Informações:
Falhas:
ID
13701
Descrição
Safety and Biological Activity of InfraDure Biopump Secreting Sustained Interferon in HCV Patients; ODM derived from: https://clinicaltrials.gov/show/NCT01433133
Link
https://clinicaltrials.gov/show/NCT01433133
Palavras-chave
Versões (1)
- 29/02/2016 29/02/2016 -
Transferido a
29 de fevereiro de 2016
DOI
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Licença
Creative Commons BY 4.0
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Eligibility Hepatitis C NCT01433133
Eligibility Hepatitis C NCT01433133
- StudyEvent: Eligibility
Similar models
Eligibility Hepatitis C NCT01433133
- StudyEvent: Eligibility
Name
Tipo
Description | Question | Decode (Coded Value)
Tipo de dados
Alias
informed consent
Item
signed patient consent form
boolean
C0021430 (UMLS CUI [1])
Hepatitis C, Chronic
Item
genotype 3 chronic hcv with detectable hcv rna
boolean
C0524910 (UMLS CUI [1])
infection Hepatitis C
Item
no previous treatment for hcv infection
boolean
C3714514 (UMLS CUI [1,1])
C0019196 (UMLS CUI [1,2])
C0019196 (UMLS CUI [1,2])
Hepatitis B test negative; human immunodeficiency virus negative
Item
hepatitis b and human immunodeficiency virus negative at screening visit
boolean
C1611173 (UMLS CUI [1])
C0481430 (UMLS CUI [2])
C0481430 (UMLS CUI [2])
Contraception status
Item
able and willing to follow contraception requirements
boolean
C0420837 (UMLS CUI [1])
physical examination; laboratory
Item
screening laboratory values, test, and physical exam within acceptable ranges
boolean
C0031809 (UMLS CUI [1])
C0022877 (UMLS CUI [2])
C0022877 (UMLS CUI [2])
Study Subject Participation Status
Item
current enrollment in another investigational device or drug study
boolean
C2348568 (UMLS CUI [1])
compliance
Item
anticipated inability to complete all clinic visits and comply with study procedures
boolean
C1321605 (UMLS CUI [1])
Compliance behavior Limited Comorbidity
Item
history of, or any current medical condition, which could impact the safety of the subject during the study
boolean
C1321605 (UMLS CUI [1,1])
C0439801 (UMLS CUI [1,2])
C0009488 (UMLS CUI [1,3])
C0439801 (UMLS CUI [1,2])
C0009488 (UMLS CUI [1,3])
autoimmune hepatitis; hepatocellular carcinoma
Item
autoimmune hepatitis, suspected hepatocellular carcinoma, decompensated liver disease, or other known liver disease other than hcv
boolean
C0241910 (UMLS CUI [1])
C2239176 (UMLS CUI [2])
C2239176 (UMLS CUI [2])
Substance Use Disorder
Item
alcoholism or substance abuse with <6 documented months of sobriety
boolean
C0038586 (UMLS CUI [1])
hypersensitivity ribavirin
Item
known allergy or sensitivity to interferons or ribavirin
boolean
C0020517 (UMLS CUI [1,1])
C0035525 (UMLS CUI [1,2])
C0035525 (UMLS CUI [1,2])
Compliance behavior Limited Comorbidity
Item
any other condition that, in the opinion of the investigator, would make the subject unsuitable for enrollment or could interfere with the subject participating in and completing the study
boolean
C1321605 (UMLS CUI [1,1])
C0439801 (UMLS CUI [1,2])
C0009488 (UMLS CUI [1,3])
C0439801 (UMLS CUI [1,2])
C0009488 (UMLS CUI [1,3])