ID

27825

Beschrijving

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

Trefwoorden

Versies (1)
  1. 30-11-17 30-11-17 -
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See clinicaltrials.gov

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30 november 2017

DOI

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Creative Commons BY 4.0
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Eligibility Chronic Hepatitis B NCT00715715

Engels

Eligibility Chronic Hepatitis B NCT00715715

1 Formulieren  
Inclusion Criteria
Beschrijving

Inclusion Criteria

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

Client Characteristics

Datatype

boolean

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

Asians | Age

Datatype

boolean

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

Chronic Hepatitis B HBeAg positive

Datatype

boolean

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

Liver function

Datatype

boolean

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

Hepatitis B surface antigen positive

Datatype

boolean

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

Chronic Hepatitis Biopsy of liver

Datatype

boolean

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

Hepatitis B DNA detectable Hematologic Tests

Datatype

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
Beschrijving

HBV DNA increased Hematologic Test

Datatype

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).
Beschrijving

Alanine aminotransferase increased Liver Function Tests

Datatype

boolean

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

Exclusion Criteria

Alias
UMLS CUI
C0680251
ongoing drug abuse
Beschrijving

Drug abuse

Datatype

boolean

Alias
UMLS CUI [1]
C0013146
active alcoholism
Beschrijving

Alcoholic Intoxication, Chronic

Datatype

boolean

Alias
UMLS CUI [1]
C0001973
coinfection with hepatitis c, hepatitis d, or hiv
Beschrijving

HCV coinfection | HDV Coinfection | HIV coinfection

Datatype

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
Beschrijving

Liver diseases

Datatype

boolean

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

Interferon-alpha | Thymosin | Antiviral Agents Against Hepatitis B

Datatype

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
Beschrijving

Lamivudine

Datatype

boolean

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

adefovir dipivoxil

Datatype

boolean

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

serum alpha-fetoprotein (AFP) measurement

Datatype

boolean

Alias
UMLS CUI [1]
C0546833
decompensated liver disease
Beschrijving

Decompensated liver disease

Datatype

boolean

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

Ascites Requirement Diuretics | Ascites Requirement Paracentesis

Datatype

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 Formulieren
Name
Type
Description | Question | Decode (Coded Value)
Datatype
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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