ID

4874

Beskrivning

ODM derived from http://clinicaltrials.gov/show/NCT00233662

Länk

http://clinicaltrials.gov/show/NCT00233662

Nyckelord

Versioner (2)
  1. 2012-02-14 2012-02-14 -
  2. 2014-04-13 2014-04-13 - Julian Varghese
Uppladdad den

13 april 2014

DOI

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Licens

Creative Commons BY 4.0
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Eligibility NCT00233662 Chronic Plaque Psoriasis

Tysk Engelsk

Eligibility

1 Formulär  
  1. StudyEvent: Eligibility
    1. Eligibility
Einschlusskriterien
Beskrivning

Einschlusskriterien

16 Jahre und älter
Beskrivning

Age

Datatyp

boolean

Written informed consent
Beskrivning

consent

Datatyp

boolean

Diagnosed with chronic plaque psoriasis and require systemic therapy
Beskrivning

Chronic Plaque Psoriasis

Datatyp

boolean

CD4+ lymphocyte counts at or above the lower limit of normal for Covance Central Laboratory Services, Inc., unless on a stable dose of prednisone (counts must be at or above 300 cells/mm3).
Beskrivning

CD4+

Datatyp

boolean

Ausschlusskriterien
Beskrivning

Ausschlusskriterien

Unstable erthrodermic or pustular psoriasis
Beskrivning

Unstable erthrodermic or pustular psoriasis

Datatyp

boolean

Diagnosis of guttate psoriasis
Beskrivning

guttate psoriasis

Datatyp

boolean

Serious local infection or systemic infection within 3 months prior to first dose of alefacept
Beskrivning

Serious infection

Datatyp

boolean

Positive for HIV antibody
Beskrivning

HIV

Datatyp

boolean

Known invasive malignancy within 5 years of enrollment. Patients with a history of treated squamous cell and/or basal cell carcinomas limited to the skin are not excluded
Beskrivning

Cancer

Datatyp

boolean

Evidence of active tuberculosis, Current treatment for active tuberculosis or tuberculosis prophylaxis
Beskrivning

tuberculosis

Datatyp

boolean

Female patients unwilling to practice effective contraception as defined by the investigator
Beskrivning

contraception

Datatyp

boolean

Female patients who are pregnant or breast-feeding
Beskrivning

pregnant or breast-feeding

Datatyp

boolean

Current enrollment in any other investigational drug study
Beskrivning

other study

Datatyp

boolean

Previous participation in this study or previous alefacept studies
Beskrivning

Previous alefacept

Datatyp

boolean

Medizinische Konzepte
Beskrivning

Medizinische Konzepte

Alter
Beskrivning

Age

Datatyp

string

Alias
UMLS CUI
C0001779
SNOMED CT 2011_0131
102518004
Einverständniserklärung
Beskrivning

Informed Consent

Datatyp

string

Alias
UMLS CUI
C0021430
Diagnose
Beskrivning

Diagnosis

Datatyp

string

Alias
UMLS CUI
C0011900
SNOMED CT 2011_0131
439401001
LOINC Version 232
MTHU008876
Psoriasis
Beskrivning

Psoriasis

Datatyp

string

Alias
UMLS CUI
C0033860
SNOMED CT 2011_0131
9014002
MedDRA 14.0
10037153
ICD-10-CM Version 2010
L40
Systemische Therapie
Beskrivning

Systemic Therapy

Datatyp

string

Alias
UMLS CUI
C1515119
CD4+ Anzahl
Beskrivning

CD4+ lymphocyte count

Datatyp

string

Alias
UMLS CUI
C1277776
SNOMED CT 2011_0131
313660005
exfoliative psoriasis
Beskrivning

erythrodermic psoriasis

Datatyp

string

Alias
UMLS CUI
C0748052
SNOMED CT 2011_0131
200977004
MedDRA 14.0
10015278
Psoriasis guttata
Beskrivning

guttate psoriasis

Datatyp

string

Alias
UMLS CUI
C0343052
SNOMED CT 2011_0131
37042000
ICD-10-CM Version 2010
L40.4
pustular psoriasis
Beskrivning

pustular psoriasis

Datatyp

string

Alias
UMLS CUI
C0152081
SNOMED CT 2011_0131
200973000
MedDRA 14.0
10037159
Infektion
Beskrivning

Infection

Datatyp

string

Alias
UMLS CUI
C0009450
SNOMED CT 2011_0131
257551009
MedDRA 14.0
10021789
HIV Infektion
Beskrivning

HIV Infection

Datatyp

string

Alias
UMLS CUI
C0019693
SNOMED CT 2011_0131
86406008
MedDRA 14.0
10020161
LOINC Version 232
MTHU020829
ICD-10-CM Version 2010
B20
ICD-9-CM Version 2011
042
Krebs
Beskrivning

Cancer

Datatyp

string

Alias
UMLS CUI
C0006826
SNOMED CT 2011_0131
363346000
MedDRA 14.0
10028997
LOINC Version 232
MTHU010328
ICD-10-CM Version 2010
C00-C96
Medikation
Beskrivning

Pharmaceutical Preparations

Datatyp

string

Alias
UMLS CUI
C0013227
Tuberkulose
Beskrivning

Tuberculosis

Datatyp

string

Alias
UMLS CUI
C0041296
SNOMED CT 2011_0131
56717001
MedDRA 14.0
10044755
LOINC Version 232
MTHU020835
ICD-10-CM Version 2010
A15-A19
ICD-9-CM Version 2011
010-018.99
Kontrazeption
Beskrivning

Contraception

Datatyp

string

Alias
UMLS CUI
C0700589
SNOMED CT 2011_0131
146680009
MedDRA 14.0
10010808
schwanger
Beskrivning

pregnant

Datatyp

string

Alias
UMLS CUI
C0549206
MedDRA 14.0
10036586
Stillzeit
Beskrivning

Lactation

Datatyp

string

Alias
UMLS CUI
C0006147
MedDRA 14.0
10006247
Registrierung
Beskrivning

Enrollment

Datatyp

string

Alias
UMLS CUI
C2348568
Tillbaka till toppen

Similar models

Eligibility

1 Formulär
  1. StudyEvent: Eligibility
    1. Eligibility
Name
Typ
Description | Question | Decode (Coded Value)
Datatyp
Alias
Item Group
Einschlusskriterien
Age
Item
16 Jahre und älter
boolean
consent
Item
Written informed consent
boolean
Chronic Plaque Psoriasis
Item
Diagnosed with chronic plaque psoriasis and require systemic therapy
boolean
CD4+
Item
CD4+ lymphocyte counts at or above the lower limit of normal for Covance Central Laboratory Services, Inc., unless on a stable dose of prednisone (counts must be at or above 300 cells/mm3).
boolean
Item Group
Ausschlusskriterien
Unstable erthrodermic or pustular psoriasis
Item
Unstable erthrodermic or pustular psoriasis
boolean
guttate psoriasis
Item
Diagnosis of guttate psoriasis
boolean
Serious infection
Item
Serious local infection or systemic infection within 3 months prior to first dose of alefacept
boolean
HIV
Item
Positive for HIV antibody
boolean
Cancer
Item
Known invasive malignancy within 5 years of enrollment. Patients with a history of treated squamous cell and/or basal cell carcinomas limited to the skin are not excluded
boolean
tuberculosis
Item
Evidence of active tuberculosis, Current treatment for active tuberculosis or tuberculosis prophylaxis
boolean
contraception
Item
Female patients unwilling to practice effective contraception as defined by the investigator
boolean
pregnant or breast-feeding
Item
Female patients who are pregnant or breast-feeding
boolean
other study
Item
Current enrollment in any other investigational drug study
boolean
Previous alefacept
Item
Previous participation in this study or previous alefacept studies
boolean
Item Group
Medizinische Konzepte
Age
Item
Alter
string
C0001779 (UMLS CUI)
102518004 (SNOMED CT 2011_0131)
Informed Consent
Item
Einverständniserklärung
string
C0021430 (UMLS CUI)
Diagnosis
Item
Diagnose
string
C0011900 (UMLS CUI)
439401001 (SNOMED CT 2011_0131)
MTHU008876 (LOINC Version 232)
Psoriasis
Item
Psoriasis
string
C0033860 (UMLS CUI)
9014002 (SNOMED CT 2011_0131)
10037153 (MedDRA 14.0)
L40 (ICD-10-CM Version 2010)
Systemic Therapy
Item
Systemische Therapie
string
C1515119 (UMLS CUI)
CD4+ lymphocyte count
Item
CD4+ Anzahl
string
C1277776 (UMLS CUI)
313660005 (SNOMED CT 2011_0131)
erythrodermic psoriasis
Item
exfoliative psoriasis
string
C0748052 (UMLS CUI)
200977004 (SNOMED CT 2011_0131)
10015278 (MedDRA 14.0)
guttate psoriasis
Item
Psoriasis guttata
string
C0343052 (UMLS CUI)
37042000 (SNOMED CT 2011_0131)
L40.4 (ICD-10-CM Version 2010)
pustular psoriasis
Item
pustular psoriasis
string
C0152081 (UMLS CUI)
200973000 (SNOMED CT 2011_0131)
10037159 (MedDRA 14.0)
Infection
Item
Infektion
string
C0009450 (UMLS CUI)
257551009 (SNOMED CT 2011_0131)
10021789 (MedDRA 14.0)
HIV Infection
Item
HIV Infektion
string
C0019693 (UMLS CUI)
86406008 (SNOMED CT 2011_0131)
10020161 (MedDRA 14.0)
MTHU020829 (LOINC Version 232)
B20 (ICD-10-CM Version 2010)
042 (ICD-9-CM Version 2011)
Cancer
Item
Krebs
string
C0006826 (UMLS CUI)
363346000 (SNOMED CT 2011_0131)
10028997 (MedDRA 14.0)
MTHU010328 (LOINC Version 232)
C00-C96 (ICD-10-CM Version 2010)
Pharmaceutical Preparations
Item
Medikation
string
C0013227 (UMLS CUI)
Tuberculosis
Item
Tuberkulose
string
C0041296 (UMLS CUI)
56717001 (SNOMED CT 2011_0131)
10044755 (MedDRA 14.0)
MTHU020835 (LOINC Version 232)
A15-A19 (ICD-10-CM Version 2010)
010-018.99 (ICD-9-CM Version 2011)
Contraception
Item
Kontrazeption
string
C0700589 (UMLS CUI)
146680009 (SNOMED CT 2011_0131)
10010808 (MedDRA 14.0)
pregnant
Item
schwanger
string
C0549206 (UMLS CUI)
10036586 (MedDRA 14.0)
Lactation
Item
Stillzeit
string
C0006147 (UMLS CUI)
10006247 (MedDRA 14.0)
Enrollment
Item
Registrierung
string
C2348568 (UMLS CUI)
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