TrialPanorama/Dataset huggingface dataset:
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: Percent time in target range for oxygen saturation by pulse oximetry (24 hrs)
B: Cerebral tissue oxygen saturation (48 hours)
C: Proportion of time with SpO2 spent within set target range (Continuously from randomization until study completion. (maximum of 50 hours) Measurements during wash-out periods (up to 1 hour after ventilator switch) will be excluded.)
D: combined rate of mortality and neurodevelopmental disability in survivors at a corrected age of 18 months. (corrected age of 18 months)

Answer: D
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: Length of Hospitalization (Up to 4 months)
B: combined rate of mortality and neurodevelopmental disability in survivors at a corrected age of 18 months. (corrected age of 18 months)
C: Change in Infant Movement between Mattress ON and Mattress OFF (control) (Single sessions throughout course of hospitalization. Each session may last up to 24 hours.); Change in Infant Breathing between Mattress ON and Mattress OFF (control) (Single sessions throughout course of hospitalization. Each session may last up to 24 hours.); Change in Infant Heart Rate between Mattress ON and Mattress OFF(control) (Single sessions throughout course of hospitalization. Each session may last up to 24 hours.)
D: Cumulative dose of morphine required to treat NAS. (14 days of age); Highest dose of morphine required to treat NAS. (14 days of age)

Answer: B
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: combined rate of mortality and neurodevelopmental disability in survivors at a corrected age of 18 months. (corrected age of 18 months)
B: Neonatal Mortality Rate at 28 Days in <5th Percentile Birth Weight Infants (as a Proxy Measure for Prematurity) (Birth to 28 days)
C: Neonatal Composite Outcome (72 hours of life)
D: Incidence of respiratory morbidity (72 hours after birth)

Answer: A
Please select the outcome measures that correspond to the clinical trial below.
Title: A Randomized Controlled Trial of Two Hemoglobin Thresholds for Transfusion in Newborns <1000g Birth Weight
Brief Summary: Hypothesis: That a high hemoglobin threshold for transfusion in extremely low birth weight (ELBW) infants is associated with a lower rate of survival without severe morbidity (defined as one or more of retinopathy of prematurity, bronchopulmonary dysplasia, or periventricular leukomalacia/ventriculomegaly).

Primary Objective: To determine whether either a liberal or more restrictive threshold of hemoglobin level for red cell transfusion in ELBW infants is safer, by randomizing to either a high transfusion hemoglobin threshold or a low transfusion hemoglobin threshold.

Follow-up at a corrected age of 18 months represents a conventional age at which to first assess neurodevelopmental outcomes, and to predict long-term outcomes.


Options:
A: The Change in the Composite Multiple Organ Dysfunction Score (MODS) From the Pre-operative Baseline. The Worst Post-operative Values of Each Component of MODS Will be Used to Calculate the Change in MODS. (Through post-operative day 7, hospital discharge, or death, whichever occurs first)
B: 1. Composite Outcome of Necrotizing Enterocolitis, Intraventricular Hemorrhage, Bronchopulmonary Dysplasia and Retinopathy of Prematurity at 30 and 90-days. 2. Mortality (2 weeks, 4 weeks, 12 weeks, 90 days)
C: 12 Hour Plasma Interleukin (IL)-6 to IL-10 Ratio (12 hours post-cardiopulmonary bypass)
D: Combined mortality or survival to tertiary hospital discharge without severe morbidity (BPD, severe ROP or brain injury) (neonatal phase); Combined mortality or survival with neurodevelopmental disability (non-ambulatory cerebral palsy, blindness, deafness, cognitive delay) (follow-up phase 18 months corrected age)

Answer: D
Please select the outcome measures that correspond to the clinical trial below.
Title: Fixed Dose Unfractionated Heparin for Initial Treatment of Venous Thromboembolism
Brief Summary: FIDO was a multicentred randomized, open-label trial that compared fixed-dose UFH with fixed-dose LMWH for initial treatment of VTE. Patients were followed for 3 months during which they received warfarin (target INR 2.0-3.0).


Options:
A: The Percentage of Participants With Recurrent or New Symptomatic Venous Thromboembolism (VTE) (From Day 1 to Day 90 (±7 days))
B: The primary aim of the study is to compare the major hemorrhage risk between the use of LMWH plus thrombolytic treatment and UFH plus thrombolytic in the treatment of acute massive PE. (7 day)
C: Symptomatic Venous Thromboembolism; Major Bleeding; Death
D: Number of Patients With Clinically Relevant Bleeding Events (prior to day 90 +/- 5)

Answer: C
Please select the outcome measures that correspond to the clinical trial below.
Title: If, When and How to Ask the Question(s): Assessing Screening Approaches to Identifying Woman Abuse in Health Care Settings
Brief Summary: The purpose of the research is to evaluate whether routine screening for woman abuse in health care settings, as compared to no screening, does more good than harm. Recent reviews have identified the need for high quality research to understand 1) the actual impact on all women of instituting mass screening procedures to identify woman abuse and 2) the extent to which early identification through screening is effective in preventing or ameliorating important outcomes. The main outcomes for the study are reduction in violence, improvement in life quality, and potential harms of screening. A number of secondary outcomes to help understand the process by which screening and usual care might lead to changes in the primary outcomes will also be assessed.


Options:
A: Recurrence of intimate partner violence (18 months); Health-specific quality of life (18 months); Harms of screening and/or usual care (18 months)
B: HIV sero-incidence (24 months post-baseline)
C: Discussion of family psychosocial problem; Referral of family psychosocial problem; Contacting community resources
D: Acceptability, perceived safety and ease of administration of each survey method

Answer: A
Please select the outcome measures that correspond to the clinical trial below.
Title: If, When and How to Ask the Question(s): Assessing Screening Approaches to Identifying Woman Abuse in Health Care Settings
Brief Summary: The purpose of the research is to evaluate whether routine screening for woman abuse in health care settings, as compared to no screening, does more good than harm. Recent reviews have identified the need for high quality research to understand 1) the actual impact on all women of instituting mass screening procedures to identify woman abuse and 2) the extent to which early identification through screening is effective in preventing or ameliorating important outcomes. The main outcomes for the study are reduction in violence, improvement in life quality, and potential harms of screening. A number of secondary outcomes to help understand the process by which screening and usual care might lead to changes in the primary outcomes will also be assessed.


Options:
A: Recurrence of intimate partner violence (18 months); Health-specific quality of life (18 months); Harms of screening and/or usual care (18 months)
B: Primary Outcome Measure (3 years)
C: Abstinence (3 month follow up); Abstinence (6 month follow up); Abstinence (9 month follow up); Abstinence (12 month follow up); Abstinence (18 month follow up); Abstinence (24 month follow up); Cocaine Urine Toxicology (3 month follow up); Cocaine Urine Toxicology (6 month follow up); Cocaine Urine Toxicology (9 month follow up); Cocaine Urine Toxicology (12 month follow up); Cocaine Urine Toxicology (18 month follow up); Cocaine Urine Toxicology (24 month follow up); Comparison Across Groups in Societal Costs (24 months); Net Saving/Spending Comparisons Across Groups From Provider Perspective (24 months); Net Comparisons of Savings and Spendings Across Groups From Societal Perspective (24 months); Percent Days Cocaine Use (3 months (approximately study days 1 - 90)); Percent Days Cocaine Use (6 months (approproximately study days 91 - 180)); Percent Days Cocaine Use (9 months (approximately study days 181 - 270)); Percent Days Cocaine Use (12 months (approximately study days 271 - 365)); Percent Days Cocaine Use (18 months (approximately study days 366 - 546)); Percent Days Cocaine Use (24 months (approximately study days 547 - 730)); Percent Days Abstinent (3 months (approximately study days 1 - 90)); Percent Days Abstinent (6 months (approximately study days 91 - 180)); Percent Days Abstinent (9 months (approximately study days 181 - 270)); Percent Days Abstinent (12 months (approximately study days 271 - 365)); Percent Days Abstinent (18 months (approximately days 366 - 546)); Percent Days Abstinent (24 months (approximately study days 547 - 730))
D: Three consecutive weeks of negative urine tests (benzoyl ecgonine) for cocaine use (no slips allowed). (These must be the last three weeks (7,8,9) of the trial.)

Answer: A
Please select the outcome measures that correspond to the clinical trial below.
Title: A 12-Week, Double-Blind Trial of Olanzapine and Placebo in the Treatment of Trichotillomania
Brief Summary: Trichotillomania (TTM) or hair-pulling has been considered as part of the obsessive compulsive disorder (OCD) spectrum, although treatment with OCD medications has largely been unsuccessful. Tics/Tourrettes' Syndrome (TS) is a disorder, which appears to be related to TTM, but is treated with a different class of medications than used in OCD, namely antipsychotics such as olanzapine. This is a study of the safety and efficacy of olanzapine in the treatment of hair pulling.


Options:
A: Massachusetts General Hospital Hair Pulling Scale (MGH-HPS) (Week 12)
B: National Institute of Mental Health Trichotillomania Symptom Severity Scale (This is the final score, measured at week 8 (final visit).)
C: Clinical Global Impression (CGI)-Improvement Scale ≤ 2
D: Massachusetts General Hospital Hairpulling Scale (Baseline and final visit after 12 weeks)

Answer: C
Please select the outcome measures that correspond to the clinical trial below.
Title: Science-Based Treatment for Opioid-Dependent Adolescents
Brief Summary: The purpose of this study is to evaluate ways to optimize outcomes from combined behavioral-pharmacological treatment for opioid-dependent youth.


Options:
A: opiate use
B: Opioid Use (24 weeks)
C: Illicit Opioid Use (18 weeks)
D: HIV Risk Events (Change from Baseline in HIV Risk Events at Months 3, 6, 9 and 12)

Answer: A
Please select the outcome measures that correspond to the clinical trial below.
Title: Science-Based Treatment for Opioid-Dependent Adolescents
Brief Summary: The purpose of this study is to evaluate ways to optimize outcomes from combined behavioral-pharmacological treatment for opioid-dependent youth.


Options:
A: percentage of subjects abstinent from all opioids through the final day of detoxification (up to 12-week trial)
B: opiate use
C: Percentage of patients in each group successfully inducted onto Vivitrol (Completion of 7-day detoxification)
D: CDF of the percent of urine samples negative for opioids in Probuphine and Placebo groups from weeks 1-24 (1-24 weeks); CDF of the percent of urine samples negative for opioids from weeks 1-24 with imputation based on illicit drug use self-report data for Probuphine and placebo groups (1-24 weeks)

Answer: B
Please select the outcome measures that correspond to the clinical trial below.
Title: Primary Chemotherapy With Temozolomide Versus Radiotherapy in Patients With Low Grade Gliomas After Stratification for Genetic 1p Loss: A Phase III Study
Brief Summary: RATIONALE: Radiation therapy uses high-energy x-rays to kill tumor cells. Drugs used in chemotherapy, such as temozolomide, work in different ways to stop the growth of tumor cells, either by killing the cells or by stopping them from dividing. It is not yet known whether radiation therapy is more effective than temozolomide in treating gliomas.

PURPOSE: This randomized phase III trial is studying radiation therapy to see how well it works compared to temozolomide in treating patients with gliomas.


Options:
A: Incidence of neuropsychological and neuroendocrine function in the two arms
B: Progression Free Survival (PFS) time (5 years)
C: Progression-free survival (5 years)
D: Number of Participants With Treatment Related Adverse Events (2 months)

Answer: C
Please select the outcome measures that correspond to the clinical trial below.
Title: Action to Control Cardiovascular Risk in Diabetes (ACCORD)
Brief Summary: The purpose of this study is to prevent major cardiovascular events (heart attack, stroke, or cardiovascular death) in adults with type 2 diabetes mellitus using intensive glycemic control, intensive blood pressure control, and multiple lipid management.


Options:
A: Number of Patients With First Recurrent Stroke of Any Type, Fatal or Nonfatal (Antiplatelet Comparison Only) (time since randomization; follow-up period is 1.5 to 4.4 years); Number of Patients With First Recurrent Stroke of Any Type, Fatal or Nonfatal (Telmisartan vs. Placebo Only) (time since randomization; follow-up period is 1.5 to 4.4 years)
B: First Occurrence of a Major Cardiovascular Event (MCE); Specifically Nonfatal Heart Attack, Nonfatal Stroke, or Cardiovascular Death (Measured Throughout the Study) in the Glycemia Trial. (4.9 years); First Occurrence of Major Cardiovascular Event (MCE) in the Blood Pressure Trial. (4.7 years); First Occurrence of Major Cardiovascular Event (MCE) in the Lipid Trial. (4.7 years)
C: Composite of non-fatal stroke, non-fatal myocardial infarction or death from any cardiovascular cause (July 2001 - December 2007); Composite of new or substantially worsening nephropathy or microvascular eye disease. (July 2001 - December 2007)
D: Recurrent stroke (five years)

Answer: B
Please select the outcome measures that correspond to the clinical trial below.
Title: Action to Control Cardiovascular Risk in Diabetes (ACCORD)
Brief Summary: The purpose of this study is to prevent major cardiovascular events (heart attack, stroke, or cardiovascular death) in adults with type 2 diabetes mellitus using intensive glycemic control, intensive blood pressure control, and multiple lipid management.


Options:
A: Composite of non-fatal stroke, non-fatal myocardial infarction or death from any cardiovascular cause (July 2001 - December 2007); Composite of new or substantially worsening nephropathy or microvascular eye disease. (July 2001 - December 2007)
B: First Occurrence of a Major Cardiovascular Event (MCE); Specifically Nonfatal Heart Attack, Nonfatal Stroke, or Cardiovascular Death (Measured Throughout the Study) in the Glycemia Trial. (4.9 years); First Occurrence of Major Cardiovascular Event (MCE) in the Blood Pressure Trial. (4.7 years); First Occurrence of Major Cardiovascular Event (MCE) in the Lipid Trial. (4.7 years)
C: HbA1c Change From Baseline at Week 12 (Baseline and Week 12)
D: Number of Participants With All-Cause Mortality (five years)

Answer: B
Please select the outcome measures that correspond to the clinical trial below.
Title: Action to Control Cardiovascular Risk in Diabetes (ACCORD)
Brief Summary: The purpose of this study is to prevent major cardiovascular events (heart attack, stroke, or cardiovascular death) in adults with type 2 diabetes mellitus using intensive glycemic control, intensive blood pressure control, and multiple lipid management.


Options:
A: Composite of the First Occurrence of Cardiovascular (CV) Death, Nonfatal Myocardial Infarction (MI) or Nonfatal Stroke (from randomization until study cut-off date (median duration of follow-up: 6.2 years)); Composite of the First Occurrence of Cardiovascular (CV) Death, Nonfatal Myocardial Infarction (MI), Nonfatal Stroke, Revascularization Procedure or Hospitalization for Heart Failure (HF) (from randomization until study cut-off date (median duration of follow-up: 6.2 years))
B: Coronary heart disease 10 year risk (12 months)
C: First Occurrence of a Major Cardiovascular Event (MCE); Specifically Nonfatal Heart Attack, Nonfatal Stroke, or Cardiovascular Death (Measured Throughout the Study) in the Glycemia Trial. (4.9 years); First Occurrence of Major Cardiovascular Event (MCE) in the Blood Pressure Trial. (4.7 years); First Occurrence of Major Cardiovascular Event (MCE) in the Lipid Trial. (4.7 years)
D: Change in cognitive scores; Change in insulin sensitivity

Answer: C
Please select the outcome measures that correspond to the clinical trial below.
Title: Action to Control Cardiovascular Risk in Diabetes (ACCORD)
Brief Summary: The purpose of this study is to prevent major cardiovascular events (heart attack, stroke, or cardiovascular death) in adults with type 2 diabetes mellitus using intensive glycemic control, intensive blood pressure control, and multiple lipid management.


Options:
A: First Occurrence of a Major Cardiovascular Event (MCE); Specifically Nonfatal Heart Attack, Nonfatal Stroke, or Cardiovascular Death (Measured Throughout the Study) in the Glycemia Trial. (4.9 years); First Occurrence of Major Cardiovascular Event (MCE) in the Blood Pressure Trial. (4.7 years); First Occurrence of Major Cardiovascular Event (MCE) in the Lipid Trial. (4.7 years)
B: Composite of non-fatal stroke, non-fatal myocardial infarction or death from any cardiovascular cause (July 2001 - December 2007); Composite of new or substantially worsening nephropathy or microvascular eye disease. (July 2001 - December 2007)
C: First Occurrence of a Major Cardiovascular Event (MCE); Specifically Nonfatal Heart Attack, Nonfatal Stroke, or Cardiovascular Death (Measured Throughout the Study) in the Glycemia Trial. (4.9 years); First Occurrence of Major Cardiovascular Event (MCE) in the Blood Pressure Trial. (4.7 years); First Occurrence of Major Cardiovascular Event (MCE) in the Lipid Trial. (4.7 years)
D: Major macrovascular events -a composite of non-fatal myocardial infarction, non-fatal stroke and death from any cardiovascular cause (based on investigator diagnosis) (2014); Death from any cause (2014)

Answer: A
Please select the outcome measures that correspond to the clinical trial below.
Title: A Trial to Reduce Delirium in Aged Post Acute Patients
Brief Summary: The purpose of this study is to develop a comprehensive Delirium Abatement Program of care of delirious patients in the post acute care setting and to evaluate its impact on persistence and severity of delirium and on functional recovery.


Options:
A: achieving target sedation level (Patients will receive study drug for a maximum of 120 hours (5 days))
B: Prevalence of delirium at two weeks after admission; Activities of Daily Living (ADL) functional improvement two weeks after admission; Full ADL functional recovery to pre-illness status three months after post-acute admission
C: Number of Patients With Incidence of Delirium Across All Patients at Baseline and Over Post-operative Days 1-3 (Delirium incidence on postoperative days 1-3, calculated by any positive CAM on any day for all patients)
D: Percentage of Participants With Delirium Using the CAM Over Time (Baseline, hospital interviews, weeks 2, 4 and 6)

Answer: B
Please select the outcome measures that correspond to the clinical trial below.
Title: Geriatric Resources for Assessment and Care of Elders
Brief Summary: The purpose of this study is to test the effectiveness of a collaborative model of team care as compared to usual care in improving functional outcomes among community-dwelling low-income older adults.


Options:
A: Overall functioning (18 months); Incremental cost-effectiveness ratio (ICER) (18 months)
B: Hospitalizations: rates of first hospitalization, number and reason (Three years)
C: Functional status; health status; hospitalization and nursing home placement
D: Functional performance (independent) activities of daily living measured using Groningen Activity Restriction Scale (3 months); Mental health using subscale mental health MOS-20 (3 months); Informal caregiver burden using Zarit Burden Interview (3 months)

Answer: C