TrialPanorama/Dataset huggingface dataset:
Please select the outcome measures that correspond to the clinical trial below.
Title: From Innovation to Solutions: Autodialers, Use of Early Autumn Physicals and Vaccination Assessment as a Vital Sign to Increase Childhood Influenza Vaccination in Diverse Settings
Brief Summary: The purpose of this study is to increase childhood influenza vaccination rates using the FDA licensed influenza vaccines according to national guidelines in a randomized cluster trial in which primary care offices are randomized to intervention or control with the control group receiving the intervention in the second year.


Options:
A: Change from baseline in number of child maltreatment protective factors available to caregiver at 6 months, as measured on the Quality Improvement Center on Early Childhood (QIC) "Caregivers Assessment of Protective Factors" (t1 (Baseline): at recruitment, prior to intervention; and t2: 6 months later); Change from baseline in number and amount of income supports available to and accessed by caregiver at 6 months, as measured on the Quality Improvement Center on Early Childhood (QIC) "Self-Report Family Inventory" + supplementary questions on $ value (t1 (Baseline): at recruitment, prior to intervention; and t2: 6 months later); Change from baseline in social capital available to caregiver at 6 months, as measured on the Quality Improvement Center on Early Childhood (QIC) "Social Network Grid" (t1 (Baseline): at recruitment, prior to intervention; and t2: 6 months later); Change from baseline in parental stress at 6 months, as measured by the "Parenting Stress Index (PSI) - long form" (t1 (Baseline): at recruitment, prior to intervention; and t2: 6 months later); Change from baseline in parenting and child-rearing attitudes of child's caregiver at 6 months, as measured on the "Adult-Adolescent Parenting Inventory(AAPI-2)" (t1 (Baseline): at recruitment, prior to intervention; and t2: 6 months later)
B: Primary Outcome (3/1/2011-2/29/2012)
C: Receipt of influenza vaccine during pregnancy (Participants will be followed for the remaining duration of their pregnancy, which will range from approximately 2 weeks to 7 months depending upon their gestation at enrollment.)
D: 6 month % change in HPV vaccination (≥ 1 dose), control vs. each intervention arm (efficient or participatory), 11-12 year olds (Baseline, month 6)

Answer: B
Please select the outcome measures that correspond to the clinical trial below.
Title: A Multicenter, Randomized, Double-blind, Parallel-group, Placebo-controlled Variable Treatment Duration Study Evaluating the Efficacy and Safety of Siponimod (BAF312) in Patients With Secondary Progressive Multiple Sclerosis Followed by Extended Treatment With Open-label BAF312.
Brief Summary: Evaluate the safety and efficacy of Siponimod (BAF312) versus placebo in a variable treatment duration in patients with secondary progressive multiple sclerosis (Core Part) followed by extended treatment with open-label BAF312 to obtain data on long-term safety, tolerability and efficacy (Extension Part).


Options:
A: Time to Onset of Clinical Disability Progression (CDP) Sustained for at Least 12 Weeks During the Double-Blind Treatment Period (Maximal follow up: 216 weeks for Placebo arm and 217 weeks for Ocrelizumab arm)
B: Part 1: Percentage of Participants With Confirmed Progression of Disability in One or More of the Expanded Disability Status Scale (EDSS), Timed 25-Foot Walk (T25FW), or 9-Hole Peg Test (9HPT) (Up to 96 weeks (2 years)); Number of Participants With Treatment-Emergent Adverse Events (AEs) and Serious Adverse Events (SAEs) (218 weeks)
C: Percentage of Participants With 3-month Confirmed Disability Progression (CDP) Events as Measured by the Expanded Disability Status Scale (EDSS) (Baseline, every 3 month up to the maximum of approximately 3 years)
D: Kaplan-Meier Estimate of the Risk of 3-month Confirmed Disability Progression Based on Composite Endpoint (up to 36 months after the last patient was randomized)

Answer: C
Please select the outcome measures that correspond to the clinical trial below.
Title: A Multicenter, Randomized, Double-blind, Parallel-group, Placebo-controlled Variable Treatment Duration Study Evaluating the Efficacy and Safety of Siponimod (BAF312) in Patients With Secondary Progressive Multiple Sclerosis Followed by Extended Treatment With Open-label BAF312.
Brief Summary: Evaluate the safety and efficacy of Siponimod (BAF312) versus placebo in a variable treatment duration in patients with secondary progressive multiple sclerosis (Core Part) followed by extended treatment with open-label BAF312 to obtain data on long-term safety, tolerability and efficacy (Extension Part).


Options:
A: Percentage of Participants With 3-month Confirmed Disability Progression (CDP) Events as Measured by the Expanded Disability Status Scale (EDSS) (Baseline, every 3 month up to the maximum of approximately 3 years)
B: Mean Number of Gadolinium (Gd)-Enhanced T1-weighted Lesions at Month 6 (Core) (Month 6 (Core)); Mean Number of Gadolinium (Gd)-Enhanced T1-weighted Lesions at Month 12 (Month 12 (extension)); Mean Number of Gadolinium (Gd)-Enhanced T1-weighted Lesions at Month 60 (Month 60 (extension)); Mean Number of Gadolinium (Gd)-Enhanced T1-weighted Lesions at End of Study (Last observation (Up to 80 months in average))
C: Part A: Number of Participants With Adverse Events (AEs) (Baseline (Week 0) to Week 24); Part B: Rate of Development of New Active Lesions Over 24 Weeks (Baseline (Week 0) to Week 24)
D: Part 1: Percentage of Participants With Confirmed Progression of Disability in One or More of the Expanded Disability Status Scale (EDSS), Timed 25-Foot Walk (T25FW), or 9-Hole Peg Test (9HPT) (Up to 96 weeks (2 years)); Number of Participants With Treatment-Emergent Adverse Events (AEs) and Serious Adverse Events (SAEs) (218 weeks)

Answer: A
Please select the outcome measures that correspond to the clinical trial below.
Title: A Multicenter, Randomized, Double-blind, Parallel-group, Placebo-controlled Variable Treatment Duration Study Evaluating the Efficacy and Safety of Siponimod (BAF312) in Patients With Secondary Progressive Multiple Sclerosis Followed by Extended Treatment With Open-label BAF312.
Brief Summary: Evaluate the safety and efficacy of Siponimod (BAF312) versus placebo in a variable treatment duration in patients with secondary progressive multiple sclerosis (Core Part) followed by extended treatment with open-label BAF312 to obtain data on long-term safety, tolerability and efficacy (Extension Part).


Options:
A: Dose Responsiveness of BAF312 Based on the Number of Combined Unique Active MRI Lesions (CUAL) (3 months of treatment)
B: Total Number of Adverse Events During Evaluation of Long Term Safety and Tolerability of BAF312A in Extension Study. (Baseline up to approximately 5 years); Number of Participants With Cardiac Conduction Abnormalities During the Titration Phase of the Study (Without Washout) (Baseline Extension up to day 10); Number of Participants With Cardiac Conduction-IVCD Abnormality During the Titration Phase of the Study (With Washout) (Baseline Extension up to day 10); Number of Participants With Changes in Blood Pressure for Overall Extension Study. (Extension Analysis Set) (Baseline Extension up to approximately 5 years); Number of Participants With Viral Infections of Interest Greater or Equal to 5% in Any Dose Group (Extension Set) (Baseline Extension up to approximately 5 years); Number of Participants With Dermatologic Alterations - Basal Cell Carcinoma (Extension Set) (Baseline Extension up to approximately 5 years)
C: Percentage of Participants With 3-month Confirmed Disability Progression (CDP) Events as Measured by the Expanded Disability Status Scale (EDSS) (Baseline, every 3 month up to the maximum of approximately 3 years)
D: Change in frequency of MBP-reactive Th17 cells (From baseline to the follow-up time points (Open label phase + 6 months and OLP +12 months).)

Answer: C
Please select the outcome measures that correspond to the clinical trial below.
Title: Impact of Pre-Pregnancy Micronutrient Supplementation on Maternal and Child Outcomes
Brief Summary: The study evaluates the efficacy of providing weekly iron-folate (IFA) supplements or Multiple Micronutrient (MM) supplements before pregnancy in increasing birth weight and duration of gestation as well as maternal and infant iron status.


Options:
A: Incidence of preeclampsia
B: Weight, length and Rohrer index at birth, and gestational duration in singleton pregnancies. (At birth); Mortality, morbidity and growth during the first year of life (Monthly during infancy)
C: Birth Size (At birth); Gestational Age (At birth); Child growth (From birth through 24 months); Child development (Up to 7 years post enrollment); Weight-for-age Z score (WAZ) (Up to 7 years post enrollment); Height-for-age Z score (HAZ) (Up to 7 years post enrollment); Weight -for-Height Z (WHZ) or Body Mass Index Z score (BMIZ) (Up to 7 years post enrollment); Body composition (Lean mass/fat free mass index) (Up to 7 years post enrollment)
D: Birth weight; 3-month infant mortality

Answer: C
Please select the outcome measures that correspond to the clinical trial below.
Title: Impact of Pre-Pregnancy Micronutrient Supplementation on Maternal and Child Outcomes
Brief Summary: The study evaluates the efficacy of providing weekly iron-folate (IFA) supplements or Multiple Micronutrient (MM) supplements before pregnancy in increasing birth weight and duration of gestation as well as maternal and infant iron status.


Options:
A: Birth Size (At birth); Gestational Age (At birth); Child growth (From birth through 24 months); Child development (Up to 7 years post enrollment); Weight-for-age Z score (WAZ) (Up to 7 years post enrollment); Height-for-age Z score (HAZ) (Up to 7 years post enrollment); Weight -for-Height Z (WHZ) or Body Mass Index Z score (BMIZ) (Up to 7 years post enrollment); Body composition (Lean mass/fat free mass index) (Up to 7 years post enrollment)
B: Recurrence of cleft lip and palate (3 months)
C: Hemoglobin (February 2007-February 2008)
D: Birth weight; 3-month infant mortality

Answer: A
Please select the outcome measures that correspond to the clinical trial below.
Title: Efficacy Evaluation of the HEART Pathway in Emergency Department Patients With Acute Chest Pain
Brief Summary: Our research will examine a chest pain care strategy, called the HEART pathway, which is designed to correctly identify Emergency Department patients at high-risk for cardiovascular events, likely to benefit from further testing, and patients at very-low-risk for cardiovascular events, who may be safely discharged home. By using an individual's risk assessment to determining testing, we hope to improve the quality and efficiency of the care delivered to Emergency Department patients with chest pain. Our study will determine if the HEART pathway, which combines a clinical decision rule, the HEART score, and two serial troponin measurements, will reduce stress testing and cardiovascular imaging, decrease hospital length of stay, and reduce cost compared to usual care, while maintaining safety.


Options:
A: Objective cardiac testing (stress testing or cardiac imaging) within 30 days (30 Days)
B: All cause mortality (90 days)
C: Therapeutic efficacy: Length of stay (Duration of Initial Hospitalization)
D: Cost of Index Hospitalization (Emergency Department (ED) arrival through hospital discharge, median length of stay was 28.1 hours)

Answer: A
Please select the outcome measures that correspond to the clinical trial below.
Title: Randomized, Controlled Trial of Erythropoietin in the Prevention of Acute Mountain Sickness
Brief Summary: Acute mountain sickness (AMS) is a syndrome of nonspecific symptoms and is therefore subjective. The Lake Louise Consensus Group defined acute mountain sickness as the presence of headache in an unacclimatized person who has recently arrived at an altitude above 2,500 m plus the presence of one or more of the following: gastrointestinal symptoms (anorexia, nausea, or vomiting), insomnia, dizziness, and lassitude or fatigue. An increase in RBC mass is a natural feature of altitude acclimatization. Hypoxia-induced erythropoietin (EPO) secretion begins hours after ascent and stimulates bone marrow production of red blood cells, but this takes weeks to effect an increase in red cell mass . Therefore, it is feasible that EPO therapy weeks before altitude exposure decrease high altitude illness.

In 1996, Young et al in U.S. Army Research Institute of Environmental Medicine (USARIEM) reported that autologous erythrocyte infusion did not ameliorate the decrement in maximal oxygen uptake at 4,300m altitude despite increasing arterial oxygen carrying capacity. On the basis of this report, USARIEM did not recommend use of recombinant EPO for altitude acclimatization.

However, increases in erythrocyte count, hematocrit and hemoglobin associated with EPO therapy have been shown to decrease fatigue and increase work capacity and exercise tolerance. In addition, improvement in CNS function and cognitive ability has been noted with EPO therapy. Subjective benefits include improvement in sleep habits, tolerance to cold; decreased dyspnea, anginal symptoms and tachycardia and improved appetite, all of which are symptoms associated with high altitude illness.

The investigators also reported improved muscle energy metabolism with EPO in dialysis patients, but not with RBC transfusion.

In this study, the investigators will conduct a randomised controlled trial to assess the effect of EPO administration on AMS at an altitude of 4,130 m.


Options:
A: Effect of study treatment on 24 h ambulatory systolic blood pressure at high altitude (After 6 weeks of study treatment, during high altitude visit)
B: Acute mountain sickness score (At 3230m and 4,130m(Annapurna base camp))
C: incidence of acute mountain sickness (2 days)
D: Change in Optic Nerve Sheath Diameter by Ultrasonography (Optic Nerve Sheath Diameter: baseline, 24 hours.)

Answer: B
Please select the outcome measures that correspond to the clinical trial below.
Title: Exercise in Pediatric Autologous Stem Cell Transplant Patients: A Randomized Controlled Trial Protocol
Brief Summary: Hematopoietic stem cell transplantation is an intensive therapy used to improve survivorship and cure various oncologic diseases. However, this therapy is associated with high mortality rates and numerous negative side-effects. The recovery of the immune system is a special concern and plays a key role in the success of this treatment. In healthy populations it is known that exercise plays an important role in immune system regulation, but little is known about the role of exercise in the hematological and immunological recovery of children undergoing hematopoietic stem cell transplant. The Primary objective of this Randomized Controlled Trial is: study the effect of an exercise program on immune cell recovery in patients undergoing autologous stem cell transplantation. The Secondary objective is to determine if an exercise intervention might diminish the deterioration of quality of life, physical fitness, and the acquisition of a sedentary lifestyle.

Methods

Twenty-four participants treated for a malignancy with autologous stem cell transplant (5 to 18 years) in the Alberta Children's Hospital will be randomly assigned to an exercise or control group. The exercise group will participate in a two-phase exercise intervention (in and outpatient) from hospitalization until 10 weeks after discharge. The exercise program includes strength, flexibility and aerobic exercise. During the inpatient phase this program will be performed 5 times/week and will be supervised. The outpatient phase will combine a supervised session with two home-based exercise sessions with the use of the Wii device. The control group will follow the standard protocol without any specific exercise program. A range of outcomes, including quantitative and functional recovery of immune system, cytokine levels in serum, NK cells and their subset recovery and function, and gene expression of activating and inhibitory NK cell receptors, body composition, nutrition, quality of life, fatigue, health-related fitness assessment and physical activity levels will be examined, providing the most comprehensive assessment to date.

Discussion We expect to find an improvement in the immunological recovery, quality of life, decreased acquisition of sedentary behavior and less fitness deconditioning.


Options:
A: BMI (Baseline, 4 months)
B: Accelerometer, average counts of dynamic acceleration (physical activity) (1 week at baseline and at 12 months)
C: Hematological and Immunological Recovery (This assessments will be performed at baseline, 7, 14, 28, 56, 84 and 180 days after stem cell transplantation (SCT))
D: feasibility of isometric exercise in vertebral bony metastases (12 weeks post completion of radiotherapy)

Answer: C
Please select the outcome measures that correspond to the clinical trial below.
Title: METHOD - Phase I/II Study of Intramyocardial Injection of Bone Marrow Derived Mononuclear Cells in Chronic Ischemic Disease
Brief Summary: Intramyocardial, NOGA guided injection of bone marrow derived mononuclear cells in patients with chronic ischemic heart disease and LVEF \< 40%. The primary objective is to determine whether the administration of the cells improves recovery of the left ventricular function. Secondary objective is the finding of clinical or paraclinical parameters to predict potential benefits of the treatment (basing on MRI characteristics such as size, transmurality of the myocardial infarction and peri-lesional ischemia).

In the first part of the study 10 patients are treated without control group. This phase serves as feasibility and safety part of the study.


Options:
A: Freedom from occurrence of major adverse cardiac and cerebrovascular events (MACCE), including all-cause death, re-infarction, revascularization and stroke (12 months)
B: Troponin samples (1 day after cell injection); Number of patients with adverse events at short term (within 1 week after cell injection); Number of patients with adverse events at mid/long term (up to 12 months after cell injection)
C: Change in left ventricular ejection fraction (6 months)
D: Number of Patients With Serious Adverse Events (12 Months)

Answer: B
Please select the outcome measures that correspond to the clinical trial below.
Title: Prehabilitation to Enhance Postoperative Functional Capacity Following Esophageal Resection
Brief Summary: Consenting patients scheduled for esophageal resection surgery will be randomized to receive standard nutrition counseling (including nutritional supplements as needed) or standard nutrition counseling and exercise 4 weeks before surgery and 8 weeks after surgery.

It is hypothesized that, compared with the group receiving nutrition alone, the addition of physical exercise to nutrition starting before surgery and continuing for 8 weeks after surgery will have a significantly greater impact on functional walking capacity during the prehabilitation period and during the postoperative period, and on the incidence of postoperative pulmonary complications.


Options:
A: 6 Minute Walk Test (baseline, 3 weeks, 4 weeks, 8 weeks, 24 weeks)
B: Oswestry Disability Index (ODI) (Change in ODI from baseline to after intervention (after 3 months) and 3 months, 1 and 2 years post-surgery)
C: 6 minute walk test (6MWT) (up to 8 weeks after surgery)
D: proportion of patients in both groups with diseased quality of life (<50 points in at least one dimension) (1 year after the date of primary surgery for colorectal cancer)

Answer: C
Please select the outcome measures that correspond to the clinical trial below.
Title: Prehabilitation to Enhance Postoperative Functional Capacity Following Esophageal Resection
Brief Summary: Consenting patients scheduled for esophageal resection surgery will be randomized to receive standard nutrition counseling (including nutritional supplements as needed) or standard nutrition counseling and exercise 4 weeks before surgery and 8 weeks after surgery.

It is hypothesized that, compared with the group receiving nutrition alone, the addition of physical exercise to nutrition starting before surgery and continuing for 8 weeks after surgery will have a significantly greater impact on functional walking capacity during the prehabilitation period and during the postoperative period, and on the incidence of postoperative pulmonary complications.


Options:
A: The incidence of postoperative complications, classified by Clavien Scale (Time Frame: 30days or the postoperative hospital stay if longer than 30 days)
B: Six Minute Walk Test (6MWT) (up to 8 weeks after surgery)
C: 6 minute walk test (6MWT) (up to 8 weeks after surgery)
D: 6-minute-walking-distance (6MWD) (4 weeks postoperatively)

Answer: C
Please select the outcome measures that correspond to the clinical trial below.
Title: Reticulocyte Dynamic and Related Hemoglobin Variability in Hemodialysis Patients Treated With Darbepoetin Alfa and C.E.R.A.: a Randomized Controlled Trial
Brief Summary: Background: In a simulation based on a pharmacokinetic model we demonstrated that increasing the erythropoiesis stimulating agents (ESAs) half-life or shortening their administration interval decreases hemoglobin variability. The benefit of reducing the administration interval was however lessened by the variability induced by more frequent dosage adjustments. The purpose of this study was to analyze the reticulocyte and hemoglobin kinetics under different ESAs and administration intervals in a collective of chronic hemodialysis patients.

Methods: The study was designed as an open-label, randomized, four-period cross-over investigation, including 30 patients under chronic hemodialysis at the regional hospital of Locarno (Switzerland) in September 2009 and lasting 2 years. Four treatment strategies (C.E.R.A. every 4 weeks Q4W and every 2 weeks Q2W, Darbepoetin alfa Q4W and Q2W) were compared with each other. The mean square successive difference of hemoglobin, reticulocyte count and ESAs dose was used to quantify variability. We distinguished a short- and a long-term variability based respectively on the weekly and monthly successive difference.


Options:
A: hemoglobin variability (2 years)
B: Percentage of Participants With Lesser Than or Equal to One Gram Per Deciliter Decrease in Average Hemoglobin From Baseline and Maintaining Average Hemoglobin Level Greater Than or Equal to 10.5 g/dL Over Evaluation Period (Baseline (Week -4 to Week -1) and Evaluation period (Weeks 50 to 53))
C: TSAT (transferrin saturation), serum albumin, serum ferritin, serum transferrin, serum C reactive protein (after randomization at month 1, 2, 3, 6, 12)
D: Percentage of Time When Participants Had Hemoglobin Levels Between 9 to 11 Gram Per Deciliter (g/dL) (Week 17 up to Week 24)

Answer: A