ID

39556

Description

Assessment and Monitoring of Renal Proximal Tubular Tolerance of Nucleoside and Nucleotide Analogues Using Early Screening Tools in Patients Chronically Mono-infected With Hepatitis B Virus; ODM derived from: https://clinicaltrials.gov/show/NCT01500265

Link

https://clinicaltrials.gov/show/NCT01500265

Keywords

Versions (1)
  1. 1/28/20 1/28/20 -
Copyright Holder

See clinicaltrials.gov

Uploaded on

January 28, 2020

DOI

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License

Creative Commons BY 4.0
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Eligibility Hepatitis B NCT01500265

English

Eligibility Hepatitis B NCT01500265

1 forms  
Inclusion Criteria
Description

Inclusion Criteria

Alias
UMLS CUI
C1512693
age ≥ 18 years
Description

Age

Data type

boolean

Alias
UMLS CUI [1]
C0001779
patients with chronic hbv virus monoinfected
Description

Hepatitis B, Chronic

Data type

boolean

Alias
UMLS CUI [1]
C0524909
for groups of patients treated: patients with an indication of etv or tdf
Description

Patients Treated | Indication Entecavir | Indication Tenofovir

Data type

boolean

Alias
UMLS CUI [1,1]
C0030705
UMLS CUI [1,2]
C1522326
UMLS CUI [2,1]
C3146298
UMLS CUI [2,2]
C0971023
UMLS CUI [3,1]
C3146298
UMLS CUI [3,2]
C0384228
for the group of naive patients: treatment-naive patients who have no indication of treatment (or do not want) for the duration of the study
Description

Patients Therapy naive | Indication Absent Treatment | Treatment Unwilling

Data type

boolean

Alias
UMLS CUI [1,1]
C0030705
UMLS CUI [1,2]
C0919936
UMLS CUI [2,1]
C3146298
UMLS CUI [2,2]
C0332197
UMLS CUI [2,3]
C0087111
UMLS CUI [3,1]
C0087111
UMLS CUI [3,2]
C0558080
globular filtration rate (gfr) ≥ 50 ml / min / 1.73 m2 with no known cause of renal disease
Description

Glomerular Filtration Rate | Kidney Disease Etiology unknown

Data type

boolean

Alias
UMLS CUI [1]
C0017654
UMLS CUI [2,1]
C0022658
UMLS CUI [2,2]
C0743626
patients who have given their informed and written informed consent
Description

Informed Consent

Data type

boolean

Alias
UMLS CUI [1]
C0021430
women of childbearing potential with an effective method of contraception without interruption for the duration of the research and during the 4 months after stopping treatment
Description

Childbearing Potential Contraceptive methods

Data type

boolean

Alias
UMLS CUI [1,1]
C3831118
UMLS CUI [1,2]
C0700589
Exclusion Criteria
Description

Exclusion Criteria

Alias
UMLS CUI
C0680251
patients co-infected with hiv, hepatitis c or hepatitis delta
Description

HIV coinfection | HCV coinfection | Coinfection Hepatitis Delta Virus

Data type

boolean

Alias
UMLS CUI [1]
C4062778
UMLS CUI [2]
C1698259
UMLS CUI [3,1]
C0275524
UMLS CUI [3,2]
C0011220
patients who have already received the tdf in the group to receive the tdf and having already received etv in the group to receive etv
Description

Tenofovir Received | Entecavir Received

Data type

boolean

Alias
UMLS CUI [1,1]
C0384228
UMLS CUI [1,2]
C1514756
UMLS CUI [2,1]
C0971023
UMLS CUI [2,2]
C1514756
patient with a gfr <50 ml / min / 1.73 m2 or with known causes of renal disease
Description

Glomerular Filtration Rate | Kidney Disease Cause Known

Data type

boolean

Alias
UMLS CUI [1]
C0017654
UMLS CUI [2,1]
C0022658
UMLS CUI [2,2]
C0015127
UMLS CUI [2,3]
C0205309
patient with hypophosphatemia <0.48 mmol / l
Description

Hypophosphatemia

Data type

boolean

Alias
UMLS CUI [1]
C0085682
patients with hepatocellular carcinoma (diagnosed or suspected)
Description

Liver carcinoma | Liver carcinoma Suspected

Data type

boolean

Alias
UMLS CUI [1]
C2239176
UMLS CUI [2,1]
C2239176
UMLS CUI [2,2]
C0750491
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Similar models

Eligibility Hepatitis B NCT01500265

1 forms
Name
Type
Description | Question | Decode (Coded Value)
Data type
Alias
Item Group
C1512693 (UMLS CUI)
Age
Item
age ≥ 18 years
boolean
C0001779 (UMLS CUI [1])
Hepatitis B, Chronic
Item
patients with chronic hbv virus monoinfected
boolean
C0524909 (UMLS CUI [1])
Patients Treated | Indication Entecavir | Indication Tenofovir
Item
for groups of patients treated: patients with an indication of etv or tdf
boolean
C0030705 (UMLS CUI [1,1])
C1522326 (UMLS CUI [1,2])
C3146298 (UMLS CUI [2,1])
C0971023 (UMLS CUI [2,2])
C3146298 (UMLS CUI [3,1])
C0384228 (UMLS CUI [3,2])
Patients Therapy naive | Indication Absent Treatment | Treatment Unwilling
Item
for the group of naive patients: treatment-naive patients who have no indication of treatment (or do not want) for the duration of the study
boolean
C0030705 (UMLS CUI [1,1])
C0919936 (UMLS CUI [1,2])
C3146298 (UMLS CUI [2,1])
C0332197 (UMLS CUI [2,2])
C0087111 (UMLS CUI [2,3])
C0087111 (UMLS CUI [3,1])
C0558080 (UMLS CUI [3,2])
Glomerular Filtration Rate | Kidney Disease Etiology unknown
Item
globular filtration rate (gfr) ≥ 50 ml / min / 1.73 m2 with no known cause of renal disease
boolean
C0017654 (UMLS CUI [1])
C0022658 (UMLS CUI [2,1])
C0743626 (UMLS CUI [2,2])
Informed Consent
Item
patients who have given their informed and written informed consent
boolean
C0021430 (UMLS CUI [1])
Childbearing Potential Contraceptive methods
Item
women of childbearing potential with an effective method of contraception without interruption for the duration of the research and during the 4 months after stopping treatment
boolean
C3831118 (UMLS CUI [1,1])
C0700589 (UMLS CUI [1,2])
Item Group
C0680251 (UMLS CUI)
HIV coinfection | HCV coinfection | Coinfection Hepatitis Delta Virus
Item
patients co-infected with hiv, hepatitis c or hepatitis delta
boolean
C4062778 (UMLS CUI [1])
C1698259 (UMLS CUI [2])
C0275524 (UMLS CUI [3,1])
C0011220 (UMLS CUI [3,2])
Tenofovir Received | Entecavir Received
Item
patients who have already received the tdf in the group to receive the tdf and having already received etv in the group to receive etv
boolean
C0384228 (UMLS CUI [1,1])
C1514756 (UMLS CUI [1,2])
C0971023 (UMLS CUI [2,1])
C1514756 (UMLS CUI [2,2])
Glomerular Filtration Rate | Kidney Disease Cause Known
Item
patient with a gfr <50 ml / min / 1.73 m2 or with known causes of renal disease
boolean
C0017654 (UMLS CUI [1])
C0022658 (UMLS CUI [2,1])
C0015127 (UMLS CUI [2,2])
C0205309 (UMLS CUI [2,3])
Hypophosphatemia
Item
patient with hypophosphatemia <0.48 mmol / l
boolean
C0085682 (UMLS CUI [1])
Liver carcinoma | Liver carcinoma Suspected
Item
patients with hepatocellular carcinoma (diagnosed or suspected)
boolean
C2239176 (UMLS CUI [1])
C2239176 (UMLS CUI [2,1])
C0750491 (UMLS CUI [2,2])
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