TrialPanorama/Dataset huggingface dataset:
Please select the outcome measures that correspond to the clinical trial below.
Title: The Effect of a Nurse-driven ICT-supported Disease Management Program to Improve the Treatment of Patients With Atrial Fibrillation.
Brief Summary: * Randomized controlled trial comparing specialized AF Clinic with 'care as usual'
* Hypothesis: treatment of AF patients in the AF-Clinic by a nurse, specialised in AF, using guideline-based dedicated software, under supervision of a cardiologist, is efficient, safe and not inferior to care as usual by a cardiologists.


Options:
A: Compare Edoxaban to Warfarin for Composite of Stroke and Systemic Embolic Events (SEE). (on-treatment period 2.5 years of median study drug exposure and 2.8 year of median follow-up); Compare Edoxaban to Warfarin for Composite of Stroke and Systemic Embolic Events (SEE). (overall study period 2.5 years of median study drug exposure and 2.8 year of median follow-up); Compare Edoxaban to Warfarin for Composite of Stroke and Systemic Embolic Events (SEE). (on-treatment period 2.5 years of median study drug exposure and 2.8 year of median follow-up); Compare Edoxaban to Warfarin for Composite of Stroke and Systemic Embolic Events (SEE). (overall study period 2.5 years of median study drug exposure and 2.8 year of median follow-up); Compare Edoxaban to Warfarin for Superiority for Composite of Stroke and Systemic Embolic Events (SEE). (overall study period 2.5 years of median study drug exposure and 2.8 year of median follow-up)
B: Composite of heart failure, thromboembolic complications, bleeding, severe adverse effects of drugs and death from cardiovascular causes. (minimum of 1 year)
C: Self-Reported Medication Adherence (2 & 4 weeks post discharge)
D: Anticoagulation-related quality of life (Four months)

Answer: B
Please select the outcome measures that correspond to the clinical trial below.
Title: Observer-blind Superior Efficacy Trial With GlaxoSmithKline Biologicals' Influenza Vaccine GSK2186877A in Elderly Subjects
Brief Summary: The purpose of this study is to evaluate the efficacy of GlaxoSmithKline Biologicals' influenza vaccine GSK2186877A in adults 65 year of age and older. The study design is divided in two surveillance phases: one passive phase along the study during the influenza season and one active surveillance phase during the influenza peak season.


Options:
A: The appearance among patients of symptomatic laboratory-confirmed influenza. (Influenza season Nov-Apr. Within 72 hours of illness onset throat swab specimens will be obtained from participants with influenza like illness (ILI).)
B: Number of Seroconverted Subjects Against A/Indonesia/5/2005 (H5N1) (At Day 42 post Dose 1 (Day 42 post Dose 1 = Day 21 post Dose 2)); Number of Seroprotected Subjects Against A/Indonesia/5/2005 (H5N1) (At Day 0 and Day 42 post Dose 1 (Day 42 post Dose 1 = Day 21 post Dose 2)); Number of Subjects With Any Solicited Local Symptoms. (During a 7-day follow-up period (i.e., day of vaccination and 6 subsequent days) after each vaccine administration); Number of Subjects With Any Solicited General Symptoms. (During a 7-day follow-up period (i.e., day of vaccination and 6 subsequent days) after each vaccine administration); Number of Subjects With Any Unsolicited Adverse Events (AEs). (During a 21-day follow-up period for each vaccine administration, as well as overall (Day 0 through Day 84)); Number of Subjects With Serious Adverse Events (SAEs) (From Day 0 through Day 182 and through Day 379.); Number of Subjects With Medically Attended Events (MAEs) (From Day 0 through Day 182 and through Day 364.)
C: Number of Subjects Reporting Polymerase Chain Reaction (PCR)-Confirmed Influenza A and/or B Infection. (After the first dose during the corresponding surveillance period (from mid November 2008 to the end of April 2009 (end of influenza season))); Serum Hemagglutination-inhibition (HI) Antibody Titers, Against Each of the 3 Vaccine Influenza Strains, in the FluNG Groups. (At Days 0 (pre-vaccination Dose 1) and 21 (post-vaccination Dose 1) of the first year (2008/2009) of the study)
D: Incidence ratio for acute MI (28 days)

Answer: C
Please select the outcome measures that correspond to the clinical trial below.
Title: Renal Denervation in Patients With Refractory Hypertension
Brief Summary: The purpose of this study is to investigate the clinical utility of renal denervation for the treatment of refractory hypertension.


Options:
A: Change in BP (measured by ABPM) (6 months)
B: Change in Office Systolic Blood Pressure (Baseline to 6 months post-randomization)
C: Acute and Chronic Safety by Evaluating Incidence of Major Adverse Events (From baseline to 1 month post-procedure (6 months for new renal artery stenosis)); Change in Systolic Blood Pressure as Measured by 24-hour Ambulatory Blood Pressure Monitoring (ABPM) (From baseline to 6 months post-procedure)
D: Safety - complications associated with delivery and/or use of the Ardian Catheter, adverse renal events, electrolyte disturbances, hemodynamic events. (Through 3 years)

Answer: D
Please select the outcome measures that correspond to the clinical trial below.
Title: Renal Denervation in Patients With Refractory Hypertension
Brief Summary: The purpose of this study is to investigate the clinical utility of renal denervation for the treatment of refractory hypertension.


Options:
A: BP Measurements (6 months)
B: Safety - complications associated with delivery and/or use of the Ardian Catheter, adverse renal events, electrolyte disturbances, hemodynamic events. (Through 3 years)
C: Change in systolic blood pressure (ABPM mean value) (6 months)
D: Freedom of AF or other atrial arrhythmias (1 year)

Answer: B
Please select the outcome measures that correspond to the clinical trial below.
Title: A Double Blind Placebo Controlled Study On The Neuroprotective And Anti-Atherogenic Effects Of Palm TocotrienolRich Fraction(Palm Vitamin E)
Brief Summary: The purpose of the study is to assess the neuroprotective, anti atherogenic and hepatoprotective properties of tocotrienols (palm vitamin E) supplementation as determined by white matter lesion load on serial magnetic resonance imaging (MRI), carotid artery magnetic resonance angiography (MRA) and liver ultrasound (US) as well as lipid profile analysis.


Options:
A: effect on cerebrospinal fluid (CSF) biomarkers related to oxidative damage (baseline and 4 months)
B: Prostate cancer (Ongoing); Total cancer (Ongoing); Major cardiovascular events (Ongoing)
C: Regression of white matter lesion load in terms of numbers and size in the brain (1 to 2 years)
D: Number of Participants With Prostate Cancer (Every six months for 7 to 12 years depending on when the participant was randomized.)

Answer: C
Please select the outcome measures that correspond to the clinical trial below.
Title: A Double Blind Placebo Controlled Study On The Neuroprotective And Anti-Atherogenic Effects Of Palm TocotrienolRich Fraction(Palm Vitamin E)
Brief Summary: The purpose of the study is to assess the neuroprotective, anti atherogenic and hepatoprotective properties of tocotrienols (palm vitamin E) supplementation as determined by white matter lesion load on serial magnetic resonance imaging (MRI), carotid artery magnetic resonance angiography (MRA) and liver ultrasound (US) as well as lipid profile analysis.


Options:
A: The primary endpoint is the reduction in hepatic triglyceride content from baseline to week 24. (24 weeks)
B: Change in Liver Fat (24 weeks); Change in Liver Fibrosis (24 weeks); Change in Liver Injury (24 weeks)
C: Change From Baseline to Week 12 in % Liver Fat as Assessed by MRI (Comparison Versus Placebo) (12 weeks)
D: Regression of white matter lesion load in terms of numbers and size in the brain (1 to 2 years)

Answer: D
Please select the outcome measures that correspond to the clinical trial below.
Title: A Double Blind Placebo Controlled Study On The Neuroprotective And Anti-Atherogenic Effects Of Palm TocotrienolRich Fraction(Palm Vitamin E)
Brief Summary: The purpose of the study is to assess the neuroprotective, anti atherogenic and hepatoprotective properties of tocotrienols (palm vitamin E) supplementation as determined by white matter lesion load on serial magnetic resonance imaging (MRI), carotid artery magnetic resonance angiography (MRA) and liver ultrasound (US) as well as lipid profile analysis.


Options:
A: Insulin Resistance and Glucose Homeostasis (baseline and 6 weeks)
B: Grade of steatosis as judged by repeat biopsy (6 mo)
C: N/A
D: Regression of white matter lesion load in terms of numbers and size in the brain (1 to 2 years)

Answer: D
Please select the outcome measures that correspond to the clinical trial below.
Title: A Double Blind Placebo Controlled Study On The Neuroprotective And Anti-Atherogenic Effects Of Palm TocotrienolRich Fraction(Palm Vitamin E)
Brief Summary: The purpose of the study is to assess the neuroprotective, anti atherogenic and hepatoprotective properties of tocotrienols (palm vitamin E) supplementation as determined by white matter lesion load on serial magnetic resonance imaging (MRI), carotid artery magnetic resonance angiography (MRA) and liver ultrasound (US) as well as lipid profile analysis.


Options:
A: The goal is to determine the effects of the vitamin C and vitamin E on surrogate markers of atherosclerosis following an atherogenic meal in type 2 diabetes (2 months)
B: Frequency of adverse events (baseline, monthly for 1 year, then 15 and 18 months)
C: Regression of white matter lesion load in terms of numbers and size in the brain (1 to 2 years)
D: effect on cerebrospinal fluid (CSF) biomarkers related to oxidative damage (baseline and 4 months)

Answer: C
Please select the outcome measures that correspond to the clinical trial below.
Title: Phase II Randomised, Double Blind, Multicentre Study to Assess the Efficacy of AZD2281 in the Treatment of Patients With Platinum Sensitive Relapsed Serous Ovarian Cancer Following Treatment With Two or More Platinum Containing Regimens
Brief Summary: The primary purpose of this study to determine if AZD2281 is effective and well tolerated in maintaining the improvement in your cancer after previous platinum-based chemotherapy


Options:
A: Objective Response Rate as Evaluated by Response Evaluation Criteria In Solid Tumors ( RECIST) (Response is evaluated from randomization to objective disease progression per RECIST criteria or death due to any cause in the absence of progression (conducted when a minimum of 78 progression free survival events had occurred))
B: Progression Free Survival (PFS) (Tumour assessment was to be assessed at screening, every 8 weeks during the study and at the withdrawal visit, up to 56 weeks. (Data cut-off for primary analysis of PFS: 15 September 2009))
C: 6 Month Progression-free Survival (PFS) (6 months); Objective Tumor Response Based on the Gynecologic Oncology Group (GOG) Response Evaluation Criteria in Solid Tumors (RECIST) Criteria (Up to 5 years); Frequency and Severity of Adverse Events as Assessed by the Common Terminology Criteria for Adverse Events Version 3.0 (CTCAE v3.0) (Up to 5 years)
D: Progression Free Survival (PFS) (According to Response Evaluation Criteria in Solid Tumours [RECIST]) (Radiologic scans performed at baseline then every 12 weeks (+/- 1 week) for the first 60 weeks, then every 24 weeks (+/-1 week) thereafter, assessed maximum up to 14 months.)

Answer: D
Please select the outcome measures that correspond to the clinical trial below.
Title: Phase II Randomised, Double Blind, Multicentre Study to Assess the Efficacy of AZD2281 in the Treatment of Patients With Platinum Sensitive Relapsed Serous Ovarian Cancer Following Treatment With Two or More Platinum Containing Regimens
Brief Summary: The primary purpose of this study to determine if AZD2281 is effective and well tolerated in maintaining the improvement in your cancer after previous platinum-based chemotherapy


Options:
A: Progression Free Survival (PFS) (Radiologic scans performed at weeks 9 and 18 (+/-1 week) and every 12 weeks thereafter relative to the date of randomisation until the primary analysis (approximately 20 months))
B: Overall Objective Response (1 year after end inclusion)
C: Progression Free Survival (PFS) Using Investigator Assessment According to Modified Response Evaluation Criteria in Solid Tumours (RECIST 1.1) (Radiologic scans performed at baseline then every 12 weeks up to 156 weeks, then every 24 weeks thereafter until objective radiological disease progression. DCO: 17 May 2018)
D: Progression Free Survival (PFS) (According to Response Evaluation Criteria in Solid Tumours [RECIST]) (Radiologic scans performed at baseline then every 12 weeks (+/- 1 week) for the first 60 weeks, then every 24 weeks (+/-1 week) thereafter, assessed maximum up to 14 months.)

Answer: D
Please select the outcome measures that correspond to the clinical trial below.
Title: Phase II Randomised, Double Blind, Multicentre Study to Assess the Efficacy of AZD2281 in the Treatment of Patients With Platinum Sensitive Relapsed Serous Ovarian Cancer Following Treatment With Two or More Platinum Containing Regimens
Brief Summary: The primary purpose of this study to determine if AZD2281 is effective and well tolerated in maintaining the improvement in your cancer after previous platinum-based chemotherapy


Options:
A: Overall Survival (OS) (From date of randomizationrandomization to date of death from any cause assessed up to 40 months); Progression-free survival (From date of randomization until the date of first documented progression or date of death from any cause, whichever occurs earlier, assessed up to 40 months)
B: Progression Free Survival (PFS) (According to Response Evaluation Criteria in Solid Tumours [RECIST]) (Radiologic scans performed at baseline then every 12 weeks (+/- 1 week) for the first 60 weeks, then every 24 weeks (+/-1 week) thereafter, assessed maximum up to 14 months.)
C: Progression-Free Survival (PFS) (Randomization up to disease progression or death from any cause, whichever occurs first (up to approximately 24 months))
D: Percentage of Participants With Disease Progression or Death (Data Cutoff 14 November 2011) (Screening Visit, Every 8 weeks (or 9 weeks if receiving topotecan) until progression reported between day of first participant randomized (29 October 2009) until cutoff date of 14 November 2011); Progression Free Survival (PFS; Data Cutoff 14 November 2011) (Screening Visit, Every 8 weeks (or 9 weeks if receiving topotecan) until progression reported between day of first participant randomized (29 October 2009) until cutoff date of 14 November 2011)

Answer: B
Please select the outcome measures that correspond to the clinical trial below.
Title: Phase II Randomised, Double Blind, Multicentre Study to Assess the Efficacy of AZD2281 in the Treatment of Patients With Platinum Sensitive Relapsed Serous Ovarian Cancer Following Treatment With Two or More Platinum Containing Regimens
Brief Summary: The primary purpose of this study to determine if AZD2281 is effective and well tolerated in maintaining the improvement in your cancer after previous platinum-based chemotherapy


Options:
A: Overall survival (After follow-up is complete (year 3-4 of the trial))
B: Progression Free Survival (2 years)
C: Progression free survival (3 years)
D: Progression Free Survival (PFS) (According to Response Evaluation Criteria in Solid Tumours [RECIST]) (Radiologic scans performed at baseline then every 12 weeks (+/- 1 week) for the first 60 weeks, then every 24 weeks (+/-1 week) thereafter, assessed maximum up to 14 months.)

Answer: D
Please select the outcome measures that correspond to the clinical trial below.
Title: Phase II Randomised, Double Blind, Multicentre Study to Assess the Efficacy of AZD2281 in the Treatment of Patients With Platinum Sensitive Relapsed Serous Ovarian Cancer Following Treatment With Two or More Platinum Containing Regimens
Brief Summary: The primary purpose of this study to determine if AZD2281 is effective and well tolerated in maintaining the improvement in your cancer after previous platinum-based chemotherapy


Options:
A: Objective Response Rate as Evaluated by Response Evaluation Criteria In Solid Tumors ( RECIST) (Response is evaluated from randomization to objective disease progression per RECIST criteria or death due to any cause in the absence of progression (conducted when a minimum of 78 progression free survival events had occurred))
B: To determine the safety, tolerability, dose-limiting toxicity (DLT), and (MTD) of KU-0059436 (assessed at each visit)
C: Progression Free Survival (PFS) (According to Response Evaluation Criteria in Solid Tumours [RECIST]) (Radiologic scans performed at baseline then every 12 weeks (+/- 1 week) for the first 60 weeks, then every 24 weeks (+/-1 week) thereafter, assessed maximum up to 14 months.)
D: Tolerability of regimen (4 weeks)

Answer: C
Please select the outcome measures that correspond to the clinical trial below.
Title: Phase II Randomised, Double Blind, Multicentre Study to Assess the Efficacy of AZD2281 in the Treatment of Patients With Platinum Sensitive Relapsed Serous Ovarian Cancer Following Treatment With Two or More Platinum Containing Regimens
Brief Summary: The primary purpose of this study to determine if AZD2281 is effective and well tolerated in maintaining the improvement in your cancer after previous platinum-based chemotherapy


Options:
A: Progression Free Survival (PFS) Using Investigator Assessment According to Modified Response Evaluation Criteria in Solid Tumours (RECIST 1.1) (Radiologic scans performed at baseline then every 12 weeks up to 156 weeks, then every 24 weeks thereafter until objective radiological disease progression. DCO: 17 May 2018)
B: Progression Free Survival (PFS) (According to Response Evaluation Criteria in Solid Tumours [RECIST]) (Radiologic scans performed at baseline then every 12 weeks (+/- 1 week) for the first 60 weeks, then every 24 weeks (+/-1 week) thereafter, assessed maximum up to 14 months.)
C: Peritoneal adhesion ORR (pORR) (3weeks after the last treatment)
D: Investigator-assessed Progression-free Survival (PFS) (From the date of randomization until the date of progression or death due to any cause (median time of follow-up was 17.9 months for pazopanib and 12.3 months for placebo))

Answer: B
Please select the outcome measures that correspond to the clinical trial below.
Title: Phase II Randomised, Double Blind, Multicentre Study to Assess the Efficacy of AZD2281 in the Treatment of Patients With Platinum Sensitive Relapsed Serous Ovarian Cancer Following Treatment With Two or More Platinum Containing Regimens
Brief Summary: The primary purpose of this study to determine if AZD2281 is effective and well tolerated in maintaining the improvement in your cancer after previous platinum-based chemotherapy


Options:
A: Progression free survival (up to 18 months)
B: PK Phase Primary Outcome: To determine the comparative bioavailability of a new tablet formulation of AZD2281 compared to the existing capsule formulation (Blood samples (12) will be taken at pre-defined intervals following dosing of a single capsule and a single tablet dose); Continued Supply Phase: To enable patients to continue to receive treatment with AZD2281. Safety and tolerability data will be collected to further determine the safety and tolerability of the capsule formulation of AZD2281 in these patients (every 28 days); Continued Supply Expansion Phase: To compare the safety and tolerability of the tablet and capsule formulation of AZD2281 in all patients: Safety, AEs, Physical Exam, vital signs (at every visit); Dose Escalation Phase of continued supply expansion: To determine safety & tolerability of higher than 200mg bid (to 400mg) of tablet & compare safety & tolerability profile of tablet with 400mg capsule (at every visit); Randomised tablet formulation continued supply expansion phase (Group 8): To determine the safety and tolerability profile of selected tablet dose schedules of the melt-extrusion (tablet) formulation. (at every visit)
C: Progression Free Survival (PFS) (According to Response Evaluation Criteria in Solid Tumours [RECIST]) (Radiologic scans performed at baseline then every 12 weeks (+/- 1 week) for the first 60 weeks, then every 24 weeks (+/-1 week) thereafter, assessed maximum up to 14 months.)
D: Overall Response Rate Per RECIST Version 1.1 (Part 2) (Time from first dose to date of progression, up to approximately 8 months); Number of Participants With a Dose Limiting Toxicity (DLT) (Cycle 1 Day 1 to Cycle 1 Day 21); PK Profile of Rucaparib - Cmax (Part 1) (Cycle 1 Day 1 to Cycle 1 Day 15, or approximately 15 days); PK Profile of Rucaparib - Tmax (Part 1) (Cycle 1 Day 1 to Cycle 1 Day 15, or approximately 15 days); PK Profile of Rucaparib - AUC Last (Part 1) (Cycle 1 Day 1 to Cycle 1 Day 15, or approximately 15 days)

Answer: C
Please select the outcome measures that correspond to the clinical trial below.
Title: A Randomized, Multicentre, Phase II, Parallel-Group Trial of Vandetanib Monotherapy or Vandetanib in Combination With Gemcitabine Versus Gemcitabine Plus Vandetanib Matching Placebo in Subjects With Advanced Biliary Tract Cancer (Gallbladder Cancer, Cancer of the Extrahepatic Bile Duct, Intrahepatic Cholangiocarcinoma and Ampullary Carcinoma)
Brief Summary: The primary objective of the trial is to determine the efficacy of VANDETANIB monotherapy or VANDETANIB plus GEMCITABINE or PLACEBO plus GEMCITABINE in prolonging the progression-free survival (PFS) at the trial closure in patients with advanced (unresectable or metastatic) biliary tract cancer.


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

Answer: A
Please select the outcome measures that correspond to the clinical trial below.
Title: Multicenter, Randomized, Double Blind, Clinical Trial to Compare the Clinical and Radiological Efficacy of Equivalent Doses of Methylprednisolone Administered Orally or Intravenously in Patients With Multiple Sclerosis During Relapse
Brief Summary: This is a phase IV, multicenter, randomized, double blind clinical trial. The investigators will study 48 patients with remitting relapsing multiple sclerosis (MS) experiencing moderate or severe attack receiving immunomodulatory therapy or not. Patients will be randomly assigned to one of the two groups.


Options:
A: Cumulative area under the concentration-time curve (AUC), as measured by area under the concentration-time curve from time zero to 336 hours post dose (AUC0-336h) (2 weeks)
B: Annualized Relapse Rate (ARR) in Participants With Relapsing Multiple Sclerosis (MS) at 96 Weeks In Double Blind Period (Week 96)
C: Time to Clinically Definite Multiple Sclerosis (CDMS) Conversion (up to 3 years); Twenty-fifth Percentile (25%) Kaplan-Meier Estimates for Time From Randomization to Conversion to Clinically Definite Multiple Sclerosis (CDMS) During the Double-blind Period (up to 3 years)
D: Change in the punctuation of diana functional system score corresponding to in relapse of optic neuritis, trunk's syndrome and myelitis (day 28); Change in EDSS in patients who present a relapse from different type or unknown topography (day 28)

Answer: D
Please select the outcome measures that correspond to the clinical trial below.
Title: N/A
Brief Summary: The purpose of this study is to compare the effects on visual development, growth, cognitive development, tolerance, and blood chemistry parameters in term infants fed one of four study formulas containing various levels of DHA and ARA.


Options:
A: Calcium absorption (18 days)
B: visual development
C: Cognitive development
D: Growth; Body composition; Intestinal microbiota; Blood pressure; Plasma lipid profile; Insulin - glucose; Erythrocyte fatty acid composition; Ex vivo cytokine production; IGF-1 and IGFBP-3; Adipokines; Plasma CRP; Plasma IgE

Answer: B