Informações:
Falhas:
ID
45563
Descrição
Principal Investigator: Huiman Barnhart, Duke University Medical Center, Durham, NC, USA MeSH: Drug-Induced Liver Injury https://www.ncbi.nlm.nih.gov/projects/gap/cgi-bin/study.cgi?study_id=phs000663 The National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK) has established the Drug-Induced Liver Injury Network (DILIN) to collect and analyze cases of severe liver injury caused by prescription drugs, over-the-counter drugs, and alternative medicines, such as herbal products and supplements.
Link
https://www.ncbi.nlm.nih.gov/projects/gap/cgi-bin/study.cgi?study_id=phs000663
Palavras-chave
Versões (1)
- 13/01/2023 13/01/2023 - Nelly Zental
Titular dos direitos
Huiman Barnhart, Duke University Medical Center, Durham, NC, USA
Transferido a
13 de janeiro de 2023
DOI
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Licença
Creative Commons BY 4.0
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dbGaP phs000663 Drug-Induced Liver Injury Network (DILIN)
Eligibility Criteria
- StudyEvent: SEV1
- Eligibility Criteria
- The subject consent data table includes subject IDs, consent information, and subject aliases.
- The subject sample mapping data table includes a mapping of study subject IDs to sample IDs. Samples are the final preps submitted for genotyping, sequencing, and/or expression data. For example, if one patient (subject ID) gave one sample, and that sample was processed differently to generate 2 sequencing runs, there would be two rows, both using the same subject ID, but having 2 unique sample IDs. The data table also includes sample aliases.
- The subject phenotypes data table includes gender, race (n=3 variables), ethnicity, European ancestry, affection status for drug-induced liver injury (DILI), age at DILI onset, adjudicated DILI diagnosis, candidate drugs (n=3 variables), causality scores of drugs (n=4 variables), injury type, severity, and peak ALT, bilirubin, and AKP measurements, and R-value at DILI onset.
- This sample attributes data table includes body site where sample was extracted, analyte type, tumor status, and histological type.
Similar models
Eligibility Criteria
- StudyEvent: SEV1
- Eligibility Criteria
- The subject consent data table includes subject IDs, consent information, and subject aliases.
- The subject sample mapping data table includes a mapping of study subject IDs to sample IDs. Samples are the final preps submitted for genotyping, sequencing, and/or expression data. For example, if one patient (subject ID) gave one sample, and that sample was processed differently to generate 2 sequencing runs, there would be two rows, both using the same subject ID, but having 2 unique sample IDs. The data table also includes sample aliases.
- The subject phenotypes data table includes gender, race (n=3 variables), ethnicity, European ancestry, affection status for drug-induced liver injury (DILI), age at DILI onset, adjudicated DILI diagnosis, candidate drugs (n=3 variables), causality scores of drugs (n=4 variables), injury type, severity, and peak ALT, bilirubin, and AKP measurements, and R-value at DILI onset.
- This sample attributes data table includes body site where sample was extracted, analyte type, tumor status, and histological type.
Name
Tipo
Description | Question | Decode (Coded Value)
Tipo de dados
Alias
Item Group
Inclusion and exclusion criteria
C1512693 (UMLS CUI [1,1])
C0680251 (UMLS CUI [1,2])
C0680251 (UMLS CUI [1,2])
Elig.phs000663.v3.p3.1
Item
*Inclusion Criteria:* Age > 2 years at enrollment into the study.
boolean
C1512693 (UMLS CUI [1,1])
C0001779 (UMLS CUI [1,2])
C0001779 (UMLS CUI [1,2])
Elig.phs000663.v3.p3.2
Item
Evidence of liver injury that is known or suspected to be related to consumption of a drug or CAM product in the 6-month period prior to enrollment.
boolean
C0023895 (UMLS CUI [1,1])
C0277579 (UMLS CUI [1,2])
C2826667 (UMLS CUI [1,3])
C0277579 (UMLS CUI [1,2])
C2826667 (UMLS CUI [1,3])
Elig.phs000663.v3.p3.3
Item
Written Informed consent from the patient or the patient's legal guardian.
boolean
C0021430 (UMLS CUI [1,1])
C0023226 (UMLS CUI [1,2])
C0023226 (UMLS CUI [1,2])
Elig.phs000663.v3.p3.4
Item
Documented clinically important DILI, defined as any of the following:
boolean
C0860207 (UMLS CUI [1,1])
Elig.phs000663.v3.p3.5
Item
ALT or AST > 5 x ULN or A P'ase > 2 x ULN observed on at least 2 consecutive blood draws in patients with previously normal values.
boolean
C0242192 (UMLS CUI [1,1])
C1519815 (UMLS CUI [1,2])
C0022885 (UMLS CUI [1,3])
C0201850 (UMLS CUI [2,1])
C1519815 (UMLS CUI [2,2])
C0022885 (UMLS CUI [2,3])
C1519815 (UMLS CUI [1,2])
C0022885 (UMLS CUI [1,3])
C0201850 (UMLS CUI [2,1])
C1519815 (UMLS CUI [2,2])
C0022885 (UMLS CUI [2,3])
Elig.phs000663.v3.p3.6
Item
If baseline (BL) ALT, AST or A P'ase are known to be elevated, then ALT or AST > 5 x BL or A P'ase > 2 x BL on at least 2 consecutive blood draws. "Baseline" is defined as the average of at least 2 measurements performed during the 12-month period prior to starting the DILI medication.
boolean
C0201850 (UMLS CUI [1,1])
C0235996 (UMLS CUI [1,2])
C0201899 (UMLS CUI [2,1])
C0201836 (UMLS CUI [2,2])
C0235996 (UMLS CUI [2,3])
C1704788 (UMLS CUI [3,1])
C1442488 (UMLS CUI [3,2])
C0235996 (UMLS CUI [1,2])
C0201899 (UMLS CUI [2,1])
C0201836 (UMLS CUI [2,2])
C0235996 (UMLS CUI [2,3])
C1704788 (UMLS CUI [3,1])
C1442488 (UMLS CUI [3,2])
Elig.phs000663.v3.p3.7
Item
Any elevation of ALT, A P'ase, or AST, associated with (a) increased total bilirubin [≥ 2.5 mg/dL], in the absence of prior diagnosis of liver disease, Gilbert's syndrome, or evidence of hemolysis or (b) coagulopathy with INR > 1.5 in absence of coumadin therapy or known vitamin K deficiency.
boolean
C0235996 (UMLS CUI [1,1])
C1278039 (UMLS CUI [1,2])
C0235996 (UMLS CUI [2,1])
C0005779 (UMLS CUI [2,2])
C0853225 (UMLS CUI [2,3])
C1278039 (UMLS CUI [1,2])
C0235996 (UMLS CUI [2,1])
C0005779 (UMLS CUI [2,2])
C0853225 (UMLS CUI [2,3])
Elig.phs000663.v3.p3.8
Item
*Exclusion Criteria:*<br> Patients with any of the following will not be eligible for participation: Competing cause of acute liver injury such as hepatic ischemia that is felt by the investigator to be the primary reason for observed liver injury and supported by laboratory tests, serologies, liver biopsy, or radiology.
boolean
C0680251 (UMLS CUI [1,1])
C2242583 (UMLS CUI [1,2])
C2242583 (UMLS CUI [1,2])
Elig.phs000663.v3.p3.9
Item
Known, pre-existing autoimmune hepatitis, primary biliary cirrhosis, primary sclerosing cholangitis, or other chronic biliary tract disease which may confound the ability to make a diagnosis of DILI.
boolean
C0521987 (UMLS CUI [1,1])
C0241910 (UMLS CUI [1,2])
C0008312 (UMLS CUI [1,3])
C0566602 (UMLS CUI [1,4])
C0005424 (UMLS CUI [1,5])
C0241910 (UMLS CUI [1,2])
C0008312 (UMLS CUI [1,3])
C0566602 (UMLS CUI [1,4])
C0005424 (UMLS CUI [1,5])
Elig.phs000663.v3.p3.10
Item
Acetaminophen hepatotoxicity
boolean
C0000970 (UMLS CUI [1,1])
C0235378 (UMLS CUI [1,2])
C0235378 (UMLS CUI [1,2])
Elig.phs000663.v3.p3.11
Item
Liver transplant or allogeneic bone marrow transplant prior to the development of drug- or CAM-induced liver injury.
boolean
C0023911 (UMLS CUI [1,1])
C0149615 (UMLS CUI [2,1])
C0149615 (UMLS CUI [2,1])