TrialPanorama/Dataset huggingface dataset:
Please select the outcome measures that correspond to the clinical trial below.
Title: A 4-week Multicentre, Randomized, Open Label, Parallel Group, Active Control Phase IV Study to Evaluate Efficacy and Safety of Oxycodone/Naloxone in Comparison With Oxycontin in Korean Patients With Cancer Pain(TOP)
Brief Summary: Objectives:

To prove non-inferiority of Targin compared to Oxycontin in terms of change of pain intensity

1. Primary objective: Change of pain intensity (NRS 0-10) score (average pain over 24 hours obtained each evening) within 4 weeks
2. Secondary objectives: Bowel Habit (worsening/no change/improving), Total dose and frequency of rescue medication, Quality of Life (QOL; EORTC QLQ-C30), Duration to need of laxative use and Adverse events


Options:
A: Change of Pain Intensity From Baseline(visit1) to 4weeks.(visit3) (4weeks)
B: Efficacy of SC MNTX compared with placebo in inducing laxation (29 days)
C: Rescue-free Laxation After Administration of Subcutaneous Methylnaltrexone (4 hours after the dose of subcutaneous methylnaltrexone)
D: Rescue-free laxation response (Within 4 hours after at least 2 of the first 4 doses (the first week of treatment).)

Answer: A
Please select the outcome measures that correspond to the clinical trial below.
Title: N/A
Brief Summary: Intraoperative myocardial and pulmonary protection is important for better outcome after cardiac surgery. Ischemic preconditioning is one of organ protective strategies against ischemia-reperfusion injury by applying brief ischemia to the target organ before a subsequent critical ischemia, and its effect has been confirmed. However, its clinical application is not easy because ischemic insult may aggravate the function of vulnerable organ.

On the other hand, remote ischemic preconditioning (RIPC) is another protective approach by applying ischemia to other less vulnerable organ such as skeletal muscle before critical ischemia-reperfusion injury to heart. The effect of RIPC has been well demonstrated in adults and children. However, Little is known about the effect of remote ischemic precondition on the pediatric myocardium to ischemia and reperfusion injury. The effect of RIPC on the children remains to be further evaluated because the degree of ischemia-reperfusion injury is different according to age, cardiac pathology and cyanosis. In addition, the previous report on children dealt with a diverse range of congenital heart defects with a wide age range. The purpose of this study was to evaluate the effect of RIPC on myocardial and pulmonary protection in infants with pulmonary hypertension who need repair of simple ventricular septal defect.


Options:
A: troponin level (within the 1 day after operation)
B: Impact of RIPC on length of hospital stay. (Assessed through post-operative hospitalization.)
C: Plasma Creatine Concentration of the Recipients (within the first 3days after the operation); Urinary Output of the Recipients Postoperatively (within the first 3days after the operation); Plasma Concentration of NGAL in the Recipients (within the first 24hours after the operation)
D: Salvage index (%): Difference in infarct growth (PWI-DWI) after 24 hours among patients treated with preconditioning and those not treated. (February 2012)

Answer: A
Please select the outcome measures that correspond to the clinical trial below.
Title: Pharmacogenetics of Nicotine Addiction Treatment (PNAT)
Brief Summary: The purpose of this research program is to understand how a biomarker called the "nicotine metabolite ratio" (also referred to as NMR) may influence a smoker's ability to quit smoking.


Options:
A: Continuous Abstinence Rate (CAR) From Week 9 Through Week 12 (Week 9 through Week 12)
B: Continuous 4-week Abstinence From Smoking Between Weeks 8-11 After the Quit Date (Through the End of Treatment) (weeks 8-11 after quit date)
C: 7-day Point Prevalence Quit Rate at End-of-Treatment (EOT) (Week 11)
D: N/A

Answer: C
Please select the outcome measures that correspond to the clinical trial below.
Title: Pharmacogenetics of Nicotine Addiction Treatment (PNAT)
Brief Summary: The purpose of this research program is to understand how a biomarker called the "nicotine metabolite ratio" (also referred to as NMR) may influence a smoker's ability to quit smoking.


Options:
A: 4 week Continuous Quit Rate ( 4 week CQR ) for weeks 9 -12
B: 4 week Continuous Quit Rate ( 4 week CQR ) for Weeks 9 -12.
C: 7-day Point Prevalence Quit Rate at End-of-Treatment (EOT) (Week 11)
D: Change in Weight (Baseline, 3 months, 6 months, 9 months, 12 months and 1 year post program follow up); Change in the 6 minute walk test (Baseline, 3 months, 6 monhts, 9 months, 12 months, and 1 year post program completion follow up); Change in Days of Abstinence-Timeline follow back interview for tobacco smokers (Baseline, 3 months, 6 months, 9 months, 12 months, and 1 year post program completion follow up); Change in Carbon Monoxide Level (Baseline, 3 months, 6 months, 9 months, 12 months, and 1 year post program completion follow up)

Answer: C
Please select the outcome measures that correspond to the clinical trial below.
Title: Pharmacogenetics of Nicotine Addiction Treatment (PNAT)
Brief Summary: The purpose of this research program is to understand how a biomarker called the "nicotine metabolite ratio" (also referred to as NMR) may influence a smoker's ability to quit smoking.


Options:
A: Composite criterion : fatal and non-fatal cardiovascular or cerebrovascular events (During all the study)
B: 7-day Point Prevalence Quit Rate at End-of-Treatment (EOT) (Week 11)
C: Cotinine validated quit rates.
D: sustained smoking abstinence (during the study)

Answer: B
Please select the outcome measures that correspond to the clinical trial below.
Title: Pharmacogenetics of Nicotine Addiction Treatment (PNAT)
Brief Summary: The purpose of this research program is to understand how a biomarker called the "nicotine metabolite ratio" (also referred to as NMR) may influence a smoker's ability to quit smoking.


Options:
A: 7-day Point Prevalence Quit Rate at End-of-Treatment (EOT) (Week 11)
B: Continuous 4-week Abstinence From Smoking Between Weeks 8-11 After the Quit Date (Through the End of Treatment) (weeks 8-11 after quit date)
C: Continuous Abstinence From Smoking at Ten Weeks Post-quit (May 2009)
D: Participants Abstinent From Cigarettes (Two years)

Answer: A
Please select the outcome measures that correspond to the clinical trial below.
Title: Pharmacogenetics of Nicotine Addiction Treatment (PNAT)
Brief Summary: The purpose of this research program is to understand how a biomarker called the "nicotine metabolite ratio" (also referred to as NMR) may influence a smoker's ability to quit smoking.


Options:
A: 7-day Point Prevalence Quit Rate at End-of-Treatment (EOT) (Week 11)
B: Rating of urges to smoke one week after the target quit date assessed by Mood and Physical Symptoms Scale (1 week)
C: Four-week Continuous Abstinence From Cigarette Smoking (Study week 8 thru week 11)
D: Continuous abstinence for the last 4 weeks of varenicline and NRT (Nicotine Replacement Therapy) treatment period

Answer: A
Please select the outcome measures that correspond to the clinical trial below.
Title: Enhancing the Effectiveness of Physical Therapy for People With Knee
Brief Summary: The overall aim of the project is to examine the clinical and cost-effectiveness of utilizing booster sessions(periodic face-to-face follow-up appointments that take place several weeks or months following discharge from the supervised therapy program designed to review the patient's current rehabilitation program, troubleshoot any problems with the program, and make recommendations for program progression or modification) in the delivery of exercise therapy, and supplementing exercise therapy with manual therapy techniques(manually applied treatment techniques such as joint mobilization/manipulation, manual traction, soft tissue manipulations, passive stretching and range of motion). The investigators will do this in a randomized, multi-center, clinical trial. The investigators hypothesize that adding manual therapy techniques will be more clinically effective than exercise alone and that using booster sessions will maintain longer term clinical effects and be more cost-effective than not using booster sessions.


Options:
A: Patient Global Impression of Change for Knee Pain (Assessed after the 8-16 week intervention)
B: Change in Western Ontario and McMaster University Osteoarthritis Index (WOMAC) (Change from baseline at 9 weeks, 1 year and 2 years)
C: N/A
D: Pain: Numerical pain scale (Baseline, 6 weeks, 3 months, 1 year)

Answer: B
Please select the outcome measures that correspond to the clinical trial below.
Title: Edwards SAPIEN XT Transcatheter Heart Valve Therapy for Intermediate and High Risk Patients
Brief Summary: The purpose of this trial is to determine the safety and effectiveness of the Edwards SAPIEN XT transcatheter heart valve and delivery systems which are intended for use in patients with symptomatic, calcific, severe aortic stenosis.


Options:
A: Safety: All Cause Mortality or Disabling Stroke Rate at 24 Months, Randomized Controlled Trial Safety: All Cause Mortality or All Stroke Rate at 12 Months, Continued Access Study (Randomized Controlled Trial - 24 months Continued Access Study - 12 months)
B: All-cause Mortality or Disabling Stroke Rate Expressed as a Posterior Probability (24 months)
C: All-cause Death or Disabling Stroke to Two Years (2 Years)
D: Death (1 Year); Composite of Death and Recurrence Hospitalization. (duration of study)

Answer: C
Please select the outcome measures that correspond to the clinical trial below.
Title: DYSPORT™ for Injection AbobotulinumtoxinA Neurotoxin Clinical & Health Economics Outcomes Registry in Cervical Dystonia (ANCHOR-CD)
Brief Summary: The purpose of the protocol is to determine typical patient response to Dysport in the treatment of adult cervical dystonia (CD).


Options:
A: Change From Baseline in Toronto Western Spasmodic Torticollis Rating Scale (TWSTRS) Total Score Following First Treatment Cycle (Baseline and Week 4)
B: Proportion of treatment responders using the Toronto Western Spasmodic Torticollis Rating Scale (TWSTRS) severity scale score (Cycle 1 - Baseline and week 4); Patient Global Impression of Change using the 7-point Likert scale (Cycle 1 - Baseline and week 4)
C: Change From Baseline in Toronto Western Spasmodic Torticollis Rating Scale (TWSTRS) Total Score at Week 4. (4 weeks post-treatment)
D: Change in Toronto Western Spasmodic Torticollis Rating Scale Total Score From Baseline (Week 4 follow-up visit)

Answer: B
Please select the outcome measures that correspond to the clinical trial below.
Title: A Phase 3, Double-Blind, Multicenter, Randomized, Placebo-Controlled Trial Evaluating Repeated Courses of Aztreonam for Inhalation Solution/Aztreonam 75 mg Powder and Solvent for Nebuliser Solution in Subjects With Non-CF Bronchiectasis and Gram-Negative Endobronchial Infection (AIR-BX2)
Brief Summary: The AIR-BX2 study enrolled people with non-cystic fibrosis (non-CF) bronchiectasis and gram-negative airway infection. Participants received two 28-day courses of either Aztreonam for Inhalation Solution (AZLI) or placebo taken 3 times a day. Each course was followed by a 28-day off-drug period. Following the two blinded courses, all participants received a 28-day course of open-label AZLI then were followed for an additional 56 days.


Options:
A: Change in QOL-B Respiratory Symptoms Score at Day 28 (Baseline to Day 28)
B: Reduction in bacterial load (1 year)
C: Change From Baseline in Total Bacterial Load in the Sputum at End of Treatment (Day 29). (Baseline and 29 days)
D: Does prolonged antibiotic treatment with AZM reduce the number of bacterial exacerbations in patients with bronchiectasis? (1 year); Does treatment with AZM increase lung function parameters (Δ FEV1, Δ FVC )? (1 year)

Answer: A
Please select the outcome measures that correspond to the clinical trial below.
Title: A Phase 3, Double-Blind, Multicenter, Randomized, Placebo-Controlled Trial Evaluating Repeated Courses of Aztreonam for Inhalation Solution/Aztreonam 75 mg Powder and Solvent for Nebuliser Solution in Subjects With Non-CF Bronchiectasis and Gram-Negative Endobronchial Infection (AIR-BX2)
Brief Summary: The AIR-BX2 study enrolled people with non-cystic fibrosis (non-CF) bronchiectasis and gram-negative airway infection. Participants received two 28-day courses of either Aztreonam for Inhalation Solution (AZLI) or placebo taken 3 times a day. Each course was followed by a 28-day off-drug period. Following the two blinded courses, all participants received a 28-day course of open-label AZLI then were followed for an additional 56 days.


Options:
A: Change in QOL-B Respiratory Symptoms Score at Day 28 (Baseline to Day 28)
B: 24 hour sputum volume and assessment of cough severity (Leicester Cough Questionnaire) (3 months)
C: Change From Baseline in Total Bacterial Load in the Sputum at End of Treatment (Day 29). (Baseline and 29 days)
D: 24 Hour Sputum Volume (Visit 3 (Baseline); Visit 6 (Week 12); Visit 8 (Week 24))

Answer: A
Please select the outcome measures that correspond to the clinical trial below.
Title: A Phase 3, Double-Blind, Multicenter, Randomized, Placebo-Controlled Trial Evaluating Repeated Courses of Aztreonam for Inhalation Solution/Aztreonam 75 mg Powder and Solvent for Nebuliser Solution in Subjects With Non-CF Bronchiectasis and Gram-Negative Endobronchial Infection (AIR-BX2)
Brief Summary: The AIR-BX2 study enrolled people with non-cystic fibrosis (non-CF) bronchiectasis and gram-negative airway infection. Participants received two 28-day courses of either Aztreonam for Inhalation Solution (AZLI) or placebo taken 3 times a day. Each course was followed by a 28-day off-drug period. Following the two blinded courses, all participants received a 28-day course of open-label AZLI then were followed for an additional 56 days.


Options:
A: Does prolonged antibiotic treatment with AZM reduce the number of bacterial exacerbations in patients with bronchiectasis? (1 year); Does treatment with AZM increase lung function parameters (Δ FEV1, Δ FVC )? (1 year)
B: Time to First Exacerbation Event Within 48 Weeks (Up to Week 48)
C: Reduction in bacterial load (1 year)
D: Change in QOL-B Respiratory Symptoms Score at Day 28 (Baseline to Day 28)

Answer: D
Please select the outcome measures that correspond to the clinical trial below.
Title: A Phase 3, Double-Blind, Multicenter, Randomized, Placebo-Controlled Trial Evaluating Repeated Courses of Aztreonam for Inhalation Solution/Aztreonam 75 mg Powder and Solvent for Nebuliser Solution in Subjects With Non-CF Bronchiectasis and Gram-Negative Endobronchial Infection (AIR-BX2)
Brief Summary: The AIR-BX2 study enrolled people with non-cystic fibrosis (non-CF) bronchiectasis and gram-negative airway infection. Participants received two 28-day courses of either Aztreonam for Inhalation Solution (AZLI) or placebo taken 3 times a day. Each course was followed by a 28-day off-drug period. Following the two blinded courses, all participants received a 28-day course of open-label AZLI then were followed for an additional 56 days.


Options:
A: Change From Baseline to Day 29 in Pseudomonas Aeruginosa (P. Aeruginosa) Density in Sputum (log10 CFUs) (Baseline (Visit 101/Day 1), Visit 102 (Day 8), Visit 103 (Day 29))
B: Change in QOL-B Respiratory Symptoms Score at Day 28 (Baseline to Day 28)
C: Change in QOL-B Respiratory Symptoms Score at Day 28 (Baseline to Day 28)
D: Reduction in bacterial load (1 year)

Answer: B
Please select the outcome measures that correspond to the clinical trial below.
Title: Clinical and Radiographic Comparison and Evaluation of Two Types of Lingual Fixed Retainers on the Health of Periodontium
Brief Summary: Different types of retainers have been used to assure the stability of orthodontic treatment. The aim of this study is clinical and radiographic comparison and evaluation of two common types of lingual fixed retainers on the health of periodontium.

The participants in this study will be examined both clinically and radiographically just after the completion of orthodontic treatment and after a 6-month-period.

The results of the study will be analyzed with Mann-whitney and independent t-test.


Options:
A: Compliance of retainer wear (3 months)
B: Wear of removable retainer per day (hours) in the intervention and the control groups (3 months - 6 months - 12 months)
C: Oral Health-Related Quality Of Life (6 month)
D: Measuring periodontal status through clinical examination (approximately 20 months); measuring PDL width in periapical radiographs (approximately 20 months)

Answer: D
Please select the outcome measures that correspond to the clinical trial below.
Title: A Randomized Controlled Clinical Trial of Two Different Oral Care Regimens Combined With Ventilator-Associated Pneumonia (VAP) Bundle Strategy for Reduction of Duration of Mechanical Ventilation in a Neonatal Population
Brief Summary: The goal of this pilot study is to test the hypothesis that mechanically ventilated infants receiving Biotene OralBalance® gel for oral care would have a reduced intubation time compared to infants receiving oral care placebo. This study is also performed to test the feasibility as well the safety of Biotene OralBalance® gel.


Options:
A: Feasibility (duration of study, for up to 30 months); Duration of Mechanical Ventilation (3 days)
B: Rate of ventilator associated pneumonia (30 days)
C: N/A
D: Ventilator-Associated Pneumonia (VAP) (28 days)

Answer: A
Please select the outcome measures that correspond to the clinical trial below.
Title: A Randomized Controlled Clinical Trial of Two Different Oral Care Regimens Combined With Ventilator-Associated Pneumonia (VAP) Bundle Strategy for Reduction of Duration of Mechanical Ventilation in a Neonatal Population
Brief Summary: The goal of this pilot study is to test the hypothesis that mechanically ventilated infants receiving Biotene OralBalance® gel for oral care would have a reduced intubation time compared to infants receiving oral care placebo. This study is also performed to test the feasibility as well the safety of Biotene OralBalance® gel.


Options:
A: Occurrence of ventilator associated pneumonia as defined by CDC diagnostic criteria (21 days)
B: Development of VAP (Clinical Pulmonary Infection Score) (Baseline up to 5 days)
C: Feasibility (duration of study, for up to 30 months); Duration of Mechanical Ventilation (3 days)
D: Ventilator-Associated Pneumonia (VAP) (28 days)

Answer: C
Please select the outcome measures that correspond to the clinical trial below.
Title: Systemic Consequences and Comorbidities in Mild/Moderate COPD, Time for Action!
Brief Summary: The aim of this prospective case-control study is to investigate the prevalence, severity and incidence of systemic consequences in newly detected patients with mild and moderate Chronic obstructive pulmonary disease (COPD). Special attention will be paid to skeletal muscle dysfunction and physical inactivity as these factors are, together with smoking, potentially modifiable.


Options:
A: The benefits of resistance training during exacerbation of COPD on peripheral muscle strength during hospitalization (Will be evaluated on the second day of hospitalization, the day of hospital discharge (this time interval must be longer than five days))
B: Prevalence of risk factors to develop comorbidities (vascular dysfunction, osteoporosis, muscle wasting and metabolic syndrome) (baseline); Incidence and worsening of risk factors to develop comorbidities (vascular dysfunction, osteoporosis, muscle wasting and metabolic syndrome) (3 years)
C: Physical activity in daily life (measuremet unit: number of steps per day) (four years)
D: Quality of life score, St George's Quality of Life score (Initial, 8 weeks and 3 months)

Answer: B
Please select the outcome measures that correspond to the clinical trial below.
Title: ADMINISTRATION OF NIFIDEPINE VERSUS ATOSIBAN IN PREGNANT WOMEN WITH A THREAT OF PREMATURE LABOR
Brief Summary: This is a study for pregnant women who have been diagnosed with Threatened Preterm Labor. The principal aim of this study is to compare the efficacy and safety of Nifedipine treatment versus Atosiban treatment over these patients' newborn babies.


Options:
A: In women with singleton gestations, to contemporarily assess the efficacy of oral nifedipine versus intravenous magnesium sulfate in the acute management of preterm labor in terms of defined early and late neonatal measures (At delivery)
B: Incidence of delivery within 2 days (48 h) from start of IMP administration (48 hours); Incidence of delivery within 7 days (168 h) from start of IMP administration (168 hours); Incidence of delivery before 37 weeks of GA (Up to 13 weeks from start of IMP administration); Time to delivery measured from start of IMP administration (Up to 17 weeks from start of IMP administration)
C: Neonatal Respiratory Distress Syndrome (RDS) at birth (Measured in the newborn at birth and at 30 days after labor)
D: Time to delivery (through study completion, approximately 1 year); Gestational age (through study completion, approximately 1 year)

Answer: C
Please select the outcome measures that correspond to the clinical trial below.
Title: A Phase IIb Randomized, Placebo- and Active Comparator (Tolterodine)-Controlled, 2-Part Clinical Study of the Efficacy and Safety of MK-4618 in Patients With Overactive Bladder A 52-week Extension to: A Phase IIb Randomized, Placebo- and Active Comparator (Tolterodine)-Controlled, 2-Part Clinical Study of the Efficacy and Safety of MK-4618 in Patients With Overactive Bladder
Brief Summary: This is a 2-part study to assess if vibegron (MK-4618) reduces the number of daily urinations more effectively than placebo in participants with overactive bladder (OAB). The primary hypothesis of the base study is that administration of vibegron demonstrates a dose-related reduction, compared with placebo, in average number of daily micturitions in participants with OAB after 8 weeks of treatment.


Options:
A: Change in number of episodes of urgency urinary incontinence (UUI) at week 12 compared with baseline.
B: Change From Baseline to Week 12 in Bladder Wall Thickness (Baseline and Week 12); Neutralized Urinary Nerve Growth Factor Normalized by Urine Creatinine at Week 12 (Week 12)
C: Hopkins Verbal Learning Test - Revised (Week 4); Hopkins Verbal Learning Test - Revised (Week 4)
D: Base Study/Part 1: Change From Baseline in Average Daily Micturitions at Week 8 (Baseline and Week 8); Base Study/Part 1 + Part 2: Number of Participants Who Experienced an Adverse Event (AE) (Part 1: up to 8 weeks; Part 2: up to 4 weeks. The time frame was an additional 2 weeks for participants not continuing to the Extension Study.); Base Study/Part 1 + Part 2: Number of Participants Who Had Study Medication Withdrawn Due to an AE (Part 1: up to 8 weeks; Part 2: up to 4 weeks); Extension Study: Number of Participants Who Experienced an Adverse Event (AE) (Extension: up to 54 weeks (including 2-week follow-up)); Extension Study: Number of Participants Who Had Study Medication Withdrawn Due to an AE (Extension: up to 52 weeks)

Answer: D