TrialPanorama/Dataset huggingface dataset:
Please select the outcome measures that correspond to the clinical trial below.
Title: Randomized Controlled Trial of a Sugar-Sweetened Beverage Intervention in Overweight Mothers and Their Children Ages 3-5
Brief Summary: The purpose of this study is to test the effect of a novel six-month behavioral program to reduce sugar-sweetened beverage consumption among preschoolers and their mothers. The behavioral intervention tested will be delivered via a mobile-based website, text messages and email in addition to one face-to-face group meeting. The intervention will be compared to a waitlist control group. Participants will be 42 overweight/obese mothers and their children ages 3-5 living in the Chapel Hill/Raleigh/Durham area. Sugar-sweetened beverage consumption and weight in both children and mothers will be measured at three- and six-months post-randomization. It is hypothesized that children randomized to the intervention will have a greater reduction in sugar-sweetened beverage consumption at 6 months compared to children randomized to the control group.


Options:
A: Change in child sugar-sweetened beverage consumption from baseline to 6 months (Baseline, 6 months)
B: Develop/evaluate effectiveness of a community-based intervention targets children of the Pacific Region who are overweight in order to slow and prevent further weight gain (for children to "grow into their weight") (Feb 2008 - Feb 2012)
C: Body fat percentage (One year (interim analysis))
D: Absolute change in mean accelerometry counts over 6 days (baseline, end of intervention, six months after end of intervention)

Answer: A
Please select the outcome measures that correspond to the clinical trial below.
Title: Red Blood Cell Transfusion Thresholds and QOL in MDS (EnhanceRBC): a Pilot, Feasibility Study
Brief Summary: Myelodysplastic syndromes (MDS) are bone marrow malignancies characterized by poor bone marrow function that may progress to acute myeloid leukemia. Many patients become red blood cell transfusion-dependent. Transfusion dependence is associated with inferior quality of life (QOL). However, the relationship between the degree of anemia and QOL is less clear. A commonly used transfusion strategy is to target the hemoglobin (Hb) in the range of 80-90 g/L (normal hemoglobin \> 120-130g/L). The question is: would a higher hemoglobin target lead to improvement in QOL despite the negative impact transfusion dependence may have on QOL (due to associated time commitments, expense, transfusion reactions etc). Several groups have prospectively shown that targeting hemoglobin levels of greater than 120 g/L (with hematopoietic growth factors (HGFs) and/or blood transfusions) or incremental increases of 15-20 g/L (with HGFs alone) were associated with improved QOL. The investigators MDS program has been conducting prospective assessments of QOL since 2007 in all registered and consented patients using a variety of validated questionnaires. Preliminary analysis (in 236 patients) revealed that, compared with an age-matched healthy general population, MDS patients have inferior QOL. Transfusion dependence and anemia were independently predictive of poor functioning, fatigue and decreased health utility. Furthermore, a hemoglobin level of ≥100 g/L seemed to be the key threshold for improvement in function and symptom scores. The investigators hypothesize that the target hemoglobins in transfusion dependent MDS patients are too low and this may account for their inferior quality of life. Our goal is to compare the effect on QOL of a restrictive strategy (which is the current standard of care), with a liberal transfusion strategy in a large randomized controlled trial of transfusion dependent MDS outpatients. Before embarking on such an endeavor, the investigators must first prove feasibility in a smaller pilot randomized controlled trial.


Options:
A: To compare mortality between groups 28 day after ICU admission (28 days after ICU admission)
B: Primary outcomes are related to feasibility and include recruitment rate, protocol adherence & difference in mean Hb concentration and RBC exposure between the 2 groups. (60 days following randomisation)
C: Percentage compliance of q2weekly hemoglobins (3 months)
D: Randomization Rate (12 months)

Answer: C
Please select the outcome measures that correspond to the clinical trial below.
Title: Red Blood Cell Transfusion Thresholds and QOL in MDS (EnhanceRBC): a Pilot, Feasibility Study
Brief Summary: Myelodysplastic syndromes (MDS) are bone marrow malignancies characterized by poor bone marrow function that may progress to acute myeloid leukemia. Many patients become red blood cell transfusion-dependent. Transfusion dependence is associated with inferior quality of life (QOL). However, the relationship between the degree of anemia and QOL is less clear. A commonly used transfusion strategy is to target the hemoglobin (Hb) in the range of 80-90 g/L (normal hemoglobin \> 120-130g/L). The question is: would a higher hemoglobin target lead to improvement in QOL despite the negative impact transfusion dependence may have on QOL (due to associated time commitments, expense, transfusion reactions etc). Several groups have prospectively shown that targeting hemoglobin levels of greater than 120 g/L (with hematopoietic growth factors (HGFs) and/or blood transfusions) or incremental increases of 15-20 g/L (with HGFs alone) were associated with improved QOL. The investigators MDS program has been conducting prospective assessments of QOL since 2007 in all registered and consented patients using a variety of validated questionnaires. Preliminary analysis (in 236 patients) revealed that, compared with an age-matched healthy general population, MDS patients have inferior QOL. Transfusion dependence and anemia were independently predictive of poor functioning, fatigue and decreased health utility. Furthermore, a hemoglobin level of ≥100 g/L seemed to be the key threshold for improvement in function and symptom scores. The investigators hypothesize that the target hemoglobins in transfusion dependent MDS patients are too low and this may account for their inferior quality of life. Our goal is to compare the effect on QOL of a restrictive strategy (which is the current standard of care), with a liberal transfusion strategy in a large randomized controlled trial of transfusion dependent MDS outpatients. Before embarking on such an endeavor, the investigators must first prove feasibility in a smaller pilot randomized controlled trial.


Options:
A: Composite end-point of mortality and severe complication (30 days)
B: Percentage compliance of q2weekly hemoglobins (3 months)
C: Number of Participants With All-cause Mortality or Nonfatal Myocardial Reinfarction (Within 30 days of randomization)
D: Enrollment rate (Time Frame: 6 months); Non-adherence (30 days)

Answer: B
Please select the outcome measures that correspond to the clinical trial below.
Title: Red Blood Cell Transfusion Thresholds and QOL in MDS (EnhanceRBC): a Pilot, Feasibility Study
Brief Summary: Myelodysplastic syndromes (MDS) are bone marrow malignancies characterized by poor bone marrow function that may progress to acute myeloid leukemia. Many patients become red blood cell transfusion-dependent. Transfusion dependence is associated with inferior quality of life (QOL). However, the relationship between the degree of anemia and QOL is less clear. A commonly used transfusion strategy is to target the hemoglobin (Hb) in the range of 80-90 g/L (normal hemoglobin \> 120-130g/L). The question is: would a higher hemoglobin target lead to improvement in QOL despite the negative impact transfusion dependence may have on QOL (due to associated time commitments, expense, transfusion reactions etc). Several groups have prospectively shown that targeting hemoglobin levels of greater than 120 g/L (with hematopoietic growth factors (HGFs) and/or blood transfusions) or incremental increases of 15-20 g/L (with HGFs alone) were associated with improved QOL. The investigators MDS program has been conducting prospective assessments of QOL since 2007 in all registered and consented patients using a variety of validated questionnaires. Preliminary analysis (in 236 patients) revealed that, compared with an age-matched healthy general population, MDS patients have inferior QOL. Transfusion dependence and anemia were independently predictive of poor functioning, fatigue and decreased health utility. Furthermore, a hemoglobin level of ≥100 g/L seemed to be the key threshold for improvement in function and symptom scores. The investigators hypothesize that the target hemoglobins in transfusion dependent MDS patients are too low and this may account for their inferior quality of life. Our goal is to compare the effect on QOL of a restrictive strategy (which is the current standard of care), with a liberal transfusion strategy in a large randomized controlled trial of transfusion dependent MDS outpatients. Before embarking on such an endeavor, the investigators must first prove feasibility in a smaller pilot randomized controlled trial.


Options:
A: Inability to Walk 10 Feet or Across a Room Without Human Assistance or Death (60 days after randomization)
B: Percentage compliance of q2weekly hemoglobins (3 months)
C: Composite score of any one of the following: (1) all-cause mortality; (2) myocardial infarction; (3) new renal failure requiring dialysis; or (4) new focal neurological deficit (Up to hospital discharge or postoperative day 28 (whichever occurs first))
D: Recruitment: screening (One year); Recruitment: consent (One year); Recruitment: enrolment (One year)

Answer: B
Please select the outcome measures that correspond to the clinical trial below.
Title: Reducing Unintended Pregnancies Through Reproductive Life Planning and Contraceptive Action Planning
Brief Summary: The purpose of this web-based study is to determine whether reproductive life planning (RLP), with or without contraceptive action planning (RLP+), will result in reduced risk of unintended pregnancy when compared to an information-only control group.


Options:
A: Assessment of acceptability of Implanon in comparison to the TCu380A IUD and the LNG-IUS (Participants will receive counseling before admission and at 12 months after)
B: Adherence Rate (Rate of Perfect Method Use) (For the first 3 months)
C: N/A
D: Contraceptive Use (24 months)

Answer: D
Please select the outcome measures that correspond to the clinical trial below.
Title: N/A
Brief Summary: The Ketogenic diet is a now proven, evidence based treatment of refractory epilepsy. the classic ketogenic diet (KD) is based on a ratio of fat to carbohydrate and protein, usually 3:1 or 4:1. Fat is proven long-chain triglycerides. The efficacy of the KD has been proven by many multicenter trials. But, side effects of ketogenic diet therapy is severe. The modified atkins diet (MAD) was designed and investigated at Johns Hopkins Hospital, which aimed to propose a less restrictive dietary treatment that would be more palatable to children and adolescents with less side effects. The MAD consist of a nearly balance diet (60% fat, 30% protein, and 10% carbohydrates by weight), without any restriction on the recommended daily calories. Some literature suggested that the MAD is an effective treatment for refractory epilepsy. But, no randomised controlled study has been tried. the investigators aimed in this prospective study to evaluate the efficacy, safety and tolerability of MAD comparing to KD. The patients were recruited between age 3 to 18 years old with intractable epilepsy. Enrolled patients were randomly assigned to either one of two groups; the KD group and MAD group. The patients were required to attend outpatient clinic after 1, 3month to record their seizure frequency and severity, while their dietary treatment.


Options:
A: Change in seizure frequency (3 months)
B: Number of seizures (6 - 8 weeks)
C: Reduction in seizure frequency at 3 months in the two groups: the modified Atkins diet group, and the control group. (3 months)
D: seizure outcome 3months after dietary therapy. (3 months)

Answer: D
Please select the outcome measures that correspond to the clinical trial below.
Title: A 52 Week Phase 3 Double-blind, Randomized, Placebo-controlled, Parallel-group Study To Assess The Efficacy, Safety And Tolerability Of Pf-04950615 In Subjects With Primary Hyperlipidemia Or Mixed Dyslipidemia At Risk Of Cardiovascular Events
Brief Summary: This study is a multicenter, double-blind, randomized study to access the efficacy, safety and tolerability of Bococizumab (PF-04950615; RN316) in subjects with hyperlipidemia receiving background statin therapy.


Options:
A: Percent Change From Baseline in Fasting Low Density Lipoprotein Cholesterol (LDL-C) at Week 12 (Baseline, Week 12)
B: Percent Change From Baseline in Calculated LDL-C at Week 24 - Intent-to-Treat (ITT) Analysis (From Baseline to Week 24)
C: Time to Cardiovascular Death, Myocardial Infarction, Hospitalization for Unstable Angina, Stroke, or Coronary Revascularization (Events that occurred from randomization to the last confirmed survival status date; the median duration of follow-up was 26 months. KM estimates at 6, 12, 18, 24, 30 and 36 months are reported.)
D: Percent Change From Baseline in Fasting Low Density Lipoprotein Cholesterol (LDL-C) at Week 12 (Baseline, Week 12)

Answer: D
Please select the outcome measures that correspond to the clinical trial below.
Title: A 52 Week Phase 3 Double-blind, Randomized, Placebo-controlled, Parallel-group Study To Assess The Efficacy, Safety And Tolerability Of Pf-04950615 In Subjects With Primary Hyperlipidemia Or Mixed Dyslipidemia At Risk Of Cardiovascular Events
Brief Summary: This study is a multicenter, double-blind, randomized study to access the efficacy, safety and tolerability of Bococizumab (PF-04950615; RN316) in subjects with hyperlipidemia receiving background statin therapy.


Options:
A: Percentage of Participants Who Experienced Adverse Events (AEs) (Up to 10 weeks after last study drug administration (maximum of 86 weeks))
B: Percent Change From Baseline in LDL-C at the Mean of Weeks 22 and 24 (Baseline and weeks 22 and 24); Percent Change From Baseline in LDL-C at Week 24 (Baseline and week 24)
C: The primary endpoint in the study is the incidence of treatment-emergent adverse events in subjects treated with REGN727 or placebo, reported from the administration of study drug on day 1 to the completion of the study on day 106. (106 days)
D: Percent Change From Baseline in Fasting Low Density Lipoprotein Cholesterol (LDL-C) at Week 12 (Baseline, Week 12)

Answer: D
Please select the outcome measures that correspond to the clinical trial below.
Title: Gene and Environment in Schizophrenia- Research Groups in Madrid
Brief Summary: The AGES-CM consortium aims to study the interaction between the polymorphisms of the candidate genes related with neurodevelopment, neurotransmission, brain progressive changes, cognitive functioning and stressful life events (prospective- and retrospectively assessed) and the association of the interactions with structural and functional brain measures, neuropsychological performance, biochemical and oxidative status in both in patients and controls. The investigators study aimed to examine the effectiveness of a parallel, structured, and specific psychoeducational group intervention (PE) for adolescent patients and their families by comparing it with treatment as usual).


Options:
A: transition to subthreshold psychosis (and psychosis or schizophrenia)
B: Change in subthreshold psychotic (positive and negative) symptoms (Change from pretreatment (assessed for the 3 months prior to randomization) to 12 month reassessment)
C: Cognitive performance (20 weeks)
D: number of relapses (Change from baseline to 1 -year follow-up and 2 years follow-up)

Answer: D
Please select the outcome measures that correspond to the clinical trial below.
Title: Effects of Sprinkles With and Without Iron on Zinc Absorption From Local Foods in Kenyan Toddlers, Including the Gut Microbiome
Brief Summary: The investigators propose to study the effects of increased iron intake by home fortification of complementary foods on the gastrointestinal microbial development, inflammatory responses, and zinc (Zn) absorption. The proposed subjects are 9 month olds living in a malaria endemic area of rural Kenya who are randomized at 6 months of age to one of three fortificant groups: 1) Sprinkles™ with 12mg Iron(Fe)/day + other micronutrients, including 5mg/d Zn (test); Sprinkles™ with 0 mg/d Fe + other micronutrients, including 5mg/d Zn (control); Sprinkles™ with no micronutrients (placebo). The investigators hypothesize that the microbiome will be significantly different in the three groups and that Zn absorption and status, in addition to immune and oxidant status will be improved in the non-Fe fortified groups when compared to the Fe-fortified group.


Options:
A: "negative nutritional outcome" of a child (6 months follow-up)
B: Change from baseline in the isotopic ratio of iron in blood at week 5 (Baseline and Week 5)
C: gut microbiota composition (Fecal sample after 2 months)
D: Changes in GI microbiome (6 and 9 months of age)

Answer: D
Please select the outcome measures that correspond to the clinical trial below.
Title: Motivational Interviewing and Medication Review in the Secondary Prevention of Coronary Heart Disease
Brief Summary: Low medication adherence in patients with coronary heart disease increases mortality.

This study investigates if an intervention of medication review and counselling can improve patients' medication adherence and treatment results.


Options:
A: Patient-reported Adherence to Triple Therapy (Aspirin/Antiplatelet; Beta Blocker; and Statin) at 6 Months (6 months)
B: Percentage of patients who achieve the treatment goal for Low density lipoprotein cholesterol (LDL-C) (16 months)
C: Medication Adherence (12 months); Days Lost Due to Unplanned Cardiovascular Hospitalizations or Death of Any Cause (12 months)
D: Glucose Monitoring Adherence at Acute Outcome (Measured at Month 4); Percent Medication Adherence Via MEMS (month 4); Clinician Rated Depression (MADRS) at the Acute Timepoint (month 4); Depression on the CGI at Acute Outcome (Month 4)

Answer: B
Please select the outcome measures that correspond to the clinical trial below.
Title: Single Center, Placebo Controlled Clinical Study in Desensitization vs Tolerance Induction in Peanut Allergy Subjects
Brief Summary: Determine whether peanut oral immunotherapy (OIT) induces clinical tolerance as assessed after the initial 3 month avoidance period

Secondary Objectives:

* Identify the basic immune mechanisms which can explain the differences in the effects of OIT in desensitized vs. tolerant individuals.
* Determine whether immune monitoring measurements reflecting underlying mechanisms during OIT can be used to predict responses to OIT in individual subjects and, ultimately, to improve the safety and efficacy outcomes in peanut OIT protocols.


Options:
A: Passing the Week 117 DBPCFC to Peanut (Week 117 - Number of participants with no clinical reactivity to peanuts)
B: Percentage of Participants Achieving Peak Esophageal Intraepithelial Eosinophil Count of ≤6 Eosinophils Per High-power Field (Eos/Hpf) in All Three Regions at Week 24 (At week 24); Absolute Change From Baseline in Dysphagia Symptom Questionnaire (DSQ) Total Score at Week 24 (Baseline and week 24)
C: evaluate effectiveness of oral montelukast in treatment of EE. (6 months)
D: Rate of clinico-pathological remission (6 weeks)

Answer: A
Please select the outcome measures that correspond to the clinical trial below.
Title: Umbilical Cord Blood Use For Admission Blood Tests of Very Low Birth Weight (VLBW) Preterm Neonates: A Multi-center Randomized Clinical Trial
Brief Summary: The goal of this protocol is to establish a randomized clinical trial comparing the use of cord blood vs. infant blood with the primary outcome of comparing both the absolute hemoglobin concentration and the percent change in hemoglobin concentration from baseline around 24 hours of life.


Options:
A: Absolute hemoglobin concentration (24 hours of life); Percent change in hemoglobin concentration from baseline (24 hours of life)
B: Bayley III Composite Cognitive Score (22-26 months corrected age (a median of 25 months corrected age, which corresponds to a median of 29 months calendar age in the analysis population), unless the subject died earlier)
C: Incidence of death or major neurodevelopmental impairment (24 months of age corrected for prematurity)
D: Death or Neurodevelopmental Impairment (Birth to 22-26 months corrected age); Death (Birth to 22-26 months corrected age); Neurodevelopmental Impairment (at 22-26 months corrected age); Cognitive Delay (at 22-26 months corrected age); Moderate or Severe Cerebral Palsy (at 22-26 months corrected age); Severe Vision Impairment (at 22-26 months corrected age); Severe Hearing Impairment (at 22-26 months corrected age)

Answer: A
Please select the outcome measures that correspond to the clinical trial below.
Title: Physical Training Program in Patients Hospitalized for Community-acquired Pneumonia
Brief Summary: Hospitalized patients with community-acquired pneumonia (CAP) have reduced functional capacity, peripheral muscle strength and quality of life. Despite the high incidence and severity has not yet been demonstrated whether a physical training program can change these outcomes. Objectives: To evaluate the effects of an exercise training program in patients hospitalized for CAP, to compare this effects with traditional physical therapy and assess whether the inflammatory markers correlate with the functional status of the patient and type of treatment. Methods: A controlled, prospective, randomized clinical trial. Patients hospitalized for CAP, adults, conscious, hemodynamically stable and independent to walk will be studied. In the first day, a medical history, measured dyspnea, incremental shuttle walk test, Glittre test, measurement of peripheral muscle strength, spirometry, and the application of quality of life questionnaire Shor Form 36 will be held. The measurement of inflammatory markers (C-reactive protein and tumor necrosis factor) will also be held. Patients will be randomized into two groups: one will perform a program of physical training (stretching, active resistance exercises and aerobic exercises) and the other group held the traditional physical therapy (bronchial hygiene, breathing exercises and walking) for eight days. On the tenth day the same assessment will be carried out initially described.


Options:
A: Glittre test (up to 9 months)
B: Length of Stay (At time of discharge from hospital (an expected average of 8 days post admission))
C: Falls (18 months); Amount of Time Spent Out of Bed as Measured by Wireless Accelerometers (During hospital stay)
D: Muscle strength (Participants will be followed for the duration of hospital stay, an expected average of 8 days); Exercise capacity (Participants will be followed for the duration of hospital stay, an expected average of 8 days)

Answer: A