Eligibility Hepatitis C NCT01413490

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StudyEvent: Eligibility
1. Eligibility Hepatitis C NCT01413490

Name

Typ

Description | Question | Decode (Coded Value)

Datatyp

Alias

Inclusion Criteria

Item Group

C1512693 (UMLS CUI)

infection Hepatitis C; Genotype

Item

have a diagnosis of hcv infection, genotype 1 or genotype 3

boolean

C3714514 (UMLS CUI [1,1])
C0019196 (UMLS CUI [1,2])

combination therapy ribavirin

Item

be eligible for standard combination therapy with pegylated ifn and ribavirin

boolean

C0013218 (UMLS CUI [1,1])
C0035525 (UMLS CUI [1,2])

age

Item

be at least 18 but no more than 65 years of age

boolean

C0001779 (UMLS CUI [1])

informed consent

Item

have signed an informed consent indicating that the patient is aware of the infectious nature of their disease and have been informed of the procedures of the protocol, the experimental nature of the therapy, alternatives, potential benefits, side effects, risks, and discomforts

boolean

C0021430 (UMLS CUI [1])

compliance

Item

be willing and able to comply with scheduled visits, the treatment plan, and laboratory tests

boolean

C1321605 (UMLS CUI [1])

contraindication rimantadine

Item

have no contraindications to receiving rimantadine therapy

boolean

C1301624 (UMLS CUI [1,1])
C0035629 (UMLS CUI [1,2])

haemoglobin; platelet count

Item

have blood results within defined acceptable haematological and biochemical parameters (haemoglobin >10 g/dl, platelet count >150 x 109/l, bilirubin <25 umol/l, albumin >35 g/l, creatinine <150 umol/l

boolean

C0518015 (UMLS CUI [1])
C0032181 (UMLS CUI [2])

Exclusion Criteria

Item Group

C0680251 (UMLS CUI)

Informed Consent Limited Comorbidity

Item

have dementia or altered mental status that would prohibit informed consent

boolean

C0021430 (UMLS CUI [1,1])
C0439801 (UMLS CUI [1,2])
C0009488 (UMLS CUI [1,3])

therapy hepatitis c

Item

have previously received treatment for hcv infection (i.e. are currently treatment naïve)

boolean

C0087111 (UMLS CUI [1,1])
C0019196 (UMLS CUI [1,2])

comorbidity affecting treatment

Item

have any condition which would deem the patient ineligible for combination therapy with pegylated ifn or ribavirin. this includes pregnancy, significant cardiac, renal or autoimmune disease, severe depression or psychosis, and previous organ transplantation

boolean

C0009488 (UMLS CUI [1,1])
C0392760 (UMLS CUI [1,2])
C0087111 (UMLS CUI [1,3])

cirrhosis; liver failure; encephalopathy

Item

cirrhosis or liver failure as evidenced by clinical (cutaneous stigmata of chronic liver disease, ascites, encephalopathy), ultrasonic (cirrhotic appearance of liver, ascites) or biochemical (platelet count >150 x 109/l, bilirubin <25 umol/l, albumin >35 g/l) evidence, routinely collated in all patients diagnosed with hcv

boolean

C0023890 (UMLS CUI [1])
C0085605 (UMLS CUI [2])
C0085584 (UMLS CUI [3])

rimantadine; epilepsy; Renal Insufficiency

Item

any condition which would preclude the use of rimantadine. this comprises significant renal impairment (creatinine >150), pregnancy, epilepsy or history of unexplained seizures

boolean

C0035629 (UMLS CUI [1])
C0014544 (UMLS CUI [2])
C1565489 (UMLS CUI [3])

Compliance behavior Limited Comorbidity

Item

have any other severe, acute, or chronic medical or psychiatric condition or laboratory abnormality that may increase the risk associated with study participation or study drug administration or may interfere with the interpretation of study results and, in the judgment of the chief investigators, would make the patient inappropriate for this study. this includes the presence of end stage liver disease (cirrhosis), and hiv infection

boolean

C1321605 (UMLS CUI [1,1])
C0439801 (UMLS CUI [1,2])
C0009488 (UMLS CUI [1,3])

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Eligibility Hepatitis C NCT01413490