ID

16661

Beschrijving

Short-Term Effects of Medicinal Cannabis Therapy on Spasticity in Multiple Sclerosis; ODM derived from: https://clinicaltrials.gov/show/NCT00248378

Link

https://clinicaltrials.gov/show/NCT00248378

Trefwoorden

  1. 30-07-16 30-07-16 -
Geüploaded op

30 juli 2016

DOI

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Licentie

Creative Commons BY 4.0

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Eligibility Multiple Sclerosis NCT00248378

Eligibility Multiple Sclerosis NCT00248378

Inclusion Criteria
Beschrijving

Inclusion Criteria

Alias
UMLS CUI
C1512693
clinically definite or probable, laboratory-supported ms
Beschrijving

multiple sclerosis

Datatype

boolean

Alias
UMLS CUI [1]
C0026769
complaints of spasticity and at least moderate increase in tone as evidenced by a score of >= 2 on the modified ashworth scale at either the elbow, hip, or knee
Beschrijving

complaints of spasticity and increase in tone, ashworth scale

Datatype

boolean

Alias
UMLS CUI [1]
C0026838
UMLS CUI [2]
C0026841
UMLS CUI [3]
C0451002
if on disease-modifying therapy ("abc"), have been on a stable dose for at least six months
Beschrijving

disease-modifying therapy on stable dose

Datatype

boolean

Alias
UMLS CUI [1]
C0087111
fluent in english
Beschrijving

fluent in english

Datatype

boolean

Alias
UMLS CUI [1]
C1145677
if not cannabis-naive, must refrain from smoking cannabis for two weeks prior to screening (confirmed by urinalysis)
Beschrijving

cannabis use

Datatype

boolean

Alias
UMLS CUI [1]
C3160814
if on either lioresal (baclofen) or tizanadine (zanaflex), have been on a stable dose for at least three months
Beschrijving

lioresal or tizanadine

Datatype

boolean

Alias
UMLS CUI [1]
C0699999
UMLS CUI [2]
C0595425
>=18 years of age
Beschrijving

age

Datatype

boolean

Alias
UMLS CUI [1]
C0001779
Exclusion Criteria
Beschrijving

Exclusion Criteria

Alias
UMLS CUI
C0680251
axis i psychiatric disorder especially depression or significant neurological disease other than ms as determined by the pi
Beschrijving

axis i psychiatric disorder

Datatype

boolean

Alias
UMLS CUI [1,1]
C0270287
UMLS CUI [1,2]
C0004936
recent history of active substance abuse defined as daily use for at least 14 days within the past month
Beschrijving

active substance abuse

Datatype

boolean

Alias
UMLS CUI [1]
C0038586
drug use restrictions, eg, subjects on probation or parole, employment involving high risk to themselves and/or the public (airline pilot, bus driver, etc.)
Beschrijving

drug use restrictions

Datatype

boolean

Alias
UMLS CUI [1]
C0522473
any unstable medical health problem
Beschrijving

comorbidity

Datatype

boolean

Alias
UMLS CUI [1]
C0009488
any known pulmonary disorders, including tuberculosis, asthma, or copd
Beschrijving

pulmonary disorders

Datatype

boolean

Alias
UMLS CUI [1]
C0024115
pregnant or nursing
Beschrijving

pregnant or nursing

Datatype

boolean

Alias
UMLS CUI [1,1]
C0032961
UMLS CUI [1,2]
C0006147
require benzodiazepines to control spasticity
Beschrijving

benzodiazepines

Datatype

boolean

Alias
UMLS CUI [1]
C0005064
require high doses of analgesic medications on a daily basis
Beschrijving

require high doses of analgesic medications on a daily basis

Datatype

boolean

Alias
UMLS CUI [1]
C0002771

Similar models

Eligibility Multiple Sclerosis NCT00248378

Name
Type
Description | Question | Decode (Coded Value)
Datatype
Alias
Item Group
C1512693 (UMLS CUI)
multiple sclerosis
Item
clinically definite or probable, laboratory-supported ms
boolean
C0026769 (UMLS CUI [1])
complaints of spasticity and increase in tone, ashworth scale
Item
complaints of spasticity and at least moderate increase in tone as evidenced by a score of >= 2 on the modified ashworth scale at either the elbow, hip, or knee
boolean
C0026838 (UMLS CUI [1])
C0026841 (UMLS CUI [2])
C0451002 (UMLS CUI [3])
disease-modifying therapy on stable dose
Item
if on disease-modifying therapy ("abc"), have been on a stable dose for at least six months
boolean
C0087111 (UMLS CUI [1])
fluent in english
Item
fluent in english
boolean
C1145677 (UMLS CUI [1])
cannabis use
Item
if not cannabis-naive, must refrain from smoking cannabis for two weeks prior to screening (confirmed by urinalysis)
boolean
C3160814 (UMLS CUI [1])
lioresal or tizanadine
Item
if on either lioresal (baclofen) or tizanadine (zanaflex), have been on a stable dose for at least three months
boolean
C0699999 (UMLS CUI [1])
C0595425 (UMLS CUI [2])
age
Item
>=18 years of age
boolean
C0001779 (UMLS CUI [1])
Item Group
C0680251 (UMLS CUI)
axis i psychiatric disorder
Item
axis i psychiatric disorder especially depression or significant neurological disease other than ms as determined by the pi
boolean
C0270287 (UMLS CUI [1,1])
C0004936 (UMLS CUI [1,2])
active substance abuse
Item
recent history of active substance abuse defined as daily use for at least 14 days within the past month
boolean
C0038586 (UMLS CUI [1])
drug use restrictions
Item
drug use restrictions, eg, subjects on probation or parole, employment involving high risk to themselves and/or the public (airline pilot, bus driver, etc.)
boolean
C0522473 (UMLS CUI [1])
comorbidity
Item
any unstable medical health problem
boolean
C0009488 (UMLS CUI [1])
pulmonary disorders
Item
any known pulmonary disorders, including tuberculosis, asthma, or copd
boolean
C0024115 (UMLS CUI [1])
pregnant or nursing
Item
pregnant or nursing
boolean
C0032961 (UMLS CUI [1,1])
C0006147 (UMLS CUI [1,2])
benzodiazepines
Item
require benzodiazepines to control spasticity
boolean
C0005064 (UMLS CUI [1])
require high doses of analgesic medications on a daily basis
Item
require high doses of analgesic medications on a daily basis
boolean
C0002771 (UMLS CUI [1])

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