ID
28083
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
December 16, 2017
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
Description
Information staff member
Data type
text
Description
Informed consent date
Data type
date
Description
Informed consent time
Data type
time
Description
Informed consent version number
Data type
text
Description
handing over documents
Data type
boolean
Description
medical report
Data type
boolean
Description
information medical condition
Data type
boolean
Description
medical condition information staff member
Data type
text
Description
!!!! auch bei männlichen Pat. abfragen
Data type
text
Description
contraception refusal reason
Data type
text
Description
contraception not specified reason
Data type
text
Description
Type of contraception
Data type
text
Description
II. Demographie
Description
Year of birth
Data type
integer
Alias
- UMLS CUI [1]
- C2826771
Description
Age at consent
Data type
integer
Description
Sex
Data type
text
Description
skin type Fitzpatrick
Data type
text
Description
race caucasian
Data type
boolean
Description
other race
Data type
boolean
Description
race specification
Data type
text
Description
race Hispanic or Latino
Data type
boolean
Description
III. Medical History
Description
Concomitant diagnosis
Data type
boolean
Description
Medical History
Data type
boolean
Description
Prior and concomitant medication
Data type
boolean
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
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
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
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
Description
ECG time
Data type
time
Description
ECG physician
Data type
text
Description
ECG analysis
Data type
text
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
Description
urine sample time
Data type
time
Description
pregnancy test staff member
Data type
text
Description
pregnancy test result
Data type
text
Description
VI. Sonstiges
Description
usage care products
Data type
boolean
Description
randomization
Data type
boolean
Description
Date
Data type
date
Description
signature physician
Data type
text
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Screening Visit 1 Psoriasis NCT02695940
- StudyEvent: ODM