TrialPanorama/Dataset huggingface dataset:
Please select the outcome measures that correspond to the clinical trial below.
Title: Patient-Centered Depression Care for African Americans
Brief Summary: The investigators propose to answer the following research question: Does a multifaceted, culturally tailored intervention that focuses on the specific concerns and preferences of African American patients with depression and their primary care providers improve the processes and outcomes of care for African Americans to a greater degree than a standard state-of-the art depression intervention?

This study will determine whether two new educational programs can improve the care for depression in African Americans. These programs may include visits with a depression case manager and access to educational materials, such as a videotape, a calendar, pamphlets, and books. One program is a standard quality improvement program for depression that has been shown to be effective in most patients. The other program is similar, but has materials that focus more on the patient's specific culture, beliefs, values, and preferences.


Options:
A: Hamilton Depression Rating Scale; Scale for Suicide Ideation
B: N/A
C: Compare the effectiveness of a culturally tailored intervention with the effectiveness of a standard intervention by evaluating its impact on patient outcomes (remission of depression, depression symptom level, functional status) at 6 and 12 months.
D: Compare efficacy of 3-component model telemedicine intervention to standard care in terms of depression and pain at baseline and 1, 3, 6, and 12 months

Answer: C
Please select the outcome measures that correspond to the clinical trial below.
Title: Locomotor Experience Applied Post Stroke (LEAPS) Trial
Brief Summary: The purpose of this study is to compare two different treatments to improve walking after stroke (or post-stroke).


Options:
A: Korean-Montreal Cognitive Assessment (K-MoCA) (Change of K-MoCa after intensive cognitive rehabilitation for 4 weeks)
B: Berg Balance Scale (BBS) (The BBS will be used to assess the changes from the baseline balance at 8 weeks (post-intervention) as well as at 3-months after intervention (3-months follow-up).); Timed Up and Go Test (TUG) (The TUG will be used to evaluate the changes from baseline functional mobility at 8 weeks (post-intervention) as well as at 3-months after intervention (3-months follow-up).); 10-meter Walk Test (10mWT) (The 10mWT will be used to assess the changes from the baseline walking speed (meters per second) at 8 weeks (post-intervention) as well as at 3-months after intervention (3-months follow-up).); Barthel Index (BI) (The BI will be used to measure the changes from baseline functional independency at 8 weeks (post-intervention) as well as at 3-months after intervention (3-months follow-up).); Instrumental analysis of balance (NedSVE/IBV® system will be used to assess the changes from baseline balance and postural control at 8 weeks (post-intervention) as well as at 3-months after intervention (3-months follow-up).); Instrumental analysis of gait (NedAMH/IBV® system will be used to assess the changes from baseline gait parameters at 8 weeks (post-intervention) as well as at 3-months after intervention (3-months follow-up).)
C: Change in peak walking speed (At baseline, following 8 weeks of training and a 2 month follow-up)
D: Percentage of Patients Who Successfully Improved Functional Level of Walking at 1 Year Post-stroke (12 months post-stroke); Walking Speed: Measured During a 10-meter Walk (Baseline and 12 months post-stroke)

Answer: D
Please select the outcome measures that correspond to the clinical trial below.
Title: Locomotor Experience Applied Post Stroke (LEAPS) Trial
Brief Summary: The purpose of this study is to compare two different treatments to improve walking after stroke (or post-stroke).


Options:
A: walking speed (meters/second); walking distance (distance walked in 6-minutes)
B: Improvement ín motor function among patients in each group
C: Percentage of Patients Who Successfully Improved Functional Level of Walking at 1 Year Post-stroke (12 months post-stroke); Walking Speed: Measured During a 10-meter Walk (Baseline and 12 months post-stroke)
D: Change from Baseline in the gait velocity (Baseline, immediately after and six weeks after training cessation.)

Answer: C
Please select the outcome measures that correspond to the clinical trial below.
Title: Locomotor Experience Applied Post Stroke (LEAPS) Trial
Brief Summary: The purpose of this study is to compare two different treatments to improve walking after stroke (or post-stroke).


Options:
A: Difference in physical activity scale for the elderly (24 months)
B: Proportion of participants walking independently (defined for the purposes of this study as'being able to walk 15 m continuously across flat ground without any aids'). (Within 6 months)
C: systolic blood pressure (primary vascular risk factor being assessed) (baseline, post-intervention, 6 months, 12 months); diastolic blood pressure (baseline, post-intervention, 6 months, 12 months); waist circumference (baseline, post-intervention, 6 months, 12 months); 12-hour fasting lipid profile (baseline, post-intervention, 6 months, 12 months); 12-hour fasting glucose/hemoglobin A1C (baseline, post-intervention, 6 months, 12 months)
D: Percentage of Patients Who Successfully Improved Functional Level of Walking at 1 Year Post-stroke (12 months post-stroke); Walking Speed: Measured During a 10-meter Walk (Baseline and 12 months post-stroke)

Answer: D
Please select the outcome measures that correspond to the clinical trial below.
Title: Locomotor Experience Applied Post Stroke (LEAPS) Trial
Brief Summary: The purpose of this study is to compare two different treatments to improve walking after stroke (or post-stroke).


Options:
A: walking speed (meters/second); walking distance (distance walked in 6-minutes)
B: Proportion of participants walking independently (defined for the purposes of this study as'being able to walk 15 m continuously across flat ground without any aids'). (Within 6 months)
C: Percentage of Patients Who Successfully Improved Functional Level of Walking at 1 Year Post-stroke (12 months post-stroke); Walking Speed: Measured During a 10-meter Walk (Baseline and 12 months post-stroke)
D: Self selected over ground gait speed - 5 metre walk test (8 week follow up)

Answer: C
Please select the outcome measures that correspond to the clinical trial below.
Title: Effects of Nutritional Supplementation on Protein and Energy Homeostasis in Malnourished Chronic Hemodialysis Patients
Brief Summary: The goal of this study is to evaluate the metabolic effects of concomitant use of three consecutive doses of recombinant human growth hormone over three days and exercise during continuous nutrient infusion in chronic hemodialysis patients. We would also like to evaluate the metabolic effects of nutritional supplementation alone without the additional anabolic strategies.


Options:
A: Serum albumin (Change from baseline serum albumin at 6 months of the study); Body mass index (BMI) (Change from BMI at 6 months of the study)
B: net muscle protein balance (10 hours)
C: increase in lean body mass (13 months)
D: Change of physical endurance on bicycle (At months 3 and 15 after inclusion)

Answer: B
Please select the outcome measures that correspond to the clinical trial below.
Title: Delivery Room Management of Premature Infants at High Risk of Respiratory Distress Syndrome
Brief Summary: The best mode of delivery room stabilization for premature infants at high risk for respiratory distress syndrome is unknown. The protocol evaluates the impact of three distinct methods of post-delivery stabilization and subsequent early respiratory care on chronic lung disease and survival in premature infants at high risk for respiratory distress syndrome.


Options:
A: Need for mechanical ventilation (Death or discharge from the NICU)
B: Death or Chronic Lung Disease (at 36 weeks postmenstrual age); Death (36 weeks adjusted age)
C: Survival Without Bronchopulmonary Dysplasia (BPD) (36 weeks); Survival Without Severe Retinopathy of Prematurity (ROP) (Threshold Disease or the Need for Surgery) (55 weeks)
D: Need for MV (Within the first 5 days of life)

Answer: B
Please select the outcome measures that correspond to the clinical trial below.
Title: Delivery Room Management of Premature Infants at High Risk of Respiratory Distress Syndrome
Brief Summary: The best mode of delivery room stabilization for premature infants at high risk for respiratory distress syndrome is unknown. The protocol evaluates the impact of three distinct methods of post-delivery stabilization and subsequent early respiratory care on chronic lung disease and survival in premature infants at high risk for respiratory distress syndrome.


Options:
A: Survival Without Bronchopulmonary Dysplasia (BPD) (36 weeks); Survival Without Severe Retinopathy of Prematurity (ROP) (Threshold Disease or the Need for Surgery) (55 weeks)
B: Death or Chronic Lung Disease (at 36 weeks postmenstrual age); Death (36 weeks adjusted age)
C: Need for mechanical ventilation (Death or discharge from the NICU)
D: Need for mechanical ventilation

Answer: B
Please select the outcome measures that correspond to the clinical trial below.
Title: Delivery Room Management of Premature Infants at High Risk of Respiratory Distress Syndrome
Brief Summary: The best mode of delivery room stabilization for premature infants at high risk for respiratory distress syndrome is unknown. The protocol evaluates the impact of three distinct methods of post-delivery stabilization and subsequent early respiratory care on chronic lung disease and survival in premature infants at high risk for respiratory distress syndrome.


Options:
A: Death or Chronic Lung Disease (at 36 weeks postmenstrual age); Death (36 weeks adjusted age)
B: Need for mechanical ventilation (Death or discharge from the NICU)
C: Need for mechanical ventilation
D: Survival Without Bronchopulmonary Dysplasia (BPD) (36 weeks); Survival Without Severe Retinopathy of Prematurity (ROP) (Threshold Disease or the Need for Surgery) (55 weeks)

Answer: A
Please select the outcome measures that correspond to the clinical trial below.
Title: Delivery Room Management of Premature Infants at High Risk of Respiratory Distress Syndrome
Brief Summary: The best mode of delivery room stabilization for premature infants at high risk for respiratory distress syndrome is unknown. The protocol evaluates the impact of three distinct methods of post-delivery stabilization and subsequent early respiratory care on chronic lung disease and survival in premature infants at high risk for respiratory distress syndrome.


Options:
A: Efficacy of nasal intermittent mandatory ventilation (IMV) and nasal continuous positive airway pressure (CPAP) in early rescue surfactant treatment in preterm infants (3 months)
B: need for mechanical ventilation after the procedure (72hours)
C: Death or Chronic Lung Disease (at 36 weeks postmenstrual age); Death (36 weeks adjusted age)
D: Death or physiological bronchopulmonary dysplasia (36 weeks post menstrual age)

Answer: C
Please select the outcome measures that correspond to the clinical trial below.
Title: Delivery Room Management of Premature Infants at High Risk of Respiratory Distress Syndrome
Brief Summary: The best mode of delivery room stabilization for premature infants at high risk for respiratory distress syndrome is unknown. The protocol evaluates the impact of three distinct methods of post-delivery stabilization and subsequent early respiratory care on chronic lung disease and survival in premature infants at high risk for respiratory distress syndrome.


Options:
A: Need for MV (Within the first 5 days of life)
B: Survival Without Bronchopulmonary Dysplasia (BPD) (36 weeks); Survival Without Severe Retinopathy of Prematurity (ROP) (Threshold Disease or the Need for Surgery) (55 weeks)
C: Need for mechanical ventilation (Death or discharge from the NICU)
D: Death or Chronic Lung Disease (at 36 weeks postmenstrual age); Death (36 weeks adjusted age)

Answer: D
Please select the outcome measures that correspond to the clinical trial below.
Title: Delivery Room Management of Premature Infants at High Risk of Respiratory Distress Syndrome
Brief Summary: The best mode of delivery room stabilization for premature infants at high risk for respiratory distress syndrome is unknown. The protocol evaluates the impact of three distinct methods of post-delivery stabilization and subsequent early respiratory care on chronic lung disease and survival in premature infants at high risk for respiratory distress syndrome.


Options:
A: Death or Chronic Lung Disease (at 36 weeks postmenstrual age); Death (36 weeks adjusted age)
B: Patient comfort (EDIN score) (48 h (CPAP 24 h and HFNC 24 h); cumulative EDIN score for each 24 epoch is calculated and a change between the two interventions are assessed)
C: number of patients needing intubation and mechanical ventilation within 72 hrs from the beginning of the study mode (within 72 hrs from the beginning of the study mode)
D: Compare extubation success rate, defined as % infants remaining extubated for > 72 hrs, among infants managed with HHFNC versus nCPAP (72 hrs)

Answer: A
Please select the outcome measures that correspond to the clinical trial below.
Title: Delivery Room Management of Premature Infants at High Risk of Respiratory Distress Syndrome
Brief Summary: The best mode of delivery room stabilization for premature infants at high risk for respiratory distress syndrome is unknown. The protocol evaluates the impact of three distinct methods of post-delivery stabilization and subsequent early respiratory care on chronic lung disease and survival in premature infants at high risk for respiratory distress syndrome.


Options:
A: Survival Without Bronchopulmonary Dysplasia (BPD) (36 weeks); Survival Without Severe Retinopathy of Prematurity (ROP) (Threshold Disease or the Need for Surgery) (55 weeks)
B: Death or Chronic Lung Disease (at 36 weeks postmenstrual age); Death (36 weeks adjusted age)
C: Need for mechanical ventilation
D: Incidence of respiratory morbidity (72 hours after birth)

Answer: B
Please select the outcome measures that correspond to the clinical trial below.
Title: The Care Transitions Intervention
Brief Summary: This intervention tests whether encouraging older patients and their caregivers to assert a more active role in their care transitions could improve clinical outcomes. Patients are supported by a nurse transition coach and specific tools, including a Personal Health Record.


Options:
A: Hemoglobin A1c (6 months)
B: Rehospitalization rate at 30, 90 and 180 days after index hospitalization.
C: Combined Effect of Intervention on SCL-20, Systolic Blood Pressure, LDL and HbA1c (Baseline to 12 months); Symptom Checklist-20 Score at Baseline, 6 Months and 12 Months (Measured at Baseline, 6 Months, 12 months); Systolic Blood Pressure at Baseline, 6 Months and 12 Months (Measured at Baseline, 6 Months, 12 months); LDL Cholesterol at Baseline and 12 Months (Measured at Baseline and 12 months); Glycated Hemoglobin (HbA1c) at Baseline, 6 Months and 12 Months (Measured at Baseline, 6 months and 12 months)
D: HbA1c level (6 months)

Answer: B
Please select the outcome measures that correspond to the clinical trial below.
Title: A Phase III, Randomized, Multicentre, Double-Blind, Placebo-Controlled Study of ISA247 in Plaque Psoriasis Patients
Brief Summary: The purpose of this study is to determine which dose of voclosporin is effective in the treatment of plaque psoriasis compared to placebo.


Options:
A: Percentage of Participants Achieving a 90% or Higher Improvement From Baseline in Psoriasis Area and Severity Index (PASI) Score at Week 12 (Week 12)
B: Percentage improvement of PASI from baseline to Week 16 (Week 16)
C: Proportion of Subjects Achieving a PASI-75 at 12 Weeks at Each of the 3 Dose Levels of Voclosporin. (Twelve Weeks)
D: Percentage of Participants Who Achieved a Psoriasis Area and Severity Index (PASI)-90 Response at Week 48 (Week 48)

Answer: C
Please select the outcome measures that correspond to the clinical trial below.
Title: A Phase III, Randomized, Multicentre, Double-Blind, Placebo-Controlled Study of ISA247 in Plaque Psoriasis Patients
Brief Summary: The purpose of this study is to determine which dose of voclosporin is effective in the treatment of plaque psoriasis compared to placebo.


Options:
A: Proportion of Subjects Achieving a PASI-75 at 12 Weeks at Each of the 3 Dose Levels of Voclosporin. (Twelve Weeks)
B: Change in PASI score from baseline in the two groups (12 weeks)
C: Percentage of Participants With a Psoriasis Area and Severity Index (PASI)75 Response at Week 16 (Week 16); Number of Participants Experiencing Adverse Events (Up to 72 weeks); Number of Particpants Discontinuing Study Treatment Due to Adverse Events (Up to 52 weeks)
D: Percentage of Participants With a Physician's Global Assessment (PGA) Response of "Clear" or "Almost Clear" at Week 12 (Week 12); Percentage of Participants With a Psoriasis Area and Severity Index 75 (PASI75) Response at Week 12 (Week 12)

Answer: A
Please select the outcome measures that correspond to the clinical trial below.
Title: A Phase III, Randomized, Multicentre, Double-Blind, Placebo-Controlled Study of ISA247 in Plaque Psoriasis Patients
Brief Summary: The purpose of this study is to determine which dose of voclosporin is effective in the treatment of plaque psoriasis compared to placebo.


Options:
A: Percentage of Participants With Physician Global Assessment (PGA) Score of Cleared (0) or Minimal (1) at Week 16 (Week 16)
B: Percentage of Participants Who Achieve a PASI75 Response at Week 16 Compared With Baseline (Week 0) (Week 0 and Week 16)
C: Proportion of Subjects Achieving a PASI-75 at 12 Weeks at Each of the 3 Dose Levels of Voclosporin. (Twelve Weeks)
D: Change in Target Lesion Individual Component Scores for Erythema, Scaling and Thickness Compared to Baseline (Baseline, Days 8, 15, 22, 28 and 56); Change in Target Lesion TOTAL Score (Sum of Erythema + Scaling + Thickness) Compared to Baseline (Baseline, Days 8, 15, 22, 28 and 56); Number of Participants With Treatment Emergent Adverse Events (3 months); Pharmacokinetics Parameter : Skin Flux of INCB018424 (Days 8, 15, 22, and 28); Pharmacokinetics Parameter : Bioavailability of INCB018424 (Days 8, 15, 22, and 28)

Answer: C
Please select the outcome measures that correspond to the clinical trial below.
Title: A Phase III, Randomized, Multicentre, Double-Blind, Placebo-Controlled Study of ISA247 in Plaque Psoriasis Patients
Brief Summary: The purpose of this study is to determine which dose of voclosporin is effective in the treatment of plaque psoriasis compared to placebo.


Options:
A: Percentage of Participants With a Physician's Global Assessment (PGA) Response of "Clear" or "Almost Clear" at Week 12 (Week 12); Percentage of Participants With a Psoriasis Area and Severity Index 75 (PASI75) Response at Week 12 (Week 12)
B: Proportion of Subjects Achieving a PASI-75 at 12 Weeks at Each of the 3 Dose Levels of Voclosporin. (Twelve Weeks)
C: Proportion of patients in remission defined by disease specific composite scores Study part A (30 weeks); Sustained disease control throughout the study period without disease worsening defined by disease specific composite scores Study part B (52 weeks)
D: Number of Participants Who Achieved Psoriasis Area and Severity Index (PASI) 75% Improvement at Week 12 (Week 12)

Answer: B
Please select the outcome measures that correspond to the clinical trial below.
Title: A Phase III, Randomized, Multicentre, Double-Blind, Placebo-Controlled Study of ISA247 in Plaque Psoriasis Patients
Brief Summary: The purpose of this study is to determine which dose of voclosporin is effective in the treatment of plaque psoriasis compared to placebo.


Options:
A: N/A
B: The Percentage of Participants With Moderate to Severe Psoriasis Experiencing a 75% Improvement (Reduction From Baseline) in PASI Score (PASI-75 Response Rate) on Day 85 (Week 12) (Day 1 to Day 85); Number of Participants With Adverse Events (Day 1 to day 115)
C: Number of Patients Achieving "Clear" or "Almost Clear" on Physician Global Assessment (PGA) of Psoriasis (12 weeks)
D: Proportion of Subjects Achieving a PASI-75 at 12 Weeks at Each of the 3 Dose Levels of Voclosporin. (Twelve Weeks)

Answer: D
Please select the outcome measures that correspond to the clinical trial below.
Title: Metabolism and Bone Health
Brief Summary: Estrogen is a hormone that helps prevent calcium loss and bone breakdown. During menopause, estrogen levels decrease. Insufficient amounts of estrogen may lead to bone loss and possibly osteoporosis. Isoflavones are natural compounds found in soy plants that may help provide protection against bone loss. This study will evaluate the effect of soy isoflavones on calcium absorption and bone loss in post menopausal women.


Options:
A: Urinary markers of bone resorption; measured at the end of each treatment phase (Every 50 days)
B: To assess the impact of physician's reinforcement using bone marker data on the treatment adherence of women with PMO. (collected at week 10 and 22)
C: Mean percent change from baseline in hip trochanter bone mineral density (BMD) at 12 months (Baseline and 12 months); Mean percent change from baseline in hip trochanter BMD at 24 months (Baseline and 24 months)
D: Percent Change From Baseline Lumbar Spine Bone Mineral Density (BMD) at Week 52 / Endpoint, ITT Population (52 weeks / Endpoint)

Answer: A
Please select the outcome measures that correspond to the clinical trial below.
Title: Evaluation of the Impact of a Bulletin Board on a Web-Based Smoking Cessation Intervention
Brief Summary: RATIONALE: Stop-smoking information on the smokefree.gov website may help people quit smoking and remain a nonsmoker.

PURPOSE: This clinical trial is studying how well the smokefree.gov website works with an electronic bulletin board in helping United States federal employees quit smoking.


Options:
A: Smoking abstinence (1, 3, 6 and 12 month follow-ups)
B: Number of smokers referred to tobacco cessation website (12 months)
C: Abstinence for 7 consecutive days and 24 hours at 1, 3, and 6 months
D: 7-day point prevalence abstinence (Measured at Months 3, 6, and 12)

Answer: C
Please select the outcome measures that correspond to the clinical trial below.
Title: Cognitive Processes in PTSD: Treatment
Brief Summary: This study will evaluate the effectiveness of cognitive processing therapy versus its individual components in treating women with post-traumatic stress disorder (PTSD) and depression brought on by sexual assault.


Options:
A: Severity of mental health symptoms (previous 4 weeks)
B: Depression symptoms; measured immediately post-treatment and 6 months post-treatment; Post-traumatic stress disorder symptoms; measured immediately post-treatment and 6 months post-treatment
C: Good end-state functioning: Beck Depression Inventory-II and Posttraumatic Distress Scale Scores (2 weeks post-treatment)
D: Alcohol Use Interview (Past month); Alcohol Use Self-Report (Past month); Posttraumatic Stress Disorder Severity (PTSD) Interview (Past two weeks); Posttraumatic Stress Disorder Severity (PTSD) Self-Report (Past two weeks)

Answer: B