TrialPanorama/Dataset huggingface dataset:
Please select the outcome measures that correspond to the clinical trial below.
Title: Invested in Diabetes: Comparing Patient-Centered Outcomes of Standardized Versus Patient-Driven Diabetes Shared Medical Appointments (PCORI IHS-1609-36322)
Brief Summary: In this study, the investigators will compare the effectiveness of patient-driven diabetes Shared Medical Appointments (SMAs) to standardized diabetes SMAs. The curriculum to be used is Targeted Training for Illness Management (TTIM), a 6-session modular group intervention for chronic illness self-management, and has been tested in diabetes. The standardized group visit model will consist of diabetes SMAs with the full TTIM 6-session curriculum, led by a health educator.


Options:
A: N/A
B: Diabetes Distress - Change in Patient Reported Outcomes (PROs) (At end of 6 group visits (time differs by practice, up to 6 months))
C: SF-12 MCS (6-Month Follow-up)
D: Brief Psychiatric Rating Scale, Expanded Version (BPRS-E) (12 months post-randomisation (18 months for secondary outcome))

Answer: B
Please select the outcome measures that correspond to the clinical trial below.
Title: Nurse-led Care Model in Swiss Nursing Homes: Improving INTERprofessional CARE for Better Resident Outcomes (INTERCARE)
Brief Summary: This implementation science project aims to implement a nurse-led model of care in 11 nursing homes in the German speaking part of Switzerland, to reduce avoidable hospitalisations. The model will be introduced using a non-randomized stepped-wedge design. First, training will be delivered to leadership teams and to geriatric nurse experts, secondly after a baseline measurement period, including distribution of questionnaires and collection of resident data mainly national quality indicators and data regarding hospitalisations, the nurse led model will be implemented and thereafter 2 measurement periods will follow (6 months after the beginning of the intervention and at the end). Quantitative resident data will be retrieved from the RAI-NH three-monthly, and hospitalization data with the help of a data platform, reflection tools and hospital discharge reports continuously from the baseline period until the end of the data collection in 02.2020. The hypotheses of the project are:

* To assess the effectiveness of the nurse-led care model on unplanned hospitalizations (primary outcome) and additional resident and staff outcomes, hypothesizing that nursing homes with a nurse-led care model have lower rates of unplanned hospitalizations and show improvements in additional resident and staff outcomes
* To assess the effect of the degree of adoption on client outcomes, hypothesizing that a higher degree of adoption is related to better client outcomes
* To describe the implementation costs the Swiss nurse-led interprofessional NH care model on the NH level and to assess the economic impact of INTERCARE with a cost-effectiveness analysis adopting a health care system perspective (comparing the increase in staff costs with the decrease of days of avoidable hospitalizations)
* To explore resident/family and staff perceptions of service outcomes (e.g., timeliness) and the acceptability of the nurse-led care model;
* To describe the degree to which the model was adopted, its feasibility, the fidelity with which it was applied, and the barriers and facilitators met by NH leadership and nurse experts.


Options:
A: Total direct cost of hospitalization, $ (From date of admission to date of discharge, an expected average of 4 days)
B: Number of all unplanned hospitalizations /1000 resident care days (21 months)
C: The primary outcome is a composite outcome of all-cause mortality (30 days post-discharge); 30-day readmission. (30 days post-discharge)
D: Anxiety and depression (HADS) (At 1 month, 3 months and 12 months, change from baseline)

Answer: B
Please select the outcome measures that correspond to the clinical trial below.
Title: Obesity Prevention in Head Start: Míranos! Program
Brief Summary: The prevalence of obesity remains high in American children aged 2-5 while one in three Head Start children is overweight or obese. The proposed study is designed to test the efficacy of an early childhood obesity prevention program which promotes healthy growth in predominantly Latino children in Head Start.

The program is a group clustered randomized controlled trial in partnership with two local Head Start organizations to address key enablers and barriers in obesity prevention in young children. The study has three specific aims:

1. To test the efficacy of the Miranos! intervention on healthy weight growth (primary outcome) in normal weight, overweight, and obese children.
2. To test the impact of the Miranos! intervention on children's physical activity, sedentary behavior, sleep, and dietary behaviors (secondary outcomes).
3. To evaluate cost-effectiveness of the Miranos! intervention.

Miranos! will be delivered in Fall and Spring (8 months) and followed by a summer health campaign.


Options:
A: Change of BMI Z-score for preschoolers (Baseline to 6 month (Midline) Follow-up or 1 year (Post Intervention) Follow-up)
B: Absolute change in mean accelerometry counts over 6 days (baseline, end of intervention, six months after end of intervention)
C: Change in Fruit and Vegetable Consumption at School Lunch (assessed 4 times each 9-month school year; once prior to intervention beginning (i.e., September), approximately 10 weeks and then 20 weeks later, and finally once after the intervention ends (i.e., May).); Change in Student Activity Level (assessed 3 times over 1 year; initially prior to the intervention beginning (i.e., September), a 2nd time once the intervention ends (i.e., May), and then again at the beginning of the following school year (i.e., September))
D: Change in Body Mass Index (Baseline, 8 months, 21 months)

Answer: D
Please select the outcome measures that correspond to the clinical trial below.
Title: Obesity Prevention in Head Start: Míranos! Program
Brief Summary: The prevalence of obesity remains high in American children aged 2-5 while one in three Head Start children is overweight or obese. The proposed study is designed to test the efficacy of an early childhood obesity prevention program which promotes healthy growth in predominantly Latino children in Head Start.

The program is a group clustered randomized controlled trial in partnership with two local Head Start organizations to address key enablers and barriers in obesity prevention in young children. The study has three specific aims:

1. To test the efficacy of the Miranos! intervention on healthy weight growth (primary outcome) in normal weight, overweight, and obese children.
2. To test the impact of the Miranos! intervention on children's physical activity, sedentary behavior, sleep, and dietary behaviors (secondary outcomes).
3. To evaluate cost-effectiveness of the Miranos! intervention.

Miranos! will be delivered in Fall and Spring (8 months) and followed by a summer health campaign.


Options:
A: Change in Observed Child Dietary Intake (8 Months); Change in Measured Child Physical Activity in Child Care (8 months); Change in Observed Child Dietary Intake (12 Months); Change in Measured Child Physical Activity in Child Care (12 Months)
B: Change in Body Mass Index (Baseline, 8 months, 21 months)
C: Change of BMI Z-score for preschoolers (Baseline to 6 month (Midline) Follow-up or 1 year (Post Intervention) Follow-up)
D: Mean Nutrition Environment Score (Measures collected 3-12 weeks prior to start of intervention (Baseline) and 1-8 weeks post-12-month intervention (Follow-up)); Mean Physical Activity Environment Score (Measures collected 3-12 weeks prior to start of intervention (Baseline) and 1-8 weeks post-12-month intervention (Follow-up))

Answer: B
Please select the outcome measures that correspond to the clinical trial below.
Title: Obesity Prevention in Head Start: Míranos! Program
Brief Summary: The prevalence of obesity remains high in American children aged 2-5 while one in three Head Start children is overweight or obese. The proposed study is designed to test the efficacy of an early childhood obesity prevention program which promotes healthy growth in predominantly Latino children in Head Start.

The program is a group clustered randomized controlled trial in partnership with two local Head Start organizations to address key enablers and barriers in obesity prevention in young children. The study has three specific aims:

1. To test the efficacy of the Miranos! intervention on healthy weight growth (primary outcome) in normal weight, overweight, and obese children.
2. To test the impact of the Miranos! intervention on children's physical activity, sedentary behavior, sleep, and dietary behaviors (secondary outcomes).
3. To evaluate cost-effectiveness of the Miranos! intervention.

Miranos! will be delivered in Fall and Spring (8 months) and followed by a summer health campaign.


Options:
A: Fidelity to WISE Evidence-Based Practices using the WISE fidelity observational measure (Through study completion, an average of 2 years)
B: Change in Educators' Observed Implementation Fidelity Scores for Use of Evidence-Based Obesity Practices (From Baseline Up to 8 months)
C: Change in Body Mass Index (Baseline, 8 months, 21 months)
D: Fruit and vegetable acceptance (post intervention) (The parents filled in the questionnaire after the intervention (4-5 weeks after the onset of the intervention).); Relative fruit and vegetable acceptance (post intervention) (The parents filled in the questionnaire after the intervention (4-5 weeks after the onset of the intervention).)

Answer: C
Please select the outcome measures that correspond to the clinical trial below.
Title: Efficacy and Cost Analysis of Steroids in Treatment of Otitis Media With Effusion (OME) Compared to That of Combination of Antibiotic, Antihistaminic, and Nasal Decongestant
Brief Summary: We intend to study the cost of treatment, efficacy and adverse effects for Otitis media with effusion.


Options:
A: Number of Subjects With Complete Normalization of Abnormal Tympanometry, Regardless of Additional Treatment (6 weeks)
B: Number of visits to health clinic (Two years after randomisation)
C: Non B type tympanogram (one month)
D: All measures at 9 to 11 years of age:; Woodcock Reading Mastery Tests-Revised-Normative Update; Number of words in a grade-level passage read correctly in one minute; Dictation Samples subtest of the Woodcock-Johnson III Tests of Achievement, Standard Battery; Writing Samples subtests of the Woodcock-Johnson III Tests of Achievement, Standard Battery; Elision and Rapid Letter Naming subtests of the Comprehensive Test of Phonological Processing; Children's version of the Hearing in Noise Test; Disruptive Behavior Disorders Rating Scale; Child Behavior Checklist, parent report; Child Behavior Checklist, teacher report; Impairment Rating Scales, parent report; Impairment Rating Scales, teacher report; Computerized visual continuous performance test; Computerized auditory continuous performance test; Wechsler Abbreviated Scale of Intelligence; Computational subtest of the Woodcock-Johnson III Tests of Achievement, Standard Battery

Answer: C
Please select the outcome measures that correspond to the clinical trial below.
Title: Efficacy and Cost Analysis of Steroids in Treatment of Otitis Media With Effusion (OME) Compared to That of Combination of Antibiotic, Antihistaminic, and Nasal Decongestant
Brief Summary: We intend to study the cost of treatment, efficacy and adverse effects for Otitis media with effusion.


Options:
A: Number of Subjects With Complete Normalization of Abnormal Tympanometry, Regardless of Additional Treatment (6 weeks)
B: Non B type tympanogram (one month)
C: Treatment response (1 months)
D: Number of visits to health clinic (Two years after randomisation)

Answer: B
Please select the outcome measures that correspond to the clinical trial below.
Title: Efficacy and Cost Analysis of Steroids in Treatment of Otitis Media With Effusion (OME) Compared to That of Combination of Antibiotic, Antihistaminic, and Nasal Decongestant
Brief Summary: We intend to study the cost of treatment, efficacy and adverse effects for Otitis media with effusion.


Options:
A: Number of Subjects With Complete Normalization of Abnormal Tympanometry, Regardless of Additional Treatment (6 weeks)
B: Number of visits to health clinic (Two years after randomisation)
C: Treatment response (1 months)
D: Non B type tympanogram (one month)

Answer: D
Please select the outcome measures that correspond to the clinical trial below.
Title: Efficacy and Cost Analysis of Steroids in Treatment of Otitis Media With Effusion (OME) Compared to That of Combination of Antibiotic, Antihistaminic, and Nasal Decongestant
Brief Summary: We intend to study the cost of treatment, efficacy and adverse effects for Otitis media with effusion.


Options:
A: Number of visits to health clinic (Two years after randomisation)
B: Non B type tympanogram (one month)
C: All measures at 9 to 11 years of age:; Woodcock Reading Mastery Tests-Revised-Normative Update; Number of words in a grade-level passage read correctly in one minute; Dictation Samples subtest of the Woodcock-Johnson III Tests of Achievement, Standard Battery; Writing Samples subtests of the Woodcock-Johnson III Tests of Achievement, Standard Battery; Elision and Rapid Letter Naming subtests of the Comprehensive Test of Phonological Processing; Children's version of the Hearing in Noise Test; Disruptive Behavior Disorders Rating Scale; Child Behavior Checklist, parent report; Child Behavior Checklist, teacher report; Impairment Rating Scales, parent report; Impairment Rating Scales, teacher report; Computerized visual continuous performance test; Computerized auditory continuous performance test; Wechsler Abbreviated Scale of Intelligence; Computational subtest of the Woodcock-Johnson III Tests of Achievement, Standard Battery
D: Proportion of children with middle ear effusion (end of intervention); Proportion of study visits at which middle ear effusion detected (during intervention)

Answer: B
Please select the outcome measures that correspond to the clinical trial below.
Title: Efficacy and Cost Analysis of Steroids in Treatment of Otitis Media With Effusion (OME) Compared to That of Combination of Antibiotic, Antihistaminic, and Nasal Decongestant
Brief Summary: We intend to study the cost of treatment, efficacy and adverse effects for Otitis media with effusion.


Options:
A: - number of acute otitis media; - quality of life issues
B: Proportion of children with middle ear effusion (end of intervention); Proportion of study visits at which middle ear effusion detected (during intervention)
C: Non B type tympanogram (one month)
D: All measures at 9 to 11 years of age:; Woodcock Reading Mastery Tests-Revised-Normative Update; Number of words in a grade-level passage read correctly in one minute; Dictation Samples subtest of the Woodcock-Johnson III Tests of Achievement, Standard Battery; Writing Samples subtests of the Woodcock-Johnson III Tests of Achievement, Standard Battery; Elision and Rapid Letter Naming subtests of the Comprehensive Test of Phonological Processing; Children's version of the Hearing in Noise Test; Disruptive Behavior Disorders Rating Scale; Child Behavior Checklist, parent report; Child Behavior Checklist, teacher report; Impairment Rating Scales, parent report; Impairment Rating Scales, teacher report; Computerized visual continuous performance test; Computerized auditory continuous performance test; Wechsler Abbreviated Scale of Intelligence; Computational subtest of the Woodcock-Johnson III Tests of Achievement, Standard Battery

Answer: C
Please select the outcome measures that correspond to the clinical trial below.
Title: Communication App to Manage Symptoms and Improve Adjuvant Endocrine Therapy Adherence
Brief Summary: This study will test the use of a web-enabled app that is integrated directly with patients' electronic health records, with and without tailored feedback. The app-based intervention is designed to improve patient-provider communication outside of clinic visits, resulting in improved symptom management and adjuvant endocrine therapy adherence among diverse patients with hormone receptor-positive breast cancer. The researchers will evaluate the impact of the intervention on a comprehensive set of outcomes, including rigorous measures of long-term adherence, quality of life, and costs.


Options:
A: Flare Occurrence (Anticipated length of study is two years.); Flare-to-visit Time (Anticipated length of study is two years.)
B: Adjuvant Endocrine Therapy (AET) Medication Adherence (Up to Month 12)
C: General practitioners'adherence to treatment recommendations (3-6 months after end of intervention)
D: Change from baseline Estimated Glomerular Filtration Rate (eGFR) at 18 months (Measured at baseline, 6, 12 and 18 months after randomisation)

Answer: B
Please select the outcome measures that correspond to the clinical trial below.
Title: The Effects of an In-school Physical Activity Intervention on Adolescents' Brain Structure and Function ('Fit to Study' Brain Imaging Sub-study)
Brief Summary: Physical activity has shown beneficial effects for cognitive and brain health, suggesting it may provide a highly scalable intervention to improve academic achievement. This project is part of a large-scale randomised controlled trial called Fit to Study (ClinicalTrials.gov ID: NCT03286725). The main Fit to Study trial aims to test the effect of a school-based physical activity intervention on academic performance (as well as cognition and physical measures) across Year 8 pupils in 100 secondary schools. The current study - the Fit to Study - Brain imaging sub-study - will target a sub-sample of participants in the large-scale trial, in order to test pre- to post intervention changes in hippocampal volume, as well as cognitive performance, mental health and brain organisation. We hypothesise that the intervention will change anterior hippocampal volume of Year-8 pupils, as well as mental health, cognitive performance, and more generally, brain structure and function. We further hypothesise that changes in brain organisation (e.g. hippocampal volume) may mediate changes in cognitive performance and mental health.


Options:
A: Physical activity opportunities delivered (minutes/week); School environment scores; Height (cm); Weight (kg); Body mass index (kg/m^2); Physical fitness (Fitnessgram (C)); Children's leisure time physical activity (PAQ-C); Children's dietary intake; Physical activity interventions planned
B: Difference between control and intervention groups in the mean change in questionnaire's scoring from baseline to 3-year and 6-year intervention for children. (3-year, and 6-year changes from baseline of questionnaire scoring for children); Cardiovascular health markers (blood pressure, height, weight, waist circumference and triceps and subscapular skinfold thickness) of children from baseline to 3-year and 6-year intervention. (3-year, and 6-year changes from baseline on cardiovascular health markers of children)
C: Anterior hippocampal volume (change) (5mins, Baseline/pre-intervention (July - September 2017) and after 1 year (July - September 2018))
D: MET-weighted MVPA: Daily Minutes of Moderate-to-vigorous Physical Activity (MVPA) Weighted by Metabolic Equivalent of Task (MET) (Post-2 year intervention); MET-weighted MVPA: Daily Minutes of Moderate-to-vigorous Physical Activity (MVPA) Weighted by Metabolic Equivalent of Task (MET) (Post-3 year intervention)

Answer: C
Please select the outcome measures that correspond to the clinical trial below.
Title: Efficacy of a Nursing Intervention in the Process of Becoming a Mother, in First-time Mothers
Brief Summary: Experimental study will determine the efficacy of nursing intervention named Maternal support to become first-time mothers based on the theory of Ramona Mercer. Sequential explanatory design will be used. It is a mixed design with approach quantitative and qualitative in order to obtain a better approach of the phenomen. The approach quantitative will be randomized controlled clinical trial. The qualitative analysis of the content will be done according to Bardin.


Options:
A: Scale name unabbreviated: "La escala de Adopción del Rol Materno (ARM) de la Doctora María del Carmen Garrido Hidalgo y la Doctora Marleny Marchán Coronado". (4 Months); Perceived Maternal Parenting Self-Efficacy (PMP S-E) by Dr. Christopher R. Barnes and Dr. Elvidina N. Adamson-Macedo: measures maternal self-efficacy. (4 months); "Perinatal Infant Care Social Support Scale" (PICSS) by Dr. Patricia Leahy-Warren: Construct: measures social support and has been widely applied in first-time mothers. (4 months); "Bond between parents and children of MSc Alix Nathalya Vargas Vásquez and Doctor Myriam Patricia Pardo Torres" (4 months)
B: School Climate (Up to 7 months)
C: School Climate (Up to 7 months)
D: The Change in QIDS-16 Scores From Baseline to 24 Weeks Postpartum (Baseline and 12 and 24-week postpartum follow-up)

Answer: A
Please select the outcome measures that correspond to the clinical trial below.
Title: Prospective, Randomised, Crossover, Controlled, Feasibility Study to Assess the Efficacy of BurstDR Spinal Cord Stimulation (SCS) as a Treatment for Persistent AbdomiNal RefrActory VisCEral PAin Secondary to Chronic Pancreatitis: PANACEA Trial
Brief Summary: To evaluate the effectiveness of Burst DR stimulation as a treatment for persistent abdominal refractory visceral pain secondary to chronic pancreatitis. Abdominal pain is a main symptom in patients with chronic pancreatitis. Patients have a background constant pain with acute episodes needing admissions. Spinal cord stimulation (SCS) is a recognised treatment for neuropathic pain. This involves placing an electric wire in the spine and the use of electricity to manage the pain. This is a pacemaker for controlling pain. Burst DR stimulation delivers a wave form which mimics the way nerves conduct electrical signals, there are short bursts or spikes of stimulation followed by short periods of rest. The key aims and objectives of this study are to evaluate the efficacy of Burst DR SCS as a treatment for persistent pain secondary to chronic pancreatitis


Options:
A: The primary endpoint is to assesses the pain coverage capability of the RESTORE SCS system.
B: Mean pain score
C: Change in Multidimensional Pain Inventory (MPI)-SCI average activity score (Baseline, 9 months); Motor recovery as measured by EMG (Up to 9 months); Motor recovery as measured by dynamometry (Up to 9 months)
D: Completion of EQ-5D5L Health questionnaire (1 hour); Numeric Rating Scale (NRS) recording pain severity (1 hour)

Answer: D