ID

15477

Beschreibung

Alemtuzumab in Autoimmune Inflammatory Neurodegeneration: Mechanisms of Action and Neuroprotective Potential (ALAIN01) https://clinicaltrials.gov/ct2/show/NCT02419378 Principal Investigator Prof. Dr. Dr. Sven Meuth, University Hospital Muenster, Germany Part: Baseline: Repitition of Assessments Please complete the following pages only if Baseline Assessments had to be repeated prior to initiation of Lemtrada® (relapse after first examination, see Study Protocol 8.1.1.2)

Link

https://clinicaltrials.gov/ct2/show/NCT02419378

Stichworte

Versionen (1)
  1. 01.06.16 01.06.16 -
Hochgeladen am

1. Juni 2016

DOI

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Lizenz

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Baseline: Repitition of AssessmentsMSFC Multiple Sclerosis ALAIN01 NCT02419378

Englisch

Baseline: Repitition of AssessmentsMSFC Multiple Sclerosis ALAIN01 NCT02419378

1 Formulare  
Multiple Sclerosis Functional Composite
Beschreibung

Multiple Sclerosis Functional Composite

Patient ID (derived)
Beschreibung

Patient ID (derived)

Datentyp

text

Alias
UMLS CUI [1]
C2348585
MSFC+ Quest.: add. quarterly inf. consent yes/no
Beschreibung

informed consent, quarterly

Datentyp

text

Alias
UMLS CUI [1,1]
C0021430
UMLS CUI [1,2]
C0332179
MSFC+ Quest.: add. semiannual inf. consent yes/no
Beschreibung

Informed consent, semi annual

Datentyp

text

Alias
UMLS CUI [1,1]
C0021430
UMLS CUI [1,2]
C0585339
MSFC + Questionnaires: Date
Beschreibung

MSFC + Questionnaires: Date

Datentyp

date

Alias
UMLS CUI [1,1]
C0034394
UMLS CUI [1,2]
C0011008
Timed 25-Foot Walk
Beschreibung

Timed 25-Foot Walk

Alias
UMLS CUI-1
C0430517
Timed 25-Foot Walk: AFO yes/no
Beschreibung

AFO

Datentyp

text

Alias
UMLS CUI [1]
C3843016
Timed 25-Foot Walk: assistive device yes/no
Beschreibung

assistive device

Datentyp

text

Alias
UMLS CUI [1]
C0036605
Timed 25-Foot Walk: Unilateral Ass.
Beschreibung

Unilateral Assistance

Datentyp

text

Alias
UMLS CUI [1,1]
C0205092
UMLS CUI [1,2]
C0036605
Timed 25-Foot Walk: Bilateral Ass.
Beschreibung

Bilateral Assistance

Datentyp

text

Alias
UMLS CUI [1,1]
C0238767
UMLS CUI [1,2]
C0036605
Timed 25-Foot Walk: Unilateral Ass. (Category)
Beschreibung

Unilateral Assistance (Category)

Datentyp

text

Alias
UMLS CUI [1,1]
C0205092
UMLS CUI [1,2]
C0036605
UMLS CUI [1,3]
C0683312
Timed 25-Foot Walk: Bilateral Ass. (Category)
Beschreibung

Bilateral Assistance (Category)

Datentyp

text

Alias
UMLS CUI [1,1]
C0238767
UMLS CUI [1,2]
C0036605
UMLS CUI [1,3]
C0683312
Timed 25-Foot Walk: Time Trial 1
Beschreibung

Time 25-Foot Walk Trial 1

Datentyp

float

Maßeinheiten
  • sec
Alias
UMLS CUI [1,1]
C0430517
UMLS CUI [1,2]
C0750480
UMLS CUI [1,3]
C0040223
sec
Timed 25-Foot Walk: not completed Trial 1
Beschreibung

Timed 25-Foot Walk: not completed Trial 1

Datentyp

text

Alias
UMLS CUI [1,1]
C0430517
UMLS CUI [1,2]
C0750480
UMLS CUI [1,3]
C2732579
Timed 25-Foot Walk: Time Trial 2
Beschreibung

Time 25-Foot Walk Trial 2

Datentyp

float

Maßeinheiten
  • sec
Alias
UMLS CUI [1,1]
C0430517
UMLS CUI [1,2]
C0750480
UMLS CUI [1,3]
C0040223
sec
Timed 25-Foot Walk: not completed Trial 2
Beschreibung

Timed 25-Foot Walk: not completed Trial 2

Datentyp

text

Alias
UMLS CUI [1,1]
C0430517
UMLS CUI [1,2]
C0750480
UMLS CUI [1,3]
C2732579
9-Hole Peg Test
Beschreibung

9-Hole Peg Test

Alias
UMLS CUI-1
C0451335
9-Hole Peg Test: dominant hand
Beschreibung

Dominant hand

Datentyp

text

Alias
UMLS CUI [1,1]
C0451335
UMLS CUI [1,2]
C0449722
9-Hole Peg Test: Time dom. Trial 1
Beschreibung

9 hole peg test Time dominant hand Trial 1

Datentyp

float

Maßeinheiten
  • sec
Alias
UMLS CUI [1,1]
C0451335
UMLS CUI [1,2]
C0449722
UMLS CUI [1,3]
C0750480
UMLS CUI [1,4]
C0040223
sec
9-Hole Peg Test: not completed dom. Trial 1
Beschreibung

9-Hole Peg Test: not completed dom. Trial 1

Datentyp

text

Alias
UMLS CUI [1,1]
C0451335
UMLS CUI [1,2]
C0449722
UMLS CUI [1,3]
C0750480
UMLS CUI [1,4]
C2732579
9-Hole Peg Test: Time non-dom. Trial 1
Beschreibung

9-Hole Peg Test Time non-dominant hand Trial 1

Datentyp

float

Maßeinheiten
  • sec
Alias
UMLS CUI [1,1]
C0451335
UMLS CUI [1,2]
C0445549
UMLS CUI [1,3]
C0750480
UMLS CUI [1,4]
C0040223
sec
9-Hole Peg Test: not completed non-dom. Trial 1
Beschreibung

9-Hole Peg Test: not completed non-dom. Trial 1

Datentyp

text

Alias
UMLS CUI [1,1]
C0451335
UMLS CUI [1,2]
C0445549
UMLS CUI [1,3]
C0750480
UMLS CUI [1,4]
C2732579
9-Hole Peg Test: Time (sec) dom. Trial 2
Beschreibung

9-Hole Peg Test: Time (sec) dom. Trial 2

Datentyp

float

Alias
UMLS CUI [1,1]
C0451335
UMLS CUI [1,2]
C0449722
UMLS CUI [1,3]
C0750480
UMLS CUI [1,4]
C0040223
9-Hole Peg Test: not completed dom. Trial 2
Beschreibung

9-Hole Peg Test: not completed dom. Trial 2

Datentyp

text

Alias
UMLS CUI [1,1]
C0451335
UMLS CUI [1,2]
C0449722
UMLS CUI [1,3]
C0750480
UMLS CUI [1,4]
C2732579
9-Hole Peg Test: Time (sec) non-dom. Trial 2
Beschreibung

9-Hole Peg Test: Time (sec) non-dom. Trial 2

Datentyp

float

Alias
UMLS CUI [1,1]
C0451335
UMLS CUI [1,2]
C0445549
UMLS CUI [1,3]
C0750480
UMLS CUI [1,4]
C0040223
9-Hole Peg Test: not completed non-dom. Trial 2
Beschreibung

9-Hole Peg Test: not completed non-dom. Trial 2

Datentyp

text

Alias
UMLS CUI [1,1]
C0451335
UMLS CUI [1,2]
C0445549
UMLS CUI [1,3]
C0750480
UMLS CUI [1,4]
C2732579
PASAT
Beschreibung

PASAT

Alias
UMLS CUI-1
C0589060
PASAT Form used
Beschreibung

PASAT Form used

Datentyp

text

Alias
UMLS CUI [1,1]
C0589060
UMLS CUI [1,2]
C0180975
PASAT3: Total correct
Beschreibung

PASAT3 total correct

Datentyp

integer

Alias
UMLS CUI [1,1]
C3898055
UMLS CUI [1,2]
C0205449
PASAT3: not completed
Beschreibung

PASAT3: not completed

Datentyp

text

Alias
UMLS CUI [1,1]
C0589060
UMLS CUI [1,2]
C0205449
UMLS CUI [1,3]
C2732579
PASAT2: Total correct
Beschreibung

PASAT2 total correct

Datentyp

integer

Alias
UMLS CUI [1,1]
C3898055
UMLS CUI [1,2]
C0205448
PASAT2: not completed
Beschreibung

PASAT2: not completed

Datentyp

text

Alias
UMLS CUI [1,1]
C0589060
UMLS CUI [1,2]
C0205448
UMLS CUI [1,3]
C2732579
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Ähnliche Modelle

Baseline: Repitition of AssessmentsMSFC Multiple Sclerosis ALAIN01 NCT02419378

1 Formulare
Name
Typ
Description | Question | Decode (Coded Value)
Datentyp
Alias
Item Group
Multiple Sclerosis Functional Composite
Patient ID (derived)
Item
Patient ID (derived)
text
C2348585 (UMLS CUI [1])
Item
MSFC+ Quest.: add. quarterly inf. consent yes/no
text
C0021430 (UMLS CUI [1,1])
C0332179 (UMLS CUI [1,2])
MSFC+ Quest.: add. quarterly inf. consent yes/no
Code List
MSFC+ Quest.: add. quarterly inf. consent yes/no
CL Item
yes (1)
CL Item
no (0)
Item
MSFC+ Quest.: add. semiannual inf. consent yes/no
text
C0021430 (UMLS CUI [1,1])
C0585339 (UMLS CUI [1,2])
MSFC+ Quest.: add. semiannual inf. consent yes/no
Code List
MSFC+ Quest.: add. semiannual inf. consent yes/no
CL Item
yes (1)
CL Item
no (0)
Questionnaire, date
Item
MSFC + Questionnaires: Date
date
C0034394 (UMLS CUI [1,1])
C0011008 (UMLS CUI [1,2])
Item Group
Timed 25-Foot Walk
C0430517 (UMLS CUI-1)
Item
Timed 25-Foot Walk: AFO yes/no
text
C3843016 (UMLS CUI [1])
Timed 25-Foot Walk: AFO yes/no
Code List
Timed 25-Foot Walk: AFO yes/no
CL Item
yes (1)
CL Item
no (0)
Item
Timed 25-Foot Walk: assistive device yes/no
text
C0036605 (UMLS CUI [1])
Timed 25-Foot Walk: assistive device yes/no
Code List
Timed 25-Foot Walk: assistive device yes/no
CL Item
yes (1)
CL Item
no (0)
Item
Timed 25-Foot Walk: Unilateral Ass.
text
C0205092 (UMLS CUI [1,1])
C0036605 (UMLS CUI [1,2])
Timed 25-Foot Walk: Unilateral Ass.
Code List
Timed 25-Foot Walk: Unilateral Ass.
CL Item
Unilateral Assistance (1)
Item
Timed 25-Foot Walk: Bilateral Ass.
text
C0238767 (UMLS CUI [1,1])
C0036605 (UMLS CUI [1,2])
Timed 25-Foot Walk: Bilateral Ass.
Code List
Timed 25-Foot Walk: Bilateral Ass.
CL Item
Bilateral Assistance (1)
Item
Timed 25-Foot Walk: Unilateral Ass. (Category)
text
C0205092 (UMLS CUI [1,1])
C0036605 (UMLS CUI [1,2])
C0683312 (UMLS CUI [1,3])
Timed 25-Foot Walk: Unilateral Ass. (Category)
Code List
Timed 25-Foot Walk: Unilateral Ass. (Category)
CL Item
Cane (1)
C0006856 (UMLS CUI-1)
CL Item
Crutch (2)
C0010397 (UMLS CUI-1)
Item
Timed 25-Foot Walk: Bilateral Ass. (Category)
text
C0238767 (UMLS CUI [1,1])
C0036605 (UMLS CUI [1,2])
C0683312 (UMLS CUI [1,3])
Timed 25-Foot Walk: Bilateral Ass. (Category)
Code List
Timed 25-Foot Walk: Bilateral Ass. (Category)
CL Item
Cane (1)
C0006856 (UMLS CUI-1)
CL Item
Crutch (2)
C0010397 (UMLS CUI-1)
CL Item
Walker/Rollator (3)
C0184339 (UMLS CUI-1)
Time 25-Foot Walk Trial 1
Item
Timed 25-Foot Walk: Time Trial 1
float
C0430517 (UMLS CUI [1,1])
C0750480 (UMLS CUI [1,2])
C0040223 (UMLS CUI [1,3])
Item
Timed 25-Foot Walk: not completed Trial 1
text
C0430517 (UMLS CUI [1,1])
C0750480 (UMLS CUI [1,2])
C2732579 (UMLS CUI [1,3])
Timed 25-Foot Walk: not completed Trial 1
Code List
Timed 25-Foot Walk: not completed Trial 1
CL Item
Unable due to physical limitations (1)
CL Item
Other (9)
Time 25-Foot Walk Trial 2
Item
Timed 25-Foot Walk: Time Trial 2
float
C0430517 (UMLS CUI [1,1])
C0750480 (UMLS CUI [1,2])
C0040223 (UMLS CUI [1,3])
Item
Timed 25-Foot Walk: not completed Trial 2
text
C0430517 (UMLS CUI [1,1])
C0750480 (UMLS CUI [1,2])
C2732579 (UMLS CUI [1,3])
Timed 25-Foot Walk: not completed Trial 2
Code List
Timed 25-Foot Walk: not completed Trial 2
CL Item
Unable due to physical limitations (1)
CL Item
Other (9)
Item Group
9-Hole Peg Test
C0451335 (UMLS CUI-1)
Item
9-Hole Peg Test: dominant hand
text
C0451335 (UMLS CUI [1,1])
C0449722 (UMLS CUI [1,2])
9-Hole Peg Test: dominant hand
Code List
9-Hole Peg Test: dominant hand
CL Item
right (1)
C0205090 (UMLS CUI-1)
CL Item
left (2)
C0205091 (UMLS CUI-1)
9 hole peg test Time dominant hand Trial 1
Item
9-Hole Peg Test: Time dom. Trial 1
float
C0451335 (UMLS CUI [1,1])
C0449722 (UMLS CUI [1,2])
C0750480 (UMLS CUI [1,3])
C0040223 (UMLS CUI [1,4])
Item
9-Hole Peg Test: not completed dom. Trial 1
text
C0451335 (UMLS CUI [1,1])
C0449722 (UMLS CUI [1,2])
C0750480 (UMLS CUI [1,3])
C2732579 (UMLS CUI [1,4])
9-Hole Peg Test: not completed dom. Trial 1
Code List
9-Hole Peg Test: not completed dom. Trial 1
CL Item
Unable due to physical limitations (1)
CL Item
Other (9)
9-Hole Peg Test Time non-dominant hand Trial 1
Item
9-Hole Peg Test: Time non-dom. Trial 1
float
C0451335 (UMLS CUI [1,1])
C0445549 (UMLS CUI [1,2])
C0750480 (UMLS CUI [1,3])
C0040223 (UMLS CUI [1,4])
Item
9-Hole Peg Test: not completed non-dom. Trial 1
text
C0451335 (UMLS CUI [1,1])
C0445549 (UMLS CUI [1,2])
C0750480 (UMLS CUI [1,3])
C2732579 (UMLS CUI [1,4])
9-Hole Peg Test: not completed non-dom. Trial 1
Code List
9-Hole Peg Test: not completed non-dom. Trial 1
CL Item
Unable due to physical limitations (1)
CL Item
Other (9)
9-Hole Peg Test: Time (sec) dom. Trial 2
Item
9-Hole Peg Test: Time (sec) dom. Trial 2
float
C0451335 (UMLS CUI [1,1])
C0449722 (UMLS CUI [1,2])
C0750480 (UMLS CUI [1,3])
C0040223 (UMLS CUI [1,4])
Item
9-Hole Peg Test: not completed dom. Trial 2
text
C0451335 (UMLS CUI [1,1])
C0449722 (UMLS CUI [1,2])
C0750480 (UMLS CUI [1,3])
C2732579 (UMLS CUI [1,4])
9-Hole Peg Test: not completed dom. Trial 2
Code List
9-Hole Peg Test: not completed dom. Trial 2
CL Item
Unable due to physical limitations (1)
CL Item
Other (9)
9-Hole Peg Test: Time (sec) non-dom. Trial 2
Item
9-Hole Peg Test: Time (sec) non-dom. Trial 2
float
C0451335 (UMLS CUI [1,1])
C0445549 (UMLS CUI [1,2])
C0750480 (UMLS CUI [1,3])
C0040223 (UMLS CUI [1,4])
Item
9-Hole Peg Test: not completed non-dom. Trial 2
text
C0451335 (UMLS CUI [1,1])
C0445549 (UMLS CUI [1,2])
C0750480 (UMLS CUI [1,3])
C2732579 (UMLS CUI [1,4])
9-Hole Peg Test: not completed non-dom. Trial 2
Code List
9-Hole Peg Test: not completed non-dom. Trial 2
CL Item
Unable due to physical limitations (1)
CL Item
Other (9)
Item Group
PASAT
C0589060 (UMLS CUI-1)
Item
PASAT Form used
text
C0589060 (UMLS CUI [1,1])
C0180975 (UMLS CUI [1,2])
PASAT Form used
Code List
PASAT Form used
CL Item
Form A (1)
CL Item
Form B (2)
PASAT3 total correct
Item
PASAT3: Total correct
integer
C3898055 (UMLS CUI [1,1])
C0205449 (UMLS CUI [1,2])
Item
PASAT3: not completed
text
C0589060 (UMLS CUI [1,1])
C0205449 (UMLS CUI [1,2])
C2732579 (UMLS CUI [1,3])
PASAT3: not completed
Code List
PASAT3: not completed
CL Item
Unable due to physical limitations (1)
CL Item
Other (9)
PASAT2 total correct
Item
PASAT2: Total correct
integer
C3898055 (UMLS CUI [1,1])
C0205448 (UMLS CUI [1,2])
Item
PASAT2: not completed
text
C0589060 (UMLS CUI [1,1])
C0205448 (UMLS CUI [1,2])
C2732579 (UMLS CUI [1,3])
PASAT2: not completed
Code List
PASAT2: not completed
CL Item
Unable due to physical limitations (1)
CL Item
Other (9)
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