Informações:
Falhas:
ID
43866
Descrição
Study on Chronic Hepatitis C Treatment With Interferon Alpha, Ribavirin and Amantadine in Naive Patients; ODM derived from: https://clinicaltrials.gov/show/NCT00146016
Link
https://clinicaltrials.gov/show/NCT00146016
Palavras-chave
Versões (2)
- 20/03/2016 20/03/2016 -
- 20/09/2021 20/09/2021 -
Transferido a
20 de setembro de 2021
DOI
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Licença
Creative Commons BY 4.0
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Eligibility Chronic Hepatitis C NCT00146016
Eligibility Chronic Hepatitis C NCT00146016
- StudyEvent: Eligibility
Similar models
Eligibility Chronic Hepatitis C NCT00146016
- StudyEvent: Eligibility
Name
Tipo
Description | Question | Decode (Coded Value)
Tipo de dados
Alias
HCV positivity
Item
anti-hcv positivity >6 months
boolean
C0201485 (UMLS CUI [1])
ALT and/or AST elevation
Item
alt and/or ast elevation on at least once in the previous 6 months
boolean
C0201836 (UMLS CUI [1])
C0201899 (UMLS CUI [2])
C0201899 (UMLS CUI [2])
HCV-RNA
Item
positive hcv-rna
boolean
C0369335 (UMLS CUI [1])
Liver biopsy
Item
liver biopsy within one year before the start of therapy in non- cirrhosis. in the case of known cirrhosis, liver biopsy is not necessary
boolean
C0193388 (UMLS CUI [1])
Compliance
Item
intention to be treated and participate treatment
boolean
C1321605 (UMLS CUI [1])
Written informed consent
Item
obtained written informed consent
boolean
C0021430 (UMLS CUI [1])
Age
Item
age < 18 years
boolean
C0001779 (UMLS CUI [1])
Gynaecological status
Item
pregnancy or intention to get pregnant within the 12 months period of treatment and up to 6 months after discontinuation of therapy, no adequate contraception, lactation
boolean
C0032961 (UMLS CUI [1])
C0006147 (UMLS CUI [2])
C0700589 (UMLS CUI [3])
C0006147 (UMLS CUI [2])
C0700589 (UMLS CUI [3])
Male contraceptive methods
Item
men not practicing or willing to practice acceptable methods of contraception during the treatment period and up to 6 months after discontinuation of therapy
boolean
C1869110 (UMLS CUI [1])
Life expectancy
Item
life expectancy < 1 year
boolean
C0023671 (UMLS CUI [1])
Child-Pugh-Classification
Item
child pugh b or c (appendix iii)
boolean
C4050412 (UMLS CUI [1])
Creatinine measurement
Item
creatinine > 150 μmol/l or > 1.70 mg/dl
boolean
C0201976 (UMLS CUI [1])
Hemoglobin measurement
Item
haemoglobulin < 6.5 mmol/l or < 10.5 g/dl
boolean
C0518015 (UMLS CUI [1])
White blood cell count and neutrophil count
Item
white blood cell count < 2,5 x 109/l, neutrophil < 1,5 x 109/l
boolean
C0023508 (UMLS CUI [1])
C0200633 (UMLS CUI [2])
C0200633 (UMLS CUI [2])
Platelet count
Item
platelet count < 70 x 109/l
boolean
C0032181 (UMLS CUI [1])
HIV positivity
Item
hiv positivity
boolean
C0019699 (UMLS CUI [1])
chemotherapy, systematical antiviral treatment
Item
chemotherapy, systematical antiviral treatment during the 6 months prior to study entry
boolean
C0392920 (UMLS CUI [1])
C2363964 (UMLS CUI [2])
C2363964 (UMLS CUI [2])
Comorbidity
Item
other serious disease (e.g. malignancy, uncontrolled myocardial disease or severe arrhythmias)
boolean
C0009488 (UMLS CUI [1])
Psychiatric disorders and suicidal leanings
Item
active uncontrolled psychiatric disorders and suicidal leanings
boolean
C0004936 (UMLS CUI [1])
C0563664 (UMLS CUI [2])
C0563664 (UMLS CUI [2])
Seizure or cns dysfunction
Item
patients with a history of uncontrolled seizure or other significant cns dysfunction
boolean
C0036572 (UMLS CUI [1])
C0007682 (UMLS CUI [2])
C0007682 (UMLS CUI [2])
Comorbidity affecting study participation
Item
any condition which in the opinion of the (co-)investigator might interfere with the evaluation of the study objectives
boolean
C0009488 (UMLS CUI [1,1])
C0392760 (UMLS CUI [1,2])
C2348568 (UMLS CUI [1,3])
C0392760 (UMLS CUI [1,2])
C2348568 (UMLS CUI [1,3])