TrialPanorama/Dataset huggingface dataset:
Please select the outcome measures that correspond to the clinical trial below.
Title: Vascular Effects of Regular Cigarettes Versus electronIc Cigarette Use
Brief Summary: The purpose of this study is to assess the effects of electronic cigarettes-nicotine and electronic cigarette-nicotine free on endothelial function as compared to traditional cigarettes. Due to ethical reasons, we cannot fully randomise all particpants to the three arms.

Participants who wish to quit smoking will be randomized to

1. Switch to electronic cigarettes containing nicotine plus flavor
2. Switch to electronic cigarettes containing flavor alone Those who do not wish to quit smoking will continue on the Tobacco Cigarette arm Treatment period will be 28 days


Options:
A: 7-day point prevalent CO validated smoking cessation. (Three months after lung screening)
B: Change in Flow mediated Dilation (FMD) between the TC group and the EC-nicotine and EC-nicotine free groups (Baseline and 1 month)
C: Acute electronic cigarette vaping effects on arterial stiffness. (7 minutes); Acute electronic cigarette vaping effects on endothelial integrity. (7 minutes); Chronic electronic cigarette vaping effects on arterial stiffness. (1 month); Chronic electronic cigarette vaping effects on endothelial integrity. (1 month); Chronic electronic cigarette vaping effects on platelet aggregation. (1 month); Chronic electronic cigarette vaping effects on high-shear stress-dependent platelet function. (1 month)
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: B
Please select the outcome measures that correspond to the clinical trial below.
Title: Vascular Effects of Regular Cigarettes Versus electronIc Cigarette Use
Brief Summary: The purpose of this study is to assess the effects of electronic cigarettes-nicotine and electronic cigarette-nicotine free on endothelial function as compared to traditional cigarettes. Due to ethical reasons, we cannot fully randomise all particpants to the three arms.

Participants who wish to quit smoking will be randomized to

1. Switch to electronic cigarettes containing nicotine plus flavor
2. Switch to electronic cigarettes containing flavor alone Those who do not wish to quit smoking will continue on the Tobacco Cigarette arm Treatment period will be 28 days


Options:
A: Number of cigarettes smoked per day (End of 6 week intervention)
B: Endothelial dysfunction (up to 24 weeks); Oxidative stress (up to 24 weeks)
C: urine carcinogen biomarker of exposure, NNAL (week 24)
D: Change in Flow mediated Dilation (FMD) between the TC group and the EC-nicotine and EC-nicotine free groups (Baseline and 1 month)

Answer: D
Please select the outcome measures that correspond to the clinical trial below.
Title: A Phase 3 Randomized, Open-label (Sponsor-blind), Active-controlled, Parallel-group, Multi-center, Event Driven Study in Dialysis Subjects With Anemia Associated With Chronic Kidney Disease to Evaluate the Safety and Efficacy of Daprodustat Compared to Recombinant Human Erythropoietin, Following a Switch From Erythropoietin-stimulating Agents
Brief Summary: The purpose of this multi-center event-driven study in participants with anemia associated with chronic kidney disease (CKD) to evaluate the safety and efficacy of daprodustat.


Options:
A: Time to First Occurrence of Adjudicated Major Adverse Cardiovascular Event (MACE) During Cardiovascular (CV) Events Follow-up Time Period: Non-inferiority Analysis (Up to 3.9 person-years for CV follow-up time period); Mean Change From Baseline in Hemoglobin (Hgb) Levels During Evaluation Period (Week 28 to Week 52) (Baseline (Pre-dose on Day 1) and evaluation period (Week 28 to Week 52))
B: Mean Hemoglobin (Hgb) During the Primary Efficacy Evaluation Period (Weeks 40 to 52) (Weeks 40 to 52)
C: Rate of rise in hemoglobin (g/dL/week) (Baseline and at Week-6)
D: Change in local laboratory hemoglobin level from baseline to the average during the last 4 weeks treatment period (Baseline and weeks 14 to 17)

Answer: A
Please select the outcome measures that correspond to the clinical trial below.
Title: Family Integrated Care (FICare) in Level II NICUs: An Innovative Program for Alberta
Brief Summary: In Alberta, nearly one in every twelve babies is born too soon (preterm). Preterm babies are at greater risk for breathing and feeding problems, as well as infections, than babies born on their due date (full term). As a result, parents must leave their preterm babies in the hospital to fully develop and become healthy enough to take home. When it is time for discharge, parents are often not ready to look after their baby because they may have limited involvement in the care of their baby in hospital. In addition to the distress and costs to parents of having a baby in hospital, health system costs are also increased the longer a baby is in hospital. The purpose of this project is to test a new way to integrate parents into the care of their baby through a program called Family Integrated Care (FICare). In FICare, parents are educated and supported by nurses to provide care for their baby; nurses and doctors still provide intravenous medications and medical procedures. FICare has been tested in Ontario and shows promise as a better model of care for the small percentage of babies born more than 8 weeks early, who have to spend a long time in hospital.

Now the investigators want to test FICare with the greater percentage of preterm babies who are born 4 to 8 weeks early to see if parents are able to take their baby home sooner, and if their babies are healthier. The investigators also want to know if FICare can reduce distress for parents. The investigators propose to test FICare in Level II Neonatal Intensive Care Units (NICUs) in Alberta by implementing FICare in half the Level II NICUs and comparing the outcomes with the other Level II NICUs who do not use FICare. If FICare improves outcomes for preterm babies and their parents, the investigators will implement it in all Level II NICUs. In Alberta, the investigators want the best quality care for our most vulnerable babies and their parents. This project is aligned with Alberta's Health Research and Innovation Strategy priority of wellness at every age (child and maternal health), and with Alberta Health Services' quality of care goals to increase efficiency, effectiveness, appropriateness, and acceptability of health care services delivery.


Options:
A: Peabody Developmental Motor Scales(PDMS-2) (Two years post term age)
B: Birth admission length of stay (Hospital length of stay in days, expected to range between 14 and 24 days; some infants may require a longer admission)
C: Length of Stay (From Infant's birth to discharge from NICU)
D: Index of Multisensory Processing (IMP) (At enrollment up to 36 weeks gestation (prior to intervention), and at intervention completion up to 42 weeks gestation)

Answer: B
Please select the outcome measures that correspond to the clinical trial below.
Title: Adverse Neurogenic Actions of Dietary Salt
Brief Summary: Excess dietary salt increases the risk for cardiovascular events, even in people that are not hypertensive. There is some evidence that excess dietary salt exaggerates blood pressure and sympathetic nervous system responses to various perturbations and increases blood pressure variability. This proposal will examine the effects of low, medium, and high salt diets on cardiovascular reactivity and blood pressure variability.


Options:
A: Blood Pressure Variability (Day 10 of diet (i.e., after 10 days of low, medium, and high sodium diets; crossover design)); Blood Pressure Reactivity - Handgrip exercise (Day 10 of diet (i.e., after 10 days of low, medium, and high sodium diets; crossover design))
B: laser Doppler blood flow (8 weeks)
C: Difference in mean systolic blood pressure (SBP) between completion of the high salt phase compared with the low salt phase.
D: 24-h urinary sodium (4.5 month)

Answer: A
Please select the outcome measures that correspond to the clinical trial below.
Title: An Open-label, Randomized, Parallel-Group, Phase I Study to Evaluate Pharmacokinetics, Efficacy and Safety Between Subcutaneous CT-P13 and Intravenous CT-P13 in Patients With Active Crohn's Disease and Active Ulcerative Colitis
Brief Summary: Phase 1 randomized, open-label, multicenter, parallel-group study designed to evaluate efficacy, pharmacokinetics and safety between CT-P13 subcutaneous (SC) and CT-P13 intravenous (IV) in patients with active Crohn's Disease (CD) and active Ulcerative Colitis (UC).


Options:
A: The Number and Percentage of Patients Achieving Clinical Response According to Crohn's Disease Activity Index (CDAI)-70 Criteria at Week 6 (at Week 6)
B: Percentage of Participants With Clinical Recurrence (CR) of Crohn's Disease (CD) Prior to or at Week 76 (Baseline up to Week 76)
C: Descriptive Statistics of Area Under the Concentration-time Curve (AUCτ) of Infliximab at Steady State (Part 1) (Week 22, 24, 26 and 28); Analysis of Covariance Model (ANCOVA) of Observed Ctrough,week22 (Pre-dose Level at Week 22) (Part 2) (Week 22)
D: co-primary efficacy end points (2 ans)

Answer: C
Please select the outcome measures that correspond to the clinical trial below.
Title: Effectiveness of Text Messaging on Risk Factors Control and Medication Adherence Among Patients With Coronary Heart Disease and Diabetes in China: Cardiovascular Health and Text Messaging-Diabetes Mellitus (CHAT-DM) Study
Brief Summary: The study is a two-arm, parallel, randomized clinical trial. The purpose of the study is to evaluate the effectiveness of automated mobile phone text message-based intervention for secondary prevention, including lifestyles modification, medication adherence improvement and risk factors control among coronary heart disease (CHD) patients with diabetes. The participants will be randomized into intervention and control groups in a 1:1 ratio. The intervention group will receive 6 pre-designed text messages per week in addition to usual care for 6 months, while the control group will receive usual care.


Options:
A: Change in glucose level measured by HbA1C level (Baseline; 6 months)
B: Differences in physiological variables depending on taking medications: low density lipoprotein cholesterol (Baseline and 12 months); Differences in physiological variables depending on taking medications: Systolic Blood pressure (Baseline and 12 months); Differences in physiological variables depending on taking medications: Heart Rate (Baseline and 12 months)
C: Escore of combined risk factor control (6 months)
D: Change in medication adherence score (baseline, day 3, day 6, day 9, day 12, day 15, day 18, day 21, day 24, day 27, day 30.); Change in systolic blood pressure (SBP) (baseline, day 3, day 6, day 9, day 12, day 15, day 18, day 21, day 24, day 27, day 30.); Change in diastolic blood pressure (DBP) (baseline, day 3, day 6, day 9, day 12, day 15, day 18, day 21, day 24, day 27, day 30.)

Answer: A
Please select the outcome measures that correspond to the clinical trial below.
Title: Multi-center, Randomized Non-inferiority Trial of Early Treatment Versus Expectative Management of Patent Ductus Arteriosus in Preterm Infants (BeNeDuctus Trial - Belgium Netherlands Ductus Trial)
Brief Summary: Much controversy exists about the optimal management of a patent ductus arteriosus (PDA) in preterm infants, especially in those born at a gestational age \<28 weeks and/or a birth weight ≦1000 grams due to a lack of evidence for or against different approaches. A PDA has been associated with serious complications. However, a common finding is that medical and/or surgical treatment of a PDA seems not to reduce the risk of mortality or major morbidity. This might be related to the fact that a substantial portion of preterm infants are treated unnecessarily, because the ductus arteriosus (DA) might have closed spontaneously without any specific intervention. An expectative approach is gaining interest, although convincing evidence is still missing.

The objective of this study is to investigate whether in preterm infants \<28 weeks' gestation with a PDA an expectative management is not inferior to early treatment with regard to the composite of mortality and/or necrotizing enterocolitis (NEC) and/or bronchopulmonary dysplasia (BPD) at a postmenstrual age of 36 weeks.


Options:
A: Composite of mortality, and/or NEC, and/or BPD (At a postmenstrual age of 36 completed weeks)
B: Efficacy and Safety of Oral Paracetamol Versus Oral Ibuprofen (Until discharge)
C: Days Spent on Supplemental Oxygen During the First 28 Days. (28 days of life)
D: success rate in closing PDA using paracetamol in comparison to ibuprofen. (at Visit 3 (day 3).)

Answer: A
Please select the outcome measures that correspond to the clinical trial below.
Title: Evaluation of a Web-Based Fall Prevention Program on People With Multiple Sclerosis
Brief Summary: This study evaluates the effectiveness of a web-based fall prevention program called Free From Falls Online (FFFO) on people with multiple sclerosis.


Options:
A: Fall incidence (3 months)
B: Change from Baseline in Functional Mobility at Completion of Training and the Following Three Months (At baseline, 1 week after completion of training, 3 months later); Change from Baseline in Falls at Completion of Training and the Following Three Months (First week of training, last week of training, 3 months later); Change from Baseline in Functional Neural Connectivity (fMRI) at Completion of Training (At baseline, 1 week after completion of training)
C: Difference in mean change in total falls between intervention and control arms (5 months)
D: Change from Baseline in Bergs balance scale (Change from Baseline in Bergs balance scale at 7 weeks)

Answer: C
Please select the outcome measures that correspond to the clinical trial below.
Title: Feasibility Pilot Study to Examine the Role of Mantra Meditation at Reducing Burn Out and Emotional Exhaustion in Emergency Department Staff
Brief Summary: Work in a healthcare setting, such as in an emergency department (ED), while rewarding, can be harmful to psychological well being, as demonstrated by the high numbers of Irish hospital doctors experiencing burnout. Burnout has been linked to poor healthcare quality, medical errors and low patient satisfaction. To prevent further escalation of this problem, there is a need for effective stress-reducing intervention, such as meditation. Meditation practice has a confirmed positive effect on well being; through greater insight and awareness, meditation could help ED staff to become more attentive to and understanding of their patients' complaints, enhancing patient satisfaction and safety. However, based on current research it is difficult to distinguish between the effects of meditation on well being and those associated with bringing people together. There is therefore a need for a larger randomised study (RCT) including a participants that receive no meditation intervention.

This pilot study aims to examine the suitability of RCT to assess the effect of mantra meditation on burnout among ED staff. The investigators will also examine participant recruitment and retention, data management and outcomes assessment methods for well being, patient satisfaction and biological markers. There will be two groups: intervention group (meditation) and control group (non-meditation). 30 ED staff placed in the intervention group will discuss prescribed texts and learn mantra meditation over a 7-week period, accompanied by 20 minutes of daily meditation practice. 30 ED staff placed in the control group will work in the ED as usual and not receive any texts. Biological samples and questionnaires will be obtained at three time points. Participant feedback will also be sought through interviews. This study will highlight issues related to participant recruitment, retention, and adherence, questionnaires, logistics, and data management and pave the way for an efficient, effective, and larger study that will investigate mantra meditation as a means of reducing burnout in ED staff.


Options:
A: stress levels (75 days)
B: Change from baseline in ED staff burn out using the Maslach Burnout Inventory (MBI) (Week 8 and 20)
C: NICU health professional resilience (10 days, 1 month, 6 months, 12 months)
D: Presence of job stain evaluated by the French version of the Karasek scale (6 months)

Answer: B
Please select the outcome measures that correspond to the clinical trial below.
Title: Feasibility Pilot Study to Examine the Role of Mantra Meditation at Reducing Burn Out and Emotional Exhaustion in Emergency Department Staff
Brief Summary: Work in a healthcare setting, such as in an emergency department (ED), while rewarding, can be harmful to psychological well being, as demonstrated by the high numbers of Irish hospital doctors experiencing burnout. Burnout has been linked to poor healthcare quality, medical errors and low patient satisfaction. To prevent further escalation of this problem, there is a need for effective stress-reducing intervention, such as meditation. Meditation practice has a confirmed positive effect on well being; through greater insight and awareness, meditation could help ED staff to become more attentive to and understanding of their patients' complaints, enhancing patient satisfaction and safety. However, based on current research it is difficult to distinguish between the effects of meditation on well being and those associated with bringing people together. There is therefore a need for a larger randomised study (RCT) including a participants that receive no meditation intervention.

This pilot study aims to examine the suitability of RCT to assess the effect of mantra meditation on burnout among ED staff. The investigators will also examine participant recruitment and retention, data management and outcomes assessment methods for well being, patient satisfaction and biological markers. There will be two groups: intervention group (meditation) and control group (non-meditation). 30 ED staff placed in the intervention group will discuss prescribed texts and learn mantra meditation over a 7-week period, accompanied by 20 minutes of daily meditation practice. 30 ED staff placed in the control group will work in the ED as usual and not receive any texts. Biological samples and questionnaires will be obtained at three time points. Participant feedback will also be sought through interviews. This study will highlight issues related to participant recruitment, retention, and adherence, questionnaires, logistics, and data management and pave the way for an efficient, effective, and larger study that will investigate mantra meditation as a means of reducing burnout in ED staff.


Options:
A: Change from Baseline CORE-OM measure at post-intervention and 4-month follow-up. (It is measured three weeks before the intervention starts, immediately after the 8-week intervention is finished, and 4-month after the intervention is finished.)
B: 30-day point prevalence abstinence (12 month post randomization)
C: smoking cessation: 7-day point prevalence abstinence (6 months)
D: Change from baseline in ED staff burn out using the Maslach Burnout Inventory (MBI) (Week 8 and 20)

Answer: D
Please select the outcome measures that correspond to the clinical trial below.
Title: Efficacy and Safety of Rapid Intermittent Correction Compared With Slow Continuous Correction With Hypertonic Saline in Patient With Moderately Severe or Severe Symptomatic Severe Hyponatremia (SALSA Trial)
Brief Summary: This study will investigate efficacy and safety of rapid intermittent correction compared with slow continuous correction with hypertonic saline in patient with moderately severe or severe symptomatic severe hyponatremia


Options:
A: the percentage of responders to the diuretic treatment; the percentage of patients who develop adverse effects to diuretics (within three weeks); the percentage of patients who will respond to the diuretic treatment, the percentage of patients who will develop adverse effects to diuretics (within three weeks)
B: EFFICACY:Serum Sodium; SAFETY:Physical examination, vital signs, adverse events, electrocardiogram, hematology, serum chemistry; PHARMACOKINETICS:Plasma SR121463B concentrations
C: Time to repeat therapeutic paracentesis (12 weeks)
D: Incidence of overcorrection rate at any given period (up to 48 hours)

Answer: D
Please select the outcome measures that correspond to the clinical trial below.
Title: The Bipolar Illness Onset Study (the BIO Study)
Brief Summary: This longitudinal study aims to identify 1) a composite blood-based biomarker, 2) a composite electronic Smartphone-based biomarker and 3) a neurocognitive signature for bipolar disorder


Options:
A: Composite blood based biomarker (5 years)
B: MADRS Score - Baseline (Baseline); MADRS Score - Day 1 Following Intervention (Day 1)
C: Number of Patients Demonstrating a > 50% Decrease in Depression Scores on the Montgomery-Åsberg Depression Rating Scale (MADRS) (Received drug for 8 weeks during week 0 to week 8 of the study); Number of Patients Demonstrating a > 50% Decrease in Depression Scores on the Montgomery-Åsberg Depression Rating Scale (MADRS) (Received drug for 8 weeks during week 9 to week 16 of the study); Number of Patients Demonstrating a > 30% Decrease in Depression Scores on the Montgomery-Åsberg Depression Rating Scale (MADRS) (Received drug for 8 weeks during week 0 to week 8 of the study); Number of Patients Demonstrating a > 30% Decrease in Depression Scores on the Montgomery-Åsberg Depression Rating Scale (MADRS) (Received drug for 8 weeks during week 9 to week 16 of the study)
D: Change in MADRS Total Score From Baseline to Week 6 (6 weeks)

Answer: A
Please select the outcome measures that correspond to the clinical trial below.
Title: Effectiveness of Text Messaging on Risk Factors Control and Medication Adherence Among Coronary Heart Disease Patients Without Diabetes in Cardiovascular Health and Texting Messaging (CHAT) Study
Brief Summary: The study is a two-arm, parallel, randomized clinical trial. The purpose of the study is to evaluate the effectiveness of automated mobile phone text message-based intervention for secondary prevention, including lifestyles modification, medication adherence improvement and risk factors control among coronary heart disease (CHD) patients without diabetes. The participants will be randomized into intervention and control groups in a 1:1 ratio. The intervention group will receive 6 pre-designed text messages per week in addition to usual care for 6 months, while the control group will receive usual care.


Options:
A: Medication adherence (12 months); Exercise frequency (12 months)
B: Escore of combined risk factor control (6 months)
C: Change in systolic blood pressure obtained in office during each interview (Baseline; 6months)
D: Change in glucose level measured by HbA1C level (Baseline; 6 months)

Answer: C