ID

19760

Description

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.

Keywords

Versions (1)
  1. 1/27/17 1/27/17 -
Uploaded on

January 27, 2017

DOI

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License

Creative Commons BY-NC 3.0
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Medical History CRFs Multiple Sclerosis Tysabri NCT00027300

English

Medical History CRFs Multiple Sclerosis Tysabri NCT00027300

1 forms  
Does the subject have a medical or surgical history, current or resolved, of any of the following categories?
Description

Does the subject have a medical or surgical history, current or resolved, of any of the following categories?

Alias
UMLS CUI-1
C0262926
1. Immunological (including allergies)
Description

Immune system disease

Data type

boolean

Alias
UMLS CUI [1]
C0021053
2. HEENT
Description

HEENT

Data type

boolean

Alias
UMLS CUI [1]
C1512338
3. Respiratory
Description

respiratory

Data type

boolean

Alias
UMLS CUI [1]
C0035237
4. Cardiovascular
Description

Cardiovascular

Data type

boolean

Alias
UMLS CUI [1]
C0007226
5. Gastrointestinal
Description

Gastrointestinal

Data type

boolean

Alias
UMLS CUI [1]
C0012240
6. Genitourinary
Description

Genitourinary System

Data type

boolean

Alias
UMLS CUI [1]
C0042066
7. Hematological
Description

Hematological

Data type

boolean

Alias
UMLS CUI [1]
C0279810
8. Neurological
Description

Neurological

Data type

boolean

Alias
UMLS CUI [1]
C0027763
9. Endocrine
Description

Endocrine

Data type

boolean

Alias
UMLS CUI [1]
C0014136
10. Musculoskeletal
Description

Musculoskeletal

Data type

boolean

Alias
UMLS CUI [1]
C0026860
11. Dermatological
Description

Dermatological

Data type

boolean

Alias
UMLS CUI [1]
C0037274
12. Psychosocial/ psychiatric
Description

Mental

Data type

boolean

Alias
UMLS CUI [1]
C0004936
If 'Yes' record each detail below. If a category has multiple details, record each on a separate line. Mark if resolved or current.
Description

If 'Yes' record each detail below. If a category has multiple details, record each on a separate line. Mark if resolved or current.

Line number
Description

Line

Data type

integer

Alias
UMLS CUI [1]
C0750480
Category Number
Description

Category Number

Data type

text

Alias
UMLS CUI [1]
C0683312
resolved or current
Description

resolved or current

Data type

integer

Pertinent Details
Description

details

Data type

text

Alias
UMLS CUI [1]
C1522508
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Similar models

Medical History CRFs Multiple Sclerosis Tysabri NCT00027300

1 forms
Name
Type
Description | Question | Decode (Coded Value)
Data type
Alias
Item Group
Does the subject have a medical or surgical history, current or resolved, of any of the following categories?
C0262926 (UMLS CUI-1)
Immune system disease
Item
1. Immunological (including allergies)
boolean
C0021053 (UMLS CUI [1])
HEENT
Item
2. HEENT
boolean
C1512338 (UMLS CUI [1])
respiratory
Item
3. Respiratory
boolean
C0035237 (UMLS CUI [1])
Cardiovascular
Item
4. Cardiovascular
boolean
C0007226 (UMLS CUI [1])
Gastrointestinal
Item
5. Gastrointestinal
boolean
C0012240 (UMLS CUI [1])
Genitourinary System
Item
6. Genitourinary
boolean
C0042066 (UMLS CUI [1])
Hematological
Item
7. Hematological
boolean
C0279810 (UMLS CUI [1])
Neurological
Item
8. Neurological
boolean
C0027763 (UMLS CUI [1])
Endocrine
Item
9. Endocrine
boolean
C0014136 (UMLS CUI [1])
Musculoskeletal
Item
10. Musculoskeletal
boolean
C0026860 (UMLS CUI [1])
Dermatological
Item
11. Dermatological
boolean
C0037274 (UMLS CUI [1])
Mental
Item
12. Psychosocial/ psychiatric
boolean
C0004936 (UMLS CUI [1])
Item Group
If 'Yes' record each detail below. If a category has multiple details, record each on a separate line. Mark if resolved or current.
Item
Line number
integer
C0750480 (UMLS CUI [1])
Line
Code List
Line number
Category Number
Item
Category Number
text
C0683312 (UMLS CUI [1])
Item
resolved or current
integer
resolved or current
Code List
resolved or current
CL Item
resolved (1)
CL Item
current (2)
Item
Pertinent Details
text
C1522508 (UMLS CUI [1])
Line
Code List
Pertinent Details
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