TrialPanorama/Dataset huggingface dataset:
Please select the outcome measures that correspond to the clinical trial below.
Title: A Phase 2b, Randomized, Partially Blind (Open Label Warfarin), Active-Controlled (Warfarin), Multicenter Study, To Evaluate The Safety And Efficacy In 2 Doses Of Apixaban In Comparison To Warfarin, Administered For 12 Weeks In Subjects With NVAF
Brief Summary: To assess the effect of two doses of Apixaban (2.5 mg BID and 5 mg BID) versus Warfarin on the composite endpoint of major and clinically relevant non-major bleeding during the treatment period.


Options:
A: Number of Participants With Major (Per International Society on Thrombosis and Haemostasis [ISTH] Criteria) or Clinically Relevant Non-major Bleeding Adjudicated by Clinical Event Committee During the Treatment Period (Baseline to Week 12)
B: Event Rate of the Composite Endpoint of Adjudicated Major Bleeding or Adjudicated Non-major Clinically Relevant Bleeding (Up to 2 days after the last dose)
C: Number of Participants With Recurrent Symptomatic Venous Thromboembolism (VTE) and Deaths Related to VTE (For statistical analysis 1: from randomisation to end of post treatment period (ptp), planned to be up to day 224. For statistical analysis 2: from randomisation to 6 months (up to day 180))
D: Composite of Recurrent VTE or VTE Death at 36 Months (36 months); Composite of Recurrent VTE or VTE Death at 18 Months (18 months)

Answer: A
Please select the outcome measures that correspond to the clinical trial below.
Title: A Randomized, Placebo Controlled, Double Blind, Parallel Group Multi-Center Study In Order To Investigate Safety And Efficacy Of CP- 690 550 In Subjects With Moderate To Severe Ulcerative Colitis.
Brief Summary: The hypothesis of the study is that at least one dose of CP 690 550 is superior to placebo (inactive drug) in inducing remission in patients with moderate to severe ulcerative colitis.


Options:
A: Percentage of Participants With Clinical Response (Week 8)
B: The proportion of patients with clinical response, defined as a decrease from baseline in the Mayo score by = 30% and = 3 points, with a decrease in the rectal bleeding subscore of = 1 or a rectal bleeding subscore of 0 or 1, at week 8 .
C: Clinical and Endoscopic Remission. (8 weeks)
D: Safety and toleration (up to 12 weeks); Endoscopic score changes as calculated using section 3 of the Mayo Score (up to 12 weeks); Disease activity score changes as calculated using the Mayo Score (up to 12 weeks)

Answer: A
Please select the outcome measures that correspond to the clinical trial below.
Title: A Randomized, Placebo Controlled, Double Blind, Parallel Group Multi-Center Study In Order To Investigate Safety And Efficacy Of CP- 690 550 In Subjects With Moderate To Severe Ulcerative Colitis.
Brief Summary: The hypothesis of the study is that at least one dose of CP 690 550 is superior to placebo (inactive drug) in inducing remission in patients with moderate to severe ulcerative colitis.


Options:
A: Number of Participants With Treatment Emergent Adverse Events (TEAEs) and Serious Adverse Events (SAEs) (Baseline up to 28 days after last dose of study drug (up to 81 months for Tofacitinib 5 mg BID group and up to 85 months for Tofacitinib 10 mg BID group)); Number of Participants With Serious Infections as Treatment Emergent Adverse Events (TEAEs) (Baseline up to 28 days after last dose of study drug (up to 81 months for Tofacitinib 5 mg BID group and up to 85 months for Tofacitinib 10 mg BID group)); Number of Participants With Laboratory Test Abnormalities (Baseline up to 28 days after last dose of study drug (up to 81 months for Tofacitinib 5 mg BID group and up to 85 months for Tofacitinib 10 mg BID group)); Number of Participants With Vital Sign Abnormalities (Baseline up to 28 days after last dose of study drug (up to 81 months for Tofacitinib 5 mg BID group and up to 85 months for Tofacitinib 10 mg BID group)); Number of Participants With Clinically Significant Changes in Physical Examinations From Baseline (Baseline up to 28 days after last dose of study drug (up to 81 months for Tofacitinib 5 mg BID group and up to 85 months for Tofacitinib 10 mg BID group)); Number of Participants With Electrocardiogram (ECG) Abnormalities (Baseline up to 28 days after last dose of study drug (up to 81 months for Tofacitinib 5 mg BID group and up to 85 months for Tofacitinib 10 mg BID group)); Incidence Rates for Adjudicated Cardiovascular, Malignancy, Opportunistic Infections and Thromboembolic Safety Events (Baseline up to 28 days after last dose of study drug (up to 81 months for Tofacitinib 5 mg BID group and up to 85 months for Tofacitinib 10 mg BID group))
B: Percentage of Participants With Clinical Response (Week 8)
C: 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)
D: Number of Participants With Remission Based on Modified Mayo Score at Month 6 (Month 6)

Answer: B
Please select the outcome measures that correspond to the clinical trial below.
Title: Assessment of Bifocal and Prismatic Bifocal Spectacles for Myopia Control in Children
Brief Summary: 1. To determine if the effect of near-addition lenses (bifocals) is more prominent for children with high myopia progression.
2. To study how different subject characteristics such as age, gender, baseline degree of myopia, baseline near phoria and baseline lag of accommodation affect the efficacy of bifocal lens wear in myopic children.
3. To investigate the effect of incorporating near base-in prisms along with the near-addition lenses (prismatic bifocals) on myopia progression in myopic children.


Options:
A: Determine the change in cycloplegic axial length in the study and control groups (2 years)
B: Spherical equivalent refraction determined by cycloplegic autorefraction
C: Myopia progression, measured by cycloplegic autorefraction (Every 6 months)
D: Progression of myopia, determined by cycloplegic autorefraction

Answer: C
Please select the outcome measures that correspond to the clinical trial below.
Title: Assessment of Bifocal and Prismatic Bifocal Spectacles for Myopia Control in Children
Brief Summary: 1. To determine if the effect of near-addition lenses (bifocals) is more prominent for children with high myopia progression.
2. To study how different subject characteristics such as age, gender, baseline degree of myopia, baseline near phoria and baseline lag of accommodation affect the efficacy of bifocal lens wear in myopic children.
3. To investigate the effect of incorporating near base-in prisms along with the near-addition lenses (prismatic bifocals) on myopia progression in myopic children.


Options:
A: Global Self-Worth Scale from the Self-Perception Profile for Children (3 years)
B: the progression of myopia degree, axial length elongation of eye
C: Myopia progression, measured by cycloplegic autorefraction (Every 6 months)
D: Distribution of Change in Spherical Equivalent Refractive Error From Baseline to 3 Years (Baseline to 3 years); Mean Change in Spherical Equivalent Refractive Error From Baseline to 3 Years (3 years)

Answer: C
Please select the outcome measures that correspond to the clinical trial below.
Title: Assessment of Bifocal and Prismatic Bifocal Spectacles for Myopia Control in Children
Brief Summary: 1. To determine if the effect of near-addition lenses (bifocals) is more prominent for children with high myopia progression.
2. To study how different subject characteristics such as age, gender, baseline degree of myopia, baseline near phoria and baseline lag of accommodation affect the efficacy of bifocal lens wear in myopic children.
3. To investigate the effect of incorporating near base-in prisms along with the near-addition lenses (prismatic bifocals) on myopia progression in myopic children.


Options:
A: Cycloplegic autorefraction (Baseline, 6, 12, 18, and 24 months)
B: Myopia progression, measured by cycloplegic autorefraction (Every 6 months)
C: Axial growth
D: The changes of cycloplegic refractive errors (every 6 months for 2 years)

Answer: B
Please select the outcome measures that correspond to the clinical trial below.
Title: Translational Research: Applying Drug Prevention to Obesity Prevention
Brief Summary: The proposed project takes an innovative approach to childhood obesity prevention, for which there currently no evidence-based programs, and for which results of current trials have produced mainly short-term or disappointing effects. The aim of this project is to adapt and revise parts of two nationally recognized programs for drug prevention for use with children in grades 4-6 with the express purpose of obesity prevention. The current study will attempt to promote emotion regulation, neuro-cognitive function, and social competence in order to prevent obesity. A total of 24 elementary schools from two of the largest districts in Orange County will be randomly assigned to either the obesity prevention program or control group (N=1587) 4th grade students and their parents). A cohort of students will be followed from the 4th through 6th grades. Intervention students will be administered the Pathways obesity prevention program by trained teachers. The population is ethnically diverse (36% white, 57% Hispanic, 6%Asian; 48% on free/reduced lunch programs). Self-report measures, BMI, and waist circumference will be administered at the beginning of 4th grade, and at end of 4th , 5th , and 6th grade. Teacher, administrative, and parent surveys will be administered on the same schedule to measure school environment. Program implementation will be measured by teacher self-report and research staff observations. Data will be analyzed with statistical approaches that capture effects of school and classroom, test the theoretical model of change, and evaluate developmental trends in mediators and outcomes across the three grades. Findings should be generalizable to most elementary schools, and will be used to develop evidence-based program standards for childhood obesity prevention.


Options:
A: Fruit and vegetable intake (Up to one year)
B: Targeted risk and protective factors, substance use, delinquency, violence (Baseline through thirteen-year follow-up (age 23)); CTC coalition functioning, prevention system transformation, evidence-based program (EBP) implementation (Baseline through eight-year follow-up (age 18))
C: Food Intake (9 month posttest, 21 month follow-up, 33 month follow-up); Physical Activity (baseline, 9 month posttest, 21 month posttest, 33 month posttest); Body Mass Index (baseline, 9 month posttest, 21 month posttest, 33 month posttest)
D: rates of pregnancy and out-of-wedlock child birth (At age 19); educational achievement, including graduation from high school and participation in various types of post-high school education (At age 19); participation in the work force, including enrollment in the armed services (At age 19); use of welfare (At age 19); use of substances (cigarettes, alcohol, and illegal drugs) (At age 19); involvement with the criminal justice system (arrests, convictions, incarcerations, etc.) (At age 19)

Answer: C
Please select the outcome measures that correspond to the clinical trial below.
Title: Effect of Oral N-Acetyl Cysteine on Pregnancy Outcome After Cervical Cerclage: a Randomized Controlled Trial
Brief Summary: The aim of the study is to evaluate the effect of N-acetyl cysteine (NAC) on pregnancy outcome in women undergoing cervical cerclage for cervical insufficiency.


Options:
A: Gestational age at delivery (3-6 months)
B: Gestational age of delivery (<37 weeks)
C: The frequency of spontaneous abortion before 28 weeks (14 weeks)
D: Frequency of delivery <=32 weeks (18 weeks gestation through delivery)

Answer: A
Please select the outcome measures that correspond to the clinical trial below.
Title: A Multi-Center, Double-Blind, Parallel-Group Study to Evaluate Short-term Safety and Efficacy and Long-Term Maintenance of Two Dose Levels of Rabeprazole Sodium Delayed-Release Pediatric Bead Formulation in 1- to 11-Year Old Pediatric Subjects With Endoscopically Proven GERD
Brief Summary: The purpose of the study is to access the effectiveness and safety of oral rabeprazole in the treatment of acid-related disorders in pediatric patients, focusing specifically on the manifestation of GERD (symptomatic and erosive types).


Options:
A: Change From Baseline in Normalized Number of GERD Events Observed From Video and Cardiorespiratory Monitoring (Baseline and end of treatment (10-14 days))
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: Maximum Observed Plasma Concentration (Cmax) (Predose (0 hour), and 0.5, 1, 2, 4, 6, 12 hours postdose); Time to Reach Maximum Observed Plasma Concentration (Tmax) (Predose (0 hour), and 0.5, 1, 2, 4, 6, 12 hours postdose); Area Under the Curve From Time Zero to Last Quantifiable Concentration [AUC (0-t)] (Predose (0 hour), and 0.5, 1, 2, 4, 6, 12 hours postdose); Area Under the Curve From Time Zero to Extrapolated Infinite Time [AUC (0 - ∞)] (Predose (0 hour), and 0.5, 1, 2, 4, 6, 12 hours postdose); Plasma Decay Half-Life (t1/2) (Predose (0 hour), and 0.5, 1, 2, 4, 6, 12 hours postdose); Apparent Oral Clearance (CL/F) (Predose (0 hour), and 0.5, 1, 2, 4, 6, 12 hours postdose); Terminal-Phase Volume of Distribution (Vz/F) (Predose (0 hour), and 0.5, 1, 2, 4, 6, 12 hours postdose); Plasma Concentrations After Multiple Doses (Hours 2 and 4 on Day 7)
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: B
Please select the outcome measures that correspond to the clinical trial below.
Title: A Multi-Center, Double-Blind, Parallel-Group Study to Evaluate Short-term Safety and Efficacy and Long-Term Maintenance of Two Dose Levels of Rabeprazole Sodium Delayed-Release Pediatric Bead Formulation in 1- to 11-Year Old Pediatric Subjects With Endoscopically Proven GERD
Brief Summary: The purpose of the study is to access the effectiveness and safety of oral rabeprazole in the treatment of acid-related disorders in pediatric patients, focusing specifically on the manifestation of GERD (symptomatic and erosive types).


Options:
A: 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)
B: Change From Baseline in Average Daily Frequency of Regurgitation (Double-blind Phase/ Baseline Observation Carried Forward) (Baseline, Week 8); Change From Baseline in Weight-for-Age Z-Score (Double-blind Phase/ Baseline Observation Carried Forward) (Baseline, Week 8); Change From Baseline in I-GERQ-R Total Score (Double-blind Phase/ Baseline Observation Carried Forward) (Baseline, Week 8); Change From Baseline in in Weekly Average I-GERQ-DD Total Score (Double-blind Phase/ Baseline Observation Carried Forward) (Baseline, Week 8)
C: 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.)
D: 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.

Answer: A
Please select the outcome measures that correspond to the clinical trial below.
Title: Reducing Unnecessary Use of Heavily Marketed Medicines: A Randomized Controlled Trial of Computerized Prescribing Alerts and Clinician Education
Brief Summary: Prescribing decisions by clinicians are often thought to be simple: a patient's clinical problem leads a prescriber to choose the optimal treatment. However, many factors other than the patient's condition affect prescribing decisions, including the marketing of pharmaceuticals. Clinicians are subjected to direct "detailing" by representatives of the pharmaceutical industry, advertisements in medical journals and requests for specific treatments from patients, who are increasingly exposed to direct-to-consumer (DTC) advertising. These influences, often based on biased or inaccurate information, contribute to a variety of problems in prescribing, including the unnecessary use of expensive, heavily marketed medications.

Overcoming these influences requires innovative approaches. The movement toward widespread adoption of electronic health records (EHRs) and electronic prescribing presents new opportunities to educate both clinicians and patients at the time of medication prescribing. This project, endorsed by the AHRQ-supported Centers for Education and Research on Therapeutics (CERTs; www.certs.hhs.gov) and the U.S. Food and Drug Administration (FDA), aims to test the effectiveness of computerized prescribing alerts and state-of-the-art educational outreach to reduce the unnecessary use of heavily marketed medications. A second goal is to improve clinicians' knowledge of industry marketing practices, so that they can more effectively assess information provided by drug companies. Thus, the study has two specific aims:

Specific Aim 1: To assess whether computerized prescribing alerts linked electronically to patient educational material can reduce prescribing of heavily marketed medications.

Specific Aim 2: To assess whether group academic detailing increases clinicians' knowledge about industry marketing practices and increases the effect of prescribing alerts.


Options:
A: Referral Rates to Local Hospitals (Month 7, Month 12); Number of Neonatal Deaths (Month 12)
B: proportion of prescriptions for hypnotic medications that were heavily marketed medications (study medications). Hypnotic medications were defined as the study medications intervention plus zolpidem and trazodone. (one year)
C: HbA1c (6 months)
D: rate of potentially inappropriate psychotropic medication (September 2008-July 2010)

Answer: B
Please select the outcome measures that correspond to the clinical trial below.
Title: Fluid Lavage of Open Wounds (FLOW): A Multi-center, Blinded, Factorial Trial Comparing Alternative Irrigating Solutions and Pressures in Patients With Open Fractures
Brief Summary: Open fracture wounds are a constant challenge to orthopaedic surgeons, with infections a common complication. There is currently little evidence as to which is the most effective way to wash out these wounds. This study is a multi-center, prospective, randomized study. The infection rates will be compared between irrigation using high pressure versus low pressure versus gravity flow, and also saline versus a soap solution as the irrigation solution. The results from this study will help to determine the best method of washing out open fractures wounds. In this study, all open wounds will be washed out using methods commonly used by orthopaedic surgeons


Options:
A: Modified Von Korff Pain Scale for low back pain (baseline 1&2, 6, 12, 18, 24, 39, 52 weeks); Modified Von Korff Disability Scale (baseline 1&2, 6, 12, 18, 24, 39, 52 weeks)
B: Re-operation within 12 months post initial surgery to treat an infection, manage a wound healing problem, or promote fracture healing. (within 12 months)
C: Sickness leave (2008-2020)
D: Return-to-work=the proportion of patients who during 1-18 months regained a degree of work ability>0 for at least 30 days in succession. (18 months.)

Answer: B
Please select the outcome measures that correspond to the clinical trial below.
Title: Fluid Lavage of Open Wounds (FLOW): A Multi-center, Blinded, Factorial Trial Comparing Alternative Irrigating Solutions and Pressures in Patients With Open Fractures
Brief Summary: Open fracture wounds are a constant challenge to orthopaedic surgeons, with infections a common complication. There is currently little evidence as to which is the most effective way to wash out these wounds. This study is a multi-center, prospective, randomized study. The infection rates will be compared between irrigation using high pressure versus low pressure versus gravity flow, and also saline versus a soap solution as the irrigation solution. The results from this study will help to determine the best method of washing out open fractures wounds. In this study, all open wounds will be washed out using methods commonly used by orthopaedic surgeons


Options:
A: Post-operative infection (6 weeks)
B: Re-operation within 12 months post initial surgery to treat an infection, manage a wound healing problem, or promote fracture healing. (within 12 months)
C: Drainage volume (7 days)
D: N/A

Answer: B