Informationen:
Fehler:
ID
36524
Beschreibung
An Intravenous Infusion Study of rHIgM22 in Patients With Multiple Sclerosis Immediately Following a Relapse; ODM derived from: https://clinicaltrials.gov/show/NCT02398461
Link
https://clinicaltrials.gov/show/NCT02398461
Stichworte
Versionen (1)
- 20.05.19 20.05.19 -
Rechteinhaber
See clinicaltrials.gov
Hochgeladen am
20. Mai 2019
DOI
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Lizenz
Creative Commons BY 4.0
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Eligibility Multiple Sclerosis, Acute Relapsing NCT02398461
Eligibility Multiple Sclerosis, Acute Relapsing NCT02398461
- StudyEvent: Eligibility
Ähnliche Modelle
Eligibility Multiple Sclerosis, Acute Relapsing NCT02398461
- StudyEvent: Eligibility
Name
Typ
Description | Question | Decode (Coded Value)
Datentyp
Alias
Age | Body Weight
Item
males or females (18-70 years of age; < 104 kg)
boolean
C0001779 (UMLS CUI [1])
C0005910 (UMLS CUI [2])
C0005910 (UMLS CUI [2])
Informed Consent
Item
capable of giving informed consent
boolean
C0021430 (UMLS CUI [1])
Multiple Sclerosis
Item
meet diagnostic criteria for ms, as defined by revised (2010) mcdonald criteria
boolean
C0026769 (UMLS CUI [1])
Relapse | Neurologic Symptoms New Multiple Sclerosis | Neurologic Symptoms Worsening Multiple Sclerosis | Status post Neurological status Stable | Status post Neurological status Improving | Fever Absent | Communicable Disease Absent | Neurologic Examination
Item
present with a clinical acute relapse defined as a new or worsening neurological symptoms attributable to ms preceded by a stable or improving neurological state of at least 30 days, not associated with fever or infection, lasting at least 24 hours and accompanied by an objective physical (neurological) exam finding as confirmed by the investigator
boolean
C0035020 (UMLS CUI [1])
C0235031 (UMLS CUI [2,1])
C0205314 (UMLS CUI [2,2])
C0026769 (UMLS CUI [2,3])
C0235031 (UMLS CUI [3,1])
C0332271 (UMLS CUI [3,2])
C0026769 (UMLS CUI [3,3])
C0231290 (UMLS CUI [4,1])
C0746866 (UMLS CUI [4,2])
C0205360 (UMLS CUI [4,3])
C0231290 (UMLS CUI [5,1])
C0746866 (UMLS CUI [5,2])
C1272745 (UMLS CUI [5,3])
C0015967 (UMLS CUI [6,1])
C0332197 (UMLS CUI [6,2])
C0009450 (UMLS CUI [7,1])
C0332197 (UMLS CUI [7,2])
C0027853 (UMLS CUI [8])
C0235031 (UMLS CUI [2,1])
C0205314 (UMLS CUI [2,2])
C0026769 (UMLS CUI [2,3])
C0235031 (UMLS CUI [3,1])
C0332271 (UMLS CUI [3,2])
C0026769 (UMLS CUI [3,3])
C0231290 (UMLS CUI [4,1])
C0746866 (UMLS CUI [4,2])
C0205360 (UMLS CUI [4,3])
C0231290 (UMLS CUI [5,1])
C0746866 (UMLS CUI [5,2])
C1272745 (UMLS CUI [5,3])
C0015967 (UMLS CUI [6,1])
C0332197 (UMLS CUI [6,2])
C0009450 (UMLS CUI [7,1])
C0332197 (UMLS CUI [7,2])
C0027853 (UMLS CUI [8])
Measurable lesion New Quantity MRI gadolinium-enhanced
Item
has at least one new, identifiable, measurable and active lesion on mri (gd+) meeting the criteria of the imaging charter.
boolean
C1513041 (UMLS CUI [1,1])
C0205314 (UMLS CUI [1,2])
C1265611 (UMLS CUI [1,3])
C0855566 (UMLS CUI [1,4])
C0205314 (UMLS CUI [1,2])
C1265611 (UMLS CUI [1,3])
C0855566 (UMLS CUI [1,4])
Comorbidity Specified | Pregnancy
Item
certain specified co-morbidities (including pregnancy)
boolean
C0009488 (UMLS CUI [1,1])
C0205369 (UMLS CUI [1,2])
C0032961 (UMLS CUI [2])
C0205369 (UMLS CUI [1,2])
C0032961 (UMLS CUI [2])
Prescribed medication
Item
taking certain proscribed medications
boolean
C2239117 (UMLS CUI [1])
Treatment regimen Changed
Item
a medical regimen that has changed in the month prior to screening
boolean
C0040808 (UMLS CUI [1,1])
C0392747 (UMLS CUI [1,2])
C0392747 (UMLS CUI [1,2])
MRI Evaluation Receive Unable
Item
inability to undergo requisite mri evaluations
boolean
C0024485 (UMLS CUI [1,1])
C1261322 (UMLS CUI [1,2])
C1514756 (UMLS CUI [1,3])
C1299582 (UMLS CUI [1,4])
C1261322 (UMLS CUI [1,2])
C1514756 (UMLS CUI [1,3])
C1299582 (UMLS CUI [1,4])
Substance Use Disorders
Item
drug or alcohol abuse
boolean
C0038586 (UMLS CUI [1])
Factor Study Subject Participation Status Unfavorable
Item
any other reason for which, in the opinion of the investigator, the subject should not participate in the study.
boolean
C1521761 (UMLS CUI [1,1])
C2348568 (UMLS CUI [1,2])
C3640815 (UMLS CUI [1,3])
C2348568 (UMLS CUI [1,2])
C3640815 (UMLS CUI [1,3])