ID

42668

Descripción

ODM derived from http://clinicaltrials.gov/show/NCT00754559

Link

http://clinicaltrials.gov/show/NCT00754559

Palabras clave

Versiones (2)
  1. 6/12/13 6/12/13 - Martin Dugas
  2. 17/9/21 17/9/21 -
Subido en

17 de septiembre de 2021

DOI

Para solicitar uno, por favor iniciar sesión.

Licencia

Creative Commons BY 4.0
Comentarios del modelo :

Puede comentar sobre el modelo de datos aquí. A través de las burbujas de diálogo en los grupos de elementos y elementos, puede agregar comentarios específicos.

Volver a los comentarios del modelo
Comentarios de grupo de elementos para :

Comentarios del elemento para :

Para descargar modelos de datos, debe haber iniciado sesión. Por favor iniciar sesión o Registrate gratis.

Eligibility NCT00754559 Rheumatoid Arthritis

Alemán Inglés

Eligibility

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

Einschlusskriterien

Alias
UMLS CUI 2011AA
CL425202
Alter mindestens 18 Jahre
Descripción

age at least 18 Years

Tipo de datos

boolean

Alias
UMLS CUI 2011AA
C0001779
SNOMED CT 2011_0131
397669002
Erwachsener, erwachsen
Descripción

adult patients, >=18 years of age

Tipo de datos

boolean

Alias
UMLS CUI 2011AA
C0001675
SNOMED CT 2011_0131
133936004
rheumatoid arthritis of >=6 months duration diagnosed according to the revised 1987 ACR criteria
Descripción

rheumatoid arthritis of >=6 months duration diagnosed according to the revised 1987 ACR criteria

Tipo de datos

boolean

Alias
UMLS CUI 2011AA
C0003873
SNOMED CT 2011_0131
69896004
MedDRA 14.1
10039073
ICD-10-CM Version 2010
M06.9
ICD-9-CM Version 2011
714.0
UMLS CUI 2011AA
C0011900
SNOMED CT 2011_0131
439401001
LOINC Version 232
MTHU008876
UMLS CUI 2011AA
C0439091
SNOMED CT 2011_0131
276138003
HL7 V3 2006_05
GE
UMLS CUI 2011AA
C0205452
SNOMED CT 2011_0131
68244004
UMLS CUI 2011AA
C0439231
SNOMED CT 2011_0131
258706009
HL7 V3 2006_05
MO
UMLS CUI 2011AA
C0439617
SNOMED CT 2011_0131
272129003
UMLS CUI 2011AA
C0596070
UMLS CUI 2011AA
C0557806
SNOMED CT 2011_0131
224864007
UMLS CUI 2011AA
C0035452
SNOMED CT 2011_0131
394810000
UMLS CUI 2011AA
CL414621
Disease activity score using 28 joint count
Descripción

DAS28 of >3.2

Tipo de datos

boolean

Alias
UMLS CUI 2011AA
C2711347
SNOMED CT 2011_0131
441870009
At screening either ESR >=28 mm/h or CRP >=1 mg/dL
Descripción

At screening either ESR >=28 mm/h or CRP >=1 mg/dL

Tipo de datos

boolean

Alias
UMLS CUI 2011AA
C1409616
UMLS CUI 2011AA
C1176468
SNOMED CT 2011_0131
416838001
MedDRA 14.1
10049184
LOINC Version 232
MTHU007980
UMLS CUI 2011AA
C0006560
SNOMED CT 2011_0131
61425002
LOINC Version 232
MTHU002335
Having received permitted DMARDs >= 1. Current DMARD therapy must have been at a stable dose for at least 8 weeks prior to baseline.
Descripción

Having received permitted DMARDs >= 1. Current DMARD therapy must have been at a stable dose for at least 8 weeks prior to baseline.

Tipo de datos

boolean

Alias
UMLS CUI 2011AA
C0521104
SNOMED CT 2011_0131
75554001
UMLS CUI 2011AA
C0242708
UMLS CUI 2011AA
C2827774
UMLS CUI 2011AA
C0205360
SNOMED CT 2011_0131
58158008
LOINC Version 232
MTHU015276
UMLS CUI 2011AA
C0178602
SNOMED CT 2011_0131
260911001
UMLS CUI 2011AA
C0205454
SNOMED CT 2011_0131
7319005
UMLS CUI 2011AA
C0439230
SNOMED CT 2011_0131
258705008
HL7 V3 2006_05
WK
UMLS CUI 2011AA
C0332152
SNOMED CT 2011_0131
288556008
UMLS CUI 2011AA
C1442488
Ausschlusskriterien
Descripción

Ausschlusskriterien

Alias
UMLS CUI 2011AA
CL425201
major surgery (including joint surgery) within 8 weeks prior to screening or planned major surgery within 6 months following screening
Descripción

major surgery (including joint surgery) within 8 weeks prior to screening or planned major surgery within 6 months following screening

Tipo de datos

boolean

Alias
UMLS CUI 2011AA
C0679637
UMLS CUI 2011AA
C0185132
SNOMED CT 2011_0131
112698002
MedDRA 14.1
10051056
UMLS CUI 2011AA
C0205454
SNOMED CT 2011_0131
7319005
UMLS CUI 2011AA
C0439230
SNOMED CT 2011_0131
258705008
HL7 V3 2006_05
WK
UMLS CUI 2011AA
C0332152
SNOMED CT 2011_0131
288556008
UMLS CUI 2011AA
C1409616
UMLS CUI 2011AA
C1301732
SNOMED CT 2011_0131
397943006
UMLS CUI 2011AA
C0679637
functional class IV as identified by the ACR classification of functional status in RA
Descripción

functional class IV as identified by the ACR classification of functional status in RA

Tipo de datos

boolean

Alias
UMLS CUI 2011AA
C0598463
LOINC Version 232
MTHU027728
UMLS CUI 2011AA
C0003873
SNOMED CT 2011_0131
69896004
MedDRA 14.1
10039073
ICD-10-CM Version 2010
M06.9
ICD-9-CM Version 2011
714.0
UMLS CUI 2011AA
C0441888
SNOMED CT 2011_0131
264750004
UMLS CUI 2011AA
C0596070
UMLS CUI 2011AA
C0557806
SNOMED CT 2011_0131
224864007
UMLS CUI 2011AA
C0035452
SNOMED CT 2011_0131
394810000
UMLS CUI 2011AA
C0008902
SNOMED CT 2011_0131
278201002
rheumatoid autoimmune disease other than RA
Descripción

rheumatoid autoimmune disease other than RA

Tipo de datos

boolean

Alias
UMLS CUI 2011AA
C1406307
UMLS CUI 2011AA
C0004364
SNOMED CT 2011_0131
85828009
MedDRA 14.1
10061664
ICD-10-CM Version 2010
M30-M36
CTCAE 1105E
E11258
UMLS CUI 2011AA
CL411789
UMLS CUI 2011AA
C0003873
SNOMED CT 2011_0131
69896004
MedDRA 14.1
10039073
ICD-10-CM Version 2010
M06.9
ICD-9-CM Version 2011
714.0
prior history of or current inflammatory joint disease other than RA.
Descripción

prior history of or current inflammatory joint disease other than RA.

Tipo de datos

boolean

Alias
UMLS CUI 2011AA
CL421546
SNOMED CT 2011_0131
392521001
UMLS CUI 2011AA
C0521116
SNOMED CT 2011_0131
15240007
UMLS CUI 2011AA
C0683381
UMLS CUI 2011AA
CL411789
UMLS CUI 2011AA
C0003873
SNOMED CT 2011_0131
69896004
MedDRA 14.1
10039073
ICD-10-CM Version 2010
M06.9
ICD-9-CM Version 2011
714.0
Volver a la parte superior de la página

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 at least 18 Years
Item
Alter mindestens 18 Jahre
boolean
C0001779 (UMLS CUI 2011AA)
397669002 (SNOMED CT 2011_0131)
adult patients, >=18 years of age
Item
Erwachsener, erwachsen
boolean
C0001675 (UMLS CUI 2011AA)
133936004 (SNOMED CT 2011_0131)
rheumatoid arthritis of >=6 months duration diagnosed according to the revised 1987 ACR criteria
Item
rheumatoid arthritis of >=6 months duration diagnosed according to the revised 1987 ACR criteria
boolean
C0003873 (UMLS CUI 2011AA)
69896004 (SNOMED CT 2011_0131)
10039073 (MedDRA 14.1)
M06.9 (ICD-10-CM Version 2010)
714.0 (ICD-9-CM Version 2011)
C0011900 (UMLS CUI 2011AA)
439401001 (SNOMED CT 2011_0131)
MTHU008876 (LOINC Version 232)
C0439091 (UMLS CUI 2011AA)
276138003 (SNOMED CT 2011_0131)
GE (HL7 V3 2006_05)
C0205452 (UMLS CUI 2011AA)
68244004 (SNOMED CT 2011_0131)
C0439231 (UMLS CUI 2011AA)
258706009 (SNOMED CT 2011_0131)
MO (HL7 V3 2006_05)
C0439617 (UMLS CUI 2011AA)
272129003 (SNOMED CT 2011_0131)
C0596070 (UMLS CUI 2011AA)
C0557806 (UMLS CUI 2011AA)
224864007 (SNOMED CT 2011_0131)
C0035452 (UMLS CUI 2011AA)
394810000 (SNOMED CT 2011_0131)
CL414621 (UMLS CUI 2011AA)
DAS28 of >3.2
Item
Disease activity score using 28 joint count
boolean
C2711347 (UMLS CUI 2011AA)
441870009 (SNOMED CT 2011_0131)
At screening either ESR >=28 mm/h or CRP >=1 mg/dL
Item
At screening either ESR >=28 mm/h or CRP >=1 mg/dL
boolean
C1409616 (UMLS CUI 2011AA)
C1176468 (UMLS CUI 2011AA)
416838001 (SNOMED CT 2011_0131)
10049184 (MedDRA 14.1)
MTHU007980 (LOINC Version 232)
C0006560 (UMLS CUI 2011AA)
61425002 (SNOMED CT 2011_0131)
MTHU002335 (LOINC Version 232)
Having received permitted DMARDs >= 1. Current DMARD therapy must have been at a stable dose for at least 8 weeks prior to baseline.
Item
Having received permitted DMARDs >= 1. Current DMARD therapy must have been at a stable dose for at least 8 weeks prior to baseline.
boolean
C0521104 (UMLS CUI 2011AA)
75554001 (SNOMED CT 2011_0131)
C0242708 (UMLS CUI 2011AA)
C2827774 (UMLS CUI 2011AA)
C0205360 (UMLS CUI 2011AA)
58158008 (SNOMED CT 2011_0131)
MTHU015276 (LOINC Version 232)
C0178602 (UMLS CUI 2011AA)
260911001 (SNOMED CT 2011_0131)
C0205454 (UMLS CUI 2011AA)
7319005 (SNOMED CT 2011_0131)
C0439230 (UMLS CUI 2011AA)
258705008 (SNOMED CT 2011_0131)
WK (HL7 V3 2006_05)
C0332152 (UMLS CUI 2011AA)
288556008 (SNOMED CT 2011_0131)
C1442488 (UMLS CUI 2011AA)
Item Group
Ausschlusskriterien
CL425201 (UMLS CUI 2011AA)
major surgery (including joint surgery) within 8 weeks prior to screening or planned major surgery within 6 months following screening
Item
major surgery (including joint surgery) within 8 weeks prior to screening or planned major surgery within 6 months following screening
boolean
C0679637 (UMLS CUI 2011AA)
C0185132 (UMLS CUI 2011AA)
112698002 (SNOMED CT 2011_0131)
10051056 (MedDRA 14.1)
C0205454 (UMLS CUI 2011AA)
7319005 (SNOMED CT 2011_0131)
C0439230 (UMLS CUI 2011AA)
258705008 (SNOMED CT 2011_0131)
WK (HL7 V3 2006_05)
C0332152 (UMLS CUI 2011AA)
288556008 (SNOMED CT 2011_0131)
C1409616 (UMLS CUI 2011AA)
C1301732 (UMLS CUI 2011AA)
397943006 (SNOMED CT 2011_0131)
C0679637 (UMLS CUI 2011AA)
functional class IV as identified by the ACR classification of functional status in RA
Item
functional class IV as identified by the ACR classification of functional status in RA
boolean
C0598463 (UMLS CUI 2011AA)
MTHU027728 (LOINC Version 232)
C0003873 (UMLS CUI 2011AA)
69896004 (SNOMED CT 2011_0131)
10039073 (MedDRA 14.1)
M06.9 (ICD-10-CM Version 2010)
714.0 (ICD-9-CM Version 2011)
C0441888 (UMLS CUI 2011AA)
264750004 (SNOMED CT 2011_0131)
C0596070 (UMLS CUI 2011AA)
C0557806 (UMLS CUI 2011AA)
224864007 (SNOMED CT 2011_0131)
C0035452 (UMLS CUI 2011AA)
394810000 (SNOMED CT 2011_0131)
C0008902 (UMLS CUI 2011AA)
278201002 (SNOMED CT 2011_0131)
rheumatoid autoimmune disease other than RA
Item
rheumatoid autoimmune disease other than RA
boolean
C1406307 (UMLS CUI 2011AA)
C0004364 (UMLS CUI 2011AA)
85828009 (SNOMED CT 2011_0131)
10061664 (MedDRA 14.1)
M30-M36 (ICD-10-CM Version 2010)
E11258 (CTCAE 1105E)
CL411789 (UMLS CUI 2011AA)
C0003873 (UMLS CUI 2011AA)
69896004 (SNOMED CT 2011_0131)
10039073 (MedDRA 14.1)
M06.9 (ICD-10-CM Version 2010)
714.0 (ICD-9-CM Version 2011)
prior history of or current inflammatory joint disease other than RA.
Item
prior history of or current inflammatory joint disease other than RA.
boolean
CL421546 (UMLS CUI 2011AA)
392521001 (SNOMED CT 2011_0131)
C0521116 (UMLS CUI 2011AA)
15240007 (SNOMED CT 2011_0131)
C0683381 (UMLS CUI 2011AA)
CL411789 (UMLS CUI 2011AA)
C0003873 (UMLS CUI 2011AA)
69896004 (SNOMED CT 2011_0131)
10039073 (MedDRA 14.1)
M06.9 (ICD-10-CM Version 2010)
714.0 (ICD-9-CM Version 2011)
Volver a la parte superior de la página 

Contacto

Utilice este formulario para comentarios, preguntas y sugerencias.

Los campos marcados con * son obligatorios.

Ayuda

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