ID

43333

Beschreibung

ODM derived from http://clinicaltrials.gov/show/NCT00306215

Link

http://clinicaltrials.gov/show/NCT00306215

Stichworte

Versionen (3)
  1. 16.03.12 16.03.12 -
  2. 14.04.14 14.04.14 - Julian Varghese
  3. 20.09.21 20.09.21 -
Hochgeladen am

20. September 2021

DOI

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Eligibility NCT00306215 Crohn's Disease

Deutsch Englisch

Eligibility

1 Formulare  
  1. StudyEvent: Eligibility
    1. Eligibility
Inclusion Criteria
Beschreibung

Inclusion Criteria

Age 18 Years and older
Beschreibung

Age

Datentyp

boolean

moderate to severe Crohn's Disease
Beschreibung

Crohn's Disease

Datentyp

boolean

CDAI 250-450
Beschreibung

CDAI 250-450

Datentyp

boolean

CRP >7.5
Beschreibung

CRP >7.5

Datentyp

boolean

signed written informed consent
Beschreibung

informed consent

Datentyp

boolean

Exclusion Criteria
Beschreibung

Exclusion Criteria

> 100 cm of small bowel resected
Beschreibung

small bowel resected

Datentyp

boolean

ileostomy, colostomy or rectal pouch
Beschreibung

ileostomy, colostomy or rectal pouch

Datentyp

boolean

diagnosis of ulcerative colitis or indeterminate colitis
Beschreibung

ulcerative colitis or indeterminate colitis

Datentyp

boolean

evidence of short bowel syndrome requiring enteral or parenteral supplementation or total parenteral nutrition
Beschreibung

short bowel syndrome requiring enteral or parenteral supplementation

Datentyp

boolean

hepatitis B, C or HIV infection
Beschreibung

hepatitis B, C or HIV infection

Datentyp

boolean

history of infection requiring IV antibiotics
Beschreibung

infection requiring IV antibiotics

Datentyp

boolean

serious or GI infection in the previous 12 weeks
Beschreibung

serious or GI infection

Datentyp

boolean

Medical Concepts
Beschreibung

Medical Concepts

Age
Beschreibung

Age

Datentyp

string

Alias
UMLS CUI
C0001779
SNOMED CT 2010_0731
397669002
Diagnosis
Beschreibung

Diagnosis

Datentyp

string

Alias
UMLS CUI
C0011900
SNOMED CT 2010_0731
439401001
LOINC Version 232
MTHU008876
Crohn's Disease
Beschreibung

Crohn Disease

Datentyp

string

Alias
UMLS CUI
C0010346
SNOMED CT 2010_0731
34000006
MedDRA 13.1
10011401
ICD-10-CM Version 2010
K50.9
Crohn's disease activity index
Beschreibung

CDAI

Datentyp

string

Alias
UMLS CUI
C0451071
SNOMED CT 2010_0731
273364009
C-Reactive Protein Measurement
Beschreibung

CRP

Datentyp

string

Alias
UMLS CUI
C0201657
SNOMED CT 2010_0731
55235003
MedDRA 13.1
10006824
Informed Consent
Beschreibung

Informed Consent

Datentyp

string

Alias
UMLS CUI
C0021430
Small intestine excision
Beschreibung

Small bowel Resection

Datentyp

string

Alias
UMLS CUI
C0192601
SNOMED CT 2010_0731
107938000
MedDRA 13.1
10041105
Creation of ileostomy
Beschreibung

ileostomy

Datentyp

string

Alias
UMLS CUI
C0020883
SNOMED CT 2010_0731
173977007
MedDRA 13.1
10021321
ICD-9-CM Version 2011
46.20
Colostomy Procedure
Beschreibung

Colostomy

Datentyp

string

Alias
UMLS CUI
C0009410
SNOMED CT 2010_0731
398740003
MedDRA 13.1
10010041
ICD-9-CM Version 2011
46.10
Rectal pouch
Beschreibung

Rectal pouch

Datentyp

string

Alias
UMLS CUI
C0939964
Ulcerative calcitis
Beschreibung

Ulcerative colitis

Datentyp

string

Alias
UMLS CUI
C0302596
SNOMED CT 2010_0731
64766004
MedDRA 13.1
10009900
ICD-10-CM Version 2010
K51.9
ICD-9-CM Version 2011
556.9
Colitis of Indeterminate Type
Beschreibung

Indeterminate colitis

Datentyp

string

Alias
UMLS CUI
C0341332
SNOMED CT 2010_0731
235746007
Evidence of
Beschreibung

Evidence

Datentyp

string

Alias
UMLS CUI
C0332120
SNOMED CT 2010_0731
18669006
Short Bowel Syndrome
Beschreibung

SBS

Datentyp

string

Alias
UMLS CUI
C0036992
SNOMED CT 2010_0731
26629001
MedDRA 13.1
10049416
Enteral (qualifier value)
Beschreibung

Enteral

Datentyp

string

Alias
UMLS CUI
C1304890
SNOMED CT 2010_0731
225770002
Nutritional Supplementation
Beschreibung

Supplementation

Datentyp

string

Alias
UMLS CUI
C0242297
MedDRA 13.1
10062733
Parenteral Therapeutic Nutritional Supplementation
Beschreibung

Parenteral Therapeutic Nutritional Supplementation

Datentyp

string

Alias
UMLS CUI
C1882290
Parenteral Nutrition, Total
Beschreibung

Total parenteral nutrition (TPN)

Datentyp

string

Alias
UMLS CUI
C0030548
SNOMED CT 2010_0731
225372007
MedDRA 13.1
10044107
LOINC Version 232
MTHU014331
ICD-9-CM Version 2011
99.15
Type B viral hepatitis
Beschreibung

Hepatitis B

Datentyp

string

Alias
UMLS CUI
C0019163
SNOMED CT 2010_0731
66071002
MedDRA 13.1
10019731
Viral hepatitis C
Beschreibung

Hepatitis C

Datentyp

string

Alias
UMLS CUI
C0019196
SNOMED CT 2010_0731
50711007
MedDRA 13.1
10019744
ICD-10-CM Version 2010
B19.20
ICD-9-CM Version 2011
070.7
Human immunodeficiency virus infection
Beschreibung

HIV Infection

Datentyp

string

Alias
UMLS CUI
C0019693
SNOMED CT 2010_0731
86406008
MedDRA 13.1
10020161
LOINC Version 232
MTHU020829
ICD-10-CM Version 2010
B20
ICD-9-CM Version 2011
042
Infection
Beschreibung

Infection

Datentyp

string

Alias
UMLS CUI
C0009450
SNOMED CT 2010_0731
257551009
MedDRA 13.1
10021789
Antibiotic Drugs
Beschreibung

Antibiotics

Datentyp

string

Alias
UMLS CUI
C0003232
SNOMED CT 2010_0731
255631004
Intravenous
Beschreibung

IV

Datentyp

string

Alias
UMLS CUI
C0348016
SNOMED CT 2010_0731
255560000
Serious (qualifier value)
Beschreibung

Serious

Datentyp

string

Alias
UMLS CUI
C0205404
SNOMED CT 2010_0731
42745003
Gastrointestinal Infection
Beschreibung

GI Infection

Datentyp

string

Alias
UMLS CUI
C0729555
SNOMED CT 2010_0731
128398001
MedDRA 13.1
10017964
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Ähnliche Modelle

Eligibility

1 Formulare
  1. StudyEvent: Eligibility
    1. Eligibility
Name
Typ
Description | Question | Decode (Coded Value)
Datentyp
Alias
Item Group
Inclusion Criteria
Age
Item
Age 18 Years and older
boolean
Crohn's Disease
Item
moderate to severe Crohn's Disease
boolean
CDAI 250-450
Item
CDAI 250-450
boolean
CRP >7.5
Item
CRP >7.5
boolean
informed consent
Item
signed written informed consent
boolean
Item Group
Exclusion Criteria
small bowel resected
Item
> 100 cm of small bowel resected
boolean
ileostomy, colostomy or rectal pouch
Item
ileostomy, colostomy or rectal pouch
boolean
ulcerative colitis or indeterminate colitis
Item
diagnosis of ulcerative colitis or indeterminate colitis
boolean
short bowel syndrome requiring enteral or parenteral supplementation
Item
evidence of short bowel syndrome requiring enteral or parenteral supplementation or total parenteral nutrition
boolean
hepatitis B, C or HIV infection
Item
hepatitis B, C or HIV infection
boolean
infection requiring IV antibiotics
Item
history of infection requiring IV antibiotics
boolean
serious or GI infection
Item
serious or GI infection in the previous 12 weeks
boolean
Item Group
Medical Concepts
Age
Item
Age
string
C0001779 (UMLS CUI)
397669002 (SNOMED CT 2010_0731)
Diagnosis
Item
Diagnosis
string
C0011900 (UMLS CUI)
439401001 (SNOMED CT 2010_0731)
MTHU008876 (LOINC Version 232)
Crohn Disease
Item
Crohn's Disease
string
C0010346 (UMLS CUI)
34000006 (SNOMED CT 2010_0731)
10011401 (MedDRA 13.1)
K50.9 (ICD-10-CM Version 2010)
CDAI
Item
Crohn's disease activity index
string
C0451071 (UMLS CUI)
273364009 (SNOMED CT 2010_0731)
CRP
Item
C-Reactive Protein Measurement
string
C0201657 (UMLS CUI)
55235003 (SNOMED CT 2010_0731)
10006824 (MedDRA 13.1)
Informed Consent
Item
Informed Consent
string
C0021430 (UMLS CUI)
Small bowel Resection
Item
Small intestine excision
string
C0192601 (UMLS CUI)
107938000 (SNOMED CT 2010_0731)
10041105 (MedDRA 13.1)
ileostomy
Item
Creation of ileostomy
string
C0020883 (UMLS CUI)
173977007 (SNOMED CT 2010_0731)
10021321 (MedDRA 13.1)
46.20 (ICD-9-CM Version 2011)
Colostomy
Item
Colostomy Procedure
string
C0009410 (UMLS CUI)
398740003 (SNOMED CT 2010_0731)
10010041 (MedDRA 13.1)
46.10 (ICD-9-CM Version 2011)
Rectal pouch
Item
Rectal pouch
string
C0939964 (UMLS CUI)
Ulcerative colitis
Item
Ulcerative calcitis
string
C0302596 (UMLS CUI)
64766004 (SNOMED CT 2010_0731)
10009900 (MedDRA 13.1)
K51.9 (ICD-10-CM Version 2010)
556.9 (ICD-9-CM Version 2011)
Indeterminate colitis
Item
Colitis of Indeterminate Type
string
C0341332 (UMLS CUI)
235746007 (SNOMED CT 2010_0731)
Evidence
Item
Evidence of
string
C0332120 (UMLS CUI)
18669006 (SNOMED CT 2010_0731)
SBS
Item
Short Bowel Syndrome
string
C0036992 (UMLS CUI)
26629001 (SNOMED CT 2010_0731)
10049416 (MedDRA 13.1)
Enteral
Item
Enteral (qualifier value)
string
C1304890 (UMLS CUI)
225770002 (SNOMED CT 2010_0731)
Supplementation
Item
Nutritional Supplementation
string
C0242297 (UMLS CUI)
10062733 (MedDRA 13.1)
Parenteral Therapeutic Nutritional Supplementation
Item
Parenteral Therapeutic Nutritional Supplementation
string
C1882290 (UMLS CUI)
Total parenteral nutrition (TPN)
Item
Parenteral Nutrition, Total
string
C0030548 (UMLS CUI)
225372007 (SNOMED CT 2010_0731)
10044107 (MedDRA 13.1)
MTHU014331 (LOINC Version 232)
99.15 (ICD-9-CM Version 2011)
Hepatitis B
Item
Type B viral hepatitis
string
C0019163 (UMLS CUI)
66071002 (SNOMED CT 2010_0731)
10019731 (MedDRA 13.1)
Hepatitis C
Item
Viral hepatitis C
string
C0019196 (UMLS CUI)
50711007 (SNOMED CT 2010_0731)
10019744 (MedDRA 13.1)
B19.20 (ICD-10-CM Version 2010)
070.7 (ICD-9-CM Version 2011)
HIV Infection
Item
Human immunodeficiency virus infection
string
C0019693 (UMLS CUI)
86406008 (SNOMED CT 2010_0731)
10020161 (MedDRA 13.1)
MTHU020829 (LOINC Version 232)
B20 (ICD-10-CM Version 2010)
042 (ICD-9-CM Version 2011)
Infection
Item
Infection
string
C0009450 (UMLS CUI)
257551009 (SNOMED CT 2010_0731)
10021789 (MedDRA 13.1)
Antibiotics
Item
Antibiotic Drugs
string
C0003232 (UMLS CUI)
255631004 (SNOMED CT 2010_0731)
IV
Item
Intravenous
string
C0348016 (UMLS CUI)
255560000 (SNOMED CT 2010_0731)
Serious
Item
Serious (qualifier value)
string
C0205404 (UMLS CUI)
42745003 (SNOMED CT 2010_0731)
GI Infection
Item
Gastrointestinal Infection
string
C0729555 (UMLS CUI)
128398001 (SNOMED CT 2010_0731)
10017964 (MedDRA 13.1)
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