ID

39750

Description

Using Entecavir to Reduce Hepatitis in Highly Viremic HBV Patients During Anti-tuberculous Treatment; ODM derived from: https://clinicaltrials.gov/show/NCT01724723

Link

https://clinicaltrials.gov/show/NCT01724723

Keywords

Versions (1)
  1. 2/16/20 2/16/20 -
Copyright Holder

See clinicaltrials.gov

Uploaded on

February 16, 2020

DOI

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License

Creative Commons BY 4.0
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Eligibility Hepatitis NCT01724723

English

Eligibility Hepatitis NCT01724723

1 forms  
  1. StudyEvent: Eligibility
    1. Eligibility Hepatitis NCT01724723
Inclusion Criteria
Description

Inclusion Criteria

Alias
UMLS CUI
C1512693
culture-confirmed tuberculosis
Description

Tuberculosis

Data type

boolean

Alias
UMLS CUI [1]
C0041296
serology-confirmed chronic hbv infection without flare-up at present (igm anti-hbc-negative and either hbsag-positive or anti-hbc-positive)
Description

Hepatitis B, Chronic | Flare-up Absent | Hepatitis B core IgM antibody test Negative | Hepatitis B surface antigen positive | Hepatitis B core antibody positive

Data type

boolean

Alias
UMLS CUI [1]
C0524909
UMLS CUI [2,1]
C3830105
UMLS CUI [2,2]
C0332197
UMLS CUI [3,1]
C1277836
UMLS CUI [3,2]
C1513916
UMLS CUI [4]
C0149709
UMLS CUI [5]
C0262506
high serum hbv viral load, defined as >20,000 and >2,000 iu/ml for hbeag positive and hbeag negative patients, respectively
Description

Serum HBV viral load increased | Hepatitis B e antigen positive | Hepatitis B e antigen negative

Data type

boolean

Alias
UMLS CUI [1,1]
C0229671
UMLS CUI [1,2]
C2363760
UMLS CUI [2]
C0392390
UMLS CUI [3]
C0948827
serum ast and/or alt level <2 times uln
Description

Aspartate aminotransferase measurement | Alanine aminotransferase measurement

Data type

boolean

Alias
UMLS CUI [1]
C0201899
UMLS CUI [2]
C0201836
serum level of total bilirubin <2.0 mg/dl
Description

Serum total bilirubin measurement

Data type

boolean

Alias
UMLS CUI [1]
C1278039
willing to receive directly observed therapy, short course (dots)
Description

Directly Observed Therapy Course short-term

Data type

boolean

Alias
UMLS CUI [1,1]
C0872145
UMLS CUI [1,2]
C0750729
UMLS CUI [1,3]
C0443303
Exclusion Criteria
Description

Exclusion Criteria

Alias
UMLS CUI
C0680251
target disease exceptions: human immunodeficiency virus (hiv), hepatitis c virus (hcv) or hepatitis d virus (hdv) co-infection, multidrug-resistant tuberculosis (defined as simultaneous resistant to isoniazid and rifampin)
Description

Target Disease Exception | Human immunodeficiency virus (HIV) coinfection | HCV coinfection | Coinfection Hepatitis Delta Virus | Tuberculosis, Multidrug-Resistant | Resistant to Isoniazid | Resistant to Rifampin

Data type

boolean

Alias
UMLS CUI [1,1]
C1521840
UMLS CUI [1,2]
C0012634
UMLS CUI [1,3]
C1705847
UMLS CUI [2]
C4062778
UMLS CUI [3]
C1698259
UMLS CUI [4,1]
C0275524
UMLS CUI [4,2]
C0011220
UMLS CUI [5]
C0206526
UMLS CUI [6,1]
C0332325
UMLS CUI [6,2]
C0022209
UMLS CUI [7,1]
C0332325
UMLS CUI [7,2]
C0035608
medical history and concurrent diseases
Description

Medical History | Comorbidity

Data type

boolean

Alias
UMLS CUI [1]
C0262926
UMLS CUI [2]
C0009488
1. . ever receiving anti-viral therapy for hbv
Description

Antiviral Therapy HBV

Data type

boolean

Alias
UMLS CUI [1,1]
C0280274
UMLS CUI [1,2]
C0019169
2. . alcoholism or presence of hepatic disease other than hepatitis b
Description

Alcoholic Intoxication, Chronic | Liver disease | Exception Hepatitis B

Data type

boolean

Alias
UMLS CUI [1]
C0001973
UMLS CUI [2]
C0023895
UMLS CUI [3,1]
C1705847
UMLS CUI [3,2]
C0019163
3. . life expectancy less than 1 year
Description

Life Expectancy

Data type

boolean

Alias
UMLS CUI [1]
C0023671
sex and reproductive status
Description

Gender | Status reproductive

Data type

boolean

Alias
UMLS CUI [1]
C0079399
UMLS CUI [2,1]
C0449438
UMLS CUI [2,2]
C0035150
1. . pregnancy
Description

Pregnancy

Data type

boolean

Alias
UMLS CUI [1]
C0032961
2. . breast-feeding
Description

Breast Feeding

Data type

boolean

Alias
UMLS CUI [1]
C0006147
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Similar models

Eligibility Hepatitis NCT01724723

1 forms
  1. StudyEvent: Eligibility
    1. Eligibility Hepatitis NCT01724723
Name
Type
Description | Question | Decode (Coded Value)
Data type
Alias
Item Group
C1512693 (UMLS CUI)
Tuberculosis
Item
culture-confirmed tuberculosis
boolean
C0041296 (UMLS CUI [1])
Hepatitis B, Chronic | Flare-up Absent | Hepatitis B core IgM antibody test Negative | Hepatitis B surface antigen positive | Hepatitis B core antibody positive
Item
serology-confirmed chronic hbv infection without flare-up at present (igm anti-hbc-negative and either hbsag-positive or anti-hbc-positive)
boolean
C0524909 (UMLS CUI [1])
C3830105 (UMLS CUI [2,1])
C0332197 (UMLS CUI [2,2])
C1277836 (UMLS CUI [3,1])
C1513916 (UMLS CUI [3,2])
C0149709 (UMLS CUI [4])
C0262506 (UMLS CUI [5])
Serum HBV viral load increased | Hepatitis B e antigen positive | Hepatitis B e antigen negative
Item
high serum hbv viral load, defined as >20,000 and >2,000 iu/ml for hbeag positive and hbeag negative patients, respectively
boolean
C0229671 (UMLS CUI [1,1])
C2363760 (UMLS CUI [1,2])
C0392390 (UMLS CUI [2])
C0948827 (UMLS CUI [3])
Aspartate aminotransferase measurement | Alanine aminotransferase measurement
Item
serum ast and/or alt level <2 times uln
boolean
C0201899 (UMLS CUI [1])
C0201836 (UMLS CUI [2])
Serum total bilirubin measurement
Item
serum level of total bilirubin <2.0 mg/dl
boolean
C1278039 (UMLS CUI [1])
Directly Observed Therapy Course short-term
Item
willing to receive directly observed therapy, short course (dots)
boolean
C0872145 (UMLS CUI [1,1])
C0750729 (UMLS CUI [1,2])
C0443303 (UMLS CUI [1,3])
Item Group
C0680251 (UMLS CUI)
Target Disease Exception | Human immunodeficiency virus (HIV) coinfection | HCV coinfection | Coinfection Hepatitis Delta Virus | Tuberculosis, Multidrug-Resistant | Resistant to Isoniazid | Resistant to Rifampin
Item
target disease exceptions: human immunodeficiency virus (hiv), hepatitis c virus (hcv) or hepatitis d virus (hdv) co-infection, multidrug-resistant tuberculosis (defined as simultaneous resistant to isoniazid and rifampin)
boolean
C1521840 (UMLS CUI [1,1])
C0012634 (UMLS CUI [1,2])
C1705847 (UMLS CUI [1,3])
C4062778 (UMLS CUI [2])
C1698259 (UMLS CUI [3])
C0275524 (UMLS CUI [4,1])
C0011220 (UMLS CUI [4,2])
C0206526 (UMLS CUI [5])
C0332325 (UMLS CUI [6,1])
C0022209 (UMLS CUI [6,2])
C0332325 (UMLS CUI [7,1])
C0035608 (UMLS CUI [7,2])
Medical History | Comorbidity
Item
medical history and concurrent diseases
boolean
C0262926 (UMLS CUI [1])
C0009488 (UMLS CUI [2])
Antiviral Therapy HBV
Item
1. . ever receiving anti-viral therapy for hbv
boolean
C0280274 (UMLS CUI [1,1])
C0019169 (UMLS CUI [1,2])
Alcoholic Intoxication, Chronic | Liver disease | Exception Hepatitis B
Item
2. . alcoholism or presence of hepatic disease other than hepatitis b
boolean
C0001973 (UMLS CUI [1])
C0023895 (UMLS CUI [2])
C1705847 (UMLS CUI [3,1])
C0019163 (UMLS CUI [3,2])
Life Expectancy
Item
3. . life expectancy less than 1 year
boolean
C0023671 (UMLS CUI [1])
Gender | Status reproductive
Item
sex and reproductive status
boolean
C0079399 (UMLS CUI [1])
C0449438 (UMLS CUI [2,1])
C0035150 (UMLS CUI [2,2])
Pregnancy
Item
1. . pregnancy
boolean
C0032961 (UMLS CUI [1])
Breast Feeding
Item
2. . breast-feeding
boolean
C0006147 (UMLS CUI [1])
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