ID

42839

Description

ODM derived from http://clinicaltrials.gov/show/NCT00245765

Lien

http://clinicaltrials.gov/show/NCT00245765

Mots-clés

Versions (2)
  1. 11/12/2013 11/12/2013 - Martin Dugas
  2. 17/09/2021 17/09/2021 -
Téléchargé le

17 septembre 2021

DOI

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Licence

Creative Commons BY 4.0
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Eligibility NCT00245765 Chronic Plaque Psoriasis

Allemand Anglais

Eligibility

1 Formulaires  
  1. StudyEvent: Eligibility
    1. Eligibility
Einschlusskriterien
Description

Einschlusskriterien

Alias
UMLS CUI 2011AA
CL425202
Alter älter als 18 Jahre
Description

age >18 Years

Type de données

boolean

Alias
UMLS CUI 2011AA
C0001779
SNOMED CT 2011_0131
397669002
Chronic plaque psoriasis stable for at least 3 months and moderate to severe for at least 6 months
Description

Chronic plaque psoriasis stable for at least 3 months and moderate to severe for at least 6 months

Type de données

boolean

Alias
UMLS CUI 2011AA
C1304119
SNOMED CT 2011_0131
402310007
UMLS CUI 2011AA
C0011900
SNOMED CT 2011_0131
439401001
LOINC Version 232
MTHU008876
UMLS CUI 2011AA
C0439231
SNOMED CT 2011_0131
258706009
HL7 V3 2006_05
MO
UMLS CUI 2011AA
C1881878
UMLS CUI 2011AA
C0205082
SNOMED CT 2011_0131
24484000
PASI ≥ 12 and BSA ≥ 10%
Description

PASI ≥ 12 and BSA ≥ 10%

Type de données

boolean

Alias
UMLS CUI 2011AA
C0033860
SNOMED CT 2011_0131
9014002
MedDRA 14.1
10037153
ICD-10-CM Version 2010
L40
UMLS CUI 2011AA
C0205146
SNOMED CT 2011_0131
42798000
LOINC Version 232
MTHU009059
UMLS CUI 2011AA
C0439793
SNOMED CT 2011_0131
246112005
UMLS CUI 2011AA
C0918012
UMLS CUI 2011AA
C0005902
SNOMED CT 2011_0131
128178001
MedDRA 14.1
10050311
Candidates for systemic psoriasis therapy and/or phototherapy and/or photochemotherapy
Description

Candidates for systemic psoriasis therapy and/or phototherapy and/or photochemotherapy

Type de données

boolean

Alias
UMLS CUI 2011AA
C1515119
UMLS CUI 2011AA
C0033860
SNOMED CT 2011_0131
9014002
MedDRA 14.1
10037153
ICD-10-CM Version 2010
L40
UMLS CUI 2011AA
C0031765
SNOMED CT 2011_0131
31394004
MedDRA 14.1
10063925
UMLS CUI 2011AA
C0031740
Ausschlusskriterien
Description

Ausschlusskriterien

Alias
UMLS CUI 2011AA
CL425201
Erythrodermic, guttate, palmar or plantar, generalized pustular form of psoriasis
Description

Erythrodermic, guttate, palmar or plantar, generalized pustular form of psoriasis

Type de données

boolean

Alias
UMLS CUI 2011AA
C0748052
SNOMED CT 2011_0131
200977004
MedDRA 14.1
10015278
UMLS CUI 2011AA
C0343052
SNOMED CT 2011_0131
37042000
ICD-10-CM Version 2010
L40.4
UMLS CUI 2011AA
C0406329
SNOMED CT 2011_0131
200970002
UMLS CUI 2011AA
C0406330
SNOMED CT 2011_0131
200971003
UMLS CUI 2011AA
C0343055
SNOMED CT 2011_0131
238612002
ICD-10-CM Version 2010
L40.1
A history of chronic infection, recent serious or life-threatening infection (within six months, including herpes zoster), or any current sign or symptom that may indicate an infection (e.g. fever, cough)
Description

A history of chronic infection, recent serious or life-threatening infection (within six months, including herpes zoster), or any current sign or symptom that may indicate an infection (e.g. fever, cough)

Type de données

boolean

Alias
UMLS CUI 2011AA
CL421546
SNOMED CT 2011_0131
392521001
UMLS CUI 2011AA
C0205191
SNOMED CT 2011_0131
90734009
UMLS CUI 2011AA
C0009450
SNOMED CT 2011_0131
257551009
MedDRA 14.1
10021789
UMLS CUI 2011AA
C0332185
SNOMED CT 2011_0131
6493001
UMLS CUI 2011AA
C0205404
SNOMED CT 2011_0131
42745003
UMLS CUI 2011AA
C0009450
SNOMED CT 2011_0131
257551009
MedDRA 14.1
10021789
UMLS CUI 2011AA
C1859430
UMLS CUI 2011AA
C0439231
SNOMED CT 2011_0131
258706009
UMLS CUI 2011AA
C0332257
SNOMED CT 2011_0131
55919000
UMLS CUI 2011AA
C0019360
SNOMED CT 2011_0131
4740000
MedDRA 14.1
10019974
ICD-10-CM Version 2010
B02
ICD-9-CM Version 2011
53
UMLS CUI 2011AA
C0521116
SNOMED CT 2011_0131
15240007
UMLS CUI 2011AA
C0220912
UMLS CUI 2011AA
C1457887
LOINC Version 232
MTHU021540
ICD-9-CM Version 2011
780-789.99
UMLS CUI 2011AA
C0332149
SNOMED CT 2011_0131
371930009
UMLS CUI 2011AA
CL335836
UMLS CUI 2011AA
C0009450
SNOMED CT 2011_0131
257551009
MedDRA 14.1
10021789
UMLS CUI 2011AA
C0015967
SNOMED CT 2011_0131
386661006
MedDRA 14.1
10005911
LOINC Version 232
MTHU013518
ICD-10-CM Version 2010
R50.9
ICD-9-CM Version 2011
780.60
CTCAE 1105E
E11102
UMLS CUI 2011AA
C0010200
SNOMED CT 2011_0131
49727002
MedDRA 14.1
10011224
ICD-10-CM Version 2010
R05
ICD-9-CM Version 2011
786.2
CTCAE 1105E
E13364
Leukozyten-Anzahl
Description

White blood cell counts <4000/mm3 or >20000/mm3

Type de données

boolean

Alias
UMLS CUI 2011AA
C0023508
SNOMED CT 2011_0131
767002
MedDRA 14.1
10047939
Suspected or diagnosed demyelinating disease of the central nervous system (e.g. multiple sclerosis or optic neuritis)
Description

Suspected or diagnosed demyelinating disease of the central nervous system (e.g. multiple sclerosis or optic neuritis)

Type de données

boolean

Alias
UMLS CUI 2011AA
C0750491
SNOMED CT 2011_0131
415684004
UMLS CUI 2011AA
C0011900
SNOMED CT 2011_0131
439401001
LOINC Version 232
MTHU008876
UMLS CUI 2011AA
C0011302
SNOMED CT 2011_0131
6118003
MedDRA 14.1
10012301
ICD-10-CM Version 2010
G37.9
ICD-9-CM Version 2011
341.9
UMLS CUI 2011AA
C0026769
SNOMED CT 2011_0131
24700007
MedDRA 14.1
10028245
LOINC Version 232
MTHU020805
ICD-10-CM Version 2010
G35
ICD-9-CM Version 2011
340
UMLS CUI 2011AA
C0029134
SNOMED CT 2011_0131
66760008
MedDRA 14.1
10030942
ICD-10-CM Version 2010
H46.9
ICD-9-CM Version 2011
377.30
systemischer Lupus erythematodes
Description

Systemic Lupus

Type de données

boolean

Alias
UMLS CUI 2011AA
C0024141
SNOMED CT 2011_0131
55464009
MedDRA 14.1
10042945
ICD-10-CM Version 2010
M32.9
ICD-9-CM Version 2011
710.0
Non respect of adequate wash out periods for treatments that might have an impact on the disease
Description

Non respect of adequate wash out periods for treatments that might have an impact on the disease

Type de données

boolean

Alias
UMLS CUI 2011AA
C0680247
UMLS CUI 2011AA
C0205411
SNOMED CT 2011_0131
88323005
UMLS CUI 2011AA
C1710661
UMLS CUI 2011AA
C0039798
UMLS CUI 2011AA
C0332149
SNOMED CT 2011_0131
371930009
UMLS CUI 2011AA
C0392760
SNOMED CT 2011_0131
247591002
UMLS CUI 2011AA
C0012634
SNOMED CT 2011_0131
64572001
Any associated disease that could be impacted by the study treatment intake
Description

Any associated disease that could be impacted by the study treatment intake

Type de données

boolean

Alias
UMLS CUI 2011AA
C0243083
UMLS CUI 2011AA
C0332149
SNOMED CT 2011_0131
371930009
UMLS CUI 2011AA
C0392760
SNOMED CT 2011_0131
247591002
UMLS CUI 2011AA
C0008976
SNOMED CT 2011_0131
110465008
UMLS CUI 2011AA
C0039798
UMLS CUI 2011AA
C1512806
Any other condition, which in the Investigator's judgment would make the subject unsuitable for inclusion in the study
Description

Any other condition, which in the Investigator's judgment would make the subject unsuitable for inclusion in the study

Type de données

boolean

Alias
UMLS CUI 2011AA
C0348080
SNOMED CT 2011_0131
260905004
HL7 V3 2006_05
COND
UMLS CUI 2011AA
CL102947
UMLS CUI 2011AA
C0022423
SNOMED CT 2011_0131
61254005
UMLS CUI 2011AA
C0681850
UMLS CUI 2011AA
C1548788
UMLS CUI 2011AA
CL425202
UMLS CUI 2011AA
C0008976
SNOMED CT 2011_0131
110465008
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Similar models

Eligibility

1 Formulaires
  1. StudyEvent: Eligibility
    1. Eligibility
Name
Type
Description | Question | Decode (Coded Value)
Type de données
Alias
Item Group
Einschlusskriterien
CL425202 (UMLS CUI 2011AA)
age >18 Years
Item
Alter älter als 18 Jahre
boolean
C0001779 (UMLS CUI 2011AA)
397669002 (SNOMED CT 2011_0131)
Chronic plaque psoriasis stable for at least 3 months and moderate to severe for at least 6 months
Item
Chronic plaque psoriasis stable for at least 3 months and moderate to severe for at least 6 months
boolean
C1304119 (UMLS CUI 2011AA)
402310007 (SNOMED CT 2011_0131)
C0011900 (UMLS CUI 2011AA)
439401001 (SNOMED CT 2011_0131)
MTHU008876 (LOINC Version 232)
C0439231 (UMLS CUI 2011AA)
258706009 (SNOMED CT 2011_0131)
MO (HL7 V3 2006_05)
C1881878 (UMLS CUI 2011AA)
C0205082 (UMLS CUI 2011AA)
24484000 (SNOMED CT 2011_0131)
PASI ≥ 12 and BSA ≥ 10%
Item
PASI ≥ 12 and BSA ≥ 10%
boolean
C0033860 (UMLS CUI 2011AA)
9014002 (SNOMED CT 2011_0131)
10037153 (MedDRA 14.1)
L40 (ICD-10-CM Version 2010)
C0205146 (UMLS CUI 2011AA)
42798000 (SNOMED CT 2011_0131)
MTHU009059 (LOINC Version 232)
C0439793 (UMLS CUI 2011AA)
246112005 (SNOMED CT 2011_0131)
C0918012 (UMLS CUI 2011AA)
C0005902 (UMLS CUI 2011AA)
128178001 (SNOMED CT 2011_0131)
10050311 (MedDRA 14.1)
Candidates for systemic psoriasis therapy and/or phototherapy and/or photochemotherapy
Item
Candidates for systemic psoriasis therapy and/or phototherapy and/or photochemotherapy
boolean
C1515119 (UMLS CUI 2011AA)
C0033860 (UMLS CUI 2011AA)
9014002 (SNOMED CT 2011_0131)
10037153 (MedDRA 14.1)
L40 (ICD-10-CM Version 2010)
C0031765 (UMLS CUI 2011AA)
31394004 (SNOMED CT 2011_0131)
10063925 (MedDRA 14.1)
C0031740 (UMLS CUI 2011AA)
Item Group
Ausschlusskriterien
CL425201 (UMLS CUI 2011AA)
Erythrodermic, guttate, palmar or plantar, generalized pustular form of psoriasis
Item
Erythrodermic, guttate, palmar or plantar, generalized pustular form of psoriasis
boolean
C0748052 (UMLS CUI 2011AA)
200977004 (SNOMED CT 2011_0131)
10015278 (MedDRA 14.1)
C0343052 (UMLS CUI 2011AA)
37042000 (SNOMED CT 2011_0131)
L40.4 (ICD-10-CM Version 2010)
C0406329 (UMLS CUI 2011AA)
200970002 (SNOMED CT 2011_0131)
C0406330 (UMLS CUI 2011AA)
200971003 (SNOMED CT 2011_0131)
C0343055 (UMLS CUI 2011AA)
238612002 (SNOMED CT 2011_0131)
L40.1 (ICD-10-CM Version 2010)
A history of chronic infection, recent serious or life-threatening infection (within six months, including herpes zoster), or any current sign or symptom that may indicate an infection (e.g. fever, cough)
Item
A history of chronic infection, recent serious or life-threatening infection (within six months, including herpes zoster), or any current sign or symptom that may indicate an infection (e.g. fever, cough)
boolean
CL421546 (UMLS CUI 2011AA)
392521001 (SNOMED CT 2011_0131)
C0205191 (UMLS CUI 2011AA)
90734009 (SNOMED CT 2011_0131)
C0009450 (UMLS CUI 2011AA)
257551009 (SNOMED CT 2011_0131)
10021789 (MedDRA 14.1)
C0332185 (UMLS CUI 2011AA)
6493001 (SNOMED CT 2011_0131)
C0205404 (UMLS CUI 2011AA)
42745003 (SNOMED CT 2011_0131)
C0009450 (UMLS CUI 2011AA)
257551009 (SNOMED CT 2011_0131)
10021789 (MedDRA 14.1)
C1859430 (UMLS CUI 2011AA)
C0439231 (UMLS CUI 2011AA)
258706009 (SNOMED CT 2011_0131)
C0332257 (UMLS CUI 2011AA)
55919000 (SNOMED CT 2011_0131)
C0019360 (UMLS CUI 2011AA)
4740000 (SNOMED CT 2011_0131)
10019974 (MedDRA 14.1)
B02 (ICD-10-CM Version 2010)
53 (ICD-9-CM Version 2011)
C0521116 (UMLS CUI 2011AA)
15240007 (SNOMED CT 2011_0131)
C0220912 (UMLS CUI 2011AA)
C1457887 (UMLS CUI 2011AA)
MTHU021540 (LOINC Version 232)
780-789.99 (ICD-9-CM Version 2011)
C0332149 (UMLS CUI 2011AA)
371930009 (SNOMED CT 2011_0131)
CL335836 (UMLS CUI 2011AA)
C0009450 (UMLS CUI 2011AA)
257551009 (SNOMED CT 2011_0131)
10021789 (MedDRA 14.1)
C0015967 (UMLS CUI 2011AA)
386661006 (SNOMED CT 2011_0131)
10005911 (MedDRA 14.1)
MTHU013518 (LOINC Version 232)
R50.9 (ICD-10-CM Version 2010)
780.60 (ICD-9-CM Version 2011)
E11102 (CTCAE 1105E)
C0010200 (UMLS CUI 2011AA)
49727002 (SNOMED CT 2011_0131)
10011224 (MedDRA 14.1)
R05 (ICD-10-CM Version 2010)
786.2 (ICD-9-CM Version 2011)
E13364 (CTCAE 1105E)
White blood cell counts <4000/mm3 or >20000/mm3
Item
Leukozyten-Anzahl
boolean
C0023508 (UMLS CUI 2011AA)
767002 (SNOMED CT 2011_0131)
10047939 (MedDRA 14.1)
Suspected or diagnosed demyelinating disease of the central nervous system (e.g. multiple sclerosis or optic neuritis)
Item
Suspected or diagnosed demyelinating disease of the central nervous system (e.g. multiple sclerosis or optic neuritis)
boolean
C0750491 (UMLS CUI 2011AA)
415684004 (SNOMED CT 2011_0131)
C0011900 (UMLS CUI 2011AA)
439401001 (SNOMED CT 2011_0131)
MTHU008876 (LOINC Version 232)
C0011302 (UMLS CUI 2011AA)
6118003 (SNOMED CT 2011_0131)
10012301 (MedDRA 14.1)
G37.9 (ICD-10-CM Version 2010)
341.9 (ICD-9-CM Version 2011)
C0026769 (UMLS CUI 2011AA)
24700007 (SNOMED CT 2011_0131)
10028245 (MedDRA 14.1)
MTHU020805 (LOINC Version 232)
G35 (ICD-10-CM Version 2010)
340 (ICD-9-CM Version 2011)
C0029134 (UMLS CUI 2011AA)
66760008 (SNOMED CT 2011_0131)
10030942 (MedDRA 14.1)
H46.9 (ICD-10-CM Version 2010)
377.30 (ICD-9-CM Version 2011)
Systemic Lupus
Item
systemischer Lupus erythematodes
boolean
C0024141 (UMLS CUI 2011AA)
55464009 (SNOMED CT 2011_0131)
10042945 (MedDRA 14.1)
M32.9 (ICD-10-CM Version 2010)
710.0 (ICD-9-CM Version 2011)
Non respect of adequate wash out periods for treatments that might have an impact on the disease
Item
Non respect of adequate wash out periods for treatments that might have an impact on the disease
boolean
C0680247 (UMLS CUI 2011AA)
C0205411 (UMLS CUI 2011AA)
88323005 (SNOMED CT 2011_0131)
C1710661 (UMLS CUI 2011AA)
C0039798 (UMLS CUI 2011AA)
C0332149 (UMLS CUI 2011AA)
371930009 (SNOMED CT 2011_0131)
C0392760 (UMLS CUI 2011AA)
247591002 (SNOMED CT 2011_0131)
C0012634 (UMLS CUI 2011AA)
64572001 (SNOMED CT 2011_0131)
Any associated disease that could be impacted by the study treatment intake
Item
Any associated disease that could be impacted by the study treatment intake
boolean
C0243083 (UMLS CUI 2011AA)
C0332149 (UMLS CUI 2011AA)
371930009 (SNOMED CT 2011_0131)
C0392760 (UMLS CUI 2011AA)
247591002 (SNOMED CT 2011_0131)
C0008976 (UMLS CUI 2011AA)
110465008 (SNOMED CT 2011_0131)
C0039798 (UMLS CUI 2011AA)
C1512806 (UMLS CUI 2011AA)
Any other condition, which in the Investigator's judgment would make the subject unsuitable for inclusion in the study
Item
Any other condition, which in the Investigator's judgment would make the subject unsuitable for inclusion in the study
boolean
C0348080 (UMLS CUI 2011AA)
260905004 (SNOMED CT 2011_0131)
COND (HL7 V3 2006_05)
CL102947 (UMLS CUI 2011AA)
C0022423 (UMLS CUI 2011AA)
61254005 (SNOMED CT 2011_0131)
C0681850 (UMLS CUI 2011AA)
C1548788 (UMLS CUI 2011AA)
CL425202 (UMLS CUI 2011AA)
C0008976 (UMLS CUI 2011AA)
110465008 (SNOMED CT 2011_0131)
Retour au début de la page 

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