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Study SHIP-TREND_TREND0_LAX - t0.xtd_metabo

- 26.10.24 - 14 Formulare, 1 Itemgruppe, 9 Datenelemente, 2 Sprachen
Itemgruppe: t0.xtd_metabo
SHIP Study https://doi.org/10.1093/ije/dyac034

t0.xtd_rheuma

1 Itemgruppe 3 Datenelemente

t0.merckpanel

1 Itemgruppe 47 Datenelemente

t0.omics_tma

1 Itemgruppe 10 Datenelemente

t0.xtd_omics

1 Itemgruppe 3 Datenelemente

t0.xtd_espr

1 Itemgruppe 5 Datenelemente

t0.prot

1 Itemgruppe 1 Datenelement

Hypersensitivity Reaction Record GSK study Chronic Coronary Heart Disease NCT00799903

- 03.01.18 - 1 Formular, 16 Itemgruppen, 69 Datenelemente, 1 Sprache
Itemgruppen: Event number, Food allergies, Hymenoptera sting allergy, Latex allergy, 5. Penicillin allergy, Cephalosporin allergy, Aspirin allergy, NSAID allergy, ACE inhibitor allergy, Other allergies, Stevens-Johnson syndrome, Toxic epidermal necrolysis, Urticaria (hives), Angioedema, Anaphylactic/Anaphylactoid reaction, Other symptoms of hypersensitivity reaction
Study ID: 100601 Clinical Study ID: LPL100601 Study Title: LPL100601, A Clinical Outcomes Study of Darapladib versus Placebo in Subjects with Chronic Coronary Heart Disease to Compare the Incidence of Major Adverse Cardiovascular Events (MACE) Patient Level Data: Study Listed on ClinicalStudyDataRequest.com Clinicaltrials.gov Identifier: NCT00799903 Sponsor: GlaxoSmithKline Collaborators: N/A Phase: phase 3 Study Recruitment Status: Completed Generic Name: darapladib Trade Name: darapladib Study Indication: Atherosclerosis Study part: Hypersensitivity Reaction Record - Repeating form (Scheduled visits)

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

- 26.06.23 - 4 Formulare, 1 Itemgruppe, 4 Datenelemente, 1 Sprache
Itemgruppe: pht006199
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 pht006201

1 Itemgruppe 10 Datenelemente

Dataset pht006202

1 Itemgruppe 27 Datenelemente

Dataset pht006200

1 Itemgruppe 5 Datenelemente

Anaphylaxis diagnosis Repeating form GSK study Chronic Coronary Heart Disease NCT00799903

- 01.01.18 - 1 Formular, 1 Itemgruppe, 16 Datenelemente, 1 Sprache
Itemgruppe: Anaphylaxis diagnosis
Study ID: 100601 Clinical Study ID: LPL100601 Study Title: LPL100601, A Clinical Outcomes Study of Darapladib versus Placebo in Subjects with Chronic Coronary Heart Disease to Compare the Incidence of Major Adverse Cardiovascular Events (MACE) Patient Level Data: Study Listed on ClinicalStudyDataRequest.com Clinicaltrials.gov Identifier: NCT00799903 Sponsor: GlaxoSmithKline Collaborators: N/A Phase: phase 3 Study Recruitment Status: Completed Generic Name: darapladib Trade Name: darapladib Study Indication: Atherosclerosis Study part: Anaphylaxis diagnosis - Repeating form (Scheduled visits)

Ethanol-Free Clobetasol Propionate Foam vs Vehicle Foam in Chronic Hand Dermatitis NCT01323673 - Subject Enrollment; Study Product Accountability; Study Product Usage; Photographs

- 27.01.19 - 1 Formular, 4 Itemgruppen, 19 Datenelemente, 1 Sprache
Itemgruppen: Subject Enrollment, Study Product Accountability, Study Product Usage, Photographs
Study ID: 115054 Clinical Study ID: 115054 Study Title: Ethanol-Free Clobetasol Propionate Foam 0.05% (Olux-E Foam) vs Vehicle Foam in the Treatment of Chronic Hand Dermatitis. Patient Level Data: Study Listed on ClinicalStudyDataRequest.com Clinicaltrials.gov Identifier: NCT01323673 Sponsor: GlaxoSmithKline Phase: Phase 4 Study Recruitment Status: Completed Generic Name: Vehicle / Placebo Trade Name: clobetasol propionate Study Indication: Dermatitis, Chronic

Safety and reactogenicity of booster dose of either an investigational vaccination regimen or DTPw HBVHib 103812 & 104727 - Visit 2 103812 (DTPW-HBV=HIB-MENAC-TT-014 BST:013&004 (15-18/24M) - Study Continuation; Date of Birth; Large swelling reaction; Concomitant vaccination

- 22.01.19 - 1 Formular, 7 Itemgruppen, 36 Datenelemente, 1 Sprache
Itemgruppen: Administrative, Check for Study Continuation, Date of Birth, Large swelling reaction - Report of physical examination, Large swelling reaction - Clinical case desciption and outcome of the adverse event, Concomitant Vaccination, Concomitant Vaccination specification
Study ID:103812 & 104727 Clinical Study ID:103812 & 104727 Study Title: Study to assess safety and reactogenicity of booster dose of either an investigational vaccination regimen or DTPw-HBV/Hib when administered at 15 to 18 months of age and of a dose of Mencevax ACWY vaccine. Patient Level Data:N/A Clinicaltrials.gov Identifier:N/A Sponsor: GlaxoSmithKline Collaborators: N/A Phase: phase 3 Study Recruitment Status: Completed Generic Name: Combined Diphtheria, Tetanus, Whole Cell Pertussis, Hepatitis B, Haemophilus influenzae Type b Vaccine Trade Name: Tritanrix HepB/Hiberix Study Indication: Diphtheria; Haemophilus influenzae type b; Hepatitis B; Tetanus; Whole Cell Pertussis

Vaccine Administration Safety and Immunogenicity Study of a Booster Dose of GSK Biologicals 10-valent Pneumococcal Conjugate Vaccine NCT00370396 - Vaccine Administration "Safety and Immunogenicity Study of a Booster Dose of GSK Biologicals' 10-valent Pneumococcal Conjugate Vaccine" NCT00370396

- 08.05.16 - 1 Formular, 5 Itemgruppen, 28 Datenelemente, 1 Sprache
Itemgruppen: Identification, Vaccine Administration Meta, Vaccine Administration Details: 10Pn-PD-DiT Vaccine OR Prevenar Vaccine, Vaccine Administration Details: DTPa-HBV-IPV/Hib Vaccine, Non Administration
This study will evaluate the safety, reactogenicity and immunogenicity of a booster dose of GSK Biologicals' pneumococcal conjugate vaccine compared to Prevenar™ given at 12-18 mo of age to children primed with either pneumococcal vaccine or Prevenar™ in study 105553. Antibody persistence will be evaluated at 8-14 mo after completion of the 3-dose immunization course in study 105553. The immune response to a booster dose of GSK Biologicals' pneumococcal conjugate vaccine will also be evaluated when given at 12-18 mo to subjects not primed with GSK Biologicals' vaccine but with Prevenar™. The study has 3 groups. 1 group of children primed with GSK Biologicals' pneumococcal conjugate vaccine will receive a booster dose of the same vaccine. 2nd group of children primed with Prevenar™ will receive a booster dose of Prevenar™ (control group). 3rd group of children primed with Prevenar™ will receive a booster dose of GSK Biologicals' pneumococcal conjugate vaccine. All children will receive concomitantly a booster dose of DTPa-HBV-IPV/Hib vaccine. NCT00370396 Part: Vaccine administration

Ethanol-Free Clobetasol Propionate Foam vs Vehicle Foam in Chronic Hand Dermatitis NCT01323673 - Day 15/ Early Termination - Visit Date; Efficacy Assessments; Investigator Assessment; Subject Assessment; Vital Signs; End of Study

- 27.01.19 - 1 Formular, 7 Itemgruppen, 21 Datenelemente, 1 Sprache
Itemgruppen: Visit Date, Efficacy Assessments, Investigator Assessment, Subject Assessment, Vital Signs , End of Study, Fatal Outcome
Study ID: 115054 Clinical Study ID: 115054 Study Title: Ethanol-Free Clobetasol Propionate Foam 0.05% (Olux-E Foam) vs Vehicle Foam in the Treatment of Chronic Hand Dermatitis. Patient Level Data: Study Listed on ClinicalStudyDataRequest.com Clinicaltrials.gov Identifier: NCT01323673 Sponsor: GlaxoSmithKline Phase: Phase 4 Study Recruitment Status: Completed Generic Name: Vehicle / Placebo Trade Name: clobetasol propionate Study Indication: Dermatitis, Chronic

Ethanol-Free Clobetasol Propionate Foam vs Vehicle Foam in Chronic Hand Dermatitis NCT01323673 - Unscheduled Visit; Concomitant Medications; Concomitant Procedures; Adverse Events; General Comments; Subject's Post-Study Questionnaire

- 30.01.19 - 1 Formular, 12 Itemgruppen, 60 Datenelemente, 1 Sprache
Itemgruppen: Unscheduled Visit, Concomitant Medications, Concomitant Procedures, Adverse Events, General Comments, Subject's Post-Study Questionnaire, 1 - Skin Medicines used in past, 2 - Rate Qualities of Foam, 3 - Rate the Foam, 4 - Compare Foam to Other Types of Skin Medicines, 5 - Likely to be compliant using various types of Medicines, 6 - What do you like or not like about the Foam?
Study ID: 115054 Clinical Study ID: 115054 Study Title: Ethanol-Free Clobetasol Propionate Foam 0.05% (Olux-E Foam) vs Vehicle Foam in the Treatment of Chronic Hand Dermatitis. Patient Level Data: Study Listed on ClinicalStudyDataRequest.com Clinicaltrials.gov Identifier: NCT01323673 Sponsor: GlaxoSmithKline Phase: Phase 4 Study Recruitment Status: Completed Generic Name: Vehicle / Placebo Trade Name: clobetasol propionate Study Indication: Dermatitis, Chronic

Safety and reactogenicity of booster dose of either an investigational vaccination regimen or DTPw HBVHib 103812 & 104727 - 104727 (DTPW-HBV=HIB-MENAC-TT-016 BST 013 (15/24M)) - Check for Study Continuation; Large Swelling Reaction

- 22.01.19 - 1 Formular, 5 Itemgruppen, 36 Datenelemente, 1 Sprache
Itemgruppen: Check for Study Continuation, Laboratory Tests, Protocol required concomitant vaccination, Large swelling reaction, Large swelling reaction - Clinical case desciption and outcome of the adverse event
Study ID:103812 & 104727 Clinical Study ID:103812 & 104727 Study Title: Study to assess safety and reactogenicity of booster dose of either an investigational vaccination regimen or DTPw-HBV/Hib when administered at 15 to 18 months of age and of a dose of Mencevax ACWY vaccine. Patient Level Data:N/A Clinicaltrials.gov Identifier:N/A Sponsor: GlaxoSmithKline Collaborators: N/A Phase: phase 3 Study Recruitment Status: Completed Generic Name: Combined Diphtheria, Tetanus, Whole Cell Pertussis, Hepatitis B, Haemophilus influenzae Type b Vaccine Trade Name: Tritanrix HepB/Hiberix Study Indication: Diphtheria; Haemophilus influenzae type b; Hepatitis B; Tetanus; Whole Cell Pertussis

Safety and reactogenicity of booster dose of either an investigational vaccination regimen or DTPw HBVHib 103812 & 104727 - 103812 (DTPW-HBV=HIB-MENAC-TT-014 BST:013&004 (15-18M)) - Medication; Non- Serious Adverse Events; Study Conclusion

- 22.01.19 - 1 Formular, 6 Itemgruppen, 34 Datenelemente, 1 Sprache
Itemgruppen: Medication, Medication, Non- serious Adverse Event, Non- serious Adverse Event, Study Conclusion, Investigator's signature
Study ID:103812 & 104727 Clinical Study ID:103812 & 104727 Study Title: Study to assess safety and reactogenicity of booster dose of either an investigational vaccination regimen or DTPw-HBV/Hib when administered at 15 to 18 months of age and of a dose of Mencevax ACWY vaccine. Patient Level Data:N/A Clinicaltrials.gov Identifier:N/A Sponsor: GlaxoSmithKline Collaborators: N/A Phase: phase 3 Study Recruitment Status: Completed Generic Name: Combined Diphtheria, Tetanus, Whole Cell Pertussis, Hepatitis B, Haemophilus influenzae Type b Vaccine Trade Name: Tritanrix HepB/Hiberix Study Indication: Diphtheria; Haemophilus influenzae type b; Hepatitis B; Tetanus; Whole Cell Pertussis

Safety and reactogenicity of booster dose of either an investigational vaccination regimen or DTPw HBVHib 103812 & 104727 - 104727 (DTPW-HBV=HIB-MENAC-TT-016 BST 013 (15/24M)) - Concomitant Vaccination; Medication, Non- serious Adverse Events; Study Conclusion

- 22.01.19 - 1 Formular, 8 Itemgruppen, 39 Datenelemente, 1 Sprache
Itemgruppen: Concomitant Vaccination, Concomitant Vaccination , Medication, Medication, Non- serious Adverse Event, Non- serious Adverse Event , Study Conclusion , Investigator's signature
Study ID:103812 & 104727 Clinical Study ID:103812 & 104727 Study Title: Study to assess safety and reactogenicity of booster dose of either an investigational vaccination regimen or DTPw-HBV/Hib when administered at 15 to 18 months of age and of a dose of Mencevax ACWY vaccine. Patient Level Data:N/A Clinicaltrials.gov Identifier:N/A Sponsor: GlaxoSmithKline Collaborators: N/A Phase: phase 3 Study Recruitment Status: Completed Generic Name: Combined Diphtheria, Tetanus, Whole Cell Pertussis, Hepatitis B, Haemophilus influenzae Type b Vaccine Trade Name: Tritanrix HepB/Hiberix Study Indication: Diphtheria; Haemophilus influenzae type b; Hepatitis B; Tetanus; Whole Cell Pertussis

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