TrialPanorama/Dataset huggingface dataset:
Please select the outcome measures that correspond to the clinical trial below.
Title: Evaluation of a Web-based Psycho-Educational Program for Informal Caregivers of Patients With Alzheimer's Disease (AD).
Brief Summary: The aim of the project is to evaluate the efficacy of a web-based psycho-educational programme designed to support informal caregivers of patients with Alzheimer's disease (AD).This program focuses on information about the illness, her progression, how to prevent psychological strain using anticipation and relaxation techniques and providing a virtual space (forum) to discuss with other caregivers.


Options:
A: Perceived stress (every 3 months (between 0 and 6 months))
B: length of re-hospitalizations (at recruitment, six-month, 18-month and 36-month post-intervention)
C: Mental Component Summary of the General Health Questionaires Short Form 12 (SF-12) (3 months)
D: Revised Memory and Behavior Problems Checklist (6 Months)

Answer: A
Please select the outcome measures that correspond to the clinical trial below.
Title: Evaluation of a Web-based Psycho-Educational Program for Informal Caregivers of Patients With Alzheimer's Disease (AD).
Brief Summary: The aim of the project is to evaluate the efficacy of a web-based psycho-educational programme designed to support informal caregivers of patients with Alzheimer's disease (AD).This program focuses on information about the illness, her progression, how to prevent psychological strain using anticipation and relaxation techniques and providing a virtual space (forum) to discuss with other caregivers.


Options:
A: Change from Baseline in Health Related Quality of Life at One, Three and Six Months (One, three and six months)
B: Perceived stress (every 3 months (between 0 and 6 months))
C: Quality of Life-Alzheimer's Disease, Change From Baseline to 1 Year (Baseline to one year)
D: Effects of the WeCareAdvisor Tool on Caregiver Upset (4 weeks); Effect of the WeCareAdvisor Tool on Caregiver Confidence (4 weeks)

Answer: B
Please select the outcome measures that correspond to the clinical trial below.
Title: Preventative Omalizumab or Step-up Therapy for Severe Fall Exacerbations (ICAC-20)
Brief Summary: The purpose of this trial is to compare the efficacy of 4 to 5 months of three treatments - omalizumab, corticosteroid therapy boost, and placebo - in reducing fall exacerbations in inner-city children and adolescents with allergic persistent asthma when initiated approximately 4 -6 weeks prior to the start of the first day of each participant's school year.


Options:
A: Mean Percentage of Days With Worsening Asthma (as Measured on Daily Diaries) in Pediatric Asthmatic Participants (8 Week treatment period initiated at the beginning of a school year)
B: Asthma exacerbations (Measured at Years 1 and 2)
C: Occurrence of One or More Asthma Exacerbations (All Treatment Steps [Steps 2-5]) (90 Day outcome period); Occurrence of One or More Asthma Exacerbations (Treatment Steps 2-4) (90 Day outcome period)
D: Total Number of Asthma Exacerbations Reported During the Treatment Period (From Baseline (Week 1) until the end of treatment (up to Week 16))

Answer: C
Please select the outcome measures that correspond to the clinical trial below.
Title: Prevention of Postrape Drug Abuse: Replication Study
Brief Summary: The purpose of this study is to evaluate whether a brief intervention in video format, that includes education about reactions to assault and modeling of adaptive coping strategies, designed to reduce post assault drug use or abuse and PTSD and shown to recent victims of sexual assault at the time of receipt of post assault medical care is associated with better post-assault outcomes as compared to a comparable length video that includes pleasant imagery and relaxation instruction or standard care.


Options:
A: Severity of mental health symptoms (previous 4 weeks)
B: Drug Abuse Screening Test (DAST-10) (6 months); Alcohol Use Disorders Identification Test (AUDIT) (6 months); Cigarettes (Estimated Number) (14 days preceding 6 week, 3 month and 6 month follow-up); Amount of Alcohol Use (14 days prior to 6 week, 3 month, 6 month follow-up); Marijuana Use Frequency (14 days prior to 6 week, 3 month, 6 month follow-up)
C: Posttraumatic Stress Disorder Symptom Scale- Interview Version (PSS-I) (12 weeks); Timeline Followback Heavy Episodic Drinking Episodes (12 weeks)
D: Change in Pittsburgh Sleep Quality Index total score (Pre-Treatment; Post-Treatment 1 (5 weeks after pre-treatment); Post-Treatment 2 (20 weeks after pre-treatment); 3-month FU; 6-month FU; 12-month FU); Change in Modified PTSD Symptom Scale - Self Report total score (Pre-Treatment; Post-Treatment 1 (5 weeks after pre-treatment); Post-Treatment 2 (20 weeks after pre-treatment); 3-month FU; 6-month FU; 12-month FU)

Answer: B
Please select the outcome measures that correspond to the clinical trial below.
Title: Prevention of Postrape Drug Abuse: Replication Study
Brief Summary: The purpose of this study is to evaluate whether a brief intervention in video format, that includes education about reactions to assault and modeling of adaptive coping strategies, designed to reduce post assault drug use or abuse and PTSD and shown to recent victims of sexual assault at the time of receipt of post assault medical care is associated with better post-assault outcomes as compared to a comparable length video that includes pleasant imagery and relaxation instruction or standard care.


Options:
A: Impact of Events Scale-Revised 'IESR' (Change from Baseline PTSD symptomology at up to 5 months); The Psychology Experiment Building Language 'PEBL' Test (Change from Baseline neuropsychological functioning at up to 5 months); Generalized Anxiety Disorder 7 (GAD-7) Scale (Change from Baseline anxiety levels at up to 5 months); Patient Health Questionnaire 9 (PHQ-9) Scale (Change from Baseline depression levels at up to 5 months); Weekly Problems Rating Scale (Change from Baseline emotional and behavioural functioning at up to 5 months); Rosenberg Self-Esteem Scale 'RSES' (Change from Baseline levels of self-worth at up to 5 months); The Valued Living Questionnaire 'VLQ' (Change from Baseline quality of life issues at up to 5 months)
B: Drug Abuse Screening Test (DAST-10) (6 months); Alcohol Use Disorders Identification Test (AUDIT) (6 months); Cigarettes (Estimated Number) (14 days preceding 6 week, 3 month and 6 month follow-up); Amount of Alcohol Use (14 days prior to 6 week, 3 month, 6 month follow-up); Marijuana Use Frequency (14 days prior to 6 week, 3 month, 6 month follow-up)
C: Problem Drinking Scores at Baseline and 3 Weeks (Baseline, post-intervention (3 weeks after baseline)); Problem Drinking Scores at Baseline and 3 Months (Baseline, 3 month follow-up); Posttraumatic Stress Symptom Severity Score at Baseline and 3 Weeks (Baseline, post-intervention (3 weeks after baseline)); Posttraumatic Stress Symptom Severity Score at Baseline and 3 Months (Baseline, 3 month follow-up)
D: Effectiveness of brief intervention for decreasing problem drinking and partner violence (Weekly for 3 months; then 6 and 12 months)

Answer: B
Please select the outcome measures that correspond to the clinical trial below.
Title: Cerebral Tissue Oxygen Saturation in Preterm Neonates Below 1500g Birth Weight During the First 72 Hours
Brief Summary: The purpose of this study is to examine the range of cerebral tissue oxygen saturation in healthy and sick very low birthweight infants during the first 72 hours of life.


Options:
A: Neonatal Composite Outcome (72 hours of life)
B: closure of PDA (6 days)
C: Cerebral tissue oxygen saturation during first 72 hours of life (during first 72 hours of life)
D: The primary efficacy variable for this study will be the pain scores obtained during the study period. Procedural pain will be measured once a day by the PIPP scale. Chronic pain will be evaluated through the application of the EDIN scale 3 times a day. (7 days)

Answer: C
Please select the outcome measures that correspond to the clinical trial below.
Title: Seasonal Influenza Vaccination Reminders for Children With High-risk Conditions
Brief Summary: The objective of this study was to assess the feasibility and effectiveness of using a statewide immunization information system (IIS) to send seasonal influenza vaccine reminders from Local Health Departments (LHDs), targeting children with high-risk conditions.


Options:
A: Completion of 3 Doses of Pentavalent Vaccine (8 months of age)
B: seasonal influenza vaccination (up to 4 months following reminder notification)
C: 1) the percentage receiving any vaccine after the baseline time point (6 months after intervention); The percentage of adolescents becoming up-to-date on all needed immunizations (6 months post intervention)
D: 1) Change in up-to-date rates for 19- to 35-month-olds (who needed an immunization at baseline) in collaborative population-based counties compared to practice-based intervention counties (every 6 months for 2 years); 2) Change in percent of children (who needed an immunization at baseline) who received any additional vaccines in each type of intervention county. (every 6 months for two years)

Answer: B
Please select the outcome measures that correspond to the clinical trial below.
Title: Seasonal Influenza Vaccination Reminders for Children With High-risk Conditions
Brief Summary: The objective of this study was to assess the feasibility and effectiveness of using a statewide immunization information system (IIS) to send seasonal influenza vaccine reminders from Local Health Departments (LHDs), targeting children with high-risk conditions.


Options:
A: Change in Infant immunization status; Change in Infant well child care status
B: Proportion of Children Under 5 Years in Vulnerable Households That Have a Birth Certificate (1 year); Proportion of Children Under 5 Years in Vulnerable Households That Have Up-to-date Vaccinations (1 year); Proportion of Children Aged 6-12 Years That Attended Primary School 80% of Days in the Last Month (1 year)
C: EPI vaccines and other health interventions coverage (1 year); Molecular makers of resistance of P. falciparum to Sulfaxodine- pyrimethamine (1 year)
D: seasonal influenza vaccination (up to 4 months following reminder notification)

Answer: D
Please select the outcome measures that correspond to the clinical trial below.
Title: Neck Exercises, Physical and Cognitive Behavioural Graded Activity as a Treatment for Adult Whiplash Patients With Chronic Neck Pain
Brief Summary: The purpose of this study is to test whether a physiotherapy intervention containing pain management, general training and specific neck exercises can improve function for patients with chronic neck pain.


Options:
A: N/A
B: Medical Outcomes Study Short Form 36 (SF36) - Physical Component Summary (PCS) (12 months)
C: Neck Pain (Up to 10 months)
D: neck/shoulder pain, selfreported (20 weeks)

Answer: B
Please select the outcome measures that correspond to the clinical trial below.
Title: A Randomised, Double-blind, Parallel Group Study to Assess the Efficacy and Safety of 52 Weeks of Once Daily Treatment of Orally Inhaled Tiotropium + Olodaterol Fixed Dose Combination (2.5 µg / 5 µg; 5 µg / 5 µg) (Delivered by the Respimat® Inhaler) Compared With the Individual Components (2.5 µg and 5 µg Tiotropium, 5 µg Olodaterol) (Delivered by the Respimat® Inhaler) in Patients With Chronic Obstructive Pulmonary Disease (COPD). [TOnado TM 1]
Brief Summary: The overall objective of this study is to assess the efficacy and safety of 52 weeks once daily treatment with orally inhaled tiotropium + olodaterol FDC (delivered by the RESPIMAT Inhaler) compared with the individual components ( tiotropium, olodaterol) (delivered by the RESPIMAT Inhaler) in patients with Chronic Obstructive Pulmonary Disease (COPD).


Options:
A: Change From Baseline (BL) in Trough Forced Expiratory Volume in One Second (FEV1) on Day 169 (Week 24) (Baseline and Day 169)
B: Peak Forced Expiratory Volume in One Second (FEV1) at Week 24 (At Week 24)
C: Change From Baseline in Trough Forced Expiratory Volume in One Second (FEV1) on Treatment Day 85 (Visit 8) (Baseline (BL) and Day 85)
D: Forced Expiratory Volume in One Second (FEV1) Area Under the Curve (AUC) (0-3h) Response on Day 169. (1 hour (h) and 10 minutes (min) prior to dose to on the first day of randomized treatment and on Day 169 and 5 min, 15 min, 30 min, 1 h, 2 h, 3 h post-dose on Day 169.); Trough FEV1 Response on Day 170. (1 h and 10 min prior to dose on the first day of randomized treatment (baseline) and at 23 h and at 23 h 50 min after inhalation of study medication on Day 170); Saint George's Respiratory Questionnaire (SGRQ) Total Score on Day 169 From the Two Twin Trials, Present 1237.5 (NCT01431274) and 1237.6 (NCT01431287) (Day 169)

Answer: D
Please select the outcome measures that correspond to the clinical trial below.
Title: A Randomised, Double-blind, Parallel Group Study to Assess the Efficacy and Safety of 52 Weeks of Once Daily Treatment of Orally Inhaled Tiotropium + Olodaterol Fixed Dose Combination (2.5 µg / 5 µg; 5 µg / 5 µg) (Delivered by the Respimat® Inhaler) Compared With the Individual Components (2.5 µg and 5 µg Tiotropium, 5 µg Olodaterol) (Delivered by the Respimat® Inhaler) in Patients With Chronic Obstructive Pulmonary Disease (COPD). [TOnado TM 1]
Brief Summary: The overall objective of this study is to assess the efficacy and safety of 52 weeks once daily treatment with orally inhaled tiotropium + olodaterol FDC (delivered by the RESPIMAT Inhaler) compared with the individual components ( tiotropium, olodaterol) (delivered by the RESPIMAT Inhaler) in patients with Chronic Obstructive Pulmonary Disease (COPD).


Options:
A: Endurance Time During Endurance Shuttle Walk Test (ESWT) to Symptom Limitation After 8 Weeks (Week 8)
B: FEV1 AUC0-3h Response at 12 Weeks; Defined as Change From Baseline to Week 12 (baseline and 12 weeks); Trough FEV1 Response at 12 Weeks; Defined as Change From Baseline to Week 12 (baseline and 12 weeks)
C: Forced Expiratory Volume in One Second (FEV1) Area Under the Curve (AUC) (0-3h) Response on Day 169. (1 hour (h) and 10 minutes (min) prior to dose to on the first day of randomized treatment and on Day 169 and 5 min, 15 min, 30 min, 1 h, 2 h, 3 h post-dose on Day 169.); Trough FEV1 Response on Day 170. (1 h and 10 min prior to dose on the first day of randomized treatment (baseline) and at 23 h and at 23 h 50 min after inhalation of study medication on Day 170); Saint George's Respiratory Questionnaire (SGRQ) Total Score on Day 169 From the Two Twin Trials, Present 1237.5 (NCT01431274) and 1237.6 (NCT01431287) (Day 169)
D: FEV1 AUC0-24 on Day 29 (Day 29)

Answer: C
Please select the outcome measures that correspond to the clinical trial below.
Title: A Randomised, Double-blind, Parallel Group Study to Assess the Efficacy and Safety of 52 Weeks of Once Daily Treatment of Orally Inhaled Tiotropium + Olodaterol Fixed Dose Combination (2.5 µg / 5 µg; 5 µg / 5 µg) (Delivered by the Respimat® Inhaler) Compared With the Individual Components (2.5 µg and 5 µg Tiotropium, 5 µg Olodaterol) (Delivered by the Respimat® Inhaler) in Patients With Chronic Obstructive Pulmonary Disease (COPD) [TOnado TM 2]
Brief Summary: The overall objective of this study is to assess the efficacy and safety of 52 weeks once daily treatment with orally inhaled tiotropium + olodaterol FDC (delivered by the RESPIMAT Inhaler) compared with the individual components (tiotropium, olodaterol) (delivered by the RESPIMAT Inhaler) in patients with COPD.


Options:
A: Trough Forced Expiratory Volume in 1 Second (FEV1) 24 Hours Post-dose at the End of Treatment (Week 12 + 1 Day, Day 85) (End of treatment (Week 12 + 1 day, Day 85))
B: Change From Baseline in Morning Pre-dose (Trough) Forced Expiratory Volume in the First Second (FEV1) at Week 24 on Treatment (Baseline and Week 24); Change From Baseline in Morning Pre-dose (Trough) Forced Expiratory Volume in the First Second (FEV1) at Week 12 on Treatment (Baseline and Week 12)
C: Total Total Transient Dyspnea Index (TDI) Score After 6 Weeks of Treatment QVA149 Compared to Placebo (Baseline and 6 weeks)
D: Forced Expiratory Volume in One Second (FEV1) Area Under the Curve (AUC) (0-3h) Response on Day 169 (1 hour (h) and 10 minutes (min) prior to dose to on the first day of randomized treatment and on Day 169 and 5 min, 15 min, 30 min, 1 h, 2 h, 3 h post-dose on Day 169); Trough FEV1 Response on Day 170 (1 h and 10 min prior to dose on the first day of randomized treatment (baseline) and at 23 h and at 23 h 50 min after inhalation of study medication on Day 170); Saint George's Respiratory Questionnaire (SGRQ) Total Score on Day 169 From the Two Twin Trials, Present 1237.6 (NCT01431287) and 1237.5 (NCT01431274). (Day 169)

Answer: D
Please select the outcome measures that correspond to the clinical trial below.
Title: A Randomised, Double-blind, Parallel Group Study to Assess the Efficacy and Safety of 52 Weeks of Once Daily Treatment of Orally Inhaled Tiotropium + Olodaterol Fixed Dose Combination (2.5 µg / 5 µg; 5 µg / 5 µg) (Delivered by the Respimat® Inhaler) Compared With the Individual Components (2.5 µg and 5 µg Tiotropium, 5 µg Olodaterol) (Delivered by the Respimat® Inhaler) in Patients With Chronic Obstructive Pulmonary Disease (COPD) [TOnado TM 2]
Brief Summary: The overall objective of this study is to assess the efficacy and safety of 52 weeks once daily treatment with orally inhaled tiotropium + olodaterol FDC (delivered by the RESPIMAT Inhaler) compared with the individual components (tiotropium, olodaterol) (delivered by the RESPIMAT Inhaler) in patients with COPD.


Options:
A: FEV1 AUC0-3h Response at 12 Weeks; Defined as Change From Baseline to Week 12 (baseline and 12 weeks); Trough FEV1 Response at 12 Weeks; Defined as Change From Baseline to Week 12 (baseline and 12 weeks)
B: Change From Baseline (BL) in Trough Forced Expiratory Volume in One Second (FEV1) on Day 169 (Week 24) (Baseline and Day 169)
C: Forced Expiratory Volume in One Second (FEV1) Area Under the Curve (AUC) (0-3h) Response on Day 169 (1 hour (h) and 10 minutes (min) prior to dose to on the first day of randomized treatment and on Day 169 and 5 min, 15 min, 30 min, 1 h, 2 h, 3 h post-dose on Day 169); Trough FEV1 Response on Day 170 (1 h and 10 min prior to dose on the first day of randomized treatment (baseline) and at 23 h and at 23 h 50 min after inhalation of study medication on Day 170); Saint George's Respiratory Questionnaire (SGRQ) Total Score on Day 169 From the Two Twin Trials, Present 1237.6 (NCT01431287) and 1237.5 (NCT01431274). (Day 169)
D: Trough Forced Expiratory Volume in 1 Second (FEV1) at End of Treatment (Week 12) (End of treatment (Week 12))

Answer: C
Please select the outcome measures that correspond to the clinical trial below.
Title: Prospective Double Blind Multicentre Randomized Trial of Vitamine D Estimating the Profit of a Treatment by Vitamin D3 at the Dose of 100000 UI by Comparison With a Treatment in the Dose of 12 000 UI at Renal Transplanted Patients
Brief Summary: It has been proposed that the intake of high dose of cholecalciferol may have beneficial non classical effects (beside bone health). This could include the reduction of type 2 diabetes mellitus, cardiovascular diseases, cancers, autoimmune and infectious diseases. These pleiotropic effects are mostly documented by observational and experimental studies or small intervention trials. In renal transplant recipients, vitamin D insufficiency, defined as circulating 25(OH)vitamin D (25OHD) less than 30 ng/mL, is a frequent finding and this population is at risk of the previously cited complications.The primary purpose of this study is to compare the effects of high dose vs. low dose of cholecalciferol on a composite endpoint consisting in de novo diabetes mellitus, cardiovascular diseases, de novo cancer and patient death.Renal transplant recipients between 12 and 48 months after transplantation will be randomized to blindly receive either high or low dose of cholecalciferol with a follow-up of 2 years.


Options:
A: De novo diabetes mellitus (2 years); Cardiovascular complications (2 years); De novo cancer (2 years); Patient death (2 years)
B: Correction of metabolic acidosis (12 months)
C: N/A
D: Proportion of subjects with a mean reduction of greater than or equal to 30% in iPTH at 32 weeks

Answer: A
Please select the outcome measures that correspond to the clinical trial below.
Title: A Randomised, Double-blind, Multi-centre Study to Evaluate the Efficacy and Safety of Inhaled Fluticasone Furoate in the Treatment of Persistent Asthma in Adults and Adolescents Currently Receiving Mid to High Strength Inhaled Corticosteroids.
Brief Summary: A randomised, double-blind, multi-centre study to evaluate the efficacy and safety of two doses of inhaled fluticasone furoate in the treatment of persistent asthma in adults and adolescents currently receiving mid to high strength inhaled corticosteroids.


Options:
A: FEV1 peak0-3 Change From Baseline (Baseline and 12 weeks)
B: Change From Baseline in Clinic Visit Evening (Pre-bronchodilator and Pre-dose) Forced Expiratory Volume in One Second (FEV1) at the End of the 24-week Treatment Period (Baseline and Week 24)
C: Peak FEV1 Within 3 Hours Post-dose Response (24 weeks); Trough FEV1 Response (24 weeks); The Responder Rate as Assessed by the ACQ From the Two Twin Trials 205.418 (NCT01172808) and the Present 205.419 (NCT01172821) (24 weeks)
D: Change in Forced Expiratory Volume in 1 s (FEV-1) over 12 weeks recorded in electronic diary. Discontinuation due to lack of efficacy (Week 0 and 12 visits)

Answer: B
Please select the outcome measures that correspond to the clinical trial below.
Title: A Randomised, Double-blind, Multi-centre Study to Evaluate the Efficacy and Safety of Inhaled Fluticasone Furoate in the Treatment of Persistent Asthma in Adults and Adolescents Currently Receiving Mid to High Strength Inhaled Corticosteroids.
Brief Summary: A randomised, double-blind, multi-centre study to evaluate the efficacy and safety of two doses of inhaled fluticasone furoate in the treatment of persistent asthma in adults and adolescents currently receiving mid to high strength inhaled corticosteroids.


Options:
A: Participants With Treatment-Emergent Adverse Experiences (TEAE) During the Treatment Period (Day 1 to Week 26 of the Treatment Period)
B: Change From Baseline in Weighted-mean 24-hour Serial Forced Expiratory Volume in One Second (FEV1) at Week 12 (Baseline and Week 12)
C: Peak FEV1 Within 3 Hours Post-dose Response (24 weeks); Trough FEV1 Response (24 weeks); The Responder Rate as Assessed by the ACQ From the Two Twin Trials 205.418 (NCT01172808) and the Present 205.419 (NCT01172821) (24 weeks)
D: Change From Baseline in Clinic Visit Evening (Pre-bronchodilator and Pre-dose) Forced Expiratory Volume in One Second (FEV1) at the End of the 24-week Treatment Period (Baseline and Week 24)

Answer: D
Please select the outcome measures that correspond to the clinical trial below.
Title: Enhancing Human Intestinal Absorption of Carotenoids and Bioconversion of Carotene to Vitamin A in the Presence of Hass Avocados
Brief Summary: Vitamin A is necessary in the human diet. The form of vitamin A found in fruits and vegetables is not "active" and must be converted to the active form in the human body. However, information on the ability of humans to absorb and convert vitamin A to the active form is still lacking. In this study, the investigators will observe the absorption and conversion of vitamin A from orange tomato sauce and/or carrots after a meal with fat (from avocado fruit) and a meal without fat. The investigators will also test whether eating these foods might protect the blood against damage that could lead to heart disease.


Options:
A: Post-prandial levels of provitamin A and vitamin A (Nine post-prandial blood samples will be taken over twelve hours)
B: Diarrhea; Pneumonia; Febrile illness; Growth; Development; Activity
C: N/A
D: Morbidity (0 months, 6 months, 12 months); Growth (0 months, 6 months, 12 months); Development (0 months, 6 months, 12 months); School performance (0 months, 6 months, 12 months); Status Indicators for iron, zinc, vitamin A and iodine (0 months, 6 months, 12 months)

Answer: A