ID

15280

Description

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.

Mots-clés

  1. 17/09/2015 17/09/2015 - Julian Varghese
  2. 22/09/2015 22/09/2015 - Julian Varghese
  3. 24/05/2016 24/05/2016 -
Téléchargé le

24 mai 2016

DOI

Pour une demande vous connecter.

Licence

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
Description

General Instructions

Instructions
Description

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.

Type de données

text

Medical Examination
Description

Medical Examination

Medical Examination performed at:
Description

Medical Examination performed at:

Type de données

date

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

HEART RATE

Type de données

integer

Unités de mesure
  • bpm
Alias
UMLS CUI [1]
C0018810
bpm
Systolic blood pressure
Description

Systolic blood pressure

Type de données

integer

Unités de mesure
  • mmHg
Alias
UMLS CUI [1]
C0871470
mmHg
Diastolic
Description

Diastolic blood pressure

Type de données

integer

Unités de mesure
  • mmHg
Alias
UMLS CUI [1]
C0428883
mmHg
Temperature
Description

Temperature

Type de données

float

Unités de mesure
  • °C
Alias
UMLS CUI [1]
C0039476
°C
Body weight
Description

Weight

Type de données

float

Unités de mesure
  • kg
Alias
UMLS CUI [1]
C0005910
kg
Height
Description

Height

Type de données

float

Unités de mesure
  • cm
Alias
UMLS CUI [1]
C0005890
cm
Expanded disability status scale (EDSS)
Description

Expanded disability status scale (EDSS)

EDSS performed at
Description

EDSS performed at

Type de données

date

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

Converted FS Score

Type de données

integer

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

Brianstem testing

Type de données

integer

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

Pyramidal testing

Type de données

text

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

Cerebellar testing

Type de données

text

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

Bowel/Bladder

Type de données

integer

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

Cerebral testing

Type de données

text

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

Ambulation Score

Type de données

text

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

EDSS score

Type de données

float

Alias
UMLS CUI [1]
C0451246
Signature
Description

Signature

Date
Description

Investigator Signature Date

Type de données

date

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

Name/Signature

Type de données

text

Alias
UMLS CUI [1]
C2346576

Similar models

NON-MS Treatment and symptomatic MS Treatment

Name
Type
Description | Question | Decode (Coded Value)
Type de données
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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