ID

15251

Beschrijving

Safety and Efficacy Study of Etanercept (Enbrel®) In Children With Systemic Onset Juvenile Rheumatoid Arthritis; ODM derived from: https://clinicaltrials.gov/show/NCT00078806

Link

https://clinicaltrials.gov/show/NCT00078806

Trefwoorden

  1. 23-05-16 23-05-16 -
Geüploaded op

23 mei 2016

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 Juvenile Rheumatoid Arthritis NCT00078806

Eligibility Juvenile Rheumatoid Arthritis NCT00078806

Inclusion Criteria
Beschrijving

Inclusion Criteria

Alias
UMLS CUI
C1512693
2 - 18 years of age
Beschrijving

age

Datatype

boolean

Alias
UMLS CUI [1]
C0001779
sojra for at least 3 months, with stable systemic features
Beschrijving

SOJRA

Datatype

boolean

Alias
UMLS CUI [1]
C1384600
if taking methotrexate, hydroxychloroquine, or nsaids, dose must be stable
Beschrijving

stable dose

Datatype

boolean

Alias
UMLS CUI [1,1]
C0678766
UMLS CUI [1,2]
C0025677
UMLS CUI [2,1]
C0678766
UMLS CUI [2,2]
C0020336
UMLS CUI [3,1]
C0678766
UMLS CUI [3,2]
C0003211
must take prednisone at a stable dose
Beschrijving

prednisone

Datatype

boolean

Alias
UMLS CUI [1,1]
C0032952
UMLS CUI [1,2]
C0178602
Exclusion Criteria
Beschrijving

Exclusion Criteria

Alias
UMLS CUI-1
C0680251
need for other dmards or prestudy requirements for oral or parenteral pulse steroids or intra-articular steroids
Beschrijving

need for other dmards

Datatype

boolean

Alias
UMLS CUI [1,1]
C0242708
UMLS CUI [1,2]
C0205394
UMLS CUI [2]
C0038317
pregnant or nursing female
Beschrijving

pregnant or nursing female

Datatype

boolean

Alias
UMLS CUI [1]
C0032961
UMLS CUI [2]
C0006147
clinically significant abnormal laboratory test results for blood cells, liver or kidney function, or serology
Beschrijving

abnormal laboratory test

Datatype

boolean

Alias
UMLS CUI [1]
C0438215
previous receipt of any tnf inhibitor
Beschrijving

tnf inhibitor

Datatype

boolean

Alias
UMLS CUI [1]
C3653350
live virus vaccine within 12 weeks of study entry
Beschrijving

live virus vaccine

Datatype

boolean

Alias
UMLS CUI [1]
C0042742
participation in another study requiring informed consent within 12 weeks of entry
Beschrijving

participation in another study

Datatype

boolean

Alias
UMLS CUI [1]
C2348568
diabetes that requires insulin treatment
Beschrijving

diabetes that requires insulin treatment

Datatype

boolean

Alias
UMLS CUI [1]
C0011854
infection, chronic, recurrent, or currently active
Beschrijving

infection

Datatype

boolean

Alias
UMLS CUI [1]
C0009450
any serious medical or psychiatric condition or history of alcohol or drug abuse
Beschrijving

serious medical condition or drug abuse

Datatype

boolean

Alias
UMLS CUI [1]
C0009488
UMLS CUI [2]
C0013146

Similar models

Eligibility Juvenile Rheumatoid Arthritis NCT00078806

Name
Type
Description | Question | Decode (Coded Value)
Datatype
Alias
Item Group
C1512693 (UMLS CUI)
age
Item
2 - 18 years of age
boolean
C0001779 (UMLS CUI [1])
SOJRA
Item
sojra for at least 3 months, with stable systemic features
boolean
C1384600 (UMLS CUI [1])
stable dose
Item
if taking methotrexate, hydroxychloroquine, or nsaids, dose must be stable
boolean
C0678766 (UMLS CUI [1,1])
C0025677 (UMLS CUI [1,2])
C0678766 (UMLS CUI [2,1])
C0020336 (UMLS CUI [2,2])
C0678766 (UMLS CUI [3,1])
C0003211 (UMLS CUI [3,2])
prednisone
Item
must take prednisone at a stable dose
boolean
C0032952 (UMLS CUI [1,1])
C0178602 (UMLS CUI [1,2])
Item Group
Exclusion Criteria
C0680251 (UMLS CUI-1)
need for other dmards
Item
need for other dmards or prestudy requirements for oral or parenteral pulse steroids or intra-articular steroids
boolean
C0242708 (UMLS CUI [1,1])
C0205394 (UMLS CUI [1,2])
C0038317 (UMLS CUI [2])
pregnant or nursing female
Item
pregnant or nursing female
boolean
C0032961 (UMLS CUI [1])
C0006147 (UMLS CUI [2])
abnormal laboratory test
Item
clinically significant abnormal laboratory test results for blood cells, liver or kidney function, or serology
boolean
C0438215 (UMLS CUI [1])
tnf inhibitor
Item
previous receipt of any tnf inhibitor
boolean
C3653350 (UMLS CUI [1])
live virus vaccine
Item
live virus vaccine within 12 weeks of study entry
boolean
C0042742 (UMLS CUI [1])
participation in another study
Item
participation in another study requiring informed consent within 12 weeks of entry
boolean
C2348568 (UMLS CUI [1])
diabetes that requires insulin treatment
Item
diabetes that requires insulin treatment
boolean
C0011854 (UMLS CUI [1])
infection
Item
infection, chronic, recurrent, or currently active
boolean
C0009450 (UMLS CUI [1])
serious medical condition or drug abuse
Item
any serious medical or psychiatric condition or history of alcohol or drug abuse
boolean
C0009488 (UMLS CUI [1])
C0013146 (UMLS CUI [2])

Gebruik dit formulier voor feedback, vragen en verbeteringsvoorstellen.

Velden gemarkeerd met een * zijn verplicht.

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