injections of ranibizumab) versus intravitreous ranibizumab (IVR) alone in patients with proliferative diabetic retinopathy (PDR).

Primary outcome:

The primary endpoint for this study is the mean change in the total area of active retinal neovessels, as measured by fluorescein angiography leakage area, in mm2, from baseline to week 48.

Secondary objectives:

* To assess the mean changes in best corrected visual acuity (BCVA), the mean changes in central subfield foveal thickness (CSFT), the mean changes in wave B amplitude and oscillatory potentials on a full-field electroretinogram (ERG), and the mean changes on the peripheral visual field by static perimetry (30:2 strategy), from baseline to week 48.
* To assess the incidence of adverse events during the study.

Strategic goal:

In the era of anti-VEGF treatment for retinal neovascularization 1, 2, 3, 4 , it is time to determine what would be the best association of PRP + anti-VEGF for proliferative diabetic retinopathy (PDR), or still, if just intravitreal anti-VEGF treatment would be even better regarding morphologic (new vessels area and CSFT) and functional parameters (BCVA, ERG response and visual field).


Options:
A: fluorescein angiography leakage area (from baseline to week 48.)
B: N/A
C: Change From Baseline in BCVA in the Study Eye Averaged Over Weeks 48, 52, and 56, ITT and Treatment-Naive Populations (From Baseline through Week 56)
D: Percentage of Patients Who Gained ≥ 15 Letters in Their Best Corrected Visual Acuity (BCVA) Score From Baseline at Month 24 (Baseline to Month 24)

Answer: A