TrialPanorama/Dataset huggingface dataset:
Please select the outcome measures that correspond to the clinical trial below.
Title: A Randomized, Double-blind, Placebo-controlled, Multicenter Phase III Study to Compare the Safety and Efficacy of RAD001 Plus Best Supportive Care (BSC) Versus BSC Plus Placebo in Patients With Metastatic Carcinoma of the Kidney Which Has Progressed on VEGF Receptor Tyrosine Kinase Inhibitor
Brief Summary: To assess whether daily treatment with RAD001 could slow the growth and spread of metastatic carcinoma of the kidney. The safety of RAD001 was also to be studied in this trial.


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: N/A
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: Final Overall Survival (OS) - Primary Analysis in the ITT (Intent To Treat) Population (From start of randomization of the first subject (1Dec2003) until the data cut-off (8Sep2006) for the final OS analysis, approximately 33 months later); Final Overall Survival - Secondary Analysis (Placebo Data Censored at 30June2005) in the ITT Population (From start of randomization of the first subject (1Dec2003) until the data cut-off (8Sep2006) for the final OS analysis, approximately 33 months later)

Answer: C
Please select the outcome measures that correspond to the clinical trial below.
Title: An Open-labeled, Randomized, Two-dose, Parallel Group Trial of Ofatumumab, a Fully Human Monoclonal Anti-CD20 Antibody, in Combination With Fludarabine and Cyclophosphamide, in Patients With Previously Untreated B-cell CLL
Brief Summary: To investigate the safety and efficacy of two dose regimes of ofatumumab in combination with chemotherapy in previously untreated patients with B-CLL


Options:
A: Progression-free Survival (PFS) (Median observation time at time of analysis was approximately 21 months); Final Analysis: Time to Progression-free Survival Event (Median observation time was approximately 66.4 months)
B: Number of Participants (Par.) With Complete Remission (CR), Measured From Start of Treatment Until 3 Months After Last Infusion (Start of treatment (Day 1 of Week 0) until 3 months after start of last infusion (up to Week 32)); Number of Participants (Par.) Who Were Classified as Responders and Non-responders (From start of treatment (Day 1 of Week 0) until 3 months after start of last infusion (up to Week 32))
C: Progression-Free Survival (PFS), as Assessed by the Independent Review Committee (IRC) (From randomization to the date of first documented disease progression or death due to any cause, whichever occured first, reported between day of first patient randomized up to about 49 months)
D: Number of Participants (Par.) Classified as Responders and Non-responders for Objective Response as Assessed by an Independent Endpoint Review Committee (IRC) in Accordance With the National Cancer Institute Working Group (NCIWG) 1996 Guidelines (Start of treatment (Week 0 of Visit 2) until Week 24)

Answer: B
Please select the outcome measures that correspond to the clinical trial below.
Title: Allergen Challenge
Brief Summary: Primary purpose of the protocol is to determine if IMA-638 prevents a mild asthma attack by a subject with mild asthma inhaling an allergen.


Options:
A: Maximum Percent Drop From Pre-allergen Baseline in Forced Expiratory Volume in 1 Second (FEV1) for Late-Phase Asthma Response (LAR) at Screening (Pre-allergen baseline, 3, 4, 5, 6, 7 hours post-allergen inhalation at Screening (Day -14)); Maximum Percent Drop From Pre-allergen Baseline in Forced Expiratory Volume in 1 Second (FEV1) for Late-Phase Asthma Response (LAR) at Day 14 (Pre-allergen baseline, 3, 4, 5, 6, 7 hours post-allergen inhalation at Day 14); Maximum Percent Drop From Pre-allergen Baseline in Forced Expiratory Volume in 1 Second (FEV1) for Late-Phase Asthma Response (LAR) at Day 35 (Pre-allergen baseline, 3, 4, 5, 6, 7 hours post-allergen inhalation at Day 35)
B: Late airway response (LAR) area under the concentration-time curve (AUC) (percent decline in forced expiratory volume in 1 second [FEV1] over time) (Between 3 and 7 hours after allergen challenge at Day 86 after the first dose)
C: Number of Participants With the Indicated Percent Reduction From Baseline in Oral Corticosteroid (OCS) Dose During Weeks 20 to 24 While Maintaining Asthma Control (Baseline; Weeks 20 to 24)
D: Percentage of Participants With First Clinically Significant Exacerbation in Part C (Weeks 12, 24, 36 and 52)

Answer: A
Please select the outcome measures that correspond to the clinical trial below.
Title: Allergen Challenge
Brief Summary: Primary purpose of the protocol is to determine if IMA-638 prevents a mild asthma attack by a subject with mild asthma inhaling an allergen.


Options:
A: Maximum Percent Drop From Pre-allergen Baseline in Forced Expiratory Volume in 1 Second (FEV1) for Late-Phase Asthma Response (LAR) at Screening (Pre-allergen baseline, 3, 4, 5, 6, 7 hours post-allergen inhalation at Screening (Day -14)); Maximum Percent Drop From Pre-allergen Baseline in Forced Expiratory Volume in 1 Second (FEV1) for Late-Phase Asthma Response (LAR) at Day 14 (Pre-allergen baseline, 3, 4, 5, 6, 7 hours post-allergen inhalation at Day 14); Maximum Percent Drop From Pre-allergen Baseline in Forced Expiratory Volume in 1 Second (FEV1) for Late-Phase Asthma Response (LAR) at Day 35 (Pre-allergen baseline, 3, 4, 5, 6, 7 hours post-allergen inhalation at Day 35)
B: Persistency of Response and Non-response as Based on Investigator's Global Evaluation of Treatment Effectiveness (GETE) (Weeks 16 and 32)
C: Rate of asthma exacerbations during the 52-week placebo-controlled period (weeks 0-52)
D: N/A

Answer: A
Please select the outcome measures that correspond to the clinical trial below.
Title: N/A
Brief Summary: The purpose of this study is to compare a specific fear-reducing information with symptom-based exercise


Options:
A: Intensity of pain, measured at baseline, 90, and 180 days later (6 months); Disability, measured at baseline, 90, and 180 days later (6 months); Sick leave, measured at baseline, 90, and 180 days later (6 months)
B: N/A
C: Pain Scores (Baseline, Midtreatment, Posttreatment, 3 month follow-up, 6 month follow-up)
D: Patient-rated pain (0-11 box scale) (short term = 12 weeks; long term = 52 weeks)

Answer: B
Please select the outcome measures that correspond to the clinical trial below.
Title: N/A
Brief Summary: The purpose of this study is to compare a specific fear-reducing information with symptom-based exercise


Options:
A: Oswestry Disability Index; Cost-effectiveness (full economic analysis)
B: N/A
C: Pain VAS
D: Adjusted Change in Pain-related Function (Roland Disability Score) (12 months)

Answer: B
Please select the outcome measures that correspond to the clinical trial below.
Title: A Phase 3, Multi-Center, Randomized, Double-Blind, Placebo-Controlled, 76-Week Study to Evaluate the Efficacy and Safety of Belimumab (HGS1006, LymphoStat-B™), a Fully Human Monoclonal Anti-BLyS Antibody, in Subjects With Systemic Lupus Erythematosus (SLE)
Brief Summary: The purpose of this study is to evaluate the efficacy, safety, tolerability, and impact on quality of life of two different doses of belimumab administered in addition to standard therapy in subjects with active, autoantibody-positive systemic lupus erythematosus (SLE) disease.


Options:
A: Percentage Change From Baseline in Safety of Estrogens in Lupus Erythematosus National Assessment SLE Disease Activity Index (SELENA SLEDAI) Score at Week 24. (Baseline, 24 weeks); Time to First Mild/Moderate or Severe SLE Flare (SLE Flare Index) (0 to 52 weeks)
B: SLE Responder Index (SRI) Response Rate at Week 52 (Baseline, 52 Weeks)
C: SLE Responder Index (SRI) Response Rate at Week 52 (Baseline, 52 weeks)
D: Number of Participants With the Indicated Type of Adverse Event (AEs) and Serious Adverse Event (SAEs) (Up to Week 440); AE Rates by System Organ Class (SOC) During the Study (Up Week 440); SAE Rates by System Organ Class (SOC) During the Study (Up to Week 440); Change From Baseline in Activated Partial Thromboplastin Time (APTT) and Prothrombin Time (PT) at the Indicated Time Points (Up to Week 440); Change From Baseline in Basophils, Eosinophils, Lymphocytes, Monocytes, Neutrophils, Neutrophils Segmented and Platelets at the Indicated Time Points (Up to Week 440); Change From Baseline in Erythrocytes at the Indicated Time Points (Up to Week 440); Change From Baseline in Hematocrit at the Indicated Time Points (Up to Week 440); Change From Baseline in Hemoglobin at the Indicated Time Points (Up to Week 440); Change From Baseline in Albumin and Protein at the Indicated Time Points (Up to Week 440); Change From Baseline in Blood Urea Nitrogen, Glucose, Calcium, Carbon Dioxide, Chloride, Magnesium, Phosphate, Potassium and Sodium at the Indicated Time Points (Up to Week 440); Change From Baseline in Creatinine, Urate and Bilirubin at the Indicated Time Points (Up to Week 440); Change From Baseline in Creatinine Clearance at the Indicated Time Points (Up to Week 440); Change From Baseline in BUN/Creatinine at the Indicated Time Points (Up to Week 440); Change From Baseline in Alanine Aminotransferase, Alkaline Phosphatase, Aspartate Aminotransferase, Gamma Glutamyl Transferase and Lactate Dehydrogenase at the Indicated Time Points (Up to Week 432); Number of Participants With the Indicated Immunogenic Response (Up to Week 440); Systolic Blood Pressure and Diastolic Blood Pressure at Indicated Time Points. (Up to Week 432); Percentage of Participants With at Least 25% Increase From Baseline in Creatinine at Indicated Time Points. (Up to Week 440); Percentage of Participants With at Least 25% Reduction From Baseline in Creatinine at Indicated Time Points. Amongst Subjects With Abnormal (>124 Umol/L) Creatinine at Baseline by Year Interval. (Up to Week 440)

Answer: B
Please select the outcome measures that correspond to the clinical trial below.
Title: A Phase 3, Multi-Center, Randomized, Placebo-Controlled Study to Evaluate the Clinical Efficacy and Safety of Induction and Maintenance Therapy With Abatacept in Subjects With Active Ulcerative Colitis (UC) Who Have Had an Inadequate Clinical Response and/or Intolerance to Medical Therapy
Brief Summary: The purpose of this clinical research study is to learn if abatacept can improve signs and symptoms of active ulcerative colitis in patients who have not had an adequate response to other therapies. The safety of this treatment will also be studied


Options:
A: 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)])
B: Clinical remission defined as a Mayo Clinic Score (MCS) </= 2 with no individual subscore exceeding 1 point (Week 10)
C: Induction Period (IP); Number of Participants With Clinical Response (Per Mayo Score) at Week 12: IP Cohort 1 (IP1C) (Week 12 (Day IP-85)); Maintenance Period (MP); Number of Participants With Clinical Response (Per Mayo Score) at Month 12 (Month 12 (Day MP-365)); Open-Label Extension Period (OL); Number of Participants With Adverse Events (AEs), Related AEs, Deaths, Serious AEs (SAEs), Related SAEs, and AEs Leading to Discontinuation (Day OL-1 through the end of the OL); OL; Number of Participants With AEs of Special Interest (Day OL-1 through Day OL-729); OL; Number of Participants With Physical Examination Findings (Day OL-1 through Day OL-729); OL; Number of Participants With Marked Hematology Laboratory Abnormalities (Day OL-1 through Day OL-729); OL; Number of Participants With Liver and Kidney Function and Electrolyte Laboratory Abnormalities (Day OL-1 through Day OL-729); OL; Number of Participants With Chemistry and Urinalysis Laboratory Abnormalities (Day OL-1 through Day OL-729)
D: Percentage of Treatment Success Patients at Week 6, ITT (Intent to Treat) Population (6 Weeks)

Answer: C
Please select the outcome measures that correspond to the clinical trial below.
Title: A Repeated-Dose Evaluation of Analgesic Use and Safety of Dilaudid SR (Hydromorphone HCI) in Patients With Chronic Non-Malignant Pain
Brief Summary: The purpose of this repeated dose study is to develop recommended dosing information for initiation of therapy with OROS Hydromorphone in patients with chronic non-malignant pain converting from other strong oral or transdermal opioids. It will also assist in the development of a recommended starting dose by which patients can be titrated to an appropriate maintenance dose of OROS Hydromorphone HCI. The safety profile for OROS Hydromorphone HCI will also be evaluated.


Options:
A: Change in pain intensity from baseline (pre-randomization) to last assessment.
B: The primary outcomes include incidence of adverse events, changes in laboratory measures, results of physical exams, and results of 12-Lead ECG.
C: Average Pain Over the Last 24 Hours Scores at Week 12 of the Double-blind Phase. (Prerandomization phase consisted of a 6-10 day screening period and a <27 day open-label run-in period; and a 12-week double-blind phase.)
D: No primary efficacy variable was defined in report. Protocol variables measured included: Total daily dose of OROS hydromorphone, daily use of rescue medication, daily pain relief scores, and time/number of steps needed for dose stabilization.

Answer: D
Please select the outcome measures that correspond to the clinical trial below.
Title: Effect of Nuts on Glycemic Control and Cardiovascular Disease Risk in Type 2 Diabetes
Brief Summary: To determine if tree nuts (Almonds, Hazelnuts, Pistachios, Peanuts, Macadamia nuts, Pecans, Walnuts and Cashews) improve glycemic control in type 2 diabetes, as assessed by HbA1c and serum fructosamine, and to assess whether these outcomes relate to improvements in cardiovascular health (i.e. plasma lipids and measures of oxidative stress, inflammatory biomarkers and nitric oxide generation). The investigators have found that nuts tend to reduce the glycemic index of bread and have little effect of raising blood glucose on their own. Therefore the investigators believe that they would be ideal foods to displace high glycemic foods from the diet and lower the dietary glycemic load. This will result in improved blood glucose control in type 2 diabetes, with additional benefits on coronary heart disease risk factors due to other effects of nuts.


Options:
A: Metabolic syndrome status (12 weeks)
B: N/A
C: Change in Weight (2, 4, 6, 8, 10, and 12 weeks); Change in Blood Lipids (4, 8, and 12 weeks); Change in Blood Pressure (2, 4, 6, 8, 10, and 12 weeks); Change in Hedonics of peanut consumption (12 weeks); Change in Body Composition (2, 4, 6, 8, 10, and 12 weeks); Change in Fasting Blood Glucose (4, 8, and 12 weeks); Change in Cortisol (4, 8, and 12 weeks); Change in Insulin (4, 8, and 12 weeks); Change in Pulse (2, 4, 6, 8, 10, and 12 weeks)
D: Markers of glycemic control: Fasting serum fructosamine (From prestudy and week 0, to end of treatment weeks 8, 10, 12); Fasting serum HbA1c (From prestudy and week 0, to end of treatment weeks 8, 10, and 12); Fasting glucose (From prestudy and week 0, to end of treatment and weeks 8, 10, and 12); Fasting insulin (From prestudy and week 0, to end of treatment and weeks 8, 10, and 12)

Answer: D
Please select the outcome measures that correspond to the clinical trial below.
Title: Multicenter Randomized Phase II Study of Erlotinib, Cisplatin and Radiotherapy Versus Cisplatin and Radiotherapy in Patients With Stage III and IV Squamous Cell Carcinoma of the Head and Neck
Brief Summary: This randomized phase II trial is studying cisplatin and radiation therapy together with or without erlotinib hydrochloride to compare how well they work in treating patients with stage III or stage IV head and neck cancer. Drugs used in chemotherapy, such as cisplatin, work in different ways to stop the growth of tumor cells, either by killing the cells or by stopping them from dividing. Specialized radiation therapy that delivers a high dose of radiation directly to the tumor may kill more tumor cells and cause less damage to normal tissue. Erlotinib hydrochloride may stop the growth of tumor cells by blocking some of the enzymes needed for cell growth. It may also make tumor cells more sensitive to radiation therapy. Giving cisplatin and radiation therapy together with erlotinib hydrochloride may kill more tumor cells. It is not yet known whether cisplatin and radiation therapy are more effective with or without erlotinib hydrochloride in treating head and neck cancer


Options:
A: Objective Response Rate (ORR) - BRAF Wild-type (WT) Participants (From 12 weeks after Randomization, assessed every 6 weeks up to Week 49 of study treatment and then every 12 weeks until disease progression (up to approximately 76 months))
B: N/A
C: Comparison of the Percentage of Participants With a Complete Response in Each Treatment Arm (12 weeks after the completion of therapy)
D: Local Regional Control Rate at 2 Years (from study day 1 to 2 years)

Answer: C
Please select the outcome measures that correspond to the clinical trial below.
Title: A Phase III Study Comparing Adjuvant Chemotherapy Consisting of Capecitabine/Oxaliplatin vs Surgery Alone in Patients With Stage II (T1N2, T2N1, T3N0), IIIa (T2N2, T3N1, T4NO), and IIIb (T3N2) Gastric Adenocarcinoma
Brief Summary: Primary:

* To demonstrate that capecitabine/oxaliplatin as adjuvant chemotherapy is superior to observation alone in terms of 3 year disease-free survival (DFS) rate in chemotherapy-naïve patients who underwent potentially curative resection for gastric cancer.

Secondary:

* To compare the overall survival of surgery and capecitabine/ oxaliplatin as adjuvant therapy versus surgery alone. To evaluate the safety profile of capecitabine/oxaliplatin adjuvant therapy.


Options:
A: Recurrence of the original cancer (From the beginning to end of the study); Development of a new gastric cancer (From beginning to end of study); Death due to any cause (From the beginning to the end of study); Adverse events (From beginning to end of study); Clinical laboratory tests (From beginning to end of study)
B: Time to progression (The time from randomization until objective tumor progression or death)
C: median overall survival (2 years follow-up)
D: Time to Progression (every 8 weeks up to a maximum of 36 months)

Answer: A
Please select the outcome measures that correspond to the clinical trial below.
Title: Everolimus (RAD001)Therapy of Giant Cell Astrocytomas in Patients With Tuberous Sclerosis Complex
Brief Summary: The purpose of the study is to evaluate the safety and potential side effects of everolimus (an experimental drug) on a person with Tuberous Sclerosis Complex who also has been diagnosed with a brain tumor (astrocytoma)

The hypothesis is that the drug will cause the tumor size to decrease, and may have beneficial activity separate from effects on tumors in patients.


Options:
A: Number With Observed Adverse Side Effects (During the entire study)
B: Change From Baseline in the Facial Angiofibroma Grading Scale (AGS) Score (baseline, 6 months)
C: Angiomyolipoma Response Rate as Per Central Radiology Review (From date of randomization until the earliest date of first documented AML progression, date of further anti-AML medication (including open-label Everolimus)/surgery or up to 5.7 years)
D: longest diameter of renal angiomyolipomas assessed by MRI scan, toxicity graded by National Cancer Institute's Common Terminology Criteria for Adverse Events v3.0 (assessments at baseline and 2,6,12 and 24 months); toxicity graded by National Cancer Institute's Common Terminology Criteria for Adverse Events (throughout study)

Answer: A
Please select the outcome measures that correspond to the clinical trial below.
Title: Everolimus (RAD001)Therapy of Giant Cell Astrocytomas in Patients With Tuberous Sclerosis Complex
Brief Summary: The purpose of the study is to evaluate the safety and potential side effects of everolimus (an experimental drug) on a person with Tuberous Sclerosis Complex who also has been diagnosed with a brain tumor (astrocytoma)

The hypothesis is that the drug will cause the tumor size to decrease, and may have beneficial activity separate from effects on tumors in patients.


Options:
A: longest diameter of renal angiomyolipomas assessed by MRI scan, toxicity graded by National Cancer Institute's Common Terminology Criteria for Adverse Events v3.0 (assessments at baseline and 2,6,12 and 24 months); toxicity graded by National Cancer Institute's Common Terminology Criteria for Adverse Events (throughout study)
B: Number With Observed Adverse Side Effects (During the entire study)
C: Volume of Angiomyolipomata
D: Angiomyolipoma Response Rate as Per Central Radiology Review (From date of randomization until the earliest date of first documented AML progression, date of further anti-AML medication (including open-label Everolimus)/surgery or up to 5.7 years)

Answer: B
Please select the outcome measures that correspond to the clinical trial below.
Title: A Dose-escalating Study of the Safety and Pharmacokinetics of GSK679586A in Healthy Volunteers and Mild Asthmatics.
Brief Summary: This is a two part study. Part I is designed to test single doses of GSK678586A in healthy volunteers. Part II is designed to test repeat doses (two doses) of GSK679586A in patients with mild asthma. Both parts are designed to investigate the safety, tolerability and the way the body absorbs GSK679586A when given by intravenous infusion (through a vein in your arm).


Options:
A: Rate of Clinically Significant Asthma Exacerbations Per Patient in the 24-week Fixed-dose Steroid Treatment Period (Baseline to end of the fixed-dose steroid treatment period (Week 24)); Percentage of Participants With at Least 1 Adverse Event (Baseline to end of the study (Week 68))
B: Safety and tolerability in healthy volunteers.Assessed using clinical safety assessments and blood and urine analysis (Throughout the study); Safety and tolerability in mild asthmatics.Assessed using clinical safety assessments and blood and urine analysis. (Throughout the study)
C: Percentage of Participants Who Experienced an HES Flare or Who Withdrew From the Study During the 32-Week Study Treatment Period (Up to Week 32)
D: Number of Clinically Significant Exacerbations of Asthma Per Year (From randomization (Week 0) to Week 52 or early withdrawal (EW))

Answer: B