ID

175

Beschreibung

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

Link

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

Stichworte

Versionen (2)
  1. 16.02.12 16.02.12 -
  2. 13.04.14 13.04.14 - Julian Varghese
Hochgeladen am

16. Februar 2012

DOI

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Eligibility NCT00220779 Multiple sclerosis

Deutsch Englisch

Eligibility

1 Formulare  
  1. StudyEvent: Eligibility
    1. Eligibility
Inclusion Criteria
Beschreibung

Inclusion Criteria

18 Years to 55 Years
Beschreibung

Age

Datentyp

boolean

both
Beschreibung

Gender

Datentyp

boolean

Symptoms consistent with Multiple Sclerosis up to 5 years
Beschreibung

Symptoms of Multiple Sclerosis

Datentyp

boolean

Diagnosis of multiple sclerosis according to McDonald criteria.
Beschreibung

Diagnosis of Multiple Sclerosis

Datentyp

boolean

Diagnosis of relapsing-remitting (RR) multiple sclerosis (MS) (Defined as periods of worsening of neurological function with full recovery or with sequelae and residual deficit upon recovery, periods between disease relapses characterized by lack of disease progression)
Beschreibung

relapsing-remitting multiple sclerosis

Datentyp

boolean

Kurtzke Extended Disability Status Scale (EDSS) < 5.0
Beschreibung

Kurtzke Extended Disability Status Scale

Datentyp

boolean

Females or males, females of childbearing potential must use adequate contraception
Beschreibung

Contraception

Datentyp

boolean

Clinically stable for at least 30 days prior to entry
Beschreibung

Stable Disease

Datentyp

boolean

At least 9 hyperintense T2 lesions on MRI or 1 Gd-enhancing lesion according to McDonald/Barkhof dissemination-in-space criteria at entry
Beschreibung

Hyperintense lesions in the basal ganglia on MRI

Datentyp

boolean

Written informed consent obtained prior to the initiation of any study related procedures
Beschreibung

informed consent

Datentyp

boolean

Exclusion criteria
Beschreibung

Exclusion criteria

Females who are pregnant, breast feeding, or if, of childbearing potential, unwilling to practice adequate contraception throughout the study
Beschreibung

pregnant, breast feeding or without adequate contraception

Datentyp

boolean

Prior therapy with azathioprine or any immunosuppressant agents within 6 months prior to study entry
Beschreibung

Immunomodulatory or immunosuppressive therapy

Datentyp

boolean

Prior steroid, methylprednisolone or adrenocorticotropic hormone (ACTH) therapy within 30 days prior to study entry
Beschreibung

steroid therapy

Datentyp

boolean

Therapy with interferons (Betaseron(R), Avonex(R), Rebif(R)), glatiramer acetate (Copaxone(R)) or IGIV within 3 months prior to study entry or during the study
Beschreibung

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

Datentyp

boolean

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

Use of an investigational compound

Datentyp

boolean

Cardiac insufficiency (NYHA III/IV), cardiomyopathy, significant cardiac dysrhythmia requiring treatment, unstable or advanced ischemic heart disease (CCS III or IV), or malignant hypertension
Beschreibung

heart diseases

Datentyp

boolean

History of renal insufficiency or serum creatinine levels greater than 2.5 mg/dL (221 umol/L)
Beschreibung

renal insufficiency

Datentyp

boolean

Known selective IgA deficiency or known antibodies to IgA
Beschreibung

IgA deficiency

Datentyp

boolean

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

regulation of protein catabolic process

Datentyp

boolean

Medical Concepts
Beschreibung

Medical Concepts

age
Beschreibung

age

Datentyp

string

Alias
UMLS CUI
C0001779
SNOMED CT 2010_0731
102518004
gender
Beschreibung

Gender

Datentyp

string

Alias
UMLS CUI
C0079399
SNOMED CT 2010_0731
263495000
LOINC Version 232
MTHU002975
diagnosis
Beschreibung

diagnosis

Datentyp

string

Alias
UMLS CUI
C0011900
SNOMED CT 2010_0731
439401001
LOINC Version 232
MTHU008876
Medication
Beschreibung

Pharmaceutical Preparations

Datentyp

string

Alias
UMLS CUI
C0013227
Multiple Sclerosis
Beschreibung

Multiple Sclerosis

Datentyp

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
Symptoms
Beschreibung

Symptoms

Datentyp

string

Alias
UMLS CUI
C1457887
LOINC Version 232
MTHU021540
ICD-9-CM Version 2011
780-789.99
Multiple Sclerosis, Relapsing-Remitting
Beschreibung

Multiple Sclerosis, Relapsing-Remitting

Datentyp

string

Alias
UMLS CUI
C0751967
SNOMED CT 2010_0731
426373005
MedDRA 13.1
10063399
Stable Disease
Beschreibung

Stable Disease

Datentyp

string

Alias
UMLS CUI
C0677946
Contraception
Beschreibung

Contraception

Datentyp

string

Alias
UMLS CUI
C0700589
SNOMED CT 2010_0731
146680009
MedDRA 13.1
10010808
Hyperintense lesions in the basal ganglia on MRI
Beschreibung

Hyperintense lesions in the basal ganglia on MRI

Datentyp

string

Alias
UMLS CUI
C1865351
Informed Consent
Beschreibung

Informed Consent

Datentyp

string

Alias
UMLS CUI
C0021430
pregnant
Beschreibung

pregnant

Datentyp

string

Alias
UMLS CUI
C0549206
MedDRA 13.1
10036586
Mother currently breast-feeding
Beschreibung

Mother currently breast-feeding

Datentyp

string

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

Immunomodulatory or immunosuppressive therapy

Datentyp

string

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

corticosteroids

Datentyp

string

Alias
UMLS CUI
C0001617
SNOMED CT 2010_0731
79440004
steroids
Beschreibung

steroids

Datentyp

string

Alias
UMLS CUI
C0038317
SNOMED CT 2010_0731
116566001
Interferons
Beschreibung

Interferons

Datentyp

string

Alias
UMLS CUI
C0021747
SNOMED CT 2010_0731
49327004
LOINC Version 232
MTHU021353
Immunoglobulins, Intravenous
Beschreibung

Immunoglobulins, Intravenous

Datentyp

string

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

glatiramer acetate

Datentyp

string

Alias
UMLS CUI
C0289884
SNOMED CT 2010_0731
108755008
Cardiac disorder
Beschreibung

Heart Diseases

Datentyp

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
Renal Insufficiency
Beschreibung

renal insufficiency

Datentyp

string

Alias
UMLS CUI
C1565489
MedDRA 13.1
10022467
Immunoglobulin A deficiency
Beschreibung

Immunoglobulin A deficiency

Datentyp

string

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

regulation of protein catabolic process

Datentyp

string

Alias
UMLS CUI
C1158003
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Ähnliche Modelle

Eligibility

1 Formulare
  1. StudyEvent: Eligibility
    1. Eligibility
Name
Typ
Description | Question | Decode (Coded Value)
Datentyp
Alias
Item Group
Inclusion Criteria
Age
Item
18 Years to 55 Years
boolean
Gender
Item
both
boolean
Symptoms of Multiple Sclerosis
Item
Symptoms consistent with Multiple Sclerosis up to 5 years
boolean
Diagnosis of Multiple Sclerosis
Item
Diagnosis of multiple sclerosis according to McDonald criteria.
boolean
relapsing-remitting multiple sclerosis
Item
Diagnosis of relapsing-remitting (RR) multiple sclerosis (MS) (Defined as periods of worsening of neurological function with full recovery or with sequelae and residual deficit upon recovery, periods between disease relapses characterized by lack of disease progression)
boolean
Kurtzke Extended Disability Status Scale
Item
Kurtzke Extended Disability Status Scale (EDSS) < 5.0
boolean
Contraception
Item
Females or males, females of childbearing potential must use adequate contraception
boolean
Stable Disease
Item
Clinically stable for at least 30 days prior to entry
boolean
Hyperintense lesions in the basal ganglia on MRI
Item
At least 9 hyperintense T2 lesions on MRI or 1 Gd-enhancing lesion according to McDonald/Barkhof dissemination-in-space criteria at entry
boolean
informed consent
Item
Written informed consent obtained prior to the initiation of any study related procedures
boolean
Item Group
Exclusion criteria
pregnant, breast feeding or without adequate contraception
Item
Females who are pregnant, breast feeding, or if, of childbearing potential, unwilling to practice adequate contraception throughout the study
boolean
Immunomodulatory or immunosuppressive therapy
Item
Prior therapy with azathioprine or any immunosuppressant agents within 6 months prior to study entry
boolean
steroid therapy
Item
Prior steroid, methylprednisolone or adrenocorticotropic hormone (ACTH) therapy within 30 days prior to study entry
boolean
Therapy with interferons (Betaseron(R), Avonex(R), Rebif(R)), glatiramer acetate (Copaxone(R)) or IGIV
Item
Therapy with interferons (Betaseron(R), Avonex(R), Rebif(R)), glatiramer acetate (Copaxone(R)) or IGIV within 3 months prior to study entry or during the study
boolean
Use of an investigational compound
Item
Use of an investigational compound within 6 months prior to study entry
boolean
heart diseases
Item
Cardiac insufficiency (NYHA III/IV), cardiomyopathy, significant cardiac dysrhythmia requiring treatment, unstable or advanced ischemic heart disease (CCS III or IV), or malignant hypertension
boolean
renal insufficiency
Item
History of renal insufficiency or serum creatinine levels greater than 2.5 mg/dL (221 umol/L)
boolean
IgA deficiency
Item
Known selective IgA deficiency or known antibodies to IgA
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
Medical Concepts
age
Item
age
string
C0001779 (UMLS CUI)
102518004 (SNOMED CT 2010_0731)
Gender
Item
gender
string
C0079399 (UMLS CUI)
263495000 (SNOMED CT 2010_0731)
MTHU002975 (LOINC Version 232)
diagnosis
Item
diagnosis
string
C0011900 (UMLS CUI)
439401001 (SNOMED CT 2010_0731)
MTHU008876 (LOINC Version 232)
Pharmaceutical Preparations
Item
Medication
string
C0013227 (UMLS CUI)
Multiple Sclerosis
Item
Multiple Sclerosis
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
Symptoms
string
C1457887 (UMLS CUI)
MTHU021540 (LOINC Version 232)
780-789.99 (ICD-9-CM Version 2011)
Multiple Sclerosis, Relapsing-Remitting
Item
Multiple Sclerosis, Relapsing-Remitting
string
C0751967 (UMLS CUI)
426373005 (SNOMED CT 2010_0731)
10063399 (MedDRA 13.1)
Stable Disease
Item
Stable Disease
string
C0677946 (UMLS CUI)
Contraception
Item
Contraception
string
C0700589 (UMLS CUI)
146680009 (SNOMED CT 2010_0731)
10010808 (MedDRA 13.1)
Hyperintense lesions in the basal ganglia on MRI
Item
Hyperintense lesions in the basal ganglia on MRI
string
C1865351 (UMLS CUI)
Informed Consent
Item
Informed Consent
string
C0021430 (UMLS CUI)
pregnant
Item
pregnant
string
C0549206 (UMLS CUI)
10036586 (MedDRA 13.1)
Mother currently breast-feeding
Item
Mother currently breast-feeding
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
steroids
string
C0038317 (UMLS CUI)
116566001 (SNOMED CT 2010_0731)
Interferons
Item
Interferons
string
C0021747 (UMLS CUI)
49327004 (SNOMED CT 2010_0731)
MTHU021353 (LOINC Version 232)
Immunoglobulins, Intravenous
Item
Immunoglobulins, Intravenous
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
Cardiac disorder
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
Renal Insufficiency
string
C1565489 (UMLS CUI)
10022467 (MedDRA 13.1)
Immunoglobulin A deficiency
Item
Immunoglobulin A deficiency
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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