ID

22157

Description

Parcopa Versus Carbidopa-Levodopa in a Single Dose Cross-Over Comparison Study; ODM derived from: https://clinicaltrials.gov/show/NCT00590122

Link

https://clinicaltrials.gov/show/NCT00590122

Keywords

  1. 5/21/17 5/21/17 -
Uploaded on

May 21, 2017

DOI

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License

Creative Commons BY 4.0

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Eligibility Parkinson's Disease NCT00590122

Eligibility Parkinson's Disease NCT00590122

Inclusion Criteria
Description

Inclusion Criteria

Alias
UMLS CUI
C1512693
male or female between the age of 31 and 80 -diagnosis of idiopathic parkinson's disease for at least three years duration
Description

gender, age, parkinson

Data type

boolean

Alias
UMLS CUI [1]
C0079399
UMLS CUI [2]
C0001779
UMLS CUI [3]
C0030567
patients requiring levodopa for their pd
Description

levodopa

Data type

boolean

Alias
UMLS CUI [1]
C0023570
good subjective response to levodopa
Description

levodopa response

Data type

boolean

Alias
UMLS CUI [1,1]
C0023570
UMLS CUI [1,2]
C1704632
fluctuating symptoms defined by wearing off phenomenon, any dyskinesia, and/or dose failures
Description

parkinson symptoms

Data type

boolean

Alias
UMLS CUI [1,1]
C0030567
UMLS CUI [1,2]
C1457887
a updrs -off- motor score of at least 25
Description

updrs

Data type

boolean

Alias
UMLS CUI [1]
C3639721
subjects willing to give informed consent
Description

informed consent

Data type

boolean

Alias
UMLS CUI [1]
C0021430
subjects who are able and willing to comply with study procedures
Description

compliance

Data type

boolean

Alias
UMLS CUI [1]
C1321605
if female of child-bearing potential, will use one of the approved birth control measures:
Description

birth control

Data type

boolean

Alias
UMLS CUI [1]
C0700589
1. hormonal contraceptives
Description

hormonal contraceptives

Data type

boolean

Alias
UMLS CUI [1]
C0009907
2. spermicidal and barrier
Description

spermicidal, barrier

Data type

boolean

Alias
UMLS CUI [1]
C0037862
UMLS CUI [2]
C0004764
3. intrauterine device
Description

intrauterine device

Data type

boolean

Alias
UMLS CUI [1]
C0021900
4. partner sterility
Description

partner infertility

Data type

boolean

Alias
UMLS CUI [1,1]
C0021359
UMLS CUI [1,2]
C0682323
Exclusion Criteria
Description

Exclusion Criteria

Alias
UMLS CUI
C0680251
subjects with evidence of significant dementia
Description

dementia

Data type

boolean

Alias
UMLS CUI [1]
C0497327
subjects with significant oral lesions
Description

oral lesions

Data type

boolean

Alias
UMLS CUI [1]
C0026636
history of unstable cardiac disease including angina or congestive heart failure within 3 months prior to study entry
Description

cardiac disease

Data type

boolean

Alias
UMLS CUI [1]
C0018799
history of clinically significant renal disease including renal insufficiency of sufficient degree to require adjunctive treatment or dietary restrictions
Description

renal disease

Data type

boolean

Alias
UMLS CUI [1]
C0022658
history of clinically significant hepatic disease, including previously documented cirrhosis or hepatic insufficiency or jaundice within 3 months prior to study entry.
Description

hepatic disease

Data type

boolean

Alias
UMLS CUI [1]
C0023895
subjects with poor response to levodopa
Description

levodopa response

Data type

boolean

Alias
UMLS CUI [1,1]
C0023570
UMLS CUI [1,2]
C1704632
women who are pregnant, breast-feeding, or planning to become pregnant during this study are excluded from participation due to unknown effects of the study drug on the fetus.
Description

pregnancy, breast feeding

Data type

boolean

Alias
UMLS CUI [1]
C0032961
UMLS CUI [2]
C0006147

Similar models

Eligibility Parkinson's Disease NCT00590122

Name
Type
Description | Question | Decode (Coded Value)
Data type
Alias
Item Group
C1512693 (UMLS CUI)
gender, age, parkinson
Item
male or female between the age of 31 and 80 -diagnosis of idiopathic parkinson's disease for at least three years duration
boolean
C0079399 (UMLS CUI [1])
C0001779 (UMLS CUI [2])
C0030567 (UMLS CUI [3])
levodopa
Item
patients requiring levodopa for their pd
boolean
C0023570 (UMLS CUI [1])
levodopa response
Item
good subjective response to levodopa
boolean
C0023570 (UMLS CUI [1,1])
C1704632 (UMLS CUI [1,2])
parkinson symptoms
Item
fluctuating symptoms defined by wearing off phenomenon, any dyskinesia, and/or dose failures
boolean
C0030567 (UMLS CUI [1,1])
C1457887 (UMLS CUI [1,2])
updrs
Item
a updrs -off- motor score of at least 25
boolean
C3639721 (UMLS CUI [1])
informed consent
Item
subjects willing to give informed consent
boolean
C0021430 (UMLS CUI [1])
compliance
Item
subjects who are able and willing to comply with study procedures
boolean
C1321605 (UMLS CUI [1])
birth control
Item
if female of child-bearing potential, will use one of the approved birth control measures:
boolean
C0700589 (UMLS CUI [1])
hormonal contraceptives
Item
1. hormonal contraceptives
boolean
C0009907 (UMLS CUI [1])
spermicidal, barrier
Item
2. spermicidal and barrier
boolean
C0037862 (UMLS CUI [1])
C0004764 (UMLS CUI [2])
intrauterine device
Item
3. intrauterine device
boolean
C0021900 (UMLS CUI [1])
partner infertility
Item
4. partner sterility
boolean
C0021359 (UMLS CUI [1,1])
C0682323 (UMLS CUI [1,2])
Item Group
C0680251 (UMLS CUI)
dementia
Item
subjects with evidence of significant dementia
boolean
C0497327 (UMLS CUI [1])
oral lesions
Item
subjects with significant oral lesions
boolean
C0026636 (UMLS CUI [1])
cardiac disease
Item
history of unstable cardiac disease including angina or congestive heart failure within 3 months prior to study entry
boolean
C0018799 (UMLS CUI [1])
renal disease
Item
history of clinically significant renal disease including renal insufficiency of sufficient degree to require adjunctive treatment or dietary restrictions
boolean
C0022658 (UMLS CUI [1])
hepatic disease
Item
history of clinically significant hepatic disease, including previously documented cirrhosis or hepatic insufficiency or jaundice within 3 months prior to study entry.
boolean
C0023895 (UMLS CUI [1])
levodopa response
Item
subjects with poor response to levodopa
boolean
C0023570 (UMLS CUI [1,1])
C1704632 (UMLS CUI [1,2])
pregnancy, breast feeding
Item
women who are pregnant, breast-feeding, or planning to become pregnant during this study are excluded from participation due to unknown effects of the study drug on the fetus.
boolean
C0032961 (UMLS CUI [1])
C0006147 (UMLS CUI [2])

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