TrialPanorama/Dataset huggingface dataset:
Please select the outcome measures that correspond to the clinical trial below.
Title: A Study to Evaluate Efficacy and Safety of Pazopanib Versus Sunitinib for the Treatment of Asian Subjects With Locally Advanced and/or Metastatic Renal Cell Carcinoma - A Substudy to VEG108844
Brief Summary: This was a randomized, open label, parallel group, Phase II study to evaluate the efficacy and safety of pazopanib compared to sunitinib in Asian subjects with advanced renal cell carcinoma (RCC) who have not received prior systemic therapy for advanced or metastatic RCC.


Options:
A: Overall progression-free survival
B: Progression-free Survival (PFS) (From randomization until the earliest date of disease progression or date of death from any cause, assessed up to approximately 24 months (Primary analysis cut-off date = 21-May-2012) at the same time as the main study VEG108844 (NCT00720941).)
C: Progression-free Survival (PFS) (Assessed every 2 cycles for the first 12 cycles, then every 3 cycles until treatment discontinuation, then every 8 weeks until disease progression or up to 5 years)
D: Progression-free Survival (PFS) of Subjects With Advanced Renal Cell Cancer (RCC) Randomized to Treatment With Tivozanib or Sorafenib (From date of randomization until the date of first documented progression or date of death from any cause, whichever came first. Disease progression was assessed every 8 weeks.)

Answer: B
Please select the outcome measures that correspond to the clinical trial below.
Title: A Randomised, Double-blind, Double-dummy, Parallel-group Multicentre Study to Assess Efficacy and Safety of Fluticasone Furoate/GW642444 Inhalation Powder and Fluticasone Propionate/Salmeterol Inhalation Powder in the Treatment of Persistent Asthma in Adults and Adolescents
Brief Summary: The purpose of the study is to compare the efficacy and safety of fluticasone furoate/vilanterol (GW642444) inhalation powder administered once daily with fluticasone propionate/salmeterol administered twice daily in adolescent and adult subjects 12 years of age and older with persistent bronchial asthma over a 24-week period.


Options:
A: Change From Baseline in Clinic Visit Trough (Pre-bronchodilator and Pre-dose) Forced Expiratory Volume in One Second (FEV1) at the End of the 24-week Treatment Period (Baseline and Week 24); Change From Baseline in Weighted Mean Serial FEV1 Over 0-24 Hours Post-dose at Week 24 (Baseline and Week 24)
B: Change From Baseline in Weighted-mean 24 Hour Serial FEV1 on Day 168/Week 24 (Baseline and Day 168/Week 24)
C: Mean Change From Baseline in Trough (Evening Pre-dose and Pre- Rescue Bronchodilator) FEV1 at Week 8 (Baseline and Week 8)
D: Mean Change From Baseline (BL) in Daily Evening (PM) Peak Expiratory Flow (PEF) Averaged Over the 12-week Treatment Period (Baseline and Weeks 1-12 (up to Day 84))

Answer: B
Please select the outcome measures that correspond to the clinical trial below.
Title: A Randomised, Double-blind, Double-dummy, Parallel-group Multicentre Study to Assess Efficacy and Safety of Fluticasone Furoate/GW642444 Inhalation Powder and Fluticasone Propionate/Salmeterol Inhalation Powder in the Treatment of Persistent Asthma in Adults and Adolescents
Brief Summary: The purpose of the study is to compare the efficacy and safety of fluticasone furoate/vilanterol (GW642444) inhalation powder administered once daily with fluticasone propionate/salmeterol administered twice daily in adolescent and adult subjects 12 years of age and older with persistent bronchial asthma over a 24-week period.


Options:
A: 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)
B: Change From Baseline in Weighted-mean 24 Hour Serial FEV1 on Day 168/Week 24 (Baseline and Day 168/Week 24)
C: Peak FEV1 Within 3 Hours Post-dose Response (24 weeks); Trough FEV1 Response (24 weeks); The Responder Rate as Assessed by the ACQ From the Two Twin Trials 205.418 (NCT01172808) and the Present 205.419 (NCT01172821) (24 weeks)
D: 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) for MF/F Versus MF (Baseline to Endpoint (12 weeks)); Time-to-first Asthma Exacerbation Over the 26-week Treatment Period for the Comparison of MF/F Versus F (26-week Treatment Period)

Answer: B
Please select the outcome measures that correspond to the clinical trial below.
Title: A Randomised, Double-blind, Double-dummy, Parallel-group Multicentre Study to Assess Efficacy and Safety of Fluticasone Furoate/GW642444 Inhalation Powder and Fluticasone Propionate/Salmeterol Inhalation Powder in the Treatment of Persistent Asthma in Adults and Adolescents
Brief Summary: The purpose of the study is to compare the efficacy and safety of fluticasone furoate/vilanterol (GW642444) inhalation powder administered once daily with fluticasone propionate/salmeterol administered twice daily in adolescent and adult subjects 12 years of age and older with persistent bronchial asthma over a 24-week period.


Options:
A: Asthma exacerbations, ECG and Holter monitors, lung function, adverse events, requirement of other asthma therapies and other routine safety assessments. (7 assessments within 12 month treatment period)
B: FEV1 peak0-3 Change From Baseline (Baseline and 12 weeks)
C: Change From Baseline in Weighted-mean 24 Hour Serial FEV1 on Day 168/Week 24 (Baseline and Day 168/Week 24)
D: Peak Forced Expiratory Volume in 1 Second (FEV1) Response Within 3 Hours Post Dosing (0-3h) After a Treatment Period of 24 Weeks. (Baseline and 24 weeks); Trough FEV1 Response Determined After a Treatment Period of 24 Weeks. (Baseline and 24 weeks); Time to First Severe Asthma Exacerbation During the 48-week Treatment of the Pooled Data From the Two Twin Trials 205.416 (NCT00772538) and the Present 205.417 (NCT00776984). (48 weeks)

Answer: C
Please select the outcome measures that correspond to the clinical trial below.
Title: Prevalence of Psoriatic Arthritis in Adults With Psoriasis: An Estimate From Dermatology Practice
Brief Summary: This is a phase 4, multicenter, randomized, non-therapeutic interventional trial in subjects with psoriasis looking for the prevalence of psoriatic arthritis. Subjects will be seen and evaluated by a dermatologist at visit 1 and by a rheumatologist at visit 2. A subset of subjects will then go on to visit 3 for imaging procedures (x-ray, MRI, and ultrasound).


Options:
A: Number of Participants Achieving American College of Rheumatology 20 (ACR20) Response Criteria (Week 24)
B: Proportion of patients achieving an ACR20 response. (48 weeks)
C: Percentage of Participants With Psoriatic Arthritis (PsA) Based on Physical Examination, Medical History and Laboratory Results (Week 0 through Week 8)
D: Number of Subjects Achieving ACR20 (at Least 20% Improvement in American College of Rheumatology Criteria From Baseline) at Week 16 (between baseline and week 16)

Answer: C
Please select the outcome measures that correspond to the clinical trial below.
Title: A Randomised Trial of the Effect of Exercise on Peripheral Blood Gene Expression in Patients With Stable Angina
Brief Summary: Regular exercise is known to produce significant health benefits and to reduce the risk of heart diseases, although how this benefit occurs is not well understood. White blood cells are known to be involved in triggering heart attacks, and which genes are switched on or off in white blood cells determines whether they have beneficial or harmful effects. Previous studies, and studies ongoing in our group, have demonstrated measurement of peripheral blood gene expression (which reflects white blood cell gene expression) is able to distinguish between patients with and without coronary artery disease, or patients who are able to develop good compared with poor coronary collateral arteries. Therefore, the gene expression signature in peripheral blood may provide novel diagnostic or prognostic information, and insight into the pathogenesis of heart disease.

We therefore hypothesise that exercise alters peripheral blood gene expression in patients with coronary artery disease and angina. This will identify possible ways that exercise improves angina and reduces the risk of heart disease.


Options:
A: coronary collateral blod flow (4 weeks)
B: Peripheral blood gene expression (baseline); Peripheral blood gene expression (6wks after starting 12week exercise training (or conventional care)); peripheral blood gene expression (12 weeks after exercise training (or conventional care)); Peripheral blood gene expression (24 weeks after starting 12 weeks exercise training programme)
C: exercise tolerance (1 year); exercise tolerance (12 weeks)
D: Autonomic Function (Change from Baseline in Autonomic Function at 8 weeks of Cardiac Rehabilitation Program)

Answer: B
Please select the outcome measures that correspond to the clinical trial below.
Title: A Randomised Trial of the Effect of Exercise on Peripheral Blood Gene Expression in Patients With Stable Angina
Brief Summary: Regular exercise is known to produce significant health benefits and to reduce the risk of heart diseases, although how this benefit occurs is not well understood. White blood cells are known to be involved in triggering heart attacks, and which genes are switched on or off in white blood cells determines whether they have beneficial or harmful effects. Previous studies, and studies ongoing in our group, have demonstrated measurement of peripheral blood gene expression (which reflects white blood cell gene expression) is able to distinguish between patients with and without coronary artery disease, or patients who are able to develop good compared with poor coronary collateral arteries. Therefore, the gene expression signature in peripheral blood may provide novel diagnostic or prognostic information, and insight into the pathogenesis of heart disease.

We therefore hypothesise that exercise alters peripheral blood gene expression in patients with coronary artery disease and angina. This will identify possible ways that exercise improves angina and reduces the risk of heart disease.


Options:
A: flow mediated dilation, serum concentrations of biomarkers, restenosis-rate/ late luminal loss, heart rate variability in SDNN (6 months)
B: Peripheral blood gene expression (baseline); Peripheral blood gene expression (6wks after starting 12week exercise training (or conventional care)); peripheral blood gene expression (12 weeks after exercise training (or conventional care)); Peripheral blood gene expression (24 weeks after starting 12 weeks exercise training programme)
C: Proportion of Patients With Hospital Length of Stay Greater Than 7 Days. (Post-surgery (approximately 9 weeks after baseline))
D: Maximal oxygen consumption (At baseline and after 6 months)

Answer: B
Please select the outcome measures that correspond to the clinical trial below.
Title: The Patient as a Driver of Change: an Intervention Study to Reduce the Use and Impact of Potentially Inappropriate Medications Among Older Adults
Brief Summary: An educational intervention targeting community-dwelling older adults will lead to a reduction in potentially inappropriate prescriptions (e.g. benzodiazepines, oxybutynin).

Cessation of potentially inappropriate medications (e.g. benzodiazepines, oxybutynin)will lead to improved cognitive outcomes in older adults.


Options:
A: Complete discontinuation of the targeted potentially inappropriate medication (e.g. benzodiazepines, oxybutynin) (6 months post-intervention)
B: Systolic Blood Pressure (SBP) (one year)
C: Adherence of medical regimen/treatment to all of the Guideline Advantage criteria that apply. (12 months for each participant)
D: Knowledge of Asthma (6 months after the first evaluation)

Answer: A
Please select the outcome measures that correspond to the clinical trial below.
Title: The Patient as a Driver of Change: an Intervention Study to Reduce the Use and Impact of Potentially Inappropriate Medications Among Older Adults
Brief Summary: An educational intervention targeting community-dwelling older adults will lead to a reduction in potentially inappropriate prescriptions (e.g. benzodiazepines, oxybutynin).

Cessation of potentially inappropriate medications (e.g. benzodiazepines, oxybutynin)will lead to improved cognitive outcomes in older adults.


Options:
A: Emergency medical visits (12 months after hospital discharge)
B: The evolution of the level of functional autonomy of the patients assessed using the scale IADL of Lawton (At inclusion); The evolution of the level of functional autonomy of the patients assessed using the scale IADL of Lawton (At 1 month); The evolution of the level of functional autonomy of the patients assessed using the scale IADL of Lawton (At 6 months); The evolution of the level of functional autonomy of the patients assessed using the scale IADL of Lawton (At 18 months); The evolution of the level of functional autonomy of the patients assessed using the scale DAD-6. (At inclusion); The evolution of the level of functional autonomy of the patients assessed using the scale DAD-6. (At 1 month); The evolution of the level of functional autonomy of the patients assessed using the scale DAD-6. (At 6 months); The evolution of the level of functional autonomy of the patients assessed using the scale DAD-6. (At 18 months)
C: The primary outcome measure will be the "improvement" of prescribing for efficacious therapies in patients with a chronic cardiovascular disease within six months of the intervention.
D: Complete discontinuation of the targeted potentially inappropriate medication (e.g. benzodiazepines, oxybutynin) (6 months post-intervention)

Answer: D
Please select the outcome measures that correspond to the clinical trial below.
Title: Interaction of Orally Administered Lactobacillus Rhamnosus GG With Skin and Gut Microbiota and Humoral Immunity in Infants With Atopic Dermatitis
Brief Summary: Hypothesis: Probiotics have been used as novel adjunct therapeutic approach in atopic dermatitis. In addition to balancing the gut microecology and promoting host immune defences, specific probiotics might further aid in controlling the microbial colonization of the skin, thereby reducing proneness to secondary infections which typically cause sustained symptoms.

Thirty-nine infants with atopic dermatitis,randomized for a three-month-period in a double-blind design to receive extensively hydrolysed casein formula (NutramigenR, Mead-Johnson, USA) supplemented with (n=19) or without (n=20) Lactobacillus rhamnosus GG (ATCC 53103) 5.0 x 107 cfu/g to achieve a daily intake of 3.4 x 109 cfu.

Sampling (blood and faecal samples, cotton swab from the skin) and clinical examination of the infant, including SCORAD assessment to determine the severity of atopic dermatitis, at each study visit (at entry and one month and three months thereafter).


Options:
A: severity of atopic dermatitis (March 2007 - July 2008)
B: The Effects of probiotics in improving life quality and symptomatic severity (2 years)
C: Prevalence of atopic disease in infant (two years)
D: episodes of wheezing, drug use (inhalative steroids and betamimetics), hospital treatment (October 2002 - October 2004)

Answer: A
Please select the outcome measures that correspond to the clinical trial below.
Title: Randomized Controlled Trial Comparing the Metabolic Efficiency of Allogeneic Pancreatic Islet Transplantation to Intensive Insulin Therapy for the Treatment of Type 1 Diabetes
Brief Summary: Efficacy of pancreatic islet transplantation at 6 months compared to an intensive insulin therapy for 2 categories of patients: patients with unstable diabetes and patients who underwent kidney transplantation.


Options:
A: Time to the First Occurrence of Any of the Following Adjudicated Components of the Primary Composite Endpoint (3-point MACE): CV Death (Including Fatal Stroke and Fatal MI), Non-fatal MI (Excluding Silent MI), and Non-fatal Stroke. (From randomisation to individual end of observation, up to 4.6 years)
B: ß score evaluation 6 months after first infusion (group 1 'immediate registration on infusion waiting list') or 6 months after inclusion (group 2: 'delayed registration on infusion waiting list') (6 months after first infusion (group 1) or 6 months after inclusion (group 2))
C: First Occurrence of a Major Cardiovascular Event (MCE); Specifically Nonfatal Heart Attack, Nonfatal Stroke, or Cardiovascular Death (Measured Throughout the Study) in the Glycemia Trial. (4.9 years); First Occurrence of Major Cardiovascular Event (MCE) in the Blood Pressure Trial. (4.7 years); First Occurrence of Major Cardiovascular Event (MCE) in the Lipid Trial. (4.7 years)
D: Time From Randomisation to First Occurrence of a MACE, Defined as Cardiovascular Death, Non-fatal Myocardial Infarction, or Non-fatal Stroke (Time from randomisation up to end of follow-up (scheduled at week 109))

Answer: B
Please select the outcome measures that correspond to the clinical trial below.
Title: Finding the M.I.N.C. for Mammography Maintenance
Brief Summary: RATIONALE: Mammography reminders may encourage women to undergo regular mammography screenings for breast cancer.

PURPOSE: This randomized clinical trial is studying three different mammography reminder interventions to compare how well they work in encouraging women to undergo regular mammography screenings for breast cancer.


Options:
A: Change in Numeric Rating Scale of Pain Intensity (post-treatment (12 weeks), 3 and 6 months post-baseline)
B: Tobacco Abstinence - 6 Month Follow-up (6 months)
C: colorectal cancer screening (one year)
D: Mammography Adherence (12 months)

Answer: D
Please select the outcome measures that correspond to the clinical trial below.
Title: Phase III Study of Gemcitabine/Oxaliplatin (GEMOX) With or Without Erlotinib in Unresectable, Metastatic Biliary Tract Carcinoma
Brief Summary: The purpose of this study is to determine whether Gemcitabine/Oxaliplatin (GEMOX) with or without Erlotinib (Tarceva) is effective in the treatment of unresectable, metastatic biliary tract carcinoma.


Options:
A: Evaluation of treatment efficacy by assessing the crude progression-free survival (PFS) rate at 4 months (4 months)
B: Progression Free Survival (up to 1032 days)
C: Progression Free Survival (every 6 weeks)
D: objective response rate (baseline and every 8 weeks)

Answer: C
Please select the outcome measures that correspond to the clinical trial below.
Title: N/A
Brief Summary: The ideal mean arterial pressure in patients with septic shock is unknown. The expert's recommandations have stated a target between 65 and 70 mm Hg. However the scientific basis are weak. Indead there are only few prospective studies which addressed this question without clear answer. Therefore we designed a RCT in order to assess the effect on mortality of two levels of mean arterial pressure in patients with septic shock.(800 patients, 30 centres)


Options:
A: Composite score of any one of the following: (1) all-cause mortality; (2) myocardial infarction; (3) new renal failure requiring dialysis; or (4) new focal neurological deficit (Up to hospital discharge or postoperative day 28 (whichever occurs first))
B: composite of post-operative all-cause mortality and major complications (participants will be followed for the duration of hospital stay after the index cardiac operation, an expected average of 2 weeks)
C: mortality (day 28)
D: Incidence of Delirium (Participants will be followed for the duration of the hospital stay, an average of 5 days)

Answer: C
Please select the outcome measures that correspond to the clinical trial below.
Title: N/A
Brief Summary: The ideal mean arterial pressure in patients with septic shock is unknown. The expert's recommandations have stated a target between 65 and 70 mm Hg. However the scientific basis are weak. Indead there are only few prospective studies which addressed this question without clear answer. Therefore we designed a RCT in order to assess the effect on mortality of two levels of mean arterial pressure in patients with septic shock.(800 patients, 30 centres)


Options:
A: Efficacy and Safety of Dopamine Versus Norepinephrine in Septic Shock (28 days)
B: Systemic hemodynamic and Microcirculatory flow index of small and medium vessels (MFI) (over a period of 6 hrs from the time of randomization); Oxygen transport variables (over a period of 6 from the time of randomization)
C: The primary outcome measure for the study is death from all causes (90 days)
D: mortality (day 28)

Answer: D
Please select the outcome measures that correspond to the clinical trial below.
Title: A Long-Term Multicenter, Randomized, Double-blind, Placebo-controlled Study to Evaluate the Efficacy, Safety, and Tolerability of Aripiprazole (OPC 14597) as Maintenance Treatment in Adolescent Patients With Schizophrenia
Brief Summary: This will be a randomized, double-blind, placebo-controlled study consisting of a screening period, a conversion phase (Phase 1), a stabilization phase (Phase 2), and a double-blind maintenance treatment phase (Phase 3), and a follow up period.

Subjects may be either outpatients or inpatients between screening and through the time they reach stabilization at the end of Phase 2; hospitalization is not a study requirement. However, eligible subjects must be outpatients at the beginning of Phase 3.

Subjects will be assessed weekly during Phase 1, weekly for the first 4 weeks of Phase 2 and 3, and biweekly for the remaining weeks during each of Phases 2 and 3. Subjects will be encouraged to call the investigators with any exacerbation of psychotic symptoms and/or any tolerability issues. The investigator will also have the option to phone the subjects and their guardian(s) at any time to ensure clinical stability.

A data monitoring committee (DMC) will provide oversight for safety monitoring and reviewing the interim analysis. One interim analysis is planned after 75% of the total expected number of impending relapse events (28 events) are achieved and will be conducted by an independent data analysis center. The DMC will make a recommendation about stopping or continuing the study based on safety and efficacy reviews. The results of the interim analysis and individual subject data will remain blinded to the sponsor during the course of the study until the DMC determines that the study will conclude based on the results of the interim analysis, or the study is completed after 37 endpoint events.


Options:
A: Overall Relapse Rate (in Percent) From Randomization to Exacerbation of Psychotic Symptoms/Impending Relapse. (Baseline to Week 52/End of Phase 3 visit.)
B: Change From Baseline to Week 6 in the PANSS Total Score (Baseline to Week 6)
C: Change in the PANSS Total Score From Baseline to the Last Postrandomization Assessment in the Double-blind Period of the Study. (6 weeks)
D: Poor clinical outcome (In one month previous to the final assessment)

Answer: A