TrialPanorama/Dataset huggingface dataset:
Please select the outcome measures that correspond to the clinical trial below.
Title: Vitamin D vs. Placebo in the Prevention of Viral-induced Exacerbations in Preschoolers With Asthma: a Pilot RCT
Brief Summary: Viral infections are the main cause of asthma attacks in preschoolers, an age group with the highest rate of emergency visits due to asthma. While high doses of inhaled or oral corticosteroids provide benefits, these have been associated with adverse outcomes. Most asthmatic children have lower blood levels of vitamin D compared to non-asthmatic children. Low vitamin D level has been linked to more frequent and more severe asthma attacks as well as with higher dose requirement of inhaled corticosteroid. Recent studies show that vitamin D supplements can reduce the number of asthma attacks triggered by viral infections in children. Unfortunately, most people forget to take vitamin D every day during the fall and winter season as recommended in Canada. A solution is to give a vitamin D bolus by mouth. This has been shown to safely and effectively increase vitamin D levels in children. The investigators hypothesise that a vitamin D bolus given in clinic will sufficiently increase the blood level of vitamin D to prevent the expected winter decline in vitamin D, compared with placebo in preschool-aged children with asthma. This six-month pilot randomized controlled trial aims to: (1) show that a vitamin D bolus is superior to placebo in raising vitamin D levels; (2) record the number of asthma attacks and viral infections in enrolled participants; and (3) identify problems that may call for protocol changes.


Options:
A: Reduction of allergic bronchial inflammation (Up to 3 months); Reduction of allergic bronchial inflammation (Up to 3 months)
B: Decline in total IgE (Two months)
C: Time to first upper respiratory tract infection (One year); Time to first severe asthma exacerbation (One year)
D: serum Vitamin D (3 months)

Answer: D
Please select the outcome measures that correspond to the clinical trial below.
Title: Vitamin D vs. Placebo in the Prevention of Viral-induced Exacerbations in Preschoolers With Asthma: a Pilot RCT
Brief Summary: Viral infections are the main cause of asthma attacks in preschoolers, an age group with the highest rate of emergency visits due to asthma. While high doses of inhaled or oral corticosteroids provide benefits, these have been associated with adverse outcomes. Most asthmatic children have lower blood levels of vitamin D compared to non-asthmatic children. Low vitamin D level has been linked to more frequent and more severe asthma attacks as well as with higher dose requirement of inhaled corticosteroid. Recent studies show that vitamin D supplements can reduce the number of asthma attacks triggered by viral infections in children. Unfortunately, most people forget to take vitamin D every day during the fall and winter season as recommended in Canada. A solution is to give a vitamin D bolus by mouth. This has been shown to safely and effectively increase vitamin D levels in children. The investigators hypothesise that a vitamin D bolus given in clinic will sufficiently increase the blood level of vitamin D to prevent the expected winter decline in vitamin D, compared with placebo in preschool-aged children with asthma. This six-month pilot randomized controlled trial aims to: (1) show that a vitamin D bolus is superior to placebo in raising vitamin D levels; (2) record the number of asthma attacks and viral infections in enrolled participants; and (3) identify problems that may call for protocol changes.


Options:
A: Treatment Failure (Twenty-eight week intervention period from randomization until end of trial.)
B: serum Vitamin D (3 months)
C: Number of Laboratory confirmed upper respiratory tract infections (Up to 8 months)
D: median time to next exacerbation. (1 year)

Answer: B
Please select the outcome measures that correspond to the clinical trial below.
Title: Vitamin D vs. Placebo in the Prevention of Viral-induced Exacerbations in Preschoolers With Asthma: a Pilot RCT
Brief Summary: Viral infections are the main cause of asthma attacks in preschoolers, an age group with the highest rate of emergency visits due to asthma. While high doses of inhaled or oral corticosteroids provide benefits, these have been associated with adverse outcomes. Most asthmatic children have lower blood levels of vitamin D compared to non-asthmatic children. Low vitamin D level has been linked to more frequent and more severe asthma attacks as well as with higher dose requirement of inhaled corticosteroid. Recent studies show that vitamin D supplements can reduce the number of asthma attacks triggered by viral infections in children. Unfortunately, most people forget to take vitamin D every day during the fall and winter season as recommended in Canada. A solution is to give a vitamin D bolus by mouth. This has been shown to safely and effectively increase vitamin D levels in children. The investigators hypothesise that a vitamin D bolus given in clinic will sufficiently increase the blood level of vitamin D to prevent the expected winter decline in vitamin D, compared with placebo in preschool-aged children with asthma. This six-month pilot randomized controlled trial aims to: (1) show that a vitamin D bolus is superior to placebo in raising vitamin D levels; (2) record the number of asthma attacks and viral infections in enrolled participants; and (3) identify problems that may call for protocol changes.


Options:
A: Number of Participants with D- deficiency or access (at 40 (+/-2 weeks) PMA (postmenstrual age)); Number of Participants with D- deficiency or access (at 4 weeks of age); Number of Participants with D- deficiency or access (At 35 (+/-2 weeks) PMA (postmenstrual age)); Number of Participants with D- deficiency or access (At 52 (+/-2 weeks) PMA (postmenstrual age))
B: Bacille-Calmette-Guerin (BCG) vaccine efficacy (2 months); Bacille-Calmette-Guerin (BCG) vaccine efficacy (6 months); Bacille-Calmette-Guerin (BCG) vaccine efficacy (1 year)
C: serum Vitamin D (3 months)
D: XR healing of rickets (6 months)

Answer: C
Please select the outcome measures that correspond to the clinical trial below.
Title: Extended-Release Naltrexone Opioid Treatment at Jail Re-Entry
Brief Summary: The purpose of this study is to compare the effectiveness of extended-release naltrexone (XR-NTX) vs. enhanced treatment-as-usual (TAU) among opioid dependent adults leaving NYC jails. In parallel, we propose to recruit a matched, quasi-experimental methadone cohort, which will result in a naturalistic comparison of XR-NTX vs. an established jail-based methadone treatment program standard-of-care. Our primary aim is to compare time-to-relapse among participants treated with XR-NTX vs. randomized TAU controls and time-to-relapse among XR-NTX arm vs. jail-based MTP participants, following release from jail. Secondary aims will compare related opioid treatment outcomes post-release across all arms.


Options:
A: Percentage of Those Maintain or Improve to HIV RNA-1 Viral Load Less Then 400 Copies/mL (Baseline to month 6 post release)
B: Time-to-Relapse: XRNTX vs. ETAU Following Release From Jail (up to 24 weeks)
C: Service Cascade: % Referred to Substance Use Treatment (120 weeks); Staff Perception: Value of Evidenced Based Substance Use Treatment (120 weeks)
D: Participants Who Had Undetectable HIV-1 RNA Levels at Less Than 400 Copies/mL at Six Month (6 months)

Answer: B
Please select the outcome measures that correspond to the clinical trial below.
Title: Assessing the Effectiveness of a Weight Watchers-based Lifestyle Intervention for the Primary Prevention of Type 2 Diabetes
Brief Summary: This study is a randomized pilot study to assess the applicability of the Weight Watchers model for lifestyle modification to the primary prevention of type 2 diabetes. The approach developed by Weight Watchers to achieve weight loss is based on similar nutritional principals and techniques used in the Diabetes Prevention Program (DPP) lifestyle intervention; monitoring food intake, exercising calorie control, setting modest weight loss goals and using physical activity.


Options:
A: Fasting Glucose (Change from Baseline at 6, 12, 18, 24, 36, 42, 48, 54, 60, 66, 72 and 78 months from randomization)
B: Changes in weight (6, 12, 19 and 24 months from baseline)
C: decreased dietary fat intake; increased vegetable consumption; increased self-reported leisure physical activity
D: weight (6 months and 1 year); body mass index (6 months and 1 year); % body fat (6 months and 1 year); lipids (6 months and 1 year); blood pressure (6 months and 1 year); glucose (6 months and 1 year); insulin (6 months and 1 year); HOMA index (6 months and 1 year)

Answer: B
Please select the outcome measures that correspond to the clinical trial below.
Title: Do Progressive Levels of Simulation Fidelity Enhance Colonoscopic Skill Acquisition and Transfer in Novice Endoscopic Trainees?
Brief Summary: It is hypothesized that a progressive simulated learning strategy will result in better global clinical performance (e.g., technical, communication) and transfer of endoscopic skill, as compared with a high-fidelity simulation strategy.


Options:
A: Difference Between Progressive and High-Fidelity Groups on Clinical Colonoscopy Peformance (JAG/DOPS) (4-6 weeks post-intervention)
B: Technical skills (6 months)
C: Evaluation of trainee skills included success of diagnostic CBD and deep CBD cannulation (3 months)
D: Colorectal cancer-related mortality (10 years)

Answer: A
Please select the outcome measures that correspond to the clinical trial below.
Title: N/A
Brief Summary: The investigators propose to perform a clinical randomized trial to evaluate the effect of a frozen-thawed embryo transfer and a fresh embryo transfer on pregnancy and implantation rates; with the added benefit of a blastocyst biopsy and whole chromosome analysis by Next Generation Sequencing (NGS).


Options:
A: Ongoing pregnancy (12 weeks of gestation)
B: Live birth rates (≥ 35 weeks of gestation after the first single blastocyst embryo transfer according to fresh or deferred-frozen transfer.)
C: Ongoing pregnancy rates (Two years)
D: Implantation rate (8 weeks after replacement)

Answer: D
Please select the outcome measures that correspond to the clinical trial below.
Title: N/A
Brief Summary: The investigators propose to perform a clinical randomized trial to evaluate the effect of a frozen-thawed embryo transfer and a fresh embryo transfer on pregnancy and implantation rates; with the added benefit of a blastocyst biopsy and whole chromosome analysis by Next Generation Sequencing (NGS).


Options:
A: live birth rate (10 months for group A, 12 months for group B)
B: Clinical pregnancy (fetal heartbeat observed on ultrasound at 7 weeks gestation) (7 weeks gestation)
C: Ongoing pregnancy (12 weeks of gestation)
D: Implantation rate (8 weeks after replacement)

Answer: D
Please select the outcome measures that correspond to the clinical trial below.
Title: A Phase III, Open Label, Randomised, Controlled, Multi-centre Study to Assess the Efficacy and Safety of Olaparib Monotherapy Versus Physicians Choice Chemotherapy in the Treatment of Metastatic Breast Cancer Patients With Germline BRCA1/2 Mutations.
Brief Summary: This open label, randomised, controlled, multi-centre phase III study will assess the efficacy and safety of single agent olaparib vs standard of care based on physician's choice of capecitabine, vinorelbine or eribulin in metastatic breast cancer patients with gBRCA 1/2 mutations.


Options:
A: Pathological Complete Response (pCR). (At the time of definitive surgery (approximately 24-36 weeks from first dose of study drug).)
B: Progression-free Survival (PFS) Using Blinded Independent Central Review (BICR) According to Modified Response Evaluation Criteria In Solid Tumours (RECIST v1.1) (Radiological scans performed at baseline then every ~6 weeks up to 24 weeks, then every ~ 12 weeks thereafter until objective radiological disease progression. Assessed up to a maximum of 30 months.)
C: Clinical benefit rate (until cut-off date established so that all patients were evaluable for primary outcome measure)
D: progression free survival (until cut-off date established from deaths rate); Overall survival (until cut-off date established from deaths rate)

Answer: B
Please select the outcome measures that correspond to the clinical trial below.
Title: A Phase 1b Open-label Study to Evaluate the Safety and Tolerability of MEDI4736 in Combination With Tremelimumab in Subjects With Advanced Non-small Cell Lung Cancer
Brief Summary: The purpose of this study is to determine if MEDI4736 will be adequately tolerated in combination with tremelimumab in subjects with advanced non-small cell lung cancer (NSCLC).


Options:
A: Overall Survival (OS) Time in Months for All Randomized Participants at Primary Endpoint (Randomization until 413 deaths, up to March 2015 (approximately 29 months))
B: Overall Survival (OS) (Through pre-specified database cutoff date of 30 Sep 2015 (Up to approximately 24 months)); Progression-free Survival (PFS) by Response Evaluation Criteria in Solid Tumors Version 1.1 (RECIST 1.1) (Through pre-specified database cutoff date of 30 Sep 2015 (Up to approximately 24 months)); Percentage of Participants Experiencing Adverse Events (AEs) (Through pre-specified database cutoff date of 30 Sep 2015 (Up to approximately 24 months)); Percentage of Participants Discontinuing Study Drug Due to AEs (Through pre-specified database cutoff date of 30 Sep 2015 (Up to approximately 24 months))
C: Number of subjects reporting adverse events (Screening through 90 days after the last dose of study medication); Objective response (At least 24 weeks as compared to baseline); Number of subjects experiencing dose-limiting toxicities (DLTs) (Depending upon the cohort, the DLT evaluation period is from the 1st dose of study medication until (1) the 3rd dose of MEDI4736 and tremelimumab (2) the 2nd dose of MEDI4736 and tremelimumab or (3) the 3rd dose of MEDI4736 and 2nd dose of tremelimumab)
D: Progression-Free Survival in Participants With PD-L1 Expression >= 5% (From date of randomization until date of documented tumor progression (assessed up to August 2016, approximately 28 months))

Answer: C
Please select the outcome measures that correspond to the clinical trial below.
Title: A Phase 1b Open-label Study to Evaluate the Safety and Tolerability of MEDI4736 in Combination With Tremelimumab in Subjects With Advanced Non-small Cell Lung Cancer
Brief Summary: The purpose of this study is to determine if MEDI4736 will be adequately tolerated in combination with tremelimumab in subjects with advanced non-small cell lung cancer (NSCLC).


Options:
A: Progression Free Survival (PFS) Rate at Month 6 (Month 6)
B: Number of Participants Experiencing Dose-Limiting Toxicities (DLTs) According to National Cancer Institute Common Terminology Criteria for Adverse Events Version 4.0 (NCI-CTCAE v.4.0) in Participants With Solid Tumors (Parts A and A1) (Up to 28 days in Cycle 1); Number of Participants Who Experienced an Adverse Event (AE) (Up to approximately 91 months (through Final Database cut-off date of 05-Nov-2018)); Overall Response Rate (ORR) According to Response Evaluation Criteria In Solid Tumors Version 1.1 (RECIST 1.1) as Assessed by Integrated Radiology and Oncology (IRO): Melanoma Participants (Parts B Plus D) (Up to approximately 53 months (through Interim Database cut-off date of 18-Sep-2015)); ORR According to RECIST 1.1 as Assessed by Independent Review Committee (IRC): Non-Small Cell Lung Cancer (NSCLC) Participants (Parts C Plus F) (Up to approximately 53 months (through Interim Database cut-off date of 18-Sep-2015))
C: Overall Survival (OS); PD-L1 (TC >=25%) Analysis Set Population, Durvalumab Monotherapy Vs SoC Chemotherapy and Durvalumab + Tremelimumab Vs SoC Chemotherapy (From baseline (Day 1, Week 0) until death due to any cause, assessed up to the data cut-off date (a maximum of approximately 3 years).); Progression-Free Survival (PFS); PD-L1 (TC >=25%) Analysis Set Population, Durvalumab + Tremelimumab Vs SoC Chemotherapy (Tumour scans performed at baseline then every 6 weeks up to 48 weeks relative to the date of randomization, then every 8 weeks thereafter until confirmed disease progression. Assessed up to the data cut-off date (a maximum of approximately 3 years).)
D: Number of subjects reporting adverse events (Screening through 90 days after the last dose of study medication); Objective response (At least 24 weeks as compared to baseline); Number of subjects experiencing dose-limiting toxicities (DLTs) (Depending upon the cohort, the DLT evaluation period is from the 1st dose of study medication until (1) the 3rd dose of MEDI4736 and tremelimumab (2) the 2nd dose of MEDI4736 and tremelimumab or (3) the 3rd dose of MEDI4736 and 2nd dose of tremelimumab)

Answer: D
Please select the outcome measures that correspond to the clinical trial below.
Title: Sleep and Pain Interventions in Fibromyalgia: Hyperalgesia and Central Sensitization
Brief Summary: This is a single-center, randomized controlled trial study design. Enrolled participants had comorbid fibromyalgia and chronic insomnia. Participants were randomized to a behavioral intervention for pain, a behavioral intervention for insomnia, or a waitlist control. The study intervention period lasted eight weeks. The objective of the study is to examine the impact of two behavioral treatments on sleep and pain and to better understand what causes chronic pain and chronic sleep disturbance.


Options:
A: Change in Pain intensity (Change from baseline pain intensity at 12 months); Change in Depression (Change from baseline depression at 12 months); Change in Catastrophizing (Change from baseline catastrophizing at 12 months); Change in Acceptance (Change from baseline acceptance at 12 months); Change in Disability (Change from baseline disability at 12 months)
B: Brief Pain Inventory-Intensity (BPI-Intensity) (Post-treatment (10-weeks) and follow-up (6 months))
C: Insomnia Severity Index (ISI) (Baseline); Insomnia Severity Index (ISI) (Post treatment- 2 months post baseline assessment); Insomnia Severity Index (ISI) (9 months post baseline assessment); Insomnia Severity Index (ISI) (18 months post baseline assessment); Global Pain Severity-Graded Chronic Pain Scale (Baseline); Global Pain Severity-Graded Chronic Pain Scale (Post treatment-2 mos. post baseline); Global Pain Severity-Graded Chronic Pain Scale (9 months post baseline assessment); Global Pain Severity- Graded Chronic Pain Scale (18 months post baseline assessment)
D: Change in time spent awake during the night. (Change from baseline to the two study follow-ups (immediately and 3-months following treatment)); Change in mood. (Change from baseline to the two follow-up periods (immediately and 3-months following treatment))

Answer: D
Please select the outcome measures that correspond to the clinical trial below.
Title: A Phase 2a, Multi-site, Randomized, Double-blind, Vehicle-controlled, Parallel-group Study Of The Pilot Efficacy, Safety, Tolerability, And Pharmacokinetics Of 2% Tofacitinib Ointment In Subjects With Mild To Moderate Atopic Dermatitis
Brief Summary: The study is being conducted to evaluate the efficacy, safety and tolerability of 2% tofacitinib ointment (20 mg/g) BID (twice daily) in subjects with mild to moderate atopic dermatitis compared to placebo (vehicle) BID for 4 weeks.


Options:
A: Percent Change From Baseline in Eczema Area and Severity Index (EASI) Total Score at Week 4 (Baseline (pre-dose on Day 1) and Week 4)
B: Percentage of Participants Who Achieved Treatment Success Based on Investigator's Static Global Assessment (ISGA) at Day 29 (Day 29); Number of Participants With Treatment-Emergent Adverse Events (AEs) And Serious Adverse Events (SAEs) (AEs: Baseline (Day 1) up to Day 29, SAEs: Baseline (Day 1) up to Day 36); Number of Participants With Clinically Significant Change From Baseline in Vital Signs at Day 29 (Baseline, Day 29); Number of Participants With Clinically Significant Change From Baseline in Laboratory Values at Day 29 (Baseline, Day 29)
C: Change in whole-body insulin sensitivity (Baseline, after 14 days daily treatment, and after 4 weeks of twice daily treatment twice weekly)
D: Adherence to topical Therapy (12 months)

Answer: A
Please select the outcome measures that correspond to the clinical trial below.
Title: A Phase 2a, Multi-site, Randomized, Double-blind, Vehicle-controlled, Parallel-group Study Of The Pilot Efficacy, Safety, Tolerability, And Pharmacokinetics Of 2% Tofacitinib Ointment In Subjects With Mild To Moderate Atopic Dermatitis
Brief Summary: The study is being conducted to evaluate the efficacy, safety and tolerability of 2% tofacitinib ointment (20 mg/g) BID (twice daily) in subjects with mild to moderate atopic dermatitis compared to placebo (vehicle) BID for 4 weeks.


Options:
A: Percent Change in Eczema Area and Severity Index Score (EASI) From Baseline to Week 16 (Baseline to Week 16)
B: Change in EASI Scores (Mean change in EASI score measured at Baseline and Month 3, (if on 20mg arm) or Baseline and Month 6 (if on 30mg arm))
C: Percent Change From Baseline in Eczema Area and Severity Index (EASI) Total Score at Week 4 (Baseline (pre-dose on Day 1) and Week 4)
D: Percent Change From Baseline in Eczema Area and Severity Index (EASI) Score at Week 12- Last Observation Carried Forward (LOCF) (Baseline to Week 12)

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


Options:
A: International Consultation on Incontinence Modular Questionnaire Urinary Incontinence Short Form (ICIQ-UI SF) (15 weeks)
B: Group Behavioral Treatment Effectiveness as Shown by Changes From Baseline to 3 Months in Urinary Incontinence Severity. (Baseline and 3 months)
C: Evaluation of subjective cure (At the end of 3 months of supervised treatment)
D: Change from baseline in mean number of micturitions per 24 hours after 8 weeks (8 weeks)

Answer: B