ID
28107
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 (2)
- 12/18/17 12/18/17 -
- 1/22/18 1/22/18 -
Copyright Holder
Prof. Dr. Dr. h.c. Thomas Luger
Uploaded on
December 18, 2017
DOI
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License
Creative Commons BY-NC 3.0
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Visit 6 Psoriasis NCT02695940
Visit 6 Psoriasis NCT02695940
- StudyEvent: ODM
Description
I. Medical history und körperliche Untersuchung
Description
Physical Examination
Data type
boolean
Description
Concomitant Medication
Data type
boolean
Description
Physician Global Assessment score completed
Data type
boolean
Description
Total Sign score completed
Data type
boolean
Description
treated body regions
Data type
boolean
Description
blood values
Data type
boolean
Description
Folgebesuch in 2 Wochen planen, falls AE`s bestehen, die im möglichen Zusammenhang zur Studienmedikation stehen
Data type
text
Description
change concomitant medication
Data type
text
Description
Physical examination skin mucosal status
Data type
boolean
Description
Total Sign Score
Data type
boolean
Description
Physician Global Assessment
Data type
boolean
Description
Plaque Psoriasis
Data type
boolean
Description
Plaque Psoriasis localisation
Data type
text
Description
II. 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
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
Description
Im Falle von abnormen Werten, bitte Wiederholung der Vitalzeichenkontrolle nach 15 Minuten.
Data type
time
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
Description
Im Falle von normalen Werten, bitte eine dritte Messung durchführen.
Data type
time
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
Description
Weight
Data type
float
Measurement units
- kg
Alias
- UMLS CUI [1]
- C0005910
Description
II. 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
Description
ECG time
Data type
time
Description
ECG physician
Data type
text
Description
ECG analysis staff member
Data type
text
Description
II. Labor: c) Blutentnahme
Description
II. Labor: d) Urin Dip-Stick
Description
Ergebnis siehe Dipsticksheet. Im Falle von Blut oder Eiweiß im Urin, Untersuchung im Zentrallabor.
Data type
text
Description
urine sample time
Data type
time
Description
pregnancy test staff member
Data type
text
Description
pregnancy test result
Data type
text
Description
II. Labor: e) Foto (vom selben Areal wie bei Baseline)
Description
Unterschrift
Similar models
Visit 6 Psoriasis NCT02695940
- StudyEvent: ODM