TrialPanorama/Dataset huggingface dataset:
Please select the outcome measures that correspond to the clinical trial below.
Title: A Multicenter, Randomized, Double-Blind, Placebo-Controlled Study to Assess the Safety and Efficacy of Risankizumab Using a New Formulation for the Treatment of Adult Subjects With Moderate to Severe Plaque Psoriasis
Brief Summary: The primary objective of this study was to evaluate the safety and efficacy of risankizumab (150 mg/mL) administered by prefilled syringe (PFS) for the treatment of adult participants with moderate to severe plaque psoriasis.


Options:
A: Percentage of Participants Achieving Psoriasis Area Severity Index (PASI) 90 at Week 16 (At Week 16); Percentage of Participants Achieving Static Physician Global Assessment (sPGA) of Clear or Almost Clear at Week 16 (At Week 16)
B: Number of subjects reporting at least 1 Treatment-Emergent Adverse Event (TEAE) during the Treatment Period (20 Weeks) (Baseline to 20 Weeks); Number of subjects prematurely discontinuing due to a Treatment-Emergent Adverse Event (TEAE) during the Treatment Period (20 Weeks) (Baseline to 20 Weeks); Number of subjects reporting at least 1 Serious Adverse Event (SAE) during the Treatment Period (20 Weeks) (Baseline to 20 Weeks)
C: Percentage of Participants Achieving 90% Improvement in Psoriasis Area and Severity Index (PASI) Score (PASI90) at Week 16 (Part A) (Week 16)
D: Number of Participants Achieving a Static Physician Global Assessment (sPGA) of (0, 1) (Efficacy of Ixekizumab in Participants With Moderate to Severe Chronic Plaque Psoriasis. Measure: sPGA) (Week 12); Number of Participants Achieving Psoriasis Area and Severity Index ≥75% (PASI 75) Improvement (Efficacy of Ixekizumab in Participants With Moderate to Severe Chronic Plaque Psoriasis. Measure: PASI) (Week 12)

Answer: A
Please select the outcome measures that correspond to the clinical trial below.
Title: A Multicenter, Randomized, Double-Blind, Placebo-Controlled Study to Assess the Safety and Efficacy of Risankizumab Using a New Formulation for the Treatment of Adult Subjects With Moderate to Severe Plaque Psoriasis
Brief Summary: The primary objective of this study was to evaluate the safety and efficacy of risankizumab (150 mg/mL) administered by prefilled syringe (PFS) for the treatment of adult participants with moderate to severe plaque psoriasis.


Options:
A: 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)
B: Percentage of Participants Achieving Psoriasis Area Severity Index (PASI) 90 at Week 16 (At Week 16); Percentage of Participants Achieving Static Physician Global Assessment (sPGA) of Clear or Almost Clear at Week 16 (At Week 16)
C: Number of Participants With an Investigator's Global Assessment (IGA) Score of 0 or 1 (Week 12, as compared to Week 0 (baseline))
D: Number of Participants Achieving Static Physician Global Assessment (sPGA) of Genitalia (0,1) (Week 12)

Answer: B
Please select the outcome measures that correspond to the clinical trial below.
Title: A Randomized Cross-over Trial in the Effect of Automated Oxygen Control Devices on the Distribution of Oxygen Saturation in Preterm Infants
Brief Summary: Premature infants often receive respiratory support and supplemental oxygen for a prolonged period of time during their admission in the NICU. While maintaining the oxygen saturation within a narrow target range is important to prevent morbidity, manual oxygen titration can be very challenging. Automatic titration by a controller has been proven to be more effective. However, to date the performance of different controllers has not been compared. The proposed randomized crossover trial Comparing Oxygen Controllers in Preterm InfanTs (COCkPIT) is designed to compare the effect on time spent within target range. The results of this trial will help determining which algorithm is most successful in controlling oxygen, improve future developments in automated oxygen control and ultimately reduce the morbidity associated with hypoxemia and hyperoxemia.


Options:
A: Cerebral tissue oxygen saturation (48 hours)
B: Percent time in target range for oxygen saturation by pulse oximetry (24 hrs)
C: Proportion of time with SpO2 spent within set target range (Continuously from randomization until study completion. (maximum of 50 hours) Measurements during wash-out periods (up to 1 hour after ventilator switch) will be excluded.)
D: The duration of mechanical ventilation (Through study completion, an average of 2 years)

Answer: C
Please select the outcome measures that correspond to the clinical trial below.
Title: Randomized Prospective Trial of Telemedicine Based Remote Home Monitoring After Liver Transplantation
Brief Summary: A significant opportunity exists to involve patients and their caregivers in more effective perioperative care and transition to home for transplant patients. Stakeholders were engaged through the University of Cincinnati Liver Transplant Program to prioritize changes in improving post transplant care. The initial findings indicated that increasing "care between visits" is the top priority for patients for improving function, quality of life and independence. Building on existing telehealth research, an enhanced home management program (HMP) to leverage and improve patient self-care following liver transplantation was developed, specifically by improving adherence, reducing readmissions and improving the transition from hospital to home. The improvement of care may have profound effect in the first 90 days after transplant on important long-term health parameters that affect clinical outcomes such as depression, weight gain, blood pressure control and diabetes management. With patient engagement, a randomized controlled trial is proposed comparing traditional provider-based care vs. traditional care with HMP. These two arms will need 50 patients in each arm with a 0.5 year follow up. Patients have said that the primary outcomes are quality of life, function and independence. To that end, the primary study outcomes are assessment of adherence, readmissions (90-day), patient satisfaction. The HMP model will advise providers, health care systems, and transplant centers how to improve patient care, especially among those at greatest risk of poor outcomes specifically minorities and those of low socioeconomic status.


Options:
A: Change in Medication Knowledge Score from baseline to 3 months (Baseline and 3 months)
B: The primary end-point was the influence of pharmaceutical intervention in tacrolimus intra-subject variability during the first 3 months after kidney transplant. variability during the first 3 months after transplantation. (3 months)
C: electronic monitor of medication taking (4 months)
D: 90- day readmission (90 days)

Answer: D
Please select the outcome measures that correspond to the clinical trial below.
Title: Happy Mother-Healthy Baby: An Anxiety-focused Early Prenatal Intervention for the Prevention of Common Mental Disorders in Pakistan
Brief Summary: In the proposed study the investigators will develop an early prenatal preventive intervention targeting anxiety and conduct a randomized controlled trial in Pakistan to test its efficacy in reducing generalized anxiety disorder and major depression in mothers in late pregnancy and the postnatal period. Investigators will evaluate the impact of the intervention on fetal and infant growth restriction as well as examine how the impact of the intervention is mediated (to elucidate mechanisms) and/or modified (to help optimize future adaptations of the program) by various social factors. A cost-effectiveness evaluation will shed light on the costs and benefits of intervention components in relation to outcomes, enabling policy-makers and public health planners to scale up this intervention according to resource budgeting requirements.


Options:
A: skin to skin contact (within first 28 days after birth); careseeking for newborn (within first 28 days after birth)
B: Number of Participants With Combined Common Mental Disorders (CMDs, i.e. Anxiety and Depression). (6 weeks postpartum)
C: Postpartum Clinic Attendance (assessed at 12 weeks postpartum)
D: Maternal stress and anxiety (Baselibne to 12 weeks); Breast milk volume at 12 weeks assessed non-invasively using stable isotope techniques (12 weeks); Breast milk cortisol concentrations at 12 weeks (12 weeks); Infant behaviour measured using a 3-day diary at 12 weeks (12 weeks); Infant weight and body composition measured using stable isotopes at 12 weeks (12 weeks); Physiological changes (maternal saliva cortisol, breast milk cortisol and milk volume) before and after physiological-mini test in intervention group at 2,6 and 12 weeks. (2,6,12 weeks)

Answer: B
Please select the outcome measures that correspond to the clinical trial below.
Title: Happy Mother-Healthy Baby: An Anxiety-focused Early Prenatal Intervention for the Prevention of Common Mental Disorders in Pakistan
Brief Summary: In the proposed study the investigators will develop an early prenatal preventive intervention targeting anxiety and conduct a randomized controlled trial in Pakistan to test its efficacy in reducing generalized anxiety disorder and major depression in mothers in late pregnancy and the postnatal period. Investigators will evaluate the impact of the intervention on fetal and infant growth restriction as well as examine how the impact of the intervention is mediated (to elucidate mechanisms) and/or modified (to help optimize future adaptations of the program) by various social factors. A cost-effectiveness evaluation will shed light on the costs and benefits of intervention components in relation to outcomes, enabling policy-makers and public health planners to scale up this intervention according to resource budgeting requirements.


Options:
A: Change in Post-natal depression (6 weeks following child birth)
B: Change in receipt of primary care services - self report (2-months and 6-months Postpartum (baseline and 4-months from baseline data collection)); Change in receipt of primary care services - EMR review (2-months and 6-months Postpartum (baseline and 4-months from baseline data collection))
C: HIV-related transmission acts (18 months); Baby's health status (18 months); Maternal adherence to HIV-related and general health routines (18 months); Mental health (18 months); Social support (18 months)
D: Number of Participants With Combined Common Mental Disorders (CMDs, i.e. Anxiety and Depression). (6 weeks postpartum)

Answer: D
Please select the outcome measures that correspond to the clinical trial below.
Title: Happy Mother-Healthy Baby: An Anxiety-focused Early Prenatal Intervention for the Prevention of Common Mental Disorders in Pakistan
Brief Summary: In the proposed study the investigators will develop an early prenatal preventive intervention targeting anxiety and conduct a randomized controlled trial in Pakistan to test its efficacy in reducing generalized anxiety disorder and major depression in mothers in late pregnancy and the postnatal period. Investigators will evaluate the impact of the intervention on fetal and infant growth restriction as well as examine how the impact of the intervention is mediated (to elucidate mechanisms) and/or modified (to help optimize future adaptations of the program) by various social factors. A cost-effectiveness evaluation will shed light on the costs and benefits of intervention components in relation to outcomes, enabling policy-makers and public health planners to scale up this intervention according to resource budgeting requirements.


Options:
A: Change in child mental health-related symptoms (6 months post enrollment)
B: Number of Participants With Combined Common Mental Disorders (CMDs, i.e. Anxiety and Depression). (6 weeks postpartum)
C: Psychiatric diagnosis at 6-month follow-up (6-month follow-up)
D: Depression (10-16 weeks); Posttraumatic Stress Symptoms (10-16 weeks)

Answer: B
Please select the outcome measures that correspond to the clinical trial below.
Title: Advanced REperfusion STrategies for Refractory Cardiac Arrest (The ARREST Trial)
Brief Summary: This is a Phase II, single center (Under the Center for Resuscitation Medicine at the University of Minnesota Medical School), partially blinded, prospective, intention to treat, safety and efficacy clinical trial, randomizing adult patients (18-75 years old) with refractory ventricular fibrillation/pulseless ventricular tachycardia (VF/VT) out-of hospital cardiac arrest (OHCA) who are transferred by emergency medical services (EMS) with ongoing mechanical cardiopulmonary resuscitation (CPR) or who are resuscitated to receive one of the 2 local standards of care practiced in our community: 1) Early Extracorporeal Membrane Oxygenation (ECMO) Facilitated Resuscitation or 2) Standard Advanced Cardiac Life Support (ACLS) Resuscitation


Options:
A: All cause mortality on day 60 following randomization (60 days)
B: Feasibility of telephone interview (At completion of telephone interview, expected average of 6 months)
C: 30-day survival rate with favorable neurological status (30 days)
D: Survival (Approximately 25 days)

Answer: D
Please select the outcome measures that correspond to the clinical trial below.
Title: Effectiveness of a Hybrid Cardiac Rehabilitation Program for Coronary Artery Disease Patients. Randomized, Multicenter, Non-inferiority Clinical Trial in a Low-resource Setting. HYCARET Study
Brief Summary: This clinical trial aim to evaluate if the prevention of recurrent cardiovascular events is not inferior in the hybrid mobile and exercise-based cardiac rehabilitation programs in comparison to the standard cardiac rehabilitation program.


Options:
A: Mortality rate (10-year)
B: Health-related Quality of Life (SF-36v2-acute Form) (9 weeks)
C: Heart Failure-specific Quality of Life (twelve-month followup)
D: Recurrent cardiovascular events (12 months (or more for first recruited participants, but until 36 months).)

Answer: D
Please select the outcome measures that correspond to the clinical trial below.
Title: Sí Texas: Improving Access to Integrated Care for Rio Grande Valley Residents With Severe & Persistent Mental Illness
Brief Summary: This study evaluated whether patients with severe and persistent mental illness (SPMI) who received coordinated co-located behavioral health and primary care services were more likely to improve health outcomes after 12 months compared to SPMI patients who receive only behavioral health services from the local mental health authority (LMHA) Tropical Texas Behavioral Health (TTBH).The study employed a randomized control trial (RCT) design where intervention participants receiving integrated behavioral health were compared to control participants receiving the usual care provided within an LMHA for SPMI patients. Patients were placed in each group using a randomized number process. Demographic and health outcome data were collected from intervention and control participants at baseline. Health outcome data was subsequently collected at 6-month and 12-month follow-up points.


Options:
A: Depressive symptoms reduction (Measured at months 6 and 12)
B: Severity of depression symptoms
C: Recovery from Common Mental Disorder (defined by ICD10) (6 months)
D: Blood pressure (One year)

Answer: D
Please select the outcome measures that correspond to the clinical trial below.
Title: Effectiveness of Two Types of Fixed Lingual Retainers in Preventing Mandibular Incisor Relapse
Brief Summary: The study evaluates effectiveness of two types of fixed retainers in post orthodontic patients. Half of the subjects are randomly allocated Group 1 retainer (FRC) and other half is given Group 2 retainer (MSW) and followed for a period of one year.


Options:
A: Relapse tendency (12 months)
B: Wear of removable retainer per day (hours) in the intervention and the control groups (3 months - 6 months - 12 months)
C: Oral Health-Related Quality Of Life (6 month)
D: Compliance of retainer wear (3 months)

Answer: A
Please select the outcome measures that correspond to the clinical trial below.
Title: Dialysis Adequacy and Clotting Complications During Anticoagulation-free Hemodialysis Using a Heparin-grafted Dialyzer and a Citrate-enriched Dialysate: a Prospective Randomized Crossover Study. (EvoCit-HD Study)
Brief Summary: After providing informed consent, patients will be randomized to either the intervention treatment ("EvoCit procedure") or the control treatment ("EvoHep procedure").

After randomization, each study arm consists of four weeks of 3x4 hours hemodialysis treatments according to the allocated protocol. After the last dialysis treatment of the fourth treatment week and after a long interdialytic interval, patients will crossover to the alternative hemodialysis procedure. After crossover, the study will be completed with, again, four weeks of 3x4 hours hemodialysis treatments according to the allocated protocol.


Options:
A: Rate of major, clinically important non-major or minor bleeding (26 weeks)
B: Prothrombin time (Pre-dialysis; the 2nd, 4th, 6th and 8th hours of dialysis); Activated partial thromboplastin time (Pre-dialysis; the 2nd, 4th, 6th and 8th hours of dialysis); Anti-Xa level (Pre-dialysis; the 2nd, 4th, 6th and 8th hours of dialysis; 24 hours after administration of LMWH); Dialyser urea and creatinine clearances (At 15 mins after starting hemodialysis and 15 mins before the end of hemodialysis); Dialyser thrombus score (At the end of hemodialysis (8th hour))
C: change in dialysis adequacy (every midweek dialysis session through study duration, ie 2x4 weeks)
D: Levels of osteoprotegerin after administration of UFH or LMWH used as anticoagulant therapy for hemodialysis (during and after dialysis sessions)

Answer: C
Please select the outcome measures that correspond to the clinical trial below.
Title: A Randomized Placebo-controlled Trial of ARBaclofen vs. Placebo in the Treatment of Children and Adolescents With ASD
Brief Summary: This study will examine the safety and efficacy of arbaclofen vs. placebo on social function in children and adolescents with Autism Spectrum Disorder (ASD).


Options:
A: Core autistic symptoms (ATEC) (Once every 4 weeks during the first three mounth); Side effects and adverse events questionnaire (Once every 4 weeks during the first phase(12 weeks))
B: Rate of Recruitment (19 months)
C: Vineland Adaptive Behavior Scales, Third Edition (Vineland-3) - Social Domain (16 weeks)
D: Change in Mullen Scales of Early Learning - Expressive Language Raw Score (From baseline visit to six-month visit); Change in Mullen Scales of Early Learning - Combined Age Equivalent Score (From baseline visit to six-month visit)

Answer: C
Please select the outcome measures that correspond to the clinical trial below.
Title: A Randomized Placebo-controlled Trial of ARBaclofen vs. Placebo in the Treatment of Children and Adolescents With ASD
Brief Summary: This study will examine the safety and efficacy of arbaclofen vs. placebo on social function in children and adolescents with Autism Spectrum Disorder (ASD).


Options:
A: Vineland Adaptive Behavior Scales, Third Edition (Vineland-3) - Social Domain (16 weeks)
B: Number of Participants With Improvement on the Clinical Global Impression-Improvement (CGI-I) Scale (6 Weeks)
C: Yale-Brown Obsessive Compulsive Scale (YBOCS): to measure repetitive behaviors (baseline, 2, 4, 6, 8, 10, 12, 14, 16 weeks); Aberrant Behavior Checklist (ABC): to measure aggression and irritability (baseline, 2, 4, 6, 8, 10, 12, 14, 16 weeks); Clinical Global Impression - Improvement (CGI-I): to measure global functioning (baseline, 2, 4, 6, 8, 10, 12, 14, 16 weeks)
D: Efficacy of Intranasal Oxytocin vs. Placebo on Measures of Social Function (12 and 24 weeks)

Answer: A
Please select the outcome measures that correspond to the clinical trial below.
Title: Northwell Health Visits: A Family Connects Pilot Implementation at Northwell Health
Brief Summary: Northwell Health Visits (NHV) is a three year pilot replication of the evidence-based model, Family Connects, which is a brief universal Nurse Practitioner home visiting program for new mothers and their infants. We seek to compare outcomes among mothers and infants enrolled in the NHV enhanced intervention arm, those enrolled in the NHV screening-only arm, and those in the control arm. NHV will follow a three- armed randomized control trial design.


Options:
A: Complications detected (3 days after delivery); Successful referrals (10 days after delivery (survey and administrative records)); Care Seeking Behavior around complications and well baby check-up (10 days after delivery (survey)); Knowledge of danger signs (10 days after delivery (survey)); Breastfeeding (10 days and 9 weeks after delivery (survey))
B: Number of Participants With Implant Use at Three Months (Three months)
C: Child Emergency Room Presentation Rates (Program enrollment until 24 months of Child Age.); Mother Emergency Room Presentation Rates (Program enrollment until 24 months postnatal.); Child Hospital Admissions (Program enrollment until 24 months postnatal.); Mother Hospital Admissions (Program enrollment until 24 months postnatal.)
D: DSS Investigated and Substantiated Child Maltreatment Rates (0 - 12 Years of Child Age)

Answer: C
Please select the outcome measures that correspond to the clinical trial below.
Title: Northwell Health Visits: A Family Connects Pilot Implementation at Northwell Health
Brief Summary: Northwell Health Visits (NHV) is a three year pilot replication of the evidence-based model, Family Connects, which is a brief universal Nurse Practitioner home visiting program for new mothers and their infants. We seek to compare outcomes among mothers and infants enrolled in the NHV enhanced intervention arm, those enrolled in the NHV screening-only arm, and those in the control arm. NHV will follow a three- armed randomized control trial design.


Options:
A: Child Emergency Room Presentation Rates (Program enrollment until 24 months of Child Age.); Mother Emergency Room Presentation Rates (Program enrollment until 24 months postnatal.); Child Hospital Admissions (Program enrollment until 24 months postnatal.); Mother Hospital Admissions (Program enrollment until 24 months postnatal.)
B: Quality of life assessed by World Health Organization Quality of Life Assessment Instrument (WHOQOL-Bref) (3 months); Fatigue assessed by Visual Analogue Scale for Fatigue (3 months); Sleep quality assessed by Pittsburg Sleep Quality Index (3 months)
C: HIV-related transmission acts (18 months); Baby's health status (18 months); Maternal adherence to HIV-related and general health routines (18 months); Mental health (18 months); Social support (18 months)
D: Change in receipt of primary care services - self report (2-months and 6-months Postpartum (baseline and 4-months from baseline data collection)); Change in receipt of primary care services - EMR review (2-months and 6-months Postpartum (baseline and 4-months from baseline data collection))

Answer: A