ID

20920

Beschrijving

Comparing Efficacy and Safety of Tacrolimus With Steroids or Monoclonal Anti-IL2R Antibody in Hepatitis C Virus (HCV) Positive Liver Transplant Patients; ODM derived from: https://clinicaltrials.gov/show/NCT00295607

Link

https://clinicaltrials.gov/show/NCT00295607

Trefwoorden

Versies (1)
  1. 27-03-17 27-03-17 -
Geüploaded op

27 maart 2017

DOI

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Licentie

Creative Commons BY 4.0
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Eligibility Hepatitis C NCT00295607

Engels

Eligibility Hepatitis C NCT00295607

1 Formulieren  
Inclusion Criteria
Beschrijving

Inclusion Criteria

Alias
UMLS CUI
C1512693
patients 18 to 65 years of age who will undergo primary orthotopic liver or split liver allograft transplantation for hcv-cirrhosis are eligible for the study.
Beschrijving

Age | Orthotopic liver transplant Allograft Primary | Transplantation of liver Allograft Split | cirrhosis due to hepatitis C

Datatype

boolean

Alias
UMLS CUI [1]
C0001779
UMLS CUI [2,1]
C0400447
UMLS CUI [2,2]
C0040739
UMLS CUI [2,3]
C0205225
UMLS CUI [3,1]
C0023911
UMLS CUI [3,2]
C0040739
UMLS CUI [3,3]
C1534709
UMLS CUI [4]
C2075271
patients receiving a cadaveric liver transplant with compatible abo blood type can be included.
Beschrijving

Liver transplant recipient Cadaver donor | ABO blood type Compatible

Datatype

boolean

Alias
UMLS CUI [1,1]
C3811922
UMLS CUI [1,2]
C0524354
UMLS CUI [2,1]
C0200499
UMLS CUI [2,2]
C1524057
Exclusion Criteria
Beschrijving

Exclusion Criteria

Alias
UMLS CUI
C0680251
recipient of multi-organ transplant
Beschrijving

Recipient Transplanted organ multiple

Datatype

boolean

Alias
UMLS CUI [1,1]
C1709854
UMLS CUI [1,2]
C0524930
UMLS CUI [1,3]
C0439064
recipient of an auxiliary graft
Beschrijving

Recipient Heterotopic graft

Datatype

boolean

Alias
UMLS CUI [1,1]
C1709854
UMLS CUI [1,2]
C0686910
patient is receiving abo incompatible graft
Beschrijving

Recipient Graft Blood type ABO incompatibility

Datatype

boolean

Alias
UMLS CUI [1,1]
C1709854
UMLS CUI [1,2]
C0332835
UMLS CUI [1,3]
C0238580
patients requiring immunosuppressive treatment
Beschrijving

Therapeutic immunosuppression Patient need for

Datatype

boolean

Alias
UMLS CUI [1,1]
C0021079
UMLS CUI [1,2]
C0686904
patients requiring ongoing corticosteroid therapy.
Beschrijving

Steroid therapy Patient need for

Datatype

boolean

Alias
UMLS CUI [1,1]
C0149783
UMLS CUI [1,2]
C0686904
patient has significant, uncontrolled concomitant infections and/or severe diarrhoea, vomiting, active upper gastro-intestinal tract malabsorption or active peptic ulcer.
Beschrijving

Communicable Diseases Uncontrolled | Severe diarrhea | Vomiting | Upper Gastrointestinal Tract Malabsorption | Peptic Ulcer

Datatype

boolean

Alias
UMLS CUI [1,1]
C0009450
UMLS CUI [1,2]
C0205318
UMLS CUI [2]
C1443924
UMLS CUI [3]
C0042963
UMLS CUI [4,1]
C3203348
UMLS CUI [4,2]
C3714745
UMLS CUI [5]
C0030920
patient or donor is known to be hiv positive.
Beschrijving

HIV Seropositivity | Donor HIV Seropositivity

Datatype

boolean

Alias
UMLS CUI [1]
C0019699
UMLS CUI [2,1]
C0013018
UMLS CUI [2,2]
C0019699
patient is allergic or intolerant to study medication
Beschrijving

Hypersensitivity Investigational New Drugs | Intolerance to Investigational New Drugs

Datatype

boolean

Alias
UMLS CUI [1,1]
C0020517
UMLS CUI [1,2]
C0013230
UMLS CUI [2,1]
C1744706
UMLS CUI [2,2]
C0013230
patient is pregnant or breast-feeding.
Beschrijving

Pregnancy | Breast Feeding

Datatype

boolean

Alias
UMLS CUI [1]
C0032961
UMLS CUI [2]
C0006147
patient has been previously enrolled in this study
Beschrijving

Study Subject Participation Status

Datatype

boolean

Alias
UMLS CUI [1]
C2348568
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Similar models

Eligibility Hepatitis C NCT00295607

1 Formulieren
Name
Type
Description | Question | Decode (Coded Value)
Datatype
Alias
Item Group
C1512693 (UMLS CUI)
Age | Orthotopic liver transplant Allograft Primary | Transplantation of liver Allograft Split | cirrhosis due to hepatitis C
Item
patients 18 to 65 years of age who will undergo primary orthotopic liver or split liver allograft transplantation for hcv-cirrhosis are eligible for the study.
boolean
C0001779 (UMLS CUI [1])
C0400447 (UMLS CUI [2,1])
C0040739 (UMLS CUI [2,2])
C0205225 (UMLS CUI [2,3])
C0023911 (UMLS CUI [3,1])
C0040739 (UMLS CUI [3,2])
C1534709 (UMLS CUI [3,3])
C2075271 (UMLS CUI [4])
Liver transplant recipient Cadaver donor | ABO blood type Compatible
Item
patients receiving a cadaveric liver transplant with compatible abo blood type can be included.
boolean
C3811922 (UMLS CUI [1,1])
C0524354 (UMLS CUI [1,2])
C0200499 (UMLS CUI [2,1])
C1524057 (UMLS CUI [2,2])
Item Group
C0680251 (UMLS CUI)
Recipient Transplanted organ multiple
Item
recipient of multi-organ transplant
boolean
C1709854 (UMLS CUI [1,1])
C0524930 (UMLS CUI [1,2])
C0439064 (UMLS CUI [1,3])
Recipient Heterotopic graft
Item
recipient of an auxiliary graft
boolean
C1709854 (UMLS CUI [1,1])
C0686910 (UMLS CUI [1,2])
Recipient Graft Blood type ABO incompatibility
Item
patient is receiving abo incompatible graft
boolean
C1709854 (UMLS CUI [1,1])
C0332835 (UMLS CUI [1,2])
C0238580 (UMLS CUI [1,3])
Therapeutic immunosuppression Patient need for
Item
patients requiring immunosuppressive treatment
boolean
C0021079 (UMLS CUI [1,1])
C0686904 (UMLS CUI [1,2])
Steroid therapy Patient need for
Item
patients requiring ongoing corticosteroid therapy.
boolean
C0149783 (UMLS CUI [1,1])
C0686904 (UMLS CUI [1,2])
Communicable Diseases Uncontrolled | Severe diarrhea | Vomiting | Upper Gastrointestinal Tract Malabsorption | Peptic Ulcer
Item
patient has significant, uncontrolled concomitant infections and/or severe diarrhoea, vomiting, active upper gastro-intestinal tract malabsorption or active peptic ulcer.
boolean
C0009450 (UMLS CUI [1,1])
C0205318 (UMLS CUI [1,2])
C1443924 (UMLS CUI [2])
C0042963 (UMLS CUI [3])
C3203348 (UMLS CUI [4,1])
C3714745 (UMLS CUI [4,2])
C0030920 (UMLS CUI [5])
HIV Seropositivity | Donor HIV Seropositivity
Item
patient or donor is known to be hiv positive.
boolean
C0019699 (UMLS CUI [1])
C0013018 (UMLS CUI [2,1])
C0019699 (UMLS CUI [2,2])
Hypersensitivity Investigational New Drugs | Intolerance to Investigational New Drugs
Item
patient is allergic or intolerant to study medication
boolean
C0020517 (UMLS CUI [1,1])
C0013230 (UMLS CUI [1,2])
C1744706 (UMLS CUI [2,1])
C0013230 (UMLS CUI [2,2])
Pregnancy | Breast Feeding
Item
patient is pregnant or breast-feeding.
boolean
C0032961 (UMLS CUI [1])
C0006147 (UMLS CUI [2])
Study Subject Participation Status
Item
patient has been previously enrolled in this study
boolean
C2348568 (UMLS CUI [1])
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