ID

34801

Beschrijving

Screening, Baseline and Visit 1 CRFs of DIMAT-MS and ALAIN studies for semantic analysis of Multiple Sclerosis study documentation. Provided by Prof. Dr. Luisa Klotz of the Department of Neurology of the University Hospital Muenster.

Trefwoorden

Versies (4)
  1. 27-02-18 27-02-18 -
  2. 29-01-19 29-01-19 - Sarah Riepenhausen
  3. 13-04-21 13-04-21 - Dr. rer. medic Philipp Neuhaus
  4. 20-09-21 20-09-21 -
Houder van rechten

Prof. Dr. Luisa Klotz

Geüploaded op

29 januari 2019

DOI

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Licentie

Creative Commons BY-NC 3.0
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Multiple sclerosis studies NCT02461069 NCT02419378

Engels

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

18 Formulieren  
Date of blood sampling
Beschrijving

Date of blood sampling

Date of blood sampling
Beschrijving

Date of blood sampling

Datatype

date

Alias
UMLS CUI [1,1]
C0178913
UMLS CUI [1,2]
C0011008
UMLS CUI [2]
C1254595
Hematology
Beschrijving

Hematology

Leucocytes
Beschrijving

Leucocytes

Datatype

float

Alias
UMLS CUI [1]
C0023508
Leucocytes measurement unit
Beschrijving

Leucocytes measurement unit

Datatype

text

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

Leucocytes Count Procesdure not done

Datatype

boolean

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

Lymphocytes

Datatype

float

Alias
UMLS CUI [1]
C0200635
Lymphocytes measurement unit
Beschrijving

Lymphocytes measurement unit

Datatype

text

Alias
UMLS CUI [1,1]
C0200635
UMLS CUI [1,2]
C1519795
Lymphocytes Count Procesdure not done
Beschrijving

Lymphocytes Count Procesdure not done

Datatype

boolean

Alias
UMLS CUI [1,1]
C0200635
UMLS CUI [1,2]
C1272696
Liver Function
Beschrijving

Liver Function

Aspartate transaminase (AST) (SGOT)
Beschrijving

AST

Datatype

float

Alias
UMLS CUI [1]
C0201899
AST Measurement Unit
Beschrijving

AST Measurement Unit

Datatype

text

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

AST measurement not done

Datatype

boolean

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

ALT

Datatype

float

Alias
UMLS CUI [1]
C0428324
ALT Measurement Unit
Beschrijving

ALT measurement unit

Datatype

text

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

ALT measurement not done

Datatype

boolean

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

GGT

Datatype

float

Alias
UMLS CUI [1]
C0202035
GGT Measurement Unit
Beschrijving

GGT Measurement Unit

Datatype

text

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

GGT Measurement not done

Datatype

boolean

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

Renal function

Serum creatinine
Beschrijving

Creatinine, Serum

Datatype

float

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

Creatinine, Serum Measurment Unit

Datatype

text

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

Serum Creatinine Measurment not done

Datatype

boolean

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

Blood Urea Nitrogen

Datatype

float

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

Blood urea nitrogen measurement unit

Datatype

text

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

Blood urea nitrogen measurement not done

Datatype

boolean

Alias
UMLS CUI [1,1]
C0005845
UMLS CUI [1,2]
C1272696
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
  • °C
Alias
UMLS CUI [1]
C0428883
°C
Temperature
Beschrijving

Temperature

Datatype

float

Maateenheden
  • °C
Alias
UMLS CUI [1]
C0005903
°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]
C3830336
UMLS CUI [1,2]
C0011008
Visual testing
Beschrijving

Converted FS Score

Datatype

integer

Alias
UMLS CUI [1]
C3827261
Brainstem testing
Beschrijving

Brainstem testing

Datatype

integer

Alias
UMLS CUI [1]
C1446204
Pyramidal testing
Beschrijving

Pyramidal testing

Datatype

text

Alias
UMLS CUI [1]
C3829393
Cerebellar testing
Beschrijving

Cerebellar testing

Datatype

text

Alias
UMLS CUI [1]
C3829398
Bowel/Bladder
Beschrijving

Bowel/Bladder

Datatype

integer

Alias
UMLS CUI [1]
C3829400
Cerebral testing
Beschrijving

Cerebral testing

Datatype

text

Alias
UMLS CUI [1]
C3829397
Ambulation Score
Beschrijving

Ambulation Score

Datatype

text

Alias
UMLS CUI [1]
C3890899
EDSS step
Beschrijving

EDSS score

Datatype

float

Alias
UMLS CUI [1]
C3830336
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
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Similar models

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

18 Formulieren
Name
Type
Description | Question | Decode (Coded Value)
Datatype
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])
C1254595 (UMLS CUI [2])
Item Group
Hematology
Leucocytes
Item
Leucocytes
float
C0023508 (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
C0200635 (UMLS CUI [1])
Item
Lymphocytes measurement unit
text
C0200635 (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
C0200635 (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
C0005903 (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
C3830336 (UMLS CUI [1,1])
C0011008 (UMLS CUI [1,2])
Item
Visual testing
integer
C3827261 (UMLS CUI [1])
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
Brainstem testing
integer
C1446204 (UMLS CUI [1])
Brianstem testing
Code List
Brainstem 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
C3829393 (UMLS CUI [1])
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
C3829398 (UMLS CUI [1])
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
C3829400 (UMLS CUI [1])
Bowel/Bladder
Code List
Bowel/Bladder
CL Item
Cerebellar testing (1)
Item
Cerebral testing
text
C3829397 (UMLS CUI [1])
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
C3890899 (UMLS CUI [1])
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
C3830336 (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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