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Información:
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ID
61
Descripción
e.g. ODM derived from http://clinicaltrials.gov/ct2/show/record/NCT00048295
Link
http://clinicaltrials.gov/ct2/show/record/NCT00048295
Palabras clave
Versiones (4)
- 14/11/11 14/11/11 -
- 14/11/11 14/11/11 -
- 22/3/14 22/3/14 - Martin Dugas
- 17/9/21 17/9/21 -
Subido en
14 de noviembre de 2011
DOI
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Licencia
Creative Commons BY-NC 3.0 Legacy
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Alicaforsen (ISIS 2302) in Patients With Active Crohns Disease
Eligibility
- StudyEvent: Eligibility
Similar models
Eligibility
- StudyEvent: Eligibility
Name
Tipo
Description | Question | Decode (Coded Value)
Tipo de datos
Alias
Age
Item
Age at least 12 years
boolean
Weight
Item
Weight at least 36 kg
boolean
CDAI score
Item
CDAI score of 220 - 400
boolean
Active Crohns disease
Item
Documentation of Crohns disease activity by endoscopy, biopsy or imaging in the last 2 years
boolean
No TNF-alpha inhibitor
Item
No TNF-alpha inhibitor treatment for three months prior to first study drug infusion
boolean
Severe intestinal stenosis
Item
Known severe, fixed, symptomatic stenosis of the small or large intestine with significant dilation
boolean
External fistulization
Item
Extensive external fistulization (> 3 external fistulae which are expressible with gentle compression); colostomy or ileostomy
boolean
Infection
Item
Active infection, including infectious colitis, or infection with HIV, Hepatitis B or Hepatitis C
boolean
Malignancy
Item
Malignancy within 3 years or poorly controlled medical illness
boolean
Bleeding problem
Item
Requires intravenous heparin therapy or with a history of a bleeding problem
boolean
Age
Item
Age
string
C0001779 (UMLS CUI)
102518004 (SNOMED CT 2010_0731)
102518004 (SNOMED CT 2010_0731)
Weight
Item
Weight
string
C1305866 (UMLS CUI)
107647005 (SNOMED CT 2010_0731)
10047890 (MedDRA 13.1)
LP18015-5 (LOINC Version 232)
107647005 (SNOMED CT 2010_0731)
10047890 (MedDRA 13.1)
LP18015-5 (LOINC Version 232)
CDAI score
Item
Crohns disease activity index
string
C0451071 (UMLS CUI)
273364009 (SNOMED CT 2010_0731)
273364009 (SNOMED CT 2010_0731)
Diagnosis
Item
Diagnosis
string
C0011900 (UMLS CUI)
Crohns Disease
Item
Crohn Disease
string
C0010346 (UMLS CUI)
34000006 (SNOMED CT 2010_0731)
10011401 (MedDRA 13.1)
K50.9 (ICD-10-CM Version 2010)
34000006 (SNOMED CT 2010_0731)
10011401 (MedDRA 13.1)
K50.9 (ICD-10-CM Version 2010)
Pharmaceutical Preparations
Item
Medication
string
C0013227 (UMLS CUI)
GI tract stenosis
Item
Gastrointestinal stenosis
string
C0521587 (UMLS CUI)
95520009 (SNOMED CT 2010_0731)
10018007 (MedDRA 13.1)
95520009 (SNOMED CT 2010_0731)
10018007 (MedDRA 13.1)
Infection
Item
Infection
string
C0021311 (UMLS CUI)
257551009 (SNOMED CT 2010_0731)
10021789 (MedDRA 13.1)
257551009 (SNOMED CT 2010_0731)
10021789 (MedDRA 13.1)
Cancer
Item
Malignant Neoplasms
string
C0006826 (UMLS CUI)
363346000 (SNOMED CT 2010_0731)
10028997 (MedDRA 13.1)
363346000 (SNOMED CT 2010_0731)
10028997 (MedDRA 13.1)
Bleeding diathesis
Item
Bleeding tendency
string
C1458140 (UMLS CUI)
64779008 (SNOMED CT 2010_0731)
10005134 (MedDRA 13.1)
64779008 (SNOMED CT 2010_0731)
10005134 (MedDRA 13.1)