ID

156

Description

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

Link

http://clinicaltrials.gov/show/

Keywords

Versions (2)
  1. 2/7/12 2/7/12 -
  2. 12/22/14 12/22/14 - Martin Dugas
Uploaded on

February 7, 2012

DOI

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License

Creative Commons BY-NC 3.0 Legacy
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Eligibility NCT01428726 Relapsing Remitting Multiple Sclerosis

German English

Eligibility

1 forms  
  1. StudyEvent: Eligibility
    1. Eligibility
Inclusion Criteria
Description

Inclusion Criteria

Age 18 Years to 55 Years
Description

Age

Data type

boolean

Patients who meet the diagnosis criteria for RRMS
Description

Relapsing Remitting Multiple Sclerosis

Data type

boolean

clinical disability measured by EDSS score between 0 and 5.0
Description

EDSS score

Data type

boolean

Exclusion Criteria
Description

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)
Description

medical conditions

Data type

boolean

Patients who had received or are candidates for liver transplantation
Description

Liver transplantation

Data type

boolean

Relapse in the 30 days period before baseline visit
Description

Relapse

Data type

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
Description

Medications

Data type

boolean

Patients treated with chemotherapy
Description

Chemotherapy

Data type

boolean

Positive pregnancy test, breast feeding women or childbearing potential
Description

Positive pregnancy test

Data type

boolean

Medical Concepts
Description

Medical Concepts

Age
Description

Age

Data type

string

Alias
UMLS CUI
C0001779
SNOMED CT 2010_0731
102518004
Diagnosis
Description

Diagnosis

Data type

string

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

Multiple Sclerosis, Relapsing-Remitting

Data type

string

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

EDSS

Data type

string

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

Diabetes mellitus

Data type

string

Alias
UMLS CUI
C0011849
SNOMED CT 2010_0731
191044006
Hypotension
Description

Hypotension

Data type

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
insulinoma
Description

insulinoma

Data type

string

Alias
UMLS CUI
C0021670
SNOMED CT 2010_0731
25324008
MedDRA 13.1
10022498
Hyperuricemia
Description

Hyperuricemia

Data type

string

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

Drug abuse

Data type

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
Description

Compliance

Data type

string

Alias
UMLS CUI
C1321605
SNOMED CT 2010_0731
405078008
Transplantation of liver
Description

Transplantation of liver

Data type

string

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

Relapse

Data type

string

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

Steroid therapy

Data type

string

Alias
UMLS CUI
C0149783
SNOMED CT 2010_0731
297279009
MedDRA 13.1
10062117
Chemotherapy
Description

Chemotherapy

Data type

string

Alias
UMLS CUI
C0392920
SNOMED CT 2010_0731
150415003
Pregnancy Tests
Description

Pregnancy Tests

Data type

string

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

Lactation

Data type

string

Alias
UMLS CUI
C0006147
MedDRA 13.1
10006247
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Similar models

Eligibility

1 forms
  1. StudyEvent: Eligibility
    1. Eligibility
Name
Type
Description | Question | Decode (Coded Value)
Data type
Alias
Item Group
Inclusion Criteria
Age
Item
Age 18 Years to 55 Years
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
Item Group
Exclusion Criteria
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
Item Group
Medical Concepts
Age
Item
Age
string
C0001779 (UMLS CUI)
102518004 (SNOMED CT 2010_0731)
Diagnosis
Item
Diagnosis
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
Hypotension
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
insulinoma
string
C0021670 (UMLS CUI)
25324008 (SNOMED CT 2010_0731)
10022498 (MedDRA 13.1)
Hyperuricemia
Item
Hyperuricemia
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
Transplantation of liver
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
Chemotherapy
string
C0392920 (UMLS CUI)
150415003 (SNOMED CT 2010_0731)
Pregnancy Tests
Item
Pregnancy Tests
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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