TrialPanorama/Dataset huggingface dataset:
Please select the outcome measures that correspond to the clinical trial below.
Title: A Phase 1, Randomized, Open-Label, Parallel Group, Multicenter Study to Evaluate the Pharmacokinetics and Safety of Dexlansoprazole Modified Release Capsules (30 mg and 60 mg) in Adolescents With Symptomatic Gastroesophageal Reflux Disease
Brief Summary: The purpose of this study is to asses the pharmacokinetics and safety of dexlansoprazole modified release (MR), once daily (QD), in adolescent subjects (age 12-17 years old) with Symptomatic Gastroesophageal Reflux Disease.


Options:
A: Tmax: Time to Reach the Maximum Plasma Concentration (Cmax) Pharmacokinetic Parameter (After 7 days of dosing.); Cmax: Maximum Observed Plasma Concentration Pharmacokinetic Parameter. (After 7 days of dosing.); AUC(0-tlqc): Area Under the Plasma Concentration-Time Curve From Time 0 to the Time of the Last Quantifiable Concentration Pharmacokinetic Parameter. (After 7 days of dosing.); AUC(0-24): Area Under the Plasma Concentration-Time Curve From Time 0 to 24 Hours Postdose Pharmacokinetic Parameter. (After 7 days of dosing.); Terminal Phase Elimination Half-life (T1/2) Pharmacokinetic Parameter. (After 7 days of dosing.); Oral Clearance (CL/F) Pharmacokinetic Parameter. (After 7 days of dosing.); Terminal Elimination Rate Constant (λz) Pharmacokinetic Parameter. (After 7 days of dosing.); Apparent Volume of Distribution (Vz/F) Pharmacokinetic Parameter. (After 7 days of dosing.)
B: The primary objective of the study is to evaluate the safety of once daily treatment with esomeprazole in relieving GERD-associated symptoms in pediatric patients 1 to 11 years of age, inclusive.; The primary outcome variables include assessment of changes from baseline in medical history, physical examination, clinical laboratory evaluations, and adverse events.
C: Number of Participants Discontinuing Due to Symptom Worsening in the Randomized Treatment Withdrawal Phase (Treatment Withdrawal Phase Endpoint) (Treatment-withdrawal phase (up to 4 weeks following randomization, or until earlier discontinuation from the study))
D: Peak Concentration (Cmax) (1 day); Time to Peak Concentration (Tmax) Profile (1 day); Disposition Half-life (1 day); Area Under the Concentration-time Curve (AUC) (1 day); Apparent Oral Clearance (CL/F) (1 day); Pantoprazole Plasma Concentration After Multiple-Dose Oral Administration (7 days); Intragastric pH (7 days); Median Intragastric pH (7 days); Percentage of Time Intragastric pH Was >4 (7 days); Mean Intraesophageal pH (7 days); Median Intraesophageal pH (7 days); Percentage of Time That Intraesophageal pH Was <4 (7 days); Normalized Area of Gastric Hydrogen Ion Activity Over Time (7 days); Normalized Area of Esophageal Hydrogen Ion Activity Over Time (7 days)

Answer: A
Please select the outcome measures that correspond to the clinical trial below.
Title: A Phase 1, Randomized, Open-Label, Parallel Group, Multicenter Study to Evaluate the Pharmacokinetics and Safety of Dexlansoprazole Modified Release Capsules (30 mg and 60 mg) in Adolescents With Symptomatic Gastroesophageal Reflux Disease
Brief Summary: The purpose of this study is to asses the pharmacokinetics and safety of dexlansoprazole modified release (MR), once daily (QD), in adolescent subjects (age 12-17 years old) with Symptomatic Gastroesophageal Reflux Disease.


Options:
A: Tmax: Time to Reach the Maximum Plasma Concentration (Cmax) Pharmacokinetic Parameter (After 7 days of dosing.); Cmax: Maximum Observed Plasma Concentration Pharmacokinetic Parameter. (After 7 days of dosing.); AUC(0-tlqc): Area Under the Plasma Concentration-Time Curve From Time 0 to the Time of the Last Quantifiable Concentration Pharmacokinetic Parameter. (After 7 days of dosing.); AUC(0-24): Area Under the Plasma Concentration-Time Curve From Time 0 to 24 Hours Postdose Pharmacokinetic Parameter. (After 7 days of dosing.); Terminal Phase Elimination Half-life (T1/2) Pharmacokinetic Parameter. (After 7 days of dosing.); Oral Clearance (CL/F) Pharmacokinetic Parameter. (After 7 days of dosing.); Terminal Elimination Rate Constant (λz) Pharmacokinetic Parameter. (After 7 days of dosing.); Apparent Volume of Distribution (Vz/F) Pharmacokinetic Parameter. (After 7 days of dosing.)
B: The Percentage of Patients With Healing by Week 12 (Short-term Double-blind Treatment Phase) (12 weeks); The Percentage of Patients With Healing by Week 36 (Double-blind Maintenance Treatment Phase) (36 weeks)
C: Change in Weekly Gastroesophageal Reflux Disease (GERD) Symptom Scores (WGSS) (Baseline and 8 weeks)
D: efficacy on GER (2 months)

Answer: A
Please select the outcome measures that correspond to the clinical trial below.
Title: Randomized Controlled Trial of Early Versus Standard Postpartum Insertion of the Etonogestrel Contraceptive Implant
Brief Summary: A highly effective single rod contraceptive implant is now available for use in the US. Delays in the insertion of the device until later in the postpartum period may negatively impact initiation rates. The objective of this study is to compare outcomes of early postpartum insertion (prior to postpartum hospital discharge) of the etonogestrel-releasing contraceptive implant with routine postpartum insertion at 4-8 weeks after delivery. Primary outcome of interest will be time to lactogenesis. Secondary outcomes will include rates of breastfeeding supplementation, infant growth, vaginal bleeding patterns, incidence of side effects, time to resume sexual intercourse after delivery, and incidence of missed routine postpartum follow-up. In addition, a subset of patients who randomize to early postpartum insertion will have expressed breastmilk ascertained for nutrient composition.


Options:
A: Implant utilization as measured by the proportion of women using LNG contraceptive implants at 6 months after delivery in women randomized to insertion within 5 days of delivery (immediate insertion) or 6-8 weeks after delivery (delayed insertion). (6 months)
B: Expulsion rate (6 months); The percentage of females seeking contraception (6 months)
C: Use of the LNG-IUS for Contraception (12 months after cesarean delivery)
D: Time to Lactogenesis Stage II (5 days postpartum)

Answer: D
Please select the outcome measures that correspond to the clinical trial below.
Title: Randomized Controlled Trial of Early Versus Standard Postpartum Insertion of the Etonogestrel Contraceptive Implant
Brief Summary: A highly effective single rod contraceptive implant is now available for use in the US. Delays in the insertion of the device until later in the postpartum period may negatively impact initiation rates. The objective of this study is to compare outcomes of early postpartum insertion (prior to postpartum hospital discharge) of the etonogestrel-releasing contraceptive implant with routine postpartum insertion at 4-8 weeks after delivery. Primary outcome of interest will be time to lactogenesis. Secondary outcomes will include rates of breastfeeding supplementation, infant growth, vaginal bleeding patterns, incidence of side effects, time to resume sexual intercourse after delivery, and incidence of missed routine postpartum follow-up. In addition, a subset of patients who randomize to early postpartum insertion will have expressed breastmilk ascertained for nutrient composition.


Options:
A: IUD Usage Rate at 6 Months (6 months after delivery)
B: Number of Participants Who Continued to Breastfeed at 6 Months (Baseline to Week 8, Week 8, 2-6 months)
C: Initiation of long term contraception with 6 month postpartum (6 month)
D: Time to Lactogenesis Stage II (5 days postpartum)

Answer: D
Please select the outcome measures that correspond to the clinical trial below.
Title: Phase 3 Randomized, Double Blind, Placebo Controlled Study Of The Efficacy And Safety Of 2 Doses Of CP-690,550 In Patients With Active Rheumatoid Arthritis On Background Methotrexate
Brief Summary: This study is designed to provide safety and efficacy data to support the development of CP-690,550 in patients with moderate to severe rheumatoid arthritis on background of methotrexate.


Options:
A: Number of Participants Who Achieved American College of Rheumatology (ACR) 50 Response at Week 24 (Week 24); Change From Baseline in Total Van Der Heijde Modified Sharp (vdH-S) Score at Week 52 (Baseline and Week 52)
B: Percentage of Participants Achieving American College of Rheumatology 20% (ACR20) Response at Month 6 (Month 6); Changes From Baseline in Modified Total Sharp Score (mTSS) at Month 6 (Baseline, Month 6); Change From Baseline in Health Assessment Questionnaire-Disability Index (HAQ-DI) Score at Month 3 (Baseline, Month 3); Percentage of Participant 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)
C: American college of Rheumatolofy (ACR)-20 responder rate at Week 24
D: 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)

Answer: B
Please select the outcome measures that correspond to the clinical trial below.
Title: Phase 3 Randomized, Double Blind, Placebo Controlled Study Of The Efficacy And Safety Of 2 Doses Of CP-690,550 In Patients With Active Rheumatoid Arthritis On Background Methotrexate
Brief Summary: This study is designed to provide safety and efficacy data to support the development of CP-690,550 in patients with moderate to severe rheumatoid arthritis on background of methotrexate.


Options:
A: Change From Baseline to Week 24 in the Disease Activity Score 28 (DAS28) (Baseline to Week 24)
B: Percentage of Participants Achieving 28 Joint Disease Activity Score (DAS28) Less Than or Equal to (≤) 3.2 at Week 88 (Week 88)
C: Percentage of Participants Achieving American College of Rheumatology 20% (ACR20) Response at Month 6 (Month 6); Changes From Baseline in Modified Total Sharp Score (mTSS) at Month 6 (Baseline, Month 6); Change From Baseline in Health Assessment Questionnaire-Disability Index (HAQ-DI) Score at Month 3 (Baseline, Month 3); Percentage of Participant 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)
D: Mean 48-week Change in DAS28 (48 weeks after baseline assessment)

Answer: C
Please select the outcome measures that correspond to the clinical trial below.
Title: Phase 3 Randomized, Double Blind, Placebo Controlled Study Of The Efficacy And Safety Of 2 Doses Of CP-690,550 In Patients With Active Rheumatoid Arthritis On Background Methotrexate
Brief Summary: This study is designed to provide safety and efficacy data to support the development of CP-690,550 in patients with moderate to severe rheumatoid arthritis on background of methotrexate.


Options:
A: Percentage of Participants Achieving American College of Rheumatology 20% (ACR20) Response at Month 3 (Month 3); Change From Baseline in Health Assessment Questionnaire-Disability Index (HAQ-DI) Score at Month 3 (Baseline, Month 3); Percentage of Participant With Disease Activity Score Using 28-Joint Count and Erythrocyte Sedimentation Rate (4 Variables) (DAS28-4 [ESR]) Less Than 2.6 at Month 3 (Month 3)
B: Percentage of Participants Achieving American College of Rheumatology 20% (ACR20) Response at Month 6 (Month 6); Changes From Baseline in Modified Total Sharp Score (mTSS) at Month 6 (Baseline, Month 6); Change From Baseline in Health Assessment Questionnaire-Disability Index (HAQ-DI) Score at Month 3 (Baseline, Month 3); Percentage of Participant 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)
C: Proportion of Participants With an American College of Rheumatology (ACR) 20 Response at Week 14 (Week 14)
D: EULAR Good Response (at 24 weeks); ACR50 Response Rate (at 24 weeks); Radiographic Progression Defined by Change in Van Der Heijde-modified Total Sharp Score (at 52 weeks)

Answer: B
Please select the outcome measures that correspond to the clinical trial below.
Title: Phase 3 Randomized, Double Blind, Placebo Controlled Study Of The Efficacy And Safety Of 2 Doses Of CP-690,550 In Patients With Active Rheumatoid Arthritis On Background Methotrexate
Brief Summary: This study is designed to provide safety and efficacy data to support the development of CP-690,550 in patients with moderate to severe rheumatoid arthritis on background of methotrexate.


Options:
A: Percentage of Participants Achieving American College of Rheumatology 20% (ACR20) Response at Month 6 (Month 6); Changes From Baseline in Modified Total Sharp Score (mTSS) at Month 6 (Baseline, Month 6); Change From Baseline in Health Assessment Questionnaire-Disability Index (HAQ-DI) Score at Month 3 (Baseline, Month 3); Percentage of Participant 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)
B: 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)
C: Percentage of Patients With an American College of Rheumatology 20 (ACR20) Response at Week 24 (Baseline to Week 24)
D: 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)

Answer: A
Please select the outcome measures that correspond to the clinical trial below.
Title: Randomized Controlled Trial of IIb Preserving Neck Dissection VS Neck Dissections Involving IIb Removal (Selective/Functional) in Patients With N0 Neck With Oral Cavity Malignancies
Brief Summary: The treatment of clinically N0 neck in malignancies of oral cavity is controversial. The options include the policy of "wait and watch"(close observation and follow-up), elective irradiation of the neck, elective surgery of the neck (neck dissection).

In elective neck dissections, the procedures commonly performed are modified radical neck dissection-III (functional neck dissection) and selective (supraomohyoid) neck dissection depending on the site of the primary lesion within the oral cavity. There are no trials of IIb preserving neck dissection in cancers of the oral cavity.


Options:
A: Time to local or locoregional failure or death from any cause (Defined as time from randomization up to 36 month)
B: Quality of Life (1-year post treatment)
C: Spinal accessary nerve function (2 years)
D: Change in Neck Dissection Impairment Index (NDII) score from pre- to post-op. (6 months per patient)

Answer: C
Please select the outcome measures that correspond to the clinical trial below.
Title: A Phase 3b Multicenter, Single-Blind Trial to Evaluate the Efficacy of Dexlansoprazole MR 30 mg in Maintaining Control of Gastroesophageal Reflux Disease Symptoms in Subjects on Prior Twice Daily Proton Pump Inhibitor Therapy
Brief Summary: The purpose of this study is to determine if patients with well-controlled heartburn symptoms on twice-daily proton pump inhibitor therapy remain well-controlled after stepping down to once-daily (QD) dexlansoprazole modified release (MR) 30 mg.


Options:
A: Proportion of Participants Who Remain Well Controlled After Switching From Their Current Twice-daily Proton Pump Inhibitor Therapy to Dexlansoprazole MR. (Week 3 through Week 6)
B: Percentage of Heartburn Free 24 Hour Days During 14 Days of Randomized Treatment (From randomisation to day 14)
C: Mean Change From Baseline to Month 12 for Hemoglobin Values (Baseline and Month 12); Mean Change From Baseline to Month 12 for Hematocrit Values (Baseline and Month 12); Mean Change From Baseline to Month 12 for Red Blood Cell Count Values (Baseline and Month 12); Mean Change From Baseline to Month 12 for Mean Corpuscular Hemoglobin Concentration Values (Baseline and Month 12); Mean Change From Baseline to Month 12 for Platelet Count Values (Baseline and Month 12); Mean Change From Baseline to Month 12 for White Blood Cell Count Values (Baseline and Month 12); Mean Change From Baseline to Month 12 for Blood Urea Nitrogen Values (Baseline and Month 12); Mean Change From Baseline to Month 12 for Creatinine Values (Baseline and Month 12); Mean Change From Baseline to Month 12 for Calcium Values (Baseline and Month 12); Mean Change From Baseline to Month 12 for Inorganic Phosphorus Values (Baseline and Month 12); Mean Change From Baseline to Month 12 for Total Bilirubin Values (Baseline and Month 12); Mean Change From Baseline to Month 12 for Alkaline Phosphatase Values (Baseline and Month 12); Mean Change From Baseline to Month 12 for Aspartate Aminotransferase Values (Baseline and Month 12); Mean Change From Baseline to Month 12 for Alanine Aminotransferase Values (Baseline and Month 12); Mean Change From Baseline to Month 12 for Serum Gastrin Levels (Baseline and Month 12); Mean Change From Baseline to Month 12 for Systolic Blood Pressure (Baseline and Month 12); Mean Change From Baseline to Month 12 for Diastolic Blood Pressure (Baseline and Month 12); Mean Change From Baseline to Month 12 for Pulse Rate (Baseline and Month 12); Changes From Baseline to Final Visit in Antrum Biopsy Results (Baseline and Final Visit (up to 12 months)); Changes From Baseline to Final Visit in Fundus Biopsy Results (Baseline and Final Visit (up to 12 months))
D: Percentage of Heartburn Free 24 Hour Days During 14 Days of Randomized Treatment (From randomisation to day 14); Percentage of Heartburn Free 24 Hour Days During 14 Days of Randomized Treatment (From randomization to day 14)

Answer: A
Please select the outcome measures that correspond to the clinical trial below.
Title: Cilostazol Verse Asprin for Vascular Dementia in Poststroke Patients With White
Brief Summary: The purpose of this study is to evaluate the efficacy of PDE-3 inhibitor, cilostazol, in prevention and treatment of vascular dementia, in those with brain white matter lesions and vascular risk factors.


Options:
A: changes of the scores of MMSE, MOCA,CDR,and Blessed-Roth (one year)
B: Feasibility of Phase III Trial (36 months (24 Months Recruitment + 12 months Follow Up))
C: The Changes of Middle Cerebral Artery (MCA) and Basilar Artery (BA) Pulsatility Index (PI) at 14 and 90 Days From the Baseline Transcranial Doppler (TCD) Study (14 days and 90 days from the baseline TCD study)
D: The First Occurrence of the Composite Primary Efficacy Outcome, Myocardial Infarction (MI), Stroke, or Cardiovascular (CV) Death (For each participant, the first occurrence of the composite primary efficacy outcome after randomization up until the global rivaroxaban/aspirin outcomes cut-off date (06 FEB 2017) was considered. The mean time in follow-up until that date was 702 days.); The First Occurrence of the Primary Safety Outcome Major Bleeding Based on a Modification of the International Society on Thrombosis and Haemostasis (ISTH) Criteria (For each participant, the first occurrence of modified ISTH major bleeding after randomization up until the global rivaroxaban/aspirin outcomes cut-off date (06 FEB 2017) was considered. The mean time in follow-up until that date was 702 days.)

Answer: A
Please select the outcome measures that correspond to the clinical trial below.
Title: Intérêt d'Utiliser Des solutés de Remplissage équilibrés à la Phase précoce d'un Traumatisme crânien Grave Pour Limiter l'Acidose hyperchlorémique
Brief Summary: isotonic NaCl serum is the first intent solution for infusion during the initial phase of reanimation for an acute cranial traumatism.

However, its use can trigger an hyperchloremic metabolic acidosis, what could be deleterious for the future of this patient.

Isofundine present all charateristics to be use in this indication: pharmacokinetic and pharmacodynamic similar to the physiologic serum, iso-osmolarity to plasma, no glucose provision and no interaction with hemostasis.


Options:
A: Quality of Recovery-40 Score at 24 Hours (24 hours after ED visit)
B: Type of resuscitation fluid in ICU (24-hour study day)
C: Mean base excess during hospital stay (Six month control period (before) and 6 month intervention period (after))
D: Incidence of hyperchloremic acidosis during the 2 first days of acute cranial traumatism. (J1 and J2)

Answer: D
Please select the outcome measures that correspond to the clinical trial below.
Title: A Prospective Study to Establish Normative Values, Demographic Variations, Referent Diagnostic Values and Disease Severity Correlations for Dry Eye Disease and TearLab Osmometry.
Brief Summary: This is a prospective, observational case series to determine the clinical utility of tear osmolarity and other commonly used objective tests to diagnose dry eye disease, as well as to establish referent values for objective tests of the disease.


Options:
A: Diagnostic Test Data for Disease Using Tear Osmolarity Threshold > 308 mOsm/L (Single visit); Diagnostic Test Data for Disease Using Schirmer Test Threshold < 7 mm (Single visit); Diagnostic Test Data for Disease Using Tear Film Breakup Time Threshold < 5 Seconds (Single visit); Diagnostic Test Data for Disease Using Corneal Staining Threshold > Grade 4/15 (Single visit); Diagnostic Test Data for Disease Using Conjunctival Staining Threshold > Grade 3/12 (Single visit); Diagnostic Test Data for Disease Using Meibomian Gland Grading Threshold > Grade 5/27 (Single visit); Diagnostic Test Data for Disease Using Ocular Surface Disease Index Threshold > 15/100 (Single visit)
B: C Corneal fluorescein staining (up to 12 weeks)
C: To compare the score reduction in the Ocular Surface Disease Index (OSDI) between patients treated with autologous serum and conventional artificial tears. (5 weeks)
D: Corneal epithelial damage evaluated by fluorescein staining (micron meter squares) with digital photos (28 days treatment)

Answer: A
Please select the outcome measures that correspond to the clinical trial below.
Title: A Prospective Study to Establish Normative Values, Demographic Variations, Referent Diagnostic Values and Disease Severity Correlations for Dry Eye Disease and TearLab Osmometry.
Brief Summary: This is a prospective, observational case series to determine the clinical utility of tear osmolarity and other commonly used objective tests to diagnose dry eye disease, as well as to establish referent values for objective tests of the disease.


Options:
A: Diagnostic Test Data for Disease Using Tear Osmolarity Threshold > 308 mOsm/L (Single visit); Diagnostic Test Data for Disease Using Schirmer Test Threshold < 7 mm (Single visit); Diagnostic Test Data for Disease Using Tear Film Breakup Time Threshold < 5 Seconds (Single visit); Diagnostic Test Data for Disease Using Corneal Staining Threshold > Grade 4/15 (Single visit); Diagnostic Test Data for Disease Using Conjunctival Staining Threshold > Grade 3/12 (Single visit); Diagnostic Test Data for Disease Using Meibomian Gland Grading Threshold > Grade 5/27 (Single visit); Diagnostic Test Data for Disease Using Ocular Surface Disease Index Threshold > 15/100 (Single visit)
B: Symptom severity: symptom questionnaires and clinical dry eye tests (3 months intervention + 1 month after the intervention)
C: Mean of Change From Baseline in Ocular Surface Disease Index (OSDI) Score at 6 and 12 Months (12 months)
D: Schirmer tear test (Screening, Week 4, Week 12, Week 24); Ocular Surface Disease Index (Screening, Week 4, Week 12, Week 24); Tear Breakup Time (Screening, Week 4, Week 12, Week 24); Corneal Staining with Fluorescein (Screening, Week 4, Week 12, Week 24); Impression Cytology (Screening, Week 12, Week 24); Conjunctival staining with lissamine (Screening, Week 4, Week 12, Week 24)

Answer: A