ID
28562
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 (2)
- 18-12-17 18-12-17 -
- 22-01-18 22-01-18 -
Houder van rechten
Prof. Dr. Dr. h.c. Thomas Luger
Geüploaded op
22 januari 2018
DOI
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Licentie
Creative Commons BY-NC 3.0
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Visit 6 Psoriasis NCT02695940
Visit 6 Psoriasis NCT02695940
- StudyEvent: ODM
Beschrijving
I. Medical history und körperliche Untersuchung
Beschrijving
Physical Examination
Datatype
boolean
Alias
- UMLS CUI [1]
- C0031809
Beschrijving
Concomitant Medication
Datatype
boolean
Alias
- UMLS CUI [1]
- C2347852
Beschrijving
Physician Global Assessment score completed
Datatype
boolean
Alias
- UMLS CUI [1]
- C0450973
Beschrijving
Total Sign score completed
Datatype
boolean
Alias
- UMLS CUI [1]
- C2964552
Beschrijving
treated body regions
Datatype
boolean
Alias
- UMLS CUI [1,1]
- C0087111
- UMLS CUI [1,2]
- C1515974
Beschrijving
blood values
Datatype
boolean
Alias
- UMLS CUI [1]
- C0849535
Beschrijving
Folgebesuch in 2 Wochen planen, falls AE`s bestehen, die im möglichen Zusammenhang zur Studienmedikation stehen
Datatype
text
Alias
- UMLS CUI [1]
- C0877248
Beschrijving
change concomitant medication
Datatype
text
Alias
- UMLS CUI [1]
- 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
II. Labor: a) Vitalzeichen
Beschrijving
Examiner vital signs
Datatype
text
Alias
- UMLS CUI [1]
- C0518766
Beschrijving
Time vital signs
Datatype
time
Alias
- UMLS CUI [1]
- C2826762
Beschrijving
vital signs first measurement time
Datatype
time
Alias
- UMLS CUI [1,1]
- C0518766
- UMLS CUI [1,2]
- C0242485
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]
- C2826762
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]
- C0489453
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
Weight
Datatype
float
Maateenheden
- kg
Alias
- UMLS CUI [1]
- C0005910
Beschrijving
II. 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 staff member
Datatype
text
Alias
- UMLS CUI [1,1]
- C0013893
- UMLS CUI [1,2]
- C1550483
Beschrijving
II. Labor: c) Blutentnahme
Beschrijving
II. 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]
- C0032976
Beschrijving
II. Labor: e) Foto (vom selben Areal wie bei Baseline)
Beschrijving
small pictures
Datatype
text
Alias
- UMLS CUI [1]
- C0441468
Beschrijving
picture of body area
Datatype
text
Alias
- UMLS CUI [1,1]
- C0005902
- UMLS CUI [1,2]
- C0441469
Beschrijving
close-up picture
Datatype
text
Alias
- UMLS CUI [1]
- C0441469
Beschrijving
Unterschrift
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- StudyEvent: ODM
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