ID

28562

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)
  1. 12/18/17 12/18/17 -
  2. 1/22/18 1/22/18 -
Copyright Holder

Prof. Dr. Dr. h.c. Thomas Luger

Uploaded on

January 22, 2018

DOI

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License

Creative Commons BY-NC 3.0
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Visit 6 Psoriasis NCT02695940

German

Visit 6 Psoriasis NCT02695940

1 forms  
Administrative Daten
Description

Administrative Daten

Date
Description

Date

Data type

date

Alias
UMLS CUI [1]
C0011008
Pat. #
Description

Patient ID

Data type

integer

Alias
UMLS CUI [1]
C2348585
Die Fragenbögen an den Patienten ausgehändigt durch:
Description

questionnaires staff member

Data type

text

Alias
UMLS CUI [1,1]
C4042892
UMLS CUI [1,2]
C1552089
Patiententagebuch zurückgenommen
Description

return patient diary

Data type

boolean

Alias
UMLS CUI [1]
C3890583
Patiententagebuch zurückgenommen durch:
Description

patient diary return staff member

Data type

text

Rücknahme der Studienmedikation
Description

return study medication

Data type

boolean

Alias
UMLS CUI [1]
C2826299
Patient hat 12 Stunden vor der Visite Pflegeprodukte benutzt?
Description

usage care products

Data type

boolean

Alias
UMLS CUI [1,1]
C3897599
UMLS CUI [1,2]
C0457083
I. Medical history und körperliche Untersuchung
Description

I. Medical history und körperliche Untersuchung

a) Physical Examination ausgefüllt
Description

Physical Examination

Data type

boolean

Alias
UMLS CUI [1]
C0031809
b) Concomitant Medikation ausgefüllt
Description

Concomitant Medication

Data type

boolean

Alias
UMLS CUI [1]
C2347852
c) PGA Score ausgefüllt
Description

Physician Global Assessment score completed

Data type

boolean

Alias
UMLS CUI [1]
C0450973
d) TSS Sign Score ausgefüllt
Description

Total Sign score completed

Data type

boolean

Alias
UMLS CUI [1]
C2964552
e) Überprüfung der Behandlungsareale (Körperregion u. Größe in cm²) ausgefüllt
Description

treated body regions

Data type

boolean

Alias
UMLS CUI [1,1]
C0087111
UMLS CUI [1,2]
C1515974
Blutwerte kontrolliert und abgezeichnet
Description

blood values

Data type

boolean

Alias
UMLS CUI [1]
C0849535
AEs seit letzter Visite
Description

Folgebesuch in 2 Wochen planen, falls AE`s bestehen, die im möglichen Zusammenhang zur Studienmedikation stehen

Data type

text

Alias
UMLS CUI [1]
C0877248
Änderung Begleitmedikation
Description

change concomitant medication

Data type

text

Alias
UMLS CUI [1]
C2347852
Körperliche Untersuchung ausfüllen/Haut Schleimhaut Status
Description

Physical examination skin mucosal status

Data type

boolean

Alias
UMLS CUI [1,1]
C0031809
UMLS CUI [1,2]
C0037267
TSS
Description

Total Sign Score

Data type

boolean

Alias
UMLS CUI [1]
C2964552
PGA
Description

Physician Global Assessment

Data type

boolean

Alias
UMLS CUI [1]
C0450973
Hat Patient auch Plaque Psoriasis?
Description

Plaque Psoriasis

Data type

boolean

Alias
UMLS CUI [1]
C0033860
Falls ja, wo?
Description

Plaque Psoriasis localisation

Data type

text

Alias
UMLS CUI [1,1]
C0033860
UMLS CUI [1,2]
C0475264
II. Labor: a) Vitalzeichen
Description

II. Labor: a) Vitalzeichen

Vitalzeichen durch:
Description

Examiner vital signs

Data type

text

Alias
UMLS CUI [1]
C0518766
Uhrzeit (nach 5 Minuten Ruhezeit)
Description

Time vital signs

Data type

time

Alias
UMLS CUI [1]
C2826762
1. Messung um:
Description

vital signs first measurement time

Data type

time

Alias
UMLS CUI [1,1]
C0518766
UMLS CUI [1,2]
C0242485
1. Messung: Blutdruck
Description

RR > 90/60 und < 140/90 mmHg

Data type

text

Measurement units
  • mmHg
Alias
UMLS CUI [1]
C0005823
mmHg
1. Messung: Puls
Description

Pulsfrequenz > 50 und < 100

Data type

integer

Measurement units
  • /min
Alias
UMLS CUI [1]
C0232117
/min
1. Messung: Temp (Ohr)
Description

Temp > 25°C und <37,5°C

Data type

float

Measurement units
  • °C
Alias
UMLS CUI [1]
C0039476
°C
2. Messung um:
Description

Im Falle von abnormen Werten, bitte Wiederholung der Vitalzeichenkontrolle nach 15 Minuten.

Data type

time

Alias
UMLS CUI [1]
C2826762
2. Messung: Blutdruck
Description

RR > 90/60 und < 140/90 mmHg

Data type

text

Measurement units
  • mmHg
Alias
UMLS CUI [1]
C0005823
mmHg
2. Messung: Puls
Description

Pulsfrequenz > 50 und < 100

Data type

integer

Measurement units
  • /min
Alias
UMLS CUI [1]
C0232117
/min
2. Messung: Temp (Ohr)
Description

Temp > 25°C und <37,5°C

Data type

float

Measurement units
  • °C
Alias
UMLS CUI [1]
C0489453
°C
3. Messung um:
Description

Im Falle von normalen Werten, bitte eine dritte Messung durchführen.

Data type

time

Alias
UMLS CUI [1]
C0518766
3. Messung: Blutdruck
Description

RR > 90/60 und < 140/90 mmHg

Data type

text

Measurement units
  • mmHg
Alias
UMLS CUI [1]
C0005823
mmHg
3. Messung: Puls
Description

Pulsfrequenz > 50 und < 100

Data type

integer

Measurement units
  • /min
Alias
UMLS CUI [1]
C0232117
/min
3. Messung: Temp (Ohr)
Description

Temp > 25°C und <37,5°C

Data type

float

Measurement units
  • °C
Alias
UMLS CUI [1]
C0005903
°C
Gewicht
Description

Weight

Data type

float

Measurement units
  • kg
Alias
UMLS CUI [1]
C0005910
kg
II. Labor: b) 12-Kanal EKG (nach 5-15 Min. Ruhezeit)
Description

II. Labor: b) 12-Kanal EKG (nach 5-15 Min. Ruhezeit)

Geschrieben durch:
Description

PR >220ms, QRS interval l> 100ms, QTcb > 470ms(Females) / > 450 (Males)

Data type

text

Alias
UMLS CUI [1,1]
C0025082
UMLS CUI [1,2]
C1623258
Uhrzeit:
Description

ECG time

Data type

time

Alias
UMLS CUI [1,1]
C0013798
UMLS CUI [1,2]
C0040223
EKG eingesehen durch Arzt:
Description

ECG physician

Data type

text

Alias
UMLS CUI [1,1]
C1710470
UMLS CUI [1,2]
C1623258
Zur Analyse zu ERT geschickt durch:
Description

ECG analysis staff member

Data type

text

Alias
UMLS CUI [1,1]
C0013893
UMLS CUI [1,2]
C1550483
II. Labor: c) Blutentnahme
Description

II. Labor: c) Blutentnahme

Blutentnahme durch:
Description

(Haematologie, Biochemie)

Data type

text

Alias
UMLS CUI [1,1]
C0005834
UMLS CUI [1,2]
C1550483
Uhrzeit:
Description

blood sample time

Data type

time

Alias
UMLS CUI [1,1]
C0200345
UMLS CUI [1,2]
C0474523
UMLS CUI [1,3]
C0040223
II. Labor: d) Urin Dip-Stick
Description

II. Labor: d) Urin Dip-Stick

Urin Dip-Stick durch:
Description

Ergebnis siehe Dipsticksheet. Im Falle von Blut oder Eiweiß im Urin, Untersuchung im Zentrallabor.

Data type

text

Alias
UMLS CUI [1]
C0200354
Uhrzeit:
Description

urine sample time

Data type

time

Alias
UMLS CUI [1,1]
C0011008
UMLS CUI [1,2]
C0200354
SST durch:
Description

pregnancy test staff member

Data type

text

Alias
UMLS CUI [1,1]
C0032976
UMLS CUI [1,2]
C1550483
SST
Description

pregnancy test result

Data type

text

Alias
UMLS CUI [1]
C0032976
II. Labor: e) Foto (vom selben Areal wie bei Baseline)
Description

II. Labor: e) Foto (vom selben Areal wie bei Baseline)

2x Kärtchen
Description

small pictures

Data type

text

Alias
UMLS CUI [1]
C0441468
2x Arealaufnahme (mit Umgebung)
Description

picture of body area

Data type

text

Alias
UMLS CUI [1,1]
C0005902
UMLS CUI [1,2]
C0441469
2x Arealaufnahme (Nahaufnahme)
Description

close-up picture

Data type

text

Alias
UMLS CUI [1]
C0441469
Unterschrift
Description

Unterschrift

Datum
Description

Date

Data type

date

Alias
UMLS CUI [1]
C0011008
Unterschrift Prüfarzt
Description

signature physician

Data type

text

Alias
UMLS CUI [1]
C0807938
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Similar models

Visit 6 Psoriasis NCT02695940

1 forms
Name
Type
Description | Question | Decode (Coded Value)
Data type
Alias
Item Group
Administrative Daten
Date
Item
Date
date
C0011008 (UMLS CUI [1])
Patient ID
Item
Pat. #
integer
C2348585 (UMLS CUI [1])
questionnaires staff member
Item
Die Fragenbögen an den Patienten ausgehändigt durch:
text
C4042892 (UMLS CUI [1,1])
C1552089 (UMLS CUI [1,2])
return patient diary
Item
Patiententagebuch zurückgenommen
boolean
C3890583 (UMLS CUI [1])
patient diary return staff member
Item
Patiententagebuch zurückgenommen durch:
text
return study medication
Item
Rücknahme der Studienmedikation
boolean
C2826299 (UMLS CUI [1])
usage care products
Item
Patient hat 12 Stunden vor der Visite Pflegeprodukte benutzt?
boolean
C3897599 (UMLS CUI [1,1])
C0457083 (UMLS CUI [1,2])
Item Group
I. Medical history und körperliche Untersuchung
Physical Examination
Item
a) Physical Examination ausgefüllt
boolean
C0031809 (UMLS CUI [1])
Concomitant Medication
Item
b) Concomitant Medikation ausgefüllt
boolean
C2347852 (UMLS CUI [1])
Physician Global Assessment score completed
Item
c) PGA Score ausgefüllt
boolean
C0450973 (UMLS CUI [1])
Total Sign score completed
Item
d) TSS Sign Score ausgefüllt
boolean
C2964552 (UMLS CUI [1])
treated body regions
Item
e) Überprüfung der Behandlungsareale (Körperregion u. Größe in cm²) ausgefüllt
boolean
C0087111 (UMLS CUI [1,1])
C1515974 (UMLS CUI [1,2])
blood values
Item
Blutwerte kontrolliert und abgezeichnet
boolean
C0849535 (UMLS CUI [1])
Item
AEs seit letzter Visite
text
C0877248 (UMLS CUI [1])
adverse events
Code List
AEs seit letzter Visite
CL Item
Ja, siehe AE-Bogen (Ja, siehe AE-Bogen)
CL Item
Nein (Nein)
Item
Änderung Begleitmedikation
text
C2347852 (UMLS CUI [1])
change concomitant medication
Code List
Änderung Begleitmedikation
CL Item
Ja, siehe Concom. Medi.-Bogen (Ja, siehe Concom. Medi.-Bogen)
CL Item
Nein (Nein)
Physical examination skin mucosal status
Item
Körperliche Untersuchung ausfüllen/Haut Schleimhaut Status
boolean
C0031809 (UMLS CUI [1,1])
C0037267 (UMLS CUI [1,2])
Total Sign Score
Item
TSS
boolean
C2964552 (UMLS CUI [1])
Physician Global Assessment
Item
PGA
boolean
C0450973 (UMLS CUI [1])
Plaque Psoriasis
Item
Hat Patient auch Plaque Psoriasis?
boolean
C0033860 (UMLS CUI [1])
Plaque Psoriasis localisation
Item
Falls ja, wo?
text
C0033860 (UMLS CUI [1,1])
C0475264 (UMLS CUI [1,2])
Item Group
II. Labor: a) Vitalzeichen
Examiner vital signs
Item
Vitalzeichen durch:
text
C0518766 (UMLS CUI [1])
Time vital signs
Item
Uhrzeit (nach 5 Minuten Ruhezeit)
time
C2826762 (UMLS CUI [1])
vital signs first measurement time
Item
1. Messung um:
time
C0518766 (UMLS CUI [1,1])
C0242485 (UMLS CUI [1,2])
Blood Pressure first measurement
Item
1. Messung: Blutdruck
text
C0005823 (UMLS CUI [1])
Pulse first measurement
Item
1. Messung: Puls
integer
C0232117 (UMLS CUI [1])
Temperature first measurement
Item
1. Messung: Temp (Ohr)
float
C0039476 (UMLS CUI [1])
time vital signs second measurement
Item
2. Messung um:
time
C2826762 (UMLS CUI [1])
Blood Pressure second measurement
Item
2. Messung: Blutdruck
text
C0005823 (UMLS CUI [1])
Pulse second measurement
Item
2. Messung: Puls
integer
C0232117 (UMLS CUI [1])
Temperature second measurement
Item
2. Messung: Temp (Ohr)
float
C0489453 (UMLS CUI [1])
vital signs third measurement time
Item
3. Messung um:
time
C0518766 (UMLS CUI [1])
Blood Pressure third measurement
Item
3. Messung: Blutdruck
text
C0005823 (UMLS CUI [1])
Pulse third measurement
Item
3. Messung: Puls
integer
C0232117 (UMLS CUI [1])
Temperature third measurement
Item
3. Messung: Temp (Ohr)
float
C0005903 (UMLS CUI [1])
Weight
Item
Gewicht
float
C0005910 (UMLS CUI [1])
Item Group
II. Labor: b) 12-Kanal EKG (nach 5-15 Min. Ruhezeit)
ECG examiner
Item
Geschrieben durch:
text
C0025082 (UMLS CUI [1,1])
C1623258 (UMLS CUI [1,2])
ECG time
Item
Uhrzeit:
time
C0013798 (UMLS CUI [1,1])
C0040223 (UMLS CUI [1,2])
ECG physician
Item
EKG eingesehen durch Arzt:
text
C1710470 (UMLS CUI [1,1])
C1623258 (UMLS CUI [1,2])
ECG analysis staff member
Item
Zur Analyse zu ERT geschickt durch:
text
C0013893 (UMLS CUI [1,1])
C1550483 (UMLS CUI [1,2])
Item Group
II. Labor: c) Blutentnahme
blood sample staff member
Item
Blutentnahme durch:
text
C0005834 (UMLS CUI [1,1])
C1550483 (UMLS CUI [1,2])
blood sample time
Item
Uhrzeit:
time
C0200345 (UMLS CUI [1,1])
C0474523 (UMLS CUI [1,2])
C0040223 (UMLS CUI [1,3])
Item Group
II. Labor: d) Urin Dip-Stick
Urine sample staff member
Item
Urin Dip-Stick durch:
text
C0200354 (UMLS CUI [1])
urine sample time
Item
Uhrzeit:
time
C0011008 (UMLS CUI [1,1])
C0200354 (UMLS CUI [1,2])
pregnancy test staff member
Item
SST durch:
text
C0032976 (UMLS CUI [1,1])
C1550483 (UMLS CUI [1,2])
Item
SST
text
C0032976 (UMLS CUI [1])
pregnancy test result
Code List
SST
CL Item
Positiv (exclusion) (Positiv (exclusion))
CL Item
Negativ (Negativ)
CL Item
N/A (N/A)
Item Group
II. Labor: e) Foto (vom selben Areal wie bei Baseline)
small pictures
Item
2x Kärtchen
text
C0441468 (UMLS CUI [1])
picture of body area
Item
2x Arealaufnahme (mit Umgebung)
text
C0005902 (UMLS CUI [1,1])
C0441469 (UMLS CUI [1,2])
close-up picture
Item
2x Arealaufnahme (Nahaufnahme)
text
C0441469 (UMLS CUI [1])
Item Group
Unterschrift
Date
Item
Datum
date
C0011008 (UMLS CUI [1])
signature physician
Item
Unterschrift Prüfarzt
text
C0807938 (UMLS CUI [1])
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