ID
44477
Description
NCT02695940 A Phase 2a, Proof of Concept Trial, Testing Twice Daily Application of LEO 124249 Ointment 30 mg/g in the Treatment of Mild to Moderate Inverse Psoriasis. Quelle: Prof. Dr. Dr. h.c. Thomas Luger University Hospital of Muenster Department of Dermatology
Keywords
Versions (5)
- 12/16/17 12/16/17 -
- 12/18/17 12/18/17 -
- 1/17/18 1/17/18 -
- 1/19/18 1/19/18 -
- 9/27/21 9/27/21 -
Copyright Holder
Prof. Dr. Dr. h.c. Thomas Luger
Uploaded on
September 27, 2021
DOI
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License
Creative Commons BY-NC 3.0
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Screening Visit 1 Psoriasis NCT02695940
Screening Visit 1 Psoriasis NCT02695940
- StudyEvent: ODM
Description
I. Eignungskriterien
Description
Eligibility staff member
Data type
text
Alias
- UMLS CUI [1,1]
- C0013893
- UMLS CUI [1,2]
- C1550483
Description
Information staff member
Data type
text
Alias
- UMLS CUI [1]
- C1955348
Description
Informed consent date
Data type
date
Alias
- UMLS CUI [1]
- C2985782
Description
Informed consent time
Data type
time
Alias
- UMLS CUI [1,1]
- C0011008
- UMLS CUI [1,2]
- C0021430
Description
Informed consent version number
Data type
integer
Alias
- UMLS CUI [1,1]
- C0021430
- UMLS CUI [1,2]
- C0333052
Description
handing over documents
Data type
boolean
Alias
- UMLS CUI [1]
- C1301746
Description
medical report
Data type
boolean
Alias
- UMLS CUI [1]
- C0422136
Description
information medical condition
Data type
boolean
Alias
- UMLS CUI [1,1]
- C1955348
- UMLS CUI [1,2]
- C2598106
Description
medical condition information staff member
Data type
text
Alias
- UMLS CUI [1,1]
- C1955348
- UMLS CUI [1,2]
- C1550483
Description
!!!! auch bei männlichen Pat. abfragen
Data type
text
Alias
- UMLS CUI [1]
- C0700589
Description
contraception refusal reason
Data type
text
Alias
- UMLS CUI [1,1]
- C0700589
- UMLS CUI [1,2]
- C1136454
Description
contraception not specified reason
Data type
text
Alias
- UMLS CUI [1,1]
- C0700589
- UMLS CUI [1,2]
- C1136454
- UMLS CUI [1,3]
- C0205370
Description
Type of contraception
Data type
text
Alias
- UMLS CUI [1]
- C0700589
Description
II. Demographie
Description
Year of birth
Data type
integer
Alias
- UMLS CUI [1]
- C2826771
Description
Age at consent
Data type
integer
Alias
- UMLS CUI [1,1]
- C0001779
- UMLS CUI [1,2]
- C0021430
Description
Sex
Data type
text
Alias
- UMLS CUI [1]
- C0079399
Description
skin type Fitzpatrick
Data type
text
Alias
- UMLS CUI [1]
- C2732923
Description
race caucasian
Data type
boolean
Alias
- UMLS CUI [1]
- C0043157
Description
other race
Data type
boolean
Alias
- UMLS CUI [1]
- C0034510
Description
race specification
Data type
text
Alias
- UMLS CUI [1,1]
- C0034510
- UMLS CUI [1,2]
- C2348235
Description
race Hispanic or Latino
Data type
boolean
Alias
- UMLS CUI [1]
- C0019576
Description
III. Medical History
Description
Concomitant diagnosis
Data type
boolean
Alias
- UMLS CUI [1]
- C2347852
Description
Medical History
Data type
boolean
Alias
- UMLS CUI [1]
- C0262926
Description
Prior and concomitant medication
Data type
boolean
Alias
- UMLS CUI [1,1]
- C2826257
- UMLS CUI [1,2]
- C2347852
Description
Physical examination skin mucosal status
Data type
boolean
Alias
- UMLS CUI [1,1]
- C0031809
- UMLS CUI [1,2]
- C0037267
Description
Total Sign Score
Data type
boolean
Alias
- UMLS CUI [1]
- C2964552
Description
Physician Global Assessment
Data type
boolean
Alias
- UMLS CUI [1]
- C0450973
Description
Plaque Psoriasis
Data type
boolean
Alias
- UMLS CUI [1]
- C0033860
Description
Plaque Psoriasis localisation
Data type
text
Alias
- UMLS CUI [1,1]
- C0033860
- UMLS CUI [1,2]
- C0475264
Description
IV. Vorläufige Behandlungsareale
Description
V. Labor: a) Vitalzeichen
Description
Examiner vital signs
Data type
text
Description
Time vital signs
Data type
time
Description
vital signs first measurement time
Data type
time
Alias
- UMLS CUI [1]
- C0518766
Description
RR > 90/60 und < 140/90 mmHg
Data type
text
Measurement units
- mmHg
Alias
- UMLS CUI [1]
- C0005823
Description
Pulsfrequenz > 50 und < 100
Data type
integer
Measurement units
- /min
Alias
- UMLS CUI [1]
- C0232117
Description
Temp > 25°C und <37,5°C
Data type
float
Measurement units
- °C
Alias
- UMLS CUI [1]
- C0039476
Description
Im Falle von abnormen Werten, bitte Wiederholung der Vitalzeichenkontrolle nach 15 Minuten.
Data type
time
Alias
- UMLS CUI [1]
- C0518766
Description
RR > 90/60 und < 140/90 mmHg
Data type
text
Measurement units
- mmHg
Alias
- UMLS CUI [1]
- C0005823
Description
Pulsfrequenz > 50 und < 100
Data type
integer
Measurement units
- /min
Alias
- UMLS CUI [1]
- C0232117
Description
Temp > 25°C und <37,5°C
Data type
float
Measurement units
- °C
Alias
- UMLS CUI [1]
- C0039476
Description
Im Falle von normalen Werten, bitte eine dritte Messung durchführen.
Data type
time
Alias
- UMLS CUI [1]
- C0518766
Description
RR > 90/60 und < 140/90 mmHg
Data type
text
Measurement units
- mmHg
Alias
- UMLS CUI [1]
- C0005823
Description
Pulsfrequenz > 50 und < 100
Data type
integer
Measurement units
- /min
Alias
- UMLS CUI [1]
- C0232117
Description
Temp > 25°C und <37,5°C
Data type
float
Measurement units
- °C
Alias
- UMLS CUI [1]
- C0005903
Description
Height
Data type
float
Measurement units
- cm
Alias
- UMLS CUI [1]
- C0005890
Description
Weight
Data type
float
Measurement units
- kg
Alias
- UMLS CUI [1]
- C0005910
Description
V. Labor: b) 12-Kanal EKG (nach 5-15 Min. Ruhezeit)
Description
PR >220ms, QRS interval l> 100ms, QTcb > 470ms(Females) / > 450 (Males)
Data type
text
Alias
- UMLS CUI [1,1]
- C0025082
- UMLS CUI [1,2]
- C1623258
Description
ECG time
Data type
time
Alias
- UMLS CUI [1,1]
- C0013798
- UMLS CUI [1,2]
- C0040223
Description
ECG physician
Data type
text
Alias
- UMLS CUI [1,1]
- C1710470
- UMLS CUI [1,2]
- C1623258
Description
ECG analysis
Data type
text
Alias
- UMLS CUI [1]
- C1623258
Description
V. Labor: c) Blutentnahme
Description
V. Labor: d) Urin Dip-Stick
Description
Ergebnis siehe Dipsticksheet. Im Falle von Blut oder Eiweiß im Urin, Untersuchung im Zentrallabor.
Data type
text
Alias
- UMLS CUI [1]
- C0200354
Description
urine sample time
Data type
time
Alias
- UMLS CUI [1,1]
- C0011008
- UMLS CUI [1,2]
- C0200354
Description
pregnancy test staff member
Data type
text
Alias
- UMLS CUI [1,1]
- C0032976
- UMLS CUI [1,2]
- C1550483
Description
pregnancy test result
Data type
text
Alias
- UMLS CUI [1]
- C0427777
Description
VI. Sonstiges
Description
usage care products
Data type
boolean
Alias
- UMLS CUI [1,1]
- C3897599
- UMLS CUI [1,2]
- C0457083
Description
randomization
Data type
boolean
Alias
- UMLS CUI [1]
- C0034656
Description
Date
Data type
date
Alias
- UMLS CUI [1]
- C0011008
Description
signature physician
Data type
text
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Screening Visit 1 Psoriasis NCT02695940
- StudyEvent: ODM
C1550483 (UMLS CUI [1,2])
C0021430 (UMLS CUI [1,2])
C0333052 (UMLS CUI [1,2])
C2598106 (UMLS CUI [1,2])
C1550483 (UMLS CUI [1,2])
C1136454 (UMLS CUI [1,2])
C1136454 (UMLS CUI [1,2])
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(Comment:de)
(Comment:de)
C2348235 (UMLS CUI [1,2])
C2347852 (UMLS CUI [1,2])
C0037267 (UMLS CUI [1,2])
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C1623258 (UMLS CUI [1,2])
C0040223 (UMLS CUI [1,2])
C1623258 (UMLS CUI [1,2])
C1550483 (UMLS CUI [1,2])
C0040223 (UMLS CUI [1,2])
C0200354 (UMLS CUI [1,2])
C1550483 (UMLS CUI [1,2])
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(Comment:de)
C1513916 (UMLS CUI-2)
(Comment:de)
C0457083 (UMLS CUI [1,2])