ID

29690

Description

Entecavir and Pegasys Sequential Therapy Versus Pegasys for HBeAg Positive Chronic Hepatitis B; ODM derived from: https://clinicaltrials.gov/show/NCT00921180

Link

https://clinicaltrials.gov/show/NCT00921180

Keywords

  1. 4/12/18 4/12/18 -
  2. 9/27/21 9/27/21 -
Copyright Holder

See clinicaltrials.gov

Uploaded on

April 12, 2018

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 B, Chronic NCT00921180

Eligibility Hepatitis B, Chronic NCT00921180

Inclusion Criteria
Description

Inclusion Criteria

Alias
UMLS CUI
C1512693
chronic hepatitis b (presence of hbsag > 6 months) with hbeag persistence for more than 3 months
Description

Hepatitis B, Chronic | Hepatitis B Surface Antigens Presence | Hepatitis B e Antigens persistent

Data type

boolean

Alias
UMLS CUI [1]
C0524909
UMLS CUI [2,1]
C0019168
UMLS CUI [2,2]
C0150312
UMLS CUI [3,1]
C0019167
UMLS CUI [3,2]
C0205322
age older than 18 years
Description

Age

Data type

boolean

Alias
UMLS CUI [1]
C0001779
hbv dna > 20,000 iu/ml for more than 2 occasions
Description

Hepatitis B DNA Measurement Quantity

Data type

boolean

Alias
UMLS CUI [1,1]
C3641250
UMLS CUI [1,2]
C1265611
serum alt levels between 2 to 10 folds the upper limit of normal (uln)
Description

ALT level raised

Data type

boolean

Alias
UMLS CUI [1]
C1443982
a liver biopsy compatible with chronic hepatitis b
Description

Biopsy of liver Consistent with Chronic Hepatitis B

Data type

boolean

Alias
UMLS CUI [1,1]
C0193388
UMLS CUI [1,2]
C0332290
UMLS CUI [1,3]
C0524909
Exclusion Criteria
Description

Exclusion Criteria

Alias
UMLS CUI
C0680251
anemia (hemoglobin < 13 gram per deciliter for men and < 12 gram per deciliter for women)
Description

Anemia | Hemoglobin measurement | Gender

Data type

boolean

Alias
UMLS CUI [1]
C0002871
UMLS CUI [2]
C0518015
UMLS CUI [3]
C0079399
neutropenia (neutrophil count <1,500 per cubic milliliter)
Description

Neutropenia | Neutrophil count

Data type

boolean

Alias
UMLS CUI [1]
C0027947
UMLS CUI [2]
C0200633
thrombocytopenia (platelet <90,000 per cubic milliliter)
Description

Thrombocytopenia | Platelet Count measurement

Data type

boolean

Alias
UMLS CUI [1]
C0040034
UMLS CUI [2]
C0032181
co-infection with hepatitis b virus (hbv), hepatitis d virus (hdv) or human immunodeficiency virus (hiv)
Description

HBV coinfection | HDV Coinfection | HIV coinfection

Data type

boolean

Alias
UMLS CUI [1]
C2242656
UMLS CUI [2,1]
C0011220
UMLS CUI [2,2]
C0275524
UMLS CUI [3]
C4062778
chronic alcohol abuse (daily consumption > 20 gram per day)
Description

Alcoholic Intoxication, Chronic | Alcohol consumption grams per day

Data type

boolean

Alias
UMLS CUI [1]
C0001973
UMLS CUI [2,1]
C0001948
UMLS CUI [2,2]
C0439417
decompensated liver disease (child-pugh class b or c)
Description

Decompensated liver disease Child-Pugh Classification

Data type

boolean

Alias
UMLS CUI [1,1]
C4075847
UMLS CUI [1,2]
C2347612
serum creatinine level more than 1.5 times the upper limit of normal
Description

Serum creatinine raised

Data type

boolean

Alias
UMLS CUI [1]
C0700225
autoimmune liver disease
Description

Autoimmune liver disease

Data type

boolean

Alias
UMLS CUI [1]
C0400936
neoplastic disease
Description

Neoplastic disease

Data type

boolean

Alias
UMLS CUI [1]
C1882062
an organ transplant
Description

Organ Transplantation

Data type

boolean

Alias
UMLS CUI [1]
C0029216
immunosuppressive therapy
Description

Therapeutic immunosuppression

Data type

boolean

Alias
UMLS CUI [1]
C0021079
poorly controlled autoimmune diseases, pulmonary diseases, cardiac diseases, psychiatric diseases, neurological diseases, diabetes mellitus evidence of drug abuse
Description

Autoimmune Diseases Poorly controlled | Lung diseases Poorly controlled | Heart Diseases Poorly controlled | Mental disorders Poorly controlled | Nervous system disorder Poorly controlled | Poorly controlled diabetes mellitus | Drug abuse

Data type

boolean

Alias
UMLS CUI [1,1]
C0004364
UMLS CUI [1,2]
C3853134
UMLS CUI [2,1]
C0024115
UMLS CUI [2,2]
C3853134
UMLS CUI [3,1]
C0018799
UMLS CUI [3,2]
C3853134
UMLS CUI [4,1]
C0004936
UMLS CUI [4,2]
C3853134
UMLS CUI [5,1]
C0027765
UMLS CUI [5,2]
C3853134
UMLS CUI [6]
C0554876
UMLS CUI [7]
C0013146
unwilling to have contraception
Description

Contraceptive methods Unwilling

Data type

boolean

Alias
UMLS CUI [1,1]
C0700589
UMLS CUI [1,2]
C0558080
known allergic reaction to entecavir or peginterferon alfa-2a
Description

Allergic Reaction Entecavir | Allergic Reaction Peginterferon alfa-2a

Data type

boolean

Alias
UMLS CUI [1,1]
C1527304
UMLS CUI [1,2]
C0971023
UMLS CUI [2,1]
C1527304
UMLS CUI [2,2]
C0391001
unwilling to sign inform consent
Description

Informed Consent Unwilling

Data type

boolean

Alias
UMLS CUI [1,1]
C0021430
UMLS CUI [1,2]
C0558080

Similar models

Eligibility Hepatitis B, Chronic NCT00921180

Name
Type
Description | Question | Decode (Coded Value)
Data type
Alias
Item Group
C1512693 (UMLS CUI)
Hepatitis B, Chronic | Hepatitis B Surface Antigens Presence | Hepatitis B e Antigens persistent
Item
chronic hepatitis b (presence of hbsag > 6 months) with hbeag persistence for more than 3 months
boolean
C0524909 (UMLS CUI [1])
C0019168 (UMLS CUI [2,1])
C0150312 (UMLS CUI [2,2])
C0019167 (UMLS CUI [3,1])
C0205322 (UMLS CUI [3,2])
Age
Item
age older than 18 years
boolean
C0001779 (UMLS CUI [1])
Hepatitis B DNA Measurement Quantity
Item
hbv dna > 20,000 iu/ml for more than 2 occasions
boolean
C3641250 (UMLS CUI [1,1])
C1265611 (UMLS CUI [1,2])
ALT level raised
Item
serum alt levels between 2 to 10 folds the upper limit of normal (uln)
boolean
C1443982 (UMLS CUI [1])
Biopsy of liver Consistent with Chronic Hepatitis B
Item
a liver biopsy compatible with chronic hepatitis b
boolean
C0193388 (UMLS CUI [1,1])
C0332290 (UMLS CUI [1,2])
C0524909 (UMLS CUI [1,3])
Item Group
C0680251 (UMLS CUI)
Anemia | Hemoglobin measurement | Gender
Item
anemia (hemoglobin < 13 gram per deciliter for men and < 12 gram per deciliter for women)
boolean
C0002871 (UMLS CUI [1])
C0518015 (UMLS CUI [2])
C0079399 (UMLS CUI [3])
Neutropenia | Neutrophil count
Item
neutropenia (neutrophil count <1,500 per cubic milliliter)
boolean
C0027947 (UMLS CUI [1])
C0200633 (UMLS CUI [2])
Thrombocytopenia | Platelet Count measurement
Item
thrombocytopenia (platelet <90,000 per cubic milliliter)
boolean
C0040034 (UMLS CUI [1])
C0032181 (UMLS CUI [2])
HBV coinfection | HDV Coinfection | HIV coinfection
Item
co-infection with hepatitis b virus (hbv), hepatitis d virus (hdv) or human immunodeficiency virus (hiv)
boolean
C2242656 (UMLS CUI [1])
C0011220 (UMLS CUI [2,1])
C0275524 (UMLS CUI [2,2])
C4062778 (UMLS CUI [3])
Alcoholic Intoxication, Chronic | Alcohol consumption grams per day
Item
chronic alcohol abuse (daily consumption > 20 gram per day)
boolean
C0001973 (UMLS CUI [1])
C0001948 (UMLS CUI [2,1])
C0439417 (UMLS CUI [2,2])
Decompensated liver disease Child-Pugh Classification
Item
decompensated liver disease (child-pugh class b or c)
boolean
C4075847 (UMLS CUI [1,1])
C2347612 (UMLS CUI [1,2])
Serum creatinine raised
Item
serum creatinine level more than 1.5 times the upper limit of normal
boolean
C0700225 (UMLS CUI [1])
Autoimmune liver disease
Item
autoimmune liver disease
boolean
C0400936 (UMLS CUI [1])
Neoplastic disease
Item
neoplastic disease
boolean
C1882062 (UMLS CUI [1])
Organ Transplantation
Item
an organ transplant
boolean
C0029216 (UMLS CUI [1])
Therapeutic immunosuppression
Item
immunosuppressive therapy
boolean
C0021079 (UMLS CUI [1])
Autoimmune Diseases Poorly controlled | Lung diseases Poorly controlled | Heart Diseases Poorly controlled | Mental disorders Poorly controlled | Nervous system disorder Poorly controlled | Poorly controlled diabetes mellitus | Drug abuse
Item
poorly controlled autoimmune diseases, pulmonary diseases, cardiac diseases, psychiatric diseases, neurological diseases, diabetes mellitus evidence of drug abuse
boolean
C0004364 (UMLS CUI [1,1])
C3853134 (UMLS CUI [1,2])
C0024115 (UMLS CUI [2,1])
C3853134 (UMLS CUI [2,2])
C0018799 (UMLS CUI [3,1])
C3853134 (UMLS CUI [3,2])
C0004936 (UMLS CUI [4,1])
C3853134 (UMLS CUI [4,2])
C0027765 (UMLS CUI [5,1])
C3853134 (UMLS CUI [5,2])
C0554876 (UMLS CUI [6])
C0013146 (UMLS CUI [7])
Contraceptive methods Unwilling
Item
unwilling to have contraception
boolean
C0700589 (UMLS CUI [1,1])
C0558080 (UMLS CUI [1,2])
Allergic Reaction Entecavir | Allergic Reaction Peginterferon alfa-2a
Item
known allergic reaction to entecavir or peginterferon alfa-2a
boolean
C1527304 (UMLS CUI [1,1])
C0971023 (UMLS CUI [1,2])
C1527304 (UMLS CUI [2,1])
C0391001 (UMLS CUI [2,2])
Informed Consent Unwilling
Item
unwilling to sign inform consent
boolean
C0021430 (UMLS CUI [1,1])
C0558080 (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