ID

12733

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

December 16, 2015

DOI

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License

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

English

Physical Examinations MIPSO EudraCT 2014-003022-4

1 forms  
Use of the form
Description

Use of the form

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

Physical Examination
Description

Physical Examination

Patient number
Description

Patient number

Data type

text

Visit date
Description

Visit date

Data type

date

Planned therapy
Description

Planned therapy

Data type

integer

Body weight
Description

Body weight

Data type

integer

Measurement units
  • kg
kg
Identification of plaques for sampling (only at 1st Visite)
Description

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

lesional skin area (plaque)
Description

lesional skin area (plaque)

Data type

integer

non-lesional skin area
Description

non-lesional skin area

Data type

integer

Smear sample lesion
Description

Smear sample lesion

Data type

boolean

Biopsy lesion
Description

Biopsy lesion

Data type

boolean

Smear sample non-lesion
Description

Smear sample non-lesion

Data type

boolean

Biopsy non-lesion
Description

Biopsy non-lesion

Data type

boolean

Stool sample
Description

Stool sample

Data type

boolean

Physical Examination (Screening/Termination visite)
Description

Physical Examination (Screening/Termination visite)

Body weight
Description

Body weight

Data type

integer

Measurement units
  • kg
kg
Height
Description

Height

Data type

integer

Measurement units
  • cm
cm
General condition
Description

General condition

Data type

text

General condition comment
Description

General condition comment

Data type

text

Skin condition (except Psoriasis)
Description

Skin condition (except Psoriasis)

Data type

text

Skin condition comment (except Psoriasis)
Description

Skin condition comment (except Psoriasis)

Data type

text

Head and Neck
Description

Head and Neck

Data type

text

Head and Neck comment
Description

Head and Neck comment

Data type

text

Lymph nodes
Description

Lymph nodes

Data type

text

Lymph nodes comment
Description

Lymph nodes comment

Data type

text

Thyroid gland
Description

Thyroid gland

Data type

text

Thyroid gland comment
Description

Thyroid gland comment

Data type

text

Extremities
Description

Extremities

Data type

text

Extremities comment
Description

Extremities comment

Data type

text

Cardiovascular system
Description

Cardiovascular system

Data type

text

Cardiovascular system comment
Description

Cardiovascular system comment

Data type

text

Lung
Description

Lung

Data type

text

Lung comment
Description

Lung comment

Data type

text

Abdomen
Description

Abdomen

Data type

text

Abdomen comment
Description

Abdomen comment

Data type

text

Nervous System
Description

Nervous System

Data type

text

Nervous System comment
Description

Nervous System comment

Data type

text

Sampling performed
Description

Sampling performed

Smear sample lesion
Description

Smear sample lesion

Data type

boolean

Biopsy lesion
Description

Biopsy lesion

Data type

boolean

Stool sample
Description

Stool sample

Data type

boolean

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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
Item
Form has to be used several times. Please mark the time of use.
integer
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
Patient number
Item
text
Visit date
Item
date
Item
integer
Planned therapy
Code List
Planned therapy
CL Item
Adalimumab (1)
CL Item
Ustekinumab (2)
CL Item
Ciclosporin (3)
Body weight
Item
integer
Item Group
Identification of plaques for sampling (only at 1st Visite)
lesional skin area (plaque)
Code List
lesional skin area (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)
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
Biopsy lesion
Item
boolean
Smear sample non-lesion
Item
boolean
Biopsy non-lesion
Item
boolean
Stool sample
Item
boolean
Item Group
Physical Examination (Screening/Termination visite)
Body weight
Item
integer
Height
Item
integer
Item
General condition
text
General condition
Code List
General condition
CL Item
normal (1)
CL Item
not normal (2)
General condition comment
Item
text
General condition
Code List
Skin condition (except Psoriasis)
CL Item
normal (1)
CL Item
not normal (2)
Skin condition comment (except Psoriasis)
Item
text
Item
text
General condition
Code List
Head and Neck
CL Item
normal (1)
CL Item
not normal (2)
Head and Neck comment
Item
text
Item
text
General condition
Code List
Lymph nodes
CL Item
normal (1)
CL Item
not normal (2)
Lymph nodes comment
Item
text
Item
text
General condition
Code List
Thyroid gland
CL Item
normal (1)
CL Item
not normal (2)
Thyroid gland comment
Item
text
Item
text
General condition
Code List
Extremities
CL Item
normal (1)
CL Item
not normal (2)
Extremities comment
Item
text
General condition
Code List
Cardiovascular system
CL Item
normal (1)
CL Item
not normal (2)
Cardiovascular system comment
Item
text
Item
text
General condition
Code List
Lung
CL Item
normal (1)
CL Item
not normal (2)
Lung comment
Item
text
Item
text
General condition
Code List
Abdomen
CL Item
normal (1)
CL Item
not normal (2)
Abdomen comment
Item
text
General condition
Code List
Nervous System
CL Item
normal (1)
CL Item
not normal (2)
Nervous System comment
Item
text
Item Group
Sampling performed
Smear sample lesion
Item
boolean
Biopsy lesion
Item
boolean
Stool sample
Item
boolean
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