TrialPanorama/Dataset huggingface dataset:
Please select the outcome measures that correspond to the clinical trial below.
Title: Comparison of PEG-Intron 1.5µg/kg/wk Plus REBETOL vs PEG-Intron 1µg/kg/wk Plus REBETOL vs PEGASYS 180µg/wk Plus COPEGUS in Previously Untreated Adult Subjects With Chronic Hepatitis C Infected With Genotype 1
Brief Summary: The objective is to compare the safety and efficacy of the following three treatment regimens in previously untreated adult subjects with chronic hepatitis C infected with Genotype 1: (1) PegIntron 1.5 µg/kg/wk in combination with weight based REBETOL (800-1400 mg/day); (2) PegIntron 1µg/kg/wk in combination with weight based REBETOL (800-1400 mg/day); and (3) PEGASYS 180 µg/wk plus COPEGUS 1000-1200 mg/day.


Options:
A: Change From Baseline in Viral Load (log10 Reduction) at Week 12 (From Baseline to Week 12)
B: Sustained Virologic Response (SVR) Rate (Assessed at the end of a 24-week post-treatment follow-up)
C: Progression of Liver Disease as Indicated by Death, Hepatic Decompensation, Hepatocellular Carcinoma, or for Patients With Noncirrhotic Fibrosis at Baseline, an Increase in the Ishak Hepatic Fibrosis Score of 2 or More Points (1400 days (3.85 years) post randomization); Increase in Ishak Fibrosis Score by 2 Points or More at 2 or 4 Year Biopsies (1400 days (3.85 years) post randomization); Death From Any Cause (1400 days (3.85 years) post randomization); Development of Hepatocellular Carcinoma (HCC) (1400 days (3.85 years) post randomization); Child-Turcotte-Pugh (CTP) Score of 7 or Higher at Two Consecutive Study Visits (1400 days (3.85 years) post randomization); Variceal Hemorrhage (1400 days (3.85 years) post randomization); Ascites (1400 days (3.85 years) post randomization); Spontaneous Bacterial Peritonitis (1400 days (3.85 years) post randomization); Hepatic Encephalopathy (1400 days (3.85 years) post randomization)
D: SVR, defined as undetectable serum HCV RNA (24 weeks after discontinuation of treatment)

Answer: B
Please select the outcome measures that correspond to the clinical trial below.
Title: Comparison of PEG-Intron 1.5µg/kg/wk Plus REBETOL vs PEG-Intron 1µg/kg/wk Plus REBETOL vs PEGASYS 180µg/wk Plus COPEGUS in Previously Untreated Adult Subjects With Chronic Hepatitis C Infected With Genotype 1
Brief Summary: The objective is to compare the safety and efficacy of the following three treatment regimens in previously untreated adult subjects with chronic hepatitis C infected with Genotype 1: (1) PegIntron 1.5 µg/kg/wk in combination with weight based REBETOL (800-1400 mg/day); (2) PegIntron 1µg/kg/wk in combination with weight based REBETOL (800-1400 mg/day); and (3) PEGASYS 180 µg/wk plus COPEGUS 1000-1200 mg/day.


Options:
A: Sustained Virologic Response (SVR) Rate (Assessed at the end of a 24-week post-treatment follow-up)
B: Percentage of Subjects With Undetectable Plasma Hepatitis C Virus (HCV) Ribonucleic Acid (RNA) at Week 24 After the Completion of Study Drug Dosing (24 weeks after the completion of study drug dosing (up to Week 72))
C: Percentage of Subjects With Undetectable Plasma Hepatitis C Virus (HCV) Ribonucleic Acid (RNA) at Week 24 After the Completion of Study Drug Dosing (24 weeks after the completion of study drug dosing (up to Week 72))
D: Percentage of Participants With Sustained Virological Response (SVR) (Groups A and B) (At 24-week untreated follow-up visit (up to 72 weeks for Group A, up to 96 weeks for Group B))

Answer: A
Please select the outcome measures that correspond to the clinical trial below.
Title: Injection of Autologous CD34-Positive Cells for Neovascularization and Symptom Relief in Patients With Myocardial Ischemia
Brief Summary: The purpose of this study is to determine if cell therapy with your own cells (autologous cells) delivered with a catheter to regions of the heart with poor blood flow will be safe and if it will relieve your chest pain and/or your ability to exercise.


Options:
A: Efficacy between groups post-index procedure (39 weeks post-index)
B: Freedom from occurrence of major adverse cardiac and cerebrovascular events (MACCE), including all-cause death, re-infarction, revascularization and stroke (12 months)
C: Change in global left ventricular ejection fraction (12 months)
D: N/A

Answer: D
Please select the outcome measures that correspond to the clinical trial below.
Title: Phase 2 Randomized Trial of a Moxifloxacin-Containing Regimen For Treatment of Smear-Positive Pulmonary Tuberculosis in Adults With and Without HIV Infection
Brief Summary: Current treatment of tuberculosis (TB) requires patients to take four drugs for 8 weeks and then two drugs for 4 months. New drug regimens that are shorter and effective against drug-resistant TB are needed. This study will evaluate whether using the drug moxifloxacin (MOX) in place of ethambutol (EMB) during the first 8 weeks of treatment will effectively treat TB.


Options:
A: Proportion of Patients With Sterile Sputum Cultures (8 weeks)
B: The Time to Sputum Culture Conversion at Week 8 (Stage 1) (Week 8, Stage 1); The Time to Sputum Culture Conversion at Week 24 (Stage 2) (Week 24, Stage 2)
C: • To compare the culture-conversion rate at the end of the intensive phase of therapy of the moxifloxacin regimen vs. that of the isoniazid regimen (8 weeks)
D: Rifampicin and Moxifloxacin concentration in plasma and CSF (Plasma drug concentration samplings at 0, 1, 2, 4, 6 and 24h post dose (6 time points). CSF samples at 2 time points.)

Answer: A
Please select the outcome measures that correspond to the clinical trial below.
Title: Phase 2 Randomized Trial of a Moxifloxacin-Containing Regimen For Treatment of Smear-Positive Pulmonary Tuberculosis in Adults With and Without HIV Infection
Brief Summary: Current treatment of tuberculosis (TB) requires patients to take four drugs for 8 weeks and then two drugs for 4 months. New drug regimens that are shorter and effective against drug-resistant TB are needed. This study will evaluate whether using the drug moxifloxacin (MOX) in place of ethambutol (EMB) during the first 8 weeks of treatment will effectively treat TB.


Options:
A: The Time to Sputum Culture Conversion at Week 8 (Stage 1) (Week 8, Stage 1); The Time to Sputum Culture Conversion at Week 24 (Stage 2) (Week 24, Stage 2)
B: The percentage of participants with TB recurrence/relapse by 24 months after the end of treatment. (24 months after treatment completion for all 3 groups); Percentage of participants with treatment failure at either 4.5 months or 6 months after randomization. (4.5 months after randomization for experimental group1 and 2; 6 months after randomization for control group)
C: Proportion of Patients With Sterile Sputum Cultures (8 weeks)
D: To Compare, by Treatment Group, the Percentage of Patients With a Negative Sputum Culture at the End of Intensive Phase Therapy. (Week 8); To Compare the Safety and Tolerability of the 2 Intensive Phase Regimens. (Weekly or more frequent)

Answer: C
Please select the outcome measures that correspond to the clinical trial below.
Title: A Phase IV Randomized, Multicenter, Open-Label Study to Compare the Safety, Tolerability and Efficacy of Trizivir (Abacavir 300mg, Lamivudine 150mg, and Zidovudine 300mg) BID vs Combivir (Lamivudine 150mg and Zidovudine 300mg) BID Plus Atazanavir 400mg QD in Antiretroviral Naive HIV-1 Infected Subjects Over 48 Weeks
Brief Summary: The aim of this study was to assess whether TRIZIVIR, administered twice-daily was as safe, tolerable and efficacious as a combination of the drugs COMBIVIR administered twice-daily and atazanavir administered once daily. Over the course of 48 weeks, various parameters that measure safety, tolerability and efficacy of the investigational drugs were measured and compared.


Options:
A: Number of Participants With Virologic Suppression (Throughout study, including breastfeeding, assessed up to 24 months); Number of HIV+ Infants (Throughout study, including breastfeeding, assessed up to 24 months)
B: The primary endpoint was drug efficacy, measured as the proportion of study subjects who had plasma HIV-1 RNA less than 50 copies/mL at week 48 and did not meet the definition of virologic failure through this timepoint. (48 Weeks)
C: HIV PCR (1 month)
D: Incidence of clinically-suspected ABC HSR during the 6-week observation period. Incidence of immunologically-confirmed ABC HSR. The clinical diagnosis of which occurs over the 6-week observation period.

Answer: B
Please select the outcome measures that correspond to the clinical trial below.
Title: A Multi-Center, Open-Label Study to Assess the Durability and Safety of the Prevention of Bone Loss by Treatment With GL701 (Prestara™) in Women With Systemic Lupus Erythematosus Receiving Treatment With Glucocorticoids
Brief Summary: Open label safety and efficacy follow-up.


Options:
A: N/A
B: Maintenance of bone mineral density (BMD) in women with systemic lupus erythematosus receiving glucocorticoids. (12 months)
C: blood and urine tests (beginning of treatment, and after six weeks of treatment.)
D: Total satisfying sexual activity over 24 weeks (6, 12, 24, 36, and 52 weeks)

Answer: B
Please select the outcome measures that correspond to the clinical trial below.
Title: A Phase III Randomized Study of Exemestane Versus Placebo in Postmenopausal Women at Increased Risk of Developing Breast Cancer
Brief Summary: RATIONALE: The MAP.3 study was designed to test whether hormone therapy using exemestane may prevent breast cancer by blocking the production of estrogen.

PURPOSE: The study protocol was amended in May 2011 and the current purpose of the study is to allow all study participants the opportunity to complete 5 years of exemestane.


Options:
A: Number of Participants With Major Cardiovascular Events (a Combined Endpoint of Nonfatal Myocardial Infarction, Nonfatal Stroke, and Total Cardiovascular Death) (Average follow-up 10.1 years); Number of Participants With Cancer, Excluding Nonmelanoma Skin Cancer (Average follow-up 10.1 years)
B: Percentage of Women With Serious Adverse Events (5 years open-label extension period); Invasive Breast Cancer Incidence (Breast Cancer-Free Survival) (Over randomization period of study (median follow-up 35 months))
C: Time to first occurrence of coronary death, non-fatal myocardial infarction (MI), or hospitalized acute coronary syndrome other than MI combined after an expected 5 to 7.5 years of follow-up.; Time to first occurrence of invasive breast cancer after an expected 5 to 7.5 years of follow-up.
D: Percentage of serum estradiol suppression in postmenopausal women at high risk for breast cancer (Baseline to week 30)

Answer: B
Please select the outcome measures that correspond to the clinical trial below.
Title: UARK 98-036, A Phase II Trial of Combination Bisphosphonate and Anti-Angiogenesis Therapy With Pamidronate and Thalidomide in Patients With Smoldering/Indolent Myeloma
Brief Summary: The purpose of this research is to study how helpful the combination of thalidomide and Pamidronate or thalidomide and Zometa is in controlling the myeloma disease and to study any side effects.


Options:
A: Time to Disease Progression (TTP) (randomization to progression (up to 5 years))
B: Best Response (2 years)
C: Time to the First On-Study SRE (Non-inferiority) (Up to 40.5 months)
D: Physical function at 12 months estimated by EORTC QLQ-C30 questionnaire

Answer: B
Please select the outcome measures that correspond to the clinical trial below.
Title: A Randomized, Double-blind, Placebo- and Active-controlled, Parallel-group, Dose-response Study to Evaluate the Efficacy and Safety of 3 Fixed Dosages of Paliperidone Extended Release (ER) Tablets and Olanzapine, With Open-label Extension, in the Treatment of Patients With Schizophrenia
Brief Summary: The primary objective of the double-blind phase of this study is to evaluate the efficacy and safety of 3 fixed dosages of paliperidone ER (3, 9, and 15 mg/day) compared with placebo in adult patients with schizophrenia


Options:
A: Change from baseline in total PANSS score to the end of the double-blind phase.
B: Withdrawal from allocated treatment within 3 months.
C: Change from baseline in the total PANSS score to the end of the double-blind phase.
D: Measurement of Schizophrenia Symptoms: Change From Baseline in Positive and Negative Syndrome Scale (PANSS) Total Score. (Baseline to Week 6)

Answer: C
Please select the outcome measures that correspond to the clinical trial below.
Title: A Phase 3, Randomized Study Of SU011248 Versus Interferon-Alfa As First-Line Systemic Therapy For Patients With Metastatic Renal Cell Carcinoma
Brief Summary: The purpose of this study is to test whether SU011248 has activity and is safe compared to interferon-alfa as first-line therapy in patients with metastatic renal cell carcinoma (RCC).


Options:
A: 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.)
B: Progression-free Survival (PFS) of Participants Who Received RAD001 Plus Bevacizumab Versus Participants Who Received IFN Plus Bevacizumab (Time from randomization to the date of radiological progressive disease as per independent central review, death from any cause, or last tumor assessment, reported between date of first participant randomized until 31Dec2011, cutoff date.)
C: Progression Free Survival First-Line (PFS 1-L) (based on radiological assessments every 3 months until disease progression, start of another antineoplastic therapy or for any other reason up to 35 months)
D: Progression-Free Survival (PFS), Core Radiology Assessment (Day 28 of each 6-week cycle: duration of treatment phase); Progression-Free Survival (PFS), Investigator's Assessment (Day 28 of each 6-week cycle: duration of treatment phase)

Answer: D
Please select the outcome measures that correspond to the clinical trial below.
Title: A Phase 3, Randomized Study Of SU011248 Versus Interferon-Alfa As First-Line Systemic Therapy For Patients With Metastatic Renal Cell Carcinoma
Brief Summary: The purpose of this study is to test whether SU011248 has activity and is safe compared to interferon-alfa as first-line therapy in patients with metastatic renal cell carcinoma (RCC).


Options:
A: Progression-Free Survival (PFS), Core Radiology Assessment (Day 28 of each 6-week cycle: duration of treatment phase); Progression-Free Survival (PFS), Investigator's Assessment (Day 28 of each 6-week cycle: duration of treatment phase)
B: progression-free rate (at 48 weeks post-treatment)
C: Progression-Free Survival (PFS): Independent-Assessment (Baseline until disease progression, initiation of new anticancer treatment, or death, assessed every 8 weeks (up to cut-off date: 19 April 2012))
D: Progression Free Survival (PFS) (From randomization to disease progression or death (up to approximately 2 years))

Answer: A
Please select the outcome measures that correspond to the clinical trial below.
Title: A Phase 3, Randomized Study Of SU011248 Versus Interferon-Alfa As First-Line Systemic Therapy For Patients With Metastatic Renal Cell Carcinoma
Brief Summary: The purpose of this study is to test whether SU011248 has activity and is safe compared to interferon-alfa as first-line therapy in patients with metastatic renal cell carcinoma (RCC).


Options:
A: Progression-free Survival (Randomization until progression (up to 2 years))
B: Progression-free Survival (PFS) by Independent Imaging Review (IIR) (From the date of randomization to the date of the first documentation of PD or date of death, whichever occurred first or up to data cutoff date 28 Aug 2020 (up to approximately 46 months))
C: Progression-Free Survival (PFS), Core Radiology Assessment (Day 28 of each 6-week cycle: duration of treatment phase); Progression-Free Survival (PFS), Investigator's Assessment (Day 28 of each 6-week cycle: duration of treatment phase)
D: Treatment failure rate (progressive disease, treatment withdrawal due to unacceptable toxicities, or any death) (12 months)

Answer: C
Please select the outcome measures that correspond to the clinical trial below.
Title: A Phase 3, Randomized Study Of SU011248 Versus Interferon-Alfa As First-Line Systemic Therapy For Patients With Metastatic Renal Cell Carcinoma
Brief Summary: The purpose of this study is to test whether SU011248 has activity and is safe compared to interferon-alfa as first-line therapy in patients with metastatic renal cell carcinoma (RCC).


Options:
A: Overall Survival (OS) (Baseline up to Month 80)
B: Safety parameters (From signing consent to 30 days after last dose of study drug)
C: Progressive Free Survival (PFS) in Patients Who Receive RAD001 Plus Best Supportive Care(BSC) Versus Patients Who Receive Matching Placebo Plus BSC (Time from randomization to dates of disease progression, death from any cause or last tumor assessment reported between date of first patient randomized until 28Feb2008 cut of date.)
D: Progression-Free Survival (PFS), Core Radiology Assessment (Day 28 of each 6-week cycle: duration of treatment phase); Progression-Free Survival (PFS), Investigator's Assessment (Day 28 of each 6-week cycle: duration of treatment phase)

Answer: D
Please select the outcome measures that correspond to the clinical trial below.
Title: An Open Label Clinical Trial of Replagal Enzyme Replacement Therapy In Children With Fabry Disease Who Have Completed Study TKT023 or Who Are Naive to Enzyme Replacement Therapy
Brief Summary: Primary Objective(s):

* To assess the safety of Replagal at a dose of 0.2 mg/kg administered over 40 (+/-10) minutes in children with Fabry disease
* To assess the effect of Replagal on heart rate variability in patients 7 to 17 years of age

Secondary Objective(s):

* To determine the pharmacokinetics of Replagal at baseline and after the initiation of enzyme replacement therapy (ERT)
* To determine exploratory measurements of efficacy including renal function (ie, estimated glomerular filtration rate \[eGFR\] and creatinine clearance), clinical outcomes (in Cohorts 1 and 2), and sweating and left ventricular mass index (LVMI) (Cohort 1, Phase 1 only)


Options:
A: Globotriaosylceramide (GL-3) Clearance in Capillary Endothelium in the Skin (Baseline, Week 24 and Week 48)
B: Number of Participants Experiencing a Clinically Significant Renal, Cardiac or Cerebrovascular Event and/or Death in Fabrazyme (Agalsidase Beta) Patients as Compared to Placebo Patients (up to 35 months)
C: Skin Globotriaosylceramide (GL-3) Clearance From Superficial Skin Capillary Endothelium (Baseline, Week 52, Week 156 and Week 260)
D: Patients Who Experienced At Least One Adverse Event (AE) (362 weeks)

Answer: D
Please select the outcome measures that correspond to the clinical trial below.
Title: A Phase 3 Multicenter Study of the Safety and Efficacy of the Human Anti-TNF Monoclonal Antibody Adalimumab in Subjects With Active Ankylosing Spondylitis
Brief Summary: The objective of this study was to evaluate the safety and efficacy of adalimumab 40 mg given every other week (eow) in subjects with active ankylosing spondylitis (AS) who have had an inadequate response to, or who are intolerant to, treatment with at least 1 nonsteroidal anti-inflammatory drug (NSAID) and who may have also failed treatment with at least 1 disease-modifying antirheumatic drug (DMARD).


Options:
A: Number of Subjects With a Reduction in Signs and Symptoms as Measured by Assessments of Ankylosing Spondylitis (ASAS) 20 Response at Week 12 (Week 12); Mean Change in the Modified Stoke Ankylosing Spondylitis Spine Score (mSASSS) Compared Against a Historical Control Group (Outcomes in Ankylosing Spondylitis International Study [OASIS]) Using the ANCOVA Model Adjusting for Baseline mSASSS Score (Baseline and Week 104)
B: Number of Subjects With Clinically Significant Upper and/or Lower Gastrointestinal Events (CSULGIEs) (6 month treatment duration)
C: Number of Responders With a Reduction of Signs and Symptoms of Ankylosing Spondylitis (AS) as Measured With ASAS International Working Group Response Criteria (ASAS 20). (Week 12); Mean Change in the Modified Stoke Ankylosing Spondylitis Spine Score (mSASSS) Compared Against a Historical Control Group (Outcomes in Ankylosing Spondylitis International Study [OASIS]) Using the ANCOVA Model Adjusting for Baseline mSASSS Score (Week 104)
D: Treatment Response (using ASAS criteria) of at least 20% and absolute improvement of at least 10 units on a 0-100 scale in at least 3 of the 4 domains (Up to 4 years); Absence of deterioration (using ASAS criteria) of at least 20% and absolute improvement of at least 10 units on a 0-100 scale in the potential remaining ASAS domain (Up to 4 years)

Answer: C
Please select the outcome measures that correspond to the clinical trial below.
Title: A Phase 3 Multicenter Study of the Safety and Efficacy of the Human Anti-TNF Monoclonal Antibody Adalimumab in Subjects With Active Ankylosing Spondylitis
Brief Summary: The objective of this study was to evaluate the safety and efficacy of adalimumab 40 mg given every other week (eow) in subjects with active ankylosing spondylitis (AS) who have had an inadequate response to, or who are intolerant to, treatment with at least 1 nonsteroidal anti-inflammatory drug (NSAID) and who may have also failed treatment with at least 1 disease-modifying antirheumatic drug (DMARD).


Options:
A: Number of Responders With a Reduction of Signs and Symptoms of Ankylosing Spondylitis (AS) as Measured With ASAS International Working Group Response Criteria (ASAS 20). (Week 12); Mean Change in the Modified Stoke Ankylosing Spondylitis Spine Score (mSASSS) Compared Against a Historical Control Group (Outcomes in Ankylosing Spondylitis International Study [OASIS]) Using the ANCOVA Model Adjusting for Baseline mSASSS Score (Week 104)
B: Proportion of subjects achieving clinical response at Week 16 relative to the Baseline (Week 0) PASI score (Week 16)
C: N/A
D: Clinical response at Week 26, in the strata defined by CRP ≥ 10 mg/L.

Answer: A
Please select the outcome measures that correspond to the clinical trial below.
Title: A Phase 3 Multicenter Study of the Safety and Efficacy of the Human Anti-TNF Monoclonal Antibody Adalimumab in Subjects With Active Ankylosing Spondylitis
Brief Summary: The objective of this study was to evaluate the safety and efficacy of adalimumab 40 mg given every other week (eow) in subjects with active ankylosing spondylitis (AS) who have had an inadequate response to, or who are intolerant to, treatment with at least 1 nonsteroidal anti-inflammatory drug (NSAID) and who may have also failed treatment with at least 1 disease-modifying antirheumatic drug (DMARD).


Options:
A: Number of Subjects With a Reduction in Signs and Symptoms as Measured by Assessments of Ankylosing Spondylitis (ASAS) 20 Response at Week 12 (Week 12); Mean Change in the Modified Stoke Ankylosing Spondylitis Spine Score (mSASSS) Compared Against a Historical Control Group (Outcomes in Ankylosing Spondylitis International Study [OASIS]) Using the ANCOVA Model Adjusting for Baseline mSASSS Score (Baseline and Week 104)
B: Number of Patients Achieving Assessment in Ankylosing Spondylitis (ASAS) 20. (12 weeks)
C: Normalized Net Incremental Area Under the Curve (AUC) for the Bath Ankylosing Spondylitis Disease Activities Index (BASDAI) Between Randomization and Week 12 (Baseline, Week 2, Week 4, Week 8, Week 12)
D: Number of Responders With a Reduction of Signs and Symptoms of Ankylosing Spondylitis (AS) as Measured With ASAS International Working Group Response Criteria (ASAS 20). (Week 12); Mean Change in the Modified Stoke Ankylosing Spondylitis Spine Score (mSASSS) Compared Against a Historical Control Group (Outcomes in Ankylosing Spondylitis International Study [OASIS]) Using the ANCOVA Model Adjusting for Baseline mSASSS Score (Week 104)

Answer: D