ID

61

Description

e.g. ODM derived from http://clinicaltrials.gov/ct2/show/record/NCT00048295

Link

http://clinicaltrials.gov/ct2/show/record/NCT00048295

Keywords

  1. 11/14/11 11/14/11 -
  2. 11/14/11 11/14/11 -
  3. 3/22/14 3/22/14 - Martin Dugas
  4. 9/17/21 9/17/21 -
Uploaded on

November 14, 2011

DOI

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License

Creative Commons BY-NC 3.0 Legacy

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Alicaforsen (ISIS 2302) in Patients With Active Crohns Disease

Eligibility

  1. StudyEvent: Eligibility
    1. Eligibility
Inclusion
Description

Inclusion

Age at least 12 years
Description

Age

Data type

boolean

Weight at least 36 kg
Description

Weight

Data type

boolean

CDAI score of 220 - 400
Description

CDAI score

Data type

boolean

Documentation of Crohns disease activity by endoscopy, biopsy or imaging in the last 2 years
Description

Active Crohns disease

Data type

boolean

No TNF-alpha inhibitor treatment for three months prior to first study drug infusion
Description

No TNF-alpha inhibitor

Data type

boolean

Exclusion
Description

Exclusion

Known severe, fixed, symptomatic stenosis of the small or large intestine with significant dilation
Description

Severe intestinal stenosis

Data type

boolean

Extensive external fistulization (> 3 external fistulae which are expressible with gentle compression); colostomy or ileostomy
Description

External fistulization

Data type

boolean

Active infection, including infectious colitis, or infection with HIV, Hepatitis B or Hepatitis C
Description

Infection

Data type

boolean

Malignancy within 3 years or poorly controlled medical illness
Description

Malignancy

Data type

boolean

Requires intravenous heparin therapy or with a history of a bleeding problem
Description

Bleeding problem

Data type

boolean

Medical Concepts
Description

Medical Concepts

Age
Description

Age

Data type

string

Alias
UMLS CUI
C0001779
SNOMED CT 2010_0731
102518004
Weight
Description

Weight

Data type

string

Alias
UMLS CUI
C1305866
SNOMED CT 2010_0731
107647005
MedDRA 13.1
10047890
LOINC Version 232
LP18015-5
Crohns disease activity index
Description

CDAI score

Data type

string

Alias
UMLS CUI
C0451071
SNOMED CT 2010_0731
273364009
Diagnosis
Description

Diagnosis

Data type

string

Alias
UMLS CUI
C0011900
Crohn Disease
Description

Crohns Disease

Data type

string

Alias
UMLS CUI
C0010346
SNOMED CT 2010_0731
34000006
MedDRA 13.1
10011401
ICD-10-CM Version 2010
K50.9
Medication
Description

Pharmaceutical Preparations

Data type

string

Alias
UMLS CUI
C0013227
Gastrointestinal stenosis
Description

GI tract stenosis

Data type

string

Alias
UMLS CUI
C0521587
SNOMED CT 2010_0731
95520009
MedDRA 13.1
10018007
Infection
Description

Infection

Data type

string

Alias
UMLS CUI
C0021311
SNOMED CT 2010_0731
257551009
MedDRA 13.1
10021789
Malignant Neoplasms
Description

Cancer

Data type

string

Alias
UMLS CUI
C0006826
SNOMED CT 2010_0731
363346000
MedDRA 13.1
10028997
Bleeding tendency
Description

Bleeding diathesis

Data type

string

Alias
UMLS CUI
C1458140
SNOMED CT 2010_0731
64779008
MedDRA 13.1
10005134

Similar models

Eligibility

  1. StudyEvent: Eligibility
    1. Eligibility
Name
Type
Description | Question | Decode (Coded Value)
Data type
Alias
Item Group
Inclusion
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
Item Group
Exclusion
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
Item Group
Medical Concepts
Age
Item
Age
string
C0001779 (UMLS CUI)
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)
CDAI score
Item
Crohns disease activity index
string
C0451071 (UMLS CUI)
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)
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)
Infection
Item
Infection
string
C0021311 (UMLS CUI)
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)
Bleeding diathesis
Item
Bleeding tendency
string
C1458140 (UMLS CUI)
64779008 (SNOMED CT 2010_0731)
10005134 (MedDRA 13.1)

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