TrialPanorama/Dataset huggingface dataset:
Please select the outcome measures that correspond to the clinical trial below.
Title: A Phase III Randomized Study of Cetuximab (Erbitux™, C225) and Best Supportive Care Versus Best Supportive Care in Patients With Pretreated Metastatic Epidermal Growth Factor Receptor (EGFR)-Positive Colorectal Carcinoma
Brief Summary: RATIONALE: Monoclonal antibodies, such as cetuximab, can target tumor cells and either kill them or deliver tumor-killing substances to them without harming normal cells. Best supportive care is the use of drugs and other treatments to improve the quality of life of patients. Combining cetuximab with best supportive care may slow the growth of the tumor and help patients live longer and more comfortably. It is not yet known whether cetuximab combined with best supportive care is more effective than best supportive care alone in treating metastatic epidermal growth factor receptor-positive colorectal cancer.

PURPOSE: This randomized phase III trial is studying cetuximab and best supportive care to see how well they work compared to best supportive care alone in treating patients with metastatic epidermal growth factor receptor-positive colorectal cancer.


Options:
A: Safety Part: Number of Subjects Experiencing DLTs (Dose Limiting Toxicity) (Time from the first dose of study drug up to 2 weeks); Randomized Part: Progression Free Survival (PFS) (Time from randomization until progressive disease or death; assessed up to 18 months (i.e data cut-off date: 09 Oct 2013))
B: Overall Survival (OS) (Randomization to Date of Death from Any Cause Up to 39.36 Months)
C: Overall survival
D: Progression-free Survival Time (From randomization to the data cut-off date of 30 June 2005. The median follow-up time was 20.0 weeks in the panitumumab plus BSC group and 18.2 weeks in the BSC alone group.)

Answer: C
Please select the outcome measures that correspond to the clinical trial below.
Title: Phase III Randomized Comparison Study of Vinorelbine, Gemcitabine, and Docetaxel Versus Paclitaxel and Carboplatin in Patients With Advanced Non-Small Cell Lung Cancer
Brief Summary: RATIONALE: Drugs used in chemotherapy, such as vinorelbine, gemcitabine, docetaxel, paclitaxel, and carboplatin, work in different ways to stop tumor cells from dividing so they stop growing or die. Combining more than one drug may kill more tumor cells. It is not yet known which combination chemotherapy regimen is more effective in treating non-small cell lung cancer.

PURPOSE: This randomized phase III trial is studying how well giving vinorelbine together with gemcitabine and docetaxel works compared to giving paclitaxel together with carboplatin in treating patients with stage IIIB, stage IV, or recurrent non-small cell lung cancer.


Options:
A: N/A
B: Overall survival (1-year)
C: Change in the total score from baseline measured by the Functional Assessment of Cancer Therapy-Lung (FACT-L), FACT-Taxane, and Functional Assessment of Chronic Illness Therapy-Spirituality (FACIT-Sp) questionnaires at 9, 18, and 22 weeks or withdrawal
D: Overall survival (From ICF signature date until e until death date for any cause)

Answer: A
Please select the outcome measures that correspond to the clinical trial below.
Title: Benefits & Risks of Popular Weight Loss Diets
Brief Summary: This study will compare the safety and effectiveness of three popular weight loss plans. These plans will be compared with the USDA Dietary Guidelines.


Options:
A: Body weight; Fat mass and fat-free mass; Food intake
B: Weight; measured at each study visit; Percent body fat; measured at each study visit
C: Change in body weight (kg) (26 weeks)
D: Blood Flow in Brain Areas of Intake Control. (4 hours postprandial)

Answer: B
Please select the outcome measures that correspond to the clinical trial below.
Title: Benefits & Risks of Popular Weight Loss Diets
Brief Summary: This study will compare the safety and effectiveness of three popular weight loss plans. These plans will be compared with the USDA Dietary Guidelines.


Options:
A: Cardiovascular Disease Prevention based on dietary approach. (Two years)
B: N/A
C: N/A
D: Weight; measured at each study visit; Percent body fat; measured at each study visit

Answer: D
Please select the outcome measures that correspond to the clinical trial below.
Title: A 1 Year, Randomized, Double-blind, Parallel-group, Placebo-controlled, Multicenter Evaluation of Efficacy, Safety, Pharmacokinetics, and Pharmacodynamics of Omalizumab in Children (6 - < 12 Years) With Moderate-severe, Persistent, Inadequately Controlled Allergic Asthma
Brief Summary: A substance called immunoglobulin E (IgE), which is naturally produced by our body, has a key role in generating asthma attacks. In patients with allergies, there is an exaggerated production of IgE in response to specific substances such as pollens. Omalizumab is a new drug that inactivates IgE. This study tested the safety and efficacy of omalizumab against asthma attacks in children with allergic asthma.


Options:
A: Number of severe asthma patients eligible for one or more biologic treatments for asthma (Day 1)
B: Evaluate the safety and tolerability of MEDI-563 in adults with atopic asthma and evaluate the effects of MEDI-563 on eosinophil counts in airway mucosal biopsies 28 days after completion of dosing in adults with atopic asthma. (Study Day 84 or Day 140 - (dose-driven))
C: 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))
D: Persistency of Response and Non-response as Based on Investigator's Global Evaluation of Treatment Effectiveness (GETE) (Weeks 16 and 32)

Answer: C
Please select the outcome measures that correspond to the clinical trial below.
Title: A 1 Year, Randomized, Double-blind, Parallel-group, Placebo-controlled, Multicenter Evaluation of Efficacy, Safety, Pharmacokinetics, and Pharmacodynamics of Omalizumab in Children (6 - < 12 Years) With Moderate-severe, Persistent, Inadequately Controlled Allergic Asthma
Brief Summary: A substance called immunoglobulin E (IgE), which is naturally produced by our body, has a key role in generating asthma attacks. In patients with allergies, there is an exaggerated production of IgE in response to specific substances such as pollens. Omalizumab is a new drug that inactivates IgE. This study tested the safety and efficacy of omalizumab against asthma attacks in children with allergic asthma.


Options:
A: Number of Clinically Significant Exacerbations of Asthma Per Year (From randomization (Week 0) to Week 32 or if Early Withdrawal (EW) 4 weeks post last dose)
B: 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))
C: Evaluate the safety and tolerability of MEDI-563 in adults with atopic asthma and evaluate the effects of MEDI-563 on eosinophil counts in airway mucosal biopsies 28 days after completion of dosing in adults with atopic asthma. (Study Day 84 or Day 140 - (dose-driven))
D: Comparison of the maximum change in FEV1 from baseline for the LAR between IMA-026 and placebo (11 weeks)

Answer: B
Please select the outcome measures that correspond to the clinical trial below.
Title: A 1 Year, Randomized, Double-blind, Parallel-group, Placebo-controlled, Multicenter Evaluation of Efficacy, Safety, Pharmacokinetics, and Pharmacodynamics of Omalizumab in Children (6 - < 12 Years) With Moderate-severe, Persistent, Inadequately Controlled Allergic Asthma
Brief Summary: A substance called immunoglobulin E (IgE), which is naturally produced by our body, has a key role in generating asthma attacks. In patients with allergies, there is an exaggerated production of IgE in response to specific substances such as pollens. Omalizumab is a new drug that inactivates IgE. This study tested the safety and efficacy of omalizumab against asthma attacks in children with allergic asthma.


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: Change (%) From Baseline in FcεRI (High-affinity IgE Receptor) Expression on Blood Basophils and Dendritic Cells After 16 Weeks of Treatment With Omalizumab as Compared With Placebo (Baseline and Week 16); Change (%) From Baseline in Mean Fluorescence Intensity of FcεRI After 16 Weeks of Treatment With Omalizumab as Compared With Placebo (Baseline and Week 16)
C: Maximum Number of Asthma Symptom Days (Weeks 12-60: 12 months of assessments starting 12 weeks after the initiation of study treatment.)
D: Integrated Asthma Quality of Life Questionnaire (AQLQ) Score (Change From Baseline) (Baseline, 12 Months)

Answer: A
Please select the outcome measures that correspond to the clinical trial below.
Title: A Randomized, Double Blind, Placebo Controlled Trial to Determine the Efficacy of Isoniazid (INH) in Preventing Tuberculosis Disease and Latent Tuberculosis Infection Among Infants With Perinatal Exposure to HIV
Brief Summary: Tuberculosis (TB) is highly endemic in sub-Saharan Africa. The increased burden of TB in settings with high prevalence of the Human Immunodeficiency Virus (HIV) is associated with high rates of transmission of Mycobacterium tuberculosis (M.tb) to both adults and children. Children infected with TB have a higher risk of developing severe disease than adults with TB. The purpose of this study was to determine if the antibiotic isoniazid (INH) prevented TB infection in infants born to HIV-infected mothers.


Options:
A: Incident tuberculosis (During enrolment)
B: to compare the compliance; to compare the side effects
C: Cumulative Rate of Culture-Confirmed TB Disease in Participants ≥18 Years of Age AND Culture-Confirmed or Probable (Clinical) TB Disease in Participants Less Than [<]18 Years of Age at 33 Months After Enrollment (Baseline up to Month 33)
D: Time to Development of Tuberculosis (TB) Disease or Death Among HIV-infected Children (Through to week 96); Time From Randomization to Development of TB Infection or Death Among Perinatally Exposed, HIV-uninfected Children (Through to week 96)

Answer: D
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 the effects of three types of treatments for depressed teenagers who have attempted suicide.


Options:
A: suicidal ideation - Suicidal Ideation Questionnaire-JR (3 month)
B: N/A
C: Change in Young Mania Rating Scale (Y-MRS) Total Score at Week 4 (Baseline and Week 4)
D: Suicidal Ideation Questionnaire - JR (SIQ-JR) (Baseline, 6 weeks, 12 weels, 24 weeks); Beck Depression Inventory - II (BDI-II) (Baseline, 6 weeks, 12 weeks, 24 weeks); Scale for Suicidal Ideation (SSI) (baseline, 6 weeks, 12 weeks, 24 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 the effects of three types of treatments for depressed teenagers who have attempted suicide.


Options:
A: Alcohol Use Behaviors (Average number of drinks as recorded on the Timeline Follow-Back (subject-reported) measure daily over the 12-week acute phase.); Depressive Symptoms (Average score as measured by participant's report on the Beck Depression Inventory (BDI).)
B: recurrence of depression (52 weeks)
C: Mood Severity Index (Measured at Months 6 and 12)
D: N/A

Answer: D
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 the effects of three types of treatments for depressed teenagers who have attempted suicide.


Options:
A: Scale of Suicidal Ideation (baseline to Day 3 of TMS treatment)
B: Persons repeating a suicidal act (One, two and three years)
C: N/A
D: Beck scale for suicidal ideation (six months)

Answer: C
Please select the outcome measures that correspond to the clinical trial below.
Title: An Open-Label Evaluation of the Safety and Efficacy of a Combination of Niacin ER and Simvastatin in Patients With Dyslipidemia (OCEANS)
Brief Summary: The purpose of this 24 week study is to compare the effectiveness and safety of different doses of Niacin ER/Simvastatin (NS) in subjects with elevated fat levels in their blood (dyslipidemia).

At least 600 subjects with a similar medical condition will take part in this study.


Options:
A: Time to First Occurrence of Cardiovascular Death, Major Coronary Event, or Non-fatal Stroke (Kaplan-Meier Estimate of Percentage of Participants Experiencing a Qualifying Event) (Up to approximately 9 years)
B: Major Vascular Event (During scheduled treatment period (median duration 3.9 years))
C: change in percent atheroma volume at 12 months intravascular ultrasonography (12 months)
D: N/A

Answer: D
Please select the outcome measures that correspond to the clinical trial below.
Title: A Randomized Double-Blind Phase II Trial of Celecoxib, A COX-2 Inhibitor, in the Treatment of Patients With Cervical Intraepithelial Neoplasia 2/3 or 3 (CIN 2/3 or 3)
Brief Summary: This randomized phase II trial studies how well celecoxib works in treating patients with cervical intraepithelial neoplasia, a precancerous lesion of the cervix which can develop into cervical cancer. Celecoxib may be effective in preventing the development of cervical cancer in patients who have cervical intraepithelial neoplasia.


Options:
A: To evaluate the effects of celecoxib in reducing the proportion of subjects with new colorectal adenomas post baseline polypectomy after Month 13 (Year 1) and Month 37 (Year 3) of study drug administration. (3 years)
B: Number of Subjects With Histopathologically-confirmed Cervical Intraepithelial Neoplasia (CIN)2+ Associated With HPV-16 and/or -18 Cervical Infection in Subjects HPV DNA Negative and Seronegative at Baseline or Overall (Any Serostatus at Baseline) (Up to the moment when 36 cases of CIN2+ lesions associated with HPV-16 or HPV-18 infection had been detected, including at least 15 cases of CIN2+ associated with HPV-18 infection. Mean follow-up was 34.9 months post-dose 3); Number of Subjects With Histopathologically-confirmed Cervical Intraepithelial Neoplasia (CIN)2+ Associated With HPV-16 and/or -18 Cervical Infection in Subjects HPV DNA Negative and Seronegative at Baseline or Overall (Any Serostatus at Baseline) (at Month 48)
C: Percentage of subjects with newly detected adenomas, and will be estimated using the life table method for each treatment group (Year 3 (cumulative for year one and year three)); Percentage of patients with adenomas, aspirin use at baseline, and covariates (Year 5)
D: Histologic Regression (Post treatment evaluation was done 14 to 18 weeks after treatment randomization); Incidence of Adverse Effects (Grade 3 or Higher) as Assessed by Common Terminology Criteria for Adverse Events Version 3.0 (Assessed every cycle while on treatment, 30 days after the last cycle of treatment)

Answer: D
Please select the outcome measures that correspond to the clinical trial below.
Title: Studies to Treat Or Prevent Pediatric Type 2 Diabetes (STOPP-T2D) Treatment Options for Type 2 Diabetes in Adolescents and Youth (TODAY) Clinical Trial
Brief Summary: The National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK) of the National Institutes of Health (NIH) has sponsored a consortium of investigators to conduct a clinical treatment trial, Treatment Options for type 2 Diabetes in Adolescents and Youth (TODAY).

The primary objective of the TODAY trial is to compare the efficacy of three treatment arms on time to treatment failure based on glycemic control. The secondary aims are to:

* compare and evaluate the safety of the three treatment arms;
* compare the effects of the three treatments on the pathophysiology of type 2 diabetes (T2D) with regards to beta cell function and insulin resistance, body composition, nutrition, physical activity and aerobic fitness, cardiovascular risk factors, microvascular complications, quality of life, and psychological outcomes;
* evaluate the influence of individual and family behaviors on treatment response; and
* compare the relative cost effectiveness of the three treatment arms.

The three treatment regimens are: (1) metformin alone, (2) metformin plus rosiglitazone, and (3) metformin plus an intensive lifestyle intervention called the TODAY Lifestyle Program (TLP). The study recruits patients over a three-year period and follows patients for a minimum of two years. Patients are randomized within two years of the diagnosis of T2D.


Options:
A: Change in Hemoglobin A1c From Baseline to 26 Weeks, Adjusted for Baseline Hemoglobin A1c. (0-26 weeks)
B: Body weight (24 weeks)
C: Treatment Failure (Loss of Glycemic Control) (Study duration - 2 years to 6.5 years of follow up from randomization)
D: Absolute change in body mass index (BMI) from baseline to endpoint. (12 months)

Answer: C
Please select the outcome measures that correspond to the clinical trial below.
Title: Community-Based Cognitive Therapy for Suicide Attempters
Brief Summary: This study will determine the effectiveness of cognitive behavioral therapy (CBT) in preventing future suicide attempts in repeat suicide attempters.


Options:
A: Change in BPD (Borderline Personality Disorder) behaviors (8-weeks)
B: State-Trait Anxiety Inventory (week 0 (baseline)); Hamilton Anxiety Rating Scale (week 0 (baseline)); Clinical Global Impression - Severity scale (week 0 (baseline)); Clinical Global Impression - Improvement scale (week 0 (baseline)); Mini-International Neuropsychiatric Interview 5 (week 0 (screening)); Becks Depression Inventory II (week 0 (screening)); State-Trait Anxiety Inventory (week 12 (end of treatment)); Hamilton Anxiety Rating Scale (week 12 (end of treatment)); Clinical Global Impression - Severity scale (week 12 (end of treatment)); Clinical Global Impression - Improvement scale (week 12 (end of treatment)); Mini-International Neuropsychiatric Interview 5 (week 12 (end of treatment)); Becks Depression Inventory II (week 12 (end of treatment)); State-Trait Anxiety Inventory (week 24 (follow-up)); Hamilton Anxiety Rating Scale (week 24 (follow-up)); Clinical Global Impression - Severity scale (week 24 (follow-up)); Clinical Global Impression - Improvement scale (week 24 (follow-up)); Mini-International Neuropsychiatric Interview 5 (week 24 (follow-up)); Becks Depression Inventory II (week 24 (follow-up))
C: Repeat suicide attempts (Measured during treatment and 1, 3, 6, 12, 18, and 24 months after study completion)
D: Time to Fatal or Non-fatal Suicide Attempt or Self-Harm (18 Months after randomization)

Answer: C
Please select the outcome measures that correspond to the clinical trial below.
Title: Community-Based Cognitive Therapy for Suicide Attempters
Brief Summary: This study will determine the effectiveness of cognitive behavioral therapy (CBT) in preventing future suicide attempts in repeat suicide attempters.


Options:
A: Number of suicide re-attempters (six months)
B: Suicide Mortality Rates (Study Completion (2 years))
C: Scale for Suicide Ideation Index (SSI) (Over 8 weeks of treatment); Columbia Suicide Severity Rating Scale (C-SSRS): the Suicidal Ideation Scale (8 weeks of treatment)
D: Repeat suicide attempts (Measured during treatment and 1, 3, 6, 12, 18, and 24 months after study completion)

Answer: D
Please select the outcome measures that correspond to the clinical trial below.
Title: Community-Based Cognitive Therapy for Suicide Attempters
Brief Summary: This study will determine the effectiveness of cognitive behavioral therapy (CBT) in preventing future suicide attempts in repeat suicide attempters.


Options:
A: Completion of follow-up (End of treatment at 12 weeks); The fraction of eligible participants who consent to inclusion and randomization (End of treatment at 12 weeks); Compliance (End of treatment at 12 weeks); Non-suicidal self-injury as explorative primary clinical outcome (End of treatment at 12 weeks)
B: Scale for Suicide Ideation Index (SSI) (Over 8 weeks of treatment); Columbia Suicide Severity Rating Scale (C-SSRS): the Suicidal Ideation Scale (8 weeks of treatment)
C: Change on the severity of borderline personality disorder measured by Borderline Personality Symptom List (BSL-23). (Baseline and up to 12 months after inclusion.)
D: Repeat suicide attempts (Measured during treatment and 1, 3, 6, 12, 18, and 24 months after study completion)

Answer: D
Please select the outcome measures that correspond to the clinical trial below.
Title: A Phase II, Multicenter, Randomized, Double-Blind Clinical Trial to Evaluate the Efficacy and Safety of Tarceva (Erlotinib Hydrochloride) in Combination With Avastin (Bevacizumab) Versus Avastin Alone for Treatment of Metastatic Renal Cell Carcinoma
Brief Summary: The primary purpose of the study is to assess the potential benefit of combining two targeted therapies (an anti-EGF inhibitor along with an anti-VEGF inhibitor). The goal will be to determine whether the addition of Erlotinib to Avastin will improve the benefit in metastatic renal cell carcinoma (RCC) with regard to time to progression, response rate, duration of response, and survival compared with Avastin alone. Since Avastin has been shown to be active in renal cancer, the goal will be to assess whether this activity can be enhanced with Erlotinib.


Options:
A: Progression Free Survival (PFS) by Blinded Independent Central Review (BICR) (RECIST tumour assessments every 6 weeks from randomisation until disease progression as defined by Recist 1.1 and confirmed by BICR.)
B: N/A
C: Number of Participants With AEs, SAEs, and AEs Leading to Discontinuation (From date of first dose to date of last dose plus 100 days (assessed up to March 2016, approximately 49 months))
D: Phase 1b: Maximum Tolerated Dose (MTD) and Recommended Phase 2 Dose (RP2D) of Lenvatinib (Cycle 1 (21 days)); Phase 1b: Number of Participants With Dose Limiting Toxicities (DLTs) of Lenvatinib (Cycle 1 (21 days)); Objective Response Rate (ORR) Based on Immune-related Response Evaluation Criteria in Solid Tumors (irRECIST) Version 1.1 at Week 24 (Week 24)

Answer: B
Please select the outcome measures that correspond to the clinical trial below.
Title: Cardiovascular Outcomes in Renal Atherosclerotic Lesions (CORAL)
Brief Summary: This study will compare medical therapy plus stenting of hemodynamically significant renal artery stenoses versus medical therapy alone in patients with systolic hypertension and renal artery stenosis.


Options:
A: Glomerular filtration rate in the ischemic kidney after revascularization by means of percutaneous renal angioplasty (PTRAS) or optimal medical treatment. (24 months)
B: Composite Endpoint: Death From Cardiovascular or Renal Causes, Stroke, Myocardial Infarction, Hospitalization for CHF, Progressive Renal Insufficiency, or Permanent Renal Replacement Therapy (Measured at every 3 months for the first year and annually thereafter); Cardiovascular or Renal Death (Measured at every 3 months for the first year and annually thereafter); Myocardial Infarction (Measured at every 3 months for the first year and annually thereafter); Hospitalization for Congestive Heart Failure (Measured at every 3 months for the first year and annually thereafter); Stroke (Measured at every 3 months for the first year and annually thereafter); 30% Reduction of eGFR From Baseline, Persisting for Greater Than or Equal to 60 Days (Measured at every 3 months for the first year and annually thereafter); Need for Renal Replacement Therapy (Measured at every 3 months for the first year and annually thereafter)
C: Progressive renal function loss (= reduction in estimated Cr clearance by >20%) after 2 yrs follow-up, with an extended follow-up of 5 yrs
D: Difference between treatments in change of estimated glomerular filtration rate (eGFR) (12 months)

Answer: B