TrialPanorama/Dataset huggingface dataset:
Please select the outcome measures that correspond to the clinical trial below.
Title: A Randomised, Parallel-group, Open-label, Multinational Trial Comparing the Safety and Efficacy of Insulin Aspart (NovoRapid®) Versus Human Insulin (Actrapid®), Used in a Multiple Injection Regimen, in the Treatment of Pregnant Women With Type 1 Diabetes, Focusing on Maternal Hypoglycaemia and Pregnancy Outcomes
Brief Summary: This trial was conducted in Europe, Middle East, North America and South America.

The aim of this trial was to compare the use of an intensified insulin treatment with insulin aspart (NovoRapid®) versus human insulin (Actrapid®) in pregnancy.


Options:
A: Hemoglobin A1C (HbA1C) (After 16 weeks of treatment)
B: Relative risk of major maternal hypoglycaemia (after 24 hours)
C: HbA1c (After 16 weeks treatment)
D: Mean Blood Glucose Concentration (hospital stay days 2-10)

Answer: B
Please select the outcome measures that correspond to the clinical trial below.
Title: A Randomised, Parallel-group, Open-label, Multinational Trial Comparing the Safety and Efficacy of Insulin Aspart (NovoRapid®) Versus Human Insulin (Actrapid®), Used in a Multiple Injection Regimen, in the Treatment of Pregnant Women With Type 1 Diabetes, Focusing on Maternal Hypoglycaemia and Pregnancy Outcomes
Brief Summary: This trial was conducted in Europe, Middle East, North America and South America.

The aim of this trial was to compare the use of an intensified insulin treatment with insulin aspart (NovoRapid®) versus human insulin (Actrapid®) in pregnancy.


Options:
A: hemoglobin A1c
B: - Primary outcomes include HbA1c, glucose, total cholesterol, LDL cholesterol, HDL cholesterol, and triglycerides levels. (3 months)
C: Fasting and Post Prandial Blood Glucose, Glycosylated Hemoglobin (90 days)
D: Relative risk of major maternal hypoglycaemia (after 24 hours)

Answer: D
Please select the outcome measures that correspond to the clinical trial below.
Title: A Phase 3 Double Blinded, Randomized, Placebo Controlled Trial of Proton Pump Inhibitor for the Prevention of Recurrent Ulcer Bleeding in Patients Receiving a COX-2 Inhibitor
Brief Summary: The purpose of this study is to compare the effect of Esomeparzole with Placebo in the Prevention of Recurrent Ulcer Bleeding in Patients Receiving a COX-2 Inhibitor


Options:
A: Number of Subjects With Clinically Significant Upper and/or Lower Gastrointestinal Events (CSULGIEs) (6 month treatment duration)
B: ulcer rebleeding over period of 13 months
C: Changes in '100 mm pain VAS' value from baseline (-14, 0, 14, 28, 42 day)
D: 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)

Answer: B
Please select the outcome measures that correspond to the clinical trial below.
Title: A Randomized, Double-Blind, Placebo-Controlled Study to Assess the Efficacy and Safety of XP13512 in Patients With Restless Legs Syndrome.
Brief Summary: The primary objective of this trial is to assess the efficacy of XP13512 taken once daily compared to placebo for the treatment of patients suffering from Restless Legs Syndrome (RLS).


Options:
A: Change From Baseline in IRLS Rating Scale Total Score at Week 12 Using Last Observation Carried Forward (LOCF) (Baseline and Week 12); Number of Participants With a Score of "Much Improved" or "Very Much Improved" on the Investigator-rated CGI-I Scale (Response) at (Week 12) Using LOCF (Week 12)
B: IRLS severity scale (24 and 48 wks)
C: Mean Css, Max and Css, Min (Weeks 4 and 12); Mean Tmax and T1/2 (Weeks 4 and 12); Mean AUCss (Weeks 4 and 12)
D: The change from baseline to the end of treatment in International Restless Legs Syndrome (IRLS) rating scale score. (12-week treatment period); The proportion of subjects at the end of treatment who are "much improved" or "very much improved" on the Investigator-rated CGI of Improvement (12-week treatment period)

Answer: A
Please select the outcome measures that correspond to the clinical trial below.
Title: Study of Pilot Manufacturing Lot of HPV 16 Virus-Like Particle (VLP) Vaccine in the Prevention of HPV 16 Infection in 16- to 23-Year-Old Females
Brief Summary: Subjects received HPV 16 L1 VLP vaccine or placebo (1:1 ratio). Endpoints included efficacy, immunogenicity, and safety.


Options:
A: Incidence of Persistent HPV 16 Infection (Through Month 48); Incidence of HPV 16-related CIN1, CIN2 or C1N3 (Through Month 48); Serum Anti-HPV 16 Geometric Mean Titers (Month 7)
B: HPV-6 Antibody Level (Geometric Mean Titer of HPV-6) (Week 28); HPV-11 Antibody Level (Geometric Mean Titer of HPV-11) (Week 28); HPV-16 Antibody Level (Geometric Mean Titer of HPV-16) (Week 28); HPV-18 Antibody Level (Geometric Mean Titer of HPV-18) (Week 28)
C: Number of Female Subjects With Overall Vaccine Effectiveness Against Genital Infection With Human Papilloma Virus (HPV)-16/18 Types in Cervarix/Engerix-B B Group Versus Engerix-B Group and in Cervarix/Engerix-B A Group Versus Engerix-B Group (At the time of Visit 5 (i.e. at 18.5 years of age))
D: 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)

Answer: A
Please select the outcome measures that correspond to the clinical trial below.
Title: Study of Pilot Manufacturing Lot of HPV 16 Virus-Like Particle (VLP) Vaccine in the Prevention of HPV 16 Infection in 16- to 23-Year-Old Females
Brief Summary: Subjects received HPV 16 L1 VLP vaccine or placebo (1:1 ratio). Endpoints included efficacy, immunogenicity, and safety.


Options:
A: 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))
B: Incidence of the Composite Endpoint of Human Papillomavirus (HPV) 16/18-related Cervical Intraepithelial Neoplasia (CIN) 2 or Worse in the Base Study (Up to 4 years); Incidence of the Composite Endpoint of Human Papillomavirus (HPV) 16/18-related Cervical Intraepithelial Neoplasia (CIN) 2 or Worse in the Long-term Follow-up (LTFU) Study (Up to 14 years since Vaccine Dose 1); Incidence of the Composite Endpoint of HPV16/18-related CIN 2 or Worse in the Long-term Follow-up (LTFU) Study (up to 22 years post Vaccination Dose 1)
C: Number of Subjects With Injection Site Adverse Experiences (Days 1-5 following any vaccination visit)
D: Incidence of Persistent HPV 16 Infection (Through Month 48); Incidence of HPV 16-related CIN1, CIN2 or C1N3 (Through Month 48); Serum Anti-HPV 16 Geometric Mean Titers (Month 7)

Answer: D
Please select the outcome measures that correspond to the clinical trial below.
Title: SAFE or SORRY? Development and Testing of an Evidence Based Inpatient Safety Program for the Prevention of Common Complications.
Brief Summary: The aim of SAFE or SORRY? is to develop and test an evidence based inpatient safety program for the prevention of three frequently occuring adverse events: pressure ulcers, urinary tract infections and falls.


Options:
A: Falls (1 year)
B: Proportion of residents receiving at least one antipsychotic medication after 12 months (12 months)
C: Number of actually stopped or adjusted drugs (Patients will be followed for the duration of hospital stay, an expected average of 14 days.)
D: Incidence of adverse events (count incidence of Pressure Ulcers, Urinary Tract Infections, and Falls (nine months)

Answer: D
Please select the outcome measures that correspond to the clinical trial below.
Title: SAFE or SORRY? Development and Testing of an Evidence Based Inpatient Safety Program for the Prevention of Common Complications.
Brief Summary: The aim of SAFE or SORRY? is to develop and test an evidence based inpatient safety program for the prevention of three frequently occuring adverse events: pressure ulcers, urinary tract infections and falls.


Options:
A: Change in antibiotic prescription patterns for respiratory infections (1 year)
B: Episiotomies; Oxytocin use in third stage of labor
C: The difference between groups in the change in parent and nurse ratings of specific communication skills and professionalism behaviors from baseline to follow-up (average 5 months later)
D: Incidence of adverse events (count incidence of Pressure Ulcers, Urinary Tract Infections, and Falls (nine months)

Answer: D
Please select the outcome measures that correspond to the clinical trial below.
Title: SAFE or SORRY? Development and Testing of an Evidence Based Inpatient Safety Program for the Prevention of Common Complications.
Brief Summary: The aim of SAFE or SORRY? is to develop and test an evidence based inpatient safety program for the prevention of three frequently occuring adverse events: pressure ulcers, urinary tract infections and falls.


Options:
A: General practitioners'adherence to treatment recommendations (3-6 months after end of intervention)
B: Changes in a set of predefined quality indicators measuring appropriateness of prescriptions for elderly out-patients (1 year)
C: Incidence of adverse events (count incidence of Pressure Ulcers, Urinary Tract Infections, and Falls (nine months)
D: The difference between groups in the change in parent and nurse ratings of specific communication skills and professionalism behaviors from baseline to follow-up (average 5 months later)

Answer: C
Please select the outcome measures that correspond to the clinical trial below.
Title: A Randomised, Double-Blind, Placebo-Controlled, Crossover Efficacy and Safety Evaluation of 8-Week Treatment Periods of Two Doses [5 Mcg (2 Actuations of 2.5 Mcg) and 10 Mcg (2 Actuations of 5 Mcg)] of Tiotropium Inhalation Solution Delivered by the Respimat Inhaler® as Add-on Therapy in Patients With Severe Persistent Asthma
Brief Summary: The primary objective of this study is to examine efficacy and safety of tiotropium compared to plac ebo as add-on therapy in severe asthmatics according to GINA step 4 classification


Options:
A: Forced Expiratory Volume in One Second (FEV1) Peak Within 0-3 Hours Post-dose Response (10 minutes (min) before drug administration and 30 min, 1h, 2h, 3h after drug administration)
B: Forced Expiratory Volume in One Second (FEV1) Area Under the Curve 0-24 Hours (AUC0-24h) Response (10 minutes (min) prior to first dose (baseline) and -10 min, 30 min, 60 min, 2 hours (h) , 3 h, 4 h , 11 h 50 min, 12 h 30 min, 13 h, 14 h, 15 h, 16 h, 18 h, 20 h, 22 h, 23 h, and 23 h 50 min related to evening dose at week 4)
C: The primary efficacy endpoint is the FEV1 response (within 3 hours post dosing) determined at the end of the 8-week treatment period
D: Change in Mean Weekly Morning Peak Expiratory Flow From Baseline to the End of the Trial (baseline and after 16 weeks of treatment)

Answer: C
Please select the outcome measures that correspond to the clinical trial below.
Title: A Randomised, Double-Blind, Placebo-Controlled, Crossover Efficacy and Safety Evaluation of 8-Week Treatment Periods of Two Doses [5 Mcg (2 Actuations of 2.5 Mcg) and 10 Mcg (2 Actuations of 5 Mcg)] of Tiotropium Inhalation Solution Delivered by the Respimat Inhaler® as Add-on Therapy in Patients With Severe Persistent Asthma
Brief Summary: The primary objective of this study is to examine efficacy and safety of tiotropium compared to plac ebo as add-on therapy in severe asthmatics according to GINA step 4 classification


Options:
A: Rate of Asthma Exacerbations Over the 48 Week Treatment Period (48 weeks)
B: Morning Peak Expiratory Flow
C: Change (%) From Baseline in FcεRI (High-affinity IgE Receptor) Expression on Blood Basophils and Dendritic Cells After 16 Weeks of Treatment With Omalizumab as Compared With Placebo (Baseline and Week 16); Change (%) From Baseline in Mean Fluorescence Intensity of FcεRI After 16 Weeks of Treatment With Omalizumab as Compared With Placebo (Baseline and Week 16)
D: The primary efficacy endpoint is the FEV1 response (within 3 hours post dosing) determined at the end of the 8-week treatment period

Answer: D
Please select the outcome measures that correspond to the clinical trial below.
Title: Phase IV, Open-Label, Randomized, Multicenter Study Evaluating Efficacy and Tolerability of Single Tablet Regimen of Efavirenz/Emtricitabine/Tenofovir DF Compared to Unmodified HAART in HIV-1 Infected Subjects Who Have Achieved Virological Suppression on Their HAART Regimen
Brief Summary: To compare the effectiveness (efficacy, safety \& tolerability) of a Single Tablet Regimen of efavirenz/emtricitabine/tenofovir DF to subjects continuing on unmodified HAART as measured by the proportion of patients who maintain viral load (HIV-1 RNA) \<200 copies/mL at Week 48.


Options:
A: N/A
B: Change in Glycemic Control (HbA1c) (6 months (baseline to 6 months))
C: Primary: Proportion of patients with HIV-1 RNA levels <200 copies/mL at Week 48; Safety Outcome Measures: Adverse Events, Laboratory Tests; Outcomes Research Measures: Quality of life, adherence, preference of medication, perceived ease of regimen, HIV symptoms
D: N/A

Answer: C
Please select the outcome measures that correspond to the clinical trial below.
Title: Effects of Simvastatin on Clinical, Endocrine, Metabolic and Biochemical Parameters of Women With Polycystic Ovary Syndrome: Prospective, Randomized Trial.
Brief Summary: The purpose of this study is to determine whether statins (simvastatin) improve clinical (excessive hair, skin problems), endocrine (androgens) and metabolic (lipids, markers of systemic inflammation) in women with polycystic ovary syndrome (PCOS).


Options:
A: Development of Diabetes. (Outcomes were assessed from 1996-2008 (approximately 12 years including 6 years of DPP).); Prevalence of Aggregate Microvascular Complication (Outcomes were assessed from 2012-2013 (approximately 2 years).); Total Cancer Except Non-melanoma Skin Cancer (Outcomes were assessed from 1996-2020 (approximately 24 years).); Major Adverse Cardiovascular Events (MACE): Myocardial Infarction (MI), Stroke, or Cardiovascular Death (CVD) (Outcomes were assessed from 1996-2025 (approximately 29 years).)
B: Androgen secretion (0, 3, 6 months); Glucose metabolism (0, (3), 6 months)
C: Serum testosterone
D: serum testosterone

Answer: D
Please select the outcome measures that correspond to the clinical trial below.
Title: Effects of Simvastatin on Clinical, Endocrine, Metabolic and Biochemical Parameters of Women With Polycystic Ovary Syndrome: Prospective, Randomized Trial.
Brief Summary: The purpose of this study is to determine whether statins (simvastatin) improve clinical (excessive hair, skin problems), endocrine (androgens) and metabolic (lipids, markers of systemic inflammation) in women with polycystic ovary syndrome (PCOS).


Options:
A: serum testosterone
B: Change in Testosterone After 6 Months of Treatment (baseline and 6 months)
C: Metformin versus Metformin plus low-dose Spironolactone on metabolic parameters of Patients with Polycystic Ovary Syndrome: a randomized study (six months)
D: To compare the effects of two EP combinations on endocrine-metabolic parameters in normal weight PCOS women (twelve months)

Answer: A
Please select the outcome measures that correspond to the clinical trial below.
Title: Telephone-Delivered Coping Improvement Intervention for HIV Infected Older Adults
Brief Summary: This study will evaluate the effectiveness of a telephone-delivered coping improvement group intervention in improving quality of life in older adults with HIV.


Options:
A: Baby's health status (6 days after birth; 6 months after birth; 12 months after birth)
B: Depression (Measured at pre-intervention, post-intervention, and 4- and 8-month follow-up)
C: Substance use (1 year); Unsafe sexual behavior (1 year)
D: Percent Medication Adherence at 3-month Follow-up Assessment (3-month assessment); Percent Medication Adherence at 12-month Follow-up Assessment (12-month follow-up assessment)

Answer: B
Please select the outcome measures that correspond to the clinical trial below.
Title: A Placebo-Controlled, Dose-Ranging Study of Quadrivalent HPV Virus-Like Particle (VLP) Vaccine in 16- to 23-Year-Old Women
Brief Summary: This study was conducted in 2 parts. Part A was a randomized, double-blind, placebo-controlled, multicenter, sequential dose-escalating evaluation. Part B was a randomized, double-blind (operating under in-house blinding procedures), placebo-controlled, multicenter, dose-ranging study.


Options:
A: Number of Subjects With Injection Site Adverse Experiences (Days 1-5 following any vaccination visit)
B: Base Study: Geometric Mean Titers (GMTs) for Each of the HPV Types Contained in the Vaccine (9- to 15-Year-Old Females [Lot 1] and 16- to 26-Year-Old Females [Lot 1]) (4 weeks post-vaccination 3 (Month 7)); Base Study: GMTs for Each of the HPV Types Contained in the Vaccine (9- to 15-Year-Old Males [Lot 1] and 16- to 26-Year-Old Females [Lot 1]) (4 weeks post-vaccination 3 (Month 7)); Base Study: GMTs for Each of the HPV Types Contained in the Vaccine (Lot Consistency Study) (4 weeks post-vaccination 3 (Month 7)); Base Study: Percentage of Participants With Injection Site Adverse Experiences (AEs) (Up to 5 days after any vaccination); Base Study: Percentage of Participants With Systemic AEs (Up to 15 days after any vaccination); Base Study: Percentage of Participants With Body Temperature ≥100.0°F (≥37.8ºC) (Up to 5 days after any vaccination); Extension Study: GMTs For Each of the HPV Types Contained in the Vaccine (Up to ~Month 126); Extension Study: Percentage of Participants Who Are Seropositive to Each of the HPV Types Contained in the Vaccine (Up to ~Month 126)
C: To monitor immunogenicity levels induced by anti/HPV vaccine in traditional squeme (6 months)
D: Primary Objective Part 1 (Measured after Month 7); Primary Objective Part 2 (At 18, 24 and 36mths post dose 1); Primary Objective Part 2 (Measured at 36 mths)

Answer: A
Please select the outcome measures that correspond to the clinical trial below.
Title: A Placebo-Controlled, Dose-Ranging Study of Quadrivalent HPV Virus-Like Particle (VLP) Vaccine in 16- to 23-Year-Old Women
Brief Summary: This study was conducted in 2 parts. Part A was a randomized, double-blind, placebo-controlled, multicenter, sequential dose-escalating evaluation. Part B was a randomized, double-blind (operating under in-house blinding procedures), placebo-controlled, multicenter, dose-ranging study.


Options:
A: Incidence of the Composite Endpoint of Human Papillomavirus (HPV) 16/18-related Cervical Intraepithelial Neoplasia (CIN) 2 or Worse in the Base Study (Up to 4 years); Incidence of the Composite Endpoint of Human Papillomavirus (HPV) 16/18-related Cervical Intraepithelial Neoplasia (CIN) 2 or Worse in the Long-term Follow-up (LTFU) Study (Up to 14 years since Vaccine Dose 1); Incidence of the Composite Endpoint of HPV16/18-related CIN 2 or Worse in the Long-term Follow-up (LTFU) Study (up to 22 years post Vaccination Dose 1)
B: Number of Subjects With Injection Site Adverse Experiences (Days 1-5 following any vaccination visit)
C: Incidence of Persistent HPV 16 Infection (Through Month 48); Incidence of HPV 16-related CIN1, CIN2 or C1N3 (Through Month 48); Serum Anti-HPV 16 Geometric Mean Titers (Month 7)
D: 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))

Answer: B
Please select the outcome measures that correspond to the clinical trial below.
Title: Comparison of High Dose Rapid Schedule With Conventional Schedule Chemotherapy for Stage 4 Neuroblastoma Over the Age of One Year
Brief Summary: RATIONALE: Drugs used in chemotherapy work in different ways to stop the growth of tumor cells, either by killing the cells or by stopping them from dividing. Giving more than one drug (combination chemotherapy) may kill more tumor cells. Giving combination chemotherapy before surgery may make the tumor smaller and reduce the amount of normal tissue that needs to be removed. A bone marrow transplant, using bone marrow from the patient, may be able to replace blood-forming cells that were destroyed by chemotherapy. It is not yet know which combination chemotherapy schedule is more effective, when given before surgery and an autologous bone marrow transplant, in treating patients with disseminated neuroblastoma.

PURPOSE: This randomized phase III trial is studying two different chemotherapy schedules to compare how well they work in treating young patients who are undergoing surgery and an autologous bone marrow transplant for disseminated neuroblastoma.


Options:
A: Event-free survival rate (Time from study registration until the time of the first occurrence of either relapse, progression, secondary malignancy, or death, or until the time of last contact with the patient if none of these events occurs, assessed up to 6 years); Rate of occurrence of toxic (non disease-related) deaths where a toxic death will be "counted" if it occurs prior to the initiation of the immunotherapy (Up to day 42)
B: Event Free Survival (R1: MAT therapy) (Up to three years); Event Free Survival (immunotherapy) (Up to three years); Complete metastatic response (R3: Induction therapy) (Up to 95 days); Event free survival (R3: Induction therapy) (Up to three years)
C: N/A
D: N/A

Answer: C