ID

36461

Description

Resistance Training and Amino Pyridine in Multiple Sclerosis; ODM derived from: https://clinicaltrials.gov/show/NCT02143167

Link

https://clinicaltrials.gov/show/NCT02143167

Keywords

Versions (1)
  1. 5/15/19 5/15/19 -
Copyright Holder

See clinicaltrials.gov

Uploaded on

May 15, 2019

DOI

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License

Creative Commons BY 4.0
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Eligibility Multiple Sclerosis NCT02143167

English

Eligibility Multiple Sclerosis NCT02143167

1 forms  
Inclusion Criteria
Description

Inclusion Criteria

Alias
UMLS CUI
C1512693
patients with relapsing remitting multiple sclerosis (rrms), secondary progressive multiple sclerosis (spms) or primary progressive multiple sclerosis (ppms) fulfilling the mcdonald criteria
Description

Multiple Sclerosis, Relapsing-Remitting | Multiple Sclerosis, Secondary Progressive | Multiple Sclerosis, Primary Progressive

Data type

boolean

Alias
UMLS CUI [1]
C0751967
UMLS CUI [2]
C0751965
UMLS CUI [3]
C0751964
expandend disability status scale (edss) 3-6.5
Description

EDSS

Data type

boolean

Alias
UMLS CUI [1]
C0451246
pyramidal functional score ≥ 2
Description

KFSS - Pyramidal Functions

Data type

boolean

Alias
UMLS CUI [1]
C3829393
participants must be able to transport self to gym and to the university of southern denmark
Description

Patient Transport Self

Data type

boolean

Alias
UMLS CUI [1,1]
C0150390
UMLS CUI [1,2]
C0036588
participants must be able to complete t25fw and ssst
Description

Timed 25-Foot Walk Functional Test Completion | Other Coding

Data type

boolean

Alias
UMLS CUI [1,1]
C3897356
UMLS CUI [1,2]
C0205197
UMLS CUI [2]
C3846158
fertile female participants are obliged to use hormonal contraceptive measures
Description

Childbearing Potential Hormonal contraception

Data type

boolean

Alias
UMLS CUI [1,1]
C3831118
UMLS CUI [1,2]
C2985296
Exclusion Criteria
Description

Exclusion Criteria

Alias
UMLS CUI
C0680251
history of epileptic seizures
Description

Epileptic Seizures

Data type

boolean

Alias
UMLS CUI [1]
C4317109
ms relapse or change in disease modifying treatment (dmt) within 60 days
Description

Multiple sclerosis relapse | Change in Disease Modification Therapy

Data type

boolean

Alias
UMLS CUI [1]
C0856120
UMLS CUI [2,1]
C0443172
UMLS CUI [2,2]
C0012634
UMLS CUI [2,3]
C3840684
UMLS CUI [2,4]
C0087111
cancer within five years
Description

Malignant Neoplasms

Data type

boolean

Alias
UMLS CUI [1]
C0006826
blood pressure ≥ 160/100
Description

Blood pressure determination

Data type

boolean

Alias
UMLS CUI [1]
C0005824
severe arrhythmia or ischaemic heart disease or unexplained abnormal cardiac auscultation
Description

Cardiac Arrhythmia Severe | Myocardial Ischemia | Heart Auscultation Abnormal Unexplained

Data type

boolean

Alias
UMLS CUI [1,1]
C0003811
UMLS CUI [1,2]
C0205082
UMLS CUI [2]
C0151744
UMLS CUI [3,1]
C0018793
UMLS CUI [3,2]
C0205161
UMLS CUI [3,3]
C4288071
≥ alt 90 u/l, ≥ bsp 210 u/l, ≥ γ-gt 230 u/l
Description

Alanine aminotransferase measurement | Bromsulphtalein measurement | Gamma glutamyl transferase measurement

Data type

boolean

Alias
UMLS CUI [1]
C0201836
UMLS CUI [2,1]
C0282359
UMLS CUI [2,2]
C0242485
UMLS CUI [3]
C0202035
gfr < 80 ml/min.
Description

Glomerular Filtration Rate

Data type

boolean

Alias
UMLS CUI [1]
C0017654
history of severe pulmonary disease or unexplained abnormal pulmonary auscultation
Description

Lung disease Severe | Auscultation pulmonary abnormal unexplained

Data type

boolean

Alias
UMLS CUI [1,1]
C0024115
UMLS CUI [1,2]
C0205082
UMLS CUI [2,1]
C0004339
UMLS CUI [2,2]
C0024109
UMLS CUI [2,3]
C0205161
UMLS CUI [2,4]
C4288071
pregnancy
Description

Pregnancy

Data type

boolean

Alias
UMLS CUI [1]
C0032961
breastfeeding
Description

Breast Feeding

Data type

boolean

Alias
UMLS CUI [1]
C0006147
allergy to substances contained in prolonged release fampridine tablets
Description

Hypersensitivity Dalfampridine Prolonged-release

Data type

boolean

Alias
UMLS CUI [1,1]
C0020517
UMLS CUI [1,2]
C0000477
UMLS CUI [1,3]
C4544856
concomitant treatment with carvedilol, propranolol or metformin.
Description

carvedilol | Propranolol | Metformin

Data type

boolean

Alias
UMLS CUI [1]
C0054836
UMLS CUI [2]
C0033497
UMLS CUI [3]
C0025598
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Similar models

Eligibility Multiple Sclerosis NCT02143167

1 forms
Name
Type
Description | Question | Decode (Coded Value)
Data type
Alias
Item Group
C1512693 (UMLS CUI)
Multiple Sclerosis, Relapsing-Remitting | Multiple Sclerosis, Secondary Progressive | Multiple Sclerosis, Primary Progressive
Item
patients with relapsing remitting multiple sclerosis (rrms), secondary progressive multiple sclerosis (spms) or primary progressive multiple sclerosis (ppms) fulfilling the mcdonald criteria
boolean
C0751967 (UMLS CUI [1])
C0751965 (UMLS CUI [2])
C0751964 (UMLS CUI [3])
EDSS
Item
expandend disability status scale (edss) 3-6.5
boolean
C0451246 (UMLS CUI [1])
KFSS - Pyramidal Functions
Item
pyramidal functional score ≥ 2
boolean
C3829393 (UMLS CUI [1])
Patient Transport Self
Item
participants must be able to transport self to gym and to the university of southern denmark
boolean
C0150390 (UMLS CUI [1,1])
C0036588 (UMLS CUI [1,2])
Timed 25-Foot Walk Functional Test Completion | Other Coding
Item
participants must be able to complete t25fw and ssst
boolean
C3897356 (UMLS CUI [1,1])
C0205197 (UMLS CUI [1,2])
C3846158 (UMLS CUI [2])
Childbearing Potential Hormonal contraception
Item
fertile female participants are obliged to use hormonal contraceptive measures
boolean
C3831118 (UMLS CUI [1,1])
C2985296 (UMLS CUI [1,2])
Item Group
C0680251 (UMLS CUI)
Epileptic Seizures
Item
history of epileptic seizures
boolean
C4317109 (UMLS CUI [1])
Multiple sclerosis relapse | Change in Disease Modification Therapy
Item
ms relapse or change in disease modifying treatment (dmt) within 60 days
boolean
C0856120 (UMLS CUI [1])
C0443172 (UMLS CUI [2,1])
C0012634 (UMLS CUI [2,2])
C3840684 (UMLS CUI [2,3])
C0087111 (UMLS CUI [2,4])
Malignant Neoplasms
Item
cancer within five years
boolean
C0006826 (UMLS CUI [1])
Blood pressure determination
Item
blood pressure ≥ 160/100
boolean
C0005824 (UMLS CUI [1])
Cardiac Arrhythmia Severe | Myocardial Ischemia | Heart Auscultation Abnormal Unexplained
Item
severe arrhythmia or ischaemic heart disease or unexplained abnormal cardiac auscultation
boolean
C0003811 (UMLS CUI [1,1])
C0205082 (UMLS CUI [1,2])
C0151744 (UMLS CUI [2])
C0018793 (UMLS CUI [3,1])
C0205161 (UMLS CUI [3,2])
C4288071 (UMLS CUI [3,3])
Alanine aminotransferase measurement | Bromsulphtalein measurement | Gamma glutamyl transferase measurement
Item
≥ alt 90 u/l, ≥ bsp 210 u/l, ≥ γ-gt 230 u/l
boolean
C0201836 (UMLS CUI [1])
C0282359 (UMLS CUI [2,1])
C0242485 (UMLS CUI [2,2])
C0202035 (UMLS CUI [3])
Glomerular Filtration Rate
Item
gfr < 80 ml/min.
boolean
C0017654 (UMLS CUI [1])
Lung disease Severe | Auscultation pulmonary abnormal unexplained
Item
history of severe pulmonary disease or unexplained abnormal pulmonary auscultation
boolean
C0024115 (UMLS CUI [1,1])
C0205082 (UMLS CUI [1,2])
C0004339 (UMLS CUI [2,1])
C0024109 (UMLS CUI [2,2])
C0205161 (UMLS CUI [2,3])
C4288071 (UMLS CUI [2,4])
Pregnancy
Item
pregnancy
boolean
C0032961 (UMLS CUI [1])
Breast Feeding
Item
breastfeeding
boolean
C0006147 (UMLS CUI [1])
Hypersensitivity Dalfampridine Prolonged-release
Item
allergy to substances contained in prolonged release fampridine tablets
boolean
C0020517 (UMLS CUI [1,1])
C0000477 (UMLS CUI [1,2])
C4544856 (UMLS CUI [1,3])
carvedilol | Propranolol | Metformin
Item
concomitant treatment with carvedilol, propranolol or metformin.
boolean
C0054836 (UMLS CUI [1])
C0033497 (UMLS CUI [2])
C0025598 (UMLS CUI [3])
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