ID

36036

Beschreibung

The purpose of this study is to provide insights into the cause, development and effects of de novo autoimmune hepatitis so that prevention and treatment strategies can be developed in order to reduce post-liver transplant morbidity, the frequency of liver allograft loss and the need for re-transplantation. ODM derived from: https://clinicaltrials.gov/show/NCT02056054

Link

https://clinicaltrials.gov/show/NCT02056054

Stichworte

Versionen (1)
  1. 10.04.19 10.04.19 -
Rechteinhaber

Yale University

Hochgeladen am

10. April 2019

DOI

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Lizenz

Creative Commons BY-NC 3.0
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De Novo Autoimmune Hepatitis in Pediatric Liver Transplantation NCT02056054

Englisch

Eligibility

1 Formulare  
  1. StudyEvent: Eligibility
    1. Eligibility
Inclusion Criteria for Pediatric Transplant Patients
Beschreibung

Inclusion Criteria for Pediatric Transplant Patients

Alias
UMLS CUI-1
C1512693
UMLS CUI-2
C0008976
UMLS CUI-3
C0449719
UMLS CUI-4
C1521725
UMLS CUI-5
C0023911
Patient is >3-months and <21 years of age and a recipient of a single organ liver transplant
Beschreibung

Age and transplant status

Datentyp

boolean

Alias
UMLS CUI [1]
C0001779
UMLS CUI [2,1]
C1709854
UMLS CUI [2,2]
C0023911
Patient has allograft dysfunction (an ALT and/or GGTP > 2 times the upper limit of normal) due to acute rejection without a prior diagnosis of d-AIH
Beschreibung

d-AIH = de novo - autoimmune hepatitis

Datentyp

boolean

Alias
UMLS CUI [1,1]
C0040739
UMLS CUI [1,2]
C0086565
UMLS CUI [1,3]
C1736177
UMLS CUI [2,1]
C0201836
UMLS CUI [2,2]
C0205217
UMLS CUI [3]
C4272243
UMLS CUI [4,1]
C0332132
UMLS CUI [4,2]
C0241910
UMLS CUI [4,3]
C1515568
UMLS CUI [4,4]
C0332197
Patient has allograft dysfunction (an ALT and/or GGT > 2 times the upper limit of normal) due to chronic rejection without a prior diagnosis of d-AIH
Beschreibung

d-AIH = de novo - autoimmune hepatitis

Datentyp

boolean

Alias
UMLS CUI [1,1]
C0040739
UMLS CUI [1,2]
C0086565
UMLS CUI [1,3]
C0301948
UMLS CUI [2,1]
C0201836
UMLS CUI [2,2]
C0205217
UMLS CUI [3]
C4272243
UMLS CUI [4,1]
C0332132
UMLS CUI [4,2]
C0241910
UMLS CUI [4,3]
C1515568
UMLS CUI [4,4]
C0332197
Patient has a diagnosis of d-AIH
Beschreibung

d-AIH = de novo - autoimmune hepatitis

Datentyp

boolean

Alias
UMLS CUI [1,1]
C0241910
UMLS CUI [1,2]
C1515568
UMLS CUI [1,3]
C0011900
Inclusion criteria for healthy pediatric control subjects
Beschreibung

Inclusion criteria for healthy pediatric control subjects

Alias
UMLS CUI-1
C1512693
UMLS CUI-2
C0008976
UMLS CUI-3
C0449719
UMLS CUI-4
C1521725
UMLS CUI-5
C0009932
Participant is ≥ 1-year and < 18-years of age
Beschreibung

Age

Datentyp

boolean

Alias
UMLS CUI [1]
C0001779
Participant is not on any immune modulators
Beschreibung

Immune modulation therapy

Datentyp

boolean

Alias
UMLS CUI [1,1]
C0279021
UMLS CUI [1,2]
C0332197
Participant is not on steroid therapy
Beschreibung

Steroid therapy

Datentyp

boolean

Alias
UMLS CUI [1,1]
C0149783
UMLS CUI [1,2]
C0332197
Participant has no underlying chronic inflammatory condition
Beschreibung

Underlying inflammatory condition

Datentyp

boolean

Alias
UMLS CUI [1,1]
C0008679
UMLS CUI [1,2]
C0333348
UMLS CUI [1,3]
C0332197
Inclusion Criteria for Adult Control Subjects
Beschreibung

Inclusion Criteria for Adult Control Subjects

Alias
UMLS CUI-1
C1512693
UMLS CUI-2
C0008976
UMLS CUI-3
C0449719
UMLS CUI-4
C0001675
UMLS CUI-5
C0009932
Non-transplanted adult aged 18 years or older with autoimmune hepatitis
Beschreibung

Adults with AIH

Datentyp

boolean

Alias
UMLS CUI [1]
C0001675
UMLS CUI [2,1]
C0040732
UMLS CUI [2,2]
C0332197
UMLS CUI [3,1]
C0011900
UMLS CUI [3,2]
C0241910
Non-transplanted adult 18 years or older with chronic hepatitis c who is treatment naive.
Beschreibung

Adults with chronic hepatitis C

Datentyp

boolean

Alias
UMLS CUI [1]
C0001675
UMLS CUI [2,1]
C0029216
UMLS CUI [2,2]
C0332197
UMLS CUI [3,1]
C0011900
UMLS CUI [3,2]
C0524910
UMLS CUI [3,3]
C0919936
Exclusion Criteria Pediatric Transplant Patients
Beschreibung

Exclusion Criteria Pediatric Transplant Patients

Alias
UMLS CUI-1
C0680251
UMLS CUI-2
C0008976
UMLS CUI-3
C0449719
UMLS CUI-4
C1521725
UMLS CUI-5
C0023911
Pediatric transplant patient with multi-visceral organ transplants
Beschreibung

Multi-visceral organ transplantation

Datentyp

boolean

Alias
UMLS CUI [1,1]
C1709854
UMLS CUI [1,2]
C0812808
Exclusion Criteria Healthy Pediatric Control Subjects
Beschreibung

Exclusion Criteria Healthy Pediatric Control Subjects

Alias
UMLS CUI-1
C0680251
UMLS CUI-2
C0008976
UMLS CUI-3
C0449719
UMLS CUI-4
C1521725
UMLS CUI-5
C0009932
Participant <1-year and > 18-years of age
Beschreibung

Age

Datentyp

boolean

Alias
UMLS CUI [1]
C0001779
Participant has chronic inflammatory condition
Beschreibung

Chronic inflammatory condition

Datentyp

boolean

Alias
UMLS CUI [1,1]
C0008679
UMLS CUI [1,2]
C0333348
Participant is on immune modulators or steroids
Beschreibung

Immune modulation therapy

Datentyp

boolean

Alias
UMLS CUI [1]
C0279021
UMLS CUI [2]
C0149783
Participant is on chronic medication(s)
Beschreibung

Chronic medication

Datentyp

boolean

Alias
UMLS CUI [1,1]
C0013227
UMLS CUI [1,2]
C0205191
Exclusion Criteria Adult transplanted patients with d-AIH
Beschreibung

Exclusion Criteria Adult transplanted patients with d-AIH

Alias
UMLS CUI-1
C0680251
UMLS CUI-2
C0008976
UMLS CUI-3
C0449719
UMLS CUI-4
C0001675
UMLS CUI-5
C0009932
Transplanted patient ≥21-years with diagnosis of d-AIH
Beschreibung

Adults transplanted with AIH

Datentyp

boolean

Alias
UMLS CUI [1]
C0001675
UMLS CUI [2]
C0040732
UMLS CUI [3,1]
C0011900
UMLS CUI [3,2]
C0241910
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Ähnliche Modelle

Eligibility

1 Formulare
  1. StudyEvent: Eligibility
    1. Eligibility
Name
Typ
Description | Question | Decode (Coded Value)
Datentyp
Alias
Item Group
C1512693 (UMLS CUI-1)
C0008976 (UMLS CUI-2)
C0449719 (UMLS CUI-3)
C1521725 (UMLS CUI-4)
C0023911 (UMLS CUI-5)
Age and transplant status
Item
Patient is >3-months and <21 years of age and a recipient of a single organ liver transplant
boolean
C0001779 (UMLS CUI [1])
C1709854 (UMLS CUI [2,1])
C0023911 (UMLS CUI [2,2])
Allograft dysfunction due to acute rejection
Item
Patient has allograft dysfunction (an ALT and/or GGTP > 2 times the upper limit of normal) due to acute rejection without a prior diagnosis of d-AIH
boolean
C0040739 (UMLS CUI [1,1])
C0086565 (UMLS CUI [1,2])
C1736177 (UMLS CUI [1,3])
C0201836 (UMLS CUI [2,1])
C0205217 (UMLS CUI [2,2])
C4272243 (UMLS CUI [3])
C0332132 (UMLS CUI [4,1])
C0241910 (UMLS CUI [4,2])
C1515568 (UMLS CUI [4,3])
C0332197 (UMLS CUI [4,4])
Allgraft dysfunction due to chronic rejection
Item
Patient has allograft dysfunction (an ALT and/or GGT > 2 times the upper limit of normal) due to chronic rejection without a prior diagnosis of d-AIH
boolean
C0040739 (UMLS CUI [1,1])
C0086565 (UMLS CUI [1,2])
C0301948 (UMLS CUI [1,3])
C0201836 (UMLS CUI [2,1])
C0205217 (UMLS CUI [2,2])
C4272243 (UMLS CUI [3])
C0332132 (UMLS CUI [4,1])
C0241910 (UMLS CUI [4,2])
C1515568 (UMLS CUI [4,3])
C0332197 (UMLS CUI [4,4])
Diagnosis of AIH
Item
Patient has a diagnosis of d-AIH
boolean
C0241910 (UMLS CUI [1,1])
C1515568 (UMLS CUI [1,2])
C0011900 (UMLS CUI [1,3])
Item Group
C1512693 (UMLS CUI-1)
C0008976 (UMLS CUI-2)
C0449719 (UMLS CUI-3)
C1521725 (UMLS CUI-4)
C0009932 (UMLS CUI-5)
Age
Item
Participant is ≥ 1-year and < 18-years of age
boolean
C0001779 (UMLS CUI [1])
Immune modulation therapy
Item
Participant is not on any immune modulators
boolean
C0279021 (UMLS CUI [1,1])
C0332197 (UMLS CUI [1,2])
Steroid therapy
Item
Participant is not on steroid therapy
boolean
C0149783 (UMLS CUI [1,1])
C0332197 (UMLS CUI [1,2])
Underlying inflammatory condition
Item
Participant has no underlying chronic inflammatory condition
boolean
C0008679 (UMLS CUI [1,1])
C0333348 (UMLS CUI [1,2])
C0332197 (UMLS CUI [1,3])
Item Group
C1512693 (UMLS CUI-1)
C0008976 (UMLS CUI-2)
C0449719 (UMLS CUI-3)
C0001675 (UMLS CUI-4)
C0009932 (UMLS CUI-5)
Adults with AIH
Item
Non-transplanted adult aged 18 years or older with autoimmune hepatitis
boolean
C0001675 (UMLS CUI [1])
C0040732 (UMLS CUI [2,1])
C0332197 (UMLS CUI [2,2])
C0011900 (UMLS CUI [3,1])
C0241910 (UMLS CUI [3,2])
Adults with chronic hepatitis C
Item
Non-transplanted adult 18 years or older with chronic hepatitis c who is treatment naive.
boolean
C0001675 (UMLS CUI [1])
C0029216 (UMLS CUI [2,1])
C0332197 (UMLS CUI [2,2])
C0011900 (UMLS CUI [3,1])
C0524910 (UMLS CUI [3,2])
C0919936 (UMLS CUI [3,3])
Item Group
C0680251 (UMLS CUI-1)
C0008976 (UMLS CUI-2)
C0449719 (UMLS CUI-3)
C1521725 (UMLS CUI-4)
C0023911 (UMLS CUI-5)
Multi-visceral organ transplantation
Item
Pediatric transplant patient with multi-visceral organ transplants
boolean
C1709854 (UMLS CUI [1,1])
C0812808 (UMLS CUI [1,2])
Item Group
Exclusion Criteria Healthy Pediatric Control Subjects
C0680251 (UMLS CUI-1)
C0008976 (UMLS CUI-2)
C0449719 (UMLS CUI-3)
C1521725 (UMLS CUI-4)
C0009932 (UMLS CUI-5)
Age
Item
Participant <1-year and > 18-years of age
boolean
C0001779 (UMLS CUI [1])
Chronic inflammatory condition
Item
Participant has chronic inflammatory condition
boolean
C0008679 (UMLS CUI [1,1])
C0333348 (UMLS CUI [1,2])
Immune modulation therapy
Item
Participant is on immune modulators or steroids
boolean
C0279021 (UMLS CUI [1])
C0149783 (UMLS CUI [2])
Chronic medication
Item
Participant is on chronic medication(s)
boolean
C0013227 (UMLS CUI [1,1])
C0205191 (UMLS CUI [1,2])
Item Group
C0680251 (UMLS CUI-1)
C0008976 (UMLS CUI-2)
C0449719 (UMLS CUI-3)
C0001675 (UMLS CUI-4)
C0009932 (UMLS CUI-5)
Adults transplanted with AIH
Item
Transplanted patient ≥21-years with diagnosis of d-AIH
boolean
C0001675 (UMLS CUI [1])
C0040732 (UMLS CUI [2])
C0011900 (UMLS CUI [3,1])
C0241910 (UMLS CUI [3,2])
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