ID

13080

Description

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

Lien

https://clinicaltrials.gov/show/NCT02233023

Mots-clés

  1. 15/01/2016 15/01/2016 -
Détendeur de droits

CC BY-NC 3.0

Téléchargé le

15 janvier 2016

DOI

Pour une demande vous connecter.

Licence

Creative Commons BY-NC 3.0

Modèle Commentaires :

Ici, vous pouvez faire des commentaires sur le modèle. À partir des bulles de texte, vous pouvez laisser des commentaires spécifiques sur les groupes Item et les Item.

Groupe Item commentaires pour :

Item commentaires pour :

Vous devez être connecté pour pouvoir télécharger des formulaires. Veuillez vous connecter ou s’inscrire gratuitement.

Eligibility Parkinson Disease NCT02233023

Eligibility Parkinson Disease NCT02233023

Inclusion Criteria
Description

Inclusion Criteria

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

parkinson's disease

Type de données

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
Description

parkinson treatment

Type de données

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
Description

informed consent

Type de données

boolean

Alias
UMLS CUI [1]
C0021430
Exclusion Criteria
Description

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)
Description

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

Type de données

boolean

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

ropinirole

Type de données

boolean

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

hereditary retinal disease

Type de données

boolean

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

drug-induced retinopathies

Type de données

boolean

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

diabetic retinopathy

Type de données

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)
Description

atypical parkinsonian syndromes

Type de données

boolean

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

informed consent

Type de données

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
Description

participation in other studies

Type de données

boolean

Alias
UMLS CUI [1]
C2348568

Similar models

Eligibility Parkinson Disease NCT02233023

Name
Type
Description | Question | Decode (Coded Value)
Type de données
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])

Utilisez ce formulaire pour les retours, les questions et les améliorations suggérées.

Les champs marqués d’un * sont obligatoires.

Do you need help on how to use the search function? Please watch the corresponding tutorial video for more details and learn how to use the search function most efficiently.

Watch Tutorial