ID

13300

Description

Open Label Sumanirole Study of Safety, Tolerability, and Therapeutic Response In Patients With Parkinson's Disease; ODM derived from: https://clinicaltrials.gov/show/NCT00036205

Link

https://clinicaltrials.gov/show/NCT00036205

Keywords

  1. 2/1/16 2/1/16 -
Uploaded on

February 1, 2016

DOI

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License

Creative Commons BY 4.0

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Eligibility Parkinson Disease NCT00036205

Eligibility Parkinson Disease NCT00036205

Inclusion Criteria
Description

Inclusion Criteria

Alias
UMLS CUI
C1512693
idiopathic parkinson's disease
Description

idiopathic parkinson

Data type

boolean

Alias
UMLS CUI [1,1]
C0030567
UMLS CUI [1,2]
C0332240
modified hoehn and yahr scale stages 1-4
Description

disease stage

Data type

boolean

Alias
UMLS CUI [1]
C0699749
age over 30 years
Description

age

Data type

boolean

Alias
UMLS CUI [1]
C0001779
previous participation in prior sumanirole studies
Description

study subject participation status

Data type

boolean

Alias
UMLS CUI [1]
C2348568
Exclusion Criteria
Description

Exclusion Criteria

Alias
UMLS CUI
C0680251
use of dopamine agonist medications and other medications in defined timeframe
Description

medication

Data type

boolean

Alias
UMLS CUI [1]
C0013227
unstable dose of cns active therapies (eg, hypnotics, antidepressants, anxiolytics) within the last 30 days
Description

cns medication

Data type

boolean

Alias
UMLS CUI [1]
C0007680
atypical parkinson's syndromes due to drugs, metabolic disorders, encephalitis, or degenerative diseases
Description

atypical parkinson

Data type

boolean

Alias
UMLS CUI [1]
C1868596
dementia
Description

dementia

Data type

boolean

Alias
UMLS CUI [1]
C0497327
history of active epilepsy within the past year
Description

epilepsy

Data type

boolean

Alias
UMLS CUI [1]
C0014544
significant liver disease with defined laboratory criteria
Description

liver diseases

Data type

boolean

Alias
UMLS CUI [1]
C0023895
significant renal disease with defined laboratory criteria
Description

kidney diseases

Data type

boolean

Alias
UMLS CUI [1]
C0022658
certain cardiac conditions
Description

heart diseases

Data type

boolean

Alias
UMLS CUI [1]
C0018799
electroconvulsive therapy in the previous 90 days
Description

electroconvulsive therapy

Data type

boolean

Alias
UMLS CUI [1]
C0013806
subjects participating in other drug studies or receiving other investigational drugs within previous 30 days
Description

study subject participation status

Data type

boolean

Alias
UMLS CUI [1]
C2348568
positive pregnancy test at screen
Description

pregnancy test

Data type

boolean

Alias
UMLS CUI [1]
C0032976
unwillingness to use adequate contraceptive methods
Description

contraception

Data type

boolean

Alias
UMLS CUI [1]
C0700589
lactating women
Description

lactation

Data type

boolean

Alias
UMLS CUI [1]
C0006147
history of stereotaxic brain surgery
Description

radiotherapy

Data type

boolean

Alias
UMLS CUI [1]
C1522449
malignant melanoma or history of treated melanoma
Description

melanoma

Data type

boolean

Alias
UMLS CUI [1]
C0025202

Similar models

Eligibility Parkinson Disease NCT00036205

Name
Type
Description | Question | Decode (Coded Value)
Data type
Alias
Item Group
C1512693 (UMLS CUI)
idiopathic parkinson
Item
idiopathic parkinson's disease
boolean
C0030567 (UMLS CUI [1,1])
C0332240 (UMLS CUI [1,2])
disease stage
Item
modified hoehn and yahr scale stages 1-4
boolean
C0699749 (UMLS CUI [1])
age
Item
age over 30 years
boolean
C0001779 (UMLS CUI [1])
study subject participation status
Item
previous participation in prior sumanirole studies
boolean
C2348568 (UMLS CUI [1])
Item Group
C0680251 (UMLS CUI)
medication
Item
use of dopamine agonist medications and other medications in defined timeframe
boolean
C0013227 (UMLS CUI [1])
cns medication
Item
unstable dose of cns active therapies (eg, hypnotics, antidepressants, anxiolytics) within the last 30 days
boolean
C0007680 (UMLS CUI [1])
atypical parkinson
Item
atypical parkinson's syndromes due to drugs, metabolic disorders, encephalitis, or degenerative diseases
boolean
C1868596 (UMLS CUI [1])
dementia
Item
dementia
boolean
C0497327 (UMLS CUI [1])
epilepsy
Item
history of active epilepsy within the past year
boolean
C0014544 (UMLS CUI [1])
liver diseases
Item
significant liver disease with defined laboratory criteria
boolean
C0023895 (UMLS CUI [1])
kidney diseases
Item
significant renal disease with defined laboratory criteria
boolean
C0022658 (UMLS CUI [1])
heart diseases
Item
certain cardiac conditions
boolean
C0018799 (UMLS CUI [1])
electroconvulsive therapy
Item
electroconvulsive therapy in the previous 90 days
boolean
C0013806 (UMLS CUI [1])
study subject participation status
Item
subjects participating in other drug studies or receiving other investigational drugs within previous 30 days
boolean
C2348568 (UMLS CUI [1])
pregnancy test
Item
positive pregnancy test at screen
boolean
C0032976 (UMLS CUI [1])
contraception
Item
unwillingness to use adequate contraceptive methods
boolean
C0700589 (UMLS CUI [1])
lactation
Item
lactating women
boolean
C0006147 (UMLS CUI [1])
radiotherapy
Item
history of stereotaxic brain surgery
boolean
C1522449 (UMLS CUI [1])
melanoma
Item
malignant melanoma or history of treated melanoma
boolean
C0025202 (UMLS CUI [1])

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