TrialPanorama/Dataset huggingface dataset:
Please select the outcome measures that correspond to the clinical trial below.
Title: A Multicenter, Randomized, Double-blind, Placebo-controlled Trial of Golimumab, an Anti-TNFalpha Monoclonal Antibody, Administered Intravenously, in Patients With Active Rheumatoid Arthritis Despite Methotrexate Therapy
Brief Summary: The purpose of this study is to evaluate clinical effectiveness and safety of golimumab with methotrexate (MTX) in the treatment of rheumatoid arthritis (RA) when compared to MTX alone.


Options:
A: American College of Rheumatology 20% (ACR20) Response at Week 12 (Baseline, Week 12)
B: Percentage of Participants With American College of Rheumatology-ACR20 Response (Baseline, Week 24); Change From Baseline in Modified Total Sharp-Genant Score at Week 52 (Baseline, Week 52); Change in Physical Function as Measured by the Area Under the Curve (AUC) for the Change From Baseline in the Health Assessment Questionnaire (HAQ) Disability Index at Week 52 (Baseline to Week 52); Change From Baseline in the Modified Total Sharp-Genant Score at Week 104 (Baseline, Week 104); Change in Physical Function as Measured by the Area Under the Curve for the Change From Baseline in the Health Assessment Questionnaire- Disability Index (HAQ-DI) at Week 104 (Baseline to Week 104)
C: Proportion of Participants With an American College of Rheumatology (ACR) 20 Response at Week 14 (Week 14)
D: Percentage of Participants Achieving American College of Rheumatology 20% (ACR20) Response at Month 6 (Month 6); Change From Baseline in the Health Assessment Questionnaire-Disability Index (HAQ-DI) at Month 3 (Baseline, Month 3); Percentage of Participants With Disease Activity Score Using 28-Joint Count and Erythrocyte Sedimentation Rate (4 Variables) (DAS28-4 [ESR]) Less Than 2.6 at Month 6 (Month 6)

Answer: C
Please select the outcome measures that correspond to the clinical trial below.
Title: A Multicenter, Randomized, Double-blind, Placebo-controlled Trial of Golimumab, an Anti-TNFalpha Monoclonal Antibody, Administered Intravenously, in Patients With Active Rheumatoid Arthritis Despite Methotrexate Therapy
Brief Summary: The purpose of this study is to evaluate clinical effectiveness and safety of golimumab with methotrexate (MTX) in the treatment of rheumatoid arthritis (RA) when compared to MTX alone.


Options:
A: Change From Baseline in Modified Total Sharp X-Ray Score at Week 26 (Baseline, Week 26)
B: Number of Participants With American College of Rheumatology 20 Response at Week 24 (Week 24)
C: Proportion of Participants With an American College of Rheumatology (ACR) 20 Response at Week 14 (Week 14)
D: EULAR individual response (12 months)

Answer: C
Please select the outcome measures that correspond to the clinical trial below.
Title: Evaluation of a Smoking Cessation Program Among ADOlescents in Vocational Training Centers
Brief Summary: Background: Most of the efforts to fight against young people's tobacco addiction have focused on smoking prevention and little on smoking cessation. A smoking cessation program, associating pharmacologic and cognitive-behavioural strategy, on a particularly vulnerable population (vocational trainees), was developed by a team of tobacco addiction specialist physicians. We developed a study to evaluate the efficacy of the program. Its main objective is to compare the efficacy of a smoking cessation program offered to all smokers in a population aged 15 to 20 years in Vocational Training Centers (VTC) with that in a control population. The objective of this paper is to present the TABADO study protocol and the results of the pilot study.

Methods: The study is quasi-experimental, prospective, evaluative and comparative and takes place during the 2 years of vocational training. The final population will be composed of 2000 trainees entering a VTC (in Lorraine, France): The intervention group (1000 trainees) benefited from the TABADO program while no specific intervention took place in the "control" group (1000 trainees) other than the treatment and education services usually available. Our primary outcome will be the tobacco abstinence rate at 12 months.

The pilot study is a descriptive monocentric cross-sectional study conducted among the whole group of students, completed by a longitudinal prospective study of smoker volunteers.


Options:
A: The primary outcome is the rate of smoking abstinence after 12 months, measured on the basis of the statements of the whole sample, not only among volunteers. (12 months)
B: Reduction in number of cigarettes smoked as measured by the Timeline Follow-back. (Baseline, Pre Counseling Sessions 1-5, Weeks 8, 12, 24)
C: The change in smoking prevalence between baseline and 24 months of follow-up between the two groups measured via questionnaires. (24 months post intervention)
D: Biologically-verified 7-day Point Prevalence Smoking Abstinence (End of treatment (week 6))

Answer: A
Please select the outcome measures that correspond to the clinical trial below.
Title: Randomized Placebo-Controlled Trial of Bactrim on 7 Day Outcome in Emergency Department Patients With Uncomplicated Abscesses at Risk for Community Acquired Methicillin Resistant Staph Aureus
Brief Summary: Patients will be enrolled in a multi-center study to prospectively evaluate outcome after treatment for an uncomplicated skin abscess. All patients will receive incision and drainage and wound cultures. Patients will then be randomized to 1) placebo two tablets PO BID X 7 days or 2) bactrim DS (800/160) two tablets PO BID x 7 days. Patients will then return to the emergency department ED) at 48 hours and 7 for wound repacking and evaluation. The primary outcome is treatment failure rates at 7 days after incision and drainage. Patients who are clinically worsening or not improving after 48 hours will then be treated with additional antibiotics or admission if needed. Data will be analyzed both by initial randomization and intention to treat.


Options:
A: Clinical Cure Rate at Test of Cure (TOC) (MITT Population) (8-15 days after last dose of study drug administration); The Primary Efficacy Outcome Measure Was the Per-subject Clinical Cure Rate at the TOC Visit in the Clinically Evaluable (CE) Populations. (8-15 days after last dose of study drug)
B: Percentage of Cured Participants as Determined by the Data Review Committee (DRC) at Test of Cure Visit in the Per Protocol (PP) Population (14 - 28 days after last dose of study medication)
C: Treatment Failures at 7 Days (7 days)
D: Clinical Success at Test of Cure (TOC) for the intent-to-treat (ITT) population (7 to 14 days after the last dose of study drug); Clinical Success at Test of Cure (TOC) for the clinically evaluable (CE) population (7 to 14 days after the last dose of study drug)

Answer: C
Please select the outcome measures that correspond to the clinical trial below.
Title: Magnetic Seizure Therapy (MST) for the Treatment of Major Depression
Brief Summary: This two-center, between-subject, randomized, double-masked study (n=20) will provide the first evidence for the antidepressant efficacy of Magnetic Seizure Therapy (MST) and contrast the therapeutic properties and side effects of two forms of MST in patients in a major depressive episode (MDE).


Options:
A: MADRS (2 weeks)
B: Hamilton Rating Scale for Depression (HRSD), 24 item (A blinded rater will administer the test at Baseline, every Tuesday and Thursday during the treatment course and at the end of the MST course)
C: Remission (score </= 10) on the Hamilton Rating Scale for Depression - 24 (HRSD-24) (Greater than 8 treatments (2.5 weeks)); Cognitive adverse effects as indexed by the Autobiographical Memory Test (AMT) (Greater than 8 treatments (2.5 weeks))
D: Improvement in symptom severity of depression as measured by the Hamilton Rating Scale for Depression - 24 (HRSD-24) (7 weeks); Cognitive adverse effects as indexed by the Autobiographical Memory Test (AMT) (7 weeks)

Answer: B
Please select the outcome measures that correspond to the clinical trial below.
Title: Effects of Exenatide on Postprandial Hyperlipidemia and Inflammation
Brief Summary: The primary goal of this study is to determine the acute effects of exenatide on postprandial hypertriglyceridemia. Secondary goals are to determine whether there are additional improvements in postprandial lipids and lipoproteins and whether (by the reduction of hyperglycemia alone or in combination with declines in hyperlipidemia) exenatide reduces the pro-inflammatory potential of the postprandial period.


Options:
A: Triglyceride concentration in serum (Before and up to 8-hours post-injection)
B: Effect of Exenatide on Brain (Total Gray Matter) Glucose Metabolism (120 minutes after exenatide or placebo injection)
C: Percentage of Participants With Primary Major Adverse Cardiac Events (MACE) (From randomization until the adjudication cut-off date of May 31 2013 (maximum time on study was 41 months).)
D: Steady State Beta Cell Compensation (24 months)

Answer: A
Please select the outcome measures that correspond to the clinical trial below.
Title: Affirm: A Multinational Phase 3, Randomized, Double-blind, Placebo-controlled Efficacy And Safety Study Of Oral Mdv3100 In Patients With Progressive Castration-resistant Prostate Cancer Previously Treated With Docetaxel Based Chemotherapy
Brief Summary: This is a phase 3 study to compare the clinical benefit of MDV3100 versus placebo in patients with castration-resistant prostate cancer who have been previously treated with docetaxel-based chemotherapy.


Options:
A: Overall Survival (During study period (up to 101 months))
B: Disease specific mortality (Median 15 years follow up)
C: Radiographic Progression-free Survival (rPFS) (Up to 35 months); Overall Survival (OS) (Up to 57 months)
D: Overall Survival (Up to 60 months)

Answer: A
Please select the outcome measures that correspond to the clinical trial below.
Title: Analysis of Calcium Balance in Chronic Kidney Disease
Brief Summary: Subjects with normal kidney function are able to excrete in their urine the calcium and phosphorus absorbed via the gastrointestinal tract and are thereby are able to maintain calcium and phosphorus balance. Patients with chronic kidney disease often have normal blood levels of calcium and phosphorus but no research has been conducted to determine if they are able to excrete their daily intake of these minerals. If they are not able to excrete their daily intake, these minerals could be deposited in soft tissue and blood vessels and contribute to the increased risk of cardiovascular disease seen in patients with chronic kidney disease. This study will determine if subjects with chronic kidney disease are in balance primarily with regard to calcium and at what level of kidney function they are no longer able to maintain balance. Understanding whether patients with chronic kidney disease are in balance will help direct future therapeutic interventions.


Options:
A: Calcium Balance (2 weeks)
B: The change in plasma phosphorus after 8 weeks of niacinamide versus placebo (8 weeks)
C: Change in Serum Inorganic Phosphorus at the End of Treatment From Baseline (baseline and end of the chewing treatment during three week treatment period)
D: Calcium balance (48 hour)

Answer: D
Please select the outcome measures that correspond to the clinical trial below.
Title: Lowering Salt Intake in Chronic Kidney Disease: A Pilot Randomized Crossover Trial
Brief Summary: ABSTRACT

Background:

It is well recognized that excess dietary salt intake plays a major role in the development of hypertension. Chronic Kidney Disease (CKD) is associated with excess salt and water retention (excess volume) which is associated with hypertension.

Hypotheses:

Hypothesis 1:

Dietary salt restriction will improve volume status in subjects with CKD stages 3-4 as assessed by Bioelectrical Impedance Analysis (BIA).

Hypothesis 2:

Dietary salt restriction will result in improved blood pressure control in patients with CKD stages 3-4.

Hypothesis 3:

Dietary salt restriction will decrease albuminuria in patients with CKD stages 3-4.

Patients and Trial Design: This randomized crossover pilot study is designed to assess the effect of salt restriction on volume status in patients with CKD stages 3 and 4.

Subjects will be randomized to a treatment order: (1) 4 weeks of salt restriction of \<85 mmol sodium per day, a 2 week washout period, and 4 weeks of usual salt diet, OR (2) 4 weeks of usual diet, 2 weeks washout, and 4 weeks of salt restriction. Patients will receive dietary counseling in person at each study visit and at weekly intervals by phone calls from study dieticians. At weeks 0, 4, 6 and 10, patients will undergo assessments for (i) physical examination with assessments for weight, blood pressure, pulse, anthropometrics and a standardized clinical assessment of volume status. (ii) volume status using bioelectrical impedance analysis (BIA) (iii) 24-hour urine testing for, albumin, creatinine and aldosterone Every 2 weeks throughout the study, a 24-hour urine sodium will be measured for compliance, and serum electrolytes will be assessed for safety.

Data Analysis: BIA measurements in the low salt group will be compared with the regular diet group using the standard linear model analysis for 2x2 crossover trials. Additionally, 24-hour ambulatory and static blood pressure and 24-hour urine aldosterone levels will be compared between the two groups.

Future Implications: A significant reduction in the degree of volume expansion (as assessed by BIA) and blood pressure as a result of a salt restricted diet would have implications for renal and cardiovascular protection and would warrant confirmation by a larger randomized trial.


Options:
A: 24 hour blood pressure (Two weeks after start of each intervention)
B: Reduction in blood pressure (Six months)
C: Primary Outcome: Change in volume status (intracellular, extracellular volume, and total body water) as measured by BIA using both whole body and segmental techniques (12 Weeks)
D: Quality of life (12 months)

Answer: C
Please select the outcome measures that correspond to the clinical trial below.
Title: A Double-Blind, Placebo Controlled Study to Assess the Pharmacokinetics, Safety and Tolerability of Multiple Intravenous Doses of 3 Dose Levels of CAT-354 in Subjects With Moderate Asthma
Brief Summary: The study includes participants with moderate asthma who were randomly assigned to receive the study medication (CAT-354) or placebo.


Options:
A: Maximum Observed Serum Concentration (Cmax) for CAT-354 After First Dose (Pre-dose, 10 minutes and 12 hours post-end of infusion on Day 0; Day 4, 7, 14 and 21); Maximum Observed Serum Concentration (Cmax) for CAT-354 After Second Dose (Pre-dose, 10 minutes and 12 hours post-end of infusion on Day 28; Day 35); Maximum Observed Serum Concentration (Cmax) for CAT-354 After Third Dose (Pre-dose, 10 minutes and 12 hours post-end of infusion on Day 56; Day 63, 84, 105 and 147); Area Under the Serum Concentration Time Curve From Time Zero to Last Measurable Concentration (AUC[0 - t]) for CAT-354 After First Dose (Pre-dose, 10 minutes and 12 hours post-end of infusion on Day 0; Day 4, 7, 14 and 21); Area Under the Serum Concentration-Time Curve From Time Zero to Infinity (AUC[0 - Infinity]) for CAT-354 After First Dose (Pre-dose, 10 minutes and 12 hours post-end of infusion on Day 0; Day 4, 7, 14 and 21); Apparent Terminal Elimination Phase Half-Life (t[1/2]el) for CAT-354 After First Dose (Pre-dose, 10 minutes and 12 hours post-end of infusion on Day 0; Day 4, 7, 14 and 21); Clearance (CL) for CAT-354 After First Dose (Pre-dose, 10 minutes and 12 hours post-end of infusion on Day 0; Day 4, 7, 14 and 21); Volume of Distribution (Vd) for CAT-354 After First Dose (Pre-dose, 10 minutes and 12 hours post-end of infusion on Day 0; Day 4, 7, 14 and 21); Observed Serum Drug Concentration for CAT-354 28 Days (C28) After First Dose (Pre-dose on Day 28); Observed Serum Drug Concentration for CAT-354 28 Days (C28) After Second Dose (Pre-dose on Day 56); Observed Serum Concentration for CAT-354 28 Days (C28) After Third Dose (Day 84); Accumulation Ratio (R0) for CAT-354 (Pre-dose, 10 minutes and 12 hours post-end of infusion on Day 0 and 56; Pre-dose on Day 28; Day 4, 7, 14, 21, 63 and 84)
B: To understand the mechanisms driving eosinophilia and disease pathogenesis in patients with a wide range of eosinophilic disorders (Ongoing assessment)
C: Change From Baseline in the Mean Asthma Control Questionnaire (ACQ) Score at Day 92 (Day 1 and 92)
D: Change From Baseline in Prebronchodilator Clinic-Measured, Percent-Predicted Forced Expiratory Volume in 1 Second (Baseline and Week 24); Number of Severe Asthma Exacerbations Per Patient From Baseline Through 6 Months (Baseline to Week 24)

Answer: A
Please select the outcome measures that correspond to the clinical trial below.
Title: A Double-Blind, Placebo Controlled Study to Assess the Pharmacokinetics, Safety and Tolerability of Multiple Intravenous Doses of 3 Dose Levels of CAT-354 in Subjects With Moderate Asthma
Brief Summary: The study includes participants with moderate asthma who were randomly assigned to receive the study medication (CAT-354) or placebo.


Options:
A: Maximum Observed Serum Concentration (Cmax) for CAT-354 After First Dose (Pre-dose, 10 minutes and 12 hours post-end of infusion on Day 0; Day 4, 7, 14 and 21); Maximum Observed Serum Concentration (Cmax) for CAT-354 After Second Dose (Pre-dose, 10 minutes and 12 hours post-end of infusion on Day 28; Day 35); Maximum Observed Serum Concentration (Cmax) for CAT-354 After Third Dose (Pre-dose, 10 minutes and 12 hours post-end of infusion on Day 56; Day 63, 84, 105 and 147); Area Under the Serum Concentration Time Curve From Time Zero to Last Measurable Concentration (AUC[0 - t]) for CAT-354 After First Dose (Pre-dose, 10 minutes and 12 hours post-end of infusion on Day 0; Day 4, 7, 14 and 21); Area Under the Serum Concentration-Time Curve From Time Zero to Infinity (AUC[0 - Infinity]) for CAT-354 After First Dose (Pre-dose, 10 minutes and 12 hours post-end of infusion on Day 0; Day 4, 7, 14 and 21); Apparent Terminal Elimination Phase Half-Life (t[1/2]el) for CAT-354 After First Dose (Pre-dose, 10 minutes and 12 hours post-end of infusion on Day 0; Day 4, 7, 14 and 21); Clearance (CL) for CAT-354 After First Dose (Pre-dose, 10 minutes and 12 hours post-end of infusion on Day 0; Day 4, 7, 14 and 21); Volume of Distribution (Vd) for CAT-354 After First Dose (Pre-dose, 10 minutes and 12 hours post-end of infusion on Day 0; Day 4, 7, 14 and 21); Observed Serum Drug Concentration for CAT-354 28 Days (C28) After First Dose (Pre-dose on Day 28); Observed Serum Drug Concentration for CAT-354 28 Days (C28) After Second Dose (Pre-dose on Day 56); Observed Serum Concentration for CAT-354 28 Days (C28) After Third Dose (Day 84); Accumulation Ratio (R0) for CAT-354 (Pre-dose, 10 minutes and 12 hours post-end of infusion on Day 0 and 56; Pre-dose on Day 28; Day 4, 7, 14, 21, 63 and 84)
B: Rate of protocol-defined asthma exacerbations (new or increased asthma symptoms that lead to treatment with systemic corticosteroids or to hospitalization) from baseline to Week 36 (36 weeks)
C: Persistency of Response and Non-response as Based on Investigator's Global Evaluation of Treatment Effectiveness (GETE) (Weeks 16 and 32)
D: The primary objective is to evaluate the efficacy of AMG 317 compared with placebo as measured by change in Asthma Control Questionnaire (ACQ) symptom scores from baseline to week 12. (12 weeks)

Answer: A
Please select the outcome measures that correspond to the clinical trial below.
Title: DIATOR - Diabetes Intervention With Atorvastatin. A Randomized, Double-blind, Placebo-controlled, Parallel Group Study to Investigate the Effect of Atorvastatin on Residual Beta-cell Function and Glycemic Control in Patients With Newly Diagnosed Type 1 Diabetes Mellitus
Brief Summary: Clinical studies have shown that immunomodulators (like Anti-CD3 antibodies) have effects on beta-cell-preservation. The lipid-lowering agent atorvastatin is also a potent immunomodulator. In this study the effects of 80 mg atorvastatin per day on preservation of beta-cell function in recent onset type 1 diabetes were studied, as determined by stimulated C-peptide levels.


Options:
A: C-peptide after a liquid mixed meal stimulation (at randomization, after 12 months, and after 18 months of treatment)
B: Thrombin generation (8 weeks)
C: Time of Atrial Fibrillation Recurrence (Upon recurrence, up to 12 months)
D: Effects on "bad" cholesterol, LDL-C, after 12 weeks

Answer: A
Please select the outcome measures that correspond to the clinical trial below.
Title: A Study To Evaluate The Safety And Efficacy Of IPX066 In Advanced Parkinson's Disease
Brief Summary: This is a study to evaluate the safety and efficacy of IPX066 in advanced Parkinson's disease.


Options:
A: Changes from baseline Balance Systems Evaluation Test total and subsection scores at post 4-week training, post 8-week training, 6- and 12-month follow-ups (12 months after intervention)
B: Ten meters walking test (about 4 weeks)
C: Percentage of "Off" Time During Waking Hours at End of Study (22 weeks)
D: frequency and severity of adverse events, active vs placebo (Every two weeks during dosing (week 0 to week 12) and weekly thereafter for 2 weeks following cessation of dosing); measure of impulse control (rMIDI), active vs placebo (at screening and 4 weeks, 10 weeks, 12 weeks and 14 weeks)

Answer: C
Please select the outcome measures that correspond to the clinical trial below.
Title: A Randomised, Double-blind, Active-controlled Study to Evaluate the Impact of Stepwise Withdrawal of Inhaled Corticosteroid Treatment in Patients With Severe to Very Severe Chronic Obstructive Pulmonary Disease (COPD) on Optimized Bronchodilator Therapy
Brief Summary: This is a randomised study to be conducted in patients with severe to very severe Chronic Obstructive Pulmonary Disease (COPD) to establish whether there is a need for these patients to be continuously treated with an inhaled corticosteroid on top of two potent long-acting bronchodilators. The study also aims to identify the type of patients who are likely to benefit from inhaled corticosteroid maintenance therapy.


Options:
A: FEV1 AUC0-4 (at Week 24); Change From Baseline in Morning Pre-dose Trough FEV1 (at Week 24)
B: Identifying new patient subtypes and endpoints for COPD (3 years)
C: Time to First Moderate or Severe On-treatment COPD Exacerbation (During randomised treatment, up to 488 days)
D: Pre-dose and 2-hour post-dose morning FEV1 at week 26 and TDI score at week 26 (week 26)

Answer: C