TrialPanorama/Dataset huggingface dataset:
Please select the outcome measures that correspond to the clinical trial below.
Title: A Placebo-controlled Study to Evaluate the Immunogenicity, Reactogenicity and Safety of Two Doses of GSK Biologicals' Oral Live Attenuated Human Rotavirus (HRV) Liquid Vaccine, When Given to Healthy Infants, in Vietnam
Brief Summary: To provide specific data on immunogenicity of GSK Biologicals' HRV liquid vaccine, when co-administered with the routine Expanded Program of Immunization (EPI) in Vietnam. The study will also assess reactogenicity and safety of the HRV liquid vaccine relative to the placebo


Options:
A: Percentage of subjects with vaccine take (At 2 months post-Dose 2)
B: 1. Occurrence of severe RV GE caused by the wild RV strains during the period starting from 2 weeks after Dose 2 until one year of age. 2. Occurrence of definite IS cases within 31 days (Day 0 -Day 30) after each HRV vaccination dose.
C: Number of Participants With Any Severity of Rotavirus Gastroenteritis (From 14 days after the third dose of V260 or placebo through the first rotavirus season (up to 15 months))
D: Anti-RV IgA antibody SC at Month 2 • Safety: solicited & unsolicited adverse events and SAEs

Answer: D
Please select the outcome measures that correspond to the clinical trial below.
Title: A Placebo-controlled Study to Evaluate the Immunogenicity, Reactogenicity and Safety of Two Doses of GSK Biologicals' Oral Live Attenuated Human Rotavirus (HRV) Liquid Vaccine, When Given to Healthy Infants, in Vietnam
Brief Summary: To provide specific data on immunogenicity of GSK Biologicals' HRV liquid vaccine, when co-administered with the routine Expanded Program of Immunization (EPI) in Vietnam. The study will also assess reactogenicity and safety of the HRV liquid vaccine relative to the placebo


Options:
A: 1. Occurrence of severe RV GE caused by the wild RV strains during the period starting from 2 weeks after Dose 2 until one year of age. 2. Occurrence of definite IS cases within 31 days (Day 0 -Day 30) after each HRV vaccination dose.
B: Immunogenicity of rotavirus vaccine (28 days post dose 3)
C: Anti-RV IgA antibody SC at Month 2 • Safety: solicited & unsolicited adverse events and SAEs
D: Immunoglobulin A (IgA) Seroconversion: 6 & 10 Week vs. 6, 10, & 14 Week Vaccination Schedules (4-weeks post-vaccination (All Groups) and 8 weeks post-vaccination (6 & 10 week Group))

Answer: C
Please select the outcome measures that correspond to the clinical trial below.
Title: A Placebo-controlled Study to Evaluate the Immunogenicity, Reactogenicity and Safety of Two Doses of GSK Biologicals' Oral Live Attenuated Human Rotavirus (HRV) Liquid Vaccine, When Given to Healthy Infants, in Vietnam
Brief Summary: To provide specific data on immunogenicity of GSK Biologicals' HRV liquid vaccine, when co-administered with the routine Expanded Program of Immunization (EPI) in Vietnam. The study will also assess reactogenicity and safety of the HRV liquid vaccine relative to the placebo


Options:
A: Seroprotection for each polio serotype 1 month after the 3rd dose.
B: Percentage of Participant Responding to Pertussis Antigens Post-Dose 3 of Pentacel® or DAPTACEL®, IPOL®, and ActHIB® Vaccinations. (30 Days post-dose 3 vaccination); Percentage of Participants With a Four-fold Rise in Pertussis Antigens Post-Dose 3 of Pentacel® or DAPTACEL®, IPOL®, and ActHIB® Vaccinations (Seroconversion) (30 Days post-dose 3 vaccination); Geometric Mean Titers (GMTs) of Antibodies to Pentacel® or DAPTACEL®, IPOL®, and ActHIB® Antigens Post-dose 3 Vaccinations. (30 Days post-dose 3 vaccination.)
C: Anti-RV IgA antibody SC at Month 2 • Safety: solicited & unsolicited adverse events and SAEs
D: Number of Participants With Vaccine Induced Reactions (7 days following each dose); Number of Participants With Serious Adverse Events (within 28 days of a study dose and at any time); Number of Participants Reporting Any Non-Serious Adverse Event (6 mo following first vaccination); Number/Percentage of Infant Participants With Anti-P2-VP8 IgA to P[8] Seroresponse. (Baseline to day 84); Number/Percentage of Infants With Anti-P2-VP8 IgG to P[8] Seroresponses (Baseline to day 84); Number/Percentage of Infants With Neutralizing Antibody Response to WA Strain (G1[P8]) (Baseline to Day 84)

Answer: C
Please select the outcome measures that correspond to the clinical trial below.
Title: Augmenting Clozapine With Sertindole - a Double Blinded Randomized Placebo Study
Brief Summary: The purpose of the study is to determine whether addition of sertindole to clozapine treatment can improve psychosis or the metabolic side-effects of clozapine in patients with treatment-resistant schizophrenia.


Options:
A: PANSS total score (12 weeks)
B: Positive Syndrome Scale (PANSS) Total Score (Variable change from baseline to week 12); Negative Syndrome Scale (PANSS) Total Score (Variable change from baseline to week 12)
C: Withdrawal from allocated treatment within 3 months.
D: For 100 subjects with incomplete response to adequate treatment with clozapine, the primary objective is to determine if risperidone augmentation of clozapine is superior to augmentation with placebo, using the outcome measure of total PANSS score

Answer: A
Please select the outcome measures that correspond to the clinical trial below.
Title: A 12 Week, Open-Label, Safety Trial Of Pregabalin In Patients With Fibromyalgia
Brief Summary: The main purpose of this protocol is to evaluate the long-term safety of pregabalin in patients who participated in the previous fibromyalgia Study A0081100 and who wish to receive open-label pregabalin therapy.


Options:
A: Percentage of Participants Who Reported Adequate vs. Inadequate Pain Relief at Baseline (Baseline (Day 1)); Percentage of Participants Who Reported Adequate vs. Inadequate Pain Relief at Month 12 (Month 12)
B: Endpoint mean pain score derived from the subject's daily pain diary (Endpoint); Patient Global Assessment (Patient Global Impression of Change) at Termination Visit (Weeks 5 and 13); Change from baseline in functioning (score created from the Short Form-36 [SF-36] Social and Physical Functioning, Fibromyalgia Impact Questionnaire [FIQ]-Total Score, and Sheehan Disability Scale [SDS] Total Score) at Termination Visit (Baseline and Weeks 5, 9, and 13)
C: Pain score evaluation by NRS (8 weeks)
D: Change From Baseline to Week 4 in Pain Visual Analog Scale (VAS) Score (Week 4); Change From Baseline to Week 12 in Pain Visual Analog Scale (VAS) Score (Week 12 (end of treatment))

Answer: D
Please select the outcome measures that correspond to the clinical trial below.
Title: A Randomized, Double Blind, Parallel-group Study Of Cardiovascular Safety In Osteoarthritis Or Rheumatoid Arthritis Patients With Or At High Risk For Cardiovascular Disease Comparing Celecoxib With Naproxen And Ibuprofen
Brief Summary: To answer the question of overall benefit: risk of celecoxib when compared to two most commonly prescribe traditional (non-selective) nonsteroidal anti-inflammatory drugs (NSAIDs) in the treatment of arthritis pain. For this purpose, patients with osteoarthritis or rheumatoid arthritis with or at risk of developing cardiovascular disease will be recruited. The cardiovascular, gastrointestinal and renal safety and symptomatic benefit in each treatment group will be assessed accordingly.


Options:
A: Number of Subjects With Clinically Significant Upper and/or Lower Gastrointestinal Events (CSULGIEs) (6 month treatment duration)
B: The First Occurrence of Antiplatelet Trialists Collaboration (APTC) Composite Endpoint, Confirmed by the Clinical Events Committee (CEC). (Intent to Treat (ITT) Population - 30 months; Modified ITT (MITT) Population - 42 months)
C: ulcer rebleeding over period of 13 months
D: Changes in '100 mm pain VAS' value from baseline (-14, 0, 14, 28, 42 day)

Answer: B
Please select the outcome measures that correspond to the clinical trial below.
Title: Evaluation of Efficacy of Zoledronic Acid in Patients With Haemoglobin Syndromes (Thalassemia and Sicle Cell Anaemia) and Risk of Skeletal Events
Brief Summary: The evaluation of efficacy is performed by laboratory monitoring of bone density and resorption markers and clinical monitoring of bone density improvement. This is a prospective, randomized, parallel group, single blind study of one year treatment with zoledronic acid every 6 months as compared to one year treatment with zoledronic acid every 3 months and to placebo every 3 months in patients with hemoglobin syndromes and risk of skeletal complications.


Options:
A: Number of Participants With New Vertebral Fractures (36 months)
B: The percent change in the lumbar spine BMD (12 months)
C: Bone density by means of bone densitometry with dual energy x-ray absorptiometry (DEXA) at three body sites (lumbar region, femoral head, wrist) prior to treatment initiation the start and at the end of treatment; N-telopeptide of type I collagen (NTx) levels, TRACP-5b, with ELISA, prior to the start of treatment initiation and every 3 or 6 months; Serum Bone alkaline phosphatase, Osteocalcin, OPG and S-RANKL with ELISA, prior to the start of treatment initiation, and every 3 or 6 months
D: Change in Lumbar Spine Bone Mineral Density (BMD) by DXA (Baseline to 18 Months) (0 to 18 months); Change in Whole Body Bone Mineral Content (BMC) by DXA (Baseline to 18 Months) (Baseline to 18 months)

Answer: C
Please select the outcome measures that correspond to the clinical trial below.
Title: A Phase II Multicenter, Controlled, Double-Blind Study Using Immunoprophylaxis in the Primary Prevention of Allergic Disease (ITN025AD)
Brief Summary: The purpose of this study is to determine whether early childhood exposure to common allergens (substances that can trigger allergies and asthma) can prevent the development of asthma in children at high risk for developing the disease.


Options:
A: determine the proportion of patients who achieve well-controlled asthma with SLIT compared to placebo (September 2009)
B: Average Adjusted Symptom Score (Year 2 of treatment)
C: Number of Participants With Allergic Sensitization at Month 36 Status Post Treatment Completion (Three years (36 months) after Treatment Completion)
D: Immunological mechanisms of SLIT by phenotyping different subsets of cytokine positive T cells, regulatory T cells, and memory T cells in peripheral blood of subjects before, during and after immunotherapy. (12 and 24 months); -Expression of "immunoregulatory" cytokines by CD4+ T (12 and 24 months); cells (12 and 24 months); - Helper, regulatory and memory T cell subsets (12 and 24 months); (a) Helper T cells (12 and 24 months); (b) Regulatory T cells (12 and 24 months); b1- Regulatory T cell phenotype (12 and 24 months); b2- Regulatory T cell function (12 and 24 months)

Answer: C
Please select the outcome measures that correspond to the clinical trial below.
Title: A Phase II Multicenter, Controlled, Double-Blind Study Using Immunoprophylaxis in the Primary Prevention of Allergic Disease (ITN025AD)
Brief Summary: The purpose of this study is to determine whether early childhood exposure to common allergens (substances that can trigger allergies and asthma) can prevent the development of asthma in children at high risk for developing the disease.


Options:
A: Number of Participants With Allergic Sensitization at Month 36 Status Post Treatment Completion (Three years (36 months) after Treatment Completion)
B: Total Combined Score (TCS) During the Peak Ragweed Season (RS) (The 15-day period during the ragweed season with the highest moving pollen average)
C: determine the proportion of patients who achieve well-controlled asthma with SLIT compared to placebo (September 2009)
D: Pharmacodynamics - Immunological assessments (Pre- and post treatment)

Answer: A
Please select the outcome measures that correspond to the clinical trial below.
Title: Reactogenicity & Immunogenicity Study of Two Doses of GSK Biologicals' Oral Live Attenuated HRV Vaccine Co-administered With Either OPV or IPV in Healthy Infants (Approximately 5-10 Weeks Old) in South Africa
Brief Summary: "The primary objective of this study was to demonstrate that co-administering HRV vaccine with OPV does not induce a significant decrease in poliovirus immune response one month after the third dose of combined vaccines.

The primary objective was reached if one month after the third dose of polio vaccine, upper limit of the 95% CI for the difference in Seroprotection rate between the group B and C pooled and (minus) the group A was below 10% for each polio serotype."


Options:
A: Number of Participants With Vaccine Induced Reactions (7 days following each dose); Number of Participants With Serious Adverse Events (within 28 days of a study dose and at any time); Number of Participants Reporting Any Non-Serious Adverse Event (6 mo following first vaccination); Number/Percentage of Infant Participants With Anti-P2-VP8 IgA to P[8] Seroresponse. (Baseline to day 84); Number/Percentage of Infants With Anti-P2-VP8 IgG to P[8] Seroresponses (Baseline to day 84); Number/Percentage of Infants With Neutralizing Antibody Response to WA Strain (G1[P8]) (Baseline to Day 84)
B: Seroprotection for each polio serotype 1 month after the 3rd dose.
C: Occurrence of any RV GE caused by the circulating wild-type RV strains during the first efficacy follow-up period.
D: Number of Seroconverted Subjects for Serum Anti-rotavirus Immunoglobulin A (IgA) Antibody. (2 months post-Dose 2 (at study Month 4))

Answer: B
Please select the outcome measures that correspond to the clinical trial below.
Title: Reactogenicity & Immunogenicity Study of Two Doses of GSK Biologicals' Oral Live Attenuated HRV Vaccine Co-administered With Either OPV or IPV in Healthy Infants (Approximately 5-10 Weeks Old) in South Africa
Brief Summary: "The primary objective of this study was to demonstrate that co-administering HRV vaccine with OPV does not induce a significant decrease in poliovirus immune response one month after the third dose of combined vaccines.

The primary objective was reached if one month after the third dose of polio vaccine, upper limit of the 95% CI for the difference in Seroprotection rate between the group B and C pooled and (minus) the group A was below 10% for each polio serotype."


Options:
A: Occurrence of RV GE
B: Efficacy against severe rotavirus gastroenteritis (>=11 on the 20 point Vesikari scoring scale) caused by non vaccine rotavirus (Up to 2 years of age)
C: Laboratory-confirmed episode of severe rotavirus gastroenteritis (From 28 days post-Dose 3 until 117 cases are accrued or when all participating infants reach 2 years of age if 117 cases are not attained)
D: Seroprotection for each polio serotype 1 month after the 3rd dose.

Answer: D
Please select the outcome measures that correspond to the clinical trial below.
Title: Reactogenicity & Immunogenicity Study of Two Doses of GSK Biologicals' Oral Live Attenuated HRV Vaccine Co-administered With Either OPV or IPV in Healthy Infants (Approximately 5-10 Weeks Old) in South Africa
Brief Summary: "The primary objective of this study was to demonstrate that co-administering HRV vaccine with OPV does not induce a significant decrease in poliovirus immune response one month after the third dose of combined vaccines.

The primary objective was reached if one month after the third dose of polio vaccine, upper limit of the 95% CI for the difference in Seroprotection rate between the group B and C pooled and (minus) the group A was below 10% for each polio serotype."


Options:
A: Intussusception Within 42 Days Following Any Dose of RotaTeq™/Placebo (Within 42 days following any dose of RotaTeq™/placebo); Occurrence of Rotavirus Disease Caused by Serotypes G1, G2, G3 and G4 That Occurs 14 Days Following the 3rd Vaccination (At least 14 days following the 3rd vaccination through the first full rotavirus season)
B: 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)
C: Endpoints : Safety/immunogenicity.Immunogenicity of GSK Biologicals' HRV vaccine in terms of anti-rotavirus IgA antibody seroconversion at Visit 6 in the group receiving of HRV vaccine concomitantly with OPV versus placebo group.
D: Seroprotection for each polio serotype 1 month after the 3rd dose.

Answer: D
Please select the outcome measures that correspond to the clinical trial below.
Title: Sirolimus (Rapamune®) for Patients With Autosomal Dominant Polycystic Kidney Disease (ADPKD): a Randomized Controlled Study.
Brief Summary: The aim of our study is to investigate whether Rapamune used at a low dose (2 mg/d) retards cyst growth and slows renal functional deterioration in patients with ADPKD.


Options:
A: renal volume measured by high resolution magnetic resolution imaging (1.5 yrs)
B: Safety Assessments Based on Vital Signs, Electrocardiogram (ECG's), Clinical Laboratory Tests, Physical Examinations Are Reported as Adverse Events (AEs) Upon Study Physician Discretion. (AEs were recorded from screening (ICF was signed) until 7-Day follow-up)
C: Primary Efficacy Analysis of Total Kidney Volume (mITT Set, Multiple Imputation) (Baseline, Month 24)
D: Percentage Change Per Year in Total Kidney Volume From Baseline to Month 36 (Baseline to Month 36)

Answer: A
Please select the outcome measures that correspond to the clinical trial below.
Title: Randomized Clinical Trial to Study the Effect of Extended Release Niacin on Endothelial Function, Oxidative Stress and Endothelial Progenitor Cells in Patients With the Metabolic Syndrome.
Brief Summary: The aim of the present study is to characterize novel mechanisms whereby HDL may exert potent vasculoprotective effects independent of reverse cholesterol transport, in particular the effect of HDL on the regulation of the vascular NAD(P)H oxidase enzyme system, a major vascular source of superoxide, known to be important for endothelial dysfunction. In addition, the present study will characterize the effect of HDL on endothelial progenitor cell (EPC) mobilization, nitric oxide production and in vivo regenerative capacity.


Options:
A: Coadministered MK0524B will be more efficacious in reducing LDL-C concentrations compared to MK0524A.
B: N/A
C: Percent Change at Week (Wk) 12 Compared to Baseline (Bl) in Low-density Lipoprotein Cholesterol in Patients With Type 2 Diabetes When Compared to Placebo (Baseline and 12 Weeks)
D: Antioxidative Properties of Endothelial Progenitor Cells (3 months); FDD (3 months)

Answer: D
Please select the outcome measures that correspond to the clinical trial below.
Title: The Effect of Insulin Analogues and Human Insulin on the Incidence of Severe Hypoglycaemia in Hypoglycaemia Prone Type 1 Diabetic Patients
Brief Summary: Severe hypoglycaemia is hampering the lives of many diabetic patients. The effect on the occurrence of severe hypoglycaemia during two different insulin regimens are to be investigated. In total, 250 hypoglycaemia prone type 1 diabetic patients will be randomised to receive analogue and human insulin for one year in random order. Outcomes will be number of episodes of severe hypoglycaemia


Options:
A: Main Trial (Primary Endpoint): Change in Glycosylated Haemoglobin (HbA1c) After 26 Weeks of Treatment (Week 0, Week 26); Extension Trial (Primary Endpoint): Rate of Confirmed Hypoglycaemic Episodes (Week 0 to Week 53 + 7 days follow up); Extension Trial (Primary Endpoint): Rate of Nocturnal Confirmed Hypoglycaemic Episodes (Week 0 to Week 53 + 7 days follow up); Extension Trial (Primary Endpoint): Rate of Treatment Emergent Adverse Events (AEs) (Week 0 to Week 53 + 7 days of follow up)
B: N/A
C: Severe hypoglycaemia (9 months)
D: Glycosylated Haemoglobin A1c (HbA1c) (after 52 weeks of treatment)

Answer: C
Please select the outcome measures that correspond to the clinical trial below.
Title: Coordinated Anxiety Learning and Management (CALM): Improving Primary Care Anxiety Outcomes
Brief Summary: This study will compare the effectiveness of an intervention strategy for the treatment of people with post traumatic stress disorder, generalized anxiety disorder, panic disorder, and social anxiety disorder in the primary care setting.


Options:
A: Rates of Adequate Depression Treatment at Discharge (5 days after enrollment)
B: Adjusted Change in Pain-related Function (Roland Disability Score) (12 months)
C: Mean SCL-20 depression scores (6 & 12 months post-baseline); Depression treatment response, defined as greater than 50% decrease in SCL-20 score from baseline (6 & 12 months post-baseline); Complete depression remission defined as SCL-20 score less than 0.5. (6 & 12 months post-baseline)
D: BSI-12 (Anxiety and Somatization Subscales) (Measured at Month 18)

Answer: D
Please select the outcome measures that correspond to the clinical trial below.
Title: Coordinated Anxiety Learning and Management (CALM): Improving Primary Care Anxiety Outcomes
Brief Summary: This study will compare the effectiveness of an intervention strategy for the treatment of people with post traumatic stress disorder, generalized anxiety disorder, panic disorder, and social anxiety disorder in the primary care setting.


Options:
A: HbA1c (baseline, after 12 months and after 24 months)
B: Depression Severity (2 week)
C: BSI-12 (Anxiety and Somatization Subscales) (Measured at Month 18)
D: Change in PTSD Symptom Severity (PDS) (Baseline, 6 months)

Answer: C
Please select the outcome measures that correspond to the clinical trial below.
Title: Zinc as an Immunomodulator in the Treatment of Possible Serious Bacterial Infections in Infants 7 Days and up to 4 Months of Age
Brief Summary: Infections are the important cause of high mortality in young infants in developing countries. Zinc is a crucial micronutrient as it influences various immune mechanisms and modulates host resistance to several pathogens. It has shown benefits as an adjunct therapy in infections like diarrhea and pneumonia in older children Given the predisposition of young infants in developing countries to zinc deficiency and infections, addition of zinc to standard treatment of serious bacterial infections may lead to significant improvements in the outcomes.

Several hypotheses will be examined in this clinical trial. The primary objective is to measure, in a double blind randomized controlled trial, the efficacy of giving 2 RDA (Required Daily Allowance 10 mg) of zinc orally in addition to routine antibiotics, for treatment of possible serious bacterial infection in infants \>= 7 days and up to 4 months of age in reducing the proportion of treatment failures and time to discharge from the hospital. This will evaluate the clinical consequences of the possible immunomodulation by zinc supplementation. This is critical to demonstrate because nearly 80% of infant mortality occurs in first months of life.

Young infants with possible serious bacterial infections fulfilling the inclusion criteria will be enrolled in the study and stratified into 4 groups on basis of weight for age 'z' scores \< -2 z and \>=- 2 z and whether he/she has diarrhea or not. Within each stratum the subjects will be randomized to receive zinc or placebo. Treatment failures will be defined by the need for a change of initial antibiotic therapy. The minimum duration of monitoring will be till clinical recovery (using predetermined criteria). Serum copper, serum ferritin and serum transferrin receptors will be determined at enrollment, 72 hours after enrollment and at discharge from the hospital. Concentrations of CRP and procalcitonin will be measured at baseline, 72 hours after enrolment and at clinical recovery.

Documentation of efficacy of addition of zinc to standard therapy may provide a simple and low-cost strategy to improve survival in serious infections in young infants. This is likely to have a significant impact on infant morbidity and mortality. It will be good example of using a simple immunomodulator beneficially in improving child health.


Options:
A: Incidence of diarrhea (from ages 6 weeks to 18 months); respiratory tract infections (from ages 6 weeks to 18 months)
B: Linear growth velocity (6 to 18 months of age)
C: Death among children 1-36 months of age
D: proportion with treatment failures (Within 3 weeks after enrollment)

Answer: D