ID

27879

Descrição

Evaluation of Neurocognitive Performance in Drug Substituted Patients Under Hepatitis C Therapy; ODM derived from: https://clinicaltrials.gov/show/NCT00682591

Link

https://clinicaltrials.gov/show/NCT00682591

Palavras-chave

  1. 03/12/2017 03/12/2017 -
Titular dos direitos

See clinicaltrials.gov

Transferido a

3 de dezembro de 2017

DOI

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Licença

Creative Commons BY 4.0

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Eligibility Chronic Hepatitis C Infection NCT00682591

Eligibility Chronic Hepatitis C Infection NCT00682591

Inclusion Criteria
Descrição

Inclusion Criteria

Alias
UMLS CUI
C1512693
opioid-dependent patients on current stable agonist maintenance therapy (for at least 6 months prior to study enrolment) with methadone, buprenorphine, or suboxone.
Descrição

Opiate Addiction | Maintenance therapy Agonists Stable | Methadone | Buprenorphine | Suboxone

Tipo de dados

boolean

Alias
UMLS CUI [1]
C0524662
UMLS CUI [2,1]
C0677908
UMLS CUI [2,2]
C0243192
UMLS CUI [2,3]
C0205360
UMLS CUI [3]
C0025605
UMLS CUI [4]
C0006405
UMLS CUI [5]
C1170625
patients need to be infected with chronic hepatitis c and must have indication for therapy with peginterferon alfa and ribavirin.
Descrição

Hepatitis C, Chronic | Indication peginterferon alfa-2b | Indication peginterferon alfa-2a | Indication Ribavirin

Tipo de dados

boolean

Alias
UMLS CUI [1]
C0524910
UMLS CUI [2,1]
C3146298
UMLS CUI [2,2]
C0796545
UMLS CUI [3,1]
C3146298
UMLS CUI [3,2]
C0391001
UMLS CUI [4,1]
C3146298
UMLS CUI [4,2]
C0035525
patients with informed written consent with respect to a follow-up of psychiatric side effects and in particular neurocognitive performance.
Descrição

Informed Consent | Follow-up Adverse effects Psychiatric | Follow-up Performance neurocognitive

Tipo de dados

boolean

Alias
UMLS CUI [1]
C0021430
UMLS CUI [2,1]
C3274571
UMLS CUI [2,2]
C0879626
UMLS CUI [2,3]
C0205487
UMLS CUI [3,1]
C3274571
UMLS CUI [3,2]
C0597198
UMLS CUI [3,3]
C0518895
patients with baseline monitoring of emotional state and neurocognitive performance.
Descrição

Monitoring Emotional state | Monitoring Performance neurocognitive

Tipo de dados

boolean

Alias
UMLS CUI [1,1]
C1516647
UMLS CUI [1,2]
C0935620
UMLS CUI [2,1]
C1516647
UMLS CUI [2,2]
C0597198
UMLS CUI [2,3]
C0518895
Exclusion Criteria
Descrição

Exclusion Criteria

Alias
UMLS CUI
C0680251
according to spc
Descrição

Pharmaceutical Product Characteristics according

Tipo de dados

boolean

Alias
UMLS CUI [1,1]
C1709515
UMLS CUI [1,2]
C0680240
according to legal requirements reg. drug substitution therapy (btmvv)
Descrição

Agreement Requirement Legal Drug substitution therapy

Tipo de dados

boolean

Alias
UMLS CUI [1,1]
C0680240
UMLS CUI [1,2]
C1514873
UMLS CUI [1,3]
C1301860
UMLS CUI [1,4]
C0815134
insufficient knowledge of the german language or cognitive impairment (due to the indispensable application of questionnaires and the tap, test battery of attentional performance).
Descrição

German language Comprehension Insufficient | Impaired cognition

Tipo de dados

boolean

Alias
UMLS CUI [1,1]
C0017477
UMLS CUI [1,2]
C0162340
UMLS CUI [1,3]
C0231180
UMLS CUI [2]
C0338656
age under 18 years or over 65 years
Descrição

Age

Tipo de dados

boolean

Alias
UMLS CUI [1]
C0001779
coinfections such as hepatitis b virus or human immunodeficiency virus
Descrição

HBV coinfection | HIV coinfection

Tipo de dados

boolean

Alias
UMLS CUI [1]
C2242656
UMLS CUI [2]
C4062778

Similar models

Eligibility Chronic Hepatitis C Infection NCT00682591

Name
Tipo
Description | Question | Decode (Coded Value)
Tipo de dados
Alias
Item Group
C1512693 (UMLS CUI)
Opiate Addiction | Maintenance therapy Agonists Stable | Methadone | Buprenorphine | Suboxone
Item
opioid-dependent patients on current stable agonist maintenance therapy (for at least 6 months prior to study enrolment) with methadone, buprenorphine, or suboxone.
boolean
C0524662 (UMLS CUI [1])
C0677908 (UMLS CUI [2,1])
C0243192 (UMLS CUI [2,2])
C0205360 (UMLS CUI [2,3])
C0025605 (UMLS CUI [3])
C0006405 (UMLS CUI [4])
C1170625 (UMLS CUI [5])
Hepatitis C, Chronic | Indication peginterferon alfa-2b | Indication peginterferon alfa-2a | Indication Ribavirin
Item
patients need to be infected with chronic hepatitis c and must have indication for therapy with peginterferon alfa and ribavirin.
boolean
C0524910 (UMLS CUI [1])
C3146298 (UMLS CUI [2,1])
C0796545 (UMLS CUI [2,2])
C3146298 (UMLS CUI [3,1])
C0391001 (UMLS CUI [3,2])
C3146298 (UMLS CUI [4,1])
C0035525 (UMLS CUI [4,2])
Informed Consent | Follow-up Adverse effects Psychiatric | Follow-up Performance neurocognitive
Item
patients with informed written consent with respect to a follow-up of psychiatric side effects and in particular neurocognitive performance.
boolean
C0021430 (UMLS CUI [1])
C3274571 (UMLS CUI [2,1])
C0879626 (UMLS CUI [2,2])
C0205487 (UMLS CUI [2,3])
C3274571 (UMLS CUI [3,1])
C0597198 (UMLS CUI [3,2])
C0518895 (UMLS CUI [3,3])
Monitoring Emotional state | Monitoring Performance neurocognitive
Item
patients with baseline monitoring of emotional state and neurocognitive performance.
boolean
C1516647 (UMLS CUI [1,1])
C0935620 (UMLS CUI [1,2])
C1516647 (UMLS CUI [2,1])
C0597198 (UMLS CUI [2,2])
C0518895 (UMLS CUI [2,3])
Item Group
C0680251 (UMLS CUI)
Pharmaceutical Product Characteristics according
Item
according to spc
boolean
C1709515 (UMLS CUI [1,1])
C0680240 (UMLS CUI [1,2])
Agreement Requirement Legal Drug substitution therapy
Item
according to legal requirements reg. drug substitution therapy (btmvv)
boolean
C0680240 (UMLS CUI [1,1])
C1514873 (UMLS CUI [1,2])
C1301860 (UMLS CUI [1,3])
C0815134 (UMLS CUI [1,4])
German language Comprehension Insufficient | Impaired cognition
Item
insufficient knowledge of the german language or cognitive impairment (due to the indispensable application of questionnaires and the tap, test battery of attentional performance).
boolean
C0017477 (UMLS CUI [1,1])
C0162340 (UMLS CUI [1,2])
C0231180 (UMLS CUI [1,3])
C0338656 (UMLS CUI [2])
Age
Item
age under 18 years or over 65 years
boolean
C0001779 (UMLS CUI [1])
HBV coinfection | HIV coinfection
Item
coinfections such as hepatitis b virus or human immunodeficiency virus
boolean
C2242656 (UMLS CUI [1])
C4062778 (UMLS CUI [2])

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