ID

15589

Description

Multicenter Validation of The Evergreen Myometric Strength Test for Lower Extremities (EMST-LE) in Multiple Sclerosis: Protocol for Strength Testing and Reliability Characteristics; ODM derived from: https://clinicaltrials.gov/show/NCT02369224

Link

https://clinicaltrials.gov/show/NCT02369224

Keywords

Versions (1)
  1. 6/4/16 6/4/16 -
Uploaded on

June 4, 2016

DOI

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License

Creative Commons BY 4.0
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Eligibility Multiple Sclerosis NCT02369224

English

Eligibility Multiple Sclerosis NCT02369224

1 forms  
Inclusion Criteria
Description

Inclusion Criteria

Alias
UMLS CUI
C1512693
stable patients with clinically definite ms, aged ≥18, edss of 0-7.5
Description

Stable status | Multiple Sclerosis | Age | Kurtzke multiple sclerosis rating scale

Data type

boolean

Alias
UMLS CUI [1]
C0205360
UMLS CUI [2]
C0026769
UMLS CUI [3]
C0001779
UMLS CUI [4]
C0451246
clinical stability defined as no ms exacerbation or change in disease modifying therapy for 30 days prior to screening.
Description

Stable status Clinical | Exacerbation of multiple sclerosis | Biological Response Modifier Therapy Changing

Data type

boolean

Alias
UMLS CUI [1,1]
C0205360
UMLS CUI [1,2]
C0205210
UMLS CUI [2]
C0581392
UMLS CUI [3,1]
C0005527
UMLS CUI [3,2]
C0392747
edss as described above
Description

Kurtzke multiple sclerosis rating scale

Data type

boolean

Alias
UMLS CUI [1]
C0451246
Exclusion Criteria
Description

Exclusion Criteria

Alias
UMLS CUI
C0680251
contraindications to strength testing:
Description

Medical contraindication Oxford grading scale for muscle strength

Data type

boolean

Alias
UMLS CUI [1,1]
C1301624
UMLS CUI [1,2]
C0451362
inflammatory myopathy
Description

Myositis

Data type

boolean

Alias
UMLS CUI [1]
C0027121
endocarditis, pericarditis or other unstable heart disease
Description

Endocarditis | Pericarditis | Heart Diseases Unstable status

Data type

boolean

Alias
UMLS CUI [1]
C0014118
UMLS CUI [2]
C0031046
UMLS CUI [3,1]
C0018799
UMLS CUI [3,2]
C0443343
cardiac surgery or myocardial infarction in the last 3 months
Description

Cardiac Surgery procedures | Myocardial Infarction

Data type

boolean

Alias
UMLS CUI [1]
C0018821
UMLS CUI [2]
C0027051
decompensated congestive heart failure
Description

CONGESTIVE HEART FAILURE DECOMPENSATED

Data type

boolean

Alias
UMLS CUI [1]
C0742746
severe aortic stenosis
Description

Aortic stenosis, severe

Data type

boolean

Alias
UMLS CUI [1]
C3806272
severe pulmonary hypertension
Description

Pulmonary hypertension, severe

Data type

boolean

Alias
UMLS CUI [1]
C2750273
pulmonary embolus or infarction in the last 6 months
Description

Pulmonary Embolism | Pulmonary Infarction

Data type

boolean

Alias
UMLS CUI [1]
C0034065
UMLS CUI [2]
C0034074
uncontrolled hypertension by history or by screening or baseline diastolic blood pressure >170, or systolic blood pressure > 105)
Description

Uncontrolled hypertension | Diastolic blood pressure | Systolic Pressure

Data type

boolean

Alias
UMLS CUI [1]
C1868885
UMLS CUI [2]
C0428883
UMLS CUI [3]
C0871470
marfan's syndrome
Description

Marfan Syndrome

Data type

boolean

Alias
UMLS CUI [1]
C0024796
pacemaker or cardiac defibrillator
Description

Artificial cardiac pacemaker | presence of cardiac defibrillator

Data type

boolean

Alias
UMLS CUI [1]
C0030163
UMLS CUI [2]
C1391956
concomitant neurodegenerative neurological disease, such as als or parkinson disease or hemiplegic stroke
Description

Neurodegenerative Disorders Nervous system disorder | Amyotrophic Lateral Sclerosis | Parkinson Disease | Hemiplegia Cerebrovascular accident

Data type

boolean

Alias
UMLS CUI [1,1]
C0524851
UMLS CUI [1,2]
C0027765
UMLS CUI [2]
C0002736
UMLS CUI [3]
C0030567
UMLS CUI [4,1]
C0018991
UMLS CUI [4,2]
C0038454
females who are pregnant
Description

Pregnancy

Data type

boolean

Alias
UMLS CUI [1]
C0032961
cognitive deficits that would interfere with the subject's ability to give informed consent or perform study testing.
Description

Cognition Disorders Interferes with Ability Informed Consent | Cognition Disorders Compliance behavior Limited

Data type

boolean

Alias
UMLS CUI [1,1]
C0009241
UMLS CUI [1,2]
C0521102
UMLS CUI [1,3]
C0085732
UMLS CUI [1,4]
C0021430
UMLS CUI [2,1]
C0009241
UMLS CUI [2,2]
C1321605
UMLS CUI [2,3]
C0439801
anticipated treatment with novantrone (mitoxantrone) or cancer chemotherapy or surgical procedure during the study period
Description

Therapeutic procedure Novantrone | Therapeutic procedure Mitoxantrone | Chemotherapy Malignant Neoplasms | Operative Surgical Procedures

Data type

boolean

Alias
UMLS CUI [1,1]
C0087111
UMLS CUI [1,2]
C0282248
UMLS CUI [2,1]
C0087111
UMLS CUI [2,2]
C0026259
UMLS CUI [3,1]
C0392920
UMLS CUI [3,2]
C0006826
UMLS CUI [4]
C0543467
painful orthopedic condition affecting the lower extremities
Description

orthopedic problem Pain Affecting Lower Extremity

Data type

boolean

Alias
UMLS CUI [1,1]
C0029354
UMLS CUI [1,2]
C0030193
UMLS CUI [1,3]
C0392760
UMLS CUI [1,4]
C0023216
any other serious and/or unstable medical condition
Description

medical condition Serious | medical condition Unstable status

Data type

boolean

Alias
UMLS CUI [1,1]
C1699700
UMLS CUI [1,2]
C0205404
UMLS CUI [2,1]
C1699700
UMLS CUI [2,2]
C0443343
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Similar models

Eligibility Multiple Sclerosis NCT02369224

1 forms
Name
Type
Description | Question | Decode (Coded Value)
Data type
Alias
Item Group
C1512693 (UMLS CUI)
Stable status | Multiple Sclerosis | Age | Kurtzke multiple sclerosis rating scale
Item
stable patients with clinically definite ms, aged ≥18, edss of 0-7.5
boolean
C0205360 (UMLS CUI [1])
C0026769 (UMLS CUI [2])
C0001779 (UMLS CUI [3])
C0451246 (UMLS CUI [4])
Stable status Clinical | Exacerbation of multiple sclerosis | Biological Response Modifier Therapy Changing
Item
clinical stability defined as no ms exacerbation or change in disease modifying therapy for 30 days prior to screening.
boolean
C0205360 (UMLS CUI [1,1])
C0205210 (UMLS CUI [1,2])
C0581392 (UMLS CUI [2])
C0005527 (UMLS CUI [3,1])
C0392747 (UMLS CUI [3,2])
Kurtzke multiple sclerosis rating scale
Item
edss as described above
boolean
C0451246 (UMLS CUI [1])
Item Group
C0680251 (UMLS CUI)
Medical contraindication Oxford grading scale for muscle strength
Item
contraindications to strength testing:
boolean
C1301624 (UMLS CUI [1,1])
C0451362 (UMLS CUI [1,2])
Myositis
Item
inflammatory myopathy
boolean
C0027121 (UMLS CUI [1])
Endocarditis | Pericarditis | Heart Diseases Unstable status
Item
endocarditis, pericarditis or other unstable heart disease
boolean
C0014118 (UMLS CUI [1])
C0031046 (UMLS CUI [2])
C0018799 (UMLS CUI [3,1])
C0443343 (UMLS CUI [3,2])
Cardiac Surgery procedures | Myocardial Infarction
Item
cardiac surgery or myocardial infarction in the last 3 months
boolean
C0018821 (UMLS CUI [1])
C0027051 (UMLS CUI [2])
CONGESTIVE HEART FAILURE DECOMPENSATED
Item
decompensated congestive heart failure
boolean
C0742746 (UMLS CUI [1])
Aortic stenosis, severe
Item
severe aortic stenosis
boolean
C3806272 (UMLS CUI [1])
Pulmonary hypertension, severe
Item
severe pulmonary hypertension
boolean
C2750273 (UMLS CUI [1])
Pulmonary Embolism | Pulmonary Infarction
Item
pulmonary embolus or infarction in the last 6 months
boolean
C0034065 (UMLS CUI [1])
C0034074 (UMLS CUI [2])
Uncontrolled hypertension | Diastolic blood pressure | Systolic Pressure
Item
uncontrolled hypertension by history or by screening or baseline diastolic blood pressure >170, or systolic blood pressure > 105)
boolean
C1868885 (UMLS CUI [1])
C0428883 (UMLS CUI [2])
C0871470 (UMLS CUI [3])
Marfan Syndrome
Item
marfan's syndrome
boolean
C0024796 (UMLS CUI [1])
Artificial cardiac pacemaker | presence of cardiac defibrillator
Item
pacemaker or cardiac defibrillator
boolean
C0030163 (UMLS CUI [1])
C1391956 (UMLS CUI [2])
Neurodegenerative Disorders Nervous system disorder | Amyotrophic Lateral Sclerosis | Parkinson Disease | Hemiplegia Cerebrovascular accident
Item
concomitant neurodegenerative neurological disease, such as als or parkinson disease or hemiplegic stroke
boolean
C0524851 (UMLS CUI [1,1])
C0027765 (UMLS CUI [1,2])
C0002736 (UMLS CUI [2])
C0030567 (UMLS CUI [3])
C0018991 (UMLS CUI [4,1])
C0038454 (UMLS CUI [4,2])
Pregnancy
Item
females who are pregnant
boolean
C0032961 (UMLS CUI [1])
Cognition Disorders Interferes with Ability Informed Consent | Cognition Disorders Compliance behavior Limited
Item
cognitive deficits that would interfere with the subject's ability to give informed consent or perform study testing.
boolean
C0009241 (UMLS CUI [1,1])
C0521102 (UMLS CUI [1,2])
C0085732 (UMLS CUI [1,3])
C0021430 (UMLS CUI [1,4])
C0009241 (UMLS CUI [2,1])
C1321605 (UMLS CUI [2,2])
C0439801 (UMLS CUI [2,3])
Therapeutic procedure Novantrone | Therapeutic procedure Mitoxantrone | Chemotherapy Malignant Neoplasms | Operative Surgical Procedures
Item
anticipated treatment with novantrone (mitoxantrone) or cancer chemotherapy or surgical procedure during the study period
boolean
C0087111 (UMLS CUI [1,1])
C0282248 (UMLS CUI [1,2])
C0087111 (UMLS CUI [2,1])
C0026259 (UMLS CUI [2,2])
C0392920 (UMLS CUI [3,1])
C0006826 (UMLS CUI [3,2])
C0543467 (UMLS CUI [4])
orthopedic problem Pain Affecting Lower Extremity
Item
painful orthopedic condition affecting the lower extremities
boolean
C0029354 (UMLS CUI [1,1])
C0030193 (UMLS CUI [1,2])
C0392760 (UMLS CUI [1,3])
C0023216 (UMLS CUI [1,4])
medical condition Serious | medical condition Unstable status
Item
any other serious and/or unstable medical condition
boolean
C1699700 (UMLS CUI [1,1])
C0205404 (UMLS CUI [1,2])
C1699700 (UMLS CUI [2,1])
C0443343 (UMLS CUI [2,2])
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