ID

34047

Descrição

Safety, Tolerability, Pharmacokinetics and Pharmacodynamics of PF-06649751 in Parkinson`s Disease; ODM derived from: https://clinicaltrials.gov/show/NCT02224664

Link

https://clinicaltrials.gov/show/NCT02224664

Palavras-chave

  1. 12/01/2019 12/01/2019 -
Titular dos direitos

See clinicaltrials.gov

Transferido a

12 de janeiro de 2019

DOI

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Licença

Creative Commons BY 4.0

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Eligibility Parkinson`s Disease NCT02224664

Eligibility Parkinson`s Disease NCT02224664

Inclusion Criteria
Descrição

Inclusion Criteria

Alias
UMLS CUI
C1512693
clinical diagnosis of idiopathic parkinson's disease with at least 2 out of 3 cardinal characteristics (tremor, rigidity, bradykinesia)
Descrição

Parkinson Disease | Characteristics Main Quantity | Tremor | Rigidity | Bradykinesia

Tipo de dados

boolean

Alias
UMLS CUI [1]
C0030567
UMLS CUI [2,1]
C1521970
UMLS CUI [2,2]
C1542147
UMLS CUI [2,3]
C1265611
UMLS CUI [3]
C0040822
UMLS CUI [4]
C0026837
UMLS CUI [5]
C0233565
mini-mental state examination (mmse) ≥ 25
Descrição

Mini-mental state examination

Tipo de dados

boolean

Alias
UMLS CUI [1]
C0451306
hoehn & yahr stage i-iii inclusive
Descrição

Hoehn and Yahr Stage

Tipo de dados

boolean

Alias
UMLS CUI [1]
C3639483
documented history of end of l-dopa wearing off
Descrição

End Levodopa Wearing off

Tipo de dados

boolean

Alias
UMLS CUI [1,1]
C2746065
UMLS CUI [1,2]
C0023570
UMLS CUI [1,3]
C1504539
cohort 5 only: history of dyskinesia following l-dopa dosing and score of at least 2 on part iv, item 4.2 (functional impact of dyskinesia) of the mds-updrs
Descrição

Dyskinesia Following Levodopa Dosage | MDS-UPDRS - Functional Impact of Dyskinesias

Tipo de dados

boolean

Alias
UMLS CUI [1,1]
C0013384
UMLS CUI [1,2]
C0332282
UMLS CUI [1,3]
C0023570
UMLS CUI [1,4]
C0178602
UMLS CUI [2]
C3639485
Exclusion Criteria
Descrição

Exclusion Criteria

Alias
UMLS CUI
C0680251
atypical/secondary parkinsonism
Descrição

Atypical Parkinsonism | Secondary Parkinson Disease

Tipo de dados

boolean

Alias
UMLS CUI [1]
C4302185
UMLS CUI [2]
C0030569
history of surgical intervention for parkinson's disease
Descrição

Surgical intervention Parkinson Disease

Tipo de dados

boolean

Alias
UMLS CUI [1,1]
C0549433
UMLS CUI [1,2]
C0030567
dementia/cognitive impairment that can interfere with study assessments
Descrição

Dementia Interferes with Clinical Trial Assessment | Impaired cognition Interferes with Clinical Trial Assessment

Tipo de dados

boolean

Alias
UMLS CUI [1,1]
C0497327
UMLS CUI [1,2]
C0521102
UMLS CUI [1,3]
C0008976
UMLS CUI [1,4]
C1516048
UMLS CUI [2,1]
C0338656
UMLS CUI [2,2]
C0521102
UMLS CUI [2,3]
C0008976
UMLS CUI [2,4]
C1516048

Similar models

Eligibility Parkinson`s Disease NCT02224664

Name
Tipo
Description | Question | Decode (Coded Value)
Tipo de dados
Alias
Item Group
C1512693 (UMLS CUI)
Parkinson Disease | Characteristics Main Quantity | Tremor | Rigidity | Bradykinesia
Item
clinical diagnosis of idiopathic parkinson's disease with at least 2 out of 3 cardinal characteristics (tremor, rigidity, bradykinesia)
boolean
C0030567 (UMLS CUI [1])
C1521970 (UMLS CUI [2,1])
C1542147 (UMLS CUI [2,2])
C1265611 (UMLS CUI [2,3])
C0040822 (UMLS CUI [3])
C0026837 (UMLS CUI [4])
C0233565 (UMLS CUI [5])
Mini-mental state examination
Item
mini-mental state examination (mmse) ≥ 25
boolean
C0451306 (UMLS CUI [1])
Hoehn and Yahr Stage
Item
hoehn & yahr stage i-iii inclusive
boolean
C3639483 (UMLS CUI [1])
End Levodopa Wearing off
Item
documented history of end of l-dopa wearing off
boolean
C2746065 (UMLS CUI [1,1])
C0023570 (UMLS CUI [1,2])
C1504539 (UMLS CUI [1,3])
Dyskinesia Following Levodopa Dosage | MDS-UPDRS - Functional Impact of Dyskinesias
Item
cohort 5 only: history of dyskinesia following l-dopa dosing and score of at least 2 on part iv, item 4.2 (functional impact of dyskinesia) of the mds-updrs
boolean
C0013384 (UMLS CUI [1,1])
C0332282 (UMLS CUI [1,2])
C0023570 (UMLS CUI [1,3])
C0178602 (UMLS CUI [1,4])
C3639485 (UMLS CUI [2])
Item Group
C0680251 (UMLS CUI)
Atypical Parkinsonism | Secondary Parkinson Disease
Item
atypical/secondary parkinsonism
boolean
C4302185 (UMLS CUI [1])
C0030569 (UMLS CUI [2])
Surgical intervention Parkinson Disease
Item
history of surgical intervention for parkinson's disease
boolean
C0549433 (UMLS CUI [1,1])
C0030567 (UMLS CUI [1,2])
Dementia Interferes with Clinical Trial Assessment | Impaired cognition Interferes with Clinical Trial Assessment
Item
dementia/cognitive impairment that can interfere with study assessments
boolean
C0497327 (UMLS CUI [1,1])
C0521102 (UMLS CUI [1,2])
C0008976 (UMLS CUI [1,3])
C1516048 (UMLS CUI [1,4])
C0338656 (UMLS CUI [2,1])
C0521102 (UMLS CUI [2,2])
C0008976 (UMLS CUI [2,3])
C1516048 (UMLS CUI [2,4])

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