TrialPanorama/Dataset huggingface dataset:
Please select the outcome measures that correspond to the clinical trial below.
Title: N/A
Brief Summary: The principal objective is to test whether offering pregnant smokers a proactive telephone counseling program throughout pregnancy and for 2 months postpartum increases the rate of smoking cessation at end of pregnancy and 3 months postpartum, compared to a "best practice" control condition.


Options:
A: Biochemically-validated 7-day point prevalence tobacco abstinence at end of pregnancy
B: Biochemically-validated smoking cessation (middle and late pregnancy)
C: Participants' Smoking Status (around the 32nd week of gestation.); The Effectiveness of the Interventions According the Levels of Urine Cotinine Before and After Intervention. (At the baseline and at the 32nd week of gestation)
D: Biochemical verification of smoking status. (15 months)

Answer: A
Please select the outcome measures that correspond to the clinical trial below.
Title: N/A
Brief Summary: The principal objective is to test whether offering pregnant smokers a proactive telephone counseling program throughout pregnancy and for 2 months postpartum increases the rate of smoking cessation at end of pregnancy and 3 months postpartum, compared to a "best practice" control condition.


Options:
A: Self-reported, Smoking Abstinence Rate: 6-month Prolonged Abstinence (12 months after randomization)
B: Motivation to quit smoking, utilization of available resources, smoking cessation rate (1 year)
C: Biochemically-validated 7-day point prevalence tobacco abstinence at end of pregnancy
D: Biochemically verified smoking cessation rates at 6 months post-quit date

Answer: C
Please select the outcome measures that correspond to the clinical trial below.
Title: A Randomized Trial of Diabetes Intervention in the Community to Help Achieve Reduced Glucose Elevation: Diabetes IN-CHARGE
Brief Summary: The purpose of this study is to test whether providing personalized diabetes self-management recommendations and feedback improves blood sugar control more than providing generalized diabetes educational material alone.


Options:
A: Blood Pressure and Hemaglobin A1c
B: Target goal of HbA1c (< 7.0%) without hypoglycemia (24 weeks)
C: A1c (6 months and 1 year)
D: Hemoglobin A1c

Answer: C
Please select the outcome measures that correspond to the clinical trial below.
Title: Perioperative Ischemic Evaluation Study (POISE) Trial
Brief Summary: This trial will evaluate the ability of metoprolol (a beta-blocker drug) to prevent heart attacks and deaths around the time of surgery.


Options:
A: major cardiovascular events (defined as cardiovascular death, nonfatal myocardial infarction, or nonfatal cardiac arrest) (30 days)
B: left ventricular hypertrophy (3 months)
C: Doubling of Interstitium or Any ESRD (Baseline to 5 years)
D: Change in left ventricular ejection fraction, as assessed by cardiac MRI (Baseline and end of study (up to 72 weeks))

Answer: A
Please select the outcome measures that correspond to the clinical trial below.
Title: Perioperative Ischemic Evaluation Study (POISE) Trial
Brief Summary: This trial will evaluate the ability of metoprolol (a beta-blocker drug) to prevent heart attacks and deaths around the time of surgery.


Options:
A: All cause mortality (6-year); Composite of death, myocardial infarction, acute coronary syndrome, heart failure hospitalization (6-year)
B: A composite of all-cause mortality, recurrent MI, revascularisation with PCI or CABG, ischemic stroke, incident heart failure, malignant ventricular arrhythmia, or resuscitated cardiac arrest. (Estimated follow-up min 6 months - max 6.25 years)
C: major cardiovascular events (defined as cardiovascular death, nonfatal myocardial infarction, or nonfatal cardiac arrest) (30 days)
D: Death and the composite outcome of death, non-fatal reinfarction or stroke

Answer: C
Please select the outcome measures that correspond to the clinical trial below.
Title: Perioperative Ischemic Evaluation Study (POISE) Trial
Brief Summary: This trial will evaluate the ability of metoprolol (a beta-blocker drug) to prevent heart attacks and deaths around the time of surgery.


Options:
A: 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)
B: Combined number of units of allogeneic blood products (platelets + FFP + RBCs) administered to subjects. (From administration of Haemocomplettan® P until 24 hours later)
C: Proportion of Subjects Achieving Hemostasis by Five Minutes After Treatment Start at the TBS (From start of treatment until 5 minutes after treatment start)
D: major cardiovascular events (defined as cardiovascular death, nonfatal myocardial infarction, or nonfatal cardiac arrest) (30 days)

Answer: D
Please select the outcome measures that correspond to the clinical trial below.
Title: Perioperative Ischemic Evaluation Study (POISE) Trial
Brief Summary: This trial will evaluate the ability of metoprolol (a beta-blocker drug) to prevent heart attacks and deaths around the time of surgery.


Options:
A: major cardiovascular events (defined as cardiovascular death, nonfatal myocardial infarction, or nonfatal cardiac arrest) (30 days)
B: Composite of All-cause Mortality and Nonfatal MI (30 days); All-cause Mortality and Nonfatal MI (1 year)
C: To preform feasibility study looking at the safety and efficacy of adding clonidine to chronic b-blockade on patient-relevant outcomes (mortality, myocardial infarction, prolonged hospitalization) in large randomized controlled trials (Daily until discharge and 30 days after surgery)
D: administered doses of propofol and of remifentanil during anesthesia (end of anesthesia)

Answer: A
Please select the outcome measures that correspond to the clinical trial below.
Title: Perioperative Ischemic Evaluation Study (POISE) Trial
Brief Summary: This trial will evaluate the ability of metoprolol (a beta-blocker drug) to prevent heart attacks and deaths around the time of surgery.


Options:
A: All causes mortality at each follow-up period (6 months, each year)
B: All cause mortality (6-year); Composite of death, myocardial infarction, acute coronary syndrome, heart failure hospitalization (6-year)
C: major cardiovascular events (defined as cardiovascular death, nonfatal myocardial infarction, or nonfatal cardiac arrest) (30 days)
D: Infarct size evaluated primarily by area of delayed enhancement on cardiac magnetic resonance imaging. (5-7 days after reperfusion)

Answer: C
Please select the outcome measures that correspond to the clinical trial below.
Title: A Study of Sertraline to Prevent PTSD
Brief Summary: The broad, long-term objectives of this proposal are to prevent the emergence of posttraumatic stress and depressive symptoms in children admitted for an acute burn, reconstructive surgery, or non-burn injury. This study is investigating the early use of a medication in the prevention of posttraumatic stress disorder and depression. Specific Aims 1 and 2: To assess the efficacy of sertraline to prevent the development of (Aim 1)posttraumatic stress disorder and (Aim 2)depression in children aged 6-20, after burn or non-burn injury or after reconstructive surgery. Hypotheses 1 and 2: Administration of sertraline after an acute burn or non-burn injury, or after reconstructive surgery will lead to greater reduction in post-traumatic and depressive symptoms over 12 and 24 weeks, compared with placebo.

This study is completing the evaluation of 90 children and adolescents, aged 6-20 years. It is comparing 60 subjects receiving sertraline with 30 placebo control subjects matched for age, severity of injury, and type of hospitalization (acute vs. reconstructive). Children and families are evaluated for the presence of acute stress symptoms. Children are reassessed in a double-blind placebo-controlled design, with evaluations at Baseline, Week 2, Week 4, Week 8, Week 12, and Week 24. In addition, there is weekly monitoring for the first 14 weeks of the study and again at 18 weeks (the midpoint of the study). At each reassessment, information is collected on the child's compliance with the study medication, the parents' assessment of the child's functioning, and the child's self-report of posttraumatic and depressive symptomatology. The main outcome variable used in this study is the child's posttraumatic symptoms.


Options:
A: Diagnostic Interview Schedule for Children and Adolescents (DICA) - Parent (Baseline to Week 24); Diagnostic Interview for Children and Adolescents (DICA) - Child (Baseline to Week 24)
B: Physiological Posterior Probability of Posttraumatic Stress Disorder (PTSD) as Determined From Psychophysiologic Responses During Script-Driven Mental Imagery at Month 1 (Month 1); Physiological Posterior Probability of PTSD as Determined From Psychophysiologic Responses During Script-Driven Mental Imagery at Month 3 (Month 3)
C: Change in PTSD symptoms and severity - Clinician-Administered PTSD Scale - 5 (CAPS-5) (The full interview takes 45-60 minutes to administer and will be given at baseline, at approximately 31 days post event, and at three months.)
D: Total score of Clinician-Administrated PTSD Scale (Three month)

Answer: A
Please select the outcome measures that correspond to the clinical trial below.
Title: An International Multi Centre Randomized Clinical Trial Of Anticoagulation In Children Following Fontan Procedures
Brief Summary: Compare heparin/warfarin to ASA for thromboembolic prophylaxis in the first two years following Fontan procedures.


Options:
A: Warfarin vs ASA in prevention of thrombosis 2 yrs after Fontan
B: Graft patency (28 days)
C: Postoperative ATIII Levels at the ICU Admission (ICU admission); Percentage of Subjects With ATIII Levels of 58% or Higher at ICU Admission (ICU admission)
D: The Primary Outcome Measure Was the Number of Participants With New Heparin Platelet Factor 4 (HIT Positive) Antibodies in Each Group Within 30 Days Following Surgery. (30 days after surgery)

Answer: A
Please select the outcome measures that correspond to the clinical trial below.
Title: Quality Initiative in Rectal Cancer (QIRC) Trial
Brief Summary: The Quality initiative in rectal cancer (QIRC) trial will test if a strategy designed to positively influence surgeon practice can decrease hospital rates of permanent colostomy and local tumour recurrence for surgically treated rectal cancer patients.


Options:
A: Hospital rate of permanent colostomy; Hospital rate of local recurrence
B: decreased of occured of iatrogenic event in ICU (one month)
C: The following dependant variables were measured in this study;; Diabetes medical error in the 12 months post-intervention, Glycated hemoglobin (A1c) values and A1c test rates in the 12 months post-intervention, and; LDL-cholesterol levels and test rates in the 12 months post-intervention.
D: Primary Process Outcome: A composite score counting the number of appropriate processes achieved for patients within appropriate time-frames, including laboratory testing, blood pressure measurements and active prescriptions (24 months); Primary Disease-Related Outcomes: mean BP and mean LDL level. (24 months)

Answer: A
Please select the outcome measures that correspond to the clinical trial below.
Title: Quality Initiative in Rectal Cancer (QIRC) Trial
Brief Summary: The Quality initiative in rectal cancer (QIRC) trial will test if a strategy designed to positively influence surgeon practice can decrease hospital rates of permanent colostomy and local tumour recurrence for surgically treated rectal cancer patients.


Options:
A: The primary outcome measure will be the "improvement" of prescribing for efficacious therapies in patients with a chronic cardiovascular disease within six months of the intervention.
B: Hospital rate of permanent colostomy; Hospital rate of local recurrence
C: Percentage of adherence of opportunities for hand hygiene (march 2008, october 2008, may 2009, november 2009)
D: difference in change in systolic BP between the intervention and usual care groups (6 months)

Answer: B
Please select the outcome measures that correspond to the clinical trial below.
Title: Quality Initiative in Rectal Cancer (QIRC) Trial
Brief Summary: The Quality initiative in rectal cancer (QIRC) trial will test if a strategy designed to positively influence surgeon practice can decrease hospital rates of permanent colostomy and local tumour recurrence for surgically treated rectal cancer patients.


Options:
A: General practitioners'adherence to treatment recommendations (3-6 months after end of intervention)
B: Hospital rate of permanent colostomy; Hospital rate of local recurrence
C: The difference between groups in the change in parent and nurse ratings of specific communication skills and professionalism behaviors from baseline to follow-up (average 5 months later)
D: Adherence to guidelines G10 and G17 of the 2003 International Consensus Guidelines on nonvariceal upper GI bleeding. (1 year)

Answer: B
Please select the outcome measures that correspond to the clinical trial below.
Title: PROphylaxis for ThromboEmbolism in Critical Care Trial (PROTECT)
Brief Summary: The purpose of this study is to evaluate the effect of Low Molecular Weight Heparin (LMWH) (Fragmin, dalteparin) versus Unfractionated Heparin (UFH) on the primary outcome of proximal leg Deep Vein Thrombosis (DVT) diagnosed by compression ultrasound, and the secondary outcomes of Pulmonary Embolism (PE), bleeding, Heparin-Induced Thrombocytopenia (HIT), and objectively confirmed venous thrombosis at any site.


Options:
A: Symptomatic deep venous thrombosis (DVT) (3 Months); Pulmonary Embolism (PE) (3 months); Major Bleeding (3 months)
B: Symptomatic deep venous thrombosis (DVT) (3 Months); Pulmonary Embolism (PE) (3 months); Major Bleeding (3 months)
C: To evaluate the effect of LMWH (Fragmin, dalteparin) versus UFH on the primary outcome of proximal leg DVT diagnosed by compression ultrasound (While in ICU to a maximum of 90 days)
D: Clinically important venous thromboembolism at 3 months

Answer: C
Please select the outcome measures that correspond to the clinical trial below.
Title: A Randomized Trial of a Lung-Open Ventilation Strategy in Acute Lung Injury
Brief Summary: A multinational, randomized trial comparing two lung protecting strategies of respiratory life support among critically ill patients with severe lung injury.


Options:
A: adherence to our explicit mechanical ventilation protocols; (duration of mechanical ventilation); to measure and understand the reasons for crossovers between groups (duration of mechanical ventilation); to estimate the rate of patient recruitment, and understand barriers to recruitment; to document our ability to achieve close to complete follow-up for mortality and quality of life in the 6 months following enrolment
B: Survival to days 28 and 60 post-randomization, and to Hospital Discharge (28 days to more than 60 days post-randomization)
C: All-cause hospital mortality (Randomised patients will be ventilated according to their assigned ventilation strategy for up to 60 days, until they die on the ventilator or are successfully (for >24 hours) liberated from mechanical ventilation.)
D: Hospital Mortality

Answer: D
Please select the outcome measures that correspond to the clinical trial below.
Title: A Randomized Trial of a Lung-Open Ventilation Strategy in Acute Lung Injury
Brief Summary: A multinational, randomized trial comparing two lung protecting strategies of respiratory life support among critically ill patients with severe lung injury.


Options:
A: Development of ARDS (28 days)
B: Hospital Mortality
C: 28-day mortality from all causes (28 days)
D: Number of Ventilator Free Days at Day 28 Post Randomisation (28 days post randomisation)

Answer: B
Please select the outcome measures that correspond to the clinical trial below.
Title: A Randomized Trial of a Lung-Open Ventilation Strategy in Acute Lung Injury
Brief Summary: A multinational, randomized trial comparing two lung protecting strategies of respiratory life support among critically ill patients with severe lung injury.


Options:
A: Hospital Mortality
B: Development of ARDS (28 days)
C: Oxygenation (PaO2) measured 5 min after the onset of mechanical ventilation (5 min after the onset of mechanical ventilation)
D: 60 day mortality (60 days)

Answer: A
Please select the outcome measures that correspond to the clinical trial below.
Title: A Randomized Trial of a Lung-Open Ventilation Strategy in Acute Lung Injury
Brief Summary: A multinational, randomized trial comparing two lung protecting strategies of respiratory life support among critically ill patients with severe lung injury.


Options:
A: Oxygenation as measured by the PO2/FiO2 (P/F) ratio (72 hours from enrollment)
B: Number of Ventilator Free Days (VFD) (Determined 28 days after a subject entered the study)
C: Mortality at 28 days (day 28)
D: Hospital Mortality

Answer: D
Please select the outcome measures that correspond to the clinical trial below.
Title: A Study of the Effectiveness of Specialist Oncology Nursing Case Management in Improving Continuity of Supportive Cancer Care in the Community (SONICS)
Brief Summary: This research project will address the issue of gaps in continuity of supportive care for cancer patients during the early phases of the disease trajectory that result in unmet needs and unnecessary morbidity. The investigators intend to study the impact of a specialized cancer-nursing program, Interlink Community Cancer Nurses (Interlink) on patient outcomes. Impact will be assessed directly using a validated measure of continuity of care from the patients' perspective and validated measures of key supportive care patient outcomes including unmet needs, distress, uncertainty in illness, and quality of life, in a randomized trial.


Options:
A: Fear of Recurrence Level-ACCRE FCR (6-8 weeks after treatment)
B: Patient satisfaction with nurse communication during the Mini-AFTERc intervention (1 week post intervention)
C: Subscale quality of life of the questionnaire: EORTC QLQ C30 (After each treatment completion, during follow up; first year every 3 months, second year every 6 months)
D: Difference in unmet supportive care needs between intervention and control group (2 to 3 weeks after baseline; 8 to 10 weeks after baseline); Difference in continuity of care between intervention and control group (2 to 3 weeks after baseline; 8 to 10 weeks after baseline); Difference in quality of life between intervention and control group (2 to 3 weeks after baseline; 8 to 10 weeks after baseline)

Answer: D
Please select the outcome measures that correspond to the clinical trial below.
Title: A Study of the Effectiveness of Specialist Oncology Nursing Case Management in Improving Continuity of Supportive Cancer Care in the Community (SONICS)
Brief Summary: This research project will address the issue of gaps in continuity of supportive care for cancer patients during the early phases of the disease trajectory that result in unmet needs and unnecessary morbidity. The investigators intend to study the impact of a specialized cancer-nursing program, Interlink Community Cancer Nurses (Interlink) on patient outcomes. Impact will be assessed directly using a validated measure of continuity of care from the patients' perspective and validated measures of key supportive care patient outcomes including unmet needs, distress, uncertainty in illness, and quality of life, in a randomized trial.


Options:
A: Overall and cancer-specific mortality (5 years)
B: Quality of life; EORTC-QLQ-C30 and EQ 5D (2 years)
C: Difference in unmet supportive care needs between intervention and control group (2 to 3 weeks after baseline; 8 to 10 weeks after baseline); Difference in continuity of care between intervention and control group (2 to 3 weeks after baseline; 8 to 10 weeks after baseline); Difference in quality of life between intervention and control group (2 to 3 weeks after baseline; 8 to 10 weeks after baseline)
D: Overall Survival (OS) (5-year OS); Health Related Quality of Life (Yearly assessment over 5 years)

Answer: C
Please select the outcome measures that correspond to the clinical trial below.
Title: A Study of the Effectiveness of Specialist Oncology Nursing Case Management in Improving Continuity of Supportive Cancer Care in the Community (SONICS)
Brief Summary: This research project will address the issue of gaps in continuity of supportive care for cancer patients during the early phases of the disease trajectory that result in unmet needs and unnecessary morbidity. The investigators intend to study the impact of a specialized cancer-nursing program, Interlink Community Cancer Nurses (Interlink) on patient outcomes. Impact will be assessed directly using a validated measure of continuity of care from the patients' perspective and validated measures of key supportive care patient outcomes including unmet needs, distress, uncertainty in illness, and quality of life, in a randomized trial.


Options:
A: To investigate whether the use of QOL questionnaires during the assessment and management of lung cancer patients results in improved quality of life
B: The primary outcomes to be measured include measures of spiritual well-being (meaning) and psychological distress (depression, hopelessness, optimism quality of life). (16 weeks)
C: Difference in unmet supportive care needs between intervention and control group (2 to 3 weeks after baseline; 8 to 10 weeks after baseline); Difference in continuity of care between intervention and control group (2 to 3 weeks after baseline; 8 to 10 weeks after baseline); Difference in quality of life between intervention and control group (2 to 3 weeks after baseline; 8 to 10 weeks after baseline)
D: Mental condition (from baseline until 6 months)

Answer: C
Please select the outcome measures that correspond to the clinical trial below.
Title: Efficacy and Safety of Methylxanthines in Very Low Birthweight Infants
Brief Summary: At least 5 of every 1000 live-born babies are very premature and weigh only 500 to 1250 grams at birth. Approximately 30-40% of these high-risk infants either die or survive with lasting disabilities. The aim of this research is to reduce this heavy burden of illness. A multi-center randomized controlled trial has been designed in which 2000 very low birth weight infants will be enrolled. Our goal is to determine whether the avoidance of methylxanthine drugs will improve survival without disability to 18 months, corrected for prematurity.

Methylxanthine drugs such as caffeine are used to prevent or treat periodic breathing and breath-holding spells in premature infants. However, there is a striking lack of evidence for the long-term efficacy and safety of this therapy. Methylxanthines block a naturally occurring substance, called adenosine, which protects the brain during episodes of oxygen deficiency. Such episodes are common in infants who are treated with methylxanthines. It is possible that methylxanthines may worsen the damage caused by lack of oxygen. Therefore, this trial will clarify whether methylxanthines cause more good than harm in very low birth weight infants.


Options:
A: Composite of survival to 36 weeks gestational age, free of moderate-severe bronchopulmonary dysplasia (36 weeks gestational age)
B: The percent of infants who will fail NRS and need endotracheal ventilation or will be switched to another mode of NRS. (1 year)
C: Duration of NIV Support (10 days); Failure of NIV Support (10 days)
D: combined rate of mortality and neurodevelopmental disability in survivors at a corrected age of 18 months. (corrected age of 18 months)

Answer: D