ID

19218

Description

Omegaven in Patients With Rheumatoid Arthritis (ORA-Trial); ODM derived from: https://clinicaltrials.gov/show/NCT00412256

Link

https://clinicaltrials.gov/show/NCT00412256

Keywords

Versions (1)
  1. 12/12/16 12/12/16 -
Uploaded on

December 12, 2016

DOI

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License

Creative Commons BY 4.0
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Eligibility Rheumatoid Arthritis NCT00412256

English

Eligibility Rheumatoid Arthritis NCT00412256

1 forms  
Inclusion Criteria
Description

Inclusion Criteria

Alias
UMLS CUI
C1512693
written informed consent
Description

Informed Consent

Data type

boolean

Alias
UMLS CUI [1]
C0021430
ra according to the acr criteria
Description

Rheumatoid Arthritis

Data type

boolean

Alias
UMLS CUI [1]
C0003873
active ra (das28 > 4.0) at the screening visit
Description

Rheumatoid Arthritis DAS 28 joint in rheumatoid arthritis

Data type

boolean

Alias
UMLS CUI [1,1]
C0003873
UMLS CUI [1,2]
C2732493
insignificant das28-change (<0.6) between screening and the first intervention
Description

DAS 28 joint in rheumatoid arthritis Change

Data type

boolean

Alias
UMLS CUI [1,1]
C2732493
UMLS CUI [1,2]
C0392747
Exclusion Criteria
Description

Exclusion Criteria

Alias
UMLS CUI
C0680251
age lower than 18 yrs.
Description

Age

Data type

boolean

Alias
UMLS CUI [1]
C0001779
pregnancy and insufficient birth control
Description

Pregnancy | Contraceptive methods Insufficient

Data type

boolean

Alias
UMLS CUI [1]
C0032961
UMLS CUI [2,1]
C0700589
UMLS CUI [2,2]
C0231180
lactation
Description

Breast Feeding

Data type

boolean

Alias
UMLS CUI [1]
C0006147
army service
Description

military service branch Army

Data type

boolean

Alias
UMLS CUI [1]
C2135826
lack of independence
Description

Independence Lack

Data type

boolean

Alias
UMLS CUI [1,1]
C0085862
UMLS CUI [1,2]
C0332268
relevant therapeutic or dietary changes during the last three months
Description

Therapy change Relevant | Change in diet Relevant

Data type

boolean

Alias
UMLS CUI [1,1]
C3665894
UMLS CUI [1,2]
C2347946
UMLS CUI [2,1]
C3671772
UMLS CUI [2,2]
C2347946
relevant therapeutic or dietary changes foreseen for the study duration (including surgery)
Description

Therapy change Relevant Planned | Change in diet Relevant Planned

Data type

boolean

Alias
UMLS CUI [1,1]
C3665894
UMLS CUI [1,2]
C2347946
UMLS CUI [1,3]
C1301732
UMLS CUI [2,1]
C3671772
UMLS CUI [2,2]
C2347946
UMLS CUI [2,3]
C1301732
application of omega-3 fatty acids during the last three months
Description

Omega-3 Fatty Acids

Data type

boolean

Alias
UMLS CUI [1]
C0015689
application of omega-3 fatty acids intended for the study duration
Description

Omega-3 Fatty Acids intended

Data type

boolean

Alias
UMLS CUI [1,1]
C0015689
UMLS CUI [1,2]
C1283828
prednisolone > 10 mg/day
Description

prednisolone U/day

Data type

boolean

Alias
UMLS CUI [1,1]
C0032950
UMLS CUI [1,2]
C0456683
contraindication for omegaven or lipovenös (according to the label)
Description

Medical contraindication omegaven

Data type

boolean

Alias
UMLS CUI [1,1]
C1301624
UMLS CUI [1,2]
C3252719
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Similar models

Eligibility Rheumatoid Arthritis NCT00412256

1 forms
Name
Type
Description | Question | Decode (Coded Value)
Data type
Alias
Item Group
C1512693 (UMLS CUI)
Informed Consent
Item
written informed consent
boolean
C0021430 (UMLS CUI [1])
Rheumatoid Arthritis
Item
ra according to the acr criteria
boolean
C0003873 (UMLS CUI [1])
Rheumatoid Arthritis DAS 28 joint in rheumatoid arthritis
Item
active ra (das28 > 4.0) at the screening visit
boolean
C0003873 (UMLS CUI [1,1])
C2732493 (UMLS CUI [1,2])
DAS 28 joint in rheumatoid arthritis Change
Item
insignificant das28-change (<0.6) between screening and the first intervention
boolean
C2732493 (UMLS CUI [1,1])
C0392747 (UMLS CUI [1,2])
Item Group
C0680251 (UMLS CUI)
Age
Item
age lower than 18 yrs.
boolean
C0001779 (UMLS CUI [1])
Pregnancy | Contraceptive methods Insufficient
Item
pregnancy and insufficient birth control
boolean
C0032961 (UMLS CUI [1])
C0700589 (UMLS CUI [2,1])
C0231180 (UMLS CUI [2,2])
Breast Feeding
Item
lactation
boolean
C0006147 (UMLS CUI [1])
military service branch Army
Item
army service
boolean
C2135826 (UMLS CUI [1])
Independence Lack
Item
lack of independence
boolean
C0085862 (UMLS CUI [1,1])
C0332268 (UMLS CUI [1,2])
Therapy change Relevant | Change in diet Relevant
Item
relevant therapeutic or dietary changes during the last three months
boolean
C3665894 (UMLS CUI [1,1])
C2347946 (UMLS CUI [1,2])
C3671772 (UMLS CUI [2,1])
C2347946 (UMLS CUI [2,2])
Therapy change Relevant Planned | Change in diet Relevant Planned
Item
relevant therapeutic or dietary changes foreseen for the study duration (including surgery)
boolean
C3665894 (UMLS CUI [1,1])
C2347946 (UMLS CUI [1,2])
C1301732 (UMLS CUI [1,3])
C3671772 (UMLS CUI [2,1])
C2347946 (UMLS CUI [2,2])
C1301732 (UMLS CUI [2,3])
Omega-3 Fatty Acids
Item
application of omega-3 fatty acids during the last three months
boolean
C0015689 (UMLS CUI [1])
Omega-3 Fatty Acids intended
Item
application of omega-3 fatty acids intended for the study duration
boolean
C0015689 (UMLS CUI [1,1])
C1283828 (UMLS CUI [1,2])
prednisolone U/day
Item
prednisolone > 10 mg/day
boolean
C0032950 (UMLS CUI [1,1])
C0456683 (UMLS CUI [1,2])
Medical contraindication omegaven
Item
contraindication for omegaven or lipovenös (according to the label)
boolean
C1301624 (UMLS CUI [1,1])
C3252719 (UMLS CUI [1,2])
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