Eligibility NCT00220779 Multiple sclerosis

ODM derived from http://clinicaltrials.gov/ct2/show/NCT00220779?term=NCT00220779&rank=1

Eligibility

  1. StudyEvent: Eligibility
    1. Eligibility
Name
Type
Description | Question | Decode (Coded Value)
Data type
Alias
Item Group
Einschlusskriterien
Age
Item
Alter
boolean
Gender
Item
Geschlecht
boolean
Symptoms of Multiple Sclerosis
Item
Symptoms consistent with Multiple Sclerosis up to 5 years
boolean
Diagnosis of Multiple Sclerosis
Item
Symptome Multiple Sklerose
boolean
relapsing-remitting multiple sclerosis
Item
Diagnose Multiple Sklerose
boolean
Kurtzke Extended Disability Status Scale
Item
Kurtzke Extended Disability Status Scale (EDSS) < 5.0
boolean
Contraception
Item
Kontrazeption
boolean
Stable Disease
Item
Klinisch stabil
boolean
Hyperintense lesions in the basal ganglia on MRI
Item
Hyperintense Läsionen in den Basalganglien im MRI
boolean
informed consent
Item
Einverständniserklärung
boolean
Item Group
Ausschlusskriterien
pregnant, breast feeding or without adequate contraception
Item
Schwanger, stillen oder ohne ausreichende Kontrazeption
boolean
Immunomodulatory or immunosuppressive therapy
Item
Immunsuppression
boolean
steroid therapy
Item
Steroid Therapie
boolean
Therapy with interferons (Betaseron(R), Avonex(R), Rebif(R)), glatiramer acetate (Copaxone(R)) or IGIV
Item
Interferon, Glatiramer Azetat oder IGIV Therapie
boolean
Use of an investigational compound
Item
Use of an investigational compound within 6 months prior to study entry
boolean
heart diseases
Item
Herzerkrankungen
boolean
renal insufficiency
Item
Niereninsuffizienz
boolean
IgA deficiency
Item
IgA Defizienz
boolean
regulation of protein catabolic process
Item
Conditions whose symptoms and effects could alter protein catabolism and/or IgG utilization (e.g., protein-losing enteropathies, nephrotic syndrome)
boolean
Item Group
Medizinische Konzepte
age
Item
Alter
string
C0001779 (UMLS CUI)
102518004 (SNOMED CT 2010_0731)
Gender
Item
Geschlecht
string
C0079399 (UMLS CUI)
263495000 (SNOMED CT 2010_0731)
MTHU002975 (LOINC Version 232)
diagnosis
Item
Diagnose
string
C0011900 (UMLS CUI)
439401001 (SNOMED CT 2010_0731)
MTHU008876 (LOINC Version 232)
Pharmaceutical Preparations
Item
Medikamente
string
C0013227 (UMLS CUI)
Multiple Sclerosis
Item
Multiple Sklerose
string
C0026769 (UMLS CUI)
24700007 (SNOMED CT 2010_0731)
10028245 (MedDRA 13.1)
MTHU020805 (LOINC Version 232)
G35 (ICD-10-CM Version 2010)
340 (ICD-9-CM Version 2011)
Symptoms
Item
Symptome
string
C1457887 (UMLS CUI)
MTHU021540 (LOINC Version 232)
780-789.99 (ICD-9-CM Version 2011)
Multiple Sclerosis, Relapsing-Remitting
Item
schubförmig remittierende Multiple Sklerose
string
C0751967 (UMLS CUI)
426373005 (SNOMED CT 2010_0731)
10063399 (MedDRA 13.1)
Stable Disease
Item
Stabile Erkrankung
string
C0677946 (UMLS CUI)
Contraception
Item
Kontrazeption
string
C0700589 (UMLS CUI)
146680009 (SNOMED CT 2010_0731)
10010808 (MedDRA 13.1)
Hyperintense lesions in the basal ganglia on MRI
Item
Hyperintense Läsionen in den Basalganglien im MRI
string
C1865351 (UMLS CUI)
Informed Consent
Item
Einverständniserklärung
string
C0021430 (UMLS CUI)
pregnant
Item
pregnant
string
C0549206 (UMLS CUI)
10036586 (MedDRA 13.1)
Mother currently breast-feeding
Item
Stillen, Stillzeit
string
C0585066 (UMLS CUI)
169750002 (SNOMED CT 2010_0731)
Immunomodulatory or immunosuppressive therapy
Item
Immunomodulatory or immunosuppressive therapy
string
C1963758 (UMLS CUI)
86553008 (SNOMED CT 2010_0731)
10067473 (MedDRA 13.1)
corticosteroids
Item
Therapeutic Corticosteroid
string
C0001617 (UMLS CUI)
79440004 (SNOMED CT 2010_0731)
steroids
Item
Steroide
string
C0038317 (UMLS CUI)
116566001 (SNOMED CT 2010_0731)
Interferons
Item
Interferone
string
C0021747 (UMLS CUI)
49327004 (SNOMED CT 2010_0731)
MTHU021353 (LOINC Version 232)
Immunoglobulins, Intravenous
Item
Immunglobuline, intravenös
string
C0085297 (UMLS CUI)
350344000 (SNOMED CT 2010_0731)
87 (HL7 V3 02-34)
glatiramer acetate
Item
glatiramer acetate
string
C0289884 (UMLS CUI)
108755008 (SNOMED CT 2010_0731)
Heart Diseases
Item
Kardiale Erkrankungen
string
C0018799 (UMLS CUI)
56265001 (SNOMED CT 2010_0731)
10061024 (MedDRA 13.1)
I51.9 (ICD-10-CM Version 2010)
429.9 (ICD-9-CM Version 2011)
renal insufficiency
Item
Niereninsuffizienz
string
C1565489 (UMLS CUI)
10022467 (MedDRA 13.1)
Immunoglobulin A deficiency
Item
Immunglobulin A Defizienz
string
C0162538 (UMLS CUI)
29260007 (SNOMED CT 2010_0731)
10021260 (MedDRA 13.1)
regulation of protein catabolic process
Item
regulation of protein catabolic process
string
C1158003 (UMLS CUI)

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