ID

21478

Descripción

Characteristic Study on Chinese Patients With Multiple Sclerosis; ODM derived from: https://clinicaltrials.gov/show/NCT00818103

Link

https://clinicaltrials.gov/show/NCT00818103

Palabras clave

Versiones (1)
  1. 24/4/17 24/4/17 -
Subido en

24 de abril de 2017

DOI

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Licencia

Creative Commons BY 4.0
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Eligibility Multiple Sclerosis NCT00818103

Inglés

Eligibility Multiple Sclerosis NCT00818103

1 formularios  
Inclusion Criteria
Descripción

Inclusion Criteria

Alias
UMLS CUI
C1512693
criteria for neuromyelitis optical
Descripción

Criteria for neuromyelitis optica

Tipo de datos

boolean

Alias
UMLS CUI [1,1]
C0027873
UMLS CUI [1,2]
C0243161
optic neuritis
Descripción

Optic neuritis

Tipo de datos

boolean

Alias
UMLS CUI [1]
C0029134
acute myelitis
Descripción

Acute myelitis

Tipo de datos

boolean

Alias
UMLS CUI [1]
C0014059
at least two of three supportive criteria:
Descripción

Supportive criteria

Tipo de datos

boolean

Alias
UMLS CUI [1,1]
C1521721
UMLS CUI [1,2]
C0243161
contiguous spinal cord mri lesion extending over >= 3 vertebral segments
Descripción

Spinal MRI lesion

Tipo de datos

boolean

Alias
UMLS CUI [1,1]
C0024485
UMLS CUI [1,2]
C0221198
UMLS CUI [1,3]
C0521329
brain mri not meeting diagnostic criteria for multiple sclerosis
Descripción

Brain MRI for multiple sclerosis

Tipo de datos

boolean

Alias
UMLS CUI [1,1]
C0412675
UMLS CUI [1,2]
C0026769
nmo-igg seropositive status
Descripción

NMO-IgG Status

Tipo de datos

boolean

Alias
UMLS CUI [1,1]
C0027873
UMLS CUI [1,2]
C0020852
criteria for multiple sclerosis:
Descripción

Multiple Sclerosis Criteria

Tipo de datos

boolean

Alias
UMLS CUI [1,1]
C0026769
UMLS CUI [1,2]
C0243161
two or more attacks; objective clinical evidence of two or more lesions, or
Descripción

Attacks or lesion

Tipo de datos

boolean

Alias
UMLS CUI [1]
C0014544
UMLS CUI [2,1]
C0026769
UMLS CUI [2,2]
C0221198
two or more attacks; objective clinical evidence of one lesion, dissemination in space, demonstrated by: mri or two or more mri-detected lesions consistent with ms plus positive csf or wait further clinical attack implicating a different site, or
Descripción

MRI for MS, CSF

Tipo de datos

boolean

Alias
UMLS CUI [1,1]
C0026769
UMLS CUI [1,2]
C0024485
UMLS CUI [2]
C0007806
one attack; objective clinical evidence of two or more lesions, dissemination in time, demonstrated by: mri or second clinical attack, or
Descripción

Lesion: Dissemination in time

Tipo de datos

boolean

Alias
UMLS CUI [1,1]
C0205221
UMLS CUI [1,2]
C0040223
UMLS CUI [1,3]
C0221198
one attack; objective clinical evidence of one lesion (monosymptomatic presentation; clinically isolated syndrome), dissemination in space, demonstrated by: mri or two or more mri-detected lesions consistent with ms plus positive csf and dissemination in time, demonstrated by: mri or second clinical attack, or
Descripción

Lesion: Dissemination in space

Tipo de datos

boolean

Alias
UMLS CUI [1,1]
C0205221
UMLS CUI [1,2]
C1883067
UMLS CUI [1,3]
C0221198
insidious neurological progression suggestive of ms, one year of disease progression (retrospectively or prospectively determined) and two of the following:
Descripción

Disease progression

Tipo de datos

boolean

Alias
UMLS CUI [1]
C0242656
1. positive brain mri (nine t2 lesions or four or more t2 lesions with positive vep)
Descripción

Brain MRI

Tipo de datos

boolean

Alias
UMLS CUI [1]
C0412675
2. positive spinal cord mri (two focal t2 lesions)
Descripción

Spinal Cord MRI

Tipo de datos

boolean

Alias
UMLS CUI [1]
C2454646
3. positive csf
Descripción

CSF

Tipo de datos

boolean

Alias
UMLS CUI [1]
C0007806
Exclusion Criteria
Descripción

Exclusion Criteria

Alias
UMLS CUI
C0680251
> 65 yrs old
Descripción

Age

Tipo de datos

boolean

Alias
UMLS CUI [1]
C0001779
heavy damage of heart, lung, liver, renal function
Descripción

Organ function

Tipo de datos

boolean

Alias
UMLS CUI [1]
C0678852
late neuromyelitis optical or edss > 6.0
Descripción

Late neuromyelitis optica or EDSS

Tipo de datos

boolean

Alias
UMLS CUI [1,1]
C0027873
UMLS CUI [1,2]
C0205087
UMLS CUI [2]
C0451246
serious hypertension and diabetes
Descripción

Hypertension and diabetes mellitus

Tipo de datos

boolean

Alias
UMLS CUI [1]
C0020538
UMLS CUI [2]
C0011849
serious mental disorders and depression
Descripción

Mental disorder or depression

Tipo de datos

boolean

Alias
UMLS CUI [1]
C0004936
UMLS CUI [2]
C0011581
allergic to drug: atorvastatin, β-interferon, epo, immunoglobulin
Descripción

Hypersensitivity to atorvastatin, β-interferon, epo, immunoglobulin

Tipo de datos

boolean

Alias
UMLS CUI [1,1]
C0020517
UMLS CUI [1,2]
C0286651
UMLS CUI [2,1]
C0020517
UMLS CUI [2,2]
C0015980
UMLS CUI [3,1]
C0020517
UMLS CUI [3,2]
C0014822
UMLS CUI [4,1]
C0020517
UMLS CUI [4,2]
C0021027
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Similar models

Eligibility Multiple Sclerosis NCT00818103

1 formularios
Name
Tipo
Description | Question | Decode (Coded Value)
Tipo de datos
Alias
Item Group
C1512693 (UMLS CUI)
Criteria for neuromyelitis optica
Item
criteria for neuromyelitis optical
boolean
C0027873 (UMLS CUI [1,1])
C0243161 (UMLS CUI [1,2])
Optic neuritis
Item
optic neuritis
boolean
C0029134 (UMLS CUI [1])
Acute myelitis
Item
acute myelitis
boolean
C0014059 (UMLS CUI [1])
Supportive criteria
Item
at least two of three supportive criteria:
boolean
C1521721 (UMLS CUI [1,1])
C0243161 (UMLS CUI [1,2])
Spinal MRI lesion
Item
contiguous spinal cord mri lesion extending over >= 3 vertebral segments
boolean
C0024485 (UMLS CUI [1,1])
C0221198 (UMLS CUI [1,2])
C0521329 (UMLS CUI [1,3])
Brain MRI for multiple sclerosis
Item
brain mri not meeting diagnostic criteria for multiple sclerosis
boolean
C0412675 (UMLS CUI [1,1])
C0026769 (UMLS CUI [1,2])
NMO-IgG Status
Item
nmo-igg seropositive status
boolean
C0027873 (UMLS CUI [1,1])
C0020852 (UMLS CUI [1,2])
Multiple Sclerosis Criteria
Item
criteria for multiple sclerosis:
boolean
C0026769 (UMLS CUI [1,1])
C0243161 (UMLS CUI [1,2])
Attacks or lesion
Item
two or more attacks; objective clinical evidence of two or more lesions, or
boolean
C0014544 (UMLS CUI [1])
C0026769 (UMLS CUI [2,1])
C0221198 (UMLS CUI [2,2])
MRI for MS, CSF
Item
two or more attacks; objective clinical evidence of one lesion, dissemination in space, demonstrated by: mri or two or more mri-detected lesions consistent with ms plus positive csf or wait further clinical attack implicating a different site, or
boolean
C0026769 (UMLS CUI [1,1])
C0024485 (UMLS CUI [1,2])
C0007806 (UMLS CUI [2])
Lesion: Dissemination in time
Item
one attack; objective clinical evidence of two or more lesions, dissemination in time, demonstrated by: mri or second clinical attack, or
boolean
C0205221 (UMLS CUI [1,1])
C0040223 (UMLS CUI [1,2])
C0221198 (UMLS CUI [1,3])
Lesion: Dissemination in space
Item
one attack; objective clinical evidence of one lesion (monosymptomatic presentation; clinically isolated syndrome), dissemination in space, demonstrated by: mri or two or more mri-detected lesions consistent with ms plus positive csf and dissemination in time, demonstrated by: mri or second clinical attack, or
boolean
C0205221 (UMLS CUI [1,1])
C1883067 (UMLS CUI [1,2])
C0221198 (UMLS CUI [1,3])
Disease progression
Item
insidious neurological progression suggestive of ms, one year of disease progression (retrospectively or prospectively determined) and two of the following:
boolean
C0242656 (UMLS CUI [1])
Brain MRI
Item
1. positive brain mri (nine t2 lesions or four or more t2 lesions with positive vep)
boolean
C0412675 (UMLS CUI [1])
Spinal Cord MRI
Item
2. positive spinal cord mri (two focal t2 lesions)
boolean
C2454646 (UMLS CUI [1])
CSF
Item
3. positive csf
boolean
C0007806 (UMLS CUI [1])
Item Group
C0680251 (UMLS CUI)
Age
Item
> 65 yrs old
boolean
C0001779 (UMLS CUI [1])
Organ function
Item
heavy damage of heart, lung, liver, renal function
boolean
C0678852 (UMLS CUI [1])
Late neuromyelitis optica or EDSS
Item
late neuromyelitis optical or edss > 6.0
boolean
C0027873 (UMLS CUI [1,1])
C0205087 (UMLS CUI [1,2])
C0451246 (UMLS CUI [2])
Hypertension and diabetes mellitus
Item
serious hypertension and diabetes
boolean
C0020538 (UMLS CUI [1])
C0011849 (UMLS CUI [2])
Mental disorder or depression
Item
serious mental disorders and depression
boolean
C0004936 (UMLS CUI [1])
C0011581 (UMLS CUI [2])
Hypersensitivity to atorvastatin, β-interferon, epo, immunoglobulin
Item
allergic to drug: atorvastatin, β-interferon, epo, immunoglobulin
boolean
C0020517 (UMLS CUI [1,1])
C0286651 (UMLS CUI [1,2])
C0020517 (UMLS CUI [2,1])
C0015980 (UMLS CUI [2,2])
C0020517 (UMLS CUI [3,1])
C0014822 (UMLS CUI [3,2])
C0020517 (UMLS CUI [4,1])
C0021027 (UMLS CUI [4,2])
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