ID

5040

Description

ODM derived from http://clinicaltrials.gov/show/NCT00906399

Link

http://clinicaltrials.gov/show/NCT00906399

Keywords

Versions (2)
  1. 12/9/13 12/9/13 - Martin Dugas
  2. 4/17/14 4/17/14 - Julian Varghese
Uploaded on

April 17, 2014

DOI

To request one please log in.

License

Creative Commons BY 4.0
Model comments :

You can comment on the data model here. Via the speech bubbles at the itemgroups and items you can add comments to those specificially.

Back to model comments
Itemgroup comments for :

Item comments for :

In order to download data models you must be logged in. Please log in or register for free.

Eligibility NCT00906399 Relapsing Multiple Sclerosis

German English

Eligibility

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

Inclusion Criteria

Alias
UMLS CUI 2011AA
CL425202
age 18 Years to 65 Years
Description

age 18 Years to 65 Years

Data type

boolean

Alias
UMLS CUI 2011AA
C0001779
SNOMED CT 2011_0131
397669002
Informed Consent
Description

Aged 18 to 65 years old, inclusive, at the time of informed consent.

Data type

boolean

Alias
UMLS CUI 2011AA
C0021430
Must have a confirmed diagnosis of relapsing MS, as defined by McDonald criteria #1-4
Description

Must have a confirmed diagnosis of relapsing MS, as defined by McDonald criteria #1-4

Data type

boolean

Alias
UMLS CUI 2011AA
C0750484
UMLS CUI 2011AA
C0011900
SNOMED CT 2011_0131
439401001
LOINC Version 232
MTHU008876
UMLS CUI 2011AA
C0751967
SNOMED CT 2011_0131
426373005
MedDRA 14.1
10063399
UMLS CUI 2011AA
C1704788
UMLS CUI 2011AA
C0679228
EDSS - Expanded disability status scale <= 5.0
Description

Must have an EDSS score between 0.0 and 5.0.

Data type

boolean

Alias
UMLS CUI 2011AA
C0451246
SNOMED CT 2011_0131
273554001
Must have experienced at least 2 relapses that have been medically documented within the last 3 years with one occurring in the last 12 months
Description

Must have experienced at least 2 relapses that have been medically documented within the last 3 years with one occurring in the last 12 months

Data type

boolean

Alias
UMLS CUI 2011AA
C0439091
SNOMED CT 2011_0131
276138003
HL7 V3 2006_05
GE
UMLS CUI 2011AA
C0205448
SNOMED CT 2011_0131
19338005
UMLS CUI 2011AA
C0035020
SNOMED CT 2011_0131
263855007
UMLS CUI 2011AA
C0205476
SNOMED CT 2011_0131
74188005
UMLS CUI 2011AA
C1301725
SNOMED CT 2011_0131
397934002
Exclusion Criteria
Description

Exclusion Criteria

Alias
UMLS CUI 2011AA
CL425201
Other chronic disease of immune system, malignancies, urologic, pulmonary, gastrointestinal disease
Description

Other chronic disease of immune system, malignancies, urologic, pulmonary, gastrointestinal disease

Data type

boolean

Alias
UMLS CUI 2011AA
C0205394
SNOMED CT 2011_0131
74964007
UMLS CUI 2011AA
C1290894
SNOMED CT 2011_0131
128299006
UMLS CUI 2011AA
C0006826
SNOMED CT 2011_0131
363346000
MedDRA 14.1
10028997
LOINC Version 232
MTHU010328
ICD-10-CM Version 2010
C00-C96
UMLS CUI 2011AA
C0042075
SNOMED CT 2011_0131
128606002
MedDRA 14.1
10046566
ICD-10-CM Version 2010
N39.9
ICD-9-CM Version 2011
599.9
UMLS CUI 2011AA
C0024115
SNOMED CT 2011_0131
19829001
MedDRA 14.1
10025082
ICD-10-CM Version 2010
J98.4
UMLS CUI 2011AA
C0017178
SNOMED CT 2011_0131
119292006
MedDRA 14.1
10017944
Pregnant or nursing women
Description

Pregnant or nursing women

Data type

boolean

Alias
UMLS CUI 1
C0549206
MedDRA 1
10036586
UMLS CUI 2
C0006147
MedDRA 2
10006247
Back to the top of the page

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 18 Years to 65 Years
Item
age 18 Years to 65 Years
boolean
C0001779 (UMLS CUI 2011AA)
397669002 (SNOMED CT 2011_0131)
Aged 18 to 65 years old, inclusive, at the time of informed consent.
Item
Informed Consent
boolean
C0021430 (UMLS CUI 2011AA)
Must have a confirmed diagnosis of relapsing MS, as defined by McDonald criteria #1-4
Item
Must have a confirmed diagnosis of relapsing MS, as defined by McDonald criteria #1-4
boolean
C0750484 (UMLS CUI 2011AA)
C0011900 (UMLS CUI 2011AA)
439401001 (SNOMED CT 2011_0131)
MTHU008876 (LOINC Version 232)
C0751967 (UMLS CUI 2011AA)
426373005 (SNOMED CT 2011_0131)
10063399 (MedDRA 14.1)
C1704788 (UMLS CUI 2011AA)
C0679228 (UMLS CUI 2011AA)
Must have an EDSS score between 0.0 and 5.0.
Item
EDSS - Expanded disability status scale <= 5.0
boolean
C0451246 (UMLS CUI 2011AA)
273554001 (SNOMED CT 2011_0131)
Must have experienced at least 2 relapses that have been medically documented within the last 3 years with one occurring in the last 12 months
Item
Must have experienced at least 2 relapses that have been medically documented within the last 3 years with one occurring in the last 12 months
boolean
C0439091 (UMLS CUI 2011AA)
276138003 (SNOMED CT 2011_0131)
GE (HL7 V3 2006_05)
C0205448 (UMLS CUI 2011AA)
19338005 (SNOMED CT 2011_0131)
C0035020 (UMLS CUI 2011AA)
263855007 (SNOMED CT 2011_0131)
C0205476 (UMLS CUI 2011AA)
74188005 (SNOMED CT 2011_0131)
C1301725 (UMLS CUI 2011AA)
397934002 (SNOMED CT 2011_0131)
Item Group
Exclusion Criteria
CL425201 (UMLS CUI 2011AA)
Other chronic disease of immune system, malignancies, urologic, pulmonary, gastrointestinal disease
Item
Other chronic disease of immune system, malignancies, urologic, pulmonary, gastrointestinal disease
boolean
C0205394 (UMLS CUI 2011AA)
74964007 (SNOMED CT 2011_0131)
C1290894 (UMLS CUI 2011AA)
128299006 (SNOMED CT 2011_0131)
C0006826 (UMLS CUI 2011AA)
363346000 (SNOMED CT 2011_0131)
10028997 (MedDRA 14.1)
MTHU010328 (LOINC Version 232)
C00-C96 (ICD-10-CM Version 2010)
C0042075 (UMLS CUI 2011AA)
128606002 (SNOMED CT 2011_0131)
10046566 (MedDRA 14.1)
N39.9 (ICD-10-CM Version 2010)
599.9 (ICD-9-CM Version 2011)
C0024115 (UMLS CUI 2011AA)
19829001 (SNOMED CT 2011_0131)
10025082 (MedDRA 14.1)
J98.4 (ICD-10-CM Version 2010)
C0017178 (UMLS CUI 2011AA)
119292006 (SNOMED CT 2011_0131)
10017944 (MedDRA 14.1)
Pregnant or nursing women
Item
Pregnant or nursing women
boolean
C0549206 (UMLS CUI 1)
10036586 (MedDRA 1)
C0006147 (UMLS CUI 2)
10006247 (MedDRA 2)
Back to the top of the page 

Contact

Please use this form for feedback, questions and suggestions for improvements.

Fields marked with * are required.

Help

Do you need help on how to use the search function? Please watch the corresponding tutorial video for more details and learn how to use the search function most efficiently.

Watch Tutorial