TrialPanorama/Dataset huggingface dataset:
Please select the outcome measures that correspond to the clinical trial below.
Title: Intensive Versus Standard Blood Pressure Lowering to Prevent Functional Decline in Older People
Brief Summary: This randomized clinical trial examines if lowering and maintaining 24-hour ambulatory systolic blood pressure to \<130 mmHg (intensive control) versus \<145 mmHg (standard control) slows/halts the progression of deterioration of mobility and cognitive function linked to white-matter disease (also known as white-matter hyperintensity or WMH) in patients with normal or mildly impaired mobility and cognition in subjects with detectable cerebrovascular disease (\>0.5% WMH fraction of intracranial contents). The study patients will be enrolled and randomized to one of two levels of ambulatory blood pressure control (intensive to achieve a goal 24-hour systolic blood pressure of \< 130 mmHg or standard to achieve a goal 24-hour systolic blood pressure of \< 145 mmHg) for a total of 36 months.


Options:
A: Evidence of clinically defined ischemic stroke (focal neurological deficits persisting for more than 24 hours) confirmed by non-investigational CT or MRI (Mean follow up of 4 years); Evidence of hemorrhagic stroke; a neurologic deficit associated with intraparenchymal or subarachnoid space lesion on CT/MRI or cerebral hemorrhage demonstrated by surgery or autopsy. (within mean follow-up of 4 years)
B: First occurrence of death or nonfatal myocardial infarction (MI) or nonfatal stroke
C: Mobility - Measured by Change in Gait Speed (Change from baseline to 36 months)
D: changes in Left Ventricular Hypertrophy (LVH) at Electro Cardio Gramme (ECG). (0, 12, 24 months)

Answer: C
Please select the outcome measures that correspond to the clinical trial below.
Title: School-Based Telemedicine Enhanced Asthma Management: A Randomized Control Trial Using Novel Technology to Improve Preventive Asthma Care
Brief Summary: This project aims to improve guideline-based asthma care using enhanced communication and screening tools, telemedicine and directly observed therapy of preventive medications in city schools. Web-based screening will be used to identify children with persistent or poorly controlled asthma and to send reports to the child's primary care doctor. Children in the SB-TEAM group will receive a telemedicine asthma assessment in school and be prescribed a daily preventive asthma medication to be taken through school-based directly observed therapy. The overall aim of this study is to evaluate the use of the SB-TEAM intervention for improving guideline based care, enhancing adherence to effective preventive medications and at reducing morbidity among young urban children with asthma.


Options:
A: Emergency Department Visit (12 months)
B: Average Number of Days Without Asthma Symptoms (Symptom Free Days) (Average number of days, over 2 weeks, during peak winter season (November-March), assessed over 4 years.)
C: Change in Asthma Control Test Scores (Baseline and Six months)
D: Percentage Changed in Adherence Score (Baseline compared to the mean of the combined 3, 6, 9, and 12 month scores); Number of Symptom-free Days (Baseline compared to the mean of the combined 3, 6, 9, and 12 month scores)

Answer: B
Please select the outcome measures that correspond to the clinical trial below.
Title: Open Label, Non-Randomized, Study to Evaluate the Pharmacokinetics of Tranexamic Acid in Patients Undergoing Major Liver Resection
Brief Summary: Tranexamic acid (TXA) is an antifibrinolytic agent that has been shown to reduce blood loss and blood transfusion requirements in the following patient populations: multisystem trauma, liver transplantation, cardiac surgery and spine surgery. Patients undergoing major liver resection are at risk of severe perioperative blood loss and may also benefit from perioperative TXA administration.

This open label, non-randomized study to evaluate the pharmacokinetic and pharmacodynamic properties of two well studied dosing regimens of TXA will provide guidance in determining the optimal TXA dosing regimen for patients undergoing major liver resection. Compelling evidence of the effectiveness of TXA comes from the large multicentred, multi-national CRASH-2 trial where TXA was administered as a 1 g bolus + 1 g infusion over 8 hours. In liver transplant surgery, the following dose regimen has been shown to have great effect:10 mg/kg/h from the start of surgery until 2 hours after reperfusion of the liver transplant.

Although TXA is not currently approved for use in patients undergoing major liver resection, Health Canada has allowed the use of tranexamic acid for use in this research study.


Options:
A: Proportion of subjects achieving hemostasis at the Target Bleeding Site (TBS). (Intra-operative)
B: Receipt of blood transfusion(s) (7 days)
C: Time to Hemostasis (TTH) for Participants Receiving Spinal Surgery (Within 5 minutes); Time to Hemostasis (TTH) for Participants Receiving Vascular Surgery (Within 5 minutes); Time to Hemostasis (TTH) for Participants Receiving Hepatic Resection (Within 5 minutes); Time to Hemostasis (TTH) for Participants Receiving Soft Tissue Dissection (Within 5 minutes)
D: Hemostasis at the Target Bleeding Site (TBS) at 4-minutes Following Randomization (Intraoperative, 4 minutes following randomization)

Answer: B
Please select the outcome measures that correspond to the clinical trial below.
Title: Individual, Telephone-delivered Acceptance and Commitment Therapy for Smoking Cessation in the Primary Healthcare Setting: Feasibility and Potential Efficacy
Brief Summary: The purpose of this study is to evaluate the feasibility and potential efficacy of Acceptance and Commitment Therapy (ACT) in enhancing smoking cessation among attendees in primary healthcare settings.


Options:
A: Change from baseline in ED staff burn out using the Maslach Burnout Inventory (MBI) (Week 8 and 20)
B: Change in Stress (baseline, 8wks (post-intervention),12-month follow-up)
C: 7-day point prevalence by self report (at 6 months)
D: Smoking abstinence (7 days)

Answer: C
Please select the outcome measures that correspond to the clinical trial below.
Title: Individual, Telephone-delivered Acceptance and Commitment Therapy for Smoking Cessation in the Primary Healthcare Setting: Feasibility and Potential Efficacy
Brief Summary: The purpose of this study is to evaluate the feasibility and potential efficacy of Acceptance and Commitment Therapy (ACT) in enhancing smoking cessation among attendees in primary healthcare settings.


Options:
A: 7-day point prevalence by self report (at 6 months)
B: 7-day point prevalence of smoking six months following completion of the intervention protocol (nine months post randomization). (2 years)
C: Biochemically-validated 7-day point prevalence tobacco abstinence at end of pregnancy
D: 30 days prolonged abstinence (6-months postpartum)

Answer: A
Please select the outcome measures that correspond to the clinical trial below.
Title: Individual, Telephone-delivered Acceptance and Commitment Therapy for Smoking Cessation in the Primary Healthcare Setting: Feasibility and Potential Efficacy
Brief Summary: The purpose of this study is to evaluate the feasibility and potential efficacy of Acceptance and Commitment Therapy (ACT) in enhancing smoking cessation among attendees in primary healthcare settings.


Options:
A: Biochemically confirmed continuous 30-day abstinence from smoking (12 weeks post-Target Quit Day (TQD))
B: Feasibility of study recruitment into the three interventions (Baseline); Feasibility of retention of participants at 3-month follow-up (3-month follow-up); Feasibility of retention of participants at 6-month follow-up (6-month follow-up); Acceptability of the three interventions (3-month follow-up)
C: 7-day point prevalence (3 months and 6 months post treatment)
D: 7-day point prevalence by self report (at 6 months)

Answer: D
Please select the outcome measures that correspond to the clinical trial below.
Title: A Randomized Controlled Trial of Live Attenuated Vaccine Versus Trivalent Inactivated Vaccine in Hutterite Children
Brief Summary: There is uncertainty about whether a live attenuated vaccine (LAIV) offers additional benefit over inactivated trivalent influenza vaccine (TIV) in providing indirect benefit to those who are unvaccinated through herd immunity. The goal of this randomized clinical trial is to determine whether immunizing children in Hutterite colonies with LAIV can provide increased community-wide protection over TIV. Children aged 3 to 15 years in Hutterite colonies from Alberta and Saskatchewan will be randomized to one of two regimens: TIV or LAIV. The primary outcome of this study will be laboratory-confirmed influenza as detected by PCR in all participants (i.e vaccine recipients and nonrecipients). Secondary outcomes will include influenza-like illness, hospitalization, pneumonia, death, antibiotic use, absenteeism.


Options:
A: Laboratory-confirmed influenza infection. (up to 3 years)
B: The primary endpoint for efficacy is the first episode in the first season in a study child of a culture-confirmed influenza illness, caused by community-acquired subtypes antigenically similar to those contained in the vaccine.
C: Number of Subjects (Unprimed) 6 to <36 Months Age With Local and Systemic Reactions After Any Vaccination for All Seasons, Comparison of Adjuvanted Trivalent Influenza Vaccine (aTIV) and Flu Vaccine Control. (7 days post-vaccination); Percentage of Subjects (Unprimed) Aged 6 to <36 Months With Virus-Confirmed Influenza, Comparison of aTIV and Non-flu Vaccine Control (Men C/TBE Vaccine) (3 weeks after 2nd vaccination)
D: Geometric Mean Titer 30 Days After the Last Study Vaccination (30 days after the last study vaccination); Percentage of Participants With Seroconversion 30 Days After the Last Study Vaccination (30 days after the last study vaccination)

Answer: A
Please select the outcome measures that correspond to the clinical trial below.
Title: A Study of Simvastatin on Myocardial Protection and Cardiac Function Undergoing Cardiac Surgery With Cardiopulmonary Bypass
Brief Summary: Statins have been used to low cholesterol to prevent and treat coronary artery diseases. It was also reported that statins could protect endothelial function and cardiac function during coronary artery bypass graft. The investigators recent found simvastatin reduced myocardial injury during noncoronary artery cardiac surgery in single medical center. The investigators further investigate that whether simvastatin can protect myocardium during noncoronary artery cardiac surgery with cardiopulmonary bypass and improve cardiac function with long term use postoperatively in two medical centers.


Options:
A: Number of Participants With Acute Kidney Injury (postoperative day 2); Number of Participants With Delirium (while in ICU (about 2 days))
B: troponin (within the first 7 days after surgery); ejection fraction (within two years)
C: Post operative atrial fibrillation detected on continuous ECG monitoring. (Monitoring will commence soon after surgery and will be continued until the end of post operative day 5); Myocardial injury assessed by Troponin release (Serial blood samples for Troponin assay will be collected at 6, 24, 48 and 120 hours after surgery)
D: to evaluate whether 2 years of treatment with 40 mg rosuvastatin results in regression of coronary artery atheroma burden via the total atheroma volume in the most diseased segment or the percent atheroma volume, as measured by IVUS

Answer: B
Please select the outcome measures that correspond to the clinical trial below.
Title: A Randomized Controlled Trial of "Coping Coach," a Web-based Preventive Intervention for Children
Brief Summary: This study will evaluate the impact of a psychosocial intervention, Coping Coach, delivered online to children who have experience an acute medical event.

The core study hypotheses are that children receiving the intervention will (1) endorse fewer maladaptive trauma-related appraisals and (2) demonstrate more adaptive coping (more support-seeking, more cognitive restructuring, less avoidant coping) at a 6-week follow-up, and (3) demonstrate lower severity of post traumatic stress (PTS) symptoms and higher health related quality of life (HRQOL) at 12 week follow-up.


Options:
A: Evaluation of Child mental health, social & behavioral functioning and quality of life as measured from multiple informants and sources. (Immediately post-intervention and 6-months post intervention)
B: Change in scores on the Oxford Measure of Psychosocial Adjustment & World Health Organization Disability Assessment Schedule, 2.0 (WHODAS 2.0) (Administered at 4 timepoints: (1) baseline; (2) within 15 days of YRI completion; (3) 6 months post-YRI; (4) 12 months post-YRI)
C: Change in adolescent mental health symptoms (baseline, 4 month followup, and 12 month followup); Change in parent mental health symptoms (baseline, 4 month followup, 12 month followup); Change in parent-child conflict (baseline, 4 month followup, 12 month followup); Change in parent-child relationship quality (baseline, 4 month followup, 12 month followup)
D: Feasibility of the Coping Coach Online Intervention (6 weeks); Mean Time Spent Using the Intervention (6 weeks)

Answer: D
Please select the outcome measures that correspond to the clinical trial below.
Title: Multisite Prevention of Conduct Problems
Brief Summary: The primary aim of this project is to evaluate the effects of a comprehensive intervention to prevent severe and chronic conduct problems in a sample of children selected as high-risk when they first entered school. It is hypothesized that the intervention will have positive effects on proximal child behavior in middle school, and high school affecting long-term adolescent outcomes such as conduct disorder, juvenile delinquency, school dropout, substance use, teen pregnancy, relational competence with peers, romantic partners and parents, education and employment and social and community integration.


Options:
A: Efficacy of Motivation and Problem Solving (MAPS) in Cancer Risk Reduction (6 months)
B: alcohol use, alcohol related consequences (3 -12 month period)
C: Anti-Social Behaviors (Grades 1-12 and Ages 19, 20, 25, 32, 34, 41)
D: Substance Use (Quarterly for up to 1 year post-baseline)

Answer: C
Please select the outcome measures that correspond to the clinical trial below.
Title: A Matched Pair Cluster-randomized Implementation Study to Measure the Effectiveness of an Intervention Package Aiming to Decrease Perinatal Mortality and Increase Institution-based Obstetric Care Among Indigenous Populations in Guatemala
Brief Summary: A matched pair cluster-randomized trial of this intervention package will be conducted in four rural and indigenous districts (Huehuetenango, Quiche, Alta Verapaz and San Marcos) of the Republic of Guatemala, using the health clinic as the unit of randomization. No external intervention is planned for control facilities, although enhanced monitoring, surveillance and data collection will occur throughout the study in all facilities in the four districts.

The package includes 3 interventions: 1) To train health care professionals in emergency obstetric and perinatal care using an innovative high-fidelity, low-tech, in situ, multidisciplinary simulation training curriculum (PRONTO); 2) To design and implement a social marketing strategy that promotes institution-based delivery; and 3) To integrate the role of obstetric nurse and professional midwife in intervention communities to act as liaisons between traditional birth attendants (TBA) and public health units. A fourth, cross-cutting component involves ongoing analysis, monitoring, surveillance and evaluation to strengthen information systems and monitor perinatal outcomes throughout the two years of the study.


Options:
A: all-cause neonatal mortality among preterms/low birth weight newborns (28-days after facility-based delivery)
B: increase the proportion of institutional deliveries in intervention vs. control clusters (Up to 15 months)
C: The primary outcome was the proportion of deliveries at greater than or equal to 20 weeks gestation in which one or more adverse maternal and/or neonatal outcomes occurred (Adverse Outcome Index).
D: Knowledge test by written test as multiple-choice questions (MCQ). (The participants will get a knowledge test at the training day they will participate in. Ten training days will be conducted in a 3 months period)

Answer: B
Please select the outcome measures that correspond to the clinical trial below.
Title: A Matched Pair Cluster-randomized Implementation Study to Measure the Effectiveness of an Intervention Package Aiming to Decrease Perinatal Mortality and Increase Institution-based Obstetric Care Among Indigenous Populations in Guatemala
Brief Summary: A matched pair cluster-randomized trial of this intervention package will be conducted in four rural and indigenous districts (Huehuetenango, Quiche, Alta Verapaz and San Marcos) of the Republic of Guatemala, using the health clinic as the unit of randomization. No external intervention is planned for control facilities, although enhanced monitoring, surveillance and data collection will occur throughout the study in all facilities in the four districts.

The package includes 3 interventions: 1) To train health care professionals in emergency obstetric and perinatal care using an innovative high-fidelity, low-tech, in situ, multidisciplinary simulation training curriculum (PRONTO); 2) To design and implement a social marketing strategy that promotes institution-based delivery; and 3) To integrate the role of obstetric nurse and professional midwife in intervention communities to act as liaisons between traditional birth attendants (TBA) and public health units. A fourth, cross-cutting component involves ongoing analysis, monitoring, surveillance and evaluation to strengthen information systems and monitor perinatal outcomes throughout the two years of the study.


Options:
A: increase the proportion of institutional deliveries in intervention vs. control clusters (Up to 15 months)
B: Difference in differences: change in use of oxytocin for prevention of postpartum hemorrhage (Baseline, Midline (6 months), Endline (12 months))
C: Composite of either >28 week / >1000 gram stillbirth or 7 day neonatal mortality rate (7 days post delivery)
D: Knowledge test by written test as multiple-choice questions (MCQ). (The participants will get a knowledge test at the training day they will participate in. Ten training days will be conducted in a 3 months period)

Answer: A
Please select the outcome measures that correspond to the clinical trial below.
Title: A Matched Pair Cluster-randomized Implementation Study to Measure the Effectiveness of an Intervention Package Aiming to Decrease Perinatal Mortality and Increase Institution-based Obstetric Care Among Indigenous Populations in Guatemala
Brief Summary: A matched pair cluster-randomized trial of this intervention package will be conducted in four rural and indigenous districts (Huehuetenango, Quiche, Alta Verapaz and San Marcos) of the Republic of Guatemala, using the health clinic as the unit of randomization. No external intervention is planned for control facilities, although enhanced monitoring, surveillance and data collection will occur throughout the study in all facilities in the four districts.

The package includes 3 interventions: 1) To train health care professionals in emergency obstetric and perinatal care using an innovative high-fidelity, low-tech, in situ, multidisciplinary simulation training curriculum (PRONTO); 2) To design and implement a social marketing strategy that promotes institution-based delivery; and 3) To integrate the role of obstetric nurse and professional midwife in intervention communities to act as liaisons between traditional birth attendants (TBA) and public health units. A fourth, cross-cutting component involves ongoing analysis, monitoring, surveillance and evaluation to strengthen information systems and monitor perinatal outcomes throughout the two years of the study.


Options:
A: the number and spacing of subsequent pregnancies and births (When first child is 12); the rates of marriage and cohabitation with the father of the child (When first child is 12); mothers' employment, career growth, economic self-sufficiency, and welfare dependence (When first child is 12); mothers' behavioral problems due to substance abuse (When first child is 12); children's academic achievement, placements in special education, rates of grade retention, conduct in school, and academic achievement (At age 12); rates of developmental disability, grade retention, placement in special education, and school disciplinary actions among subsequent children (At age 12); mothers' arrests for serious misdemeanors and felonies (When first child is 12)
B: Baby's health status (6 days after birth; 6 months after birth; 12 months after birth)
C: Neonatal mortality rate
D: increase the proportion of institutional deliveries in intervention vs. control clusters (Up to 15 months)

Answer: D
Please select the outcome measures that correspond to the clinical trial below.
Title: A Matched Pair Cluster-randomized Implementation Study to Measure the Effectiveness of an Intervention Package Aiming to Decrease Perinatal Mortality and Increase Institution-based Obstetric Care Among Indigenous Populations in Guatemala
Brief Summary: A matched pair cluster-randomized trial of this intervention package will be conducted in four rural and indigenous districts (Huehuetenango, Quiche, Alta Verapaz and San Marcos) of the Republic of Guatemala, using the health clinic as the unit of randomization. No external intervention is planned for control facilities, although enhanced monitoring, surveillance and data collection will occur throughout the study in all facilities in the four districts.

The package includes 3 interventions: 1) To train health care professionals in emergency obstetric and perinatal care using an innovative high-fidelity, low-tech, in situ, multidisciplinary simulation training curriculum (PRONTO); 2) To design and implement a social marketing strategy that promotes institution-based delivery; and 3) To integrate the role of obstetric nurse and professional midwife in intervention communities to act as liaisons between traditional birth attendants (TBA) and public health units. A fourth, cross-cutting component involves ongoing analysis, monitoring, surveillance and evaluation to strengthen information systems and monitor perinatal outcomes throughout the two years of the study.


Options:
A: mortality (day 28)
B: Placental malaria (After delivery)
C: Composite of either >28 week / >1000 gram stillbirth or 7 day neonatal mortality rate (7 days post delivery)
D: increase the proportion of institutional deliveries in intervention vs. control clusters (Up to 15 months)

Answer: D