Informatie:
Fout:
ID
29740
Beschrijving
Effect of Insulin Resistance on the Safety and Efficacy of Pegylated Interferon and Ribavirin Treatment in HCV (Study P05562); ODM derived from: https://clinicaltrials.gov/show/NCT00705224
Link
https://clinicaltrials.gov/show/NCT00705224
Trefwoorden
Versies (1)
- 17-04-18 17-04-18 -
Houder van rechten
See clinicaltrials.gov
Geüploaded op
17 april 2018
DOI
Voor een aanvraag inloggen.
Licentie
Creative Commons BY 4.0
Model Commentaren :
Hier kunt u commentaar leveren op het model. U kunt de tekstballonnen bij de itemgroepen en items gebruiken om er specifiek commentaar op te geven.
Itemgroep Commentaren voor :
Item Commentaren voor :
U moet ingelogd zijn om formulieren te downloaden. AUB inloggen of schrijf u gratis in.
Eligibility Hepatitis C, Chronic NCT00705224
Eligibility Hepatitis C, Chronic NCT00705224
- StudyEvent: Eligibility
Similar models
Eligibility Hepatitis C, Chronic NCT00705224
- StudyEvent: Eligibility
Name
Type
Description | Question | Decode (Coded Value)
Datatype
Alias
Hepatitis C, Chronic
Item
confirmed diagnosis of chc according to local regulations
boolean
C0524910 (UMLS CUI [1])
Peginterferon naive Chronic Hepatitis C
Item
naïve pegylated interferon (peg-ifn) chc patient
boolean
C0982327 (UMLS CUI [1,1])
C0919936 (UMLS CUI [1,2])
C0524910 (UMLS CUI [1,3])
C0919936 (UMLS CUI [1,2])
C0524910 (UMLS CUI [1,3])
Absence Medical contraindication Peginterferon Chronic Hepatitis C
Item
no contraindications for peg-ifn chc therapy
boolean
C0332197 (UMLS CUI [1,1])
C1301624 (UMLS CUI [1,2])
C0982327 (UMLS CUI [1,3])
C0524910 (UMLS CUI [1,4])
C1301624 (UMLS CUI [1,2])
C0982327 (UMLS CUI [1,3])
C0524910 (UMLS CUI [1,4])
Childbearing Potential Urine pregnancy test negative | Childbearing Potential Contraceptive methods Quantity | Gender Partner Childbearing Potential Contraceptive methods Quantity
Item
negative urine pregnancy test result (for females of childbearing potential) documented within the 24-hour period prior to the first dose of study drugs. additionally, all female patients of childbearing potential and all males with female partners of childbearing potential must use two forms of effective contraception (combined) during treatment and 6 months after treatment end
boolean
C3831118 (UMLS CUI [1,1])
C0430057 (UMLS CUI [1,2])
C3831118 (UMLS CUI [2,1])
C0700589 (UMLS CUI [2,2])
C1265611 (UMLS CUI [2,3])
C0079399 (UMLS CUI [3,1])
C0682323 (UMLS CUI [3,2])
C3831118 (UMLS CUI [3,3])
C0700589 (UMLS CUI [3,4])
C1265611 (UMLS CUI [3,5])
C0430057 (UMLS CUI [1,2])
C3831118 (UMLS CUI [2,1])
C0700589 (UMLS CUI [2,2])
C1265611 (UMLS CUI [2,3])
C0079399 (UMLS CUI [3,1])
C0682323 (UMLS CUI [3,2])
C3831118 (UMLS CUI [3,3])
C0700589 (UMLS CUI [3,4])
C1265611 (UMLS CUI [3,5])
Informed Consent | Protocol Compliance
Item
willingness to give written informed consent and willingness to participate in and comply with the study requirements.
boolean
C0021430 (UMLS CUI [1])
C0525058 (UMLS CUI [2])
C0525058 (UMLS CUI [2])
Peginterferon History
Item
peg-ifn treatment in history
boolean
C0982327 (UMLS CUI [1,1])
C0019665 (UMLS CUI [1,2])
C0019665 (UMLS CUI [1,2])
Medical contraindication Peginterferon Chronic Hepatitis C
Item
contraindications for peg-ifn chc therapy
boolean
C1301624 (UMLS CUI [1,1])
C0982327 (UMLS CUI [1,2])
C0524910 (UMLS CUI [1,3])
C0982327 (UMLS CUI [1,2])
C0524910 (UMLS CUI [1,3])
Pregnancy | Breast Feeding
Item
females who are pregnant or breast-feeding
boolean
C0032961 (UMLS CUI [1])
C0006147 (UMLS CUI [2])
C0006147 (UMLS CUI [2])
Gender Partner Pregnancy
Item
male partners of females who are pregnant
boolean
C0079399 (UMLS CUI [1,1])
C0682323 (UMLS CUI [1,2])
C0032961 (UMLS CUI [1,3])
C0682323 (UMLS CUI [1,2])
C0032961 (UMLS CUI [1,3])
Study Subject Unreliable | Study Subject Participation Status Inappropriate
Item
potentially unreliable participants, and those judged by the investigator to be unsuitable for the study.
boolean
C0681850 (UMLS CUI [1,1])
C4061925 (UMLS CUI [1,2])
C2348568 (UMLS CUI [2,1])
C1548788 (UMLS CUI [2,2])
C4061925 (UMLS CUI [1,2])
C2348568 (UMLS CUI [2,1])
C1548788 (UMLS CUI [2,2])