ID

14655

Description

Evaluation of a New Therapeutic Strategy in Early and Active Relapsing-Remitting Multiple Sclerosis; ODM derived from: https://clinicaltrials.gov/show/NCT00219908

Link

https://clinicaltrials.gov/show/NCT00219908

Keywords

  1. 4/25/16 4/25/16 -
Uploaded on

April 25, 2016

DOI

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License

Creative Commons BY 4.0

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Eligibility Relapsing-Remitting Multiple Sclerosis NCT00219908

Eligibility Relapsing-Remitting Multiple Sclerosis NCT00219908

Inclusion Criteria
Description

Inclusion Criteria

Alias
UMLS CUI
C1512693
age : 18-45 years,
Description

Age

Data type

boolean

Alias
UMLS CUI [1]
C0001779
clinical disease satisfying the poser criteria (amdmt n°4)
Description

Clinical disease

Data type

boolean

Alias
UMLS CUI [1]
C0012634
relapsing-remitting disease (amdmt n°4)
Description

Relapsing-Remitting Multiple Sclerosis

Data type

boolean

Alias
UMLS CUI [1]
C0751967
at least 2 exacerbations within the preceding 12 months, having left sequelae,
Description

MS exacerbation

Data type

boolean

Alias
UMLS CUI [1]
C0581392
mri activity at inclusion expressed by at least one gadolinium-enhanced lesion (cranial mri with 0.1mmol/kg gadolinium),
Description

MRI with gadolinium

Data type

boolean

Alias
UMLS CUI [1,1]
C0024485
UMLS CUI [1,2]
C0016911
a significant disability at inclusion: edss score between 2.5 and 5.5 (amdt n° 4)
Description

EDSS score

Data type

boolean

Alias
UMLS CUI [1]
C0451246
written informed consent
Description

Informed consent

Data type

boolean

Alias
UMLS CUI [1]
C0021430
Exclusion Criteria
Description

Exclusion Criteria

Alias
UMLS CUI
C0680251
pregnancy and breast-feeding
Description

Gynaecological status

Data type

boolean

Alias
UMLS CUI [1]
C0032961
UMLS CUI [2]
C0006147
use of an insufficiency effective contraceptive method,
Description

Contraception

Data type

boolean

Alias
UMLS CUI [1]
C0700589
general immunosuppressive therapy using cyclophosphamide, mitoxantrone,or total lymphoid irradiation
Description

iImunosuppressive therapy

Data type

boolean

Alias
UMLS CUI [1]
C0021079
treatment with azathioprine during the 3 months preceding the study
Description

Azathioprine

Data type

boolean

Alias
UMLS CUI [1]
C0004482
clinical relapse or intensive corticosteroid treatment within the 30 days preceding inclusion,
Description

Relapse and corticosteroid treatment

Data type

boolean

Alias
UMLS CUI [1]
C0277556
UMLS CUI [2]
C0149783
associated disease (psychiatric disorder, depressive statenot controlled by appropriate drug therapy, history of heart disease at inclusion examination
Description

Comorbidity

Data type

boolean

Alias
UMLS CUI [1]
C0009488

Similar models

Eligibility Relapsing-Remitting Multiple Sclerosis NCT00219908

Name
Type
Description | Question | Decode (Coded Value)
Data type
Alias
Item Group
C1512693 (UMLS CUI)
Age
Item
age : 18-45 years,
boolean
C0001779 (UMLS CUI [1])
Clinical disease
Item
clinical disease satisfying the poser criteria (amdmt n°4)
boolean
C0012634 (UMLS CUI [1])
Relapsing-Remitting Multiple Sclerosis
Item
relapsing-remitting disease (amdmt n°4)
boolean
C0751967 (UMLS CUI [1])
MS exacerbation
Item
at least 2 exacerbations within the preceding 12 months, having left sequelae,
boolean
C0581392 (UMLS CUI [1])
MRI with gadolinium
Item
mri activity at inclusion expressed by at least one gadolinium-enhanced lesion (cranial mri with 0.1mmol/kg gadolinium),
boolean
C0024485 (UMLS CUI [1,1])
C0016911 (UMLS CUI [1,2])
EDSS score
Item
a significant disability at inclusion: edss score between 2.5 and 5.5 (amdt n° 4)
boolean
C0451246 (UMLS CUI [1])
Informed consent
Item
written informed consent
boolean
C0021430 (UMLS CUI [1])
Item Group
C0680251 (UMLS CUI)
Gynaecological status
Item
pregnancy and breast-feeding
boolean
C0032961 (UMLS CUI [1])
C0006147 (UMLS CUI [2])
Contraception
Item
use of an insufficiency effective contraceptive method,
boolean
C0700589 (UMLS CUI [1])
iImunosuppressive therapy
Item
general immunosuppressive therapy using cyclophosphamide, mitoxantrone,or total lymphoid irradiation
boolean
C0021079 (UMLS CUI [1])
Azathioprine
Item
treatment with azathioprine during the 3 months preceding the study
boolean
C0004482 (UMLS CUI [1])
Relapse and corticosteroid treatment
Item
clinical relapse or intensive corticosteroid treatment within the 30 days preceding inclusion,
boolean
C0277556 (UMLS CUI [1])
C0149783 (UMLS CUI [2])
Comorbidity
Item
associated disease (psychiatric disorder, depressive statenot controlled by appropriate drug therapy, history of heart disease at inclusion examination
boolean
C0009488 (UMLS CUI [1])

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