ID

44230

Description

A Observational, Prospective Study to Assess the Impact of Fatigue in the Quality of Life of Patients With Multiple Sclerosis in Argentina; ODM derived from: https://clinicaltrials.gov/show/NCT01080001

Link

https://clinicaltrials.gov/show/NCT01080001

Keywords

  1. 7/8/18 7/8/18 -
  2. 9/20/21 9/20/21 -
Copyright Holder

See clinicaltrials.gov

Uploaded on

September 20, 2021

DOI

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License

Creative Commons BY 4.0

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Eligibility Multiple Sclerosis, Relapsing-remitting NCT01080001

Eligibility Multiple Sclerosis, Relapsing-remitting NCT01080001

Inclusion Criteria
Description

Inclusion Criteria

Alias
UMLS CUI
C1512693
subjects with ms diagnosis (mcdonald's criteria) in its relapsing remitting form
Description

Multiple Sclerosis, Relapsing-Remitting

Data type

boolean

Alias
UMLS CUI [1]
C0751967
subjects between 21-60 years of age
Description

Age

Data type

boolean

Alias
UMLS CUI [1]
C0001779
subjects who did not have relapses during the 3 months before the inclusion
Description

Relapse Absent

Data type

boolean

Alias
UMLS CUI [1,1]
C0035020
UMLS CUI [1,2]
C0332197
subjects with more than 1 year since the ms diagnosis or with a clinically defined ms
Description

Multiple Sclerosis Disease length | Multiple Sclerosis Definition Clinical

Data type

boolean

Alias
UMLS CUI [1,1]
C0026769
UMLS CUI [1,2]
C0872146
UMLS CUI [2,1]
C0026769
UMLS CUI [2,2]
C0679227
UMLS CUI [2,3]
C0205210
Exclusion Criteria
Description

Exclusion Criteria

Alias
UMLS CUI
C0680251
subjects with life expectancy of less than 5 years at the moment of inclusion
Description

Life Expectancy

Data type

boolean

Alias
UMLS CUI [1]
C0023671
subjects with other associated neurological disease
Description

Nervous system disorder

Data type

boolean

Alias
UMLS CUI [1]
C0027765
subjects with psychiatric diseases
Description

Mental disorders

Data type

boolean

Alias
UMLS CUI [1]
C0004936
subjects who have familiar antecedents (first grade) of severe depression
Description

First Degree Relative Severe depression

Data type

boolean

Alias
UMLS CUI [1,1]
C1517194
UMLS CUI [1,2]
C0588008
subjects with alcohol or drug abuse
Description

Substance Use Disorders

Data type

boolean

Alias
UMLS CUI [1]
C0038586
subjects who are pregnant
Description

Pregnancy

Data type

boolean

Alias
UMLS CUI [1]
C0032961
subjects with fss between 4 and 5
Description

Fatigue Severity Scale

Data type

boolean

Alias
UMLS CUI [1]
C3813323
subjects who have used anxiolytics and anti depressants that could affect the fatigue symptoms during the 3 months before the inclusion
Description

Anti-Anxiety Agents Affecting Fatigue symptoms | Antidepressive Agents Affecting Fatigue symptoms

Data type

boolean

Alias
UMLS CUI [1,1]
C0040616
UMLS CUI [1,2]
C0392760
UMLS CUI [1,3]
C0015672
UMLS CUI [2,1]
C0003289
UMLS CUI [2,2]
C0392760
UMLS CUI [2,3]
C0015672

Similar models

Eligibility Multiple Sclerosis, Relapsing-remitting NCT01080001

Name
Type
Description | Question | Decode (Coded Value)
Data type
Alias
Item Group
C1512693 (UMLS CUI)
Multiple Sclerosis, Relapsing-Remitting
Item
subjects with ms diagnosis (mcdonald's criteria) in its relapsing remitting form
boolean
C0751967 (UMLS CUI [1])
Age
Item
subjects between 21-60 years of age
boolean
C0001779 (UMLS CUI [1])
Relapse Absent
Item
subjects who did not have relapses during the 3 months before the inclusion
boolean
C0035020 (UMLS CUI [1,1])
C0332197 (UMLS CUI [1,2])
Multiple Sclerosis Disease length | Multiple Sclerosis Definition Clinical
Item
subjects with more than 1 year since the ms diagnosis or with a clinically defined ms
boolean
C0026769 (UMLS CUI [1,1])
C0872146 (UMLS CUI [1,2])
C0026769 (UMLS CUI [2,1])
C0679227 (UMLS CUI [2,2])
C0205210 (UMLS CUI [2,3])
Item Group
C0680251 (UMLS CUI)
Life Expectancy
Item
subjects with life expectancy of less than 5 years at the moment of inclusion
boolean
C0023671 (UMLS CUI [1])
Nervous system disorder
Item
subjects with other associated neurological disease
boolean
C0027765 (UMLS CUI [1])
Mental disorders
Item
subjects with psychiatric diseases
boolean
C0004936 (UMLS CUI [1])
First Degree Relative Severe depression
Item
subjects who have familiar antecedents (first grade) of severe depression
boolean
C1517194 (UMLS CUI [1,1])
C0588008 (UMLS CUI [1,2])
Substance Use Disorders
Item
subjects with alcohol or drug abuse
boolean
C0038586 (UMLS CUI [1])
Pregnancy
Item
subjects who are pregnant
boolean
C0032961 (UMLS CUI [1])
Fatigue Severity Scale
Item
subjects with fss between 4 and 5
boolean
C3813323 (UMLS CUI [1])
Anti-Anxiety Agents Affecting Fatigue symptoms | Antidepressive Agents Affecting Fatigue symptoms
Item
subjects who have used anxiolytics and anti depressants that could affect the fatigue symptoms during the 3 months before the inclusion
boolean
C0040616 (UMLS CUI [1,1])
C0392760 (UMLS CUI [1,2])
C0015672 (UMLS CUI [1,3])
C0003289 (UMLS CUI [2,1])
C0392760 (UMLS CUI [2,2])
C0015672 (UMLS CUI [2,3])

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