Information:
Fel:
ID
16662
Beskrivning
Safety and Efficacy of Natalizumab in the Treatment of Multiple Sclerosis; ODM derived from: https://clinicaltrials.gov/show/NCT00027300
Länk
https://clinicaltrials.gov/show/NCT00027300
Nyckelord
Versioner (1)
- 2016-07-30 2016-07-30 -
Uppladdad den
30 juli 2016
DOI
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Licens
Creative Commons BY 4.0
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Eligibility Multiple Sclerosis, Relapsing-Remitting NCT00027300
Eligibility Multiple Sclerosis, Relapsing-Remitting NCT00027300
- StudyEvent: Eligibility
Similar models
Eligibility Multiple Sclerosis, Relapsing-Remitting NCT00027300
- StudyEvent: Eligibility
Name
Typ
Description | Question | Decode (Coded Value)
Datatyp
Alias
multiple sclerosis
Item
diagnosis of ms, as defined by mcdonald et al., criteria # 1-4 (mcdonald et al., 2001)
boolean
C0026769 (UMLS CUI [1])
age
Item
between the ages of 18 and 50, inclusive.
boolean
C0001779 (UMLS CUI [1])
baseline edss score
Item
baseline edss score between 0.0 and 5.0, inclusive.
boolean
C3830336 (UMLS CUI [1])
relapse
Item
have experienced at least one relapse within the 12 months prior to randomization.
boolean
C0856120 (UMLS CUI [1])
cranial mri scan
Item
cranial mri scan demonstrating lesion(s) consistent with ms.
boolean
C0412674 (UMLS CUI [1,1])
C0221198 (UMLS CUI [1,2])
C0221198 (UMLS CUI [1,2])
written informed consent
Item
have given written informed consent to participate in the study.
boolean
C0021430 (UMLS CUI [1])
primary progressive, secondary progressive, or progressive relapsing ms.
Item
primary progressive, secondary progressive, or progressive relapsing ms.
boolean
C0751964 (UMLS CUI [1])
C0751965 (UMLS CUI [2])
C0393666 (UMLS CUI [3])
C0751965 (UMLS CUI [2])
C0393666 (UMLS CUI [3])
ms relapse
Item
ms relapse has occurred,in the opinion of the investigator, within 50 days prior to randomization and/or the subject has not stabilized from a previous relapse.
boolean
C0856120 (UMLS CUI [1])
communicable disease
Item
a clinically significant infectious illness within 30 days prior to randomization.
boolean
C0009450 (UMLS CUI [1])
abnormal laboratory results contraindicative for the administration of a recombinant humanized antibody
Item
history of, or abnormal laboratory results indicative of any significant cardiac, endocrinologic, hematologic, hepatic, immunologic, metabolic, urologic, pulmonary, gastrointestinal, dermatologic, psychiatric, renal and/or other major disease, that in the opinion of the investigator, would preclude the administration of a recombinant humanized antibody immunomodulating agent for 116 weeks.
boolean
C1254595 (UMLS CUI [1,1])
C0522473 (UMLS CUI [1,2])
C2985546 (UMLS CUI [1,3])
C0522473 (UMLS CUI [1,2])
C2985546 (UMLS CUI [1,3])
drug hypersensitivity.
Item
history of severe allergic or anaphylactic reactions or known drug hypersensitivity.
boolean
C0013182 (UMLS CUI [1])
unable to perform the timed 25-foot walk, 9hpt, and pasat 3.
Item
unable to perform the timed 25-foot walk, 9hpt, and pasat 3.
boolean
C3897356 (UMLS CUI [1])
abnormal blood tests
Item
abnormal blood tests performed at the screening visit.
boolean
C0854146 (UMLS CUI [1])