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ID

35969

Description

Entecavir Combined Short-term Intravenous Hepatitis B Immune Globulin (HBIG) to Prevent Hepatitis B Recurrence After Liver Transplantation; ODM derived from: https://clinicaltrials.gov/show/NCT02417207

Link

https://clinicaltrials.gov/show/NCT02417207

Keywords

Versions (1)
  1. 4/7/19 4/7/19 -
Copyright Holder

See clinicaltrials.gov

Uploaded on

April 7, 2019

DOI

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License

Creative Commons BY 4.0
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    Eligibility Hepatitis B NCT02417207

    English

    Eligibility Hepatitis B NCT02417207

    1 forms  
    Inclusion Criteria
    Description

    Inclusion Criteria

    Alias
    UMLS CUI
    C1512693
    1. correlation disease hepatitis b viral hepatitis liver transplantation recipients for the first time;
    Description

    Correlation Hepatitis B Viral hepatitis | Liver transplant recipient Firstly

    Data type

    boolean

    Alias
    UMLS CUI [1,1]
    C1707520
    UMLS CUI [1,2]
    C0019163
    UMLS CUI [1,3]
    C0042721
    UMLS CUI [2,1]
    C3811922
    UMLS CUI [2,2]
    C1279901
    2. older than 18 years old, men and women not limited;
    Description

    Age

    Data type

    boolean

    Alias
    UMLS CUI [1]
    C0001779
    3. preoperative hbsag positive, regardless of whether preoperative hbv dna level, regardless of whether preoperative antiviral treatment, regardless of whether associated with primary liver cancer;
    Description

    Hepatitis B surface antigen positive Preoperative | Independent of Hepatitis B DNA Measurement Preoperative | Independent of Antiviral treatment Preoperative | Independent of Liver carcinoma

    Data type

    boolean

    Alias
    UMLS CUI [1,1]
    C0149709
    UMLS CUI [1,2]
    C0445204
    UMLS CUI [2,1]
    C0332291
    UMLS CUI [2,2]
    C3641250
    UMLS CUI [2,3]
    C0445204
    UMLS CUI [3,1]
    C0332291
    UMLS CUI [3,2]
    C2363964
    UMLS CUI [3,3]
    C0445204
    UMLS CUI [4,1]
    C0332291
    UMLS CUI [4,2]
    C2239176
    4. donor hbsag negative, other virology negative in liver conditions;
    Description

    Donor Hepatitis B surface antigen negative | Virology Negative Liver disease

    Data type

    boolean

    Alias
    UMLS CUI [1,1]
    C0013018
    UMLS CUI [1,2]
    C0919711
    UMLS CUI [2,1]
    C0205466
    UMLS CUI [2,2]
    C1513916
    UMLS CUI [2,3]
    C0023895
    5. to integrate research, good adherence.
    Description

    Compliance behavior

    Data type

    boolean

    Alias
    UMLS CUI [1]
    C1321605
    Exclusion Criteria
    Description

    Exclusion Criteria

    Alias
    UMLS CUI
    C0680251
    1. overlap other types of viral hepatitis;
    Description

    Overlap Viral hepatitis Other

    Data type

    boolean

    Alias
    UMLS CUI [1,1]
    C1948020
    UMLS CUI [1,2]
    C0042721
    UMLS CUI [1,3]
    C0205394
    2. the correlation of end-stage liver disease hepatitis b;
    Description

    Correlation End Stage Liver Disease Hepatitis B

    Data type

    boolean

    Alias
    UMLS CUI [1,1]
    C1707520
    UMLS CUI [1,2]
    C0745744
    UMLS CUI [1,3]
    C0019163
    3. again to liver transplantation, or joint organ transplantation;
    Description

    Transplantation of liver Repeated | Organ Transplantation Additional

    Data type

    boolean

    Alias
    UMLS CUI [1,1]
    C0023911
    UMLS CUI [1,2]
    C0205341
    UMLS CUI [2,1]
    C0029216
    UMLS CUI [2,2]
    C1524062
    4. allergic to hepatitis b immune globulin;
    Description

    Hypersensitivity Hepatitis B immune globulin

    Data type

    boolean

    Alias
    UMLS CUI [1,1]
    C0020517
    UMLS CUI [1,2]
    C0062525
    5. of primary hepatocellular carcinoma with vena cava, portal vein around the trunk or branch, hepatic vein and other large vascular invasion;
    Description

    Liver carcinoma | Vena cava Invasion | Portal vein Invasion | Hepatic vein Invasion | Invasion Vascular Large

    Data type

    boolean

    Alias
    UMLS CUI [1]
    C2239176
    UMLS CUI [2,1]
    C0042460
    UMLS CUI [2,2]
    C1269955
    UMLS CUI [3,1]
    C1305775
    UMLS CUI [3,2]
    C1269955
    UMLS CUI [4,1]
    C0019155
    UMLS CUI [4,2]
    C1269955
    UMLS CUI [5,1]
    C1269955
    UMLS CUI [5,2]
    C1801960
    UMLS CUI [5,3]
    C0549177
    6. abo blood group incompatibility in liver transplantation;
    Description

    ABO blood group incompatibility Transplantation of liver

    Data type

    boolean

    Alias
    UMLS CUI [1,1]
    C4540767
    UMLS CUI [1,2]
    C0023911
    7. moderately severe renal insufficiency, serum creatinine 180 umol/l or higher;
    Description

    Renal Insufficiency Moderate | Renal Insufficiency Severe | Creatinine measurement, serum

    Data type

    boolean

    Alias
    UMLS CUI [1,1]
    C1565489
    UMLS CUI [1,2]
    C0205081
    UMLS CUI [2,1]
    C1565489
    UMLS CUI [2,2]
    C0205082
    UMLS CUI [3]
    C0201976
    8. there has been a drug resistance of entecavir before liver transplantation.
    Description

    Drug resistance Entecavir | Status pre- Transplantation of liver

    Data type

    boolean

    Alias
    UMLS CUI [1,1]
    C0013203
    UMLS CUI [1,2]
    C0971023
    UMLS CUI [2,1]
    C0332152
    UMLS CUI [2,2]
    C0023911
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    Similar models

    Eligibility Hepatitis B NCT02417207

    1 forms
    Name
    Type
    Description | Question | Decode (Coded Value)
    Data type
    Alias
    Item Group
    C1512693 (UMLS CUI)
    Correlation Hepatitis B Viral hepatitis | Liver transplant recipient Firstly
    Item
    1. correlation disease hepatitis b viral hepatitis liver transplantation recipients for the first time;
    boolean
    C1707520 (UMLS CUI [1,1])
    C0019163 (UMLS CUI [1,2])
    C0042721 (UMLS CUI [1,3])
    C3811922 (UMLS CUI [2,1])
    C1279901 (UMLS CUI [2,2])
    Age
    Item
    2. older than 18 years old, men and women not limited;
    boolean
    C0001779 (UMLS CUI [1])
    Hepatitis B surface antigen positive Preoperative | Independent of Hepatitis B DNA Measurement Preoperative | Independent of Antiviral treatment Preoperative | Independent of Liver carcinoma
    Item
    3. preoperative hbsag positive, regardless of whether preoperative hbv dna level, regardless of whether preoperative antiviral treatment, regardless of whether associated with primary liver cancer;
    boolean
    C0149709 (UMLS CUI [1,1])
    C0445204 (UMLS CUI [1,2])
    C0332291 (UMLS CUI [2,1])
    C3641250 (UMLS CUI [2,2])
    C0445204 (UMLS CUI [2,3])
    C0332291 (UMLS CUI [3,1])
    C2363964 (UMLS CUI [3,2])
    C0445204 (UMLS CUI [3,3])
    C0332291 (UMLS CUI [4,1])
    C2239176 (UMLS CUI [4,2])
    Donor Hepatitis B surface antigen negative | Virology Negative Liver disease
    Item
    4. donor hbsag negative, other virology negative in liver conditions;
    boolean
    C0013018 (UMLS CUI [1,1])
    C0919711 (UMLS CUI [1,2])
    C0205466 (UMLS CUI [2,1])
    C1513916 (UMLS CUI [2,2])
    C0023895 (UMLS CUI [2,3])
    Compliance behavior
    Item
    5. to integrate research, good adherence.
    boolean
    C1321605 (UMLS CUI [1])
    Item Group
    C0680251 (UMLS CUI)
    Overlap Viral hepatitis Other
    Item
    1. overlap other types of viral hepatitis;
    boolean
    C1948020 (UMLS CUI [1,1])
    C0042721 (UMLS CUI [1,2])
    C0205394 (UMLS CUI [1,3])
    Correlation End Stage Liver Disease Hepatitis B
    Item
    2. the correlation of end-stage liver disease hepatitis b;
    boolean
    C1707520 (UMLS CUI [1,1])
    C0745744 (UMLS CUI [1,2])
    C0019163 (UMLS CUI [1,3])
    Transplantation of liver Repeated | Organ Transplantation Additional
    Item
    3. again to liver transplantation, or joint organ transplantation;
    boolean
    C0023911 (UMLS CUI [1,1])
    C0205341 (UMLS CUI [1,2])
    C0029216 (UMLS CUI [2,1])
    C1524062 (UMLS CUI [2,2])
    Hypersensitivity Hepatitis B immune globulin
    Item
    4. allergic to hepatitis b immune globulin;
    boolean
    C0020517 (UMLS CUI [1,1])
    C0062525 (UMLS CUI [1,2])
    Liver carcinoma | Vena cava Invasion | Portal vein Invasion | Hepatic vein Invasion | Invasion Vascular Large
    Item
    5. of primary hepatocellular carcinoma with vena cava, portal vein around the trunk or branch, hepatic vein and other large vascular invasion;
    boolean
    C2239176 (UMLS CUI [1])
    C0042460 (UMLS CUI [2,1])
    C1269955 (UMLS CUI [2,2])
    C1305775 (UMLS CUI [3,1])
    C1269955 (UMLS CUI [3,2])
    C0019155 (UMLS CUI [4,1])
    C1269955 (UMLS CUI [4,2])
    C1269955 (UMLS CUI [5,1])
    C1801960 (UMLS CUI [5,2])
    C0549177 (UMLS CUI [5,3])
    ABO blood group incompatibility Transplantation of liver
    Item
    6. abo blood group incompatibility in liver transplantation;
    boolean
    C4540767 (UMLS CUI [1,1])
    C0023911 (UMLS CUI [1,2])
    Renal Insufficiency Moderate | Renal Insufficiency Severe | Creatinine measurement, serum
    Item
    7. moderately severe renal insufficiency, serum creatinine 180 umol/l or higher;
    boolean
    C1565489 (UMLS CUI [1,1])
    C0205081 (UMLS CUI [1,2])
    C1565489 (UMLS CUI [2,1])
    C0205082 (UMLS CUI [2,2])
    C0201976 (UMLS CUI [3])
    Drug resistance Entecavir | Status pre- Transplantation of liver
    Item
    8. there has been a drug resistance of entecavir before liver transplantation.
    boolean
    C0013203 (UMLS CUI [1,1])
    C0971023 (UMLS CUI [1,2])
    C0332152 (UMLS CUI [2,1])
    C0023911 (UMLS CUI [2,2])
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