TrialPanorama/Dataset huggingface dataset:
Please select the outcome measures that correspond to the clinical trial below.
Title: A Phase II Evaluation of CCI-779 (Temsirolimus, NCI-Supplied Agent, NSC #683864, IND #61010) in the Treatment of Persistent or Recurrent Epithelial Ovarian, Fallopian Tube or Primary Peritoneal Carcinoma
Brief Summary: This phase II trial is studying the side effects and how well temsirolimus works in treating patients with refractory or recurrent ovarian epithelial cancer, fallopian tube cancer, or primary peritoneal cancer. Temsirolimus may stop the growth of tumor cells by blocking some of the enzymes needed for cell growth.


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: Objective Response Rate (ORR) Evaluated According to Response Evaluation Criteria In Solid Tumors (RECIST) Guidelines (Each patient with measurable disease at baseline was assessed for Objective Response from the sequence of RECIST scan data up to data cut-off, 26 March 2010. RECIST scans were performed every 8 weeks (+/- 2 weeks) from randomization.)
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: Number of Participants With Dose Limiting Toxicities of Cediranib Maleate in Combination With Olaparib (Phase I) (At 28 days); The Maximum Tolerated Dose (MTD) of Cediranib in Combination With Olaparib in the Treatment of Recurrent Ovarian, Fallopian Tube, or Peritoneal Cancer or Metastatic Triple-negative Breast Cancer (Phase I) (At 28 Days); Progression-free Survival (PFS) at the Maximum Tolerated Dose/Recommended Phase 2 Dose of Cediranib Maleate With Olaparib Compared to That of Olaparib Alone (Phase II) (Time from start of treatment to time of objective disease progression, assessed up to 5 years); The Maximum Tolerated Dose (MTD) of Cediranib in Combination With Olaparib Tablet Formulation in the Treatment of Recurrent Ovarian, Fallopian Tube, or Peritoneal Cancer (Phase I-T). (At 28 days)

Answer: C
Please select the outcome measures that correspond to the clinical trial below.
Title: A Phase II Evaluation of CCI-779 (Temsirolimus, NCI-Supplied Agent, NSC #683864, IND #61010) in the Treatment of Persistent or Recurrent Epithelial Ovarian, Fallopian Tube or Primary Peritoneal Carcinoma
Brief Summary: This phase II trial is studying the side effects and how well temsirolimus works in treating patients with refractory or recurrent ovarian epithelial cancer, fallopian tube cancer, or primary peritoneal cancer. Temsirolimus may stop the growth of tumor cells by blocking some of the enzymes needed for cell growth.


Options:
A: To determine the safety, tolerability, dose-limiting toxicity (DLT), and (MTD) of KU-0059436 (assessed at each visit)
B: 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)
C: 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))
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: B
Please select the outcome measures that correspond to the clinical trial below.
Title: Randomized Trial of Intravenous Pulse Versus Oral Continuous Cyclophosphamide for Induction of Remission in Systemic ANCA-Associated Vasculitides
Brief Summary: A comparison of intermittent pulsed cyclophosphamide to daily oral cyclophosphamide for the treatment of ANCA-associated systemic vasculitides with kidney involvement.

Performed by the European Vasculitis Study group.


Options:
A: the disease-free period, defined as the time between the beginning; of the maintenance therapy (AZA or MMF) and the first relapse (minor or major); or the end of the protocol (at 48 months)
B: Time to First Relapse (Approximately up to 4 years)
C: Disease free period, time from remission to relapse or study end.
D: Number of side effects (morbidity) (at 3 years)

Answer: C
Please select the outcome measures that correspond to the clinical trial below.
Title: Randomized Trial of Intravenous Pulse Versus Oral Continuous Cyclophosphamide for Induction of Remission in Systemic ANCA-Associated Vasculitides
Brief Summary: A comparison of intermittent pulsed cyclophosphamide to daily oral cyclophosphamide for the treatment of ANCA-associated systemic vasculitides with kidney involvement.

Performed by the European Vasculitis Study group.


Options:
A: Disease free period, time from remission to relapse or study end.
B: Safety/Efficacy; Frequency of severe adverse events in each arm. Hypothesis based upon NIH data was a rate of 6% severe adverse event with methotrexate compared to 30% with azathioprine (24% in one study on RA and 46% in one study on Sjögren syndrome).; Evaluation was planned after the last included patient has completed the assigned trial regimen (after 12 months of maintenance regimen or because of drug withdrawal).
C: the remission rate after 9 months of therapy with intravenous immunoglobulins,; in relapsing patients with ANCA+ vasculitides (Microscopic Polyangiitis, Wegener's granulomatosis and Churg-Strauss syndrome); during 6 months, after relapse
D: Number of events (failures, relapses and/or deaths) occurring in each group, defining the disease-free survival rate, measured at study end (mean follow-up of 5 years)

Answer: A
Please select the outcome measures that correspond to the clinical trial below.
Title: ALL-BFM 2000 Multi-Center Study for the Treatment of Children and Adolescents With Acute Lymphoblastic Leukemia
Brief Summary: RATIONALE: Drugs used in chemotherapy work in different ways to stop the growth of cancer cells, either by killing the cells or by stopping them from dividing. Giving more than one drug (combination chemotherapy) may kill more cancer cells. It is not yet known which combination chemotherapy regimen is more effective in treating young patients with acute lymphoblastic leukemia.

PURPOSE: Thisphase III trial is studying several different combination chemotherapy regimens to compare how well they work in treating young patients with acute lymphoblastic leukemia.


Options:
A: Efficacy of dexamethasone vs prednisone during the induction phase (End of Trial); Event-free survival (EFS) and overall survival after initial remission in intermediate-risk and high-risk patients (End of Trial); Safety and efficacy of treatment reduction during reintensification in standard-risk patients (End of Trial); EFS after second delayed reintensification in intermediate-risk patients (End of Trial); Outcome after extended reintensification therapy in high-risk patients (End of Trial)
B: To determine the rate of patients with complete asparagine (ASN) depletion in serum during induction treatment and to demonstrate non-inferiority of rASNase compared to Asparaginase medac™ with respect to this parameter (March 2012)
C: Two Year Event-free Survival (EFS) (Up to Two Year After Enrollment)
D: Efficacy of dexamethasone vs prednisone during the induction phase (5 years); Event-free survival (EFS) and overall survival after initial remission in intermediate-risk and high-risk patients (5 years); Safety and efficacy of treatment reduction during reintensification in standard-risk patients (5 years); EFS after second delayed reintensification in intermediate-risk patients (5 years); Outcome after extended reintensification therapy in high-risk patients (5 years)

Answer: A
Please select the outcome measures that correspond to the clinical trial below.
Title: A Phase 3, Randomized, Multicenter, Double-Blind, Allopurinol-Controlled Study Assessing the Efficacy and Safety of Oral Febuxostat in Subjects With Gout.
Brief Summary: The purpose of this study is to compare the efficacy and safety of febuxostat, once Daily (QD), to allopurinol in subjects with hyperuricemia and gout.


Options:
A: Plasma Uric Acid (PUA) Responder (Months 3 and 6)
B: N/A
C: Uric Acid (mg/dL) (Week 13, Week 25, Week 53, Week 101)
D: Percentage of Subjects Whose Serum Urate Level is <6.0 Milligrams Per Deciliter (mg/dL) at the Final Visit. (Last Visit on treatment (up to 6 months))

Answer: D
Please select the outcome measures that correspond to the clinical trial below.
Title: A Phase 3, Randomized, Multicenter, Double-Blind, Allopurinol-Controlled Study Assessing the Efficacy and Safety of Oral Febuxostat in Subjects With Gout.
Brief Summary: The purpose of this study is to compare the efficacy and safety of febuxostat, once Daily (QD), to allopurinol in subjects with hyperuricemia and gout.


Options:
A: Number of Gout Flares Per Participant Assessed From Day 1 to Day 84 (Week 12) (Day 1 (Baseline) to Day 84 (Week 12))
B: Percentage of Subjects Whose Serum Urate Level is <6.0 Milligrams Per Deciliter (mg/dL) at the Final Visit. (Last Visit on treatment (up to 6 months))
C: Percentage of Subjects Whose Serum Urate Level Decreases to < 6.0 mg/dL at Month 1. (Month 1); Percentage of Subjects Whose Serum Urate Level Decreases to < 6.0 mg/dL at Month 12. (Month 12); Percentage of Subjects Whose Serum Urate Level Decreases to < 6.0 mg/dL at Month 24. (Month 24); Percentage of Subjects Whose Serum Urate Level Decreases to < 6.0 mg/dL at Month 36. (Month 36); Percentage of Subjects Whose Serum Urate Level Decreases to < 6.0 mg/dL at Last Visit on Treatment. (Last Visit on treatment (up to 40 months).)
D: Percentage of Subjects Whose Last Three Serum Urate Levels Are <6.0 Milligram Per Deciliter (mg/dL). (Last 3 visits (any last 3 visits up to week 28))

Answer: B
Please select the outcome measures that correspond to the clinical trial below.
Title: A Phase II/III Multi-Center, Randomized, Double-Blind, Placebo-Controlled Study to Evaluate the Efficacy and Safety of Abatacept Versus Placebo on a Background of Mycophenolate Mofetil and Glucocorticosteroids in Subjects With Active Proliferative Glomerulonephritis Due to Systemic Lupus Erythematosus (SLE)
Brief Summary: The purpose of this clinical research study is to learn if addition of abatacept is safe and improves the effectiveness of treatment of patients with active lupus nephritis who are also taking mycophenolate mofetil (MMF) and corticosteroids.


Options:
A: Time to First Confirmed Complete Renal Response (CRR) During the Short-term (Double-blind) Period (Day 1 (randomization) to 12 months.)
B: Efficacy and Safety (6 months)
C: Assessment of Primary Renal Response (12 months)
D: N/A

Answer: A
Please select the outcome measures that correspond to the clinical trial below.
Title: A MULTINATIONAL, MULTICENTRE, RANDOMIZED, PARALLEL GROUP, DOUBLE-BLIND STUDY TO ASSESS THE EFFICACY AND SAFETY OF 1MG, 5MG AND 20 MG TID OF ORAL SILDENAFIL IN THE TREATMENT OF SUBJECTS AGED 18 YEARS AND OVER WITH PULMONARY ARTERIAL HYPERTENSION (PAH)
Brief Summary: To demonstrate a dose response for 1 mg, 5 mg and 20 mg TID oral sildenafil for the treatment of subjects with PAH.


Options:
A: Change From Baseline in the Total Distance Walked During 6-Minute Walk Test (6MWT) at Week 12 (Baseline and Week 12)
B: 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))
C: 6 minute walking distance (3 months)
D: Safety; Standard safety data; Efficacy; 6-Minute Walk Test; BORG Dyspnoea Score; WHO Functional Class; Quality of Life SF-36 and EQ-5D

Answer: A
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 Weeks Double Blind Study With 500mcg Roflumilast Once Daily Versus Placebo. Ratio-Study.
Brief Summary: The purpose of this study is to investigate the effect of 500mcg roflumilast vs placebo on exacerbation rate and pulmonary function as well as quality of life 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: The frequency of patients experiencing at least one moderate or severe exacerbation during the treatment period.; Change in FEV1 from baseline during the treatment period.
C: Change from baseline in forced expiratory volume in 1 second (FEV1) compared to placebo
D: Rate of Moderate or Severe COPD Exacerbations Per Patient Per Year. (Baseline to Week 52)

Answer: B
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 Weeks Double Blind Study With 500mcg Roflumilast Once Daily Versus Placebo. Ratio-Study.
Brief Summary: The purpose of this study is to investigate the effect of 500mcg roflumilast vs placebo on exacerbation rate and pulmonary function as well as quality of life in patients with chronic obstructive pulmonary disease (COPD).


Options:
A: Change From Baseline in Pre-bronchodilator Forced Expiratory Volume in First Second (FEV1) (Baseline to Week 24)
B: 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)
C: The frequency of patients experiencing at least one moderate or severe exacerbation during the treatment period.; Change in FEV1 from baseline during the treatment period.
D: Rate of Moderate or Severe COPD Exacerbations Per Patient Per Year. (Baseline to Week 52)

Answer: C
Please select the outcome measures that correspond to the clinical trial below.
Title: A Randomized, Double-Blind, Placebo-Controlled Evaluation of the Safety, Efficacy, and Pharmacokinetics of Multiple Doses of Basiliximab, With Concomitant Corticosteroids, in Steroid-Refractory Ulcerative Colitis
Brief Summary: The purpose of this study is to assess the safety, effectiveness and pharmacokinetics of two levels of intravenous basiliximab in ulcerative colitis, compared to placebo.


Options:
A: Change in Mayo Score, Safety (At week 8)
B: Proportion of the subjects with clinical remission (defined as Mayo score ≤ 2 points with no individual subscore > 1 point) of BMS-936557 with that of the placebo (End of Induction [Week 11, Induction Period-78 (IP-78)])
C: Number of Participants in Clinical Response Through Week 54 (Induction Baseline, Week 0 through Week 54)
D: Clinical and Endoscopic Remission. (8 weeks)

Answer: A
Please select the outcome measures that correspond to the clinical trial below.
Title: N/A
Brief Summary: A randomized trial comparing radiotherapy with supportive care in patients aged 70 years or older with newly diagnosed, histologically confirmed anaplastic astrocytoma or glioblastoma, and a Karnofsky performance status \> 70.


Options:
A: Progression-free Survival (from the date of randomisation to the date of first progression or death due to any cause, until 6 months from the date the last patient finished trial treatment (the day after the date that the last trial drug was taken))
B: 1. Percentage of patients with a histologically confirmed malignant glioma (grade III or IV -WHO) without definite residual contrast agent-accumulating tumour in the early post-operative control MRI (within 72 hours of the operation). (Within 72 hours after surgery); 2. Progression-free survival 6 months after primary surgical treatment of a malignant gli-oma in patients with histologically confirmed malignant glioma (grade III or IV -WHO). (Within 6 month after surgery)
C: To determine the rate of non-progressive disease at 6 months after inclusion in each arms (after half of each arms has been completed at 6 months of treatment)
D: Survival

Answer: D
Please select the outcome measures that correspond to the clinical trial below.
Title: N/A
Brief Summary: A randomized trial comparing radiotherapy with supportive care in patients aged 70 years or older with newly diagnosed, histologically confirmed anaplastic astrocytoma or glioblastoma, and a Karnofsky performance status \> 70.


Options:
A: Overall survival (12 months)
B: N/A
C: Survival
D: N/A

Answer: C
Please select the outcome measures that correspond to the clinical trial below.
Title: The Effect of Aldosterone Inhibition on Proteinuria in Patients With Progressive Renal Disease
Brief Summary: The purpose of this study is to examine whether the inhibition of aldosterone will result in lower excretion of protein via urine. The hypothesis is that if loss of protein is lowered, progression of renal disease with be slower than otherwise expected.


Options:
A: Number of Participants Remaining on Spironolactone at Week 12 (At week 12)
B: Proteinuria reduction (bi-monthly)
C: Change of serum potassium (4 weeks)
D: 96 Hour Change in NT-proBNP (Randomization to 96 hours)

Answer: B
Please select the outcome measures that correspond to the clinical trial below.
Title: Large, Randomised, Parallel-group, Controlled Trial, With Patients Randomly Allocated to Either N2O-containing (70% N2O in Oxygen [FiO2 0.3]) or N2O-free (70% Nitrogen in Oxygen [FiO2 0.3]).
Brief Summary: To investigate the safety of nitrous oxide (N2O) anaesthesia in patients with risk factors for coronary artery disease undergoing major surgery.


Options:
A: The Primary Endpoint is a Composite of Death and Cardiovascular Events (Clinical and Silent MI, Cardiac Failure, Cardiac Arrest, Pulmonary Embolism, and Stroke) Measured at 30 Days After Surgery. (30 days post op)
B: The Percentage of Incidences With Explicit Recall in the BIS Versus MAC Alert Groups. (Outcome of awareness is assessed 30-days after the operation)
C: The incidence of explicit recall of events during the surgical and anesthetic periods. (Three years)
D: The incidence of explicit recall of events during the surgical and anesthetic periods. (30 days)

Answer: A
Please select the outcome measures that correspond to the clinical trial below.
Title: Large, Randomised, Parallel-group, Controlled Trial, With Patients Randomly Allocated to Either N2O-containing (70% N2O in Oxygen [FiO2 0.3]) or N2O-free (70% Nitrogen in Oxygen [FiO2 0.3]).
Brief Summary: To investigate the safety of nitrous oxide (N2O) anaesthesia in patients with risk factors for coronary artery disease undergoing major surgery.


Options:
A: Surgical site infection (2 weeks)
B: Myocardial Infarct Size (At 72 hours post infarct)
C: The primary endpoint is hospital length of stay (LOS), defined from the start of surgery until actual hospital discharge. Patients transferred to another hospital will be tracked until final discharge to home (or other final destination). LOS is likely
D: The Primary Endpoint is a Composite of Death and Cardiovascular Events (Clinical and Silent MI, Cardiac Failure, Cardiac Arrest, Pulmonary Embolism, and Stroke) Measured at 30 Days After Surgery. (30 days post op)

Answer: D
Please select the outcome measures that correspond to the clinical trial below.
Title: A Comparison of Oral Methylprednisolone Plus Azathioprine or Mycophenolate Mofetil for the Treatment of Bullous Pemphigoid
Brief Summary: To investigate the safety and efficacy of oral methylprednisolone combined with azathioprine or mycophenolate mofetil for the treatment of bullous pemphigoid.


Options:
A: Number of patients with pemphigus controlled 24 months after the start of Rituximab treatment (2 years)
B: The cumulative total methylprednisolone doses and rate of remission.
C: Drug-related Adverse Event profile of BIVV009 (6 weeks)
D: Primary Safety Endpoint (1 year)

Answer: B
Please select the outcome measures that correspond to the clinical trial below.
Title: ARDSnet Protocol vs. the Open Lung Approach for the Ventilatory Management of Severe, Established ARDS: A Global Randomized Controlled Trial
Brief Summary: Many patients with Acute Respiratory Distress Syndrome or ARDS need breathing support that is provided by a machine called a ventilator or respirator. The purpose of this study is to find out if a new method of setting the ventilator for patients with severe ARDS is better than the standard, commonly used way of setting the ventilator.


Options:
A: A composite outcome of mortality and time off the ventilator at 28-days. (Day 28)
B: Number of Ventilator Free Days at Day 28 Post Randomisation (28 days post randomisation)
C: Mortality at 28 days (day 28)
D: 60 day mortality (60 days)

Answer: D
Please select the outcome measures that correspond to the clinical trial below.
Title: ARDSnet Protocol vs. the Open Lung Approach for the Ventilatory Management of Severe, Established ARDS: A Global Randomized Controlled Trial
Brief Summary: Many patients with Acute Respiratory Distress Syndrome or ARDS need breathing support that is provided by a machine called a ventilator or respirator. The purpose of this study is to find out if a new method of setting the ventilator for patients with severe ARDS is better than the standard, commonly used way of setting the ventilator.


Options:
A: Development of ARDS (28 days)
B: Oxygenation (PaO2) measured 5 min after the onset of mechanical ventilation (5 min after the onset of mechanical ventilation)
C: 60 day mortality (60 days)
D: Hospital Mortality

Answer: C
Please select the outcome measures that correspond to the clinical trial below.
Title: A Phase III Multicenter, Randomized, Double-Blind, Active-Controlled, Parallel Group Study of the Efficacy and Safety of the Intravenous and Oral Formulations of the Neurokinin-1 Receptor Antagonist, Casopitant, Administered in Combination With ZOFRAN and Dexamethasone for Prevention of Chemotherapy-Induced Nausea and Vomiting in Cancer Subjects Receiving Highly Emetogenic Cisplatin-Based Chemotherapy
Brief Summary: This is a Phase III trial designed to demonstrate that casopitant when added to dexamethasone and ondansetron is more effective in the prevention of vomiting then dexamethasone and ondansetron alone, in patients who receive a cisplatin-based highly emetogenic chemotherapy.


Options:
A: Home Record: Severity of Delayed Nausea (average of day 1 afternoon, evening and night, and all of days 2 and 3)
B: Number of participants who achieved complete response (Up to 120 hours of cycle 1 of HEC)
C: A Complete Response (no Vomiting and no Use of Rescue Therapy) Overall (in the 120 Hours Following Initiation of Cisplatin). (Overall (in the 120 hours following initiation of cisplatin chemotherapy).)
D: Complete Response. (Participants were evaluated from start of treatment through day 8 of cycle 2.)

Answer: B