TrialPanorama/Dataset huggingface dataset:
Please select the outcome measures that correspond to the clinical trial below.
Title: A Randomized, Phase 3, Controlled, Double-Blind, Parallel-Group, Multicenter Study to Evaluate the Safety and Efficacy of Rituximab in Combination With Methotrexate (MTX) Compared to MTX Alone, in Methotrexate-Naive Patients With Active Rheumatoid Arthritis
Brief Summary: This is a phase III, randomized, controlled, double-blind, parallel group, international study in approximately 750 patients with active Rheumatoid Arthritis (RA) who are naive to Methotrexate (MTX) therapy. Rheumatoid Factor (RF)-positive and RF-negative patients will be enrolled and will be allocated equally between 3 treatment arms.


Options:
A: Percentage of Participants Who Responded to ≥ 6 of 12 Anti-pneumococcal Antibody Serotypes (Baseline (Week 3) and Week 8 (5 weeks post-vaccination))
B: Pharmacokinetics (PK) (Cmax, AUClast, AUCinf, t1/2, systemic clearance, and volume of distribution) following IV administration (169 days); Pharmacokinetics (PK) [Cmax, tmax, AUC (0-4wk), t1/2 for last dose only, R[AUC(0-4wk)] following SC administration (211 days); Plasma concentrations of golimumab following IV administration (169 days); Plasma concentrations of golimumab following SC administration (211 days)
C: Change From Baseline in Modified Total Sharp Score (mTSS) From Screening at Week 52 (Baseline and week 52)
D: ACR 20% response (Week 14)

Answer: C
Please select the outcome measures that correspond to the clinical trial below.
Title: A Randomized, Phase 3, Controlled, Double-Blind, Parallel-Group, Multicenter Study to Evaluate the Safety and Efficacy of Rituximab in Combination With Methotrexate (MTX) Compared to MTX Alone, in Methotrexate-Naive Patients With Active Rheumatoid Arthritis
Brief Summary: This is a phase III, randomized, controlled, double-blind, parallel group, international study in approximately 750 patients with active Rheumatoid Arthritis (RA) who are naive to Methotrexate (MTX) therapy. Rheumatoid Factor (RF)-positive and RF-negative patients will be enrolled and will be allocated equally between 3 treatment arms.


Options:
A: Number of Participants Meeting American College of Rheumatology 50% (ACR50) Response Criteria at Week 52 (Baseline and 52 Weeks); Change From Baseline in Modified Total Sharp Score (mTSS) at Week 52 (Baseline and Week 52)
B: The Number of Participants Achieving Remission As Measured by a Disease Activity Score for 28 Joints (DAS 28) < 2.6. (12 months); Year 1 Participants Having an Annualized Modified Total Sharp Score (mTSS) < 0.5. (12 months)
C: To assess the efficacy of CDP870 in combination with Methotrexate in the treatment of Rheumatoid Arthritis and prevention of structural damage by measuring the ACR20 response at week 24 and change from Baseline
D: Change From Baseline in Modified Total Sharp Score (mTSS) From Screening at Week 52 (Baseline and week 52)

Answer: D
Please select the outcome measures that correspond to the clinical trial below.
Title: A Randomized, Phase 3, Controlled, Double-Blind, Parallel-Group, Multicenter Study to Evaluate the Safety and Efficacy of Rituximab in Combination With Methotrexate (MTX) Compared to MTX Alone, in Methotrexate-Naive Patients With Active Rheumatoid Arthritis
Brief Summary: This is a phase III, randomized, controlled, double-blind, parallel group, international study in approximately 750 patients with active Rheumatoid Arthritis (RA) who are naive to Methotrexate (MTX) therapy. Rheumatoid Factor (RF)-positive and RF-negative patients will be enrolled and will be allocated equally between 3 treatment arms.


Options:
A: Percentage of Participants Who Responded to ≥ 6 of 12 Anti-pneumococcal Antibody Serotypes (Baseline (Week 3) and Week 8 (5 weeks post-vaccination))
B: Change From Baseline in Modified Total Sharp Score (mTSS) From Screening at Week 52 (Baseline and week 52)
C: Number of Participants With American College of Rheumatology 20 Response at Week 24 (Week 24)
D: 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)

Answer: B
Please select the outcome measures that correspond to the clinical trial below.
Title: A Randomized, Phase 3, Controlled, Double-Blind, Parallel-Group, Multicenter Study to Evaluate the Safety and Efficacy of Rituximab in Combination With Methotrexate (MTX) Compared to MTX Alone, in Methotrexate-Naive Patients With Active Rheumatoid Arthritis
Brief Summary: This is a phase III, randomized, controlled, double-blind, parallel group, international study in approximately 750 patients with active Rheumatoid Arthritis (RA) who are naive to Methotrexate (MTX) therapy. Rheumatoid Factor (RF)-positive and RF-negative patients will be enrolled and will be allocated equally between 3 treatment arms.


Options:
A: Change From Baseline in Modified Total Sharp Score (mTSS) From Screening at Week 52 (Baseline and week 52)
B: Proportion of patients with an ACR20 response (24 weeks)
C: Percentage of Participants With a Response as Determined by American College of Rheumatology (ACR) 20% Improvement (ACR20) (Week 48)
D: Percentage of Patients With a Positive Immune Response to Tetanus Toxoid Adsorbed Booster Vaccine (Week 24 to Week 28 for Group A and Day 1 to Week 4 for Group B)

Answer: A
Please select the outcome measures that correspond to the clinical trial below.
Title: A Randomized, Phase 3, Controlled, Double-Blind, Parallel-Group, Multicenter Study to Evaluate the Safety and Efficacy of Rituximab in Combination With Methotrexate (MTX) Compared to MTX Alone, in Methotrexate-Naive Patients With Active Rheumatoid Arthritis
Brief Summary: This is a phase III, randomized, controlled, double-blind, parallel group, international study in approximately 750 patients with active Rheumatoid Arthritis (RA) who are naive to Methotrexate (MTX) therapy. Rheumatoid Factor (RF)-positive and RF-negative patients will be enrolled and will be allocated equally between 3 treatment arms.


Options:
A: American College of Rheumatology (ACR) 20 Response at Week 14. (Week 14)
B: Change From Baseline in Modified Total Sharp Score (mTSS) From Screening at Week 52 (Baseline and week 52)
C: The Proportion of Participants Meeting the American College of Rheumatology (ACR) Criteria of 20% Improvement (ACR20) After 12 Months of Treatment - Intent to Treat Population (Day 1 to Day 365)
D: American College of Rheumatology 20% (ACR20) Response at Week 12 (Baseline, Week 12)

Answer: B
Please select the outcome measures that correspond to the clinical trial below.
Title: Phase 4 Efficacy Study of Antimicrobials in the Treatment of Acute Otitis Media in Young Children
Brief Summary: This is a prospective, randomized, double-blind, placebo controlled one-center study carried out in primary care setting of the health center of City of Turku, Finland. The study patients will be allocated to one of the two parallel treatment groups (amoxicillin-clavulanate or placebo). The hypothesis is that the symptoms and signs of acute otitis media are resolved more effectively with antimicrobial treatment than with placebo. Furthermore, this study aims at finding out prognostic factors that could help to direct antimicrobial treatment for correct subgroups of young patients.


Options:
A: The Time to Resolution of Symptoms, Defined as Acute Otitis Media-Severity of Symptoms (AOM-SOS) Score of 0 or 1, According to Treatment Assignment (The first 7 days on therapy); The Time to Resolution of Symptoms, Defined as Acute Otitis Media-Severity of Symptoms (AOM-SOS) Score of 0 or 1 on Two Consecutive Occasions, According to Treatment Assignment (The first 7 days on therapy); The Weighted Average Acute Otitis Media - Severity of Symptom (AOM-SOS) Score, According to Treatment Assignment (During the first 7 days of therapy)
B: Time (days) to disappearance of middle ear effusion (Within 60 days)
C: Proportion of each group that filled the antibiotic prescription
D: Compare time to treatment failure in children receiving amoxicillin-clavulanate to children receiving placebo (During the first 8 days of follow-up)

Answer: D
Please select the outcome measures that correspond to the clinical trial below.
Title: Phase 4 Efficacy Study of Antimicrobials in the Treatment of Acute Otitis Media in Young Children
Brief Summary: This is a prospective, randomized, double-blind, placebo controlled one-center study carried out in primary care setting of the health center of City of Turku, Finland. The study patients will be allocated to one of the two parallel treatment groups (amoxicillin-clavulanate or placebo). The hypothesis is that the symptoms and signs of acute otitis media are resolved more effectively with antimicrobial treatment than with placebo. Furthermore, this study aims at finding out prognostic factors that could help to direct antimicrobial treatment for correct subgroups of young patients.


Options:
A: Proportion of each group that filled the antibiotic prescription
B: Compare time to treatment failure in children receiving amoxicillin-clavulanate to children receiving placebo (During the first 8 days of follow-up)
C: The Time to Resolution of Symptoms, Defined as Acute Otitis Media-Severity of Symptoms (AOM-SOS) Score of 0 or 1, According to Treatment Assignment (The first 7 days on therapy); The Time to Resolution of Symptoms, Defined as Acute Otitis Media-Severity of Symptoms (AOM-SOS) Score of 0 or 1 on Two Consecutive Occasions, According to Treatment Assignment (The first 7 days on therapy); The Weighted Average Acute Otitis Media - Severity of Symptom (AOM-SOS) Score, According to Treatment Assignment (During the first 7 days of therapy)
D: Time (days) to disappearance of middle ear effusion (Within 60 days)

Answer: B
Please select the outcome measures that correspond to the clinical trial below.
Title: A Multicenter, Randomized, Double-blind, Placebo-controlled Trial of Golimumab, a Fully Human Anti-TNFa Monoclonal Antibody, Administered Subcutaneously in Subjects With Active Rheumatoid Arthritis and Previously Treated With Biologic Anti- TNFa Agent(s)
Brief Summary: The purpose of this study is to evaluate the efficacy and safety of golimumab (CNTO 148) in subjects who have active rheumatoid arthritis and have been treated previously with at least 1 dose of a biologic anti-TNFa agent (etanercept, adalimumab or infliximab).


Options:
A: Percentage of patients with ACR 20 response (Week 24); AEs, laboratory parameters, vital signs, ECGs. (Throughout study)
B: American College of Rheumatology (ACR) 20 Response at Week 14. (Week 14)
C: American college of Rheumatolofy (ACR)-20 responder rate at Week 24
D: Number of Participants With American College of Rheumatology 20 Response at Week 24 (Week 24)

Answer: B
Please select the outcome measures that correspond to the clinical trial below.
Title: A Multicenter, Randomized, Double-blind, Placebo-controlled Trial of Golimumab, a Fully Human Anti-TNFa Monoclonal Antibody, Administered Subcutaneously in Subjects With Active Rheumatoid Arthritis and Previously Treated With Biologic Anti- TNFa Agent(s)
Brief Summary: The purpose of this study is to evaluate the efficacy and safety of golimumab (CNTO 148) in subjects who have active rheumatoid arthritis and have been treated previously with at least 1 dose of a biologic anti-TNFa agent (etanercept, adalimumab or infliximab).


Options:
A: Number of Subjects With Low Disease Activity (DAS28 Less Than 3.2) and No Radiographic Progression From Baseline (Change in mTSS Less Than or Equal to 0.5) at Week 78, Arm 2 vs. Arm 4 (Week 78)
B: American College of Rheumatology (ACR) 20 Response at Week 14. (Week 14)
C: N/A
D: Adjusted Geometric (Geo) Mean-Fold Change at End of Period 1 From Baseline in Measured Glomerular Filtration Rate (mGFR) (Day 1 of Period 1, Day 43 of Period 1)

Answer: B
Please select the outcome measures that correspond to the clinical trial below.
Title: Can Alendronate Suppress Aortic and Coronary Artery Calcification and Improve Bone Mineral Density in Chronic Peritoneal Dialysis Patients?
Brief Summary: Hyperphosphatemia is frequently seen in patients with end-stage renal disease (ESRD). Hyperphosphatemia usually results in a high calcium-phosphorus product (CPP) which may subsequently lead to artery and become a risk factor of cardiovascular complications. Alendronate, due to its effect of inhibiting osteoclasts, is approved for treatment of osteoporosis. Previous reports found the use of bisphosphonates could suppress arterial calcification in hemodialysis dialysis patients. The aim of this study is to evaluate the safety and efficacy of alendronate to suppress coronary artery and aortic calcifications, as well as to improve bone density in chronic peritoneal dialysis (PD) patients.

This study will include ESRD patients who had received maintenance PD for more than 3 months, have high CPP level (≧55), and have chest X-ray proven aortic calcification or coronary artery calcification. All participants are randomly allocated to either group 1 or group 2. Group 1 patients receive alendronate 70 mg once weekly in the first 16 weeks, while group 2 patients receive the same dose of drug every week in the second 16 weeks. The extent of coronary artery and aortic calcification is evaluated by using multi-detector spiral computed tomography, whereas bone mineral density is measured by dual-energy X-ray absorptiometry. Both examinations are performed at week 0, 16 and 32 for each participant. Laboratory studies and possible adverse reactions were regularly monitored.

We expect that alendronate can alleviate the progression of arterial calcification or even improve it. Bone density may also be improved after treatment. Besides, we wish to find the independent factor(s) influencing the efficacy of alendronate. These results may help clinical physicians for early intervention and prevention of cardiovascular complications in ESRD patients.


Options:
A: 1.Changes of calcification score of coronary arteries and aorta; 2.Changes of bone density
B: Relative variation of femoral bone mineral density after 24 months of follow-up (T-score evaluated by osteodensitometry) (24 months after inclusion)
C: Change in degree of arterial stiffness measured by pulse wave velocity (18 months); Changes in vascular calcification on CT scans of superficial femoral artery and aorta (18 months)
D: Number of Participants With New Vertebral Fractures (36 months)

Answer: A
Please select the outcome measures that correspond to the clinical trial below.
Title: Systematic Early Use of Neuromuscular Blocking Agents in ARDS Patients
Brief Summary: The use of neuromuscular blocking agents (NMBA) in ARDS patients has not been extensively investigated. The aim of the study is to show a reduction of the mortality rate of ARDS patients.


Options:
A: Compare the adverse events between mesenchymal stem cell treatment and placebo groups (From day 0 at the start of treatment to day 28.)
B: Incidence of Pre-specified Infusion Associated Adverse Events (24 hours)
C: Reduction of the mortality rate of ARDS patients at d90 (36 months)
D: Heart Rate Assessments Upto Day 7 (Part B) (Up to Day 7); Diastolic and Systolic Blood Pressure Assessments Upto Day 7 (Part B) (Up to Day 7); Electrocardiogram (ECG) Parameters, Including PR, QRS, QT, and QTCU and RR Intervals Upto Day 7 (Part B) (Up to Day 7); Hematology Parameters Basophils, Eosinophil, Lymphocytes, Monocytes, Total Neutrophils, Platelet Count and White Blood Cell Count Upto Day 7 (Part B) (Up to Day 7); Hematology Parameters Red Blood Cell Count and Reticulocyte Count Assessment Upto Day 7 (Part B) (Up to Day 7); Hematology Parameter Hemoglobin and Mean Corpuscle Hemoglobin Concentration (MCHC) Assessment Upto Day 7 (Part B) (Up to Day 7); Hematology Parameter Mean Corpuscle Volume (MCV) Assessment Upto Day 7 (Part B) (Up to Day 7); Hematology Parameter Mean Corpuscle Hemoglobin (MCH) Assessment Upto Day 7 (Part B) (Up to Day 7); Hematology Parameter Hematocrit Assessment Upto Day 7 (Part B) (Up to Day 7); Clinical Chemistry Parameters Calcium, Chloride, Carbon Dioxide, Glucose, Potassium, Sodium, Urea/Blood Urea Nitrogen Assessment Upto Day 7 (Part B) (Up to Day 7); Clinical Chemistry Parameters Direct Bilirubin, Total Bilirubin, Creatinine and Uric Acid Assessment Upto Day 7 (Part B) (Up to Day 7); Clinical Chemistry Parameters Alkaline Phosphatase, Asparatate Amino Transferase, Alanine Amino Transferase, Gamma Glutamyl Transferase Assessment Upto Day 7 (Part B) (Up to Day 7); Clinical Chemistry Parameters Albumin and Total Protein Assessment Upto Day 7 (Part B) (Up to Day 7); Number of Participant With Adverse Event (AE) and Serious Adverse Event (SAE) Assessment Upto Day 7 (Part A) (Up to Day 7); Number of Par With AE and Serious Adverse Event (SAE) Assessment Upto Day 7 (Part B) (Up to Day 7)

Answer: C
Please select the outcome measures that correspond to the clinical trial below.
Title: Systematic Early Use of Neuromuscular Blocking Agents in ARDS Patients
Brief Summary: The use of neuromuscular blocking agents (NMBA) in ARDS patients has not been extensively investigated. The aim of the study is to show a reduction of the mortality rate of ARDS patients.


Options:
A: Mortality rates (measured at time of hospital discharge or 60 days after study entry)
B: Reduction of the mortality rate of ARDS patients at d90 (36 months)
C: Development of ARDS (28 days)
D: All-cause hospital mortality (Randomised patients will be ventilated according to their assigned ventilation strategy for up to 60 days, until they die on the ventilator or are successfully (for >24 hours) liberated from mechanical ventilation.)

Answer: B
Please select the outcome measures that correspond to the clinical trial below.
Title: Systematic Early Use of Neuromuscular Blocking Agents in ARDS Patients
Brief Summary: The use of neuromuscular blocking agents (NMBA) in ARDS patients has not been extensively investigated. The aim of the study is to show a reduction of the mortality rate of ARDS patients.


Options:
A: Length of stay in ICU and length of stay in the hospital. (2 years)
B: Effect of early IVIG versus placebo on CIPNM on day 14 (day 14)
C: Lower Extremity Strength, at Hospital Discharge, of 3 Bilateral Muscle Groups (Pretibial, Triceps Surae, and Quadriceps) Measured Via MMT Using a Composite Medical Research Council (MRC) Score (At hospital discharge)
D: Reduction of the mortality rate of ARDS patients at d90 (36 months)

Answer: D
Please select the outcome measures that correspond to the clinical trial below.
Title: A 2-year, Prospective, Blinded-rater, Open-label, Active-controlled, Multicenter, Randomized Study of Long-term Efficacy and Effectiveness Comparing Risperdal® Consta® and Abilify® (Aripiprazole) in Adults With Schizophrenia
Brief Summary: The purpose of this study is to compare the effectiveness of two antipsychotic medications, RisperdalÂ® ConstaÂ® versus AbilifyÂ®, over a 2-year treatment period in the long-term maintenance of patients with schizophrenia.


Options:
A: Time to Relapse (Day 1 to relapse); Time in Remission (Day 1 to last PANSS measurement)
B: Change in the Positive and Negative Syndrome Scale (PANSS) Total Score for Schizophrenia (Baseline to the last postrandomization assessment in the double-blind treatment period (approximately 13 weeks))
C: Hospitalization-free Survival - Time to Event (From randomization until date of first re-hospitalization, assessed up to 24 months); Hazard Ratio for Hospitalization (24 months)
D: To assess the impact of switching subjects from an existing antipsychotic to risperidone long acting on healthcare resource utilization. This will be evaluated by assessing:; Direct cost of care; Frequency and duration of institutional care; Discharge; Relapse

Answer: A
Please select the outcome measures that correspond to the clinical trial below.
Title: A DB, Randomized, Placebo-controlled Study of the Tolerability, Efficacy, Safety, and Dose Range of Intramyocardial CLBS14 for Reduction of Angina Episodes in Patients With Refractory Chronic Myocardial Ischemia (ACT34-CMI)
Brief Summary: The purpose of this study is to evaluate the efficacy and safety of intramyocardial injections of CLBS14 in patients with refractory chronic myocardial ischemia.


Options:
A: N/A
B: Safety of Autologous-bone-marrow Injections (up to 2 weeks post-procedure, 3 months and 6 months)
C: Number of Angina Episodes Per Week at 6 and 12 Months (6 and 12 months)
D: Change From Baseline in Total Exercise Time on Exercise Tolerance Test (ETT) Using the Modified Bruce Protocol (Baseline and 12 month visit)

Answer: C
Please select the outcome measures that correspond to the clinical trial below.
Title: A Multicenter Randomized, Double-Blind, Controlled Study of NGX-4010 for the Treatment of Postherpetic Neuralgia
Brief Summary: The purpose of the study is to assess the efficacy and safety of NGX-4010 applied for 60 minutes for the treatment of postherpetic neuralgia (PHN).


Options:
A: Percent change from baseline in "average pain for the past 24 hours" Numeric Pain Rating Scale (NPRS) score (i.e., average of scores during Weeks 2 to 12, compared to baseline)
B: Percent change from baseline in the "average pain for the past 24 hours" Numeric Pain Rating Scale (NPRS) score (i.e., average of scores during Weeks 2-12, compared to baseline)
C: Change From Baseline in Mean Pain Score at Endpoint (Up to Week 14) (Baseline, Week 14); Patient Global Impression of Change (PGIC) (Week 14)
D: Endpoint mean pain score derived from the subject's daily pain diary (Endpoint); Patient Global Assessment (Patient Global Impression of Change) at Termination Visit (Weeks 5 and 13); Change from baseline in functioning (score created from the Short Form-36 [SF-36] Social and Physical Functioning, Fibromyalgia Impact Questionnaire [FIQ]-Total Score, and Sheehan Disability Scale [SDS] Total Score) at Termination Visit (Baseline and Weeks 5, 9, and 13)

Answer: A
Please select the outcome measures that correspond to the clinical trial below.
Title: The Improving Care of Acute Lung Injury Patients (ICAP) Study
Brief Summary: Acute lung injury/acute respiratory distress syndrome (ALI/ARDS) is a severe lung condition that causes respiratory failure. Individuals with ALI/ARDS often require the use of a respirator or artificial breathing machine, known as a mechanical ventilator, while in an intensive care unit (ICU). Past research has shown that improved short-term clinical outcomes result from the use of a protective mechanical ventilation technique for the lungs. This study will evaluate the effects of lower tidal volume ventilation, and other aspects of critical illness and ICU care, on the long-term clinical outcomes of individuals with ALI/ARDS.


Options:
A: N/A
B: Mortality (Measured at Months 3, 6, 12, 24, 36, 48 and 60)
C: Individual Physical Function and Mental Health domains from SF-36 (for participants who complete the phone surveys); 6-minute walk distance and memory evaluation (for participants who attend the study visits) (Measured at Months 6 and 12)
D: Incremental Shuttle Walk Test (Eight weeks)

Answer: B