ID

19911

Beschreibung

The purpose of this study is to determine the safety and efficacy of natalizumab in the treatment of individuals who have been diagnosed with relapsing remitting multiple sclerosis (MS). It is hoped that natalizumab will prevent certain types of white blood cells from moving out of the bloodstream into organs, including the brain, that are being damaged by autoimmune disease (a disease in which the body's own immune system attacks certain organs). These white blood cells are thought to cause inflammation that can result in lesions (small areas of damage) in the brain. These lesions are thought to be the cause of relapses and disability in MS. Documentation process: This form is to be obtained in Screening.

Stichworte

Versionen (1)
  1. 30.01.17 30.01.17 -
Hochgeladen am

30. Januar 2017

DOI

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Creative Commons BY-NC 3.0
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MRI Site Evaluation MS Diagnostic Criteria CRFs Multiple Sclerosis Tysabri NCT00027300

Englisch

MRI Site Evaluation MS Diagnostic Criteria CRFs Multiple Sclerosis Tysabri NCT00027300

1 Formulare  
MRI Evaluation: Site Screening Documentation
Beschreibung

MRI Evaluation: Site Screening Documentation

Alias
UMLS CUI-1
C0024485
UMLS CUI-2
C0220825
UMLS CUI-3
C0920316
Date MRI performed
Beschreibung

Date MRI

Datentyp

date

Alias
UMLS CUI [1,1]
C0011008
UMLS CUI [1,2]
C0024485
T1 weighted gadolinium-enhancing lesions present in brain MRI
Beschreibung

Brain MRI

Datentyp

boolean

Alias
UMLS CUI [1,1]
C0412675
UMLS CUI [1,2]
C2029669
UMLS CUI [1,3]
C1333400
Number of T2 hypertensive lesions on brain MRI
Beschreibung

Number of T2 lesions

Datentyp

integer

Alias
UMLS CUI [1,1]
C0750480
UMLS CUI [1,2]
C0412675
UMLS CUI [1,3]
C2086440
MS Diagnostic Criteria
Beschreibung

MS Diagnostic Criteria

Alias
UMLS CUI-1
C0026769
UMLS CUI-2
C0679228
2 or more clinical attacks; 2 or more objective Lesions; none additional Requirements to Make Diagnosis: clinical evidence will suffice (additional evidence desirable but must be consistent with MS.)
Beschreibung

1. 2 or more clinical attacks, 2 or more objective Lesions and none additional Requirements

Datentyp

integer

Alias
UMLS CUI [1]
C0026769
UMLS CUI [2]
C0221198
UMLS CUI [3,1]
C3887511
UMLS CUI [3,2]
C0205210
2 or more clinical attacks; 1 objective Lesion; Additional Requirements to Make Diagnosis: Dissemination is SPACE by MRI OR positive CSF and 2 more MRI lesions constant wit MS OR further clinical attack involving different site
Beschreibung

2.. 2 or more clinical attacks, 1 objective Lesion and Dissemination in space

Datentyp

integer

Alias
UMLS CUI [1]
C0026769
UMLS CUI [2]
C0221198
UMLS CUI [3,1]
C3887511
UMLS CUI [3,2]
C0205210
1 clinical attack; 2 or more objective Lesions; Additional Requirements to Make Diagnosis: Dissemination in TIME by MRI OR second clinical attack
Beschreibung

3. 1 clinical attack, 2 or more objective Lesions and Dissemination in time

Datentyp

integer

Alias
UMLS CUI [1]
C0026769
UMLS CUI [2]
C0221198
UMLS CUI [3,1]
C3887511
UMLS CUI [3,2]
C0205210
1 (monosymptomatic) clinical attack; 1 objective Lesion; Additional Requirements to Make Diagnosis: Dissemination in SPACE by MRI OR positive CSF and 2 or more MRI lesions consitent with MS AND Dissemination in TIME by MRI OR second clinical attack
Beschreibung

4. 1 clinical attack, 1 objective Lesion and Dissemination in space AND time

Datentyp

integer

Alias
UMLS CUI [1]
C0026769
UMLS CUI [2]
C0221198
UMLS CUI [3,1]
C3887511
UMLS CUI [3,2]
C0205210
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Ähnliche Modelle

MRI Site Evaluation MS Diagnostic Criteria CRFs Multiple Sclerosis Tysabri NCT00027300

1 Formulare
Name
Typ
Description | Question | Decode (Coded Value)
Datentyp
Alias
Item Group
MRI Evaluation: Site Screening Documentation
C0024485 (UMLS CUI-1)
C0220825 (UMLS CUI-2)
C0920316 (UMLS CUI-3)
Date MRI
Item
Date MRI performed
date
C0011008 (UMLS CUI [1,1])
C0024485 (UMLS CUI [1,2])
Brain MRI
Item
T1 weighted gadolinium-enhancing lesions present in brain MRI
boolean
C0412675 (UMLS CUI [1,1])
C2029669 (UMLS CUI [1,2])
C1333400 (UMLS CUI [1,3])
Item
Number of T2 hypertensive lesions on brain MRI
integer
C0750480 (UMLS CUI [1,1])
C0412675 (UMLS CUI [1,2])
C2086440 (UMLS CUI [1,3])
Number of T2 lesions
Code List
Number of T2 hypertensive lesions on brain MRI
CL Item
<9 Lesions (1)
CL Item
>9 Lesions (2)
Item Group
MS Diagnostic Criteria
C0026769 (UMLS CUI-1)
C0679228 (UMLS CUI-2)
1. 2 or more clinical attacks, 2 or more objective Lesions and none additional Requirements
Item
2 or more clinical attacks; 2 or more objective Lesions; none additional Requirements to Make Diagnosis: clinical evidence will suffice (additional evidence desirable but must be consistent with MS.)
integer
C0026769 (UMLS CUI [1])
C0221198 (UMLS CUI [2])
C3887511 (UMLS CUI [3,1])
C0205210 (UMLS CUI [3,2])
2.. 2 or more clinical attacks, 1 objective Lesion and Dissemination in space
Item
2 or more clinical attacks; 1 objective Lesion; Additional Requirements to Make Diagnosis: Dissemination is SPACE by MRI OR positive CSF and 2 more MRI lesions constant wit MS OR further clinical attack involving different site
integer
C0026769 (UMLS CUI [1])
C0221198 (UMLS CUI [2])
C3887511 (UMLS CUI [3,1])
C0205210 (UMLS CUI [3,2])
3. 1 clinical attack, 2 or more objective Lesions and Dissemination in time
Item
1 clinical attack; 2 or more objective Lesions; Additional Requirements to Make Diagnosis: Dissemination in TIME by MRI OR second clinical attack
integer
C0026769 (UMLS CUI [1])
C0221198 (UMLS CUI [2])
C3887511 (UMLS CUI [3,1])
C0205210 (UMLS CUI [3,2])
4. 1 clinical attack, 1 objective Lesion and Dissemination in space AND time
Item
1 (monosymptomatic) clinical attack; 1 objective Lesion; Additional Requirements to Make Diagnosis: Dissemination in SPACE by MRI OR positive CSF and 2 or more MRI lesions consitent with MS AND Dissemination in TIME by MRI OR second clinical attack
integer
C0026769 (UMLS CUI [1])
C0221198 (UMLS CUI [2])
C3887511 (UMLS CUI [3,1])
C0205210 (UMLS CUI [3,2])
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