TrialPanorama/Dataset huggingface dataset:
Please select the outcome measures that correspond to the clinical trial below.
Title: Prostate Cancer Screening: Fostering Informed Decisions
Brief Summary: The primary goal of this study is to develop and evaluate a print-based method of patient education with a decision tool that is designed to provide detailed information about prostate cancer and to clarify patient preferences and values, ultimately assisting men in making an informed screening decision.


Options:
A: Incidence choice for eSET (after embryo transfer)
B: Patient Activation (Baseline, 30days, 90days); Patient Self-Management (Baseline, 30days, 90days); Engagement in mental health care (Six months following last research interview); Retention in mental health treatment (Six months following last research interview)
C: Prenatal test use (9 months)
D: Patient knowledge and decisional satisfaction measured at one month following the intervention. (one-month and one-year follow-up assesments)

Answer: D
Please select the outcome measures that correspond to the clinical trial below.
Title: Evaluate the Safety and Immunogenicity of GSK Biologicals' HPV-16/18 Vaccine Administered Intramuscularly According to a 0,1,6 Month Schedule in Healthy Female Subjects (10 - 14 Years)
Brief Summary: Human Papilloma virus (HPV) are viruses that cause a common infection of the skin and genitals in men and women. Several types of HPV infection are transmitted by sexual activity and, in women, can infect the cervix (part of the uterus or womb). This infection often goes away by itself, but if it does not go away (this is called persistent infection), it can lead in women over a long period of time to cancer of the cervix. If a woman is not infected by HPV, it is very unlikely that she will get cervical cancer. This study will evaluate the safety and immunogenicity of GSK Biologicals HPV-16/18 vaccine over 12 months, in pre-teen and adolescent women of 10-14 years of age at study start. Approximately 2000 study subjects will receive the HPV vaccine or a control vaccine (hepatitis A vaccine) administered intramuscularly according to a 0-1-6 month schedule.


Options:
A: Number of Subjects With Anti-Hepatitis B Surface Antigen (Anti-HBs) Antibody Concentrations Above the Cut-off Value for Seroprotection (Month 7); Number of Subjects With Anti-human Papillomavirus 16 and 18 (Anti-HPV-16 and Anti-HPV-18) Antibody Concentrations Above the Cut-off Value for Seroconversion (Month 7); Anti-HPV-16/18 Antibody Titres (Month 7)
B: Number of Seroconverted Subjects With Anti-HPV-16/18 Antibody Titers Equal to or Above Cut-off Values. (At Month 60); Number of Seroconverted Subjects With Anti-HPV-16/18 Antibody Titers Equal to or Above Cut-off Values. (At Month 72); Number of Seroconverted Subjects With Anti-HPV-16/18 Antibody Titers Equal to or Above Cut-off Values. (At Month 84); Number of Seroconverted Subjects With Anti-HPV-16/18 Antibody Titers Equal to or Above Cut-off Values. (At Month 96); Anti-human Papillomavirus-16 and 18 (Anti-HPV-16/18) Antibody Titers (At Month 60); Anti-human Papillomavirus-16 and 18 (Anti-HPV-16/18) Antibody Titers (At month 72); Anti-human Papillomavirus-16 and 18 (Anti-HPV-16/18) Antibody Titers (At Month 84); Anti-human Papillomavirus-16 and 18 (Anti-HPV-16/18) Antibody Titers (At Month 96); Number of Seroconverted Subjects With Anti-HPV-16/18 Antibody Titers Equal to or Above Cut-off Values. (At Month 108); Anti-human Papillomavirus-16 and 18 (Anti-HPV-16/18) Antibody Titers (At Month 108); Anti-human Papillomavirus-16 and 18 (Anti-HPV-16/18) Antibody Titers (At Month 120); Number of Seroconverted Subjects With Anti-HPV-16/18 Antibody Titers Equal to or Above Cut-off Values. (At Month 120)
C: Demonstration of safety of the HPV vaccine compared to the control (occurrence of SAEs) up to month 7.
D: Titers of Anti-human Papilloma Virus 16 (Anti-HPV-16) and Anti-human Papilloma Virus 18 (Anti-HPV-18) Antibodies (At 18, 24, 36 and 48 months)

Answer: C
Please select the outcome measures that correspond to the clinical trial below.
Title: A Multicentre, Randomised, Double-blind, Parallel Group Study to Compare the Efficacy and Safety of Salmeterol/Fluticasone Propionate Combination Product (Seretide®) 50/100 mcg With Fluticasone Propionate (Flixotide® ) 200 mcg, Both Delivered Twice Daily Via the DISKUS Inhaler, in the Treatment of Children Aged 6-12 Years With Symptomatic Asthma
Brief Summary: This study is being conducted to investigate whether in childhood salmeterol/ fluticasone propionate 50/100 bd delivered via the Diskus® inhaler and fluticasone propionate 200 mcg bd delivered via the Diskus® inhaler are non- inferior in terms of symptom control. Additionally we aim to show that salmeterol/ fluticasone propionate 50/100 bd is at least as good in terms of lung function improvement and bronchial hyperreactivity and enables a steroid-sparing management of asthma in children.


Options:
A: N/A
B: time to first moderate or severe asthma exacerbation. (24 weeks)
C: Change From Baseline in Morning Peak Expiratory Flow (PEF) (Baseline and Week 12)
D: Percentage of Symptom-free Days During the Last 10 Weeks of the Treatment Period (Last 10 weeks of the treatment period (Weeks 16-26))

Answer: D
Please select the outcome measures that correspond to the clinical trial below.
Title: A Multicentre, Randomised, Double-blind, Parallel Group Study to Compare the Efficacy and Safety of Salmeterol/Fluticasone Propionate Combination Product (Seretide®) 50/100 mcg With Fluticasone Propionate (Flixotide® ) 200 mcg, Both Delivered Twice Daily Via the DISKUS Inhaler, in the Treatment of Children Aged 6-12 Years With Symptomatic Asthma
Brief Summary: This study is being conducted to investigate whether in childhood salmeterol/ fluticasone propionate 50/100 bd delivered via the Diskus® inhaler and fluticasone propionate 200 mcg bd delivered via the Diskus® inhaler are non- inferior in terms of symptom control. Additionally we aim to show that salmeterol/ fluticasone propionate 50/100 bd is at least as good in terms of lung function improvement and bronchial hyperreactivity and enables a steroid-sparing management of asthma in children.


Options:
A: The Number of Participants With a Differential Response to the Three Step-up Therapies Based on Fixed Threshold Criteria for the Following Three Asthma Control Measures: Use of Oral Prednisone for Acute Asthma Exacerbations, Asthma Control Days and FEV1. (Measured during the last 12 weeks of each 16-week treatment period)
B: Percentage of Symptom-free Days During the Last 10 Weeks of the Treatment Period (Last 10 weeks of the treatment period (Weeks 16-26))
C: Oral montelukast is associated with reduced school absences in comparison to inhaled salmeterol over a period of 1 year in Arg/Arg-16 asthmatic children (Every 3 months)
D: The Area Under the Curve From 0 to 12 Hours [AUC](0-12 hr) of the Change From Baseline to the Week 12 Endpoint in Forced Expiratory Volume in One Second (FEV1) (Baseline to Week 12)

Answer: B
Please select the outcome measures that correspond to the clinical trial below.
Title: A Phase III, Double-blind, Randomized, Placebo-controlled, Multi-country and Multi-center Study to Assess the Efficacy and Safety of Two Doses of GSK Biologicals' Oral Live Attenuated Human Rotavirus (HRV) Vaccine in Healthy Infants
Brief Summary: The main objectives of this study are to determine vaccine efficacy against severe rotavirus (RV) gastroenteritis (GE) during the period starting from 2 weeks after Dose 2 until two years of age and to determine the safety of GSK Biologicals' HRV vaccine with respect to definite intussusception (IS) within 31 days (Day 0-Day 30) after each HRV vaccine dose.


Options:
A: Occurrence of severe RV GE caused by the wild RV strains from 2 weeks after Dose 2 until two years of age. Occurrence of definite IS cases within 31 days (Day 0 -Day 30) after each HRV vaccination dose.
B: 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.
C: Number of Subjects Reporting Any Serious Adverse Events (SAEs). (From Day 0 up to 1 month after Dose 2 of Rotarix vaccine/Placebo)
D: Number of Seroconverted Subjects for Serum Anti-rotavirus Immunoglobulin A (IgA) Antibody. (2 months post-Dose 2 (at study Month 4))

Answer: A
Please select the outcome measures that correspond to the clinical trial below.
Title: A Phase III, Double-blind, Randomized, Placebo-controlled, Multi-country and Multi-center Study to Assess the Efficacy and Safety of Two Doses of GSK Biologicals' Oral Live Attenuated Human Rotavirus (HRV) Vaccine in Healthy Infants
Brief Summary: The main objectives of this study are to determine vaccine efficacy against severe rotavirus (RV) gastroenteritis (GE) during the period starting from 2 weeks after Dose 2 until two years of age and to determine the safety of GSK Biologicals' HRV vaccine with respect to definite intussusception (IS) within 31 days (Day 0-Day 30) after each HRV vaccine dose.


Options:
A: Occurrence of severe RV GE caused by the wild RV strains from 2 weeks after Dose 2 until two years of age. Occurrence of definite IS cases within 31 days (Day 0 -Day 30) after each HRV vaccination dose.
B: Occurrence of any RV GE caused by the circulating wild-type RV strains during the first efficacy follow-up period.
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: occurrence of Severe Rotavirus Gastroenteritis (Up to 2 years of age of participants)

Answer: A
Please select the outcome measures that correspond to the clinical trial below.
Title: A Phase III, Double-blind, Randomized, Placebo-controlled, Multi-country and Multi-center Study to Assess the Efficacy and Safety of Two Doses of GSK Biologicals' Oral Live Attenuated Human Rotavirus (HRV) Vaccine in Healthy Infants
Brief Summary: The main objectives of this study are to determine vaccine efficacy against severe rotavirus (RV) gastroenteritis (GE) during the period starting from 2 weeks after Dose 2 until two years of age and to determine the safety of GSK Biologicals' HRV vaccine with respect to definite intussusception (IS) within 31 days (Day 0-Day 30) after each HRV vaccine dose.


Options:
A: Seropositivity as anti-rotavirus IgA concentration >/= 20 U/ml (6, 10, 14 and 18 weeks)
B: Occurrence of severe RV GE caused by the wild RV strains from 2 weeks after Dose 2 until two years of age. Occurrence of definite IS cases within 31 days (Day 0 -Day 30) after each HRV vaccination dose.
C: Immunogenicity (7 months)
D: Demonstrate lot-to-lot consistency of HRV vaccine liquid formulation and non-inferiority of liquid formulation versus the lyophilised formulation of the HRV vaccine.

Answer: B
Please select the outcome measures that correspond to the clinical trial below.
Title: A Randomized, Double-blind, Placebo-controlled, Post-marketing Phase III Study to Evaluate the Efficacy of GSK Biologicals' Influenza Vaccine (Fluarix™) Administered Intramuscularly in Adults.
Brief Summary: As a result of the recent supply shortages in the U.S., as well as an anticipated increase in demand during the coming years, GSK Biologicals is pursuing licensure of Fluarix in the U.S. under the accelerated approval process; marketing approval most likely will be granted before the start of this clinical trial. GSK proposes to support U.S. licensure of Fluarix with this confirmatory post-marketing study. The purpose of the study is to evaluate the efficacy of a single dose of Fluarix in preventing influenza in adults during the 2005/2006 Influenza season.


Options:
A: Safety (28 days)
B: CSL's IVV Overall Vaccine Efficacy (VE) Versus Placebo Through Assessment of Incidence of Laboratory Confirmed Influenza A/B Infection (2008 and 2009 Southern Hemisphere influenza seasons, until 30 November 2009)
C: the proportion of subjects with antibody titers of 1:40 or more on hemagglutination-inhibition assay (21 days after each vaccination)
D: Incidence of culture confirmed influenza A and/or B during the surveillance period

Answer: D
Please select the outcome measures that correspond to the clinical trial below.
Title: A Trial of Micronutrients and Adverse Pregnancy Outcomes
Brief Summary: The purpose of this study is to examine the efficacy of multivitamin supplementation on fetal loss, low birth weight and severe preterm birth in healthy (HIV negative) women.


Options:
A: Changes in Maternal Serum B12 Concentration From 1st to 3rd Trimester (from 1st to 3rd trimester)
B: Change of Red blood cells (RBC) count in first and second trimester (at two time points: on the 8th-10th and 22nd-24th weeks of pregnancy); Change of Hemoglobin (Hgb) concentration in first and second trimester (at two time points: on the 8th-10th and 22nd-24th weeks of pregnancy); Change of Hematocrit in first and second trimester (at two time points: on the 8th-10th and 22nd-24th weeks of pregnancy); Change of Mean corpuscular volume (MCV) in first and second trimester (at two time points: on the 8th-10th and 22nd-24th weeks of pregnancy); Change of Mean corpuscular hemoglobin concentration (MCHC) in first and second trimester (at two time points: on the 8th-10th and 22nd-24th weeks of pregnancy); Change of Mean corpuscular hemoglobin (MCH) in first and second trimester (at two time points: on the 8th-10th and 22nd-24th weeks of pregnancy); Change of Iron (Fe) in first and second trimester (at two time points: on the 8th-10th and 22nd-24th weeks of pregnancy); Change of Haptoglobin in first and second trimester (at two time points: on the 8th-10th and 22nd-24th weeks of pregnancy); Change of Ferritin in first and second trimester (at two time points: on the 8th-10th and 22nd-24th weeks of pregnancy); Change of Total Iron Binding Capacity (TIBC) in first and second trimester (at two time points: on the 8th-10th and 22nd-24th weeks of pregnancy); Change of Unsaturated Iron Binding Capacity (UIBC) in first and second trimester (at two time points: on the 8th-10th and 22nd-24th weeks of pregnancy)
C: Fetal loss, low birth weight and pre-term birth. (Delivery)
D: Incidence of diarrhea (from ages 6 weeks to 18 months); respiratory tract infections (from ages 6 weeks to 18 months)

Answer: C
Please select the outcome measures that correspond to the clinical trial below.
Title: A Trial of Micronutrients and Adverse Pregnancy Outcomes
Brief Summary: The purpose of this study is to examine the efficacy of multivitamin supplementation on fetal loss, low birth weight and severe preterm birth in healthy (HIV negative) women.


Options:
A: Birth weight; 3-month infant mortality
B: Fetal loss, low birth weight and pre-term birth. (Delivery)
C: Preeclampsia (40 weeks); Preeclampsia (9 months)
D: Recurrence of cleft lip and palate (3 months)

Answer: B
Please select the outcome measures that correspond to the clinical trial below.
Title: A Trial of Micronutrients and Adverse Pregnancy Outcomes
Brief Summary: The purpose of this study is to examine the efficacy of multivitamin supplementation on fetal loss, low birth weight and severe preterm birth in healthy (HIV negative) women.


Options:
A: Fetal loss, low birth weight and pre-term birth. (Delivery)
B: To evaluate innate and adaptive immune response.; Future occurrence of acute diarrhoea, ARI and impetigo.
C: - To measure the impact of zinc and vitamin A on the duration of diarrheal illness (Weekly home visits for 6 months)
D: Change in length and length-for-age Z-score (12 months); Change in weight and weight-for-age (12 months); Incidence of diarrhea and laboratory-confirmed malaria (12 months); Change in plasma zinc concentration (12 months)

Answer: A
Please select the outcome measures that correspond to the clinical trial below.
Title: Prevention of Milk-Borne Transmission of HIV-1C in Botswana ("Mashi")
Brief Summary: The purpose of this study is to find the most effective and safe treatment to prevent the passage of HIV from an infected mother to her baby.


Options:
A: The primary endpoint was drug efficacy, measured as the proportion of study subjects who had plasma HIV-1 RNA less than 50 copies/mL at week 48 and did not meet the definition of virologic failure through this timepoint. (48 Weeks)
B: Number of Participants With Virologic Suppression (Throughout study, including breastfeeding, assessed up to 24 months); Number of HIV+ Infants (Throughout study, including breastfeeding, assessed up to 24 months)
C: Incidence of clinically-suspected ABC HSR during the 6-week observation period. Incidence of immunologically-confirmed ABC HSR. The clinical diagnosis of which occurs over the 6-week observation period.
D: HIV PCR (1 month)

Answer: D
Please select the outcome measures that correspond to the clinical trial below.
Title: Prevention of Milk-Borne Transmission of HIV-1C in Botswana ("Mashi")
Brief Summary: The purpose of this study is to find the most effective and safe treatment to prevent the passage of HIV from an infected mother to her baby.


Options:
A: HIV PCR (1 month)
B: AIDS-free survival (Week 144)
C: Virologic suppression at 6 months after randomization
D: Time to Failure of First Line Therapy or Death (From date of randomization up to failure of first-line therapy or death from any cause, whichever came first, assessed up to 4.8 years); Number of Participants Who Experienced Immunological Failure Defined as Failure of CD4% to Reach 20% or CD4% Falls Below 20% on Two Occasions, Within 4 Weeks, at Any Time After the First 24 Weeks of Therapy (Initial Therapy or Restart) (This outcome was assessed from the date of randomization to immunological failure. Immunological failure was assessed in the entire study duration of 4.8 years.); Number of Participants Who Experienced Regimen-limiting ART Drug Toxicity (Regimen limiting drug toxicity was monitored from randomization up to the entire study duration of 4.8 years.); Number of Participants Who Experienced Clinical Failure (Defined as Development of Severe CDC Stage B or Stage C Disease.) on Therapy. (Clinical failure on therapy was assessed at each visit for the entire study duration of 4.8 years.); Number of Participants Who Experienced Virological Failure Defined as Confirmed HIV-1 RNA Value of at Least 10,000 Copies Per/ml Recorded on Two Consecutive Separate Occasions After 24 Weeks of Treatment (Initial Therapy or Restart) (Virological failure was assessed from randomization through the entire study duration of 4.8 years.)

Answer: A
Please select the outcome measures that correspond to the clinical trial below.
Title: Prevention of Milk-Borne Transmission of HIV-1C in Botswana ("Mashi")
Brief Summary: The purpose of this study is to find the most effective and safe treatment to prevent the passage of HIV from an infected mother to her baby.


Options:
A: Infant HIV infection status (At Months 6 and 12)
B: HIV PCR (1 month)
C: Outcome 1: Serial HIV-1 RNA Levels in Breastmilk. (Weeks 0, 1, 2, 3 and 4)
D: Number of Participants With Virologic Suppression (Throughout study, including breastfeeding, assessed up to 24 months); Number of HIV+ Infants (Throughout study, including breastfeeding, assessed up to 24 months)

Answer: B
Please select the outcome measures that correspond to the clinical trial below.
Title: Prevention of Milk-Borne Transmission of HIV-1C in Botswana ("Mashi")
Brief Summary: The purpose of this study is to find the most effective and safe treatment to prevent the passage of HIV from an infected mother to her baby.


Options:
A: A. Rate of HIV infection at 9 months and assess HIV infection rates at 6-8 & 14 weeks, and 6, 12, 18, and 24 months. B.Determine HIV survival rates at ages 6, 12, 18, and 24 months. C. Evaluate safety of oral NVP and ZDV for 14 weeks. (9 months)
B: Rate of HIV infection in infants born to study participants in each arm of the study (At Birth, Weeks 2, 6, and 14, and Months 6, 12, and 18); Safety and tolerance of HIVIGLOB given to pregnant women at 36-37 weeks gestation and neonates at birth in combination with NVP and of NVP alone (Throughout study)
C: HIV infection detected by 4 months among children with no evidence of HIV infection at birth. (24 months of age); Magnitude of the reduction in mother-to-child HIV transmission and the magnitude of the increase in non-HIV-related under-2-year mortality, attributable to cessation of breastfeeding at 4 months.
D: HIV PCR (1 month)

Answer: D
Please select the outcome measures that correspond to the clinical trial below.
Title: Comparison of Two Multivitamin Dosage Regimens in the Prevention of Adverse Pregnancy Outcomes Among HIV-Positive Women From Tanzania
Brief Summary: The purpose of this study is to examine effects of daily administration of multivitamin supplements at doses resembling the Recommended Dietary Allowance (RDA) during pregnancy to HIV positive women decreases the risks of low birth weight (\<2500 g), and pre-term birth (\< 37 weeks gestation), compared to multivitamin supplements at doses above the RDA.


Options:
A: All-cause, Pregnancy-related Mortality (Deaths during pregnancy through 12 weeks postpartum)
B: Weight, length and Rohrer index at birth, and gestational duration in single pregnancies. (At birth); Mortality, morbidity and growth during the first year of life (Monthly during infancy)
C: cell-free viral load and/or cell-associated proviral load in breast milk (Delivery, 3 months, and 6 months after delivery); concentration of vitamins A, B12, and E in breast milk (Delivery, 3 months, and 6 months post-delivery); subclinical mastitis (Delivery, 3 months, and 6 months after delivery)
D: Low birthweight (< 2500 g) (Delivery); Pre-term birth (< 36 weeks gestation) (Monthly until the 32nd week of pregnancy, once every 2 weeks from 32nd to 36th week)

Answer: D
Please select the outcome measures that correspond to the clinical trial below.
Title: Nutrition, Immunology and Epidemiology of Tuberculosis
Brief Summary: The purpose of this study is to determine the efficacy of micronutrient supplementation among patients with active tuberculosis, half of who are co-infected with HIV-1


Options:
A: Change in Endothelial Function (Baseline and 12 weeks)
B: CD4 count (Baseline, 6, 12, 18, and 24 months)
C: Weight Gain (18 months); Immune Reconstitution (18 months); Improved Quality of Life (18 months)
D: To determine the efficacy of micronutrient supplements on sputum conversion, survival, and TB relapse and reinfection. (Sputum and culture negativity: 1 month and 2 months; Survival: 8 months and 24 months; TB relapse and reinfection: throughout follow-up.)

Answer: D
Please select the outcome measures that correspond to the clinical trial below.
Title: Nutrition, Immunology and Epidemiology of Tuberculosis
Brief Summary: The purpose of this study is to determine the efficacy of micronutrient supplementation among patients with active tuberculosis, half of who are co-infected with HIV-1


Options:
A: Time to sputum culture conversion
B: Proportion of pulmonary TB patients who are culture negative at 1 month (1 month); Difference in improvement in composite clinical endpoint comprising weight, cough clearance and FEV1 at 2 months. (2 months)
C: To determine the efficacy of micronutrient supplements on sputum conversion, survival, and TB relapse and reinfection. (Sputum and culture negativity: 1 month and 2 months; Survival: 8 months and 24 months; TB relapse and reinfection: throughout follow-up.)
D: Change in Z score for weight and improvement in X ray film (6 months)

Answer: C