Search results - Portal of Medical Data Models (MDM-Portal)

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

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LASER ADMINISTRATION FELLOW EYE (UNSCHEDULED) CRFs Roche FVF4170G Macular Edema NCT00473382

- 6/28/17 - 1 form, 2 itemgroups, 10 items, 1 language

Itemgroups: Patient administration,LASER ADMINISTRATION STUDY EYE

Terms of use: You may not use this document or the information contained herein to a regulatory authority in connection with an application for a marketing authorization or any other regulatory submission without the express written consent of Roche Study #: FVF4168g Drug: Ranibizumab Study Title: A Phase III, Double-Masked, Multicenter, Randomized, Sham-Controlled Study Of The Efficacy And Safety Of Ranibizumab Injection In Subjects With Clinically Significant Macular Edema With Center Involvement Secondary To Diabetes Mellitus

Clinical activity of recMAGE-A3 + AS15 in patients with metastatic cutaneous melanoma NCT00942162 - IMD Report - Rheumatic Diseases; Systemic Lupus Erythematosus or Cutaneous Lupus; Sjogren's Syndrome (Report Final and Annex Report 2 Final)

- 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

Study ID: 111476 Clinical Study ID: 111476 Study Title: An open, single-arm trial to assess the clinical activity of recMAGE-A3 + AS15 in patients with unresectable MAGE-A3-positive metastatic cutaneous melanoma Patient Level Data: Study Listed on ClinicalStudyDataRequest.com Clinicaltrials.gov Identifier: NCT00942162 Sponsor: GlaxoSmithKline Phase: Phase 2 Study Recruitment Status: Completed Generic Name: Antigen-Specific Cancer Immunotherapeutic Study Indication: Melanoma

dbGaP phs001297 PROP Functional and Lymphocytic Markers of Respiratory Morbidity in Hyperoxic Preemies - Dataset pht006199

- 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

GSK Influence of PPAR gamma agonist vs. Placebo on allergen-induced late asthmatic response NCT00318630 - Laboratory Examination - Treatment Period 2, Day 28, Pre-dose

- 4/29/22 - 1 form, 6 itemgroups, 47 items, 1 language

Itemgroups: Pregnancy Test,Drug Screen,Alcohol breath test,Carbon Monoxide test,Haematology,Clinical Chemistry

Study ID: 104385 Clinical Study ID: RES104385 Study Title: A randomised double-blind two-period crossover study to investigate the effect of treatment with repeat doses of a PPAR gamma agonist on the allergen-induced late asthmatic response in subjects with mild asthma compared with repeat doses of placebo Patient Level Data: Study Listed on ClinicalStudyDataRequest.com Clinicaltrials.gov Identifier: NCT00318630 https://clinicaltrials.gov/ct2/show/NCT00318630 Sponsor: GlaxoSmithKline Collaborators: N/A Phase: Phase 1 Study Recruitment Status: Completed Generic Name: rosiglitazone Trade Name: Avandia XR,Avandia; Rosiglitazone XR,Avandia XR,Avandia Study Indication: Asthma This ODM-file contains Laboratory Examinations: Pregnancy test, Drug screen, alcohol breath test, carbon monoxide test, haematology and clinical chemistry. Time: Treatment Period 2, Day 28, Pre-dose.

Evaluation of LAMICTAL for Add-on Treatment of Partial Seizures in Pediatric Patients 105-040 - Study Continuitation Record, Vital Signs/Weight, Neurological Examination, Laboratory Comments, Clinical Laboratory Examination and Plasma Samples- Treatment Phase Study Week 22

- 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

Study ID: 105-040 Clinical Study ID: 105-040 Study Title: A Multicenter, Double-Blind, Placebo-Controlled, Parallel-Design Evaluation of LAMICTAL for Add-on Treatment of Partial Seizures in Pediatric Patients Patient Level Data: Study Listed on ClinicalStudyDataRequest.com Sponsor: GlaxoSmithKline Collaborators: N/A Phase: Phase 3 Study Recruitment Status: Completed Generic Name: lamotrigine Trade Name: lamictal Study Indication: Epilepsy, Partial

Evaluation of LAMICTAL for Add-on Treatment of Partial Seizures in Pediatric Patients 105-040 - Study Continuitation Record, Vital Signs/Weight, Neurological Examination, Laboratory Comments, Clinical Laboratory Examination and Urine Samples - Treatment Phase Study Week 12

- 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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