ID
28084
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)
- 12/16/17 12/16/17 -
- 1/21/18 1/21/18 -
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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Baseline Visit 2 Psoriasis NCT02695940
Baseline Visit 2 Psoriasis NCT02695940
- StudyEvent: ODM
Description
I. Eignungskriterien
Description
Eligibility staff member
Data type
text
Description
blood values
Data type
boolean
Description
eligibility
Data type
text
Alias
- UMLS CUI [1]
- C1302261
Description
adverse events
Data type
text
Description
change concomitant medication
Data type
text
Description
handing over documents
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
usage care products
Data type
boolean
Description
II. Behandlungsareale
Description
III. Medical History
Description
Physical Examination
Data type
boolean
Description
Concomitant Medikation
Data type
boolean
Description
Physician Global Assessment
Data type
boolean
Description
Total Sign Score
Data type
boolean
Description
IV. Randomisierung
Description
Die Randomisierungsnummer entspricht der Nummer auf der Medikamentenschachtel. Dem Patienten erhält die kleinste, noch freie Nummer. Bitte die Packung für Visite 2 aushändigen!!!
Data type
text
Description
Faxformular ausfüllen und an Proinnovera faxen!!!
Data type
text
Description
V. Foto (falls Pat. zugestimmt hat): 2x Kärtchen, 2x Körperregion, 2x Nahaufnahme
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
vital signs third 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
pregnancy test
Data type
text
Description
VII. Medikation
Description
Drug Account entry
Data type
boolean
Description
instruction dosage medication
Data type
boolean
Description
instruction time medication
Data type
boolean
Description
Patienteninformation: Patient wurde darauf hingewiesen, am Tag der nächsten Visite keine Pflegeprodukte zu verwenden. WICHTIG: Bei V3 PK-Abnahme Auftragen des Studienmedikaments 2-6 Stunden vor der Blutentnahme!
Data type
boolean
Description
Unterschrift
Similar models
Baseline Visit 2 Psoriasis NCT02695940
- StudyEvent: ODM