ID

27825

Description

Efficacy Study of Prednisone Priming to Treat Asian Chronic Hepatitis B Patients; ODM derived from: https://clinicaltrials.gov/show/NCT00715715

Link

https://clinicaltrials.gov/show/NCT00715715

Keywords

Versions (1)
  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 NCT00715715

English

Eligibility Chronic Hepatitis B NCT00715715

1 forms  
Inclusion Criteria
Description

Inclusion Criteria

Alias
UMLS CUI
C1512693
this study is seeking patients with the following:
Description

Client Characteristics

Data type

boolean

Alias
UMLS CUI [1]
C0815172
asians older than 16 years of age
Description

Asians | Age

Data type

boolean

Alias
UMLS CUI [1]
C0078988
UMLS CUI [2]
C0001779
hbeag-positive chronic hepatitis b, and
Description

Chronic Hepatitis B HBeAg positive

Data type

boolean

Alias
UMLS CUI [1,1]
C0524909
UMLS CUI [1,2]
C0392390
good liver function
Description

Liver function

Data type

boolean

Alias
UMLS CUI [1]
C0232741
positive hepatitis b surface antigen (hbsag) for at least 24 weeks before screening
Description

Hepatitis B surface antigen positive

Data type

boolean

Alias
UMLS CUI [1]
C0149709
liver biopsy in the past year showing of chronic hepatitis
Description

Chronic Hepatitis Biopsy of liver

Data type

boolean

Alias
UMLS CUI [1,1]
C0019189
UMLS CUI [1,2]
C0193388
blood testing showing hbv dna in the past 4 weeks before screening
Description

Hepatitis B DNA detectable Hematologic Tests

Data type

boolean

Alias
UMLS CUI [1,1]
C1096264
UMLS CUI [1,2]
C0018941
blood test showing high hbv dna level (at least 20,000 iu/ml); and
Description

HBV DNA increased Hematologic Test

Data type

boolean

Alias
UMLS CUI [1,1]
C1262159
UMLS CUI [1,2]
C0018941
liver function test showing high serum alt level (1.0 to 5.0 times the upper limit of normal).
Description

Alanine aminotransferase increased Liver Function Tests

Data type

boolean

Alias
UMLS CUI [1,1]
C0151905
UMLS CUI [1,2]
C0023901
Exclusion Criteria
Description

Exclusion Criteria

Alias
UMLS CUI
C0680251
ongoing drug abuse
Description

Drug abuse

Data type

boolean

Alias
UMLS CUI [1]
C0013146
active alcoholism
Description

Alcoholic Intoxication, Chronic

Data type

boolean

Alias
UMLS CUI [1]
C0001973
coinfection with hepatitis c, hepatitis d, or 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
presence of other forms of liver disease
Description

Liver diseases

Data type

boolean

Alias
UMLS CUI [1]
C0023895
use of interferon alfa, thymosin, or antiviral agents with activity against hepatitis b within 24 weeks before randomization
Description

Interferon-alpha | Thymosin | Antiviral Agents Against Hepatitis B

Data type

boolean

Alias
UMLS CUI [1]
C0002199
UMLS CUI [2]
C0040106
UMLS CUI [3,1]
C0003451
UMLS CUI [3,2]
C0521124
UMLS CUI [3,3]
C0019163
prior lamivudine therapy lasting more than 12 weeks
Description

Lamivudine

Data type

boolean

Alias
UMLS CUI [1]
C0209738
previous treatment with adefovir dipivoxil
Description

adefovir dipivoxil

Data type

boolean

Alias
UMLS CUI [1]
C0540694
afp level greater than 100 ng/ml
Description

serum alpha-fetoprotein (AFP) measurement

Data type

boolean

Alias
UMLS CUI [1]
C0546833
decompensated liver disease
Description

Decompensated liver disease

Data type

boolean

Alias
UMLS CUI [1]
C4075847
history of ascites requiring diuretics or paracentesis
Description

Ascites Requirement Diuretics | Ascites Requirement Paracentesis

Data type

boolean

Alias
UMLS CUI [1,1]
C0003962
UMLS CUI [1,2]
C1514873
UMLS CUI [1,3]
C0012798
UMLS CUI [2,1]
C0003962
UMLS CUI [2,2]
C1514873
UMLS CUI [2,3]
C0034115
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Similar models

Eligibility Chronic Hepatitis B NCT00715715

1 forms
Name
Type
Description | Question | Decode (Coded Value)
Data type
Alias
Item Group
C1512693 (UMLS CUI)
Client Characteristics
Item
this study is seeking patients with the following:
boolean
C0815172 (UMLS CUI [1])
Asians | Age
Item
asians older than 16 years of age
boolean
C0078988 (UMLS CUI [1])
C0001779 (UMLS CUI [2])
Chronic Hepatitis B HBeAg positive
Item
hbeag-positive chronic hepatitis b, and
boolean
C0524909 (UMLS CUI [1,1])
C0392390 (UMLS CUI [1,2])
Liver function
Item
good liver function
boolean
C0232741 (UMLS CUI [1])
Hepatitis B surface antigen positive
Item
positive hepatitis b surface antigen (hbsag) for at least 24 weeks before screening
boolean
C0149709 (UMLS CUI [1])
Chronic Hepatitis Biopsy of liver
Item
liver biopsy in the past year showing of chronic hepatitis
boolean
C0019189 (UMLS CUI [1,1])
C0193388 (UMLS CUI [1,2])
Hepatitis B DNA detectable Hematologic Tests
Item
blood testing showing hbv dna in the past 4 weeks before screening
boolean
C1096264 (UMLS CUI [1,1])
C0018941 (UMLS CUI [1,2])
HBV DNA increased Hematologic Test
Item
blood test showing high hbv dna level (at least 20,000 iu/ml); and
boolean
C1262159 (UMLS CUI [1,1])
C0018941 (UMLS CUI [1,2])
Alanine aminotransferase increased Liver Function Tests
Item
liver function test showing high serum alt level (1.0 to 5.0 times the upper limit of normal).
boolean
C0151905 (UMLS CUI [1,1])
C0023901 (UMLS CUI [1,2])
Item Group
C0680251 (UMLS CUI)
Drug abuse
Item
ongoing drug abuse
boolean
C0013146 (UMLS CUI [1])
Alcoholic Intoxication, Chronic
Item
active alcoholism
boolean
C0001973 (UMLS CUI [1])
HCV coinfection | HDV Coinfection | HIV coinfection
Item
coinfection with hepatitis c, hepatitis d, or hiv
boolean
C1698259 (UMLS CUI [1])
C0011220 (UMLS CUI [2,1])
C0275524 (UMLS CUI [2,2])
C4062778 (UMLS CUI [3])
Liver diseases
Item
presence of other forms of liver disease
boolean
C0023895 (UMLS CUI [1])
Interferon-alpha | Thymosin | Antiviral Agents Against Hepatitis B
Item
use of interferon alfa, thymosin, or antiviral agents with activity against hepatitis b within 24 weeks before randomization
boolean
C0002199 (UMLS CUI [1])
C0040106 (UMLS CUI [2])
C0003451 (UMLS CUI [3,1])
C0521124 (UMLS CUI [3,2])
C0019163 (UMLS CUI [3,3])
Lamivudine
Item
prior lamivudine therapy lasting more than 12 weeks
boolean
C0209738 (UMLS CUI [1])
adefovir dipivoxil
Item
previous treatment with adefovir dipivoxil
boolean
C0540694 (UMLS CUI [1])
serum alpha-fetoprotein (AFP) measurement
Item
afp level greater than 100 ng/ml
boolean
C0546833 (UMLS CUI [1])
Decompensated liver disease
Item
decompensated liver disease
boolean
C4075847 (UMLS CUI [1])
Ascites Requirement Diuretics | Ascites Requirement Paracentesis
Item
history of ascites requiring diuretics or paracentesis
boolean
C0003962 (UMLS CUI [1,1])
C1514873 (UMLS CUI [1,2])
C0012798 (UMLS CUI [1,3])
C0003962 (UMLS CUI [2,1])
C1514873 (UMLS CUI [2,2])
C0034115 (UMLS CUI [2,3])
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