ID

15280

Beschrijving

Study documentation part: Visits 1 (Screening), Study week -4 to 0 Study Details: A 24-week, multicenter, exploratory, two arm study to assess the effect of Dimethyl fumarate on ImmuneModulatory Action on T cells in patients with relapsing remitting Multiple Sclerosis. Principal Investigator PD Dr. Luisa Klotz, University Hospital Münster EudraCT - No.: 2014-003481-25. Clinical Trial No.r: NCT02461069.

Trefwoorden

  1. 17-09-15 17-09-15 - Julian Varghese
  2. 22-09-15 22-09-15 - Julian Varghese
  3. 24-05-16 24-05-16 -
Geüploaded op

24 mei 2016

DOI

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Licentie

Creative Commons BY-NC 3.0 Legacy

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Visit 1 (Screening) Part 1/2, DIMAT-MS, Relapsing Remitting Multiple Sclerosis DRKS00008037 NCT02461069

NON-MS Treatment and symptomatic MS Treatment

General Instructions
Beschrijving

General Instructions

Instructions
Beschrijving

Please document medications which are taken within 30 days prior to Screening on the Concomitant Medication Form. Please document significant non-drug therapies which are performed after signing the informed consent on the Concomitant Medication Form.

Datatype

text

Medical Examination
Beschrijving

Medical Examination

Medical Examination performed at:
Beschrijving

Medical Examination performed at:

Datatype

date

Alias
UMLS CUI [1,1]
C0582103
UMLS CUI [1,2]
C0011008
Heart rate (in bpm):
Beschrijving

HEART RATE

Datatype

integer

Maateenheden
  • bpm
Alias
UMLS CUI [1]
C0018810
bpm
Systolic blood pressure
Beschrijving

Systolic blood pressure

Datatype

integer

Maateenheden
  • mmHg
Alias
UMLS CUI [1]
C0871470
mmHg
Diastolic
Beschrijving

Diastolic blood pressure

Datatype

integer

Maateenheden
  • mmHg
Alias
UMLS CUI [1]
C0428883
mmHg
Temperature
Beschrijving

Temperature

Datatype

float

Maateenheden
  • °C
Alias
UMLS CUI [1]
C0039476
°C
Body weight
Beschrijving

Weight

Datatype

float

Maateenheden
  • kg
Alias
UMLS CUI [1]
C0005910
kg
Height
Beschrijving

Height

Datatype

float

Maateenheden
  • cm
Alias
UMLS CUI [1]
C0005890
cm
Expanded disability status scale (EDSS)
Beschrijving

Expanded disability status scale (EDSS)

EDSS performed at
Beschrijving

EDSS performed at

Datatype

date

Alias
UMLS CUI [1,1]
C0451246
UMLS CUI [1,2]
C0011008
Visual testing
Beschrijving

Converted FS Score

Datatype

integer

Alias
UMLS CUI [1,1]
C0451246
UMLS CUI [1,2]
C0042789
Brianstem testing
Beschrijving

Brianstem testing

Datatype

integer

Alias
UMLS CUI [1,1]
C0451246
UMLS CUI [1,2]
C0006121
Pyramidal testing
Beschrijving

Pyramidal testing

Datatype

text

Alias
UMLS CUI [1,1]
C0451246
UMLS CUI [1,2]
C0228060
Cerebellar testing
Beschrijving

Cerebellar testing

Datatype

text

Alias
UMLS CUI [1,1]
C0451246
UMLS CUI [1,2]
C0742034
Bowel/Bladder
Beschrijving

Bowel/Bladder

Datatype

integer

Alias
UMLS CUI [1,1]
C0451246
UMLS CUI [1,2]
C2707247
Cerebral testing
Beschrijving

Cerebral testing

Datatype

text

Alias
UMLS CUI [1,1]
C0451246
UMLS CUI [1,2]
C0006104
Ambulation Score
Beschrijving

Ambulation Score

Datatype

text

Alias
UMLS CUI [1,1]
C0451246
UMLS CUI [1,2]
C0080331
EDSS step
Beschrijving

EDSS score

Datatype

float

Alias
UMLS CUI [1]
C0451246
Signature
Beschrijving

Signature

Date
Beschrijving

Investigator Signature Date

Datatype

date

Alias
UMLS CUI [1,1]
C2346576
UMLS CUI [1,2]
C0011008
Name/Signature Investigator
Beschrijving

Name/Signature

Datatype

text

Alias
UMLS CUI [1]
C2346576

Similar models

NON-MS Treatment and symptomatic MS Treatment

Name
Type
Description | Question | Decode (Coded Value)
Datatype
Alias
Item Group
General Instructions
Instructions
Item
Instructions
text
Item Group
Medical Examination
Medical Examination performed at:
Item
Medical Examination performed at:
date
C0582103 (UMLS CUI [1,1])
C0011008 (UMLS CUI [1,2])
HEART RATE
Item
Heart rate (in bpm):
integer
C0018810 (UMLS CUI [1])
Systolic blood pressure
Item
Systolic blood pressure
integer
C0871470 (UMLS CUI [1])
Diastolic blood pressure
Item
Diastolic
integer
C0428883 (UMLS CUI [1])
Temperature
Item
Temperature
float
C0039476 (UMLS CUI [1])
Weight
Item
Body weight
float
C0005910 (UMLS CUI [1])
Height
Item
Height
float
C0005890 (UMLS CUI [1])
Item Group
Expanded disability status scale (EDSS)
EDSS performed at
Item
EDSS performed at
date
C0451246 (UMLS CUI [1,1])
C0011008 (UMLS CUI [1,2])
Item
Visual testing
integer
C0451246 (UMLS CUI [1,1])
C0042789 (UMLS CUI [1,2])
Code List
Visual testing
CL Item
0 (1)
CL Item
1 (2)
CL Item
2 (3)
CL Item
3 (4)
CL Item
4 (5)
CL Item
5 (6)
CL Item
6 (7)
Item
Brianstem testing
integer
C0451246 (UMLS CUI [1,1])
C0006121 (UMLS CUI [1,2])
Code List
Brianstem testing
CL Item
0 (1)
CL Item
1 (2)
CL Item
2 (3)
CL Item
3 (4)
CL Item
4 (5)
CL Item
5 (6)
Item
Pyramidal testing
text
C0451246 (UMLS CUI [1,1])
C0228060 (UMLS CUI [1,2])
Code List
Pyramidal testing
CL Item
0 (0)
CL Item
1 (1)
CL Item
2 (2)
CL Item
3 (3)
CL Item
4 (4)
CL Item
5 (5)
CL Item
6 (6)
Item
Cerebellar testing
text
C0451246 (UMLS CUI [1,1])
C0742034 (UMLS CUI [1,2])
Code List
Cerebellar testing
CL Item
0 (0)
CL Item
1 (1)
CL Item
2 (2)
CL Item
3 (3)
CL Item
4 (4)
CL Item
5 (5)
CL Item
X (X)
Item
Bowel/Bladder
integer
C0451246 (UMLS CUI [1,1])
C2707247 (UMLS CUI [1,2])
Code List
Bowel/Bladder
CL Item
Cerebellar testing (1)
Item
Cerebral testing
text
C0451246 (UMLS CUI [1,1])
C0006104 (UMLS CUI [1,2])
Code List
Cerebral testing
CL Item
0 (0)
CL Item
1 (1)
CL Item
2 (2)
CL Item
3 (3)
CL Item
4 (4)
CL Item
5 (5)
Item
Ambulation Score
text
C0451246 (UMLS CUI [1,1])
C0080331 (UMLS CUI [1,2])
Code List
Ambulation Score
CL Item
0 (0)
CL Item
1 (1)
CL Item
2 (2)
CL Item
3 (3)
CL Item
4 (4)
CL Item
5 (5)
CL Item
6 (6)
CL Item
7 (7)
CL Item
8 (8)
CL Item
9 (9)
CL Item
10 (10)
CL Item
11 (11)
CL Item
12 (12)
EDSS score
Item
EDSS step
float
C0451246 (UMLS CUI [1])
Item Group
Signature
Investigator Signature Date
Item
Date
date
C2346576 (UMLS CUI [1,1])
C0011008 (UMLS CUI [1,2])
Name/Signature Investigator
Item
Name/Signature Investigator
text
C2346576 (UMLS CUI [1])

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