ID

27844

Description

Efficacy of Clevudine Plus Lamivudine for Lamivudine-resistant Chronic Hepatitis B Patients; ODM derived from: https://clinicaltrials.gov/show/NCT00798460

Link

https://clinicaltrials.gov/show/NCT00798460

Keywords

  1. 11/30/17 11/30/17 -
Copyright Holder

See clinicaltrials.gov

Uploaded on

November 30, 2017

DOI

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License

Creative Commons BY 4.0

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Eligibility Chronic Hepatitis B NCT00798460

Eligibility Chronic Hepatitis B NCT00798460

Inclusion Criteria
Description

Inclusion Criteria

Alias
UMLS CUI
C1512693
hbsag positive and anti-hbs negative more than 6 months
Description

Hepatitis B surface antigen positive | Hepatitis B surface antibody negative

Data type

boolean

Alias
UMLS CUI [1]
C0149709
UMLS CUI [2]
C0744842
ymdd mutation (+)during lamivudine therapy
Description

YMDD mutation | Lamivudine

Data type

boolean

Alias
UMLS CUI [1]
C1717884
UMLS CUI [2]
C0209738
serum alt more than two times upper normal value
Description

Alanine aminotransferase increased

Data type

boolean

Alias
UMLS CUI [1]
C0151905
Exclusion Criteria
Description

Exclusion Criteria

Alias
UMLS CUI
C0680251
hav igm ab + and/or hcv ab+ and/or hdv ab and/or hiv av+
Description

IgM antibody Positive | Hepatitis C Antibody Positive | Hepatitis D antibody | HIV antibody positive

Data type

boolean

Alias
UMLS CUI [1,1]
C1292066
UMLS CUI [1,2]
C1514241
UMLS CUI [2,1]
C0166049
UMLS CUI [2,2]
C1514241
UMLS CUI [3]
C0312635
UMLS CUI [4]
C0920548
the sign of decompensated liver disease
Description

Sign Liver disease Decompensated

Data type

boolean

Alias
UMLS CUI [1,1]
C0311392
UMLS CUI [1,2]
C0023895
UMLS CUI [1,3]
C0205434
pregnant or lactating woman
Description

Pregnancy | Breast Feeding

Data type

boolean

Alias
UMLS CUI [1]
C0032961
UMLS CUI [2]
C0006147
the history of hemoglobinopathy, autoimmune hepatitis, alcoholic liver disease
Description

Hemoglobinopathy | Hepatitis, Autoimmune | Alcoholic Liver Diseases

Data type

boolean

Alias
UMLS CUI [1]
C0019045
UMLS CUI [2]
C0241910
UMLS CUI [3]
C0023896
hemoglobin less than 8 g/dl (male), 7.5g/dl (female) or neutrophil count less than 1500/mm3 or platelet count less than 50,000/mm3
Description

Hemoglobin measurement | Gender | Neutrophil count | Platelet Count measurement

Data type

boolean

Alias
UMLS CUI [1]
C0518015
UMLS CUI [2]
C0079399
UMLS CUI [3]
C0200633
UMLS CUI [4]
C0032181
serum creatinine more than 1.5 times upper normal limit value
Description

Serum creatinine raised

Data type

boolean

Alias
UMLS CUI [1]
C0700225
the sign of malignancy or suggestive of malignancy or the history of malignancy, the recurrence rate within 2 years of which is more than 20%
Description

Sign Malignant Neoplasm | Malignant Neoplasm Suggestive of | Malignant Neoplasms | Recurrence Rate Percentage

Data type

boolean

Alias
UMLS CUI [1,1]
C0311392
UMLS CUI [1,2]
C0006826
UMLS CUI [2,1]
C0006826
UMLS CUI [2,2]
C0332299
UMLS CUI [3]
C0006826
UMLS CUI [4,1]
C0034897
UMLS CUI [4,2]
C1521828
UMLS CUI [4,3]
C0439165

Similar models

Eligibility Chronic Hepatitis B NCT00798460

Name
Type
Description | Question | Decode (Coded Value)
Data type
Alias
Item Group
C1512693 (UMLS CUI)
Hepatitis B surface antigen positive | Hepatitis B surface antibody negative
Item
hbsag positive and anti-hbs negative more than 6 months
boolean
C0149709 (UMLS CUI [1])
C0744842 (UMLS CUI [2])
YMDD mutation | Lamivudine
Item
ymdd mutation (+)during lamivudine therapy
boolean
C1717884 (UMLS CUI [1])
C0209738 (UMLS CUI [2])
Alanine aminotransferase increased
Item
serum alt more than two times upper normal value
boolean
C0151905 (UMLS CUI [1])
Item Group
C0680251 (UMLS CUI)
IgM antibody Positive | Hepatitis C Antibody Positive | Hepatitis D antibody | HIV antibody positive
Item
hav igm ab + and/or hcv ab+ and/or hdv ab and/or hiv av+
boolean
C1292066 (UMLS CUI [1,1])
C1514241 (UMLS CUI [1,2])
C0166049 (UMLS CUI [2,1])
C1514241 (UMLS CUI [2,2])
C0312635 (UMLS CUI [3])
C0920548 (UMLS CUI [4])
Sign Liver disease Decompensated
Item
the sign of decompensated liver disease
boolean
C0311392 (UMLS CUI [1,1])
C0023895 (UMLS CUI [1,2])
C0205434 (UMLS CUI [1,3])
Pregnancy | Breast Feeding
Item
pregnant or lactating woman
boolean
C0032961 (UMLS CUI [1])
C0006147 (UMLS CUI [2])
Hemoglobinopathy | Hepatitis, Autoimmune | Alcoholic Liver Diseases
Item
the history of hemoglobinopathy, autoimmune hepatitis, alcoholic liver disease
boolean
C0019045 (UMLS CUI [1])
C0241910 (UMLS CUI [2])
C0023896 (UMLS CUI [3])
Hemoglobin measurement | Gender | Neutrophil count | Platelet Count measurement
Item
hemoglobin less than 8 g/dl (male), 7.5g/dl (female) or neutrophil count less than 1500/mm3 or platelet count less than 50,000/mm3
boolean
C0518015 (UMLS CUI [1])
C0079399 (UMLS CUI [2])
C0200633 (UMLS CUI [3])
C0032181 (UMLS CUI [4])
Serum creatinine raised
Item
serum creatinine more than 1.5 times upper normal limit value
boolean
C0700225 (UMLS CUI [1])
Sign Malignant Neoplasm | Malignant Neoplasm Suggestive of | Malignant Neoplasms | Recurrence Rate Percentage
Item
the sign of malignancy or suggestive of malignancy or the history of malignancy, the recurrence rate within 2 years of which is more than 20%
boolean
C0311392 (UMLS CUI [1,1])
C0006826 (UMLS CUI [1,2])
C0006826 (UMLS CUI [2,1])
C0332299 (UMLS CUI [2,2])
C0006826 (UMLS CUI [3])
C0034897 (UMLS CUI [4,1])
C1521828 (UMLS CUI [4,2])
C0439165 (UMLS CUI [4,3])

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