ID

18306

Description

Cannabis for Spasticity in Multiple Sclerosis; ODM derived from: https://clinicaltrials.gov/show/NCT00682929

Link

https://clinicaltrials.gov/show/NCT00682929

Keywords

Versions (1)
  1. 10/29/16 10/29/16 -
Uploaded on

October 29, 2016

DOI

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License

Creative Commons BY 4.0
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Eligibility Multiple Sclerosis NCT00682929

English

Eligibility Multiple Sclerosis NCT00682929

1 forms  
Inclusion Criteria
Description

Inclusion Criteria

Alias
UMLS CUI
C1512693
diagnosis of clinically definite multiple sclerosis as defined by poser criteria
Description

Multiple Sclerosis Definite Clinical

Data type

boolean

Alias
UMLS CUI [1,1]
C0026769
UMLS CUI [1,2]
C0439544
UMLS CUI [1,3]
C0205210
moderate or severe spasticity
Description

Spasticity Moderate | Spasticity, severe

Data type

boolean

Alias
UMLS CUI [1,1]
C0026838
UMLS CUI [1,2]
C0205081
UMLS CUI [2]
C1861968
age 21 or older
Description

Age

Data type

boolean

Alias
UMLS CUI [1]
C0001779
must live close to the sacramento, ca area
Description

residence Sacramento County, CA

Data type

boolean

Alias
UMLS CUI [1,1]
C0237096
UMLS CUI [1,2]
C3828281
Exclusion Criteria
Description

Exclusion Criteria

Alias
UMLS CUI
C0680251
preexisting pulmonary conditions, including poorly controlled asthma, chronic bronchitis, emphysema, bronchiectasis, and other significant pulmonary disorders
Description

Lung Condition Pre-existing | Asthma Poorly controlled | Bronchitis, Chronic | Pulmonary Emphysema | Bronchiectasis | Lung diseases Significant

Data type

boolean

Alias
UMLS CUI [1,1]
C0024109
UMLS CUI [1,2]
C0348080
UMLS CUI [1,3]
C2347662
UMLS CUI [2,1]
C0004096
UMLS CUI [2,2]
C3853134
UMLS CUI [3]
C0008677
UMLS CUI [4]
C0034067
UMLS CUI [5]
C0006267
UMLS CUI [6,1]
C0024115
UMLS CUI [6,2]
C0750502
preexisting cardiac conditions, including ischemic heart disease, congestive heart failure, and other significant cardiac disorders
Description

Heart Condition Pre-existing | Myocardial Ischemia | Congestive heart failure | Heart Diseases Significant

Data type

boolean

Alias
UMLS CUI [1,1]
C0018787
UMLS CUI [1,2]
C0348080
UMLS CUI [1,3]
C2347662
UMLS CUI [2]
C0151744
UMLS CUI [3]
C0018802
UMLS CUI [4,1]
C0018799
UMLS CUI [4,2]
C0750502
inability to abstain from tobacco or marijuana smoking, or use of alcohol or sedative or hypnotic medications during the duration of the study
Description

Tobacco use Abstinence Unable | Marijuana Smoking Abstinence Unable | Alcohol consumption | Sedatives | Hypnotics

Data type

boolean

Alias
UMLS CUI [1,1]
C0543414
UMLS CUI [1,2]
C3843422
UMLS CUI [1,3]
C1299582
UMLS CUI [2,1]
C0024810
UMLS CUI [2,2]
C3843422
UMLS CUI [2,3]
C1299582
UMLS CUI [3]
C0001948
UMLS CUI [4]
C0036557
UMLS CUI [5]
C0020591
pre-existing dementia, mania, depression or schizophrenia or other poorly controlled psychiatric illness
Description

Dementia Pre-existing | Mania Pre-existing | Depressive disorder Pre-existing | Schizophrenia Pre-existing | Mental disorder Poorly controlled

Data type

boolean

Alias
UMLS CUI [1,1]
C0497327
UMLS CUI [1,2]
C2347662
UMLS CUI [2,1]
C0338831
UMLS CUI [2,2]
C2347662
UMLS CUI [3,1]
C0011581
UMLS CUI [3,2]
C2347662
UMLS CUI [4,1]
C0036341
UMLS CUI [4,2]
C2347662
UMLS CUI [5,1]
C0004936
UMLS CUI [5,2]
C3853134
past history of abuse of recreational drugs, including marijuana and alcohol in the last 12 months
Description

Substance Use Disorders | Marijuana Abuse

Data type

boolean

Alias
UMLS CUI [1]
C0038586
UMLS CUI [2]
C0024809
history of or currently meets dsm-iv criteria for dependence on cannabis
Description

Cannabis Dependence

Data type

boolean

Alias
UMLS CUI [1]
C0006870
use of cannabis, marijuana, or thc in the last four weeks
Description

Cannabis use | Marijuana Smoking | Tetrahydrocannabinol Use

Data type

boolean

Alias
UMLS CUI [1]
C3160814
UMLS CUI [2]
C0024810
UMLS CUI [3,1]
C0039663
UMLS CUI [3,2]
C1524063
preexisting dementia, mania, depression, or schizophrenia or other poorly controlled psychiatric illness
Description

Dementia Pre-existing | Mania Pre-existing | Depressive disorder Pre-existing | Schizophrenia Pre-existing | Mental disorder Poorly controlled

Data type

boolean

Alias
UMLS CUI [1,1]
C0497327
UMLS CUI [1,2]
C2347662
UMLS CUI [2,1]
C0338831
UMLS CUI [2,2]
C2347662
UMLS CUI [3,1]
C0011581
UMLS CUI [3,2]
C2347662
UMLS CUI [4,1]
C0036341
UMLS CUI [4,2]
C2347662
UMLS CUI [5,1]
C0004936
UMLS CUI [5,2]
C3853134
exacerbation of ms within 30 days prior to screening visit
Description

Multiple Sclerosis Exacerbation

Data type

boolean

Alias
UMLS CUI [1,1]
C0026769
UMLS CUI [1,2]
C0235874
current use of cyclophosphamide, mitoxantrone, or cladribine
Description

Cyclophosphamide | Mitoxantrone | Cladribine

Data type

boolean

Alias
UMLS CUI [1]
C0010583
UMLS CUI [2]
C0026259
UMLS CUI [3]
C0092801
arthritis, bony and soft tissue disorders interfering with spasticity measures
Description

Arthritis Interferes with Exercises for spasticity | Bone Tissue Disease Interferes with Exercises for spasticity | Disorder of soft tissue Interferes with Exercises for spasticity

Data type

boolean

Alias
UMLS CUI [1,1]
C0003864
UMLS CUI [1,2]
C0521102
UMLS CUI [1,3]
C0419111
UMLS CUI [2,1]
C0391978
UMLS CUI [2,2]
C0012634
UMLS CUI [2,3]
C0521102
UMLS CUI [2,4]
C0419111
UMLS CUI [3,1]
C0263978
UMLS CUI [3,2]
C0521102
UMLS CUI [3,3]
C0419111
inability to provide informed consent
Description

Informed Consent Unable

Data type

boolean

Alias
UMLS CUI [1,1]
C0021430
UMLS CUI [1,2]
C1299582
recent cannabis use of more than twice per week one month prior to study entry
Description

Cannabis use Frequency

Data type

boolean

Alias
UMLS CUI [1,1]
C3160814
UMLS CUI [1,2]
C0376249
for females of child bearing potential, inability to comply with adequate contraception
Description

Childbearing Potential Contraceptive methods Unable

Data type

boolean

Alias
UMLS CUI [1,1]
C3831118
UMLS CUI [1,2]
C0700589
UMLS CUI [1,3]
C1299582
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Similar models

Eligibility Multiple Sclerosis NCT00682929

1 forms
Name
Type
Description | Question | Decode (Coded Value)
Data type
Alias
Item Group
C1512693 (UMLS CUI)
Multiple Sclerosis Definite Clinical
Item
diagnosis of clinically definite multiple sclerosis as defined by poser criteria
boolean
C0026769 (UMLS CUI [1,1])
C0439544 (UMLS CUI [1,2])
C0205210 (UMLS CUI [1,3])
Spasticity Moderate | Spasticity, severe
Item
moderate or severe spasticity
boolean
C0026838 (UMLS CUI [1,1])
C0205081 (UMLS CUI [1,2])
C1861968 (UMLS CUI [2])
Age
Item
age 21 or older
boolean
C0001779 (UMLS CUI [1])
residence Sacramento County, CA
Item
must live close to the sacramento, ca area
boolean
C0237096 (UMLS CUI [1,1])
C3828281 (UMLS CUI [1,2])
Item Group
C0680251 (UMLS CUI)
Lung Condition Pre-existing | Asthma Poorly controlled | Bronchitis, Chronic | Pulmonary Emphysema | Bronchiectasis | Lung diseases Significant
Item
preexisting pulmonary conditions, including poorly controlled asthma, chronic bronchitis, emphysema, bronchiectasis, and other significant pulmonary disorders
boolean
C0024109 (UMLS CUI [1,1])
C0348080 (UMLS CUI [1,2])
C2347662 (UMLS CUI [1,3])
C0004096 (UMLS CUI [2,1])
C3853134 (UMLS CUI [2,2])
C0008677 (UMLS CUI [3])
C0034067 (UMLS CUI [4])
C0006267 (UMLS CUI [5])
C0024115 (UMLS CUI [6,1])
C0750502 (UMLS CUI [6,2])
Heart Condition Pre-existing | Myocardial Ischemia | Congestive heart failure | Heart Diseases Significant
Item
preexisting cardiac conditions, including ischemic heart disease, congestive heart failure, and other significant cardiac disorders
boolean
C0018787 (UMLS CUI [1,1])
C0348080 (UMLS CUI [1,2])
C2347662 (UMLS CUI [1,3])
C0151744 (UMLS CUI [2])
C0018802 (UMLS CUI [3])
C0018799 (UMLS CUI [4,1])
C0750502 (UMLS CUI [4,2])
Tobacco use Abstinence Unable | Marijuana Smoking Abstinence Unable | Alcohol consumption | Sedatives | Hypnotics
Item
inability to abstain from tobacco or marijuana smoking, or use of alcohol or sedative or hypnotic medications during the duration of the study
boolean
C0543414 (UMLS CUI [1,1])
C3843422 (UMLS CUI [1,2])
C1299582 (UMLS CUI [1,3])
C0024810 (UMLS CUI [2,1])
C3843422 (UMLS CUI [2,2])
C1299582 (UMLS CUI [2,3])
C0001948 (UMLS CUI [3])
C0036557 (UMLS CUI [4])
C0020591 (UMLS CUI [5])
Dementia Pre-existing | Mania Pre-existing | Depressive disorder Pre-existing | Schizophrenia Pre-existing | Mental disorder Poorly controlled
Item
pre-existing dementia, mania, depression or schizophrenia or other poorly controlled psychiatric illness
boolean
C0497327 (UMLS CUI [1,1])
C2347662 (UMLS CUI [1,2])
C0338831 (UMLS CUI [2,1])
C2347662 (UMLS CUI [2,2])
C0011581 (UMLS CUI [3,1])
C2347662 (UMLS CUI [3,2])
C0036341 (UMLS CUI [4,1])
C2347662 (UMLS CUI [4,2])
C0004936 (UMLS CUI [5,1])
C3853134 (UMLS CUI [5,2])
Substance Use Disorders | Marijuana Abuse
Item
past history of abuse of recreational drugs, including marijuana and alcohol in the last 12 months
boolean
C0038586 (UMLS CUI [1])
C0024809 (UMLS CUI [2])
Cannabis Dependence
Item
history of or currently meets dsm-iv criteria for dependence on cannabis
boolean
C0006870 (UMLS CUI [1])
Cannabis use | Marijuana Smoking | Tetrahydrocannabinol Use
Item
use of cannabis, marijuana, or thc in the last four weeks
boolean
C3160814 (UMLS CUI [1])
C0024810 (UMLS CUI [2])
C0039663 (UMLS CUI [3,1])
C1524063 (UMLS CUI [3,2])
Dementia Pre-existing | Mania Pre-existing | Depressive disorder Pre-existing | Schizophrenia Pre-existing | Mental disorder Poorly controlled
Item
preexisting dementia, mania, depression, or schizophrenia or other poorly controlled psychiatric illness
boolean
C0497327 (UMLS CUI [1,1])
C2347662 (UMLS CUI [1,2])
C0338831 (UMLS CUI [2,1])
C2347662 (UMLS CUI [2,2])
C0011581 (UMLS CUI [3,1])
C2347662 (UMLS CUI [3,2])
C0036341 (UMLS CUI [4,1])
C2347662 (UMLS CUI [4,2])
C0004936 (UMLS CUI [5,1])
C3853134 (UMLS CUI [5,2])
Multiple Sclerosis Exacerbation
Item
exacerbation of ms within 30 days prior to screening visit
boolean
C0026769 (UMLS CUI [1,1])
C0235874 (UMLS CUI [1,2])
Cyclophosphamide | Mitoxantrone | Cladribine
Item
current use of cyclophosphamide, mitoxantrone, or cladribine
boolean
C0010583 (UMLS CUI [1])
C0026259 (UMLS CUI [2])
C0092801 (UMLS CUI [3])
Arthritis Interferes with Exercises for spasticity | Bone Tissue Disease Interferes with Exercises for spasticity | Disorder of soft tissue Interferes with Exercises for spasticity
Item
arthritis, bony and soft tissue disorders interfering with spasticity measures
boolean
C0003864 (UMLS CUI [1,1])
C0521102 (UMLS CUI [1,2])
C0419111 (UMLS CUI [1,3])
C0391978 (UMLS CUI [2,1])
C0012634 (UMLS CUI [2,2])
C0521102 (UMLS CUI [2,3])
C0419111 (UMLS CUI [2,4])
C0263978 (UMLS CUI [3,1])
C0521102 (UMLS CUI [3,2])
C0419111 (UMLS CUI [3,3])
Informed Consent Unable
Item
inability to provide informed consent
boolean
C0021430 (UMLS CUI [1,1])
C1299582 (UMLS CUI [1,2])
Cannabis use Frequency
Item
recent cannabis use of more than twice per week one month prior to study entry
boolean
C3160814 (UMLS CUI [1,1])
C0376249 (UMLS CUI [1,2])
Childbearing Potential Contraceptive methods Unable
Item
for females of child bearing potential, inability to comply with adequate contraception
boolean
C3831118 (UMLS CUI [1,1])
C0700589 (UMLS CUI [1,2])
C1299582 (UMLS CUI [1,3])
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