TrialPanorama/Dataset huggingface dataset:
Please select the outcome measures that correspond to the clinical trial below.
Title: A Randomised, Double-blind, Placebo-controlled, Multi-national, Phase IIIb Study to Assess the Sustained Clinical Effect and Safety of Sublingual Immunotherapy Administered as Birch Pollen Extract Solution at a Dose of 300 IR Once Daily to Patients Suffering From Birch Pollen-induced Rhinoconjunctivitis
Brief Summary: The purpose of this 2-year study is to assess the sustained clinical efficacy and safety of 300 IR/day of a sublingual solution of birch pollen allergen extract starting 4 months prior to the birch pollen season and continuing over the birch pollen season compared with placebo for reduction of rhinoconjunctivitis-related symptoms and anti-allergy medication usage.


Options:
A: Combined Score (CS) (Pollen period (average of 42.8 days))
B: Average Adjusted Symptom Score (Year 2 of treatment)
C: Immunological mechanisms of SLIT by phenotyping different subsets of cytokine positive T cells, regulatory T cells, and memory T cells in peripheral blood of subjects before, during and after immunotherapy. (12 and 24 months); -Expression of "immunoregulatory" cytokines by CD4+ T (12 and 24 months); cells (12 and 24 months); - Helper, regulatory and memory T cell subsets (12 and 24 months); (a) Helper T cells (12 and 24 months); (b) Regulatory T cells (12 and 24 months); b1- Regulatory T cell phenotype (12 and 24 months); b2- Regulatory T cell function (12 and 24 months)
D: Use of inhaled corticosteroid (ICS).

Answer: B
Please select the outcome measures that correspond to the clinical trial below.
Title: A Randomised, Double-blind, Placebo-controlled, Multi-national, Phase IIIb Study to Assess the Sustained Clinical Effect and Safety of Sublingual Immunotherapy Administered as Birch Pollen Extract Solution at a Dose of 300 IR Once Daily to Patients Suffering From Birch Pollen-induced Rhinoconjunctivitis
Brief Summary: The purpose of this 2-year study is to assess the sustained clinical efficacy and safety of 300 IR/day of a sublingual solution of birch pollen allergen extract starting 4 months prior to the birch pollen season and continuing over the birch pollen season compared with placebo for reduction of rhinoconjunctivitis-related symptoms and anti-allergy medication usage.


Options:
A: Pharmacodynamics - Immunological assessments (Pre- and post treatment)
B: N/A
C: Average Total Nasal Symptom Score (TNSS) During Environmental Exposure Chamber (EEC) Challenge Session at Week 24 (Week 24)
D: Average Adjusted Symptom Score (Year 2 of treatment)

Answer: D
Please select the outcome measures that correspond to the clinical trial below.
Title: Efficacy of Narrative Exposure Therapy (NET) in a Sample of Iranian Women Exposed to Intimate Partner Violence (IPV)
Brief Summary: The proposed study seeks to investigate to what extent Narrative Exposure Therapy (NET) is an effective treatment for the reduction of symptoms of Post-Traumatic Stress Disorder (PTSD) and depression and for the improvement of daily functioning in Iranian women who have experienced intimate partner violence (IPV). In addition, the study seeks to investigate whether NET therapy could lead to the reduction of Intimate Partner Violence (IPV) within their marriage.


Options:
A: Change in telomerase activity (pre-intervention (baseline) and post-intervention (5.5 months later))
B: Posttraumatic Diagnostic Scale (PDS/PSS-I). (Symptoms will be assessed at pre-treatment-point and post-treatment-point (up to 6-month follow-ups)); The Patient Health Questionnaire-9 (PHQ-9) (At pre-treatment-point, post-treatment-point, and 3- and 6-month follow-ups); The Hopkins Symptom Checklist-25 (HSCL-25) (At pre-treatment-point, post-treatment-point, and 3- and 6-month follow-ups); Perceived Stress Scale-4 (At pre-treatment-point, post-treatment-point and 3- and 6-month follow-ups)
C: Reduction of risk behaviors:; Active smoking; Environmental Tobacco Smoke Exposure; Depression; Intimate Partner Violence
D: Composite Abuse Scale (CAS)-CAS Victimization Total Score (Assessed at baseline, and again three months later); Safety Behavior Checklist (SBC) (Assessed at baseline, and again three months later); Effectiveness in Obtaining Resources Scale (EOR) (Assessed at baseline, and again three months later)

Answer: B
Please select the outcome measures that correspond to the clinical trial below.
Title: Efficacy of Narrative Exposure Therapy (NET) in a Sample of Iranian Women Exposed to Intimate Partner Violence (IPV)
Brief Summary: The proposed study seeks to investigate to what extent Narrative Exposure Therapy (NET) is an effective treatment for the reduction of symptoms of Post-Traumatic Stress Disorder (PTSD) and depression and for the improvement of daily functioning in Iranian women who have experienced intimate partner violence (IPV). In addition, the study seeks to investigate whether NET therapy could lead to the reduction of Intimate Partner Violence (IPV) within their marriage.


Options:
A: Clinician Assessed Severity of PTSD (Baseline, 16, 24 and 32 weeks)
B: Number of Participants Receiving Prolonged Exposure Treatment via Telemedicine with significantly decreased PTSD symptoms Compared to Number of Participants Receiving Prolonged Exposure Treatment with Standard In-Person Delivery (36 weeks)
C: Posttraumatic Diagnostic Scale (PDS/PSS-I). (Symptoms will be assessed at pre-treatment-point and post-treatment-point (up to 6-month follow-ups)); The Patient Health Questionnaire-9 (PHQ-9) (At pre-treatment-point, post-treatment-point, and 3- and 6-month follow-ups); The Hopkins Symptom Checklist-25 (HSCL-25) (At pre-treatment-point, post-treatment-point, and 3- and 6-month follow-ups); Perceived Stress Scale-4 (At pre-treatment-point, post-treatment-point and 3- and 6-month follow-ups)
D: Composite Abuse Scale (CAS)-CAS Victimization Total Score (Assessed at baseline, and again three months later); Safety Behavior Checklist (SBC) (Assessed at baseline, and again three months later); Effectiveness in Obtaining Resources Scale (EOR) (Assessed at baseline, and again three months later)

Answer: C
Please select the outcome measures that correspond to the clinical trial below.
Title: Improving Communication and Health for Adolescents With Technology - Implementation of Immunization Strategy
Brief Summary: The human papillomavirus (HPV) vaccine is routinely recommended for both adolescent girls and boys starting at age 11, although it can be offered as young as 9 years of age. This is a 3-dose series and many adolescents do not complete it after getting the first dose. This study will study how effective it will be to send reminders to parents to schedule an appointment when their child is due for the next dose of HPV. Parents can chose whether they would like a phone call or text message reminder. This study will determine if the reminders work, and if one method is better than another (phone message vs. text message).


Options:
A: On-time Completion of the Human Papillomavirus Vaccine Series (32 weeks after receipt of initial vaccine)
B: The proportion of subjects who attain the LDL-C levels set as targets by the Guidelines for Management of Dyslipidaemias and CVR (24 months)
C: HPV completion rate (One Year)
D: self-reported status of the series of HBV vaccinations by follow-up calls in seven months after mailing the results verified by the medical records (Seven months after mailing the results)

Answer: C
Please select the outcome measures that correspond to the clinical trial below.
Title: Improving Communication and Health for Adolescents With Technology - Implementation of Immunization Strategy
Brief Summary: The human papillomavirus (HPV) vaccine is routinely recommended for both adolescent girls and boys starting at age 11, although it can be offered as young as 9 years of age. This is a 3-dose series and many adolescents do not complete it after getting the first dose. This study will study how effective it will be to send reminders to parents to schedule an appointment when their child is due for the next dose of HPV. Parents can chose whether they would like a phone call or text message reminder. This study will determine if the reminders work, and if one method is better than another (phone message vs. text message).


Options:
A: HIV propensity score (0, 6 and 12 months)
B: HPV completion rate (One Year)
C: Acceptability of at least one method of effective contraception (4 months)
D: Highly-effective contraceptive use (6 months postpartum)

Answer: B
Please select the outcome measures that correspond to the clinical trial below.
Title: Improving Communication and Health for Adolescents With Technology - Implementation of Immunization Strategy
Brief Summary: The human papillomavirus (HPV) vaccine is routinely recommended for both adolescent girls and boys starting at age 11, although it can be offered as young as 9 years of age. This is a 3-dose series and many adolescents do not complete it after getting the first dose. This study will study how effective it will be to send reminders to parents to schedule an appointment when their child is due for the next dose of HPV. Parents can chose whether they would like a phone call or text message reminder. This study will determine if the reminders work, and if one method is better than another (phone message vs. text message).


Options:
A: HPV completion rate (One Year)
B: Self-reported completion of a full course of PEP medications and receipt of a final HIV test result from their nPEP provider 12 weeks after the index exposure (12 weeks)
C: ART Adherence at 20 Weeks as Determined by VAS, Viral Load (20week [End of study]); ART Adherence at 20 Weeks as Determined by Pill Counts, ACTG Adherence Questionnaire, and VAS Scores (20week [End of study]); ART Adherence at 20 Weeks as Determined by Viral Load Count (20 week [End of study]); ART Adherence at 20 Weeks as Determined by Log of Viral Load Count (20week [End of study])
D: Acceptability of at least one method of effective contraception (4 months)

Answer: A
Please select the outcome measures that correspond to the clinical trial below.
Title: MAINtenance of Remission Using RITuximab in Systemic ANCA-associated Vasculitis II
Brief Summary: The aim of this study is to assess the efficacy of a rituximab regimen based on rate of ANCA and CD19 lymphocytes for maintenance treatment in systemic ANCA-associated vasculitis: prospective, multicenter, controlled, randomized comparative study of two rituximab regimens: one based on ANCA and CD19 lymphocytes versus systematic infusions.


Options:
A: Disease Remission (6 months post-randomization)
B: Time to First Relapse (Approximately up to 4 years)
C: Discover biomarkers in GPA/MPA capable of measuring disease activity and response to treatment. (Study completion)
D: Number of relapses (at 28 months)

Answer: D
Please select the outcome measures that correspond to the clinical trial below.
Title: A Comparative, Randomised Controlled Trial for Evaluating the Efficacy of Dexamethasone in the Treatment of Patients With Acute Respiratory Distress Syndrome
Brief Summary: BACKGROUND: Currently, there is no proven pharmacologic treatment for patients with the acute respiratory distress syndrome (ARDS). Great interest remains in the use of corticosteroids for the salvage of patients with severe acute lung injury in the early phase of their disease process, a situation that that has not been evaluated in most published trials. Dexamethasone has never been evaluated in ARDS in a randomized controlled fashion.

HYPOTHESIS AND OBJECTIVES: The investigators hypothesize that adjunctive treatment with intravenous dexamethasone of patients with established ARDS might change the pulmonary and systemic inflammatory response and thereby will increase the number of ventilator-free days and will decrease the extremely high overall mortality. Our goal is to examine the effects of dexamethasone on length of duration of mechanical ventilation (assessed by number of ventilator-free days) and on mortality, in patients admitted into a network of Spanish intensive care units (ICUs) who still meet ARDS criteria at 24 hours after ARDS onset.


Options:
A: Hospital Mortality to Day 60. (60 days after randomization)
B: Ventilator free-days (28 days)
C: change in extravascular lung water within 7 days of treatment (change from baseline - day 7)
D: Number of Ventilator Free Days (VFD) (Determined 28 days after a subject entered the study)

Answer: B
Please select the outcome measures that correspond to the clinical trial below.
Title: A Prospective Randomized Clinical Trial of Two Surgical Techniques for Pancreaticojejunostomy in Patients Undergoing Pancreaticoduodenectomy: Nonstented Stump-closed vs Duct-to-Mucosa Pancreaticojejunostomy
Brief Summary: Pancreaticojejunostomy is the key procedure of pancreaticoduodenectomy. The aim of our study is to investigate a new pancreaticojejunal (PJ) anastomosis procedure named "nonstented stump-closed pancreaticojejunostomy" in pancreatoduodenectomy, which could provide a feasible option to pancreatic surgeons for patients with pancreaticoduodenectomy.


Options:
A: postoperative pancreatic fistula(POPF) rate (30 days)
B: POPF (up to 30 days)
C: the postoperative pancreatic fistula(POPF) rate (30 days)
D: Rate of clinically relevant postoperative pancreatic fistula (POPF) (Up to 60 days after Surgery)

Answer: C
Please select the outcome measures that correspond to the clinical trial below.
Title: Multicenter Open-label RCT to Compare Colistin Alone vs. Colistin Plus Meropenem
Brief Summary: The purpose of this study is to determine whether the addition of meropenem to colistin is better than colistin alone in the treatment of clinically significant infections caused by multi-drug resistant bacteria


Options:
A: Clinical cure rate (the ratio of the number of clinically cured patients to the total number of patients in the population) (7 to 14 days after the end of therapy (EOT))
B: Treatment Failure at 48 Hours (Two Full Days After Enrollment) (48 hours)
C: Clinical success (14 days)
D: Adverse Events (Analysis of AEs assessed during the first 3 days of IV therapy and while on IV, a median of 7 days)

Answer: C
Please select the outcome measures that correspond to the clinical trial below.
Title: Calcium Plus Vitamin D Supplementation During Pregnancy of Adolescent Mothers: Effects on Maternal and Infant Bone Mass, Calcium and Bone Metabolism and Breast Milk Composition
Brief Summary: Pregnancy and lactation are periods of high calcium requirement. Inadequate maternal calcium intake and vitamin D insufficiency may adversely affect fetal and neonatal growth and maternal bone mass particularly in adolescent mothers. The investigators propose to evaluate the influence of calcium plus vitamin D supplementation during pregnancy on bone mass of lactating adolescent mothers with habitually low calcium and vitamin D, on fetal growth and neonate bone mass. Mothers are randomly assigned to receive daily calcium (600 mg) plus vitamin D3 (200 IU) supplement or placebo from mid gestation until parturition. Fetal growth parameters are assessed by standard ultrasound techniques at mid and late gestation. Maternal bone mass is assessed by dual energy x-ray absorptiometry (DXA) at 2 and 5 months postpartum and 6 months after weaning. Infant bone mass is assessed by DXA at 2 months postpartum.


Options:
A: Prevalence in plasma 25OHD and parathyroid hormone at birth (at birth (baseline))
B: Number of Infants With Recurrent Wheezing (up to 12 months adjusted age)
C: Equivalency of isoforms (3 months)
D: Differences in maternal bone mass changes postpartum between supplemented and placebo groups (2, 5 and 12 months postpartum); Differences in fetal growth and infant bone mass between supplemented and placebo groups (2nd and 3rd trimester gestation and 2 mo postpartum)

Answer: D
Please select the outcome measures that correspond to the clinical trial below.
Title: Calcium Plus Vitamin D Supplementation During Pregnancy of Adolescent Mothers: Effects on Maternal and Infant Bone Mass, Calcium and Bone Metabolism and Breast Milk Composition
Brief Summary: Pregnancy and lactation are periods of high calcium requirement. Inadequate maternal calcium intake and vitamin D insufficiency may adversely affect fetal and neonatal growth and maternal bone mass particularly in adolescent mothers. The investigators propose to evaluate the influence of calcium plus vitamin D supplementation during pregnancy on bone mass of lactating adolescent mothers with habitually low calcium and vitamin D, on fetal growth and neonate bone mass. Mothers are randomly assigned to receive daily calcium (600 mg) plus vitamin D3 (200 IU) supplement or placebo from mid gestation until parturition. Fetal growth parameters are assessed by standard ultrasound techniques at mid and late gestation. Maternal bone mass is assessed by dual energy x-ray absorptiometry (DXA) at 2 and 5 months postpartum and 6 months after weaning. Infant bone mass is assessed by DXA at 2 months postpartum.


Options:
A: Asthma or Recurrent Wheeze in First 3 Years of Life (First 3 years of life.); Achieved Maternal 25(OH)D Level of ≥ 30 ng/mL at Third Trimester Sampling. (32-38 weeks gestation)
B: 25-Hydroxyvitamin D Concentration (7 months)
C: Differences in maternal bone mass changes postpartum between supplemented and placebo groups (2, 5 and 12 months postpartum); Differences in fetal growth and infant bone mass between supplemented and placebo groups (2nd and 3rd trimester gestation and 2 mo postpartum)
D: Change in T-cell cytokine expression (16-20 wks, 26-28 wks, and 36 wks gestation)

Answer: C
Please select the outcome measures that correspond to the clinical trial below.
Title: Effects of Homebased Training With Telemonitoring Guidance in Low to Moderate Risk Patients Entering Cardiac Rehabilitation
Brief Summary: Physical exercise training appears effective for low to moderate patients assigned to cardiac rehabilitation. However, adherence to cardiac rehabilitation is low and physical activity levels often drop after attending the last supervised rehabilitation session.

This study will compare home based physical exercise training including telemonitoring with regular centre based physical exercise training. Main outcome measures are the change in physical activity and the change in physical fitness (peak Oxygen uptake) after the initial rehabilitation period (12 weeks) and after 1 year. Secondary outcome measures are cost-effectiveness, training adherence, health-related quality of life and patient satisfaction.


Options:
A: exercise tolerance (1 year); exercise tolerance (12 weeks)
B: Physical Fitness (Measured after 12 weeks and after one year); Physical Activity Level (PAL) (measured after 12 weeks and after one year)
C: Mental health related quality of life (SF-36 questionnaire mental scores) (12 month follow-up); Incremental cost-effectiveness ratio (ICER) (12 month follow-up)
D: Readmission and death rate at 6 months' follow up.

Answer: B
Please select the outcome measures that correspond to the clinical trial below.
Title: Effects of Homebased Training With Telemonitoring Guidance in Low to Moderate Risk Patients Entering Cardiac Rehabilitation
Brief Summary: Physical exercise training appears effective for low to moderate patients assigned to cardiac rehabilitation. However, adherence to cardiac rehabilitation is low and physical activity levels often drop after attending the last supervised rehabilitation session.

This study will compare home based physical exercise training including telemonitoring with regular centre based physical exercise training. Main outcome measures are the change in physical activity and the change in physical fitness (peak Oxygen uptake) after the initial rehabilitation period (12 weeks) and after 1 year. Secondary outcome measures are cost-effectiveness, training adherence, health-related quality of life and patient satisfaction.


Options:
A: Mortality rate (10-year)
B: VO2peak (baseline, after 12 weeks and after 1 year)
C: Psychologic aspect (8 weeks); Functional capacity (8 weeks); Disability level (8 weeks); Quality of life (8 weeks)
D: Physical Fitness (Measured after 12 weeks and after one year); Physical Activity Level (PAL) (measured after 12 weeks and after one year)

Answer: D
Please select the outcome measures that correspond to the clinical trial below.
Title: Effects of Homebased Training With Telemonitoring Guidance in Low to Moderate Risk Patients Entering Cardiac Rehabilitation
Brief Summary: Physical exercise training appears effective for low to moderate patients assigned to cardiac rehabilitation. However, adherence to cardiac rehabilitation is low and physical activity levels often drop after attending the last supervised rehabilitation session.

This study will compare home based physical exercise training including telemonitoring with regular centre based physical exercise training. Main outcome measures are the change in physical activity and the change in physical fitness (peak Oxygen uptake) after the initial rehabilitation period (12 weeks) and after 1 year. Secondary outcome measures are cost-effectiveness, training adherence, health-related quality of life and patient satisfaction.


Options:
A: VO2peak (baseline, after 12 weeks and after 1 year)
B: Cardiopulmonary function (Measured at Week 8)
C: Quality of life (At inclusion (baseline), change from baseline at 3, 6 and 12 months)
D: Physical Fitness (Measured after 12 weeks and after one year); Physical Activity Level (PAL) (measured after 12 weeks and after one year)

Answer: D
Please select the outcome measures that correspond to the clinical trial below.
Title: Intensive Outpatient Protocol for High Risk Suicidal Teens
Brief Summary: This study will identify the effectiveness of an intensive treatment program for teens who are at high risk for harming themselves.


Options:
A: Self-stigma related to suicide attempt (2 weeks)
B: Change from baseline on the Self-Injurious Thoughts and Behaviors Interview-Short Form (self-report) at follow-up (Pre-assessment and post-assessment (after intervention or two weeks from baseline))
C: Change in BHS Scores (Baseline, 6 weeks, and 12 weeks)
D: Suicide attempts (Measured at 18 months from Baseline)

Answer: D
Please select the outcome measures that correspond to the clinical trial below.
Title: V-TIME: A Treadmill Training Program Augmented by Virtual Reality to Decrease Fall Risk in Older Adults, Patients With Parkinson's Disease and Individuals With Mild Cognitive Impairments
Brief Summary: The proposed randomized controlled trial will evaluate the effects of treadmill training augmented with virtual reality on fall risk.

300 older adults with a history of falls will be recruited to participate in this study. This will include older adults (n=100), patients with mild cognitive impairment (MCI) (n=100), and patients with Parkinson's disease (PD)(n=100). Subjects will be randomly assigned to the intervention group (treadmill training with virtual reality) or to the active-control group (treadmill training without virtual reality). Each person will participate in a training program set in an outpatient setting 3 times per week for 6 weeks. Assessments will take place before, after, and 1 month and 6 months after the completion of the training.


Options:
A: Change from baseline in executive function at 6-months (Baseline and 6-months)
B: Change in cognitive function after three months of exercise. (3 months)
C: Falls rate (6 months post intervention)
D: Changes in Global Cognition (Both, the pre- and the post-measurements of the primary outcome measurement will take place within two weeks prior to starting or after completing the intervention.)

Answer: C