ID

4523

Descripción

ODM derived from http://clinicaltrials.gov/show/NCT00622700

Link

http://clinicaltrials.gov/show/NCT00622700

Palabras clave

Versiones (1)
  1. 10/12/13 10/12/13 - Martin Dugas
Subido en

10 de diciembre de 2013

DOI

Para solicitar uno, por favor iniciar sesión.

Licencia

Creative Commons BY 4.0
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Eligibility NCT00622700 Multiple Sclerosis

Alemán Inglés

Eligibility

1 formularios  
  1. StudyEvent: Eligibility
    1. Eligibility
Einschlusskriterien
Descripción

Einschlusskriterien

Alias
UMLS CUI 2011AA
CL425202
Alter 18 bis 55 Jahre
Descripción

age 18 Years to 55 Years

Tipo de datos

boolean

Alias
UMLS CUI 2011AA
C0001779
SNOMED CT 2011_0131
397669002
First acute or subacute, well-defined neurological event consistent with demyelination (i.e. optic neuritis confirmed by an ophthalmologist, spinal cord syndrome, brainstem/cerebellar syndromes),
Descripción

First acute or subacute, well-defined neurological event consistent with demyelination (i.e. optic neuritis confirmed by an ophthalmologist, spinal cord syndrome, brainstem/cerebellar syndromes),

Tipo de datos

boolean

Alias
UMLS CUI 2011AA
C0205435
SNOMED CT 2011_0131
255216001
UMLS CUI 2011AA
C0205178
SNOMED CT 2011_0131
272118002
UMLS CUI 2011AA
C0205365
SNOMED CT 2011_0131
19939008
UMLS CUI 2011AA
C1320718
SNOMED CT 2011_0131
405619009
UMLS CUI 2011AA
C0332290
SNOMED CT 2011_0131
385433004
UMLS CUI 2011AA
C0011304
SNOMED CT 2011_0131
32693004
MedDRA 14.1
10012305
UMLS CUI 2011AA
C0029134
SNOMED CT 2011_0131
66760008
MedDRA 14.1
10030942
ICD-10-CM Version 2010
H46.9
ICD-9-CM Version 2011
377.30
UMLS CUI 2011AA
C0750484
UMLS CUI 2011AA
C1704292
SNOMED CT 2011_0131
422234006
UMLS CUI 2011AA
C0560648
SNOMED CT 2011_0131
282784007
UMLS CUI 2011AA
C1328447
MedDRA 14.1
10063292
UMLS CUI 2011AA
C0007760
SNOMED CT 2011_0131
224186005
MedDRA 14.1
10008072
Onset of MS symptoms occurring within 90 days of randomization,
Descripción

Onset of MS symptoms occurring within 90 days of randomization,

Tipo de datos

boolean

Alias
UMLS CUI 2011AA
C0332162
SNOMED CT 2011_0131
77374008
UMLS CUI 2011AA
C0026769
SNOMED CT 2011_0131
24700007
MedDRA 14.1
10028245
LOINC Version 232
MTHU020805
ICD-10-CM Version 2010
G35
ICD-9-CM Version 2011
340
UMLS CUI 2011AA
C1457887
LOINC Version 232
MTHU021540
ICD-9-CM Version 2011
780-789.99
UMLS CUI 2011AA
C0011900
SNOMED CT 2011_0131
439401001
LOINC Version 232
MTHU008876
UMLS CUI 2011AA
C2825406
UMLS CUI 2011AA
C0439234
SNOMED CT 2011_0131
258707000
HL7 V3 2006_05
Y
UMLS CUI 2011AA
C0034656
A screening MRI scan with 2 or more T2 lesions at least 3 mm in diameter that are characteristic of MS.
Descripción

A screening MRI scan with 2 or more T2 lesions at least 3 mm in diameter that are characteristic of MS.

Tipo de datos

boolean

Alias
UMLS CUI 2011AA
C1409616
UMLS CUI 2011AA
C0917711
UMLS CUI 2011AA
C0475373
SNOMED CT 2011_0131
67673008
UMLS CUI 2011AA
C0221198
SNOMED CT 2011_0131
49755003
UMLS CUI 2011AA
C1301886
SNOMED CT 2011_0131
81827009
LOINC Version 232
MTHU002654
UMLS CUI 2011AA
C1521970
UMLS CUI 2011AA
C0026769
SNOMED CT 2011_0131
24700007
MedDRA 14.1
10028245
LOINC Version 232
MTHU020805
ICD-10-CM Version 2010
G35
ICD-9-CM Version 2011
340
Ausschlusskriterien
Descripción

Ausschlusskriterien

Alias
UMLS CUI 2011AA
CL425201
Clinically relevant cardiovascular, hepatic, neurological, endocrine or other major systemic disease,
Descripción

Clinically relevant cardiovascular, hepatic, neurological, endocrine or other major systemic disease,

Tipo de datos

boolean

Alias
UMLS CUI 2011AA
C0205210
SNOMED CT 2011_0131
58147004
UMLS CUI 2011AA
C2347946
UMLS CUI 2011AA
C0007222
SNOMED CT 2011_0131
105980002
MedDRA 14.1
10007649
ICD-9-CM Version 2011
429.2
UMLS CUI 2011AA
C1869009
MedDRA 14.1
20000005
UMLS CUI 2011AA
C0027765
SNOMED CT 2011_0131
118940003
MedDRA 14.1
10029202
ICD-10-CM Version 2010
G98.8
ICD-9-CM Version 2011
349.9
UMLS CUI 2011AA
C0014130
SNOMED CT 2011_0131
362969004
MedDRA 14.1
10014695
LOINC Version 232
MTHU021570
ICD-10-CM Version 2010
E34.9
ICD-9-CM Version 2011
259.9
UMLS CUI 2011AA
C0205164
SNOMED CT 2011_0131
255603008
UMLS CUI 2011AA
C0442893
SNOMED CT 2011_0131
56019007, 264578000
Significantly impaired bone marrow function,
Descripción

Significantly impaired bone marrow function,

Tipo de datos

boolean

Alias
UMLS CUI 2011AA
C0750502
SNOMED CT 2011_0131
386134007
UMLS CUI 2011AA
C0221099
SNOMED CT 2011_0131
260379002
UMLS CUI 2011AA
C0005953
SNOMED CT 2011_0131
14016003
LOINC Version 232
MTHU016536
UMLS CUI 2011AA
C0542341
SNOMED CT 2011_0131
246464006
Pregnancy or nursing,
Descripción

Pregnancy or nursing,

Tipo de datos

boolean

Alias
UMLS CUI 2011AA
C0032961
SNOMED CT 2011_0131
289908002
MedDRA 14.1
10036556
LOINC Version 232
MTHU035048
UMLS CUI 2011AA
C0006147
MedDRA 14.1
10006247
Alcohol or drug abuse,
Descripción

Alcohol or drug abuse,

Tipo de datos

boolean

Alias
UMLS CUI 2011AA
C0085762
SNOMED CT 2011_0131
15167005
MedDRA 14.1
10001584
LOINC Version 232
LP36309-0
ICD-10-CM Version 2010
F10.1
ICD-9-CM Version 2011
305.0
UMLS CUI 2011AA
C0013146
SNOMED CT 2011_0131
26416006
MedDRA 14.1
10013654
LOINC Version 232
LP36310-8
ICD-9-CM Version 2011
305.90
Use of cladribine, mitoxantrone, or other immunosuppressant agents such as azathioprine, cyclophosphamide, cyclosporin, methotrexate or mycophenolate before enrollment
Descripción

Use of cladribine, mitoxantrone, or other immunosuppressant agents such as azathioprine, cyclophosphamide, cyclosporin, methotrexate or mycophenolate before enrollment

Tipo de datos

boolean

Alias
UMLS CUI 2011AA
C0092801
SNOMED CT 2011_0131
386916009
UMLS CUI 2011AA
C0026259
SNOMED CT 2011_0131
386913001
UMLS CUI 2011AA
C0021081
SNOMED CT 2011_0131
372823004, 69431002
UMLS CUI 2011AA
C0004482
SNOMED CT 2011_0131
372574004
LOINC Version 232
MTHU006794
UMLS CUI 2011AA
C0010583
SNOMED CT 2011_0131
387420009
LOINC Version 232
MTHU029970
UMLS CUI 2011AA
C0010592
SNOMED CT 2011_0131
387467008
LOINC Version 232
MTHU005140
UMLS CUI 2011AA
C0025677
SNOMED CT 2011_0131
387381009
LOINC Version 232
MTHU005020
UMLS CUI 2011AA
C0883242
LOINC Version 232
MTHU011568
UMLS CUI 2011AA
C0332152
SNOMED CT 2011_0131
288556008
UMLS CUI 2011AA
C1516879
Any known condition or circumstance that would prevent in the investigator's opinion compliance or completion of the study.
Descripción

Any known condition or circumstance that would prevent in the investigator's opinion compliance or completion of the study.

Tipo de datos

boolean

Alias
UMLS CUI 2011AA
C0205309
SNOMED CT 2011_0131
36692007
UMLS CUI 2011AA
C0348080
SNOMED CT 2011_0131
260905004
HL7 V3 2006_05
COND
UMLS CUI 2011AA
C0680082
UMLS CUI 2011AA
C2700409
UMLS CUI 2011AA
CL102947
UMLS CUI 2011AA
C0022423
SNOMED CT 2011_0131
61254005
UMLS CUI 2011AA
C1321605
SNOMED CT 2011_0131
405078008
UMLS CUI 2011AA
C1554962
HL7 V3 2006_05
C
UMLS CUI 2011AA
C0008976
SNOMED CT 2011_0131
110465008
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Similar models

Eligibility

1 formularios
  1. StudyEvent: Eligibility
    1. Eligibility
Name
Tipo
Description | Question | Decode (Coded Value)
Tipo de datos
Alias
Item Group
Einschlusskriterien
CL425202 (UMLS CUI 2011AA)
age 18 Years to 55 Years
Item
Alter 18 bis 55 Jahre
boolean
C0001779 (UMLS CUI 2011AA)
397669002 (SNOMED CT 2011_0131)
First acute or subacute, well-defined neurological event consistent with demyelination (i.e. optic neuritis confirmed by an ophthalmologist, spinal cord syndrome, brainstem/cerebellar syndromes),
Item
First acute or subacute, well-defined neurological event consistent with demyelination (i.e. optic neuritis confirmed by an ophthalmologist, spinal cord syndrome, brainstem/cerebellar syndromes),
boolean
C0205435 (UMLS CUI 2011AA)
255216001 (SNOMED CT 2011_0131)
C0205178 (UMLS CUI 2011AA)
272118002 (SNOMED CT 2011_0131)
C0205365 (UMLS CUI 2011AA)
19939008 (SNOMED CT 2011_0131)
C1320718 (UMLS CUI 2011AA)
405619009 (SNOMED CT 2011_0131)
C0332290 (UMLS CUI 2011AA)
385433004 (SNOMED CT 2011_0131)
C0011304 (UMLS CUI 2011AA)
32693004 (SNOMED CT 2011_0131)
10012305 (MedDRA 14.1)
C0029134 (UMLS CUI 2011AA)
66760008 (SNOMED CT 2011_0131)
10030942 (MedDRA 14.1)
H46.9 (ICD-10-CM Version 2010)
377.30 (ICD-9-CM Version 2011)
C0750484 (UMLS CUI 2011AA)
C1704292 (UMLS CUI 2011AA)
422234006 (SNOMED CT 2011_0131)
C0560648 (UMLS CUI 2011AA)
282784007 (SNOMED CT 2011_0131)
C1328447 (UMLS CUI 2011AA)
10063292 (MedDRA 14.1)
C0007760 (UMLS CUI 2011AA)
224186005 (SNOMED CT 2011_0131)
10008072 (MedDRA 14.1)
Onset of MS symptoms occurring within 90 days of randomization,
Item
Onset of MS symptoms occurring within 90 days of randomization,
boolean
C0332162 (UMLS CUI 2011AA)
77374008 (SNOMED CT 2011_0131)
C0026769 (UMLS CUI 2011AA)
24700007 (SNOMED CT 2011_0131)
10028245 (MedDRA 14.1)
MTHU020805 (LOINC Version 232)
G35 (ICD-10-CM Version 2010)
340 (ICD-9-CM Version 2011)
C1457887 (UMLS CUI 2011AA)
MTHU021540 (LOINC Version 232)
780-789.99 (ICD-9-CM Version 2011)
C0011900 (UMLS CUI 2011AA)
439401001 (SNOMED CT 2011_0131)
MTHU008876 (LOINC Version 232)
C2825406 (UMLS CUI 2011AA)
C0439234 (UMLS CUI 2011AA)
258707000 (SNOMED CT 2011_0131)
Y (HL7 V3 2006_05)
C0034656 (UMLS CUI 2011AA)
A screening MRI scan with 2 or more T2 lesions at least 3 mm in diameter that are characteristic of MS.
Item
A screening MRI scan with 2 or more T2 lesions at least 3 mm in diameter that are characteristic of MS.
boolean
C1409616 (UMLS CUI 2011AA)
C0917711 (UMLS CUI 2011AA)
C0475373 (UMLS CUI 2011AA)
67673008 (SNOMED CT 2011_0131)
C0221198 (UMLS CUI 2011AA)
49755003 (SNOMED CT 2011_0131)
C1301886 (UMLS CUI 2011AA)
81827009 (SNOMED CT 2011_0131)
MTHU002654 (LOINC Version 232)
C1521970 (UMLS CUI 2011AA)
C0026769 (UMLS CUI 2011AA)
24700007 (SNOMED CT 2011_0131)
10028245 (MedDRA 14.1)
MTHU020805 (LOINC Version 232)
G35 (ICD-10-CM Version 2010)
340 (ICD-9-CM Version 2011)
Item Group
Ausschlusskriterien
CL425201 (UMLS CUI 2011AA)
Clinically relevant cardiovascular, hepatic, neurological, endocrine or other major systemic disease,
Item
Clinically relevant cardiovascular, hepatic, neurological, endocrine or other major systemic disease,
boolean
C0205210 (UMLS CUI 2011AA)
58147004 (SNOMED CT 2011_0131)
C2347946 (UMLS CUI 2011AA)
C0007222 (UMLS CUI 2011AA)
105980002 (SNOMED CT 2011_0131)
10007649 (MedDRA 14.1)
429.2 (ICD-9-CM Version 2011)
C1869009 (UMLS CUI 2011AA)
20000005 (MedDRA 14.1)
C0027765 (UMLS CUI 2011AA)
118940003 (SNOMED CT 2011_0131)
10029202 (MedDRA 14.1)
G98.8 (ICD-10-CM Version 2010)
349.9 (ICD-9-CM Version 2011)
C0014130 (UMLS CUI 2011AA)
362969004 (SNOMED CT 2011_0131)
10014695 (MedDRA 14.1)
MTHU021570 (LOINC Version 232)
E34.9 (ICD-10-CM Version 2010)
259.9 (ICD-9-CM Version 2011)
C0205164 (UMLS CUI 2011AA)
255603008 (SNOMED CT 2011_0131)
C0442893 (UMLS CUI 2011AA)
56019007, 264578000 (SNOMED CT 2011_0131)
Significantly impaired bone marrow function,
Item
Significantly impaired bone marrow function,
boolean
C0750502 (UMLS CUI 2011AA)
386134007 (SNOMED CT 2011_0131)
C0221099 (UMLS CUI 2011AA)
260379002 (SNOMED CT 2011_0131)
C0005953 (UMLS CUI 2011AA)
14016003 (SNOMED CT 2011_0131)
MTHU016536 (LOINC Version 232)
C0542341 (UMLS CUI 2011AA)
246464006 (SNOMED CT 2011_0131)
Pregnancy or nursing,
Item
Pregnancy or nursing,
boolean
C0032961 (UMLS CUI 2011AA)
289908002 (SNOMED CT 2011_0131)
10036556 (MedDRA 14.1)
MTHU035048 (LOINC Version 232)
C0006147 (UMLS CUI 2011AA)
10006247 (MedDRA 14.1)
Alcohol or drug abuse,
Item
Alcohol or drug abuse,
boolean
C0085762 (UMLS CUI 2011AA)
15167005 (SNOMED CT 2011_0131)
10001584 (MedDRA 14.1)
LP36309-0 (LOINC Version 232)
F10.1 (ICD-10-CM Version 2010)
305.0 (ICD-9-CM Version 2011)
C0013146 (UMLS CUI 2011AA)
26416006 (SNOMED CT 2011_0131)
10013654 (MedDRA 14.1)
LP36310-8 (LOINC Version 232)
305.90 (ICD-9-CM Version 2011)
Use of cladribine, mitoxantrone, or other immunosuppressant agents such as azathioprine, cyclophosphamide, cyclosporin, methotrexate or mycophenolate before enrollment
Item
Use of cladribine, mitoxantrone, or other immunosuppressant agents such as azathioprine, cyclophosphamide, cyclosporin, methotrexate or mycophenolate before enrollment
boolean
C0092801 (UMLS CUI 2011AA)
386916009 (SNOMED CT 2011_0131)
C0026259 (UMLS CUI 2011AA)
386913001 (SNOMED CT 2011_0131)
C0021081 (UMLS CUI 2011AA)
372823004, 69431002 (SNOMED CT 2011_0131)
C0004482 (UMLS CUI 2011AA)
372574004 (SNOMED CT 2011_0131)
MTHU006794 (LOINC Version 232)
C0010583 (UMLS CUI 2011AA)
387420009 (SNOMED CT 2011_0131)
MTHU029970 (LOINC Version 232)
C0010592 (UMLS CUI 2011AA)
387467008 (SNOMED CT 2011_0131)
MTHU005140 (LOINC Version 232)
C0025677 (UMLS CUI 2011AA)
387381009 (SNOMED CT 2011_0131)
MTHU005020 (LOINC Version 232)
C0883242 (UMLS CUI 2011AA)
MTHU011568 (LOINC Version 232)
C0332152 (UMLS CUI 2011AA)
288556008 (SNOMED CT 2011_0131)
C1516879 (UMLS CUI 2011AA)
Any known condition or circumstance that would prevent in the investigator's opinion compliance or completion of the study.
Item
Any known condition or circumstance that would prevent in the investigator's opinion compliance or completion of the study.
boolean
C0205309 (UMLS CUI 2011AA)
36692007 (SNOMED CT 2011_0131)
C0348080 (UMLS CUI 2011AA)
260905004 (SNOMED CT 2011_0131)
COND (HL7 V3 2006_05)
C0680082 (UMLS CUI 2011AA)
C2700409 (UMLS CUI 2011AA)
CL102947 (UMLS CUI 2011AA)
C0022423 (UMLS CUI 2011AA)
61254005 (SNOMED CT 2011_0131)
C1321605 (UMLS CUI 2011AA)
405078008 (SNOMED CT 2011_0131)
C1554962 (UMLS CUI 2011AA)
C (HL7 V3 2006_05)
C0008976 (UMLS CUI 2011AA)
110465008 (SNOMED CT 2011_0131)
Volver a la parte superior de la página 

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