TrialPanorama/Dataset huggingface dataset:
Please select the outcome measures that correspond to the clinical trial below.
Title: A 12-week Study to Evaluate the 24-hour Pulmonary Function Profile of Fluticasone Furoate/Vilanterol (FF/VI) Inhalation Powder 100/25 mcg Once Daily Compared With Fluticasone Propionate/Salmeterol Inhalation Powder 250/50 mcg Twice Daily in Subjects With Chronic Obstructive Pulmonary Disease (COPD)
Brief Summary: The purpose of this study is to evaluate the 24-hour spirometry effect (FEV1) of FF/VI 100/25mcg once daily compared with Fluticasone Propionate/Salmeterol 250/50mcg twice daily over a 12-week treatment period in subjects with COPD.


Options:
A: Change From Baseline Trough in 24-Hour Weighted Mean FEV1 on Treatment Day 84 (Baseline (Day 1) and Day 84)
B: Change From Baseline in Morning Pre-dose (Trough) Forced Expiratory Volume in the First Second (FEV1) at Week 24 on Treatment (Baseline and Week 24); Change From Baseline in Morning Pre-dose (Trough) Forced Expiratory Volume in the First Second (FEV1) at Week 12 on Treatment (Baseline and Week 12)
C: Trough Forced Expiratory Volume in 1 Second (FEV1) After 12 Weeks of Treatment (Week 12)
D: Forced Expiratory Volume in One Second (FEV1) Area Under Curve 0-3 Hour (h) (AUC 0-3h) Response at Day 85 (12 Weeks) (1 hour (h) and 10 minutes (min) prior to dose on the first day of randomized treatment (baseline) to -10 min, 5 min, 15 min, 30 min, 1 h, 2 h, and 3 h relative to dose on Day 85); Trough FEV1 Response at Day 85 (12 Weeks) (1 h and 10 min prior to dose on the first day of randomized treatment (baseline) and -1 h and - 10 mins prior to study drug at Day 85.)

Answer: A
Please select the outcome measures that correspond to the clinical trial below.
Title: A 12-week Study to Evaluate the 24-hour Pulmonary Function Profile of Fluticasone Furoate/Vilanterol (FF/VI) Inhalation Powder 100/25 mcg Once Daily Compared With Fluticasone Propionate/Salmeterol Inhalation Powder 250/50 mcg Twice Daily in Subjects With Chronic Obstructive Pulmonary Disease (COPD)
Brief Summary: The purpose of this study is to evaluate the 24-hour spirometry effect (FEV1) of FF/VI 100/25mcg once daily compared with Fluticasone Propionate/Salmeterol 250/50mcg twice daily over a 12-week treatment period in subjects with COPD.


Options:
A: Rate of healthcare utilisation based exacerbations of COPD
B: Trough Forced Expiratory Volume in 1 Second (FEV1) After 12 Weeks of Treatment (Non-inferiority Analysis) (Week 12)
C: Change From Baseline Trough in 24-hour Weighted-mean FEV1 on Treatment Day 84 (Baseline (Day 1) and Day 84)
D: Mean Change From Baseline (BL) in Clinic Visit Trough (Pre-bronchodilator and Pre-dose) FEV1, on Treatment Day 84 (Baseline to Day 84)

Answer: C
Please select the outcome measures that correspond to the clinical trial below.
Title: Immunogenicity and Safety of a Booster Dose of GlaxoSmithKline Biologicals' IPV (PoliorixTM) in Healthy Chinese Toddlers
Brief Summary: This study aims to evaluate the persistence of anti-poliovirus antibodies in toddlers aged 18 months who were primed with oral polio vaccine (OPV) or inactivated polio vaccine (IPV) in the primary study. The study will also assess the immunogenicity and reactogenicity of a booster dose of IPV in subjects primed with three doses of IPV.


Options:
A: Number of Seroprotected Subjects Against Poliovirus Types 1, 2 and 3 (At Month 3, one month after the third vaccine dose)
B: Immunogenicity: To provide information concerning the immunogenicity of IPV vaccine administrated intradermally as a booster vaccination. (30 days post-vaccination); Safety: To provide information concerning the safety after booster intradermal administration of IPV vaccine (30 days post-vaccination and entire study duration)
C: Seroconversion by measuring level of poliovirus antibodies in serum. Also, measure of virus titer in stools to indirectly assess the level of intestinal mucosal immunity
D: Number of Subjects Seroprotected for Poliovirus Types 1, 2 and 3 Antibodies Above the Cut-off Value (One month after Poliorix™ booster vaccination.); Number of Subjects Seroprotected for Poliovirus Types 1, 2 and 3 Antibodies Above the Cut-off Value (Before booster vaccination.); Antibody Titers Against Poliovirus Type 1, 2 and 3 (One month after Poliorix™ booster vaccination.); Antibody Titers Against Poliovirus Type 1, 2 and 3. (Before booster vaccination.)

Answer: D
Please select the outcome measures that correspond to the clinical trial below.
Title: Immunogenicity and Safety of a Booster Dose of GlaxoSmithKline Biologicals' IPV (PoliorixTM) in Healthy Chinese Toddlers
Brief Summary: This study aims to evaluate the persistence of anti-poliovirus antibodies in toddlers aged 18 months who were primed with oral polio vaccine (OPV) or inactivated polio vaccine (IPV) in the primary study. The study will also assess the immunogenicity and reactogenicity of a booster dose of IPV in subjects primed with three doses of IPV.


Options:
A: Types 1 and 3 poliovirus humoral immune response (12 months)
B: Mortality by sex
C: Number of Subjects Reporting Solicited Local Symptoms (During the 4-day follow-up period after each dose of study vaccine.); Number of Subjects Reporting Solicited General Symptoms (During the 4-day follow-up period after each dose of study vaccine.); Number of Subjects Reporting Unsolicited Adverse Events (AEs) (During the 31-days follow-up period after each dose of the study vaccine.); Number of Subjects Reporting Serious Adverse Events (SAEs) (During the entire study period (from Dose 1 up to one month following last vaccine dose).)
D: Number of Subjects Seroprotected for Poliovirus Types 1, 2 and 3 Antibodies Above the Cut-off Value (One month after Poliorix™ booster vaccination.); Number of Subjects Seroprotected for Poliovirus Types 1, 2 and 3 Antibodies Above the Cut-off Value (Before booster vaccination.); Antibody Titers Against Poliovirus Type 1, 2 and 3 (One month after Poliorix™ booster vaccination.); Antibody Titers Against Poliovirus Type 1, 2 and 3. (Before booster vaccination.)

Answer: D
Please select the outcome measures that correspond to the clinical trial below.
Title: An Open-label, Randomised, Active-controlled, Parallel Group, Multicentre, Phase 3 Study to Investigate the Safety and Efficacy of PA21 Compared With Sevelamer Carbonate Followed by a Randomised Comparison of PA21 Maintenance Dose Versus PA21-Low Dose in Dialysis Patients With Hyperphosphataemia
Brief Summary: This is a Phase 3, randomised, active controlled, multicentre study to investigate the safety and efficacy of PA21, a phosphate binder, for control of hyperphosphataemia in dialysis patients. The primary objective is to establish the efficacy of PA21 for lowering phosphate levels in these patients.


Options:
A: Change in Serum Phosphorus Levels From Week 24 to Week 27 (Week 24, Week 27)
B: Calcium Balance (2 weeks)
C: death due to cardiac arrhythmias or as sudden cardiac death defined as any deaths coded as "cardiac arrest, cause unknown" or "cardiac arrhythmia" without any exclusions (2 years)
D: Change in Serum Phosphorus From Baseline to End of Treatment (Baseline and day 28)

Answer: A
Please select the outcome measures that correspond to the clinical trial below.
Title: Delayed Educational Reminders for Long-term Medication Adherence in ST-Elevation Myocardial Infarction (DERLA-STEMI): Cluster-randomized Controlled Trial
Brief Summary: ST segment elevation myocardial infarction (STEMI) is a common presentation of heart attack constituting approximately 30% of all cases. Clinical guidelines around the world support the prolonged use of secondary preventative medications including aspirin, clopidogrel, statin, beta-blocker and angiotensin blockers with the highest recommendations. While in-hospital and discharge prescription rates are excellent, adherence to these essential life-saving medications is far less than ideal, even a few months following hospital discharge. The investigators plan to capitalize on the existing structure of the SMART-AMI project already underway in LHIN IV to undertake a randomized controlled trial evaluating a reminder sent on behalf of the interventional cardiologists, delivered by mail, at 1, 2, 5, 8, and 11-months post-discharge, reviewing the evidence for life-saving cardiac medications and urging long-term adherence to secondary preventative cardiac medications. This will be sent to the family physician and the patient, using audience-appropriate language. If the DERLA-STEMI project is accepted by physicians and patients, found to be both feasible and effective, then this simple and low-cost intervention will be studied in all patients with an abnormal coronary angiogram.


Options:
A: Cardiac Medication Use (3 and 12 months)
B: Total Number of Medications (Hospital Discharge, Post-Acute Care Discharge, and 90 days after discharge from the PAC)
C: Change in Systolic Blood Pressure (6 months prior to 6 months after the intervention period)
D: Health literacy levels (Measured at Week 6 and Months 6, 12, 18, and 24); Blood pressure control (Measured at Week 6 and Months 6, 12, 18, and 24); Reduction in blood pressure (Measured at Month 24)

Answer: A
Please select the outcome measures that correspond to the clinical trial below.
Title: Delayed Educational Reminders for Long-term Medication Adherence in ST-Elevation Myocardial Infarction (DERLA-STEMI): Cluster-randomized Controlled Trial
Brief Summary: ST segment elevation myocardial infarction (STEMI) is a common presentation of heart attack constituting approximately 30% of all cases. Clinical guidelines around the world support the prolonged use of secondary preventative medications including aspirin, clopidogrel, statin, beta-blocker and angiotensin blockers with the highest recommendations. While in-hospital and discharge prescription rates are excellent, adherence to these essential life-saving medications is far less than ideal, even a few months following hospital discharge. The investigators plan to capitalize on the existing structure of the SMART-AMI project already underway in LHIN IV to undertake a randomized controlled trial evaluating a reminder sent on behalf of the interventional cardiologists, delivered by mail, at 1, 2, 5, 8, and 11-months post-discharge, reviewing the evidence for life-saving cardiac medications and urging long-term adherence to secondary preventative cardiac medications. This will be sent to the family physician and the patient, using audience-appropriate language. If the DERLA-STEMI project is accepted by physicians and patients, found to be both feasible and effective, then this simple and low-cost intervention will be studied in all patients with an abnormal coronary angiogram.


Options:
A: Urinary catheter day (participants will be followed for the duration of hospital stay, an expected average of 3 weeks)
B: To assess the difference in frequency and severity of clinically significant DDIs in control arm and interventional arm between admission and discharge (90 days)
C: To test for differences in rates of screening between the early intervention and delayed groups, the chi-square test will be used for each outcome. (End of project, 12/2011)
D: Cardiac Medication Use (3 and 12 months)

Answer: D
Please select the outcome measures that correspond to the clinical trial below.
Title: Delayed Educational Reminders for Long-term Medication Adherence in ST-Elevation Myocardial Infarction (DERLA-STEMI): Cluster-randomized Controlled Trial
Brief Summary: ST segment elevation myocardial infarction (STEMI) is a common presentation of heart attack constituting approximately 30% of all cases. Clinical guidelines around the world support the prolonged use of secondary preventative medications including aspirin, clopidogrel, statin, beta-blocker and angiotensin blockers with the highest recommendations. While in-hospital and discharge prescription rates are excellent, adherence to these essential life-saving medications is far less than ideal, even a few months following hospital discharge. The investigators plan to capitalize on the existing structure of the SMART-AMI project already underway in LHIN IV to undertake a randomized controlled trial evaluating a reminder sent on behalf of the interventional cardiologists, delivered by mail, at 1, 2, 5, 8, and 11-months post-discharge, reviewing the evidence for life-saving cardiac medications and urging long-term adherence to secondary preventative cardiac medications. This will be sent to the family physician and the patient, using audience-appropriate language. If the DERLA-STEMI project is accepted by physicians and patients, found to be both feasible and effective, then this simple and low-cost intervention will be studied in all patients with an abnormal coronary angiogram.


Options:
A: Cardiac Medication Use (3 and 12 months)
B: Adherence to cardiac rehabilitation (After 8 weeks of cardiac rehabilitation); Morbidity and mortality (Three or four years after last patient into trial)
C: composite of all-cause mortality, non-fatal myocardial infarction, non-fatal stroke (every six months for an average of 5.4 years)
D: Within patient change in the Paffenbarger Exercise and Physical Activity Index (basline, at 2-month intervals(2, 4, 6, 8, 10-months) and closeout)

Answer: A
Please select the outcome measures that correspond to the clinical trial below.
Title: Delayed Educational Reminders for Long-term Medication Adherence in ST-Elevation Myocardial Infarction (DERLA-STEMI): Cluster-randomized Controlled Trial
Brief Summary: ST segment elevation myocardial infarction (STEMI) is a common presentation of heart attack constituting approximately 30% of all cases. Clinical guidelines around the world support the prolonged use of secondary preventative medications including aspirin, clopidogrel, statin, beta-blocker and angiotensin blockers with the highest recommendations. While in-hospital and discharge prescription rates are excellent, adherence to these essential life-saving medications is far less than ideal, even a few months following hospital discharge. The investigators plan to capitalize on the existing structure of the SMART-AMI project already underway in LHIN IV to undertake a randomized controlled trial evaluating a reminder sent on behalf of the interventional cardiologists, delivered by mail, at 1, 2, 5, 8, and 11-months post-discharge, reviewing the evidence for life-saving cardiac medications and urging long-term adherence to secondary preventative cardiac medications. This will be sent to the family physician and the patient, using audience-appropriate language. If the DERLA-STEMI project is accepted by physicians and patients, found to be both feasible and effective, then this simple and low-cost intervention will be studied in all patients with an abnormal coronary angiogram.


Options:
A: Adherence to guidelines G10 and G17 of the 2003 International Consensus Guidelines on nonvariceal upper GI bleeding. (1 year)
B: Cardiac Medication Use (3 and 12 months)
C: Composite measure representing improvement in cholesterol-related secondary prevention consisting of (1) provision of a statin sample (2) provision of a statin prescription or (3) dosage increase of a statin within the first 6 months post-angiogram.
D: Number of LTC residents on vitamin D (16 months)

Answer: B
Please select the outcome measures that correspond to the clinical trial below.
Title: Prospective Study on the Efficacy and Safety of Intravitreal Ranibizumab Versus Low-fluence Photodynamic Therapy in the Treatment of Chronic Central Serous Chorioretinopathy
Brief Summary: The purpose of this study is to compare the efficacy and safety of intravitreal ranibizumab injection versus low-fluence PDT in the treatment of chronic CSC.


Options:
A: Safety of Intravitreal Aflibercept Injection (6 months)
B: Absence of subretinal fluid on OCT scan (6-8 weeks after treatment)
C: Change from baseline in BCVA (1 week,2 weeks,3 weeks,1 month,3months, 6 months, 1 year)
D: Number of Participants That Achieved Complete Resolution of Subretinal Fluid on OCT Without Rescue Treatment (12 months)

Answer: D
Please select the outcome measures that correspond to the clinical trial below.
Title: Correlation Between Reoperation and Clinical Palpable Recurrence 3 Years After Ventral Hernia Repair
Brief Summary: The risk for recurrence after ventral hernia repair is often based on reoperation rates with short follow-up rather than recurrences identified by clinical examinations.

The purpose of current study is find the real incidence of recurrences 3 years after ventral hernia repair and to compare with the reoperation rate.


Options:
A: Incisional hernia or burst abdomen within 12 months (12 months)
B: Clinical recurrence after ventral hernia repair (up to 4 years)
C: Frequency of wound infection (Within the first 30 days after surgery); Frequency of incisional hernia (One year after surgery)
D: The number of wound infections (30 days after the operation)

Answer: B
Please select the outcome measures that correspond to the clinical trial below.
Title: N/A
Brief Summary: The purpose of this study is to compare the decision making of hospitalized subjects having a verbal discussion about CPR compared to subjects using a video.


Options:
A: Uptake of BRCA1/BRCA2 mutation testing as measured by genetic test results at 3 and 6 months (6 months); Knowledge assessed by genetic testing knowledge measure at post-counseling and 3 months (3 months); Decision making as assessed by Decisional Conflict Satisfaction at post-counseling and 3 months (3 months); Quality of life as assessed by SF-12 health survey at 3 and 6 months (6 months); Distress as assessed by Impact of Events Scale Brief Symptom Inventory MICRA at 3 and 6 months (6 months)
B: The number of eligible patients that can be identified who receive the uterine fibroid Option Grid patient decision aid. (Month 1-14)
C: preferences for medical care (within 48 hours of admission to the hospital)
D: Glycosylated Hemoglobin (HbA1c): (baseline and at the end of 12 months post index date)

Answer: C
Please select the outcome measures that correspond to the clinical trial below.
Title: Seizure Detection and Automatic Magnet Mode Performance Study
Brief Summary: The purpose of this study is to confirm cardiac-based seizure detection in Cyberonics Model 106 VNS Therapy System.


Options:
A: Summary of Seizures Reported by Investigators and Triple Review (Epilepsy Monitoring Unit Stay); Observed Sensitivity Based on Heart Rate Increase Associated With Seizures by Randomized SDA Setting (Epilepsy Monitoring Unit (EMU) Stay); Modeled Sensitivity Based on Heart Rate Increase Associated With Seizures by SDA Setting Post-Processed Through Bench-top Device Simulant (Epilepsy Monitoring Unit (EMU) Stay); Potential False Positives Based on Heart Rate Increase Associated With Seizures by Randomized SDA Setting (Epilepsy Monitoring Unit (EMU) Stay)
B: Changes in seizure frequency (12 weeks of stimulation)
C: Estimate the Effect Size Associated With Objective Measures and Patient Self-reports of Clinical Outcomes Including Seizure Frequency, Seizure Severity, Seizure Duration, Seizure Intensity, and Post-ictal Duration. (Up to 18 Month Visit-End of Study)
D: frequency of epileptic seizures (Change from baseline at 8, 16, 24 weeks respectively in frequency of epileptic seizures)

Answer: A
Please select the outcome measures that correspond to the clinical trial below.
Title: Does Short-term Exercise Intervention Improve Pre-operative Physical Fitness Following Neoadjuvant Chemoradiotherapy in Colorectal Cancer Patients?
Brief Summary: Neoadjuvant chemoradiotherapy (NACRT) prior to surgery for lower gastrointestinal (colon and rectal) cancer is associated with improved survival, but also adversely affects physical fitness, potentially rendering patients unfit for major surgery or increasing the risk of adverse outcome (death and serious complications) after major surgery. The investigators have pilot data using an upper gastrointestinal cancer patient cohort showing that neoadjuvant chemotherapy (NAC)reduces objectively measured exercise capacity (fitness). The investigators therefore propose a blinded, single centre, prospective interventional trial of patients undergoing NACRT prior to elective colorectal cancer resection in an NHS teaching hospital.

The investigators wish to explore various hypotheses:

1. Is exercise intervention feasible and tolerable in this cohort of patients?
2. Can fitness be improved using a structured, responsive exercise training programme (SRETP)?
3. Can SRETP improve quality of life?
4. Can SRETP improve physical activity?
5. Can SRETP improve surgical outcome?
6. Can physiological fitness and oncological outcome be matched to identify an optimal time for physiological recovery following NACRT prior to major surgery.

The investigators aim to recruit 5 patients for a feasibility and tolerably study and 30 patients for an interventional study over 24 months from Aintree University Teaching Hospitals NHS Foundation Trust. Consenting patients will undergo a series of tests designed to evaluate the ability of the muscle to take up and utilise oxygen, namely a cardiopulmonary exercise test (CPET) and VO2 Kinetics tests, all done pre-CRT and at 3,6,9 and 14 weeks post-CRT (pre-surgery). All patients will have their CPET, as well as standard restaging scans at 9 and 14 weeks post NACRT. Outcome, activity and quality of life data will also be collected.


Options:
A: Proportion of patients who are hernia- and complication-free (2 years after enrollment)
B: Maintain or improve physical fitness (anaerobic threshold measured by CPET)after treatment with neoadjuvant chemoradiotherapy in colorectal cancer patients. (3 years)
C: 6-minute-walking-distance (6MWD) (4 weeks postoperatively)
D: 6 minute walk test (6MWT) (up to 8 weeks after surgery)

Answer: B