ID

42850

Description

ODM derived from http://clinicaltrials.gov/show/NCT00385372

Link

http://clinicaltrials.gov/show/NCT00385372

Keywords

Versions (2)
  1. 12/11/13 12/11/13 - Martin Dugas
  2. 9/17/21 9/17/21 -
Uploaded on

September 17, 2021

DOI

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License

Creative Commons BY 4.0
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Eligibility NCT00385372 Urticaria

German English

Eligibility

1 forms  
  1. StudyEvent: Eligibility
    1. Eligibility
Inclusion Criteria
Description

Inclusion Criteria

Alias
UMLS CUI 2011AA
CL425202
age 7 Years to 80 Years
Description

age 7 Years to 80 Years

Data type

boolean

Alias
UMLS CUI 2011AA
C0001779
SNOMED CT 2011_0131
397669002
signed informed consent
Description

signed informed consent

Data type

boolean

Alias
UMLS CUI 2011AA
C0021430
chronic urticaria (duration: at least 6 weeks)
Description

chronic urticaria (duration: at least 6 weeks)

Data type

boolean

Alias
UMLS CUI 2011AA
C0011900
SNOMED CT 2011_0131
439401001
LOINC Version 232
MTHU008876
UMLS CUI 2011AA
C0263338
SNOMED CT 2011_0131
51611005
MedDRA 14.1
10052568
ICD-10-CM Version 2010
L50.8
ICD-9-CM Version 2011
708.8
patients who suffered from urticaria and/or angio oedema at least once a week for a duration of at least 4 weeks)
Description

patients who suffered from urticaria and/or angio oedema at least once a week for a duration of at least 4 weeks)

Data type

boolean

Alias
UMLS CUI 2011AA
C0011900
SNOMED CT 2011_0131
439401001
LOINC Version 232
MTHU008876
UMLS CUI 2011AA
C0221232
SNOMED CT 2011_0131
126485001
MedDRA 14.1
10046735
ICD-10-CM Version 2010
L50
ICD-9-CM Version 2011
708
CTCAE 1105E
E13746
UMLS CUI 2011AA
C0002994
SNOMED CT 2011_0131
41291007
MedDRA 14.1
10002424
ICD-10-CM Version 2010
T78.3
ICD-9-CM Version 2011
995.1
UMLS CUI 2011AA
C0449238
SNOMED CT 2011_0131
103335007
LOINC Version 232
MTHU001938
Males and females, age between 7 and 80 years
Description

Males and females, age between 7 and 80 years

Data type

boolean

Alias
UMLS CUI 2011AA
C0001779
SNOMED CT 2011_0131
397669002
inpatients and outpatients
Description

inpatients and outpatients

Data type

boolean

Alias
UMLS CUI 2011AA
C0021562
SNOMED CT 2011_0131
416800000
LOINC Version 232
MTHU015923
UMLS CUI 2011AA
C0029921
SNOMED CT 2011_0131
373864002
LOINC Version 232
MTHU011902
oral antihistamines and glucocorticosteroids are allowed as concomitant medication (if needed)
Description

oral antihistamines and glucocorticosteroids are allowed as concomitant medication (if needed)

Data type

boolean

Alias
UMLS CUI 2011AA
C1707479
UMLS CUI 2011AA
C1527415
SNOMED CT 2011_0131
26643006
HL7 V3 2006_05
_OralRoute
UMLS CUI 2011AA
C0019590
SNOMED CT 2011_0131
372806008
LOINC Version 232
MTHU003328
UMLS CUI 2011AA
C0001617
SNOMED CT 2011_0131
79440004
Exclusion Criteria
Description

Exclusion Criteria

Alias
UMLS CUI 2011AA
CL425201
pregnant or breastfeeding woman
Description

pregnant or breastfeeding woman

Data type

boolean

Alias
UMLS CUI 2011AA
C0549206
MedDRA 14.1
10036586
UMLS CUI 2011AA
C0006147
MedDRA 14.1
10006247
patients suffering from diabetes mellitus
Description

patients suffering from diabetes mellitus

Data type

boolean

Alias
UMLS CUI 2011AA
C0011849
SNOMED CT 2011_0131
191044006
patients with cachexia
Description

patients with cachexia

Data type

boolean

Alias
UMLS CUI 2011AA
C0006625
SNOMED CT 2011_0131
238108007
MedDRA 14.1
10006895
ICD-10-CM Version 2010
R64
ICD-9-CM Version 2011
799.4
known food allergies of food which will be administrated within the elimination diet (e.g. milk, cereals)
Description

known food allergies of food which will be administrated within the elimination diet (e.g. milk, cereals)

Data type

boolean

Alias
UMLS CUI 2011AA
C0016470
SNOMED CT 2011_0131
414285001
MedDRA 14.1
10016946
HL7 V3 2006_05
FALG
UMLS CUI 2011AA
C0452376
SNOMED CT 2011_0131
226194001
isolated urticaria with known aetiology (e.g. physical urticaria, aquagene urticaria, urticaria factitia, cholinergic urticaria), Urticaria pigmentosa mastocytoses)
Description

isolated urticaria with known aetiology (e.g. physical urticaria, aquagene urticaria, urticaria factitia, cholinergic urticaria), Urticaria pigmentosa mastocytoses)

Data type

boolean

Alias
UMLS CUI 2011AA
C0343065
SNOMED CT 2011_0131
402601007
MedDRA 14.1
10034990
ICD-10-CM Version 2010
L50.3
ICD-9-CM Version 2011
708.3
UMLS CUI 2011AA
C0263334
SNOMED CT 2011_0131
89870006
MedDRA 14.1
10046739
UMLS CUI 2011AA
C1274184
SNOMED CT 2011_0131
27720003
MedDRA 14.1
10012436
ICD-10-CM Version 2010
L98.1
ICD-9-CM Version 2011
698.4
UMLS CUI 2011AA
C0152230
SNOMED CT 2011_0131
73098005
MedDRA 14.1
10046740
ICD-10-CM Version 2010
L50.5
ICD-9-CM Version 2011
708.5
UMLS CUI 2011AA
C0042111
SNOMED CT 2011_0131
78745000
MedDRA 14.1
10046752
ICD-10-CM Version 2010
Q82.2
ICD-9-CM Version 2011
757.33
UMLS CUI 2011AA
C0024899
SNOMED CT 2011_0131
78745000
MedDRA 14.1
10026891
ICD-10-CM Version 2010
Q82.2
patients, seemed to be uncompliant under suspicion of the investigator
Description

patients, seemed to be uncompliant under suspicion of the investigator

Data type

boolean

Alias
UMLS CUI 2011AA
C0376405
MedDRA 14.1
10049414
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Similar models

Eligibility

1 forms
  1. StudyEvent: Eligibility
    1. Eligibility
Name
Type
Description | Question | Decode (Coded Value)
Data type
Alias
Item Group
Inclusion Criteria
CL425202 (UMLS CUI 2011AA)
age 7 Years to 80 Years
Item
age 7 Years to 80 Years
boolean
C0001779 (UMLS CUI 2011AA)
397669002 (SNOMED CT 2011_0131)
signed informed consent
Item
signed informed consent
boolean
C0021430 (UMLS CUI 2011AA)
chronic urticaria (duration: at least 6 weeks)
Item
chronic urticaria (duration: at least 6 weeks)
boolean
C0011900 (UMLS CUI 2011AA)
439401001 (SNOMED CT 2011_0131)
MTHU008876 (LOINC Version 232)
C0263338 (UMLS CUI 2011AA)
51611005 (SNOMED CT 2011_0131)
10052568 (MedDRA 14.1)
L50.8 (ICD-10-CM Version 2010)
708.8 (ICD-9-CM Version 2011)
patients who suffered from urticaria and/or angio oedema at least once a week for a duration of at least 4 weeks)
Item
patients who suffered from urticaria and/or angio oedema at least once a week for a duration of at least 4 weeks)
boolean
C0011900 (UMLS CUI 2011AA)
439401001 (SNOMED CT 2011_0131)
MTHU008876 (LOINC Version 232)
C0221232 (UMLS CUI 2011AA)
126485001 (SNOMED CT 2011_0131)
10046735 (MedDRA 14.1)
L50 (ICD-10-CM Version 2010)
708 (ICD-9-CM Version 2011)
E13746 (CTCAE 1105E)
C0002994 (UMLS CUI 2011AA)
41291007 (SNOMED CT 2011_0131)
10002424 (MedDRA 14.1)
T78.3 (ICD-10-CM Version 2010)
995.1 (ICD-9-CM Version 2011)
C0449238 (UMLS CUI 2011AA)
103335007 (SNOMED CT 2011_0131)
MTHU001938 (LOINC Version 232)
Males and females, age between 7 and 80 years
Item
Males and females, age between 7 and 80 years
boolean
C0001779 (UMLS CUI 2011AA)
397669002 (SNOMED CT 2011_0131)
inpatients and outpatients
Item
inpatients and outpatients
boolean
C0021562 (UMLS CUI 2011AA)
416800000 (SNOMED CT 2011_0131)
MTHU015923 (LOINC Version 232)
C0029921 (UMLS CUI 2011AA)
373864002 (SNOMED CT 2011_0131)
MTHU011902 (LOINC Version 232)
oral antihistamines and glucocorticosteroids are allowed as concomitant medication (if needed)
Item
oral antihistamines and glucocorticosteroids are allowed as concomitant medication (if needed)
boolean
C1707479 (UMLS CUI 2011AA)
C1527415 (UMLS CUI 2011AA)
26643006 (SNOMED CT 2011_0131)
_OralRoute (HL7 V3 2006_05)
C0019590 (UMLS CUI 2011AA)
372806008 (SNOMED CT 2011_0131)
MTHU003328 (LOINC Version 232)
C0001617 (UMLS CUI 2011AA)
79440004 (SNOMED CT 2011_0131)
Item Group
Exclusion Criteria
CL425201 (UMLS CUI 2011AA)
pregnant or breastfeeding woman
Item
pregnant or breastfeeding woman
boolean
C0549206 (UMLS CUI 2011AA)
10036586 (MedDRA 14.1)
C0006147 (UMLS CUI 2011AA)
10006247 (MedDRA 14.1)
patients suffering from diabetes mellitus
Item
patients suffering from diabetes mellitus
boolean
C0011849 (UMLS CUI 2011AA)
191044006 (SNOMED CT 2011_0131)
patients with cachexia
Item
patients with cachexia
boolean
C0006625 (UMLS CUI 2011AA)
238108007 (SNOMED CT 2011_0131)
10006895 (MedDRA 14.1)
R64 (ICD-10-CM Version 2010)
799.4 (ICD-9-CM Version 2011)
known food allergies of food which will be administrated within the elimination diet (e.g. milk, cereals)
Item
known food allergies of food which will be administrated within the elimination diet (e.g. milk, cereals)
boolean
C0016470 (UMLS CUI 2011AA)
414285001 (SNOMED CT 2011_0131)
10016946 (MedDRA 14.1)
FALG (HL7 V3 2006_05)
C0452376 (UMLS CUI 2011AA)
226194001 (SNOMED CT 2011_0131)
isolated urticaria with known aetiology (e.g. physical urticaria, aquagene urticaria, urticaria factitia, cholinergic urticaria), Urticaria pigmentosa mastocytoses)
Item
isolated urticaria with known aetiology (e.g. physical urticaria, aquagene urticaria, urticaria factitia, cholinergic urticaria), Urticaria pigmentosa mastocytoses)
boolean
C0343065 (UMLS CUI 2011AA)
402601007 (SNOMED CT 2011_0131)
10034990 (MedDRA 14.1)
L50.3 (ICD-10-CM Version 2010)
708.3 (ICD-9-CM Version 2011)
C0263334 (UMLS CUI 2011AA)
89870006 (SNOMED CT 2011_0131)
10046739 (MedDRA 14.1)
C1274184 (UMLS CUI 2011AA)
27720003 (SNOMED CT 2011_0131)
10012436 (MedDRA 14.1)
L98.1 (ICD-10-CM Version 2010)
698.4 (ICD-9-CM Version 2011)
C0152230 (UMLS CUI 2011AA)
73098005 (SNOMED CT 2011_0131)
10046740 (MedDRA 14.1)
L50.5 (ICD-10-CM Version 2010)
708.5 (ICD-9-CM Version 2011)
C0042111 (UMLS CUI 2011AA)
78745000 (SNOMED CT 2011_0131)
10046752 (MedDRA 14.1)
Q82.2 (ICD-10-CM Version 2010)
757.33 (ICD-9-CM Version 2011)
C0024899 (UMLS CUI 2011AA)
78745000 (SNOMED CT 2011_0131)
10026891 (MedDRA 14.1)
Q82.2 (ICD-10-CM Version 2010)
patients, seemed to be uncompliant under suspicion of the investigator
Item
patients, seemed to be uncompliant under suspicion of the investigator
boolean
C0376405 (UMLS CUI 2011AA)
10049414 (MedDRA 14.1)
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