TrialPanorama/Dataset huggingface dataset:
Please select the outcome measures that correspond to the clinical trial below.
Title: Promoting Behavioral Change for Oral Health in American Indian Mothers and Children
Brief Summary: A program of motivational interviewing plus enhanced community services in prevention of early childhood caries vs. enhanced community services alone for American Indian mothers and their children will reduce the childrens' decayed, missing, and filled tooth surfaces measure over a 3-year period.


Options:
A: Blood Glucose, levels of glucose in blood (Postprandial 0-180 min after breakfast); Insulin, levels of insulin in blood (Postprandial 0-180 min after breakfast); Appetite hormones, levels of Peptide YY (PYY) in blood (Postprandial 0-180 min after breakfast); Markers of colonic fermentation, levels of hydrogen in breath (Postprandial 0-180 min after breakfast); Inflammation markers, levels of Interleukin-6 (IL-6) in blood (Postprandial 0-180 min after breakfast)
B: Effectiveness of a nutrition advice programme in exclusive breastfeeding. (1 year); Effectiveness of a nutrition advice programme in dietary intake (1 year); Effectiveness of a nutrition advice programme in dietary intake (4 years); Effectiveness of a nutrition advice programme in dietary intake (8 years); Effectiveness of a nutrition advice programme in dietary intake (12 years)
C: Change in the prevalence of stunting (<-2 SD of the WHO, 2006 growth reference standards) (6-8, 12-16, 20-24 (main outcome time point), 36 months, 7-10 years)
D: Decayed,missing, and filled tooth surfaces (dmfs) (Over 3 years)

Answer: D
Please select the outcome measures that correspond to the clinical trial below.
Title: Preventing Caries in Preschoolers: Testing a Unique Service Delivery Model in American Indian Head Start Programs
Brief Summary: An intensive intervention of specially trained paraprofessionals, called community oral health specialists (COHS), administering on a quarterly basis for 2 years fluoride varnish and oral health promotion education, compared to usual care, will reduce decayed, missing, and filled tooth surface measures at 2 years for children in American Indian Head Start Programs.


Options:
A: Reduction in the 2-year caries increment (dmfs/DMFS index); final follow-up at 24 months.
B: Evaluation of Decayed, Missing, and Filled Tooth Surfaces (Dmfs) at Baseline (Baseline); Evaluation of Decayed, Missing, and Filled Tooth Surfaces (Dmfs) at Year 1 (1 Year); Evaluation of Decayed, Missing, and Filled Tooth Surfaces (Dmfs) at Year 2 (2 Years); Evaluation of Decayed, Missing, and Filled Tooth Surfaces (Dmfs) at Year 3 (3 Years)
C: Child cognitive development, behavior, and health (At-risk sample: Up to 8 years; Not-at risk sample: Up to 2 years); Child social-emotional development (At-risk sample: Up to 6 years; Not-at risk sample: Up to 1 year); Child depression (At-risk sample: Up to 8 years; Not-at risk sample: Up to 2 years)
D: Reduction in SSB initiation and frequency among infants up to 12-months of age (12-months of age); Change in optimal complementary feeding and responsive parenting practices in mothers who receive FSN vs controls (3-months and 12-months of age); Change in SSB consumption among infants due to water insecurity (6-months of age)

Answer: B
Please select the outcome measures that correspond to the clinical trial below.
Title: Safe Drinking Water For Households With Infants Born to HIV-Positive Mothers in Zambia: Piloting a Household Water Treatment Intervention
Brief Summary: The purpose of this study is to assess whether children under 2 years and other members of households in which HIV-positive mothers are providing replacement and complementary feeding would potentially benefit from the use of a filter designed to eliminate microbial pathogens from drinking water at the household level.


Options:
A: Dysentery disease rate (12 month); Diarrhoea disease rate (12 months)
B: diarrhoea morbidity (monthly visits for 12 months)
C: Length-for-Age Z-scores (Measured 24 months after intervention); Diarrhea Prevalence (Measured 12 and 24 months after intervention)
D: Use of LifeStraw Family for children under 2 and all household members (One year)

Answer: D
Please select the outcome measures that correspond to the clinical trial below.
Title: Laryngeal Mask Airway (LMA) for Surfactant Administration in Neonates
Brief Summary: The primary objective of this research is to compare the need for intubation and mechanical ventilation in the first seven days of life for infants with respiratory distress syndrome (RDS) on nasal continuous positive airway pressure (nCPAP) who receive surfactant via a Laryngeal Mask Airway (LMA) with those who are maintained on nCPAP and do not receive surfactant.


Options:
A: Need for Intubation and Mechanical Ventilation in the First Seven Days of Life. (Seven days)
B: Number of Participants Failing to Avoid Invasive Mechanical Ventilation (120 hours)
C: Survival Without Bronchopulmonary Dysplasia (BPD) (36 weeks); Survival Without Severe Retinopathy of Prematurity (ROP) (Threshold Disease or the Need for Surgery) (55 weeks)
D: Composite outcome of either a) early neonatal death or b) neonatal encephalopathy (Day 7 of life)

Answer: A
Please select the outcome measures that correspond to the clinical trial below.
Title: An Open-Label, Rollover Study to Evaluate the Long Term Safety and Efficacy of VX-770 in Subjects With Cystic Fibrosis
Brief Summary: The primary objective of the study was to evaluate the safety of long-term VX-770 treatment in participants with cystic fibrosis (CF). The secondary objective of the study was to evaluate the efficacy of long-term VX-770 treatment in subjects with CF.


Options:
A: Number of Participants With Non-Serious Adverse Events (AEs) and Serious Adverse Events (SAEs) (Study 105: Day 1 up to Week 168)
B: Number of Participants With Treatment Emergent Adverse Events (TEAEs) or Serious Adverse Events (SAEs) in Ivacaftor Arm (Day 1 up to Week 108 (Study 112))
C: Number of Subjects With Adverse Events (Combined Part 1 and Part 2) (Baseline to Follow-up); Number of Adverse Events (Combined Part 1 and Part 2) (Baseline to Follow-up)
D: Part A: Number of Participants With Adverse Events (AEs), Serious Adverse Events (SAEs) and Related AEs (Part A: Up to 93 Days); Part B: Number of Participants With Adverse Events (AEs), Serious Adverse Events (SAEs) and Related AEs (Part B: Up to 28 Weeks); Part A: Plasma Concentration of Ivacaftor and Its Metabolites (Part A: up to 24 hours post-dose on Day 4)

Answer: A
Please select the outcome measures that correspond to the clinical trial below.
Title: The Role of Renal Denervation in Improving Outcomes of Catheter Ablation in Patients With Refractory Symptomatic Atrial Fibrillation and Resistant Hypertension
Brief Summary: The purpose of this study is the comparative evaluation of systolic blood pressure (SBP) lowering, atrial fibrillation (AF) recurrence and clinical data in patients with paroxysmal/persistent AF and resistant hypertension, undergoing AF ablation alone or combined with percutaneous renal denervation.


Options:
A: Change in Office Systolic Blood Pressure (Baseline to 6 months post-randomization)
B: Change in systolic blood pressure (ABPM mean value) (6 months)
C: Office Systolic Blood Pressure Reduction (Baseline to 6 months)
D: Freedom of AF or other atrial arrhythmias (1 year)

Answer: D
Please select the outcome measures that correspond to the clinical trial below.
Title: The Role of Renal Denervation in Improving Outcomes of Catheter Ablation in Patients With Refractory Symptomatic Atrial Fibrillation and Resistant Hypertension
Brief Summary: The purpose of this study is the comparative evaluation of systolic blood pressure (SBP) lowering, atrial fibrillation (AF) recurrence and clinical data in patients with paroxysmal/persistent AF and resistant hypertension, undergoing AF ablation alone or combined with percutaneous renal denervation.


Options:
A: Number of Participants With Major Adverse Events (MAE) Defined as a Composite of Events. (From baseline to 1 month post-procedure (6 months for new renal artery stenosis)); Baseline Adjusted Change (Using Analysis of Covariance) in Systolic Blood Pressure as Measured by 24-hour Ambulatory Blood Pressure Monitoring (From baseline to 3 months post-procedure)
B: Freedom of AF or other atrial arrhythmias (1 year)
C: Solo Cohort - Mean Difference in Average Daytime Ambulatory Systolic BP (from baseline to 2 months post procedure); Trio Cohort - Median Change in Daytime Ambulatory Systolic BP (from baseline to 2 months post procedure)
D: Change in Office Systolic Blood Pressure (Baseline to 6 months post-randomization)

Answer: B
Please select the outcome measures that correspond to the clinical trial below.
Title: Apathy in Dementia Methylphenidate Trial (ADMET)
Brief Summary: The Apathy in Dementia Methylphenidate Trial (ADMET) is a masked, placebo-controlled trial that will examine the efficacy and safety of methylphenidate for the treatment of clinically significant apathy in patients with Alzheimer's dementia.


Options:
A: Presence of Agitation and/or Psychosis Measured by the Neuropsychiatric Inventory (NPI) Combined With an Assessment of the Clinical Significance of Behavioral Change Rated by the Study Clinician (24 months)
B: Apathy Evaluation Scale (AES) (baseline to 6 weeks); Alzheimer's Disease Cooperative Study- Clinical Global Impression of Change (baseline to 6 weeks)
C: Apathy (at baseline); Apathy (after 8 weeks of treatment)
D: N/A

Answer: B
Please select the outcome measures that correspond to the clinical trial below.
Title: Implementation and Evaluation of an Effective Community Occupational Therapy in Dementia (COTiD) Program
Brief Summary: The main purpose of this cluster randomized controlled trial is to evaluate the difference in effectiveness between a combined implementation strategy and an educational strategy on the implementation of a community occupational therapy program for clients with dementia and their primary caregivers.


Options:
A: Adherence of occupational therapists to the COTiD program (one year (baseline, T1, and T2)); Community occupational therapy use according to the COTiD program (one year); Costs of the implementation strategies (October 2009 - December 2011)
B: Composite of readmission to hospital or death. (30 days after hospital discharge)
C: functional gain as measured by motor FIM score (One year post team training intervention)
D: Patient Health Questionaire (PHQ-9) (At 3- and 6- months following the death of the patient)

Answer: A
Please select the outcome measures that correspond to the clinical trial below.
Title: Women of Color and Asthma Control
Brief Summary: The proposed randomized controlled trial will evaluate an innovative intervention in 420 African American women with asthma. It will be the first to use a highly tailored, telephone counseling approach to address both specific cultural factors affecting asthma and the influence of female sex and gender on control.


Options:
A: Parental asthma-related quality of life (one year); Urgent care events for asthma (One year)
B: Adherence to inhaled corticosteroid medication (12 months)
C: Emergency department visits - 1st time point (12months prior to baseline interview); Emergency Department Visits -2nd time point (Interval between baseline interview and 12 month interview); Emergency Department Visits - 3rd time point (Interval between 12 month and 24 month telephone interview)
D: change in asthma control between baseline and six months as measured by ACQ.24 The ACQ measures clinical goals of asthma management on a scale: 0 (good control) to 6, is responsive to change,24 with a intra-individual minimum important difference (6 months)

Answer: C
Please select the outcome measures that correspond to the clinical trial below.
Title: Women of Color and Asthma Control
Brief Summary: The proposed randomized controlled trial will evaluate an innovative intervention in 420 African American women with asthma. It will be the first to use a highly tailored, telephone counseling approach to address both specific cultural factors affecting asthma and the influence of female sex and gender on control.


Options:
A: Adherence to inhaled corticosteroid medication (12 months)
B: Percentage Changed in Adherence Score (Baseline compared to the mean of the combined 3, 6, 9, and 12 month scores); Number of Symptom-free Days (Baseline compared to the mean of the combined 3, 6, 9, and 12 month scores)
C: Emergency department visits - 1st time point (12months prior to baseline interview); Emergency Department Visits -2nd time point (Interval between baseline interview and 12 month interview); Emergency Department Visits - 3rd time point (Interval between 12 month and 24 month telephone interview)
D: change in asthma control between baseline and six months as measured by ACQ.24 The ACQ measures clinical goals of asthma management on a scale: 0 (good control) to 6, is responsive to change,24 with a intra-individual minimum important difference (6 months)

Answer: C
Please select the outcome measures that correspond to the clinical trial below.
Title: Women of Color and Asthma Control
Brief Summary: The proposed randomized controlled trial will evaluate an innovative intervention in 420 African American women with asthma. It will be the first to use a highly tailored, telephone counseling approach to address both specific cultural factors affecting asthma and the influence of female sex and gender on control.


Options:
A: Emergency Department Visits - 1st time point (12 months prior to baseline interview); Emergency Department Visits - 2nd time point (Interval between baseline and 9 months); Emergency Department Visits - 3rd time point (interval between 9 month and 18 month telephone interview)
B: Emergency department visits - 1st time point (12months prior to baseline interview); Emergency Department Visits -2nd time point (Interval between baseline interview and 12 month interview); Emergency Department Visits - 3rd time point (Interval between 12 month and 24 month telephone interview)
C: ER visits (18 months)
D: Follow-up with a Primary Care Physician (PCP) (4 weeks, 3 months and 6 months after Emergency Department visit)

Answer: B
Please select the outcome measures that correspond to the clinical trial below.
Title: Promoting Healthy Weight Gain During Pregnancy
Brief Summary: Study goal is to determine whether behavioral lifestyle intervention during pregnancy can reduce the number of women who exceed the Institute of Medicine recommendations for weight gain during pregnancy.

It is hypothesized that the intervention will reduce the number of women who exceed weight gain guidelines relative to standard care. The investigators also expect the intervention to reduce the proportion of women exceeding weight gain guidelines in both normal weight and overweight groups.


Options:
A: Percentage of women above the Institute of Medicine Guidelines for gestational weight gain (40 weeks)
B: Maternal weight gain in pregnancy (Measured at the time of delivery); Weight of the newborn (Measured at the time of delivery); Maternal fasting serum glucose level (Measured at gestational week 30); Incidence of operative delivery, both cesarean section and operative vaginal delivery (Assessed following delivery); Maternal body composition (Measured at 36 weeks of gestation)
C: Number of Participants With Composite Neonatal Morbidity (Delivery through discharge of infant from hospital up to 120 days); Number of Children at the 5-10 Year Followup With BMI ≥ 95th Percentile for Age and Sex (Age 5-10 years)
D: The investigators primary outcome is the rate of adherence to the IOM guidelines between our study groups. (3 - 6 months)

Answer: A
Please select the outcome measures that correspond to the clinical trial below.
Title: Promoting Healthy Weight Gain During Pregnancy
Brief Summary: Study goal is to determine whether behavioral lifestyle intervention during pregnancy can reduce the number of women who exceed the Institute of Medicine recommendations for weight gain during pregnancy.

It is hypothesized that the intervention will reduce the number of women who exceed weight gain guidelines relative to standard care. The investigators also expect the intervention to reduce the proportion of women exceeding weight gain guidelines in both normal weight and overweight groups.


Options:
A: OGTT
B: The investigators primary outcome is the rate of adherence to the IOM guidelines between our study groups. (3 - 6 months)
C: Percentage of women above the Institute of Medicine Guidelines for gestational weight gain (40 weeks)
D: Gestational diabetes (20 and 36 weeks pregnancy and 3 months post partum); Gestational diabetes (18 months postpartum)

Answer: C
Please select the outcome measures that correspond to the clinical trial below.
Title: Promoting Healthy Weight Gain During Pregnancy
Brief Summary: Study goal is to determine whether behavioral lifestyle intervention during pregnancy can reduce the number of women who exceed the Institute of Medicine recommendations for weight gain during pregnancy.

It is hypothesized that the intervention will reduce the number of women who exceed weight gain guidelines relative to standard care. The investigators also expect the intervention to reduce the proportion of women exceeding weight gain guidelines in both normal weight and overweight groups.


Options:
A: Gestational diabetes (20 and 36 weeks pregnancy and 3 months post partum); Gestational diabetes (18 months postpartum)
B: Postpartum weight retention (no more than 1.5 years)
C: Percentage of women above the Institute of Medicine Guidelines for gestational weight gain (40 weeks)
D: Body Mass Index standard deviation score (On average 2.9 years of age)

Answer: C
Please select the outcome measures that correspond to the clinical trial below.
Title: Promoting Healthy Weight Gain During Pregnancy
Brief Summary: Study goal is to determine whether behavioral lifestyle intervention during pregnancy can reduce the number of women who exceed the Institute of Medicine recommendations for weight gain during pregnancy.

It is hypothesized that the intervention will reduce the number of women who exceed weight gain guidelines relative to standard care. The investigators also expect the intervention to reduce the proportion of women exceeding weight gain guidelines in both normal weight and overweight groups.


Options:
A: Percentage of women above the Institute of Medicine Guidelines for gestational weight gain (40 weeks)
B: The investigators primary outcome is the rate of adherence to the IOM guidelines between our study groups. (3 - 6 months)
C: Number of participants with allergic disease (Up to 13 years); Weight gain (Up to 13 years); Number of patients with chronic inflammatory disease (Up to 13 years)
D: Birth weight as assessed by z-scores (At birth)

Answer: A
Please select the outcome measures that correspond to the clinical trial below.
Title: Promoting Healthy Weight Gain During Pregnancy
Brief Summary: Study goal is to determine whether behavioral lifestyle intervention during pregnancy can reduce the number of women who exceed the Institute of Medicine recommendations for weight gain during pregnancy.

It is hypothesized that the intervention will reduce the number of women who exceed weight gain guidelines relative to standard care. The investigators also expect the intervention to reduce the proportion of women exceeding weight gain guidelines in both normal weight and overweight groups.


Options:
A: The investigators primary outcome is the rate of adherence to the IOM guidelines between our study groups. (3 - 6 months)
B: Percentage of women above the Institute of Medicine Guidelines for gestational weight gain (40 weeks)
C: Weight gain during pregnancy (From 14 weeks pregnancy to delivery)
D: Birth weight as assessed by z-scores (At birth)

Answer: B
Please select the outcome measures that correspond to the clinical trial below.
Title: Rehabilitation of IPF Patients: Effects of Exercise and Oxidant Stress
Brief Summary: The incidence and prevalence of IPF increase exponentially with age, and IPF occurs more often in older males. Cigarette smoking and environmental dust exposures are known risk factors for developing IPF. For example, the recently deployed military population, as it ages, is at especially increased risk of IPF. No effective therapies exist, although lung transplantation is used to extend survival of selected patients.

Defining specific therapy to improve exercise tolerance and dyspnea in IPF patients is thus an urgent priority of veteran-oriented research programs.


Options:
A: 6 Minute Walk Distance (The 6-MWD will be measured at 0 and 3 months.)
B: Annual Rate of Decline in Forced Vital Capacity - Overall Population (Baseline, 2, 4, 6, 12, 24, 36, 52 weeks after first drug intake (planned post-baseline visits)); Annual Rate of Decline in Forced Vital Capacity - Participants With HRCT Fibrotic Pattern=UIP-like Fibrotic Pattern Only (Baseline, 2, 4, 6, 12, 24, 36, 52 weeks after first drug intake (planned post-baseline visits))
C: Functional performance (12 weeks)
D: Change in Percent Predicted Forced Vital Capacity (%FVC) From Baseline to Week 52 (52 weeks)

Answer: A
Please select the outcome measures that correspond to the clinical trial below.
Title: International, Multicentre, Randomized Phase III Study of Rituximab as Maintenance Treatment Versus Observation Alone in Patients With Chronic Lymphocytic Leukemia
Brief Summary: The purpose of the study is to evaluate the ability of Rituximab maintenance therapy to prolong progression free survival in patients with chronic lymphocytic leukemia, who responded to a Rituximab induction therapy.


Options:
A: progression free survival (48 months)
B: Number of Participants (Par.) Classified as Responders (Rs) and Non-responders (NRs) for Objective Response in Accordance With the National Cancer Institute Working Group (NCIWG) 1996 Guidelines (Start of treatment (Week 0/Visit 2) until Week 52)
C: Progression-free Survival (PFS) Per Independent Review Committee (IRC) Assessment (IRC assessments from randomization date until disease progression or death or IRC discontinuation on 15Jan2019 (as IA per this data cutoff showed crossing superiority boundary) whichever came first, up to 22 months of follow-up)
D: Percentage of Participants With PD as Assessed by the Investigator Using Standard International Workshop on Chronic Lymphocytic Leukemia (iwCLL) Guidelines or Death (Baseline up to PD or death from any cause, whichever occurred first (up to approximately 8 years 5 months)); Progression-Free Survival (PFS) as Assessed by the Investigator Using Standard iwCLL Guidelines (Baseline up to PD or death, whichever occurred first (up to approximately 8 years 5 months))

Answer: A