ID

21990

Description

A Study of the Pharmacokinetics and Immunologic Effects of Lipoic Acid in Multiple Sclerosis; ODM derived from: https://clinicaltrials.gov/show/NCT00676156

Link

https://clinicaltrials.gov/show/NCT00676156

Keywords

Versions (2)
  1. 5/13/17 5/13/17 -
  2. 5/13/17 5/13/17 -
Uploaded on

May 13, 2017

DOI

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License

Creative Commons BY 4.0
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Eligibility Multiple Sclerosis NCT00676156

English

Eligibility Multiple Sclerosis NCT00676156

1 forms  
Inclusion Criteria
Description

Inclusion Criteria

Alias
UMLS CUI
C1512693
definite ms by mcdonald's or poser's criteria
Description

Multiple Sclerosis

Data type

boolean

Alias
UMLS CUI [1]
C0026769
edss ≤ 7.5
Description

Kurtzke multiple sclerosis rating scale

Data type

boolean

Alias
UMLS CUI [1]
C0451246
age 18 to 80
Description

Age

Data type

boolean

Alias
UMLS CUI [1]
C0001779
Exclusion Criteria
Description

Exclusion Criteria

Alias
UMLS CUI
C0680251
no clinically significant ms exacerbation within 30 days of the screening
Description

Exacerbation of multiple sclerosis

Data type

boolean

Alias
UMLS CUI [1]
C0581392
no systemically administered corticosteroids within 30 days of study entry
Description

CORTICOSTEROIDS FOR SYSTEMIC USE

Data type

boolean

Alias
UMLS CUI [1]
C3653708
patient not pregnant or breast feeding
Description

Pregnancy | Breast Feeding

Data type

boolean

Alias
UMLS CUI [1]
C0032961
UMLS CUI [2]
C0006147
no la in previous 2 weeks
Description

Lipoic Acid

Data type

boolean

Alias
UMLS CUI [1]
C0023791
not on anti-coagulants such as heparin, coumadin, or aspirin during study
Description

Anticoagulants | Heparin | Coumadin | Aspirin

Data type

boolean

Alias
UMLS CUI [1]
C0003280
UMLS CUI [2]
C0019134
UMLS CUI [3]
C0699129
UMLS CUI [4]
C0004057
no other significant health problem (e.g. active coronary heart disease, liver disease, pulmonary disease, diabetes mellitus) that might increase risk of patient experiencing adverse events
Description

Disease At risk Adverse event | Coronary heart disease | Liver diseases | Lung diseases | Diabetes Mellitus

Data type

boolean

Alias
UMLS CUI [1,1]
C0012634
UMLS CUI [1,2]
C1444641
UMLS CUI [1,3]
C0877248
UMLS CUI [2]
C0010068
UMLS CUI [3]
C0023895
UMLS CUI [4]
C0024115
UMLS CUI [5]
C0011849
inability to give informed consent
Description

Informed Consent Unable

Data type

boolean

Alias
UMLS CUI [1,1]
C0021430
UMLS CUI [1,2]
C1299582
any condition which would make the patient, in the opinion of the investigator, unsuitable for the study
Description

Condition Study Subject Participation Status Inappropriate

Data type

boolean

Alias
UMLS CUI [1,1]
C0348080
UMLS CUI [1,2]
C2348568
UMLS CUI [1,3]
C1548788
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Similar models

Eligibility Multiple Sclerosis NCT00676156

1 forms
Name
Type
Description | Question | Decode (Coded Value)
Data type
Alias
Item Group
C1512693 (UMLS CUI)
Multiple Sclerosis
Item
definite ms by mcdonald's or poser's criteria
boolean
C0026769 (UMLS CUI [1])
Kurtzke multiple sclerosis rating scale
Item
edss ≤ 7.5
boolean
C0451246 (UMLS CUI [1])
Age
Item
age 18 to 80
boolean
C0001779 (UMLS CUI [1])
Item Group
C0680251 (UMLS CUI)
Exacerbation of multiple sclerosis
Item
no clinically significant ms exacerbation within 30 days of the screening
boolean
C0581392 (UMLS CUI [1])
CORTICOSTEROIDS FOR SYSTEMIC USE
Item
no systemically administered corticosteroids within 30 days of study entry
boolean
C3653708 (UMLS CUI [1])
Pregnancy | Breast Feeding
Item
patient not pregnant or breast feeding
boolean
C0032961 (UMLS CUI [1])
C0006147 (UMLS CUI [2])
Lipoic Acid
Item
no la in previous 2 weeks
boolean
C0023791 (UMLS CUI [1])
Anticoagulants | Heparin | Coumadin | Aspirin
Item
not on anti-coagulants such as heparin, coumadin, or aspirin during study
boolean
C0003280 (UMLS CUI [1])
C0019134 (UMLS CUI [2])
C0699129 (UMLS CUI [3])
C0004057 (UMLS CUI [4])
Disease At risk Adverse event | Coronary heart disease | Liver diseases | Lung diseases | Diabetes Mellitus
Item
no other significant health problem (e.g. active coronary heart disease, liver disease, pulmonary disease, diabetes mellitus) that might increase risk of patient experiencing adverse events
boolean
C0012634 (UMLS CUI [1,1])
C1444641 (UMLS CUI [1,2])
C0877248 (UMLS CUI [1,3])
C0010068 (UMLS CUI [2])
C0023895 (UMLS CUI [3])
C0024115 (UMLS CUI [4])
C0011849 (UMLS CUI [5])
Informed Consent Unable
Item
inability to give informed consent
boolean
C0021430 (UMLS CUI [1,1])
C1299582 (UMLS CUI [1,2])
Condition Study Subject Participation Status Inappropriate
Item
any condition which would make the patient, in the opinion of the investigator, unsuitable for the study
boolean
C0348080 (UMLS CUI [1,1])
C2348568 (UMLS CUI [1,2])
C1548788 (UMLS CUI [1,3])
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