ID

30937

Descrição

AT RISK FOR MS - Clinical Conversion of Female Monozygotic Twins Discordant for CIS/MS; ODM derived from: https://clinicaltrials.gov/show/NCT00617383

Link

https://clinicaltrials.gov/show/NCT00617383

Palavras-chave

Versões (1)
  1. 04/07/2018 04/07/2018 -
Titular dos direitos

See clinicaltrials.gov

Transferido a

4 de julho de 2018

DOI

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Licença

Creative Commons BY 4.0
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Eligibility Multiple Sclerosis NCT00617383

Inglês

Eligibility Multiple Sclerosis NCT00617383

1 Formulários  
Inclusion Criteria
Descrição

Inclusion Criteria

Alias
UMLS CUI
C1512693
'at risk' individuals for ms - female co-twins discordant for cis/ms.
Descrição

Patients At risk Multiple Sclerosis | Twin sibling female Discordant Clinically isolated syndrome | Twin sibling female Discordant Multiple Sclerosis

Tipo de dados

boolean

Alias
UMLS CUI [1,1]
C0030705
UMLS CUI [1,2]
C1444641
UMLS CUI [1,3]
C0026769
UMLS CUI [2,1]
C0041427
UMLS CUI [2,2]
C0043210
UMLS CUI [2,3]
C3639994
UMLS CUI [2,4]
C2921627
UMLS CUI [3,1]
C0041427
UMLS CUI [3,2]
C0043210
UMLS CUI [3,3]
C3639994
UMLS CUI [3,4]
C0026769
'at risk' individuals for ms who at the time of randomization have not converted to ms or cis.
Descrição

Patients At risk Multiple Sclerosis | Multiple Sclerosis Absent | Clinically isolated syndrome Absent

Tipo de dados

boolean

Alias
UMLS CUI [1,1]
C0030705
UMLS CUI [1,2]
C1444641
UMLS CUI [1,3]
C0026769
UMLS CUI [2,1]
C0026769
UMLS CUI [2,2]
C0332197
UMLS CUI [3,1]
C2921627
UMLS CUI [3,2]
C0332197
'at risk' individuals will be treatment-naïve for immunomodulatory/suppressive medications.
Descrição

Patients At risk Therapy naive Immunomodulators | Patients At risk Therapy naive Immunosuppressive Agents

Tipo de dados

boolean

Alias
UMLS CUI [1,1]
C0030705
UMLS CUI [1,2]
C1444641
UMLS CUI [1,3]
C0919936
UMLS CUI [1,4]
C1527392
UMLS CUI [2,1]
C0030705
UMLS CUI [2,2]
C1444641
UMLS CUI [2,3]
C0919936
UMLS CUI [2,4]
C0021081
< 46 years old.
Descrição

Age

Tipo de dados

boolean

Alias
UMLS CUI [1]
C0001779
Exclusion Criteria
Descrição

Exclusion Criteria

Alias
UMLS CUI
C0680251
individuals diagnosed with ms or cis.
Descrição

Multiple Sclerosis | Clinically isolated syndrome

Tipo de dados

boolean

Alias
UMLS CUI [1]
C0026769
UMLS CUI [2]
C2921627
other 'at risk' individuals who do not conform to the specific 'at risk' groups outlined above e.g., 1st degree, 2nd degree and 3rd degree relative of ms index cases.
Descrição

First Degree Relative Multiple Sclerosis Index case | Second Degree Relative Multiple Sclerosis Index case | Third Degree Relative Multiple Sclerosis Index case

Tipo de dados

boolean

Alias
UMLS CUI [1,1]
C1517194
UMLS CUI [1,2]
C0026769
UMLS CUI [1,3]
C2597943
UMLS CUI [2,1]
C1519210
UMLS CUI [2,2]
C0026769
UMLS CUI [2,3]
C2597943
UMLS CUI [3,1]
C3639750
UMLS CUI [3,2]
C0026769
UMLS CUI [3,3]
C2597943
subjects over 45.
Descrição

Age

Tipo de dados

boolean

Alias
UMLS CUI [1]
C0001779
use of immunomodulatory medications such as azathioprine, gold, sulfasalazine, minocycline, statins, and mtx or prednisone > 7.5 mg/day within 30 days of randomization for any reason.
Descrição

Immunomodulators | Azathioprine U/day | Gold U/day | Sulfasalazine U/day | Minocycline U/day | Statins U/day | Methotrexate U/day | Prednisone U/day

Tipo de dados

boolean

Alias
UMLS CUI [1]
C1527392
UMLS CUI [2,1]
C0004482
UMLS CUI [2,2]
C0456683
UMLS CUI [3,1]
C0018026
UMLS CUI [3,2]
C0456683
UMLS CUI [4,1]
C0036078
UMLS CUI [4,2]
C0456683
UMLS CUI [5,1]
C0026187
UMLS CUI [5,2]
C0456683
UMLS CUI [6,1]
C0360714
UMLS CUI [6,2]
C0456683
UMLS CUI [7,1]
C0025677
UMLS CUI [7,2]
C0456683
UMLS CUI [8,1]
C0032952
UMLS CUI [8,2]
C0456683
active drug use or dependence that, in the opinion of the site investigator, would interfere with adherence to study requirements or a psychiatric disorder that is unstable or would preclude reliable participation in the study.
Descrição

Drug Use Disorders Interferes with Protocol Compliance | Drug Dependence Interferes with Protocol Compliance | Mental disorders Unstable | Mental disorders Study Subject Participation Status Excluded

Tipo de dados

boolean

Alias
UMLS CUI [1,1]
C0013222
UMLS CUI [1,2]
C0521102
UMLS CUI [1,3]
C0525058
UMLS CUI [2,1]
C1510472
UMLS CUI [2,2]
C0521102
UMLS CUI [2,3]
C0525058
UMLS CUI [3,1]
C0004936
UMLS CUI [3,2]
C0443343
UMLS CUI [4,1]
C0004936
UMLS CUI [4,2]
C2348568
UMLS CUI [4,3]
C0332196
serious illness (requiring systemic treatment and/or hospitalization) such as diabetes mellitus, renal, cardiac, or pulmonary disease. subjects with a history of alcoholism, or in whom intellectual functioning is impaired sufficiently to interfere with the understanding of the protocol, or participation in the treatment and evaluation program.
Descrição

Illness Serious Requirement Systemic therapy | Illness Serious Hospitalization Required | Diabetes Mellitus | Kidney Diseases | Heart Diseases | Lung diseases | Alcoholic Intoxication, Chronic | Impaired cognition Interferes with Protocol Compliance

Tipo de dados

boolean

Alias
UMLS CUI [1,1]
C0221423
UMLS CUI [1,2]
C0205404
UMLS CUI [1,3]
C1514873
UMLS CUI [1,4]
C1515119
UMLS CUI [2,1]
C0221423
UMLS CUI [2,2]
C0205404
UMLS CUI [2,3]
C1708385
UMLS CUI [3]
C0011849
UMLS CUI [4]
C0022658
UMLS CUI [5]
C0018799
UMLS CUI [6]
C0024115
UMLS CUI [7]
C0001973
UMLS CUI [8,1]
C0338656
UMLS CUI [8,2]
C0521102
UMLS CUI [8,3]
C0525058
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Similar models

Eligibility Multiple Sclerosis NCT00617383

1 Formulários
Name
Tipo
Description | Question | Decode (Coded Value)
Tipo de dados
Alias
Item Group
C1512693 (UMLS CUI)
Patients At risk Multiple Sclerosis | Twin sibling female Discordant Clinically isolated syndrome | Twin sibling female Discordant Multiple Sclerosis
Item
'at risk' individuals for ms - female co-twins discordant for cis/ms.
boolean
C0030705 (UMLS CUI [1,1])
C1444641 (UMLS CUI [1,2])
C0026769 (UMLS CUI [1,3])
C0041427 (UMLS CUI [2,1])
C0043210 (UMLS CUI [2,2])
C3639994 (UMLS CUI [2,3])
C2921627 (UMLS CUI [2,4])
C0041427 (UMLS CUI [3,1])
C0043210 (UMLS CUI [3,2])
C3639994 (UMLS CUI [3,3])
C0026769 (UMLS CUI [3,4])
Patients At risk Multiple Sclerosis | Multiple Sclerosis Absent | Clinically isolated syndrome Absent
Item
'at risk' individuals for ms who at the time of randomization have not converted to ms or cis.
boolean
C0030705 (UMLS CUI [1,1])
C1444641 (UMLS CUI [1,2])
C0026769 (UMLS CUI [1,3])
C0026769 (UMLS CUI [2,1])
C0332197 (UMLS CUI [2,2])
C2921627 (UMLS CUI [3,1])
C0332197 (UMLS CUI [3,2])
Patients At risk Therapy naive Immunomodulators | Patients At risk Therapy naive Immunosuppressive Agents
Item
'at risk' individuals will be treatment-naïve for immunomodulatory/suppressive medications.
boolean
C0030705 (UMLS CUI [1,1])
C1444641 (UMLS CUI [1,2])
C0919936 (UMLS CUI [1,3])
C1527392 (UMLS CUI [1,4])
C0030705 (UMLS CUI [2,1])
C1444641 (UMLS CUI [2,2])
C0919936 (UMLS CUI [2,3])
C0021081 (UMLS CUI [2,4])
Age
Item
< 46 years old.
boolean
C0001779 (UMLS CUI [1])
Item Group
C0680251 (UMLS CUI)
Multiple Sclerosis | Clinically isolated syndrome
Item
individuals diagnosed with ms or cis.
boolean
C0026769 (UMLS CUI [1])
C2921627 (UMLS CUI [2])
First Degree Relative Multiple Sclerosis Index case | Second Degree Relative Multiple Sclerosis Index case | Third Degree Relative Multiple Sclerosis Index case
Item
other 'at risk' individuals who do not conform to the specific 'at risk' groups outlined above e.g., 1st degree, 2nd degree and 3rd degree relative of ms index cases.
boolean
C1517194 (UMLS CUI [1,1])
C0026769 (UMLS CUI [1,2])
C2597943 (UMLS CUI [1,3])
C1519210 (UMLS CUI [2,1])
C0026769 (UMLS CUI [2,2])
C2597943 (UMLS CUI [2,3])
C3639750 (UMLS CUI [3,1])
C0026769 (UMLS CUI [3,2])
C2597943 (UMLS CUI [3,3])
Age
Item
subjects over 45.
boolean
C0001779 (UMLS CUI [1])
Immunomodulators | Azathioprine U/day | Gold U/day | Sulfasalazine U/day | Minocycline U/day | Statins U/day | Methotrexate U/day | Prednisone U/day
Item
use of immunomodulatory medications such as azathioprine, gold, sulfasalazine, minocycline, statins, and mtx or prednisone > 7.5 mg/day within 30 days of randomization for any reason.
boolean
C1527392 (UMLS CUI [1])
C0004482 (UMLS CUI [2,1])
C0456683 (UMLS CUI [2,2])
C0018026 (UMLS CUI [3,1])
C0456683 (UMLS CUI [3,2])
C0036078 (UMLS CUI [4,1])
C0456683 (UMLS CUI [4,2])
C0026187 (UMLS CUI [5,1])
C0456683 (UMLS CUI [5,2])
C0360714 (UMLS CUI [6,1])
C0456683 (UMLS CUI [6,2])
C0025677 (UMLS CUI [7,1])
C0456683 (UMLS CUI [7,2])
C0032952 (UMLS CUI [8,1])
C0456683 (UMLS CUI [8,2])
Drug Use Disorders Interferes with Protocol Compliance | Drug Dependence Interferes with Protocol Compliance | Mental disorders Unstable | Mental disorders Study Subject Participation Status Excluded
Item
active drug use or dependence that, in the opinion of the site investigator, would interfere with adherence to study requirements or a psychiatric disorder that is unstable or would preclude reliable participation in the study.
boolean
C0013222 (UMLS CUI [1,1])
C0521102 (UMLS CUI [1,2])
C0525058 (UMLS CUI [1,3])
C1510472 (UMLS CUI [2,1])
C0521102 (UMLS CUI [2,2])
C0525058 (UMLS CUI [2,3])
C0004936 (UMLS CUI [3,1])
C0443343 (UMLS CUI [3,2])
C0004936 (UMLS CUI [4,1])
C2348568 (UMLS CUI [4,2])
C0332196 (UMLS CUI [4,3])
Illness Serious Requirement Systemic therapy | Illness Serious Hospitalization Required | Diabetes Mellitus | Kidney Diseases | Heart Diseases | Lung diseases | Alcoholic Intoxication, Chronic | Impaired cognition Interferes with Protocol Compliance
Item
serious illness (requiring systemic treatment and/or hospitalization) such as diabetes mellitus, renal, cardiac, or pulmonary disease. subjects with a history of alcoholism, or in whom intellectual functioning is impaired sufficiently to interfere with the understanding of the protocol, or participation in the treatment and evaluation program.
boolean
C0221423 (UMLS CUI [1,1])
C0205404 (UMLS CUI [1,2])
C1514873 (UMLS CUI [1,3])
C1515119 (UMLS CUI [1,4])
C0221423 (UMLS CUI [2,1])
C0205404 (UMLS CUI [2,2])
C1708385 (UMLS CUI [2,3])
C0011849 (UMLS CUI [3])
C0022658 (UMLS CUI [4])
C0018799 (UMLS CUI [5])
C0024115 (UMLS CUI [6])
C0001973 (UMLS CUI [7])
C0338656 (UMLS CUI [8,1])
C0521102 (UMLS CUI [8,2])
C0525058 (UMLS CUI [8,3])
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