TrialPanorama/Dataset huggingface dataset:
Please select the outcome measures that correspond to the clinical trial below.
Title: An Extension Study to Evaluate the Persistence of the Immune Responses Induced by GSK Biologicals Zoster Vaccine, GSK324332A, Administered in Healthy Adult Subjects Aged 18-30 Years and 50-70 Years
Brief Summary: The safety and immunogenicity of the GSK324332A vaccine has been evaluated up to Month 12 post-vaccination in the primary study. In the extension studies presented here, the persistence of the cellular and humoral immune responses will be evaluated 30 and 42 months after the first vaccination in young and elderly adults who received the GSK324332A vaccine. This protocol posting deals only with objectives \& outcome measures of the extension phase at Months 30 and 42. No new recruitment will be done in these extension phases of the primary study. No vaccines are administered in this phase of the study.


Options:
A: Number of Subjects With Confirmed Herpes Zoster (HZ) Cases (During the entire study period (3 to 5 year period following Day 0))
B: Geometric Mean Titer (GMT) of Varicella-zoster Virus (VZV) Glycoprotein Enzyme-linked Immunosorbent Assay (gpELISA) Antibody (Baseline and 4 weeks after ZOSTAVAX™ vaccination (Week 4 for Concomitant group and Week 8 for Nonconcomitant group)); Geometric Mean Fold Rise From Baseline in VZV gpELISA Antibody Titers (Baseline and 4 weeks after ZOSTAVAX™ vaccination (Week 4 for Concomitant group and Week 8 for Nonconcomitant group)); Geometric Mean Titers of H1N1-specific Influenza Virus Antibody (Baseline and 4 weeks after Influenza vaccination (Week 4)); Geometric Mean Titers of H3N2-specific Influenza Virus Antibody (Baseline and 4 weeks after Influenza vaccination (Week 4)); Geometric Mean Titers of B-Yamagata-specific Influenza Virus Antibody (Baseline and 4 weeks after Influenza vaccination (Week 4)); Geometric Mean Titers of B-Victoria-specific Influenza Virus Antibody (Baseline and 4 weeks after Influenza vaccination (Week 4))
C: Frequencies of Glycoprotein E (gE)-Specific Cluster of Differentiation 4 (CD4) / CD8 T Cells With at Least Two Antigen-specific Cytokines: Interferon Gamma (IFN-γ), Interleukin 2 (IL-2), Tumor Necrosis Factor Alpha (TNF-α), CD 40 Ligand (CD40L). (At Month 30 after the first vaccination.); Frequencies of Varicella Zoster Virus (VZV)-Specific CD4 / CD8 T Cells With at Least Two Antigen-specific Cytokines (IFN-γ, IL-2, TNF-α, CD40L). (At Month 30 after the first vaccination); Frequencies of Glycoprotein E (gE)-Specific CD4 / CD8 T Cells With at Least Two Antigen-specific Cytokines (IFN-γ, IL-2, TNF-α, CD40L). (At Month 42 after the first vaccination); Frequencies of Varicella Zoster Virus (VZV)-Specific CD4 / CD8 T Cells With at Least Two Antigen-specific Cytokines (IFN-γ, IL-2, TNF-α, CD40L). (At Month 42 after the first vaccination)
D: Geometric Mean Titer (GMT) of Varicella Zoster Virus (VZV) Antibodies 4 Weeks After Each Vaccination: Groups 2 and 3 (4 weeks post-dose 1 (Month 1 for all groups) and 4 weeks post-dose 2 (Month 2 for Group 2 and Month 4 for Group 3))

Answer: C
Please select the outcome measures that correspond to the clinical trial below.
Title: An Extension Study to Evaluate the Persistence of the Immune Responses Induced by GSK Biologicals Zoster Vaccine, GSK324332A, Administered in Healthy Adult Subjects Aged 18-30 Years and 50-70 Years
Brief Summary: The safety and immunogenicity of the GSK324332A vaccine has been evaluated up to Month 12 post-vaccination in the primary study. In the extension studies presented here, the persistence of the cellular and humoral immune responses will be evaluated 30 and 42 months after the first vaccination in young and elderly adults who received the GSK324332A vaccine. This protocol posting deals only with objectives \& outcome measures of the extension phase at Months 30 and 42. No new recruitment will be done in these extension phases of the primary study. No vaccines are administered in this phase of the study.


Options:
A: Phase A: Number of Subjects With Confirmed Varicella Case (From 42 days post dose 2 until the end of Phase A)
B: Number of Subjects With Seroresponse for Antibodies to Varicella Virus (VZV) (At Day 42 after vaccination); Concentration of Antibodies to Varicella Virus (VZV) (At Day 42 after vaccination); Number of Subjects With Seroresponse for Antibodies to Mumps Virus (At Day 42 after vaccination); Number of Subjects With Seroresponse for Antibodies to Measles Virus (At Day 42 after vaccination); Number of Subjects With Seroresponse for Antibodies to Rubella Virus (At Day 42 after vaccination); Concentration of Antibodies to Hepatitis A Virus (HAV) (At Day 42 after vaccination); Concentration of Antibodies to S. Pneumoniae Serotypes 4, 6B, 9V, 14, 18C, 19F and 23F (At Day 42 after vaccination)
C: Antibody levels after vaccination.
D: Frequencies of Glycoprotein E (gE)-Specific Cluster of Differentiation 4 (CD4) / CD8 T Cells With at Least Two Antigen-specific Cytokines: Interferon Gamma (IFN-γ), Interleukin 2 (IL-2), Tumor Necrosis Factor Alpha (TNF-α), CD 40 Ligand (CD40L). (At Month 30 after the first vaccination.); Frequencies of Varicella Zoster Virus (VZV)-Specific CD4 / CD8 T Cells With at Least Two Antigen-specific Cytokines (IFN-γ, IL-2, TNF-α, CD40L). (At Month 30 after the first vaccination); Frequencies of Glycoprotein E (gE)-Specific CD4 / CD8 T Cells With at Least Two Antigen-specific Cytokines (IFN-γ, IL-2, TNF-α, CD40L). (At Month 42 after the first vaccination); Frequencies of Varicella Zoster Virus (VZV)-Specific CD4 / CD8 T Cells With at Least Two Antigen-specific Cytokines (IFN-γ, IL-2, TNF-α, CD40L). (At Month 42 after the first vaccination)

Answer: D
Please select the outcome measures that correspond to the clinical trial below.
Title: An Extension Study to Evaluate the Persistence of the Immune Responses Induced by GSK Biologicals Zoster Vaccine, GSK324332A, Administered in Healthy Adult Subjects Aged 18-30 Years and 50-70 Years
Brief Summary: The safety and immunogenicity of the GSK324332A vaccine has been evaluated up to Month 12 post-vaccination in the primary study. In the extension studies presented here, the persistence of the cellular and humoral immune responses will be evaluated 30 and 42 months after the first vaccination in young and elderly adults who received the GSK324332A vaccine. This protocol posting deals only with objectives \& outcome measures of the extension phase at Months 30 and 42. No new recruitment will be done in these extension phases of the primary study. No vaccines are administered in this phase of the study.


Options:
A: Number of Subjects With Confirmed Herpes Zoster (HZ) Cases (During the entire study period (3 to 5 year period following Day 0))
B: Geometric Mean Titer (GMT) of Varicella-zoster Virus (VZV) Glycoprotein Enzyme-linked Immunosorbent Assay (gpELISA) Antibody (Baseline and 4 weeks after ZOSTAVAX™ vaccination (Week 4 for Concomitant group and Week 8 for Nonconcomitant group)); Geometric Mean Fold Rise From Baseline in VZV gpELISA Antibody Titers (Baseline and 4 weeks after ZOSTAVAX™ vaccination (Week 4 for Concomitant group and Week 8 for Nonconcomitant group)); Geometric Mean Titers of H1N1-specific Influenza Virus Antibody (Baseline and 4 weeks after Influenza vaccination (Week 4)); Geometric Mean Titers of H3N2-specific Influenza Virus Antibody (Baseline and 4 weeks after Influenza vaccination (Week 4)); Geometric Mean Titers of B-Yamagata-specific Influenza Virus Antibody (Baseline and 4 weeks after Influenza vaccination (Week 4)); Geometric Mean Titers of B-Victoria-specific Influenza Virus Antibody (Baseline and 4 weeks after Influenza vaccination (Week 4))
C: Changes in Interferon gamma/ Interleukin 2 (IFNg/IL2) dual color fluorospot number (Measured up to Day 730)
D: Frequencies of Glycoprotein E (gE)-Specific Cluster of Differentiation 4 (CD4) / CD8 T Cells With at Least Two Antigen-specific Cytokines: Interferon Gamma (IFN-γ), Interleukin 2 (IL-2), Tumor Necrosis Factor Alpha (TNF-α), CD 40 Ligand (CD40L). (At Month 30 after the first vaccination.); Frequencies of Varicella Zoster Virus (VZV)-Specific CD4 / CD8 T Cells With at Least Two Antigen-specific Cytokines (IFN-γ, IL-2, TNF-α, CD40L). (At Month 30 after the first vaccination); Frequencies of Glycoprotein E (gE)-Specific CD4 / CD8 T Cells With at Least Two Antigen-specific Cytokines (IFN-γ, IL-2, TNF-α, CD40L). (At Month 42 after the first vaccination); Frequencies of Varicella Zoster Virus (VZV)-Specific CD4 / CD8 T Cells With at Least Two Antigen-specific Cytokines (IFN-γ, IL-2, TNF-α, CD40L). (At Month 42 after the first vaccination)

Answer: D
Please select the outcome measures that correspond to the clinical trial below.
Title: An Extension Study to Evaluate the Persistence of the Immune Responses Induced by GSK Biologicals Zoster Vaccine, GSK324332A, Administered in Healthy Adult Subjects Aged 18-30 Years and 50-70 Years
Brief Summary: The safety and immunogenicity of the GSK324332A vaccine has been evaluated up to Month 12 post-vaccination in the primary study. In the extension studies presented here, the persistence of the cellular and humoral immune responses will be evaluated 30 and 42 months after the first vaccination in young and elderly adults who received the GSK324332A vaccine. This protocol posting deals only with objectives \& outcome measures of the extension phase at Months 30 and 42. No new recruitment will be done in these extension phases of the primary study. No vaccines are administered in this phase of the study.


Options:
A: Frequencies of Glycoprotein E (gE)-Specific Cluster of Differentiation 4 (CD4) / CD8 T Cells With at Least Two Antigen-specific Cytokines: Interferon Gamma (IFN-γ), Interleukin 2 (IL-2), Tumor Necrosis Factor Alpha (TNF-α), CD 40 Ligand (CD40L). (At Month 30 after the first vaccination.); Frequencies of Varicella Zoster Virus (VZV)-Specific CD4 / CD8 T Cells With at Least Two Antigen-specific Cytokines (IFN-γ, IL-2, TNF-α, CD40L). (At Month 30 after the first vaccination); Frequencies of Glycoprotein E (gE)-Specific CD4 / CD8 T Cells With at Least Two Antigen-specific Cytokines (IFN-γ, IL-2, TNF-α, CD40L). (At Month 42 after the first vaccination); Frequencies of Varicella Zoster Virus (VZV)-Specific CD4 / CD8 T Cells With at Least Two Antigen-specific Cytokines (IFN-γ, IL-2, TNF-α, CD40L). (At Month 42 after the first vaccination)
B: Number of Subjects With Confirmed Herpes Zoster (HZ) Cases (During the entire study period (3 to 5 year period following Day 0))
C: Geometric Mean Titer (GMT) of Varicella Zoster Virus (VZV) Antibodies 4 Weeks After Each Vaccination: Groups 2 and 3 (4 weeks post-dose 1 (Month 1 for all groups) and 4 weeks post-dose 2 (Month 2 for Group 2 and Month 4 for Group 3))
D: Reduce burden of illness due to herpes zoster (HZ) (Incidence of postherpetic neuralgia (PHN), where PHN is defined as HZ-associated pain greater than or equal to 3 persisting or appearing more than 30 days after the onset of the HZ rash)

Answer: A
Please select the outcome measures that correspond to the clinical trial below.
Title: A Multi-centre, Double Blind, Randomised, Placebo Controlled, Parallel Group Study Investigating Simvastatin as an Add-on Treatment IM Administered Interferon-beta-1a for the Treatment of Relapsing-Remitting Multiple Sclerosis
Brief Summary: This study is to find out if there is any benefit to adding Simvastatin to Interferon-beta-1a in patients with Multiple Sclerosis.


Options:
A: number of MRI contrast enhancing lesions (treatment months 6 to 9 compared to baseline)
B: attack number (1 year)
C: Evaluate safety of BHT-3009 alone and when combined with atorvastatin in patients with multiple sclerosis.; Determine dose of BHT-3009 and regimen for phase II testing.
D: The time to first documented relapse (months 4, 6, 9, 12, and every 3 months from months 18-39)

Answer: D
Please select the outcome measures that correspond to the clinical trial below.
Title: Effects of a Vitamin D (Cholecalciferol) Supplement on Body Composition, Blood Pressure, and Lipid and Diabetes Parameters in Overweight Patients Attending a Telemedically Guided Weight Loss Program
Brief Summary: The purpose of the study is to investigate in overweight patients who are on a telemedically guided weight loss program the influence of a daily vitamin D supplement on

* weight loss and body composition,
* selected inflammation markers and biochemical parameters of lipid and glucose metabolism .
* selected clinical parameters such as blood pressure, heart rate


Options:
A: Change in Body Weight From Baseline to 12 Months (baseline, 12 months)
B: C peptide
C: AUC for increment in serum 25(OH)D (12 weeks)
D: Chang in Disposition Index, a Measure of Beta Cell Function (baseline and 4 months)

Answer: A
Please select the outcome measures that correspond to the clinical trial below.
Title: Antipsychotic Polypharmacy in Schizophrenia
Brief Summary: The literature suggests that when a patient is prescribed more than one antipsychotic for at least 30 days, he or she is likely to continue on that combination. In this 12 week study 100 adult patients being treated on more than one antipsychotic medication for at least 30 days will be recruited. In order to control for the natural course of the illness, patients will be randomly assigned to one of two groups: the first group will continue the second medication hidden in a capsule at the same dose, while the second group will be given an inactive capsule (placebo) - the capsules in both group will be identical such that neither the patient nor the treating doctor will be able to identify the group assignment.


Options:
A: 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
B: change from baseline in Positive and Negative Syndrome Scale (PANSS) total scores (The PANSS was rated at baseline, and again at weeks 1, 2, 3, 4, and 6 (or on early termination).)
C: Brief Psychiatric Rating Scale (BPRS) (intermittent); Clinical Global Impression Scale (intermittent)
D: Risperidone effectiveness is measured by time to relapse within the 52 week period.

Answer: C
Please select the outcome measures that correspond to the clinical trial below.
Title: Clinical Investigation of In-vivo Susceptibility of P.Falciparum to Artesunate in Western Cambodia
Brief Summary: There are worrying signs that parasitological responses to the artemisinin drugs for uncomplicated falciparum malaria are slower than elsewhere in the world.If responses to artesunate are poor it is essential to have characterised the blood concentration profile as well as the parasitological response to differentiate resistance from abnormal pharmacokinetics.

The primary objective of the study is to assess the level of resistance to artemisinin derivatives in Western Cambodia.

A detailed evaluation of 2 different artesunate containing regimens in patients with uncomplicated malaria will be performed. Patients will be randomised to receive either a) Artesunate 2mg/kg/day for 7 days or b) Artesunate 4mg/kg/day for 3 days plus mefloquine 15mg/kg on day 3 and 10mg/kg on day 4 The effect on parasite clearance and cure will be assessed in relation to blood concentrations of the antimalarial drugs ('PK-PD').


Options:
A: Percentage of Subjects With PCR-corrected Adequate Clinical and Parasitological Response (ACPR) on Day 28 (Day 28)
B: parasite clearance times in relation to artesunate/DHA plasma concentrations (PK-PD) (June 2008)
C: Percentage of Participants With PCR-Corrected ACPR on Day 28 (Day 28)
D: PCR-Corrected ACPR at Day 28 (Day 28)

Answer: B
Please select the outcome measures that correspond to the clinical trial below.
Title: Clinical Investigation of In-vivo Susceptibility of P.Falciparum to Artesunate in Western Cambodia
Brief Summary: There are worrying signs that parasitological responses to the artemisinin drugs for uncomplicated falciparum malaria are slower than elsewhere in the world.If responses to artesunate are poor it is essential to have characterised the blood concentration profile as well as the parasitological response to differentiate resistance from abnormal pharmacokinetics.

The primary objective of the study is to assess the level of resistance to artemisinin derivatives in Western Cambodia.

A detailed evaluation of 2 different artesunate containing regimens in patients with uncomplicated malaria will be performed. Patients will be randomised to receive either a) Artesunate 2mg/kg/day for 7 days or b) Artesunate 4mg/kg/day for 3 days plus mefloquine 15mg/kg on day 3 and 10mg/kg on day 4 The effect on parasite clearance and cure will be assessed in relation to blood concentrations of the antimalarial drugs ('PK-PD').


Options:
A: parasite clearance times in relation to artesunate/DHA plasma concentrations (PK-PD) (June 2008)
B: PCR-Corrected Adequate Clinical and Parasitological Response (ACPR) Rate on Day 28 (Day 28)
C: PCR-corrected adequate clinical and parasitological response (ACPR) (day 28 after initial dose)
D: Evaluation and identification of hepatic safety events, including raised liver function tests (Assessment up to Day 28.)

Answer: A
Please select the outcome measures that correspond to the clinical trial below.
Title: Clinical Investigation of In-vivo Susceptibility of P.Falciparum to Artesunate in Western Cambodia
Brief Summary: There are worrying signs that parasitological responses to the artemisinin drugs for uncomplicated falciparum malaria are slower than elsewhere in the world.If responses to artesunate are poor it is essential to have characterised the blood concentration profile as well as the parasitological response to differentiate resistance from abnormal pharmacokinetics.

The primary objective of the study is to assess the level of resistance to artemisinin derivatives in Western Cambodia.

A detailed evaluation of 2 different artesunate containing regimens in patients with uncomplicated malaria will be performed. Patients will be randomised to receive either a) Artesunate 2mg/kg/day for 7 days or b) Artesunate 4mg/kg/day for 3 days plus mefloquine 15mg/kg on day 3 and 10mg/kg on day 4 The effect on parasite clearance and cure will be assessed in relation to blood concentrations of the antimalarial drugs ('PK-PD').


Options:
A: Overall Cure Rate at Day 42
B: Proportion of patients with parasitological cure up to day 28 after treatment (defined as clearance of circulating vivax parasites by day 7 and absence until end of follow-up).
C: parasite clearance times in relation to artesunate/DHA plasma concentrations (PK-PD) (June 2008)
D: Cure rate (63 days)

Answer: C
Please select the outcome measures that correspond to the clinical trial below.
Title: An Individually Randomised Trial of Rapid Diagnostic Tests in Rural Ghana
Brief Summary: 1) To compare in a setting where microscopy for malaria is available whether introducing rapid diagnostic tests (RDTs) improves targetting of antimalarial drugs and antibiotics (RDT v microscopy). 2) To compare whether, in a setting where microscopy for malaria is not available, introducing rapid diagnostic tests (RDTs) improves targetting of antimalarial drugs and antibiotics (RDT v clinical diagnosis).


Options:
A: N/A
B: The proportion of RDT test-negative patients who are prescribed an antimalarial in two settings: where there is microscopy and where diagnosis is on clinical basis (Two years)
C: Number of patients with fever prescribed artemether-lumefantrine for the treatment of malaria in respective study groups (28 days)
D: Number of Children Who Received Early and Appropriate Treatment for Pneumonia. (one year); Number of Children With Fever Who Received Coartem (Artemether-lumefantrine) (one year)

Answer: B
Please select the outcome measures that correspond to the clinical trial below.
Title: An Individually Randomised Trial of Rapid Diagnostic Tests in Rural Ghana
Brief Summary: 1) To compare in a setting where microscopy for malaria is available whether introducing rapid diagnostic tests (RDTs) improves targetting of antimalarial drugs and antibiotics (RDT v microscopy). 2) To compare whether, in a setting where microscopy for malaria is not available, introducing rapid diagnostic tests (RDTs) improves targetting of antimalarial drugs and antibiotics (RDT v clinical diagnosis).


Options:
A: Incidence of malaria (fever + any level of parasite density) in < 48 month-old children (Stage 2, Component A) (Three years)
B: The proportion of RDT test-negative patients who are prescribed an antimalarial in two settings: where there is microscopy and where diagnosis is on clinical basis (Two years)
C: Assessment of the councils delivered by the community-based service provider to the parents or guardians of children and assessment of the observance of the treatment given by the parents or guardians. (one year)
D: the proportion of study children receiving prescriptions of antimalarial drugs in the respective arms (Day 0)

Answer: B
Please select the outcome measures that correspond to the clinical trial below.
Title: An Individually Randomised Trial of Rapid Diagnostic Tests in Rural Ghana
Brief Summary: 1) To compare in a setting where microscopy for malaria is available whether introducing rapid diagnostic tests (RDTs) improves targetting of antimalarial drugs and antibiotics (RDT v microscopy). 2) To compare whether, in a setting where microscopy for malaria is not available, introducing rapid diagnostic tests (RDTs) improves targetting of antimalarial drugs and antibiotics (RDT v clinical diagnosis).


Options:
A: The proportion of RDT test-negative patients who are prescribed an antimalarial in two settings: where there is microscopy and where diagnosis is on clinical basis (Two years)
B: Effectiveness (PCR adjusted parasitological cure rate) of artemether-lumefantrine; during 42 days follow-up.
C: Number of Children Who Received Early and Appropriate Treatment for Pneumonia. (one year); Number of Children With Fever Who Received Coartem (Artemether-lumefantrine) (one year)
D: The primary outcome measurement will be treatment incidence density (antimalarial treatments received per time at risk) for each study arm.

Answer: A
Please select the outcome measures that correspond to the clinical trial below.
Title: An Intervention to Enhance CHD Risk Factor Modification: The Heart to Heart Feasibility Study
Brief Summary: Coronary heart disease (CHD) is the leading cause of death in the United States, but fewer than half of all individuals at risk for CHD take advantage of proven strategies to lower their chances of developing this disease. This study will assess the effectiveness of Heart to Heart, a Web-based program, at educating people on ways to incorporate CHD risk-reduction strategies into their lives.


Options:
A: Development and testing of a decision aid that describes the risks and benefits of taking tamoxifen citrate to prevent primary breast cancer
B: preferences (at time of interview)
C: decisional conflict scale (Change from baseline in decisional conflict at 3 months)
D: Feasibility of subject recruitment; feasibility of delivery of the CHD intervention and surveys in a busy practice setting; feasibility of measuring study outcomes (Measured at the end of the study period (approximately 2 years))

Answer: D