Sökresultat - Portal för medicinska datamodeller (MDM-portal)

Infection Episode

- 2021-09-20 - 1 Formulär, 1 Item-grupp, 11 Dataelement, 1 Språk

Item-grupp: Infection Episode

Information summarizing episodes of infection associated with treatment. Source Form: NCI FormBuilder: https://formbuilder.nci.nih.gov/FormBuilder/formDetailsAction.do?method=getFormDetails&formIdSeq=ACFF6F4C-B15B-1776-E040-BB89AD43285B

dbGaP phs001011 CCHMC-eMERGE-Phase IIIA - Eligibility

- 2023-10-02 - 6 Formulär, 1 Item-grupp, 33 Dataelement, 1 Språk

Item-grupp: IG.elig

Principal Investigator: John B. Harley, MD (Cytogenetics-Obesity, FSR, DSR, CLRR), National Institutes of Health, Bethesda, MD, USA MeSH: NA,Arthritis, Juvenile,Child Development Disorders, Pervasive,Cholangitis, Sclerosing,Developmental Disabilities,Eosinophilic Esophagitis,Hernia, Diaphragmatic,Infection,Lupus Erythematosus, Systemic,Neutropenia,Pediatric Obesity,Polymicrogyria,Rheumatic Diseases,Staphylococcus aureus https://www.ncbi.nlm.nih.gov/projects/gap/cgi-bin/study.cgi?study_id=phs001011 This submission includes genotyping or sequencing data from separate cohorts, each is described in separate paragraphs below. **Extreme early onset obesity** Obesity is a serious epidemic condition and on the rise in the United States. Today, nearly one out of three children is overweight or obese in this country. According to the Center for Disease Control, 35.7% of American adults and 17% of American children are obese. The medical costs associated with obesity are estimated to be in the billions. Without a doubt, interplay of additive genetic effects and common environmental effects influence this complex disease. However, despite being exposed to so-called "obesogenic environment", a large proportion of the population remains of normal weight. These observations suggest that innate, non-environmental, factors make some individuals more susceptible to obesity providing support for biological mechanisms, and thus genetic factors, to underlie the individual's response to the obesogenic environment. In young children with severe obesity the relative role of genetics and in utero programming are likely to outweigh the short duration of environmental and lifestyle exposures. This group is therefore an ideal one to study as they are likely enriched for variants that influence the risk of developing obesity. The purpose of this project is to further study and understand obesity in childhood and to develop a repository of samples for future studies into obesity. **Eosinophilic Esophagitis (EoE)** Eosinophilic Esophagitis (EoE) is one of the manifestations of eosinophilic gastrointestinal inflammation which have profound effects on a patient's health and development. Results of epidemiologic studies performed through our center demonstrate that eosinophil-associated gastrointestinal disease is not an uncommon entity. While the epidemiology of eosinophilic esophagitis has not been thoroughly studied until recently, there appears to be a significant increase in the diagnosis of EoE in the last decade. Based on our research, this mainly reflects increased disease recognition, but there is also a bona-fide increase in disease incidence which coincides with the increasing incidence of asthma and allergic diseases in the industrialized world. In addition, many patients with intractable symptoms thought in the past to represent atypical GERD or other disorders are now being recognized as having EoE. Diagnosis of EoE requires endoscopy and biopsies to document the characteristic histologic findings of esophageal eosinophilia. In general, this study proposed to elucidate the mechanisms underlying eosinophil growth, survival, migration, and function, and to investigate and further characterize the pathophysiology of, clinical manifestations of, and spectrum of disease severity of eosinophilic esophagitis in humans. The de-identified genotyping and genome wide association data generated as part of this research will be used for further genome research. **Familial Sample Repository (FSR) and Directed Sample Repository (DSR)** *De novo* mutations could cause many diseases, which has been demonstrated in mental retardation, autism and many rare genetic disorders. Family-based studies have a variety of advantages over case/control studies, including the elimination of analysis artifacts related to population stratification, the detection of genes that act through a recessive mechanism of inheritance and validation that the trait is not transmitted from a parent, something not possible using a case/control design. Additionally, DNA from families can be used to identify *de novo* mutations suggesting strong candidate causal polymorphisms. For this project, samples will be collected from families on an on-going basis. Families may be recruited because the patient either has a disease which is thought to be of genetic origin or from the general patient population to serve as controls or future identified diseases. Some phenotypes under study include fibroblastic rheumatism, diaphragmatic hernia, polymicrogyria, severe congenital neutropenia, primary sclerosing cholangitis and staph infection. **CLRR-Cincinnati Lupus Registry and Repository** Systemic lupus erythematosus (SLE) is a complex, partially understood autoimmune disorder. Genetic origins for SLE are supported by high heritability ( 66%), familial aggregation, increased monozygotic twin concordance, genetic linkages, and candidate gene genetic association, including HLA genes, Fc receptors, and complement components. Relevant environmental factors likely include infections (Epstein-Barr virus), therapeutics, personal habits (smoking), and diet. To continue a research resource facility for collection of well-characterized pedigrees containing a proband with systemic lupus erythematosus we develop this repository. **Juvenile Idiopathic Arthritis (JIA)** Juvenile Idiopathic Arthritis (JIA) is a debilitating complex genetic disorder characterized by inflammation of the joints and other tissues and shares histopathological features with other autoimmune diseases. It is considered complex genetic traits. There are more than 50,000 children with JIA in the USA, approximately 1 per 1000 births, which is about the same incidence as juvenile diabetes. It is believed that genes in the major histocompatibility complex (MHC) play a role in defining genetic risk, and it can be hypothesized that loci in other chromosomal regions are involved in conferring risk in JIA. These candidate chromosomal regions can be identified using genome-wide association analyses. The long-term goal is a comprehensive understanding of the genetic basis of these disabling arthropathies for which the molecular basis is not presently understood. These data will contribute to a national resource for the study of autoimmunity in children. **Better Outcomes for Children-Cytogenetics** Since 2007, more than 4000 samples, enriched with various rare or common genetic diseases as well as specific chromosomal abnormalities such as deletions and duplications have been genotyped for the purpose of subsequent GWAS and Phewas analyses and uncovering main genetic effects.

Safety and efficacy of topical Retapamulin Ointment vs. oral Linezolid in Secondarily-Infected Traumatic Lesions and Impetigo due to MRSA, NCT00852540 - Demography

- 2021-09-20 - 1 Formulär, 3 Item-grupper, 16 Dataelement, 1 Språk

Item-grupper: Administrative data, Demography, Geographic Ancestry

Study ID: 110978 Clinical Study ID: 110978 Study Title: A Randomized, Double-Blind, Double Dummy, Comparative, Multicenter Study to Assess the Safety and Efficacy of Topical Retapamulin Ointment, 1%, versus Oral Linezolid in the Treatment of Secondarily-Infected Traumatic Lesions and Impetigo Due to Methicillin-Resistant Staphylococcus aureus Patient Level Data: Study Listed on ClinicalStudyDataRequest.com Clinicaltrials.gov Identifier: NCT00852540 https://clinicaltrials.gov/ct2/show/NCT00852540 Sponsor: GlaxoSmithKline Collaborators: N/A Phase: Phase 3 Study Recruitment Status: Completed Generic Name: Retapamulin Ointment, Oral Linezolid Trade Name: N/A Study Indication: Skin Infections, Bacterial The study consists of 5 vists. The studys period extends over 19 days: Visit 1 (Day 1): Baseline (for both, topical and oral visit) Visit 2 (Day 3-4): On-Therapy (for both, topical and oral visit) Visit 3 (Day 7-9): End of Therapy for topical visit, On-Therapy for oral visit. Visit 4 (Day 12-14): Follow-up for topical visit, End of Therapy for oral visit. Visit 5 (Day 17-19): Final Follow-up for topical visit, Follow-up for oral visit. This document contains the demography form. It has to be filled in for screening.

Iodine-131 Anti-B1 Antibody for Patients With Previously Treated Non Hodgkin's Lymphoma NCT00992758 - Infection Summary; Concomitant Medications and Transfusions; Adverse Experiences

- 2021-03-29 - 1 Formulär, 9 Item-grupper, 48 Dataelement, 1 Språk

Item-grupper: Administrative, Infection Summary, Infection Summary - Culture information, Infection Summary - Anti-infective, Infection Summary - Anti-infective , Concomitant Medications and Transfusions, Adverse Experiences, Adverse Experiences, Adverse Experiences - Investigator Signature

Study ID: 104512 Clinical Study ID: 104512 Study Title: Phase I, Dose-Escalation Study of Iodine-131 Anti-B1 Antibody for Patients With Previously Treated Non Hodgkin's Lymphoma With More Than 25% Bone Marrow Involvement Patient Level Data: Study Listed on ClinicalStudyDataRequest.com Clinicaltrials.gov Identifier: NCT00992758 Sponsor: GlaxoSmithKline Phase: Phase 1 Study Recruitment Status: Completed Generic Name: Iodine-131 Anti-B1 Antibody Trade Name: Tositumomab Study Indication: Lymphoma, Non-Hodgkin

Safety, tolerability and pharmacokinetics of single, ascending and twice-daily repeat doses of intranasal SB-705498 NCT00907933 - Screen - Date of Visit; Demography; Eligibility Question; Subject Identification; Randomisation Number; Nasal Endoscopy

- 2019-10-26 - 1 Formulär, 17 Item-grupper, 33 Dataelement, 1 Språk

Item-grupper: Inform Screening, Inform Enrolment, Date of Visit, Demography, Eligibility Question, Subject Identification, Randomisation Number, Nasal Endoscopy - Screening, Nasal Endoscopy - Colour of Mucosa, Nasal Endoscopy - Turbinate Swelling, Nasal Endoscopy - Alignment of the Septum, Nasal Endoscopy - Secretions, Nasal Endoscopy - Infection, Nasal Endoscopy - Post Nasal Drip, Nasal Endoscopy - Crusting, Nasal Endoscopy - Signs of Bleeding, Nasal Endoscopy - Nasal Polyps

Study ID: 111610 Clinical Study ID: 111610 Study Title: A randomised, double-blind, placebo-controlled study in healthy volunteers to examine the safety, tolerability and pharmacokinetics of a) single, ascending and b) twice-daily repeat doses of intranasal SB-705498. Patient Level Data: Study Listed on ClinicalStudyDataRequest.com Clinicaltrials.gov Identifier: NCT00907933 Sponsor: GlaxoSmithKline Phase: Phase 1 Study Recruitment Status: Completed Generic Name: SB705498, Placebo Study Indication: Rhinitis

Mencevax™ ACWY (new process) versus Mencevax™ ACWY (current process); NCT00227422 - Visit 2 - Month 1

- 2019-05-26 - 1 Formulär, 3 Item-grupper, 8 Dataelement, 1 Språk

Item-grupper: Administrative Documentation, Continuation status, Clinical Trials, Collection of blood specimen for laboratory procedure

Study ID: 102394 Clinical Study ID: 102394 Study Title: A Phase IV, partially double-blind study to demonstrate non-inferiority of GSK Biologicals’ Mencevax™ ACWY (new process) versus Mencevax™ ACWY (current process) when administered as a single dose to subjects aged 2-30 yrs Patient Level Data: Study Listed on ClinicalStudyDataRequest.com Clinicaltrials.gov Identifier: NCT00227422 Sponsor: GlaxoSmithKline Collaborators: N/A Phase: Phase 4 Study Recruitment Status: Completed clinical study under GSK sponsorship. The product that is studied in this clinical study, together with the rights to the data and results generated, has been transferred by GSK to Pfizer. GSK’s Clinical Study Register is no longer maintained for this study. To request access to clinical study data from Pfizer, go here: http://www.pfizer.com/research/clinical_trials/trial_data_and_results Generic Name: Meningococcal Serogroups A, C, W-135 and Y Vaccine Trade Name: Mencevax Study Indication: Infections, Meningococcal

Mencevax™ ACWY (new process) versus Mencevax™ ACWY (current process); NCT00227422 - Visit 1 - Month 0 - Vaccination

- 2019-05-26 - 1 Formulär, 16 Item-grupper, 87 Dataelement, 1 Språk

Item-grupper: Administrative Documentation, Exclusion Criteria, During, Clinical Trials, Informed Consent, Demographics Domain, Eligibility Determination, Inclusion, Exclusion Criteria, Randomization, Medical History, Physical Examination, Collection of blood specimen for laboratory procedure, Urine pregnancy test, Vaccination, Administration of Vaccine, Adverse Event, Vaccination, Adverse Event, Symptoms, Local, Adverse Event, General symptom, Adverse Event, General symptom

Study ID: 102394 Clinical Study ID: 102394 Study Title: A Phase IV, partially double-blind study to demonstrate non-inferiority of GSK Biologicals’ Mencevax™ ACWY (new process) versus Mencevax™ ACWY (current process) when administered as a single dose to subjects aged 2-30 yrs Patient Level Data: Study Listed on ClinicalStudyDataRequest.com Clinicaltrials.gov Identifier: NCT00227422 Sponsor: GlaxoSmithKline Collaborators: N/A Phase: Phase 4 Study Recruitment Status: Completed clinical study under GSK sponsorship. The product that is studied in this clinical study, together with the rights to the data and results generated, has been transferred by GSK to Pfizer. GSK’s Clinical Study Register is no longer maintained for this study. To request access to clinical study data from Pfizer, go here: http://www.pfizer.com/research/clinical_trials/trial_data_and_results Generic Name: Meningococcal Serogroups A, C, W-135 and Y Vaccine Trade Name: Mencevax Study Indication: Infections, Meningococcal

Mencevax™ ACWY (new process) versus Mencevax™ ACWY (current process); NCT00227422 - Diary Card - "6-30 years"

- 2019-05-26 - 1 Formulär, 6 Item-grupper, 35 Dataelement, 1 Språk

Item-grupper: Administrative Documentation, Adverse Event, Symptoms, Local, Symptoms, Local, Other, Adverse Event, General symptom, General symptom, Other, Pharmaceutical Preparations

Study ID: 102394 Clinical Study ID: 102394 Study Title: A Phase IV, partially double-blind study to demonstrate non-inferiority of GSK Biologicals’ Mencevax™ ACWY (new process) versus Mencevax™ ACWY (current process) when administered as a single dose to subjects aged 2-30 yrs Patient Level Data: Study Listed on ClinicalStudyDataRequest.com Clinicaltrials.gov Identifier: NCT00227422 Sponsor: GlaxoSmithKline Collaborators: N/A Phase: Phase 4 Study Recruitment Status: Completed clinical study under GSK sponsorship. The product that is studied in this clinical study, together with the rights to the data and results generated, has been transferred by GSK to Pfizer. GSK’s Clinical Study Register is no longer maintained for this study. To request access to clinical study data from Pfizer, go here: http://www.pfizer.com/research/clinical_trials/trial_data_and_results Generic Name: Meningococcal Serogroups A, C, W-135 and Y Vaccine Trade Name: Mencevax Study Indication: Infections, Meningococcal

Mencevax™ ACWY (new process) versus Mencevax™ ACWY (current process); NCT00227422 - Diary Card - "2-5 years"

- 2019-05-26 - 1 Formulär, 6 Item-grupper, 35 Dataelement, 1 Språk

Item-grupper: Administrative Documentation, Adverse Event, Symptoms, Local, Symptoms, Local, Other, Adverse Event, General symptom, General symptom, Other, Pharmaceutical Preparations

Study ID: 102394 Clinical Study ID: 102394 Study Title: A Phase IV, partially double-blind study to demonstrate non-inferiority of GSK Biologicals’ Mencevax™ ACWY (new process) versus Mencevax™ ACWY (current process) when administered as a single dose to subjects aged 2-30 yrs Patient Level Data: Study Listed on ClinicalStudyDataRequest.com Clinicaltrials.gov Identifier: NCT00227422 Sponsor: GlaxoSmithKline Collaborators: N/A Phase: Phase 4 Study Recruitment Status: Completed clinical study under GSK sponsorship. The product that is studied in this clinical study, together with the rights to the data and results generated, has been transferred by GSK to Pfizer. GSK’s Clinical Study Register is no longer maintained for this study. To request access to clinical study data from Pfizer, go here: http://www.pfizer.com/research/clinical_trials/trial_data_and_results Generic Name: Meningococcal Serogroups A, C, W-135 and Y Vaccine Trade Name: Mencevax Study Indication: Infections, Meningococcal

Mencevax™ ACWY (new process) versus Mencevax™ ACWY (current process); NCT00227422 - Study Conclusion

- 2019-05-26 - 1 Formulär, 7 Item-grupper, 18 Dataelement, 1 Språk

Item-grupper: Administrative documentation, Serious Adverse Event, Pregnancy, Information, Treatment Status, Blinded Clinical Study, Exclusion Criteria, Withdraw, Investigator Signature

Study ID: 102394 Clinical Study ID: 102394 Study Title: A Phase IV, partially double-blind study to demonstrate non-inferiority of GSK Biologicals’ Mencevax™ ACWY (new process) versus Mencevax™ ACWY (current process) when administered as a single dose to subjects aged 2-30 yrs Patient Level Data: Study Listed on ClinicalStudyDataRequest.com Clinicaltrials.gov Identifier: NCT00227422 Sponsor: GlaxoSmithKline Collaborators: N/A Phase: Phase 4 Study Recruitment Status: Completed clinical study under GSK sponsorship. The product that is studied in this clinical study, together with the rights to the data and results generated, has been transferred by GSK to Pfizer. GSK’s Clinical Study Register is no longer maintained for this study. To request access to clinical study data from Pfizer, go here: http://www.pfizer.com/research/clinical_trials/trial_data_and_results Generic Name: Meningococcal Serogroups A, C, W-135 and Y Vaccine Trade Name: Mencevax Study Indication: Infections, Meningococcal

Mencevax™ ACWY (new process) versus Mencevax™ ACWY (current process); NCT00227422 - Medication

- 2019-05-26 - 1 Formulär, 2 Item-grupper, 9 Dataelement, 1 Språk

Item-grupper: Administrative Documentation, Pharmaceutical Preparations

Study ID: 102394 Clinical Study ID: 102394 Study Title: A Phase IV, partially double-blind study to demonstrate non-inferiority of GSK Biologicals’ Mencevax™ ACWY (new process) versus Mencevax™ ACWY (current process) when administered as a single dose to subjects aged 2-30 yrs Patient Level Data: Study Listed on ClinicalStudyDataRequest.com Clinicaltrials.gov Identifier: NCT00227422 Sponsor: GlaxoSmithKline Collaborators: N/A Phase: Phase 4 Study Recruitment Status: Completed clinical study under GSK sponsorship. The product that is studied in this clinical study, together with the rights to the data and results generated, has been transferred by GSK to Pfizer. GSK’s Clinical Study Register is no longer maintained for this study. To request access to clinical study data from Pfizer, go here: http://www.pfizer.com/research/clinical_trials/trial_data_and_results Generic Name: Meningococcal Serogroups A, C, W-135 and Y Vaccine Trade Name: Mencevax Study Indication: Infections, Meningococcal

Mencevax™ ACWY (new process) versus Mencevax™ ACWY (current process); NCT00227422 - Concomitant Vaccination

- 2019-05-26 - 1 Formulär, 2 Item-grupper, 5 Dataelement, 1 Språk

Item-grupper: Administrative Documentation, Concomitant Agent, Vaccination

Study ID: 102394 Clinical Study ID: 102394 Study Title: A Phase IV, partially double-blind study to demonstrate non-inferiority of GSK Biologicals’ Mencevax™ ACWY (new process) versus Mencevax™ ACWY (current process) when administered as a single dose to subjects aged 2-30 yrs Patient Level Data: Study Listed on ClinicalStudyDataRequest.com Clinicaltrials.gov Identifier: NCT00227422 Sponsor: GlaxoSmithKline Collaborators: N/A Phase: Phase 4 Study Recruitment Status: Completed clinical study under GSK sponsorship. The product that is studied in this clinical study, together with the rights to the data and results generated, has been transferred by GSK to Pfizer. GSK’s Clinical Study Register is no longer maintained for this study. To request access to clinical study data from Pfizer, go here: http://www.pfizer.com/research/clinical_trials/trial_data_and_results Generic Name: Meningococcal Serogroups A, C, W-135 and Y Vaccine Trade Name: Mencevax Study Indication: Infections, Meningococcal

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Valda datamodeller

Infection Episode

dbGaP phs001011 CCHMC-eMERGE-Phase IIIA - Eligibility

pht005529.v1.p1

pht005530.v1.p1

pht005531.v1.p1

pht005532.v1.p1

pht005533.v1.p1