TrialPanorama/Dataset huggingface dataset:
Please select the outcome measures that correspond to the clinical trial below.
Title: Red Cell Storage Duration Study
Brief Summary: The RECESS study will compare the effects of transfusing red blood cell units stored \<= 10 days vs. red blood cell units stored \>= 21 days, in patients who are undergoing complex cardiac surgery and are likely to need a red blood cell transfusion. The primary hypothesis is that there is a clinically important difference between the effects of shorter-storage red cell units and longer-storage red cell units on clinical outcomes and mortality risk.


Options:
A: Physical Fatigue (on day 3 postpartum)
B: Total Number of Units Transfused (From randomization until discharge from admission for delivery, an average of 2-3 days)
C: Occurrence of a composite endpoint (90 days)
D: The Change in the Composite Multiple Organ Dysfunction Score (MODS) From the Pre-operative Baseline. The Worst Post-operative Values of Each Component of MODS Will be Used to Calculate the Change in MODS. (Through post-operative day 7, hospital discharge, or death, whichever occurs first)

Answer: D
Please select the outcome measures that correspond to the clinical trial below.
Title: Red Cell Storage Duration Study
Brief Summary: The RECESS study will compare the effects of transfusing red blood cell units stored \<= 10 days vs. red blood cell units stored \>= 21 days, in patients who are undergoing complex cardiac surgery and are likely to need a red blood cell transfusion. The primary hypothesis is that there is a clinically important difference between the effects of shorter-storage red cell units and longer-storage red cell units on clinical outcomes and mortality risk.


Options:
A: 1. Composite Outcome of Necrotizing Enterocolitis, Intraventricular Hemorrhage, Bronchopulmonary Dysplasia and Retinopathy of Prematurity at 30 and 90-days. 2. Mortality (2 weeks, 4 weeks, 12 weeks, 90 days)
B: Combined mortality or survival to tertiary hospital discharge without severe morbidity (BPD, severe ROP or brain injury) (neonatal phase); Combined mortality or survival with neurodevelopmental disability (non-ambulatory cerebral palsy, blindness, deafness, cognitive delay) (follow-up phase 18 months corrected age)
C: The Change in the Composite Multiple Organ Dysfunction Score (MODS) From the Pre-operative Baseline. The Worst Post-operative Values of Each Component of MODS Will be Used to Calculate the Change in MODS. (Through post-operative day 7, hospital discharge, or death, whichever occurs first)
D: 12 Hour Plasma Interleukin (IL)-6 to IL-10 Ratio (12 hours post-cardiopulmonary bypass)

Answer: C
Please select the outcome measures that correspond to the clinical trial below.
Title: Red Cell Storage Duration Study
Brief Summary: The RECESS study will compare the effects of transfusing red blood cell units stored \<= 10 days vs. red blood cell units stored \>= 21 days, in patients who are undergoing complex cardiac surgery and are likely to need a red blood cell transfusion. The primary hypothesis is that there is a clinically important difference between the effects of shorter-storage red cell units and longer-storage red cell units on clinical outcomes and mortality risk.


Options:
A: The Change in the Composite Multiple Organ Dysfunction Score (MODS) From the Pre-operative Baseline. The Worst Post-operative Values of Each Component of MODS Will be Used to Calculate the Change in MODS. (Through post-operative day 7, hospital discharge, or death, whichever occurs first)
B: Adherence to the study protocol (up to 28 days)
C: Glasgow Outcome Scale (at 6 months after injury)
D: Timed Up and Go-test (TUG)in seconds. (30 days)

Answer: A
Please select the outcome measures that correspond to the clinical trial below.
Title: Comparative Evaluation of the Effectiveness of 2 Available Resources in Estrie, for the Prevention of Type 2 Diabetes in High-risk Subjects
Brief Summary: This study compared the efficacy at one year of an interdisciplinary approach including individual counseling and group seminars versus group seminars alone to induce weight loss in subjects at high risk of developing type 2 diabetes.

This study also compare if a participant's presence in small informative meeting groups as the only form of intervention is sufficient to induce a lifestyle change, thus inducing the weight loss needed for the prevention of the diseases associated with obesity.


Options:
A: a weight loss of 7% in at least 19% of the subjects (one year); reduced body weight of at least 5.6 kg in at least 25% of the subjects (one year); an increase in the level of physical activity by at least 150 minutes per week in at least 29% of the subjects (one year); a reduced daily caloric intake of at least 450 kcal/jour in at least 25% of the subjects (one year); a reduced percentage of the calories introduced in the form of fat of at least 6.6%, in absolute value, in at least 25% of the subjects (one year)
B: Number of self-reported falls: Falls surveillance report (10 minutes)
C: Physical activity measured by pedometer. (2 years); Healthy eating index quantified by the Food Frequency Questionnaire. (2 years)
D: Time to Service Disengagement (12 months)

Answer: A
Please select the outcome measures that correspond to the clinical trial below.
Title: Impact of an Integrated Obesity Management System on Patient's Care
Brief Summary: The investigators developed a program aimed at enhancing primary care physician (PCP) teams' expertise, self-efficacy and attitudes with respect to obesity management. The investigators implemented and evaluated this obesity management system based on a preceptorship combined with a virtual learning community favouring continuous support of family medicine groups (FMGs, Groupes de Médecine Familiale) by a team of experts in obesity management; significant improvements regarding their attitudes and perception of self-efficacy were observed immediately after the preceptorship and maintained after one year. Furthermore, the investigators observed significant changes in their practice that were maintained one year later.

The investigators hypothesize that their program combining preceptorships with a virtual community will improve: (1) management and weight loss of obese/overweight subjects who are treated by PCPs for hypertension (HTN), type 2 diabetes (DM2) or impaired glucose tolerance (IGT); and (2) screening and initial management of obesity among unselected patients of PCPs who practice in FMGs.


Options:
A: First Occurrence of a Severe Cardiovascular Event (up to 11 years)
B: Percent Change From Baseline Weight (Baseline, 2 years)
C: Number of weight management visits/ practitioner Full Time Equivalent(FTE) (Data will be collected monthly and analyzed at 6, 12 and 18 Months); Change in BMI (3,6,12,and 18 month where possible); Change in Self-reported health measures-SF12 (3,6,12 months and 18 months where possible)
D: Among patients from the targeted diseases group, we aim at improving: a)the proportion of subjects who have an initial intervention planned, according to the CCPGO; b)the proportion of subjects who lose at least 5% of their initial weight. (18 months); Among patients from the regular follow-up group, we aim at improving: a)the proportion of patients who have measured weight, BMI and waist circumference and b)the proportion of overweight or obese subjects who have an initial intervention planned. (18 months)

Answer: D
Please select the outcome measures that correspond to the clinical trial below.
Title: A Multisite Trial of ACQUIREc Therapy
Brief Summary: A multisite trial to testing different dosage levels of a systematic form of Pediatric Constraint-Induced (CI) Therapy called ACQUIREc Therapy. The high dosage treatment involved 6 hours of daily therapy services for 21 days. This was compared to a moderate dosage level of 3 hours of daily therapy services for 21 days. It was hypothesized that children receiving the higher therapy dosage would have greater and more clinically significant benefits from ACQUIREc Therapy but that both groups of children would benefit from the therapy services.


Options:
A: Kinematics of reach (Change from Baseline to Post intervention (1 month), and 6 months later); Somatosensory processing measurement by ERP (Change from Baseline to Post intervention (1 month), and 6 months later); Bayley Scales of Infant and Toddler Development (Bayley III) - 3rd Edition (Change from Baseline to Post intervention (1 month), and 6 months later)
B: N/A
C: N/A
D: Bruininks-Oseretsky Test of Motor Proficiency (BOTMP) (4 weeks (post-treatment), 12 week, 24 week); Peabody Development Motor Scales, subtest fine motor (PDMS-Ⅱ) (4 weeks (post-treatment), 12 week, 24 week); Kinematic analysis (4 weeks (post-treatment), 12 week, 24 week)

Answer: C
Please select the outcome measures that correspond to the clinical trial below.
Title: Optimizing an Online Motivational Tobacco Cessation Program
Brief Summary: The current study tested the effectiveness of four potentially important tailoring factors (decisional framework, self-efficacy, navigation autonomy, and proactive outreach) in the context of an online motivational intervention for smoking cessation. A fifth factor was originally planned by dropped during intervention development due to confounds with the other planned factors. Information learned from this study will inform how to best design an online interventions for smoking cessation. Participants were recruited from a large, regional U.S. health plan. Using a full factorial design to screen for important main effects and 2-way interactions, participants were randomized to receive one of 16 different experimental factor combinations and followed for one year to assess program impact on smokers' use of empirically-validated cessation treatment and abstinence.


Options:
A: 7-day point prevalence abstinence at 3 months (3 months post baseline); 7-day point prevalence abstinence at 6 months (6 months post baseline); 7-day point prevalence abstinence at 12 months (12 months post baseline)
B: Self-reported 30-day Point Prevalence Abstinence (9 months post-randomization)
C: Smoking Abstinence (12 months); Treatment Utilization for Smoking Cessation (12 months)
D: Smoking abstinence (1, 3, 6 and 12 month follow-ups)

Answer: C
Please select the outcome measures that correspond to the clinical trial below.
Title: Oral Misoprostol Titrated Solution Versus Vaginal Misoprostol for Induction of Labour: Randomized Controlled Trial
Brief Summary: The purpose of this study is to compare effectiveness and safety of an oral titrated solution of misoprostol with vaginal misoprostol for induction of labour with an alive fetus.


Options:
A: success rate of cervical ripening in labor induction (12 hours after intervention)
B: the percentage of women delivering infants vaginally within 12 hours of augmentation (post vaginal delivery)
C: Vaginal delivery (24 hours); Hyperstimulation syndrome (24 hours); Cesarean section (3 days); Severe neonatal morbidity or perinatal death (28 days); Serious maternal morbidity or maternal death (42)
D: The interval from the first misoprostol dose to vaginal delivery and the percentage of women who delivered infants vaginally within 12 and 24 hours of induction. The incidence of tachysystole, hypertonus, uterine hyperstimulation and neonatal outcomes. (within the first week after delivery)

Answer: C
Please select the outcome measures that correspond to the clinical trial below.
Title: Oral Misoprostol Titrated Solution Versus Vaginal Misoprostol for Induction of Labour: Randomized Controlled Trial
Brief Summary: The purpose of this study is to compare effectiveness and safety of an oral titrated solution of misoprostol with vaginal misoprostol for induction of labour with an alive fetus.


Options:
A: The interval from the first misoprostol dose to vaginal delivery and the percentage of women who delivered infants vaginally within 12 and 24 hours of induction. The incidence of tachysystole, hypertonus, uterine hyperstimulation and neonatal outcomes. (within the first week after delivery)
B: Vaginal delivery (24 hours); Hyperstimulation syndrome (24 hours); Cesarean section (3 days); Severe neonatal morbidity or perinatal death (28 days); Serious maternal morbidity or maternal death (42)
C: Attainment of vaginal delivery within 24 hours. (24 hours)
D: success rate of cervical ripening in labor induction (12 hours after intervention)

Answer: B
Please select the outcome measures that correspond to the clinical trial below.
Title: A Multi-Center, Double-Blind, Randomized, Placebo-Controlled, Parallel Group, Withdrawal Study to Evaluate the Safety and Efficacy of Delayed Release Rabeprazole in 1- to 11-Month-Old Pediatric Subjects With Symptomatic/Gastroesophageal Erosive Reflux Disease (GERD)
Brief Summary: The purpose of this study is to assess the effectiveness and safety of rabeprazole sodium, an inhibitor of gastric acid secretion of the protein pump inhibitor (PPI) class, compared with placebo in the treatment of gastrointestinal esophageal reflux disease (GERD) in infants 1 to 11 months of age.


Options:
A: Change From Baseline in Average Daily Frequency of Regurgitation (Double-blind Phase/ Baseline Observation Carried Forward) (Baseline, Week 8); Change From Baseline in Weight-for-Age Z-Score (Double-blind Phase/ Baseline Observation Carried Forward) (Baseline, Week 8); Change From Baseline in I-GERQ-R Total Score (Double-blind Phase/ Baseline Observation Carried Forward) (Baseline, Week 8); Change From Baseline in in Weekly Average I-GERQ-DD Total Score (Double-blind Phase/ Baseline Observation Carried Forward) (Baseline, Week 8)
B: Therapeutic efficacy (24 hour)
C: Percentage of subjects in each treatment group responding to treatment with a reduction from baseline in the percentage and duration of crying/fussing/irritability episodes associated with feeding after 4 weeks of treatment. (Week 4); Safety Assessments (Baseline through week 8)
D: Peak Concentration (Cmax) (1 day); Time to Peak Concentration (Tmax) Profile (1 day); Disposition Half-life (1 day); Area Under the Concentration-time Curve (AUC) (1 day); Apparent Oral Clearance (CL/F) (1 day); Pantoprazole Plasma Concentration After Multiple-Dose Oral Administration (7 days); Intragastric pH (7 days); Median Intragastric pH (7 days); Percentage of Time Intragastric pH Was >4 (7 days); Mean Intraesophageal pH (7 days); Median Intraesophageal pH (7 days); Percentage of Time That Intraesophageal pH Was <4 (7 days); Normalized Area of Gastric Hydrogen Ion Activity Over Time (7 days); Normalized Area of Esophageal Hydrogen Ion Activity Over Time (7 days)

Answer: A
Please select the outcome measures that correspond to the clinical trial below.
Title: The Effect of Nordic Diet Rich in Whole Grain, Berries, Fruits, Vegetables and Fish on Features of Metabolic Syndrome - a Systems Biology Approach
Brief Summary: SYSDIET (Systems biology in controlled dietary interventions and cohort studies) is one of the three centres in the NCoE Food, Nutrition and Health, 2007-2011. It consists of 12 partners from five Nordic countries working on multidisciplinary fields of science related to nutritional biology. The main objective of SYSDIET is to reveal mechanisms by which Nordic foods and diets could be modified to promote health and prevent insulin resistance, type 2 diabetes and cardiovascular diseases, all of which being connected to metabolic syndrome. Furthermore, the aim is to build up a Nordic platform for cohort studies and carefully conducted multi-centre dietary intervention studies, where novel nutritional systems biology tools can be applied besides human studies also in animal and cell culture studies. In order to achieve the main objective a Nordic multi-centre randomized controlled human intervention study is being conducted in 2009-2010 in 6-8 centres of SYSDIET consortium.

Health of the Nordic populations has substantially improved during the last 30 years. This is due e.g. to marked decline in cardiovascular morbidity and mortality. However, during the last 10-20 years increasing obesity and sedentary lifestyle have resulted in an increase of metabolic syndrome and type 2 diabetes.

Having this background, the aim of the SYSDIET consortium is to carry out a controlled, randomized dietary intervention study in persons with features of metabolic syndrome to find out the effects of a healthy Nordic food on major abnormalities in metabolic syndrome.

Altogether 167 persons aged 30 to 65 years were recruited from 6-8 centers (40-60 subjects/center) of the SYSDIET cohort. The main inclusion criterion is BMI 27-38 kg/m2. The subjects should also have at least two other IDF criteria for metabolic syndrome. Recruited persons will start the study by following their conventional diet for one month as a run-in period. After that subjects will be randomly assigned into Experimental- or Control-diet-group for 6 months. Experimental diet is rich in whole grain products, berries, fruits, vegetables and fish, and its fat intake is modified according to current Nordic recommendations. Control diet is based on the current information of the mean dietary intake and food consumption. The diets will be realized according to eating habits in each Nordic country.


Options:
A: Composity of Major Cardiovascular Events (up to 48 month)
B: N/A
C: Change in body weight (kg) (26 weeks)
D: Glucose metabolism (Study weeks 0); Glucose metabolism (12 weeks); Glucose metabolism (24 weeks)

Answer: D
Please select the outcome measures that correspond to the clinical trial below.
Title: The Effect of Nordic Diet Rich in Whole Grain, Berries, Fruits, Vegetables and Fish on Features of Metabolic Syndrome - a Systems Biology Approach
Brief Summary: SYSDIET (Systems biology in controlled dietary interventions and cohort studies) is one of the three centres in the NCoE Food, Nutrition and Health, 2007-2011. It consists of 12 partners from five Nordic countries working on multidisciplinary fields of science related to nutritional biology. The main objective of SYSDIET is to reveal mechanisms by which Nordic foods and diets could be modified to promote health and prevent insulin resistance, type 2 diabetes and cardiovascular diseases, all of which being connected to metabolic syndrome. Furthermore, the aim is to build up a Nordic platform for cohort studies and carefully conducted multi-centre dietary intervention studies, where novel nutritional systems biology tools can be applied besides human studies also in animal and cell culture studies. In order to achieve the main objective a Nordic multi-centre randomized controlled human intervention study is being conducted in 2009-2010 in 6-8 centres of SYSDIET consortium.

Health of the Nordic populations has substantially improved during the last 30 years. This is due e.g. to marked decline in cardiovascular morbidity and mortality. However, during the last 10-20 years increasing obesity and sedentary lifestyle have resulted in an increase of metabolic syndrome and type 2 diabetes.

Having this background, the aim of the SYSDIET consortium is to carry out a controlled, randomized dietary intervention study in persons with features of metabolic syndrome to find out the effects of a healthy Nordic food on major abnormalities in metabolic syndrome.

Altogether 167 persons aged 30 to 65 years were recruited from 6-8 centers (40-60 subjects/center) of the SYSDIET cohort. The main inclusion criterion is BMI 27-38 kg/m2. The subjects should also have at least two other IDF criteria for metabolic syndrome. Recruited persons will start the study by following their conventional diet for one month as a run-in period. After that subjects will be randomly assigned into Experimental- or Control-diet-group for 6 months. Experimental diet is rich in whole grain products, berries, fruits, vegetables and fish, and its fat intake is modified according to current Nordic recommendations. Control diet is based on the current information of the mean dietary intake and food consumption. The diets will be realized according to eating habits in each Nordic country.


Options:
A: Change in body weight (measured at Year 2)
B: Glucose metabolism (Study weeks 0); Glucose metabolism (12 weeks); Glucose metabolism (24 weeks)
C: Breast Cancer Recurrence (Lifetime)
D: Body mass index (BMI); Glycated Haemoglobin (HbA1c); Triglycerides; Dietary intake as measured by 3-day weighed diet records; All measures to be compared at end of study (6 months)

Answer: B
Please select the outcome measures that correspond to the clinical trial below.
Title: Protease Inhibitors to Reduce Malaria Morbidity in HIV-Infected Pregnant Women
Brief Summary: This study is an open-label, single site, randomized controlled trial comparing protease inhibitor (PI)-based antiretroviral therapy (ART) to non-PI based ART for HIV-infected pregnant and breastfeeding women of all CD4 cell counts at high risk of malaria. The study is designed to test the hypothesis that pregnant women receiving a PI-based ART regimen will have lower risk of placental malaria compared to pregnant women receiving a non-PI based ART regimen. The primary study endpoint of the study is placental malaria. This study also enrolls the infants of these women at the time of delivery.


Options:
A: Weight gain during the 12-week follow-up (in grams)
B: Prevalence of Malaria Defined as Positive Placental Blood Smear (Delivery); Prevalence of Malaria Defined as Positive Placental Blood PCR (Delivery)
C: N/A
D: Change in Length for Age (Once per month for 6 months, then once after 12 months.)

Answer: B
Please select the outcome measures that correspond to the clinical trial below.
Title: Evaluation of an Active Strategy to Implement the Canadian CT Head Rule: Phase III
Brief Summary: Each year, Canadian emergency department physicians treat 600,000 patients with head injury. Many of these are adults with "minor head injury", i.e. loss of consciousness or amnesia and a Glasgow Coma Scale (GCS) score of 13-15. Only 6.2% of these "minor" patients have some acute injury on computed tomography (CT scan) and only 0.5% have an epidural hematoma requiring surgery. Among Canadian teaching hospital emergency departments, we have shown a fourfold variation in use of CT and that a small but important number of intracranial hematomas are missed at the first visit.


Options:
A: To test for differences in rates of screening between the early intervention and delayed groups, the chi-square test will be used for each outcome. (End of project, 12/2011)
B: Episiotomies; Oxytocin use in third stage of labor
C: Computed tomography ordering proportions (January 2009)
D: Cardiac Medication Use (3 and 12 months)

Answer: C