ID

16661

Description

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

Lien

https://clinicaltrials.gov/show/NCT00248378

Mots-clés

  1. 30/07/2016 30/07/2016 -
Téléchargé le

30 juillet 2016

DOI

Pour une demande vous connecter.

Licence

Creative Commons BY 4.0

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Eligibility Multiple Sclerosis NCT00248378

Eligibility Multiple Sclerosis NCT00248378

Inclusion Criteria
Description

Inclusion Criteria

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

multiple sclerosis

Type de données

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
Description

complaints of spasticity and increase in tone, ashworth scale

Type de données

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
Description

disease-modifying therapy on stable dose

Type de données

boolean

Alias
UMLS CUI [1]
C0087111
fluent in english
Description

fluent in english

Type de données

boolean

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

cannabis use

Type de données

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
Description

lioresal or tizanadine

Type de données

boolean

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

age

Type de données

boolean

Alias
UMLS CUI [1]
C0001779
Exclusion Criteria
Description

Exclusion Criteria

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

axis i psychiatric disorder

Type de données

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
Description

active substance abuse

Type de données

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.)
Description

drug use restrictions

Type de données

boolean

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

comorbidity

Type de données

boolean

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

pulmonary disorders

Type de données

boolean

Alias
UMLS CUI [1]
C0024115
pregnant or nursing
Description

pregnant or nursing

Type de données

boolean

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

benzodiazepines

Type de données

boolean

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

require high doses of analgesic medications on a daily basis

Type de données

boolean

Alias
UMLS CUI [1]
C0002771

Similar models

Eligibility Multiple Sclerosis NCT00248378

Name
Type
Description | Question | Decode (Coded Value)
Type de données
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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