ID

35969

Beschreibung

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

Stichworte

Versionen (1)
  1. 07.04.19 07.04.19 -
Rechteinhaber

See clinicaltrials.gov

Hochgeladen am

7. April 2019

DOI

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Lizenz

Creative Commons BY 4.0
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Eligibility Hepatitis B NCT02417207

Englisch

Eligibility Hepatitis B NCT02417207

1 Formulare  
Inclusion Criteria
Beschreibung

Inclusion Criteria

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

Correlation Hepatitis B Viral hepatitis | Liver transplant recipient Firstly

Datentyp

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;
Beschreibung

Age

Datentyp

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;
Beschreibung

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

Datentyp

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;
Beschreibung

Donor Hepatitis B surface antigen negative | Virology Negative Liver disease

Datentyp

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.
Beschreibung

Compliance behavior

Datentyp

boolean

Alias
UMLS CUI [1]
C1321605
Exclusion Criteria
Beschreibung

Exclusion Criteria

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

Overlap Viral hepatitis Other

Datentyp

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;
Beschreibung

Correlation End Stage Liver Disease Hepatitis B

Datentyp

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;
Beschreibung

Transplantation of liver Repeated | Organ Transplantation Additional

Datentyp

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;
Beschreibung

Hypersensitivity Hepatitis B immune globulin

Datentyp

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;
Beschreibung

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

Datentyp

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;
Beschreibung

ABO blood group incompatibility Transplantation of liver

Datentyp

boolean

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

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

Datentyp

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.
Beschreibung

Drug resistance Entecavir | Status pre- Transplantation of liver

Datentyp

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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Ähnliche Modelle

Eligibility Hepatitis B NCT02417207

1 Formulare
Name
Typ
Description | Question | Decode (Coded Value)
Datentyp
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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