ID

17551

Description

Telbivudine Versus Lamivudine in Adults With Decompensated Chronic Hepatitis B and Evidence of Cirrhosis; ODM derived from: https://clinicaltrials.gov/show/NCT00076336

Link

https://clinicaltrials.gov/show/NCT00076336

Keywords

  1. 9/23/16 9/23/16 -
Uploaded on

September 23, 2016

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 Hepatitis NCT00076336

Eligibility Hepatitis NCT00076336

  1. StudyEvent: Eligibility
    1. Eligibility Hepatitis NCT00076336
Inclusion Criteria
Description

Inclusion Criteria

Alias
UMLS CUI
C1512693
documented decompensated chronic hepatitis b defined by all of the following: 1. clinical history compatible with decompensated chronic hepatitis b related cirrhosis;
Description

Hepatitis B, Chronic; Decompensated | Decompensated Chronic Hepatitis B Related Liver Cirrhosis

Data type

boolean

Alias
UMLS CUI [1,1]
C0524909
UMLS CUI [1,2]
C0205434
UMLS CUI [2,1]
C0524909
UMLS CUI [2,2]
C0205434
UMLS CUI [2,3]
C0439849
UMLS CUI [2,4]
C0023890
2. child-turcotte-pugh score > 7 points.
Description

Child-Pugh-Turcotte score

Data type

boolean

Alias
UMLS CUI [1]
C3854424
evidence of hepatic cirrhosis or portal hypertension.
Description

Liver Cirrhosis Evidence of | Portal Hypertension Evidence of

Data type

boolean

Alias
UMLS CUI [1,1]
C0023890
UMLS CUI [1,2]
C0332120
UMLS CUI [2,1]
C0020541
UMLS CUI [2,2]
C0332120
other protocol-defined inclusion criteria may apply.
Description

Inclusion criteria Study Protocol

Data type

boolean

Alias
UMLS CUI [1,1]
C1512693
UMLS CUI [1,2]
C2348563
Exclusion Criteria
Description

Exclusion Criteria

Alias
UMLS CUI
C0680251
patient is pregnant or breastfeeding.
Description

Pregnancy | Breast Feeding

Data type

boolean

Alias
UMLS CUI [1]
C0032961
UMLS CUI [2]
C0006147
patient is coinfected with hepatitis c virus (hcv), hepatitis d virus (hdv), or human immunodeficiency virus (hiv).
Description

HCV coinfection | HDV Coinfection | HIV coinfection

Data type

boolean

Alias
UMLS CUI [1]
C1698259
UMLS CUI [2,1]
C0011220
UMLS CUI [2,2]
C0275524
UMLS CUI [3]
C4062778
patient previously received lamivudine, adefovir, or an investigational anti-hepatitis b virus (hbv) nucleoside or nucleotide analog at any time
Description

Lamivudine | adefovir | Nucleosides Investigational Against Hepatitis B Virus | nucleotide analog

Data type

boolean

Alias
UMLS CUI [1]
C0209738
UMLS CUI [2]
C0050175
UMLS CUI [3,1]
C0028621
UMLS CUI [3,2]
C1517586
UMLS CUI [3,3]
C0521124
UMLS CUI [3,4]
C0019169
UMLS CUI [4]
C0597107
patient has received interferon or other immunomodulatory treatment for hbv infection in the 12 months before screening for this study.
Description

interferon | Biological Response Modifier Therapy Hepatitis B

Data type

boolean

Alias
UMLS CUI [1]
C0733470
UMLS CUI [2,1]
C0005527
UMLS CUI [2,2]
C0019163
other protocol-defined exclusion criteria may apply.
Description

Exclusion Criteria Study Protocol

Data type

boolean

Alias
UMLS CUI [1,1]
C0680251
UMLS CUI [1,2]
C2348563

Similar models

Eligibility Hepatitis NCT00076336

  1. StudyEvent: Eligibility
    1. Eligibility Hepatitis NCT00076336
Name
Type
Description | Question | Decode (Coded Value)
Data type
Alias
Item Group
C1512693 (UMLS CUI)
Hepatitis B, Chronic; Decompensated | Decompensated Chronic Hepatitis B Related Liver Cirrhosis
Item
documented decompensated chronic hepatitis b defined by all of the following: 1. clinical history compatible with decompensated chronic hepatitis b related cirrhosis;
boolean
C0524909 (UMLS CUI [1,1])
C0205434 (UMLS CUI [1,2])
C0524909 (UMLS CUI [2,1])
C0205434 (UMLS CUI [2,2])
C0439849 (UMLS CUI [2,3])
C0023890 (UMLS CUI [2,4])
Child-Pugh-Turcotte score
Item
2. child-turcotte-pugh score > 7 points.
boolean
C3854424 (UMLS CUI [1])
Liver Cirrhosis Evidence of | Portal Hypertension Evidence of
Item
evidence of hepatic cirrhosis or portal hypertension.
boolean
C0023890 (UMLS CUI [1,1])
C0332120 (UMLS CUI [1,2])
C0020541 (UMLS CUI [2,1])
C0332120 (UMLS CUI [2,2])
Inclusion criteria Study Protocol
Item
other protocol-defined inclusion criteria may apply.
boolean
C1512693 (UMLS CUI [1,1])
C2348563 (UMLS CUI [1,2])
Item Group
C0680251 (UMLS CUI)
Pregnancy | Breast Feeding
Item
patient is pregnant or breastfeeding.
boolean
C0032961 (UMLS CUI [1])
C0006147 (UMLS CUI [2])
HCV coinfection | HDV Coinfection | HIV coinfection
Item
patient is coinfected with hepatitis c virus (hcv), hepatitis d virus (hdv), or human immunodeficiency virus (hiv).
boolean
C1698259 (UMLS CUI [1])
C0011220 (UMLS CUI [2,1])
C0275524 (UMLS CUI [2,2])
C4062778 (UMLS CUI [3])
Lamivudine | adefovir | Nucleosides Investigational Against Hepatitis B Virus | nucleotide analog
Item
patient previously received lamivudine, adefovir, or an investigational anti-hepatitis b virus (hbv) nucleoside or nucleotide analog at any time
boolean
C0209738 (UMLS CUI [1])
C0050175 (UMLS CUI [2])
C0028621 (UMLS CUI [3,1])
C1517586 (UMLS CUI [3,2])
C0521124 (UMLS CUI [3,3])
C0019169 (UMLS CUI [3,4])
C0597107 (UMLS CUI [4])
interferon | Biological Response Modifier Therapy Hepatitis B
Item
patient has received interferon or other immunomodulatory treatment for hbv infection in the 12 months before screening for this study.
boolean
C0733470 (UMLS CUI [1])
C0005527 (UMLS CUI [2,1])
C0019163 (UMLS CUI [2,2])
Exclusion Criteria Study Protocol
Item
other protocol-defined exclusion criteria may apply.
boolean
C0680251 (UMLS CUI [1,1])
C2348563 (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