ID

35205

Description

Roll-over After 3-year Trial for Tenofovir in Mild Chronic Hepatitis B; ODM derived from: https://clinicaltrials.gov/show/NCT02463019

Link

https://clinicaltrials.gov/show/NCT02463019

Keywords

Versions (1)
  1. 2/24/19 2/24/19 -
Copyright Holder

See clinicaltrials.gov

Uploaded on

February 24, 2019

DOI

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License

Creative Commons BY 4.0
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Eligibility Chronic Hepatitis B NCT02463019

English

Eligibility Chronic Hepatitis B NCT02463019

1 forms  
Inclusion Criteria
Description

Inclusion Criteria

Alias
UMLS CUI
C1512693
all participants should have finished the clinical trial <efficacy of tenofovir disoproxil fumarate in chronic hepatitis b patients with high viral load but slight aminotransferase elevation> without drop-out.
Description

Study Subject All | Completion of clinical trial Specified

Data type

boolean

Alias
UMLS CUI [1,1]
C0681850
UMLS CUI [1,2]
C0444868
UMLS CUI [2,1]
C2732579
UMLS CUI [2,2]
C0205369
willingness to adhere to treatment and follow-up plans
Description

Protocol Compliance

Data type

boolean

Alias
UMLS CUI [1]
C0525058
Exclusion Criteria
Description

Exclusion Criteria

Alias
UMLS CUI
C0680251
co-infection with hiv, hcv, or hdv
Description

HIV Coinfection | HCV coinfection | Coinfection HDV

Data type

boolean

Alias
UMLS CUI [1]
C4505456
UMLS CUI [2]
C1698259
UMLS CUI [3,1]
C0275524
UMLS CUI [3,2]
C0011220
presence of cirrhosis on histopathology
Description

Liver Cirrhosis

Data type

boolean

Alias
UMLS CUI [1]
C0023890
hepatic decompensation defined as serum bilirubin > 2mg/dl and prolonged prothrombin time > 3 seconds
Description

Hepatic decompensation | Serum total bilirubin measurement | Prolonged prothrombin time

Data type

boolean

Alias
UMLS CUI [1]
C1394798
UMLS CUI [2]
C1278039
UMLS CUI [3]
C2673577
concurrent malignant diseases including hepatocellular carcinoma
Description

Cancer Other | Liver carcinoma

Data type

boolean

Alias
UMLS CUI [1]
C1707251
UMLS CUI [2]
C2239176
severe co-morbidity with life expectancy < 1year
Description

Comorbidity Severe | Life Expectancy

Data type

boolean

Alias
UMLS CUI [1,1]
C0009488
UMLS CUI [1,2]
C0205082
UMLS CUI [2]
C0023671
pregnant or lactating women
Description

Pregnancy | Breast Feeding

Data type

boolean

Alias
UMLS CUI [1]
C0032961
UMLS CUI [2]
C0006147
organ transplantation except cornea or hair transplant
Description

Organ Transplantation | Exception Keratoplasty | Exception Hair transplant

Data type

boolean

Alias
UMLS CUI [1]
C0029216
UMLS CUI [2,1]
C1705847
UMLS CUI [2,2]
C0010042
UMLS CUI [3,1]
C1705847
UMLS CUI [3,2]
C0191626
suspected or confirmed chronic liver diseases from etiologies other than hbv (e.g. alcoholic hepatitis, wilson disease, hemochromatosis…etc)
Description

Chronic liver disease Suspected | Chronic liver disease | Exception Etiology Hepatitis B Virus | Hepatitis, Alcoholic | Hepatolenticular Degeneration | Hemochromatosis

Data type

boolean

Alias
UMLS CUI [1,1]
C0341439
UMLS CUI [1,2]
C0750491
UMLS CUI [2]
C0341439
UMLS CUI [3,1]
C1705847
UMLS CUI [3,2]
C0015127
UMLS CUI [3,3]
C0019169
UMLS CUI [4]
C0019187
UMLS CUI [5]
C0019202
UMLS CUI [6]
C0018995
serum creatinine >1.5mg/dl
Description

Creatinine measurement, serum

Data type

boolean

Alias
UMLS CUI [1]
C0201976
refusal to undergo liver biopsy
Description

Biopsy of liver Refused

Data type

boolean

Alias
UMLS CUI [1,1]
C0193388
UMLS CUI [1,2]
C1705116
lack of informed consent
Description

Informed Consent Lacking

Data type

boolean

Alias
UMLS CUI [1,1]
C0021430
UMLS CUI [1,2]
C0332268
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Similar models

Eligibility Chronic Hepatitis B NCT02463019

1 forms
Name
Type
Description | Question | Decode (Coded Value)
Data type
Alias
Item Group
C1512693 (UMLS CUI)
Study Subject All | Completion of clinical trial Specified
Item
all participants should have finished the clinical trial <efficacy of tenofovir disoproxil fumarate in chronic hepatitis b patients with high viral load but slight aminotransferase elevation> without drop-out.
boolean
C0681850 (UMLS CUI [1,1])
C0444868 (UMLS CUI [1,2])
C2732579 (UMLS CUI [2,1])
C0205369 (UMLS CUI [2,2])
Protocol Compliance
Item
willingness to adhere to treatment and follow-up plans
boolean
C0525058 (UMLS CUI [1])
Item Group
C0680251 (UMLS CUI)
HIV Coinfection | HCV coinfection | Coinfection HDV
Item
co-infection with hiv, hcv, or hdv
boolean
C4505456 (UMLS CUI [1])
C1698259 (UMLS CUI [2])
C0275524 (UMLS CUI [3,1])
C0011220 (UMLS CUI [3,2])
Liver Cirrhosis
Item
presence of cirrhosis on histopathology
boolean
C0023890 (UMLS CUI [1])
Hepatic decompensation | Serum total bilirubin measurement | Prolonged prothrombin time
Item
hepatic decompensation defined as serum bilirubin > 2mg/dl and prolonged prothrombin time > 3 seconds
boolean
C1394798 (UMLS CUI [1])
C1278039 (UMLS CUI [2])
C2673577 (UMLS CUI [3])
Cancer Other | Liver carcinoma
Item
concurrent malignant diseases including hepatocellular carcinoma
boolean
C1707251 (UMLS CUI [1])
C2239176 (UMLS CUI [2])
Comorbidity Severe | Life Expectancy
Item
severe co-morbidity with life expectancy < 1year
boolean
C0009488 (UMLS CUI [1,1])
C0205082 (UMLS CUI [1,2])
C0023671 (UMLS CUI [2])
Pregnancy | Breast Feeding
Item
pregnant or lactating women
boolean
C0032961 (UMLS CUI [1])
C0006147 (UMLS CUI [2])
Organ Transplantation | Exception Keratoplasty | Exception Hair transplant
Item
organ transplantation except cornea or hair transplant
boolean
C0029216 (UMLS CUI [1])
C1705847 (UMLS CUI [2,1])
C0010042 (UMLS CUI [2,2])
C1705847 (UMLS CUI [3,1])
C0191626 (UMLS CUI [3,2])
Chronic liver disease Suspected | Chronic liver disease | Exception Etiology Hepatitis B Virus | Hepatitis, Alcoholic | Hepatolenticular Degeneration | Hemochromatosis
Item
suspected or confirmed chronic liver diseases from etiologies other than hbv (e.g. alcoholic hepatitis, wilson disease, hemochromatosis…etc)
boolean
C0341439 (UMLS CUI [1,1])
C0750491 (UMLS CUI [1,2])
C0341439 (UMLS CUI [2])
C1705847 (UMLS CUI [3,1])
C0015127 (UMLS CUI [3,2])
C0019169 (UMLS CUI [3,3])
C0019187 (UMLS CUI [4])
C0019202 (UMLS CUI [5])
C0018995 (UMLS CUI [6])
Creatinine measurement, serum
Item
serum creatinine >1.5mg/dl
boolean
C0201976 (UMLS CUI [1])
Biopsy of liver Refused
Item
refusal to undergo liver biopsy
boolean
C0193388 (UMLS CUI [1,1])
C1705116 (UMLS CUI [1,2])
Informed Consent Lacking
Item
lack of informed consent
boolean
C0021430 (UMLS CUI [1,1])
C0332268 (UMLS CUI [1,2])
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