Eligibility Hepatitis C NCT00108563

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StudyEvent: Eligibility
1. Eligibility Hepatitis C NCT00108563

Name

Type

Description | Question | Decode (Coded Value)

Type de données

Alias

Inclusion Criteria

Item Group

C1512693 (UMLS CUI)

Adult | Age

Item

adult male or female, age 18 or older

boolean

C0001675 (UMLS CUI [1])
C0001779 (UMLS CUI [2])

pegylated interferon alfa | Ribavirin | Combined Modality Therapy Hepatitis C, Chronic

Item

planning to receive any brand of pegylated interferon/ribavirin combination therapy for chronic hcv (hepatitis c virus)

boolean

C0907160 (UMLS CUI [1])
C0035525 (UMLS CUI [2])
C0009429 (UMLS CUI [3,1])
C0524910 (UMLS CUI [3,2])

Exclusion Criteria

Item Group

C0680251 (UMLS CUI)

Chronic liver disease | Hepatitis C, Chronic

Item

chronic liver disease other than chronic hcv

boolean

C0341439 (UMLS CUI [1])
C0524910 (UMLS CUI [2])

Liver disease Advanced | Ascites | Bleeding varices | Encephalopathy Spontaneous

Item

evidence of advanced liver disease such as a history of or presence of ascites, bleeding varices, or spontaneous encephalopathy

boolean

C0023895 (UMLS CUI [1,1])
C0205179 (UMLS CUI [1,2])
C0003962 (UMLS CUI [2])
C0333106 (UMLS CUI [3])
C0085584 (UMLS CUI [4,1])
C0205359 (UMLS CUI [4,2])

Organ Transplantation

Item

a history of organ transplantation

boolean

C0029216 (UMLS CUI [1])

medical condition Pre-existing Interferes with Study Subject Participation Status | Epilepsy Requirement Pharmaceutical Preparations | Injury of central nervous system Major | Accidental event Causing Loss of consciousness | Accidental event Causing Personality change

Item

any known preexisting medical condition that could interfere with the patient's participation in the protocol, including: *active seizure disorders requiring medication; *history of major cns (central nervous system) trauma (as suggested by accident or other event leading to loss of consciousness, personality changes, etc)

boolean

C3843040 (UMLS CUI [1,1])
C2347662 (UMLS CUI [1,2])
C0521102 (UMLS CUI [1,3])
C2348568 (UMLS CUI [1,4])
C0014544 (UMLS CUI [2,1])
C1514873 (UMLS CUI [2,2])
C0013227 (UMLS CUI [2,3])
C1264238 (UMLS CUI [3,1])
C0205164 (UMLS CUI [3,2])
C1690974 (UMLS CUI [4,1])
C0678227 (UMLS CUI [4,2])
C0840361 (UMLS CUI [4,3])
C1690974 (UMLS CUI [5,1])
C0678227 (UMLS CUI [5,2])
C0240735 (UMLS CUI [5,3])

medical condition Requirement systemic steroids chronic | Adrenal Cortex Hormones | Injection of steroid

Item

any medical condition requiring, or likely to require during the course of the study, chronic systemic administration of steroids (e.g. oral or injection).

boolean

C3843040 (UMLS CUI [1,1])
C1514873 (UMLS CUI [1,2])
C2825233 (UMLS CUI [1,3])
C0205191 (UMLS CUI [1,4])
C0001617 (UMLS CUI [2])
C1261311 (UMLS CUI [3])

Able to read Insufficient | Able to write Insufficient | Patient Self-Report Completion Unable

Item

inability to read and write at a level sufficient to complete self-report forms

boolean

C0586740 (UMLS CUI [1,1])
C0231180 (UMLS CUI [1,2])
C0584993 (UMLS CUI [2,1])
C0231180 (UMLS CUI [2,2])
C0681906 (UMLS CUI [3,1])
C0205197 (UMLS CUI [3,2])
C1299582 (UMLS CUI [3,3])

Compliance behavior Limited

Item

history of significant non-compliance with medical treatments and appointments

boolean

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

Antidepressive Agents Dose Full | Pharmaceutical Preparations Affecting Significant Depressive Symptoms

Item

patients currently, or within the last three months, on a full therapeutic dose of antidepressant medication, or a dose of other medication such that it may significantly affect depressive symptomatology

boolean

C0003289 (UMLS CUI [1,1])
C0178602 (UMLS CUI [1,2])
C0443225 (UMLS CUI [1,3])
C0013227 (UMLS CUI [2,1])
C0392760 (UMLS CUI [2,2])
C0750502 (UMLS CUI [2,3])
C0086132 (UMLS CUI [2,4])

Depressive disorder | Beck depression inventory

Item

patients with active depression in the previous 3 months and/or those with bdi (beck depression inventory)-ii greater than or equal to 15 at the time of study entry.

boolean

C0011581 (UMLS CUI [1])
C0451022 (UMLS CUI [2])

Bipolar Disorder

Item

patients with bipolar disorder or history of bipolar disorder

boolean

C0005586 (UMLS CUI [1])

Psychotic symptom | Schizophrenia

Item

patients with active psychotic symptoms or diagnosis of schizophrenia in the previous 3 months

boolean

C0871189 (UMLS CUI [1])
C0036341 (UMLS CUI [2])

Substance Use Disorders | intravenous drug Abuse | inhaled substance Abuse | sustained remission

Item

active substance abuse, such as alcohol (greater than 80 gm/day), iv (intravenous) drugs, and inhaled drugs. if the patient has a history of substance abuse, in order to be considered for inclusion into the protocol, the patient must have been in a sustained remission for at least 6 months

boolean

C0038586 (UMLS CUI [1])
C0683092 (UMLS CUI [2,1])
C1546935 (UMLS CUI [2,2])
C0683094 (UMLS CUI [3,1])
C1546935 (UMLS CUI [3,2])
C0814128 (UMLS CUI [4])

Opiate Substitution Treatment | Drug addiction therapy - methadone

Item

patients receiving opiate agonist therapy (e.g., methadone maintenance therapy) within the past year, unless a program of testing for continued substance abuse is initiated (testing at entry and then randomly at least every 2-3 months) and the patient is withdrawn from study for any violation.

boolean

C2936530 (UMLS CUI [1])
C0588202 (UMLS CUI [2])

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Eligibility Hepatitis C NCT00108563