ID

30970

Description

Efficacy and Safety of Methylprednisolone Per os Versus IV for the Treatment of Multiple Sclerosis (MS) Relapses; ODM derived from: https://clinicaltrials.gov/show/NCT00984984

Link

https://clinicaltrials.gov/show/NCT00984984

Keywords

  1. 7/8/18 7/8/18 -
Copyright Holder

See clinicaltrials.gov

Uploaded on

July 8, 2018

DOI

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License

Creative Commons BY 4.0

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Eligibility Multiple Sclerosis, Relapsing-Remitting NCT00984984

Eligibility Multiple Sclerosis, Relapsing-Remitting NCT00984984

Inclusion Criteria
Description

Inclusion Criteria

Alias
UMLS CUI
C1512693
age 18 to 55
Description

Age

Data type

boolean

Alias
UMLS CUI [1]
C0001779
informed written consent
Description

Informed Consent

Data type

boolean

Alias
UMLS CUI [1]
C0021430
multiple sclerosis (mc donald criteria, relapsing-remitting
Description

Multiple Sclerosis, Relapsing-Remitting

Data type

boolean

Alias
UMLS CUI [1]
C0751967
edss before relapse : 0 to 5
Description

EDSS Before Relapse

Data type

boolean

Alias
UMLS CUI [1,1]
C0451246
UMLS CUI [1,2]
C0332152
UMLS CUI [1,3]
C0035020
relapse : increase of 1 point or more for 1 or more functional systems of kurtzke, with sf score most affected > 1 for all functions except for sensory (> 2); duration of symptoms > 24 h
Description

Relapse | Expanded disability status scale score increased | Symptoms Duration

Data type

boolean

Alias
UMLS CUI [1]
C0035020
UMLS CUI [2]
C3203539
UMLS CUI [3,1]
C1457887
UMLS CUI [3,2]
C0449238
Exclusion Criteria
Description

Exclusion Criteria

Alias
UMLS CUI
C0680251
fever
Description

Fever

Data type

boolean

Alias
UMLS CUI [1]
C0015967
previous relapse, and/or corticosteroid treatment < 1 month before present relapse
Description

Relapse Previous | Steroid therapy Before Relapse

Data type

boolean

Alias
UMLS CUI [1,1]
C0035020
UMLS CUI [1,2]
C0205156
UMLS CUI [2,1]
C0149783
UMLS CUI [2,2]
C0332152
UMLS CUI [2,3]
C0035020
first symptoms of the present relapse appeared > 15 days before inclusion
Description

Relapse Symptoms First

Data type

boolean

Alias
UMLS CUI [1,1]
C0035020
UMLS CUI [1,2]
C1457887
UMLS CUI [1,3]
C0205435
under mitoxantrone of cyclophosphamid or natalizumab treatment
Description

Mitoxantrone | Cyclophosphamide | natalizumab

Data type

boolean

Alias
UMLS CUI [1]
C0026259
UMLS CUI [2]
C0010583
UMLS CUI [3]
C1172734
diabetes
Description

Diabetes Mellitus

Data type

boolean

Alias
UMLS CUI [1]
C0011849
infection not under control
Description

Communicable Disease Uncontrolled

Data type

boolean

Alias
UMLS CUI [1,1]
C0009450
UMLS CUI [1,2]
C0205318
liver or kidney failure
Description

Liver Failure | Kidney Failure

Data type

boolean

Alias
UMLS CUI [1]
C0085605
UMLS CUI [2]
C0035078
psychiatric symptoms not under control
Description

Psychiatric symptoms Uncontrolled

Data type

boolean

Alias
UMLS CUI [1,1]
C0233401
UMLS CUI [1,2]
C0205318
pregnancy
Description

Pregnancy

Data type

boolean

Alias
UMLS CUI [1]
C0032961
hypersensibility to methylprednisolone
Description

Methylprednisolone allergy

Data type

boolean

Alias
UMLS CUI [1]
C0571614

Similar models

Eligibility Multiple Sclerosis, Relapsing-Remitting NCT00984984

Name
Type
Description | Question | Decode (Coded Value)
Data type
Alias
Item Group
C1512693 (UMLS CUI)
Age
Item
age 18 to 55
boolean
C0001779 (UMLS CUI [1])
Informed Consent
Item
informed written consent
boolean
C0021430 (UMLS CUI [1])
Multiple Sclerosis, Relapsing-Remitting
Item
multiple sclerosis (mc donald criteria, relapsing-remitting
boolean
C0751967 (UMLS CUI [1])
EDSS Before Relapse
Item
edss before relapse : 0 to 5
boolean
C0451246 (UMLS CUI [1,1])
C0332152 (UMLS CUI [1,2])
C0035020 (UMLS CUI [1,3])
Relapse | Expanded disability status scale score increased | Symptoms Duration
Item
relapse : increase of 1 point or more for 1 or more functional systems of kurtzke, with sf score most affected > 1 for all functions except for sensory (> 2); duration of symptoms > 24 h
boolean
C0035020 (UMLS CUI [1])
C3203539 (UMLS CUI [2])
C1457887 (UMLS CUI [3,1])
C0449238 (UMLS CUI [3,2])
Item Group
C0680251 (UMLS CUI)
Fever
Item
fever
boolean
C0015967 (UMLS CUI [1])
Relapse Previous | Steroid therapy Before Relapse
Item
previous relapse, and/or corticosteroid treatment < 1 month before present relapse
boolean
C0035020 (UMLS CUI [1,1])
C0205156 (UMLS CUI [1,2])
C0149783 (UMLS CUI [2,1])
C0332152 (UMLS CUI [2,2])
C0035020 (UMLS CUI [2,3])
Relapse Symptoms First
Item
first symptoms of the present relapse appeared > 15 days before inclusion
boolean
C0035020 (UMLS CUI [1,1])
C1457887 (UMLS CUI [1,2])
C0205435 (UMLS CUI [1,3])
Mitoxantrone | Cyclophosphamide | natalizumab
Item
under mitoxantrone of cyclophosphamid or natalizumab treatment
boolean
C0026259 (UMLS CUI [1])
C0010583 (UMLS CUI [2])
C1172734 (UMLS CUI [3])
Diabetes Mellitus
Item
diabetes
boolean
C0011849 (UMLS CUI [1])
Communicable Disease Uncontrolled
Item
infection not under control
boolean
C0009450 (UMLS CUI [1,1])
C0205318 (UMLS CUI [1,2])
Liver Failure | Kidney Failure
Item
liver or kidney failure
boolean
C0085605 (UMLS CUI [1])
C0035078 (UMLS CUI [2])
Psychiatric symptoms Uncontrolled
Item
psychiatric symptoms not under control
boolean
C0233401 (UMLS CUI [1,1])
C0205318 (UMLS CUI [1,2])
Pregnancy
Item
pregnancy
boolean
C0032961 (UMLS CUI [1])
Methylprednisolone allergy
Item
hypersensibility to methylprednisolone
boolean
C0571614 (UMLS CUI [1])

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