TrialPanorama/Dataset huggingface dataset:
Please select the outcome measures that correspond to the clinical trial below.
Title: Effect of Roflumilast on Exacerbation Rate in Patients With Chronic Obstructive Pulmonary Disease. A 52-week, Multicenter, Double-blind Study With 500 mcg Roflumilast Once Daily Versus Placebo.
Brief Summary: The purpose of this study is to determine whether roflumilast is effective in the treatment of exacerbations in patients with chronic obstructive pulmonary disease (COPD).


Options:
A: Pre-bronchodilator Forced Expiratory Volume in First Second (FEV1) (Change from baseline over 52 weeks of treatment); COPD Exacerbation Rate (Moderate or Severe) (52 weeks treatment period)
B: Number of participants with adverse events (AEs) and serious adverse events (SAEs) (Up to follow up (approximately 56 days)); Change from Baseline (Day 0 [pre-bronchodilator]) in 12-lead electrocardiogram (ECG) findings (Baseline (Day 0 [pre-bronchodilator]) and up to Day 28 (Visit 6b)); Change from Baseline (Day 0 [pre-bronchodilator]) in 12-lead electrocardiogram (ECG) findings-ventricular rate (Baseline (Day 0 [pre-bronchodilator]) and up to Day 28 (Visit 6b)); Number of participants with abnormal (potential clinical importance [PCI]) systolic blood pressure (SBP), diastolic blood pressure (DBP) and heart rate (HR) (Up to Day 27 (Visit 6a)); Number of participants with abnormal (PCI) clinical chemistry (Up to Day 42 (follow up visit)); Number of participants with abnormal (PCI) hematology (Up to Day 42 (follow up visit)); Number of participants with abnormal urinalysis (Up to Day 56 (Visit follow up)); Change from Baseline (Day 0) in lung function parameters: forced expiratory volume in one second (FEV1) and forced vital capacity (FVC) (Baseline (Day 0) and up to Day 27 (Visit 6a)); Number of participants with abnormal Holter interpretations (Up to Day 27 (Visit 6a)); Number of participants who withdrawn for exacerbations of chronic obstructive pulmonary disease (COPD) (Up to Day 27 (Visit 6a))
C: Induced Sputum Proline-glycine-proline (PGP) Levels at Baseline (baseline); Mean Induced Sputum Proline-glycine-proline (PGP) Levels at 1 Month After Randomization. (1 month after baseline); Mean Induced Sputum Proline-glycine-proline (PGP) Levels at 3 Months After Randomization (3 months after baseline)
D: change in FEV1 from baseline during the treatment period; number of COPD exacerbations.

Answer: D
Please select the outcome measures that correspond to the clinical trial below.
Title: CSP #530 - Intensive vs. Conventional Renal Support in Acute Renal Failure
Brief Summary: This is a multi-center, prospective, randomized, parallel-group trial of an intensive strategy vs conventional strategy of renal replacement therapy for the treatment of acute renal failure secondary to acute tubular necrosis in critically ill patients. The primary hypothesis is that the intensive strategy will reduce 60-day all cause mortality by 10% compared to the conventional strategy - i.e.,a reduction from 55% in the conventional arm to 45% in the intensive arm. Secondary outcomes are 60-day in-hospital all-cause mortality, 1-year all cause mortality, and recovery of renal function by day 28. The study will recruit 1164 patients over a period of 3 years, 8 months and each patient will be actively followed for 60 days.


Options:
A: 60-day All-cause Mortality (60 days)
B: Death (90 days)
C: N/A
D: The primary outcome measure for this study is noradrenaline free time in the first week after randomization (24 months)

Answer: A
Please select the outcome measures that correspond to the clinical trial below.
Title: CSP #530 - Intensive vs. Conventional Renal Support in Acute Renal Failure
Brief Summary: This is a multi-center, prospective, randomized, parallel-group trial of an intensive strategy vs conventional strategy of renal replacement therapy for the treatment of acute renal failure secondary to acute tubular necrosis in critically ill patients. The primary hypothesis is that the intensive strategy will reduce 60-day all cause mortality by 10% compared to the conventional strategy - i.e.,a reduction from 55% in the conventional arm to 45% in the intensive arm. Secondary outcomes are 60-day in-hospital all-cause mortality, 1-year all cause mortality, and recovery of renal function by day 28. The study will recruit 1164 patients over a period of 3 years, 8 months and each patient will be actively followed for 60 days.


Options:
A: All-cause Mortality. (90 days following study randomization.)
B: 60-day All-cause Mortality (60 days)
C: Death from all causes at 30 days after randomisation (30 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: CSP #530 - Intensive vs. Conventional Renal Support in Acute Renal Failure
Brief Summary: This is a multi-center, prospective, randomized, parallel-group trial of an intensive strategy vs conventional strategy of renal replacement therapy for the treatment of acute renal failure secondary to acute tubular necrosis in critically ill patients. The primary hypothesis is that the intensive strategy will reduce 60-day all cause mortality by 10% compared to the conventional strategy - i.e.,a reduction from 55% in the conventional arm to 45% in the intensive arm. Secondary outcomes are 60-day in-hospital all-cause mortality, 1-year all cause mortality, and recovery of renal function by day 28. The study will recruit 1164 patients over a period of 3 years, 8 months and each patient will be actively followed for 60 days.


Options:
A: Middle molecular weight molecules clearances (18 months)
B: Functions of inflammatory cells (24 hours); Regulation of inflammatory reactions and and opsonization in microorganisms (24 hours); Activity of acute phase protein during acute inflammation (24 hours)
C: 60-day All-cause Mortality (60 days)
D: Mortality (Day 28 after ICU admission)

Answer: C
Please select the outcome measures that correspond to the clinical trial below.
Title: CSP #530 - Intensive vs. Conventional Renal Support in Acute Renal Failure
Brief Summary: This is a multi-center, prospective, randomized, parallel-group trial of an intensive strategy vs conventional strategy of renal replacement therapy for the treatment of acute renal failure secondary to acute tubular necrosis in critically ill patients. The primary hypothesis is that the intensive strategy will reduce 60-day all cause mortality by 10% compared to the conventional strategy - i.e.,a reduction from 55% in the conventional arm to 45% in the intensive arm. Secondary outcomes are 60-day in-hospital all-cause mortality, 1-year all cause mortality, and recovery of renal function by day 28. The study will recruit 1164 patients over a period of 3 years, 8 months and each patient will be actively followed for 60 days.


Options:
A: all-cause mortality. (28-day)
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: 60-day All-cause Mortality (60 days)

Answer: D
Please select the outcome measures that correspond to the clinical trial below.
Title: CSP #530 - Intensive vs. Conventional Renal Support in Acute Renal Failure
Brief Summary: This is a multi-center, prospective, randomized, parallel-group trial of an intensive strategy vs conventional strategy of renal replacement therapy for the treatment of acute renal failure secondary to acute tubular necrosis in critically ill patients. The primary hypothesis is that the intensive strategy will reduce 60-day all cause mortality by 10% compared to the conventional strategy - i.e.,a reduction from 55% in the conventional arm to 45% in the intensive arm. Secondary outcomes are 60-day in-hospital all-cause mortality, 1-year all cause mortality, and recovery of renal function by day 28. The study will recruit 1164 patients over a period of 3 years, 8 months and each patient will be actively followed for 60 days.


Options:
A: Death from all causes at 90 days after randomisation. (Within 90 days after randomisation)
B: all-cause mortality. (28-day)
C: Death from all causes at 30 days after randomisation (30 days)
D: 60-day All-cause Mortality (60 days)

Answer: D
Please select the outcome measures that correspond to the clinical trial below.
Title: CSP #530 - Intensive vs. Conventional Renal Support in Acute Renal Failure
Brief Summary: This is a multi-center, prospective, randomized, parallel-group trial of an intensive strategy vs conventional strategy of renal replacement therapy for the treatment of acute renal failure secondary to acute tubular necrosis in critically ill patients. The primary hypothesis is that the intensive strategy will reduce 60-day all cause mortality by 10% compared to the conventional strategy - i.e.,a reduction from 55% in the conventional arm to 45% in the intensive arm. Secondary outcomes are 60-day in-hospital all-cause mortality, 1-year all cause mortality, and recovery of renal function by day 28. The study will recruit 1164 patients over a period of 3 years, 8 months and each patient will be actively followed for 60 days.


Options:
A: Filter Life (72 hours)
B: Mean daily dialysis delivered dose during intensive care stay (dialysis days during intensive care stay)
C: the time of 1st membrane exchange (the time of 'filter is clotted')
D: 60-day All-cause Mortality (60 days)

Answer: D
Please select the outcome measures that correspond to the clinical trial below.
Title: CSP #530 - Intensive vs. Conventional Renal Support in Acute Renal Failure
Brief Summary: This is a multi-center, prospective, randomized, parallel-group trial of an intensive strategy vs conventional strategy of renal replacement therapy for the treatment of acute renal failure secondary to acute tubular necrosis in critically ill patients. The primary hypothesis is that the intensive strategy will reduce 60-day all cause mortality by 10% compared to the conventional strategy - i.e.,a reduction from 55% in the conventional arm to 45% in the intensive arm. Secondary outcomes are 60-day in-hospital all-cause mortality, 1-year all cause mortality, and recovery of renal function by day 28. The study will recruit 1164 patients over a period of 3 years, 8 months and each patient will be actively followed for 60 days.


Options:
A: 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)
B: 60-day All-cause Mortality (60 days)
C: Death (90 days)
D: Feasibility of protocol adherence (14 days)

Answer: B
Please select the outcome measures that correspond to the clinical trial below.
Title: A Phase III, Randomized, Double-Blind, Placebo-Controlled Trial of Acyclovir for the Reduction of HIV Acquisition Among High-Risk HSV-2 Seropositive, HIV Seronegative Individuals
Brief Summary: Genital herpes (HSV-2) is the most common cause of genital sores worldwide, and the presence of genital sores is a significant risk factor for becoming infected with HIV. This study will test the effectiveness of twice-daily dosing of acyclovir, a commonly prescribed anti-herpes drug, in preventing HIV infection in HSV-2 infected women who sleep with men (WSM) and men who sleep with men (MSM).

Study hypothesis: Given that genital herpes is a significant risk factor to HIV acquisition, twice-daily HSV-2 suppressive therapy - 400 mg of acyclovir - will prevent HIV infection among high risk, HSV-2 seropositive WSM and MSM.


Options:
A: To assess the impact of HSV-2 suppressive therapy on HIV shedding among co-infected women taking highly active antiretroviral therapy (HAART) or not needing HAART
B: Plasma HIV-1 levels and HIV-1 mucosal shedding (18 weeks)
C: Serologically confirmed HIV infection (Throughout study)
D: HIV acquisition; safety of circumcision

Answer: C
Please select the outcome measures that correspond to the clinical trial below.
Title: A Phase III, Randomized, Double-Blind, Placebo-Controlled Trial of Acyclovir for the Reduction of HIV Acquisition Among High-Risk HSV-2 Seropositive, HIV Seronegative Individuals
Brief Summary: Genital herpes (HSV-2) is the most common cause of genital sores worldwide, and the presence of genital sores is a significant risk factor for becoming infected with HIV. This study will test the effectiveness of twice-daily dosing of acyclovir, a commonly prescribed anti-herpes drug, in preventing HIV infection in HSV-2 infected women who sleep with men (WSM) and men who sleep with men (MSM).

Study hypothesis: Given that genital herpes is a significant risk factor to HIV acquisition, twice-daily HSV-2 suppressive therapy - 400 mg of acyclovir - will prevent HIV infection among high risk, HSV-2 seropositive WSM and MSM.


Options:
A: Reduction in anogenital HIV-1 shedding with suppression of HSV-2 reactivation. (18 weeks)
B: Number of Participants With Clinical Adverse Experiences (Day 1 to End of Study (Week 210 for HIV uninfected participants and Week 338 for HIV infected participants)); Number of Participants With Laboratory Adverse Experiences (Day 1 to Week 208); Number of Participants With HIV-1 Infections (Day 1 to End of Study (Week 210 for HIV uninfected participants and Week 338 for HIV infected participants)); HIV-1 Viral Load in Infected Participants (Day 1 to End of Study (Week 210 for HIV uninfected participants and Week 338 for HIV infected participants))
C: Serologically confirmed HIV infection (Throughout study)
D: Plasma HIV-1 levels and HIV-1 mucosal shedding (18 weeks)

Answer: C
Please select the outcome measures that correspond to the clinical trial below.
Title: A Phase III, Randomized, Double-Blind, Placebo-Controlled Trial of Acyclovir for the Reduction of HIV Acquisition Among High-Risk HSV-2 Seropositive, HIV Seronegative Individuals
Brief Summary: Genital herpes (HSV-2) is the most common cause of genital sores worldwide, and the presence of genital sores is a significant risk factor for becoming infected with HIV. This study will test the effectiveness of twice-daily dosing of acyclovir, a commonly prescribed anti-herpes drug, in preventing HIV infection in HSV-2 infected women who sleep with men (WSM) and men who sleep with men (MSM).

Study hypothesis: Given that genital herpes is a significant risk factor to HIV acquisition, twice-daily HSV-2 suppressive therapy - 400 mg of acyclovir - will prevent HIV infection among high risk, HSV-2 seropositive WSM and MSM.


Options:
A: Investigator-assessed Time to Healing of All Non-aborted Genital Herpes Lesions (72 hours after initiation of study medication up to Day 20)
B: Frequency of HSV-2 Total Shedding From the Genital Tract as Measured by PCR, Calculated Using a Per-day Shedding Rate in Participants Treated With High-dose Valacyclovir as Compared to Once-daily Valacyclovir. (11 weeks)
C: Serologically confirmed HIV infection (Throughout study)
D: Frequency of HSV-2 Total Shedding From the Genital Tract as Measured by PCR, Calculated Using a Per-day Shedding Rate in Participants Treated With Suppressive Acyclovir as Compared to no Medication in HIV Seronegative and HIV Seropositive Individuals. (9 weeks)

Answer: C
Please select the outcome measures that correspond to the clinical trial below.
Title: Treatment With Exercise Augmentation for Depression (TREAD)
Brief Summary: This study will assess the effectiveness of an exercise program in improving antidepressant medication treatment for individuals with major depressive disorder (MDD).


Options:
A: VO2max and resting systolic blood pressure (at 6 months)
B: Endothelium-dependent flow mediated dilation (Baseline / week 32-36 of gestation)
C: Percentage of Participants With Remission (Score of 12 or Less on Inventory for Depressive Symptomatology- Clinician-rated) (12 weeks)
D: The aim of the study is to investigate whether regular exercise after adjuvant treatments of breast cancer could prevent osteoporosis and improve quality of life. (1-10 years)

Answer: C
Please select the outcome measures that correspond to the clinical trial below.
Title: A Randomized, Open-Label, Parallel Group, International, Multicenter, Phase III Study of Oral ZD1839 (IRESSA®) Versus Intravenous Docetaxel (TAXOTERE®) in Patients With Locally Advanced or Metastatic Recurrent Non-Small Cell Lung Cancer Who Have Previously Received Platinum-Based Chemotherapy
Brief Summary: The purpose of this study is to compare the effects of ZD1839 or docetaxel in patients with advanced non-small cell lung cancer (NSCLC) that has recurred or progressed after receiving prior treatment with platinum-based chemotherapy.


Options:
A: Progression Free Survival (PFS) (Randomization to the first date of measured PD or death up to 37.32 months)
B: To compare ZD1839 and vinorelbine in terms of progression free survival
C: Progression Free Survival (2-7 months)
D: To compare overall survival between ZD1839 and docetaxel

Answer: D
Please select the outcome measures that correspond to the clinical trial below.
Title: A Randomized, 2-Period, Multicenter, Dble-Blind, Parallel-Group Study Comparing Effects of 2 Doses of MK0476 and Placebo in the Tx of Respiratory Symptoms Associated w/ Respiratory Syncytial Virus-Induced Bronchiolitis in Children 3 to 24 Mths
Brief Summary: The purpose of this study is to look at whether an investigational drug can treat the breathing symptoms of RSV bronchiolitis in children 3 to 24 months of age.


Options:
A: symptom free days (2 weeks runin and 8 weeks treatment)
B: Percentage of Symptom-Free Days
C: Length of stay (hours)
D: N/A

Answer: B
Please select the outcome measures that correspond to the clinical trial below.
Title: A Randomized, Open-label Study of the Effect of Intravenous Mircera on Hemoglobin Level/Correction in Dialysis Patients With Chronic Kidney Disease
Brief Summary: This study will assess the efficacy and safety of Mircera given intravenously in the treatment of renal anemia in chronic kidney disease patients on dialysis who are not currently receiving epoetin or any other erythropoietic substance. The anticipated time on study treatment is 1-2 years and the target sample size is 100-500 individuals.


Options:
A: Mean Change in Hemoglobin (Hb) Concentration From Baseline to Evaluation Period (Baseline, Week 29 to Week 36)
B: 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))
C: Hemoglobin response rate (Weeks 1-24)
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: C
Please select the outcome measures that correspond to the clinical trial below.
Title: A Randomized, Open-label Study of the Effect of Intravenous Mircera on Hemoglobin Level/Correction in Dialysis Patients With Chronic Kidney Disease
Brief Summary: This study will assess the efficacy and safety of Mircera given intravenously in the treatment of renal anemia in chronic kidney disease patients on dialysis who are not currently receiving epoetin or any other erythropoietic substance. The anticipated time on study treatment is 1-2 years and the target sample size is 100-500 individuals.


Options:
A: The Percentage of Participants Maintaining Average Haemoglobin (Hb) Concentration During the Efficacy Evaluation Period (EEP) Within the Target Range (Weeks 16-28)
B: Time to Composite of All-Cause Mortality and Non-Fatal Cardiovascular Events (Myocardial Infarction, Stroke) Defined as Time Between First Dose of Study Medication and Date of Death or Non-Fatal Cardiovascular Events, Whichever Occurred First (Baseline up to approximately 8.5 years)
C: Hemoglobin level
D: Hemoglobin response rate (Weeks 1-24)

Answer: D
Please select the outcome measures that correspond to the clinical trial below.
Title: A Randomized, Open-label Study of the Effect of Intravenous Mircera on Hemoglobin Level/Correction in Dialysis Patients With Chronic Kidney Disease
Brief Summary: This study will assess the efficacy and safety of Mircera given intravenously in the treatment of renal anemia in chronic kidney disease patients on dialysis who are not currently receiving epoetin or any other erythropoietic substance. The anticipated time on study treatment is 1-2 years and the target sample size is 100-500 individuals.


Options:
A: hemoglobin variability (2 years)
B: Percentage of Participants Who Maintained Their Mean Hemoglobin Concentration Within +/- 1.0 Gram/Deciliter of Their Reference Hemoglobin Concentration and Between 10.0 and 12.0 Gram/Deciliter During the Efficacy Evaluation Period (EEP (Week 16 to Week 24))
C: Hemoglobin response rate (Weeks 1-24)
D: Percentage of Participants Who Maintained Average Hb Within Plus/Minus (±) 1 g/dL of Reference Hb and Within Target Range During the Efficacy Evaluation Period (EEP) (Weeks -4, -3, -2, and -1; pre-dose (0 hours) during Weeks 18, 20, 22, and 24)

Answer: C
Please select the outcome measures that correspond to the clinical trial below.
Title: A Randomized, Open-label Study of the Effect of Intravenous Mircera on Hemoglobin Level/Correction in Dialysis Patients With Chronic Kidney Disease
Brief Summary: This study will assess the efficacy and safety of Mircera given intravenously in the treatment of renal anemia in chronic kidney disease patients on dialysis who are not currently receiving epoetin or any other erythropoietic substance. The anticipated time on study treatment is 1-2 years and the target sample size is 100-500 individuals.


Options:
A: Mean Change in Hemoglobin Between Baseline and the Evaluation Period (Baseline and Weeks 29-36)
B: Hemoglobin response rate (Weeks 1-24)
C: 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))
D: Mean Change in Hemoglobin (Hb) Concentration From Baseline to Evaluation Period (Baseline, Week 29 to Week 36)

Answer: B
Please select the outcome measures that correspond to the clinical trial below.
Title: A Randomized, Controlled, Open-label, Multi-center, Parallel-group Study to Demonstrate the Efficacy and Safety of RO0503821 When Administered Intravenously for the Maintenance Treatment of Anemia in Patients With Chronic Kidney Disease Who Are on Dialysis.
Brief Summary: This study will assess the efficacy and safety of intravenous Mircera, given as maintenance treatment for renal anemia in chronic kidney disease patients on dialysis who were previously receiving iv epoetin. The anticipated time on study treatment is 1-2 years and the target sample size is 100-500 individuals.


Options:
A: Mean Change in Hemoglobin (Hb) Concentration From Baseline to Evaluation Period (Baseline, Week 29 to Week 36)
B: Change From Baseline in Left Ventricle Mass Index (LVMI) at Month 15 (Baseline, Month 15)
C: Median Time to First Cardiovascular Event (Up to 4 years)
D: changes in gene-arrays, EPC and biomarkers panels (14 days, 6 and 12 months)

Answer: A
Please select the outcome measures that correspond to the clinical trial below.
Title: A Randomized, Controlled, Open-label, Multi-center, Parallel-group Study to Demonstrate the Efficacy and Safety of RO0503821 When Administered Intravenously for the Maintenance Treatment of Anemia in Patients With Chronic Kidney Disease Who Are on Dialysis.
Brief Summary: This study will assess the efficacy and safety of intravenous Mircera, given as maintenance treatment for renal anemia in chronic kidney disease patients on dialysis who were previously receiving iv epoetin. The anticipated time on study treatment is 1-2 years and the target sample size is 100-500 individuals.


Options:
A: Percentage of Time When Participants Had Hemoglobin Levels Between 9 to 11 Gram Per Deciliter (g/dL) (Week 17 up to Week 24)
B: Mean Change in Hemoglobin (Hb) Concentration From Baseline to Evaluation Period (Baseline, Week 29 to Week 36)
C: Hemoglobin response rate (Weeks 1-24)
D: Time to All Cause Death or First Hospitalization for Worsening Heart Failure (From randomization to the end of study; maximum time on study was 73 months)

Answer: B