ID

15584

Description

Treatment of Multiple Sclerosis and Neuromyelitis Optica With Regulatory Dendritic Cell: Clinical Trial Phase 1 B; ODM derived from: https://clinicaltrials.gov/show/NCT02283671

Link

https://clinicaltrials.gov/show/NCT02283671

Keywords

Versions (1)
  1. 6/3/16 6/3/16 -
Uploaded on

June 3, 2016

DOI

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License

Creative Commons BY 4.0
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Eligibility Multiple Sclerosis NCT02283671

English

Eligibility Multiple Sclerosis NCT02283671

1 forms  
Inclusion Criteria
Description

Inclusion Criteria

Alias
UMLS CUI
C1512693
patients with multiple sclerosis or neuromyelitis optica
Description

Multiple Sclerosis | Neuromyelitis Optica

Data type

boolean

Alias
UMLS CUI [1]
C0026769
UMLS CUI [2]
C0027873
diagnosed more than a year before inclusion
Description

Multiple Sclerosis Prior diagnosis

Data type

boolean

Alias
UMLS CUI [1,1]
C0026769
UMLS CUI [1,2]
C0332132
expanded disability status scale between 3.0 and 8.5
Description

EDSS - Expanded Disability Score

Data type

boolean

Alias
UMLS CUI [1]
C3830336
all subtypes of multiple sclerosis or neuromyelitis optica
Description

Multiple Sclerosis Subtypes | Neuromyelitis Optica Subtypes

Data type

boolean

Alias
UMLS CUI [1,1]
C0026769
UMLS CUI [1,2]
C0872379
UMLS CUI [2,1]
C0027873
UMLS CUI [2,2]
C0872379
multiple sclerosis patients who have previously been offered therapeutic alternatives available in indications and either decline or that after receiving treatment for at least 6 months have had an outbreak or an increase of at least 1 point on the expanded disability status scale (edss) (non-responders) or who have not tolerated treatment
Description

Multiple Sclerosis | Alternative Therapies | EDSS - Expanded Disability Score Therapy non-responder

Data type

boolean

Alias
UMLS CUI [1]
C0026769
UMLS CUI [2]
C0949216
UMLS CUI [3,1]
C3830336
UMLS CUI [3,2]
C0919875
patients with neuromyelitis optica (nmo) in stable immunomodulatory treatment in the past 6 months or without treatment because they are not candidates to receive it
Description

Neuromyelitis Optica Immunomodulation Stable status | Neuromyelitis Optica Therapeutic procedure Absent

Data type

boolean

Alias
UMLS CUI [1,1]
C0027873
UMLS CUI [1,2]
C1963758
UMLS CUI [1,3]
C0205360
UMLS CUI [2,1]
C0027873
UMLS CUI [2,2]
C0087111
UMLS CUI [2,3]
C0332197
Exclusion Criteria
Description

Exclusion Criteria

Alias
UMLS CUI
C0680251
corticosteroid treatment in the last 30 days
Description

Steroid therapy

Data type

boolean

Alias
UMLS CUI [1]
C0149783
presence of an outbreak in the last month
Description

Disease Outbreak

Data type

boolean

Alias
UMLS CUI [1]
C0012652
inability to perform brain magnetic resonance imaging (with paramagnetic contrast)
Description

MRI brain procedure Unable | Paramagnetic Contrast Agent

Data type

boolean

Alias
UMLS CUI [1,1]
C0412675
UMLS CUI [1,2]
C1299582
UMLS CUI [2]
C2917410
serious systemic diseases, including hepatitis b virus, hepatitis c virus, and human immunodeficiency virus. uncontrolled hypertension, insulin-dependent diabetes mellitus, heart disease or kidney failure or severe respiratory
Description

Systemic disease Serious | Hepatitis B Virus | Hepatitis C virus | HIV | Uncontrolled hypertension | Diabetes Mellitus, Insulin-Dependent | Heart Diseases | Kidney Failure | Respiration Disorders Severe

Data type

boolean

Alias
UMLS CUI [1,1]
C0442893
UMLS CUI [1,2]
C0205404
UMLS CUI [2]
C0019169
UMLS CUI [3]
C0220847
UMLS CUI [4]
C0019682
UMLS CUI [5]
C1868885
UMLS CUI [6]
C0011854
UMLS CUI [7]
C0018799
UMLS CUI [8]
C0035078
UMLS CUI [9,1]
C0035204
UMLS CUI [9,2]
C0205082
personal history of cancer or family history of known hereditary cancer
Description

Personal history of malignant neoplasm | Hereditary Malignant Neoplasm Family history

Data type

boolean

Alias
UMLS CUI [1]
C0260455
UMLS CUI [2,1]
C1333600
UMLS CUI [2,2]
C0241889
patient participating in other experimental study in the last 3 months
Description

Study Subject Participation Status

Data type

boolean

Alias
UMLS CUI [1]
C2348568
women childbearing-aged that do not use effective contraceptive methods
Description

Childbearing Potential Age | Contraceptive methods

Data type

boolean

Alias
UMLS CUI [1,1]
C3831118
UMLS CUI [1,2]
C0001779
UMLS CUI [2]
C0700589
pregnant or breastfeeding women
Description

Pregnancy | Breast Feeding

Data type

boolean

Alias
UMLS CUI [1]
C0032961
UMLS CUI [2]
C0006147
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Similar models

Eligibility Multiple Sclerosis NCT02283671

1 forms
Name
Type
Description | Question | Decode (Coded Value)
Data type
Alias
Item Group
C1512693 (UMLS CUI)
Multiple Sclerosis | Neuromyelitis Optica
Item
patients with multiple sclerosis or neuromyelitis optica
boolean
C0026769 (UMLS CUI [1])
C0027873 (UMLS CUI [2])
Multiple Sclerosis Prior diagnosis
Item
diagnosed more than a year before inclusion
boolean
C0026769 (UMLS CUI [1,1])
C0332132 (UMLS CUI [1,2])
EDSS - Expanded Disability Score
Item
expanded disability status scale between 3.0 and 8.5
boolean
C3830336 (UMLS CUI [1])
Multiple Sclerosis Subtypes | Neuromyelitis Optica Subtypes
Item
all subtypes of multiple sclerosis or neuromyelitis optica
boolean
C0026769 (UMLS CUI [1,1])
C0872379 (UMLS CUI [1,2])
C0027873 (UMLS CUI [2,1])
C0872379 (UMLS CUI [2,2])
Multiple Sclerosis | Alternative Therapies | EDSS - Expanded Disability Score Therapy non-responder
Item
multiple sclerosis patients who have previously been offered therapeutic alternatives available in indications and either decline or that after receiving treatment for at least 6 months have had an outbreak or an increase of at least 1 point on the expanded disability status scale (edss) (non-responders) or who have not tolerated treatment
boolean
C0026769 (UMLS CUI [1])
C0949216 (UMLS CUI [2])
C3830336 (UMLS CUI [3,1])
C0919875 (UMLS CUI [3,2])
Neuromyelitis Optica Immunomodulation Stable status | Neuromyelitis Optica Therapeutic procedure Absent
Item
patients with neuromyelitis optica (nmo) in stable immunomodulatory treatment in the past 6 months or without treatment because they are not candidates to receive it
boolean
C0027873 (UMLS CUI [1,1])
C1963758 (UMLS CUI [1,2])
C0205360 (UMLS CUI [1,3])
C0027873 (UMLS CUI [2,1])
C0087111 (UMLS CUI [2,2])
C0332197 (UMLS CUI [2,3])
Item Group
C0680251 (UMLS CUI)
Steroid therapy
Item
corticosteroid treatment in the last 30 days
boolean
C0149783 (UMLS CUI [1])
Disease Outbreak
Item
presence of an outbreak in the last month
boolean
C0012652 (UMLS CUI [1])
MRI brain procedure Unable | Paramagnetic Contrast Agent
Item
inability to perform brain magnetic resonance imaging (with paramagnetic contrast)
boolean
C0412675 (UMLS CUI [1,1])
C1299582 (UMLS CUI [1,2])
C2917410 (UMLS CUI [2])
Systemic disease Serious | Hepatitis B Virus | Hepatitis C virus | HIV | Uncontrolled hypertension | Diabetes Mellitus, Insulin-Dependent | Heart Diseases | Kidney Failure | Respiration Disorders Severe
Item
serious systemic diseases, including hepatitis b virus, hepatitis c virus, and human immunodeficiency virus. uncontrolled hypertension, insulin-dependent diabetes mellitus, heart disease or kidney failure or severe respiratory
boolean
C0442893 (UMLS CUI [1,1])
C0205404 (UMLS CUI [1,2])
C0019169 (UMLS CUI [2])
C0220847 (UMLS CUI [3])
C0019682 (UMLS CUI [4])
C1868885 (UMLS CUI [5])
C0011854 (UMLS CUI [6])
C0018799 (UMLS CUI [7])
C0035078 (UMLS CUI [8])
C0035204 (UMLS CUI [9,1])
C0205082 (UMLS CUI [9,2])
Personal history of malignant neoplasm | Hereditary Malignant Neoplasm Family history
Item
personal history of cancer or family history of known hereditary cancer
boolean
C0260455 (UMLS CUI [1])
C1333600 (UMLS CUI [2,1])
C0241889 (UMLS CUI [2,2])
Study Subject Participation Status
Item
patient participating in other experimental study in the last 3 months
boolean
C2348568 (UMLS CUI [1])
Childbearing Potential Age | Contraceptive methods
Item
women childbearing-aged that do not use effective contraceptive methods
boolean
C3831118 (UMLS CUI [1,1])
C0001779 (UMLS CUI [1,2])
C0700589 (UMLS CUI [2])
Pregnancy | Breast Feeding
Item
pregnant or breastfeeding women
boolean
C0032961 (UMLS CUI [1])
C0006147 (UMLS CUI [2])
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