ID

5040

Beskrivning

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

Länk

http://clinicaltrials.gov/show/NCT00906399

Nyckelord

Versioner (2)
  1. 2013-12-09 2013-12-09 - Martin Dugas
  2. 2014-04-17 2014-04-17 - Julian Varghese
Uppladdad den

17 april 2014

DOI

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Licens

Creative Commons BY 4.0
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Eligibility NCT00906399 Relapsing Multiple Sclerosis

Tysk Engelsk

Eligibility

1 Formulär  
  1. StudyEvent: Eligibility
    1. Eligibility
Einschlusskriterien
Beskrivning

Einschlusskriterien

Alias
UMLS CUI 2011AA
CL425202
Alter 18 bis 65 Jahre
Beskrivning

age 18 Years to 65 Years

Datatyp

boolean

Alias
UMLS CUI 2011AA
C0001779
SNOMED CT 2011_0131
397669002
Einverständniserklärung
Beskrivning

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

Datatyp

boolean

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

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

Datatyp

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
Beskrivning

Must have an EDSS score between 0.0 and 5.0.

Datatyp

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
Beskrivning

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

Datatyp

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
Ausschlusskriterien
Beskrivning

Ausschlusskriterien

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

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

Datatyp

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
Beskrivning

Pregnant or nursing women

Datatyp

boolean

Alias
UMLS CUI 1
C0549206
MedDRA 1
10036586
UMLS CUI 2
C0006147
MedDRA 2
10006247
Tillbaka till toppen

Similar models

Eligibility

1 Formulär
  1. StudyEvent: Eligibility
    1. Eligibility
Name
Typ
Description | Question | Decode (Coded Value)
Datatyp
Alias
Item Group
Einschlusskriterien
CL425202 (UMLS CUI 2011AA)
age 18 Years to 65 Years
Item
Alter 18 bis 65 Jahre
boolean
C0001779 (UMLS CUI 2011AA)
397669002 (SNOMED CT 2011_0131)
Aged 18 to 65 years old, inclusive, at the time of informed consent.
Item
Einverständniserklärung
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
Ausschlusskriterien
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)
Tillbaka till toppen 

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