ID

41140

Description

Study on the Pharmacokinetic Characteristics of I.V. Hepabig Injection Used for Prevention of Hepatitis B Relapse After Liver Transplantation; ODM derived from: https://clinicaltrials.gov/show/NCT02125071

Link

https://clinicaltrials.gov/show/NCT02125071

Keywords

  1. 6/30/20 6/30/20 -
Copyright Holder

See clinicaltrials.gov

Uploaded on

June 30, 2020

DOI

To request one please log in.

License

Creative Commons BY 4.0

Model comments :

You can comment on the data model here. Via the speech bubbles at the itemgroups and items you can add comments to those specificially.

Itemgroup comments for :

Item comments for :

In order to download data models you must be logged in. Please log in or register for free.

Eligibility Liver Cirrhosis NCT02125071

Eligibility Liver Cirrhosis NCT02125071

Inclusion Criteria
Description

Inclusion Criteria

Alias
UMLS CUI
C1512693
male or female ≤18 years old
Description

Age

Data type

boolean

Alias
UMLS CUI [1]
C0001779
patients who understand the informed consent form and signed the form voluntarily
Description

Informed Consent

Data type

boolean

Alias
UMLS CUI [1]
C0021430
patients who underwent liver transplantation due to hbv related disease and will be treated for prevention of hepatitis b relapse after liver transplantation
Description

Transplantation of liver Due to Hepatitis B | Prophylactic treatment Hepatitis B Relapse | Status post Transplantation of liver

Data type

boolean

Alias
UMLS CUI [1,1]
C0023911
UMLS CUI [1,2]
C0678226
UMLS CUI [1,3]
C0019163
UMLS CUI [2,1]
C0199176
UMLS CUI [2,2]
C0019163
UMLS CUI [2,3]
C0035020
UMLS CUI [3,1]
C0231290
UMLS CUI [3,2]
C0023911
Exclusion Criteria
Description

Exclusion Criteria

Alias
UMLS CUI
C0680251
multi-organ recipient or reimplantation
Description

Recipient Organ multiple | Surgical Replantation

Data type

boolean

Alias
UMLS CUI [1,1]
C1709854
UMLS CUI [1,2]
C0178784
UMLS CUI [1,3]
C0439064
UMLS CUI [2]
C0035139
iga deficiency
Description

Immunoglobulin A deficiency

Data type

boolean

Alias
UMLS CUI [1]
C0162538
serious nephropathy
Description

Kidney Disease Serious

Data type

boolean

Alias
UMLS CUI [1,1]
C0022658
UMLS CUI [1,2]
C0205404
serious cardiovascular system failure within 6 months
Description

Cardiovascular system Failure Serious

Data type

boolean

Alias
UMLS CUI [1,1]
C0007226
UMLS CUI [1,2]
C0231174
UMLS CUI [1,3]
C0205404
ischemic or hemolytic anemia
Description

Anemia Ischemic | Anemia, Hemolytic

Data type

boolean

Alias
UMLS CUI [1,1]
C0002871
UMLS CUI [1,2]
C0475224
UMLS CUI [2]
C0002878
condition of immunosuppression and immunodeficiency
Description

Immunosuppression | Immunodeficiency

Data type

boolean

Alias
UMLS CUI [1]
C4048329
UMLS CUI [2]
C0021051
hypersensitivity or allergic to blood products
Description

Hypersensitivity Blood product

Data type

boolean

Alias
UMLS CUI [1,1]
C0020517
UMLS CUI [1,2]
C0456388
hiv or hcv positive
Description

HIV Seropositivity | Hepatitis C Virus Positive

Data type

boolean

Alias
UMLS CUI [1]
C0019699
UMLS CUI [2]
C4330254
participation to other clinical trial within 3 months
Description

Study Subject Participation Status | Clinical Trial

Data type

boolean

Alias
UMLS CUI [1]
C2348568
UMLS CUI [2]
C0008976
pregnancy or breast feeding
Description

Pregnancy | Breast Feeding

Data type

boolean

Alias
UMLS CUI [1]
C0032961
UMLS CUI [2]
C0006147
those who the investigator determines inappropriate to participate
Description

Study Subject Participation Status Inappropriate

Data type

boolean

Alias
UMLS CUI [1,1]
C2348568
UMLS CUI [1,2]
C1548788

Similar models

Eligibility Liver Cirrhosis NCT02125071

Name
Type
Description | Question | Decode (Coded Value)
Data type
Alias
Item Group
C1512693 (UMLS CUI)
Age
Item
male or female ≤18 years old
boolean
C0001779 (UMLS CUI [1])
Informed Consent
Item
patients who understand the informed consent form and signed the form voluntarily
boolean
C0021430 (UMLS CUI [1])
Transplantation of liver Due to Hepatitis B | Prophylactic treatment Hepatitis B Relapse | Status post Transplantation of liver
Item
patients who underwent liver transplantation due to hbv related disease and will be treated for prevention of hepatitis b relapse after liver transplantation
boolean
C0023911 (UMLS CUI [1,1])
C0678226 (UMLS CUI [1,2])
C0019163 (UMLS CUI [1,3])
C0199176 (UMLS CUI [2,1])
C0019163 (UMLS CUI [2,2])
C0035020 (UMLS CUI [2,3])
C0231290 (UMLS CUI [3,1])
C0023911 (UMLS CUI [3,2])
Item Group
C0680251 (UMLS CUI)
Recipient Organ multiple | Surgical Replantation
Item
multi-organ recipient or reimplantation
boolean
C1709854 (UMLS CUI [1,1])
C0178784 (UMLS CUI [1,2])
C0439064 (UMLS CUI [1,3])
C0035139 (UMLS CUI [2])
Immunoglobulin A deficiency
Item
iga deficiency
boolean
C0162538 (UMLS CUI [1])
Kidney Disease Serious
Item
serious nephropathy
boolean
C0022658 (UMLS CUI [1,1])
C0205404 (UMLS CUI [1,2])
Cardiovascular system Failure Serious
Item
serious cardiovascular system failure within 6 months
boolean
C0007226 (UMLS CUI [1,1])
C0231174 (UMLS CUI [1,2])
C0205404 (UMLS CUI [1,3])
Anemia Ischemic | Anemia, Hemolytic
Item
ischemic or hemolytic anemia
boolean
C0002871 (UMLS CUI [1,1])
C0475224 (UMLS CUI [1,2])
C0002878 (UMLS CUI [2])
Immunosuppression | Immunodeficiency
Item
condition of immunosuppression and immunodeficiency
boolean
C4048329 (UMLS CUI [1])
C0021051 (UMLS CUI [2])
Hypersensitivity Blood product
Item
hypersensitivity or allergic to blood products
boolean
C0020517 (UMLS CUI [1,1])
C0456388 (UMLS CUI [1,2])
HIV Seropositivity | Hepatitis C Virus Positive
Item
hiv or hcv positive
boolean
C0019699 (UMLS CUI [1])
C4330254 (UMLS CUI [2])
Study Subject Participation Status | Clinical Trial
Item
participation to other clinical trial within 3 months
boolean
C2348568 (UMLS CUI [1])
C0008976 (UMLS CUI [2])
Pregnancy | Breast Feeding
Item
pregnancy or breast feeding
boolean
C0032961 (UMLS CUI [1])
C0006147 (UMLS CUI [2])
Study Subject Participation Status Inappropriate
Item
those who the investigator determines inappropriate to participate
boolean
C2348568 (UMLS CUI [1,1])
C1548788 (UMLS CUI [1,2])

Please use this form for feedback, questions and suggestions for improvements.

Fields marked with * are required.

Do you need help on how to use the search function? Please watch the corresponding tutorial video for more details and learn how to use the search function most efficiently.

Watch Tutorial