TrialPanorama/Dataset huggingface dataset:
Please select the outcome measures that correspond to the clinical trial below.
Title: A Phase I Study of the Safety and Immunogenicity of MVA85A in Healthy Gambian Volunteers
Brief Summary: A Phase I study of the Safety and immunogenicity of MVA85A in healthy Gambian volunteers


Options:
A: The occurence and severity of local side-effects The occurence and severity of systemic side-effects (1 year)
B: To assess the safety of a single intradermal injection of 5 x 107p.f.u. MVA85A. (One year)
C: Safety of the Vaccine. This will be determined by the degree and number of adverse events reported.
D: To assess the safety of a new tuberculosis vaccine, FP85A, when administered individually and sequentially with MVA85A in a prime-boost regime, to healthy volunteers, who have previously been vaccinated with BCG (3 months)

Answer: C
Please select the outcome measures that correspond to the clinical trial below.
Title: A 52-Week Efficacy and Safety Non-Inferiority Study of Fluticasone Propionate/Salmeterol 250/50mcg BID Delivered by Dry Powder Inhaler (Diskus) Versus Mometasone Furoate/Formoterol Fumarate 200/10mcg BID Delivered by Pressurized Metered-Dose Inhaler in Persistent Asthmatics Previously Treated With Medium Doses of Inhaled Glucocorticosteroids
Brief Summary: This study is being conducted to demonstrate the non-inferiority between two inhaled glucocorticosteroids and long-acting bronchodilator combination drugs called mometasone furoate/formoterol fumarate in a metered-dose inhaler (MDI) and fluticasone propionate/salmeterol in a dry powder inhaler (DPI) on lung function. Information on the onset of action, the overall safety, and how the drugs control asthma will also be assessed. The study is approximately 1 year in duration.


Options:
A: Change Between Week 14 and Week 0 in the Morning (AM) Peak Expiratory Flow (PEF) (AM PEF was measured daily during each of the three 14-week treatment periods. The primary analysis constructed the change between week 14 and week 0.)
B: Change From Baseline in Weighted-mean 24 Hour Serial FEV1 on Day 168/Week 24 (Baseline and Day 168/Week 24)
C: Number of Patients With Drug-related Adverse Events (after the first dose of trial medication and within 30 days after the last dose of trial medication, up to 409)
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: D
Please select the outcome measures that correspond to the clinical trial below.
Title: A 52-Week Efficacy and Safety Non-Inferiority Study of Fluticasone Propionate/Salmeterol 250/50mcg BID Delivered by Dry Powder Inhaler (Diskus) Versus Mometasone Furoate/Formoterol Fumarate 200/10mcg BID Delivered by Pressurized Metered-Dose Inhaler in Persistent Asthmatics Previously Treated With Medium Doses of Inhaled Glucocorticosteroids
Brief Summary: This study is being conducted to demonstrate the non-inferiority between two inhaled glucocorticosteroids and long-acting bronchodilator combination drugs called mometasone furoate/formoterol fumarate in a metered-dose inhaler (MDI) and fluticasone propionate/salmeterol in a dry powder inhaler (DPI) on lung function. Information on the onset of action, the overall safety, and how the drugs control asthma will also be assessed. The study is approximately 1 year in duration.


Options:
A: 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)
B: Asthma control assessed by asthma exacerbations (Continuosly throughout the treatment period)
C: Number of Participants Experiencing an Event in the Composite Endpoint (Asthma-related Death, Asthma-related Intubation or Asthma-related Hospitalization) (Up to 27 weeks); Number of Participants Experiencing an Event Included in the Definition of Asthma Exacerbation (Up to 26 weeks)
D: Morning pre-dose PEF measured daily by patients (mean of the last 2 weeks of treatment period). (mean of the last 2 weeks of treatment period)

Answer: A
Please select the outcome measures that correspond to the clinical trial below.
Title: A 52-Week Efficacy and Safety Non-Inferiority Study of Fluticasone Propionate/Salmeterol 250/50mcg BID Delivered by Dry Powder Inhaler (Diskus) Versus Mometasone Furoate/Formoterol Fumarate 200/10mcg BID Delivered by Pressurized Metered-Dose Inhaler in Persistent Asthmatics Previously Treated With Medium Doses of Inhaled Glucocorticosteroids
Brief Summary: This study is being conducted to demonstrate the non-inferiority between two inhaled glucocorticosteroids and long-acting bronchodilator combination drugs called mometasone furoate/formoterol fumarate in a metered-dose inhaler (MDI) and fluticasone propionate/salmeterol in a dry powder inhaler (DPI) on lung function. Information on the onset of action, the overall safety, and how the drugs control asthma will also be assessed. The study is approximately 1 year in duration.


Options:
A: 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)
B: Mean Area Under the Time Curve From 0 to 12 Hours (AUC(0-12 Hours)) of Change From Baseline to Week 12 in Forced Expiratory Volume (Liters) in 1 Second (FEV1) (Baseline to Week 12)
C: Peak FEV1 (L) Defined as the Highest Bronchodilatory Effect on FEV1 During a Period of 5 Min to 4 h After the Last Evening Dose of Each Treatment Period (3 weeks)
D: Participants With Treatment-Emergent Adverse Experiences (TEAE) During the Treatment Period (Day 1 to Week 26 of the Treatment Period)

Answer: A
Please select the outcome measures that correspond to the clinical trial below.
Title: A 52-Week Efficacy and Safety Non-Inferiority Study of Fluticasone Propionate/Salmeterol 250/50mcg BID Delivered by Dry Powder Inhaler (Diskus) Versus Mometasone Furoate/Formoterol Fumarate 200/10mcg BID Delivered by Pressurized Metered-Dose Inhaler in Persistent Asthmatics Previously Treated With Medium Doses of Inhaled Glucocorticosteroids
Brief Summary: This study is being conducted to demonstrate the non-inferiority between two inhaled glucocorticosteroids and long-acting bronchodilator combination drugs called mometasone furoate/formoterol fumarate in a metered-dose inhaler (MDI) and fluticasone propionate/salmeterol in a dry powder inhaler (DPI) on lung function. Information on the onset of action, the overall safety, and how the drugs control asthma will also be assessed. The study is approximately 1 year in duration.


Options:
A: 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)
B: 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)
C: Change in Forced Expiratory Volume in 1 s(FEV-1) from Baseline (Week 0) to Week 12. (Week 0 and 12 visits); Discontinuation due to lack of efficacy. (Whole duration of study)
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: A
Please select the outcome measures that correspond to the clinical trial below.
Title: A Phase 3, Multicenter, Randomized, Double-blind, Comparative Study to Evaluate the Safety and Efficacy of Ceftaroline Versus Vancomycin Plus Aztreonam in Adult Subjects With Complicated Skin and Skin Structure Infection
Brief Summary: The purpose of this study is to determine whether ceftaroline is effective and safe in the treatment of complicated skin infections in adults.


Options:
A: Percentage of Cured Participants as Determined by the Data Review Committee (DRC) at Test of Cure Visit in the Per Protocol (PP) Population (14 - 28 days after last dose of study medication)
B: Clinical success at follow-up (six months)
C: Skin Abscess Resolution (10-14 days)
D: Clinical Cure Rate at Test of Cure (TOC) (MITT Population) (8-15 days after the end of treatment); Clinical Cure Rate of Ceftaroline Compared With That of Vancomycin Plus Aztreonam Treatment at TOC in the Clinically Evaluable (CE) Population (8-15 days after last dose of study drug)

Answer: D
Please select the outcome measures that correspond to the clinical trial below.
Title: Effect of Roflumilast in COPD Patients Treated With Tiotropium. A 24-week, Double-blind Study With 500 µg Roflumilast Once Daily Versus Placebo. The HELIOS Study
Brief Summary: The aim of the study is to compare the efficacy of roflumilast to placebo on pulmonary function and symptomatic parameters in patients with chronic obstructive pulmonary disease (COPD) during concomitant administration of tiotropium. The study duration will last up to 28 weeks. The study will provide further data on safety and tolerability of roflumilast.


Options:
A: Rate of Moderate or Severe COPD Exacerbations Per Patient Per Year (52 weeks)
B: Pre-bronchodilator Forced Expiratory Volume in First Second (FEV1) (Change from baseline over 24 weeks of treatment)
C: change in FEV1 from baseline during the treatment period; number of COPD exacerbations.
D: Number of CD8+ Inflammatory Cells in Bronchial Biopsy Tissue. (16 weeks); Change in Number of CD8+ Inflammatory Cells in Bronchial Biopsy Tissue (Baseline to 16 weeks)

Answer: B
Please select the outcome measures that correspond to the clinical trial below.
Title: Effect of Roflumilast in COPD Patients Treated With Tiotropium. A 24-week, Double-blind Study With 500 µg Roflumilast Once Daily Versus Placebo. The HELIOS Study
Brief Summary: The aim of the study is to compare the efficacy of roflumilast to placebo on pulmonary function and symptomatic parameters in patients with chronic obstructive pulmonary disease (COPD) during concomitant administration of tiotropium. The study duration will last up to 28 weeks. The study will provide further data on safety and tolerability of roflumilast.


Options:
A: Change From Baseline in Pre-bronchodilator Forced Expiratory Volume in First Second (FEV1) (Baseline to Week 24)
B: All cause mortality at 3 years
C: Pre-bronchodilator Forced Expiratory Volume in First Second (FEV1) (Change from baseline over 24 weeks of treatment)
D: The frequency of patients experiencing at least one moderate or severe exacerbation during the treatment period.; Change in FEV1 from baseline during the treatment period.

Answer: C
Please select the outcome measures that correspond to the clinical trial below.
Title: A Two-Week, Randomized, Modified-Blind, Double-Dummy, Parallel-Group Efficacy and Safety Study of Arformoterol Tartrate Inhalation Solution Twice-Daily, Tiotropium Once-Daily, and Arformoterol Tartrate Inhalation Solution Twice-Daily and Tiotropium Once Daily in Subjects With Chronic Obstructive Pulmonary Disease
Brief Summary: The purpose of this study is to evaluate and compare the efficacy of arformoterol twice a day and tiotropium once a day (dosed sequentially) versus tiotropium once a day alone in subjects with Chronic Obstructive Pulmonary Disease (COPD).


Options:
A: Forced Expiratory Volume in 1 second measured at 2 h post dosing following 24 weeks treatment
B: Time-normalized Area Under the Change From Study Baseline Curve for Forced Expiratory Volume in One Second (FEV1) Over 24 Hours (nAUC0-24B) (24 hours following two weeks of dosing.)
C: Trough Forced Expiratory Volume in 1 Second (FEV1) at Week 12 + 1 Day, Day 85 (Week 12 + 1 day, Day 85)
D: Trough Forced Expiratory Volume in 1 Second (FEV1) After 12 Weeks of Treatment (Week 12)

Answer: B
Please select the outcome measures that correspond to the clinical trial below.
Title: Effect of Duloxetine 60 mg to 120 mg Once Daily in Patients With Chronic Low Back Pain
Brief Summary: The primary purpose of your participation in this study is to help answer the following research question, and not to provide you treatment for your condition.

Whether duloxetine once daily can help patients with Chronic Low Back Pain.

Patients who do not have their pain reduced by at least 30% by week 7 will be given 120 mg dose for the duration of the study. After the 13 week double blind period, patients randomized to placebo will switch to duloxetine 60 mg or 120 mg in the 41-week extension period.


Options:
A: Change From Baseline in Mean Pain Score on the Numeric Rating Scale (NRS). (Baseline and 9 months)
B: Change From Baseline to Week 13 in Brief Pain Inventory (BPI), 24-hour Average Pain Scores (Baseline, Week 13)
C: Pressure Pain Threshold. (Difference between baseline (prior to treatment) compared with 10 weeks of 60 mg/daily duloxetine compared with placebo)
D: Change From Baseline to 12 Weeks in the Weekly Mean of the 24-Hour Average Pain Score on the 11-Point Numeric Rating Scale (NRS) (Baseline, Week 12)

Answer: B
Please select the outcome measures that correspond to the clinical trial below.
Title: Effect of Duloxetine 60 mg to 120 mg Once Daily in Patients With Chronic Low Back Pain
Brief Summary: The primary purpose of your participation in this study is to help answer the following research question, and not to provide you treatment for your condition.

Whether duloxetine once daily can help patients with Chronic Low Back Pain.

Patients who do not have their pain reduced by at least 30% by week 7 will be given 120 mg dose for the duration of the study. After the 13 week double blind period, patients randomized to placebo will switch to duloxetine 60 mg or 120 mg in the 41-week extension period.


Options:
A: Mean Change From Baseline to 12 Weeks in Weekly Mean of Daily 24 Hour Average Pain Score, Pregabalin Compared With Duloxetine (baseline, 12 weeks)
B: Efficacy of each ABT-894 dose (1 mg, 2 mg, or 4 mg BID) versus placebo in the treatment of pain due to DNP (Change from baseline to final 24-hour average pain score)
C: Change From Baseline to Week 13 in Brief Pain Inventory (BPI), 24-hour Average Pain Scores (Baseline, Week 13)
D: Patient's Global Impressions of Improvement (PGI-I) at Week 12 (12 weeks)

Answer: C
Please select the outcome measures that correspond to the clinical trial below.
Title: Effect of Duloxetine 60 mg to 120 mg Once Daily in Patients With Chronic Low Back Pain
Brief Summary: The primary purpose of your participation in this study is to help answer the following research question, and not to provide you treatment for your condition.

Whether duloxetine once daily can help patients with Chronic Low Back Pain.

Patients who do not have their pain reduced by at least 30% by week 7 will be given 120 mg dose for the duration of the study. After the 13 week double blind period, patients randomized to placebo will switch to duloxetine 60 mg or 120 mg in the 41-week extension period.


Options:
A: Change in Brain Gray Matter Volume (16 weeks compared to baseline)
B: Change From Baseline to Week 13 in Brief Pain Inventory (BPI), 24-hour Average Pain Scores (Baseline, Week 13)
C: Change From Baseline in the Weekly Mean of the 24-Hour Average Pain Score at 8 Weeks (Baseline, 8 weeks (blinded endpoint))
D: Weekly Change From Baseline in the 24-Hour Average Pain Rating Using an 11-Point Numerical Likert Scale Patient Diary (Over 13 Weeks)

Answer: B
Please select the outcome measures that correspond to the clinical trial below.
Title: A Randomised, Controlled Comparison of Vitamin D Strategies is Acute Hip Fracture Patients
Brief Summary: The purpose of the study is to determine the best dose of Vitamin D to give to hip fracture patients to achieve the optimal therapeutic level.


Options:
A: The primary outcome measure is change in 25OHD with various D2 and D3 dosing regimens. (12 months)
B: Number of Participants With the Indicated Components of the Composite Cardiovascular Outcome for Thiazolidinedione (TZD) (From Randomization at Visit 3 up to the Final Visit (average of 162 days)); Number of Participants With the Indicated Components of the Composite Outcome for Vitamin D (From Randomization at Visit 3 to Final Visit (up to 162 days))
C: 25-hydroxyvitamin D3 (25-OHD) (Baseline, 4 weeks and 3 months); Parathyroid Hormone (PTH) (Baseline); Calcium (Baseline, 4 weeks); Phosphate (Baseline); Alkaline Phosphatase (Baseline); Hemoglobin (Baseline); Creatinine (Baseline)
D: Incidence of spontaneous falls. (24 months.)

Answer: C
Please select the outcome measures that correspond to the clinical trial below.
Title: Effect of Procrit(Epoetin Alfa) on Preventing Delayed Graft Function After Deceased Donor Renal Transplantation
Brief Summary: Delayed graft function (DGF) is a major complication following deceased donor renal transplantation. The surgical procedure of harvesting a kidney from a cadaveric donor and implanting the kidney into the recipient inevitably causes some amount of injury. While not always clinically significant, anywhere from 10-50% of transplant patients may develop DGF. Ongoing research in animal models has demonstrated benefit with administration of erythropoietin. The investigators propose to study the effect of Procrit(Epoetin Alfa) on delayed graft function in subjects undergoing kidney transplantation.


Options:
A: Creatinine kinase (CK), creatinine kinase-MB (CK-MB) (4hr, 8hr, 12hr, 24hr, 48hr, 72hr)
B: Infarct Size in the Territory of the Infarct Related Artery (performed 2 to 6 days after study medication administration (first CMR))
C: Decrease in Delayed Graft Function
D: The primary objective of this study is to demonstrate that the administration of epoetin alfa to critically ill subjects reduces the proportion of subjects requiring red blood cell (RBC) transfusion as compared with placebo at Study Day 29.

Answer: C
Please select the outcome measures that correspond to the clinical trial below.
Title: Multi-site Evaluation of a Video Game for Adolescents and Young Adults With Cancer
Brief Summary: The purpose of this study is to determine the effects of playing the interactive video game, Re-Mission, on patient outcomes, including adherence to medical treatment regimes, self-care behaviors, quality of life, stress, communication, control, and knowledge.


Options:
A: Understanding (Directly proceeding the clinical encounter); Decisional Conflict (Directly proceeding the clinical visit); Treatment Action, adherence (Directly proceeding the clinical encounter, 6 months after the clinical encounter)
B: - Rate of influenza immunization among subjects
C: Adherence; Self-efficacy; Quality of life
D: Readmission and death rate at 6 months' follow up.

Answer: C
Please select the outcome measures that correspond to the clinical trial below.
Title: Multi-site Evaluation of a Video Game for Adolescents and Young Adults With Cancer
Brief Summary: The purpose of this study is to determine the effects of playing the interactive video game, Re-Mission, on patient outcomes, including adherence to medical treatment regimes, self-care behaviors, quality of life, stress, communication, control, and knowledge.


Options:
A: Virologic suppression at 6 months (6 months); Virologic failure at all time intervals from ART initiation (these primary outcomes added to expanded trial protocol November 2007) (Typically every 24 weeks); Adherence measured by pill counts (this primary outcome added to expanded trial protocol November 2007) (Typically weekly to monthly)
B: Adherence; Self-efficacy; Quality of life
C: N/A
D: Time until all-cause death or heart-failure hospitalization (Measured over the two years of study follow-up.)

Answer: B
Please select the outcome measures that correspond to the clinical trial below.
Title: A Randomized, Double-Blind, Placebo-Controlled, Parallel Group, Multicenter Study to Evaluate the Efficacy, Safety, and Tolerability of RWJ-333369 as Adjunctive Therapy in Subjects With Partial Onset Seizures Followed by an Open-Label Extension Study.
Brief Summary: The purpose of this study is to demonstrate that RWJ-333369 is safe and effective as add-on treatment of partial onset seizures.


Options:
A: N/A
B: The primary outcome is the change in seizure frequency of all simple partial motor, complex partial, or secondarily generalized seizures from the pretreatment baseline phase compared with the double-blind treatment phase.
C: Adverse events (Up to 1 year or until carisbamate is available by prescription or the study is terminated by the sponsor); Clinical laboratory test values (Up to 1 year or until carisbamate is available by prescription or the study is terminated by the sponsor); 12-lead ECG recordings (Up to 1 year or until carisbamate is available by prescription or the study is terminated by the sponsor); Vital sign measurements (Up to 1 year or until carisbamate is available by prescription or the study is terminated by the sponsor)
D: Primary efficacy endpoints are percent reduction in partial onset seizure frequency in the US and the rest of the world (excluding Europe, Australia, New Zealand, S Africa), and responder rate for Europe, Australia, New Zealand, S Africa (from baseline relative to the entire double-blind treatment phase (14 weeks))

Answer: B
Please select the outcome measures that correspond to the clinical trial below.
Title: Outpatient Treatment of Low-risk Patients With Pulmonary Embolism: a Randomized-controlled Trial
Brief Summary: The purpose of this randomized clinical trial is to determine whether outpatient treatment is as effective and safe as inpatient treatment among low-risk patients with pulmonary embolism.


Options:
A: Mortality rate due to pulmonary embolism or its treatment during a period of ten days in the outpatient group
B: -Thromboembolic recurrences; -Bleeding Complications; -Deaths
C: 90-day all-cause mortality, recurrent VTE, and Major Bleeding during outpatient treatment of Low-risk PE (90 Days)
D: Recurrent, symptomatic venous thromboembolism (deep vein thrombosis or pulmonary embolism) (within 3 months of randomization)

Answer: D
Please select the outcome measures that correspond to the clinical trial below.
Title: Outpatient Treatment of Low-risk Patients With Pulmonary Embolism: a Randomized-controlled Trial
Brief Summary: The purpose of this randomized clinical trial is to determine whether outpatient treatment is as effective and safe as inpatient treatment among low-risk patients with pulmonary embolism.


Options:
A: Rate of home discharge from the emergency department following treatment for pulmonary embolism (8 months post-implementation compared to 8 months pre-implementation)
B: Recurrent, symptomatic venous thromboembolism (deep vein thrombosis or pulmonary embolism) (within 3 months of randomization)
C: -Thromboembolic recurrences; -Bleeding Complications; -Deaths
D: Mortality rate due to pulmonary embolism or its treatment during a period of ten days in the outpatient group

Answer: B
Please select the outcome measures that correspond to the clinical trial below.
Title: A Randomised Controlled Trial of Face Masks and Hand Hygiene in Reducing Influenza Transmission in Households
Brief Summary: This study will test the effectiveness of face masks and hand cleaning in preventing the spread of influenza within households


Options:
A: Absenteeism rate due to gastrointestinal or respiratory illness during the study period. (8 weeks)
B: The number of individuals with self-reported URTI in each of the intervention and control groups (Over the course of 8 weeks spanning September and October)
C: To compare the overall survival of patients at high risk for developing peritoneal carcinomatosis from colorectal cancer who undergo mandatory second look surgery + HIPEC and CRS (if applicable) vs. similar patients who receive standard of care. (Follow-up will occur every 3 months for two years, every six months for three ye)
D: secondary influenza infection (7 days)

Answer: D