ID

16596

Description

MIPSO Comparative study of bacterial microbiota in the skin and intestines of psoriasis patients before and after systemic treatment with adalimumab or ustekinumab or ciclosporin (EudraCT 2014-003022-40) Principal Investigator: Prof. Dr. Dr. H. C. Thomas A. Luger

Keywords

Versions (4)
  1. 8/25/15 8/25/15 - Martin Dugas
  2. 8/26/15 8/26/15 - Martin Dugas
  3. 12/16/15 12/16/15 -
  4. 7/25/16 7/25/16 -
Uploaded on

July 25, 2016

DOI

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License

Creative Commons BY-NC 3.0
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Physical Examinations MIPSO EudraCT 2014-003022-4 DRKS00007147

English

Physical Examinations MIPSO EudraCT 2014-003022-4

1 forms  
Use of the form
Description

Use of the form

Alias
UMLS CUI-1
C0457083
UMLS CUI-2
C1516308
Form has to be used several times. Please mark the time of use.
Description

Form has to be used several times. Please mark the time of use.

Data type

integer

Alias
UMLS CUI [1,1]
C1516308
UMLS CUI [1,2]
C1265611
Physical Examination
Description

Physical Examination

Alias
UMLS CUI-1
C0031809
Patient number
Description

Patient number

Data type

text

Alias
UMLS CUI [1]
C1830427
Visit date
Description

Visit date

Data type

date

Alias
UMLS CUI [1]
C1320303
Planned therapy
Description

Planned therapy

Data type

integer

Alias
UMLS CUI [1,1]
C0087111
UMLS CUI [1,2]
C1301732
Body weight
Description

Body weight

Data type

integer

Measurement units
  • kg
Alias
UMLS CUI [1]
C0005910
kg
Identification of plaques for sampling (only at 1st Visite)
Description

Identification of plaques for sampling (only at 1st Visite)

Alias
UMLS CUI-1
C0332461
UMLS CUI-2
C0205396
Cutaneous plaque
Description

lesional skin area (plaque)

Data type

integer

Alias
UMLS CUI [1]
C0241148
non-lesional skin area
Description

non-lesional skin area

Data type

integer

Alias
UMLS CUI [1,1]
C1123023
UMLS CUI [1,2]
C1518422
UMLS CUI [1,3]
C0221198
Smear sample lesion
Description

Smear sample lesion

Data type

boolean

Alias
UMLS CUI [1,1]
C0444086
UMLS CUI [1,2]
C0221198
Biopsy lesion
Description

Biopsy lesion

Data type

boolean

Alias
UMLS CUI [1,1]
C0005558
UMLS CUI [1,2]
C0221198
Smear sample non-lesion
Description

Smear sample non-lesion

Data type

boolean

Alias
UMLS CUI [1,1]
C0444086
UMLS CUI [1,2]
C1518422
UMLS CUI [1,3]
C0221198
Biopsy non-lesion
Description

Biopsy non-lesion

Data type

boolean

Alias
UMLS CUI [1,1]
C0005558
UMLS CUI [1,2]
C1518422
UMLS CUI [1,3]
C0221198
Stool sample
Description

Stool sample

Data type

boolean

Alias
UMLS CUI [1]
C1550661
Physical Examination: Screening/Termination visit
Description

Physical Examination: Screening/Termination visit

Alias
UMLS CUI-1
C0220908
UMLS CUI-2
C0545082
Body weight
Description

Body weight

Data type

integer

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

Height

Data type

integer

Measurement units
  • cm
Alias
UMLS CUI [1]
C0005890
cm
General condition
Description

General condition

Data type

text

Alias
UMLS CUI [1]
C1142435
General condition comment
Description

General condition comment

Data type

text

Alias
UMLS CUI [1,1]
C1142435
UMLS CUI [1,2]
C0947611
Skin condition
Description

Skin condition (except Psoriasis)

Data type

text

Alias
UMLS CUI [1]
C1719933
Skin condition comment
Description

Skin condition comment (except Psoriasis)

Data type

text

Alias
UMLS CUI [1,1]
C1719933
UMLS CUI [1,2]
C0947611
Head and Neck
Description

Head and Neck

Data type

text

Alias
UMLS CUI [1]
C0460004
Head and Neck comment
Description

Head and Neck comment

Data type

text

Alias
UMLS CUI [1,1]
C0460004
UMLS CUI [1,2]
C0947611
Lymph nodes
Description

Lymph nodes

Data type

text

Alias
UMLS CUI [1]
C0024204
Lymph nodes comment
Description

Lymph nodes comment

Data type

text

Alias
UMLS CUI [1,1]
C0024204
UMLS CUI [1,2]
C0947611
Thyroid gland
Description

Thyroid gland

Data type

text

Alias
UMLS CUI [1]
C0040132
Thyroid gland comment
Description

Thyroid gland comment

Data type

text

Alias
UMLS CUI [1,1]
C0040132
UMLS CUI [1,2]
C0947611
Extremities
Description

Extremities

Data type

text

Alias
UMLS CUI [1]
C0015385
Extremities comment
Description

Extremities comment

Data type

text

Alias
UMLS CUI [1,1]
C0015385
UMLS CUI [1,2]
C0947611
Cardiovascular system
Description

Cardiovascular system

Data type

text

Alias
UMLS CUI [1]
C0007226
Cardiovascular system comment
Description

Cardiovascular system comment

Data type

text

Alias
UMLS CUI [1,1]
C0007226
UMLS CUI [1,2]
C0947611
Lung
Description

Lung

Data type

text

Alias
UMLS CUI [1]
C0024109
Lung comment
Description

Lung comment

Data type

text

Alias
UMLS CUI [1,1]
C0024109
UMLS CUI [1,2]
C0947611
Abdomen
Description

Abdomen

Data type

text

Alias
UMLS CUI [1]
C0000726
Abdomen comment
Description

Abdomen comment

Data type

text

Alias
UMLS CUI [1,1]
C0000726
UMLS CUI [1,2]
C0947611
Nervous System
Description

Nervous System

Data type

text

Alias
UMLS CUI [1]
C0027763
Nervous System comment
Description

Nervous System comment

Data type

text

Alias
UMLS CUI [1,1]
C0027763
UMLS CUI [1,2]
C0947611
Laboratory tests: Sampling performed
Description

Laboratory tests: Sampling performed

Alias
UMLS CUI-1
C0022885
Smear sample lesion
Description

Smear sample lesion

Data type

boolean

Alias
UMLS CUI [1,1]
C0444086
UMLS CUI [1,2]
C0221198
Biopsy lesion
Description

Biopsy lesion

Data type

boolean

Alias
UMLS CUI [1,1]
C0005558
UMLS CUI [1,2]
C0221198
Stool sample
Description

Stool sample

Data type

boolean

Alias
UMLS CUI [1]
C1550661
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Similar models

Physical Examinations MIPSO EudraCT 2014-003022-4

1 forms
Name
Type
Description | Question | Decode (Coded Value)
Data type
Alias
Item Group
Use of the form
C0457083 (UMLS CUI-1)
C1516308 (UMLS CUI-2)
Item
Form has to be used several times. Please mark the time of use.
integer
C1516308 (UMLS CUI [1,1])
C1265611 (UMLS CUI [1,2])
The time of use
Code List
Form has to be used several times. Please mark the time of use.
CL Item
Screening (1)
CL Item
Visite 1 (Baseline) (2)
CL Item
Visite 2 (Week 4) (3)
CL Item
Visite 3 (Week 8 (4)
CL Item
Visite 4 (Week 12) (5)
CL Item
Visite 5 (Week 16) (6)
CL Item
Visite 6 (Week 20) (7)
CL Item
Visite 7 (Week 24) (8)
CL Item
Termination visite (9)
Item Group
Physical Examination
C0031809 (UMLS CUI-1)
Patient number
Item
text
C1830427 (UMLS CUI [1])
Visit date
Item
date
C1320303 (UMLS CUI [1])
Item
integer
C0087111 (UMLS CUI [1,1])
C1301732 (UMLS CUI [1,2])
Planned therapy
Code List
Planned therapy
CL Item
Adalimumab (1)
CL Item
Ustekinumab (2)
CL Item
Ciclosporin (3)
Body weight
Item
integer
C0005910 (UMLS CUI [1])
Item Group
Identification of plaques for sampling (only at 1st Visite)
C0332461 (UMLS CUI-1)
C0205396 (UMLS CUI-2)
Item
integer
C0241148 (UMLS CUI [1])
lesional skin area (plaque)
Code List
Cutaneous plaque
CL Item
Upper arm, ventral (1)
CL Item
Upper arm, dorsal (2)
CL Item
Elbow (3)
CL Item
Crook (4)
CL Item
Forearm, ventral (5)
CL Item
Forearm, dorsal (6)
CL Item
Back of hand (7)
CL Item
Extensor side of fingers (8)
CL Item
Palm (9)
CL Item
Flexor side of fingers (10)
CL Item
Thigh, ventral (11)
CL Item
Thigh, dorsal (12)
CL Item
Patella (13)
CL Item
Knee bend (14)
CL Item
Lower leg, ventral (15)
CL Item
Lower leg, dorsal (16)
CL Item
Dorsum of foot (17)
CL Item
Sole of Foot (18)
CL Item
Toes (19)
CL Item
Upper back (20)
CL Item
Lower back (21)
CL Item
Buttocks (22)
CL Item
Rima ani (23)
CL Item
Chest (24)
CL Item
Abdomen (25)
CL Item
Umbilicus (26)
Item
integer
C1123023 (UMLS CUI [1,1])
C1518422 (UMLS CUI [1,2])
C0221198 (UMLS CUI [1,3])
non-lesional skin area
Code List
non-lesional skin area
CL Item
Upper arm, ventral (1)
CL Item
Upper arm, dorsal (2)
CL Item
Elbow (3)
CL Item
Crook (4)
CL Item
Forearm, ventral (5)
CL Item
Forearm, dorsal (6)
CL Item
Back of hand (7)
CL Item
Extensor side of fingers (8)
CL Item
Palm (9)
CL Item
Flexor side of fingers (10)
CL Item
Thigh, ventral (11)
CL Item
Thigh, dorsal (12)
CL Item
Patella (13)
CL Item
Knee bend (14)
CL Item
Lower leg, ventral (15)
CL Item
Lower leg, dorsal (16)
CL Item
Dorsum of foot (17)
CL Item
Sole of Foot (18)
CL Item
Toes (19)
CL Item
Upper back (20)
CL Item
Lower back (21)
CL Item
Buttocks (22)
CL Item
Rima ani (23)
CL Item
Chest (24)
CL Item
Abdomen (25)
CL Item
Umbilicus (26)
Smear sample lesion
Item
boolean
C0444086 (UMLS CUI [1,1])
C0221198 (UMLS CUI [1,2])
Biopsy lesion
Item
boolean
C0005558 (UMLS CUI [1,1])
C0221198 (UMLS CUI [1,2])
Smear sample non-lesion
Item
boolean
C0444086 (UMLS CUI [1,1])
C1518422 (UMLS CUI [1,2])
C0221198 (UMLS CUI [1,3])
Biopsy non-lesion
Item
boolean
C0005558 (UMLS CUI [1,1])
C1518422 (UMLS CUI [1,2])
C0221198 (UMLS CUI [1,3])
Stool sample
Item
boolean
C1550661 (UMLS CUI [1])
Item Group
Physical Examination: Screening/Termination visit
C0220908 (UMLS CUI-1)
C0545082 (UMLS CUI-2)
Body weight
Item
integer
C0005910 (UMLS CUI [1])
Height
Item
integer
C0005890 (UMLS CUI [1])
Item
General condition
text
C1142435 (UMLS CUI [1])
General condition
Code List
General condition
CL Item
normal (1)
CL Item
not normal (2)
General condition comment
Item
text
C1142435 (UMLS CUI [1,1])
C0947611 (UMLS CUI [1,2])
Item
text
C1719933 (UMLS CUI [1])
General condition
Code List
Skin condition
CL Item
normal (1)
CL Item
not normal (2)
Skin condition comment
Item
text
C1719933 (UMLS CUI [1,1])
C0947611 (UMLS CUI [1,2])
Item
text
C0460004 (UMLS CUI [1])
General condition
Code List
Head and Neck
CL Item
normal (1)
CL Item
not normal (2)
Head and Neck comment
Item
text
C0460004 (UMLS CUI [1,1])
C0947611 (UMLS CUI [1,2])
Item
text
C0024204 (UMLS CUI [1])
General condition
Code List
Lymph nodes
CL Item
normal (1)
CL Item
not normal (2)
Lymph nodes comment
Item
text
C0024204 (UMLS CUI [1,1])
C0947611 (UMLS CUI [1,2])
Item
text
C0040132 (UMLS CUI [1])
General condition
Code List
Thyroid gland
CL Item
normal (1)
CL Item
not normal (2)
Thyroid gland comment
Item
text
C0040132 (UMLS CUI [1,1])
C0947611 (UMLS CUI [1,2])
Item
text
C0015385 (UMLS CUI [1])
General condition
Code List
Extremities
CL Item
normal (1)
CL Item
not normal (2)
Extremities comment
Item
text
C0015385 (UMLS CUI [1,1])
C0947611 (UMLS CUI [1,2])
Item
text
C0007226 (UMLS CUI [1])
General condition
Code List
Cardiovascular system
CL Item
normal (1)
CL Item
not normal (2)
Cardiovascular system comment
Item
text
C0007226 (UMLS CUI [1,1])
C0947611 (UMLS CUI [1,2])
Item
text
C0024109 (UMLS CUI [1])
General condition
Code List
Lung
CL Item
normal (1)
CL Item
not normal (2)
Lung comment
Item
text
C0024109 (UMLS CUI [1,1])
C0947611 (UMLS CUI [1,2])
Item
text
C0000726 (UMLS CUI [1])
General condition
Code List
Abdomen
CL Item
normal (1)
CL Item
not normal (2)
Abdomen comment
Item
text
C0000726 (UMLS CUI [1,1])
C0947611 (UMLS CUI [1,2])
Item
text
C0027763 (UMLS CUI [1])
General condition
Code List
Nervous System
CL Item
normal (1)
CL Item
not normal (2)
Nervous System comment
Item
text
C0027763 (UMLS CUI [1,1])
C0947611 (UMLS CUI [1,2])
Item Group
Laboratory tests: Sampling performed
C0022885 (UMLS CUI-1)
Smear sample lesion
Item
boolean
C0444086 (UMLS CUI [1,1])
C0221198 (UMLS CUI [1,2])
Biopsy lesion
Item
boolean
C0005558 (UMLS CUI [1,1])
C0221198 (UMLS CUI [1,2])
Stool sample
Item
boolean
C1550661 (UMLS CUI [1])
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