TrialPanorama/Dataset huggingface dataset:
Please select the outcome measures that correspond to the clinical trial below.
Title: Multi-Center Study to Assess the Efficacy, Safety and Immunogenicity of 2 or 3 Doses of GSK Biologicals' Oral Live Attenuated Human Rotavirus (HRV) Vaccine Given Concomitantly With Routine EPI Vaccinations in Healthy Infants
Brief Summary: The primary objective of this study is to determine if the GSK Biologicals' human rotavirus (HRV) vaccine (pooled HRV groups) given concomitantly with routine expanded program on immunisation (EPI) vaccinations can prevent severe rotavirus gastroenteritis (≥11 on the 20-point Vesikari scoring system \[Ruuska, 1990\]) caused by the circulating wild-type RV strains during the period from 2 weeks after the last dose of HRV vaccine or placebo until Visit 5.

The primary objective will be reached if the lower limit of the 95% confidence interval (CI) on vaccine efficacy is \>0%.

The Protocol Posting has been updated in order to comply with the FDA Amendment Act, Sep 2007.


Options:
A: Anti-RV IgA antibody SC at Month 2 • Safety: solicited & unsolicited adverse events and SAEs
B: Geometric Mean Titer of Serum Neutralizing Antibody Response to Human Rotavirus Serotypes G1, G2, G3, G4, and P1A[8] (42 days after vaccination 3 (up to 185 days))
C: Number of Subjects With Severe Rotavirus Gastroenteritis (RV GE) Caused by the Circulating Wild-type Rotavirus Strain (From 2 weeks after the last vaccine or placebo dose up to 1 year of age)
D: occurrence of Severe Rotavirus Gastroenteritis (Up to 2 years of age of participants)

Answer: C
Please select the outcome measures that correspond to the clinical trial below.
Title: Multi-Center Study to Assess the Efficacy, Safety and Immunogenicity of 2 or 3 Doses of GSK Biologicals' Oral Live Attenuated Human Rotavirus (HRV) Vaccine Given Concomitantly With Routine EPI Vaccinations in Healthy Infants
Brief Summary: The primary objective of this study is to determine if the GSK Biologicals' human rotavirus (HRV) vaccine (pooled HRV groups) given concomitantly with routine expanded program on immunisation (EPI) vaccinations can prevent severe rotavirus gastroenteritis (≥11 on the 20-point Vesikari scoring system \[Ruuska, 1990\]) caused by the circulating wild-type RV strains during the period from 2 weeks after the last dose of HRV vaccine or placebo until Visit 5.

The primary objective will be reached if the lower limit of the 95% confidence interval (CI) on vaccine efficacy is \>0%.

The Protocol Posting has been updated in order to comply with the FDA Amendment Act, Sep 2007.


Options:
A: Number of Subjects With Severe Rotavirus Gastroenteritis (RV GE) Caused by the Circulating Wild-type Rotavirus Strain (From 2 weeks after the last vaccine or placebo dose up to 1 year of age)
B: Occurrence of RV GE
C: Percentage of Participants Developing New Grade >=3 Adverse Events (From study entry until at least 42 days after third vaccination); Percentage of Participants Classified as Responders as Measured by Serum Anti-rotavirus IgA ELISA (IgA) and Serum Neutralizing Antibodies (SNA) G1, G2, G3, G4 and P1. (Prior to first vaccination and at least 14 days after third vaccination)
D: Percentage of Participants Achieving Seroresponse for Meningiococcal Group C Serotype (28 days after the second dose of MCC vaccine (approximately 20 weeks))

Answer: A
Please select the outcome measures that correspond to the clinical trial below.
Title: Multi-Center Study to Assess the Efficacy, Safety and Immunogenicity of 2 or 3 Doses of GSK Biologicals' Oral Live Attenuated Human Rotavirus (HRV) Vaccine Given Concomitantly With Routine EPI Vaccinations in Healthy Infants
Brief Summary: The primary objective of this study is to determine if the GSK Biologicals' human rotavirus (HRV) vaccine (pooled HRV groups) given concomitantly with routine expanded program on immunisation (EPI) vaccinations can prevent severe rotavirus gastroenteritis (≥11 on the 20-point Vesikari scoring system \[Ruuska, 1990\]) caused by the circulating wild-type RV strains during the period from 2 weeks after the last dose of HRV vaccine or placebo until Visit 5.

The primary objective will be reached if the lower limit of the 95% confidence interval (CI) on vaccine efficacy is \>0%.

The Protocol Posting has been updated in order to comply with the FDA Amendment Act, Sep 2007.


Options:
A: 116E rotavirus vaccine (6,10 and 14 weeks)
B: Anti-RV IgA antibody SC at Month 2 • Safety: solicited & unsolicited adverse events and SAEs
C: Number of Subjects With Severe Rotavirus Gastroenteritis (RV GE) Caused by the Circulating Wild-type Rotavirus Strain (From 2 weeks after the last vaccine or placebo dose up to 1 year of age)
D: Seropositivity as anti-rotavirus IgA concentration >/= 20 U/ml (6, 10, 14 and 18 weeks)

Answer: C
Please select the outcome measures that correspond to the clinical trial below.
Title: Fluorescence-guided Resection of Malignant Gliomas With 5-Aminolevulinic Acid (5-ALA) vs. Conventional Resection
Brief Summary: The aim of the study "Fluorescence-guided resection of malignant gliomas with 5-Aminolevulinic acid (5-ALA) vs. conventional resection" is to determine how accurately contrast agent-accumulating tumour can be removed by primary surgery and to assess the clinical usefulness of this method.


Options:
A: 1. Percentage of patients with a histologically confirmed malignant glioma (grade III or IV -WHO) without definite residual contrast agent-accumulating tumour in the early post-operative control MRI (within 72 hours of the operation). (Within 72 hours after surgery); 2. Progression-free survival 6 months after primary surgical treatment of a malignant gli-oma in patients with histologically confirmed malignant glioma (grade III or IV -WHO). (Within 6 month after surgery)
B: Overall Survival (During treatment and every three months from end of treatment through end of study or approximately up to 5 years.)
C: Overall Survival (7 years)
D: Progression Free Survival (PFS) time (5 years)

Answer: A
Please select the outcome measures that correspond to the clinical trial below.
Title: Preschool Based Obesity Prevention Effectiveness Trial
Brief Summary: The purpose of this study is to compare changes in body mass index (BMI) among 3- to 5-year-old minority children randomized to a weight control intervention (WCI) or a general health control intervention.


Options:
A: Executive function accuracy (Up to 8 months)
B: Blood pressure (6 months)
C: % Body Fat (Boys) (Baseline and 3 years); BMI Z-score (Boys) (Baseline and three years); % Body Fat (Girls) (Baseline and 3 years); BMI Z-score (Girls) (Baseline and three years)
D: Body height and weight (Sept 2006- May 2009); Healthy Start Knowledge Quiz (Sept 2006- May 2009); 24-hour diet observation and recall (Sept 2006- May 2009); Physical activity (Sept 2006- May 2009); Television viewing (child outcomes, measured immediately after the study and at a 1-year follow-up visit) (Sept 2006- May 2009); Score on short Acculturation Scale (parent outcome, measured immediately after the study and at a 1-year follow-up visit) (Sept 2006- May 2009); Nutrition and exercise knowledge (Sept 2006- May 2009); Self-efficacy for eating and exercise behaviors (Sept 2006- May 2009); Score on Nutrition Attitudes Scale (Sept 2006- May 2009); Support and role modeling for healthy eating (teacher outcomes, measured immediately after the study and at a 1-year follow-up visit) (Sept 2006- May 2009)

Answer: D
Please select the outcome measures that correspond to the clinical trial below.
Title: Preschool Based Obesity Prevention Effectiveness Trial
Brief Summary: The purpose of this study is to compare changes in body mass index (BMI) among 3- to 5-year-old minority children randomized to a weight control intervention (WCI) or a general health control intervention.


Options:
A: Body height and weight (Sept 2006- May 2009); Healthy Start Knowledge Quiz (Sept 2006- May 2009); 24-hour diet observation and recall (Sept 2006- May 2009); Physical activity (Sept 2006- May 2009); Television viewing (child outcomes, measured immediately after the study and at a 1-year follow-up visit) (Sept 2006- May 2009); Score on short Acculturation Scale (parent outcome, measured immediately after the study and at a 1-year follow-up visit) (Sept 2006- May 2009); Nutrition and exercise knowledge (Sept 2006- May 2009); Self-efficacy for eating and exercise behaviors (Sept 2006- May 2009); Score on Nutrition Attitudes Scale (Sept 2006- May 2009); Support and role modeling for healthy eating (teacher outcomes, measured immediately after the study and at a 1-year follow-up visit) (Sept 2006- May 2009)
B: Absolute change in mean accelerometry counts over 6 days (baseline, end of intervention, six months after end of intervention)
C: Change in Child BMI-z score (Collected at the beginning and end of each academic year (i.e., fall, spring) for 3 years (BL, Y1, Y2) rather than 4 years as planned); Modified change in BMI z-score (Collected at the beginning and end of each academic year (i.e., fall, spring) for 3 years (BL, Y1, Y2))
D: Difference Between Interventions in Vegetable Intake (One meal per week for each intervention (Study weeks 1, 2, 3, and 4))

Answer: A
Please select the outcome measures that correspond to the clinical trial below.
Title: Preschool Based Obesity Prevention Effectiveness Trial
Brief Summary: The purpose of this study is to compare changes in body mass index (BMI) among 3- to 5-year-old minority children randomized to a weight control intervention (WCI) or a general health control intervention.


Options:
A: Difference Between Interventions in Vegetable Intake (One meal per week for each intervention (Study weeks 1, 2, 3, and 4))
B: Body mass index (2005, 2006, 2007, 2008); nutrition behavior (2005, 2006, 2007, 2008); physical activity (2005, 2006, 2007, 2008)
C: Body height and weight (Sept 2006- May 2009); Healthy Start Knowledge Quiz (Sept 2006- May 2009); 24-hour diet observation and recall (Sept 2006- May 2009); Physical activity (Sept 2006- May 2009); Television viewing (child outcomes, measured immediately after the study and at a 1-year follow-up visit) (Sept 2006- May 2009); Score on short Acculturation Scale (parent outcome, measured immediately after the study and at a 1-year follow-up visit) (Sept 2006- May 2009); Nutrition and exercise knowledge (Sept 2006- May 2009); Self-efficacy for eating and exercise behaviors (Sept 2006- May 2009); Score on Nutrition Attitudes Scale (Sept 2006- May 2009); Support and role modeling for healthy eating (teacher outcomes, measured immediately after the study and at a 1-year follow-up visit) (Sept 2006- May 2009)
D: Change in Educators' Observed Implementation Fidelity Scores for Use of Evidence-Based Obesity Practices (From Baseline Up to 8 months)

Answer: C
Please select the outcome measures that correspond to the clinical trial below.
Title: Preschool Based Obesity Prevention Effectiveness Trial
Brief Summary: The purpose of this study is to compare changes in body mass index (BMI) among 3- to 5-year-old minority children randomized to a weight control intervention (WCI) or a general health control intervention.


Options:
A: Body height and weight (Sept 2006- May 2009); Healthy Start Knowledge Quiz (Sept 2006- May 2009); 24-hour diet observation and recall (Sept 2006- May 2009); Physical activity (Sept 2006- May 2009); Television viewing (child outcomes, measured immediately after the study and at a 1-year follow-up visit) (Sept 2006- May 2009); Score on short Acculturation Scale (parent outcome, measured immediately after the study and at a 1-year follow-up visit) (Sept 2006- May 2009); Nutrition and exercise knowledge (Sept 2006- May 2009); Self-efficacy for eating and exercise behaviors (Sept 2006- May 2009); Score on Nutrition Attitudes Scale (Sept 2006- May 2009); Support and role modeling for healthy eating (teacher outcomes, measured immediately after the study and at a 1-year follow-up visit) (Sept 2006- May 2009)
B: 1-year, and 3-year changes from baseline in questionaires scores for knowledge, attitudes, and habits of children, parents and teachers in regards to a healthy lifestyle. (3 years)
C: Diet plan recall directly after visit (On day of primary visit); Activity plan recall directly after visit (On day of primary visit, directly after seeing physician)
D: Physical activity (baseline, after 4-5 and 8-9 months of intervention, 2-4 months after intervention); motor skills (baseline, after 4-5 and 8-9 months of intervention, 2-4 months after intervention)

Answer: A
Please select the outcome measures that correspond to the clinical trial below.
Title: Primary Care Obesity Prevention: One or Multiple Targets
Brief Summary: This study will train primary care providers to counsel families on behavior change that is aimed at reducing the rate of weight gain in at-risk children.


Options:
A: Changes in BMI z-score (Measured at Month 12)
B: Body mass index percentile ranking (5 months)
C: Percent Body Fat (Baseline and One year)
D: Change in cognitive test performance (Baseline and 5-8 hours following intervention)

Answer: A
Please select the outcome measures that correspond to the clinical trial below.
Title: Primary Care Obesity Prevention: One or Multiple Targets
Brief Summary: This study will train primary care providers to counsel families on behavior change that is aimed at reducing the rate of weight gain in at-risk children.


Options:
A: Frequency of exclusive and total breastfeeding (First year)
B: Changes in BMI z-score (Measured at Month 12)
C: changes in body mass index throughout the intervention
D: Body mass index percentile ranking (5 months)

Answer: B
Please select the outcome measures that correspond to the clinical trial below.
Title: Primary Care Obesity Prevention: One or Multiple Targets
Brief Summary: This study will train primary care providers to counsel families on behavior change that is aimed at reducing the rate of weight gain in at-risk children.


Options:
A: weight change over 6 months (Baseline, 6 months); weight change over 12 months (Baseline, 12 months)
B: Child BMI Percentile (2 years after recruitment)
C: Changes in BMI z-score (Measured at Month 12)
D: Weight (baseline, 1, 2, 3 years)

Answer: C
Please select the outcome measures that correspond to the clinical trial below.
Title: Reducing Total Cardiovascular Risk in an Urban Community
Brief Summary: PLEASE NOTE: THIS STUDY IS ONLY ENROLLING PATIENTS CURRENTLY BEING TREATED AT BELAIR-EDISON FAMILY HEALTH CENTER.

The purpose of this study is to compare the clinical effectiveness and cost effectiveness of two cardiovascular risk reduction programs - a comprehensive intensive (Cl) intervention with a less intensive (LI) intervention - in African American, and white low-income patients with known excessive cardiovascular disease risk.


Options:
A: Low-density Lipoprotein Cholesterol (Measured at 1 year); Systolic Blood Pressure (Measured at 1 year); HbA1c (Measured at 1 year)
B: Qualitative description of process-related challenges and successes as assessed by observation and survey (3 months)
C: Number of Serious Medication Errors as Determined by Interview and Medical Chart Review (Measured at Day 30)
D: Adverse Drug Events (3 and 6 months)

Answer: A
Please select the outcome measures that correspond to the clinical trial below.
Title: Reducing Total Cardiovascular Risk in an Urban Community
Brief Summary: PLEASE NOTE: THIS STUDY IS ONLY ENROLLING PATIENTS CURRENTLY BEING TREATED AT BELAIR-EDISON FAMILY HEALTH CENTER.

The purpose of this study is to compare the clinical effectiveness and cost effectiveness of two cardiovascular risk reduction programs - a comprehensive intensive (Cl) intervention with a less intensive (LI) intervention - in African American, and white low-income patients with known excessive cardiovascular disease risk.


Options:
A: Change from baseline in HbAlc level; percentage of subjects reaching or maintaining the risk target (represented by a combination of LBGI<=2.5 together with HBGI<=5). (Visit 5 (52 weeks after Visit 1 +/- 2 weeks).)
B: Percentage of Participans With A1c<7%, LDL Cholesterol <100mg/dL, Systolic Blood Pressure <130mm Hg and Diastolic Blood Pressure <80 mm Hg (4 months)
C: Primary Process Outcome: A composite score counting the number of appropriate processes achieved for patients within appropriate time-frames, including laboratory testing, blood pressure measurements and active prescriptions (24 months); Primary Disease-Related Outcomes: mean BP and mean LDL level. (24 months)
D: Low-density Lipoprotein Cholesterol (Measured at 1 year); Systolic Blood Pressure (Measured at 1 year); HbA1c (Measured at 1 year)

Answer: D
Please select the outcome measures that correspond to the clinical trial below.
Title: Reducing Total Cardiovascular Risk in an Urban Community
Brief Summary: PLEASE NOTE: THIS STUDY IS ONLY ENROLLING PATIENTS CURRENTLY BEING TREATED AT BELAIR-EDISON FAMILY HEALTH CENTER.

The purpose of this study is to compare the clinical effectiveness and cost effectiveness of two cardiovascular risk reduction programs - a comprehensive intensive (Cl) intervention with a less intensive (LI) intervention - in African American, and white low-income patients with known excessive cardiovascular disease risk.


Options:
A: Change in serum LDL-cholesterol level (at 6 months post disclosure of CAD risk)
B: Physical activity (4 years); Modelled cardiovascular risk (4 years); Health related quality of life (4 years); Functional capacity (4 years)
C: N/A
D: Low-density Lipoprotein Cholesterol (Measured at 1 year); Systolic Blood Pressure (Measured at 1 year); HbA1c (Measured at 1 year)

Answer: D
Please select the outcome measures that correspond to the clinical trial below.
Title: Reducing Total Cardiovascular Risk in an Urban Community
Brief Summary: PLEASE NOTE: THIS STUDY IS ONLY ENROLLING PATIENTS CURRENTLY BEING TREATED AT BELAIR-EDISON FAMILY HEALTH CENTER.

The purpose of this study is to compare the clinical effectiveness and cost effectiveness of two cardiovascular risk reduction programs - a comprehensive intensive (Cl) intervention with a less intensive (LI) intervention - in African American, and white low-income patients with known excessive cardiovascular disease risk.


Options:
A: Low-density Lipoprotein Cholesterol (Measured at 1 year); Systolic Blood Pressure (Measured at 1 year); HbA1c (Measured at 1 year)
B: cardiovascular mortality; non fatal re-MI; angina requiring hospitalization; urgent revascularization procedures; hospitalization for heart failure; non fatal stroke
C: Change in Mental Health-related Quality of Life From Baseline to 24 Weeks (Baseline, 24 weeks)
D: Clinician-rated posttraumatic stress level (3 months)

Answer: A
Please select the outcome measures that correspond to the clinical trial below.
Title: Impact of Neoadjuvant Chemotherapy With or Without Zometa on Occult Micrometastases and Bone Density in Women With Locally Advanced Breast Cancer
Brief Summary: This study is designed to evaluate the impact of Zometa on clearance of bone marrow micrometastases; the protective effect on chemotherapy-induced loss of bone mineral density; and quality of life in women undergoing treatment for locally advanced breast cancer.


Options:
A: Percentage Change in Bone Mineral Density (BMD) of the Lumbar Spine (L2-L4) at 12 Months of Therapy. (Baseline, 12 months)
B: Evaluate the impact of Zometa (zoledronic acid) on the clearance of bone marrow micrometastases (Prior to therapy initiation, after completion of neoadjuvant chemotherapy, and 12-15 months from registration); Evaluate the protective effect of Zometa (zoledronic acid) on chemotherapy-induced loss of bone mineral density (Prior to therapy initiation and 12-15 months from registration)
C: That bone loss, as determined through BMD every six months, will be prevented at clinically relevant sites, such as the hip & spine, through the use of bisphosphonate therapy in study subjects. (24 months)
D: Time to First Clinical Fracture (From randomization until the primary analysis cut-off date of 26 March 2014; maximum time on main study at the cut-off was 87 months)

Answer: B
Please select the outcome measures that correspond to the clinical trial below.
Title: A Double-Blind, Randomised, Dose Ranging, Multi-Centre, Phase IIIb Study to Evaluate the Efficacy and Safety of High Doses of Candesartan Cilexetil (Atacand®) on the Reduction of Proteinuria in the Treatment of Subjects With Hypertension and Moderate to Severe Proteinuria
Brief Summary: The purpose of this study is to assess the effects of high doses of candesartan cilexetil and also to assess which dose (16mg, 64mg, 128mg) is the most optimal for the maximum reduction of proteinuria.


Options:
A: Change from baseline in urinary albumin excretion after 30 weeks
B: pulse wave velocity (aortic and brachial) (0, 8, 16 and 24 weeks after start of intervention)
C: ONTARGET. Composite Endpoint of Cardiovascular Death, Non-fatal Myocardial Infarction, Non-fatal Stroke and Hospitalization for Congestive Heart Failure (56 months); ONTARGET. 3-fold Composite Endpoint of Doubling of Serum Creatinine, Progression to End Stage Renal Disease (ESRD) and All-cause Mortality in Diabetic Nephropathy Patients (56 months); TRANSCEND. Composite Endpoint of Cardiovascular Death, Non-fatal Myocardial Infarction, Non-fatal Stroke and Hospitalization for Congestive Heart Failure (56 months)
D: To determine the effects of high dose candesartan cilexetil on the overall reduction in proteinuria from baseline as evidenced by the 24-hour urine collection

Answer: D
Please select the outcome measures that correspond to the clinical trial below.
Title: A Randomized, Double-Blind, Placebo-Controlled, Multicenter, 16-Week Study to Assess the Effect of Vitamin D3 8400IU Once Weekly on Body Sway and Neuromuscular Function in Men and Women Aged 70 Years or Older
Brief Summary: This study will assess the effectiveness of an investigational drug in elderly subjects with low vitamin D levels.


Options:
A: median time to next exacerbation. (1 year)
B: Mediolateral body sway at 16 weeks. (at 16 weeks)
C: insulin secretion and sensitivity as assessed by an hyperglycemic clamp (6 months); intraocular pressure (6 months)
D: Trabecul volumetric bone mineral density (BMD) of the lower tibia (using peripheral quantitative computed tomography; pQCT)) (Baseline and 12 months)

Answer: B
Please select the outcome measures that correspond to the clinical trial below.
Title: Lamotrigine Versus Levetiracetam in the Initial Monotherapy of Epilepsy: An Open, Prospective, Multicenter, Randomized Phase III Study
Brief Summary: The purpose of this study is to compare the efficacy, safety and tolerance of the drugs Lamotrigine and Levetiracetam in the initial monotherapy of patients with newly diagnosed epilepsy.


Options:
A: Time to withdrawal from study medication (starting at V1) as a measure of combined efficacy and safety (Visit 1 to End of Study (approximately 52 weeks))
B: Assessment and comparative analysis of initial and follow-up Neuropsychological evaluation in both treated groups. (Levetiracetam and Carbamazepine) (52 weeks)
C: The primary outcome parameter is the time to first seizure during the double blind phase of the study. The statistical evaluation will analyze if there is a significant difference in the proportion of patients being seizure free between both medications.
D: Rate of seizure-free patients (in the first 6 weeks of the trial)

Answer: D