ID

15589

Beschreibung

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

Stichworte

  1. 04.06.16 04.06.16 -
Hochgeladen am

4. Juni 2016

DOI

Für eine Beantragung loggen Sie sich ein.

Lizenz

Creative Commons BY 4.0

Modell Kommentare :

Hier können Sie das Modell kommentieren. Über die Sprechblasen an den Itemgruppen und Items können Sie diese spezifisch kommentieren.

Itemgroup Kommentare für :

Item Kommentare für :

Um Formulare herunterzuladen müssen Sie angemeldet sein. Bitte loggen Sie sich ein oder registrieren Sie sich kostenlos.

Eligibility Multiple Sclerosis NCT02369224

Eligibility Multiple Sclerosis NCT02369224

Inclusion Criteria
Beschreibung

Inclusion Criteria

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

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

Datentyp

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.
Beschreibung

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

Datentyp

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
Beschreibung

Kurtzke multiple sclerosis rating scale

Datentyp

boolean

Alias
UMLS CUI [1]
C0451246
Exclusion Criteria
Beschreibung

Exclusion Criteria

Alias
UMLS CUI
C0680251
contraindications to strength testing:
Beschreibung

Medical contraindication Oxford grading scale for muscle strength

Datentyp

boolean

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

Myositis

Datentyp

boolean

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

Endocarditis | Pericarditis | Heart Diseases Unstable status

Datentyp

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
Beschreibung

Cardiac Surgery procedures | Myocardial Infarction

Datentyp

boolean

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

CONGESTIVE HEART FAILURE DECOMPENSATED

Datentyp

boolean

Alias
UMLS CUI [1]
C0742746
severe aortic stenosis
Beschreibung

Aortic stenosis, severe

Datentyp

boolean

Alias
UMLS CUI [1]
C3806272
severe pulmonary hypertension
Beschreibung

Pulmonary hypertension, severe

Datentyp

boolean

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

Pulmonary Embolism | Pulmonary Infarction

Datentyp

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)
Beschreibung

Uncontrolled hypertension | Diastolic blood pressure | Systolic Pressure

Datentyp

boolean

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

Marfan Syndrome

Datentyp

boolean

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

Artificial cardiac pacemaker | presence of cardiac defibrillator

Datentyp

boolean

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

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

Datentyp

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
Beschreibung

Pregnancy

Datentyp

boolean

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

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

Datentyp

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
Beschreibung

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

Datentyp

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
Beschreibung

orthopedic problem Pain Affecting Lower Extremity

Datentyp

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
Beschreibung

medical condition Serious | medical condition Unstable status

Datentyp

boolean

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

Ähnliche Modelle

Eligibility Multiple Sclerosis NCT02369224

Name
Typ
Description | Question | Decode (Coded Value)
Datentyp
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])

Benutzen Sie dieses Formular für Rückmeldungen, Fragen und Verbesserungsvorschläge.

Mit * gekennzeichnete Felder sind notwendig.

Benötigen Sie Hilfe bei der Suche? Um mehr Details zu erfahren und die Suche effektiver nutzen zu können schauen Sie sich doch das entsprechende Video auf unserer Tutorial Seite an.

Zum Video