ID

30955

Descrição

Correlation Between Multiple Sclerosis Functional Composite (MSFC) and Expanded Disability Status Scale (EDSS) in Patients With Multiple Sclerosis (MS) in Argentina; ODM derived from: https://clinicaltrials.gov/show/NCT01080014

Link

https://clinicaltrials.gov/show/NCT01080014

Palavras-chave

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

See clinicaltrials.gov

Transferido a

7 de julho de 2018

DOI

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Licença

Creative Commons BY 4.0
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Eligibility Multiple Sclerosis NCT01080014

Inglês

Eligibility Multiple Sclerosis NCT01080014

1 Formulários  
Inclusion Criteria
Descrição

Inclusion Criteria

Alias
UMLS CUI
C1512693
subjects with definite diagnosis of ms, according to mcdonald's criteria
Descrição

Multiple Sclerosis

Tipo de dados

boolean

Alias
UMLS CUI [1]
C0026769
all clinical types: relapsing-remitting ms (rrms), primary progressive ms (ppms) and secondary progressive ms (spms). stable disease course without any relapse for at least the previous 3 months
Descrição

Multiple Sclerosis, Relapsing-Remitting | Multiple Sclerosis, Primary Progressive | Multiple Sclerosis, Secondary Progressive | Stable Disease Without Relapse

Tipo de dados

boolean

Alias
UMLS CUI [1]
C0751967
UMLS CUI [2]
C0751964
UMLS CUI [3]
C0751965
UMLS CUI [4,1]
C0677946
UMLS CUI [4,2]
C0332288
UMLS CUI [4,3]
C0035020
subjects treated or not with disease modifying drugs
Descrição

Pharmaceutical Preparations Disease Modification | Absence Pharmaceutical Preparations Disease Modification

Tipo de dados

boolean

Alias
UMLS CUI [1,1]
C0013227
UMLS CUI [1,2]
C0012634
UMLS CUI [1,3]
C0392747
UMLS CUI [2,1]
C0332197
UMLS CUI [2,2]
C0013227
UMLS CUI [2,3]
C0012634
UMLS CUI [2,4]
C0392747
ages between 18 and 65 years and is capable of understanding and complying with protocol requirements
Descrição

Age | Protocol Compliance

Tipo de dados

boolean

Alias
UMLS CUI [1]
C0001779
UMLS CUI [2]
C0525058
subject has a stable residence with no planned move during the entire investigation period
Descrição

Residence Stable

Tipo de dados

boolean

Alias
UMLS CUI [1,1]
C0237096
UMLS CUI [1,2]
C0205360
Exclusion Criteria
Descrição

Exclusion Criteria

Alias
UMLS CUI
C0680251
life expectancy less than 5 years at admission
Descrição

Life Expectancy

Tipo de dados

boolean

Alias
UMLS CUI [1]
C0023671
diagnosis of clinically isolated syndrome (cis)
Descrição

Clinically isolated syndrome

Tipo de dados

boolean

Alias
UMLS CUI [1]
C2921627
other clinical conditions that mimic ms
Descrição

Other medical condition Multiple Sclerosis Similar

Tipo de dados

boolean

Alias
UMLS CUI [1,1]
C3843040
UMLS CUI [1,2]
C0026769
UMLS CUI [1,3]
C2348205
psychiatric diseases
Descrição

Mental disorders

Tipo de dados

boolean

Alias
UMLS CUI [1]
C0004936
alcohol or drug abuse
Descrição

Substance Use Disorders

Tipo de dados

boolean

Alias
UMLS CUI [1]
C0038586
pregnancy
Descrição

Pregnancy

Tipo de dados

boolean

Alias
UMLS CUI [1]
C0032961
the subject is unwilling or unable to comply with the protocol or scheduled appointments
Descrição

Protocol Compliance Unwilling | Protocol Compliance Unable

Tipo de dados

boolean

Alias
UMLS CUI [1,1]
C0525058
UMLS CUI [1,2]
C0558080
UMLS CUI [2,1]
C0525058
UMLS CUI [2,2]
C1299582
subject is unable to understand the language in which the approved informed consent is written
Descrição

Informed Consent Language comprehension Unable

Tipo de dados

boolean

Alias
UMLS CUI [1,1]
C0021430
UMLS CUI [1,2]
C0233733
UMLS CUI [1,3]
C1299582
the subject is a study site employee, or an immediate family member (i.e., spouse, parent, child, sibling) of a study site employee, involved in conduct of this study
Descrição

Study Site Employee | Family member Study Site Employee

Tipo de dados

boolean

Alias
UMLS CUI [1,1]
C2347790
UMLS CUI [1,2]
C0599987
UMLS CUI [2,1]
C0086282
UMLS CUI [2,2]
C2347790
UMLS CUI [2,3]
C0599987
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Similar models

Eligibility Multiple Sclerosis NCT01080014

1 Formulários
Name
Tipo
Description | Question | Decode (Coded Value)
Tipo de dados
Alias
Item Group
C1512693 (UMLS CUI)
Multiple Sclerosis
Item
subjects with definite diagnosis of ms, according to mcdonald's criteria
boolean
C0026769 (UMLS CUI [1])
Multiple Sclerosis, Relapsing-Remitting | Multiple Sclerosis, Primary Progressive | Multiple Sclerosis, Secondary Progressive | Stable Disease Without Relapse
Item
all clinical types: relapsing-remitting ms (rrms), primary progressive ms (ppms) and secondary progressive ms (spms). stable disease course without any relapse for at least the previous 3 months
boolean
C0751967 (UMLS CUI [1])
C0751964 (UMLS CUI [2])
C0751965 (UMLS CUI [3])
C0677946 (UMLS CUI [4,1])
C0332288 (UMLS CUI [4,2])
C0035020 (UMLS CUI [4,3])
Pharmaceutical Preparations Disease Modification | Absence Pharmaceutical Preparations Disease Modification
Item
subjects treated or not with disease modifying drugs
boolean
C0013227 (UMLS CUI [1,1])
C0012634 (UMLS CUI [1,2])
C0392747 (UMLS CUI [1,3])
C0332197 (UMLS CUI [2,1])
C0013227 (UMLS CUI [2,2])
C0012634 (UMLS CUI [2,3])
C0392747 (UMLS CUI [2,4])
Age | Protocol Compliance
Item
ages between 18 and 65 years and is capable of understanding and complying with protocol requirements
boolean
C0001779 (UMLS CUI [1])
C0525058 (UMLS CUI [2])
Residence Stable
Item
subject has a stable residence with no planned move during the entire investigation period
boolean
C0237096 (UMLS CUI [1,1])
C0205360 (UMLS CUI [1,2])
Item Group
C0680251 (UMLS CUI)
Life Expectancy
Item
life expectancy less than 5 years at admission
boolean
C0023671 (UMLS CUI [1])
Clinically isolated syndrome
Item
diagnosis of clinically isolated syndrome (cis)
boolean
C2921627 (UMLS CUI [1])
Other medical condition Multiple Sclerosis Similar
Item
other clinical conditions that mimic ms
boolean
C3843040 (UMLS CUI [1,1])
C0026769 (UMLS CUI [1,2])
C2348205 (UMLS CUI [1,3])
Mental disorders
Item
psychiatric diseases
boolean
C0004936 (UMLS CUI [1])
Substance Use Disorders
Item
alcohol or drug abuse
boolean
C0038586 (UMLS CUI [1])
Pregnancy
Item
pregnancy
boolean
C0032961 (UMLS CUI [1])
Protocol Compliance Unwilling | Protocol Compliance Unable
Item
the subject is unwilling or unable to comply with the protocol or scheduled appointments
boolean
C0525058 (UMLS CUI [1,1])
C0558080 (UMLS CUI [1,2])
C0525058 (UMLS CUI [2,1])
C1299582 (UMLS CUI [2,2])
Informed Consent Language comprehension Unable
Item
subject is unable to understand the language in which the approved informed consent is written
boolean
C0021430 (UMLS CUI [1,1])
C0233733 (UMLS CUI [1,2])
C1299582 (UMLS CUI [1,3])
Study Site Employee | Family member Study Site Employee
Item
the subject is a study site employee, or an immediate family member (i.e., spouse, parent, child, sibling) of a study site employee, involved in conduct of this study
boolean
C2347790 (UMLS CUI [1,1])
C0599987 (UMLS CUI [1,2])
C0086282 (UMLS CUI [2,1])
C2347790 (UMLS CUI [2,2])
C0599987 (UMLS CUI [2,3])
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