ID

39746

Beskrivning

An Observational Study on the Prevalence of Chronic Hepatitis D in Romania and the Efficacy of Treatment With Pegasys (Peginterferon Alfa-2a); ODM derived from: https://clinicaltrials.gov/show/NCT01861444

Länk

https://clinicaltrials.gov/show/NCT01861444

Nyckelord

  1. 2020-02-15 2020-02-15 -
Rättsinnehavare

See clinicaltrials.gov

Uppladdad den

15 februari 2020

DOI

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Licens

Creative Commons BY 4.0

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Eligibility Hepatitis D, Chronic NCT01861444

Eligibility Hepatitis D, Chronic NCT01861444

Inclusion Criteria
Beskrivning

Inclusion Criteria

Alias
UMLS CUI
C1512693
for epidemiological part of the study:
Beskrivning

Clinical Trial Part Epidemiological

Datatyp

boolean

Alias
UMLS CUI [1,1]
C0008976
UMLS CUI [1,2]
C0449719
UMLS CUI [1,3]
C0014507
adult patients >/= 18 years of age
Beskrivning

Adult | Age

Datatyp

boolean

Alias
UMLS CUI [1]
C0001675
UMLS CUI [2]
C0001779
positive hbsag for at least 6 months
Beskrivning

Hepatitis B surface antigen positive

Datatyp

boolean

Alias
UMLS CUI [1]
C0149709
for the non-interventional section of the study
Beskrivning

Clinical Trial | Section Without Intervention

Datatyp

boolean

Alias
UMLS CUI [1]
C0008976
UMLS CUI [2,1]
C1705191
UMLS CUI [2,2]
C0332288
UMLS CUI [2,3]
C0184661
adult patients, >/= 18 years of age
Beskrivning

Adult | Age

Datatyp

boolean

Alias
UMLS CUI [1]
C0001675
UMLS CUI [2]
C0001779
positive hbsag for at least 6 months
Beskrivning

Hepatitis B surface antigen positive

Datatyp

boolean

Alias
UMLS CUI [1]
C0149709
positive anti-delta and positive hdv rna by pcr
Beskrivning

Hepatitis D antibody Positive | Hepatitis D RNA positive PCR

Datatyp

boolean

Alias
UMLS CUI [1,1]
C0312635
UMLS CUI [1,2]
C1514241
UMLS CUI [2,1]
C1168252
UMLS CUI [2,2]
C0032520
elevated serum alt >/= 2x uln
Beskrivning

Elevated serum alanine aminotransferase (ALT)

Datatyp

boolean

Alias
UMLS CUI [1]
C4313265
Exclusion Criteria
Beskrivning

Exclusion Criteria

Alias
UMLS CUI
C0680251
patients with any of the following will not be eligible for treatment with pegasys:
Beskrivning

Patients Ineligible Pegasys

Datatyp

boolean

Alias
UMLS CUI [1,1]
C0030705
UMLS CUI [1,2]
C1512714
UMLS CUI [1,3]
C1176430
history of neurological disease
Beskrivning

Nervous system disorder

Datatyp

boolean

Alias
UMLS CUI [1]
C0027765
history of severe psychiatric disease
Beskrivning

Mental Disorders, Severe

Datatyp

boolean

Alias
UMLS CUI [1]
C4046029
decompensated diabetes
Beskrivning

Decompensated diabetes

Datatyp

boolean

Alias
UMLS CUI [1]
C4324690
history of immunologically mediated disease
Beskrivning

Disease Immune-mediated

Datatyp

boolean

Alias
UMLS CUI [1,1]
C0012634
UMLS CUI [1,2]
C4330477
history of severe cardiac disease
Beskrivning

Heart Disease Severe

Datatyp

boolean

Alias
UMLS CUI [1,1]
C0018799
UMLS CUI [1,2]
C0205082
history or other evidence of severe chronic pulmonary disease
Beskrivning

Severe chronic lung disease

Datatyp

boolean

Alias
UMLS CUI [1]
C3278799
inadequate hematologic function
Beskrivning

Hematologic function Inadequate

Datatyp

boolean

Alias
UMLS CUI [1,1]
C0221130
UMLS CUI [1,2]
C0205412

Similar models

Eligibility Hepatitis D, Chronic NCT01861444

Name
Typ
Description | Question | Decode (Coded Value)
Datatyp
Alias
Item Group
C1512693 (UMLS CUI)
Clinical Trial Part Epidemiological
Item
for epidemiological part of the study:
boolean
C0008976 (UMLS CUI [1,1])
C0449719 (UMLS CUI [1,2])
C0014507 (UMLS CUI [1,3])
Adult | Age
Item
adult patients >/= 18 years of age
boolean
C0001675 (UMLS CUI [1])
C0001779 (UMLS CUI [2])
Hepatitis B surface antigen positive
Item
positive hbsag for at least 6 months
boolean
C0149709 (UMLS CUI [1])
Clinical Trial | Section Without Intervention
Item
for the non-interventional section of the study
boolean
C0008976 (UMLS CUI [1])
C1705191 (UMLS CUI [2,1])
C0332288 (UMLS CUI [2,2])
C0184661 (UMLS CUI [2,3])
Adult | Age
Item
adult patients, >/= 18 years of age
boolean
C0001675 (UMLS CUI [1])
C0001779 (UMLS CUI [2])
Hepatitis B surface antigen positive
Item
positive hbsag for at least 6 months
boolean
C0149709 (UMLS CUI [1])
Hepatitis D antibody Positive | Hepatitis D RNA positive PCR
Item
positive anti-delta and positive hdv rna by pcr
boolean
C0312635 (UMLS CUI [1,1])
C1514241 (UMLS CUI [1,2])
C1168252 (UMLS CUI [2,1])
C0032520 (UMLS CUI [2,2])
Elevated serum alanine aminotransferase (ALT)
Item
elevated serum alt >/= 2x uln
boolean
C4313265 (UMLS CUI [1])
Item Group
C0680251 (UMLS CUI)
Patients Ineligible Pegasys
Item
patients with any of the following will not be eligible for treatment with pegasys:
boolean
C0030705 (UMLS CUI [1,1])
C1512714 (UMLS CUI [1,2])
C1176430 (UMLS CUI [1,3])
Nervous system disorder
Item
history of neurological disease
boolean
C0027765 (UMLS CUI [1])
Mental Disorders, Severe
Item
history of severe psychiatric disease
boolean
C4046029 (UMLS CUI [1])
Decompensated diabetes
Item
decompensated diabetes
boolean
C4324690 (UMLS CUI [1])
Disease Immune-mediated
Item
history of immunologically mediated disease
boolean
C0012634 (UMLS CUI [1,1])
C4330477 (UMLS CUI [1,2])
Heart Disease Severe
Item
history of severe cardiac disease
boolean
C0018799 (UMLS CUI [1,1])
C0205082 (UMLS CUI [1,2])
Severe chronic lung disease
Item
history or other evidence of severe chronic pulmonary disease
boolean
C3278799 (UMLS CUI [1])
Hematologic function Inadequate
Item
inadequate hematologic function
boolean
C0221130 (UMLS CUI [1,1])
C0205412 (UMLS CUI [1,2])

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