ID

156

Beschreibung

ODM derived from http://clinicaltrials.gov/show/

Link

http://clinicaltrials.gov/show/

Stichworte

Versionen (2)
  1. 07.02.12 07.02.12 -
  2. 22.12.14 22.12.14 - Martin Dugas
Hochgeladen am

7. Februar 2012

DOI

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Eligibility NCT01428726 Relapsing Remitting Multiple Sclerosis

Deutsch Englisch

Eligibility

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

Inclusion Criteria

Alter 18 bis 55 Jahre
Beschreibung

Age

Datentyp

boolean

Patients who meet the diagnosis criteria for RRMS
Beschreibung

Relapsing Remitting Multiple Sclerosis

Datentyp

boolean

clinical disability measured by EDSS score between 0 and 5.0
Beschreibung

EDSS score

Datentyp

boolean

Exclusion Criteria
Beschreibung

Exclusion Criteria

Patients with medical conditions such as diabetes, hypotension, insulinoma, hyperuricemia, or other conditions (drug abuse, inability to consent or to perform all the procedures of the clinical trial)
Beschreibung

medical conditions

Datentyp

boolean

Patients who had received or are candidates for liver transplantation
Beschreibung

Liver transplantation

Datentyp

boolean

Relapse in the 30 days period before baseline visit
Beschreibung

Relapse

Datentyp

boolean

Patients with corticosteroid therapy in the last month, interferon-beta or glatiramer acetate in the last 3 months, or natalizumab in the last 6 months
Beschreibung

Medications

Datentyp

boolean

Patients treated with chemotherapy
Beschreibung

Chemotherapy

Datentyp

boolean

Positive pregnancy test, breast feeding women or childbearing potential
Beschreibung

Positive pregnancy test

Datentyp

boolean

Medical Concepts
Beschreibung

Medical Concepts

Alter
Beschreibung

Age

Datentyp

string

Alias
UMLS CUI
C0001779
SNOMED CT 2010_0731
102518004
Diagnose
Beschreibung

Diagnosis

Datentyp

string

Alias
UMLS CUI
C0011900
SNOMED CT 2010_0731
439401001
LOINC Version 232
MTHU008876
Multiple Sclerosis, Relapsing-Remitting
Beschreibung

Multiple Sclerosis, Relapsing-Remitting

Datentyp

string

Alias
UMLS CUI
C0751967
SNOMED CT 2010_0731
42637300
MedDRA 13.1
10063399
Kurtzke multiple sclerosis rating scale, Expanded Disability Status Scale
Beschreibung

EDSS

Datentyp

string

Alias
UMLS CUI
C0451246
SNOMED CT 2010_0731
273554001
Diabetes mellitus
Beschreibung

Diabetes mellitus

Datentyp

string

Alias
UMLS CUI
C0011849
SNOMED CT 2010_0731
191044006
Hypotonie
Beschreibung

Hypotension

Datentyp

string

Alias
UMLS CUI
C0020649
SNOMED CT 2010_0731
45007003
MedDRA 13.1
10021097
LOINC Version 232
MTHU020790
ICD-10-CM Version 2010
195.9
ICD-9-CM Version 2011
458.9
CTCAE Version 4.03
E13791
Insulinom
Beschreibung

insulinoma

Datentyp

string

Alias
UMLS CUI
C0021670
SNOMED CT 2010_0731
25324008
MedDRA 13.1
10022498
Hyperurikämie
Beschreibung

Hyperuricemia

Datentyp

string

Alias
UMLS CUI
C0740394
SNOMED CT 2010_0731
35885006
MedDRA 13.1
10020903
CTCAE Version 4.03
E12305
Drug abuse
Beschreibung

Drug abuse

Datentyp

string

Alias
UMLS CUI
C0013146
SNOMED CT 2010_0731
26416006
MedDRA 13.1
10013654
LOINC Version 232
LP36310-8
ICD-9-CM Version 2011
305.90
Compliance
Beschreibung

Compliance

Datentyp

string

Alias
UMLS CUI
C1321605
SNOMED CT 2010_0731
405078008
Lebertransplantation
Beschreibung

Transplantation of liver

Datentyp

string

Alias
UMLS CUI
C0023911
SNOMED CT 2010_0731
18027006
MedDRA 13.1
10024714
ICD-9-CM Version 2011
50.5
Recurrent Disease
Beschreibung

Relapse

Datentyp

string

Alias
UMLS CUI
C0277556
SNOMED CT 2010_0731
58184002
Corticosteroid therapy
Beschreibung

Steroid therapy

Datentyp

string

Alias
UMLS CUI
C0149783
SNOMED CT 2010_0731
297279009
MedDRA 13.1
10062117
Chemotherapie
Beschreibung

Chemotherapy

Datentyp

string

Alias
UMLS CUI
C0392920
SNOMED CT 2010_0731
150415003
Schwangerschaftstest
Beschreibung

Pregnancy Tests

Datentyp

string

Alias
UMLS CUI
C0032976
SNOMED CT 2010_0731
74036000
MedDRA 13.1
10036572
Breast feeding, Nursing
Beschreibung

Lactation

Datentyp

string

Alias
UMLS CUI
C0006147
MedDRA 13.1
10006247
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Ähnliche Modelle

Eligibility

1 Formulare
  1. StudyEvent: Eligibility
    1. Eligibility
Name
Typ
Description | Question | Decode (Coded Value)
Datentyp
Alias
Age
Item
Alter 18 bis 55 Jahre
boolean
Relapsing Remitting Multiple Sclerosis
Item
Patients who meet the diagnosis criteria for RRMS
boolean
EDSS score
Item
clinical disability measured by EDSS score between 0 and 5.0
boolean
medical conditions
Item
Patients with medical conditions such as diabetes, hypotension, insulinoma, hyperuricemia, or other conditions (drug abuse, inability to consent or to perform all the procedures of the clinical trial)
boolean
Liver transplantation
Item
Patients who had received or are candidates for liver transplantation
boolean
Relapse
Item
Relapse in the 30 days period before baseline visit
boolean
Medications
Item
Patients with corticosteroid therapy in the last month, interferon-beta or glatiramer acetate in the last 3 months, or natalizumab in the last 6 months
boolean
Chemotherapy
Item
Patients treated with chemotherapy
boolean
Positive pregnancy test
Item
Positive pregnancy test, breast feeding women or childbearing potential
boolean
Age
Item
Alter
string
C0001779 (UMLS CUI)
102518004 (SNOMED CT 2010_0731)
Diagnosis
Item
Diagnose
string
C0011900 (UMLS CUI)
439401001 (SNOMED CT 2010_0731)
MTHU008876 (LOINC Version 232)
Multiple Sclerosis, Relapsing-Remitting
Item
Multiple Sclerosis, Relapsing-Remitting
string
C0751967 (UMLS CUI)
42637300 (SNOMED CT 2010_0731)
10063399 (MedDRA 13.1)
EDSS
Item
Kurtzke multiple sclerosis rating scale, Expanded Disability Status Scale
string
C0451246 (UMLS CUI)
273554001 (SNOMED CT 2010_0731)
Diabetes mellitus
Item
Diabetes mellitus
string
C0011849 (UMLS CUI)
191044006 (SNOMED CT 2010_0731)
Hypotension
Item
Hypotonie
string
C0020649 (UMLS CUI)
45007003 (SNOMED CT 2010_0731)
10021097 (MedDRA 13.1)
MTHU020790 (LOINC Version 232)
195.9 (ICD-10-CM Version 2010)
458.9 (ICD-9-CM Version 2011)
E13791 (CTCAE Version 4.03)
insulinoma
Item
Insulinom
string
C0021670 (UMLS CUI)
25324008 (SNOMED CT 2010_0731)
10022498 (MedDRA 13.1)
Hyperuricemia
Item
Hyperurikämie
string
C0740394 (UMLS CUI)
35885006 (SNOMED CT 2010_0731)
10020903 (MedDRA 13.1)
E12305 (CTCAE Version 4.03)
Drug abuse
Item
Drug abuse
string
C0013146 (UMLS CUI)
26416006 (SNOMED CT 2010_0731)
10013654 (MedDRA 13.1)
LP36310-8 (LOINC Version 232)
305.90 (ICD-9-CM Version 2011)
Compliance
Item
Compliance
string
C1321605 (UMLS CUI)
405078008 (SNOMED CT 2010_0731)
Transplantation of liver
Item
Lebertransplantation
string
C0023911 (UMLS CUI)
18027006 (SNOMED CT 2010_0731)
10024714 (MedDRA 13.1)
50.5 (ICD-9-CM Version 2011)
Relapse
Item
Recurrent Disease
string
C0277556 (UMLS CUI)
58184002 (SNOMED CT 2010_0731)
Steroid therapy
Item
Corticosteroid therapy
string
C0149783 (UMLS CUI)
297279009 (SNOMED CT 2010_0731)
10062117 (MedDRA 13.1)
Chemotherapy
Item
Chemotherapie
string
C0392920 (UMLS CUI)
150415003 (SNOMED CT 2010_0731)
Pregnancy Tests
Item
Schwangerschaftstest
string
C0032976 (UMLS CUI)
74036000 (SNOMED CT 2010_0731)
10036572 (MedDRA 13.1)
Lactation
Item
Breast feeding, Nursing
string
C0006147 (UMLS CUI)
10006247 (MedDRA 13.1)
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