ID

24652

Description

Modulation of Plasmacytoid Dendritic Cell Function in Multiple Sclerosis; ODM derived from: https://clinicaltrials.gov/show/NCT00468182

Lien

https://clinicaltrials.gov/show/NCT00468182

Mots-clés

Versions (1)
  1. 11/08/2017 11/08/2017 -
Téléchargé le

11 août 2017

DOI

Pour une demande vous connecter.

Licence

Creative Commons BY 4.0
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Eligibility Multiple Sclerosis NCT00468182

Anglais

Eligibility Multiple Sclerosis NCT00468182

1 Formulaires  
Inclusion Criteria
Description

Inclusion Criteria

Alias
UMLS CUI
C1512693
males and females, 18 to 60 year old, inclusive.
Description

Age

Type de données

boolean

Alias
UMLS CUI [1]
C0001779
diagnosis of a relapsing form of multiple sclerosis as determined by revised mcdonald criteria or at least one clinical demyelinating episode with abnormal brain mri study based on champs criteria
Description

Multiple Sclerosis, Acute Relapsing | Demyelination Episode Quantity | Magnetic resonance imaging of brain abnormal

Type de données

boolean

Alias
UMLS CUI [1]
C0393664
UMLS CUI [2,1]
C0011304
UMLS CUI [2,2]
C0332189
UMLS CUI [2,3]
C1265611
UMLS CUI [3]
C1319851
expanded disability status scale (edss) score less than 6 at entry.
Description

Kurtzke multiple sclerosis rating scale

Type de données

boolean

Alias
UMLS CUI [1]
C0451246
understand and sign written informed consent prior to any testing under this protocol, including screening tests and evaluations that are not considered part of the subject's routine care.
Description

Informed Consent

Type de données

boolean

Alias
UMLS CUI [1]
C0021430
Exclusion Criteria
Description

Exclusion Criteria

Alias
UMLS CUI
C0680251
treatment with corticosteroids within one month prior to the study. treatment with immunomodulatory drugs within last 3 months prior to the study.
Description

Adrenal Cortex Hormones | Biological Response Modifiers

Type de données

boolean

Alias
UMLS CUI [1]
C0001617
UMLS CUI [2]
C0005525
no history of treatment with interferon-beta(ifn-beta) based drugs to exclude the possibility of ifn-beta neutralizing antibodies
Description

Pharmaceutical Preparations Interferon-beta Based

Type de données

boolean

Alias
UMLS CUI [1,1]
C0013227
UMLS CUI [1,2]
C0015980
UMLS CUI [1,3]
C1705938
any patient who is pregnant, intend to become pregnant, or breastfeeding at any time of the study.
Description

Pregnancy | Pregnancy, Planned | Breast Feeding

Type de données

boolean

Alias
UMLS CUI [1]
C0032961
UMLS CUI [2]
C0032992
UMLS CUI [3]
C0006147
history of any significant cardiac, gastrointestinal, hepatic, pulmonary, or renal disease; immune deficiency; or other medical conditions that would preclude ifn-beta therapy.
Description

Heart Diseases | Gastrointestinal Diseases | Liver diseases | Lung diseases | Kidney Diseases | Immunologic Deficiency Syndromes | Medical condition Excludes Beta interferon therapy

Type de données

boolean

Alias
UMLS CUI [1]
C0018799
UMLS CUI [2]
C0017178
UMLS CUI [3]
C0023895
UMLS CUI [4]
C0024115
UMLS CUI [5]
C0022658
UMLS CUI [6]
C0021051
UMLS CUI [7,1]
C3843040
UMLS CUI [7,2]
C0332196
UMLS CUI [7,3]
C0854622
primary progressive multiple sclerosis patients or patients with secondary progressive multiple sclerosis with lack of recent clinical relapses for more than 2 years
Description

Multiple Sclerosis, Primary Progressive | Secondary Progressive Multiple Sclerosis Relapse Lacking

Type de données

boolean

Alias
UMLS CUI [1]
C0751964
UMLS CUI [2,1]
C0751965
UMLS CUI [2,2]
C0035020
UMLS CUI [2,3]
C0332268
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Similar models

Eligibility Multiple Sclerosis NCT00468182

1 Formulaires
Name
Type
Description | Question | Decode (Coded Value)
Type de données
Alias
Item Group
C1512693 (UMLS CUI)
Age
Item
males and females, 18 to 60 year old, inclusive.
boolean
C0001779 (UMLS CUI [1])
Multiple Sclerosis, Acute Relapsing | Demyelination Episode Quantity | Magnetic resonance imaging of brain abnormal
Item
diagnosis of a relapsing form of multiple sclerosis as determined by revised mcdonald criteria or at least one clinical demyelinating episode with abnormal brain mri study based on champs criteria
boolean
C0393664 (UMLS CUI [1])
C0011304 (UMLS CUI [2,1])
C0332189 (UMLS CUI [2,2])
C1265611 (UMLS CUI [2,3])
C1319851 (UMLS CUI [3])
Kurtzke multiple sclerosis rating scale
Item
expanded disability status scale (edss) score less than 6 at entry.
boolean
C0451246 (UMLS CUI [1])
Informed Consent
Item
understand and sign written informed consent prior to any testing under this protocol, including screening tests and evaluations that are not considered part of the subject's routine care.
boolean
C0021430 (UMLS CUI [1])
Item Group
C0680251 (UMLS CUI)
Adrenal Cortex Hormones | Biological Response Modifiers
Item
treatment with corticosteroids within one month prior to the study. treatment with immunomodulatory drugs within last 3 months prior to the study.
boolean
C0001617 (UMLS CUI [1])
C0005525 (UMLS CUI [2])
Pharmaceutical Preparations Interferon-beta Based
Item
no history of treatment with interferon-beta(ifn-beta) based drugs to exclude the possibility of ifn-beta neutralizing antibodies
boolean
C0013227 (UMLS CUI [1,1])
C0015980 (UMLS CUI [1,2])
C1705938 (UMLS CUI [1,3])
Pregnancy | Pregnancy, Planned | Breast Feeding
Item
any patient who is pregnant, intend to become pregnant, or breastfeeding at any time of the study.
boolean
C0032961 (UMLS CUI [1])
C0032992 (UMLS CUI [2])
C0006147 (UMLS CUI [3])
Heart Diseases | Gastrointestinal Diseases | Liver diseases | Lung diseases | Kidney Diseases | Immunologic Deficiency Syndromes | Medical condition Excludes Beta interferon therapy
Item
history of any significant cardiac, gastrointestinal, hepatic, pulmonary, or renal disease; immune deficiency; or other medical conditions that would preclude ifn-beta therapy.
boolean
C0018799 (UMLS CUI [1])
C0017178 (UMLS CUI [2])
C0023895 (UMLS CUI [3])
C0024115 (UMLS CUI [4])
C0022658 (UMLS CUI [5])
C0021051 (UMLS CUI [6])
C3843040 (UMLS CUI [7,1])
C0332196 (UMLS CUI [7,2])
C0854622 (UMLS CUI [7,3])
Multiple Sclerosis, Primary Progressive | Secondary Progressive Multiple Sclerosis Relapse Lacking
Item
primary progressive multiple sclerosis patients or patients with secondary progressive multiple sclerosis with lack of recent clinical relapses for more than 2 years
boolean
C0751964 (UMLS CUI [1])
C0751965 (UMLS CUI [2,1])
C0035020 (UMLS CUI [2,2])
C0332268 (UMLS CUI [2,3])
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