ID

13080

Beschrijving

Ophthalmologic Safety of Long Term Treatment With Pramipexole Compared to Bromocriptine or Other Dopamine Agonists in Patients With Parkinson's Disease; ODM derived from: https://clinicaltrials.gov/show/NCT02233023

Link

https://clinicaltrials.gov/show/NCT02233023

Trefwoorden

  1. 15-01-16 15-01-16 -
Houder van rechten

CC BY-NC 3.0

Geüploaded op

15 januari 2016

DOI

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Licentie

Creative Commons BY-NC 3.0

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Eligibility Parkinson Disease NCT02233023

Eligibility Parkinson Disease NCT02233023

Inclusion Criteria
Beschrijving

Inclusion Criteria

Alias
UMLS CUI
C1512693
patients with idiopathic parkinson's disease
Beschrijving

parkinson's disease

Datatype

boolean

Alias
UMLS CUI [1]
C0030567
patients treated consecutively with either pramipexole or bromocriptine (or other dopamine agonists except ropinirole) for at least two and a half years (i.e. 30 months). interruptions of ongoing dopamine agonists treatment for less than one month per year duration are acceptable, however, interruptions within the last 6 months are not acceptable. patients currently participating in ongoing open-label extension trials with pramipexole may be included if they meet the requirement of 30 month treatment
Beschrijving

parkinson treatment

Datatype

boolean

Alias
UMLS CUI [1]
C0074710
UMLS CUI [2]
C0006230
UMLS CUI [3]
C0178601
written informed consent in accordance with good clinical practice (gcp) and local legislation
Beschrijving

informed consent

Datatype

boolean

Alias
UMLS CUI [1]
C0021430
Exclusion Criteria
Beschrijving

Exclusion Criteria

Alias
UMLS CUI
C0680251
patients who have been treated less than two and a half years (i.e. 30 months) with their actual dopamine agonist (regardless of the duration of treatment with a previous dopamine agonist)
Beschrijving

patients who have been treated less than two and a half years (i.e. 30 months) with their actual dopamine agonist

Datatype

boolean

Alias
UMLS CUI [1]
C0178601
patient treated with ropinirole
Beschrijving

ropinirole

Datatype

boolean

Alias
UMLS CUI [1]
C0244821
patients with a hereditary retinal disease and/or a family history of hereditary retinal disease
Beschrijving

hereditary retinal disease

Datatype

boolean

Alias
UMLS CUI [1]
C0035309
patients with a history of drug-induced retinopathies
Beschrijving

drug-induced retinopathies

Datatype

boolean

Alias
UMLS CUI [1]
C0035309
patients with a history of surgically or laser-treated diabetic retinopathy
Beschrijving

diabetic retinopathy

Datatype

boolean

Alias
UMLS CUI [1]
C0011884
patients with atypical parkinsonian syndromes due to drugs, metabolic disorders, encephalitis or degenerative diseases (e.g. progressive, supranuclear palsy, multisystem atrophy)
Beschrijving

atypical parkinsonian syndromes

Datatype

boolean

Alias
UMLS CUI [1]
C1868596
dementia or other disorders that could impair the signing of informed consent
Beschrijving

informed consent

Datatype

boolean

Alias
UMLS CUI [1,1]
C0021430
UMLS CUI [1,2]
C0439801
UMLS CUI [1,3]
C0009488
patients who are participating in other drug studies or who receive other investigational drugs within 30 days prior to the first visit (patients currently participating in ongoing open-label extension trials with pramipexole may be included if they meet the requirement of 30 months treatment duration
Beschrijving

participation in other studies

Datatype

boolean

Alias
UMLS CUI [1]
C2348568

Similar models

Eligibility Parkinson Disease NCT02233023

Name
Type
Description | Question | Decode (Coded Value)
Datatype
Alias
Item Group
C1512693 (UMLS CUI)
parkinson's disease
Item
patients with idiopathic parkinson's disease
boolean
C0030567 (UMLS CUI [1])
parkinson treatment
Item
patients treated consecutively with either pramipexole or bromocriptine (or other dopamine agonists except ropinirole) for at least two and a half years (i.e. 30 months). interruptions of ongoing dopamine agonists treatment for less than one month per year duration are acceptable, however, interruptions within the last 6 months are not acceptable. patients currently participating in ongoing open-label extension trials with pramipexole may be included if they meet the requirement of 30 month treatment
boolean
C0074710 (UMLS CUI [1])
C0006230 (UMLS CUI [2])
C0178601 (UMLS CUI [3])
informed consent
Item
written informed consent in accordance with good clinical practice (gcp) and local legislation
boolean
C0021430 (UMLS CUI [1])
Item Group
C0680251 (UMLS CUI)
patients who have been treated less than two and a half years (i.e. 30 months) with their actual dopamine agonist
Item
patients who have been treated less than two and a half years (i.e. 30 months) with their actual dopamine agonist (regardless of the duration of treatment with a previous dopamine agonist)
boolean
C0178601 (UMLS CUI [1])
ropinirole
Item
patient treated with ropinirole
boolean
C0244821 (UMLS CUI [1])
hereditary retinal disease
Item
patients with a hereditary retinal disease and/or a family history of hereditary retinal disease
boolean
C0035309 (UMLS CUI [1])
drug-induced retinopathies
Item
patients with a history of drug-induced retinopathies
boolean
C0035309 (UMLS CUI [1])
diabetic retinopathy
Item
patients with a history of surgically or laser-treated diabetic retinopathy
boolean
C0011884 (UMLS CUI [1])
atypical parkinsonian syndromes
Item
patients with atypical parkinsonian syndromes due to drugs, metabolic disorders, encephalitis or degenerative diseases (e.g. progressive, supranuclear palsy, multisystem atrophy)
boolean
C1868596 (UMLS CUI [1])
informed consent
Item
dementia or other disorders that could impair the signing of informed consent
boolean
C0021430 (UMLS CUI [1,1])
C0439801 (UMLS CUI [1,2])
C0009488 (UMLS CUI [1,3])
participation in other studies
Item
patients who are participating in other drug studies or who receive other investigational drugs within 30 days prior to the first visit (patients currently participating in ongoing open-label extension trials with pramipexole may be included if they meet the requirement of 30 months treatment duration
boolean
C2348568 (UMLS CUI [1])

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