ID

39746

Descripción

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

Link

https://clinicaltrials.gov/show/NCT01861444

Palabras clave

Versiones (1)
  1. 15/2/20 15/2/20 -
Titular de derechos de autor

See clinicaltrials.gov

Subido en

15 de febrero de 2020

DOI

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Licencia

Creative Commons BY 4.0
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Eligibility Hepatitis D, Chronic NCT01861444

Inglés

Eligibility Hepatitis D, Chronic NCT01861444

1 formularios  
Inclusion Criteria
Descripción

Inclusion Criteria

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

Clinical Trial Part Epidemiological

Tipo de datos

boolean

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

Adult | Age

Tipo de datos

boolean

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

Hepatitis B surface antigen positive

Tipo de datos

boolean

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

Clinical Trial | Section Without Intervention

Tipo de datos

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
Descripción

Adult | Age

Tipo de datos

boolean

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

Hepatitis B surface antigen positive

Tipo de datos

boolean

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

Hepatitis D antibody Positive | Hepatitis D RNA positive PCR

Tipo de datos

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
Descripción

Elevated serum alanine aminotransferase (ALT)

Tipo de datos

boolean

Alias
UMLS CUI [1]
C4313265
Exclusion Criteria
Descripción

Exclusion Criteria

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

Patients Ineligible Pegasys

Tipo de datos

boolean

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

Nervous system disorder

Tipo de datos

boolean

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

Mental Disorders, Severe

Tipo de datos

boolean

Alias
UMLS CUI [1]
C4046029
decompensated diabetes
Descripción

Decompensated diabetes

Tipo de datos

boolean

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

Disease Immune-mediated

Tipo de datos

boolean

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

Heart Disease Severe

Tipo de datos

boolean

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

Severe chronic lung disease

Tipo de datos

boolean

Alias
UMLS CUI [1]
C3278799
inadequate hematologic function
Descripción

Hematologic function Inadequate

Tipo de datos

boolean

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

Eligibility Hepatitis D, Chronic NCT01861444

1 formularios
Name
Tipo
Description | Question | Decode (Coded Value)
Tipo de datos
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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