TrialPanorama/Dataset huggingface dataset:
Please select the outcome measures that correspond to the clinical trial below.
Title: Bio-equivalency Study of the Effects of Vitamin D2 and Vitamin D3 Supplements on 25-hydroxyvitamin D Levels in Exclusively Breast Fed Canadian Infants
Brief Summary: There are two different types of vitamin D - vitamin D3 (animal source) and vitamin D2 (plant source). Almost all the usual vitamin D preparations for infants available in Canadian pharmacies contain vitamin D3 which may not be suitable for families who avoid animal products for social or religious reasons. The purpose of this study is to learn more about the two forms of vitamin D and if blood levels of vitamin D are similar in infants after taking them. Forty-eight breastfed infants will be randomly assigned to 400 IU of either vitamin D2 or D3 supplement for 3 months starting at 1 month of age. The difference in blood vitamin D levels, after 3 months of supplementation, between the two groups will help determine if the two supplements are equal.


Options:
A: Equivalency of isoforms (3 months)
B: Plasma concentrations of 25-hydroxyvitamin D, parathyroid hormone, alkaline phosphatase (end of winter)
C: Infant Length-for-Age Z-Scores with Prenatal Supplementation (1 year of age); Infant Length-for-Age Z-Scores with Postpartum Supplementation (1 year of age)
D: serum 25-hydroxyvitamin D concentration, (3 time poits up to 6 months (0-3-6 months))

Answer: A
Please select the outcome measures that correspond to the clinical trial below.
Title: Bio-equivalency Study of the Effects of Vitamin D2 and Vitamin D3 Supplements on 25-hydroxyvitamin D Levels in Exclusively Breast Fed Canadian Infants
Brief Summary: There are two different types of vitamin D - vitamin D3 (animal source) and vitamin D2 (plant source). Almost all the usual vitamin D preparations for infants available in Canadian pharmacies contain vitamin D3 which may not be suitable for families who avoid animal products for social or religious reasons. The purpose of this study is to learn more about the two forms of vitamin D and if blood levels of vitamin D are similar in infants after taking them. Forty-eight breastfed infants will be randomly assigned to 400 IU of either vitamin D2 or D3 supplement for 3 months starting at 1 month of age. The difference in blood vitamin D levels, after 3 months of supplementation, between the two groups will help determine if the two supplements are equal.


Options:
A: Safety of Stoss Therapy (100 days); Efficacy of vitamin D repletion (100 days)
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: SCORAD score (May - August 2012 (3 months))
D: Equivalency of isoforms (3 months)

Answer: D
Please select the outcome measures that correspond to the clinical trial below.
Title: Cost Effectiveness of Building Capacity of Mid-level Practitioners in Sub-Saharan Africa for the Care and Prevention of HIV, Tuberculosis, Malaria and Related Infectious Diseases
Brief Summary: This evaluation aim is to investigate a cost-effective way to build capacity for the care and prevention of infectious diseases among mid-level practitioners (MLP) in sub-Saharan Africa. Classroom based training continues to be the dominant form of training, despite evidence that suggests that on-site support (OSS) is more beneficial. Definitive evidence that on-site support is the most effective way to deliver the required outputs and related outcomes is still lacking. IDCAP will provide two interventions that integrate training in TB, HIV/AIDS and malaria as well as other infectious diseases, and the effects will be studied: 1) Integrated Management of Infectious Disease (IMID) training program for individual MLP, and 2) On-site support (OSS) for team of health professionals. This study employs a mixed design with pre/post and cluster randomized trial components. Interventions are at the level of the individual participant for IMID and at the level of the site (health facility) for OSS. All participants attend a 3-week course, followed by two 1-week booster courses over a six month period. After the 3-week course, a randomized arm of half the sampled facilities also received OSS every month for 9 months and bi-monthly for 6 additional months.


Options:
A: Model of Integrated Capacity Building Program (monthly over 3 years); Competence of individual clinicians (3 observations at pre/post IMID and final); Practice of individual clinicians (Baseline and Endline (9 months)); Clinical performance indicators (Monthly beginning 5 months before OSS)
B: Knowledge; Learning efficiency
C: Improvement of drug prescribing (Participants will be followed for the duration of hospital stay, an expected average of 12 days)
D: Clinical behaviour on the A&E department, self-efficacy of the nurse in the detection of child abuse and assessment of the individual performance on screening child abuse. (2-3 months)

Answer: A
Please select the outcome measures that correspond to the clinical trial below.
Title: Prospective, Multicenter, Randomized, Double-Blind, Placebo-Controlled Trial Comparing REMICADE (Infliximab) and Placebo in the Prevention of Recurrence in Crohn's Disease Patients Undergoing Surgical Resection Who Are at Increased Risk of Recurrence
Brief Summary: REMICADE (infliximab) is a drug used to treat active Crohn's disease and is being tested in an experiment to see if it may be useful in preventing relapse of Crohn's disease after surgical resection. This study will compare the effects (both good and bad) of REMICADE (infliximab) to those of placebo. Placebo looks like the drug being studied but has no active ingredients.


Options:
A: Endoscopic Recurrence: the Proportion of Patients in Endoscopic Recurrence at One Year (one year)
B: Sustained clinical remission for the precision dosing group vs. the conventional IFX maintenance dosing group (52 weeks)
C: Percentage of Participants With Clinical Recurrence (CR) of Crohn's Disease (CD) Prior to or at Week 76 (Baseline up to Week 76)
D: Proportion of patients in remission at the end of the 24 month followup period. Remission is defined as a HBS< or = 4 without use of steroids for the treatment of CD. the primary analysis will be performed at the level of the practice. (24 months)

Answer: C
Please select the outcome measures that correspond to the clinical trial below.
Title: Prospective, Multicenter, Randomized, Double-Blind, Placebo-Controlled Trial Comparing REMICADE (Infliximab) and Placebo in the Prevention of Recurrence in Crohn's Disease Patients Undergoing Surgical Resection Who Are at Increased Risk of Recurrence
Brief Summary: REMICADE (infliximab) is a drug used to treat active Crohn's disease and is being tested in an experiment to see if it may be useful in preventing relapse of Crohn's disease after surgical resection. This study will compare the effects (both good and bad) of REMICADE (infliximab) to those of placebo. Placebo looks like the drug being studied but has no active ingredients.


Options:
A: Endoscopic recurrence of disease (18 months)
B: Endoscopic remission (Week 102)
C: Percentage of Participants With Clinical Recurrence (CR) of Crohn's Disease (CD) Prior to or at Week 76 (Baseline up to Week 76)
D: Number of endoscopic recurrences (52 weeks after the begin of the study)

Answer: C
Please select the outcome measures that correspond to the clinical trial below.
Title: A Manual Physical Therapy Approach Versus Subacromial Corticosteroid Injection for Treatment of Shoulder Impingement Syndrome: a Randomized Clinical Trial
Brief Summary: The purpose of this study is to evaluate and compare the short and long-term effectiveness of two common interventions, manual physical therapy versus corticosteroid injection, for the treatment of shoulder impingement syndrome.


Options:
A: Shoulder Pain and Disability Index (1 year)
B: Shoulder Pain and Disability Index (SPADI) (Baseline, 6 weeks, 12 weeks, 18 weeks and 12 months)
C: Shoulder Pain and Disability Index (Baseline and 11 weeks); Participant perceived global rating of change post treatment (11 weeks)
D: Constant total score as a mean and by category (at 3 months)

Answer: A
Please select the outcome measures that correspond to the clinical trial below.
Title: A Three-Period, 58-Week Safety and Efficacy Trial of KRX-0502 (Ferric Citrate) in Patients With End-Stage Renal Disease (ESRD) on Dialysis
Brief Summary: This is up to a 58 week study comparing ferric citrate to active control for 52 weeks in ESRD dialysis patients, and subsequently comparing ferric citrate to placebo for 4 weeks.


Options:
A: Change in Mean Serum Phosphorus From Baseline (Week 52) to the End of the Efficacy Assessment Period (EAP; Week 56) (4 weeks)
B: Calcium Balance (2 weeks)
C: Evaluate the change from baseline in 72-hour serum phosphate levels of 4 different doses of SBR759 versus placebo over 4 weeks of treatment (6 weeks)
D: total phosphate bound per gum piece fasting (15 min, 30 min, 45 min, 60 min post chewing); total phosphate bound per piece of gum post meal (5 min, 15 min, 30 min, 45 minutes post meal)

Answer: A
Please select the outcome measures that correspond to the clinical trial below.
Title: The Impact of LY2189265 Versus Insulin Glargine in Combination With Insulin Lispro for the Treatment to Target of Type 2 Diabetes Mellitus (AWARD-4: Assessment of Weekly AdministRation of LY2189265 in Diabetes - 4)
Brief Summary: The purpose of this study is to assess the efficacy and safety of LY2189265 in comparison to Insulin Glargine, both in combination with Insulin Lispro (plus or minus Metformin), in participants with Type 2 Diabetes treated with 1 or 2 injections of insulin.


Options:
A: Change from baseline in HbA1c at 24 weeks
B: Time to first occurence of a confirmed composite endpoint of death, myocardial infarction, stroke, heart failure, diabetic nephropathy, retinopathy or foot ulcer. (Time to first event during study period (for each patient 24-48 months, mean 36 months ))
C: Change From Baseline to 26-week Endpoint in Glycosylated Hemoglobin (HbA1c) (Baseline, 26 weeks)
D: Composite of cardiovascular events which were defined as death from a cardiovascular cause, death from any cause, nonfatal myocardial infarction, nonfatal stroke or arterial revascularization

Answer: C
Please select the outcome measures that correspond to the clinical trial below.
Title: A Multicenter, Multinational, Single-Dose, Open Label, Randomized, 2-Way Crossover, Clinical Pharmacology Study of CHF 1535 100/6 Next™ DPI (Fixed Combination of Beclomethasone Dipropionate 100 µg Plus Formoterol 6 µg) Versus the Free Combination of Licensed Beclomethasone DPI and Formoterol DPI in Asthmatic Adolescents and Adult Patients
Brief Summary: The purpose of this study is to demonstrate that the CHF 1535 (fixed combination of Beclometasone Dipropionate (BDP) 100 µg / Formoterol Fumarate (FF) 6 µg) delivered via the NEXT Dry Powder Inhaler (DPI) does not show a greater exposure to BDP, Beclometasone-17-Monopropionate(B17MP, active metabolite of BDP) and FF in comparison to a free combination of BDP DPI plus FF DPI licensed products after a morning dose administration of BDP and FF (total dose of BDP 400 µg / FF 24 µg) in adolescent and adult asthmatic patients.


Options:
A: Mean Area Under the Time Curve From 0 to 12 Hours (AUC(0-12 Hours)) of Change From Baseline to Week 12 in Forced Expiratory Volume (Liters) in 1 Second (FEV1) (Baseline to Week 12)
B: Evaluation of the efficacy and safety of a fixed-dose, single capsule budesonide-formoterol combination in comparison with budesonide alone in patients with uncontrolled asthma (12 weeks)
C: Systemic exposure to B17MP (active metabolite of BDP) after single dose (4 inhalations) of CHF1535 100/6 NEXT DPI in comparison with an already approved free combination of BDP DPI and FF DPI (0-8hrs)
D: Change in Forced Expiratory volume in 1 s (FEV-1) from morning predose at Baseline (Week 0) to predose at Week 12 (Week 0 and 12)

Answer: C
Please select the outcome measures that correspond to the clinical trial below.
Title: Comparison Between High-flow Conditioned Oxygen Therapy and Non-invasive Ventilation in Prevention of Post-extubation Respiratory Failure. A Randomized Controlled Trial
Brief Summary: The main aim is to demonstrate whether the high flow conditioned oxygen therapy reduces the reintubation rate. Post-extubation respiratory failure risk will be stratified (as the randomization). In high risk patients high flow conditioned oxygen therapy will be compared with with not conditioned non-invasive mechanical ventilation. In low risk patients comparison will be conventional oxygen therapy. Hypercapnic patients will be excluded.


Options:
A: Post-extubation respiratory failure and Reintubation rate (3 months)
B: Reintubation at Day 7 (up to 7 days)
C: Respiratory failure after extubation (72 hours)
D: Number of patients with hypoxemia (defined as a PaO2/FiO2 ratio <300) after pulmonary lobectomy in patients with lung cancer (during the first 96 hours after surgery)

Answer: A
Please select the outcome measures that correspond to the clinical trial below.
Title: Comparison Between High-flow Conditioned Oxygen Therapy and Non-invasive Ventilation in Prevention of Post-extubation Respiratory Failure. A Randomized Controlled Trial
Brief Summary: The main aim is to demonstrate whether the high flow conditioned oxygen therapy reduces the reintubation rate. Post-extubation respiratory failure risk will be stratified (as the randomization). In high risk patients high flow conditioned oxygen therapy will be compared with with not conditioned non-invasive mechanical ventilation. In low risk patients comparison will be conventional oxygen therapy. Hypercapnic patients will be excluded.


Options:
A: All-cause day-28 mortality (28 days)
B: mortality rates (day 28)
C: Post-extubation respiratory failure and Reintubation rate (3 months)
D: Oxygenation (PaO2/FiO2 ratio) (Up to 48 hours after extubation)

Answer: C
Please select the outcome measures that correspond to the clinical trial below.
Title: The Efficacy of Adductor-Canal-Blockade on Pain and Morphine Consumption After Revision Knee Arthroplasty
Brief Summary: The purpose of this study is to determine whether Adductor-Canal-Blockade is effective at reducing pain and morphine consumption after revision knee arthroplasty.


Options:
A: Pain during 45 degrees active flexion of the knee (4 hours postoperative)
B: Pain during 45 degrees active flexion of the knee (1 hour postoperative)
C: the difference in quadriceps muscle strength between the Adductor-Canal-Blockade and placebo (0-6 hours)
D: The difference in quadriceps muscle strength between the Adductor-Canal-Blockade and the femoral nerve block (24 h postoperatively)

Answer: A
Please select the outcome measures that correspond to the clinical trial below.
Title: Is the Clinical Outcome Affected by the Incidence of Progesterone Elevation on the Day of hCG Triggering When Agonist Protocol is Compared to Antagonist Protocol for IVF
Brief Summary: The aim is to explore whether the incidence of progesterone rise in the late follicular phase differs between GnRH-agonist and GnRH-antagonist protocols for IVF and whether this has an impact on the probability of pregnancy achievement.


Options:
A: Frequency of Ovarian Hyperstimulation Syndrome (OHSS) (3 years)
B: Incidence of late progesterone rise on the day of HCG triggering (Up to delivery (2010))
C: To collect data on the incidence of congenital malformations in infants of women with an ongoing pregnancy after controlled ovarian hyperstimulation. (In both cohorts a follow-up pediatric evaluation was scheduled within 6 months post-partum)
D: The Amount of International Units (IU) of Recombinant Follicle Stimulating Hormone (recFSH) Needed in a Controlled Ovarian Stimulation (COS) Cycle up to the First Day the Human Chorionic Gonadotropin (hCG) Criterion is Met. (At completion of ovarian stimulation; maximally after 18 days of recFSH administration.)

Answer: B
Please select the outcome measures that correspond to the clinical trial below.
Title: A Randomized, Open Label, Parallel-group, Multi-center Trial to Compare the Efficacy and Safety of TachoSil® Versus Surgicel® Original for the Secondary Treatment of Local Bleeding in Adult and Pediatric Patients Undergoing Hepatic Resection Surgery
Brief Summary: The efficacy and safety of TachoSil® as secondary hemostatic treatment in hepatic resection surgery will be compared to the standard USA licensed hemostatic agent, Surgicel® Original. Hemostatic efficacy will be evaluated intraoperatively after application of randomized treatment.


Options:
A: Percentage of Participants With Intraoperative Hemostasis at Target Bleeding Site Within 3 Minutes (within 3 minutes)
B: Proportion of patients with hemostasis 3 minutes after application of the haemostat product (3 minutes)
C: Time to Hemostasis (TTH) for Participants Receiving Spinal Surgery (Within 5 minutes); Time to Hemostasis (TTH) for Participants Receiving Vascular Surgery (Within 5 minutes); Time to Hemostasis (TTH) for Participants Receiving Hepatic Resection (Within 5 minutes); Time to Hemostasis (TTH) for Participants Receiving Soft Tissue Dissection (Within 5 minutes)
D: Receipt of blood transfusion(s) (7 days)

Answer: A
Please select the outcome measures that correspond to the clinical trial below.
Title: The Beneficial Effects of a Protein-rich Breakfast on Appetite Control & Cognition in Overweight and Obese Adolescents
Brief Summary: The purpose of this study is to assess whether the daily addition of a protein-rich breakfast leads to beneficial changes in appetite control, food intake regulation,and cognitive function in overweight \& obese 'breakfast skipping' young women.


Options:
A: Change from baseline in weekly time in moderate-to-vigorous physical activity at 4 months (baseline and after 4-months of intervention); Change from baseline in the daily time using TV/computer/video games at 4 months (baseline and after 4-months of intervention)
B: BMI and aerobic fitness (1 schoolyear)
C: Area Under the Curve (niAUC) of Perceived Hunger, Fullness, Desire to Eat, and Prospective Food Consumption (5 weeks); Area Under the Curve (AUC) of Plasma Total Ghrelin and Ln Peptide YY (PYY) (5 weeks); Brain Regions Displaying Differential Activation Prior to Dinner in Response to Food vs Nonfood Stimuli From Food Cue-stimulate fMRI Brain Scans (5 weeks)
D: Our outcome measure was reduction of screen time (4 waves of data)

Answer: C
Please select the outcome measures that correspond to the clinical trial below.
Title: The Beneficial Effects of a Protein-rich Breakfast on Appetite Control & Cognition in Overweight and Obese Adolescents
Brief Summary: The purpose of this study is to assess whether the daily addition of a protein-rich breakfast leads to beneficial changes in appetite control, food intake regulation,and cognitive function in overweight \& obese 'breakfast skipping' young women.


Options:
A: Area Under the Curve (niAUC) of Perceived Hunger, Fullness, Desire to Eat, and Prospective Food Consumption (5 weeks); Area Under the Curve (AUC) of Plasma Total Ghrelin and Ln Peptide YY (PYY) (5 weeks); Brain Regions Displaying Differential Activation Prior to Dinner in Response to Food vs Nonfood Stimuli From Food Cue-stimulate fMRI Brain Scans (5 weeks)
B: BMI will be assessed during lifestyle intervention in (1) children and adolescents and (2) adults vs. placebo (21 months)
C: Academic performance (October 2014 - June 2015 (8 months))
D: Body fat percentage (One year (interim analysis))

Answer: A
Please select the outcome measures that correspond to the clinical trial below.
Title: A Randomized, Double-Blind, Parallel Group Study of ADVAIR™ DISKUS™ 100/50 and FLOVENT™DISKUS™ 100, Both Twice Daily, in a Pediatric Population During the Fall Viral Season.
Brief Summary: Study ADA113872 is an exploratory 16-week multi-centre, randomized, double-blind, parallel group study in pediatric subjects, 4 to 11 years of age, with a history of seasonal asthma exacerbation(s). Approximately 40 clinical sites in the United States will randomize 316 subjects. Eligible subjects will be randomly assigned to one of two double-blind treatments using a 1:1 randomization. Subjects will be identified for their eligibility for enrolment starting in April 2010. Eligible subjects will be invited to return for randomization into the study in August 2010. This exploratory study is being conducted to assess whether treatment with ADVAIR™ DISKUS™ 100/50 mcg is more effective at reducing the risk of exacerbation and the asthma impairment associated with viral respiratory tract infections during the fall season when compared to treatment with FLOVENT™ DISKUS™ 100 mcg.


Options:
A: Number of Participants Experiencing an Event in the Composite Endpoint (Asthma-related Death, Asthma-related Intubation or Asthma-related Hospitalization) (Up to 27 weeks); Number of Participants Experiencing an Event Included in the Definition of Asthma Exacerbation (Up to 26 weeks)
B: Total Number of Asthma Exacerbations Reported During the Treatment Period (From Baseline (Week 1) until the end of treatment (up to Week 16))
C: Change From Baseline in Weighted-mean 24-hour Serial Forced Expiratory Volume in One Second (FEV1) at Week 12 (Baseline and Week 12)
D: Asthma exacerbation rate per patient per year

Answer: B
Please select the outcome measures that correspond to the clinical trial below.
Title: A Randomized, Double-Blind, Parallel Group Study of ADVAIR™ DISKUS™ 100/50 and FLOVENT™DISKUS™ 100, Both Twice Daily, in a Pediatric Population During the Fall Viral Season.
Brief Summary: Study ADA113872 is an exploratory 16-week multi-centre, randomized, double-blind, parallel group study in pediatric subjects, 4 to 11 years of age, with a history of seasonal asthma exacerbation(s). Approximately 40 clinical sites in the United States will randomize 316 subjects. Eligible subjects will be randomly assigned to one of two double-blind treatments using a 1:1 randomization. Subjects will be identified for their eligibility for enrolment starting in April 2010. Eligible subjects will be invited to return for randomization into the study in August 2010. This exploratory study is being conducted to assess whether treatment with ADVAIR™ DISKUS™ 100/50 mcg is more effective at reducing the risk of exacerbation and the asthma impairment associated with viral respiratory tract infections during the fall season when compared to treatment with FLOVENT™ DISKUS™ 100 mcg.


Options:
A: Daily asthma symptom score
B: Mean maximum symptom days per 2 weeks, as assessed by questionnaire (At Visits 3 and 8)
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: D