ID

35975

Description

Emtricitabine for Naive Chinese Chronic Hepatitis B Patients; ODM derived from: https://clinicaltrials.gov/show/NCT02327663

Link

https://clinicaltrials.gov/show/NCT02327663

Keywords

Versions (1)
  1. 4/8/19 4/8/19 -
Copyright Holder

See clinicaltrials.gov

Uploaded on

April 8, 2019

DOI

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License

Creative Commons BY 4.0
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Eligibility Hepatitis B, Chronic NCT02327663

English

Eligibility Hepatitis B, Chronic NCT02327663

1 forms  
Inclusion Criteria
Description

Inclusion Criteria

Alias
UMLS CUI
C1512693
hbsag positive for more than 6 months
Description

Hepatitis B surface antigen positive

Data type

boolean

Alias
UMLS CUI [1]
C0149709
hbeag positive patients: hbv dna ≥ 5log10 copies/ml
Description

Hepatitis B e antigen positive | Hepatitis B DNA Measurement

Data type

boolean

Alias
UMLS CUI [1]
C0392390
UMLS CUI [2]
C3641250
hbeag postive patients: alt≥2×uln;or liver biopsy g≥2;or liver biopsy s ≥2;or liver biopsy knodell hai ≥ 4
Description

Hepatitis B e antigen positive | Alanine aminotransferase increased | Biopsy of liver

Data type

boolean

Alias
UMLS CUI [1]
C0392390
UMLS CUI [2]
C0151905
UMLS CUI [3]
C0193388
hbeag negative patients: hbv dna ≥ 4log10 copies/ml
Description

Hepatitis B e Antigens Negative | Hepatitis B DNA Measurement

Data type

boolean

Alias
UMLS CUI [1,1]
C0019167
UMLS CUI [1,2]
C1513916
UMLS CUI [2]
C3641250
hbeag postive patients: alt≥2×uln;or liver biopsy g≥2;or liver biopsy s ≥2;or liver biopsy knodell hai ≥ 4
Description

Hepatitis B e antigen positive | Alanine aminotransferase increased | Biopsy of liver

Data type

boolean

Alias
UMLS CUI [1]
C0392390
UMLS CUI [2]
C0151905
UMLS CUI [3]
C0193388
nucleoside/nucleotide naive paitents
Description

Nucleosides Absent | Nucleotides Absent

Data type

boolean

Alias
UMLS CUI [1,1]
C0028621
UMLS CUI [1,2]
C0332197
UMLS CUI [2,1]
C0028630
UMLS CUI [2,2]
C0332197
Exclusion Criteria
Description

Exclusion Criteria

Alias
UMLS CUI
C0680251
diagnosed hcc with afp and ultrasound, ct or mri
Description

Liver carcinoma | Alpha one fetoprotein measurement | Ultrasonography | CT | MRI

Data type

boolean

Alias
UMLS CUI [1]
C2239176
UMLS CUI [2]
C0201539
UMLS CUI [3]
C0041618
UMLS CUI [4]
C0040405
UMLS CUI [5]
C0024485
creatine ＞130μmol/l or ccr < 70ml/min
Description

Creatinine measurement, serum | Creatinine clearance measurement

Data type

boolean

Alias
UMLS CUI [1]
C0201976
UMLS CUI [2]
C0373595
hemoglobin <100g/l
Description

Hemoglobin measurement

Data type

boolean

Alias
UMLS CUI [1]
C0518015
neutrophils <1.5e+9/l
Description

Neutrophil count

Data type

boolean

Alias
UMLS CUI [1]
C0200633
plt<80e+9/l
Description

Platelet Count measurement

Data type

boolean

Alias
UMLS CUI [1]
C0032181
coinfected with hav,hev,hcv,hdv or hiv
Description

Coinfection Hepatitis A Virus | Coinfection Hepatitis E virus | HCV coinfection | Coinfection Hepatitis Delta Virus | HIV coinfection

Data type

boolean

Alias
UMLS CUI [1,1]
C0275524
UMLS CUI [1,2]
C0376325
UMLS CUI [2,1]
C0275524
UMLS CUI [2,2]
C0085294
UMLS CUI [3]
C1698259
UMLS CUI [4,1]
C0275524
UMLS CUI [4,2]
C0011220
UMLS CUI [5]
C4062778
ana ＞ 1:100
Description

Anti-nuclear antibody measurement

Data type

boolean

Alias
UMLS CUI [1]
C0587178
uncontrolled cardiovascluar diseases, kidney diseases,lung diseases, neurological diseases, digestive diseases,metabolic disorders, immune-compromised diseases or cancer
Description

Cardiovascular Diseases Uncontrolled | Kidney Diseases Uncontrolled | Lung diseases Uncontrolled | Nervous system disorder Uncontrolled | Digestive System Disorders Uncontrolled | Metabolic Diseases Uncontrolled | Immune System Diseases Uncontrolled | Malignant Neoplasms Uncontrolled

Data type

boolean

Alias
UMLS CUI [1,1]
C0007222
UMLS CUI [1,2]
C0205318
UMLS CUI [2,1]
C0022658
UMLS CUI [2,2]
C0205318
UMLS CUI [3,1]
C0024115
UMLS CUI [3,2]
C0205318
UMLS CUI [4,1]
C0027765
UMLS CUI [4,2]
C0205318
UMLS CUI [5,1]
C0012242
UMLS CUI [5,2]
C0205318
UMLS CUI [6,1]
C0025517
UMLS CUI [6,2]
C0205318
UMLS CUI [7,1]
C0021053
UMLS CUI [7,2]
C0205318
UMLS CUI [8,1]
C0006826
UMLS CUI [8,2]
C0205318
drug abuse or alcohal addiction
Description

Drug abuse | Alcoholic Intoxication, Chronic

Data type

boolean

Alias
UMLS CUI [1]
C0013146
UMLS CUI [2]
C0001973
previous history of taking agents of lamivudine, adefovir, tenofovir entecavir or telbivudine
Description

Lamivudine | adefovir | Tenofovir | entecavir | telbivudine

Data type

boolean

Alias
UMLS CUI [1]
C0209738
UMLS CUI [2]
C0050175
UMLS CUI [3]
C0384228
UMLS CUI [4]
C0971023
UMLS CUI [5]
C1453933
long-term use of immunosuppressor or immunomodulator 6 months before enrollment to this trial
Description

Immunosuppressive Agents Long-term | Immunomodulators Long-term

Data type

boolean

Alias
UMLS CUI [1,1]
C0021081
UMLS CUI [1,2]
C0443252
UMLS CUI [2,1]
C1527392
UMLS CUI [2,2]
C0443252
underwent liver transplantation or liver transplantation in schedule
Description

Transplantation of liver | Transplantation of liver Scheduled

Data type

boolean

Alias
UMLS CUI [1]
C0023911
UMLS CUI [2,1]
C0023911
UMLS CUI [2,2]
C0205539
allergic to nucleoside or nucleotide analogues
Description

Hypersensitivity Nucleoside Analogs | Hypersensitivity Nucleotide analog

Data type

boolean

Alias
UMLS CUI [1,1]
C0020517
UMLS CUI [1,2]
C1579410
UMLS CUI [2,1]
C0020517
UMLS CUI [2,2]
C0597107
preganency or in breastfeeding
Description

Pregnancy | Breast Feeding

Data type

boolean

Alias
UMLS CUI [1]
C0032961
UMLS CUI [2]
C0006147
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Similar models

Eligibility Hepatitis B, Chronic NCT02327663

1 forms
Name
Type
Description | Question | Decode (Coded Value)
Data type
Alias
Item Group
C1512693 (UMLS CUI)
Hepatitis B surface antigen positive
Item
hbsag positive for more than 6 months
boolean
C0149709 (UMLS CUI [1])
Hepatitis B e antigen positive | Hepatitis B DNA Measurement
Item
hbeag positive patients: hbv dna ≥ 5log10 copies/ml
boolean
C0392390 (UMLS CUI [1])
C3641250 (UMLS CUI [2])
Hepatitis B e antigen positive | Alanine aminotransferase increased | Biopsy of liver
Item
hbeag postive patients: alt≥2×uln;or liver biopsy g≥2;or liver biopsy s ≥2;or liver biopsy knodell hai ≥ 4
boolean
C0392390 (UMLS CUI [1])
C0151905 (UMLS CUI [2])
C0193388 (UMLS CUI [3])
Hepatitis B e Antigens Negative | Hepatitis B DNA Measurement
Item
hbeag negative patients: hbv dna ≥ 4log10 copies/ml
boolean
C0019167 (UMLS CUI [1,1])
C1513916 (UMLS CUI [1,2])
C3641250 (UMLS CUI [2])
Hepatitis B e antigen positive | Alanine aminotransferase increased | Biopsy of liver
Item
hbeag postive patients: alt≥2×uln;or liver biopsy g≥2;or liver biopsy s ≥2;or liver biopsy knodell hai ≥ 4
boolean
C0392390 (UMLS CUI [1])
C0151905 (UMLS CUI [2])
C0193388 (UMLS CUI [3])
Nucleosides Absent | Nucleotides Absent
Item
nucleoside/nucleotide naive paitents
boolean
C0028621 (UMLS CUI [1,1])
C0332197 (UMLS CUI [1,2])
C0028630 (UMLS CUI [2,1])
C0332197 (UMLS CUI [2,2])
Item Group
C0680251 (UMLS CUI)
Liver carcinoma | Alpha one fetoprotein measurement | Ultrasonography | CT | MRI
Item
diagnosed hcc with afp and ultrasound, ct or mri
boolean
C2239176 (UMLS CUI [1])
C0201539 (UMLS CUI [2])
C0041618 (UMLS CUI [3])
C0040405 (UMLS CUI [4])
C0024485 (UMLS CUI [5])
Creatinine measurement, serum | Creatinine clearance measurement
Item
creatine ＞130μmol/l or ccr < 70ml/min
boolean
C0201976 (UMLS CUI [1])
C0373595 (UMLS CUI [2])
Hemoglobin measurement
Item
hemoglobin <100g/l
boolean
C0518015 (UMLS CUI [1])
Neutrophil count
Item
neutrophils <1.5e+9/l
boolean
C0200633 (UMLS CUI [1])
Platelet Count measurement
Item
plt<80e+9/l
boolean
C0032181 (UMLS CUI [1])
Coinfection Hepatitis A Virus | Coinfection Hepatitis E virus | HCV coinfection | Coinfection Hepatitis Delta Virus | HIV coinfection
Item
coinfected with hav,hev,hcv,hdv or hiv
boolean
C0275524 (UMLS CUI [1,1])
C0376325 (UMLS CUI [1,2])
C0275524 (UMLS CUI [2,1])
C0085294 (UMLS CUI [2,2])
C1698259 (UMLS CUI [3])
C0275524 (UMLS CUI [4,1])
C0011220 (UMLS CUI [4,2])
C4062778 (UMLS CUI [5])
Anti-nuclear antibody measurement
Item
ana ＞ 1:100
boolean
C0587178 (UMLS CUI [1])
Cardiovascular Diseases Uncontrolled | Kidney Diseases Uncontrolled | Lung diseases Uncontrolled | Nervous system disorder Uncontrolled | Digestive System Disorders Uncontrolled | Metabolic Diseases Uncontrolled | Immune System Diseases Uncontrolled | Malignant Neoplasms Uncontrolled
Item
uncontrolled cardiovascluar diseases, kidney diseases,lung diseases, neurological diseases, digestive diseases,metabolic disorders, immune-compromised diseases or cancer
boolean
C0007222 (UMLS CUI [1,1])
C0205318 (UMLS CUI [1,2])
C0022658 (UMLS CUI [2,1])
C0205318 (UMLS CUI [2,2])
C0024115 (UMLS CUI [3,1])
C0205318 (UMLS CUI [3,2])
C0027765 (UMLS CUI [4,1])
C0205318 (UMLS CUI [4,2])
C0012242 (UMLS CUI [5,1])
C0205318 (UMLS CUI [5,2])
C0025517 (UMLS CUI [6,1])
C0205318 (UMLS CUI [6,2])
C0021053 (UMLS CUI [7,1])
C0205318 (UMLS CUI [7,2])
C0006826 (UMLS CUI [8,1])
C0205318 (UMLS CUI [8,2])
Drug abuse | Alcoholic Intoxication, Chronic
Item
drug abuse or alcohal addiction
boolean
C0013146 (UMLS CUI [1])
C0001973 (UMLS CUI [2])
Lamivudine | adefovir | Tenofovir | entecavir | telbivudine
Item
previous history of taking agents of lamivudine, adefovir, tenofovir entecavir or telbivudine
boolean
C0209738 (UMLS CUI [1])
C0050175 (UMLS CUI [2])
C0384228 (UMLS CUI [3])
C0971023 (UMLS CUI [4])
C1453933 (UMLS CUI [5])
Immunosuppressive Agents Long-term | Immunomodulators Long-term
Item
long-term use of immunosuppressor or immunomodulator 6 months before enrollment to this trial
boolean
C0021081 (UMLS CUI [1,1])
C0443252 (UMLS CUI [1,2])
C1527392 (UMLS CUI [2,1])
C0443252 (UMLS CUI [2,2])
Transplantation of liver | Transplantation of liver Scheduled
Item
underwent liver transplantation or liver transplantation in schedule
boolean
C0023911 (UMLS CUI [1])
C0023911 (UMLS CUI [2,1])
C0205539 (UMLS CUI [2,2])
Hypersensitivity Nucleoside Analogs | Hypersensitivity Nucleotide analog
Item
allergic to nucleoside or nucleotide analogues
boolean
C0020517 (UMLS CUI [1,1])
C1579410 (UMLS CUI [1,2])
C0020517 (UMLS CUI [2,1])
C0597107 (UMLS CUI [2,2])
Pregnancy | Breast Feeding
Item
preganency or in breastfeeding
boolean
C0032961 (UMLS CUI [1])
C0006147 (UMLS CUI [2])
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