ID
28494
Beschrijving
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
Trefwoorden
Versies (5)
- 16-12-17 16-12-17 -
- 18-12-17 18-12-17 -
- 17-01-18 17-01-18 -
- 19-01-18 19-01-18 -
- 27-09-21 27-09-21 -
Houder van rechten
Prof. Dr. Dr. h.c. Thomas Luger
Geüploaded op
19 januari 2018
DOI
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Licentie
Creative Commons BY-NC 3.0
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Screening Visit 1 Psoriasis NCT02695940
Screening Visit 1 Psoriasis NCT02695940
- StudyEvent: ODM
Beschrijving
I. Eignungskriterien
Beschrijving
Eligibility staff member
Datatype
text
Alias
- UMLS CUI [1,1]
- C0013893
- UMLS CUI [1,2]
- C1550483
Beschrijving
Information staff member
Datatype
text
Alias
- UMLS CUI [1]
- C1955348
Beschrijving
Informed consent date
Datatype
date
Alias
- UMLS CUI [1]
- C2985782
Beschrijving
Informed consent time
Datatype
time
Alias
- UMLS CUI [1,1]
- C0011008
- UMLS CUI [1,2]
- C0021430
Beschrijving
Informed consent version number
Datatype
integer
Alias
- UMLS CUI [1,1]
- C0021430
- UMLS CUI [1,2]
- C0333052
Beschrijving
handing over documents
Datatype
boolean
Alias
- UMLS CUI [1]
- C1301746
Beschrijving
medical report
Datatype
boolean
Alias
- UMLS CUI [1]
- C0422136
Beschrijving
information medical condition
Datatype
boolean
Alias
- UMLS CUI [1,1]
- C1955348
- UMLS CUI [1,2]
- C2598106
Beschrijving
medical condition information staff member
Datatype
text
Alias
- UMLS CUI [1,1]
- C1955348
- UMLS CUI [1,2]
- C1550483
Beschrijving
!!!! auch bei männlichen Pat. abfragen
Datatype
text
Alias
- UMLS CUI [1]
- C0700589
Beschrijving
contraception refusal reason
Datatype
text
Alias
- UMLS CUI [1,1]
- C0700589
- UMLS CUI [1,2]
- C1136454
Beschrijving
contraception not specified reason
Datatype
text
Alias
- UMLS CUI [1,1]
- C0700589
- UMLS CUI [1,2]
- C1136454
- UMLS CUI [1,3]
- C0205370
Beschrijving
Type of contraception
Datatype
text
Alias
- UMLS CUI [1]
- C0700589
Beschrijving
II. Demographie
Beschrijving
Year of birth
Datatype
integer
Alias
- UMLS CUI [1]
- C2826771
Beschrijving
Age at consent
Datatype
integer
Alias
- UMLS CUI [1,1]
- C0001779
- UMLS CUI [1,2]
- C0021430
Beschrijving
Sex
Datatype
text
Alias
- UMLS CUI [1]
- C0079399
Beschrijving
skin type Fitzpatrick
Datatype
text
Alias
- UMLS CUI [1]
- C2732923
Beschrijving
race caucasian
Datatype
boolean
Alias
- UMLS CUI [1]
- C0043157
Beschrijving
other race
Datatype
boolean
Alias
- UMLS CUI [1]
- C0034510
Beschrijving
race specification
Datatype
text
Alias
- UMLS CUI [1,1]
- C0034510
- UMLS CUI [1,2]
- C2348235
Beschrijving
race Hispanic or Latino
Datatype
boolean
Alias
- UMLS CUI [1]
- C0019576
Beschrijving
III. Medical History
Beschrijving
Concomitant diagnosis
Datatype
boolean
Alias
- UMLS CUI [1]
- C2347852
Beschrijving
Medical History
Datatype
boolean
Alias
- UMLS CUI [1]
- C0262926
Beschrijving
Prior and concomitant medication
Datatype
boolean
Alias
- UMLS CUI [1,1]
- C2826257
- UMLS CUI [1,2]
- C2347852
Beschrijving
Physical examination skin mucosal status
Datatype
boolean
Alias
- UMLS CUI [1,1]
- C0031809
- UMLS CUI [1,2]
- C0037267
Beschrijving
Total Sign Score
Datatype
boolean
Alias
- UMLS CUI [1]
- C2964552
Beschrijving
Physician Global Assessment
Datatype
boolean
Alias
- UMLS CUI [1]
- C0450973
Beschrijving
Plaque Psoriasis
Datatype
boolean
Alias
- UMLS CUI [1]
- C0033860
Beschrijving
Plaque Psoriasis localisation
Datatype
text
Alias
- UMLS CUI [1,1]
- C0033860
- UMLS CUI [1,2]
- C0475264
Beschrijving
IV. Vorläufige Behandlungsareale
Beschrijving
V. Labor: a) Vitalzeichen
Beschrijving
Examiner vital signs
Datatype
text
Beschrijving
Time vital signs
Datatype
time
Beschrijving
vital signs first measurement time
Datatype
time
Alias
- UMLS CUI [1]
- C0518766
Beschrijving
RR > 90/60 und < 140/90 mmHg
Datatype
text
Maateenheden
- mmHg
Alias
- UMLS CUI [1]
- C0005823
Beschrijving
Pulsfrequenz > 50 und < 100
Datatype
integer
Maateenheden
- /min
Alias
- UMLS CUI [1]
- C0232117
Beschrijving
Temp > 25°C und <37,5°C
Datatype
float
Maateenheden
- °C
Alias
- UMLS CUI [1]
- C0039476
Beschrijving
Im Falle von abnormen Werten, bitte Wiederholung der Vitalzeichenkontrolle nach 15 Minuten.
Datatype
time
Alias
- UMLS CUI [1]
- C0518766
Beschrijving
RR > 90/60 und < 140/90 mmHg
Datatype
text
Maateenheden
- mmHg
Alias
- UMLS CUI [1]
- C0005823
Beschrijving
Pulsfrequenz > 50 und < 100
Datatype
integer
Maateenheden
- /min
Alias
- UMLS CUI [1]
- C0232117
Beschrijving
Temp > 25°C und <37,5°C
Datatype
float
Maateenheden
- °C
Alias
- UMLS CUI [1]
- C0039476
Beschrijving
Im Falle von normalen Werten, bitte eine dritte Messung durchführen.
Datatype
time
Alias
- UMLS CUI [1]
- C0518766
Beschrijving
RR > 90/60 und < 140/90 mmHg
Datatype
text
Maateenheden
- mmHg
Alias
- UMLS CUI [1]
- C0005823
Beschrijving
Pulsfrequenz > 50 und < 100
Datatype
integer
Maateenheden
- /min
Alias
- UMLS CUI [1]
- C0232117
Beschrijving
Temp > 25°C und <37,5°C
Datatype
float
Maateenheden
- °C
Alias
- UMLS CUI [1]
- C0005903
Beschrijving
Height
Datatype
float
Maateenheden
- cm
Alias
- UMLS CUI [1]
- C0005890
Beschrijving
Weight
Datatype
float
Maateenheden
- kg
Alias
- UMLS CUI [1]
- C0005910
Beschrijving
V. Labor: b) 12-Kanal EKG (nach 5-15 Min. Ruhezeit)
Beschrijving
PR >220ms, QRS interval l> 100ms, QTcb > 470ms(Females) / > 450 (Males)
Datatype
text
Alias
- UMLS CUI [1,1]
- C0025082
- UMLS CUI [1,2]
- C1623258
Beschrijving
ECG time
Datatype
time
Alias
- UMLS CUI [1,1]
- C0013798
- UMLS CUI [1,2]
- C0040223
Beschrijving
ECG physician
Datatype
text
Alias
- UMLS CUI [1,1]
- C1710470
- UMLS CUI [1,2]
- C1623258
Beschrijving
ECG analysis
Datatype
text
Alias
- UMLS CUI [1]
- C1623258
Beschrijving
V. Labor: c) Blutentnahme
Beschrijving
V. Labor: d) Urin Dip-Stick
Beschrijving
Ergebnis siehe Dipsticksheet. Im Falle von Blut oder Eiweiß im Urin, Untersuchung im Zentrallabor.
Datatype
text
Alias
- UMLS CUI [1]
- C0200354
Beschrijving
urine sample time
Datatype
time
Alias
- UMLS CUI [1,1]
- C0011008
- UMLS CUI [1,2]
- C0200354
Beschrijving
pregnancy test staff member
Datatype
text
Alias
- UMLS CUI [1,1]
- C0032976
- UMLS CUI [1,2]
- C1550483
Beschrijving
pregnancy test result
Datatype
text
Alias
- UMLS CUI [1]
- C0427777
Beschrijving
VI. Sonstiges
Beschrijving
usage care products
Datatype
boolean
Alias
- UMLS CUI [1,1]
- C3897599
- UMLS CUI [1,2]
- C0457083
Beschrijving
randomization
Datatype
boolean
Alias
- UMLS CUI [1]
- C0034656
Beschrijving
Date
Datatype
date
Alias
- UMLS CUI [1]
- C0011008
Beschrijving
signature physician
Datatype
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])
C0475264 (UMLS CUI [1,2])
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])