TrialPanorama/Dataset huggingface dataset:
Please select the outcome measures that correspond to the clinical trial below.
Title: Effectiveness of a Brain-Computer Interface Based System for Cognitive Enhancement in the Normal Elderly
Brief Summary: The primary objective is to examine the efficacy of 8-weeks of a locally developed brain-computer interface based system (BrainpalTM)intervention for improving attention and memory in normal elderly. We hypothesize that elderly who have completed the training program will have significant improvement in their attention and memory compared to the controls, based on the Repeatable Battery for the Assessment of Neuropsychological Status.


Options:
A: overall cognition (2 Monhths)
B: Total Score on the Repeatable Battery for the Assessment of Neuropsychological Status (RBANS) (Comparison in the change of RBANS total score from baseline (Week 1) to post-treatment (Week 8) in Intervention Group versus Wait-List Control group)
C: Change in Global Cognition Assessed Using the ADASCog(13 and Plus Modalities). (baseline and at 20 weeks (after interventions finalised))
D: STROOP-Negative Priming (Change from Baseline Stroop-Negative Priming task at 15 weeks and 30 weeks); ODDBALL (Change from Baseline oddball task at 15 weeks and 30 weeks); N-BACK (Change from Baseline N-back task at 15 weeks and 30 weeks); CORSI BLOCK (Participants with non-action video-game training, change from baseline Corsi block task at 15 weeks and 30 weeks)

Answer: B
Please select the outcome measures that correspond to the clinical trial below.
Title: Effectiveness of a Brain-Computer Interface Based System for Cognitive Enhancement in the Normal Elderly
Brief Summary: The primary objective is to examine the efficacy of 8-weeks of a locally developed brain-computer interface based system (BrainpalTM)intervention for improving attention and memory in normal elderly. We hypothesize that elderly who have completed the training program will have significant improvement in their attention and memory compared to the controls, based on the Repeatable Battery for the Assessment of Neuropsychological Status.


Options:
A: Total Score on the Repeatable Battery for the Assessment of Neuropsychological Status (RBANS) (Comparison in the change of RBANS total score from baseline (Week 1) to post-treatment (Week 8) in Intervention Group versus Wait-List Control group)
B: overall cognition (2 Monhths)
C: Reduction of frailty (12 months); Frailty score (continuous variable) (12 months); Measures of frailty components (BMI, fast gait speed test, knee extension, exhaustion score and time spent on physical activities per day). (12 months)
D: Composite Cognitive Function in Z-scores (i.e. Which Converts Raw Data to Standard Deviation (SD) Units: [Score-mean]/SD]). This Composite is Formed by Averaging the Z-scores From Individual Tests. (Changes from baseline at 4 months in z-scores.)

Answer: A
Please select the outcome measures that correspond to the clinical trial below.
Title: Effectiveness of a Brain-Computer Interface Based System for Cognitive Enhancement in the Normal Elderly
Brief Summary: The primary objective is to examine the efficacy of 8-weeks of a locally developed brain-computer interface based system (BrainpalTM)intervention for improving attention and memory in normal elderly. We hypothesize that elderly who have completed the training program will have significant improvement in their attention and memory compared to the controls, based on the Repeatable Battery for the Assessment of Neuropsychological Status.


Options:
A: Total Score on the Repeatable Battery for the Assessment of Neuropsychological Status (RBANS) (Comparison in the change of RBANS total score from baseline (Week 1) to post-treatment (Week 8) in Intervention Group versus Wait-List Control group)
B: overall cognition (2 Monhths)
C: Change in cognitive function summary score (12 weeks)
D: sleep measures (3-6 months)

Answer: A
Please select the outcome measures that correspond to the clinical trial below.
Title: Effectiveness of a Brain-Computer Interface Based System for Cognitive Enhancement in the Normal Elderly
Brief Summary: The primary objective is to examine the efficacy of 8-weeks of a locally developed brain-computer interface based system (BrainpalTM)intervention for improving attention and memory in normal elderly. We hypothesize that elderly who have completed the training program will have significant improvement in their attention and memory compared to the controls, based on the Repeatable Battery for the Assessment of Neuropsychological Status.


Options:
A: sleep measures (3-6 months)
B: Useful Field of View Test (12 months)
C: Total Score on the Repeatable Battery for the Assessment of Neuropsychological Status (RBANS) (Comparison in the change of RBANS total score from baseline (Week 1) to post-treatment (Week 8) in Intervention Group versus Wait-List Control group)
D: Change in Global Cognition Assessed Using the ADASCog(13 and Plus Modalities). (baseline and at 20 weeks (after interventions finalised))

Answer: C
Please select the outcome measures that correspond to the clinical trial below.
Title: Effects of Two Different Anesthesia-analgesia Methods on the Incidence of Postoperative Delirium: a Multicenter, Randomized Controlled Trial
Brief Summary: Postoperative delirium is a common complication in elderly patients after surgery. Its occurrence is associated with worse outcomes. The pathophysiology of delirium remains poorly understood. However, an universal phenomenon is that delirium frequently occurs in elderly patients after major complicated surgery, but is rarely seen after minor ambulatory surgery (such as cataract surgery). This indicates that stress response produced by surgery might have an important role in the pathogenesis of delirium. It has been reported that, when compared with general anesthesia and postoperative intravenous analgesia, neuraxial anesthesia and analgesia reduced the occurrence of postoperative complications and mortality in high risk patients. Combined epidural-general anesthesia is frequently used in clinical practice. This anesthetic method provides advantages of both epidural and general anesthesia, i.e. it blocks the afferent pathway of nociceptive stimulus by neuraxial blockade during and after surgery, and allows patients to endure long-duration surgery without any awareness. The investigators hypothesize that combined epidural-general anesthesia and postoperative epidural analgesia can decrease the incidence of delirium in elderly patients after major surgery when compared with general anesthesia alone and postoperative intravenous analgesia.


Options:
A: Incidence of postoperative delirium (During the first 7 days after surgery.)
B: Postoperative delirium rate within 7 days after surgery (7 days after surgery)
C: Number of Patients With Incidence of Delirium Across All Patients at Baseline and Over Post-operative Days 1-3 (Delirium incidence on postoperative days 1-3, calculated by any positive CAM on any day for all patients)
D: Post Operative Delirium diagnosed with the Confusion Assessment Method within four days post-surgery (Four days)

Answer: A
Please select the outcome measures that correspond to the clinical trial below.
Title: Pragmatic Clinical Trial of Vaccine Health Literacy Related Text Message Reminders to Increase Receipt of Second Dose of Influenza Vaccine for Young, Low Income, Urban Children
Brief Summary: Influenza remains a potentially significant and largely preventable source of morbidity and mortality, yet vaccine coverage is low. Young children are at particular risk for underimmunization because they may need to receive 2 doses in a current season. Even among those young children that initiate vaccination, only 40% receive the important second dose, yet one dose does not confer adequate protection. Low-income, urban children may be at particular risk of not receiving two doses. While traditional mail and phone immunization reminders notifying families that a vaccine is due have had limited efficacy in low-income, urban populations, we have demonstrated the success of using text messages. Comparing the effectiveness of different forms of reminders on receipt of this critical second dose of influenza vaccine has not been studied. Besides failure to remember to return for subsequent doses, receipt of 2 doses of influenza vaccine in a season can be affected by limited health literacy regarding influenza vaccination, particularly associated with understanding the need for a second dose since not all children require it. Text messaging offers the ability to combine health literacy promoting information and reminders in a scalable, efficient manner for populations at high risk for underimmunization, limited health literacy, and influenza spread. Therefore, the purpose of this study is to determine whether the provision of interactive vaccine health literacy-promoting information in text message vaccine reminders improves receipt and timeliness of the second dose of influenza vaccine within a season for underserved children in need of two doses.


Options:
A: HPV completion rate (One Year)
B: Receipt of 2nd Dose of the Influenza Vaccine. (by April 30th after receipt of first dose (up to 8 months))
C: The proportion of subjects who attain the LDL-C levels set as targets by the Guidelines for Management of Dyslipidaemias and CVR (24 months)
D: the first aim is to assess our ability to enroll at least 70% (N=90) of eligible parents in a text messaging program (up to 1 year)

Answer: B
Please select the outcome measures that correspond to the clinical trial below.
Title: Pragmatic Clinical Trial of Vaccine Health Literacy Related Text Message Reminders to Increase Receipt of Second Dose of Influenza Vaccine for Young, Low Income, Urban Children
Brief Summary: Influenza remains a potentially significant and largely preventable source of morbidity and mortality, yet vaccine coverage is low. Young children are at particular risk for underimmunization because they may need to receive 2 doses in a current season. Even among those young children that initiate vaccination, only 40% receive the important second dose, yet one dose does not confer adequate protection. Low-income, urban children may be at particular risk of not receiving two doses. While traditional mail and phone immunization reminders notifying families that a vaccine is due have had limited efficacy in low-income, urban populations, we have demonstrated the success of using text messages. Comparing the effectiveness of different forms of reminders on receipt of this critical second dose of influenza vaccine has not been studied. Besides failure to remember to return for subsequent doses, receipt of 2 doses of influenza vaccine in a season can be affected by limited health literacy regarding influenza vaccination, particularly associated with understanding the need for a second dose since not all children require it. Text messaging offers the ability to combine health literacy promoting information and reminders in a scalable, efficient manner for populations at high risk for underimmunization, limited health literacy, and influenza spread. Therefore, the purpose of this study is to determine whether the provision of interactive vaccine health literacy-promoting information in text message vaccine reminders improves receipt and timeliness of the second dose of influenza vaccine within a season for underserved children in need of two doses.


Options:
A: Receipt of 2nd Dose of the Influenza Vaccine. (by April 30th after receipt of first dose (up to 8 months))
B: Short-term Exclusive Breastfeeding (24-hour recall) (Measured at 1 month post-delivery via tablet based survey AND independent verification phone survey within one week); Long-term Exclusive Breastfeeding (24-hour recall) (Measured at 5 months post-delivery via tablet based survey AND independent verification phone survey within one week)
C: Linkage to care for HIV infected persons not on treatment following a point-of care CD4 count compared to referral to clinic for CD4 testing (Up to 12 Months); Uptake of male circumcision referral among HIV-uninfected men with either promotion at point of HIV testing, SMS follow-up or lay-counselor follow-up visits (Up to 9 months); Linkage to care for HIV infected persons after lay counselor follow-up, accompaniment to HIV clinic by lay counselor, or clinic referral (Up to 12 months)
D: Change in IPV assessments (Screening and at 2 months post-birth.)

Answer: A
Please select the outcome measures that correspond to the clinical trial below.
Title: Pragmatic Clinical Trial of Vaccine Health Literacy Related Text Message Reminders to Increase Receipt of Second Dose of Influenza Vaccine for Young, Low Income, Urban Children
Brief Summary: Influenza remains a potentially significant and largely preventable source of morbidity and mortality, yet vaccine coverage is low. Young children are at particular risk for underimmunization because they may need to receive 2 doses in a current season. Even among those young children that initiate vaccination, only 40% receive the important second dose, yet one dose does not confer adequate protection. Low-income, urban children may be at particular risk of not receiving two doses. While traditional mail and phone immunization reminders notifying families that a vaccine is due have had limited efficacy in low-income, urban populations, we have demonstrated the success of using text messages. Comparing the effectiveness of different forms of reminders on receipt of this critical second dose of influenza vaccine has not been studied. Besides failure to remember to return for subsequent doses, receipt of 2 doses of influenza vaccine in a season can be affected by limited health literacy regarding influenza vaccination, particularly associated with understanding the need for a second dose since not all children require it. Text messaging offers the ability to combine health literacy promoting information and reminders in a scalable, efficient manner for populations at high risk for underimmunization, limited health literacy, and influenza spread. Therefore, the purpose of this study is to determine whether the provision of interactive vaccine health literacy-promoting information in text message vaccine reminders improves receipt and timeliness of the second dose of influenza vaccine within a season for underserved children in need of two doses.


Options:
A: Receipt of 2nd Dose of the Influenza Vaccine. (by April 30th after receipt of first dose (up to 8 months))
B: Proportion of timely and complete vaccine uptake after ISAP SMS Intervention (12 months)
C: Self-reported adherence on antiretroviral therapy (12 months post-partum); Adherence on antiretroviral therapy (12 months post-partum); Adherence on antiretroviral therapy (infant) (12 months post-partum); Retention in care (12 months post-partum); Adherence on antiretroviral therapy (dried blood spots) (12 months post-partum)
D: Count of Women Who Have Excess Gestational Weight Gain (Approximately 6 months (from 10-13 weeks gestation to 35-36 weeks gestation))

Answer: A
Please select the outcome measures that correspond to the clinical trial below.
Title: A Randomized, Phase III, Multicenter, Double-Blind, Placebo-Controlled Study Evaluating the Efficacy and Safety of Onartuzumab (MetMAb) in Combination With 5-Fluorouracil, Folinic Acid, and Oxaliplatin (mFOLFOX6) in Patients With Metastatic HER2-Negative, MET-Positive Gastroesophageal Cancer
Brief Summary: This randomized, multicenter, double-blind, placebo-controlled study will evaluate the efficacy and safety of onartuzumab (MetMAb) in combination with 5-fluorouracil, folinic Acid, and oxaliplatin (mFOLFOX6) in participants with metastatic human epidermal growth receptor (HER) 2-negative and MET-positive adenocarcinoma of the stomach or gastroesophageal junction. Participants will be randomized in a 1:1 ratio to receive either onartuzumab or placebo in combination with mFOLFOX6. Participants may continue to receive onartuzumab or placebo until disease progression, unacceptable toxicity, participant or physician decision to discontinue treatment.


Options:
A: Objective response rate (ORR) (about 10 month (until progression))
B: Overall Survival in Patients With Limited Metastatic Gastric Carcinoma: Arm I (12 weeks up to 3 years); Overall Survival in Patients With Limited Metastatic Gastric Carcinoma: Arm II (12 weeks up to 3 years)
C: The primary endpoint is the Progression-free survival (PFS) according to RECIST V1.1. (Average time period: up to one year (participants are followed until progression or death))
D: Overall survival (OS) in the MET Immunohistochemistry (IHC) 2+/3+ Participant Subgroup (Baseline until death (up to approximately 38 months overall)); OS in the Intent-To-Treat (ITT) Population (Baseline until death (up to approximately 38 months overall))

Answer: D
Please select the outcome measures that correspond to the clinical trial below.
Title: A Randomized, Open-Label, Parallel-Group, Multi-Center Study for the Evaluation of Efficacy and Safety of Edoxaban Monotherapy Versus (LMW) Heparin/Warfarin in Subjects With Symptomatic Deep-Vein Thrombosis - Edoxaban Thrombus Reduction Imaging Study
Brief Summary: Assess the relative change in thrombus volume as determined by two assessments (Baseline and Day 14-21) with magnetic resonance venography (MRV) in subjects with deep-vein thrombosis (DVT) treated with either an edoxaban monotherapy regimen or a low molecular weight (LMW) heparin/warfarin regimen.


Options:
A: Relative Change From Baseline in Thrombus Volume Assessed by MRI [Using the Magnetic Resonance Venography (MRV) Method] (Baseline to final visit (Day 14-21))
B: Number of Participants With Adjudicated Recurrent Venous Thromboembolism (VTE) or Major Bleeding Event (12 months)
C: Symptomatic Recurrent VTE, i.e., the Composite of DVT, Non-fatal PE, and Fatal PE (12 months from time of randomization)
D: Percentage of Participants With Symptomatic Recurrent Venous Thromboembolism [VTE] (i.e. the Composite of Recurrent Deep Vein Thrombosis [DVT] or Fatal or Non-fatal Pulmonary Embolism [PE]) Until the Intended End of Study Treatment (3-, 6-, or 12-month study treatment period)

Answer: A
Please select the outcome measures that correspond to the clinical trial below.
Title: Performance of the Verinata Health Prenatal Aneuploidy Test Compared to Current Fetal Aneuploidy Screening Results and Pregnancy Outcomes in an 'All-Risk' Population
Brief Summary: This is a prospective, multi-center observational study designed to compare the test results of the Verinata Health Prenatal Aneuploidy Test to results of conventional prenatal screening for fetal chromosome abnormalities in 'all-risk' pregnancies.


Options:
A: Difference in sensitivity and specificity of Ariosa Harmony™ Prenatal Test (AUCt) and combined first-trimester screening for detection of T21. (Enrollment to delivery)
B: Comparison of screen positive rates between investigational testing results and conventional screening results (standard of care). (12 months)
C: The RNA study is an observational trial whose primary aim is to document the performance (sensitivity and specificity) of a laboratory developed test (LDT), using fetal nucleic acid in maternal plasma to identify Down syndrome in early pregnancy. (Within 1st and 2nd trimesters)
D: Classification of fetal status as affected or not affected for Trisomy 21 based on Artemis Health Test on maternal blood. (10 months)

Answer: B
Please select the outcome measures that correspond to the clinical trial below.
Title: A Randomized, Double-Blind, Placebo-Controlled, Parallel-Group Study to Evaluate the Effect of Alirocumab (SAR236553/REGN727) on the Occurrence of Cardiovascular Events in Patients Who Have Recently Experienced an Acute Coronary Syndrome
Brief Summary: Primary Objective:

To compare the effect of alirocumab with placebo on the occurrence of cardiovascular (CV) events (composite endpoint of coronary heart disease (CHD) death, non-fatal myocardial infarction (MI), fatal and non-fatal ischemic stroke, unstable angina (UA) requiring hospitalization) in participants who experienced an acute coronary syndrome (ACS) event 4 to 52 weeks prior to randomization and were treated with evidence-based medical and dietary management of dyslipidemia.

Secondary Objectives:

* To evaluate the effect of alirocumab on secondary endpoints (any CHD event , major CHD event, any CV event, composite of all cause mortality/non-fatal MI/non-fatal ischemic stroke, CHD deaths, CV deaths, all cause mortality).
* To evaluate the safety and tolerability of alirocumab.
* To evaluate the effect of alirocumab on lipid parameters.


Options:
A: Time to First Occurrence of Major Adverse Cardiovascular Event (MACE); Percentage of Observed Participants With Outcome Measure Events During the Study (From randomization up to 64 months)
B: Percent Change From Baseline in Fasting Low Density Lipoprotein Cholesterol (LDL-C) at Week 12 (Baseline, Week 12)
C: Number of Participants With Adverse Events (From first dose of study drug in Study 20110271 up to 30 days after the last dose or until the end of study date, whichever was earlier; median duration of treatment was 48.7 months.)
D: Percent Change From Baseline in Calculated LDL-C at Week 24 - Intent-to-treat (ITT) Analysis (From Baseline to Week 24)

Answer: A
Please select the outcome measures that correspond to the clinical trial below.
Title: A Phase 3, Multi-Center, Multinational, Randomized, Double-Blind, Study to Evaluate the Efficacy and Safety of Belimumab (HGS1006) in Combination With Azathioprine for the Maintenance of Remission in Wegener's Granulomatosis and Microscopic Polyangiitis
Brief Summary: The purpose of this study is to evaluate the efficacy and safety of belimumab, in combination with azathioprine, for the maintenance of remission following a standard induction regimen in patients with Wegener's granulomatosis or microscopic polyangiitis. The random assignment in this study is "1 to 1" which means that participants have an equal chance of receiving belimumab or placebo.


Options:
A: Discover biomarkers in GPA/MPA capable of measuring disease activity and response to treatment. (Study completion)
B: Disease free period, time from remission to relapse or study end.
C: combined rate of remission-treatment failures and minor or major relapses at 24 months (24 months)
D: Time to First Relapse (Approximately up to 4 years)

Answer: D
Please select the outcome measures that correspond to the clinical trial below.
Title: SMS Mobile Technology for Vaccine Coverage and Acceptance in Guatemalan Infants
Brief Summary: To pilot test a mobile phone SMS (Short Message Service) system that will provide periodical messaging texts to mothers or custodians of infants who come for their first dose vaccines within the first 3 months of life to improve timely immunization coverage, vaccine acceptance and ensure vaccine safety monitoring. The intervention will include a "cloud-based" information system alimented by mobile phone data entry at the health post nurse level, that links child vaccination status and is able to remind parents and nurses of the need for next vaccination appointment and provide a system for reporting of adverse events following immunization in the immediate post-vaccination period.


Options:
A: 1 Dose Coverage of the HPV vaccine series at End of Study Period (12 months); 3 Dose Coverage of the HPV vaccine series at End of Study Period (12 months)
B: receipt of vaccine of interest at 28 days (28 days)
C: HPV completion rate (One Year)
D: Completion of 3 Doses of Pentavalent Vaccine (8 months of age)

Answer: D