TrialPanorama/Dataset huggingface dataset:
Please select the outcome measures that correspond to the clinical trial below.
Title: Compare the Immunogenicity, Reactogenicity & Safety of 2 Different Formulations of GSK Biologicals' Live Attenuated Human Rotavirus (HRV) Vaccine Given as a Two-dose Primary Vaccination in Healthy Infants Previously Uninfected With HRV
Brief Summary: Rotavirus (RV) is the most important cause of acute gastroenteritis (GE) requiring the hospitalization of infants and young children in developed and developing countries and can be a frequent cause of death in children less than 5 years of age (estimated nearly 500,000 annual deaths worldwide). GlaxoSmithKline (GSK) Biologicals has developed a vaccine against human rotavirus gastroenteritis. A new formulation of the vaccine, with an alternative buffer, was developed. This study will be conducted to evaluate the new formulation compared to the existing formulation of the HRV vaccine.


Options:
A: Endpoint: immunogenicity and reactogenicity; Proportion of subjects with vaccine take
B: Percentage of Participants Achieving Seroresponse for Meningiococcal Group C Serotype (28 days after the second dose of MCC vaccine (approximately 20 weeks))
C: Number of Subjects With Severe Episode(s) of Rotavirus Gastroenteritis (RVGE) Caused by the Circulating Wild Type (WT) Strains (From Month 1 ½ to Month 21)
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: A
Please select the outcome measures that correspond to the clinical trial below.
Title: Parents Matter!: Interventions to Promote Effective Parent-Child Communication About Sex and Sexual Risk Among African American Families
Brief Summary: Parents Matter is a community-based project whose goal it is to develop and test an intervention designed to promote effective parent-child communication about sexuality in order to promote sexual health among adolescents.


Options:
A: Re-infection with a non-viral sexually transmitted infection (1 year)
B: Incidence of HPV 6/11/16/18-related Cervical Intraepithelial Neoplasia (CIN)(Any Grade), Adenocarcinoma In Situ (AIS) or Cervical Cancer (Follow-up through end of study (4 years)); Incidence of HPV 6/11/16/18-related External Genital Lesions (EGL) [Genital Warts, Vulvar/Vaginal Intraepithelial Neoplasia (Any Grade), Vulvar/Vaginal Cancer] (Follow-up through end of study (4 years))
C: Number of Subjects With Histopathologically-confirmed Cervical Intraepithelial Neoplasia (CIN)2+ Associated With HPV-16 and/or -18 Cervical Infection in Subjects HPV DNA Negative and Seronegative at Baseline or Overall (Any Serostatus at Baseline) (Up to the moment when 36 cases of CIN2+ lesions associated with HPV-16 or HPV-18 infection had been detected, including at least 15 cases of CIN2+ associated with HPV-18 infection. Mean follow-up was 34.9 months post-dose 3); Number of Subjects With Histopathologically-confirmed Cervical Intraepithelial Neoplasia (CIN)2+ Associated With HPV-16 and/or -18 Cervical Infection in Subjects HPV DNA Negative and Seronegative at Baseline or Overall (Any Serostatus at Baseline) (at Month 48)
D: Percent of teens who have initiated sexual intercourse at 3 years post intervention

Answer: D
Please select the outcome measures that correspond to the clinical trial below.
Title: Randomized, Double-blind, Placebo-controlled, Multicenter, Phase II/III Study to Evaluate the Efficacy and Safety of Rituximab in Subjects With Moderate to Severe Systemic Lupus Erythematosus
Brief Summary: This is a Phase II/III, randomized, double-blind, placebo-controlled, multicenter study to evaluate the efficacy and safety of rituximab compared with placebo when combined with a single stable background immunosuppressive medication in subjects with moderate to severe systemic lupus erythematosus (SLE). The primary efficacy endpoint of the trial will be evaluated at 52 weeks.


Options:
A: SLE response (Various timepoints through Week 52)
B: Safety and tolerability of MEDI-545 will be assessed primarily by summarizing adverse events. (Day 84)
C: Number of Participants Who Achieved a Major Clinical Response (MCR), Partial Clinical Response (PCR), or Nonclinical Response (NCR) Defined by British Isles Lupus Assessment Group (BILAG) Scores Over The 52-week Treatment Period (From baseline to 52 weeks)
D: Number of participants with adverse events (Up to 26 weeks); Pharmacokinetic profile of CNTO 136 (Up to 22 weeks); Physical examinations (Up to 26 weeks); Electrocardiograms (ECGs) (Up to 26 weeks); Sitting blood pressure (Up to 26 weeks); Heart rate (Up to 26 weeks); Respiration rate (Up to 26 weeks); Oral temperature (Up to 26 weeks); Hemoglobin (Up to 26 weeks); Hematocrit (Up to 26 weeks); Platelets and total white blood cells (WBC) (Up to 26 weeks); Albumin and total protein (Up to 26 weeks); Alkaline phosphatase, alanine aminotransferase (ALT), and aspartate aminotransferase (AST) (Up to 26 weeks); Blood urea nitrogen (BUN), calcium, creatinine, and total bilirubin (Up to 26 weeks); Chloride, potassium, and sodium (Up to 26 weeks); Bicarbonate (Up to 26 weeks); Creatine kinase (Up to 26 weeks); Gamma-glutamyl-transferase (Up to 26 weeks); Glucose (Up to 26 weeks); Lymphocytes and neutrophils (Up to 26 weeks); Inorganic phosphate (Up to 26 weeks); Fasting Lipid Panel (Up to 8 weeks)

Answer: C
Please select the outcome measures that correspond to the clinical trial below.
Title: Extension to a Study on the Efficacy and Safety of Vildagliptin Compared to Metformin in Drug Naive Patients With Type 2 Diabetes
Brief Summary: This is a 52-week extension to a study to assess the safety and effectiveness of vildagliptin, an unapproved drug, compared to metformin in lowering overall blood glucose levels in people with type 2 diabetes who have not been previously treated with drug therapy to lower their blood sugar. The purpose of the extension study is to gather data on the long-term safety and effectiveness of vildagliptin in people with type 2 diabetes.


Options:
A: Safety during 104 weeks of treatment; Change from baseline in HbA1c at 104 weeks
B: ß-cell Response Measured by Hyperglycemic Clamp (3-months after medication washout (Month 15)); M/I (3-months after a medication washout)
C: Change From Baseline to 26 Weeks Endpoint in Glycosylated Hemoglobin (HbA1c) (Baseline, 26 Weeks)
D: Change from baseline in HbA1c at 24 weeks

Answer: A
Please select the outcome measures that correspond to the clinical trial below.
Title: A Phase 3, Parallel Group, Randomized, Double-Blind, Placebo Controlled Multicenter Trial to Investigate the Efficacy, Tolerability and Safety of Fesoterodine Sustained Release in Subjects With Overactive Bladder Syndrome
Brief Summary: This Phase 3 trial will investigate the efficacy, tolerability and safety of fesoterodine fumarate (SR) (fesoterodine; SPM 907) in adult male and female subjects with overactive bladder syndrome. The trial is a randomized, double-blind placebo controlled multicenter trial.

The trial consisted of a 2 week Run-In period, 12 week double-blind Treatment period and 2 week Safety Follow-Up period. Subjects were randomized to one of 3 treatment arms receiving either fesoterodine fumarate 4mg, fesoterodine fumarate 8mg, or placebo during the double-blind Treatment period.

Two primary efficacy variables will be assessed for submission in the United States: change in the average number of micturitions (frequency) per 24 hours and the change in the average number of urge incontinence episodes per 24 hours. For the submissions in the European Union, the first primary variable will be the change in the average number of micturitions (frequency) per 24 hours and the co-primary variable is the treatment response, based on a treatment benefit scale. All continuous variables will be measured as changes from baseline to value after 12 weeks of treatment. The following safety variables were observed and assessed: adverse events, change in residual urinary volume (mL), change in laboratory parameters, change in vital signs, change in electrocardiogram (ECG), change in physical examination and change in urological/urogynecological examination.


Options:
A: N/A
B: Change From Baseline to End of Treatment (EOT) in Mean Volume Voided Per Micturition (Baseline and Week 12)
C: Change From Baseline in Number of Micturition-Related Urgency Episodes Per 24 Hours at Week 12 (Baseline and Week 12)
D: Change in Frequency of Urge Urinary Incontinence Episodes at Week 12. (Baseline and Week 12)

Answer: A
Please select the outcome measures that correspond to the clinical trial below.
Title: Evaluation of Antibacterial Soap for Treatment of Lymphedema and Elephantiasis in an Area Endemic for Lymphatic Filariasis
Brief Summary: Introduction. Lymphatic filariasis is a devastating mosquito-transmitted parasitic disease that causes lymphedema or elephantiasis of the leg in 15 million persons, the majority of whom are women. In these persons, frequent bacterial infections ("acute attacks") of the legs adversely affect physical health, economic well-being, and quality of life. Prevention of bacterial infections through hygiene and skin care can result in significant improvements in lymphedema and patient well-being.

Methods. To determine the extent to which antibacterial soap can help reduce the incidence of acute bacterial infections of the lower limbs in persons with filarial lymphedema, 200 patients of the Ste. Croix Hospital lymphedema treatment clinic in Leogane, Haiti randomly assigned to receive either antibacterial (Safeguard) or placebo (Camay) soap and acute attacks monitored monthly for 12 months. Both groups received specific instructions on washing and skin care.


Options:
A: Number of Participants Eradicated of S. Aureus Carriage - 1 Month After Intervention (1 month follow-up)
B: Number of patients with infection resolution reaching clinical stability, as a measure of effectiveness (Retrospective. Outcome measures will be determined in patients hospitalized between 2010-12-01 and 2011-01-31, from the date of hospitalization, up to the date of hospital discharge (2011-02-28 at the latest).); Number of patients reaching clinical stability, as a measure of effectiveness (Retrospective. Outcome measures will be determined in patients hospitalized between 2010-12-01 and 2011-01-31, from the date of hospitalization, up to the date of hospital discharge (2011-02-28 at the latest).); Number of patients death, as a measure of clinical failure (Retrospective. Outcome measures will be determined in patients hospitalized between 2010-12-01 and 2011-01-31, from the date of hospitalization, up to the date of hospital discharge (2011-02-28 at the latest).); Number of patients with infection recurrence, as a measure of clinical failure (Retrospective. Outcome measures will be determined in patients hospitalized between 2010-12-01 and 2011-01-31, from the date of hospitalization, up to the date of hospital discharge (2011-02-28 at the latest).); Number of patients requiring change in antibiotic, as a measure of clinical failure (Retrospective. Outcome measures will be determined in patients hospitalized between 2010-12-01 and 2011-01-31, from the date of hospitalization, up to the date of hospital discharge (2011-02-28 at the latest).)
C: Incidence of bacterial "acute attacks", assessed monthly.; Reported or observed severity of these acute attacks.; Duration of acute attacks.
D: Cessation Of Spread Or Reduction In Size Of Baseline Lesion, Absence Of Fever, And No Rescue Antibiotic Medication At Early Clinical Evaluation (ECE) (48 To 72 Hours) (48-72 hours after the initiation of study therapy)

Answer: C
Please select the outcome measures that correspond to the clinical trial below.
Title: Pilot Study of Internal Globus Pallidus or Median Centre of the Thalamus High Frequency Stimulation for the Treatment of Patients With Severe Tourette's Syndrome
Brief Summary: Tourette's syndrome is a disabling neuropsychiatric disorder with major psychosocial consequences in some patients. The pathophysiology is still unknown. Some data suggest an dysfunction of limbic circuits in basal ganglia. The aim of this study is to evaluate the effect of high frequency stimulation of the internal part of the globus pallidus and/or parafascicular-median centre of the thalamus, two structures implicated in the limbic circuit, in patients with severe Tourette's syndrome.


Options:
A: Change in Yale Global Tic Severity Scale (Three months after stimulation switched ON v three months after stimulation switched OFF)
B: Severity of tics
C: cognitive improvement (one- year)
D: To evaluate the therapeutic effect of the high frequency bilateral stimulation of GPI in severe forms and invalidating MGT, in a protocol randomized as a double blind man in parallel groups. (during the 44 months); The assumption tested is that of the frank improvement (> 60% on scale YGTSS) of the symptoms of the MGT by the bilateral stimulation of GPI in its former part. (at the end of 44 months)

Answer: B
Please select the outcome measures that correspond to the clinical trial below.
Title: Evaluate Immunogenicity, Reactogenicity & Safety of 2 Doses of GSK Biologicals' Oral Live Attenuated HRV Vaccine (RIX4414 at 106.5 CCID50) When Given Concomitantly With OPV Versus Given Alone (HRV Vaccine Dose Given 15 Days After the OPV Dose) in Healthy Infants in Bangladesh
Brief Summary: The main objective of this study is to provide immunogenicity data for GSK Biologicals' HRV vaccine when co-administered with OPV or when given alone (HRV vaccine dose given 15 days after the OPV dose).


Options:
A: 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.
B: Number of Seroconverted Subjects for Serum Anti-rotavirus Immunoglobulin A (IgA) Antibody. (2 months post-Dose 2 (at study Month 4))
C: 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))
D: 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)

Answer: A
Please select the outcome measures that correspond to the clinical trial below.
Title: Evaluate Immunogenicity, Reactogenicity & Safety of 2 Doses of GSK Biologicals' Oral Live Attenuated HRV Vaccine (RIX4414 at 106.5 CCID50) When Given Concomitantly With OPV Versus Given Alone (HRV Vaccine Dose Given 15 Days After the OPV Dose) in Healthy Infants in Bangladesh
Brief Summary: The main objective of this study is to provide immunogenicity data for GSK Biologicals' HRV vaccine when co-administered with OPV or when given alone (HRV vaccine dose given 15 days after the OPV dose).


Options:
A: Presence of Fecal Shedding of Polio Vaccine Virus Determined by Culture (Polio Trial) (25 days following week 52 visit); Number of Participants With One or More Episodes of Rotavirus-associated Diarrhea (Rotavirus Trial) (Birth to one year)
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: 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: B
Please select the outcome measures that correspond to the clinical trial below.
Title: Evaluate Immunogenicity, Reactogenicity & Safety of 2 Doses of GSK Biologicals' Oral Live Attenuated HRV Vaccine (RIX4414 at 106.5 CCID50) When Given Concomitantly With OPV Versus Given Alone (HRV Vaccine Dose Given 15 Days After the OPV Dose) in Healthy Infants in Bangladesh
Brief Summary: The main objective of this study is to provide immunogenicity data for GSK Biologicals' HRV vaccine when co-administered with OPV or when given alone (HRV vaccine dose given 15 days after the OPV dose).


Options:
A: Primary study endpoint: acute rotavirus diarrhoea occurring from 6 weeks of age to the end of the follow-up period in subjects who resided in randomized villages during the period when they were age-eligible to have received Rotarix. (24 months)
B: Presence of Rotavirus Vaccine Strain in Any Stool Sample From Twin Receiving Placebo. (On the day of each vaccine/placebo dose, then three times weekly for 6 consecutive weeks starting after each vaccine/placebo dose and on the day of Visit 3.)
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: To assess immunogenicity of a new rotavirus vaccine Rotavin-M1 in terms of anti-rotavirus IgA antibody seroconversion 1 month after complete the vaccination schedule (up to 7 months)

Answer: C
Please select the outcome measures that correspond to the clinical trial below.
Title: A Multi-country & Multi-center Study to Assess the Efficacy, Immunogenicity & Safety of Two Doses of GSK Biologicals' Oral Live Attenuated HRV Vaccine Given Concomitantly With Routine EPI Vaccinations Including OPV in Healthy Infants
Brief Summary: The main objectives of this study is to determine vaccine efficacy against severe rotavirus (RV) gastroenteritis (GE) during the period starting from 2 weeks after Dose 2 until one year of age.


Options:
A: Number of Subjects With Severe Episode(s) of Rotavirus Gastroenteritis (RVGE) Caused by the Circulating Wild Type (WT) Strains (From Month 1 ½ to Month 21)
B: Demonstrate lot-to-lot consistency of HRV vaccine liquid formulation and non-inferiority of liquid formulation versus the lyophilised formulation of the HRV vaccine.
C: Occurrence of severe RV GE caused by the wild RV strains during the period starting from 2 weeks after Dose 2 until 1 year old.
D: Mortality; Hospitalisations

Answer: C
Please select the outcome measures that correspond to the clinical trial below.
Title: A Multi-country & Multi-center Study to Assess the Efficacy, Immunogenicity & Safety of Two Doses of GSK Biologicals' Oral Live Attenuated HRV Vaccine Given Concomitantly With Routine EPI Vaccinations Including OPV in Healthy Infants
Brief Summary: The main objectives of this study is to determine vaccine efficacy against severe rotavirus (RV) gastroenteritis (GE) during the period starting from 2 weeks after Dose 2 until one year of age.


Options:
A: Safety of Rotavin-M1 vaccine in healthy adult volunteers (3 months)
B: Number/Percentage of Subjects With Seroconversion for Anti-measles Immunoglobulin G (IgG) Antibody (28 days post-vaccination); Number/Percentage of Subjects With Seroresponses for Yellow Fever Neutralizing Antibody (28 days post-vaccination)
C: Presence of Fecal Shedding of Polio Vaccine Virus Determined by Culture (Polio Trial) (25 days following week 52 visit); Number of Participants With One or More Episodes of Rotavirus-associated Diarrhea (Rotavirus Trial) (Birth to one year)
D: Occurrence of severe RV GE caused by the wild RV strains during the period starting from 2 weeks after Dose 2 until 1 year old.

Answer: D
Please select the outcome measures that correspond to the clinical trial below.
Title: A Multi-country & Multi-center Study to Assess the Efficacy, Immunogenicity & Safety of Two Doses of GSK Biologicals' Oral Live Attenuated HRV Vaccine Given Concomitantly With Routine EPI Vaccinations Including OPV in Healthy Infants
Brief Summary: The main objectives of this study is to determine vaccine efficacy against severe rotavirus (RV) gastroenteritis (GE) during the period starting from 2 weeks after Dose 2 until one year of age.


Options:
A: Anti-RV IgA antibody SC at Month 2 • Safety: solicited & unsolicited adverse events and SAEs
B: Percentage/Number of Subjects With Seroprotection for Measles Virus Serum Neutralization Antibodies (8 weeks post vaccination); Percentage/Number of Subjects With Seroprotection for Anti-measles Virus Immunoglobulin G (IgG) (8 weeks post vaccination)
C: Occurrence of severe RV GE caused by the wild RV strains during the period starting from 2 weeks after Dose 2 until 1 year old.
D: Immunogenicity (7 months)

Answer: C
Please select the outcome measures that correspond to the clinical trial below.
Title: Osteoporosis Prevention and Treatment Program: A Disease Management Demonstration Project
Brief Summary: The purpose of this study is to assess the impact of disease management interventions on bone mineral density (BMD) screening rates and osteoporosis treatment rates in women age 65 years or older.


Options:
A: The primary outcome is the proportion of patients starting prescription osteoporosis treatment within 3 months of fracture recognition (3 months)
B: Cardiac Medication Use (3 and 12 months)
C: Bone mineral density (BMD) testing rates
D: Urinary catheter day (participants will be followed for the duration of hospital stay, an expected average of 3 weeks)

Answer: C
Please select the outcome measures that correspond to the clinical trial below.
Title: Osteoporosis Prevention and Treatment Program: A Disease Management Demonstration Project
Brief Summary: The purpose of this study is to assess the impact of disease management interventions on bone mineral density (BMD) screening rates and osteoporosis treatment rates in women age 65 years or older.


Options:
A: Percentage of patients up-to-date (UTD) for colorectal cancer (CRC) screening (18 months)
B: Self-reported colorectal cancer (CRC) screening adherence with medical record verification of screening test completion (6 and 15 months post-intervention)
C: Bone mineral density (BMD) testing rates
D: Personal Health Partner (PHP) assessment with electronic health record (EHR) data exchange before pediatric primary care visits (2 week -1day before doctor's appointment and 1 week after appointment)

Answer: C
Please select the outcome measures that correspond to the clinical trial below.
Title: Osteoporosis Prevention and Treatment Program: A Disease Management Demonstration Project
Brief Summary: The purpose of this study is to assess the impact of disease management interventions on bone mineral density (BMD) screening rates and osteoporosis treatment rates in women age 65 years or older.


Options:
A: The proportion of patients starting bisphosphonate treatment within 6 months of fracture (6 months)
B: Bone mineral density (BMD) testing rates
C: The proportion of patients taking bisphosphonate therapy within 6 months of hip fracture
D: Increased use of proven efficacious osteoporosis treatment within six months of study enrollment, defined as: hormone therapy, a bisphosphonate, raloxifene, or calcitonin.

Answer: B