ID

19891

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 ist to be obtained in week 24, week 52, week 104, week, 120, week, 128 and Premature Study Withdrawl.

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  1. 30.01.17 30.01.17 -
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30. Januar 2017

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Mental health inventory CRFs Multiple Sklerosis Tysabri NCT00027300

Mental health inventory CRFs Multiple Sklerosis Tysabri NCT00027300

Mental health inventory
Beschreibung

Mental health inventory

Alias
UMLS CUI-1
C0025353
During the past 4 weeks, how much of the time has your daily life been full of things that were interesting to you?
Beschreibung

Daily life been full of things that were interesting

Datentyp

integer

Alias
UMLS CUI [1]
C3829819
During the past 4 weeks, how much of the time did you feel depressed?
Beschreibung

Feel depressed

Datentyp

integer

Alias
UMLS CUI [1]
C0497307
During the past 4 weeks, how much of the time have you felt loved and wanted?
Beschreibung

felt loved and wanted

Datentyp

integer

Alias
UMLS CUI [1]
C3829740
During the past 4 weeks, how much of the time have you been a very nervous person?
Beschreibung

Been a very nervous person

Datentyp

integer

Alias
UMLS CUI [1]
C3829750
During the past 4 weeks, how much of the time have you been in firm control of your behavior, thoughts, emotions, or feeling?
Beschreibung

Been in firm control of behavior, thoughts, emotions, feelings

Datentyp

integer

Alias
UMLS CUI [1]
C3829748
During the past 4 weeks, how much of the time have you felt tense or high-strung?
Beschreibung

Felt tense and high-strung

Datentyp

integer

Alias
UMLS CUI [1]
C3641757
During the past 4 weeks, how much of the time have you felt calm and peaceful?
Beschreibung

Felt calm and peaceful

Datentyp

integer

Alias
UMLS CUI [1]
C3829745
During the past 4 weeks, how much of the time have you felt emotionally stable?
Beschreibung

Felt emotionally stable

Datentyp

integer

Alias
UMLS CUI [1]
C3829742
During the past 4 weeks, how much of the time have you felt downhearted and blue?
Beschreibung

Felt downhearted and blue

Datentyp

integer

Alias
UMLS CUI [1]
C3829743
During the past 4 weeks, how much of the time were you able to relax without difficulty?
Beschreibung

Were able to relax without difficulty

Datentyp

integer

Alias
UMLS CUI [1]
C1821409
During the past 4 weeks, how much of the time have you felt restless, fidgety, or impatient?
Beschreibung

Felt restless, fidgety, or impatient

Datentyp

integer

Alias
UMLS CUI [1]
C3829739
During the past 4 weeks, how much of the time have you been moody or brooded about things?
Beschreibung

Been moody or brooded

Datentyp

integer

Alias
UMLS CUI [1]
C3829746
During the past 4 weeks, how much of the time have you felt cheerful, light-hearted?
Beschreibung

Felt cheerful, light-hearted

Datentyp

integer

Alias
UMLS CUI [1]
C3829744
During the past 4 weeks, how much of the time have you been in low or very low spirits?
Beschreibung

Been in low or very low spirits

Datentyp

integer

Alias
UMLS CUI [1]
C3829747
During the past 4 weeks, how much of the time were you a happy person?
Beschreibung

Were a happy person

Datentyp

integer

Alias
UMLS CUI [1]
C3829752
During the past 4 weeks, how much of the time did you feel you had nothing to look forward to?
Beschreibung

Feel you had nothing to look forward to

Datentyp

integer

Alias
UMLS CUI [1]
C3830508
During the past 4 weeks, how much of the time have you felt so down in the dumps that nothing could cheer you up?
Beschreibung

Felt so down in the dumps that nothing could cheer you up

Datentyp

integer

Alias
UMLS CUI [1]
C3829738
During the past 4 weeks, how much of the time have you been anxious or worried?
Beschreibung

Been anxious or worried

Datentyp

integer

Alias
UMLS CUI [1]
C3829751

Ähnliche Modelle

Mental health inventory CRFs Multiple Sklerosis Tysabri NCT00027300

Name
Typ
Description | Question | Decode (Coded Value)
Datentyp
Alias
Item Group
Mental health inventory
C0025353 (UMLS CUI-1)
Item
During the past 4 weeks, how much of the time has your daily life been full of things that were interesting to you?
integer
C3829819 (UMLS CUI [1])
Code List
During the past 4 weeks, how much of the time has your daily life been full of things that were interesting to you?
CL Item
All of the time (1)
CL Item
Most of the time (2)
CL Item
A good bit of time (3)
CL Item
Some of the time (4)
CL Item
A little bit of time (5)
CL Item
None of the time (6)
Item
During the past 4 weeks, how much of the time did you feel depressed?
integer
C0497307 (UMLS CUI [1])
Code List
During the past 4 weeks, how much of the time did you feel depressed?
CL Item
All of the time (1)
CL Item
Most of the time (2)
CL Item
A good bit of time (3)
CL Item
Some of the time (4)
CL Item
A little bit of time (5)
CL Item
None of the time (6)
Item
During the past 4 weeks, how much of the time have you felt loved and wanted?
integer
C3829740 (UMLS CUI [1])
Code List
During the past 4 weeks, how much of the time have you felt loved and wanted?
CL Item
All of the time (1)
CL Item
Most of the time (2)
CL Item
A good bit of time (3)
CL Item
Some of the time (4)
CL Item
A little bit of time (5)
CL Item
None of the time (6)
Item
During the past 4 weeks, how much of the time have you been a very nervous person?
integer
C3829750 (UMLS CUI [1])
Code List
During the past 4 weeks, how much of the time have you been a very nervous person?
CL Item
All of the time (1)
CL Item
Most of the time (2)
CL Item
A good bit of time (3)
CL Item
Some of the time (4)
CL Item
A little bit of time (5)
CL Item
None of the time (6)
Item
During the past 4 weeks, how much of the time have you been in firm control of your behavior, thoughts, emotions, or feeling?
integer
C3829748 (UMLS CUI [1])
Code List
During the past 4 weeks, how much of the time have you been in firm control of your behavior, thoughts, emotions, or feeling?
CL Item
All of the time (1)
CL Item
Most of the time (2)
CL Item
A good bit of time (3)
CL Item
Some of the time (4)
CL Item
A little bit of time (5)
CL Item
None of the time (6)
Item
During the past 4 weeks, how much of the time have you felt tense or high-strung?
integer
C3641757 (UMLS CUI [1])
Code List
During the past 4 weeks, how much of the time have you felt tense or high-strung?
CL Item
All of the time (1)
CL Item
Most of the time (2)
CL Item
A good bit of time (3)
CL Item
Some of the time (4)
CL Item
A little bit of time (5)
CL Item
None of the time (6)
Item
During the past 4 weeks, how much of the time have you felt calm and peaceful?
integer
C3829745 (UMLS CUI [1])
Code List
During the past 4 weeks, how much of the time have you felt calm and peaceful?
CL Item
All of the time (1)
CL Item
Most of the time (2)
CL Item
A good bit of time (3)
CL Item
Some of the time (4)
CL Item
A little bit of time (5)
CL Item
None of the time (6)
Item
During the past 4 weeks, how much of the time have you felt emotionally stable?
integer
C3829742 (UMLS CUI [1])
Code List
During the past 4 weeks, how much of the time have you felt emotionally stable?
CL Item
All of the time (1)
CL Item
Most of the time (2)
CL Item
A good bit of time (3)
CL Item
Some of the time (4)
CL Item
A little bit of time (5)
CL Item
None of the time (6)
Item
During the past 4 weeks, how much of the time have you felt downhearted and blue?
integer
C3829743 (UMLS CUI [1])
Code List
During the past 4 weeks, how much of the time have you felt downhearted and blue?
CL Item
All of the time (1)
CL Item
Most of the time (2)
CL Item
A good bit of time (3)
CL Item
Some of the time (4)
CL Item
A little bit of time (5)
CL Item
None of the time (6)
Item
During the past 4 weeks, how much of the time were you able to relax without difficulty?
integer
C1821409 (UMLS CUI [1])
Code List
During the past 4 weeks, how much of the time were you able to relax without difficulty?
CL Item
All of the time (1)
CL Item
Most of the time (2)
CL Item
A good bit of time (3)
CL Item
Some of the time (4)
CL Item
A little bit of time (5)
CL Item
None of the time (6)
Item
During the past 4 weeks, how much of the time have you felt restless, fidgety, or impatient?
integer
C3829739 (UMLS CUI [1])
Code List
During the past 4 weeks, how much of the time have you felt restless, fidgety, or impatient?
CL Item
All of the time (1)
CL Item
Most of the time (2)
CL Item
A good bit of time (3)
CL Item
Some of the time (4)
CL Item
A little bit of time (5)
CL Item
None of the time (6)
Item
During the past 4 weeks, how much of the time have you been moody or brooded about things?
integer
C3829746 (UMLS CUI [1])
Code List
During the past 4 weeks, how much of the time have you been moody or brooded about things?
CL Item
All of the time (1)
CL Item
Most of the time (2)
CL Item
A good bit of time (3)
CL Item
Some of the time (4)
CL Item
A little bit of time (5)
CL Item
None of the time (6)
Item
During the past 4 weeks, how much of the time have you felt cheerful, light-hearted?
integer
C3829744 (UMLS CUI [1])
Code List
During the past 4 weeks, how much of the time have you felt cheerful, light-hearted?
CL Item
All of the time (1)
CL Item
Most of the time (2)
CL Item
A good bit of time (3)
CL Item
Some of the time (4)
CL Item
A little bit of time (5)
CL Item
None of the time (6)
Item
During the past 4 weeks, how much of the time have you been in low or very low spirits?
integer
C3829747 (UMLS CUI [1])
Code List
During the past 4 weeks, how much of the time have you been in low or very low spirits?
CL Item
All of the time (1)
CL Item
Most of the time (2)
CL Item
A good bit of time (3)
CL Item
Some of the time (4)
CL Item
A little bit of time (5)
CL Item
None of the time (6)
Item
During the past 4 weeks, how much of the time were you a happy person?
integer
C3829752 (UMLS CUI [1])
Code List
During the past 4 weeks, how much of the time were you a happy person?
CL Item
All of the time (1)
CL Item
Most of the time (2)
CL Item
A good bit of time (3)
CL Item
Some of the time (4)
CL Item
A little bit of time (5)
CL Item
None of the time (6)
Item
During the past 4 weeks, how much of the time did you feel you had nothing to look forward to?
integer
C3830508 (UMLS CUI [1])
Code List
During the past 4 weeks, how much of the time did you feel you had nothing to look forward to?
CL Item
All of the time (1)
CL Item
Most of the time (2)
CL Item
A good bit of time (3)
CL Item
Some of the time (4)
CL Item
A little bit of time (5)
CL Item
None of the time (6)
Item
During the past 4 weeks, how much of the time have you felt so down in the dumps that nothing could cheer you up?
integer
C3829738 (UMLS CUI [1])
Code List
During the past 4 weeks, how much of the time have you felt so down in the dumps that nothing could cheer you up?
CL Item
All of the time (1)
CL Item
Most of the time (2)
CL Item
A good bit of time (3)
CL Item
Some of the time (4)
CL Item
A little bit of time (5)
CL Item
None of the time (6)
Item
During the past 4 weeks, how much of the time have you been anxious or worried?
integer
C3829751 (UMLS CUI [1])
Code List
During the past 4 weeks, how much of the time have you been anxious or worried?
CL Item
All of the time (1)
CL Item
Most of the time (2)
CL Item
A good bit of time (3)
CL Item
Some of the time (4)
CL Item
A little bit of time (5)
CL Item
None of the time (6)

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