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Clinical Trial ×
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Table of contents
  1. 1. Clinical Trial
  2. 2. Routine Documentation
  3. 3. Registry/Cohort Study
  4. 4. Quality Assurance
  5. 5. Data Standard
  6. 6. Patient-Reported Outcome
  7. 7. Medical Specialty
Selected data models

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- 6/20/18 - 1 form, 1 itemgroup, 5 items, 2 languages
Itemgroup: Subject Characteristics
- 6/20/18 - 1 form, 16 itemgroups, 95 items, 1 language
Itemgroups: LAB Information,CBC LAB Results – Leukocytes,CBC LAB Results – Neutrophils,CBC LAB Results – Lymphocytes,CBC LAB Results – Monocytes,CBC LAB Results – Eosinophils,CBC LAB Results – Basophils,CBC LAB Results – Erythrocytes,CBC LAB Results – Hemoglobin,CBC LAB Results – Hematocrit,CBC LAB Results - Platelet Count,CBC LAB Results - Ery. Mean Corpuscular Volume,CBC LAB Results - Mean Platelet Volume,CBC LAB Results - Ery. Mean Corpuscular Hemoglobin,CBC LAB Results - Ery. Mean Corpuscular HB Concentration,CBC LAB Results - Erythrocytes Distribution Width
- 11/2/20 - 1 form, 25 itemgroups, 95 items, 1 language
Itemgroups: Administrative,Rheumatic Diseases,Rheumatic Diseases - Signs and Symptoms,Rheumatic diseases - Other signs and symptoms,Rheumatic diseases - Other signs and symptoms ,Rheumatic diseases - Diagnostic Test Results,Rheumatic diseases - Other Diagnostic Test Results ,Rheumatic diseases - Other Diagnostic Test Results ,Rheumatic diseases - Other diagnostic Procedure,Systemic Lupus Erythematosus or Cutaneous Lupus,Systemic Lupus Erythematosus or Cutaneous Lupus - Signs and symptoms (supporting the final diagnosis),Systemic Lupus Erythematosus or Cutaneous Lupus - Other Signs and symptoms,Systemic Lupus Erythematosus or Cutaneous Lupus - Other Signs and symptoms ,Systemic Lupus Erythematosus or Cutaneous Lupus - Diagnostic Test Results,Systemic Lupus Erythematosus or Cutaneous Lupus - Other Diagnostic Test Results ,Systemic Lupus Erythematosus or Cutaneous Lupus - Other Diagnostic Test Results ,Systemic Lupus Erythematosus or Cutaneous Lupus - Other diagnostic Procedure ,Sjogren's Syndrome,Sjogren's Syndrome - Signs and symptoms (supporting the final diagnosis),Sjogren's Syndrome - Other Signs and symptoms ,Sjogren's Syndrome - Other Signs and symptoms ,Sjogren's Syndrome - Diagnostic Test Results ,Sjogren's Syndrome - Other Diagnostic Test Results ,Sjogren's Syndrome - Other Diagnostic Test Results ,Sjogren's Syndrome - Other diagnostic Procedure
- 5/13/22 - 4 forms, 1 itemgroup, 4 items, 1 language
Itemgroup: Data dictionary
dbGaP Study Accession: phs001297.v1.p1 NCT01607216 Approximately 550,000 babies born prematurely each year in the United States suffer from birth at a time in development when the respiratory tract and immune system would normally be protected and maintained in a naïve state. This project is a component of the NIH Prematurity and Respiratory Outcomes Program (PROP) whose goals are the identification of disease mechanisms and biomarkers to stratify premature infants, at the time of discharge, for their risk of subsequent pulmonary morbidity. This Clinical Research Center (CRC) project will investigate prematurity-dependent alterations in cellular innate and adaptive immune systems resulting in increased susceptibility to respiratory infections and environmental irritants, and leading to respiratory morbidity in the first year of life. Prior studies have established developmental (maturity) and disease-related changes in circulating and pulmonary lymphocyte populations, but a comprehensive assessment of their relationship to disease risk/outcome has not been undertaken. We hypothesize that cellular and molecular immuno-maturity is altered due to intrinsic and extrinsic factors presented by premature birth in such a way as to reduce resistance to viral infections and to promote cytotoxic damage to the lung. We will evaluate immunologic maturity by comprehensively phenotyping lymphocyte populations in peripheral blood sampled at premature delivery, at the time of discharge from the hospital and at twelve months corrected age. The lymphocytic phenotype will be analyzed particularly in the context of gestational age and maternal-fetal stressors capable of modulating oxidative stress (oxygen exposure, infection and environmental tobacco smoke exposure). Additionally, we will assess changes in the molecular phenotype of isolated CD8 lymphocytes, a cell type preferentially recruited to the lungs of premature infants and capable of contributing to disease pathogenesis, by genome-wide expression profiling, in order to uncover novel disease pathways and define a gene expression signature associated with disease risk. We propose to build a statistical model, using cellular and molecular phenotypes and additional clinical variables, for stratifying risk of lung morbidity within the first year of life. Finally, we will assess the development of the gut microbiome in the preterm subjects to correlate with the observation of development of the adaptive immune system. Study Design: Prospective Longitudinal Cohort Study Type: Observational Longitudinal Prospective Cohort Total number of consented subjects: 277 Acknowledgement Statement: Please cite/reference the use of dbGaP data by including the dbGaP accession phs001297.v1.p1. Additionally, use the following statement to acknowledge the submitter(s) of this study: The datasets used for the analyses described in this manuscript were obtained from dbGaP ( https://www.ncbi.nlm.nih.gov/projects/gap/cgi-bin/study.cgi?study_id=phs001297.v1.p1 ) through dbGaP study accession numbers phs001297.v1.p1 . The data for the study Functional and Lymphocytic Markers of Respiratory Morbidity in Hyperoxic Preemies were provided by Drs. Gloria Pryhuber, Tom Mariani, Steven Gill, Rita Ryan, and Anne Marie Reynolds, University of Rochester and University at Buffalo Center for the Prematurity and Respiratory Outcomes Program (PROP). This study was supported by the U.S. National Institutes of Health (NIH), National Heart, Lung, and Blood Institute (NHLBI) grants U01 HL101813 and U01 HL101794, NHLBI and National Institute of Child Health and Human Development (NICHD) supplement grant R01 HL101794-01S1, National Institute of Allergy and Infectious Diseases (NIAID) contract HHSN272201200005C, and National Center for Advancing Translational Sciences (NCATS) grant UL1 TR000042. Dr. Pryhuber and her collaborators request that publications resulting from these data cite their original publications: Misra RS, Bhattacharya S, Huyck HL, Wang J-C E, Slaunwhite CG, Slaunwhite SL, Wightman TR, Secor- Soch S, Misra SK, Bushnell TP, Reynolds A-M, Ryan RM, Quataert SA, Pryhuber GS, Mariani TJ. Flow-Based Sorting of Neonatal Lymphocyte Populations for Transcriptomics Analysis. J Immunol Methods 2016; 437: 13-20. PMID: 27438473. PMCID in process. (And original microbiome publication to follow, after submission).

Dataset pht006200

1 itemgroup 5 items

Dataset pht006201

1 itemgroup 10 items

Dataset pht006202

1 itemgroup 27 items
- 4/20/22 - 1 form, 24 itemgroups, 70 items, 2 languages
Itemgroups: Administrative documentation,Study Subject Participation Status | Assessment Date ,Study Subject Participation Status | Clinical Trial Eligibility Criteria,Physical Examination Date,Vital signs | Body Weight,Neurologic Examination; Date in time |On examination - neurological findings ,Neurologic Examination | Abnormalities | Mental state,Neurologic Examination; Abnormalities | Speech and language finding,Neurologic Examination; Abnormalities | Cranial Nerves,Neurologic Examination; Abnormalities | Gait,Neurologic Examination | Abnormality | Physiologic Coordination,Neurologic Examination | Abnormality | Esthesia,Neurologic Examination | Abnormality | Muscle strength,Neurologic Examination | Abnormality | Muscle Tonus,Neurologic Examination | Abnormality | Reflex action,Laboratory; Specimen collection date ,Laboratory test finding ,Laboratory Results; Clinical Significance; Unexpected ,Laboratory examination; Clinical | Hematology (discipline) ,Laboratory examination; Clinical | Chemistry, Clinical ,Urinalysis; Urine dipstick test ,Serum pregnancy test (B-HCG) ,plasma concentration; Antiepileptic Agents,Plasma specimen
- 4/20/22 - 1 form, 22 itemgroups, 64 items, 2 languages
Itemgroups: Administrative documentation,Study Subject Participation Status | Assessment Date ,Study Subject Participation Status | Clinical Trial Eligibility Criteria,Physical Examination Date,Vital signs | Body Weight,Neurologic Examination; Date in time |On examination - neurological findings ,Neurologic Examination | Abnormalities | Mental state,Neurologic Examination; Abnormalities | Speech and language finding,Neurologic Examination; Abnormalities | Cranial Nerves,Neurologic Examination; Abnormalities | Gait,Neurologic Examination | Abnormality | Physiologic Coordination,Neurologic Examination | Abnormality | Esthesia,Neurologic Examination | Abnormality | Muscle strength,Neurologic Examination | Abnormality | Muscle Tonus,Neurologic Examination | Abnormality | Reflex action,Laboratory; Specimen collection date ,Laboratory test finding ,Laboratory Results; Clinical Significance; Unexpected ,Laboratory examination; Clinical | Chemistry, Clinical ,Urinalysis; Urine dipstick test ,Serum pregnancy test (B-HCG) ,Urine Specimen Collection

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