ID

15279

Description

Study documentation part: Visit 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.

Keywords

Versions (2)
  1. 5/20/16 5/20/16 -
  2. 5/24/16 5/24/16 -
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May 24, 2016

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License

Creative Commons BY-NC 3.0
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Visit 1 (Screening) Part 2/2, Lab & Medical Examination, DIMAT-MS, Relapsing Remitting Multiple Sclerosis DRKS00008037 NCT02461069

English

Visit 1 (Screening) Part 2/2, Lab & Medical Examination, DIMAT-MS, Relapsing Remitting Multiple Sclerosis NCT02461069

1 forms  
Date of blood sampling
Description

Date of blood sampling

Date of blood sampling
Description

Date of blood sampling

Data type

date

Alias
UMLS CUI [1,1]
C0178913
UMLS CUI [1,2]
C0011008
Hematology
Description

Hematology

Leucocytes
Description

Leucocytes

Data type

float

Alias
UMLS CUI [1]
C0023516
Leucocytes measurement unit
Description

Leucocytes measurement unit

Data type

text

Alias
UMLS CUI [1,1]
C0023508
UMLS CUI [1,2]
C1519795
Leucocytes Count not done
Description

Leucocytes Count Procesdure not done

Data type

boolean

Alias
UMLS CUI [1,1]
C0023508
UMLS CUI [1,2]
C1272696
Lymphocytes
Description

Lymphocytes

Data type

float

Alias
UMLS CUI [1]
C0024264
Lymphocytes measurement unit
Description

Lymphocytes measurement unit

Data type

text

Alias
UMLS CUI [1,1]
C0024264
UMLS CUI [1,2]
C1519795
Lymphocytes Count Procesdure not done
Description

Lymphocytes Count Procesdure not done

Data type

boolean

Alias
UMLS CUI [1,1]
C0024264
UMLS CUI [1,2]
C1272696
Liver Function
Description

Liver Function

Aspartate transaminase (AST) (SGOT)
Description

AST

Data type

float

Alias
UMLS CUI [1]
C0201899
AST Measurement Unit
Description

AST Measurement Unit

Data type

text

Alias
UMLS CUI [1,1]
C0201899
UMLS CUI [1,2]
C1519795
AST measurement not done
Description

AST measurement not done

Data type

boolean

Alias
UMLS CUI [1,1]
C0201899
UMLS CUI [1,2]
C1272696
Alanine transaminase (ALT) (SGPT)
Description

ALT

Data type

float

Alias
UMLS CUI [1]
C0428324
ALT Measurement Unit
Description

ALT measurement unit

Data type

text

Alias
UMLS CUI [1,1]
C0201836
UMLS CUI [1,2]
C1519795
ALT measurement not done
Description

ALT measurement not done

Data type

boolean

Alias
UMLS CUI [1,1]
C0201836
UMLS CUI [1,2]
C1272696
Gamma Glutamyl Transpeptidase Measurement
Description

GGT

Data type

float

Alias
UMLS CUI [1]
C0202035
GGT Measurement Unit
Description

GGT Measurement Unit

Data type

text

Alias
UMLS CUI [1,1]
C0202035
UMLS CUI [1,2]
C1519795
GGT Measurement not done
Description

GGT Measurement not done

Data type

boolean

Alias
UMLS CUI [1,1]
C0202035
UMLS CUI [1,2]
C1272696
Renal function
Description

Renal function

Serum creatinine
Description

Creatinine, Serum

Data type

float

Alias
UMLS CUI [1]
C0201976
Serum Creatinine Measurment Unit
Description

Creatinine, Serum Measurment Unit

Data type

text

Alias
UMLS CUI [1,1]
C0201976
UMLS CUI [1,2]
C1519795
Serum Creatinine Measurment not done
Description

Serum Creatinine Measurment not done

Data type

boolean

Alias
UMLS CUI [1,1]
C0201976
UMLS CUI [1,2]
C1272696
Blood Urea Nitrogen
Description

Blood Urea Nitrogen

Data type

float

Alias
UMLS CUI [1]
C0005845
Blood urea nitrogen measurement unit
Description

Blood urea nitrogen measurement unit

Data type

text

Alias
UMLS CUI [1,1]
C0005845
UMLS CUI [1,2]
C1519795
Blood urea nitrogen measurement not done
Description

Blood urea nitrogen measurement not done

Data type

boolean

Alias
UMLS CUI [1,1]
C0005845
UMLS CUI [1,2]
C1272696
Medical Examination
Description

Medical Examination

Medical Examination performed at:
Description

Medical Examination performed at:

Data type

date

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

HEART RATE

Data type

integer

Measurement units
  • bpm
Alias
UMLS CUI [1]
C0018810
bpm
Systolic blood pressure
Description

Systolic blood pressure

Data type

integer

Measurement units
  • mmHg
Alias
UMLS CUI [1]
C0871470
mmHg
Diastolic
Description

Diastolic blood pressure

Data type

integer

Measurement units
  • °C
Alias
UMLS CUI [1]
C0428883
°C
Temperature
Description

Temperature

Data type

float

Measurement units
  • °C
Alias
UMLS CUI [1]
C0039476
°C
Body weight
Description

Weight

Data type

float

Measurement units
  • kg
Alias
UMLS CUI [1]
C0005910
kg
Height
Description

Height

Data type

float

Measurement units
  • 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

Data type

date

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

Converted FS Score

Data type

integer

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

Brainstem testing

Data type

integer

Pyramidal testing
Description

Pyramidal testing

Data type

text

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

Cerebellar testing

Data type

text

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

Bowel/Bladder

Data type

integer

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

Cerebral testing

Data type

text

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

Ambulation Score

Data type

text

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

EDSS score

Data type

float

Alias
UMLS CUI [1]
C0451246
Signature
Description

Signature

Date
Description

Investigator Signature Date

Data type

date

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

Name/Signature

Data type

text

Alias
UMLS CUI [1]
C2346576
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Similar models

Visit 1 (Screening) Part 2/2, Lab & Medical Examination, DIMAT-MS, Relapsing Remitting Multiple Sclerosis NCT02461069

1 forms
Name
Type
Description | Question | Decode (Coded Value)
Data type
Alias
Item Group
Date of blood sampling
Date of blood sampling
Item
Date of blood sampling
date
C0178913 (UMLS CUI [1,1])
C0011008 (UMLS CUI [1,2])
Item Group
Hematology
Leucocytes
Item
Leucocytes
float
C0023516 (UMLS CUI [1])
Item
Leucocytes measurement unit
text
C0023508 (UMLS CUI [1,1])
C1519795 (UMLS CUI [1,2])
Leucocytes measurement unit
Code List
Leucocytes measurement unit
CL Item
10^3 /µL  (10^3 /µL )
CL Item
/mm^3 (/µL )
CL Item
other (other)
Leucocytes Count Procesdure not done
Item
Leucocytes Count not done
boolean
C0023508 (UMLS CUI [1,1])
C1272696 (UMLS CUI [1,2])
Lymphocytes
Item
Lymphocytes
float
C0024264 (UMLS CUI [1])
Item
Lymphocytes measurement unit
text
C0024264 (UMLS CUI [1,1])
C1519795 (UMLS CUI [1,2])
Lymphocytes
Code List
Lymphocytes measurement unit
CL Item
other (other)
CL Item
10^3 /µL  (10^3 /µL )
CL Item
/mm^3 (/µL )
Lymphocytes Count Procesdure not done
Item
Lymphocytes Count Procesdure not done
boolean
C0024264 (UMLS CUI [1,1])
C1272696 (UMLS CUI [1,2])
Item Group
Liver Function
AST
Item
Aspartate transaminase (AST) (SGOT)
float
C0201899 (UMLS CUI [1])
Item
AST Measurement Unit
text
C0201899 (UMLS CUI [1,1])
C1519795 (UMLS CUI [1,2])
AST Measurement Unit
Code List
AST Measurement Unit
CL Item
U/L (U/L)
CL Item
nkat/L (nmol/s*L )
CL Item
other (other)
CL Item
µkat/L (µmol/s*L )
AST measurement not done
Item
AST measurement not done
boolean
C0201899 (UMLS CUI [1,1])
C1272696 (UMLS CUI [1,2])
ALT
Item
Alanine transaminase (ALT) (SGPT)
float
C0428324 (UMLS CUI [1])
Item
ALT Measurement Unit
text
C0201836 (UMLS CUI [1,1])
C1519795 (UMLS CUI [1,2])
ALT measurement unit
Code List
ALT Measurement Unit
CL Item
U/L (U/L)
CL Item
nkat/L (nmol/s*L )
CL Item
other (other)
CL Item
µkat/L (µmol/s*L )
ALT measurement not done
Item
ALT measurement not done
boolean
C0201836 (UMLS CUI [1,1])
C1272696 (UMLS CUI [1,2])
GGT
Item
Gamma Glutamyl Transpeptidase Measurement
float
C0202035 (UMLS CUI [1])
Item
GGT Measurement Unit
text
C0202035 (UMLS CUI [1,1])
C1519795 (UMLS CUI [1,2])
GGT Measurement Unit
Code List
GGT Measurement Unit
CL Item
U/L (U/L)
CL Item
nkat/L (nmol/s*L )
CL Item
other (other)
CL Item
µkat/L (µmol/s*L )
GGT Measurement not done
Item
GGT Measurement not done
boolean
C0202035 (UMLS CUI [1,1])
C1272696 (UMLS CUI [1,2])
Item Group
Renal function
Creatinine, Serum
Item
Serum creatinine
float
C0201976 (UMLS CUI [1])
Item
Serum Creatinine Measurment Unit
text
C0201976 (UMLS CUI [1,1])
C1519795 (UMLS CUI [1,2])
Creatinine, Serum Measurment Unit
Code List
Serum Creatinine Measurment Unit
CL Item
mg/dL (mg/dL)
CL Item
other (other)
CL Item
µmol/L (µmol/L)
Serum Creatinine Measurment not done
Item
Serum Creatinine Measurment not done
boolean
C0201976 (UMLS CUI [1,1])
C1272696 (UMLS CUI [1,2])
Blood Urea Nitrogen
Item
Blood Urea Nitrogen
float
C0005845 (UMLS CUI [1])
Item
Blood urea nitrogen measurement unit
text
C0005845 (UMLS CUI [1,1])
C1519795 (UMLS CUI [1,2])
Blood urea nitrogen measurement unit
Code List
Blood urea nitrogen measurement unit
CL Item
mg/dL (mg/dL)
CL Item
µmol/L (µmol/L)
CL Item
other (other)
Blood urea nitrogen measurement not done
Item
Blood urea nitrogen measurement not done
boolean
C0005845 (UMLS CUI [1,1])
C1272696 (UMLS CUI [1,2])
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])
Visual testing
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
Brianstem testing
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])
Pyramidal testing
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])
Cerebellar testing
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])
Bowel/Bladder
Code List
Bowel/Bladder
CL Item
Cerebellar testing (1)
Item
Cerebral testing
text
C0451246 (UMLS CUI [1,1])
C0006104 (UMLS CUI [1,2])
Cerebral testing
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])
Ambulation Score
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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