ID

30970

Beschreibung

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

Stichworte

  1. 08.07.18 08.07.18 -
Rechteinhaber

See clinicaltrials.gov

Hochgeladen am

8. Juli 2018

DOI

Für eine Beantragung loggen Sie sich ein.

Lizenz

Creative Commons BY 4.0

Modell Kommentare :

Hier können Sie das Modell kommentieren. Über die Sprechblasen an den Itemgruppen und Items können Sie diese spezifisch kommentieren.

Itemgroup Kommentare für :

Item Kommentare für :

Um Formulare herunterzuladen müssen Sie angemeldet sein. Bitte loggen Sie sich ein oder registrieren Sie sich kostenlos.

Eligibility Multiple Sclerosis, Relapsing-Remitting NCT00984984

Eligibility Multiple Sclerosis, Relapsing-Remitting NCT00984984

Inclusion Criteria
Beschreibung

Inclusion Criteria

Alias
UMLS CUI
C1512693
age 18 to 55
Beschreibung

Age

Datentyp

boolean

Alias
UMLS CUI [1]
C0001779
informed written consent
Beschreibung

Informed Consent

Datentyp

boolean

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

Multiple Sclerosis, Relapsing-Remitting

Datentyp

boolean

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

EDSS Before Relapse

Datentyp

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
Beschreibung

Relapse | Expanded disability status scale score increased | Symptoms Duration

Datentyp

boolean

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

Exclusion Criteria

Alias
UMLS CUI
C0680251
fever
Beschreibung

Fever

Datentyp

boolean

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

Relapse Previous | Steroid therapy Before Relapse

Datentyp

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
Beschreibung

Relapse Symptoms First

Datentyp

boolean

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

Mitoxantrone | Cyclophosphamide | natalizumab

Datentyp

boolean

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

Diabetes Mellitus

Datentyp

boolean

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

Communicable Disease Uncontrolled

Datentyp

boolean

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

Liver Failure | Kidney Failure

Datentyp

boolean

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

Psychiatric symptoms Uncontrolled

Datentyp

boolean

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

Pregnancy

Datentyp

boolean

Alias
UMLS CUI [1]
C0032961
hypersensibility to methylprednisolone
Beschreibung

Methylprednisolone allergy

Datentyp

boolean

Alias
UMLS CUI [1]
C0571614

Ähnliche Modelle

Eligibility Multiple Sclerosis, Relapsing-Remitting NCT00984984

Name
Typ
Description | Question | Decode (Coded Value)
Datentyp
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])

Benutzen Sie dieses Formular für Rückmeldungen, Fragen und Verbesserungsvorschläge.

Mit * gekennzeichnete Felder sind notwendig.

Benötigen Sie Hilfe bei der Suche? Um mehr Details zu erfahren und die Suche effektiver nutzen zu können schauen Sie sich doch das entsprechende Video auf unserer Tutorial Seite an.

Zum Video