ID

175

Description

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

Link

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

Keywords

  1. 2/16/12 2/16/12 -
  2. 4/13/14 4/13/14 - Julian Varghese
Uploaded on

February 16, 2012

DOI

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License

Creative Commons BY-NC 3.0 Legacy

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Eligibility NCT00220779 Multiple sclerosis

Eligibility

  1. StudyEvent: Eligibility
    1. Eligibility
Einschlusskriterien
Description

Einschlusskriterien

Alter
Description

Age

Data type

boolean

Geschlecht
Description

Gender

Data type

boolean

Symptoms consistent with Multiple Sclerosis up to 5 years
Description

Symptoms of Multiple Sclerosis

Data type

boolean

Symptome Multiple Sklerose
Description

Diagnosis of Multiple Sclerosis

Data type

boolean

Diagnose Multiple Sklerose
Description

relapsing-remitting multiple sclerosis

Data type

boolean

Kurtzke Extended Disability Status Scale (EDSS) < 5.0
Description

Kurtzke Extended Disability Status Scale

Data type

boolean

Kontrazeption
Description

Contraception

Data type

boolean

Klinisch stabil
Description

Stable Disease

Data type

boolean

Hyperintense Läsionen in den Basalganglien im MRI
Description

Hyperintense lesions in the basal ganglia on MRI

Data type

boolean

Einverständniserklärung
Description

informed consent

Data type

boolean

Ausschlusskriterien
Description

Ausschlusskriterien

Schwanger, stillen oder ohne ausreichende Kontrazeption
Description

pregnant, breast feeding or without adequate contraception

Data type

boolean

Immunsuppression
Description

Immunomodulatory or immunosuppressive therapy

Data type

boolean

Steroid Therapie
Description

steroid therapy

Data type

boolean

Interferon, Glatiramer Azetat oder IGIV Therapie
Description

Therapy with interferons (Betaseron(R), Avonex(R), Rebif(R)), glatiramer acetate (Copaxone(R)) or IGIV

Data type

boolean

Use of an investigational compound within 6 months prior to study entry
Description

Use of an investigational compound

Data type

boolean

Herzerkrankungen
Description

heart diseases

Data type

boolean

Niereninsuffizienz
Description

renal insufficiency

Data type

boolean

IgA Defizienz
Description

IgA deficiency

Data type

boolean

Conditions whose symptoms and effects could alter protein catabolism and/or IgG utilization (e.g., protein-losing enteropathies, nephrotic syndrome)
Description

regulation of protein catabolic process

Data type

boolean

Medizinische Konzepte
Description

Medizinische Konzepte

Alter
Description

age

Data type

string

Alias
UMLS CUI
C0001779
SNOMED CT 2010_0731
102518004
Geschlecht
Description

Gender

Data type

string

Alias
UMLS CUI
C0079399
SNOMED CT 2010_0731
263495000
LOINC Version 232
MTHU002975
Diagnose
Description

diagnosis

Data type

string

Alias
UMLS CUI
C0011900
SNOMED CT 2010_0731
439401001
LOINC Version 232
MTHU008876
Medikamente
Description

Pharmaceutical Preparations

Data type

string

Alias
UMLS CUI
C0013227
Multiple Sklerose
Description

Multiple Sclerosis

Data type

string

Alias
UMLS CUI
C0026769
SNOMED CT 2010_0731
24700007
MedDRA 13.1
10028245
LOINC Version 232
MTHU020805
ICD-10-CM Version 2010
G35
ICD-9-CM Version 2011
340
Symptome
Description

Symptoms

Data type

string

Alias
UMLS CUI
C1457887
LOINC Version 232
MTHU021540
ICD-9-CM Version 2011
780-789.99
schubförmig remittierende Multiple Sklerose
Description

Multiple Sclerosis, Relapsing-Remitting

Data type

string

Alias
UMLS CUI
C0751967
SNOMED CT 2010_0731
426373005
MedDRA 13.1
10063399
Stabile Erkrankung
Description

Stable Disease

Data type

string

Alias
UMLS CUI
C0677946
Kontrazeption
Description

Contraception

Data type

string

Alias
UMLS CUI
C0700589
SNOMED CT 2010_0731
146680009
MedDRA 13.1
10010808
Hyperintense Läsionen in den Basalganglien im MRI
Description

Hyperintense lesions in the basal ganglia on MRI

Data type

string

Alias
UMLS CUI
C1865351
Einverständniserklärung
Description

Informed Consent

Data type

string

Alias
UMLS CUI
C0021430
pregnant
Description

pregnant

Data type

string

Alias
UMLS CUI
C0549206
MedDRA 13.1
10036586
Stillen, Stillzeit
Description

Mother currently breast-feeding

Data type

string

Alias
UMLS CUI
C0585066
SNOMED CT 2010_0731
169750002
Immunomodulatory or immunosuppressive therapy
Description

Immunomodulatory or immunosuppressive therapy

Data type

string

Alias
UMLS CUI
C1963758
SNOMED CT 2010_0731
86553008
MedDRA 13.1
10067473
Therapeutic Corticosteroid
Description

corticosteroids

Data type

string

Alias
UMLS CUI
C0001617
SNOMED CT 2010_0731
79440004
Steroide
Description

steroids

Data type

string

Alias
UMLS CUI
C0038317
SNOMED CT 2010_0731
116566001
Interferone
Description

Interferons

Data type

string

Alias
UMLS CUI
C0021747
SNOMED CT 2010_0731
49327004
LOINC Version 232
MTHU021353
Immunglobuline, intravenös
Description

Immunoglobulins, Intravenous

Data type

string

Alias
UMLS CUI
C0085297
SNOMED CT 2010_0731
350344000
HL7 V3 02-34
87
glatiramer acetate
Description

glatiramer acetate

Data type

string

Alias
UMLS CUI
C0289884
SNOMED CT 2010_0731
108755008
Kardiale Erkrankungen
Description

Heart Diseases

Data type

string

Alias
UMLS CUI
C0018799
SNOMED CT 2010_0731
56265001
MedDRA 13.1
10061024
ICD-10-CM Version 2010
I51.9
ICD-9-CM Version 2011
429.9
Niereninsuffizienz
Description

renal insufficiency

Data type

string

Alias
UMLS CUI
C1565489
MedDRA 13.1
10022467
Immunglobulin A Defizienz
Description

Immunoglobulin A deficiency

Data type

string

Alias
UMLS CUI
C0162538
SNOMED CT 2010_0731
29260007
MedDRA 13.1
10021260
regulation of protein catabolic process
Description

regulation of protein catabolic process

Data type

string

Alias
UMLS CUI
C1158003

Similar models

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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