TrialPanorama/Dataset huggingface dataset:
Please select the outcome measures that correspond to the clinical trial below.
Title: Early Administration of L-carnitine in Hemodialysis Patients: Double Blind Randomized Trial Versus Placebo
Brief Summary: Hemodialysis is a cause of carnitine deficiency. The deficiency of carnitine induces an anemia by an increase fragility of the red blood cells, a muscular fatigue and a cardiac dysfunction. We proposed to evaluate the benefit of an early administration of L-carnitine in hemodialysis patients. The patients should be included in the first month after the start of chronic hemodialysis, randomized to receive L-carnitine or placebo and should be followed-up during one year.


Options:
A: The primary outcome measure is the number of intradialytic complications in each of the three study groups, only during the first study phase. (4 weeks for one study phase)
B: Resistance index to erythropoietin (during de study); Haemoglobin level/weekly rHuerythropoietin dose in patients receiving l-carnitine versus those receiving the placebo. (during the study)
C: lipid profile (at sixteen weeks after admission)
D: To assess the efficacy of L-Carnitine containing PD solution on insulin sensitivity evaluated by euglycemic hyperinsulinemic clamp (time 0, 4 months)

Answer: B
Please select the outcome measures that correspond to the clinical trial below.
Title: Efficacy and Safety of Epoetin Omega in Patients Undergoing Regular Dialysis. Part II: Comparative Trial Versus Epoetin Alfa
Brief Summary: The two epoetins, Epoetin alfa, a well established drug to treat renal anemia and Epoetin Omega, that differs from Epoetin alfa in the sugar moiety of the molecule were compared in regard of efficacy and safety to treat end stage renal disease anemia. Study hypothesis was that Epoetin Omega is non-inferior to Epoetin alfa in correcting renal anemia in dialysis patients. A 12-weeks randomized comparative efficacy study was performed including 77 end stage renal disease patients (epoetin omega:n=39, epoetin alfa: n=38). In the intent-to-treat analysis, average weekly difference in hemoglobin versus baseline value was higher in omega-treated patients: 1.94+-0.81 vs. 1.23+-0.62 g/dl. The unadjusted and adjusted omega-alfa differences were 0.71 g/dl (95%CI 0.38 to 1.04; p\<0.001) and 0.78 g/dl (0.49 to 1.08;p\<0.001), respectively. Average weekly epoetin dose was lower in the omega group: 87+-25 vs. 108+-21 IU/kg. The unadjusted and adjusted omega-alfa differences were -21IU/kg (-32 to -11; p\<0.001) and -24IU/kg (-35 to -13; p\<0.001), respectively. Epoetins were comparably well tolerated. In dialysis patients, subcutaneous epoetin omega apparently provides a greater anti-anemic effect per administered dose (IU) than epoetin alfa.


Options:
A: Hemoglobin level
B: Median Time to First Cardiovascular Event (Up to 4 years)
C: The primary outcome will be a composite consisting of mortality (all cause), myocardial infarction, stroke, and CHF hospitalization (not including those hospitalizations during which RRT occurs)
D: To establish the therapeutic equivalence of GerEpo with the standard treatment Eprex® for a treatment period of 12 weeks in patients on Hemodialysis with respect to hemoglobin response.

Answer: A
Please select the outcome measures that correspond to the clinical trial below.
Title: Efficacy and Safety of Epoetin Omega in Patients Undergoing Regular Dialysis. Part II: Comparative Trial Versus Epoetin Alfa
Brief Summary: The two epoetins, Epoetin alfa, a well established drug to treat renal anemia and Epoetin Omega, that differs from Epoetin alfa in the sugar moiety of the molecule were compared in regard of efficacy and safety to treat end stage renal disease anemia. Study hypothesis was that Epoetin Omega is non-inferior to Epoetin alfa in correcting renal anemia in dialysis patients. A 12-weeks randomized comparative efficacy study was performed including 77 end stage renal disease patients (epoetin omega:n=39, epoetin alfa: n=38). In the intent-to-treat analysis, average weekly difference in hemoglobin versus baseline value was higher in omega-treated patients: 1.94+-0.81 vs. 1.23+-0.62 g/dl. The unadjusted and adjusted omega-alfa differences were 0.71 g/dl (95%CI 0.38 to 1.04; p\<0.001) and 0.78 g/dl (0.49 to 1.08;p\<0.001), respectively. Average weekly epoetin dose was lower in the omega group: 87+-25 vs. 108+-21 IU/kg. The unadjusted and adjusted omega-alfa differences were -21IU/kg (-32 to -11; p\<0.001) and -24IU/kg (-35 to -13; p\<0.001), respectively. Epoetins were comparably well tolerated. In dialysis patients, subcutaneous epoetin omega apparently provides a greater anti-anemic effect per administered dose (IU) than epoetin alfa.


Options:
A: Mean Change in Hemoglobin Concentration (g/dL) From Baseline to Evaluation Period (Baseline (Week -4 to Week -1) and Evaluation Period (Week 29 to Week 36))
B: Hemoglobin level
C: Hemoglobin Level in blood (Monthly assessment of the levels of hemoglobin in blood at baseline and monthly for six months)
D: Composite renal outcome of chronic dialysis, kidney transplantation, eGFR 6 mL/min/1.73m2 or less, or eGFR less than 50% of initial value. (96 weeks)

Answer: B
Please select the outcome measures that correspond to the clinical trial below.
Title: Open Label, Randomised, Parallel Group, Multicentre, Ph III Study To Assess Efficacy, Safety & Tolerability Of Gefitinib (IRESSA™) Versus Carboplatin/Paclitaxel DC As 1st-Line Treatment In Selected Patients With Stage IIIB / IV NSCLC In Asia
Brief Summary: The purpose of this study is to compare gefitinib with carboplatin / paclitaxel doublet chemotherapy given as first line treatment in terms of progression free survival in selected NSCLC patients with the objective of demonstrating non-inferiority.


Options:
A: Median Progression Free Survival (PFS) in Months (Tumour assessments as per RECIST were performed at baseline and then every 42 days ± 7 days from randomization until data cut off (14th April 2008).)
B: Progression Free Survival (PFS) (Randomization to Progressive Disease or Death Due to Any Cause (Up to 58.78 Months))
C: Progression free survival (PFS) (2 years)
D: Progression-Free Survival (PFS) (Baseline to first observation of disease progression or death, 12 weeks up to 31 months)

Answer: A
Please select the outcome measures that correspond to the clinical trial below.
Title: Open Label, Randomised, Parallel Group, Multicentre, Ph III Study To Assess Efficacy, Safety & Tolerability Of Gefitinib (IRESSA™) Versus Carboplatin/Paclitaxel DC As 1st-Line Treatment In Selected Patients With Stage IIIB / IV NSCLC In Asia
Brief Summary: The purpose of this study is to compare gefitinib with carboplatin / paclitaxel doublet chemotherapy given as first line treatment in terms of progression free survival in selected NSCLC patients with the objective of demonstrating non-inferiority.


Options:
A: Objective response rate (approximate 6 months after randomisation)
B: Progression-free Survival (PFS) Time - Independent Review Committee (IRC) Assessments (Time from randomisation to disease progression, death or last tumour assessment, reported between day of first patient randomised, 10 Aug 2004, until cut-off date, 27 July 2006); Progression-free Survival Time (Chinese V-Ki-ras2 Kirsten Rat Sarcoma Viral Oncogene Homolog (KRAS) Wild-Type Population) - Independent Review Committee (IRC) Assessments (Time from randomisation to disease progression, death or last tumour assessment, reported between day of first patient randomised, 10 Aug 2004, until cut-off date, 27 July 2006); Progression-free Survival Time (KRAS Mutant Population) - Independent Review Committee (IRC) Assessments (Time from randomisation to disease progression, death or last tumour assessment, reported between day of first patient randomised, 10 Aug 2004, until cut-off date, 27 July 2006)
C: Median Progression Free Survival (PFS) in Months (Tumour assessments as per RECIST were performed at baseline and then every 42 days ± 7 days from randomization until data cut off (14th April 2008).)
D: the rate of patients converted to resection for liver metastases (3 years)

Answer: C
Please select the outcome measures that correspond to the clinical trial below.
Title: Open Label, Randomised, Parallel Group, Multicentre, Ph III Study To Assess Efficacy, Safety & Tolerability Of Gefitinib (IRESSA™) Versus Carboplatin/Paclitaxel DC As 1st-Line Treatment In Selected Patients With Stage IIIB / IV NSCLC In Asia
Brief Summary: The purpose of this study is to compare gefitinib with carboplatin / paclitaxel doublet chemotherapy given as first line treatment in terms of progression free survival in selected NSCLC patients with the objective of demonstrating non-inferiority.


Options:
A: Progression Free-survival (From the date of randomization to the date of last follow up, assessed up to 24 months)
B: Progression free survival (12 months)
C: Progression Free Survival (12 months)
D: Median Progression Free Survival (PFS) in Months (Tumour assessments as per RECIST were performed at baseline and then every 42 days ± 7 days from randomization until data cut off (14th April 2008).)

Answer: D
Please select the outcome measures that correspond to the clinical trial below.
Title: Open Label, Randomised, Parallel Group, Multicentre, Ph III Study To Assess Efficacy, Safety & Tolerability Of Gefitinib (IRESSA™) Versus Carboplatin/Paclitaxel DC As 1st-Line Treatment In Selected Patients With Stage IIIB / IV NSCLC In Asia
Brief Summary: The purpose of this study is to compare gefitinib with carboplatin / paclitaxel doublet chemotherapy given as first line treatment in terms of progression free survival in selected NSCLC patients with the objective of demonstrating non-inferiority.


Options:
A: Median Progression Free Survival (PFS) in Months (Tumour assessments as per RECIST were performed at baseline and then every 42 days ± 7 days from randomization until data cut off (14th April 2008).)
B: Overall Survival (OS) (From randomization to date of death or last follow-up. Analysis occurs after all 390 deaths have been reported.); Progression-free Survival (PFS) (From randomization to date of progression, death, or last follow-up for progression-free survival. Analysis occurs after all 390 deaths have been reported.)
C: Progression-free Survival (PFS) as Assessed by the Investigator (Time interval between the date of randomization and the earlier of the date of disease progression or the date of death due to any cause (up to 9.9 months)); Progression-free Survival (PFS) as Assessed by an Independent Radiologist: Randomized Phase (Time interval between the date of randomization and the earlier of the date of disease progression or the date of death due to any cause (up to 9.9 months))
D: Progression Free Survival (PFS) time (5 years)

Answer: A
Please select the outcome measures that correspond to the clinical trial below.
Title: Comparison of Dialysis Strategies in Critically Ill Patients With Acute Renal Failure on the Intensive Care Unit
Brief Summary: The goal of the present study is the comparison of different dialysis strategies in critically ill patients with acute renal failure on the intensive care unit. Patients are treated with either continuous dialysis or hemofiltration. Outcome measures are death, restitution of renal function, days on ICU, hemodynamic stability, dialysis efficiency.


Options:
A: Death (90 days)
B: Middle molecular weight molecules clearances (18 months)
C: The filter survival time of AN69ST and AN69 membrane hemofilter in each CRRT process (6 months); The number of patients with early filter clotting in the scheduled CRRT using AN69ST and AN69 membrane hemofilter (6 months); The number of patients in AN69ST and AN69 hemofilter group according to the final filter clotting grading (6 months)
D: Survival at 2 weeks after RRT (2 weeks after RRT in follow-up)

Answer: A
Please select the outcome measures that correspond to the clinical trial below.
Title: Comparison of Dialysis Strategies in Critically Ill Patients With Acute Renal Failure on the Intensive Care Unit
Brief Summary: The goal of the present study is the comparison of different dialysis strategies in critically ill patients with acute renal failure on the intensive care unit. Patients are treated with either continuous dialysis or hemofiltration. Outcome measures are death, restitution of renal function, days on ICU, hemodynamic stability, dialysis efficiency.


Options:
A: number of RRT-free days (Day 28 after randomization)
B: Death (90 days)
C: Death from all causes at 90 days after randomisation. (Within 90 days after randomisation)
D: N/A

Answer: B
Please select the outcome measures that correspond to the clinical trial below.
Title: Comparison of Dialysis Strategies in Critically Ill Patients With Acute Renal Failure on the Intensive Care Unit
Brief Summary: The goal of the present study is the comparison of different dialysis strategies in critically ill patients with acute renal failure on the intensive care unit. Patients are treated with either continuous dialysis or hemofiltration. Outcome measures are death, restitution of renal function, days on ICU, hemodynamic stability, dialysis efficiency.


Options:
A: N/A
B: Death (90 days)
C: We will study the feasibility of recruiting ther target population, administering the study therapies according to pre-defined protocols and following patients for clinical endpoints. (60 days)
D: Death from all causes at 90 days after randomisation. (Within 90 days after randomisation)

Answer: B
Please select the outcome measures that correspond to the clinical trial below.
Title: Maintenance of Effect of Duloxetine 60 mg Once Daily in Patients With Diabetic Peripheral Neuropathic Pain
Brief Summary: To determine if duloxetine 60 mg once daily can work up to 6 months in treating pain from Diabetic Neuropathy.


Options:
A: Change From Baseline in the Brief Pain Inventory-Short Form (BPI-SF) Average Pain Score During the 8-Week Treatment Period (Day 1 through 8 weeks); Change From Baseline in the Montgomery-Asberg Depression Rating Scale (MADRS) Total Score at Week 8 (Baseline, 8 weeks)
B: Assess efficacy of duloxetine versus placebo on the treatment of pain in patients with fibromyalgia syndrome
C: Change From Baseline (Week 8) in Brief Pain Inventory (BPI) 24-hour Average Pain Item Score at Week 34 Endpoint (Baseline (Week 8), Week 34)
D: Change From Baseline to 12 Week Endpoint in Brief Pain Inventory 24-hour Average Pain Score (Baseline and 12 weeks)

Answer: C
Please select the outcome measures that correspond to the clinical trial below.
Title: Multicentre Randomised Trial of Intermittent Versus Continuous Renal Replacement Therapy for Acute Renal Failure
Brief Summary: This multicentre SHARF4 (Stuivenberg Hospital Acute Renal Failure) study aims to investigate outcome in patients with acute renal failure (ARF), stratified according to severity of disease (SHARF score) and randomised to different treatment options.

All adult patients with a serum creatinine \>2 mg/dl were included. Patients were stratified according to disease severity and those in need for RRT were randomised to intermittent (IRRT) or continuous renal replacement therapy (CRRT)


Options:
A: Death (90 days)
B: Accumulation of anti-Xa activity in plasma and removal of anti-Xa activity by filtration. (24 hours)
C: N/A
D: Progression free survival (90 days)

Answer: C
Please select the outcome measures that correspond to the clinical trial below.
Title: Multicentre Randomised Trial of Intermittent Versus Continuous Renal Replacement Therapy for Acute Renal Failure
Brief Summary: This multicentre SHARF4 (Stuivenberg Hospital Acute Renal Failure) study aims to investigate outcome in patients with acute renal failure (ARF), stratified according to severity of disease (SHARF score) and randomised to different treatment options.

All adult patients with a serum creatinine \>2 mg/dl were included. Patients were stratified according to disease severity and those in need for RRT were randomised to intermittent (IRRT) or continuous renal replacement therapy (CRRT)


Options:
A: N/A
B: Death from all causes at 30 days after randomisation (30 days)
C: Death from all causes at 90 days after randomisation. (Within 90 days after randomisation)
D: Accumulation of anti-Xa activity in plasma and removal of anti-Xa activity by filtration. (24 hours)

Answer: A
Please select the outcome measures that correspond to the clinical trial below.
Title: Eliminating Trachoma With Repeat Mass Drug Treatment
Brief Summary: The WHO has initiated a program to eliminate trachoma, blinding eye infection caused by Chlamydia trachomatis, in large part by mass distributions of oral azithromycin. The proposed study will determine the frequency and treatment target of community-wide mass antibiotic treatment. We will also study the impact of mass antibiotic distribution on antibiotic-resistance in pneumococcus.


Options:
A: The average prevalence of ocular chlamydia infection in communities in an arm as determined by pooled NAAT (Nucleic Acid Amplification Test)(at 42 months for Aim 1, at 12 months for Aim 2, post-treatment relative to pre-treatment for Aim 3) (42 months)
B: All-cause Mortality Rate in Children Aged 1-60 Months (24 Months); All-cause Mortality Rate in Children Aged 1-60 Months (36 months)
C: Community Prevalence of Trachoma and Ocular C. Trachomatis (CT) Infection at Baseline (At baseline); Community Prevalence of Trachoma and Ocular C. Trachomatis (CT) Infection at 36 Months (3 years)
D: The average prevalence of ocular chlamydia infection in communities in an arm as determined by pooled NAAT (Nucleic Acid Amplification Test)(at 36 months versus 0 months for Aim 1, at 36 months for Aim 2 and Aim 3) (36 months)

Answer: A
Please select the outcome measures that correspond to the clinical trial below.
Title: A Phase II Clinical Trial of Lenalidomide for T-cell Non-Hodgkin's Lymphoma
Brief Summary: T-cell Non-Hodgkin's lymphomas are a group of cancers that are usually treated with chemotherapy, radiation therapy, or occasionally surgery. T-cell lymphomas are relatively uncommon and therefore not well studied. Treatment approaches are patterned after the more common B-cell lymphomas. T-cell lymphomas are more likely to relapse following standard therapy than are B-cell lymphomas. New therapies are needed for T-cell lymphomas. In this study, we will administer the drug called lenalidomide as a pill to patients with T-cell lymphoma. The goals are to determine if the drug can induce regression of the cancer, and to determine if the treatment is well tolerated in this patient group. This study will take place at six cancer centres across Canada.


Options:
A: Progression Free Survival (From date of randomization at every visit until the date of first documented progression or date of death from any cause, whichever came first, assessed up to 36 months)
B: overall response rate (every 3 months)
C: Overall response rate (complete clinical response [CCR) and partial response [PR]) (35 months after first patient in)
D: Recurrence after complete remission within 12 months post therapy (12 months after end of therapy)

Answer: B
Please select the outcome measures that correspond to the clinical trial below.
Title: PILOT-EBM: Patient Focused Intervention to Improve Long-term Adherence to Evidence Based Medications
Brief Summary: The purpose of this study is to evaluate the effectiveness of a program to help patients with heart disease stay on their heart medications.


Options:
A: Patient-reported Adherence to Triple Therapy (Aspirin/Antiplatelet; Beta Blocker; and Statin) at 6 Months (6 months)
B: Hemoglobin A1c (Change in Baseline in HbA1c at 6 Months)
C: First occurrence of fatal or non-fatal acute MI, unstable angina, stroke, congestive heart failure, or revascularization (coronary bypass, stent insertion, or angioplasty) (2.5 years)
D: Change in Systolic Blood Pressure (6 months prior to 6 months after the intervention period)

Answer: A
Please select the outcome measures that correspond to the clinical trial below.
Title: PILOT-EBM: Patient Focused Intervention to Improve Long-term Adherence to Evidence Based Medications
Brief Summary: The purpose of this study is to evaluate the effectiveness of a program to help patients with heart disease stay on their heart medications.


Options:
A: Patient-reported Adherence to Triple Therapy (Aspirin/Antiplatelet; Beta Blocker; and Statin) at 6 Months (6 months)
B: Proportion of patients achieving hypertension control (6 months after enrollment); change in systolic and diastolic blood pressure (6 months after enrollment)
C: Patient Adherence to Inhaled Corticosteroids (ICS) (1 year)
D: Medication Possession Ratio at baseline, 1-6 months, 6-12 months, and 12-18 months. Aggregate adherence categories based on MPR, anti-psychotic blood levels (present/not present) and patient self-report at baseline, 6 months, and 12 months.

Answer: A
Please select the outcome measures that correspond to the clinical trial below.
Title: A Study of the Glaukos Trabecular Micro-Bypass Stent in Combination With Cataract Surgery in Open Angle Glaucoma Subjects.
Brief Summary: The purpose of this study is to evaluate the safety and efficacy of the iStent trabecular micro-bypass stent in reducing intraocular pressure (IOP) in subjects with open-angle glaucoma or ocular hypertension and co-existing cataract.


Options:
A: Primary outcomes included IOP and reduction in medication use. (15 month)
B: Intraocular Pressure (Measured in mm Hg) Less or Equal to 21 mm Hg on no Topical Hypotensive Meds (12 months)
C: Change in Intraocular Pressure (Baseline to 5 years); Rate of Complications (5 years)
D: Efficacy (24 months)

Answer: B
Please select the outcome measures that correspond to the clinical trial below.
Title: A Multinational, Multicentre, Randomized, Double-blind Study To Assess The Efficacy And Safety Of Oral Sildenafil 20mg Tid Or Placebo When Added To Bosentan In The Treatment Of Subjects, Aged 18 Years And Above, With Pulmonary Arterial Hypertension (Pah)
Brief Summary: To assess the efficacy and safety of sildenafil when added to patients with PAH who are taking bosentan as all or part of their background therapy.


Options:
A: Safety; Standard safety data; Efficacy; 6-Minute Walk Test; BORG Dyspnoea Score; WHO Functional Class; Quality of Life SF-36 and EQ-5D
B: Change From Baseline in the Total Distance Walked During 6 Minute Walk Time (6MWT) at Week 12 (Week 12)
C: Pulmonary Artery Systolic Pressure (PASP)
D: Number of Participants With Treatment-emergent Adverse Events (TEAE) (From administration of first dose of study medication up to 2 days after end of treatment with study medication, up to 10 years); Number of Participants With Death (From baseline to end of safety follow-up visit, up to 10 years (1 month more than End of study visit))

Answer: B