ID

27879

Beskrivning

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

Länk

https://clinicaltrials.gov/show/NCT00682591

Nyckelord

Versioner (1)
  1. 2017-12-03 2017-12-03 -
Rättsinnehavare

See clinicaltrials.gov

Uppladdad den

3 december 2017

DOI

För en begäran logga in.

Licens

Creative Commons BY 4.0
Modellkommentarer :

Här kan du kommentera modellen. Med hjälp av pratbubblor i Item-grupperna och Item kan du lägga in specifika kommentarer.

Tillbaka till modellkommentarer
Itemgroup-kommentar för :

Item-kommentar för :

Du måste vara inloggad för att kunna ladda ner formulär. Var vänlig logga in eller registrera dig utan kostnad.

Eligibility Chronic Hepatitis C Infection NCT00682591

Engelsk

Eligibility Chronic Hepatitis C Infection NCT00682591

1 Formulär  
Inclusion Criteria
Beskrivning

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.
Beskrivning

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

Datatyp

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.
Beskrivning

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

Datatyp

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.
Beskrivning

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

Datatyp

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.
Beskrivning

Monitoring Emotional state | Monitoring Performance neurocognitive

Datatyp

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
Beskrivning

Exclusion Criteria

Alias
UMLS CUI
C0680251
according to spc
Beskrivning

Pharmaceutical Product Characteristics according

Datatyp

boolean

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

Agreement Requirement Legal Drug substitution therapy

Datatyp

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).
Beskrivning

German language Comprehension Insufficient | Impaired cognition

Datatyp

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
Beskrivning

Age

Datatyp

boolean

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

HBV coinfection | HIV coinfection

Datatyp

boolean

Alias
UMLS CUI [1]
C2242656
UMLS CUI [2]
C4062778
Tillbaka till toppen

Similar models

Eligibility Chronic Hepatitis C Infection NCT00682591

1 Formulär
Name
Typ
Description | Question | Decode (Coded Value)
Datatyp
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])
Tillbaka till toppen 

Kontakt

Använd detta formulär för feedback, frågor och förslag på förbättringar.

Fält markerade med * är obligatoriska.

Hjälp

Do you need help on how to use the search function? Please watch the corresponding tutorial video for more details and learn how to use the search function most efficiently.

Watch Tutorial